MX2014011667A - Expandable tissue thickness compensator. - Google Patents

Expandable tissue thickness compensator.

Info

Publication number
MX2014011667A
MX2014011667A MX2014011667A MX2014011667A MX2014011667A MX 2014011667 A MX2014011667 A MX 2014011667A MX 2014011667 A MX2014011667 A MX 2014011667A MX 2014011667 A MX2014011667 A MX 2014011667A MX 2014011667 A MX2014011667 A MX 2014011667A
Authority
MX
Mexico
Prior art keywords
staple
thickness compensator
staples
staple cartridge
view
Prior art date
Application number
MX2014011667A
Other languages
Spanish (es)
Inventor
Chunlin Yang
Christopher W Widenhouse
William B Ii Weisenburgh
Charles J Scheib
Jeffrey L Aldridge
John L Stammen
Mark H Ransick
Stephanie A Mutchler
Gary W Knight
Original Assignee
Ethicon Endo Surgery Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/433,098 external-priority patent/US9301753B2/en
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Publication of MX2014011667A publication Critical patent/MX2014011667A/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0643Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0644Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Abstract

A tissue thickness compensator (70010, 70130, 70150, 70182) may generally comprise a biocompatible material, a first component (70010A), and a second component (70010B), wherein the first component and second component form a reaction product to expand the tissue thickness compensator. The first component may comprise a first hydrogel precursor, the second component may comprise a second hydrogel precursor, and the reaction product may comprise a hydrogel. The reaction product may be formed in vivo and/or in situ by contacting the first component and the second component. The first component and/or second component may be encapsulated and configured to release the components when ruptured. The reaction product may comprise a fluid-swcllablc composition. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.

Description

EXPANSIBLE TISSUE THICKNESS COMPENSATOR CROSS REFERENCE WITH RELATED REQUESTS This non-provisional patent application is a partial continuation request in accordance with 35 U.S.C. § 120 of the Patent Application of E.U.A. Serial No. 13 / 097.891, entitled "Tissue Thickness Compensator For A Surgical Stapler Comprising An Adjustable Anvil" filed on April 29, 2011, which is a continuation in part application under 35 USC § 120 of the Patent Application No. 12 / 894,377, entitled "Selectively Orientable Implantable Fastener Cartridge", filed September 30, 2010, the complete descriptions of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION The present invention relates to surgical instruments and surgical cutting and stapling instruments and staple cartridges for these which are designed to cut and staple tissues.
BRIEF DESCRIPTION OF THE INVENTION The following is a non-exhaustive list of the embodiments of the present invention that can be claimed or claimed. 1. A tissue thickness compensator comprising: a biocompatible material; a first component; Y a second component; wherein the first component and the second component are adapted to form a reaction product to expand the tissue thickness compensator. 2. The tissue thickness compensator of Modality 1, further comprising an encapsulated component comprising one of the first component and the second component, wherein the other of the first component and the second component is incorporated into the biocompatible material. 3. The tissue thickness compensator of Modality 1, wherein the first component comprises a hydrophilic material incorporated in the biocompatible material and the second component is a body fluid. 4. The tissue thickness compensator of Modality 1, comprising a first encapsulated component comprising the first component and a second encapsulated component comprising the second component. 5. The tissue thickness compensator of Modality 4, wherein the biocompatible material comprises at least one encapsulation comprising the first encapsulated component and the second encapsulated component. 6. The compensator thickness of tissue of Embodiment 4 wherein the first encapsulated component is configured to release the first component when the first encapsulated component is broken, and the second encapsulated component is configured to release the second component when the second encapsulated component break 7. The compensator thickness of tissue of any preceding embodiment, wherein the biocompatible material comprises albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, blood plasma, starch, poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (fosfacina), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polycarbonate, polihidroxietilmetilacrilato, poly (vinylpyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly (amino acid), copoly (ether-ester), polyalkylene oxalate, polyamide, poly (iminocarbonate), polyoxaester, polyorthoester, polyphosphazene or a combination of the above. 8. The tissue thickness compensator of Modality 1, wherein the reaction product is formed in situ upon contacting the first component and the second component. 9. The tissue thickness compensator of any previous embodiment, wherein the reaction product is a fluid swellable composition. 10. The tissue thickness compensator of any one of Modalities 1 and 4 to 9, wherein the first component comprises a first hydrogel precursor, the second component comprises a second hydrogel precursor, and the reaction product comprises a hydrogel. 11. The tissue thickness compensator of any previous embodiment, wherein the first component and the second component are independently selected from albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, blood plasma, starch, poly (lactic acid), poly (glycolic acid), polycarbonate, poly (hydroxybutyrate), poly (phosphazine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polyhydroxyethyl methacrylate, poly (vinylpyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly (amino acid), copoly (ether-ester), polyalkylene oxalate, polyamide, poly (iminocarbonate) ), polyoxaester, polyorthoester, polyphosphazene or a combination of the foregoing. 12. The fabric thickness compensator of any previous embodiment, comprising an outer layer comprising a water impermeable material and an inner layer comprising the material biocompatible and at least one of the first component and the second component. 13. The fabric thickness compensator of Modality 12, wherein the water impermeable material comprises poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide , polycarbonate, polyhydroxyethyl methyl acrylate, poly (vinyl pyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly (amino acid), copolymer (ether ester), polyalkylene oxalate, polyamide, poly (iminocarbonate), polyoxaester, polyorthoester, polyphosphazene or a combination of the foregoing. 14. The fabric thickness compensator of any previous embodiment, wherein the biocompatible material comprises a reinforcing material incorporated therein, and wherein the reinforcing material comprises a mesh, a fiber, a particle, a powder, or a combination of the previous 15. The tissue thickness compensator of Modality 14, wherein the reinforcing material comprises collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, oxy cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan. , alginate, poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polyhydroxyethyl methyl acrylate, polyvinyl pyrrolidone, polyvinyl alcohol, poly (caprolactone), poly (dioxanone) ), polyacrylic acid, polyacetate, polycaprolactone, polypropylene, aliphatic polyester, glycerol, poly (amino acid), copoly (ether ester), polyalkylene oxalate, polyamide, poly (iminocarbonate), polyalkylene oxalate, polyoxaester, polyorthoester, polyphosphazene or a combination of the foregoing. 16. The tissue thickness compensator of any prior embodiment comprising a hemostatic agent, an anti-inflammatory agent, an antibiotic agent, an antimicrobial agent, an anti-adherent agent, an anticoagulant agent, a medicament, a pharmaceutically active agent, or a combination of the foregoing . 17. A selected article of an anvil of a stapling apparatus and a staple cartridge for a stapling apparatus, the article comprising: The tissue thickness compensator of Modality 1, the tissue thickness compensator comprises: an outer layer comprising a non-porous material; an inner layer comprising a porous material, a first encapsulated component comprising said first component and a second encapsulated component comprising said second component. 18. The article in Modality 17, where: the outer layer comprises glycolic acid, polyacid lactic acid, polydioxanone, polyhydroxyalkanoate, polyglecaprona, polycaprolactone, or a combination thereof; the porous material comprises regenerated oxicellulose, the first component comprises a first hydrogel precursor, and the second component comprises a second hydrogel precursor; Y wherein the reaction product is a hydrogel and the first hydrogel precursor and the second hydrogel precursor are adapted to form said hydrogel to expand the tissue thickness compensator when the first encapsulated component and the second encapsulated component are broken. 19. The article of the Modality 17 or Modality 18, wherein the article defines at least part of a staple forming path to be followed by a staple from the cartridge to an anvil or from a cartridge to the anvil as the case may be, and wherein the first and second encapsulated components align with the staple forming path so that a staple following that path pierces or otherwise breaks the encapsulations. 20. A method to form in situ a tissue thickness compensator that expands by using the tissue thickness compensator of the Modality 4, the method comprising: breaking the first encapsulated component and the second encapsulated component to allow the in situ reaction of the first encapsulated component and the second encapsulated component to form said reaction product; wherein the reaction product expands the tissue thickness compensator to compensate for different tissue thicknesses. 21. The method of Modality 20, where: The tissue thickness compensator comprises: an outer layer comprising glycolic polyacid, polyacid lactic acid, polydioxanone, polyhydroxyalkanoate, poiiglecaprona, polycaprolactone, or a combination of the foregoing; Y an inner layer comprising regenerated oxicellulose; the first encapsulated component comprises a first hydrogel precursor; the second encapsulated component comprising a second hydrogel precursor; Y the reaction product comprises a hydrogel.
BRIEF DESCRIPTION OF THE FIGURES The features and advantages of the present invention, as well as the manner of obtaining them, will be more apparent, and the invention itself will be better understood with reference to the following description of the invention taken in conjunction with the accompanying figures, wherein: Figure 1 is a cross-sectional view of one embodiment of a surgical instrument; Figure 1A is a perspective view of one embodiment of an implantable staple cartridge; Figures 1B-1E illustrate portions of an end effector that holds and staples a tissue with an implantable staple cartridge; Figure 2 is a side view in partial cross section of another end effector coupled to a portion of a surgical instrument with the end effector supporting a surgical staple cartridge and with the anvil thereof in an open position; Figure 3 is another side view in partial cross section of the end effector of Figure 2 in a closed position; Figure 4 is another side view in partial cross-section of the end effector of Figures 2 and 3 when the knife bar begins to advance through the end effector; Figure 5 is another side view in partial cross section of the end effector of Figures 2 to 4 with the knife bar partially advanced therethrough; Figure 6 is a perspective view of an alternative embodiment of the staple cartridge installed in a surgical stapling and cutting device; Figure 7 is a top view of the surgical staple cartridge and the elongated channel of the device shown in Figure 6; Figure 8 is a top view of another embodiment of the surgical staple cartridge installed in an elongate channel of an end effector; Figure 9 is a bottom view of an anvil; Figure 10 is a partial perspective view of a plurality of staples forming a portion of a line of staples; Figure 11 is another partial perspective view of the staple line of Figure 10 with staples thereof after being formed on contact with the anvil of the surgical stapling and cutting device; Figure 12 is a partial perspective view of the alternative staples forming a portion of another staple line; Figure 13 is a partial perspective view of the alternative staples forming a portion of another line of staples; Figure 14 is a partial perspective view of the alternative staples forming a portion of another embodiment of a line of staples; Figure 15 is a cross-sectional view of an end effector supporting a staple cartridge; Figure 16 is a cross-sectional view of the elongated channel portion of the end effector of Figure 15 after the body portion of the implantable staple cartridge and staples have been removed therefrom; Figure 17 is a cross-sectional view of an end effector supporting another staple cartridge; Figures 18A to 18D graphically depict the deformation of a surgical staple positioned within a body of a foldable staple cartridge according to at least one embodiment; Figure 1QA is a diagram illustrating a staple positioned in a crushable staple cartridge body; Figure 1QB is a diagram illustrating the collapsible staple cartridge body of Figure 19A being crushed by an anvil; Figure 19C is a diagram illustrating the collapsible staple cartridge body of Figure 19A that is further crushed by the anvil; Figure 19D is a diagram illustrating the clip of Figure 19A in a fully formed configuration and the collapsible staple cartridge of Figure 19A in a fully collapsed state; Figure 20 is a diagram showing a staple positioned against a staple cartridge support surface and illustrating the potential relative movement between them; Figure 21 is a cross-sectional view of a staple cartridge support surface comprising a slot, or channel, configured to stabilize the staple base of Figure 20; Figure 22 is a cross-sectional view of a staple comprising an overmolded crown and a groove, or channel, configured to receive a portion of the crown in accordance with at least an alternative modality; Figure 23 is a top view of a staple cartridge according to at least one embodiment comprising staples incorporated in a body of the staple cartridge staple; Figure 24 is an elevation view of the staple cartridge of Figure 23; Figure 25 is an elevation view of a staple cartridge according to at least one embodiment comprising a protective layer surrounding the staples positioned within a body of the staple staple cartridge; Figure 26 is a cross-sectional view of the staple cartridge of Figure 25 taken along line 26-26 in Figure 25; Figure 27 is an elevation view of a staple cartridge according to at least one embodiment comprising staples that extend at least partially outside a body of the staple cartridge staple and a protective layer surrounding the body of the staple cartridge. staples; Figure 28 is a cross-sectional view of the staple cartridge of Figure 27 taken along line 28-28 in Figure 27; Figure 29 is a partial fragmentary view of a staple cartridge according to at least one embodiment comprising staples at least partially incorporated in a body of the staple cartridge staples, staples that are at least partially positioned in a vacuum of the staple cartridge. staple pocket in the body of the staple cartridge; Figure 30 is a cross-sectional view of the staple cartridge of Figure 29 taken along line 30-30 in Figure 29; Figure 31 is a partial fractional view of a staple cartridge according to at least one embodiment; Figure 32 is a partial fractional view of a staple cartridge according to at least one embodiment comprising staples at least partially incorporated within a collapsible staple cartridge body and an alignment die connecting the staples and aligning staples with respect to each other; Figure 33 is a cross-sectional view of the staple cartridge of Figure 32 taken along line 33-33 in Figure 32; Figure 34 is a partial sectional view of an inner layer of a compressible staple cartridge body; Figure 35 is a diagram illustrating the inner layer of Figure 34 compressed between a transfer plate and a support plate; Figure 36 is a diagram illustrating staples that are inserted into the compressed inner layer of Figure 35; Figure 37 is a diagram of the support plate of Figure 35 that is removed from the inner layer; Figure 38 is a diagram of a subunit comprising the inner layer of Figure 34 and the staples of Figure 36 that are inserted into an outer layer; Figure 39 is a diagram illustrating the outer layer of Figure 38 which is sealed to form a sealed staple cartridge; Figure 40 is a cross-sectional view of the sealed staple cartridge of Figure 39; Figure 41 is a cross-sectional view of a staple cartridge and the staple cartridge channel according to at least one embodiment; Figure 42 is a diagram illustrating a portion of the staple cartridge of Figure 41 in a deformed state; Figure 43 is an elevation view of an end effector of a surgical stapler comprising an anvil in an open position and a staple cartridge positioned within a channel of the staple cartridge; Figure 44 is an elevation view of the end effector of Figure 43 illustrating the anvil in a closed position and the staple cartridge compressed between the anvil and the staple cartridge channel; Figure 45 is an elevation view of the end effector of Figure 43 illustrating the staple cartridge of Figure 43 positioned within the staple cartridge channel in an alternative manner; Figure 46 is a cross-sectional view of an end effector of a surgical stapler comprising a compressible staple cartridge positioned within a staple cartridge channel and a piece of reinforcement material coupled to an anvil; Figure 47 is a cross-sectional view of the end effector of Figure 46 illustrating the anvil in a closed position; Figure 48 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a water impermeable layer; Figure 49 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler; Figure 50 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a stepped anvil and a staple cartridge comprising a stepped cartridge body; Figure 51 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler; Figure 52 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising inclined tissue contacting surfaces; Figure 53 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler comprising inclined tissue contacting surfaces; Figure 54 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a support piece configured to support a staple cartridge; Figure 55 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a plurality of compressible layers; Figure 56 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a compressible stepped cartridge body; Figure 57 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a compressible stepped cartridge body; Figure 58 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a contact surface with the curved tissue; Figure 59 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge having a contact surface with the tissue tilted; Figure 60 is a cross-sectional view of a compressible staple cartridge comprising the staples and at least one medicament stored thereon; Figure 61 is a diagram illustrating the compressible staple cartridge of Figure 60 after it has been compressed and the staples contained therein have been deformed; Figure 62 is a partial sectional view of a staple cartridge according to at least one embodiment; Figure 63 is a cross-sectional view of the staple cartridge of Figure 62; Figure 64 is a perspective view of a staple cartridge implanted in accordance with at least one alternative embodiment; Figure 65 is a cross-sectional view of the implanted staple cartridge of Figure 64; Figure 66 is a perspective view of an alternative embodiment of a staple cartridge comprising deformable members extending from an outer layer of the staple cartridge; Figure 67 is a perspective view of an alternative embodiment of a staple cartridge comprising an outer layer of the staple cartridge that is assembled to an inner layer; Figure 68 is a cross-sectional view of an alternative embodiment of a staple cartridge comprising a plurality of staples, a compressible layer, and a compress layer; Figure 69 is a perspective view of the ply layer of Figure 68; Figure 70 is a perspective view of a napkin individualized from the ply layer of Figure 68 and a staple aligned with a slot in the napkin; Figure 71 is a perspective view of two compresses connected from the ply layer of Figure 68; Figure 72 is a perspective view of a napkin support frame of the napkin layer of Figure 68 that is removed from the individual napkins; Figure 73 is a diagrammatic perspective view of an alternative embodiment of a compressible staple cartridge comprising staples therein and a system for driving the staples against an anvil; Figure 73A is a partial sectional view of an alternative embodiment of the staple cartridge of Figure 73; Figure 74 is a cross-sectional view of the staple cartridge of Figure 73; Figure 75 is an elevation view of a slider configured to traverse the staple cartridge of Figure 73 and move the staples towards the anvil; Figure 76 is a diagram of a staple driver that can be raised toward the anvil by the slider of Figure 75; Figure 77 is a fractional view of a staple cartridge according to at least one alternative embodiment comprising staples positioned within the staple drivers; Figure 78 is a cross-sectional view of the staple cartridge of Figure 77 positioned within a channel of the staple cartridge; Figure 79 is a cross-sectional view of the staple cartridge of Figure 77 illustrating an anvil displaced to a closed position and the staples contained within the staple cartridge deformed by the anvil; Figure 80 is a cross-sectional view of the staple cartridge of Figure 77 illustrating staples moved upward toward the anvil; Figure 81 is a perspective view of an alternative embodiment of a staple cartridge comprising belts connecting the flexible sides of the staple cartridge; Figure 82 is a perspective view of a slider and a unit of the cutting member; Figure 83 is a diagram of the slider and the cutting member unit of Figure 82 that are used to lift the staples of the staple cartridge of Figure 77; Figure 84 is a diagram illustrating a slider configured to engage and raise the staples toward an anvil and a locking system configured to selectively allow the slider to move distally; Figures 85A to 85C illustrate the progression of a staple that is inserted within a crown of the staple; Figure 86 is a cross-sectional view of a staple cartridge comprising a support tray or retainer; Figure 87 is a partial cross-sectional view of a compressible staple cartridge according to at least one alternative embodiment; Figure 88 is a diagram illustrating the staple cartridge of Figure 87 in an implanted state; Figure 89 is a partial sectional view of a compressible staple cartridge according to at least one alternative embodiment; Figure 90 is a partial cross-sectional view of the staple cartridge of Figure 89; Figure 91 is a diagram illustrating the staple cartridge of Figure 89 in an implanted state; Figure 92 is a partial cross-sectional view of a collapsible staple cartridge according to at least one alternative embodiment; Figure 93 is a partial sectional view of a foldable staple cartridge according to at least one embodiment comprising a plurality of collapsible elements; Figure 94 is a perspective view of a foldable element of Figure 93 in an unfolded state; Figure 95 is a perspective view of the foldable element of Figure 94 in a folded state; Figure 96A is a partial cross-sectional view of an end effector of a surgical stapling instrument comprising a clamp, a staple cartridge channel positioned opposite the clamp, and a staple cartridge positioned within the cartridge channel of the staple cartridge. staples, wherein the clamp comprises a retainer matrix attached thereto; Figure 96B is a partial cross-sectional view of the end effector of Figure 96A illustrating the clamp moving towards the staple cartridge channel, the staple cartridge being compressed by the anvil and the retainer matrix, and a staple extending at least partially through the tissue positioned intermediate the retention die and the staple cartridge; Figure 96C is a partial cross-sectional view of the end effector of Figure 96A illustrating the clamp in a final position and the retention die coupled with the staple of Figure 96B; Figure 96D is a partial cross-sectional view of the end effector of Figure 96A illustrating the clamp and staple cartridge channel moving away from the implanted staple cartridge and the retainer matrix; Figure 97 is a perspective view of a retention opening of a retention die according to at least one alternative embodiment comprising a plurality of retention members. retainer configured to engage a clamping leg extending therethrough; Figure 98 is a perspective view of a retaining opening of a retention die according to at least one alternative embodiment comprising six retention members; Figure 99 is a perspective view of a retaining opening of a retention die according to at least one alternative embodiment comprising eight retention members; Figure 100 is a perspective view of a retaining opening of a retention die according to at least one alternative embodiment comprising a plurality of retention members configured to engage a clamping leg extending therethrough; Figure 101 is a perspective view of a retaining opening of a retention die according to at least one alternative embodiment comprising six retention members; Figure 102 is a perspective view of a retaining opening of a retention die according to at least one alternative embodiment comprising eight retention members; Figure 103 is a perspective view of a retention opening of a retention die according to at least one alternative embodiment comprising a plurality of retention members that have been stamped from a sheet of metal; Figure 104 is a perspective view of a retention opening of a retention die according to at least one alternative embodiment comprising a plurality of openings extending around the perimeter of the retention opening; Figure 105 is a top view of a retaining opening of a retention die according to at least one alternative embodiment; Figure 106 is a top view of a retaining opening of a retention die according to at least one alternative embodiment; Figure 107 is a top view of a retaining opening of a retention die according to at least one alternative embodiment; Figure 108 is a top view of a retaining opening of a retention die according to at least one alternative embodiment; Figure 109 is a top view of a retaining opening of a retention die according to at least one alternative embodiment; Figure 110 is a top view of a retaining opening of a retention die comprising a retention tab extending toward the retention opening according to at least one embodiment; Figure 111 is a top view of a retaining opening of a retention die comprising a retention tab extending in the retention opening according to at least one alternative embodiment; Figure 112 is a perspective view of a fastening system comprising a plurality of staples, a retaining die coupled with the staples, and an alignment die configured to align the staples; Figure 113 is a perspective view of the retention matrix of Figure 112; Figure 114 is a perspective view of the alignment matrix of Figure 112; Figure 115 is a partial top view of the retention die of Figure 112 coupled with the staples of Figure 112; Figure 116 is a partial bottom view of the retention die of Figure 112 coupled with the staples of Figure 112; Figure 117 is a partial elevation view of the fastening system of Figure 112; Figure 118 is a perspective view of the fastening system of Figure 112; Figure 119 is a partial cross-sectional view of the retention matrix of Figure 112 coupled with the staples of Figure 112; Figure 120 is a partial cross-sectional view of the fastening system of Figure 112; Figure 121 is a perspective view of the fastening system of Figure 112 which further comprises protective caps assembled to the legs of the staples; Figure 122 is a bottom perspective view of the arrangement of the fastening system of Figure 121; Figure 123 is a partial perspective view of the arrangement of the fastening system of Figure 121; Figure 124 is a partial cross-sectional view of the arrangement of the fastening system of Figure 121; Figure 125 is an elevation view of an end effector according to at least one embodiment comprising a clamp in an open position, a retainer matrix and a plurality of protective caps positioned in the clamp, and a staple cartridge positioned in a channel of the staple cartridge; Figure 126 is an elevation view of the end effector of Figure 125 in a closed position; Figure 127 is an elevation view of the end effector of Figure 125 in a triggered position; Figure 128 is an elevation view of the retainer matrix and the protective caps of Figure 125 assembled to the staple cartridge of Figure 125; Figure 129 is a detailed view of the arrangement of Figure 128; Figure 130 is an elevational view of the end effector of Figure 125 illustrating the clamp in an open position with the thinnest tissue positioned between the retainer matrix and the staple cartridge; Figure 131 is an elevation view of the end effector of Figure 125 illustrating the clamp in a closed position against the thinner tissue of Figure 130; Figure 132 is an elevation view of the end effector of Figure 125 illustrating the clamp in a fired position to capture the thinner tissue of Figure 130 between the retainer die and the staple cartridge; Figure 133 is an elevation view of the retainer matrix and the protective caps of Figure 125 assembled to the staple cartridge of Figure 125 with the thin fabric of Figure 130 positioned therebetween; Figure 134 is a detailed view of the arrangement of Figure 133; Figure 135 is a cross-sectional view of a protective cap positioned on the tip of a staple leg according to at least one alternative embodiment; Figure 136 is a perspective view of a plurality of protective caps incorporated within a sheet of material; Figure 137 is a perspective view of a clamp comprising a plurality of recesses configured to receive a plurality of protective caps thereon; Figure 138 is a detailed view of a portion of a clamp comprising a sheet covering the protective caps located within the clamp of Figure 137; Figure 139 is a cross-sectional view of a protective cap positioned on a tip of a staple leg according to at least one alternative embodiment, wherein the protective cap comprises an interior shaping surface; Figure 140 is another cross-sectional view of the protective cap of Figure 139 illustrating the staple leg deforming against the shaping surface; Figure 141 is a top view of an alternative embodiment of a retention matrix comprising a plurality of connected elements of the matrix; Figure 142 is a top view of an alternative embodiment of a retention matrix comprising a plurality of elements of the array connected; Figure 143 is a top view of an alternative embodiment of a retention matrix comprising a plurality of elements of the array connected; Figure 144 is a top view of an alternative embodiment of a set of retention matrices comprising a plurality of connected array elements; Figure 145 is a top view of an alternative embodiment of a retention matrix comprising a plurality of connected array elements; Figure 146 is a partial diagrammatic view of a clamp comprising a retention die including a compressible coating; Figure 147 is a detailed view of the retention matrix of Figure 146; Figure 148 is a partial cross-sectional view of a fastening system comprising a retention matrix including a compressible layer and a plurality of cells encapsulating one or more medications; Figure 149 is a diagram illustrating the staple legs that have pierced the cells of Figure 148 as they engage the retention die; Figure 150 is a partial cross-sectional view of a fastening system comprising a retention die including a compressible layer; Figure 151 is an elevation view of an insertion unit of the clamping cartridge comprising a support, a first clamping cartridge, and a second clamping cartridge; Figure 152 is an elevation view of an end effector of a surgical stapler comprising a first clamp and a second clamp, the second clamp being illustrated in an open configuration; Figure 153 is an elevation view of the end effector of Figure 152 illustrating the second clamp in a closed configuration and the clamping cartridge insertion unit of Figure 151 which is used to load the first clamp with the first cartridge and the second clamp with the second cartridge; Figure 154 is an elevation view of the loaded end effector of Figure 153 illustrating the cartridge insertion unit removed from the end effector, the second clamp in an open configuration once again, and the tissue positioned between the first clamp and the second clamp; Figure 155 is an elevation view of the charged end effector of Figure 154 in a triggered configuration; Figure 156 is an elevation view of the first cartridge and the second cartridge in an implanted state; Figure 157 is an elevation view of the end effector of Figure 152 illustrating a portion of the first cartridge still engaged with the first clip according to at least one embodiment; Figure 158 is an elevation view of an alternative embodiment of a clamping cartridge insertion unit comprising a support, a first clamping cartridge, and a second clamping cartridge; Figure 159 is an elevation view of the insertion unit of the clamping cartridge of Figure 158 which is used to load a first clamp of an end effector with the first cartridge and a second clamp with the second cartridge; Figure 160 is a cross-sectional view of the charged end effector of Figure 159; Figure 161 is a perspective view of a surgical stapler comprising a lower clamp and an upper clamp according to at least one embodiment illustrated with portions of the surgical stapler removed; Figure 162 is a perspective view of the surgical stapler of Figure 161 with the upper clamp removed; Figure 163 is a perspective view of a slidable anvil system of the upper clamp of the surgical stapler of Figure 161 comprising a first slidable anvil and a second slidable anvil; Figure 164 is a terminal view of the sliding anvil system of Figure 163; Figure 165 is a top view of the sliding anvil system of Figure 163; Figure 166 is a diagram illustrating the sliding anvil system of Figure 163 in an un-fired state; Figure 167 is a diagram illustrating the first slidable anvil of the sliding anvil system of Figure 163 in an un-fired position and the clips positioned within the clamp lower in an undeployed position; Figure 168 is a diagram illustrating the staples in the lower bracket in an unfolded configuration and the first slide anvil in Figure 167 that is pulled proximally to deform a first group of staple legs of the staples; Figure 169 is a diagram illustrating the first group of staples of Figure 168 deformed to a fully deformed state; Figure 170 is a diagram illustrating the second slidable anvil of the sliding anvil system of Figure 163 that is pushed distally to deform a second group of staple legs; Figure 171 is a partial perspective view of an anvil comprising a plurality of shaping cavities in at least one embodiment; Figure 172 is a cross-sectional terminal view of Figure 171; Figure 173 is a diagram illustrating a first step in the manufacture of the shaping cavities of Figure 171; Figure 174 is a diagram illustrating a second step in the manufacture of the shaping cavities of Figure 171; Figure 175 is a top view of the arrangement of anvil shaping cavities of Figure 171; Figure 176 is a diagram illustrating a first step of a manufacturing process for producing an anvil; Figure 177 is a diagram illustrating a second step in the manufacturing process of Figure 176; Figure 178 is a diagram illustrating a third step in the manufacturing process of Figure 176; Figure 179 is a left front perspective view of a surgical stapling and cutting instrument with a handle portion including an automatic retraction triggered by a joint and a manual ratchet retraction mechanism; Figure 180 is a right rear perspective view of the surgical stapling and cutting instrument of Figure 179 with a portion of an elongate shank cut off and a cover of the right half of a handle housing removed to expose a displacement retraction mechanism end of automatic trigger and a manual trigger retraction mechanism; Figure 181 is a right rear disassembled perspective view of the handle portion and an elongated stem of the surgical stapling and cutting instrument of Figure 179; Figure 182 is a right rear perspective view of the surgical stapling and cutting instrument of Figure 31 with a cover of the right half and outer portions of the implement portion removed to expose the closing and firing mechanisms in an initial state; Figure 183 is a right side elevational view of the partially disassembled surgical stapling and cutting instrument of Figure 182; Figure 184 is a right rear perspective view of the partially disassembled surgical stapling and cutting instrument of Figure 182 with a closed and clamped locking mechanism and the lateral ratchet firing mechanism completing a first displacement and with a retraction mechanism manual removed to expose a distal union of the junction zipper that triggers the automatic retraction of the firing mechanism; Figure 185 is a right rear perspective view of the partially disassembled surgical stapling and cutting instrument of Figure 183 with the uncoupled side ratchet firing mechanism and the distal joint approaching automatic retraction; Figure 186 is a left side elevational view of the partially disassembled surgical stapling and cutting instrument of Figure 183 in an initial state of the open end effector and an attached anti-return mechanism; Figure 187 is a left side detailed view of the cover of the right half and an anti-reverse release lever of the handle portion of Figure 186; Figure 188 is a detailed left side elevational view of the surgical stapling and cutting instrument disassembled from the Figure 179 with the closing trigger held, the firing trigger making a final displacement and the distal union positioned to trigger automatic retraction; Figure 189 is a left lateral detail in elevation of the cutting and surgical stapling instrument removed from Figure 188 immediately after the distal joint has driven and locked forward the anti-return release lever, which allows the union rack to retract; Figure 190 is a disassembled right perspective view of the intermediate and rear gears and the manual retraction lever and ratchet of a manual retraction mechanism of the surgical stapling and cutting instrument of Figure 179; Figure 191 is a right perspective view of the manual retraction mechanism of Figure 190 with the manual retraction lever partially cut to expose a smaller diameter ratchet gear in the rear engaging engagement of the pawl; Figure 192 is a left side view partially disassembled in elevation of a surgical stapling and cutting instrument of Figure 179 with the backstop mechanism coupled to a fully fired link rack that is disconnected from a tension / compression combination spring prior to the activation of the manual retraction lever of Figure 190; Figure 193 is a left side view partly disassembled in elevation from the surgical stapling and cutting instrument of Figure 192 with the hidden portions of the anti-kickback release lever, the rear gear, and the manual release release lever shown in lines of strokes; Figure 194 is a left side view partially disassembled in elevation of the surgical stapling and cutting instrument of Figure 193 after activation of the manual release release lever has manually retracted the joint rack; Figure 195 is a left side view partially disassembled in elevation of the surgical stapling and cutting instrument of Figure 194 with the joint zipper omitted, representing the manual release release lever disengaging the backstop mechanism; Figure 196 is a left side detailed view of an alternative backstop release lever and a handle housing for the surgical stapling and cutting instrument of Figure 179; Figure 197 is a disassembled left perspective view of the reciprocating backstop release lever, the rear gear shaft, and the automatic retraction cam wheel of Figure 196; Figure 198 is a right side elevational view of the reciprocating backstop release mechanism of Figure 196 with the attachment rack in a retracted position and the release lever of anti-reverse positioned proximally with the anti-reverse plate coupled to the firing rod; Figure 1Q8A is a detailed right side view on rear gear elevation, the auto-retract cam wheel and the most distal junction of Figure 198; Figure 199 is a right side elevational view of the backstop release mechanism of Figure 198 after a first shot displacement; Figure 199A is a detailed right side view in rear gear elevation, the auto-retract cam wheel and a second joint in Figure 199; Figure 200 is a right side elevational view of the backstop release mechanism of Figure 199 after a second trip displacement; Figure 200A is a detailed right side view in rear gear elevation, the auto-retract cam wheel and a third joint in Figure 200; Figure 201 is a detailed right side elevation view of the anti-reverse release mechanism of Figure 200 after a third and final trip displacement; Figure 201A is a detailed right side view in rear gear elevation, the auto-retract cam wheel and the fourth most proximal joint in Figure 201; Figure 202 is a right side elevational view of the automatic release mechanism of Figure 201 after an additional trip movement causes the self-retracting cam wheel to slide distally and lock the non-return release lever, which disengages the anti-reverse mechanism; Figure 203 is a left front perspective view of an open staple application unit with one half of the right portion of a replaceable staple cartridge included in a staple channel; Figure 204 is a diagrammatic perspective view of the staple application unit of Figure 203 with a complete replaceable staple cartridge and a non-articulated stem configuration; Figure 205 is a perspective view of a two-piece firing bar (E-beam) of the staple application unit of Figure 203; Figure 206 is a perspective view of a wedge slider of a staple cartridge of a staple application unit; Figure 207 is a left side elevational view taken in longitudinal cross section along a centerline 207-207 of the staple application unit of Figure 203; Figure 208 is a perspective view of the open staple application unit of Figure 203 without the replaceable staple cartridge, a portion of the staple channel close to a pin. intermediate of the firing bar and cutting two pieces, and without a distal portion of a staple channel; Figure 209 is a front elevation view taken in cross section along line 209-209 of the staple application unit of Figure 203 depicting the internal staple drivers of the staple cartridge and portions of the bar shooting and cutting two pieces; Figure 210 is a left-up elevation view taken, generally, along the longitudinal axis of line 207-207 of a closed staple application unit of Figure 203 to include central contact points between the two-piece blade and the wedge slider, but also laterally displaced to show the staples and staple drivers within the staple cartridge; Figure 211 is a side elevational detail view of the staple application unit of Figure 210 with the slightly retracted two-piece knife, as is typical for replacement of the staple cartridge; Figure 212 is a side elevation detail view of the staple application unit of Figure 211 with the two-piece knife starting to shoot, corresponding to the configuration shown in Figure 210; Figure 213 is a side elevation cross-sectional view in elevation of the closed staple application unit of Figure 210 after the firing bar and two-piece cut has been fired distally; Figure 214 is a side elevation cross-sectional view in elevation of the closed staple application unit of Figure 213 after firing the staple cartridge and retracting the two-piece blade; Fig. 215 is a detailed side elevation cross-sectional view of the staple application unit of Fig. 214 with the two-piece blade falling in a locked position; Figure 216 is a perspective view of a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator for use with a surgical stapling instrument according to at least one embodiment of the invention; Figure 217 is a diagrammatic view partially of the staple cartridge of Figure 216; Figure 218 is a diagrammatic view completely of the staple cartridge of Figure 216; Figure 219 is another diagrammatic view of the staple cartridge of Figure 216 without a wrap covering the tissue thickness compensator; Figure 220 is a perspective view of a cartridge body, or support portion, of the staple cartridge of Figure 216; Figure 221 is a top perspective view of a movable slider within the staple cartridge of Figure 216 to deploy the staples from the staple cartridge; Figure 222 is a bottom perspective view of the slider of Figure 221; Figure 223 is an elevation view of the slider of the Figure 221; Figure 224 is a top perspective view of an impeller configured to support one or more staples and to be raised upwardly by the slider of Figure 221 to eject the staples from the staple cartridge; Figure 225 is a bottom perspective view of the impeller of Figure 224; Figure 226 is a shell configured to at least partially encircle a compressible tissue thickness compensator of a staple cartridge; Figure 227 is a partial sectional view of a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrated with staples moving from an untriggered position to a triggered position during a first sequence; Figure 228 is an elevation view of the staple cartridge of Figure 227; Figure 229 is a detailed elevation view of the staple cartridge of Figure 227; Figure 230 is a cross sectional end view of the staple cartridge of Figure 227; Figure 231 is a bottom view of the staple cartridge of the Figure 227; Figure 232 is a detailed bottom view of the staple cartridge of Figure 227; Figure 233 is a longitudinal cross-sectional view of an anvil in a closed position and a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrated with staples moving from a non-fired position towards a position triggered during a first sequence; Figure 234 is another cross-sectional view of the anvil and the staple cartridge of Figure 233, illustrating the anvil in an open position after the firing sequence has been completed; Figure 235 is a partial detail view of the staple cartridge of Figure 233 illustrating the staples in an untriggered position; Figure 236 is a cross-sectional elevation view of a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrating the staples in an untriggered position; Figure 237 is a detailed view of the staple cartridge of Figure 236; Figure 238 is an elevation view of an anvil in an open position and a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrating the staples in an untriggered position; Figure 239 is an elevation view of an anvil in a closed position and a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrating the staples in an untriggered position and the tissue captured between the staple. anvil and the tissue thickness compensator; Figure 240 is a detailed view of the anvil and the staple cartridge of Figure 239; Figure 241 is an elevation view of an anvil in a closed position and a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrating the staples in an unprimed position illustrating the thicker tissue positioned between the anvil and the staple cartridge; Figure 242 is a detailed view of the anvil and the staple cartridge of Figure 241; Figure 243 is an elevation view of the anvil and the staple cartridge of Figure 241 illustrating tissue having different thicknesses Figure 244 is a detailed view of the anvil and the staple cartridge of Figure 241, as illustrated in Figure 243; Figure 245 is a diagram illustrating a tissue thickness compensator that compensates for different thicknesses of tissue captured within different staples; Figure 246 is a diagram illustrating a tissue thickness compensator that applies a compressive pressure to one or more vessels that have been sectioned by a line of staples; Figure 247 is a diagram illustrating a circumstance in which one or more staples have improperly formed; Figure 248 is a diagram illustrating a tissue thickness compensator that could compensate for inappropriately formed staples; Figure 249 is a diagram illustrating a tissue thickness compensator positioned in a tissue region in which multiple lines of staples intersect; Figure 250 is a diagram illustrating the tissue captured within a staple; Figure 251 is a diagram illustrating tissue and a tissue thickness compensator captured within a staple; Figure 252 is a diagram illustrating the tissue captured within a staple; Figure 253 is a diagram illustrating the coarse weave and a tissue thickness compensator captured within a staple; Figure 254 is a diagram illustrating the thin tissue and a tissue thickness compensator captured within a staple; Fig. 255 is a diagram illustrating tissue having an intermediate thickness and tissue thickness compensator captured within a staple; Figure 256 is a diagram illustrating the fabric having another intermediate thickness and a fabric thickness compensator captured within a staple; Figure 257 is a diagram illustrating the coarse weave and a tissue thickness compensator captured within a staple; Figure 258 is a partial cross-sectional view of an end effector of a surgical stapling instrument illustrating a firing bar and a staple firing slide in a retracted non-fired position; Figure 259 is another partial cross-sectional view of the end effector of Figure 258 illustrating the firing bar and staple firing slide in a partially advanced position; Figure 260 is a cross-sectional view of the end effector of Figure 258 illustrating the firing bar in a fully advanced or fired position; Figure 261 is a cross-sectional view of the end effector of Figure 258 illustrating the firing bar in one position refolded after firing and the staple firing slide remains in its fully fired position; Figure 262 is a detailed view of the firing bar in the retracted position of Figure 261; Figure 263 is a partial cross-sectional view of an end effector of a surgical stapling instrument including a staple cartridge comprising a tissue thickness compensator and staples at least partially positioned thereon; Figure 264 is another partial cross-sectional view of the end effector of Figure 263 illustrating staples at least partially moved and / or rotated relative to an anvil positioned opposite the staple cartridge; Figure 265 is a partial cross-sectional view of an end effector of a surgical stapling instrument according to at least one embodiment; Figure 266 is a partial cross-sectional view of an end effector according to at least one alternative embodiment; Figure 267 is a partial cross-sectional view of an end effector according to another alternative embodiment; Figure 268 is a perspective view of an end effector of a surgical stapling instrument according to at least one embodiment; Figure 269 is a partial cross-sectional view of the end effector of Figure 268 illustrated in a flexed condition; Figure 270 is a partial cross-sectional view of the end effector of Figure 269 in a released condition; Figure 271 is a perspective view of an end effector comprising a protector of the tissue thickness compensator; Figure 272 is a rear perspective of the tissue thickness compensator protector in Figure 271; Figure 273 is a perspective view of an end effector comprising a plurality of rails extending from a support portion and a tissue thickness compensator having a longitudinal cavity defined therein; Figure 274 is a perspective view of the tissue thickness compensator of Figure 273; Figure 275 is a perspective view of an end effector comprising a plurality of teeth extending from a support portion and a tissue thickness compensator coupled therewith; Figure 276 is a perspective view of an anvil comprising a set of cavities according to at least one embodiment; Figure 277 is a partial detailed view of the anvil of the Figure 276; Figure 278 is a partial longitudinal cross-sectional view of the anvil of Figure 276; Figure 279 is a cross-sectional view of the anvil of Figure 276; Figure 280 is an elevation view of a fired staple comprising a substantially B-shaped configuration; Figure 281 is an elevation view of a fired staple comprising an inwardly deformed leg and an outwardly deformed leg; Figure 282 is an elevation view of a fired staple comprising both legs formed outwardly; Figure 283 is a partial perspective view of a support portion of a staple cartridge comprising removable and / or movable staple foot guides; Figure 284 is a partial cross-sectional view of the staple cartridge of Figure 283 illustrating staples deployed from the staple cartridge; Figure 285 is a detailed view of the cross-sectional view of Figure 284 after the staple cartridge has been fired; Figure 286 is a diagrammatic view of a staple cartridge including a tissue thickness compensator comprising voids defined therein; Figure 287 is a diagram illustrating the compensator of tissue thickness of Figure 286 implanted against tissue; Figure 288 is another diagram illustrating the tissue thickness compensator of Figure 286 implanted against the tissue; Figure 289 is a cross-sectional perspective view of a staple cartridge comprising lateral retention members extending from a staple support portion configured to maintain a tissue thickness compensator in position; Figure 290 is a cross-sectional view of the staple cartridge of Figure 289 that is used to staple tissue; Figure 291 is another cross-sectional view of the staple cartridge of Figure 289 illustrating the support portion separating from the implanted tissue thickness compensator; Figure 292 is a cross-sectional perspective view of a staple cartridge comprising lateral retention members configured to maintain a tissue thickness compensator in a support portion; Figure 293 is a cross-sectional view of the staple cartridge of Figure 292 that is used to staple tissue; Figure 294 is another cross-sectional view of the staple cartridge of Figure 292 illustrating the support portion separating from the implanted tissue thickness compensator; Figure 295 is a detailed cross-sectional view of a retainer that maintains a tissue thickness compensator in a support portion of a staple cartridge according to at least one embodiment; Figure 296 is a partial sectional view of a staple cartridge comprising the staple drivers having different heights according to at least one embodiment; Figure 296A is a diagram illustrating the staple drivers of Figure 296 and the staples having different non-fired heights supported thereon; Figure 297 is a diagram illustrating a fabric thickness compensator comprising a variable thickness, the staple drivers having different heights, and the staples having different unformed heights; Figure 298 is a diagram illustrating the staples and tissue thickness compensator of Figure 297 implanted into the tissue; Figure 299 is a partial cross-sectional view of a staple cartridge comprising a tissue thickness compensator comprising a variable thickness according to at least one embodiment; Figure 300 is a cross-sectional view of an end effector of a surgical stapling instrument in an open configuration; Figure 301 is a cross-sectional view of the end effector of Figure 300 illustrated in a partially triggered configuration; Figure 302 is a cross-sectional view of the end effector of Figure 300 illustrated in a newly opened configuration; Figure 303 is a cross-sectional view of an end effector of a surgical stapling instrument comprising the staple drivers having different heights and a contoured cover surface according to at least one embodiment; Figure 304 is a cross-sectional view of an end effector of a surgical stapling instrument comprising the staple drivers having different heights and a stepped covered surface according to at least one embodiment; Figure 305 is a perspective view of a staple cartridge being loaded into an effector of a surgical stapling instrument using a staple cartridge applicator; Figure 306 is a bottom perspective view of the staple cartridge applicator of Fig. 305; Figure 307 is a side view of the staple cartridge applicator of Figure 305 assembled to a staple cartridge; Figure 308 is a cross-sectional view of the unit of Figure 307; Figure 309 is a perspective view of a staple cartridge applicator unit that further includes an upper tissue thickness compensator positioned on the upper surface of the staple cartridge applicator according to at least one embodiment; Figure 310 is a diagrammatic view of the upper tissue thickness compensator and the staple cartridge applicator of Figure 309; Figure 31AA is a diagrammatic view of the staple cartridge applicator unit comprising a pull member configured to separate a top tissue thickness compensator glued to the staple cartridge applicator; Figure 311 is a partial diagrammatic view of the staple cartridge applicator unit according to at least one alternative embodiment; Figure 312 is a perspective view of the staple cartridge applicator unit comprising a top fabric thickness compensator including a plurality of retaining features extending therefrom and a staple cartridge comprising a thickness compensator of inferior tissue; Figure 313 is an elevation view of the staple cartridge applicator unit of Figure 312 positioned within a staple cartridge channel and an anvil that closes over the staple cartridge applicator unit; Figure 314 is an elevational view of the anvil of Figure 313 in a newly opened position and the staple cartridge applicator of Figure 312 removed from the end effector; Figure 314A is a cross-sectional view of the fabric positioned between the upper fabric thickness compensator and the lower fabric thickness compensator of Figure 312; Figure 314B is a cross-sectional view illustrating the upper fabric thickness compensator and the lower tissue thickness compensator stapled to the tissue and cut by a cutting member; Figure 315 is a diagram illustrating a tissue thickness compensator that is inserted into an anvil according to at least one embodiment; Figure 316 is a cross-sectional view of the tissue thickness compensator of Figure 315; Figure 317 is a diagrammatic view of a tissue thickness compensator and an anvil according to at least one alternative embodiment; Figure 318 is a perspective view of the staple cartridge applicator unit comprising a top fabric thickness compensator configured to join an anvil according to at least one embodiment; Figure 319 is an elevation view of the staple cartridge applicator unit of Figure 318 positioned within a staple cartridge channel and an anvil moving toward the upper tissue thickness compensator; Figure 320 illustrates the staple cartridge applicator of Figure 318 that is removed from the end effector after the upper tissue thickness compensator has engaged with the anvil; Figure 321 is a cross sectional end view of the anvil moving toward the upper tissue thickness compensator of Figure 318; Figure 322 is a cross sectional end view of the anvil coupled with the upper fabric thickness compensator; Figure 323 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a segmented tissue thickness compensator attached to a staple cartridge support portion by a plurality of fasteners; Figure 324 is a cross-sectional view of the end effector of Figure 323 illustrating a firing member in a partially fired position; Figure 325 is a cross-sectional view of the end effector of Figure 323 illustrating the support portion separating from the partially implanted tissue thickness compensator; Figure 326 is a partial perspective view of the support portion of Figure 323; Figure 327 is a perspective view of a staple deployment slider according to at least one embodiment; Figure 328 is an elevation view of the slider of the Figure 327; Figure 329 is a perspective view of an end effector of a surgical stapling instrument comprising a cartridge of staples including a fabric thickness compensator and a plurality of staple guides positioned in the tissue thickness compensator; Figure 330 is a partial cross-sectional view of the tissue thickness compensator and the staple guides of Figure 329 in an untriggered configuration; Figure 331 is a partial cross-sectional view of the tissue thickness compensator and staple guides of Figure 329 in a fired configuration; Figure 332 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator and a support portion according to at least one embodiment; Figure 333 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an untriggered position; Figure 334 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a non-fired position according to at least one alternative embodiment; Figure 335 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a non-fired position according to at least one alternative embodiment; Figure 336 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a position not triggered according to at least one alternative mode; Figure 337 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a non-fired position according to at least one alternative embodiment; Figure 338 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a non-fired position according to at least one alternative embodiment; Figure 339 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a non-fired position according to at least one alternative embodiment; Figure 340 is a detailed view of a region surrounding a tip of the staple of Figure 339; Figure 341 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a non-fired position according to at least one alternative embodiment; Figure 342 is a detailed view of a region surrounding a tip of the clip of Figure 341; Figure 343 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in a non-fired position according to at least one alternative embodiment; Figure 344 is a perspective view of a staple guide layer and a plurality of staples in a non-fired position according to at least one alternative embodiment; Figure 345 is a terminal view of a tissue thickness compensator configured for use with a circular surgical stapler; Figure 346 is a perspective view of the tissue thickness compensator and the circular surgical stapler of Figure 345; Figure 347 is a terminal view of a tissue thickness compensator configured for use with a circular surgical stapler according to at least one alternative embodiment; Figure 348 is a perspective view of the tissue thickness compensator and the circular surgical stapler of Figure 347; Figure 349 is a terminal view of a tissue thickness compensator configured for use with a circular surgical stapler; Figure 350 is a terminal view of the tissue thickness compensator of Figure 349 in a partially expanded configuration; Figure 351 is an elevation view of a surgical stapling instrument comprising a staple cartridge according to at least one embodiment; Figure 352 is a terminal view of the surgical stapling instrument of Figure 351 positioned relative to the tissue; Figure 353 is a terminal view of the surgical stapling instrument of Figure 351 which further comprises a tissue thickness compensator positioned between the staple cartridge and the tissue; Figure 354 is a partial perspective view of staples deployed within the tissue from the surgical stapling instrument of Figure 351 without a tissue thickness compensator; Figure 355 is a partial perspective view of staples deployed within the tissue from the surgical stapling instrument of Figure 351 with a tissue thickness compensator; Figure 356 is a partial cross-sectional view of the end effector of the surgical stapling instrument of Figure 351, comprising an anvil plate in a first position; Figure 357 is a partial cross-sectional view of the end effector of the surgical stapling instrument of Figure 351 illustrating the anvil plate of Figure 356 in a second position; Figure 358 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a spacing adjustment element; Figure 359 is a perspective view illustrating a trigger member severing the spacer adjustment member of Figure 358 at the end of the firing displacement of the firing member; Figure 360 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a flexible tip; Figure 361 is a cross-sectional view of the end effector of Figure 360 illustrating the tip in a flexed configuration; Figure 362 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a slidable portion; Figure 363 is a cross-sectional view of the end effector of Figure 362 illustrating the sliding portion that slides distally; Figure 364 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a support portion comprising an inclined cover surface and a tissue thickness compensator comprising a variable thickness; Figure 365 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a support portion comprising an inclined cover surface and a tissue thickness compensator comprising a uniform thickness; Figure 366 is a perspective view of a staple cartridge comprising a tissue thickness compensator having a variable thickness; Figure 367 is a terminal view of the staple cartridge of the Figure 366; Figure 368 is a cross-sectional perspective view of a tissue thickness compensator comprising longitudinal layers; Figure 369 is a cross-sectional perspective view of a fabric thickness compensator comprising a plurality of layers according to at least one alternative embodiment; Figure 370 is a perspective view of a disposable loading unit comprising retaining members configured to removably hold a tissue thickness compensator thereto; Figure 371 is a perspective view of a fabric thickness compensator including retaining members configured to removably clamp the tissue thickness compensator to a disposable loading unit; Figure 372 is a perspective view of the tissue thickness compensator of Figure 371 attached to a disposable loading unit; Figure 373 is a terminal view of the disposable loading unit of Figure 372; Figure 374 is a perspective view of a fabric thickness compensator including retaining members configured to removably hold the tissue thickness compensator to a disposable loading unit; Figure 375 is a perspective view of the tissue thickness compensator of Figure 374 attached to a disposable loading unit; Figure 376 is a terminal view of the disposable loading unit of Figure 375; Figure 377 is a perspective view of a fabric thickness compensator including a retaining member configured to removably hold the tissue thickness compensator to a disposable loading unit; Figure 378 is a perspective view of the tissue thickness compensator of Figure 377 attached to a disposable loading unit; Figure 379 is a perspective view of an applicator of the tissue thickness compensator positioned within an effector of a disposable loading unit; Figure 380 is a top perspective view of the tissue thickness compensator applicator of Figure 379; Figure 381 is a bottom perspective view of the tissue thickness compensator applicator of Figure 379; Figure 382 is a perspective view of an applicator of the tissue thickness compensator positioned within an effector of a disposable loading unit according to at least one alternative embodiment; Figure 383 is a top perspective view of the tissue thickness compensator applicator of Figure 382; Figure 384 is a bottom perspective view of the tissue thickness compensator applicator of Figure 382; Figure 385 is an elevation view of a disposable loading unit including a rotating clamp configured to support a staple cartridge; Figure 386 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator attached to a staple cartridge support portion according to at least one embodiment; Figure 387 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator attached to a staple cartridge support portion according to at least one embodiment; Figure 388 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator attached to a staple cartridge support portion according to at least one embodiment; Figure 389 is a perspective view of the tissue thickness compensator of Figure 387; Figure 390 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 391 is a detailed view of the nonwoven material of the fabric thickness compensator of Figure 390; Figure 392 is an elevation view showing the tissue thickness compensator of Figure 390 implanted against the tissue and released from the end effector; Figure 393 is a detailed view of the non-woven material of a tissue thickness compensator according to at least one embodiment; Figure 394 is a diagram showing groups of crimped fibers randomly oriented according to at least one embodiment; Figure 395 is a diagram representing a group of crimped fibers randomly oriented according to at least one embodiment; Figure 396 is a diagram representing an array of crimped fibers randomly oriented according to at least one embodiment; Figure 397 is a diagram representing an array of crimped fibers randomly oriented according to at least one embodiment; Figure 398 is a diagram representing an array of crimped fibers randomly oriented according to at least one embodiment; Figure 399 is a cross-sectional plan view of coiled fibers in a tissue thickness compensator according to at least one embodiment; Figure 399A is a cross-sectional plan view of the twisted fibers of Figure 399; Figure 399B is a cross-sectional detail view of the tissue thickness compensator of Figure 399; Figure 400 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 401 is a diagram representing the deformation of the tissue thickness compensator of Figure 400; Figure 402 is a woven suture pattern for a fabric thickness compensator representing the woven suture in a loaded configuration according to at least one embodiment; Figure 403 is a schematic of the woven suture of Figure 402 depicting the woven suture in a loose configuration; Figure 404 is a plan view of a tissue thickness compensator having the woven suture of Figure 402 in an end effector of a surgical instrument; Figure 405 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 406 is a partial plan view of the tissue thickness compensator of Figure 405; Figure 407 is a diagrammatic view of the end effector and tissue thickness compensator end effector cartridge unit of Figure 390; Figure 408 is a partial cross-sectional view of the clamping cartridge unit of Figure 407 depicting non-fired, partially fired, and fired fasteners; Figure 409 is an elevation view of the clamping cartridge unit of Figure 407 depicting an impeller that fires fasteners from the staple cavities of the clamping cartridge unit in the tissue thickness compensator; Figure 410 is a detailed view of the clamping cartridge unit of Figure 409; Figure 411 is an elevation view of the tissue thickness compensator of Figure 390 and the tissue captured within the fired fasteners; Figure 412 is an elevation view of the tissue thickness compensator of Figure 390 and the tissue captured within the fired fasteners; Figure 413 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 414 is a diagram showing the deformation of a deformable tube of the tissue thickness compensator of Figure 413; Figure 415 is a detailed view of the deformable tube of the tissue thickness compensator of Figure 413; Figure 416 is a diagram showing the deformation of a deformable tube of a tissue thickness compensator according to at least one embodiment; Figure 417 is an elevation view of a tissue thickness compensator comprising a tubular element implanted against the tissue according to at least one embodiment; Figure 418 is an elevation view of a tissue thickness compensator comprising tubular elements implanted against the tissue according to at least one embodiment; Figure 419 is a partial perspective view of a deformable tube comprising a tubular network according to at least one embodiment; Figure 420 is an elevation view of a tubular strand of the deformable tube of Figure 419.
Figure 421 is an elevation view of the deformable tube of Figure 419; Figure 422 is an elevation view of multiple tubular strands for the deformable tube of Figure 419 according to various modalities; Figure 423 is an elevation view of the tubular network of Figure 419 implanted against the tissue; Figure 424 is a partial perspective view of a deformable tube according to at least one embodiment; Figure 425 is a partial perspective view of a deformable tube according to at least one embodiment; Figure 426 is a partial perspective view of a deformable tube according to at least one embodiment; Figure 427 is an elevation view of the deformable tube of Figure 426; Figure 428 is a partial perspective view of a deformable tube according to at least one embodiment; Figure 429 is a partial perspective view of a deformable tube according to at least one embodiment; Figure 430 is a partial perspective view of a deformable tube according to at least one embodiment; Figure 431 is a perspective view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 432 is an elevation view of a tubular element of the tissue thickness compensator of Figure 431; Figure 433 is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 431 depicting the end effector in a loose configuration; Figure 434 is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 431 depicting the end effector in a grasped and fired configuration; Figure 435 is a cross-sectional elevation view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 436 is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 435 depicting the end effector in a clamped and fired configuration; Figure 437 is a cross-sectional elevation view of a tissue thickness compensator positioned on the end effector of a surgical instrument according to at least one embodiment; Figure 438 is a cross-sectional elevation view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 439 is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 438 depicting the end effector in a grasped and fired configuration; Figure 440 is a perspective view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 441 is a cross-sectional elevation view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 442 is a cross-sectional elevation view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 443 is a cross-sectional elevation view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 444 is a cross-sectional elevation view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Fig. 445 is a partial plan view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment; Figure 446 is a partial plan view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 447 is a partial cross-sectional elevation view of the tissue thickness compensator and end effector of Figure 445 depicting the end effector in a loose configuration; Figure 448 is a partial cross-sectional elevation view of the tissue thickness compensator and the end effector of Figure 445 depicting the end effector in a clamped configuration; Figure 449 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 450 is an elevation view of the tissue thickness compensator and the end effector of Figure 449; Figure 451 is a perspective view of the tissue thickness compensator and end effector of Figure 449 depicting the anvil of the end effector moving to a clamped configuration; Figure 452 is an elevation view of the tissue thickness compensator and end effector of Figure 449 depicting the end effector in a clamped configuration; Figure 453 is a cross-sectional elevation view of the tubular elements of the tissue thickness compensator of Figure 449 in an undeformed configuration; Figure 454 is a cross-sectional elevation view of the tubular elements of the tissue thickness compensator of Figure 449 in a deformed configuration; Figure 455 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 456 is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 455 depicting the end effector in a clamped configuration; Figure 457 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of Figure 455 depicting the end effector in a fired and partially loose configuration; Figure 458 is a perspective view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 459 is a cross-sectional elevation view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument according to at least one embodiment; Figure 460 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of Figure 459 depicting the end effector in a clamped configuration; Figure 461 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of Figure 459 depicting the end effector in a fired and partially loose configuration; Figure 462 is a detailed view of the tissue thickness compensator and end effector of Figure 461; Figure 463 is a cross-sectional elevation view of a tissue thickness compensator attached to an end effector of a surgical instrument representing the deployment of staples by a staple trigger slider according to at least one embodiment; Figure 464 is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 463 depicting the end effector in a clamped configuration; Figure 465 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of Figure 463 depicting the end effector in a fired configuration; Figure 466 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 467 is a perspective view of a tubular element of the tissue thickness compensator of Figure 466; Figure 468 is a perspective view of the tubular element of Figure 467 cut between a first and a second end; Figure 469 is a perspective view of the fabric thickness compensator of Figure 466 depicting a cutting element that cuts the tissue thickness compensator and the staples that couple the tissue thickness compensator; Figure 470 is a perspective view of a frame configured to make the fabric thickness compensator of Figure 466 according to at least one embodiment; Figure 471 is an elevational cross-sectional view of the frame of Figure 470 depicting the fabric thickness compensator of Figure 466 that is cured in the frame; Figure 472 is an elevational cross-sectional view of the fabric thickness compensator removed from the frame of Figure 471 and ready to be cut by at least one cutting instrument; Figure 473 is an elevational cross-sectional view of the tissue thickness compensator of Figure 472 after which the minus one cutting instrument has cut the tissue thickness compensator; Figure 474 is an elevational cross-sectional view of the tissue thickness compensator formed in the frame of Figure 471 depicting cuttable tubes having various geometries of the cross section; Figure 475 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 476 is a detailed view of the tissue thickness compensator of Figure 475 according to at least one embodiment; Figure 477 is a partial perspective view of a tissue thickness compensator according to at least one embodiment; Figure 478 is a partial perspective view of a tissue thickness compensator according to at least one embodiment; Figure 479A is an elevational cross-sectional view of the tissue thickness compensator and the end effector of Figure 475 depicting the end effector in a loose configuration; Figure 479B is an elevational cross-sectional view of the tissue thickness compensator and the end effector of Figure 475 depicting the end effector in a clamped configuration; Figure 479C is an elevational cross-sectional view of the tissue thickness compensator and the end effector of Figure 475 depicting the end effector in a clamped and fired configuration; Figure 479D is an elevational cross-sectional view of the tissue thickness compensator of Figure 475 captured in the fired staples; Figure 479E is an elevational cross-sectional view of the tissue thickness compensator of Figure 475 captured in the fired staples representing the further expansion of the tissue thickness compensator; Figure 480 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 481 is a partial elevation view of the tissue thickness compensator of Figure 480 captured in a fired staple; Figure 482 is an elevation view of a deformable tube of the tissue thickness compensator of Figure 480; Figure 483 is an elevation view of a deformable tube according to at least one embodiment; Figure 484 is a perspective cross-sectional view of the tissue thickness compensator of Figure 480; Figure 485 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment; Figure 486 is a partial perspective view of a tissue thickness compensator according to at least one embodiment; Figure 487 is a partial cross-sectional elevation view of the fabric thickness compensator of Figure 486 showing a fastener coupled with the fabric and with the fabric thickness compensator; Figure 488 is a perspective cross-sectional view of a tissue thickness compensator according to at least one embodiment; Figure 489 is an elevation view of a tissue thickness compensator according to at least one embodiment; Figure 490 is an elevation view of a tissue thickness compensator according to at least one embodiment; Figure 491 is an elevation view of a tissue thickness compensator positioned in a circular end effector of a surgical instrument according to at least one embodiment; Figure 492 is an elevation view of a tissue thickness compensator according to at least one embodiment; Figure 493 is an elevation view of a tissue thickness compensator according to at least one embodiment; Figure 494 is an elevation view of a tissue thickness compensator according to at least one embodiment; Figure 495 is an elevation view of a tissue thickness compensator according to at least one embodiment; Figure 496 is an elevation view of a tissue thickness compensator according to at least one embodiment; Figure 497 is a partial perspective view of a tissue thickness compensator according to at least one embodiment; Figure 498 is a partial perspective view of a tissue thickness compensator positioned on an end effector of a surgical instrument according to at least one embodiment; Figure 499 is a partial perspective view of a fabric thickness compensator with a fastener positioned in the openings thereof according to at least one embodiment; Figure 500 is a partial perspective view of the fabric thickness compensator of Figure 498 depicting the tissue thickness compensator in an undeformed configuration; Figure 501 is a partial perspective view of the tissue thickness compensator of Figure 498 depicting the tissue thickness compensator in a partially deformed configuration; Figure 502 is a partial perspective view of the fabric thickness compensator of Figure 498 depicting the tissue thickness compensator in a deformed configuration; Figure 503 is a partial perspective view of a tissue thickness compensator according to at least one embodiment; Figure 504 is a perspective view of an end effector of a stapling instrument comprising an anvil and a staple cartridge according to at least one embodiment; Figure 505 is a cross-sectional view of the end effector of Figure 504 illustrating the staples positioned within the staple cartridge in an untriggered state and a tissue thickness compensator comprising a sealed container in an unperforated state, wherein the container is represented with portions thereof removed for the purposes of the illustration; Figure 506 is a cross-sectional view of the end effector of Figure 504 illustrating the staples of Figure 505 in an at least partially fired condition and the container in an at least partially perforated condition; Figure 507 is a perspective view of an end effector of a stapling instrument comprising an anvil and a staple cartridge according to at least one embodiment; Figure 508 is a cross-sectional view of the end effector of Figure 507 illustrating the staples positioned within the staple cartridge in an un-fired state and the sealed containers positioned within a tissue thickness compensator of the staple cartridge. staples in an undrilled state, wherein the containers are represented with portions of these removed for the purposes of the illustration; Figure 509 is a cross-sectional view of the end effector of Figure 507 illustrating the staples of Figure 508 in an at least partially fired condition and the containers in the staple cartridge in an at least partially perforated condition; Figure 510 is a perspective view of an end effector of a stapling instrument comprising an anvil and a sealed container attached to the anvil according to at least one alternative embodiment, wherein the container is depicted with portions thereof removed for the purposes of the illustration; Figure 511 is a cross-sectional view of the end effector of Figure 510 illustrating staples at least partially fired from a staple cartridge and containers attached to the anvil in an at least partially perforated condition; Figure 512 is a cross-sectional view of the container attached to the anvil of Figure 510 illustrated in an expanded state; Figure 513 is a detailed view of the container attached to the anvil of Figure 512 illustrated in an expanded state; Figure 514 illustrates a container extending in a direction transverse to a line of staples; Figure 515 illustrates a plurality of containers extending in directions that are transverse to a line of staples; Figure 516 is a cross-sectional view of a staple cartridge according to various embodiments; Figure 517 is a partial cross-sectional view of Figure 516 in an implanted state; Figure 518A is a partial perspective view of a tissue thickness compensator before its expansion; Figure 518B is a partial perspective view of a tissue thickness compensator of Figure 518A during its expansion; Figure 519 is a partial perspective view of a tissue thickness compensator comprising a liquid swellable composition according to various modalities; Figure 520 is a cross-sectional view of the tissue positioned adjacent a tissue thickness compensator according to various embodiments; Figure 521 is a partial cross-sectional view of the Figure 520 after the staple cartridge has been fired; Figure 522 is a diagram illustrating the tissue thickness compensator of Figure 520 implanted adjacent to a tissue; Figure 523 is a partial perspective view of a tissue thickness compensator according to various modalities; Figure 524 is a perspective view of a clamp configured to receive the tissue thickness compensator of Figure 523; Figure 525 is a partial cross-sectional view of a staple cartridge illustrating staples deployed from the staple cartridge; Figure 526 is a perspective view of an upper fabric thickness compensator and a lower tissue thickness compensator positioned within an effector of a disposable loading unit; Figure 527A is a cross-sectional view of the lower fabric thickness compensator of Figure 526 that is manufactured in a mold according to various embodiments; Figure 527B is a cross-sectional view of a three-layer fabric thickness compensator that is manufactured in a mold according to various embodiments; Figure 528 is a cross-sectional view of an anvil comprising a tissue thickness compensator comprising reinforcing material according to various embodiments; Figure 529 is a cross-sectional view of a fabric positioned between the upper fabric thickness compensator and the lower fabric thickness compensator according to various embodiments; Figure 530 is a cross-sectional view of Figure 529 illustrating staples deployed from the staple cartridge; Figure 531 is a cross-sectional view of Figure 529 after the staple cartridge has been fired; Figure 532A illustrates a needle configured to deliver a fluid to a tissue thickness compensator attached to a staple cartridge according to various embodiments; Figure 532B is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator configured to receive the needle of Figure 532A; Figure 533 illustrates a method for manufacturing a fabric thickness compensator according to various embodiments; Figure 534 is a diagram and a method for forming an expandable thickness compensator according to various embodiments; Figure 535 illustrates a micelle comprising a hydrogel precursor; Y Figure 536 is a diagram of a surgical instrument comprising a tissue and fluid thickness compensator that can be supplied to the tissue thickness compensator according to various modalities; Figure 537 is a partial perspective view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument according to at least one embodiment; Figure 538 is a perspective view of a tubular element of the tissue thickness compensator of Figure 537; Figure 539 is a perspective view of the tubular element of Figure 538 showing the tubular element cut in halves and the fluid in contact with the hydrophilic substance within each half; Figure 540 is a perspective view of a half of the cut tubular element of Figure 539 showing the expansion of the cut tubular element.
The corresponding reference characters indicate corresponding parts in the different views. The examples mentioned in the present description illustrate certain embodiments of the invention, in one form, and these examples are not to be construed, in any way, as limiting the scope of the invention.
DETAILED DESCRIPTION OF THE INVENTION The applicant of the present application is, furthermore, the owner of the United States patent applications identified below, which are each incorporated herein by reference in their respective entirety: U.S. patent application serial number 12 / 894,311, entitled "SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS" (file no.
END6734USNP / 100058); the United States patent application with serial number 12 / 894,340, entitled SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS (file number END6735USNP / 100059); the United States patent application with serial number 12 / 894,327, entitled JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS (file No. END6736USNP / 100060); U.S. patent application serial number 12 / 894,351, entitled SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS (File No. END6839USNP / 100524); U.S. Patent Application Serial Number 12 / 894,338, entitled IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT (file number END6840USNP / 1 00525); U.S. patent application serial number 12 / 894,369, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER" (file no.
END6841USNP / 1 00526); U.S. Patent Application Serial Number 12 / 894,312, entitled IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS (File No. END6842USNP / 100527); U.S. Patent Application Serial No. 12 / 894,377, entitled "SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE" (File No. END6843USNP / 100528); U.S. patent application serial number 12 / 894,339, entitled SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATED CONTROL ARRANGEMENT (file number END6847USNP / 100532); U.S. patent application serial number 12 / 894,360, entitled SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM (file number END6848USNP / 100533); U.S. patent application serial number 12 / 894,322, entitled SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS (file number END6849USNP / 100534); U.S. patent application serial number 12 / 894,350, entitled SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTUATION MOTIONS WHEN A CARTRIDGE IS NOT PRESENT (file No. END6855USNP / 100540); U.S. patent application serial number 12 / 894,383, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS" (file no.
END6856USNP / 100541); U.S. Patent Application Serial No. 12 / 894,389, entitled COMPRESSIBLE FASTENER CARTRIDGE (File No. END6857USNP / 100542); the United States patent application with serial number 12 / 894,345, entitled FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT (file number END6858USNP / 100543); U.S. Patent Application Serial Number 12 / 894,306, entitled COLLAPSIBLE FASTENER CARTRIDGE (file No. END6859USNP / 100544); U.S. Patent Application Serial No. 12 / 894,318, entitled FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTION MATRIX ELEMENTS (File No. END6860USNP / 100546); U.S. Patent Application Serial Number 12 / 894,330, entitled FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX (file number END6861USNP / 100547); U.S. Patent Application Serial No. 12 / 894,361, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (File No. END6862USNP / 100548); U.S. Patent Application Serial No. 12 / 894,367, entitled FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION MATRIX (File No. END6863USNP / 100549); the United States patent application with serial number 12 / 894,388, entitled FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER (file No. END6864USNP / 100550); U.S. Patent Application Serial Number 12 / 894,376, entitled FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES (file number END6865USNP / 1 00551); U.S. Patent Application Serial No. 13 / 097,865, entitled SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS (file No. END6735USCIP1 / 100059CIP1); the United States patent application with serial number 13 / 097,936, entitled TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER (file number END6736USCIP1 / 100060CIP1); U.S. Patent Application Serial No. 13 / 097,954, entitled STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION (file No. END6840USCIP1 / 100525CIP1); U.S. Patent Application Serial No. 13 / 097,856, entitled STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE PORTION THEREOF (File No. END6841USCIP1 / 100526CIP1); U.S. Patent Application Serial No. 13 / 097,928, entitled TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS (File No. END6842USCIP1 / 100527CIP1); U.S. Patent Application Serial No. 13 / 097,891, entitled TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN ADJUSTABLE ANVIL (File No. END6843USCIP1 / 100528CIP1); U.S. Patent Application Serial No. 13 / 097,948, entitled STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION (File No. END6847USCIP1 / 100532CIP1); U.S. Patent Application Serial No. 13 / 097,907, entitled "COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY" (File No. END6848USCIP1 / 100533CIP1); U.S. Patent Application Serial No. 13 / 097,861, entitled TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERTIES (file number END6849USCIP1 / 100534CIP1); U.S. Patent Application Serial No. 13 / 097,869, entitled "STAPLE CARTRIDGE LOADING ASSEMBLY" (File No. END6855USCIP1 / 100540CIP1); U.S. Patent Application Serial No. 13 / 097,917, entitled COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS (File No. END6856USCIP1 / 100541 CIP1); U.S. Patent Application Serial No. 13 / 097,873, entitled STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION (File No. END6857USCIP1 / 100542CIP1); U.S. Patent Application Serial No. 13 / 097,938, entitled STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS (file number END6858USCIP1 / 100543CIP1); U.S. Patent Application Serial No. 13 / 097,924, entitled "STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR" (File No. END6859USCIP1 / 100544CIP1); the United States patent application with serial number 13 / 242,029, entitled SURGICAL STAPLER WITH FLOATING ANVIL (file No. END6841USCIP2 / 100526CIP2); U.S. Patent Application Serial No. 13 / 242,066, entitled CURVED END EFFECTOR FOR A STAPLING INSTRUMENT (File No. END6841USCIP3 / 100526CIP3); U.S. Patent Application Serial No. 13 / 242,086, entitled STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK (File No. END7020USNP / 110374); U.S. Patent Application Serial No. 13 / 241,912, entitled STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGE ENT (file No. END7019USNP / 1 10375); U.S. Patent Application Serial No. 13 / 241,922, entitled SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS (File No. END7013USNP / 110377); U.S. Patent Application Serial No. 13 / 241,637, entitled SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATION MOTIONS (file number END6888USNP3 / 110378); and U.S. patent application serial number 13 / 241,629, entitled SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR (file number END6888USNP2 / 110379).
The applicant of the present application is also the owner of the United States patent applications identified below, which were filed on the same date as the present one and which are each incorporated in the present description as reference in their respective totality: the United States application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES, (file number END6864USCIP1 / 100550CIP1); the United States application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS, (file number END6864USCIP2 / 100550CIP2); the US application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR, (file number END6843USCIP3 / 100528CIP3); the United States application with serial number _, titled RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR, (file number END6843USCIP4 / 100528CIP4); the United States application with serial number _ titled TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONE MEDICATION, (file number END6843USCIP5 / 100528CIP5); the US application with serial number _ titled TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION, (file No. END6843USCIP6 / 100528CIP6); the United States application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD, (file no.
END6843USCIP7 / 100528CIP7); the United States application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD, (file no.
END6843USCIP8 / 100528CIP8); the United States application with serial number _ titled TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS, (file number END6843USCIP9 / 100528CIP9); the United States application with serial number _, entitled METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS, (file No. END6843USCIP1 0 / 100528CP10); the United States application with serial number _, titled TISSUE THICKNESS COMPENSATORS, (file no.
END6843USCIP1 1 / 100528CP11); the United States application with serial number _, entitled LAYERED TISSUE THICKNESS COMPENSATOR, (file no.
END6843USCIP12 / 100528CP12); the United States application with serial number _, titled TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS, (file number END6843USCIP13 / 100528CP13); the United States application with serial number titled TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING A LOW PRESSURE ENVIRONMENT (File No. END7100USNP / 1 10601); the US application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS (file number END7101USNP / 110602); the United States application with serial number _, entitled MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR, (file No. END7107USNP / 110603); the United States application with serial number _ titled TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS, (file number END7102USNP / 110604); the United States application with serial number _, titled TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME (file No. END7103USNP / 110605); the United States application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS (File No. END7104USNP / 1 10606); US application with serial number _, titled TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES (file number END7105USNP / 110607); and the United States application with serial number _, entitled DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS (file number END7106USNP / 110608).
In the following, certain illustrative modalities will be described to achieve a general understanding of the principles of structure, function, elaboration and use of the instruments and methods described in the present invention. In the attached figures one or more examples of said modalities are illustrated. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the appended figures are illustrative non-limiting modalities. The features illustrated or described in reference to an illustrative embodiment may be combined with the characteristics of other modalities. Said modifications and variations are included within the scope of the present invention.
Any of the methods described or claimed herein for manufacturing, forming or otherwise producing an article or product, may be employed to manufacture, shape or otherwise. produce all or part of the article or product in question, and where such a method is used to make, shape or otherwise produce part of the article or product in question, the rest of the article or product can be produced in any way, which includes employing any of the other methods that are described and claimed herein for manufacturing , conform or in any other way produce the article or product, and the various parts thus produced may be combined in any way. Similarly, any article or product that is described or claimed herein may exist alone, or in combination with, or as an integral part of, any other article or product likewise described with which it is compatible. Thus, the elements, structures, or particular features illustrated or described in relation to an article, product or method may be combined, in whole or in part, with the elements, structures, or characteristics of one or more other articles, products or methods. compatible without limitation. Said modifications and variations are included within the scope of the present invention.
Where described in the present description, whether in reference to a particular figure or in any other way, that a certain embodiment of the invention or a particular article, product or method may comprise certain structures, features or elements, it shall be understood that the reader that this means that those structures, features or elements can be incorporated into the article, product or method in question in any compatible combination. Particularly, such a description of a number of structures, features or optional elements must be understood, in addition, that describes all those structures, characteristics or elements in combination, except in the case of structures, characteristics or elements that are described as alternative to others. Where such structures, characteristics or elements are described as alternative to others, they should be understood to describe those alternatives as substitutions for each other.
The terms "proximal" and "distal" are used, in the present description, with reference to a clinician who manipulates the handle portion of a surgical instrument. The term "proximal" refers to the portion that is closest to the clinician, and the term "distal" refers to the portion that is far from the clinician. Furthermore, it will be appreciated that, for reasons of convenience and clarity, spatial terms such as "vertical", "horizontal", "up" and "down" can be used in the present description with respect to the figures. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting or absolute.
Several illustrative devices and methods are provided for performing laparoscopic procedures and minimally invasive surgical procedures. However, the reader will readily appreciate that the various methods and devices described in the present description can be used in numerous surgical procedures and applications including those related to open surgical procedures. As the present detailed description proceeds, the reader will further appreciate that the various instruments described in the present description they can be inserted into a body in any way, such as through a natural orifice, through an incision or perforation hole that is formed in the tissue, etc. The working portions or portions of the end effector of the instruments can be inserted directly into the body of a patient or can be inserted through an access device having a working channel through which the end effector can be advanced. and the elongated shank of a surgical instrument.
With reference now to figures in which similar numbers denote similar components throughout the various views, Figure 1 describes a surgical instrument 10 that is capable of implementing the unique benefits. The surgical stapling instrument 10 is designed to manipulate and / or activate various shapes and sizes of the end effectors 12 that are operatively attached thereto. In Figures 1 to 1E, for example, the end effector 12 includes an elongated channel 14 that forms a lower clamp 13 of the end effector 12. The elongate channel 14 is configured to support an "implantable" staple cartridge 30 and, in addition, to support in a mobile manner an anvil 20 that functions as an upper clamp 15 of the end effector 12.
The elongated channel 14 can be made of, for example, stainless steel of the series 300 and 400, 17-4 and 17-7, of titanium, etc. and it can be formed with separate side walls 16. The anvil 20 can be made of, for example, stainless steel of the series 300 and 400, 17-4 and 17-7, of titanium, etc. and has an inner staple-forming surface, generally labeled as 22 having a plurality of staple forming cavities 23 formed therein. See Figures 1B through 1E. Additionally, the anvil 20 has a bifurcated ramp unit 24 projecting proximally therefrom. An anvil pin 26 protrudes from each side side of the ramp unit 24 to be received within a corresponding slot or opening 18 in the side walls 16 of the elongate channel 14 to facilitate its movable or rotatable attachment thereto.
Various forms of implantable clip cartridges can be employed with the surgical instruments described in the present disclosure. The configurations and specific constructions of the staple cartridge will be discussed in more detail below. However, in Figure 1A, an implantable staple cartridge 30 is shown. The staple cartridge 30 has a portion of the body 31 that consists of a compressible hemostatic material such as, for example, oxidized regenerated cellulose ("ORC") or a bioabsorbable foam in which the lines of the unformed metal staples are supported 32. In order to avoid affecting the staple and activating the hemostatic material during the insertion and positioning process, the entire cartridge can be coated or wrapped with a biodegradable film 38 such as a polydioxanone film marketed under the trademark PDS® or with a polyglycerol sebacate film (PGS) or other biodegradable films formed of PGA (polyglycolic acid, marketed under the Vicryl trademark), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (polyhydroxyalkanoate), PGCL (polygallecapronate 25, sold under the trademark of Monocryl) or a compound of PGA, PCL, PLA, PDS that could be waterproof until rupture. The body 31 of the staple cartridge 30 is sized to be removably supported within the elongated channel 14 as shown, such that each staple 32 therein is aligned with the corresponding staple forming cavities 23 in the anvil when the anvil 20 is driven towards the forming contact with the staple cartridge 30.
In use, once the end effector 12 has been positioned adjacent to the target tissue, the end effector 12 is manipulated to capture or hold the target tissue between an upper face 36 of the staple cartridge 30 and the staple forming surface. 22 of the anvil 20. The staples 32 are formed by the movement of the anvil 20 in a path that is substantially parallel to the elongate channel 14 to bring the staple forming surface 22 and, more particularly, the staple forming cavities 23 in this towards substantially simultaneous contact with the upper face 36 of the staple cartridge 30. As the anvil 20 continues its movement in the staple cartridge 30, the legs 34 of the staples 32 come into contact with a staple forming cavity 23. corresponding to the anvil 20 which serves to bend the staple legs 34 and shape the staples 32 into a "B-shape". Further movement of the anvil 20 towards the elongate channel 14 can further compress and shape the staples 32 to a desired final shaped height "FF".
The staple forming process described above is generally represented in Figures 1B through 1E. For example, Figure 1B illustrates the end effector 12 with the target tissue "T" between the anvil 20 and the top face 36 of the implantable staple cartridge 30. Figure 1C illustrates the initial clamping position of the anvil 20, where the anvil 20 has been closed on the target tissue "T" to hold the target tissue "T" between the anvil 20 and the top face 36 of the staple cartridge 30. Figure 1D illustrates the formation of the initial staple, wherein the anvil 20 has begun to compress the staple cartridge 30, such that the legs 34 of the staples 32 begin to be formed by the staple forming cavities 23 in the anvil 20. FIG. 1E illustrates the staple 32 in its final formed condition through the objective tissue "T" with the anvil 20 removed for clarity purposes. Once the staples 32 have been formed and secured to the target tissue "T", the surgeon will move the anvil 20 to the open position to allow the body of the cartridge 31 and the staples 32 to remain fixed to the target tissue while the end effector 12 is removed from the patient. The end effector 12 forms all the staples simultaneously when the two clamps 13, 15 are clamped together. The remaining "crushed" body materials 31 act as a hemostat (the ORC) and a staple line reinforcement (of PGA, PDS or any of the film compositions 38 mentioned above). In addition, because the staples 32 never have to leave the body of the cartridge 31 during forming, the possibility of the staples 32 becoming misformed during forming is minimized. As used in this description the term "implantable" means that, in addition to the staples, the materials of the cartridge body that support the staples will also remain in the patient and could eventually be absorbed by the patient's body. Such implantable staple cartridges are distinguishable from arrays of prior cartridges that remain positioned within the end effector in its entirety after they have been fired.
In various implementations, the end effector 12 is configured to engage an elongated stem unit 40 projecting from a handle unit 100. The end effector 12 (when closed) and the elongate shaft unit 40 can have shapes of similar cross-section and dimensioning to pass operatively through a trocar tube or working channel in another form of the access instrument. As used in the present description, the term "operatively pass" means that the end effector and at least a portion of the elongated stem unit can be inserted through or pass through the opening of the tube or channel and can be manipulated. in this as needed to complete the surgical stapling procedure. When in a closed position, clamps 13 and 15 of end effector 12 can provide the end effector with an approximately circular cross-sectional shape facilitating its passage through a circular passage / opening. However, the end effectors of the present invention, as well as the modalities of the elongated stem unit, could be provided conceivably with other forms of cross section that otherwise they could pass through access passages and openings that have non-circular cross-sectional shapes. Thus, a full size of a cross-section of a closed end effector will be related to the size of the passage or the opening through which it is desired to pass. Thus, an end effector, for example, may be referred to as an end effector of "5 mm", which means that it can be operatively passed through an opening that is at least about 5 mm in diameter.
The elongate shaft unit 40 can have an outer diameter that is substantially the same as the outer diameter of the end effector 12 when in a closed position. For example, an end effector of 5 mm can be coupled to an elongated stem unit 40 having a cross-section diameter of 5 mm. However, as the present detailed description proceeds, it will be apparent that the present invention can be used effectively in connection with different sizes of the end effectors. For example, a 10-mm end effector can be attached to an elongated stem having a cross-section diameter of 5 mm. In contrast, for applications where a passageway or access opening of 10 mm or greater is provided, the elongate shaft unit 40 may have a cross-sectional diameter of 10 mm (or greater), but may also actuate , an end effector of 5 mm or 10 mm. Accordingly, the outer stem 40 may have an outer diameter that is the same or different from the outer diameter of a closed end effector 12 attached thereto.
As shown, the elongate shaft unit 40 extends distally from the handle unit 100 in a straight line, generally, to define a longitudinal axis A-A. For example, the elongated stem unit 40 can be approximately 229-406 mm (9-16 inches) long. However, the elongated stem unit 40 may be provided in other lengths and, as an alternative, may have joints thereon or otherwise configured to facilitate articulation of the end effector 12 relative to other portions of the stem unit or of mango as they will be discussed in greater detail later. The elongated shaft unit 40 includes a central tubular member 50 that extends from the handle unit 100 to the end effector 12. The proximal end of the elongate channel 14 of the end effector 12 has a pair of retaining stumps 17 that protrude of this which are dimensioned to be received within the corresponding openings of the trunnions or bases 52 that are provided at a distal end of the central tubular member 50 to allow the end effector 12 to be removably coupled to the elongated stem unit 40. The central tubular member 50 can be manufactured from, for example, 6061 or 7075 aluminum, stainless steel, titanium, etc.
The handle unit 100 comprises a handle-like housing that can be manufactured in two or more pieces for assembly purposes. For example, the handle unit 100, as shown, comprises a right cover member 102 and a left cover member (not shown) that are molded or otherwise fabricated from a polymer material or plastic and are designed to flatten together. Such housing members can be joined together by pressure features, plugs and plugs molded or otherwise formed therein and / or by adhesive, screws, etc. The central tubular member 50 has a proximal end 54 having a flange 56 formed therein. The flange 56 is configured to be rotatably supported within a groove 106 formed by paired ribs 108 projecting inwardly from each of the cover members 102, 104. Such an arrangement facilitates the attachment of the central tubular member 50 to the unit. handle 100 while allowing the central tubular member 50 to rotate relative to the handle unit 100 about the longitudinal axis AA in a 360 ° path.
As can be seen further in Figure 1, the central tubular member 50 passes through and is supported by a mounting bushing 60 which is rotatably fixed to the handle unit 100. The mounting bushing 60 has a proximal flange 62 and a distal tab 64 defining a rotating slot 65 that is configured to rotatably receive a tip portion 101 of the handle unit 100 therebetween. Such an arrangement allows the mounting bushing 60 to rotate about the longitudinal axis AA relative to the handle unit 100. The central tubular member 50 is non-rotatably secured to the mounting bushing 60 by a pin of the central tubular portion 66. In addition. , a rotation knob 70 is attached to the mounting bushing 60. For example, the rotation knob 70 has a hollow mounting projection portion 72 that is dimensioned to receive a portion of the mounting bushing 60 therein. The rotation knob 70 can made from, for example, glass or carbon filled with nylon, polycarbonate, Ultem®, etc. and is likewise fixed to the mounting dowel 60 by the central member pin 66. Additionally, an inwardly projecting retaining flange 74 is formed in the mounting flange portion 72 and is configured to extend within a radial groove 68 formed in the mounting sleeve 60. Thus, the surgeon can rotate the central tubular member 50 (and the end effector 12 attached thereto) about the longitudinal axis AA in a 360 ° path by grasping the rotation knob 70 and rotating it in relation to the mango unit 100.
The anvil 20 is retained in an open position by an anvil spring 21 and / or another pressure arrangement. The anvil 20 moves selectively from the open position to various closed positions or clamping and firing by a firing system, generally designated 109. The firing system 109 includes a "firing member" 110 comprising a hollow firing tube 110. The hollow firing tube 110 moves axially in the central tubular member 50 and thus forms the outer portion of the elongated stem unit 40. The firing tube 110 can be made of a polymer or other suitable material and has a proximal end which is attached to a firing bearing 114 of the firing system 109. For example, the firing bearing 114 may be overmoulded to the proximal end of firing tube 110. However, other arrangements of fasteners may be employed.
As can be seen in Figure 1, the firing bearing 114 can be rotatably supported within a support collar 120 which is configured to move axially within the handle unit 100. The support collar 120 has a pair of laterally extending fins which are dimensioned to be slidably received within the fin slots formed in the right cover members and left. A) Yes, the support collar 120 can slide axially within the housing of the handle 100 while allowing the firing bearing 114 and firing tube 110 to rotate relative to it about the longitudinal axis A-A. A longitudinal groove is provided through the firing tube 110 to allow the pin of the central tubular portion 66 to extend therethrough into the central tubular member 50 while facilitating axial displacement of the firing tube 110 in the central tubular member 50.
The firing system 109 further comprises a firing trigger 130 which serves to control the axial displacement of firing tube 110 in the central tubular member 50. See Figure 1. Such axial movement in the distal direction of firing tube 110. in the firing interaction with the anvil 20 it is referred to in the present invention as "firing movement". As can be seen in Figure 1, the firing trigger 130 is movably or rotatably coupled to the handle unit 100 by a pivoting pin 132. A torsion spring 135 is employed to press the firing trigger 130 away from the portion of handle 107 of handle unit 100 to a start or open position not actuated. As can be seen in Figure 1, the firing trigger 130 has an upper portion 134 which is movably connected to (with pin) the connections of trigger 136 which are attached movably (with pin) to the support collar 120. Thus, the movement of the firing trigger 130 from the starting position (Figure 1) to a final position adjacent to the handle portion 107 of the unit of handle 100 will cause the firing bearing 114 and firing tube 110 to move in the distal direction "DD". The movement of the firing trigger 130 away from the handle portion 107 of the handle unit 100 (under the pressure of the torsion spring 135) can cause the firing bearing 114 and firing tube 110 to move in the proximal direction "PD" in the central tubular member 50.
The present invention can be used with different sizes and configurations of implantable staple cartridges. For example, surgical instrument 10, when used in connection with a first trigger adapter 140, can be used with a 5 mm end effector 12 that is approximately 20 mm long (or in other lengths) that supports a cartridge. implantable clips 30. Such size of the end effector may be particularly well suited, for example, to complete vascular transactions and relatively fine dissections. However, as will be described in greater detail below, the surgical instrument 10 may also be employed, for example, other sizes of the end effectors and the staple cartridges by replacing the first trigger adapter 140 with a second adapter Shooting. In a further alternative, the elongated stem unit 40 can be configured to be attached to a single shape or size of the end effector.
A method for removably coupling the end effector 12 to the central tubular member 50 will be explained below. The coupling process is initiated by inserting the retaining stumps 17 into the elongated channel 14 into the base of the trunnions 52 in the central tubular member 50. After that, the surgeon advances the trigger trigger 130 towards the handle 107 of the housing unit 100 for distally advancing the firing tube 110 and the first firing adapter 140 over a proximal end portion 47 of the elongated channel 14 so as to retain the trunnions 17 at their respective bases 52. Such a position of the first Triggering adapter 140 on the trunnions 17 is referred to in the present description as the "coupled position". The present invention may further have an end effector blocking unit for locking the firing trigger 130 in its position after an end effector 12 has been attached to the central tubular member 50.
More specifically, one embodiment of the end effector lock unit 160 includes a latch pin 162 that is movably supported in the upper portion 134 of the firing trigger 130. As discussed above, the firing tube 110, initially , the distal position must be advanced distally, where the first trigger adapter 140 retains the retaining mandrels 17 of the end effector 12 in the bases of the trunnions 52 in the central tubular member 50. The surgeon advances the trigger adapter 140 distally toward the engaged position by pulling the trigger trigger 130 from the home position towards the handle 107. When the trigger trigger 130 is initially actuated, the latch pin 162 moves distally until the firing tube 110 has advanced the first firing adapter 140 toward the engaged position at which the latch pin 162 is moved. presses into a locking cavity 164 formed in the cover member. When the latching pin 162 enters the locking cavity 164, the pin 162 can make an audible "click" or other sound, as well as provide a tactile indication to the surgeon that the end effector 12 has been "locked". on the central tubular member 50. Additionally, the surgeon can not inadvertently continue to operate the firing trigger 130 to initiate staple formation 32 on the end effector 12 without intentionally pressing the latch pin 162 out of the lock cavity 164. Similarly, if the surgeon releases the firing trigger 130 when in the engaged position, it is held in that position by the latching pin 162 to prevent the firing trigger 130 from returning to the starting position and thus releasing the effector. of end 12 of central tubular member 50.
The present invention may further include a lock button of the firing system 137 which is rotatably coupled to the handle unit 100. In one form, the firing button of the firing system 137 has a lock 138 formed in a distal end thereof, which is oriented to engage the firing bearing 114 when the firing release button is in a first closed position. As can be seen in Figure 1, a closing spring 139 serves to press the lock button of the firing system 137 in the first closing position. In various circumstances, the closure 138 serves to engage the firing bearing 114 at a point where the position of the firing bearing 114 in the central tubular member 50 corresponds to a point where the first firing adapter 140 is about to make advancing distally the fastening ramp 28 on the anvil 20. It should be understood that, as the first firing adapter 140 advances axially along the fastening ramp 28, the anvil 20 will move in a path, such that its surface portion of staple forming 22 is substantially parallel to the upper face 36 of the staple cartridge 30.
After the end effector 12 has engaged the central tubular member 50, the staple forming process is first initiated by pressing the locking button of the firing system 137 to allow the firing bearing 114 to move, further, distally in the central tubular member 50 and, finally, compress the anvil 20 inside the staple cartridge 30. After pressing the locking button of the firing system 137, the surgeon continues to actuate the firing trigger 130 towards the handle 107 to drive thus the first staple collar 140 above the corresponding staple forming ramp 29 for forcing the anvil 20 into the forming contact with the staples 32 in the staple cartridge 30. The locking button of the trigger system 137 prevents inadvertent formation of staples 32 until the surgeon is ready to begin that process. In this example, the surgeon must press the lock button on the firing system 137 before the firing trigger 130 can also be operated to begin the staple forming process.
The surgical instrument 10 can be used only as a tissue stapling device if desired. However, the present invention may further include a fabric cutting system, generally designated 170. In at least one form, the fabric cutting system 170 comprises a cutting member 172 that can be selectively advanced from a position. not driven adjacent the proximal end of the end effector 12 to an actuated position to activate a blade advance trigger 200. The cutting member 172 is movably supported within the central tubular member 50 and attached or otherwise protrudes from a cutting rod 180. The cutting member 172 can be manufactured from, for example, 420 or 440 stainless steel with a hardness greater than 38HRC (Rockwell hardness C scale) and has a tissue cutting edge 176 formed at distal end 174 thereof and may be configured to slideably extend through a groove in the anvil 20 and a groove centrally disposed 33 in the staple cartridge 30 for cutting through the tissue that is clamped in the end effector 12. The cutter rod 180 extends through the central tubular member 50 and has a proximal end portion that interacts and drives a cutting transmission that is operatively linked to the blade advance trigger 200. The blade advance trigger 200 is attached to a pivoting pin 132, such that it can be rotated or otherwise activate without triggering the trigger trigger 130. A first cutting gear 192 is furthermore attached to pivoting pin 132, so that the activation of the knife advance trigger 200 also rotates the first cutting gear 192. A return spring The trigger 202 is joined between the first cutting gear 192 and the handle housing 100 for pressing the knife advance trigger 200 to a non-driven or starting position.
The cutting transmission further includes a second cutting gear 194 which is rotatably supported on a second gear spindle and on a gear coupling with the first cutting gear 192. The second cutting gear 194 is in gear coupling 194. gear with a third cutting gear 196 which is supported on a third gear spindle. Further, supported on the third engagement spindle 195 is a fourth cutting engagement 198. The fourth engagement engagement 198 is adapted to drive engage a series of annular meshing teeth or rings at a proximal end of the cutting rod 180. Thus, such an arrangement allows the fourth cutting gear 198 to axially drive the cutting rod 180 in the distal direction "DD" or the proximal direction "PD" while allowing the firing rod 180 to rotate about the longitudinal axis AA with with respect to the fourth cutting gear 198. Accordingly, the surgeon can axially advance the firing rod 180 and, finally, the cutting member 172 distally by pulling the blade advancing trigger 200 towards the handle 107 of the handle unit 100. .
The present invention may further include a cutting lock system 210 which prevents advancement of the cutting member 172 unless that the firing trigger 130 has been pulled to the fully fired position. Such a feature will, therefore, prevent the activation of the cutting advance system 170 unless the staples have first been fired or formed within the tissue. As can be seen in Figure 1, various implementations of the cut lock system 210 comprise a knife lock bar 211 that is rotatably supported within the handle portion 107 of the handle unit 100. The lock bar of the blade 211 has an activation end 212 which is adapted to be engaged by the firing trigger 130 when the firing trigger 130 is in the fully fired position. Additionally, the blade locking bar 211 has a retaining hook 214 at its other end that is adapted to hook a hook 216 in the first cutting engagement 192. A cut-off spring 218 is provided in the form of a hook. used to press the blade locking bar 211 into a "locked" position, wherein the retaining hook 214 is retained in engagement with the locking rod 216 to thereby prevent activation of the blade advance trigger 200 unless firing trigger 130 is in the fully fired position.
After the staples have been "fired" (formed) into the target tissue, the surgeon can press the firing trigger release button 167 to allow the firing trigger 130 to return to the start position under the torsion spring pressure. 135, which allows the anvil 20 to be pressed in an open position under the pressure of the spring 21. When in the open position, the surgeon can remove the end effector 12 when leaving the implantable staple cartridge 30 and staples 32 behind. In applications where the end effector was inserted through a passage, working channel, etc. the surgeon will return the anvil 20 to the closed position by actuating the firing trigger 130 to allow the end effector 12 to be pulled out through the working passage or channel. If, however, the surgeon wishes to cut the target tissue after firing the staples, the surgeon activates the knife advance trigger 200 in the manner described above to operate the knife bar 172 through the target tissue to the end of the effector. of end. Thereafter, the surgeon can release the blade advance trigger 200 to allow the return spring of the trigger 202 to cause the transmission of the shot to return the blade bar 172 to the start (not actuated) position. Once the knife bar 172 has been returned to the starting position, the surgeon can open the end effector clamps 13, 15 to release the implantable cartridge 30 within the patient and then remove the end effector 12 from the patient. Thus, such surgical instruments facilitate the use of small implantable staple cartridges that can be inserted through relatively smaller passages and working channels, while providing the surgeon with the option to shoot the staples without cutting tissue or if desired, in addition , cut the tissue after the staples have been fired.
Several novel and unique embodiments of the present invention employ a compressible staple cartridge that supports the staples in a substantially stationary position for the forming contact by the anvil. The anvil is driven into the unformed staples where, for example, the degree of staple formation achieved depends on how far the anvil is driven within the staples. Such an arrangement provides the surgeon with the ability to adjust the amount of firing or forming pressure applied to the staples and thus alter the final formed height of the staples. In other embodiments of the present invention, surgical stapling arrangements can employ staple driving elements that can elevate the staples towards the anvil. Such modalities are described in more detail below.
With respect to the embodiments described in detail above, the amount of firing movement that is applied to the moving anvil depends on the degree of firing of the firing trigger. For example, if the surgeon wishes to achieve only partially formed staples, then the trigger trigger is only partially pressed into the handle 107. To achieve the formation of more staples, the surgeon simply compresses the trigger trigger further so that which results in the anvil being driven further towards the forming contact with the staples. As used in the present description, the term "forming contact" means that the staple forming surface or the staple forming cavities have come into contact with the ends of the staple legs and have begun to form or bend the legs in a formed position. The degree of staple formation refers to the extent to which the legs of the staples have been bent and, finally, refers to the staple formation height as referenced above. The experts in the field they will further understand that, since the anvil 20 moves in a substantially parallel relationship with respect to the staple cartridge when the firing motions are applied to it, the staples are formed substantially simultaneously with substantially the same formed heights.
Figures 2 and 3 illustrate an alternative end effector 12"which is similar to the end effector 12 'described above, except with the following differences which are configured to accommodate a knife bar 172' The knife bar 172 'engages ao protrudes from a cutting rod 180 and is operated in another manner in the manner described above with respect to the knife bar 172. However, in this embodiment, the knife bar 172 'is long enough to traverse the full length of end effector 12"and, therefore, a separate distal cutting member is not employed in end effector 12." Cutter bar 172 'has an upper transverse member 173' and a lower transverse member 175 'formed The upper transverse member 173 'is transversely transversely oriented to a corresponding elongated slot 250 in the anvil 20"and the lower transverse member 175' is oriented to traverse an elongated slot 252 in the elongated channel 14"of the end effector 12". A decoupling slot (not shown) is further provided on the anvil 20"such that when the knife bar 172 'has been driven into a final position with the fine end effector 12", the upper transverse member 173 'is dropped through the corresponding slot for allowing the anvil 20"to move toward the open position to decouple the cut and stapled tissue. The anvil 20"may otherwise be identical to the anvil 20 described above and the elongated channel 14" may otherwise be identical to the elongated channel 14 described above.
In these embodiments, the anvil 20"is pressed in a fully open position (Figure 2) by a spring or other opening arrangement (not shown). The anvil 20"moves between the positions fully clamped and opened by the axial displacement of the firing adapter 150 in the manner described above. Once the firing adapter 150 has advanced to the fully clamped position (Figure 3), the surgeon can then advance the blade bar 172"distally in the manner described above. If the surgeon wishes to use the end effector as a grasping device for manipulating the tissue, the firing adapter can be moved proximally to allow the anvil 20 to "move out of the elongate channel 14" as shown in Figure 4 in dashed lines. In this example, when the knife bar 172"moves distally, the upper transverse member 173 'and the lower transverse member 175' remove the anvil 20" and the elongated channel 14"together to achieve the desired staple formation when the blade bar 172"is advanced distally through end effector 12". See Figure 5. Thus, in this embodiment, the staple formation occurs simultaneously with the tissue cut, but the staples themselves can be sequentially formed when the knife bar 172"is operated distally.
The novel and unique features of the various surgical staple cartridges and surgical instruments of the present invention allow the staples in those cartridges to be arranged in one or more linear or non-linear lines. A plurality of such staple lines may be provided on each side of an elongated slot that is centrally disposed within the staple cartridge to receive the tissue cutting member therethrough. In an arrangement, for example, the staples in a line may be substantially parallel with the adjacent staples (s) of staples, but displaced from them. In a further embodiment, one or more staple lines may be non-linear in nature. That is, the base of at least one staple in a staple line may extend along an axis that is substantially transverse to the bases of other staples in the same staple line. For example, as will be discussed in more detail below, in alternative embodiments, the staple lines on each side of the elongated slot may have a zigzag appearance. Such non-linear staple arrays can achieve better tissue holding results with fewer staples than several arrays of linear staples used in previous staple cartridges.
Figure 6 illustrates the use of a surgical staple cartridge embodiment 900 in an end effector mode 612 '. As can be seen in Figures 6 and 7, one embodiment of the surgical staple cartridge 900 has a cartridge body 902 having a centrally disposed elongated slot 904 extending through one end proximal 903 to an area adjacent a distal end 905. The elongated slot 904 is configured to allow a cutting body to move axially therethrough during a tissue cutting operation in the manner described above. The cartridge body 902 consists of a compressible hemostatic material such as, for example, oxidized regenerated cellulose ("ORC") or a bioabsorbable foam made of, for example, PGA (polyglycolic acid, sold under the trademark Vicryl), PCL ( polycaprolactone), PLA or PLLA (polylactic acid), PDS (polydioxanone), PHA (polyhydroxyalkanoate), PGCL (polygallecapronate 25, sold under the trademark Monocryl) or a compound of PGA, PCL, PLA and PDS in which the lines 920, 930 of the unformed staples 922. However, the cartridge body 902 can be made of other materials that serve to support the unformed staples 922 in a desired orientation such that they can be compressed when the anvil 910 ' get in touch with these. As with other embodiments already described, the staple cartridge 900 is implantable and left attached to the stapled tissue after the stapling procedure has been completed. In order to prevent the staples 922 from being affected and the hemostatic material being activated during the insertion and positioning process, the entire cartridge 900 can be coated or wrapped in a biodegradable film 906 such as a polydioxanone film sold under the registered trademark PDS ® or with a film of polyglycerol sebacate (PGS) or other biodegradable films made of, for example, PGA (polyglycolic acid, marketed under the trademark Vicryl), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (polyhydroxyalkanoate), PGCL (polygallecapronate 25, sold under the trademark Monocryl) or a compound of PGA, PCL, PLA, PDS which It would be waterproof until the break. The cartridge body 902 of the staple cartridge 900 is sized to be removably supported within the elongated channel of the end effector 612 '.
In Figures 6, 10, and 11, the surgical staple cartridge 900 operatively supports a first line 920 of the staples 922 on one side side 907 of the elongated slot 904 and a second line 930 of the staples 922 on the other side side 909 of the elongated slot 904. The staples 922 can be made of a metallic material such as, for example, titanium, titanium alloys (for example, Titanium 6AI-4V, Titanium 3AI-2.5V), stainless steel, etc. and may have a staple base 924 and two straight staple legs 926 projecting therefrom. Each staple leg 926 may have a tissue piercing tip 928 formed therein. In the first line 920 of the staples 922, the staple base 924 of at least one staple 922 is superimposed on the staple base of another staple 922. In a preferred embodiment, the staple base 924 of each staple 922 is superimposed on the staple base 924. the staple bases 924 of two adjacent staples 922, except for the base 924 of the last staple 922 at each end of the first staple line 920. See FIG. 10. Thus, the first staple line 920 has a substantially non-uniform shape. linear. More particularly, when looking from above, the first line of staples 920 has a substantially zigzag appearance.
As can be seen in Figure 9, the anvil 90 has two sequential longitudinal staple forming cavities 912 that each have a substantial zigzag shape that corresponds to the shape of the first line 920 of the staples 922 such that, when the anvil 910 is brought into formation contact with the staples 922, the legs 926 of which are formed as shown in Figure 11. Thus, the distal leg of a staple shares the same cavity as the proximal leg of the next staple longitudinally. Such an arrangement allows a denser cavity pattern, even at a point where the staples themselves interact (for example, they bend over each other). In prior staple cavity arrangements, generally, there should be between 0.13 and 0.38 mm (0.005 and 0.015 inches) of metal / distance from one set of cavities to the next. This embodiment of the present invention, however, has a separation arrangement of 0 to 0.5 mm (0 to 0.02 inches) of interference / overlap (essentially -0.5 mm (-0.020")) because, for example, a staple is coupled with the next staple. Such arrangements allow 15-30% more staples in the same space. Also, when the staples are intertwined, there is less need for multiple side rows of staples. The above arrangements commonly use three rows on each side of the tissue cutting line to avoid the existence of an open passage through which blood can pass. The staple lines of interlacing are less likely to leave passages through which blood can pass. Another distinct advantage provided by the various interlacing staple arrangements of the present invention relates to the improved "burst strength" which refers to the amount of force required to tear open an open staple line.
Another arrangement of staple-forming cavities may comprise a common staple-forming cavity. As used in the present description, the term "common staple forming cavity" means that a forming cavity can form all the staples in a single line of staples as opposed to previous anvil designs, wherein a cavity of discrete formation it is provided for each leg of each staple that is formed.
Figure 12 illustrates still another staple embodiment 922 ', wherein the base 924' has a displaced portion 929 to facilitate a tighter overlay of the bases 924 '. As indicated above, the staple cartridge 900 has a second line 930 of the staples 922 supported on a second side side 909 of the elongated slot 904. The second line 930 of the staples 922 is substantially identical to the first line 920 of the staples. staples 922. Thus, the anvil 910 has a second common staple forming cavity 912 corresponding to the second staple line 930 for the forming contact with these. Alternatively, however, the second line 930 of the staples 922 may differ from the first line 920 of staples in the shape and, perhaps, in the number of staples.
Figure 8 illustrates a surgical staple cartridge 900 'that is substantially identical to staple cartridge 900 described above, with the exception of lines 920', 930 'of staples 922 supported therein. For example, in this embodiment, the line 920 'of the staples 922 is disposed relative to one another, such that a base axis SS of at least one staple base 924 is substantially transverse to the base axis SS of the staple base 924 of at least one other adjacent staple 922. Such a predetermined pattern of staples, when viewed from above, comprises a substantially zigzag array. In Figure 13, the respective bases 924 of the staples 922 may additionally have a base support member 927 overmolded therein as shown. The base support member 927 can be manufactured from, for example, a nonabsorbable plastic such as polyether ether ketone "PEEK" or an absorbable plastic such as, for example, polyglycolic acid "PGA", polylactic acid "PLA" or "PLLA", polydioxanone "PDS", PCL (polycaprolactone ), PHA (polyhydroxyalkanoate), polyglycerol sebacate (PGS), PGCL (polygallecapronate 25, marketed under the trademark of Monocryl) or various mixtures of compounds of PGS, PDS, PLA, PGA, and PCL. The base support members 927 facilitate interlacing between the staples without causing the staples themselves to overlap. Thus, such arrangements could form staples with "B" shapes or inverted "W" shapes without the legs of the staples themselves overlapping. However, the crowns are connected by the base support members to act as staples that are overlap Such arrangements allow the combined cavities to have two discrete passages for each leg.
The embodiment shown in Figure 14 employs a staple line 920", where the legs 926 of the adjacent staples 922 are coupled together by a coupling portion 929 molded or otherwise attached to it. for example, polyether ether ketone "PEEK" or absorbable plastic such as, for example, polyglycolic acid "PGA", polylactic acid "PLA" or "PLLA", polydioxanone "PDS", PCL (polycaprolactone), PHA (polyhydroxyalkanoate), PGCL (polyglecapronate 25, sold under the trademark Monocryl) or various mixtures of compounds of PGS, PDS, PLA, PGA, and PCL Such a staple line 920"has substantial zigzag appearance when viewed from above While the various embodiments of the Surgical staple cartridges 900, 900 'have been explained with reference to use with the end effector 612', it should be understood that the staple cartridges 900, 900 'can be effectively used with various ot end effectors and surgical instruments described hereinbefore, with arrangements of appropriate staple forming cavities provided in the anvils of those instruments to achieve the desired amount of staple formation after the movement of the anvils towards contact of training with staples.
Figures 15 and 16 illustrate another embodiment of surgical staple cartridge 940 supported in an elongated channel 14 of a surgical instrument 10. The surgical staple cartridge 940 includes a cartridge body 942 having a centrally disposed elongated slot 944 extending at least partially therethrough. The elongate slot 944 is configured to allow a cutting body of the surgical instrument 10 to move axially therethrough during a tissue cutting operation in the manner described above. The cartridge body 942 consists of a compressible hemostatic material such as, for example, oxidized regenerated cellulose ("ORC") or a bioabsorbable foam of the types described above or below in which lines 946, 948, 950 are supported, 952 of the unformed staples 922. In order to prevent the staples 922 from being affected and the hemostatic material being activated during the insertion and positioning process, the complete cartridge 940 can be coated or wrapped in a biodegradable film 954 such as a film. of polydioxanone sold under the trademark PDS® or with a polyglycerol sebacate film (PGS) or other biodegradable films made of, for example, PGA (polyglycolic acid, marketed under the trademark Vicryl), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (polyhydroxyalkanoate), PGCL (polygallecapronate 25, sold under the trademark Monocryl) or a compound of PGA, PCL, PLA, PDS that would be waterproof until the break.
In Figure 15, the cartridge 940 further includes a cartridge support member 960 which is coupled to the cartridge body 942. The cartridge support member 960 may be made of a rigid material such as, for example, titanium, steel stainless steel, aluminum, any alloy of the above, etc. and can be partially incorporated into the body of the cartridge 942. The cartridge support member 960 may be held in place, for example, by film 954. In alternative cases where limited binding is desired, the sporadic use of cyanoacrylate could be used to "glue" the two components together. In further alternatives, the cartridge body 942 can be heated and "welded" or "fused" to the cartridge support member 960. The cartridge support member 960 forms at least a portion of the lower surface of the cartridge body 942 for coupling with the elongate channel 14. The cartridge support member 960 has one or more snaps 962 protruding from there to removably couple the cartridge support member 960 to the elongate channel 14. Other forms of fastener / element arrangements of pressure can be used to removably couple the cartridge support member 960 to the elongate channel 14.
The cartridge support member 960 has a series of support frames 964, 966, 968, 970, 972, 974, 976 formed therein to provide some lateral support to the bases 924 of the 922 staples in the 946 staple lines , 948, 950, 952 as shown in Figure 15. Thus, as an example, the support frames are substantially coextensive with the staple lines. Figure 17 illustrates an alternative embodiment of the staple cartridge 940 'which is substantially identical to the cartridge 940, except for the inclusion of the straight fin portions 978, 979, 980, 981, 982, 983 protruding from the support frames 964 , 966, 968, 970, 972, 976, respectively to provide additional lateral support to the staples 922. The fin portions can be formed integrally with the support member of the staple. 960 cartridge and have a height that is about ½ or less of the height of the cartridge. Thus, for example, any erect feature supporting the foam can not extend above the maximum compression height of the foam. Thus, if the cartridge is designed, for example, to be compressed to 1/3 of its original height when fired, the fins would be between 66% of the uncompressed height, and up to eMO% of the uncompressed height.
In use, once the staples 922 have been formed through contact with the anvil 20 in the manner described above, the anvil 20 is opened and the end effector 12 is pulled out of the stapled tissue. When the end effector 12 is pulled out of the stapled tissue, the cartridge body 942 remains attached to the stapled tissue and is then separated from the cartridge holder member 960 which remains coupled to the elongated channel 14. The cartridge support member 960 is provides a color different from the color of the material comprising the cartridge body 942 as well as the color of the elongate channel 14. Such an arrangement provides the surgeon with an easily recognizable indication that no staple cartridge is present within the end effector. Thus, the surgeon will not inadvertently attempt to reinsert / use the end effector without first installing a new staple cartridge in it. For this, the surgeon simply disconnects the pressure elements from the cartridge support member 960 from the elongate channel 14 to allow the cartridge holder member 960 of a new staple cartridge 940 to be placed therein. While the staple cartridges 940, 940 'have been explained with reference to the surgical instrument 10, it should be understood that such cartridges can be effectively employed with many of the other embodiments of surgical instruments described herein without departing from the spirit and scope of the present invention.
A staple cartridge may comprise a cartridge body and a plurality of staples stored within the cartridge body. In use, the staple cartridge can be inserted into a surgical site and positioned on one side of the tissue being treated. Additionally, a staple forming anvil can be positioned on the opposite side of the fabric. The anvil can be moved by a first clamp and the staple cartridge can be moved by a second clamp, wherein the first clamp and / or the second clamp can move towards the other. Once the staple cartridge and the anvil have been positioned relative to the tissue, the staples can be ejected from the body of the staple cartridge, such that the staples can pierce the tissue and come in contact with the staple forming anvil . Once the staples have been unfolded from the body of the staple cartridge, the body of the staple cartridge can then be removed from the surgical site. As described in the present invention, a staple cartridge, or at least a portion of a staple cartridge, may be implanted with the staples. For example, as described in greater detail below, a staple cartridge may comprise a cartridge body that can be compressed, crushed, and / or folded by the anvil when the anvil moves from an open position to a closed position. When the body of the cartridge is compressed, it collapses, and / or is folded, staples positioned within the cartridge body can be deformed by the anvil. Alternatively, the clamp supporting the staple cartridge can move toward the anvil in a closed position. In any case, the staples may deform while at least partially positioned within the body of the cartridge. The staples can not be ejected from the staple cartridge although the staples can be ejected from the staple cartridge along with a portion of the cartridge body.
Referring now to Figures 18A to 18D, a compressible staple cartridge, such as staple cartridge 1000, for example, may comprise a compressible implantable cartridge body 1010 and, in addition, a plurality of staples 1020 positioned in the body of the cartridge. compressible cartridge 1010, although only one staple 1020 is shown in Figures 18A to 18D. Figure 18A illustrates the staple cartridge 1000 supported by a staple cartridge holder, or staple cartridge channel, 1030, wherein the staple cartridge 1000 is illustrated in an uncompressed condition. In such an uncompressed condition, the anvil 1040 may or may not be in contact with the tissue T. In use, the anvil 1040 may move from an open position toward contact with the tissue T as illustrated in Figure 18B and position the tissue. T against the body of the cartridge 1010. Even though the anvil 1040 can position the tissue T against a tissue contacting surface 1019 of the staple cartridge body 1010, again referring to FIG. 18B, the body of the cartridge 1010 staples can be subjected to little, if any, compression force or pressure at such point and the staples 1020 may remain in an untriggered or unformed condition. As illustrated in Figures 18A and 18B, the staple cartridge body 1010 may comprise one or more layers and the staple legs 1021 of the staples 1020 may extend upwardly through these layers. The cartridge body 1010 may comprise a first layer 1011, a second layer 1012, a third layer 1013, wherein the second layer 1012 may be positioned between the first layer 1011 and the third layer 1013, and a fourth layer 1014, wherein the third layer 1013 can be positioned between second layer 1012 and fourth layer 1014. Bases 1022 of staples 1020 can be positioned within cavities 1015 in fourth layer 1014 and staple legs 1021 can extend upwardly from bases 1022 and through the fourth layer 1014, the third layer 1013, and the second layer 1012, for example. Each deformable leg 1021 may comprise a tip, such as the sharp tip 1023, for example, which may be positioned in the second layer 1012, for example, when the staple cartridge 1000 is in an uncompressed state. For example, the tips 1023 may not extend into and / or through the first layer 1011, where the tips 1023 may not protrude through the tissue contacting surface 1019 when the staple cartridge 1000 is in a condition not compressed Alternatively, the sharpened tips 1023 can be positioned in the third layer 1013, and / or in any other suitable layer, when the staple cartridge is in an uncompressed state. Alternatively, a body of the cartridge of a Staple cartridge can have any suitable number of layers such as less than four layers or more than four layers, for example.
As described in more detail below, the first layer 1011 may comprise a reinforcing material and / or plastic material, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), for example, and the second layer 1012 may comprise a bioabsorbable foam material and / or a compressible hemostatic material, such as oxidized regenerated cellulose (ORC), for example. One or more of the first layer 1011, the second layer 1012, the third layer 1013, and the fourth layer 1014 can hold the staples 1020 within the body of the staple cartridge 1010 and, additionally, keeping the staples 1020 in alignment with each other. The third layer 1013 may comprise a reinforcing material, or an almost incompressible or inelastic material, which may be configured to hold the staple legs 1021 of the staples 1020 in their mutual relative position. In addition, the second layer 1012 and the fourth layer 1014, which are positioned on opposite sides of the third layer 1013, can stabilize, or reduce the movement of, the staples 1020 even when the second layer 1012 and the fourth layer 1014 can be comprised of an elastic or compressible foam material. The staple tips 1023 of the staple legs 1021 can at least partially be embedded in the first layer 1011. For example, the first layer 1011 and the third layer 1013 can be configured to cooperatively and firmly hold the staple legs 1021 in their positions. Each of the first layer 1011 and the third layer 1013 can be comprised of a sheet of bioabsorbable plastic, such as polyglycolic acid (PGA) which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL) which is marketed under the name commercial of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example, and each of the second layer 1012 and the fourth layer 1014 may comprise at least one material or hemostatic agent.
Although the first layer 1011 may be compressible, the second layer 1012 may be substantially more compressible than the first layer 1011. For example, the second layer 1012 may be approximately two times more compressible, approximately three times more compressible, approximately four times more compressible , approximately five times more compressible, and / or approximately ten times more compressible, for example, than the first layer 1011. Indicated otherwise, the second layer 1012 may be compressed approximately twice, approximately three times, approximately four times, approximately five times. times, and / or about ten times more than the first layer 1011, for a given force. The second layer 1012 may be between about twice as compressible and about ten times as compressible, for example, as the first layer 1011. The second layer 1012 may comprise a plurality of voids with air defined therein, wherein the amount y / or the size of the voids with air in the second layer 1012 can be controlled in order to provide a desired compressibility of the second layer 1012. Similar to the previous one, although the third layer 1013 may be compressible, the fourth layer 1014 may be substantially more compressible than the third layer 1013. For example, the fourth layer 1014 may be approximately two times more compressible, approximately three times more compressible, approximately four times more compressible, approximately five times more compressible, and / or approximately ten times more compressible, for example, than third layer 1013. Indicated otherwise, fourth layer 1014 may be compressed approximately twice, approximately three times, approximately four times, approximately five times, and / or approximately ten times more than the third layer 1013, for a given force. The fourth layer 1014 may be between approximately twice as compressible and approximately ten times more compressible, for example, than the third layer 1013. The fourth layer 1014 may comprise a plurality of air voids defined therein, wherein the amount y / or size of the air voids in the fourth layer 1014 can be controlled to provide a desired compression capability of the fourth layer 1014. In various circumstances, the compressibility of a cartridge body, or cartridge body layer, can be expressed in terms of a compression ratio, that is, a distance in which a layer is compressed for a given amount of force. For example, a layer that has a high compression ratio will compress a greater distance for a given amount of compression force applied to the layer compared to a layer that has a lower compression ratio. That said, the second layer 1012 may have a higher compression ratio than the first layer 1011 and, similarly, the fourth layer 1014 may have a higher compression ratio than the third layer 1013. The second layer 1012 and the fourth layer 1014 may comprise the same material and may comprise the same compression ratio. The second layer 1012 and the fourth layer 1014 may comprise materials having different compression rates. Similarly, the first layer 1011 and the third layer 1013 can be comprised of the same material and can comprise the same compression index. The first layer 1011 and the third layer 1013 may comprise materials having different compression rates.
When the anvil 1040 moves to its closed position, the anvil 1040 can come into contact with the tissue T and apply a compressive force to the tissue T and the staple cartridge 1000, as illustrated in FIG. 18C. In such circumstances, the anvil 1040 may push the upper surface, or tissue contacting surface 1019, of the cartridge body 1010 downwardly of the staple cartridge holder 1030. The staple cartridge holder 1030 may comprise a supporting surface of the cartridge 1031, which can be configured to support the staple cartridge 1000 when the staple cartridge 1000 is compressed between the cartridge support surface 1031 and the tissue contact surface 1041 of the anvil 1040. Due to the pressure applied by the anvil 1040, the cartridge body 1010 can be compressed and the anvil 1040 can come into contact with the staples 1020. More particularly, the compression of the cartridge body 1010 and the downward movement of the tissue contacting surface 1019 can cause the tips 1023 of the staple legs 1021 to pierce the first layer 1011 of the cartridge body. 1010, pierce the tissue T, and enter the forming cavities 1042 in the anvil 1040. When the body of the cartridge 1010 is further compressed by the anvil 1040, the tips 1023 can come into contact with the walls defining the cavities 1042 and, as a result, the legs 1021 can deform or curl inwards, for example, as illustrated in Figure 18C. When the staple legs 1021 deform, as illustrated, in addition, in Figure 18C, the bases 1022 of the staples 1020 may come into contact with or be supported by the staple cartridge holder 1030. As described in more detail below , the staple cartridge holder 1030 may comprise a plurality of support elements, such as grooves, grooves, or staple support channels 1032, for example, which may be configured to support staples 1020, or at least bases 1022 of the staples 1020, while the staples 1020 are deformed. As illustrated, furthermore, in Figure 18C, the cavities 1015 in the fourth layer 1014 can be folded as a result of the compression force applied to the body of the staple cartridge 1010. In addition. to the cavities 1015, the staple cartridge body 1010 may further comprise one or more voids, such as voids 1016, for example, which may or may not comprise a portion of a staple positioned a in these, which can be configured to allow the body of the 1010 cartridge fold. The cavities 1015 and / or the voids 1016 can be configured to be folded so that the walls defining the cavities and / or the walls deviate downwardly and come into contact with the supporting surface of the cartridge 1031 and / or come into contact with a body layer of the cartridge 1010 positioned below the cavities and / or voids.
After comparing Figure 18B and Figure 18C, it is evident that the second layer 1012 and the fourth layer 1014 have been compressed substantially by the compression pressure applied by the anvil 1040. It can also be noted that the first layer 1011 and the third layer 1013 have been compressed too. When the anvil 1040 moves to its closed position, the anvil 1040 can continue to further compress the cartridge body 1010 by pushing the tissue contacting surface 1019 downwardly of the staple cartridge holder 1030. When the Cartridge body 1010 is further compressed, anvil 1040 can deform staples 1020 in its fully formed form as illustrated in Figure 18D. With reference to Figure 18D, the legs 1021 of each staple 1020 can be deformed downward from the base 1022 of each staple 1020 to capture at least a portion of the tissue T, the first layer 1011, the second layer 1012, the third layer 1013 , and the fourth layer 1014 between the deformable legs 1021 and the base 1022. After comparing Figures 18C and 18D, it is further evident that the second layer 1012 and the fourth layer 1014 have been substantially compressed, furthermore, by the pressure of compression applied by the anvil 1040. It can also be noted after comparing Figures 18C and 18D that the first layer 1011 and the third layer 1013 have been compressed even more. After the staples 1020 have been formed completely, or at least sufficiently, the anvil 1040 may rise out of the tissue T, and then the staple cartridge holder 1030 may move outward, and / or peel off, the staple cartridge 1000 As shown in Figure 18D, and as a result of the foregoing, the body of the cartridge 1010 can be implanted with the staples 1020. In various circumstances, the body of the implanted cartridge 1010 can support the tissue along the line of staples. . In some circumstances, a hemostatic agent, and / or any other suitable therapeutic medicament, contained within the body of the implanted cartridge 1010 can treat the tissue with the passage of time. A hemostatic agent, as mentioned above, can reduce bleeding of stapled and / or cut tissue while a binding agent or tissue adhesive can provide tissue resistance over time. The body of the implanted cartridge 1010 may comprise materials such as ORC (regenerated oxidized cellulose), extracellular proteins such as collagen, polyglycolic acid (PGA) which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone ( PDS), polyhydroxyalkanoate (PHA), polygallecapronate 25 (PGCL) which is marketed under the trade name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, by example. In certain circumstances, the cartridge body 1010 may comprise an antimicrobial and / or antibiotic material, such as colloidal silver and / or triclosan, for example, which may reduce the possibility of infection at the surgical site.
The body layers of the cartridge 1010 can be connected to each other. The second layer 1012 can adhere to the first layer 1011, the third layer 1013 can adhere to the second layer 1012, and the fourth layer 1014 can adhere to the third layer 1013 with the use of at least one adhesive, such as fibrin and / or a protein hydrogel, for example. Although not illustrated, the body layers of the cartridge 1010 can be connected together by mechanical interlacing elements. For example, each of the first layer 1011 and the second layer 1012 may comprise the corresponding interlacing elements, such as a tongue and groove arrangement and / or a dovetail joint arrangement, for example. Similarly, the second layer 1012 and the third layer 1013 each may comprise corresponding interlacing elements while the third layer 1013 and the fourth layer 1014 each may comprise corresponding interlacing elements. Although not illustrated, the staple cartridge 1000 may comprise one or more rivets, for example, which may extend through one or more layers of the cartridge body 1010. For example, each rivet may comprise a first end, or head , positioned adjacent the first layer 1011 and a second head positioned adjacent the fourth layer 1014 which can either be assembled to or formed by a second end of the rivet. Due to the compressible nature of the cartridge body 1010, the rivets can compress the cartridge body 1010 so that the heads of the rivets can be lowered relative to the contact surface with the cartridge. tissue 1019 and / or lower surface 1018 of cartridge body 1010, for example. For example, the rivets may be comprised of a bioabsorbable material, such as polyglycolic acid (PGA), which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 ( PGCL), which is marketed under the trade name Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. The body layers of the cartridge 1010 may not be connected to each other except for the staples 1020 contained therein. For example, frictional engagement between the staple legs 1021 and the cartridge body 1010, for example, can hold together the body layers of the cartridge 1010 and, once the staples have been formed, the layers can be captured within the staples 1020. At least a portion of the staple legs 1021 may comprise a rough surface or a rough coating which may increase the frictional forces between the staples 1020 and the body of the cartridge 1010.
As described above, a surgical instrument may comprise a first clamp including the staple cartridge holder 1030 and a second clamp including the anvil 1040. As described in greater detail below, the staple cartridge 1000 may comprise one or further retention features which can be configured to engage the staple cartridge holder 1030 and, as a result, releasably retain the staple cartridge 1000 to the staple cartridge holder 1030. The staple cartridge 1000 it can be adhered to the staple cartridge holder 1030 by at least one adhesive, such as fibrin and / or a protein hydrogel, for example. In use, in at least one circumstance, especially in laparoscopic and / or endoscopic surgery, the second clamp can be moved within a closed position opposite to the first clamp, for example, in such a way that the first and second clamps can be inserted into the clamp. crossing a trocar inside a surgical location. For example, the trocar can define an opening or cannula, of approximately 5 mm, through which the first and second clamps can be inserted. The second clamp can be moved to a partially closed position intermediate between the open position and the closed position which can allow the first and second clamps to be inserted through the trocar without deforming the staples 1020 contained in the staple cartridge body 1010 For example, the anvil 1040 may not apply a compressive force to the staple cartridge body 1010 when the second clamp is in its partially closed intermediate position although, alternatively, the anvil 1040 may compress the staple cartridge body 1010 when the second clamp is in its partially closed intermediate position. Even though the anvil 1040 can compress the staple cartridge body 1010 when it is in such an intermediate position, the anvil 1040 may not sufficiently compress the staple cartridge body 1010, such that the anvil 1040 comes in contact with the staples 1020 and / or, in such a manner that the staples 1020 are deformed by the anvil 1040. Once the First and second clamps have been inserted through the trocar into the surgical location, the second clamp can be opened once more and anvil 1040 and staple cartridge 1000 can be positioned relative to the target tissue as described above.
Referring now to Figures 19A to 19D, an end effector of a surgical stapler may comprise an implantable staple cartridge 1100 positioned between an anvil 1140 and a staple cartridge holder 1130. Similar to the foregoing, the anvil 1140 may comprise a tissue contacting surface 1141, the staple cartridge 1100 may comprise a tissue contacting surface 1119, and the staple cartridge holder 1130 may comprise a support surface 1131, which may be configured to support the staple cartridge 1100. With reference to Figure 19A, the anvil 1140 can be used to position the tissue T against the tissue contacting surface 1119 of the staple cartridge 1100 without deforming the staple cartridge 1100 and, when the anvil 1140 is in such a position , the tissue contacting surface 1141 can be positioned a distance 1101a away from the surface of the staple cartridge holder 1131 and the coater surface. In contact with the fabric 1119 a distance 1102a can be positioned away from the surface of the staple cartridge holder 1131. After that, when the anvil 1140 moves towards the staple cartridge holder 1130, now referring to Figure 19B, the anvil 1140 can push the top surface, or the tissue contacting surface 1119, of the staple cartridge 1100 downward and compress the first layer 1111 and the second layer 1112 of the cartridge body 1110. When the layers 1111 and 1112 are compressed, again with reference to Figure 19B, the second layer 1112 can be squashed and the legs 1121 of the clips 1120 can pierce the first layer 1111 and enter the tissue T For example, the staples 1120 can be positioned at least partially within the staple pockets, or the voids, 1115 in the second layer 1112 and, when the second layer 1112 is compressed, the staple pockets 1115 can be folded and, as a result , allowing the second layer 1112 to be folded around the staples 1120. The second layer 1112 may comprise the liner portions 1116, which may extend over the staple pockets 1115 and enclose, or at least partially enclose, the staple cavities 1115 Figure 19B illustrates the liner portions 1116 collapsing downwardly within the staple pockets 1115. The second layer 1112 may comprise one or more weakened portions. which may facilitate folding of the second layer 1112. Such weakened portions may comprise dot markings, perforations, and / or thin cross-sections, for example, which can facilitate a controlled folding of the cartridge body 1110. The first layer 1111 can comprising one or more weakened portions, which can facilitate the penetration of the staple legs 1121 through the first layer 1111. Such weakened portions may comprise dot marks, perforations, and / or thin cross sections, for example, which may be aligned , or at least substantially aligned, with staple legs 1121.
When the anvil 1140 is in a partially closed non-fired position with reference again to Figure 19A, the anvil 1140 can be positioned a distance 1101a away from the cartridge supporting surface 1131 such that an opening is defined therebetween. This opening can be filled by the staple cartridge 1100, which has a staple cartridge height 1102a, and the tissue T. When the anvil 1140 moves downward to compress the staple cartridge 1100, again referring to FIG. 19B, the distance between the contact surface with the fabric 1141 and the support surface of the cartridge 1131 can be defined by a distance 1101b that is smaller than the distance 1101a. In various circumstances, the opening between the contact surface with the tissue 1141 of the anvil 1140 and the cartridge support surface 1131, defined by the distance 1101b, may be larger than the height of the original non-deformed staple cartridge 1102a. When the anvil 1140 moves near the cartridge support surface 1131, now referring to FIG. 19C, the second layer 1112 can continue its folding and the distance between the staple legs 1121 and the forming cavities 1142 may decrease. Similarly, the distance between the tissue contacting surface 1141 and the cartridge support surface 1131 may decrease at a distance 1101c which may be greater than, equal to, or less than the original undistorted cartridge height 1102a. With reference now to Figure 19D, the anvil 1140 can move to a final fired position in which the staples 1120 have been formed completely, or at least formed at a desired height. In such a position, the tissue contacting surface 1141 of the anvil 1140 may be a distance 1101 d away from the cartridge support surface 1131, wherein the distance 1101 d may be smaller than the height of the original non-deformed cartridge 1102a . As illustrated, further, in Figure 19D, the staple pockets 1115 may be fully folded, or at least substantially, and the staples 1120 may be completely surrounded, or at least substantially, by the second folded layer 1112. In various circumstances, the anvil 1140 may thereafter move away from the staple cartridge 1100. Once the anvil 1140 has been decoupled from the staple cartridge 1100, the cartridge body 1110 can at least partially expand again at several locations, i.e., intermediate locations to the adjacent staples 1120, for example. The body of the squashed cartridge 1110 may not expand again elastically. The formed staples 1120 and, additionally, the cartridge body 1110 positioned intermediate the adjacent staples 1120 can apply pressure, or compression forces, to the tissue T which can provide various therapeutic benefits.
As discussed above, with reference again to Figure 19A, each staple 1120 may comprise staple legs 1121 extending therefrom. Although staples 1120 are depicted as comprising two staple legs 1121, several staples may be used, which may comprise a staple leg or, alternatively, more than two staples. staple legs, such as three staple legs or four staple legs, for example. As illustrated in Figure 19A, each staple leg 1121 can be incorporated into the second layer 1112 of the cartridge body 1110 such that the staples 1120 are secured within the second layer 1112. The staples 1120 can be inserted into the recesses 1120. staples 1115 on the cartridge body 1110, such that the tips 1123 of the staple legs 1121 enter the cavities 1115 before the bases 1122. After the tips 1123 have been inserted into the cavities 1115, the tips 1123 can be pressed into the coating portions 1116 and cut the second layer 1112. The staples 1120 can be seated to a sufficient depth within the second layer 1112, such that the staples 1120 do not move, or at least substantially do not move. move, relative to the second layer 1112. The staples 1120 may be seated to a sufficient depth within the second layer 1112, such that the bases 1122 are positioned or incorporated within the staple cavities 1115. Alternatively, the bases 1122 may not be positioned or incorporated within the second layer 1112. Referring again to FIG. 19A, the bases 1122 may extend below the bottom surface 1118 of the cartridge body 1110. The bases 1122 can rest on, or can be positioned directly against, the cartridge support surface 1130. The cartridge support surface 1130 can comprise support elements extending therefrom and / or defining therein, wherein, by example, the bases 1122 of the staples 1120 can be positioned within and supported by one or more supporting grooves, grooves, or channels, 1132, for example, on the staple cartridge holder 1130, as described in more detail below. .
In addition to the above, with reference now to Figure 20, the bases 1122 of the staples 1120 can be positioned directly against the support surface 1131 of the staple cartridge holder 1130. Where the staple bases 1122 comprise circular or curved bottom surfaces. 1124, for example, the staple bases 1122 can move or slide along the staple cartridge support surface 1131. Such sliding can occur when the anvil 1140 is pressed against the tips 1123 of the staple legs 1121 during the staple formation process. For example, as described above and with reference now to Figure 21, the staple cartridge holder 1130 may comprise one or more support grooves 1132 therein, which may be configured to eliminate, or at least reduce, the relative movement between the staple bases 1122 and the cartridge support surface 1131. For example, each support groove 1132 can be defined by a surface contour that engages, or at least substantially engages, the contour of the bottom surface of the staple positioned therein. . For example, the bottom surface 1124 of the base 1122 shown in Figure 21 may comprise a circular, or at least substantially circular, surface and the support groove 1132 may further comprise a circular, or at least substantially circular, surface. By For example, the surface defining the groove 1132 can be defined by a radius of curvature that is greater than or equal to the radius of curvature defining the lower surface 1124. Although the grooves 1132 can help to prevent or reduce the relative sliding movement between the staples 1120 and the staple cartridge holder 1130, the slots 1132 can be further configured to prevent or reduce relative rotational movement between the staples 1120 and the staple cartridge holder 1130. More particularly, the slots 1132 can be configured to receive the bases 1122 are adjusted in order to prevent or reduce the rotation of the staples 1120 about the axes 1129, for example, so that they do not twist or twist when the staples 1120 are deformed.
In addition to the above, each staple 1120 can be formed from a round, or at least substantially round, wire. The legs and the base of each staple can be formed from a wire having a non-circular cross section, such as a rectangular cross-section, for example. For example, the staple cartridge holder 1130 may comprise corresponding non-circular grooves, such as rectangular grooves, for example, configured to receive the bases of such staples. Referring now to Figure 22, each staple 1120 may comprise a crown, such as a crown 1125, for example, overmolded on a base 1122, wherein each crown 1125 can be positioned within a support groove in the holder of the staple cartridge 1130. For example, each crown 1125 can comprise a square and / or rectangular cross section, for example, which can configured to be received within the square and / or rectangular slots 1134, for example, in the staple cartridge holder 1130. The crowns 1125 may be comprised of bioabsorbable plastic, such as polyglycolic acid (PGA), which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL) which is marketed under the trade name Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS , PHA, PGCL and / or PCL, for example, and can be formed around the bases 1122 of the staples 1120 by an injection molding process, for example. Various crowns and methods for forming various crowns are described in U.S. patent application no. of series 11 / 541,123, entitled SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME, filed on September 29, 2006, the full description of which is incorporated by reference in the present invention. Referring again to Figure 22, the slots 1134 may further comprise inlets, or bevels, 1135 which may be configured to facilitate insertion of the crowns 1125 into the slots 1134. The bases and / or crowns of the staples 1120 may positioning within the slots 1134 when the staple cartridge 1100 is assembled to the staple cartridge holder 1130. The crowns 1125 of the staples 1120 can be aligned with the slots 1134 when the staple cartridge 1100 is assembled to the holder of the staple cartridge 1130 For example, crowns 1125 may not enter slots 1134 until a compression force is applied to the staple legs 1121 and the bases and / or crowns of the staples 1120 are pushed down into the grooves 1134.
Referring now to Figures 23 and 24, a staple cartridge, such as staple cartridge 1200, for example, may comprise a compressible, implantable cartridge body 1210 comprising an outer layer 1211 and an inner layer 1212. Similar to the above, the staple cartridge 1200 may comprise a plurality of staples 1220 positioned within the cartridge body 1210. Each staple 1220 may comprise a base 1222 and one or more staple legs 1221 extending therefrom. For example, the staple legs 1221 can be inserted into the inner layer 1212 and set to a depth where the bases 1222 of the staples 1220 abut and / or are positioned adjacent the lower surface 1218 of the inner layer 1212, for example . In Figures 23 and 24, the inner layer 1212 does not comprise staple pockets configured to receive a portion of the staples 1220 although, as an alternative, the inner layer 1212 may comprise such staple pockets. In addition to the above, the inner layer 1212 can be comprised of a compressible material, such as bioabsorbable foam and / or oxidized regenerated cellulose (ORC), for example, which can be configured to allow the cartridge body 1210 to be folded when a compressive load is applied. to this. The inner layer 1212 may comprise a lyophilized foam comprising polylactic acid (PLA) and / or polyglycolic acid (PGA), for example. The ORC may be available commercially under the tradename of Surgicel and may comprise a loose woven fabric (such as a surgical sponge), loose fibers (such as a cotton ball), and / or a foam. The inner layer 1212 may comprise a material that includes drugs, such as lyophilized thrombin and / or fibrin, for example, contained therein and / or coating it that can be activated with water and / or activated by the fluids within the body of the body. patient, for example. For example, lyophilized thrombin and / or fibrin can be attached in a Vicryl matrix (PGA), for example. In certain circumstances, however, the activatable medicaments may be activated unintentionally when the staple cartridge 1200 is inserted into a surgical site within the patient, for example. Referring again to Figures 23 and 24, the outer layer 1211 may be comprised of a material impervious to water, or at least substantially impermeable to water, such that the liquids do not come into contact, or at least substantially in contact, with the inner layer 1212 until after the body of the cartridge 1210 has been compressed and the legs of the staples have penetrated the outer layer 1211 and / or after the outer layer 1211 has been pierced in some way. The outer layer 1211 may comprise a reinforcing material and / or a plastic material, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), for example. The outer layer 1211 may comprise a sheath surrounding the inner layer 1212 and the staples 1220. More particularly, the staples 1220 may be inserted into the inner layer 1212 and the outer layer 1211 can then be wrapped and sealed around the subunit comprising the inner layer 1212 and the staples 1220.
Referring now to Figures 25 and 26, a staple cartridge, such as staple cartridge 1300, for example, may comprise a compressible, implantable cartridge body 1310 that includes an outer layer 1311 and an inner layer 1312. Similar to The above, the staple cartridge 1300 may further comprise staples 1320 positioned within the cartridge body 1310, wherein each staple 1320 may comprise a base 1322 and one or more legs 1321 extending therefrom. Similar to the staple cartridge 1200, the bases 1322 of the staples 1320 may extend below the lower surface 1318 of the inner layer 1312 and the outer layer 1311 may surround the bases 1322. For example, the outer layer 1311 may be sufficiently flexible to so as to wrap each staple base 1322, so that the outer layer 1311 fits the contour of the bases 1322. Alternatively, with reference again to FIG. 24, the outer layer 1211 may be sufficiently rigid, so as to be extends around the bases 1222 without adapting to each base 1222. In either case, the outer layer 1311 can be positioned between the bases 1322 of the staples 1320 and a supporting surface of the staple cartridge, such as the supporting surfaces 1031 or 1131 , for example, that support the staple cartridge 1300. For example, the outer layer 1311 can be positioned between the bases 1322 and the support slots, such as the slots 1032 or 1132, p. or example, defined on the support surface of the staple cartridge. For example, in addition to the above, the outer layer 1311 can be configured to limit the movement of the bases 1322 and / or increase the coefficient of friction between the bases 1322 and the surface of the staple cartridge holder and / or the supporting grooves. to reduce the relative movement between these. Alternatively, with reference now to Figures 27 and 28, the outer layer of a staple cartridge, such as the staple cartridge 1400, for example, may not completely surround the staples positioned therein. For example, an outer layer 1411 of a body of the compressible implantable cartridge 1410 can be assembled to the inner layer 1412 before the staple legs 1421 of the staples 1420 are inserted into the body of the cartridge 1410. As a result of the above, the bases 1422 of the staples 1420 may extend outside the outer layer 1411 and, for example, the bases 1422 may be positioned directly in the supporting grooves 1032 or 1132 within the supporting surfaces of the staple cartridge 1031 or 1131, for example. example. The staple legs 1421 can cut the outer layer 1411 when they are inserted through it. In various circumstances, the gaps created by the staple legs 1421 can closely encircle the staple legs 1421, so that very little, if any, fluid can drip between the staple legs 1421 and the outer layer 1411 which can reducing the possibility of, or preventing, the medicament contained within the body of the staple cartridge 1410 from being activated and / or leaking out of the body of the cartridge 1410 prematurely.
As discussed above, with reference again to Figures 23 and 24, the legs 1221 of the staples 1220 may be incorporated within the body of the cartridge 1210 and the bases 1222 of the staples 1220 may extend outwardly from the lower surface 1218 of the layer. interior 1212. In addition to the above, inner layer 1212 may not comprise staple pockets configured to receive staples 1220. Alternatively, with reference now to FIGS. 29 and 30, a staple cartridge, such as staple cartridge 1500, for example, it may comprise a compressible implantable cartridge body 1510 comprising the staple pockets 1515, which can be configured to receive at least a portion of the staples 1520 therein. For example, an upper portion of the staple legs 1521 of the staples 1520 can be embedded in the inner layer 1512 while a lower portion of the staple legs 1521, and the bases 1522, can be positioned within the staple pockets 1515. The bases 1522 can be completely positioned in the staple pockets 1515 although the bases 1522 can extend at least partially below the lower surface 1518 of the inner layer 1512. Similar to the foregoing, the outer layer 1511 can enclose the inner layer 1512 and staples 1520 positioned therein. Alternatively, with reference now to Figure 31, a staple cartridge 1600 may comprise staples 1620 positioned within the staple pockets 1615 in a compressible, implantable cartridge body 1610, wherein at least a portion of the staples 1620 is not encloses by outer layer 1611. By For example, each staple 1620 may comprise staple legs 1621, which are incorporated at least partially into the inner layer 1612 and, additionally, the bases 1622, which extend outwardly around the outer layer 1611.
Referring now to Figures 32 and 33, a staple cartridge, such as staple cartridge 1700, for example, may comprise a compressible, implantable cartridge body 1710 and a plurality of staples 1720 at least partially positioned within the body of the cartridge. cartridge 1710. The cartridge body 1710 may comprise an outer layer 1711, an inner layer 1712, and, in addition, an alignment die 1740 that can be configured to align and / or retain the staples 1720 in position within the cartridge body 1710. The inner layer 1712 may comprise a recess 1741, which may be configured to receive the alignment matrix 1740 therein. The alignment matrix 1140 can be snapped into the recess 1741 and / or suitably secured in any other way to the inner layer 1712 by the use of at least one adhesive, such as fibrin and / or a protein hydrogel, for example. . The recess 1741 may be configured such that the lower surface 1742 of the alignment matrix 1740 aligns, or at least substantially aligns, with the lower surface 1718 of the inner layer 1712. The lower surface 1742 of the alignment matrix it can be lowered with respect to and / or extend from the lower surface 1718 of the second layer 1712. Each staple 1720 can comprise a base 1722 and one or more legs 1721 extending from the base 1722, wherein at least a portion of the staple legs 1721 can extend through the alignment die 1740. The alignment matrix 1740 may further comprise a plurality of openings and / or slots, for example, that extend through it, which can be configured to receive the staple legs 1721 therein. For example, each aperture can be configured to tightly receive a staple leg 1721 such that there is little relative movement, if any, between the staple leg 1721 and the side walls of the aperture. The openings of the alignment die may not extend completely through the alignment die 1740 and it may be necessary for the staple legs 1721 to cut the alignment die 1740 when the staple legs 1721 are pushed through it.
The alignment matrix 1740 may comprise a molded plastic body that may be more rigid or less compressible than the inner layer 1712 and / or the outer layer 1711. For example, the alignment matrix 1740 may comprise a plastic material and / or any other suitable material, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), for example. The alignment matrix 1740 can be assembled to the inner layer 1712 and, thereafter, the staple legs 1721 can be inserted through the alignment matrix 1740 and embedded in the inner layer 1712. The lower surface 1742 of the alignment matrix 1740 may comprise one or more grooves, grooves, or channels, for example, which may be configured to at least partially receive the bases 1722 of the 1720 staples. Similar to above, the outer layer 1711 can then be placed around the subunit comprising the inner layer 1712, the alignment matrix 1740, and the staples 1720. Alternatively, the outer layer 1711 can be placed around a subunit comprising the inner layer 1712 and the alignment matrix 1740, wherein the staples 1720 can be inserted later through the outer layer 1711, the alignment matrix 1740, and the inner layer 1712. In any case, as a result of the foregoing, the inner layer 1712, the alignment matrix 1740, and / or the outer layer 1711 can be configured to retain the staples 1720 in position until and / or after they are deformed by an anvil, as described above. For example, the alignment matrix 1740 can serve to hold the staples 1720 in place before the staple cartridge 1700 is implanted within a patient and, additionally, secure the tissue along the staple line after which the staple cartridge 1700 is implanted. The staples 1720 can be secured within the alignment matrix 1740 without being embedded in the inner layer 1712 and / or the outer layer 1711, for example.
Referring now to Figures 34 to 40, a staple cartridge, such as staple cartridge 1800, for example, can be assembled by compressing an inner layer 1812, by inserting staples, such as staples 1820, by example, inside the inner layer 1812, and by wrapping the inner layer 1812 with an outer layer 1811. Referring first to Figure 34, a compressible inner layer 1812 is illustrated as comprising a plurality of staple cavities 1815 defined therein, a although other embodiments are visualized in that the inner layer 1812 does not comprise the staple cavities, as described above. Referring now to Figure 35, the compressible inner layer 1812 can be positioned intermediate a transfer plate 1850 and a support plate 1860 and compress between the compression surfaces 1852 and 1862 thereof, respectively. As illustrated in Figure 35, the upper and lower surfaces of the inner layer 1812 may be compressed toward each other and, in response to this, the inner layer 1812 may bulge outwardly in the lateral directions. The inner layer 1812 may be compressed to a height that is about one third of its original height, for example, and may have a height or thickness between about 1.5 mm (0.06") and about 2.0 mm (0.08") in its compressed state, for example. As illustrated, further, in Figure 35, the transfer plate 1850 may further comprise a plurality of staples, such as staples 1820, for example, positioned within a plurality of staple pits 1853. Additionally, the plate 1850 can further comprise a plurality of impellers 1851 that can be configured to push staples 1820 up and out of staple pits 1853. Referring now to Figure 36, impellers 1851 can be used to push the legs of staples 1821 from staples 1820 within and through the inner compressed layer 1812.
The impellers 1851 can be configured, such that the upper surfaces thereof are placed flush, or at least almost flush, with the compression surface 1852 of the transfer plate 1850 when the staples 1820 have been fully deployed from the staple pockets 1853 of the transfer plate 1850. As illustrated, furthermore, in FIG. 36, the support plate 1860 may comprise a plurality of receiving openings 1861, which may be configured to receive the legs of staples 1821, or at least the tips of the staple legs 1821, after they are pushed through the inner layer 1812. The receiving openings 1861, or the like, may be needed where the inner layer 1812 has been compressed to a height that is smaller than the height of the staples 1820 and, thus, when the staples 1820 have been completely ejected from the staple pits 1853, the staple legs 1821 may protrude from the upper surface of the compressed inner layer 1812. Alternatively, the inner layer 1812 may be compressed to a height that is higher than the height of the staples 1820 and, as a result, the receiving openings 1861 on the support plate 1860 may be unnecessary.
After the staples 1820 have been inserted into the inner layer 1812, with reference now to FIG. 37, the support plate 1860 can be moved away from the transfer plate 1850 to allow the inner layer 1812 to decompress. In such circumstances, the inner layer 1812 may resiliently expand to its original, or at least nearly original, non-compressed height. When the inner layer 1812 expands again, the height of the inner layer 1812 may increase, such that it exceeds the height of the staples 1820 and, such that the staple legs 1821 of the staples 1820 no longer protrude from the staple. upper surface of inner layer 1812. In various circumstances, the openings of Receipt 1861 can be configured to hold the staple legs 1821 in position at least until the support plate 1860 has moved sufficiently out, such that the legs 1821 are no longer positioned within the reception openings 1861. In such circumstances , the receiving openings 1861 can assist in maintaining the relative alignment of the staples 1820 within the inner layer 1812 when it expands again. In various circumstances, the inner layer 1812 and the staples 1820 positioned therein can comprise a subunit 1801 which, with reference now to Figure 38, can be inserted into an outer layer 1811, for example. For example, the outer layer 1811 may comprise a cavity 1802 defined therein, which may be configured to receive the subunit 1801 therein. In various circumstances, a tool, such as the forceps 1855, for example, can be used to pull the outer layer 1811 over the subunit 1801. Once the subunit 1801 has been sufficiently positioned within the outer layer 1811, with reference now to Figure 39, the outer layer 1811 can be sealed. The outer layer 1811 can be sealed by the application of thermal energy to a portion thereof. More particularly, the outer layer 1811 may comprise a plastic material, wherein the open end of the outer layer 1811 may be thermally staked by one or more heated elements, or plates, 1856 for the purpose of joining and / or sealing together the perimeter of the open end of outer layer 1811. For example, with reference now to Figure 40, a surplus portion 1857 of the layer The exterior 1811 can be removed and the staple cartridge 1800 can then be used as described in the present disclosure.
As described above, a staple cartridge can be positioned within and / or secured to a binding portion of the staple cartridge. Referring now to Figures 41 and 42, a joining portion of the staple cartridge may comprise a channel of the staple cartridge, such as the staple cartridge channel 1930, for example, which can be configured to receive at least a portion of a staple cartridge, such as staple cartridge 1900, for example, in this. The staple cartridge channel 1930 may comprise a lower support surface 1931, a first side support wall 1940, and a second side support wall 1941. In use, the staple cartridge 1900 may be positioned within the staple cartridge channel 1930, in such a way that the staple cartridge 1900 is positioned against and / or adjacent to the lower support surface 1931 and is positioned intermediate to the first side support wall 1940 and the second side support wall 1941. The first wall of Lateral support 1940 and second lateral support wall 1941 can define a lateral separation between these. For example, the staple cartridge 1900 may comprise a side width 1903 that is the same and / or wider than the lateral opening defined between the support walls 1940 and 1941, such that a body of the cartridge implantable cartridge 1910 of staples 1900 can be securely fitted between the walls 1940 and 1941. Alternatively, the lateral width 1903 of the staple cartridge 1900 can be shorter than the defined spacing between the first and second side walls 1940 and 1941. At least a portion of the walls 1940 and 1941 and the lower support surface 1931 can be defined by a die-cut metallic channel while at least a portion of the side support wall 1940 and / or side support wall 1941 may comprise a flexible material, such as an elastomeric material, for example. With reference first to Figure 41, the first side wall 1940 and the second side wall 1941 of the staple cartridge channel 1930 may each be comprised of a rigid portion 1933 extending upwardly from the lower support surface 1931 and a flexible portion 1934 extending upward from the rigid portions 1933.
In addition to the above, the cartridge body 1910 of the staple cartridge 1900 may comprise one or more compressible layers, such as the first layer 1911 and the second layer 1912, for example. When the cartridge body 1910 is compressed against the lower support surface 1931 by an anvil, as described above, the side portions of the cartridge body 1910 may expand laterally. Where the staple cartridge 1930 comprises rigid side walls, the lateral expansion of the cartridge body 1910 can be prevented, or at least limited, by the rigid side walls and, as a result, a significant amount of internal pressure, or strain, can be developed within the cartridge body 1910. Where at least a portion of the staple cartridge 1930 comprises the flexible side walls, the flexible side walls can be configured to flex laterally and allow the portions Laterally the cartridge body 1910 expands laterally, thereby reducing internal pressure, or stress, generated within the cartridge body 1910. Where the cartridge channel does not comprise side walls, or comprises side walls that are relatively shorter that the staple cartridge, the side portions of the staple cartridge can expand laterally without restrictions, or at least substantially without restrictions. In any case, with reference now to Figure 42, a channel of the staple cartridge 2030 may comprise sidewalls 2040 and 2041 which may be completely comprised of a flexible material, such as an elastomeric material, for example. The staple cartridge channel 2030 may further comprise side grooves 2033 extending along the sides of the lower support surface 2031 of the staple cartridge channel 2030, which may be configured to receive and secure at least a portion of the staple cartridge channel 2030. of the side walls 2040 and 2041 in this. The side walls 2040 and 2041 can be secured in the slots 2033 by snap-fitting and / or snap-fit arrangement, or the side walls 2040 and 2041 can be secured in the slots 2033 by one or more adhesives. The side walls 2040 and 2041 may be separable from the lower support surface 2031 during use. In any case, a body of the compressible implantable cartridge 2010 can be disassembled and / or uncoupled from the side walls 2040 and 2041 when the body of the cartridge 2010 is implanted with the staples 2020.
Referring now to Figure 43, a surgical instrument may comprise a shank 2150 and an end effector extending from the distal end of the shank 2150. The end effector may comprise, similar to the foregoing, a channel of the staple cartridge 2130, an anvil 2140 movable between an open position and a closed position, and a staple cartridge 2100 positioned intermediate the staple cartridge channel 2130 and the anvil 2140. In addition, similar to the foregoing, the staple cartridge 2100 may comprise a body of the compressible implantable cartridge 2110 and a plurality of staples 2120 positioned in the body of the cartridge 2110. The channel of the staple cartridge 2130 may comprise, one, a lower support surface 2131 against which the staple cartridge 2100 can be positioned, two, a distal end 2135, and three, a proximal end 2136. As illustrated in Figure 43, the staple cartridge 2100 can comprising a first end 2105 that can be positioned at the distal end 2135 of the staple cartridge channel 2130 and a second end 2106 that can be positioned at the proximal end 2136 of the staple cartridge channel 2130. The distal end 2135 of the cartridge channel of staples 2130 may comprise at least one distal holding feature, such as a retaining wall 2137, for example, and similarly, the proximal end 2136 may comprise at least one proximal holding feature, such as a retaining wall 2138, for example . For example, the distal retaining wall 2137 and the proximal retaining wall 2138 may define a gap therebetween, which may be equal to or less than the length of the staple cartridge 2100 such that the staple cartridge 2100 can be securely engaged within the staple cartridge channel 2130 when the staple cartridge 2100 is inserted therein.
Referring again to Figures 23 and 24, a staple cartridge, such as staple cartridge 1200, for example, may comprise a flat, or at least substantially flat, tissue contact surface 1219. For example, the staple cartridge body 1210 of the staple cartridge 1200 may comprise a first end 1205 that can be defined by a first height, or thickness, 1207 and a second end 1206 that can be defined by a second height, or thickness, 1208 , wherein the first height 1207 may be the same, or at least substantially equal, to the second height 1208. The body of the cartridge 1210 may comprise a constant or at least substantially constant height or thickness, between the first end 1205 and the second end. end 1206. For example, the tissue contacting surface 1219 may be parallel, or at least substantially parallel, to the bottom surface 1218 of the cartridge body 1210. Referring once again to Figure 43, the first end 2105 The cartridge body 2110 of the staple cartridge 2100 can be defined by a first height 2107 that is different from a second height 2108 of the second end 2106. In the embodiment illustrated, the first height 2107 is greater than the second height 2108, although the second height 2108 could be greater than the first height 2107 in alternative embodiments. The height of the cartridge body 2110 may decrease linearly and / or geometrically between the first end 2105 and the second end 2106. For example, the surface of contact with the fabric 2119, which extends between the first end 2105 and the second end 2106, may be oriented along an angle defined therebetween. For example, the tissue contacting surface 2119 may be non-parallel to the bottom surface 2118 of the cartridge body 2110 and / or parallel to the support surface 2131 of the staple cartridge channel 2130.
Referring again to Figures 43 and 44, the anvil 2140 may comprise a tissue contacting surface 2141, which may be parallel, or at least substantially parallel, to the support surface 2131 of the staple cartridge channel 2130 when the anvil 2140 is in a closed position, as illustrated in Figure 44. When the anvil 2140 is in a closed position, the anvil 2140 can be configured to compress the first end 2105 of the staple cartridge 2100 more than the second end 2106 due to the highest height of the first end 2105 and the smallest height of the second end 2106. In some circumstances, including the circumstances where the tissue T positioned intermediate to the tissue contacting surfaces 2119 and 2141 has a constant thickness, or at less substantially constant, the pressure generated within the tissue T and the cartridge 2100 may be greater at the distal end of the end effector than at the proximal end imal of the end effector. More particularly, when the tissue T between the anvil 2140 and the staple cartridge 2100 has a substantially constant thickness, the tissue T positioned intermediate the distal end 2145 of the anvil 2140 and the first end 2105 of the staple cartridge 2100 can be compressed more than the tissue T positioned intermediate to the end proximal 2146 of anvil 2140 and second end 2106 of staple cartridge 2100. A pressure gradient can be generated within tissue T between the proximal end and the distal end of the end effector. More particularly, when the tissue T between the anvil 2140 and the staple cartridge 2100 has a substantially constant thickness and the height of the staple cartridge 2100 decreases linearly from the distal end to the proximal end of the end effector, the pressure within the tissue T may decrease linearly from the distal end of the end effector to the proximal end of the end effector. Similarly, when the tissue T between the anvil 2140 and the staple cartridge 2100 has a substantially constant thickness and the height of the staple cartridge 2100 geometrically decreases from the distal end to the proximal end of the end effector, the pressure within the tissue T can decrease geometrically from the distal end of the end effector to the proximal end of the end effector.
Referring again to Figure 43, the tissue T positioned between the staple cartridge 2100 and the anvil 2140 may not have a constant thickness throughout. In at least one of such circumstance, the tissue T positioned between the proximal end 2146 of the anvil 2140 and the second end 2106 of the staple cartridge 2100 can be thicker than the tissue T positioned between the distal end 2145 of the anvil 2140 and the first end 2105 of the staple cartridge 2100. Under such circumstances, as a result, the thicker tissue T can be positioned generally over the smaller proximal end 2106 of the staple cartridge 2100 and the thinner tissue T can be positioned generally above the highest distal end 2105. In use, the firing collar 2152 of the rod 2150 can be advanced distally along the central tubular portion of the rod 2151 in such a manner that the firing collar 2152 engages the cam portion 2143 of the anvil 2140 and rotate the anvil 2140 towards the staple cartridge 2100 as illustrated in Figure 44. Once the anvil 2140 has been turned to a fully closed position, the tissue T can be compressed between the tissue contacting surfaces. 2119 and 2141 e, even when the height of the staple cartridge 2100 may not be constant between the proximal and distal ends of the end effector, the pressure or compression forces applied to the tissue T may be constant, or at least substantially constant, through these. More particularly, when the thinnest tissue T can be associated with the highest height of the staple cartridge 2100 and the thicker fabric T can be associated with the smaller height of the staple cartridge 2100, the cumulative height, or sum of the tissue T and the staple cartridge 2100 may be constant, or at least substantially constant, between the proximal and distal ends of the end effector and, as a result, the compression of this cumulative height by the anvil 2140 may be constant, or at least substantially constant, through these.
Referring again to Figures 43 and 44, the staple cartridge 2100 may comprise an asymmetric configuration. For example, the height of the staple cartridge 2100 at the first end 2105 thereof may be higher than the staple cartridge height 2100 in the second end 2106 of this. The staple cartridge 2100 and / or the staple cartridge channel 2130 may comprise one or more retention and / or alignment elements that can be configured to ensure that staple cartridge 2100 can be positioned within staple cartridge channel 2130 only in one orientation, i.e., an orientation in which the first end 2105 is positioned at the distal end 2135 of the staple cartridge channel 2130 and the second end 2106 is positioned at the proximal end 2136. Alternatively, the staple cartridge 2100 and / or the staple cartridge channel 2130 may comprise one or more retention and / or alignment elements which may be configured to allow the staple cartridge 2100 to be positioned within the staple cartridge channel 2130 in more than one orientation . Referring now to Figure 45, for example, the staple cartridge 2100 can be positioned within the staple cartridge channel 2130 such that the first end 2105 of the staple cartridge 2100 can be positioned at the proximal end 2136 of the cartridge channel. of staples 2130 and second end 2106 can be positioned at distal end 2135. As a result, the shortest height of staple cartridge 2100 can be positioned proximate distal retaining wall 2137 and the highest height of staple cartridge 2100 can be positioned close to the proximal retaining wall 2138. For example, the staple cartridge 2100 may be suitably arranged to apply a constant, or at least substantially constant, clamping pressure to the tissue T having a thicker portion within the distal end of the staple. end effector and a thinner portion within the proximal end of the end effector. The staple cartridge 2100, for example, can be selectively oriented within the staple cartridge channel 2130. For example, the alignment and / or retention elements of staple cartridge 2100 can be symmetrical and a surgeon can selectively target the staple cartridge 2100 within the staple cartridge channel 2130 in the orientations shown in Figure 43 and Figure 45, for example.
In addition to the above, the body of the implantable cartridge 2110 may comprise a longitudinal axis 2109 which, when the staple cartridge 2100 is positioned in the staple cartridge channel 2130, may extend between the proximal and distal ends of the end effector. The thickness of the cartridge body 2110 can generally decrease and / or increase between the first end 2105 and the second end 2106 along the longitudinal axis 2109. For example, the distance, or height, between the lower surface 2118 and the surface of contact with the fabric 2119 may generally decrease and / or increase, generally, between the first end 2105 and the second end 2106. The thickness of the cartridge body 2110 may both increase and decrease along the longitudinal axis 2109. For example, the thickness of the cartridge body 2110 may comprise one or more portions that increase in thickness and one or more portions that may decrease in thickness. The staple cartridge 2100 may comprise a plurality of staples 2120 positioned therein. In use, as described above, the staples 2120 can deform when the anvil 2140 moves to a closed position. Each staple 2120 can have the same height, or at least substantially this. For example, the height of a staple can be measured from the bottom of the base of the staple to the top, or tip, of the highest leg of the staple, for example.
The staples inside a staple cartridge can have different staple heights. For example, a staple cartridge may comprise a first group of staples having a first staple height that are positioned in a first portion of a compressible cartridge body and a second group of staples having a second staple height that are positioned in a second portion of the compressible cartridge body. The first staple height can be higher than the second staple height and the first staple group can be positioned at the first end 2105 of the staple cartridge 2100 while the second staple group can be positioned at the second end 2106. Alternatively, the first higher group of staples can be positioned at the second end 2106 of the staple cartridge 2100 while the second smaller group of staples can be positioned at the first end 2105. A plurality of groups of staples can be used, each group having a height of different staple. For example, a third group, which has an intermediate staple height, can be positioned in the cartridge body 2110 between the first group of staples and the second group of staples. Each staple within a row of staples in the staple cartridge may comprise a different staple height. The highest staple within a row of staples can be positioned at a first end of a row of staples. staples and the shortest staple can be positioned at an opposite end of the row of staples. For example, the staples positioned between the highest staple and the shortest staple can be arranged in such a way that the staple heights decrease between the highest staple and the shortest staple, for example.
Referring now to Figure 46, an end effector of a surgical stapler may comprise an anvil 2240, a staple cartridge channel 2230, and a staple cartridge 2200 supported by the staple cartridge channel 2230. The staple cartridge 2200 may comprise a compressible implantable cartridge body 2210 and a plurality of staples, such as staples 2220a and staples 2220b, for example, positioned therein. The staple cartridge channel 2230 may comprise a cartridge support surface 2231 and a plurality of staple holder grooves, such as support grooves 2232a and 2232b, for example, defined therein. For example, staple cartridge 2200 may comprise two staple outer rows 2220a and two staple inner rows 2220b, wherein support slots 2232a may be configured to support staples 2220a and support slots 2232b may be configured to support staples 2220b. With reference to Figures 46 and 47, the anvil 2240 may comprise a plurality of staple forming cavities 2242 defined therein which may be configured to receive and deform the staples 2220a and 2220b when the anvil 2240 is moved toward the staple cartridge 2200. For example, the lower surfaces of the supporting grooves 2232a can be separated at a first distance 2201a from the upper surfaces of the staple forming cavities 2242 while the lower surfaces of the supporting grooves 2232b can be separated at a second distance 2201b from the upper surfaces of the staple forming cavities 2242. For example, the supporting grooves 2232b are positioned closer to anvil 2240 due to the raised step on the support surface 2231 in which they are defined. Due to the different distances 2201a and 2201b, the outer rows of staples 2220a and the inner rows of staples 2220b can deform to different formed heights. In various circumstances, staples deformed at differently formed heights can apply different pressures or clamping forces to the staple tissue T. In addition to the above, the staples can start with different heights of non-conformed staples. For example, with reference again to Figure 46, the outer staples 2220a may have an initial unformed height that is greater than the initial unformed height of the inner staples 2220b. As illustrated in Figures 46 and 47, the inner staples 2220b, which have a non-formed height smaller than the outer staples 2220a, they may also have a smaller formed height than the outer clips 2220b. Alternatively, the inner staples 2220b may have a higher unformed height than the outer staples 2220a and still have a deformed staple height smaller than the outer staples 2220a.
In addition to the above, the anvil 2240 can move within a closed position, as illustrated in Figure 47, to compress the cartridge body 2210 and deform the staples 2220a and 2220b. A surgical stapler comprising the end effector shown in Figures 46 and 47, for example, may further comprise a cutting member which may be configured to sever the tissue T positioned between the anvil 2240 and the staple cartridge 2200. For example, the anvil 2240, the staple cartridge channel 2230 and / or the staple cartridge 2200 can define a slot configured to slideably receive therein a cutting member. More particularly, the anvil 2240 may comprise a slot portion 2249, the staple cartridge channel 2230 may comprise a slot portion 2239, and the staple cartridge 2200 may comprise a slot portion 2203, which may be aligned, or at least substantially align, with each other when the anvil 2240 is in a closed, or at least substantially closed position. The cutting member can be moved from the proximal end of the end effector to the distal end of the end effector after the anvil 2240 has been closed and the staples 2220a, 2220b have been deformed. The cutting member can move independently of the deformation process of the staples. The cutting member can be advanced at the same time that the staples are deformed. In either case, the cutting member can be configured to cut the fabric along a path positioned between the inner rows of staples 2220b.
As illustrated in Figure 47, the inner staples 2220b can be formed at a shorter height than the outer staples 2220a, wherein the inner staples 2220b can apply a greater clamping pressure or force to the tissue adjacent to the created line of cut. by the cutting member. For example, the greater clamping force or pressure created the inner staples 2220b may provide various therapeutic benefits such as reducing bleeding of the cut tissue T while the lower clamping pressure created by the outer staples 2220a may provide flexibility within the stapled tissue. Referring again to Figures 46 and 47, the anvil 2240 may further comprise at least one piece of reinforcing material, such as reinforcing material 2260, for example, attached thereto. For example, the legs of the clamps 2220a, 2220b can be configured to cut the reinforcing material 2260 and / or through the openings in the reinforcing material 2260 when the staple cartridge 2200 is compressed by the anvil 2240 and thereafter contacting the staple forming cavities. 2242 on the anvil 2240. When the staple legs 2220a, 2220b deform, the legs may contact and / or cut the reinforcing material 2260 once again. The reinforcing material 2260 can improve hemostasis and / or provide resistance to the tissue that is stapled.
Referring again to Figures 46 and 47, the lower surface of the cartridge body 2210 may comprise a stepped contour that adjusts, or at least substantially adjusts, the stepped contour of the cartridge support surface 2231. The lower surface of the cartridge body 22 The cartridge 2210 can be deformed to adjust, or at least substantially adjust, the outline of the cartridge support surface 2231. Referring now to Figure 48, an end effector, similar to the end effector shown in Figure 46, for example , it may comprise a staple cartridge 2300 positioned therein. The staple cartridge 2300 may comprise a compressible implantable body 2310 comprising an inner layer 2312 and an outer layer 2311 wherein, in addition to the foregoing, the outer layer 2311 may be comprised of a water impermeable material. The outer layer 2311 may extend around the staples 2220a, 2220b and may be positioned between the staples 2220a, 2220b and the supporting grooves 2232a, 2232b, respectively. Referring now to Figure 49, an end effector, similar to the end effector shown in Figure 46, for example, may comprise a staple cartridge 2400 positioned thereon. Similar to the staple cartridge 2300, the compressible, implantable cartridge body 2410 of the staple cartridge 2400 may comprise an inner layer 2412 and an outer layer 2411; Nevertheless; the body of the cartridge 2410 may not comprise a groove of cutting member therein. For example, the cutting member may be required to cut the inner layer 2412 and / or the outer layer 2411, for example, as it is advanced through the staple cartridge.
Referring now to Figure 50, an end effector of a surgical stapler may comprise an anvil 2540, a channel of the staple cartridge 2530, and a staple cartridge 2500 positioned in the staple cartridge channel 2530. Similar to the above , the staple cartridge 2500 may comprise a compressible implantable cartridge body 2510, the outer staple rows 2220a, and the inner rows of staples 2220b. The channel of the staple cartridge 2530 may comprise a flat, or at least substantially flat, cartridge support surface 2531 and staple holder grooves 2532 defined therein. The anvil 2540 may comprise a stepped surface 2541 and a plurality of staple forming cavities, such as the forming cavities 2542a and 2542b, for example, defined therein. Similar to the above, the forming cavities 2542a and the supporting grooves 2532 may define a distance therebetween, which is greater than the distance between the forming cavities 2452b and the supporting grooves 2532. The anvil 2540 may further comprise a piece of reinforcing material 2560 coupled to the stepped surface 2541 of the anvil 2540. For example, the reinforcing material 2560 can be adapted, or at least substantially adapted, to the stepped surface 2541. In various embodiments, the reinforcing material 2560 can coupling removably to the surface 2541 by means of at least one adhesive, such as fibrin and / or a protein hydrogel, for example. The cartridge body 2510 may further comprise a stepped profile that is analogous, or at least substantially analogous, to the stepped surface 2541 of the anvil 2540. More particularly, the anvil 2540 may comprise the steps 2548 extending toward the cartridge 2544. staples 2500, wherein the steps 2548 may comprise a step height that equals, or at least substantially equals, the step height of the steps 2508 that extend from the cartridge body 2510. For example, as a result of the foregoing , the quantity of the cartridge body compressible 2510 that can be captured in the first staples 2220a can be different from the amount of compressible cartridge body 2510 that can be captured in second staples 2220b, for example.
Referring now to Figure 51, an end effector may comprise an anvil 2640, a channel of the staple cartridge 2530, and a staple cartridge 2600 positioned thereon. The staple cartridge 2600 may comprise a compressible implantable cartridge body 2610 that includes an inner layer 2612, an outer layer 2611, and a plurality of staples, such as staples 2220a and 2200b, for example, positioned therein. The anvil 2640 may comprise a plurality of staple forming cavities 2642 on a surface 2641 and the staple cartridge channel 2530 may comprise a plurality of staple forming grooves 2532 defined on the support surface 2531. As illustrated in Figure 51, the surface of the anvil 2641 may be parallel, or at least substantially parallel, to the cartridge support surface 2531, wherein each forming cavity 2642 can be positioned a distance equal, or at least substantially equal, away from a corresponding and opposite staple holder slot 2532. The cartridge staples 2600 can comprise staples having this, or at least substantially the same, initial staple height not formed and, additionally, the same, or at least substantially the same, staple height formed. Alternatively, the outer rows of staples may comprise the staples 2220a and the inner rows of staples may comprise staples 2220b, wherein, as described above, staples 2220a and 2220b may have different staple heights not conformed. When the anvil 2640 moves towards the staple cartridge 2600 within a closed position, the staples 2220a and 2220b can be formed, such that they have this, or at least substantially the same, staple height formed. For example, as a result of the foregoing, the outer clips 2220a and the shaped inner clips 2220b may have the same amount, or at least substantially the same amount, of the body of the compressible cartridge 2610 contained therein; however, although the outer staples 2220a have a higher non-conformed staple height than the inner staples 2220b and can have the same shaped staple height, a greater clamping pressure can be generated on the outer staples 2220a than in the inner staples 2220b , for example.
Referring now to Figure 52, an end effector of a surgical stapler may comprise an anvil 2740, a staple cartridge channel 2530, and a staple cartridge 2700 positioned within the staple cartridge channel 2530. Similar to the above , the staple cartridge 2700 may comprise a compressible implantable cartridge body 2710 comprising an inner layer 2712, an outer layer 2711, and a plurality of staples, such as staples 2220a and 2220b, for example, positioned therein. The thickness of the cartridge body 2710 can vary across its width. For example, the cartridge body 2710 may comprise a central portion 2708 and the side portions 2709, wherein the central portion 2708 may comprise a thickness that is greater than the thickness of the side portions 2709. The thicker portion of the cartridge body 2710 can be located in the central portion 2708 while the thinner portion of the cartridge body 2710 can be located at the side portions 2709. For example, the thickness of the cartridge body 2710 can gradually decrease between the central portion 2708 and the side portions 2709. The thickness of the Cartridge body 2710 may decrease linearly and / or geometrically between the central portion 2708 and the side portions 2709. For example, the tissue contacting surface 2719 of the cartridge body 2710 may comprise two sloping, or angled, surfaces. which slopes down from the central portion 2708 to the side portions 2709. The anvil 2740 may comprise two inclined, or angled, surfaces which equal, or at least substantially even, the inclined surfaces in contact with the tissue 2719. The anvil 2740 may further comprise at least one piece of reinforcing material 2760 coupled to the inclined surfaces of the anvil 2740.
In addition to the above, the inner rows of staples in the staple cartridge 2700 may comprise the higher staples 2220a and the outer rows of staples may comprise the shorter staples 2220b. Higher 2220th staples can be positioned within and / or adjacent to the thicker central portion 2708 while staples 2220b can be positioned within and / or adjacent to the side portions 2709. For example, as a result, the highest staples 2220a can capture more material from the implantable cartridge body 2710 than shorter clips 2220b. Such circumstances could result in the clamps 2220a applying greater clamping pressure to the tissue T than the clamps 2220b. Even though the staples more high 2220a can capture more body material from the cartridge 2710 in the same as the smaller staples 2220b, the higher staples 2220a can have a staple height formed higher than the smaller staples 2220b due to the inclined arrangement of the forming cavities of staples 2742a and 2742b. Such considerations can be used to achieve a desired clamping pressure within the tissue captured by the staples 2220a and 2220b where, as a result, the clamping pressure on the staples 2220a can be greater than, less than, or equal to the clamping pressure. applied to the fabric by staples 2220b, for example. In various alternative embodiments to the end effector illustrated in Figure 52, the smaller staples 2220b may be positioned within and / or adjacent to the thicker central portion 2708 of the cartridge body 2710 and the higher staples 2220a may be positioned within and / or adjacent to the finer side portions 2709. Further, although the staple cartridge 2700 is depicted as comprising rows of outside and inside staples, the staple cartridge 2700 may comprise rows of additional staples, such as staple rows positioned intermediate to the rows of outside and inside staples, for example. For example, rows of intermediate staples can comprise staples having a height staple unformed that is between the heights of staple unformed the 2220th and 2220b staples and a height formed staple is between the heights of formed staple of staples 2220a and 2220b, for example.
Referring now to Figure 53, an end effector of a surgical stapler may comprise an anvil 2840, a cartridge channel of staples 2530, and a staple cartridge 2800 positioned within the staple cartridge channel 2530. Similar to the above, the staple cartridge 2800 may comprise a compressible shampoo cartridge body 2810 comprising an inner layer 2812, an outer layer 2811, and a plurality of staples, such as staples 2220a and 2220b, for example, positioned therein. The thickness of the cartridge body 2810 can vary across its width. For example, the cartridge body 2810 may comprise a central portion 2808 and the side portions 2809, wherein the central portion 2808 may comprise a thickness that is less than the thickness of the side portions 2809. The thinnest portion of the cartridge body 2810 can be located in the central portion 2808 while the thicker portion of the cartridge body 2810 can be located in the side portions 2809. For example, the thickness of the cartridge body 2810 can gradually increase between the central portion 2808 and the side portions 2809 The thickness of the cartridge body 2810 can be linearly and / or geometrically increased between the central portion 2808 and the side portions 2809. For example, the tissue contacting surface 2819 of the cartridge body 2810 can comprise two inclined surfaces, or at an angle, which inclines upwards from the central portion 2808 towards the lateral portions 2809. The yunq That 2840 may comprise two inclined, or angled, surfaces, which equal, or at least substantially even, the inclined surfaces in contact with the fabric 2819. The anvil 2840 may further comprise at least one piece of reinforcing material 2860 coupled to the inclined surfaces of anvil 2840.
In addition to the above, the inner rows of staples in the staple cartridge 2800 may comprise the higher staples 2220a and the outer rows of staples may comprise the shorter staples 2220b. The upper staples 2220a can be positioned within and / or adjacent the thicker side portions 2809 while the staples 2220b can be positioned within and / or adjacent to the central portion 2808. For example, as a result of the above, the staples more high 2220a can capture more implantable cartridge body material 2810 than shorter clips 2220b.
As described above with respect to the embodiment of Figure 46, for example, the staple cartridge channel 2230 may comprise a stepped support surface 2231 that can be configured to support staples 2220a and 2220b at different heights relative to anvil 2240 The staple cartridge channel 2230 may be comprised of metal and the steps on the support surface 2231 may be formed on the support surface 2231 by a grinding operation, for example. Referring now to Figure 54, an end effector of a surgical instrument may comprise a channel of staple cartridge 2930 comprising a support insert 2935 positioned therein. More particularly, the staple cartridge channel 2930 can be formed such that it has a flat support surface 2931, or at least substantially planar, for example, that can be configured to support the insert 2935 comprising the staggered surfaces to support the staples 2220a and 2220b of the staple cartridge 2200 in different heights. By For example, the insert 2935 may comprise a flat, or at least substantially planar, bottom surface that can be positioned against the support surface 2931. The insert 2935 may further comprise support grooves, grooves, or channels 2932a and 2932b that can configured to support staples 2220a and 2220b, respectively, in different heights. Similar to the above, the insert 2935 may comprise a blade slot 2939 defined therein, which may be configured to allow a cutting member to pass therethrough. The staple cartridge channel 2930 may comprise the same material or a material other than the support insert 2935. The staple cartridge channel 2930 and the support insert 2935 may both be comprised of metal, for example, while, as an alternative , the channel of the staple cartridge 2930 may be comprised of metal, for example, and the support insert 2935 may be comprised of plastic, for example. The support insert 2935 can be attached and / or welded into the staple cartridge channel 2930. The support insert 2935 can be snapped and / or snapped into the staple cartridge channel 2930. The support insert 2935 can be secured in the channel of the staple cartridge 2930 by the use of an adhesive.
Referring now to Figure 55, an end effector of a surgical stapler may comprise an anvil 3040, a channel of staple cartridge 3030, and a compressible implantable staple cartridge 3000 positioned in the staple cartridge channel 3030. Similar to the above, the anvil 3040 may comprise a plurality of forming cavities of staples 3042 defined therein and a blade slot 3049, which can be configured to slidably receive a cutting member therein. In addition, similar to the above, the staple cartridge channel 3030 may comprise a plurality of staple holder grooves 3032 defined therein and a knife groove 3039, which can additionally be configured to slidably receive a cutting member. in this. The staple cartridge 3000 may comprise a first layer 3011, a second layer 3012, and a plurality of staples, such as staples 3020a and 3020b, for example, positioned therein. Staples 3020a may comprise a staple height not formed, which is higher than the non-formed staple height of staples 3020b. The first layer 3011 can be comprised of a first compressible material and the second layer 3012 can be comprised of a second compressible material. The first compressible material can be compressed at an index that is greater than that of the second compressible material while, alternatively, the first compressible material can be compressed at an index that is less than that of the second compressible material. The first compressible material may comprise a flexible material, which may comprise a first resistance index and the second compressible material may comprise a flexible material, which may comprise a second resistance index, which is different from the first resistance index. The first compressible material may comprise a resistance index, which is greater than the resistance index of the second compressible material. Alternatively, the first compressible material may comprise a resistance index which is lower than the resistance index of the second compressible material. The first compressible layer may comprise a first stiffness and the second compressible layer may comprise a second stiffness, wherein the first stiffness is different from the second stiffness. The first compressible layer may comprise a stiffness that is greater than the stiffness of the second compressible layer. Alternatively, the first compressible layer may comprise a stiffness that is less than the stiffness of the second compressible layer.
Referring again to Figure 55, the second layer 3012 of the staple cartridge 3000 may comprise a constant thickness, or at least substantially constant, across the width thereof. The first layer 3011 can comprise a thickness that varies across the width thereof. For example, the first layer 3011 may comprise one or more steps 3008 that can increase the thickness of the cartridge body 3010 in certain portions of the cartridge body 3010, such as the central portion, for example. Referring again to Figure 55, the smaller staples 3020b can be positioned or aligned with the rungs 3008, ie, the thicker portions of the cartridge body 3010, and the higher staples 3020a can be positioned or aligned with the thinner portions of the cartridge body 3010. As a result of the thicker and thinner portions of the cartridge body 3010, the rigidity of the cartridge body 3010 may be greater along the inner rows of staples 3020b than the outer rows of staples 3020a . The first layer 3011 can be connected to the second layer 3012. For example, the first layer 3011 and the second layer 3012 may comprise interlacing elements, which may retain the layers 3011 and 3012 together. The first layer 3011 may comprise a first laminate and the second layer 3012 may comprise a second laminate, wherein the first laminate may be adhered to the second laminate by one or more adhesives. The staple cartridge 3000 may comprise a knife slot 3003, which can be configured to slidably receive a cutting member therein.
Referring now to Figure 56, a staple cartridge 3100 may comprise an implantable, compressible cartridge body 3110 comprising a single layer of compressible material and, additionally, a plurality of staples, such as staples 3020b, for example, positioned in this. The thickness of the cartridge body 3110 can vary across its width. For example, the cartridge body 3110 may comprise the steps 3108 extending along the side portions thereof. Referring now to Figure 57, a staple cartridge 3200 may comprise an implantable, compressible cartridge body 3210 comprising a single layer of compressible material and, additionally, a plurality of staples, such as staples 3020b, for example, positioned in this. The thickness of the cartridge body 3210 can vary across its width. For example, the cartridge body 3210 may comprise the steps 3208 that extend along the central portion thereof. Referring now to Figure 58, a staple cartridge 3300 may comprise an implantable, compressible cartridge body 3310 wherein, similar to the foregoing, the thickness of the cartridge body 3310 can vary across its width. The thickness of the cartridge body 3310 can geometrically increase between the side portions and the central portion of the cartridge body 3310. For example, the thickness of the cartridge body 3310 can be defined by an arched or curved profile and can comprise a contact surface with the fabric 3319 arched or curved. The thickness of the body of the cartridge 3310, and the outline of the contact surface with the fabric 3319, can be defined by a radius of curvature or, alternatively, by several radii of curvature, for example. Referring now to Figure 59, a staple cartridge 3400 may comprise a compressible implantable cartridge body 3410, wherein the thickness of the cartridge body 3410 may increase linearly, or at least substantially linearly, between the side portions and the central portion of the cartridge body 3410.
Referring now to Figure 60, a staple cartridge 3500 may comprise an implantable, compressible cartridge body 3510 and a plurality of staples 3520 positioned therein. The body of the implantable cartridge 3510 may comprise a first inner layer 3512, a second inner layer 3513, and an outer layer 3511. The first inner layer 3512 may comprise a first thickness and the second inner layer 3513 may comprise a second thickness, wherein the second inner layer 3513 may be thicker than the first inner layer 3512. Alternatively, the first inner layer 3512 may be thicker than the inner layer 3512. second inner layer 3513. In another alternative, the first inner layer 3512 may have the same thickness, or at least substantially the same, as the second inner layer 3513. Each staple 3520 may comprise a base 3522 and one or more deformable legs 3521 which they extend from the base 3522. Each leg 3521 may comprise a tip 3523 that is embedded in the first inner layer 3511 and, additionally, each base 3522 of the clips 3520 may be embedded in the second inner layer 3512. The first interior layer 3512 and / or the second inner layer 3513 may comprise at least one medicament stored therein and the outer layer 3511 may encapsulate and seal the first inner layer 3512 and the second inner layer 3513 in such a way that the medicament does not flow out of the cartridge body of the cartridge. staples 3510 until after outer layer 3511 has been pierced by staples 3520. More particularly, in addition to the above, an anvil can be pushed down against the tissue positioned against the tissue contacting surface 3519 of the staple cartridge 3500, such that the body of the cartridge 3510 is compressed and the surface 3519 moves downward, and at least partially below, the tips of the staples 3523 , such that the tips 3523 break or puncture the outer layer 3511. After the outer layer 3511 has been pierced by the legs of the clips 3521, at least one drug M can flow out of the body of the cartridge 3510 around the legs of staples 3521. In various circumstances, the compression of the cartridge body 3510 can drain the additional drug M out of the cartridge body 3510 as illustrated in Figure 61.
Referring again to Figure 60, the outer layer 3511 may comprise a waterproof, or at least substantially impermeable, shell, which may be configured to prevent the medicament from flowing prematurely out of the staple cartridge 3500 and, two, avoid that fluids within a surgical site, for example, enter prematurely within staple cartridge 3500. First inner layer 3512 may comprise a first medicament stored, or absorbed, in this and second inner layer 3513 may comprise a second stored medicament , or absorbed, in this, where the second medication may be different from the first medication. An initial compression of the cartridge body 3510, which causes the outer layer 3511 to rupture, can generally discharge the first medicament out of the first inner layer 3512 and a subsequent compression of the cartridge body 3510 can generally dispense the second one. medicament outside the second inner layer 3513. In such cases, however, portions of the first medicament and of the second medicament may be poured simultaneously, although most of the medicament initially discharged may comprise the first medicament, and most of the medicament subsequently discharged. , after that, you can understand the second medication. In addition to the foregoing, the first inner layer 3512 may comprise a more compressible material than the second inner layer 3513 such that the initial compression or pressure forces, which may be less than the subsequent compression or pressure forces, may cause a larger initial deflection within the first inner layer 3512 than within the second inner layer 3513. This larger initial deflection within the first inner layer 3512 may cause a larger portion of the first medicament to be expressed from the first layer interior 3512 than the second medicament from the second inner layer 3513. The first inner layer 3512 may be more porous and / or more flexible than the second inner layer 3513. For example, the first inner layer 3512 may comprise a plurality of pores, or voids, 3508 defined therein and the second inner layer 3513 may comprise a plurality of pores, or voids, 3509 defined therein, wherein the pores 3508 may be configured to store the first medicament in the first inner layer 3512 and the pores 3509 may configured to store the second medicament in the second inner layer 3513. The size and density of the pores 3508 within the first inner layer 3512 and pores 3509 within second inner layer 3513 may be selected to provide a desired result described in the present disclosure.
Referring again to Figures 60 and 61, the outer layer 3511, the first inner layer 3512, and / or the second inner layer 3513 may be comprised of a bioabsorbable material. The first inner layer 3512 can be comprised of a first bioabsorbable material, the second inner layer 3513 can be comprised of a second bioabsorbable material, and the outer layer 3511 may be comprised of a third bioabsorbable material, wherein the first bioabsorbable material, the second bioabsorbable material, and / or the third bioabsorbable material may be comprised of different materials. The first bioabsorbable material can be bioabsorbable to a first index, the second bioabsorbable material can be bioabsorbable to a second index, and the third bioabsorbable material can be bioabsorbed to a third index, wherein the first index, the second index, and / or the third index they can be different For example, when a material is bioabsorbed at a particular index, such an index can be defined as the amount of mass of material that is absorbed by a patient's body over a unit of time. As it is known, the bodies of different patients can absorb different materials at different rates and, thus, such indices can be expressed as average rates to explain such variability. In any case, a faster index can be an index to which more mass is bioabsorbed by a unit of time than a slower index. Referring again to Figures 60 and 61, the first inner layer 3512 and / or the second inner layer 3513 can be comprised of a material that bioabsorbs faster than the material comprising the outer layer 3511. For example, the first inner layer 3512 and / or the second inner layer 3513 can be comprised of a bioabsorbable foam, a tissue sealant, and / or a hemostatic material, such as oxidized regenerated cellulose (ORC), for example, and the outer layer 3511 can be comprised of a material of reinforcement and / or a plastic material, such as polyglycolic acid (PGA) which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL) which is marketed under the trade name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, by example. In such cases, the first inner layer 3512 and / or the second inner layer 3513 can immediately treat the fabric and can reduce bleeding of the fabric, for example, where the outer layer 3514 can provide longer term structural support and can bioabsorb at a slower rate.
Due to the slower rate of bioabsorptof the outer layer 3511, in additto the foregoing, the outer layer 3511 may reinforce or support structurally the tissue within the staple line as it heals. One of the first inner layer 3512 and the second inner layer 3513 can be comprised of a material that can bioabsorb faster than the other such that one of the layers can provide an initial release of a therapeutic material and the other layer can provide a release sustained from the same therapeutic material and / or a different therapeutic material. For example, the rate at which a therapeutic material can be released from a layer 3512, 3513 may be a functof the bioabsorptof the substrate layer in which the medicament is absorbed or dispersed. For example, the substrate comprising the first inner layer 3512 can be bioabsorbable faster than the substrate comprising the second inner layer 3513 and, as a result, a medicament can be released from the first inner layer 3512 faster than the second inner layer 3513, for example. As described in the present invent one or more of the layers 3511, 3512, and 3513 of the cartridge body 3510 can adhering to each other by at least one adhesive, such as fibrin and / or a protein hydrogel, for example. The adhesive can be water soluble and can be configured to release the connectbetween the layers when the staple cartridge 3500 is implanted and / or some time after that. For example, the adhesive can be configured to bioabsorb faster than the outer layer 3511, the inner first layer 3512, and / or the second inner layer 3513.
Referring now to Figures 62 and 63, a staple cartridge, such as staple cartridge 3600, for example, may comprise a cartridge body 3610 that includes a first compressible layer 3611, a second layer 3612 attached to the first layer 3611, and a removable compressible layer 3613 attached to the second layer 3612. For example, the first layer 3611 may be comprised of a compressible foam material, the second layer 3612 may comprise a laminate material adhered to the first layer 3611 by the use of one or more adhesives, and the third layer 3613 may comprise a compressible foam material removably adhered to the second layer 3612 by the use of one or more adhesives, for example. The staple cartridge 3600 may further comprise a plurality of staples, such as staples 3620, for example, positioned in the cartridge body 3610. For example, each staple 3620 may comprise a base 3622 positioned in the third layer 3613 and one or more deformable legs 3621 that extend upwardly from the base 3622 through the second layer 3612 and into the first layer 3611, for example. In use, in addition to above, the upper surface 3619 of the staple cartridge body 3610 can be pushed down an anvil until the legs of the staples 3621 penetrate through the upper surface 3619 and the target tissue and come into contact with the anvil. After the legs of the staples 3621 have deformed sufficiently, the anvil can move out of the staple cartridge 3600, such that the compressible layers thereof can at least partially expand again. In various circumstances, the insertion of the staples through the tissue can cause the tissue to bleed. The third layer 3613 can be comprised of an absorbent material, such as protein hydrogel, for example, which can draw blood out of the stapled tissue. Additionally or in lieu of the foregoing, third layer 3613 may comprise a hemostatic material and / or a tissue sealant, such as lyophilized thrombin and / or fibrin, for example, which may be configured to reduce tissue bleeding. The third layer 3613 may provide structural support to the first layer 3611 and the second layer 3612, wherein the third layer 3613 may be comprised of a bioabsorbable material and / or a non-bioabsorbable material. In any case, the third layer 3613 can be separated from the second layer 3612 after the staple cartridge 3610 has been implanted. Where the third layer 3613 comprises a material of implantable quality, the surgeon can choose whether to remove the third layer 3613 from the cartridge body 3610. The third layer 3613 can be configured to be removed from the second layer 3612 in one piece.
The first layer 3611 may be comprised of a first foam material and the third layer 3613 may be comprised of a second foam material which may be different from the first foam material. The first foam material may have a first density and the second foam material may have a second density, wherein the first density may be different from the second density. For example, the second density may be greater than the first density, where, as a result, the third layer 3613 may be less compressible, or have a lower compression ratio, than the first layer 3611. Alternatively, the first density may be be greater than the second density where, as a result, the first layer 3611 may be less compressible, or have a lower compression ratio, than the third layer 3613. Referring now to Figures 64 and 65, a staple cartridge 3700, similar to the staple cartridge 3600, may comprise a cartridge body 3710 comprising a first layer of compressible foam 3711, a second layer 3712 attached to the first layer 3711, and a third layer of removable compressible foam 3713 removably attached to the second layer 3712. For example, the third layer 3713 may comprise a plurality of staple receiving slots, or slits, 3709 which may each be configured to receive at least one portion. n of a clip 3620, as a base staple 3622, for example, in these. Staples 3620 can be configured to slide within staple receiver slots 3709 or, put another way, the third layer 3713 can be configured to slide relative to the staples 3620 when the staple cartridge 3700 is positioned against the target tissue and compressed by an anvil, for example. Receiving slots 3709 may be configured such that there is a clearance between staples 3620 and side walls of receiving slots 3709. For example, as a result of the above, staples 3620 may not capture a portion of the third layer 3713 in these when the staples 3620 are deformed, as illustrated in Figures 64 and 65. Alternatively, the ends of the staple receiving slots 3709 adjacent the second layer 3712 can be closed by a portion of the third layer 3713 and, as a result, at least a portion of the third layer 3713 can be captured within the staples 3620 when they are deformed. In any case, the third layer 3713 may comprise one or more perforations and / or dot markings 3708, for example, which can be configured to allow the third layer 3713 to be removed from the second layer 3712 in two or more pieces as illustrated in Figure 64. In Figure 64, one of the pieces of the third layer 3713 is illustrated when removed by a tool 3755. The perforations 3708 may be arranged along a line positioned between a first row of staples and a second row of staples.
Referring again to Figures 64 and 65, the bases 3622 of the clips 3620 can be positioned within the receiving slots. 3709, wherein the side walls of the receiving slots 3709 can be configured to come into contact and releasably retain the legs of the Staples 3621 in position. Although not illustrated, third layer 3713 may comprise an elongated slot that surrounds all staples within a line of staples. For example, a staple cartridge comprising four rows of staples, for example, may comprise an elongated slot aligned with each row of staples in the lower layer of the staple cartridge. In addition to the above, at least a portion of the staple cartridge 3600 and / or staple cartridge 3700 can be implanted within a patient and at least a portion of the staple cartridge can be removed from the patient. Referring again to Figures 64 and 65, the first layer 3711 and the second layer 3712 can be captured within the staples 3620 and can be implanted with the staples 3620, while the third layer 3713 can be removed or optionally separated from the staple cartridge 3700. In various circumstances, removal of a portion of the implanted staple cartridge can reduce the amount of material that the patient's body has to reabsorb which can provide several therapeutic benefits. In the event that a portion of a staple cartridge is removed or separated, such as by a laparoscopic tool 3755, for example, the portion of the staple cartridge separated can be removed from the surgical site through a trocar, such as a trocar. which has an opening of 5 mm, for example. A cartridge body may comprise more than one removable layer. For example, the cartridge body 3710 may comprise a fourth layer, wherein the third layer 3713 of the cartridge body 3710 may be comprised of a hemostatic material and the fourth layer it can be understood as a support layer. For example, a surgeon can remove the support layer and then choose whether to remove the hemostatic layer, for example.
Referring now to Figure 66, a staple cartridge, such as staple cartridge 3800, for example, can comprise a cartridge body 3810 that includes an outer layer 3811 and an inner layer 3812. The inner layer 3812 can be comprised of a compressible foam material and the outer layer 3811 may be wrapped at least partially around the inner layer 3812. The outer layer 3811 may comprise a first portion 3811a configured to be positioned on a first side of the inner layer 3812 and a second portion 3811b configured to position on a second side of the inner layer 3812, wherein the first portion 3811a and the second portion 3811b can be connected by a flexible hinge, such as the hinge 3809, for example. For example, at least one adhesive, such as fibrin and / or protein hydrogel, for example, can be applied to the first side and / or the second side of the inner layer 3812 to secure the portions of the outer layer 3811 thereto. The outer layer 3811 may comprise one or more fastening members extending therefrom. For example, the outer layer 3811 may comprise a plurality of deformable legs 3821 that extend from one side of the outer layer 3811, which may be seated in the compressible inner layer 3812. For example, the legs 3821 may not protrude from the second side of the inner layer 3812 or, alternatively, the legs 3821 can project at least partially from the inner layer 3812. When the cartridge body compressible 3810 is compressed, in use, the legs 3821 can be configured to pierce the inner layer 3812 and the second portion 3811b of the outer layer 3811. The second portion 3811b of the outer layer 3811 can comprise openings, such as the openings 3808, by example, defined therein, which can be configured to receive the legs of the staples 3821. At least portions of the staple cartridge 3800 can comprise a knife slot 3803, which can be configured to slidably receive a cutting member therein. For example, the knife slot 3803 may not extend completely through the thickness of the cartridge body 3810 and, as a result, the cutting member may cut the body of the cartridge 3810 as it moves relative to it.
Referring now to Figure 67, a staple cartridge 3900 may comprise, similar to the staple cartridge 3800, a cartridge body 3910 that includes an inner layer 3812 and an outer layer 3811, wherein the outer layer 3811 may comprise a first portion 3811a positioned adjacent the first side of the inner layer 3812 and a second portion 3811b positioned adjacent the second side of the inner layer 3812. Similar to the foregoing, the outer layer 3811 may comprise one or more attachment members extending therefrom. . For example, the outer layer 3811 may comprise a plurality of deformable legs 3921 extending from one side of the outer layer 3811, which may be inserted into the compressible inner layer 3812. Each deformable leg 3921 may comprise at least one hook or tab 3923 protruding from it, which can be configured to couple the second portion 3811b of the outer layer 3811 and, as a result, retain the outer layer 3811 to the inner layer 3812. For example, the tabs 3923 can be configured to project from the second side the inner layer 3812 and extend through the openings 3808 in the second portion 3811b of the outer layer 3811 in such a manner that the tabs 3923 can be coupled to the outside surface of the outer layer 3811 and block the outer layer 3811 to the layer interior 3812. For the purpose of constructing the staple cartridge 3900, the inner layer 3812 may be at least partially compressed to cause the tabs to protrude therefrom and to enter the openings 3808. For example, the staple cartridge 3900 may be pre-compressed at least partially when inserted into a staple cartridge, for example. In addition to the above, at least a portion of the legs 3921 can be incorporated within the first portion 3811a of the outer layer 3811, wherein the outer layer 3811 can be comprised of a plastic material, such as polydioxanone (PDS) and / or acid polyglycolic (PGA), for example, and the plastic material can be overmoulded around at least a portion of the legs 3921.
Referring now to Figures 68 to 72, a staple cartridge, such as staple cartridge 4000, for example, may comprise a cartridge body 4010 that includes a first compressible layer 4011 and a second layer 4012 and, addition to the mind , a plurality of staples 4020 positioned within the cartridge body 4010. With reference to Figure 70, each staple 4020 may comprise a base 4022 and at least one deformable leg 4023 extending from the base 4022. With reference to Figure 68, the staple cartridge 4000 it can be positioned between a staple cartridge channel 4030 and an anvil 4040 of an end effector of a surgical stapler, wherein the second layer 4012 of the cartridge body 4010 and / or the bases 4022 of the staples 4020 can be positioned against the channel of staple cartridge 4030. Referring now to Figure 69, the second layer 4012 may comprise a layer of pads 4060 interconnected to one another by a pad support frame 4061. For example, pads 4060 and the support frame 4061 pads can be comprised of a molded plastic material, such as polyglycolic acid (PGA), for example. Each pad 4060 may comprise one or more openings or slots 4062 that can be configured to receive a staple leg 4021 that extends therethrough as illustrated in FIGS. 70 and 71. Each pad 4060 may further comprise a slot. receiving 4063 defined therein, which can be configured to receive a base 4022 of a staple 4020. Referring again to Figure 69, the pads 4060 and / or the support frame of pads 4061 may comprise a plurality of dot markings, perforations , or the like, which can be configured to allow the pads 4060 to be separated from the pad support frame 4061 at a desired location. Similarly, with reference to Figure 71, one or more 4060 compresses can connect to each other along a line that it comprises perforations and / or dot markings 4064, for example. In use, the compressible foam layer 4011 can be positioned against the target tissue T and the body of the cartridge 4010 can be compressed by the anvil 4040, such that the anvil 4040 can deform the staples 4020. When the staples 4020 become deformed, the staple legs 4021 of each staple 4020 can capture the tissue T, a portion of the first layer 4011, and a napkin 4060 within the deformed staple. When the staple cartridge channel 4030 moves away from the implanted staple cartridge 4060, for example, the pad support frame 4061 can be separated from the pads 4060 and / or the pads 4060 can be separated from each other. In certain circumstances, the pads 4060 may be separated from the frame 4061 and / or from one another when the staples 4020 are deformed by the anvil 4040 as described above.
The staples of a staple cartridge can be formed completely by an anvil when the anvil moves to a closed position. Alternatively, with reference now to Figures 73 to 76, the staples of a staple cartridge, such as staple cartridge 4100, for example, can be deformed by an anvil when the anvil is moved to a closed position and, additionally, by a staple driver system that moves the staples towards the closed anvil. The staple cartridge 4100 may comprise a compressible cartridge body 4110 which may be comprised of a foam material, for example, and a plurality of staples 4120 at least partially positioned within the compressible cartridge body 4110. The staple driver system may comprising a driver support 4160, a plurality of staple drivers 4162 positioned within the impeller holder 4160, and a staple cartridge tray 4180, which can be configured to retain the staple drivers 4162 in the impeller holder 4160. For example , the staple drivers 4162 can be positioned within one or more slots 4163 in the impeller holder 4160, wherein the side walls of the slots 4163 can help guide the staple drivers 4162 up toward the anvil. The staples 4120 can be supported within the slots 4163 by the staple drivers 4162 where the staples 4120 can be fully placed in the slots 4163 when the staples 4120 and the staple drivers 4162 are in their non-fired positions. Alternatively, at least a portion of the staples 4120 may extend upwardly through the open ends 4161 of the slots 4163 when the staples 4120 and the staple drivers 4162 are in their non-fired positions. For example, with reference first now to Figure 74, the bases of the staples 4120 can be positioned within the driver support 4160 and the tips of the staples 4120 can be incorporated within the compressible cartridge body 4110. Approximately one third of the Staple height 4120 can be positioned within the impeller holder 4160, and approximately two thirds of the height of the staples 4120 can be positioned within the cartridge body 4110. With reference to FIG. 73A, the staple cartridge 4100 can further comprise , a wrap or water impermeable membrane 4111 surrounding the cartridge body 4110 and the impeller holder 4160, for example.
In use, the staple cartridge 4100 can be positioned within a staple cartridge channel, for example, and the anvil can move towards staple cartridge 4100 in a closed position. The anvil may come into contact with and compress the compressible cartridge body 4110 when the anvil moves to its closed position. The anvil may not come into contact with the staples 4120 when the anvil is in its closed position. Alternatively, the anvil may come into contact with the staple legs 4120 and deform at least partially the staples 4120 when the anvil moves towards its closed position. In any case, the staple cartridge 4100 may further comprise one or more sliders 4170 that can be advanced longitudinally within the staple cartridge 4100, such that the sliders 4170 can sequentially couple the staple drivers 4162 and move the staple drivers 4162. and staples 4120 towards the anvil. The sliders 4170 can slide between the staple cartridge tray 4180 and the staple drivers 4162. Where the closure of the anvil has begun the staple forming process 4120, the upward movement of the staples 4120 toward the anvil can complete the forming process and deforming staples 4120 at their fully formed, or at least desired, height. Where the closure of the anvil has not deformed the staples 4120, the upward movement of the staples 4120 towards the anvil it can initiate and complete the forming process and deform staples 4120 to its fully formed, or at least desired, height. The sliders 4170 can be advanced from a proximal end of the staple cartridge 4100 to a distal end of the staple cartridge 4100, such that the staples 4120 positioned at the proximal end of the staple cartridge 4100 are formed completely before they conform completely staples 4120 positioned at the distal end of staple cartridge 4100. With reference to Figure 75, sliders 4170 may each comprise at least one angled or inclined surface 4711, which may be configured to slide below the impellers of staples 4162 and raise the staple drivers 4162, as illustrated in Figure 76.
In addition to the above, the staples 4120 can be formed with the aim of capturing at least a portion of the tissue T and at least a portion of the body of the compressible cartridge 4110 of the staple cartridge 4100 therein. After the staples 4120 have been formed, the anvil and staple cartridge channel 4130 of the surgical stapler can be separated from the staple cartridge 4100. In various circumstances, the cartridge tray 4180 can be fixedly attached to the cartridge channel. of staples 4130 wherein, as a result, the cartridge tray 4180 can be separated from the body of the compressible cartridge 4110 when the staple cartridge channel 4130 is removed from the body of the implanted cartridge 4110. Referring again to FIG. 73, FIG.
Cartridge tray 4180 may comprise opposite side walls 4181 between which the cartridge body 4110 can be removably positioned. For example, the compressible cartridge body 4110 can be compressed between the side walls 4181, such that the cartridge body 4110 can be retained between them removably during use and removably detachable from the cartridge tray 4180 when removed the cartridge tray 4180. For example, the impeller holder 4160 can be connected to the cartridge tray 4180 such that the impeller holder 4160, the impellers 4162, and / or the sliders 4170 can remain in the cartridge tray 4180 when the cartridge tray 4180 is removed from the surgical site. Alternatively, the impellers 4162 can be ejected from the impeller holder 4160 and left inside the surgical site. For example, impellers 4162 may comprise a bioabsorbable material, such as polyglycolic acid (PGA) which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecapronate. (PGCL) which is marketed under the trade name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. The impellers 4162 may be coupled to the staples 4120, such that the impellers 4162 are deployed with the staples 4120. For example, each impeller 4162 may comprise a channel configured to receive the bases of staples 4120, for example, wherein, the channels can be configured to receive the staple bases in a snap and / or snap-fit fashion.
In addition to the above, the support of impellers 4160 and / or the sliders 4170 can be ejected from the cartridge tray 4180. For example, the sliders 4170 can slide between the cartridge tray 4180 and the impeller holder 4160, in such a way that , as the sliders 4170 are advanced with the aim of driving the staple drivers 4162 and the staples 4120 upwards, the sliders 4170 can move the driver support 4160 upwardly also out of the cartridge tray 4180. For example , the support of impellers 4160 and / or the sliders 4170 can be comprised of a bioabsorbable material, such as polyglycolic acid (PGA), which is marketed under the trade name of Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL), which is marketed under the trade name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. The sliders 4170 can be integrally formed and / or coupled to a drive rod, or cutting member, which pushes the sliders 4170 through the staple cartridge 4100. In such cases, the sliders 4170 may not be ejected from the cartridge tray 4180 and can remain with the surgical stapler while, in other embodiments in which the sliders 4170 are not attached to the actuator rod, the sliders 4170 can be left in the surgical site. In any In addition, from the above, the compressibility of the cartridge body 4110 may allow thicker staple cartridges to be used within an end effector of a surgical stapler since the body of the cartridge 4110 may be compressed, or reduced, when closes the anvil of the stapler. As a result of the staples being deformed at least partially after the closure of the anvil, the higher staples, such as staples having a staple height of about 4.6 mm (0.18"), for example, could be used, where about 3.0 mm (0.12") of the staple height can be positioned within the compressible layer 4110, and wherein the compressible layer 4110 can have a non-compressed height of about 3.6 mm (0.14"), for example.
Referring now to Figures 77 to 80, a staple cartridge, such as staple cartridge 4200, for example, may comprise a compressible cartridge body 4210, a plurality of staples 4220 positioned therein, and a plurality of staple members. flexible side supports 4234. Referring now to Figure 78, the staple cartridge 4200 can be positioned between an anvil 4240 and a staple cartridge channel 4230 where the side support members 4234 can be attached to the staple cartridge channel 4230 When the anvil 4240 moves downward to compress the cartridge body 4210 and at least partially deform the staples 4220, as illustrated in Figure 79, the side portions of the cartridge body 4210 can bulge laterally and push the support members lateral 4234 out. For example, members side brackets 4234 can be attached to the cartridge body 4210 and, when the cartridge body 4210 bulks laterally as described above, the side support members 4234 can be separated from the cartridge body 4210 as illustrated in Figure 79. The members side supports 4234 can be adhered to the body of the cartridge 4210 by using at least one adhesive, such as fibrin and / or a protein hydrogel, for example. Similar to the above, closing the anvil 4240 can only partially deform the staples 4220, wherein the staple conformation 4220 can be completed by advancing one or more sliders 4270 through the staple cartridge 4200 as illustrated in Figure 80 With reference now to Figures 82 and 83, the sliders 4270 can be advanced from a proximal end of the staple cartridge 4200 to a distal end of the staple cartridge 4200 by a cutting member 4280. For example, the cutting member 4280 it can comprise a cutting element, or blade, 4283, which can be advanced through the tissue T and / or the body of the compressible cartridge 4210. The cutting member 4280 can comprise the cam members 4282 that can travel along the outer surfaces of the clamps 4230 and 4240 and moving or holding the clamps in position. As a result of the foregoing, the staples 4220 can be formed in their final forms at the same time, or at least substantially at the same time, as the T fabric is cut. For example, the sliders 4270 can be positioned distally with respect to the blade 4283, such that the tissue T is only cut when the preceding portion of the fabric has been fully stapled, for example.
Referring again to Figures 82 and 83, the sliders 4270 may comprise distinct slidable members that are advanced together by the cutting member 4280. For example, the sliders 4270 may be contained within the staple cartridge 4200 and the cutting member 4280 it can be advanced within the staple cartridge 4200 by a firing bar 4281, such that the cutting member 4280 engages the sliders 4270 and advances the sliders 4270 distally. The sliders 4270 can be connected together. In any case, each slider 4270 may comprise an angled surface, or cam, 4271, which may be configured to elevate staples 4220 aligned within a row of staples. The angled surfaces 4271 may be integrally formed with the cutting member 4280. Referring again to Figures 82 and 83, each staple 4200 may comprise a base, at least one deformable member extending from the base, and an overmolded crown 4229. on and / or positioned around at least a portion of the base and / or the deformable members of the staple 4200. Such crowns 4229 can be configured to be driven directly by a slider 4270, for example. More particularly, the crowns 4229 of the staples 4220 can be configured, such that the angled surfaces 4271 of the sliders 4270 can slide underneath and directly contact the crowns 4229 without a staple driver located among them. In such cases, each crown 4229 can comprise at least one auxiliary angled or inclined surface, which can be coupled by an angled surface 4271 of the sliders 4270, such that the auxiliary angled surfaces can drive the staples 4220 upwardly when the sliders 4270 slide under staples 4220.
Referring now to Figure 81, a staple cartridge, such as staple cartridge 4300, for example, may comprise a compressible body 4310 and a plurality of staples 4320 positioned within the compressible body 4310. Similar to the above, the cartridge of staples 4300 can comprise flexible side supports 4334 that can be attached to a staple cartridge channel and / or adhere to compressible body 4310. In addition to the foregoing, flexible side supports 4334 can be connected together by one or more supports, or members 4335 that can be configured to hold the side supports 4334 together. In operation, the connecting members 4335 can be configured to prevent, or at least inhibit, the side supports 4334 from prematurely separating from the body of the cartridge 4310. The members of connection 4335 can be configured to hold the side supports 4334 together after the staple cartridge 4300 has been compressed po r an anvil. In such cases, the side supports 4334 may resist bulging or lateral displacement of the side portions of the cartridge body 4310. A cutting member, such as the cutting member 4280, for example, may be configured to sever the connecting members. 4335 when the cutting member 4280 moves Distally within the body of the cartridge 4310. For example, the cutting member 4280 may be configured to push distally one or more sliders, such as the sliders 4270, for example, in order to form the staples 4320 against an anvil. The sliders 4270 can direct the cutting edge 4283, such that the cutting member 4280 does not sever a connecting member 4335 until the staples 4320 adjacent to that connecting member 4335 have been fully formed, or at least shaped to a desired height. In various circumstances, the connecting members 4335, in cooperation with the lateral supports 4334, can prevent, or at least reduce, the lateral movement of the body of the compressible cartridge 4310 and, simultaneously, prevent, or at least reduce, the lateral movement of the the staples 4320 positioned within the body of the cartridge 4310. Under such circumstances, the connecting members 4335 can hold the staples 4320 in position until after they deform and the connecting members 4335 can be cut after that to release the side portions. of the cartridge body 4310. As mentioned above, the side supports 4334 can be connected to the staple cartridge channel and, as a result, can be removed from the surgical site with the staple cartridge channel after the cartridge has been implanted. staples 4300. The side supports 4334 may comprise an implantable material and may be left inside a surgical site. or. The connecting members 4335 can be positioned between the cartridge body 4310 and the tissue T and, after the connecting members 4335 have been separated from the side supports 4334, the Connection members 4335 may remain implanted in the patient. For example, the connecting members 4335 may comprise an implantable material and the connecting members 4335 may comprise the same material as the side supports 4334, for example. Connection members 4335 and / or side supports 4334 may comprise a flexible bioabsorbable material such as polyglycolic acid (PGA), which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL), which is marketed under the trade name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. The connecting member may comprise a sheet of material connecting the side supports 4334. The staple cartridge may comprise connecting members that extend through the upper surface of the cartridge body 4310 and, additionally, connecting members that extend around the lower surface of the cartridge body 4310.
Referring now to Figure 84, a staple cartridge may comprise staples, such as staples 4420, for example, which may comprise a portion of wire inserted into a portion of the crown. The wire portion may comprise a metal, such as titanium and / or stainless steel, for example, and / or a plastic, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), for example. The crown portion may comprise a metal, such as titanium and / or stainless steel, for example, and / or a plastic, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), for example. The wire portion of each staple 4420 may comprise a base 4422 and deformable legs 4421 extending from the base 4422, wherein the crown portion of each staple 4420 may comprise a crown 4429 which may be configured to receive therein at least one portion of a base 4422. In order to assemble the portions of each staple 4420, now referring to Figures 85A to 85C, legs 4421 of the wire portion can be inserted into an opening 4426 in a crown 4429, where the opening 4426 may be configured to guide legs 4421 within a base chamber 4427. The wire portion may also be inserted in crown 4429, such that legs 4421 exit from base chamber 4427 and base 4422 of the wire portion enters the base chamber 4427. For example, the base chamber 4427 can be configured, such that the wire portion is rotated within the crown 4429 as the base 4422 enters the chamber of the base 4427, such that the staple legs 4421 are oriented in an upward direction, or at least substantially upwards. Referring again to Figure 84, the crown 4429 may comprise the exit holes 4425 which may be configured to receive the staple legs 4421 therein.
In addition to the above, a surgical stapler may comprise a slider 4470 configured to traverse the staple cartridge 4400 and the staple cartridge channel 4430 and move staples 4420 contained within the cartridge body 4410 toward an anvil. In various circumstances, the 4470 slider can be moved from a proximal end from staple cartridge channel 4430 to a distal end of cartridge channel 4430 for the purpose of implanting staple cartridge body 4410 and staples 4420. In certain circumstances, slider 4470 can be retracted or returned to the proximal end of the channel of cartridge 4430 and another staple cartridge 4400 can be inserted into the cartridge channel 4430. Once the new staple cartridge 4400 has been positioned within the cartridge channel 4430, the slider 4470 can advance distally once more. The surgical stapler may comprise one or more locking elements that can prevent the slider 4470 from advancing distally once more if a new staple cartridge 4400 has not been positioned within the cartridge channel 4430. For example, with reference again to Figure 84, the staple cartridge channel 4430 may comprise a locking support 4439, which may be configured to prevent, or at least limit, the distal movement of the slider 4470. More particularly, the slider 4470 may be configured to abut the support 4439 unless the slider 4470 is at least partially raised up on the support 4439 by a lifting member 4428, for example, which extends between the most proximal clips 4420 within a staple cartridge 4400. In other words, in the absence of the most proximal staples 4420 in a new 4400 staple cartridge, the 4470 slider can not advance. Thus, when a staple cartridge is worn or 4400 is present within the cartridge channel 4430, or no staple cartridge 4400 in cartridge channel 4430, slider 4470 can not advance within cartridge channel 4430.
In addition to the foregoing, with reference now to Figure 86, a staple cartridge, such as staple cartridge 4500, for example, may be positioned within a staple cartridge channel 4530 and may comprise a compressible cartridge body 4510, a plurality of staples 4520 positioned within the cartridge body 4510, and a cartridge tray, or retainer, 4580. The compressible cartridge body 4510 may comprise an outer layer 4511 and an inner layer 4512 wherein, the outer layer 4511 may enclose hermetically the inner layer 4512. For example, the outer layer 4511 may extend between the inner layer 4512 and the cartridge tray 4580. Alternatively, the outer layer 4511 may only partially surround the inner layer 4512 and, for example, the outer layer 4511 and the cartridge tray 4580 can cooperate to encompass, or at least substantially encompass, the inner layer 4512. In addition to the above, the staples 4520 can be supported by the cartridge tray 4580, wherein the cartridge tray 4580 may comprise one or more staple holder channels configured to support the staples 4520. The cartridge tray 4580 may be coupled to the cartridge body 4510 where, for example, the cartridge body 4580 The cartridge 4510 can be compressed laterally between the opposite side walls of the cartridge tray 4580. The side walls of the cartridge tray 4580 can support the cartridge body 4510 laterally and, for example, the cartridge tray 4580 can comprise one or more walls, or fins, 4582 extending upwardly from the lower support 4583 within the cartridge body 4510. For example, the cartridge body 4510 may comprise one or more slots, or channels, therein which can be configured to receive and / or interlock with the walls 4582. The walls 4582 may extend partially, or almost entirely, through the body of the cartridge 4510. For example, the walls 4582 may extend longitudinally through the staple cartridge 4500 between a first row of staples 4520 and a second row of staples 4520.
The cartridge body 4510 and / or the cartridge tray 4580 may comprise auxiliary retaining features that can provide a snap fit between the cartridge tray 4580 and the cartridge body 4510. The staple cartridge 4500 may be positioned within the cartridge channel. cartridge 4530 in such a way that the cartridge tray 4580 is positioned against and / or engages the cartridge channel 4530. The cartridge tray 4580 can be removably attached to the cartridge channel 4530, such that, after the staple cartridge 4500 has been compressed by the anvil 4540 and the staples 4520 have been deformed, the cartridge tray 4580 can be separated from the cartridge channel 4530 and can be implanted with the cartridge body 4510. For example, the cartridge tray 4580 may comprise a bioabsorbable material such as polyglycolic acid (PGA), which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA) , polyglecaprona 25 (PGCL), which is marketed under the name commercial of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. The surgical stapler may further comprise a trigger mechanism and / or trigger that can be slid between the staple cartridge channel 4530 and a lower actuating surface in the cartridge tray 4580, which can be configured to raise or eject the staple tray. cartridge 4580 of the cartridge channel 4530. The cartridge body 4510 can be removably attached to the cartridge tray 4580 such that, after the staple cartridge 4500 has been compressed by the anvil 4540 and the staples 4520 have been deformed, the cartridge body 4510 can be separated from the cartridge tray 4580. For example, the cartridge tray 4580 can remain fixedly engaged with the cartridge channel 4530, such that the cartridge tray 4580 is removed from the surgical site with the cartridge channel 4530. The surgical stapler may further comprise a mechanism and / or firing impeller that can be slid between the staple cartridge tray 4580 and a lower actuating surface in the cartridge body 4510 that can be configured to lift or eject the cartridge body 4510 from the cartridge tray of the cartridge 4580. For example, the staple cartridge 4500 may further comprise staple drivers positioned between staple cartridge tray 4580 and staples 4520 such that, as the firing mechanism slides distally, the staple drivers and staples 4520 may act up towards the anvil. For example, Staple drivers may be at least partially embedded within the compressible cartridge body 4510.
Similar to the above, the staple cartridge 4500 may comprise a locking element which can be configured to prevent, or at least limit, the distal movement of a cutting member unless an unsprung staple cartridge 4500 has been positioned within of the staple cartridge channel 4530. The staple cartridge tray 4580 may comprise a surface that raises the cutting member up and over a locking surface within the staple cartridge channel 4530, for example. In the event that a staple cartridge 4500 comprising a cartridge tray 4580 is not present in the cartridge channel 4530, the cutting member can not advance. The most proximal staples and / or any other suitable staple, within a staple cartridge 4500 may comprise a lifting surface that can sufficiently raise the cutting member over the locking surface. In addition or in lieu of the foregoing, several portions of the staple cartridge 4500 may comprise materials having different colors. In such cases, a surgeon can visually identify when a non-fired and / or a fired staple cartridge is present in the staple cartridge channel 4530. For example, the outer layer 4511 of the cartridge body 4510 may have a first color, the cartridge tray 4580 may have a second color, and the staple cartridge channel 4530 may have a third color. In the event that the surgeon sees the first color, the surgeon may know that a cartridge of staples not fired 4500 is present in the staple cartridge channel 4530. In the event that the surgeon sees the second color the surgeon may know that a fired cartridge is present in the staple cartridge channel 4530 and that the cartridge tray 4580 What remains must be removed; and in the event that the surgeon sees the third color, the surgeon may know that no portion of a staple cartridge 4500 remains within the cartridge channel 4530.
Referring now to Figure 87, a staple cartridge, such as staple cartridge 4600, for example, may comprise a compressible, implantable cartridge body 4610 and a plurality of staples 4620 positioned therein. The body of the cartridge 4610 may comprise an outer layer 4611 and an inner layer 4612. The inner layer 4612 may comprise a plurality of cavities, such as pockets, or cavities, 4615, for example, defined therein, which may facilitate the folding of the cartridge body 4610. For example, the inner layer 4612 may comprise a crimped, or honeycombed, network that can be configured to withstand a compression force, or pressure, as long as the compression force, or the pressure, do not exceed a certain threshold value. When the threshold value has not been exceeded, the inner layer 4612 may be deformed, with respect to the compressive force, or the pressure, which is applied, at a linear speed, or at least substantially linear. After the compression force, or pressure, has exceeded the threshold value, the inner layer 4612 may suddenly succumb to large deflections and bend, or bend, as a result of the compression load. The network of the inner layer 4612 may comprise a plurality of sublayers 4612a that can be connected together. Each sublayer 4612a may comprise a plurality of alternate grooves and ridges, or waves, which may be aligned with the alternate grooves and ridges of an adjacent sublayer 4612a. For example, the grooves of a first sublayer 4612a may be positioned adjacent the ridges of a second sublayer 4612a and, similarly, the ridges of the first sublayer 4612a may be positioned adjacent the grooves of the second sublayer 4612a. Adjacent sublayers 4612a may adhere to each other and / or to outer layer 4611 by at least one adhesive, such as fibrin and / or a protein hydrogel, for example. Figure 88 illustrates the staple cartridge 4600 after the body of the cartridge 4610 has been folded and the staples 4620 have been deformed in order to capture and hold the tissue T against the body of the cartridge 4610.
Referring now to Figures 89 to 91, a staple cartridge, such as staple cartridge 4700, for example, may comprise a compressible, implantable cartridge body 4710 and a plurality of staples 4720 positioned within the cartridge body 4710. Similar to the above, the cartridge body 4710 may comprise an outer layer 4711 and an inner layer 4712, wherein the inner layer 4712 may comprise a plurality of sublayers 4712a. Similar to the above, in addition, each sublayer 4712a may comprise grooves 4717 and alternating crests 4718 that can be aligned with each other to define pockets or cavities, 4715 therebetween. For example, grooves 4717 and / or crests 4718 may extend along axes that are parallel to each other and / or parallel to a longitudinal axis 4709. The staples 4720 can be aligned in a plurality of rows of staples that can extend along axes that are parallel to each other and / or parallel to the longitudinal axis 4709. Alternatively, with Referring again to Figures 87 and 88, the staples 4620 contained in the body of the cartridge 4600 may extend along axes that are transverse or perpendicular to the axes defined by the grooves and ridges of the sublayers 4612a. Referring again to Figures 89 to 91, staples 4720 may extend through grooves 4717 and ridges 4718, where friction forces between staples 4720 and sublayers 4712a may hold staples 4720 within the cartridge body. 4710. The plurality of sublayers 4712a may comprise a reinforcing material and / or a plastic material, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), for example, which may be configured to hold staples 4720 in a vertical orientation , for example, and / or keeping staples 4720 in alignment with one another as illustrated in Figures 89 and 90. Figure 91 illustrates the staple cartridge 4700 after the body of the cartridge 4710 has been folded and the staples 4720 have been deformed in order to capture and hold the tissue T against the body of the cartridge 4710.
Referring again to Figures 89 to 91, the cartridge body 4710 when compressed can be flexibly or elastically folded. For example, the waves formed within each sublayer 4712a by the grooves 4717 and the ridges 4718 can be flattened, or at least substantially flattened, when the cartridge body 4710 is compressed which can fold, or at least substantially fold, the cavities 4715 defined therebetween. In various circumstances, the cartridge body 4710, or at least portions of the body of the cartridge 4710, may be expanded again flexibly or elastically after the compression force, or pressure, has been removed from the cartridge body 4710. For example , the connections between the grooves 4717 and the ridges 4718 of the adjacent sublayers 4712a may remain intact, or at least substantially intact, when the cartridge body 4710 is compressed in such a way that, after the compression force has been removed from the cartridge body 4710, the sublayers 4712a can deflect themselves from each other and, as a result, at least partially expand the cartridge body 4710. The cartridge body 4710 can be plastically deformed, or crushed, when it is compressed and , as a result, the cartridge body 4710 may not expand again after the compression force, or pressure, has been removed from the cartridge body 471 0. Referring now to Figure 92, a staple cartridge, such as the staple cartridge 4800, for example, may comprise a collapsible cartridge body 4810 comprising an outer layer 4811 and an inner layer 4812, wherein the layer interior 4812 may comprise a corrugated network, configured in the form of a honeycomb, having a plurality of pockets, or cavities, 4815 defined therein. The walls defining the network of the inner layer 4812 may comprise one or more weakened, or thin, 4819 cross sections that can be configured to allowing the walls defining the network to break when the cartridge body 4810 is compressed. In such circumstances, the body of the cartridge 4810 can be crushed when the staple cartridge 4800 is implanted.
Referring now to Figures 93 to 95, a staple cartridge, such as staple cartridge 4900, for example, may comprise a cartridge body 4910 comprising an outer layer 4911 and a plurality of foldable elements 4912 positioned between the portions upper and lower of the outer layer 4911, for example. With reference principally to Figures 93 and 94, the staple cartridge 4900 may further comprise a plurality of staples 4920, wherein each staple 4920 may be positioned on a folding member 4912. More particularly, each folding member 4912 may comprise a first portion 4912a, a second portion 4012b, and a third portion 4012c that can cooperate to define a cavity 4915 therein, which is configured to receive a staple 4920. In operation, in addition to the above, the staple cartridge 4900 can be positioned within a staple cartridge channel and a compressive force can be applied to the tissue contacting surface 4919 for the purpose of compressing the body of the cartridge 4910. As the tissue contacting surface 4919 moves downward, they can folding the foldable elements 4912. In such circumstances, the second portion 4912b of each folding element 4912 can be folded into a first portion 4912a corresponding and, similarly, the third portion 4912c of each element foldable 4912 can be folded into a corresponding second portion 4912b. As the body of the cartridge 4910 is compressed and the folding elements 4912 are folded, the staples 4920 positioned within the folding elements 4912 can be deformed, as illustrated in Figure 95. The second portion 4912b of each folding element 4912 can be engaged by friction and / or snapping into a corresponding first portion 4912a, such that, once the compression force applied to the folding element 4912 exceeds the holding force retaining the first portion 4912a and the second portion 4912b in its extended position (Figure 94), the first portion 4912a and the second portion 4912b may begin to slide relative to each other. Similarly, the third portion 4912c of each folding element 4912 can be frictionally engaged and / or snapped into a corresponding second portion 4912b, such that, once the compression force applied to the folding element 4912 exceeds the force of retaining retaining the second portion 4912b and the third portion 4912c in its extended position (Figure 94), the second portion 4912b and the third portion 4912c may begin to slide relative to each other.
In many embodiments described in the present disclosure, a staple cartridge may comprise in the plurality of staples. Such staples may comprise a deformed metal wire in a substantially U-shaped configuration having two staple legs. Other modalities are contemplated in which the staples may comprise different configurations such as two or more wires that have been joined together having three or more staple legs. The wire, or wires, used to form the staples may comprise a round, or at least substantially round, cross section. The staple wires may comprise any other suitable cross section, such as square and / or rectangular cross sections, for example. The staples may comprise plastic threads. The staples may comprise metal wires coated with plastic. A cartridge can comprise any suitable type of fastener, in addition to or in place of the staples. For example, such a fastening element may comprise rotating arms that are bent when engaged by an anvil. Two piece fasteners could be used. For example, a staple cartridge may comprise a plurality of first portions of the clamping element and an anvil may comprise a plurality of second portions of the clamping element which are connected to the first portions of the clamping element when the anvil is compressed against the cartridge of staples. As described above, a slider or pusher can be advanced within a staple cartridge in order to complete the staple forming process. A slider or pusher may be advanced within an anvil in order to move one or more forming members downwardly in engagement with the opposite staple cartridge and staples, or fasteners, positioned therein.
A staple cartridge may comprise four rows of staples stored therein. The four rows of staples can be arranged in two rows of inner staples and two rows of outer staples. For example, a row of inner staples and a row of outer staples can be positioned on a first side of a cutting member, or knife, slot within the staple cartridge and, similarly, a row of inner staples and a row of staples. outer staples can be positioned on a second side of the cutting member or blade slot. Alternatively, the staple cartridge may not comprise a cut member slot; however, such a staple cartridge may comprise a designated portion configured to be cut by a cutting member instead of a staple cartridge slot. The rows of inner staples can be disposed within the staple cartridge, such that they are equally, or at least substantially equally, separated from the groove of the cutting member. Similarly, the rows of outer staples may be disposed within the staple cartridge, such that they will separate equally, or at least substantially equally, from the groove of the cutting member. A staple cartridge may comprise more or less than four rows of staples stored within a staple cartridge. A staple cartridge can comprise six rows of staples. For example, the staple cartridge may comprise three rows of staples on a first side of a cutting member groove and three rows of staples on a second side of the cutting member groove. A staple cartridge may comprise an odd number of rows of staples. For example, a staple cartridge can comprising two rows of staples on a first side of a cutting member groove and three rows of staples on a second side of the cutting member groove. The staple rows may comprise staples having the same staple height not formed, or at least substantially the same height. Alternatively, one or more of the rows of staples may comprise staples having a non-formed staple height different from the other staples. For example, the staples on a first side of a cutting member groove may have a first non-shaped height and the staples on a second side of a cutting member groove may have a second non-shaped height that is different from the first one. height, for example.
Referring now to Figures 96A to 96D, an end effector of a surgical stapler may comprise a cartridge engaging portion, such as the staple cartridge channel 5030, for example, a retainer cartridge removably positioned in the holder. staple cartridge channel 5030, such as the staple cartridge 5000, for example, and a clamp 5040 positioned opposite the staple cartridge 5000 and the staple cartridge channel 5030. The staple cartridge 5000 may comprise a compressible body 5010 and a plurality of staples 5020, and / or any other suitable fasteners, at least partially positioned in the compressible body 5010. For example, each staple 5020 may comprise a base 5022 and, additionally, the legs 5021 extending upwardly from the base 5022, wherein at least a portion of the legs 5021 can be incorporated into the cartridge body 5010. The compressible body 5010 may comprise an upper surface, or in contact with the fabric, 5019 and a lower surface 5018, wherein the lower surface 5018 may be positioned against and supported by a bearing surface 5031 of the staple cartridge channel 5030. Similar to the above , the support surface 5031 may comprise a plurality of support slots 5032 (Figure 96D), for example, defined therein which may be configured to receive and support the bases 5022 of the staples 5020. The end effector of the surgical stapler can also include a retention matrix, such as the holding matrix 5050, for example, which can be configured to engage the staples 5020 and capture the tissue therebetween. For example, the holding matrix 5050 can be removably mounted to the clamp 5040. In operation, once the staple cartridge 5000 has been positioned within the staple cartridge channel 5030, the clamp 5040, and the holding matrix 5050 attached thereto can be moved to the staple cartridge 5000 and the staple cartridge channel 5030. The clamp 5040 can be moved down along a shaft 5099 in such a manner that the clamp 5040 and the staple cartridge channel 5030 remain parallel, or at least substantially parallel, to each other when the clamp 5040 is closed. More particularly, for example, the clamp 5040 can be closed in a manner, such that a tissue contacting surface 5051 of the retention matrix 5050 is parallel, or at least substantially parallel, to the tissue contacting surface 5019 of the staple cartridge 5000 when the clamp 5040 is moved towards the staple cartridge 5000.
Referring now to Figure 96A, retainer 5050 can be removably secured to clamp 5040, such that there is little relative movement, if any, between retention die 5050 and clamp 5040 when the retention matrix 5050 is attached to clamp 5040. Clamp 5040 may comprise one or more retention features that can be configured to hold retention die 5050 in place. For example, the holding matrix 5050 can be snapped and / or snapped into the clamp 5040. The holding matrix 5050 can be adhered to the clamp 5040 by using at least one adhesive. In any case, the clamp 5040 can be moved to a position in which the holding matrix 5050 is in contact with the tissue T and the tissue T is positioned against the tissue contacting surface 5019 of the staple cartridge 5000. When the T tissue is positioned against the staple cartridge 5000 by the clamp 5040, the compressible body 5010 of the staple cartridge 5000 may or may not be compressed by the clamp 5040. In all circumstances, the legs 5021 of the staples 5200 may not protrude through the clamp 5040. the tissue contacting surface 5019 of the staple cartridge 5000 as illustrated in Figure 96A. In addition, as illustrated, further, in Figure 96A, the clamp 5040 can hold the tissue T against the compressible body 5010 without coupling the retaining matrix 5050 with the staples 5020. Such modalities can allow a surgeon to open and close the clamp 5040 multiple times in order to obtain a desired positioning of the end effector within of a surgical site, for example, without damaging the tissue T. Other embodiments are contemplated, however, wherein the staple tips 5023 may protrude from the tissue contacting surface 5019 before the cartridge body 5010 is compressed. by the anvil 5040. Once the end effector has been properly positioned, with reference now to FIG. 96B, the clamp 5040 can move downward towards the staple cartridge channel 5030 so that the compressible body 5010 is compressed by the anvil 5040 and, in such a way that the tissue contacting surface 5019 is pushed down relative to the staples 5020. As the tissue contacting surface 5019 is pushed down, the tips 5023 of the legs 5021 can pierce the tissue contacting surface 5019 and perforate at least a portion of the T fabric. In such circumstances, the holding matrix 5050 can be positioned above the staples 5020 , such that the retaining openings 5052 of the retaining die 5050 align, or at least substantially align, with the tips 5023 of the staple legs 5021.
As the holding matrix 5050 is pushed down along the axis 5099, now referring to Figure 96C, the staple legs 5021 of the staples 5020 can enter the retaining openings 5052. The staple legs 5021 they can be attached to the side walls of the retaining apertures 5052. As described in greater detail below, the retaining mat 5050 may comprise one or more retention members that extend into and / or around the retaining members 5050. retaining openings 5052 which can be attached to the staple legs 5021. In any case, the staple legs 5021 can be retained in the retaining openings 5052. In various circumstances, the tips 5023 of the staple legs 5021 can enter the retaining apertures 5052 and can frictionally couple the retaining features and / or the side walls of the openings 5052. As the retainer 5050 is pushed toward the bases 5022 of the staples 5020, the staple legs 5021 can slide in relation to the side walls and / or the retaining members. As a result of the above, sliding friction forces can be created between staple legs 5021 and retention die 5050, wherein such sliding friction forces can oppose the insertion of retention die 5050 in staples 5020. Friction forces Sliding between the holding matrix 5050 and the staples 5020 may be constant, or at least substantially constant, as the holding matrix 5050 slides down along the staple legs 5021 of the 5020 staples. sliding friction may increase and / or decrease as retaining matrix 5050 slides down along staple legs 5021 due to variations in the geometry of staple legs 5021, retention openings 5052 , and / or retaining members extending in and / or around the retaining openings 5052, for example. The insertion of the retention die 5050 into the staples 5020 can also be counteracted by the compressible body 5010 of the staple cartridge 5000. More particularly, the compressible body 5010 may comprise an elastic material, for example, which can apply a strength of resistance to the retaining matrix 5050 which increases as the distance in which it rises increases. For example, the increase in the resistance force generated by the cartridge body 5010 can be linearly proportional, or at least substantially linearly proportional, with respect to the distance at which the cartridge body 5010 is compressed. The increase in the strength of resistance generated by the cartridge body 5010 can be geometrically proportional with respect to the distance at which the body of the cartridge 5010 is compressed.
In addition to the above, a sufficient firing force can be applied to the clamp 5040 and the holding die 5050 in order to overcome the strength and friction forces described above. In operation, the holding matrix 5050 can be seated at any suitable depth with respect to the staples 5020. The holding matrix 5050 can be seated at a depth with respect to the bases 5022 of the staples 5020 in order to secure two or more layers of tissue together and generate compressive forces, or pressure, within the tissue. In various circumstances, the system comprising the retention matrix 5050 and the staples 5020 may allow a surgeon to select the magnitude of the compression forces, or the pressure, which is applied to the tissue by selecting the depth at which it is applied. set the holding matrix 5050. For example, the retaining matrix 5050 can be pushed down towards the staple bases 5022 of staples 5020 until retaining matrix 5050 is seated at a certain depth 5011 spaced from the bottom of supporting grooves 5032, where a shorter depth 5011 it can result in higher compression forces, or pressure, that are applied to tissue T than a higher depth 5011, which can result in lower compression forces, or pressure, that are applied to tissue T. Compression forces, or pressures , applied to the fabric T may be linearly proportional, or at least substantially linearly proportional, to the depth 5011 at which the retaining matrix 5050 sits. In various circumstances, the compression forces, or pressure, applied to the tissue T may depending on the thickness of the tissue T positioned between the holding matrix 5050 and the staple cartridge 5020. More particularly, for a given distance 5011, the presence A thicker T tissue may result in higher compression forces, or pressure, than the presence of thinner T tissue.
In various circumstances, in addition to the above, a surgeon can adjust the depth at which the retention matrix 5050 sits with the objective of considering the thicker and / or thinner tissue positioned within the end effector and applying a given pressure or predetermined to the tissue T regardless of the thickness of the tissue. For example, the surgeon can seat the retention matrix 5050 at a smaller depth 5011 when fixing the thinner T tissue or a greater depth 5011 when fixing the thicker T tissue in order to reach the same compression pressure, or at less substantially the same, within the tissue. In addition to the above, a surgeon can selectively determine the magnitude of the compression pressure to be applied to the tissue T positioned between the retaining matrix 5050 and the staple cartridge 5010. In various circumstances, a surgeon can couple the retaining matrix 5050 with the staples 5020 and positioning the holding matrix 5050 at a first distance separated from the bases 5022 of the staples 5020 in order to apply a first compression pressure to the fabric. The surgeon can alternatively position the holding matrix 5050 at a second distance apart from the 5022 bases, which is shorter than the first distance, with the aim of applying a second compression pressure to the tissue, which is greater than the first pressure. The surgeon can alternatively position the retaining matrix 5050 at a third distance spaced from the bases 5022, which is shorter than the second distance, in order to apply a third compression pressure to the tissue, which is greater than the second pressure. The fastening system comprising the retaining matrix 5050 and the staples 5020 can be configured to allow a surgeon to apply a wide range of compression pressures to the target tissue.
Referring now to Figure 96D, the staple legs 5021 can be inserted through the retainer 5050 in such a manner that the tips of the staple legs 5023 extend above the upper surface of the retainer mat 5050. Referring again to Figure 96C, the clamp 5040 may further comprise clearance openings 5042 defined in it that can be configured to receive the tips of the staple legs 5023 as they pass through the retaining openings 5052 in the retaining array 5050. For example, the clearance openings 5042 can be aligned with the retaining openings 5052 so that the legs 5021 do not contact the bracket 5040 The clearance openings 5042 may be of sufficient depth such that the staple legs 5021 do not come into contact with the clamp 5040 regardless of the distance at which the retaining matrix 5050 settles. 5050 has been coupled with staples 5020 and seated to a desired position, now referring to Figure 96D, staple cartridge channel 5030 and clamp 5040 can be separated from tissue T. More particularly, staple cartridge channel 5030 can be separated from the staple cartridge 5000 implanted and the anvil 5040 can be separated from the implanted retention matrix 5050. As the clamp 5040 is separated of the holding matrix 5050 and the staple holders 5032 are separated from the staple bases 5022, the distance 5011 between the holding matrix 5050, and the lower part of the bases 5022 can be maintained even when the clamp 5040 and the channel 5030 staple cartridge no longer provide support for these. The static friction forces between the staple legs 5021 and the retainer 5050 may be sufficient to maintain the retainer 5050 in its position despite a pressing force applied to the retainer 5050 by the body of the staple 5050. 5010 compressed cartridge and / or compressed T tissue. For example, the cartridge body 5010 may comprise a flexible material that, when compressed, may apply a force of elastic pressure to the holding matrix 5050 and the staples 5020 in a manner that tends to push apart the holding matrix 5050 and the staples 5020, although such movement is counteracted by the frictional engagement between the staple legs 5021 and the retaining matrix 5050.
As described above, a retainer matrix may comprise a plurality of retention openings, wherein each retainer opening may be configured to receive therein a leg of a retainer. Referring now to Figure 97, a portion of a retainer 5150 is illustrated therein, which may comprise a retention opening 5152 defined by a perimeter 5156. The perimeter 5156 of the opening 5152 may comprise a circular profile, or less substantially circular, and / or any other suitable profile. The retainer 5150 may comprise one or more retention members, such as retention members 5153, for example, which extend into opening 5152 and may be configured to engage a clamping leg when the clamping leg is inserted. through these. For example, each retaining member 5153 may comprise a cantilever which extends inward toward a central axis 5159, ie, toward the center of the opening 5152. Each cantilever may comprise a first end, which engages the body of the holding matrix 5158 and a second end forming the perimeter 5156 of the retaining opening 5152. The perimeter 5156 of a retaining opening 5152 can be defined by a first diameter, or width, and a holding leg can be defined by a second diameter , or width, where the second diameter may be larger than the first diameter. For example, the clamping leg can be configured to contact and deflect one or more of the retaining members 5153 in order to increase the diameter of the retaining opening 5152 while the clamping leg is inserted through it. In addition to the above, the clamping leg can define a perimeter which is larger than the perimeter 5156 of the retaining opening 5152, in such a way that the clamping leg can expand the perimeter 5156 when the clamping leg is inserted therein.
Referring again to Figure 97, the opening 5152 can be defined by the deformable members 5153, wherein each deformable member 5153 can be configured to deflect relative to, or independently of, the other deformable members 5153. For example, adjacent deformable members 5153 can be separated by slots 5154 that can be configured to allow each deformable member 5153 to flex relative to the others. Each slot 5154 may comprise a first end 5155 in the body of the retaining die 5158, a second end opening in the retaining opening 5152, and a constant width, or at least substantially constant, extending between the first end 5155 and the second extreme. Alternatively, the width of each slot 5154 may not be constant and each slot 5154 may increase and / or decrease in width between the first and second end thereof. The first ends 5155 of the slots 5154 may comprise an enlarged portion, such as a circular portion, that can provide, one, tension relief to the bases of the deformable members 5153 connected to the body of the retaining matrix 5158 and, two, means to increase the flexibility of the deformable members 5153. The geometry of the deformable members 5153, and / or of the 5154 slots, can be selected in order to provide the deformable members 5153 with a desired flexibility. For example, the slots 5154 may be lengthened with the aim of creating longer deformable members 5153 which may be more flexible than the deformable members 5153 having a shorter length. The width of each deformable member 5153 can be selected to provide a desired flexibility. More particularly, the deformable members having a thinner width may be more flexible than the deformable members having a thicker width. Referring again to Figure 97, the first ends of the cantilevers of the deformable members 5153 that engage the body of the retaining die 5158 may be wider than the second ends of the cantilevers. For example, the overhangs may taper in a linear, or at least substantially linear, manner between the first and second ends thereof.
Referring again to Figure 97, the body of the retaining matrix 5158 may comprise a flat, or at least substantially flat, sheet of a material having a tissue contacting surface 5151 and an upper surface 5157. For example, the tissue contacting surface 5151 and the upper surface 5157 may be parallel, or at least substantially parallel, to each other. Each deformable member 5153 can comprising a first portion 5153a and a second portion 5153b, wherein the first portion 5153a may extend in a first direction and the second portion 5153b may extend in a second or different direction. For example, the body of the retaining die 5158 can define a plane and the first portions 5153a of the deformable members 5153 can be pd within that plane. The second portions 5153b of the deformable members 5153 may extend at an angle relative to the first portions 5153a. For example, the second portions 5153b may extend in directions pointing away from the upper surface 5157 of the body of the retaining die 5158 and the second portions 5153b may converge toward the central axis 5159 of the retaining opening 5152. In any In this case, the second portions 5153b can be configured to deviate out of the central axis 5159 when the clamping leg is inserted through them. Where a staple leg 5021 of a staple 5020 is inserted into a retaining opening 5152, the deformable members 5153 may deform in a direction generally outside the bases 5122 of the staples 5120. As a result, the deformable members 5153 may deviate in a general direction that is the same, or at least substantially the same, as the direction in which the staple legs 5021 are inserted.
Referring again to Figure 97, each of the second portions 5153b of the deformable members 5153 may comprise a sharp tip, for example, which may be configured to slide against a staple leg 5021 as the staple leg 5021 is inserted in this. The sharp tips of the second portions 5153b can be further configured to bite into the staple leg 5021 in the event that the staple leg 5021 is pulled in the opposite direction, i.e., in a direction that would remove the staple leg. 5021 of the retaining opening 5052. In certain circumstances, the second portions 5153b may be inclined at an angle relative to the side of the staple leg 5021 that is greater than 90 degrees and, as a result, the second portions 5153b may be driven, or penetrate, on the side of the staple leg 5021 when the staple leg 5021 undergoes a force tending to remove the staple leg 5021 from the retainer opening 5052. The staple legs 5021 may comprise indentations and / or depressions, such as micromuescas, for example, on the surfaces of these which can be configured to receive therein the tips of the deformable members 5053, for example. For example, the tips of the deformable members 5053 can be captured and penetrated into the notches in the staple legs 5021 when an extraction force is applied to the staple legs 5021. As a result of the penetration of the second portions 5153b into the staple legs 5021. staple legs 5021, the forces acting to remove the staple legs 5021 from the retaining openings 5022 can only seat the second portions 5153b deeper into the staple legs 5021 and increase the force necessary to remove the staple legs 5021. In addition, due to the upward tilt of the second portions 5153b, the second portions 5153b may be more permissive to the insertion of a staple leg 5021 into a retainer opening 5152 and more resistant to removal of the staple leg 5021. As a result, the force required to insert a staple leg 5021 into a retaining opening 5022 may be less than the force required to remove the staple leg 5021 from the staple leg 5021. retaining opening 5022. The force required to remove the staple leg 5021 from the retaining opening 5022 may be approximately 50 percent greater than the force required to insert the staple leg 5021 into the retaining opening 5022, for example. Alternatively, the force required to remove the staple leg 5021 may be between about 10 percent and about 100 percent greater than the force needed to insert the staple leg 5021, for example. The force required to remove the staple leg 5021 may be about 100 percent, about 150 percent, about 200 percent, and / or greater than about 200 percent greater than the force needed to insert the leg. of staple 5021, for example.
Referring again to Figure 97, the second portions 5153b may be arranged circumferentially around the opening 5152 and may define a cavity therebetween. More particularly, the second portions 5153b can define a cavity 5160, which can be configured to receive the tip of the clamping leg when it is inserted in the retaining opening 5152. The second portions 5153b of the deformable members 5153 can comprise an annular contour , or at least substantially annular, which can define cooperatively a ring profile, or at least substantially annular, of the cavity 1560, for example. For example, the second portions 5153b may define a conical or frustoconical cavity. The cavity can be defined by an adequate number of deformable members, such as four deformable members 5153 (Figure 97), six deformable members 5153 (Figure 98), or eight deformable members 5153 (Figure 99), for example. Referring now to Figure 100, the deformable members of a retention matrix, such as retention die 5250, for example, can form a pyramidal shape, or at least substantially pyramidal form, for example. A retaining matrix 5250 may comprise a plurality of retention openings, such as retention opening 5252, for example, which can be defined by a perimeter 5256. Perimeter 5256 may comprise a polygonal profile, or at least substantially polygonal, and / or any other suitable profile. The retaining matrix 5250 may comprise one or more retaining members, such as the retaining members 5253, for example, which extend into the opening 5252 and may be configured to engage with a clamping leg when the clamping leg is inserted. through these. For example, each retention member 5253 may comprise a cantilever which extends inward toward a central axis 5259, ie, toward the center of the aperture 5252. Each cantilever may comprise a first end, which engages the body of the retaining matrix 5258 and a second end forming the perimeter 5256 of retaining opening 5252. Perimeter 5256 of a retaining opening 5252 can be defined by a first diameter, or width, and a clamping leg can be defined by a second diameter, or width, wherein the second diameter can be larger than the first diameter. For example, the clamping leg can be configured to contact and deflect one or more of the retaining members 5253 in order to increase the diameter of the retaining opening 5252 while the clamping leg is inserted through it. In addition to the above, the clamping leg can define a perimeter which is larger than the perimeter 5256 of the retaining opening 5252, such that the clamping leg can expand the perimeter 5256 when the clamping leg is inserted in this. .
Referring again to Figure 100, the opening 5252 can be defined by the deformable members 5253, wherein each deformable member 5253 can be configured to deflect relative to, or independently of, the other deformable members 5253. For example, adjacent deformable members 5253 can be separated by slots 5254 that can be configured to allow each deformable member 5253 flexes in relation to the others. The body of the retaining matrix 5258 may comprise a flat, or at least substantially flat, sheet of a material having a tissue contacting surface 5251 and an upper surface 5257. For example, the contact surface with the fabric 5251 and the upper surface 5257 may be parallel, or at least substantially parallel, with each other. Each deformable member 5253 may comprise a first portion 5253a and a second portion 5253b, in where the first portion 5253a may extend in a first direction and the second portion 5253b may extend in a second or different direction. For example, the body of the retaining die 5258 can define a plane and the first portions 5253a of the deformable members 5253 can be located within that plane. The second portions 5253b of the deformable members 5253 may extend at an angle relative to the first portions 5253a. For example, the second portions 5253b may extend in directions pointing away from the upper surface 5257 of the body of the retaining die 5258 and, the second portions 5253b may converge toward the central axis 5259 of the retaining opening 5252. In any In this case, the second portions 5253b can be configured to deviate away from the central axis 5259 when the clamping leg is inserted through them. Referring again to Figure 100, the second portions 5253b may be arranged circumferentially around the opening 5252 and may define a cavity therebetween. More particularly, the second portions 5253b can define a cavity, which can be configured to receive the tip of the clamping leg when it is inserted in the retaining opening 5252. The second portions 5253b of the deformable members 5253 can define a polygonal cavity, or at least substantially polygonal, for example. The cavity can be defined by an adequate number of deformable members, such as four deformable members 5253 (Figure 100), which can define a square, six deformable members 5253 (Figure 101), which can define a hexagon, or eight deformable members 5253 (Figure 102), which can define an octagon, for example.
Referring now to Figure 103, a retention die, such as retention die 5350, for example, can be formed from a flat, or at least substantially flat, sheet of material such as titanium and / or stainless steel. , for example. For example, a plurality of openings 5352 may be formed in the body 5358 of the retaining die 5350 by one or more stamping processes. The sheet of the material can be positioned in a stamping die which, when actuated, can perforate certain portions of the material in order to form the grooves 5354, the openings 5355 of the grooves 5354, and / or the perimeter 5356 of the retaining opening 5352, for example. The stamping die may also be configured to bend the deformable members 5353 in a suitable configuration. For example, the stamping die may deform the second portions 5353b upwardly relative to the first portions 5353a along a fold line 5353c. Referring now to Figure 104, a retention die, such as the retention die 5450, for example, may comprise a plurality of retention apertures 5452. Similar to the foregoing, the perimeter 5456 of each retention aperture 5452 may be defined by a plurality of deformable members 5453 separated by grooves, or slits, 5454. For example, the entirety of each deformable member 5453 can be bent upwardly, wherein the free ends of the cantilevers comprising the deformable members 5453 can define the perimeter 5456. The retaining matrix 5450 may comprise a plurality of openings 5455 surrounding, or at least substantially surrounding, the retaining opening 5452. For example, the openings 5455 may be arranged in a circular array that surrounds or encloses a defined perimeter by the fixed ends of the cantilevers of the deformable members 5453. Each opening 5455 may comprise a circular perimeter, or at least substantially circular, and / or any other suitable perimeter. In operation, the openings 5455 can provide, one, the tension compensation for the bases of the deformable members 5453 attached to the body of the retaining matrix 5458 and, two, means for increasing the flexibility of the deformable members 5453. The openings further large 5455 may provide more flexibility to deformable members 5453 compared to smaller openings 5455. In addition, openings 5455 that are closer to deformable members 5453 may provide more flexibility compared to openings 5455 that are further away.
Referring now to Figure 105, a retention die, such as retention die 5550, for example, may comprise a plurality of retention apertures 5552. Each retention aperture 5552 may comprise an elongated recess 5554 having elongated circular ends. , or at least substantially circular, 5555. For example, the ends 5555 may be defined by a diameter that is wider than the slot 5554. The elongated slot 5554 and the ends 5555 may be positioned along, and / or centered along , of a longitudinal axis 5559.
Slot 5554 and ends 5555 can define two opposing tabs 5553 that can be configured to engage a leg of a fastener and deviate as the clamping leg is inserted through them. The ends 5555 having a perimeter, or larger diameter, can define the longer tabs 5553 which can be more flexible than the tabs 5553 defined by the ends 5555 having a smaller perimeter, or diameter. The ends 5555 may have the same perimeter and diameter and, for example, each tab 5553 may be symmetrical about an axis that is perpendicular, or at least substantially perpendicular, to the longitudinal axis 5559. Alternatively, the ends 5555 may have different perimeters and / or diameters, wherein each tab 5553 may not be symmetric about its axis. For example, the tabs 5553 may be twisted about their axes as the clamping leg is inserted through the retaining opening 5552. Referring now to Figure 106, a retention die, such as the retainer 5650 , for example, may comprise a plurality of retaining apertures 5652. Each retaining aperture 5652 may comprise an elongated slot 5654 comprising the circular, or at least substantially circular, ends 5655. For example, the elongated slot 5654 and the ends 5655 they can be positioned along, and / or centered along, a longitudinal axis 5659. Each end 5655 can be defined by a diameter that is the same, or at least substantially the same, as the width of the slot 5654.
Referring now to Figure 107, a retention die, such as retention die 5750, for example, may comprise a plurality of retention openings 5752. Each retention opening 5752 may comprise a plurality of slots, such as slots. 5754, for example, having enlarged ends 5755. For example, slots 5754 and ends 5755 can be positioned along and / or centered along longitudinal axes 5759. Axes 5759 can extend in directions that are perpendicular or transverse to each other. The slots 5754 and the ends 5755 can define four tabs 5753, for example, which can be configured to engage a clamping leg and deviate when the clamping leg is inserted through the retaining opening 5752. Each tab 5753 can comprise a triangular configuration, or at least substantially triangular, such as an equilateral triangle, for example. Alternatively, with reference now to Figure 108, a retention die, such as the retention die 5850, for example, may comprise a plurality of retention apertures 5852. Each retention aperture 5852 may comprise a plurality of recesses, such as the grooves 5854, for example, having the ends 5855, wherein the grooves 5854 and the ends 5855 can be positioned along and / or centered along the longitudinal axes 5859. The axes 5859 can extend in directions that are perpendicular or transverse to each other. The slots 5854 and the ends 5855 can define the tabs 5853 that can be configured to be coupled to a leg clamping and deflecting when the clamping leg is inserted through the retaining opening 5852. Each tab 5853 may comprise a curved profile. More particularly, each tab 5853 may comprise a curved end, as opposed to a sharp end shown in Figure 105, which may be configured to contact the clamping leg.
Referring now to Figure 109, a retention die, such as retention die 5950, for example, may comprise a plurality of retention openings 5952. Each retention opening 5952 may comprise a plurality of slots, such as slots. 5954, for example, wherein each slot 5954 may extend along, and / or may be centered along, an axis 5959. Shafts 5959 may be transverse to each other and, for example, axes 5959 may be disposed of All of the axes 5959 extend through a center of the retaining opening 5952 and are spaced apart equidistantly, or at least substantially equidistantly, from one another. Each slot 5954 may comprise an open end facing the center of the retaining opening 5952 and a second, or closed, end 5955 at the opposite end of the slot 5954. Similar to the above, the slots 5954 and the ends 5955 may define three tabs 5953, for example, which can be configured to engage a clamping leg and deflect when the clamping leg is inserted into the retaining opening 5952. Each tab 5953 can comprise an arcuate configuration extending between adjacent ends 5955 of the slots 5954. With reference now to the Figure 110, a retention die, such as the retention die 6050, for example, may comprise a plurality of retention apertures 6052. Each retention aperture 6052 may comprise a tab 6053, which may be configured to be attached to a retaining leg and to deviate when the clamping leg is inserted in the retaining opening 6052. For example, the tongue 6053 may comprise a base fixed to the body of the retaining die 6058 and a free end comprising a curved or arcuate profile 6056 which can configured to come into contact with the clamping leg. The clamping leg can be a staple leg composed of a round wire, wherein the curved profile 6056 can be configured to match, or at least substantially coincide with, a curved outer surface of the round wire.
Referring again to Figure 110, the body of the retainer die 6058 may comprise a plurality of slots 6054 and openings 6055 that can be configured to define the tab 6053 and several portions of the retainer opening 6052. The tab 6053 may comprise a rectangular configuration comprising parallel, or at least substantially parallel, sides. Referring now to Figure 111, a retention die, such as retention die 6150, for example, may comprise a plurality of retainer openings 6152. Each retention aperture 6152 may comprise a tab 6153, which may be configured to engage to a clamping leg and to deflect when the clamping leg is inserted in the retaining opening 6152. For example, the tab 6153 may comprise a base fixed to the body of the retainer die 6158 and a free end comprising a curved or arched profile 6156 which may be configured to contact the retainer leg. The body of the retaining die 6158 may comprise a plurality of grooves 6154 and openings 6155 that can be configured to define the tongue 6153 and various portions of the retaining opening 6152. The tongue 6153 can comprise a tapered configuration comprising arcuate sides. For example, the tongue 6153 can be narrowed geometrically with the base wider than the free end, for example.
As described above, a fastening system may comprise a plurality of staples comprising the staple legs which are inserted through a plurality of retention openings in a retaining matrix. As described in more detail below, the staples can be held in a first clamp and the retention matrix can be held in a second clamp, wherein at least one of the first clamp and the second clamp can move in the direction of the other. In various circumstances, staples positioned within the first clamp can be secured therein, such that the staple legs align with the retention openings when the retainer matrix engages the staple legs. With reference to Figures 112 and 113, a fastening system may comprise a staple cartridge 6200, for example, positioned in a first clamp of a surgical stapler and a retainer 6250, for example, positioned in a second clamp of the stapler. stapler surgical Referring now to Figures 119 and 120, in addition to the foregoing, retaining die 6250 may comprise a plurality of retainer openings 6252, wherein each retainer opening 6252 may comprise a perimeter 6256 defined by one or more deflectable members 6253 For example, in addition to the above, the deflecting members 6253 defining each opening 6252 may define a cavity 6201. Each cavity 6201 may comprise a curved and / or concave surface, for example, which may be configured to guide a tip of a leg of staple inside the opening 6252 in the event that the staple leg is misaligned with the retainer opening 6252 and initially contact the deflectable members 6253 and / or the tissue contact surface 6251, for example.
In addition to the above, the fastening system may further comprise a plurality of staples 6220 comprising the staple legs 6221 that can be inserted through the retaining openings 6252 in the retaining die 6250. For example, each staple 6220 it may comprise a substantially U-shaped configuration, for example, comprising a base 6222 from which the staple legs 6221 may extend upwards. Referring now to Figures 115 and 116, the retention apertures 6252 in the retention die 6250 may be arranged in two longitudinal rows parallel, or at least substantially parallel, for example, which may extend along, or parallel to, a longitudinal axis of the retention matrix. The retaining openings 6252 in a first row can be displaced, or staggered, with respect to the retaining openings 6252 in a second row. For example, each staple 6220 may comprise a first staple leg 6221 positioned in a retention aperture 6252 in the first row and a second staple leg 6221 positioned in a retention aperture 6252 in the second row, wherein, as a result, the bases 6222 may extend in a direction that is transverse to the longitudinal axis of the retention die 6250. For example, the staples 6220 may be parallel, or at least substantially parallel, to each other. More particularly, a base 6222a of a staple 6220a is parallel, or at least substantially parallel, to a base 6222b of a staple 6220b, which may be parallel, or at least substantially parallel, to a base 6222c of a staple 6220c, for example . The staple legs 6221a of the staple 6220a may define a plane that is parallel, or at least substantially parallel, to a plane defined by the staple legs 6221b of the staple 6220b which may be parallel, or at least substantially parallel, to a staple. flat defined by the staple legs 6221 of the staple 6220c, for example.
Referring now to Figures 112 and 114, the staple cartridge 6200 may comprise a plurality of staples 6220 and, in addition, an alignment die 6260 comprising a plurality of alignment guides, such as grooves, grooves, and / or openings , for example, that can be configured to align the staples 6220. In various circumstances, the alignment matrix 6260 can be configured, such that the staple legs 6221 of the staples 6220 are aligned with the retaining openings 6252 in the staple die. retention 6250 before the holding die 6250 engages with the staple legs 6221. Referring now to FIGS. 117 and 118, the die alignment 6260 may comprise a plurality of alignment openings 6262 which can be configured to tightly receive staple legs 6221 of staples 6220. For example, each staple 6220 may comprise a base 6222 and two staple legs 6221 extending from the base 6222, wherein the bases 6222 of the staples 6220 may extend around a lower surface 6264 of the retaining die 6260 and the staple legs 6221 may extend upwardly through the alignment openings 6262. Each alignment aperture 6262 may be circular, or at least substantially circular, and can be defined by a diameter that is equal to or slightly greater than the diameter of the staple leg 6221 extending therethrough. The alignment matrix 6260 may further comprise a plurality of raised members 6263 which may extend upwardly from the upper surface 6261 of the alignment die 6260 and surround, or at least partially surround, the alignment openings 6262. The raised members 6263 may provide longer alignment openings 6262 where, in various circumstances, the longer openings 6262 may provide more control over the alignment of the staple legs 6221 than the shorter openings 6262.
In operation, a first clamp supporting the staple cartridge 6200 can be positioned on one side of the tissue to be stapled and a second clamp supporting the retaining mat 6250 can be positioned on the other side of the tissue. Once the clamps are properly positioned relative to the tissue, the second clamp and the retention die 6250 can move in the direction of the staple cartridge 6200. As the staple legs 6221 are inserted through the retaining openings 6252 of the retaining die 6250, a tissue contacting surface, or lower surface, 6251 of the retaining mat 6250 can come into contact with the tissue and pressing the tissue against the contact surface with the tissue, or upper surface, 6261 of the alignment die 6260. Alternatively, as described in more detail below, the staple cartridge 6200 may further comprise a compressible cartridge body. which is placed above the upper surface 6261 of the alignment die 6260, for example, which may come into contact with the fabric. Referring again to Figures 114 and 118, the alignment matrix 6260 may further comprise one or more apertures 6203 defined therein which, when the alignment die 6260 is positioned against the tissue, may be configured to receive a portion of the tissue. in this. Where a compressible cartridge body is placed above and / or against the alignment die 6260, a portion of the compressible cartridge body can enter the openings 6203 when the cartridge body is compressed. Similarly, the retention die 6250 can comprise a plurality of openings 6202 that can be configured to receive at least a portion of the tissue therein when the retention die 6250 is positioned against the tissue.
As the staple legs 6221 of the staples 6220 are inserted through the retaining apertures 6252 of the retaining die 6250, in addition to the above, the tips of the staple legs 6221 can protrude upwardly from the top surface 6257 of the matrix of 6250. In various circumstances, as described above, the tips of the staple legs 6221 can remain unfolded after they have been inserted through the retainer openings 6252. Referring now to FIGS. 121 to 124, a The fastening system comprising the staple cartridge 6200 and the retaining die 6250 may further comprise a plurality of protective covers or covers, such as the covers 6270, for example, which may be assembled to the protruding staple legs 6221. above the retention die 6250. Each cap 6270 may completely cover, or at least partially, the sharpened end of a staple leg 6221, such that the sharpened end does not come into contact with the tissue positioned adjacent thereto. Referring now to Figure 124, each cap 6270 may comprise an aperture 6271 defined therein that can be configured to densely receive a tip of a staple leg 6221 therein. The covers 6270 may comprise an elastomeric material, such as silicone, polyisoprene, sanoprene, and / or natural rubber, for example. The opening 6271 may comprise a perimeter or diameter that is smaller than the perimeter or diameter of the staple leg 6221 inserted therein. For example, the opening 6271 in the protective cap 6270 can be expanded in order to receive the staple leg 6221 therein. Alternatively, the covers 6270 may not comprise openings and the tips of the staple legs 6221 may be configured to cut the covers 6270 while the legs 6221 are inserted therein. In any case, each cover 6270 can be seated on a staple leg 6221 until the base 6272 of the cap 6270 abuts, or is positioned adjacent to, the top surface 6257 of the retainer 6250. In various circumstances, the covers 6270 can be configured in such a way that they sit snugly on the tips of the staple legs 6221, so that they are not easily removed from them. Each cap 6270 may comprise a conical outer surface, or at least substantially conical, for example. The covers 6270 may comprise any suitable shape, such as shapes comprising a parabolic outer surface, or at least substantially parabolic, for example.
The fastening system described above, for example, could be implemented by using the surgical stapler shown in Figures 125 to 127, for example. The end effector may comprise a first clamp, or the staple cartridge channel, 6230, which can be configured to support the staple cartridge 6200 in this and a second clamp 6240 that can be configured to support the staple die 6250 and the plurality of protection caps 6270. With reference principally to Figure 125, which illustrates the second clamp 6240 in an open configuration, the clamps 6230 and 6240 can be positioned relative to the tissue T, such that the tissue T is positioned between the retention matrix 6250 and the cartridge of staples 6200. As described above, the staple cartridge 6200 may further comprise a compressible cartridge body, such as the cartridge body 6210, for example, in which staples 6220 and alignment die 6260 may be positioned. For example, tissue T can positioning against an upper surface of the cartridge body 6210. The second bracket 6240 may comprise a plurality of recesses, or openings, 6245, configured to receive the plurality of protection caps 6270 and, in addition, one or more retaining features, or retainers , which can be configured to hold the retaining die 6250 in position over the caps 6270. For example, the retainer die 6250 can be configured to retain the caps 6270 in the openings 6245. Referring now to Figure 137, each opening 6245 it can be configured to receive therein a portion, or all, of a lid 6270. The openings 6245 can be sufficiently sized and configured in such a way that the caps 6270 can be secured therein by at least one of a press fit arrangement and / or brooch, for example. At least one adhesive could be used to secure the caps 6270 in the openings 6245. For example, such an adhesive could be selected, so that the caps 6270 can be separated from the second clamp 6240 after the caps 6270 have been coupled with the legs 6270. staple 6221 and second clamp 6240 move away from the implanted holding unit. Referring now to Figure 138, the second clamp 6240 may further comprise at least one cover sheet 6246 which can be assembled to the second clamp 6240 and may extend over and retain the covers 6270 in the openings 6245. For example, at less a portion of the cover sheet 6246 can be fixed to the bracket 6240 by using at least one adhesive, for example.
In operation, cover sheet 6246 can be separated at least partially from clamp 6240 before inserting the end effector into a surgical site. The cover sheet 6246 may comprise an implantable material, such as PDS and / or PGA, for example, which can be cut by the staple legs 6221 when the staple legs 6221 emerge from the retainer 6250. For example, the sheet 6246 can be fixed to the clamping system between the covers 6270 and the retainer 6250.
In addition to the above, with reference now to Figure 126, the clamp 6240 can be moved from an open position to a closed position in which the tissue T is positioned against the retaining die 6250 and the body of the cartridge 6210. In such a position , the holding die 6250 may not yet be coupled with the staples 6220. The clamp 6240 may be moved between its open position and its closed position by an actuator 6235. For example, the clamp 6240 may comprise a distal pin 6243 and a proximal pin 6244 extending therefrom, wherein the distal pin 6243 can slide vertically, or at least substantially vertically, within a distal groove 6233 defined in the channel of the cartridge 6230, and wherein the proximal pin 6244 can slide vertically, or at least substantially vertically, within a proximal groove 6234 which is also defined in the staple cartridge channel 6230. In operation, the actuator 6235 can be retracted proximally with the objective of driving the pins 6243 and 6244 into the upper ends of their respective slots 6233 and 6234 as illustrated in the Figure 126. For example, the actuator 6235 may comprise a drive slot distal 6236 and a proximal drive groove 6237, wherein the side walls of the drive grooves 6236 and 6237 can be configured to contact the distal pin 6243 and the proximal pin 6244, respectively, and drive pins 6243 and 6244 toward up, as the actuator 6235 moves proximally. More particularly, as the actuator 6235 moves proximally, the distal pin 6243 can slide up a first inclined portion 6236a of the distal drive groove 6236 into an intermediate, or second, portion 6236b and, similarly, the proximal pin 6244 can slide up a first inclined portion 6237a of the distal drive slot 6237 into an intermediate portion, or second, 6237b. As the pins 6243 and 6244 move both upwards, the clamp 6240 can be rotated downward toward the tissue T to a closed position.
In addition to the foregoing, with reference now to Figure 127, the actuator 6235 can be pulled more proximally with the objective of pushing the second clamp 6240 down towards the first clamp 6230, compressing the body of the cartridge 6210, and coupling the holding matrix 6250 and the plurality of protection caps 6270 with the staple legs of the staples 6220. For example, further proximal movement of the actuator 6235 may cause the side walls of the drive grooves 6236 and 6237 to come into contact with the pins 6243. and 6244, respectively, and actuate pins 6243 and 6244 downward, toward the lower ends of slots 6233 and 6234, respectively. In such circumstances, the actuator 6235 may be pulled proximally, such that, one, the distal pin 6243 exits the second portion 6236b of the drive groove 6236 and enters a third inclined portion 6236c and, similarly, the proximal pin. 6244 leaves the second portion 6237b of the drive slot 6237 and enters into a third inclined portion 6237c. As the pins 6243 and 6244 move both downwards, the second clamp 6240 can move downward towards the first clamp 6230 to a triggered position. For example, the second clamp 6240 can be moved downward, such that the retainer 6250 is held parallel, or at least substantially parallel, to the upper surface of the cartridge body 6210 and / or parallel, or at least substantially parallel , to the alignment die 6260. In any case, once the holding die 6250 and the protective caps 6270 have been coupled with the staple legs 6221 of the staples 6220, as illustrated in Fig. 129, the second Clamp 6240 can be returned to an open, or at least substantially open, position. For example, the actuator 6235 can be pushed distally in order to drive the pins 6243 and 6244 towards the upper ends of the grooves 6233 and 6234, respectively, and then propel downward towards the lower ends of the grooves 6233 and 6234 once the pins have traversed the intermediate portions 6236b and 6237b of the respective driving grooves 6236 and 6237. Once the second clamp 6240 has been opened, the first Clamp 6230 can be separated from the implanted staple cartridge 6200 and the first and second clamps 6230, 6240 can be moved away from the implanted clamping assembly, as illustrated in Figure 128.
Referring to Figure 127 once again, the reader will note that the pins 6243 and 6244 are not illustrated as being seated in the same bottom portions of their respective slots 6233 and 6234 although the retainer die 6250 and the caps 6270 have been coupled with the staple legs 6221. Such circumstances may arise when thick tissue T is positioned between the retention die 6250 and the cartridge body 6210. In circumstances where thinner tissue T is positioned between the retention die 6250 and the body 6210 cartridge, with reference now to Figure 130, the pins 6243 and 6244 can be propelled further downwardly into their respective slots 6233 and 6234 as illustrated in Figure 132. Generally, for example, the actuator 6235 can be pulled proximally with the objective of driving the pins 6243 and 6244 up and down by the progressions described above and illustrated in Figures 130 to 132 and, due to the thinner tissue T, the retaining die 6250 and the protective caps 6270 can be further urged on the staple legs 6221 of the staples 6220, as illustrated in Figures 133 and 134. As a result of the adjustability provided by the retention die 6250, the same compression pressure can be achieved, or at least substantially the same, in the subject tissue regardless of whether the tissue captured within the effector of Extreme is thick or thin. The adjustability provided by the retention matrix 6250 may allow a surgeon to select whether to apply a higher compression pressure or a lower compression pressure to the tissue by selecting the depth at which the retention matrix 6250 sits. For example, the interval in which the holding die 6250 can settle on the staple legs 6221 can be determined by the lengths, or intervals, of the grooves 6233 and 6234, for example.
As described above, the protection caps 6270 can comprise a soft or flexible material, for example, which can be configured to grip the ends of the staple legs 6221. The protective caps 6270 can comprise a bioabsorbable plastic, polyglycolic acid (PGA). ) which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL) which is marketed under the trade name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example, and / or a biocompatible metal, such as titanium and / or stainless steel, for example. As illustrated in Figure 124, each cap 6270 may be without any connection to the other caps 6270. Alternatively, one or more caps 6270 may be mounted on the retainer 6250. For example, the caps 6270 may be connected to the matrix 6270. retainer 6250 by at least one adhesive, for example, wherein the openings 6271 in the caps 6270 can be aligned, or at least substantially aligned, with the retainer openings 6252 in the holding matrix 6270. With reference now to Figure 135, a protective cap, such as a cap 6370, for example, can define an interior cavity, or dome, 6374 that can be configured to receive therein a tip of a staple leg 6221, for example. For example, the cap 6370 may comprise a lower portion 6372 and an opening 6371 extending through the lower portion 6372. The opening 6371 may be defined by one or more deflectable members 6373 that may be configured to deviate when the staple foot 6221 it is inserted through them. Two or more lids 6370, for example, may be connected together to form a set of lids 6370. For example, with reference now to Figure 136, a plurality of lids 6370 may be connected together by a sheet 6375 of material. The sheet 6375 may be sufficiently rigid in order to maintain a desired arrangement and / or alignment of the caps 6370. The caps 6370 may be comprised of a biocompatible metal, such as titanium and / or stainless steel, for example, and sheet 6375 it may be comprised of a bioabsorbable plastic, polyglycolic acid (PGA) which is sold under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL) which is marketed under the commercial name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. A sheet 6375 can be comprised of a bioabsorbable material that includes an antimicrobial agent, such as colloidal silver and / or triclosan, for example, which is stored and / or dispersed therein which can be released while the lamina 6375 is bioabsorbed, for example.
In addition to the above, the sheet 6375 can be injection molded around the caps 6370 by the use of an injection molding process, for example, in such a way that the covers 6370 are incorporated in the sheet 6375. Alternatively, the sheet 6375 it can be molded by the use of an injection molding process, for example, where the openings 6376 can be formed in the sheet 6375 during the injection molding process and / or after the injection molding process by using a process of stamping, for example. In any case, the lids 6370 can be inserted and secured in the openings 6376 by using a snap-fit interlock and / or snap and / or at least one adhesive. Each cover 6370 may comprise an annular groove that surrounds, or at least partially surrounds, the perimeter of the lid 6370, which can be configured to receive therein the perimeter of an opening 6376. The sheet 6375 can be comprised of a flexible material and / or foldable that can allow relative movement between the lids 6370. For example, the flexible sheet 6375 may be comprised of a rubber, plastic, and / or silicone material, for example, and the lids 6370 may be comprised of a rigid material, such as metal, for example. For example, similar to the foregoing, the flexible material can be molded around the caps 6370. The caps 6370 can be pressed into a pre-molded sheet 6375, for example. The hardness of the flexible material can be selected to provide a desired stiffness of the sheet 6375. The sheet 6375 can configured, such that it comprises a flexible band. In any case, the sheet 6375 can facilitate the joining of the caps 6370 within an end effector since a plurality of the caps 6370 can be positioned and / or aligned simultaneously within the end effector. In addition, the sheet 6375 connecting the caps 6370, once implanted, can strengthen or reinforce the tissue along the staple line, for example. In addition or instead of a sheet connecting the caps 6370, the caps 6370 can be connected together by a plurality of joints. For example, such hinges may be flexible and may allow relative movement between caps 6370.
Referring now to Figures 139 and 140, a protective cap, such as the cap 6470, for example, may comprise a shaping surface, which may be configured to deform a tip of a staple leg. For example, lid 6470 may comprise a base 6472, which may include an opening 6471 extending therethrough. The opening 6471 may be configured to receive a staple leg, such as a staple leg 6221, for example, in this manner. The opening 6471 may be defined by a diameter or perimeter which may be equal to or greater than the diameter or perimeter of the staple leg 6221. The cover 6470 may further comprise a cavity, or dome, 6474, which may be configured to receive the tip of the staple leg 6221, as it is inserted into the lid 6470. With reference mainly to Figure 140, the lid 6470 may further comprise an anvil, or surface forming, 6473 which may be configured to deflect and deform staple leg 6221. In various circumstances, the shaping surface 6473 may be curved and / or concave, for example, and may be configured to bend staple leg 6221 as it is inserted into the cover 6470. The staple leg 6221 can be deformed sufficiently, so that it can not be removed through the opening 6471 and, as a result, the cover 6470 can be locked to the staple leg 6221. For example, the base 6472 from the top 6470 may define a flange extending around the opening 6471 which may prevent the deformed staple leg 6221 from being removed from the cavity 6474. In various circumstances, as a result of the foregoing, one or more covers 6470 may impede, or limiting, that a retention matrix, such as the retention die 6250, for example, retracts or decouples from the staples 6220. Although not illustrated, the cap 6470 may be formed symmetrically, or at least substantially symmetrically, and the opening 6471 may be positioned along a central axis 6479 extending through the cover 6470. Alternatively, with reference again to Figure 139, the opening 6471 may be displaced with respect to the central axis 6479. For example, the aperture of displacement 6471 may allow the staple leg 6221 to contact one side of the shaping surface 6473 and curve to the other side of the shaping surface 6473 instead of coming into contact with the center of the shaping surface 6473, as it may occur in the embodiments comprising a centered aperture 6471 mentioned above.
As described above, a retention die, such as retention die 6250, for example, may be comprised of a sheet of material and a plurality of retention apertures 6252 extending therethrough. The sheet of material comprising the retainer die 6250 may be rigid or substantially inflexible. Alternatively, a retention matrix can be comprised of a set of elements of the retention matrix and a plurality of flexible connectors, or joints, that connect the elements of the retention matrix. With reference now to Figure 141, a retention matrix, or a portion of the retention matrix, 6550 may comprise a plurality of element bodies 6505 that can be connected together by one or more connection joints 6507. Each element body 6505 may comprise a plurality of deformable members 6553 defining a retention opening 6552 therein. The element bodies 6505 and the connection joints 6507 of a holding die 6550 can be integrally formed and can comprise a unitary piece of material. The holding matrix 6550 can be stamped or fused, for example, from a metallic material, such as titanium and / or stainless steel, for example. The retention matrix 6550 can be comprised of plastic such as polyetheretherketone (PEEK), polypropylene which is marketed under the tradename Prolene, polyester, polyethylene terephthalate which is marketed under the trade names Ethibond and Mersilene, polyvinylidene fluoride, polyvinylidene fluoride -co-hexafluoropropylene, polyhexafluoropropylene VDF which is marketed under the trade name of Pronova, and / or long chain 6-nylon and nylon 6,6 aliphatic polymers which are marketed under the tradenames Ethilon and Nurolon, for example, and can be formed by a molding process by injection, for example. Element bodies 6505 may not be integrally formed with connection joints 6507. A plurality of singular element bodies 6505 may be produced which, subsequently, are connected together and embedded in a retainer matrix. For example, element bodies 6505 can be stamped from a metallic material, such as titanium and / or stainless steel, for example, and placed in a plastic injection mold, where a plastic material can be injected into the mold to form, one, a border 6506 of material that surrounds, or at least partially surrounds, the element bodies 6505 and, two, the linkages 6507 extending from the edges 6506. Alternatively, one or more webs may be formed. connectors comprising openings defined within a plurality of edges 6506, wherein each of said openings can be configured to receive an element body 6505 therein. Each element body 6505 may comprise a circular, or at least substantially circular, outer perimeter and, similarly, each edge 6506 may define in the a circular, or at least substantially circular, opening in which the diameter of the opening may be equal to or lesser. that the diameter of the element body 6505. For example, the element bodies 6505 can be press fit or embedded within the openings at the edges 6506. The element bodies 6505 can be fixed in the openings by using at least one adhesive.
In addition to the above, a retention matrix may comprise a plurality of element bodies 6505 and a plurality of connection joints 6507 that can connect element bodies 6505 in any suitable assembly, such as those illustrated in Figures 142 to 145, for example. Regardless of the pattern of the arrangement, the connecting joints 6507 can be configured to allow the element bodies 6505 and the retaining openings 6552 to move relative to each other. For example, the network of element bodies 6505 and the connecting joints 6507 comprising the retaining matrix 6550, once coupled with the tissue, can be configured to stretch, twist, contract, and / or in any other way flex with the objective to allow at least some movement within the tissue, although, at the same time, resist the larger movements of this. Each connecting link 6507 may comprise a flexible element that is configured to stretch, twist, and / or contract in order to allow the holding matrix 6550 to flex between the retention members of the matrix 6505, for example. Referring again to Figure 141, each hinge 6507 extending from an edge 6506 can be defined by a width that is narrower than the width of the element body 6505 and / or the edge 6506. With reference to Figures 142 to 145 , one or more joints 6507 may comprise straight portions extending along the line between the adjacent element bodies 6506, for example. For example, each link 6507 may comprise a first end attached to a first edge 6506 and a second end joined to a second edge 6506. With reference once more to Figure 141, two or more links 6507 may be connected to each other. For example, two or more joints 6507 can be connected to an intermediate hinge 6509, for example. The hinge 6509 may comprise a reduction in the thickness of the cross section in one or more directions compared to the thickness of the cross section of the joints 6507 which may allow the connected joints 6507 to move relative to one another for example. The holding matrix 6550 may comprisein addition, the hinges 6508 which can connect the joints 6507 to the edges 6506 and allow relative movement between the joints 6507 and the edges 6506. Similar to the hinges 6509, the hinges 6508 can comprise a reduction in the thickness of the cross section in one or more directions compared to the thickness of the cross section of the joints 6507, for example.
In addition to the above, the 6507 connected joints can extend in different directions. For example, a first link 6507 may extend in a first direction and a second link 6507 may extend in a second direction, wherein the first address may be different from the second direction. The first link 6507 may extend along a first line and the second link 6507 may extend along a second line, where the first line and the second line may cross each other at an angle, such as about 30 degrees, about 45 degrees, about 60 degrees, and / or about 90 degrees, for example. The hinges 6508 and / or the hinges 6509 may comprise live hinges which may allow the joints 6507 to move relative to each other a number of times without breaking. The hinges 6508 and / or the hinges 6509 may comprise fragile, or easily breakable, portions that can break when flexed too much and / or flexed too many times. For example, such fragile portions may allow one or more portions of the holding matrix 6550 to be separated from another portion of the holding matrix 6550. The hinges 6508 and / or the hinges 6509, for example, may comprise sections of the matrix retention 6550 which are easier to cut than the other portions of the retaining matrix 6550. More particularly, an implanted retention matrix, and the tissue held by the implanted retention matrix, can be cut many times by a cutting member for various reasons and, in order to facilitate such a cross section, the hinges 6508 and / or the hinges 6509 can provide tracks, or thin sections, through which a cutting member can more easily traverse the holding matrix 6550, for example . In addition to the above, the connecting links 6507 can comprise one or more stamped elements or alterations of the material, for example, defined therein that can facilitate bending, breaking, and / or incision of the connecting links 6507.
* A retention matrix may comprise a plurality of elements of the retention matrix, such as matrix element bodies 6505, for example, which can be inserted into a flexible sheet, or band, of material. A flexible sheet of material can be formed from a bioabsorbable, elastomeric material, such as silicone, for example, wherein the flexible sheet can be produced with a plurality of openings defined therein. For example, a solid flexible sheet can be molded and a plurality of openings in the flexible sheet can be cut. Alternatively, the flexible sheet can be molded and the openings defined therein can be formed during the molding process. In any case, the retainer array elements 6505, for example, can be inserted and retained within the flexible sheet. Alternatively, similar to the foregoing, the flexible sheet may be formed around the elements of the matrix 6505. The flexible sheet may comprise a woven mesh, for example, and / or any other suitable material. Such a woven mesh, in addition to the above, can be easy to cut transversely.
Referring now to Figures 146 and 147, a fastening system comprising a retainer matrix, such as retainer die 6250, for example, may further comprise a cover, such as cover 6670, for example, which it can cover the tips of the staple legs 6221 when they extend above the upper surface 6257 of the retainer die 6250. The cover 6670 can be attached to the retainer die 6250. The cover 6670 and / or the retainer 6250 may comprising retaining features that can be configured to retain the cover 6670 to the retaining matrix 6250. At least one adhesive can be used to adhere the cover 6670 to the retaining matrix 6250. The cover 6670 can comprise a single layer, although the cover 6670 it is illustrated as comprising two layers as described in greater detail below. With reference principally Figure 147, the tips of the staple legs 6221 can extend through a lower surface 6673 of the cover 6670; however, the cover may comprise a sufficient thickness such that the staple legs do not extend through the upper surface of the cover 6670. For example, as a result, the tips of the staple legs 6221 may not protrude of cover 6670. Cover 6670 may comprise a plurality of layers. For example, the cover 6670 may comprise a first layer 6671 and a second layer 6672. The first layer 6671 and the second layer 6672 may be joined together, wherein the second layer 6672 may comprise a lower surface 6676, which adheres to the first layer 6671. First layer 6671 and second layer 6672 may comprise different thicknesses or may comprise the same thickness. The first layer 6671 and the second layer 6672 may comprise substantially the same width and / or length. Alternatively, the layers 6671 and 6672 may comprise different widths and / or lengths.
In addition to the above, the first layer 6671 can be comprised of a compressible foam, a mesh material, and / or a hydrogel, for example, which can be cut by the staple legs 6211. second layer 6672 may be comprised of a harder material, or skin, such as PGA and / or PDS, for example, and / or any suitable reinforcing material. For example, the staple legs 6221 can be configured to penetrate the first layer 6671; however, the staple legs 6221 may not be able to penetrate the second layer 6672. The second layer 6672 may be comprised of a material having a sufficient flexibility and / or hardness, which may allow the second layer 6672 to come into contact and move. by staple leg 6221 but not cut, or only cut marginally, by the staple tip of staple leg 6221. Although not illustrated, a cover may comprise more than two layers, wherein one or more such layers can be resistant to penetration. In use, for example, the retention die 6250 can be placed against the tissue to be held and pushed down in such a manner that the staple legs 6221 of the staples 6220 are pushed through the tissue T and the retaining openings 6252 in the retaining die 6250 and enter the first layer 6271 of the cover 6270. The tips of the staple legs 6221 may not enter, or at least substantially not enter, within the second layer 6272 of the cover 6270. After the holding die 6250 has been properly positioned, the clamp 6240 can be opened and the cover 6670 and the holding die 6250 can be separated from the clamp 6240 as illustrated in Figure 146. As illustrated in Figure 146, a clamp 6640 can be configured to hold more than one holding die 6250 and the cover 6670. For example, the clamp 6640 can comprise two channels 6679 each of which can be configured to receive a cover 6670 therein and a retaining die 6250 which is positioned on it in such a way that the tissue contacting surface 6251 of each retaining die 6250 hangs down from of the lower part of the clamp 6240. For example, a retaining die 6250 and a cover 6270 can be housed in the clamp 6640 on each side of a knife groove 6678. In operation, both holding dies 6250 and covers 6670 can be deployed simultaneously and / or at the same depth with respect to opposed staple cartridges, such as cartridges 6200, for example, positioned through them. After this, the subject fabric can be cut along a cut line by a cutting member passing through the knife slot 6678 where the clamp 6640 can then be reopened. The covers 6670 may not be attached to the holding die 6250. For example, the covers 6670 may be positioned in the channels 6679 and may be retained in the channels 6679 by the holding dies 6250 that can be secured to the clip 6640. Each holding matrix 6250 may be wider and / or longer than its respective covers 6670, such that retaining dies 6250 may retain all of its covers 6670 in position. Each retainer die 6250 may comprise the same width and / or length as its respective cover 6670, for example.
As described above, a fastening system can comprise a layer of material that can be coupled to a matrix of retention, such as the retention matrix 6250, for example. Referring now to Figure 150, a layer of material 6870 can be attached to the lower surface 6251 of the retaining matrix 6250. The layer 6870 and / or the retaining matrix 6250 can comprise retention features that can be configured to retain the layer 6870 to the retention die 6250. At least one adhesive can be used to adhere the 6870 layer to the retention die 6250. In any case, the layer 6870 may comprise a lower surface, or tissue contacting surface, 6873, which may be configured to contact the fabric T when the retaining die 6250 moves down toward the staples 6220 to engage the retaining openings 6252 with the staple legs 6221. For example, the layer 6870 may be comprised of a compressible material, such as a bioabsorbable foam, for example, which may be compressed between the bottom surface 6251 of the retainer 6250 and the tissue T. layer 6870 may further comprise at least one medicament stored and / or absorbed therein that may be poured from layer 6870 as layer 6870 is compressed. The medicament may comprise at least one tissue sealant, hemostatic agent, and / or antimicrobial material, such as ionized silver and / or triclosan, for example. Compression of layer 6870 can squeeze the medicament from layer 6870 such that all, or at least a significant portion of the surface of tissue T is covered with the medicament. In addition, as the layer 6870 is compressed and the staple legs 6221 penetrate the tissue T and in layer 6870, the medicament can flow down the staple legs 6221 and treat the tissue that has just been cut by the staple legs 6221, for example. The body of the holding matrix 6250 may comprise a first layer comprising a biocompatible material, such as titanium and / or stainless steel, for example, and the lower layer 6870 may comprise a second layer comprising a bioabsorbable material, such as cellulose oxidized regenerated (ORC), biologically active agents such as fibrin and / or thrombin (either in its liquid or freeze-dried state), glycerin, absorbable porcine gelatin either in its flowing or foam configurations, and / or antimicrobial , such as ionized silver and / or triclosan, for example. Additional bioabsorbable materials may comprise Surgicel Nu-Knit, Surgicel Fibrillar, collagen / ORC which is a hybrid with an incorporated collagen matrix and is marketed under the tradename Promogran, polyglycolic acid (PGA), which is marketed under the tradename Vicryl , polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglecaprona 25 (PGCL), which is marketed under the trade name of Monocryl, polycaprolactone (PCL), and / or a compound of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. Although only one layer 6870 is illustrated in Figure 150, any suitable number of layers could be used. A first layer comprising a first drug could be attached to the retention matrix 6250 and a second layer comprising a second medication, or different, could be attached to the first layer. For example, a plurality of layers could be used wherein each layer may comprise a different medicament and / or a different combination of medicaments contained therein.
Referring now to Figure 148, a fastening system may comprise a layer of material 6770 bonded to the lower surface 6251 of the retaining die 6250. The layer 6770 and / or the retaining die 6250 may comprise retaining features that can configured to retain the layer 6770 to the holding matrix 6250. At least one adhesive can be used to adhere the layer 6770 to the holding matrix 6250. In either case, the layer 6770 may comprise a lower surface, or in contact with the fabric , 6773, which can be configured to come into contact with the fabric T when the retaining die 6250 moves down towards the staples 6220 to engage the retaining openings 6252 with the staple legs 6221. For example, the layer 6770 can be comprised of of a compressible material, such as a bioabsorbable foam, for example, which can be compressed between the surface 6251 of the retaining matrix 6250 and the tissue T. The layer 6770 can be of further comprising one or more encapsulates, or cells, 6774 that can be configured to store at least one medicament therein. With reference to Figure 149, the encapsulates 6774 can be aligned, or at least substantially aligned, with the retaining apertures 6252 such that, when the staple legs 6221 are pushed through the tissue T and layer 6770, the legs Staples 6221 can pierce and / or in any other way break the 6774 encapsulations. After the encapsulated 6774 have been broken, at least the only medication M stored in the encapsulates 6774 can flow out onto the tissue T. For example, the drug M can comprise a fluid that can flow or be absorbed down the staple legs 6221 and treat the T tissue that has just been cut by the staple legs. As a result of the foregoing, the medicament stored within the 6774 encapsulates can provide localized treatment to the tissue. Encapsulates 6774 in sheet 6770 may comprise different drugs stored therein. For example, a first group of encapsulates 6774 may comprise a first drug, or a first combination of drugs, stored therein and a second group of encapsulates may comprise a different drug, or a different combination of drugs, stored therein. The layer 6770 may comprise a flexible silicone sheet and the encapsulates 6774 may represent hollow spaces in the silicone sheet. For example, the silicone sheet can comprise two layers that can be coupled together, wherein the encapsulates 6774 can be defined between the two layers. Layer 6770 may comprise one or more thin sections or weakened portions, such as partial perforations, for example, which may facilitate cutting of layer 6770 and rupture of encapsulations 6774 by legs 6221. At least a portion of the encapsulations 6774 can be positioned within the domes 6777, where the domes 6777 can extend upwardly from the sheet 6770. For example, the domes 6777 and / or at least a portion of the Encapsulated 6774 can be positioned within the cavities 6201 formed within the retaining matrix 6250. The encapsulates 6774 may comprise discrete cells not connected together. Alternatively, one or more of the encapsulates 6774 may be in continuous communication with each other through one or more passages, conduits, and / or channels, for example, that extend through the layer 6770. The description of the United States no. 7,780,685, entitled ADHESIVE and MECHANICAL FASTENER, granted on August 24, 2010, is incorporated herein by reference in its entirety.
In addition to the above, a staple cartridge comprising a cartridge body, staples, and / or an alignment matrix thereon, can be loaded into a first clamp of an end effector and, similarly, a retention matrix and / or one or more covers can be loaded in a second clamp of the end effector. Referring now to Figure 151, an instrument, such as the cartridge magazine 6990, for example, can be used to insert two or more fastener cartridges into an end effector therein. The cartridge magazine 6990 may comprise a handle 6991 and a cartridge carrier 6992, wherein the cartridge holder 6992 may comprise a first retaining portion that is configured to retain the cartridge body 6210 of the staple cartridge 6200 thereto and, in addition, a second retainer portion configured to retain a cartridge body 6980 that supports, one, a plurality of protection caps 6270 thereon and, two, a retainer 6250 along the lower surface of the cartridge.
This, for example. Each of the first and second retainer portions may comprise one or more retention members configured to removably engage the cartridge bodies 6210 and 6980. In operation, with reference now to FIGS. 152 and 153, an end effector of FIG. The end may comprise a first clamp, or lower, 6230 and a second clamp, or upper clamp, 6940, wherein the staple cartridge 6200 may be loaded in the first clamp 6230 and the body of the cartridge 6980 may be loaded in the second clamp 6940. various circumstances, the upper clamp 6940 can be rotated from an open position (Figure 152) to a closed position (Figure 153) by an actuator 6235, where the operation of the actuator 6235 is described above and is not repeated herein of brevity. Once the upper clamp 6940 is in its closed position, with reference now to Figure 153, the distal end 6993 of the cartridge holder 6992 can be inserted into the end effector, such that the staple cartridge 6200 slides into position. through the distal end 6938 of the first clamp 6930 and into a first engaging portion, or channel, 6939 in the first clamp 6230. Similantly, the distal end 6993 of the cartridge holder 6992 can be inserted into the end effector, in such a manner that the body of the cartridge 6980 slides through the distal end 6948 of the second clamp 6940 and into a second engaging portion, or channel, 6949 in the second clamp 6940. A surgeon, or other clinician, who holds the handle 6991 of the cartridge charger 6990 can push the staple cartridge 6200 and the cartridge body 6980 to through the channels 6939 and 6949, respectively, until the staple cartridge 6200 and the cartridge body 6980 settle completely therein.
When the staple cartridge 6200 and the cartridge body 6980 are seated, each of the staple cartridge 6200 and the cartridge body 6980 can be attached to one or more retainer portions in their respective clamps 6230 and 6940, as described in greater detail. detail later. In any case, once the staple cartridge 6200 and the body of the cartridge 6980 have settled, with reference now to Figure 154, the cartridge magazine 6990 can be separated from the staple cartridge 6200 and the cartridge body 6980 and removed from the end effector. For example, the holding force holding the staple cartridge 6200 in the first clamp 6230 may be greater than the holding force holding the staple cartridge 6200 to the cartridge carrier 6992, such that when the carrier is pulled of cartridge 6992 distally outwardly from the end effector, the staple cartridge 6200 may remain behind in the first clamp 6230. Similarly, the retention force that maintains the body of the cartridge 6980 in the second clamp 6940 may be greater than the force of retention that maintains the cartridge body 6940 to the cartridge carrier 6992, such that, as the cartridge holder 6992 pulls distally out of the end effector, the cartridge body 6940 may remain behind in the second bracket 6940. Once the 6990 cartridge magazine has been removed from the end effector, they can be positioned relative to the T tissue to be stapled the first loaded clamp 6230 and the second loaded clamp 6940. Referring now to Figure 155, the second clamp 6940 can be moved from an open position (Figure 154) to a triggered position (Figure 155) in order to couple the matrix retainer 6250 and the plurality of protection caps 6270 carried by the cartridge body 6980 with the staples 6220 positioned within the staple cartridge 6200.
Referring now to Figures 156 and 157, the second clamp 6940 can be re-opened and the plurality of protection caps 6270 and retention die 6250 can be separated from the cartridge body. 6980, in such a way that the caps 6270 and the holding die 6250 can remain coupled with the tissue T and the staple cartridge 6200. The cartridge body 6980 can comprise a plurality of cavities, wherein the plurality of caps 6270 can be placed in a removable manner and one or more retention grooves that are configured to removably retain the retention die 6250 thereto. The retaining members of the second clamp 6940 coupled with the body of the cartridge 6980 can retain the body of the cartridge 6980 in the second clamp 6940 after the second clamp 6940 is opened. The body of the cartridge 6980 can be configured to break while the second clamp 6940 is opened in such a way that a portion of the cartridge body 6980 is implanted with the caps 6270 and the retainer 6250 and a portion of the cartridge body 6980 remains in the second clamp 6940. Similarly, with reference again to Figures 156 and 157, the retention members of the first clamp 6230 coupled with the body of the cartridge 6210 can retain the body of the cartridge 6210 in the first clamp 6230 after the second clamp 6940 has been opened. The cartridge 6210 can be configured to break while the first clamp 6230 is removed from the implanted cartridge 6200, such that a portion of the cartridge body 6210 is implanted with the staples 6220 and the alignment die 6260 and a portion of the cartridge body 6210 remains in the first clamp 6230. Referring now to Figures 158 to 160, a staple cartridge, such as the staple cartridge 6900, for example, may comprise one or more longitudinal retention grooves 6913 extending along the length of the staple cartridge. length of the cartridge body 6910 which, when the staple cartridge 6900 is inserted in a clamp 6930, for example, can be configured to receive one or more longitudinal retention rails 6916 extending therein from the bracket 6930. In operation, one end of the retaining grooves 6913 can be aligned with the distal ends of the retaining rails 6916 before the staple cartridge 6900 slides through of the distal end 6938 of the retaining channel 6939, for example.
Referring again to Figure 160, clamp 6940 may comprise two retaining channels 6949, wherein each retaining channel 6949 may be configured to receive a cartridge body 6980 comprising therein a plurality of caps 6270 and a retainer 6250. Each body of the cartridge 6980 may comprise one or more supports of longitudinal retention 6917 which can be configured to slide along one or more longitudinal retention rails 6918 of second clamp 6940 as the cartridge bodies 6980 are inserted into their respective retention channels 6949 in clamp 6940. retainer 6918 and retainer brackets 6917 may cooperate to retain cartridge body 6980 in second bracket 6940 when cartridge bodies 6980 separate from caps 6270 and retainer die 6250 stored therein. Referring now to Figure 159, the second clamp 6940 may further comprise one or more distal protuberances., or retention members, 6915 extending therefrom which can be configured to removably lock the bodies of the cartridge 6980 in their respective retention channels. For example, the second clamp 6940 may comprise a distal protrusion 6915 that is configured and positioned relative to each retention channel 6949, such that each body of the cartridge 6980 can flex around the protrusions 6915 while the bodies of the cartridge 6980 insert into the channels 6949 where, when the bodies of the cartridges 6915 are completely seated in the channels 6949, the distal ends of the bodies of the cartridge 6980 can clear and fasten on the protuberances 6915. With the aim of removing the cartridge bodies 6980 after they have been worn, as described above, the cartridge bodies 6980 can be pulled back on the protrusions 6915 and removed from the retention channels 6949. Similar to the above, the first clamp 6930 it may comprise one or more distal retention protrusions 6914 extending therefrom which can be configured to be received in one or more grooves, or retention grooves, 6912 (Figure 158) in the body of the cartridge 6910 when the staple cartridge 6900 has been seated completely.
In addition to the above, a first clamping element cartridge comprising a plurality of first clamping elements placed thereon can be placed in a first clamp of a surgical clamping device and a second clamping element cartridge comprising a plurality of clamping elements. second fasteners placed therein can be placed in a second clamp of the surgical fastening device. In operation, the first clamp and / or the second clamp can be moved towards each other in order to couple the first clamps with the second clamps and secure the tissue therebetween. The cartridge of the first fasteners and the cartridge of the second fasteners can be coupled together when the first fasteners are engaged with the second fasteners. The body of the first clamping cartridge can comprise a first compressible material and the body of the second clamping cartridge can comprise a second compressible material, wherein the first body and / or the second body can be compressed against the tissue that is clamped. After the tissue has been fixed, the first clamp can be separated from the cartridge of the first implant fixation elements and the second clamp can be separated from the cartridge of the second implant fixation elements. After that, the first clamp can be recharged with another cartridge first fasteners, or the like, and the second clamp can be reloaded with another fasteners second cartridge, or the like, and the surgical fastening instrument can be reused. Although the staples may be used in some embodiments, other embodiments are contemplated that comprise other types of fasteners, such as two-piece fasteners that lock together when engaged with one another, for example. For example, the first holding cartridge may comprise a first storage portion for storing the first portions of fastening elements and the second holding element cartridge may comprise a second storage portion for storing the second portions of fastening elements. The fastening systems described herein may use fasteners comprising any suitable type of material and / or form. The fasteners may comprise penetration members. Such penetration elements could comprise a polymer, a compound, and / or a multilayer substrate, for example. An example of a multi-layer substrate can be a wire or a substrate sheet with an elastomeric or polymer coating. This could be a thin sheet formed, such that the penetration elements are oriented perpendicular, or at least substantially perpendicular, to the connection member. The penetrating members could comprise a rectangular profile, a semicircular profile, and / or any bar profile. The fasteners described herein may be manufactured by using any suitable process, such as a wire extrusion process, for example. Another possibility is the use of microfabrication to create hollow penetration members. These penetration members could be manufactured from a process that is different from a wire extrusion process and could use a combination of materials.
As described above, the tips of the staple legs that protrude through a retention die can be covered by one or more covers and / or covers. The tips of the staple legs can be deformed after they are inserted through the retention die. A clamp that holds the retention matrix may comprisein addition, anvil cavities positioned above and / or aligned with the retention openings that can be configured to deform the measured staple legs protruding above the retention die. The staple legs of each staple may curl inwardly toward each other and / or towards the center of the staple, for example. Alternatively, one or more of the staple legs of a staple may curl outwardly away from the other staple legs and / or away from the center of the staple. Regardless of the direction in which the staple legs are curved, the tips of the staple legs may come into contact with the body of the retainer matrix and may not re-enter the tissue that is held by the staples. The deformation of the staple legs after they pass through the retainer matrix can block the retainer matrix in place.
With reference now to Figures 161 and 162, a surgical stapling instrument, such as surgical stapler 7000, for example, can comprising a first clamp 7030 and a second clamp 7040, wherein the second clamp 7040 can approach and move away from the first clamp 7030 by movement of the actuator 6235. The operation of the actuator 6235 was described above and is not repeated herein for the sake of of brevity. The first clamp 7030 may comprise a distal end 7031 and a proximal end 7032, wherein the first clamp 7030 may define a channel extending between the distal end 7031 and the proximal end 7032 that is configured to receive a staple cartridge. For purposes of illustration, the cartridge body of such a staple cartridge is not shown in Figure 161, although such a staple cartridge may comprise a cartridge body, the staples 6220 positioned within the body of the cartridge, and the staple drivers. 7012 positioned below the staples 6220. Although not illustrated in Figure 161 for the sake of clarity, the second clamp 7040 can be configured to maintain a retention matrix, such as the retention die 6250, for example, over the staples 6220 and / or move the retention die in engagement with the legs of the staples 6220 as described above. Surgical stapler 7000 may further comprise a slider 7010 placed in the first clamp 7030 which can slide from the distal end 7031 of the first clamp 7030 in the direction of the proximal end 7032, for example, and raise the staple drivers 7012, and the staple 6220 which is supported on these, in the direction of the retaining matrix and the second clamp 7040. Alternatively, the slider 7010 can move from proximal end 7032 towards distal end 7031 in order to deploy staples 6020, for example. The slider 7010 may comprise one or more inclined ramps, or cams, 7011 which may be configured to slide below the staple drivers 7012 and raise the staple drivers 7012 upwardly. The surgical stapler 7000 may further comprise a pull or push rod, operatively coupled to the slider 7010 that can be moved proximally and / or distally by an actuator located in a handle and / or the shank of the surgical stapler 7000, for example .
Referring again to Figure 161, the second clamp 7040 of the surgical stapler 7000 may comprise a frame 7041, a distal end 7048, and a proximal end 7049 positioned opposite the distal end 7048. The second clamp 7040 may further comprise a guide system comprising one or more guide rails, such as guide rails 7045 and 7046, for example, which extend along the longitudinal axis of the frame 7041 which, as described in greater detail below, can be configured to guide one or more anvils or cams, which can couple and deform the staple legs of the staples 6220 after the staple legs 6221 of the staples 6220 pass through the retention die. For example, the guide rails 7045 and 7046 may comprise a wire or guide wire extending along a portion or upper surface of the frame 7041, around a distal post 7047, and back along the portion or surface top of frame 7041, for example. As mentioned above and with reference now mainly to Figures 163 and 165, the second clamp 7040 may further comprise one or more anvils, or cams, such as the first anvil 7050 and the second anvil 7060, for example, which can moving longitudinally along the second clamp 7040 in order to deform staple legs 6220 after they have passed through the retention matrix. The surgical stapler 7000 can also include, a first anvil driver, or actuator 7051, connected and / or operatively coupled to the first anvil 7050 which can be configured to pull the first anvil 7050 proximally and / or push the first anvil 7050 distally. Similarly, the surgical stapler 7000 may further comprise a second anvil driver, or actuator, connected and / or operatively coupled to the second anvil 7060 which can be configured to push the second anvil 7060 distally and / or pull the second anvil 7060 proximally. The first anvil 7050 may comprise the guide grooves 7052 and the second anvil 7060 may comprise the guide grooves 7062 each which may be configured to slidably receive the guide rail 7045 or the guide rail 7046 therein. For example, the guide rails 7045 and 7046 can be received snugly within the guide grooves 7052 and 7062, in such a way that the movement, relative lateral, or from side to side, between these can be prevented, or at least limited.
In addition to the above, the first anvil 7050 can be pulled proximally and the second anvil 7060 distally pulled. With Referring to Figure 161, the guide rails 7045 and 7046 and the distal post 7047 may comprise a pulley system configured to pull the second anvil 7060 distally and / or pull the second anvil 7060 proximally. For example, the guide rail 7045 and the guide rail 7046 may comprise a continuous wire or cable extending around the distal post 7047, wherein a portion of the continuous wire can be pulled in order to cyclically move the wire around the distal post 7047. The guide rail 7046, for example, can be mounted on the second anvil 7060, such that, when the continuous cable cycles in a first direction, the second anvil 7060 can be pulled distally in the direction of the distal end 7048 of the clamp. 7040 and, when the continuous cable cycles in a second, or opposite, direction, the second anvil 7060 can be pulled proximally in the direction of the proximal end 7049. Referring now to Figure 163, the guide rail 7046 can be secured within a groove. guide 7062, in such a way that a pulling force can be transmitted between them. For example, the guide rail 7045 can be configured to slide into the other guide groove 7062. The first anvil 7050 can operate independently of the second anvil 7060 and the pulley system and the guide grooves 7052 defined in the first anvil 7050 can be configured to receive In a sliding manner the guide rails 7045 and 7046, in such a way that relative movement between them is allowed. The continuous cable comprising the guide rails 7045 and 7046 can be sufficiently flexible in order to accommodate the opening and the closure of the upper clamp 7040. The continuous cable can also be sufficiently flexible in order to accommodate the vertical movement of the second anvil 7060 approaching and moving away from the lower clamp 7030, which is described in more detail more ahead.
With reference again to Figures 163 and 165, the first anvil 7050 may comprise cam followers 7055 extending therefrom which can be configured to mount in one or more cam slots, or guide slots, such as cam groove 7070 (Figure 166), for example, defined in the frame 7041 of the second bracket 7040. More particularly, the frame 7041 may comprise a first cam groove 7070 extending longitudinally along a first side of the frame 7041 and a second cam 7070 extending longitudinally along a second, or opposite, side of the frame 7041, wherein the cam followers 7055 extending from a first side of the first anvil 7050 can mount in the first cam groove 7070 and the Cam followers 7055 extending from a second side of the first anvil 7050 can be mounted on the second cam groove 7070. For example, the contours of each cam groove 7070 can be identical s, or at least substantially identical, and can be aligned, or at least substantially aligned, with each other. Similarly, second anvil 7060 may comprise cam followers 7065 extending therefrom, which may be configured to mount in cam slots 7070 (Figure 166) defined in frame 7041 of the second clamp 7040. More particularly, the cam followers 7065 extending from a first side of the second anvil 7060 can mount in the first cam groove 7070 and the cam followers 7065 extending from a second side of the second anvil 7060 can mount in the second cam groove 7070. In operation, the cam followers 7055 of the first anvil 7050 and the cam followers 7065 of the second anvil 7060 can slide within the cam grooves 7070, such that the first anvil 7050 and the second anvil 7060 they follow the contours of the cam grooves 7070 as the first anvil 7050 and the second anvil 7060 are pulled proximally and / or pushed distally. Each cam groove 7070 may comprise a plurality of seating portions, or greater, 7071 and a plurality of drive portions, or lower, 7072 that can be configured to move the anvils 7050 and 7060 vertically, ie, to and from the lower clamp 7030, at the same time that the anvils 7050 and 7060 are move longitudinally, that is, between the distal end 7048 and the proximal end 7049 of the frame 7041, as described in more detail below.
When the surgical stapler 7000 is in a non-triggered condition with reference to Figure 166, the first anvil 7050 can be positioned at the distal end 7048 of the frame 7041 and the second anvil 7060 can be positioned at the proximal end 7049 of the frame 7041; further, with reference now to Figure 167, the staples 6220 positioned in the first clamp 7030 may not yet be inserted into the tissue and / or the retainer matrix positioned above it when the surgical stapler 7000 is in a non-triggered condition. In operation, with reference now to Figure 168, the staples 6220 can be urged upwardly within the staple pockets 7033 of a staple cartridge by the staple drivers 7012 and, further, the first anvil 7050 can move proximally from the end. distal 7048 of frame 7041 to distal end 7049 for attaching staple legs 6221 to staples 6220. Staples 6220 can be urged upward before the first anvil 7050 engages staple legs 6221 thereof. All of the staples 6220 can be deployed upwardly by the slider 7010 before the first anvil 7050 is advanced in contact with the staple legs 6221 or, alternatively, the slider 7010 can move proximally at the same time as the first anvil 7050 is moved proximally, although the slider 7010 can sufficiently advance the first anvil 7050 in order to deploy the staples 6220 in front of the first anvil 7050. As illustrated in FIG. 168, the cam slots 7070 can be configured and arranged in such a way that forming surfaces, such as the forming, or camming surfaces 7053 and 7054, for example, of the first cam 7050 may come into contact with at least some of the staple legs 6221 when the first cam 7050 passes through a resting position, or higher. In various circumstances, each of the cam followers 7055 of the first anvil 7050 can be positioned in a seat portion 7071 of the cam grooves 7070, such that the surfaces of Shapes 7053 and 7054 are in an elevated position and in such a manner that the staple legs 6221 deform only partially when the anvil 7050 passes there in the rest position. As the first cam 7050 moves further along the cam grooves 7070, as illustrated in Figure 169, the cam followers 7055 of the first anvil 7050 can be driven in the actuated, or lower, portions 7072 of the cam slots 7070 so that the shaping surfaces 7053 and 7054 move vertically downward toward the staple legs 6021 in order to urge the staple legs 6021 to their definite shaped configurations. After that, as the first anvil 7050 is further advanced along the cam grooves 7070, the first anvil 7050 can be driven vertically upward into another set of seat portions 7071 of the cam grooves 7070 As illustrated in Figures 168 and 169, the reader will observe that the first anvil 7050 will only be able to couple some of the staple legs and the others will not. For example, the first anvil 7050 may be configured to deform only one group of staple legs comprising the distal staple legs 6221 of the staples 6220, for example. For example, the first anvil 7050 can be configured to deform the distal staple legs 6221 toward the center of the staples 6220. Each proximal staple leg 6221 can come into contact twice with the first anvil 7050, that is, by a first forming surface 7053 and by a second forming surface 7054 aligned with the first forming surface 7053. For example, the first surfaces of forming 7053 may deform the distal staple legs 6221 in a partially deformed configuration when the first anvil 7050 is in a rest position, or upper, and the second forming surfaces 7054 may deform the distal staple legs 6221 in a fully formed configuration when the first anvil 7050 is moved to an actuated, or lower, position. Referring now to Figures 163 and 164, the first anvil 7050 may comprise a plurality of first forming surfaces 7053 and a plurality of second forming surfaces 7054 for the purpose of deforming the distal staple legs 6221 of the staples 6220 when the 6221 staple legs are arranged in more than one row or line. As described in more detail below, the proximal staple legs 6221 of the staples 6020 can be deformed by the second anvil 7060, for example.
In addition to the above, the first anvil 7050 can be moved from the distal end 7048 of the frame 7041 to the proximal end 7049 in order to deform all the distal staple legs 6221 of the staples 6220. As the reader will see, the first anvil 7050 can moving up and down relative to the proximal non-deformed staple legs 6221 and, in order to accommodate such relative movement, the first anvil 7050 may comprise one or more clearance grooves 7057 (FIG. 165) that can be configured to receive the proximal staple legs without bending 6221 while the first anvil 7050 bends the staple staple legs 6221. Similarly, with reference again to FIG. 163, the second anvil 7060 may comprise a clearance groove 7067 which can be configured to accommodate the vertical movement of the first cam actuator 7051 moving up and down when the first anvil 7050 moves between its rest and actuated positions as described above. After all of the distal staple legs 6221 are bent, the second anvil 7060 can move from the proximal end 7049 of the frame 7041 to the distal end 7048 by the anvil actuator 7061. Similar to the foregoing, with reference now to Figure 170 , the cam followers 7065 of the second anvil 7060 can slide within the cam grooves 7070 so that the second anvil 7060 moves between the rest positions, or higher, and the positions actuated, or lower, with the aim of deforming the proximal staple legs 6221 inward toward the staple centers 6220, for example. Similar to the above, the second anvil 7060 may comprise a plurality of first shaping, or camming, surfaces 7063 and a plurality of second shaping, or camming surfaces, 7064 each of which may be configured to deform at least partially and / or completely one or more of the proximal staple legs 6021. Referring again to FIG. 164, the second anvil 7060 may comprise a plurality of first shaping surfaces 7063 and a plurality of second shaping surfaces 7064 that can be configured to deform the shaping surfaces 7064. proximal staple legs 6221 of staples 6220 disposed in a plurality of rows, or lines, for example.
As further illustrated in Figure 164, the first shaping surfaces 7063 and the second shaping surfaces 7064 of the second anvil 7060 may not align with the first shaping surfaces 7053 and the second shaping surfaces 7054 of the first anvil 7050, where , as a result, the proximal legs 6221 of the staples 6220 can be positioned in rows, or different lines, of the distal legs 6221 of the staples 6220. As the reader will further observe, the second anvil 7060 can push the first custom anvil 7050 that the second anvil 7060 moves distally. For example, the second anvil 7060 can push the first anvil 7050 back into the distal end 7048 of the frame 7041, such that the first anvil 7050 can be returned to its initial position, or without firing. After all of the proximal staple legs 6221 of the staples 6220 have been deformed, the second anvil 7060 can be retracted proximally and returned to its initial position, or not fired. In this way, the surgical stapler 7000 can be reset, so that a new staple cartridge can be positioned in the first clamp 7030 and a new retention matrix can be positioned in the second clamp 7040 in order to use the surgical stapler 7000 once. plus.
As described above, a surgical stapler can comprise two or more anvils that can travel longitudinally for the purpose of coupling the legs of a plurality of staples in a transverse direction. A surgical stapler can comprise an anvil which moves proximally, for example, with the aim of deforming a first group of staple legs and distally, for example, in order to deform a second group of staple legs. For example, such an anvil may comprise proximally oriented shaping surfaces and distally oriented shaping surfaces, for example.
Referring now to Figure 171, an anvil, such as anvil 7140, for example, may comprise a lower surface, or in contact with tissue, 7141 and a plurality of forming cavities 7142 defined therein. The anvil 7140 may comprise more than one plate, such as the cavity plates 7143, for example, which may be welded in a frame 7144. For example, each cavity plate 7143 may be positioned in a plate channel 7145 in the frame 7144 and the frame 7144 is welded through a weld slot 7146 extending through the frame 7144 with the aim of forming a longitudinal weld 7147. In various circumstances, the longitudinal weld 7147 may comprise a continuous weld extending along of the entire length of the welding groove 7146 or a series of welding points spaced apart from one another extending along the length thereof, for example. Each cavity plate 7143 may comprise two or more plate portions that have been welded together. For example, each cavity plate 7143 may comprise a first plate portion 7143a and a second plate portion 7143b that can be welded together along a junction 7148. The first plate portion 7143a and the second plate portion 7143a. plate 7143b of each plate 7143 may be welded together before the plates 7143 are welded in the plate channels 7145 in the frame 7144. For example, the first plate portion 7143a and the second plate portion 7143b may comprise cooperating profiles, such as the toothed profiles illustrated in Figure 171, for example, which can be adjusted together to form a tight joint 7148. Each plate 7143 can comprise a height of approximately 0.5 mm (.02"), for example, which may be more high that the depth of the plate channels 7145, such that the fabric contacting surfaces 7141 thereof extend from the frame 7044 of the anvil 7040. Referring now to Figure 172, the plates 7143 can be connected together by at least one weld 7149 at the distal ends of the plates 7143, for example.
As illustrated in Figures 171 and 172, each plate of cavities 7143 may comprise a plurality of forming cavities 7142 defined therein. The forming cavities 7142 can be formed in the plates 7143 by any suitable manufacturing process, such as a grinding process and / or an electroerosion process, for example. For example, with reference now to Figures 173 and 174, each shaping cavity 7142 can be fabricated by first forming a deep well 7150, then forming an arcuate or curved surface 7151 surrounding the deep well 7150. and, thereafter, the formation of a staple leg guide groove 7152 on the curved surface 7151, for example. Alternatively, these stages can be executed in any suitable order. Referring now to Figure 175, the staple forming cavities 7142 can be formed, such that the inner edges 7153 of the forming cavities are separated by a constant, or at least substantially constant, distance 7154. For example, the separation 7154 may be approximately 0.2 mm (.008"), for example. Further, for example, the forming cavities 7142 can be positioned along two or more rows or lines, the center lines of which can be separated by a constant, or at least substantially constant, separation 7155. For example, the separation between the center lines 7155 can be approximately 0.89 mm (.035"), for example. Referring again to Figure 175, each shaping cavity 7142 may taper between a narrow width 7156 and a wide width 7157. For example, the narrow width 7156 may be approximately 1.1 mm (.045") and the wide width 7157 may be be about 1.9 mm (.075"), for example. The plates 7143 can be comprised of the same material as the frame 7144. For example, the plates 7143 and the frame 7144 can both be comprised of stainless steel, such as a stainless steel of the 300 series or one of the 400 series, for example, and / or titanium, for example. Alternatively, plates 7143 and frame 7144 may be comprised of different materials. For example, the plates 7143 may be comprised of a ceramic material, for example, and the frame 7144 may be comprised of stainless steel and / or titanium, for example. In various circumstances, depending on the materials used, at least one brazing process could be used to secure the plates 7143 in the frame 7144, in addition, or instead of the welding processes described above, for example.
Referring now to Figures 176 to 178, an anvil 7240 may comprise a frame 7244 and a plurality of cavity plates 7243 that may be inserted into the frame 7244. Similar to the foregoing, each plate of cavities 7243 may comprise a plurality of cavities of conformation 7242 defined in this. The anvil frame 7244 may comprise retention grooves 7246 defined in each of which may be configured to receive a retaining rail 7247 extending from a cavity plate 7243. In order to assemble the cavity plates 7243 to the frame of anvil 7244, the sidewalls 7245 of the anvil frame 7244 can flex or extend outwardly, as illustrated in Figure 177, with the aim of enlarging the retention slots 7246, such that each retention slot 7246 can receive therein a retaining rail 7247 of a cavity plate 7243. Once the retaining rails 7247 have been positioned in the retaining grooves 7246, the side walls 7245 can be released, as illustrated in Figure 178, thereby allowing that the frame 7244 flexibly contracts and / or returns to its non-flexed state. In such circumstances, the retaining grooves 7246 can be contracted and thereby capture the retaining rails 7247. The retaining rails 7247 and / or the retaining grooves 7246 can comprise one or more auxiliary tapered surfaces which, after the grooves Retained flexion 7246 have been released, can form a lock coupling tapered that can retain the retention rails 7247 in the retention grooves 7246. Similar to the above, the cavity plates 7243 may comprise the same material or a different material from the frame 7244. For example, the plates 7243 may be comprised of a material ceramic, for example, and the frame 7244 may be comprised of stainless steel and / or titanium, for example. In various circumstances, depending on the materials used, at least one brazing process and / or at least one welding process, for example, could be used to secure the plates 7243 in the frame 7244.
In Figures 179 and 180, a surgical stapling and cutting instrument 8010 can comprise an anvil 8014, which can be repeatedly opened and closed around its rotary union to an elongated staple channel 8016. A staple application unit 8012 can comprise the anvil 8014 and channel 8016, wherein the unit 8012 can be proximally attached to the elongated shaft 8018 that forms a portion of the instrument 8022. When the staple application unit 8012 is closed, or at least substantially closed, the portion of the instrument 8022 can present a sufficiently small cross section suitable for inserting the staple application unit 8012 through a trocar. The unit 8012 can be operated by a handle 8020 connected to the rod 8018. The handle 8020 can comprise the user controls such as a rotation knob 8030 which rotates the elongate shaft 8018 and the staple application unit 8012 about a longitudinal axis of the rod 8018. A closing trigger 8026, which can rotate in front of a handle 8036 around a latch trigger pin 8152 (FIG. 181) coupled laterally through the handle housing 8154, may be pressed to close the staple application unit 8012. A latch release button 8038 may be presented outwardly in the housing. handle 8020 when closing trigger 8026 is clamped, such that release button 8038 can be pressed to release closing trigger 8026 and open staple application unit 8012, as described in more detail below. A trigger 8034which can rotate in front of the closing trigger 8026, can cause the staple application unit 8012 to simultaneously cut and staple the tissue attached thereto. In various circumstances, as described in more detail below, multiple trip displacements may be employed by using the trigger trigger 8034 to reduce the amount of force that is required to be applied by the surgeon's hand by displacement. The handle 8020 may comprise rotating indicator wheels on the right and / or left 8040, 8041 (Figure 181) which may indicate the progress of the shot. For example, the full stroke of the shot may require three full trip movements of the shot trigger 8034 and thus the indicator wheels 8040, 8041 may rotate up to one third of one revolution each by displacement of the shot trigger 8034. As described in FIG. In more detail below, a manual release release lever 8042 may allow the firing system to retract before the full stroke has been completed, if In addition, the trigger release lever 8042 may allow a surgeon, or other clinician, to retract the firing system in the event that the firing system sticks and / or fails.
With reference to Figures 179 and 181, the elongate shaft 8018 may comprise an outer structure that includes a longitudinally alternating closure tube 8024 that rotates the anvil 8014 toward its closed position in response to the proximal depression of the closure trigger 8026 of the handle 8020. The elongated channel 8018 can be connected to the handle 8020 by a frame 8028 (Figure 181) which is internal to the closure tube 8024. The frame 8028 can be rotatably coupled to the handle 8020 so that rotation of the rotation knob 8030 (Figure 179) can rotate the portion of the instrument 8022. With particular reference to Figure 181, the rotation knob 8030 may comprise two cover halves which may include one or more interior projections 8031 that may extend through one or more elongated side openings 8070 in the closure tube 8024 and attached to the frame 8028. As a result of the above, the rotation knob 8030 and the frame 8028 can be rotated together, or synchronously, such that the rotated position of the knob 8030 determines the rotated position of the instrument portion 8022. The length along the longest opening 8070 is the sufficiently long to allow the longitudinal closing movement, and the opening movement, of the closing tube 8024. With respect to generating the closing movement of the closing tube 8024, with reference mainly to FIGS. 181 and 183, an upper portion 8160 of the closure trigger 8026 can push a closure bearing 8162 forward by means of a lock hinge 8164. The closure hinge 8164 is rotatably connected at its distal end by a bearing pin 8164. closure 8166 to the seal bearing 8162 and rotatably connected at its proximal end by a latch of the latch joint 8168. The latch trigger 8026 can be pushed to an open position by a tension spring of the closure trigger 8246 which is connects proximally to the upper portion 8160 of the closing trigger 8026 and a handle housing 8154 formed by the right and left cover halves 8156, 8158. The tension force applied by the tension spring 8246 can be overcome by an applied closing force to shut-off trigger 8026 with the aim of advancing distally the bearing 8162, the locking link 8164, and the closing tube 8024.
As the closing trigger 8026 is actuated, or pressed, as described above, the lock release button 8038 can be positioned, such that the surgeon, or other clinician, can push the lock release button 8038 , if desired, and allow the closing trigger 8026, and the rest of the surgical instrument, to return to a non-actuated state. The lock release button 8038 can be connected to a rotary lock arm 8172 by a central lateral pivot 8173, such that movement between the release button 8038 and the lock arm 8172 can be transferred. Referring again to the Figure 181, a compression spring 8174 can press the lock release button 8038 proximally, i.e., clockwise about the center lateral pivot 8173 as seen from the right and upper portion 8160 of the closing trigger 8026 may include a proximal ridge 8170 with a rear notch 8171. As the closing trigger 8026 is pressed, the pivoting locking arm 8172 can be mounted on the proximal ridge 8170 and when the closing trigger 8026 reaches its fully depressed position, it should be noted that the rear notch 8171 is presented below the locking arm 8172 which falls and locks against the rear notch 8171 under the thrust of the compression spring 8174. At that point, the manual depression of the lock release button 8038 rotates the swivel lock arm 8172 upwards and outwards from the rear notch 8171 which thus unlocks the closing trigger 8026 and allows the closing trigger 8026 to return to its unclamped position.
Once the closure trigger 8026 is held proximally, as discussed above, the trigger trigger 8034 can be withdrawn toward the handle 8036 for the purpose of advancing a trigger bar 8032 distally from the handle 8020. The trigger 8032 shot 8034 can be rotated about a trigger trigger pin 8202 which traverses laterally and engages the right and left cover halves 8156, 8158 of handle 8020. Trigger trigger 8034, when actuated, can advance a cocking mechanism. 8150 articulated transmission shot. The 8150 articulated transmission trigger mechanism can be pushed to a retracted, non-fired position, by means of a spring 8184 which, one, is attached to the handle 8036 of the handle 8020 and, two, is attached to one of the articulations, for example, of the articulated transmission firing mechanism 8150 as described in greater detail below. The spring 8184 may comprise a stationary end 8186 connected to the housing 8154 and a mobile end 8188 connected to a proximal end 8190 of a steel strip 8192. A distally disposed end 8194 of the steel strip 8192 may be attached to a joining element 8195 in a front articulation 8196a of a plurality of articulations 8196a-8196d which form a joint rack 8200. The joint rack 8200 can be flexible, such that it can be easily retracted within the grip 8036 and minimize the length of the handle 8020 and still forming a straight rigid frame assembly that can transfer significant firing force towards and / or through the firing bar 8032. As described in more detail below, firing trigger 8034 can be coupled with a first articulation 8196a during a first actuation of trigger 8034, coupled with a second articulation 8196b dur in the case of a second activation of the trigger trigger 8034, coupled with a third link 8196c during a third actuation of the trigger trigger 8034, and coupling with a fourth link 8196d during a fourth actuation of the trigger 8034, wherein each actuation of the trigger shot 8034 can advance the joint rack 8200 distally an incremental amount. In addition to what above, the multiple trips of the firing trigger 1034 can rotate the right and left indicator wheels 1040, 1041 to indicate the distance that the rack of joints 8200 has advanced.
Referring now to Figures 181 and 183, an anti-reverse mechanism 8250 can prevent the tension / compression combination spring 8184 from retracting the joint rack 8200 between the trip movements. A coupling slide tube 8131 abuts the first link 8196a and is connected to the trigger bar 8032 to communicate the firing movement. The firing bar 8032 extends proximally out of a proximal end of the frame 8028 and through a through hole 8408 of a backstop plate 8266. The through hole 8408 is dimensioned to slidably receive the firing bar 8032 when it is aligned perpendicularly but to stick it when it enters inclined. A coupling of the lower tab 8271 extends proximally from a lower edge of the proximal end of the frame 8028, which extends through an opening 8269 at a lower edge of the non-return plate 8266. This coupling of the lower tab 8271 extracts the portion bottom of the backstop plate 8266 next to the frame 8028 so that the backstop plate 8266 is perpendicular when the firing bar 8032 advances distally and the rear upper part is allowed to tilt in a stuck state when the firing bar 8032 is retracted. 8264 Anti-Return Compression Spring is limited distally by the proximal end of the frame 8028 and proximally abuts an upper portion of the backstop plate 8266, which presses the backstop plate 8266 to a locked state. In opposition to the spring pressure, a backstop cam tube 8268 slidably encloses the coupling slide tube 8131 and abuts the backstop plate 8266. A proximally projecting backspin 8256 attached to the backstop cam tube 8268 extends over the upper part of the closing bearing 8162.
With reference to Figure 181, an articulated, automatic retracting mechanism 8289 is incorporated in the surgical stapling and cutting instrument 8010 to cause the retraction of the blade at the end of the full stroke travel. For that purpose, the distal articulation 8196d includes a pin 8290 projecting upwards when the distal joint 8196d advances within the rack channel 8291 (Figure 181) formed in the closure bearing 8162. This pin 8290 is aligned to activate a cam proximal lower 8292 on an anti-reverse release lever 8248 (Figure 186). With particular reference to Figures 186 and 187, the structures formed in the right and left cover halves 8156, 8158 limit the movement of the anti-reverse release lever 8248. A pin receptacle 8296 and the circular pin 8293 formed respectively between the halves of right and left cover 8156, 8158 are received through a longitudinally elongated opening 8294 formed in the anti-reverse release lever 8248 distal to the lower proximal cam 8292, thus allowing the longitudinal translation as well as rotation about the circular pin 8293. In the right cover half 8156, a proximally open channel 8295 includes a horizontal proximal portion 8295a communicating with an upwardly angled portion and distally facing 8295b receiving a right rear pin 8297 (Figure 187) near the proximal end of the anti-reverse release lever 8248, which thus imparts an upward rotation as the anti-reverse release lever 8248 reaches the most distal portion of its translation. A locking structure formed in the right cover half 8156 proximal to the anti-reverse release lever 8248 prevents proximal movement thereof once it is assembled to hold the rear pin 8297 to the right in the proximally open channel 8295.
In addition to the foregoing, as shown in Figures 187 and 188, a distal end 8254 of the anti-reverse release lever 8248 is thus pushed distally and downward, which causes a front right-hand pin 8298 to fall into the step structure. open distally 8299 formed in the right cover half 8156, which is pushed to this coupling by a compression spring 8300 (Figure 188) hooked to a left hook 8301 in the anti-reverse release lever 8248 between the front pin to the right 8298 and the longitudinally elongated opening 8294. The other end of the compression spring 8300 is attached to a hook 8302 (Figures 186, 188, 189) formed in the right cover half 8156 in a further position. proximal and lower just above the seal bearing 8266. The compression spring 8300 thus pulls the distal end 8254 of the anti-reverse release lever 8248 back and forth, which results in the right front pin 8298 being blocked in the step structure open distally 8299 when advancing distally. Thus, once actuated, with reference to Figure 189, the anti-reverse release lever 8248 remains as a front support of the backstop plate 8266 in a perpendicular position and thus allows the rack of joints 8200 to be retracted. When the lock bearing 8266 is subsequently folds when the end effector 8012 is released, a projecting pin projecting upwards 8303 in the closure bearing 8266 comes into contact with a lower distal cam 8305 of the anti-reverse release lever 8248, which raises the front pin to the right 8298 outside the open step structure distally 8299 so that the backstop compression spring 8264 can proximally push the backstop cam tube 8268 and the backstop release lever 8248 to their retracted positions (Figure 186).
With reference to Figures 179 and 189, the firing trigger 8034 can be operatively coupled to the joint rack 8200 in any suitable manner. With particular reference to Figures 180 and 185, the trigger trigger 8034 rotates about a trigger trigger pin 8202 which is connected to the housing 8154. An upper portion 8204 of the trigger trigger 8034 is moved distally about the pin of the trigger. trigger trigger 8202 as firing trigger 8034 is pressed towards handle 8036, which pulls a proximally located firing trigger voltage spring 8206 (Figure 181) connected proximally between upper portion 8204 of firing trigger 8034 and housing 8154. The upper portion 8204 of the firing trigger 8034 is coupled to the joint rack 8200 during each depression of the firing trigger by means of a spring-loaded lateral ratchet mechanism 8210. When the firing trigger is released, the mechanism The lateral ratchet is uncoupled from the 8200 joint zipper and the trigger can be returned to a non-pressed position, or not fired. In operation, a track with right side ramp formed by a bevelled surface facing to the right and proximally 8284 in each of the joints 8196a-8196d is coupled by a side ratchet assembly 8285. Particularly, a ratchet slide 8270 (FIGS. 181 and 183) has right and left lower guides 8272 that slide respectively in a left track 8274 (Figure 181) formed in the closing bearing 8266 below the rack channel 8291 and a right track 8275 in a closing bearing rail 8276 which equalizes the rack channel 8291 and is joined to a cover of the rack channel 8277 which closes an open portion to the right of the rack channel 8291 in the closure bearing 8266 which is distal to the travel of the ratchet slide 8270. In Figures 181, 182, and 185, a compression spring 8278 is joined between a hook 8279 in a proximal upper position on the bearing rail 8276 and a hook 8280 on a distal right side of the ratchet slide 8270, which holds the ratcheting slide 8270 proximally in contact with the upper portion 8204 of the firing trigger 8034.
With particular reference to Figure 181, a ratchet block 8318 sits on the ratchet slide 8270 which revolves around a vertical rear pin 8320 that traverses a left proximal corner of the ratchet block 8318 and the ratchet slide 8270. A recess of ejector block 8322 is formed in a distal portion of an upper surface of block 8318 to receive an ejector block 8324 fixed therearound by a vertical pin 8326 whose lower tip extends within ratcheting spring recess 8328 in the upper surface of the ratchet slide 8270. A ratchet spring 8330 in the ratchet spring recess 8328 extends to the right of the vertical front pin 8326 which urges the ratchet block 8318 to rotate in the counter-clockwise direction. clock when looking from above in coupling with the track with right side on ramp 8282. A small helical spring 8332 on the recess of the ejector block 8322 pushes the eject block 8324 to rotate clockwise when viewed from above, its proximal end being pushed into contact with a contoured edge 8334 formed in the seal bearing 8266 by above the rack channel 8291. As shown in Fig. 184, the strongest mechanical advantage of the ratchet spring 8330 on the small coil spring 8332 means that the ratchet block 8318 tends to engage with the ejector block 8324 rotated in the clockwise direction. In Figure 185When the trigger trigger 8034 is fully depressed and begins to release, the ejector block 8324 encounters a ridge 8336 at the contoured edge 8334 as the ratchet slide 8270 retracts, forcing the ejector block 8324 to rotate clockwise when viewed from above and thus ejects the ratchet block 8318 from its coupling with the joint rack 8200. The shape of the ejector block recess 8322 stops rotation in the clockwise direction of the hands. 8324 ejection block clock in an orientation perpendicular to the contoured edge 8334 that maintains this disengagement during full retraction and thus ratchet noise is eliminated.
In Figures 181, 183, 190, and 195, the surgical stapling and cutting instrument 8010 may include a manual retraction mechanism 8500 that provides a manual release of the trigger mechanism, manual retraction, and in one version (FIGS. 202) also performs automatic retraction at the end of the complete trip of the shot. Referring now to Figures 181, 190, and 191, particularly, a front intermediate gear 8220 engages an upper, toothed surface left 8222 of the joint rack 8200, wherein the front intermediate gear 8220 is further coupled to a rear intermediate gear 8230 having a ratchet gear with smaller right side 8231. Both the front intermediate gear 8220 and the rear intermediate gear 8230 are rotatably connected to the handle housing 8154 respectively on the front intermediate shaft 8232 and the rear intermediate shaft 8234. Each end of the rear axle 8232 extends through the respective right and left cover halves of the housing 8156, 8158 and joins the left and right indicator wheels 8040, 8041 and, because the rear axle 8234 rotates freely in the handle housing 8154 and has a fixed engagement to the rear gear 8230, the indicator wheels 8040, 8041 rotate with the rear gear 8230. The gear ratio between the joint rack 8200, the intermediate gear 8220 and the rear gear 8230 can advantageously be selected such that the toothed top surface 8222 has tooth dimensions that are adequately strong and that the rear gear 8230 realizes no more one turn during the full stroke of the 8150 articulated transmission trigger mechanism. In addition to the gear mechanism 8502 which visually indicates the trip path, or the progress, the gear mechanism 8502 can also be used to manually retract the blade. The smaller right side ratchet gear 8231 of the rear intermediate gear 8230 extends into a hub 8506 of the manual retraction lever 8042, which is specifically aligned with a longitudinally aligned vertical slot 8508 (Figure 190) that bisects the hub 8506 A side through hole 8510 of the hub 8506 communicates with an upper recess 8512. A forward portion 8514 is shaped to receive a locking ratchet. proximally directed 8516 that rotates about a right-hand side pin 8518 formed at a distal end of the upper recess 8512. A rear portion 8520 is shaped to receive an L-shaped spring tab 8522 that urges the locking pawl 8516 toward down in engagement with the smaller ratchet gear on the right side 8231. A delay structure 8524 (Figures 186 and 193) projects from the right cover half 8156 into the upper recess 8512 which delays the locking ratchet coupling 8516 with the ratchet gear on the smaller right side 8231 when the manual retract lever 8042 is down (Figure 193). A coil spring 8525 (Figure 181) pushes the manual retract lever 8042 down.
In operation, as shown in Figures 192 and 193, the tension / compression combination spring 8184 can be disconnected with the joint rack positioned distally. In Figures 194 and 195, as the manual retract lever 8042 is raised, the locking pawl 8516 rotates clockwise and is no longer held by the delay structure 8524 and engages with the gear. smaller ratchet right side 8231, which rotates the rear intermediate gear 8230 clockwise when viewed from the left. Thus, the intermediate forward gear 8220 responds with the folding of the joint rack 8200 in the counterclockwise direction. In addition, a curved crest to the right 8510 projects outward from the concentrator 8506, dimensioned to contact and move distally the anti-reverse release lever 8248 to release the anti-reverse mechanism 8250 when the manual retract lever 8042 is rotated.
In Figures 196 to 202, an automatic retraction mechanism 8600 for a surgical stapling and cutting instrument 8010a can incorporate automatic retraction at the end of the full travel of the shot in a forward intermediate gear 8220a having a tooth 8602 moving within a circular groove 8604 on a cam wheel 8606 until a block 8608 is found after an almost complete turn corresponding to three trip movements. In such circumstances, the right crest 8610 is rotated upwardly in contact with a lower cam recess 8612 to distally move a non-return release lever 8248a. With particular reference to Figure 197, the anti-reverse release lever 8248a includes the distal end 8254 which functions as described above. The circular pin 8293 and the pin receptacle 8296 formed between the right and left cover halves 8156, 8158 is received through a generally rectangular opening 8294a formed in the anti-kickback release lever 8248a at the rear of the lower cam 8192, thus allowing the longitudinal translation as well as the downward locking movement of the distal end 8254 of the anti-reverse release lever 8248a. In its right cover half 8156, a channel open proximally horizontal 8295a receives the rear pin to the right 8297 near the proximal end of the anti-reverse release lever 8248a.
In operation, prior to firing in Figures 198, 198A, the joint rack 8200 and the non-return cam tube 8268 are in a retracted position, which locks the backstop mechanism 8250 because the non-return compression spring 8264 proximally tilts the plate. backstop 8266. The automatic retracting mechanism 8600 is in an initial state with the anti-reverse release lever 8248a retracted with the articulation 8196a in contact with the intermediate forward gear 8220a. The tooth 8602 is in a position of the six o'clock with the full travel of the circular groove 8604 which progresses in the counterclockwise direction of this with the crest to the right 8610 just proximal to the tooth 8602. In the Figures 199 , 199A, there has been a trip displacement that raises a distal joint 8196b in contact with the intermediate forward gear 8220a. The tooth 8602 has progressed a third of a turn through the circular groove 8604 of the immobile cam wheel 8606. In Figures 200, 200A, a second trip movement has occurred which raises a joint plus 8196c in contact with the gear intermediate forward 8220a. The tooth 8602 has progressed two thirds of a turn through the circular groove 8604 of the immobile cam wheel 8606. In Figures 201, 201 A, there has been a third trip movement that raises a distal joint 8196d in contact with the intermediate gear towards forward 8220th. The tooth 8602 has progressed completely around the circular groove 8604 in contact with the lock 8608 which starts the rotation in the counterclockwise direction (when viewed from the right) of the cam wheel 8606 leading the edge towards right 8608 in contact with the anti-reverse release lever 8248a. In Figure 202, the anti-reverse release lever 8248a has moved distally in response to that, which locks the forward pin to the right 8298 within the distally open step structure 8299 and which releases the backstop mechanism 8250. The stapling instruments Similar surgical procedures are described in U.S. Pat. 7,083,075, issued August 1, 2006, the full description of which is incorporated by reference in the present description.
With reference to Figure 203, the staple application unit 9012 of a surgical stapling instrument 9010 performs the functions of holding the tissue, driving the staples and cutting the tissue by two separate movements transferred longitudinally along the rod 9016 to a shank frame 9070. This shank frame 9070 is proximally attached to a handle of a surgical stapling instrument and engages thereto to rotate about a longitudinal axis. A multi-displacement handle illustrative for the surgical stapling and cutting instrument is described in greater detail in the co-pending and co-owned US patent application entitled SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITION INDICATOR AND RETRACTION MECHANISM, no. series 10 / 374,026, the description of which is incorporated herein by reference in its entirety. Other applications consistent with the present invention may incorporate a single shot displacement, as described in the co-pending United States patent application SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS, no. series 10 / 441,632, the description of which is incorporated herein by reference in its entirety.
With particular reference to Figure 204, the distal end of the shank frame 9070 is attached to the staple channel 9018. The anvil 9022 has a rotating proximal end 9072 that is rotatably received within a proximal end 9074 of the staple channel 9018 , just distal to its engagement with the shank frame 9070. When the anvil 9022 is rotated downward, the anvil 9022 moves a tissue contacting surface 9028 and the forming cavities 9026 toward an opposite staple cartridge, described in FIG. more detail later. The rotating end 9072 of the anvil 9022 includes a closure member 9076 proximal but distal to its rotatable junction with the staple channel 9018. Thus, a closure tube 9078, the distal end of which includes a horseshoe opening 9080 which engages this element. of closure 9076, selectively imparts an opening movement to anvil 9022 during proximal longitudinal movement and a closing movement to anvil 9022 during distal longitudinal movement of closure tube 9078 that slides on stem frame 9070 in response to a closing trigger, similar to the previous one. The shank frame 9070 comprises and guides a firing movement from the handle through a longitudinally alternating movement of a two-part bladed bar and firing rod 9090. Particularly, the rod frame 9070 includes a firing bar groove longitudinal 9092 that receives a proximal portion of the blade and two-piece firing bar 9090, specifically a 9094 laminated conical firing bar. It should be noted that the laminated conical firing bar 9094 can be replaced with a solid firing bar and / or any other suitable material.
An E-beam 9102 is the distal portion of the two-piece trigger bar and bar 9090, which facilitates independent closing and firing as well as separation of the anvil 9022 from the elongated staple channel 9018 during firing. With particular reference to Figures 204 and 205, in addition to any bonding treatment such as brazing or an adhesive, the blade and bar 9090 are formed from a female vertical connecting aperture 9104 formed proximally on the E-beam 9102 which it receives a corresponding male coupling member 9106 presented distally by the laminated conical firing bar 9094, which allows each portion to conform to a selected material and the process suitable for its different functions (eg, strength, flexibility, friction). The E-beam 9102 can conveniently be formed of a material having suitable material properties to form a pair of upper pins 9110, a pair of central pins 9112 and a lower pin or foot 9114, as well as can acquire a sharp cutting edge 9116. In addition, the upper guide 9118 and the center guide 9120 integrally formed and projecting proximally holding each vertical end of the cutting edge 9116 further define , a fabric preparation area 9122 which helps to guide the fabric before cutting it to the sharp cutting edge 9116. The central guide 9120 further serves to couple and fire the staple application apparatus 9012 by contacting a member stepped central 9124 of a wedge slider 9126 (FIG. 206) that effects the staple forming by the staple application unit 9012, as described in greater detail below. The conformation of these elements (for example, the upper pins 9110, the central pins 9112, and the lower foot 9114) integrally with the E-beam 9102 facilitates manufacturing to tighter tolerances relative to each other as compared to assembling them to from a plurality of parts, which guarantees its desired operation during tripping and / or effective interaction with various locking elements of the staple application unit 9012.
In Figures 207 and 208, in the staple application unit 9012 it is shown open, with the E-beam 9102 completely retracted. During assembly, the lower foot 9114 of the E-beam 9102 is lowered through a widened hole 9130 in the staple channel 9018 and the E-beam 9102 then advances in such a way that the E-beam 9102 slides distally along a lower track 9132 formed in the staple channel 9018. Particularly, the lower track 9132 includes a narrow slot 9133 that opens as an enlarged slot 9134 on a lower surface of staple channel 9018 to form an inverted T in the lateral cross section, as shown particularly in FIGS. 208 and 209, which is communicated with the enlarged hole 9130. Once assembled, the components coupled proximally to the laminated conical firing rod 9094 do not allow the lower foot 9114 to move proximally back towards the enlarged hole 9130 to allow decoupling. With reference to Figure 210, the laminated tapered firing bar 9094 facilitates the insertion of the staple application unit 9012 through a trocar. In particular, a downward, more distal projection 9136 raises the E-beam 9102 when it fully retracts. This is done by placing the downward projection 9136 at a point where it is raised upward at a proximal edge of the enlarged hole 9130 in the staple channel 9018. Referring now to Figure 211, the laminated conical firing bar 9094 further enhances the operation of certain locking elements that may be incorporated in the staple channel 9018 by including a more proximal upward projection 9138 that is pushed downwardly by the rod frame 9070 during an initial portion of the path of travel. Shooting. Particularly, a side rod 9140 is defined between a pair of square openings 9142 in the rod frame 9070 (FIG. 204). A clip spring 9144 encompassing the side rod 9140 pushes down a portion of the laminated conical firing rod 9094 that projects distally out of the groove of the rod.
Longitudinal shot 9092, which ensures that certain advantageous locking elements are coupled when appropriate. This thrust is more pronounced or confined solely to that portion of the firing path when the upward projection 9138 comes into contact with the clip spring 9144.
In Figures 207 and 208, the E-beam 9102 is retracted with the upper pins 9110 thereof which settle within an anvil cavity 9150 near the rotating proximal end of the anvil 9022. A downward vertical open anvil groove 9152 ( Figure 203) laterally widens on the anvil 9022 on an inner track of the anvil 9154 which captures the upper pins 9110 of the E-beam 9102 as they are advanced distally during firing, as shown in Figures 210 and 211, which affirmatively separate the anvil 9022 from the staple channel 9018. Thus, with the E-beam 9102 retracted, the surgeon can repeatedly open and close the staple application unit 9012 until it is satisfied with the positioning and orientation of the fabric captured in it for its stapling and cutting, although the E-beam 9102 helps in the proper positioning of the fabric even for a staple application unit 9012 of reduced diameter and correspondingly reduced stiffness. In Figures 203, 204, 206, 207, 209, and 215, the staple application unit 9012 is shown with the replaceable staple cartridge 9020 that includes the wedge slider 9126. The plurality aligned and longitudinally parallel to the grooves in open wedge 9202 (Figure 209) receives the respective wedges 9204 integral to the wedge slider 9126. In Figures 209 to 211, the wedge slider 9126 thus moves up a plurality of staple drivers 9206 vertically slidable within the recesses of the staple drivers 9208. In this illustrative version, each staple driver 9206 includes two vertical projections, each moving upwardly within a respective staple hole 9210, or cavity 9024, for ejecting upwardly and deforming a staple 9023 which sits on it against a staple forming surface 9214 (FIG. 211) of the anvil 9022. A central firing recess 9216 (Figure 204) defined within the staple cartridge 9020 proximal to the staple channel 9018 allows passage of the lower, horizontal portion 9218 (FIG. 206) of the wedge slider 9126, as well as well as the central pins 9112 of the E-beam 9102. Specifically, a staple cartridge tray 9220 (Figures 204, 209) is attached and is the base of a cartridge body of staples of polymer 9222 that has formed in this the recesses of the staple drivers 9208, the staple holes 9210, and the center trigger recess 9216. Because the staples 9023 thus conform to either side, the sharp cutting edge 9116 enters a vertical through slot 9230 passing through the longitudinal axis of the cartridge of staples 9020, with the exception of only one more distal end of this.
The firing of the staple application unit 9012 begins as shown in Figure 211 with the 9090 two-piece firing blade and bar that is pulled proximally until the downward projection 9136 moves the central guide 9120 on the E-beam 9102 up and back, which allows a new staple cartridge 9020 to be inserted into the staple channel 9018 when the anvil 9022 opens as shown in FIGS. 203 and 207. In Fig. 212, the two-part bladed bar and bar 9090 has been advanced distally a small distance, which allows the downward projection 9136 to fall into the enlarged hole 9130 of the lower track 9132 under the push of the clip spring 9144 against the upward projection 9138 of the 9094 tapered conical strike bar. Center guide 9120 prevents further downward rotation by seating it on the stepped central member 9124 of the wedge slider 9126, thus maintaining the center pin 9112 of the E-beam within the central firing recess 9216. In Figure 213, the 9090 two-piece firing bar and blade has been fired distally, which advances the slider in the nail 9126 to cause the forming of the staples 9023 while cutting the tissue 9242 held between the anvil 9022 and the staple cartridge 9020 with the sharp cutting edge 9116. After that, in FIG. 214, the knife and trigger bar Two 9090 pieces are retracted, which leaves the wedge slider 9126 positioned distally. In Figure 215, the middle pin 9112 is allowed to move downward within a locking recess 9240 formed in the staple channel 9018 (see, further, Figures 208, 211). Thus, the operator would receive a tactile indication when the middle pin 9112 encounters the distal edge of the locking recess 9240 when the wedge slider 9126 (not shown in Figure 215) is not positioned proximally (ie, the staple cartridge 9020 or staple cartridge 9020 was used). Similar surgical stapling instruments are described in U.S. Patent No. 7,380,696, issued June 3, 2008, the full disclosure of which is incorporated by reference in the present description.
As described above, a staple cartridge may comprise a cartridge body that includes a plurality of staple cavities defined therein. The cartridge body may comprise a cover and an upper cover surface, wherein each staple pocket may define an opening in the surface of the cover. As describedIn addition, above, a staple can be positioned within each staple pocket, such that the staples are stored within the body of the cartridge until they are expelled therefrom. Before being ejected from the cartridge body, the staples may be contained with the cartridge body, such that the staples do not protrude above the surface of the cover. Because the staples are positioned below the surface of the cover, in such embodiments, the possibility of the staples being damaged and / or coming into premature contact with the target tissue can be reduced. In various circumstances, the staples may move between an un-fired position in which they do not protrude from the cartridge body and a fired position in which they have emerged from the cartridge body and may be in contact with an anvil positioned opposite the staple cartridge . The anvil, and / or the forming cavities defined within the anvil, can be positioned at a predetermined distance above the the surface of the cover, such that, as the staples deploy from the cartridge body, the staples deform to a predetermined shaped height. In some circumstances, the thickness of the tissue captured between the anvil and the staple cartridge may vary and, as a result, the thicker tissue may be captured within certain staples while the thinner tissue may be captured within certain other staples. In any case, the pressure, or clamping force, applied to the fabric by the staples may vary from staple to staple or vary between a staple at one end of a row of staples and a staple at the other end of the row of staples, for example. In certain circumstances, the separation between the anvil and the cover of the staple cartridge can be controlled, such that the staples apply a certain minimum clamping pressure within each staple. In some of these circumstances, however, there may still be significant variation in clamping pressure within different staples.
A staple cartridge may comprise means for compensating the thickness of the tissue captured within the staples deployed from the staple cartridge. With reference to Figure 216, a staple cartridge, such as the staple cartridge 10000, for example, may include a first rigid portion, such as the support portion 10010, for example, and a second compressible portion, such as Fabric thickness compensator 10020, for example. With reference principally to Figure 218, the support portion 10010 may comprise a cartridge body, an upper cover surface 10011, and a plurality of staple cavities 10012 where, similar to the foregoing, each staple pocket 10012 can define an opening in the cover surface 10011. A staple 10030, for example, can be removably positioned in each staple pocket 10012. For example, with reference primarily to FIG. 245 and FIG. as described in greater detail below, each staple 10030 may comprise a base 10031 and one or more legs 10032 extending from the base 10031. Before the staples 10030 are deployed, as described, further, in greater detail more further, the bases 10031 of the staples 10030 can be supported by the staple drivers positioned within the support portion 10010 and, simultaneously, the legs 10032 of the staples 10030 can be contained at least partially within the staple pockets 10012. The staples 10030 may be deployed between an un-fired position and a fired position, such that the legs 10032 move through the tissue thickness compensator 10020, they penetrate through an upper surface of the tissue thickness compensator 10020, penetrate the tissue T, and come into contact with an anvil positioned opposite the staple cartridge 10000. As the legs 10032 deform against the anvil, the legs 10032 of each staple 10030 may capture a portion of the tissue thickness compensator 10020 and a portion of the tissue T within each staple 10030 and apply a compressive force to the tissue. In addition to the above, the legs 10032 of each staple 10030 can be deformed downwardly towards the base 10031 of the staple to form a staple capture area 10039 in which the tissue T and the tissue thickness compensator 10020 can be captured. several circumstances, the staple capture area 10039 can be defined between the internal surfaces of the deformed legs 10032 and the inner surface of the base 10031. The size of the capture zone for a staple may depend on several factors such as the length of the staples. legs, the diameter of the legs, the width of the base, and / or the degree to which legs are deformed, for example.
Previously, a surgeon frequently needed to select the appropriate staples that had the proper staple height for the stapled tissue. For example, a surgeon could select high staples for use with thick tissue and short staples for use with thin tissue. In some circumstances, however, the tissue that was stapled did not have a constant thickness and, thus, some staples were unable to achieve the desired fired configuration. For example, Figure 250 illustrates a high staple used in thin tissue. Referring now to Figure 251, when a tissue thickness compensator, such as tissue thickness compensator 10020, for example, is used with thin tissue, for example, the larger staple may conform to a desired fired configuration.
Due to the compressibility of the fabric thickness compensator, the fabric thickness compensator can compensate for the thickness of the tissue captured within each staple. More particularly, with reference now to Figures 245 and 246, a fabric thickness compensator, such as the fabric thickness compensator 10020, for example, can consume larger and / or smaller portions of the staple capture zone. 10039 of each staple 10030 depending on the thickness and / or type of tissue contained within the staple capture area 10039. For example, if thinner tissue T is captured within a staple 10030, the tissue thickness compensator 10020 may consume a larger portion of staple capture area 10039 in comparison with the circumstances where the thicker tissue T is captured within the staple 10030. Correspondingly, if thicker tissue T is captured within a staple 10030, the tissue thickness compensator 10020 may consume a smaller portion of the tissue area. 10039 staple capture compared to the circumstances where the thinnest tissue T is captured within staple 10030. In this way, the tissue thickness compensator can compensate for a thinner tissue and / or thicker tissue and ensure that a compression pressure is applied to the tissue independently, or at least substantially independently, of the thickness of the tissue captured within the staples. In addition to the foregoing, the fabric thickness compensator 10020 can compensate for the different types, or compressibilities, of the fabrics captured within different staples 10030. Referring now to FIG. 246, the fabric thickness compensator 10020 can apply a force of compression to the vascular tissue T, which may include the V vessels and, as a result, restrict the flow of blood through the less compressible vessels V while continuing to apply a desired compression pressure to the surrounding tissue T. In various circumstances, in addition to the foregoing, the fabric thickness compensator 10020 can also compensate for malformed staples. With reference to the Figure 247, the mis-shaping of several staples 10030 may result in larger staple capture areas 10039 that are defined within such staples. Due to the flexibility of the fabric thickness compensator 10020, with reference now to Figure 248, the fabric thickness compensator 10020 positioned within the malformed staples 10030 can still apply sufficient compressive pressure to the tissue T even though they can be enlarged the staple capture zones 10039 defined within such malformed staples 10030. In various circumstances, the tissue thickness compensator 10020 located between the adjacent staples 10030 may be pressed against tissue T by appropriately shaped staples 10030 surrounding a poorly formed staple. 10030 and, as a result, apply a compression pressure to the surrounding tissue and / or captured within malformed staples 10030, for example. In various circumstances, a tissue thickness compensator can compensate for different densities of tissues that may be due to calcifications, fibrous zones, and / or to the tissue being stapled or pretreated, for example.
A fixed, or non-changeable, tissue separation can be defined between the support portion and the anvil and, as a result, the staples can deform to a predetermined height regardless of the thickness of the tissue captured within the staples. When a fabric thickness compensator is used with these embodiments, the fabric thickness compensator can be adapted to the fabric captured between the anvil and the staple cartridge support portion and, due to the Because of the flexibility of the fabric thickness compensator, the fabric thickness compensator can apply an additional compression pressure to the fabric. With reference now to Figures 252 to 257, a staple 10030 has been formed at a predefined height H. With respect to Figure 252, a tissue thickness compensator has not been used and the tissue T consumes the entire staple capture area 10039. With respect to the Figure 259, a portion of a fabric thickness compensator 10020 that has been captured within the staple 10030, compresses the tissue T, and consumes at least a portion of the staple capture area 10039. Referring now to Figure 254 , the thin tissue T has been captured within the staple 10030. In this example, the compressed tissue T has a height of approximately 2 / 9H and the compressed tissue thickness compensator 10020 has a height of approximately 7 / 9H, for example . Referring now to Figure 255, the tissue T having an intermediate thickness has been captured within the staple 10030. In this example, the compressed tissue T has a height of approximately 4 / 9H and the thickness compensator of compressed tissue 10020 it has a height of approximately 5 / 9H, for example. Referring now to Figure 256, the tissue T having an intermediate thickness has been captured within the staple 10030. In this example, the compressed tissue T has a height of approximately 2 / 3H and the thickness compensator of compressed tissue 10020 it has a height of approximately 1 / 3H, for example. Referring now to Figure 255, the coarse tissue T has been captured within the staple 10030. In this example, the compressed tissue T it has a height of about 8 / 9H and the compressed tissue thickness compensator 10020 has a height of about 1 / 9H, for example. In various circumstances, the fabric thickness compensator may comprise a compressed height comprising approximately 10% of the staple capture height, approximately 20% of the staple capture height, approximately 30% of the capture height. of staple, approximately 40% of the staple capture height, approximately 50% of the staple capture height, approximately 60% of the staple capture height, approximately 70% of the staple capture height , approximately 80% of the staple capture height, and / or approximately 90% of the staple capture height, for example.
The staples 10030 may comprise any suitable non-conformed height. Staples 10030 may comprise an unformed height between about 2 mm and about 4.8 mm, for example. The staples 10030 may comprise an unshaped height of approximately 2.0 mm, approximately 2.5 mm, approximately 3. 0 mm, approximately 3.4 mm, approximately 3.5 mm, approximately 3.8 mm, approximately 4.0 mm, approximately 4. 1 mm, and / or approximately 4.8 mm, for example. The height H to which the clips can be deformed can be dictated by the distance between the surface of the cover 10011 of the support portion 10010 and the opposite anvil. The distance between the surface of the cover 10011 and the contact surface with the anvil tissue may be approximately 2.5 mm (0.097"), per example. The height H can also be dictated by the depth of the forming cavities defined within the anvil. The shaping cavities may have a measured depth from the tissue contacting surface, for example. As described in more detail below, the staple cartridge 10000 may further comprise staple drivers that can raise the staples 10030 toward the anvil and raise, or "overdrive," the staples above the surface of the cover. 10011. In such cases, the height H to which the staples 10030 are formed can also be dictated by the distance in which the staples 10030 are overdriven. For example, staples 10030 can be overdriven approximately 0.71 mm (0.028"), by example, and may result in staples 10030 being formed at a height of approximately 4.80 mm (0.189"), for example. The staples 10030 can be formed at a height of about 0.8 mm, about 1.0 mm, about 1.5 mm, about 1.8 mm, about 2.0 mm, and / or about 2.25 mm, for example. The staples can be formed at a height between about 2.25 mm and about 3.0 mm, for example. In addition to the above, the height of the staple capture area of a staple can be determined by the formed height of the staple and the width, or diameter, of the staple wire. The height of the staple capture area 10039 of a staple 10030 can comprise the staple height H of the staple minus two wire diameter widths. The staple wire may comprise a diameter of approximately 0.23 mm (0.0089"), per example. The staple wire may comprise a diameter of between about 0.18 mm (0.0069") and about 0.30 mm (0.0119"), for example. For example, the shaped height H of a staple 10030 may be approximately 4.8 mm (0.189") and the diameter of the staple wire may be approximately 0.23 mm (0.0089") resulting in a staple capture height of approximately 4.34 mm (0.171"), for example.
In addition to the foregoing, the fabric thickness compensator may comprise an uncompressed, or pre-deployed, height and may be configured to deform to one of a plurality of compressed heights. The fabric thickness compensator may comprise an uncompressed height of approximately 3.18 mm (0.125"), for example. The fabric thickness compensator may comprise an uncompressed height greater than or equal to about 2.0 mm (0.080"), for example. The fabric thickness compensator may comprise a non-compressed, or pre-deployed, height that is greater than the non-fired height of the staples. The uncompressed, or pre-deployed, height of the fabric thickness compensator may be approximately 10% higher, approximately 20% higher, approximately 30% higher, approximately 40% higher, approximately 50% higher , about 60% higher, about 70% higher, about 80% higher, about 90% higher, and / or about 100% higher than the non-triggered height of the clips, for example. The uncompressed, or pre-deployed, height of the tissue thickness compensator can be up to approximately 100% higher than the non-fired height of the staples, for example. The non-compressed, or pre-deployed, height of the fabric thickness compensator may be more than 100% higher than the non-fired height of the staples, for example. The fabric thickness compensator may comprise an uncompressed height that is equal to the non-fired height of the staples. The fabric thickness compensator may comprise an uncompressed height that is less than the non-fired height of the staples. The uncompressed, or pre-deployed, height of the thickness compensator may be approximately 10% lower, approximately 20% lower, approximately 30% lower, approximately 40% lower, approximately 50% lower, approximately 60% lower, approximately 70% lower, approximately 80% lower, and / or approximately 90% lower than the non-fired height of the staples, for example. The second compressible portion may comprise an uncompressed height which, compared to that of the staple tissue T, is higher than its uncompressed height. The fabric thickness compensator may comprise an uncompressed height which, compared to that of the staple tissue T, is equal to its uncompressed height. The fabric thickness compensator may comprise an uncompressed height which, compared to that of the staple tissue T, is lower than its uncompressed height.
As described above, a tissue thickness compensator can be compressed within a plurality of shaped staples regardless of whether coarse tissue or tissue is captured. thin inside the staples. For example, the staples within a line, or row of staples, may be deformed, such that the staple capture area of each staple comprises a height of approximately 2.0 mm, for example, where the tissue T and the compensator of fabric thickness can be compressed within this height. In certain circumstances, the fabric T may comprise a compressed height of approximately 1.75 mm within the staple capture zone while the tissue thickness compensator may comprise a compressed height of approximately 0.25 mm within the staple capture zone, which thus totals approximately 2.0 mm in height from the staple capture area, for example. In certain circumstances, the fabric T may comprise a compressed height of approximately 1.50 mm within the staple capture zone while the tissue thickness compensator may comprise a compressed height of approximately 0.50 mm within the staple capture zone, which thus totals approximately 2.0 mm in height from the staple capture area, for example. In certain circumstances, the fabric T may comprise a compressed height of approximately 1.25 mm within the staple capture zone while the tissue thickness compensator may comprise a compressed height of approximately 0.75 mm within the staple capture zone, which thus totals approximately 2.0 mm in height from the staple capture area, for example. In certain circumstances, the tissue T may comprise a compressed height of approximately 1.0 mm within the staple capture zone while the tissue thickness compensator may comprise a compressed height of approximately 1.0 mm within the staple capture area, which thus totals approximately 2.0 mm in height from the staple capture area, for example . In certain circumstances, the fabric T may comprise a compressed height of about 0.75 mm within the staple capture zone while the tissue thickness compensator may comprise a compressed height of approximately 1.25 mm within the staple capture zone, which thus totals approximately 2.0 mm in height from the staple capture area, for example. In certain circumstances, the fabric T may comprise a compressed height of approximately 1.50 mm within the staple capture zone while the tissue thickness compensator may comprise a compressed height of approximately 0.50 mm within the staple capture zone., which thus totals appmately 2.0 mm in height from the staple capture area, for example. In certain circumstances, the fabric T may comprise a compressed height of appmately 0.25 mm within the staple capture zone while the tissue thickness compensator may comprise a compressed height of appmately 1.75 mm within the staple capture zone, which thus totals appmately 2.0 mm in height from the staple capture area, for example.
In addition to the above, the fabric thickness compensator may comprise an uncompressed height that is less than the height shot of the staples. The fabric thickness compensator may comprise an uncompressed height that is equal to the fired height of the staples. Alternatively, the fabric thickness compensator may comprise an uncompressed height that is higher than the fired height of the staples. For example, the uncompressed height of a fabric thickness compensator may comprise a thickness that is approximately 110% of the formed staple height, approximately 120% of the formed staple height, approximately 130% of the height of the staple height. formed staple, approximately 140% of the formed staple height, approximately 150% of the formed staple height, approximately 160% of the formed staple height, approximately 170% of the formed staple height, approximately 180 % of the formed staple height, approximately 190% of the staple height formed, and / or approximately 200% of the formed staple height, for example. The fabric thickness compensator may comprise an uncompressed height that is more than twice as high as the fired height of the staples. The tissue thickness compensator may comprise a compressed height that is from about 85% to about 150% of the height of the formed staple, for example. As described above, the fabric thickness compensator can be compressed between an uncompressed thickness and a compressed thickness. The compressed thickness of a tissue thickness compensator can be about 10% of its uncompressed thickness, approximately 20% of its uncompressed thickness, approximately 30% of its uncompressed thickness, approximately 40% of its uncompressed thickness, approximately 50% of its uncompressed thickness, approximately 60% of its thickness. its uncompressed thickness, about 70% of its uncompressed thickness, about 80% of its uncompressed thickness, and / or about 90% of its uncompressed thickness, for example. The uncompressed thickness of the tissue thickness compensator may be about twice, about ten times, about fifty times, and / or about one hundred times thicker than its compressed thickness, for example. The compressed thickness of the fabric thickness compensator may be between about 60% and about 99% of its uncompressed thickness. The uncompressed thickness of the fabric thickness compensator can be at least 50% thicker than its compressed thickness. The uncompressed thickness of the fabric thickness compensator can be up to one hundred times thicker than its compressed thickness. The second compressible portion may be elastic, or at least partially elastic, and may press the tissue T against the deformed legs of the staples. For example, the second compressible portion can flexibly expand between the tissue T and the base of the staple in order to push the tissue T against the legs of the staple. As described in more detail below, the fabric thickness compensator can be positioned between the tissue T and the deformed staple legs. In various circumstances, as a result of what above, the fabric thickness compensator can be configured to consume any spacing within the staple capture zone.
Any of the fabric thickness compensators described in the present description may comprise materials characterized by one or more of the following properties: biocompatible, bioabsorbable, bioresorbable, biodurable, biodegradable, compressible, fluid absorbable, inflatable, self-expanding, bioactive, medicated, pharmaceutically active, non-stick, hemostatic, antibiotic, antimicrobial, antiviral, nutritive, adhesive, permeable, hydrophilic and / or hydrophobic, for example. In all cases, any surgical stapling or clamping instrument comprising an anvil and a staple or fastener cartridge may further comprise a tissue thickness compensator associated with the anvil and / or the staple cartridge. Such a tissue thickness compensator may be any of the tissue thickness compensators described in the present disclosure and may comprise, or may additionally comprise, at least one of a hemostatic agent, such as fibrin and thrombin, an antibiotic, such as doxyelomycin. , and a drug, such as matrix metalloproteinases (MMPs).
The fabric thickness compensator may comprise synthetic and / or non-synthetic materials. The fabric thickness compensator may comprise a polymer composition comprising one or more synthetic polymers and / or one or more non-synthetic polymers. The synthetic polymer may comprise a synthetic absorbable polymer and / or a non-absorbable synthetic polymer. The polymer composition may comprise one biocompatible foam, for example. The biocompatible foam may comprise an open cell, porous foam and / or a closed cell, porous foam, for example. The biocompatible foam may have a uniform pore morphology or may have a gradient pore morphology (ie, small pores that gradually increase in size to large pores through the thickness of the foam in one direction). The polymer composition may comprise one or more of a porous scaffold, a porous matrix, a gel matrix, a hydrogel matrix, a solution matrix, a filamentous matrix, a tubular matrix, a matrix of a compound, a membranous matrix, a biostable polymer, and a biodegradable polymer, and combinations of these. For example, the fabric thickness compensator may comprise a foam reinforced by a filamentous matrix or may comprise a foam having an additional hydrogel layer that expands in the presence of body fluids to additionally provide tissue compression. A tissue thickness compensator could further be comprised of a coating on a material and / or a second or third layer that expands in the presence of body fluids to further provide tissue compression. Such a layer could be a hydrogel that could be a synthetic material and / or of natural origin and could be biodurable and / or biodegradable, for example. The tissue thickness compensator may comprise a microgel or a nanogel. The hydrogel may comprise microgels and / or nanogels derived from carbohydrates. A tissue thickness compensator can be reinforced with fibrous non-woven materials or fibrous mesh-like elements, for example, which may provide additional flexibility, stiffness, and / or strength. A tissue thickness compensator having a porous morphology, exhibiting a gradient structure such as, for example, small pores on one surface and larger pores on the other surface. Such morphology could be more optimal for tissue growth or hemostatic behavior. In addition, the gradient could also be compositional with a variable bioabsorption profile. A short-term absorption profile may be preferred to address haemostasis while a long-term absorption profile may better address tissue healing without leakage.
Examples of non-synthetic materials include, but are not limited to, lyophilized polysaccharide, glycoprotein, bovine pericardium, collagen, gelatin, fibrin, fibrinogen, elastin, proteoglycan, keratin, albumin, hydroxyethylcellulose, cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC). ), hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitana, chitosan, casein, alginate, and combinations thereof.
Examples of absorbable synthetic materials include, but are not limited to, poly (lactic acid) (PLA), poly (polylactic acid) (PLLA), polycaprolactone (PCL), polyglycolic acid (PGA), poly (trimethylene carbonate) ( TMC), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), a copolymer of glycolide and e-caprolactone (PGCL), a copolymer of glycolide and trimethylene carbonate, poly (glycerol sebacate) (PGS), poly (dioxanone) (PDS), polyesters, poly (orthoesters), polyoxaesters, polyether esters, polycarbonates, polyamide esters, polyanhydrides, polysaccharides, poly (ester-amides), tyrosine-based polyarylates, polyamines, tyrosine-based polyiminocarbonates, tyrosine-based polycarbonates, poly (DL-lactide-urethane), poly (hydroxybutyrate), poly (B-hydroxybutyrate), poly (E-caprolactone), polyethylene glycol (PEG), poly [bis (carboxylatophenoxy) phosphazene] poly (amino acids), pseudopoly (amino acids) ), absorbable polyurethanes, poly (phosphazine), polyphosphazenes, polyalkylene oxides, polyacrylamides, polyhydroxyethyl methyl acrylate, polyvinyl pyrrolidone, polyvinyl alcohols, poly (caprolactone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyesters, glycerols, copolymers (ether esters), oxalates of polyalkylene, polyamides, poly (iminocarbonates), polyalkylene oxalates, and combinations thereof. The polyester can be selected from the group consisting of polylactides, polyglycolides, trimethylene carbonates, polydioxanones, polycaprolactones, polybutyesters, and combinations thereof.
The absorbable synthetic polymer may comprise one or more 90/10 poly (glycolide-L-lactide) copolymers, commercially available from Ethicon, Inc. under the trade designation VICRYL (polyglactin 910), polyglycolide, commercially available from American Cyanamid Co. under the commercial designation of DEXON, polydioxanone, commercially available from Ethicon, Inc. under the trade designation of PDS, poly (glycolide-trimethylene carbonate) random block copolymer, commercially available from American Cyanamid Co. under the trade designation of MAXON, copolymer 75/25 poly (glycolide-e-caprolactone-polygallecaprolactone 25), commercially available from Ethicon under the trade designation of MONOCRYL, for example.
Examples of synthetic nonabsorbable materials include, but are not limited to, polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate, polyamides, such as nylon, polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), polystyrene (PS) , polyester, polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCE), polyvinyl fluoride (PVF), fluorinated ethylene propylene (FEP), polyacetal, polysulfone, silicone, and combinations thereof. Synthetic nonabsorbable polymers may include, but are not limited to, foamed elastomers and porous elastomers, such as, for example, silicone, polyisoprene, and rubber. The synthetic polymers may comprise expanded polytetrafluoroethylene (ePTFE), commercially available from W.L. Gore & Associates, Inc. under the trade designation of GORE-TEX soft tissue patch and commercially available urethane copolyether ester foam from Polyganics under the commercial designation of NASOPORE.
The polymer composition may comprise from about 50% to about 90% by weight of the PLLA polymer composition and about 50% to about 10% by weight of the PCL polymer composition, for example. The polymer composition may comprise about 70% by weight of PLLA and about 30% by weight of PCL, for example. The polymer composition may comprise from about 55% up to about 85% by weight of the polymer composition of PGA and 15% to 45% by weight of the polymer composition of PCL, for example. The polymer composition may comprise about 65% by weight of PGA and about 35% by weight of PCL, for example. The polymer composition may comprise from about 90% to about 95% by weight of the polymer composition of PGA and about 5% to about 10% by weight of the polymeric composition of PLA, for example.
The synthetic polymer absorbed may comprise a biocompatible bioabsorbable elastomeric copolymer. Suitable biocompatible bioabsorbable elastomeric copolymers include, but are not limited to, copolymers of caprolactone and glycolide (having a molar ratio of caprolactone to glycolide from about 35:70 to about 70:30, preferably from about 35:65 to about 65:35 and, more preferably, from 45:55 to 35:65); elastomeric copolymers of caprolactone and lactide, which include mixtures of L-lactide, D-lactide thereof or copolymers of lactic acid (preferably, having a molar ratio of e caprolactone to lactide from about 35:65 to about 65:35 and , more preferably, from 45:55 to 30:70) elastomeric copolymers of p-dioxanone (1,4-dioxan-2-one) and lactide including L-lactide, D-lactide and lactic acid (preferably, have a molar ratio of p-dioxanone to lactide from about 40:60 to about 60:40); elastomeric copolymers of caprolactone and p-dioxanone (which preferably have a molar ratio of caprolactone to p-dioxanone from about 30:70 to about 70:30); elastomeric copolymers of p-dioxanone and trimethylene carbonate (preferably having a molar ratio of p-dioxanone to trimethylene carbonate from about 30:70 to about 70:30); elastomeric copolymers of trimethylene carbonate and glycolide (preferably having a molar ratio of trimethylene carbonate to glycolide from about 30:70 to about 70:30); elastomeric copolymer of trimethylene carbonate and lactide including copolymers of L-lactide, D-lactide, mixtures of these or of lactic acid (preferably having a molar ratio of trimethylene carbonate and lactide of about 30:70 to approximately 70:30) and mixtures of these. The elastomeric copolymer is a copolymer of glycolide and e-caprolactone. In another example, the elastomeric copolymer is a copolymer of lactide and caprolactone.
The disclosures of the United States patent no. 5,468,253, entitled ELASTOMERIC MEDICAL DEVICE, issued November 21, 1995, and United States Patent No. 6,325,810, entitled FOAM BUTTRESS FOR STAPLING APPARATUS, granted on December 4, 2001, are hereby incorporated by reference in their respective totalities.
The tissue thickness compensator may comprise an emulsifier. Examples of emulsifiers may include, but are not limited to, water-soluble polymers, such as polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polypropylene glycol (PPG), PLURONICS, TWEENS, polysaccharides and combinations thereof.
The tissue thickness compensator may comprise a surfactant.
Examples of surfactants may include, but are not limited to, polyacrylic acid, metallose, methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octylphenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether, polyoxyethylene nonylphenyl ether, poly (ethyleneoxy) dialkylphenoxy ethanol, and polyoxamers.
The polymer composition may comprise a pharmaceutically active agent. The polymer composition can release a therapeutically effective amount of the pharmaceutically active agent. The pharmaceutically active agent can be released as the polymer composition is desorbed / absorbed. The pharmaceutically active agent can be released into a fluid, such as, for example, blood, which passes over or through the polymer composition. Examples of pharmaceutically active agents may include, but are not limited to hemostatic agents and drugs such as for example fibrin, thrombin and regenerated oxidized cellulose (ORC); anti-inflammatory drugs such as, for example, diclofenac, aspirin, naproxen, sulindac, and hydrocortisone; antibiotic and antimicrobial agents or agents such as, for example, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, chloramphenicol and anticancer agents, such as, for example, cisplatin, mitomycin, adriamycin.
The polymer composition may comprise a hemostatic material. The tissue thickness compensator may comprise hemostatic materials comprising poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (caprolactone), poly (dioxanone), polyalkylene oxides, copoly (ether esters), collagen, gelatin, thrombin, fibrin, fibrinogen, fibronectin, elastin, albumin, hemoglobin, ovalbumin, polysaccharides, hyaluronic acid, chondroitin sulfate, hydroxyethyl starch, hydroxyethylcellulose, cellulose, oxidized cellulose, hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitana, chitosan, agarose , maltose, maltodextrin, alginate, coagulating factors, methacrylate, polyurethanes, cyanoacrylates, platelet agonists, vasoconstrictors, alum, calcium, RGD peptides, proteins, protamine sulfate, caproic amino acid, ferric sulfate, ferric subsulfates, ferric chloride, zinc , zinc chloride, aluminum chloride, aluminum sulphates, aluminum acetates, permanganates, tannins, cer for bone, polyethylene glycols, fucans and combinations thereof. The tissue thickness compensator can be characterized by hemostatic properties.
The polymer composition of a fabric thickness compensator can be characterized by porosity in percent, pore size, and / or hardness, for example. The polymer composition may have a porosity in percent of about 30% by volume at approximately 99% by volume, for example. The polymer composition may have a porosity in percent from about 60% by volume to about 98% by volume, for example. The polymer composition may have a porosity in percent from about 85% by volume to about 97% by volume, for example. The polymer composition may comprise about 70% by weight of PLLA and about 30% by weight of PCL, for example, and may comprise about 90% porosity by volume, for example. For example, as a result, the polymer composition would comprise approximately 10% copolymer by volume. The polymer composition may comprise about 65% by weight of PGA and about 35% by weight of PCL, for example, and may have a porosity in percent from about 93% by volume to about 95% by volume, by example. The polymer composition may comprise a porosity greater than 85% by volume. The polymer composition can have a pore size of about 5 microns to about 2000 microns, for example. The polymer composition can have a pore size of between about 10 micrometers to about 100 micrometers, for example. For example, the polymer composition may comprise a copolymer of PGA and PCL, for example. The polymer composition can have a pore size of between about 100 microns up to approximately 1000 micrometers, for example. For example, the polymer composition may comprise a copolymer of PLLA and PCL, for example.
According to certain aspects, the hardness of a polymer composition can be expressed in terms of Shore hardness, which can be defined as the resistance to permanent fingerprinting of a material as determined with a durometer, such as a Shore durometer. In order to evaluate the hardness value for a given material, a pressure is applied to the material with a durometer penetrating foot in accordance with ASTM D2240-00 procedure, entitled, "Standard Test Method for Rubber Property-Durometer Hardness", the whole of which is incorporated in the present description as a reference. The durometer penetrating foot can be applied to the material for a sufficient period of time, such as 15 seconds, for example, where a reading is then made from the appropriate scale. Depending on the type of scale used, a reading of 0 can be obtained when the penetrating foot completely penetrates the material, and a reading of 100 can be obtained when there is no penetration of the material. This reading is dimensionless. The durometer can be determined according to any suitable scale, such as type A and / or OO type scales, for example, in accordance with ASTM D2240-00. The polymer composition of a fabric thickness compensator can have a Shore A hardness value from about 4 A to about 16 A, for example, which is from about 45 OO to about 65 OO in the Shore OO range. For example, the polymer composition may comprise a copolymer of PLLA / PCL or a PGA / PCL copolymer, for example. The polymer composition of a fabric thickness compensator may have a Shore A hardness value of less than 15 A. The polymer composition of a fabric thickness compensator may have a Shore A hardness value of less than 10 A. The composition Polymer of a fabric thickness compensator may have a Shore A hardness value of less than 5 A. The polymeric material may have a Shore 00 composition value of from about 3500 to about 7500, for example.
The polymer composition can have at least two of the properties identified above. The polymer composition can have at least three of the properties identified above. The polymer composition can have a porosity of 85% to 97% by volume, a pore size of 5 micrometers up to 2000 micrometers, and a Shore A hardness value of 4 A up to 16 A and a Shore 00 hardness value of 45 00 to 65 OO, for example. The polymer composition may comprise 70% by weight of the PLLA polymer composition and 30% by weight of the PCL polymer composition having a porosity of 90% by volume, a pore size of 100 micrometers up to 1000 micrometers, and a Shore A hardness value of 4 A up to 16 A and a Shore 00 hardness value of 45 OO up to 65 00, for example. The polymer composition can comprise 65% by weight of the PGA polymer composition and 35% by weight of the PCL polymer composition having a porosity of 93% to 95% by volume, a pore size of 10 micrometers up to 100 micrometers, and a Shore A hardness value of 4 A up to 16 A and a Shore hardness value of 4500 to 6500, for example.
Any of the fabric thickness compensators described herein may comprise a material that expands. As discussed above, the fabric thickness compensator may comprise a compressed material that expands when decompressed or deployed, for example. In addition, or alternatively, any tissue thickness compensator of that type can comprise a self-expanding material that can be formed in situ. For example, the tissue thickness compensator may comprise at least one precursor selected to spontaneously crosslink when it comes into contact with at least one of: other precursor or other precursors, water, and / or body fluids. With reference to Figure 534, a first precursor may come in contact with one or more other precursors to form an expansible and / or inflatable tissue thickness compensator. The tissue thickness compensator may comprise a fluid-swellable composition, such as a water-swellable composition, and / or a gel comprising water.
With reference to Figures 518A and 518B, for example, a fabric thickness compensator 70000, representative of any of the fabric thickness compensators described in the present description, may comprise at least one hydrogel precursor 70010 selected to form a hydrogel. in situ and / or in vivo to expand the fabric thickness compensator 70000. Figure 518A illustrates such a tissue thickness compensator 70000 comprising an encapsulation comprising a first hydrogel precursor 7001 OA and a second hydrogel precursor 70010B before expansion. As shown in Figure 518A, the first hydrogel precursor 7001 OA and the second hydrogel precursor 70010B can physically separate from one another in the same encapsulation. Alternatively, a first encapsulation may comprise the first hydrogel precursor 70010A and a second encapsulation may comprise the second hydrogel precursor 70010B. Figure 518B illustrates the expansion of the tissue thickness compensator 70000 when the hydrogel is formed in situ and / or in vivo. As shown in Figure 518B, the encapsulate can be broken, and the first hydrogel precursor 70010A can come in contact with the second hydrogel precursor 70010B to form the hydrogel 70020. As illustrated, the hydrogel can comprise an expandable material. This can expand up to 72 hours, for example.
Any of the fabric thickness compensators described in the present disclosure, including those discussed in the preceding paragraph, may comprise a biodegradable foam having an encapsulation comprising dried hydrogel particles or granules incorporated therein. The encapsulates in the foam can be formed by contacting an aqueous solution of a hydrogel precursor and an organic solution of biocompatible materials to form the foam. As shown in Figure 535, the aqueous solution and the organic solution can form micelles. The aqueous solution and the organic solution can be dried to encapsulate dry hydrogel particles or granules within the foam. For example, a hydrogel precursor, such as a hydrophilic polymer, can be dissolved in water to form a dispersion of micelles. The aqueous solution may come into contact with an organic dioxane solution comprising poly (glycolic acid) and polycaprolactone. The aqueous and organic solutions can be lyophilized to form a biodegradable foam having dried hydrogel particles or granules dispersed therein. It is believed that micelles can form the encapsulate having dry hydrogel particles or granules dispersed within the foam structure. This encapsulation can later be broken, and the dried hydrogel particles or granules can then come into contact with a fluid, such as a body fluid, and expand.
Generally, any tissue thickness compensator described herein may be constituted to expand when it comes in contact with an activator, such as a fluid, for example. With reference to Figure 519, for example, a fabric thickness compensator 70050, representative of any of the fabric thickness compensators described in the present disclosure, may comprise an inflatable material, such as a hydrogel, which expands when it enters. in contact with a fluid 70055, such as body fluids, saline solution, water and / or an activator, for example. Examples of bodily fluids may include, but are not limited to, blood, blood plasma, peritoneal fluid, cerebral spinal fluid, urine, lymphatic fluid, synovial fluid, vitreous fluid, saliva, gastrointestinal luminal content, bile, and / or gas ( for example, CO2). In some cases, the fabric thickness compensator 70050 can expand when the fabric thickness compensator 70050 absorbs the fluid. In other cases, the fabric thickness compensator 70050 may comprise a hydrogel non-crosslinked which expands when in contact with an activator 70055 comprising a crosslinking agent to form a crosslinked hydrogel. In all cases, the tissue thickness compensator can be constituted to expand or swell from contact for up to 72 hours, such as from 24-72 hours, up to 24 hours, up to 48 hours, and up to 72 hours, by example, to provide continuously increasing pressure and / or compression to the tissue. As shown in Figure 519, the initial thickness of the fabric thickness compensator 70050 is thus less than an expanded thickness after the fluid 70055 comes into contact with the fabric thickness compensator 70050.
With reference to Figures 516 and 517, a staple cartridge 70100 may comprise a fabric thickness compensator 70105, representative of any of the fabric thickness compensators described in the present description, and a plurality of staples 70110 each comprising the staple legs 70112. As shown in Figure 516 , the fabric thickness compensator 70105 can have an initial thickness or compressed height that is smaller than the fired height of the staples 70110. The tissue thickness compensator 70100 can be configured to expand in situ and / or in vivo when it comes into contact with a fluid 70102, such as body fluids, saline, and / or an activator, for example, to push the tissue T against the legs 70112 of the staple 70110. As shown in Figure 517, the tissue thickness compensator 70100 can expand and / or swell when it comes in contact with a fluid 70102. The fabric thickness compensator 70105 can compensate for the thickness of the T tissue captured within each staple 70110. As shown in Figure 517, the fabric thickness compensator 70105 may have an expanded thickness or an uncompressed height that is less than the fired height of the staples 70110.
Any of the fabric thickness compensators that are described or claimed herein may comprise an initial thickness and an expanded thickness. In all cases, the initial thickness of the fabric thickness compensator may be about 0.001% of its expanded thickness, about 0.01% of its expanded thickness, about 0.1% of its expanded thickness, about 1% of its expanded thickness, about 10%. % of its expanded thickness, about 20% of its expanded thickness, about 30% of its expanded thickness, about 40% of its expanded thickness, about 50% of its expanded thickness, about 60% of its expanded thickness, about 70% of its expanded thickness its expanded thickness, approximately 80% of its expanded thickness, or approximately 90% of its expanded thickness. Alternatively, in all cases, the expanded thickness of the tissue thickness compensator may be about twice, about five times, about ten times, about fifty times, about one hundred times, about two hundred times, about three hundred times, about four hundred times, approximately five hundred times, approximately six hundred times, approximately seven hundred times, approximately eight hundred times, approximately nine hundred times, or approximately one thousand times more thick than its initial thickness. Alternatively, in all cases, the initial thickness of the fabric thickness compensator can be up to 1% of its expanded thickness, up to 5% of its expanded thickness, up to 10% of its expanded thickness, or up to 50% of its thickness expanded. Alternatively, in all cases, the expanded thickness of the fabric thickness compensator may be at least 50% thicker than its initial thickness, at least 100% thicker than its initial thickness, at least 300% thicker than its initial thickness , or at least 500% thicker than its initial thickness. As a result, the fabric thickness compensator can be configured to consume any spacing within the staple capture zone.
Any of the tissue thickness compensators described herein may comprise a hydrogel. The hydrogel may comprise homopolymer hydrogels, copolymer hydrogels, multipolymer hydrogels, interpenetrating polymer hydrogels, or combinations thereof. The hydrogel may comprise microgels, nanogels, or combinations thereof. The hydrogel may generally comprise a network of hydrophilic polymers capable of absorbing and / or retaining fluids. The hydrogel may comprise a non-crosslinked hydrogel, a crosslinked hydrogel, or combinations thereof. The hydrogel may comprise chemical cross-links, physical cross-links, hydrophobic segments and / or insoluble segments in water. The hydrogel can be chemically crosslinked by polymerization, cross-linking of small molecules, and / or cross-linking of polymer and polymer. The hydrogel can be physically crosslinked by ionic interactions, interactions hydrophobic, hydrogen bonding interactions, stereocomplexation, and / or supramolecular chemistry. The hydrogel can be substantially insoluble due to cross-links, hydrophobic segments and / or water-insoluble segments, but be expandable and / or swellable due to fluid absorption and / or retention. In addition, a hydrogel precursor that interconnects with endogenous materials and / or tissues can be used.
In any of the fabric thickness compensators comprising a hydrogel, the hydrogel may comprise an environmentally sensitive hydrogel (ESH). The ESH may comprise materials that have swelling properties by fluids related to environmental conditions. Environmental conditions may include, but are not limited to, the physical conditions, biological conditions, and / or chemical conditions at the surgical site. For example, the hydrogel can swell or shrink in response to temperature, pH, electric fields, ionic concentration, enzymatic and / or chemical reactions, electrical and / or magnetic stimuli, or other physiological and environmental variables. The ESH may comprise multifunctional acrylates, hydroxyethyl methacrylate (HEMA), elastomeric acrylates, or related monomers.
Any of the fabric thickness compensators comprising a hydrogel (which includes any tissue thickness compensator that is described or claimed in the present disclosure comprising a hydrogel or modified to comprise a hydrogel), may comprise at least one of the non-synthetic materials and synthetic materials described previously. The hydrogel may comprise a synthetic hydrogel and / or a non-synthetic hydrogel. In addition, or in contrast, the fabric thickness compensator may comprise a plurality of layers. The plurality of the layers may comprise porous layers and / or non-porous layers. For example, the fabric thickness compensator may comprise a non-porous layer and a porous layer. In another example, the fabric thickness compensator may comprise a porous layer between a first non-porous layer and a second non-porous layer. In another example, the fabric thickness compensator may comprise a non-porous layer between a first porous layer and a second porous layer. The non-porous layers and the porous layers can be positioned in any order with respect to the surfaces of the staple cartridge and / or the anvil.
Examples of the non-synthetic material mentioned in the preceding paragraph include, but are not limited to, albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, acid hyaluronic, keratin, protein, blood plasma, and starch. The cellulose may comprise hydroxyethylcellulose, oxidized cellulose, regenerated oxidized cellulose (ORC), hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, and combinations thereof. The collagen may comprise bovine pericardium. The carbohydrate may comprise a polysaccharide, such as lyophilized polysaccharide. The protein may comprise glycoprotein, proteoglycan, or combinations thereof.
Likewise, examples of the aforementioned synthetic material include, but are not limited to, poly (lactic acid), poly (acid) glycolic), poly (hydroxybutyrate), poly (phosphazine), polyesters, polyethylene glycols, polyethylene oxide, polyethylene oxide-co-polypropylene oxide, polyethylene co-oxide, polyalkylene oxides, polyacrylamides, polyhydroxyethyl methylacrylate, poly (vinyl pyrrolidone), polyvinyl alcohols, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyesters, glycerols, poly (amino acids), copolymers (ether esters), polyalkylene oxalates, polyamides, poly (iminocarbonates), polyoxates, polyorthoesters, polyphosphazenes and combinations of these. These non-synthetic materials can be prepared synthetically, for example, synthetic hyaluronic acid, by using conventional methods.
In any of the fabric thickness compensators comprising a hydrogel (which includes any tissue thickness compensator that is described or claimed in the present disclosure that comprises a hydrogel or is modified to comprise a hydrogel), the hydrogel can be made from one or more hydrogel precursors. Such precursors may comprise a monomer and / or a macromer. The hydrogel precursor may comprise an electrophilic functional group and / or a nucleophilic functional group. Generally, electrophiles can react with nucleophiles to form a bond. The term "functional group" as used herein refers to electrophilic or nucleophilic groups capable of reacting with one another to form a bond. Examples of electrophilic functional groups include, but are not limited to, N-hydroxysuccinimides ("NHS"), sulfosuccinimides, carbonyldiimidazole, sulfonyl chloride, aryl halides, sulfosuccinimidyl esters, N-hydroxysuccinimidyl esters, succinimidyl esters such as succinimidyl succinates and / or succinimidyl propionates, isocyanates, thiocyanates, carbodiimides, benzotriazole carbonates, epoxides, aldehydes, maleimides, imidoesters, combinations thereof, and the like. In a specific example, the electrophilic functional group may comprise a succinimidyl ester. Examples of nucleophilic functional groups include, but are not limited to, -NH2, -SH, -OH, -PH2, and -CO-NH-NH2.
The hydrogel can be formed from a single precursor or multiple precursors. For example, the hydrogel can be formed from a first precursor and a second precursor. The first hydrogel precursor and the second hydrogel precursor can form a hydrogel in situ and / or in vivo after coming into contact. The hydrogel precursor can generally refer to a polymer, a functional group, a macromolecule, a small molecule, and / or a crosslinking agent that can take part in a reaction to form a hydrogel. The precursor may comprise a homogeneous solution, heterogeneous solution, of separate phases in a suitable solvent, such as water or a regulator, for example. The regulator can have a pH of from about 8 to about 12, such as, about 8.2 to about 9, for example. Examples of regulators include, but are not limited to, borate regulators. In some circumstances, the precursor (s) can (are) in an emulsion. Thus, a first precursor can react with a second precursor to form the hydrogel. For example, the first precursor can spontaneously crosslink when it comes in contact with the second precursor, and / or a first set of electrophilic functional groups in a first precursor can react with a second set of nucleophilic functional groups in a second precursor. When the precursors are mixed in an environment that allows the reaction (for example, with respect to pH, temperature, and / or solvent), the functional groups can react with each other to form covalent bonds. The precursors may be crosslinked when at least some of the precursors react with more than one of the other precursor.
The tissue thickness compensator may comprise at least one monomer selected from the group consisting of the potassium salt of 3-sulfopropyl acrylate ("KSPA"), sodium acrylate ("NaA"), N- (tris (hydroxylmethyl) methyl) acrylamide ("tris acril"), and 2-acrylamide-2-methyl-1-propane sulfonic acid (AMPS). The tissue thickness compensator may comprise a copolymer comprising two or more monomers selected from the group consisting of KSPA, NaA, acryl tris, AMPS. The tissue thickness compensator may comprise homopolymers derived from KSPA, NaA, tris acril and AMPS. The tissue thickness compensator may comprise monomers that modify the hydrophilicity copolymerizable with it. Hydrophilicity modifying monomers may comprise methyl methacrylate, butylacrylate, cyclohexylacrylate, styrene, styrene sulfonic acid.
The tissue thickness compensator may comprise a crosslinking agent. The crosslinking agent may comprise an agent of low molecular weight di- or polyvinyl cross-linking, such as ethylene glycol diacrylate or dimethacrylate, di-, tri- or tetraethylene glycol diacrylate or dimethacrylate, allyl (meth) acrylate, a C2-C8 diacrylate or dimethacrylate-alkylene, divinyl, divinyl sulfone, di- and trivinylbenzene, trimethylolpropane triacrylate or trimethacrylate, pentaerythritol tetraacrylate or tetrametacrylate, bisphenol A diacrylate or dimethacrylate, bisacrylamide or methylene bismetacrylamide, ethylene bisprylamide or ethylene bismethacrylamide, triallyl phthalate or phthalate diallyl. As a specific example, the crosslinking agent may comprise N, N'-methylenebisacrylamide ("MBAA").
The tissue thickness compensator may comprise at least one of acrylate and / or methacrylate functional hydrogels, biocompatible photoinitiator, alkyl cyanoacrylates, isocyanate functional macromers, optionally comprising amine functional macromers, functional macromers of succinimidyl ester, which optionally comprise functional amine and / or sulfhydryl macromers, functional epoxy macromers, optionally comprising amine functional macromers, mixtures of proteins and / or polypeptides and aldehyde crosslinking agents, Genipin, and water soluble carbodiimides, polysaccharides anionic and polyvalent cations.
The tissue thickness compensator may comprise monomers of unsaturated organic acids, alcohols substituted by acrylics, and / or acrylamides. The tissue thickness compensator may comprise methacrylic acids, acrylic acids, glycerolacrylate, glycerol methacrylate, 2- hydroxyethylmethacrylate, 2-hydroxyethyl acrylate, 2- (dimethylaminoethyl) methacrylate, N-vinylpyrrolidone, methacrylamide, and / or N, N-dimethylacrylamide poly (methacrylic acid).
The fabric thickness compensator may comprise a reinforcing material. The reinforcing material may comprise at least one of the nonsynthetic materials and synthetic materials described above. The reinforcing material may comprise collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethylcellulose, cellulose, oxidized cellulose, hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitana, chitosan, alginate, poly (lactic acid), poly (glycolic acid). , poly (hydroxybutyrate), poly (phosphazine), polyesters, polyethylene glycols, polyalkylene oxides, polyacrylamides, polyhydroxyethyl methacrylate, polyvinyl pyrrolidone, polyvinyl alcohols, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polycaprolactone, polypropylene, aliphatic polyesters, glycerols, poly (amino acids), copolymers (ether esters), polyalkylene oxalates, polyamides, poly (iminocarbonates), polyalkylene oxalates, polyoxaesters, polyorthoesters, polyphosphazenes and combinations thereof.
The fabric thickness compensator may comprise a layer comprising the reinforcing material. A porous layer and / or a non-porous layer of a fabric thickness compensator may comprise the reinforcing material. For example, the porous layer may comprise the reinforcing material and the non-porous layer may not comprise the reinforcing material. The reinforcing layer may comprise an inner layer between a first non-porous layer and a second non-porous layer. The reinforcement layer it may comprise an outer layer of the fabric thickness compensator and / or an outer surface of the fabric thickness compensator.
The reinforcing material may comprise meshes, monofilaments, multifilament braids, fibers, mats, felts, particles, and / or powders. The reinforcing material can be incorporated into a layer of the fabric thickness compensator. The reinforcing material can be incorporated in at least one of a non-porous layer and a porous layer. A mesh comprising the reinforcing material can be formed by the use of conventional techniques, such as, for example, knit fabric, loom fabric, lace fabric, and / or knot fabric. A plurality of reinforcing materials may be oriented in a random direction and / or a common direction. The common direction can be parallel to the line of staples or perpendicular to the line of staples, for example. The monofilaments and / or the multifilament braids can be oriented in a random direction and / or a common direction. The monofilaments and the multifilament braids may be associated with the non-porous layer and / or the porous layer. The fabric thickness compensator may comprise a plurality of reinforcing fibers oriented in a random direction or a common direction within a non-porous layer.
With reference to Figure 528, an anvil 70300 may comprise a fabric thickness compensator 70305, representative of any of the fabric thickness compensators described in the present disclosure, comprising a first non-porous layer 70307 and a second non-porous layer 70309 that hermetically encloses a layer of reinforcement 70310. The reinforcing layer 70310 may comprise a hydrogel comprising ORC particles or fibers incorporated therein, and the non-porous layers may comprise ORC. As shown in Figure 528, the fabric thickness compensator 70305, representative of any of the fabric thickness compensators described in the present description, can be configured to conform to the anvil contour 70300. The inner layer of the thickness compensator of Fabric 70305 can be adapted to the inner surface of the anvil 70300, which includes the formation of cavities 70301.
In all cases where reinforcing fibers are used in a fabric thickness compensator, the fibers can form a nonwoven material, such as, for example, a mat or felt. The fibers can have any suitable length, such as, for example, from 0.1 mm to 100 mm and 0.4 mm to 50 mm. Alternatively, a reinforcing material can be ground to a powder. The powder can have a particle size of 10 micrometers to 1 cm, for example. The powder can be incorporated into the fabric thickness compensator.
Any of the fabric thickness compensators that are described or claimed in the present disclosure can be formed or partially formed in situ. For example, in the case where the tissue thickness compensator includes a hydrogel, the hydrogel can be formed in situ. The tissue thickness compensator can be formed in situ by covalent, ionic, and / or hydrophobic bonds. Physical (non-covalent) cross-links can result from complexation, hydrogen bonding, desolvation, Van der Waals interactions, ionic bonds, or combinations of these. Crosslinking Chemistry (covalent) can be carried out by any one of a number of mechanisms, including: free radical polymerization, condensation polymerization, anionic or cationic polymerization, addition polymerization, electrophilic and nucleophilic substitution reactions, and combinations thereof.
The in situ formation of the tissue thickness compensator may comprise reacting two or more precursors that are physically separated until they come in contact in situ and / or react to an environmental condition to react with each other to form a hydrogel., for example. The polymerizable in situ polymers can be prepared from the precursor (s) which can be reacted to form a polymer at the surgical site. The tissue thickness compensator can be formed by crosslinking reactions of the precursor (s) in situ. At least one precursor may comprise an initiator capable of initiating a polymerization reaction for the formation of the tissue thickness compensator in situ. The tissue thickness compensator may comprise a precursor that can be activated at the time of application to create, for example, a crosslinked hydrogel. The in situ formation of the tissue thickness compensator may comprise activating at least one precursor to form bonds to form the tissue thickness compensator. This activation can be achieved by changes in physical conditions, biological conditions, and / or chemical conditions at the surgical site, including, but not limited to, temperature, pH, electric fields, ionic concentration, enzymatic reactions and / or chemicals, electrical and / or magnetic stimuli, and other physiological and environmental variables. Alternatively, the precursors can be contacted outside the body and introduced into the surgical site.
Another way to form, or partially form, a tissue thickness compensator in situ or in vivo, applicable to any of the tissue thickness compensators described in the present disclosure, involves the use of a tissue thickness compensator comprising a tissue thickness compensator. or more encapsulations, or cells, that can be configured to store at least one component in it. For example, the encapsulation can be configured to store a hydrogel precursor therein. The encapsulation can be configured to store two components in it, for example, as already described. The encapsulation can be configured to store a first hydrogel precursor and a second hydrogel precursor therein. Alternatively, a first encapsulation can be configured to store a first hydrogel precursor therein and a second encapsulation can be configured to store a second hydrogel precursor therein. As described above, these encapsulations can be aligned, or at least substantially aligned, with the staple legs for piercing and / or otherwise breaking the encapsulations when the staple legs come into contact with the encapsulation. The encapsulates can be compressed, crushed, collapsed, and / or otherwise broken when the staples are deployed. After the encapsulates have been broken, the component (s) stored therein can flow out of the package. The component stored in these may come into contact with other components, layers of the fabric thickness compensator, and / or the fabric. These other components may flow from these or from different encapsulations, which are provided in, or in the layers of, the tissue thickness compensator, and / or are provided at the surgical site by the clinician. As a result of the foregoing, the stored component (s) within the packages can (n) provide the expansion and / or swelling of the fabric thickness compensator.
The tissue thickness compensator may comprise a layer comprising these encapsulations. Such an encapsulation may comprise a vacuum, a cavity, a dome, a tube, and combinations thereof associated with the layer. The encapsulates may comprise gaps in the layer. For example, the layer can comprise two layers that can be coupled together, wherein the encapsulates can be defined between the two layers. The encapsulates may comprise domes on the surface of the layer. For example, at least a portion of the encapsulates can be positioned within domes extending upwardly from the layer. The encapsulates may comprise cavities formed within the layer. For example, a first portion of the encapsulates may comprise a dome and a second portion of the encapsulates may comprise a cavity. The encapsulates may comprise a tube incorporated within the layer. This tube may comprise any of the non-synthetic materials and / or synthetic materials described in the present disclosure, such as PLA. The tissue thickness compensator may comprise a bioabsorbable foam, such as ORC, which comprises PLA tubes incorporated therein, and the tube can encapsulate a hydrogel, for example. The encapsulates may comprise discrete cells not connected to each other. Alternatively, one or more of the encapsulates may be in continuous communication with each other through one or more passages, passages, and / or channels, for example, that extend through the layer.
The release rate of a component from the encapsulation can be controlled by the thickness of the fabric thickness compensator, the composition of the fabric thickness compensator, the size of the component, the hydrophilicity of the component, and / or the physical and / or chemical interactions between the component, the composition of the tissue thickness compensator, and / or the surgical instrument, for example. The layer may comprise one or more thin sections or weakened portions, such as partial perforations, for example, which may facilitate the cutting of the layer and the rupture of the encapsulations. These partial perforations may extend through only a part of a layer or, alternatively, the perforations may extend completely through the layer.
With reference to Figures 523 and 524, a fabric thickness compensator 70150, representative of any of the fabric thickness compensators described in the present description, may comprise an outer layer 70152A and an inner layer 70152B comprising encapsulates 70154. Encapsulated may comprise a first encapsulated component and a second encapsulated component. Alternatively, the encapsulates can independently comprise one of a first encapsulated component and a second encapsulated component. The first encapsulated component can be separated from the second encapsulated component. The outer layer 70152A may comprise a contact surface with the fabric. The inner layer 70152B may comprise a contact surface with the instrument. The contact surface with the instrument 70152B can be removably attached to the anvil 70156. The outer layer 70152A can be attached to the inner layer 70152B to define a vacuum between the outer layer 70152A and the inner layer 70152B. As shown in Figure 523, each package 70154 'may comprise a dome on the surface of contact with the instrument of the inner layer 70152B. The dome may comprise partial perforations to facilitate the incision of the layer by the staple legs and the rupture of the encapsulation. As shown in Figure 524, the anvil 70156 can comprise a plurality of rows of forming cavities 70158, wherein the domes of the encapsulates 70154 can be aligned with the forming cavity 70158. The tissue contacting surface can comprise a flat surface without domes, and / or the tissue contacting surface may comprise one or more encapsulations, such as encapsulations 70154, for example, extending therefrom.
An anvil of any surgical stapling instrument may comprise a tissue thickness compensator comprising an encapsulated component comprising at least one microspherical particle. According to the above description, the tissue thickness compensator can comprising an encapsulation comprising a first encapsulated component and a second encapsulated component, and / or the tissue thickness compensator may comprise an encapsulation comprising a first microspherical particle and a second microspherical particle.
With reference to Figure 525, a stapling apparatus may comprise an anvil 70180 and a staple cartridge (illustrated in other figures). The staples 70190 of a staple cartridge can be deformed by an anvil 70180 when the anvil 70180 is moved to a closed position and / or by a staple driver 70192 which moves the staples 70190 toward the closed anvil 70180. The legs 70194 the staples may come into contact with the anvil 70180 in such a manner that the staples 70190 deform at least partially. The anvil 70180 may comprise a fabric thickness compensator 70182 comprising an outer layer 70183A, an inner layer 70183B. The tissue thickness compensator 70182 can comprise a first encapsulated component and a second encapsulated component the encapsulates 210185 can be aligned, or at least substantially aligned, such that, when the staple legs 70194 are pushed through the tissue T and the outer layer 70183A, staple legs 70194 can pierce and / or in any other way break encapsulated 70185. As shown in Figure 525, staple 70190C is in a fully fired position, staple 70190B is in the process of firing , and staple 70190A is in an untriggered position. Staple legs 70190C and 70190B have moved through the T fabric, the outer layer 70183A, and the inner layer 70183B of the fabric thickness compensator 70182, and have come into contact with an anvil 70180 positioned in front of the staple cartridge. After the encapsulations 70185 have been broken, the encapsulated components can flow out and come into contact with each other, with body fluids, and / or with tissue T, for example. The encapsulated components can react to form a reaction product such as a hydrogel, for example, to expand between the tissue T and the base of the staple and to push the tissue T against the legs of the staple. As a result, the fabric thickness compensator can be configured to consume any spacing within the staple capture zone.
The tissue thickness compensators described in the present disclosure, including all those that are formed or partially formed or are expandable in situ or in vivo, may be suitable for use with any surgical instrument. As described above, the tissue thickness compensator may be associated with the staple cartridge and / or the anvil. The tissue thickness compensator can be configured in any suitable shape, size and / or dimension to fit the staple cartridge and / or the anvil. As described in the present description, the fabric thickness compensator can be removably attached to the staple cartridge and / or the anvil. The tissue thickness compensator may be attached to the staple cartridge and / or to the anvil in any mechanical and / or chemical manner capable of retaining the tissue thickness compensator in contact with the staple cartridge and / or the anvil before and during the stapling process. The tissue thickness compensator can be removed or released from the cartridge staples and / or the anvil after the staple penetrates the tissue thickness compensator. The tissue thickness compensator can be removed or released from the staple cartridge and / or the anvil as the staple cartridge and / or the anvil moves away from the tissue thickness compensator.
With reference to Figures 520 to 522, any stapling apparatus 70118 may comprise an anvil 70120 and a staple cartridge 70122 comprising a firing member 70124, a plurality of staples 70128, a knife edge 70129, and a thickness compensator. 70130. The fabric thickness compensator 70130, representative of any of the fabric thickness compensators described in the present disclosure, may comprise at least one encapsulated component. The encapsulated component can be broken when the tissue thickness compensator is compressed, stapled, and / or cut. With reference to Figure 521, for example, the staples 70128 can be deployed between an un-fired position and a fired position such that the staple legs move through the tissue thickness compensator 70130, penetrate through a surface bottom and an upper surface of the fabric thickness compensator 70130, penetrate the tissue T, and come into contact with an anvil 70120 positioned opposite the staple cartridge 70118. The encapsulated components can react with each other, with a built-in hydrophilic powder or dispersed in the tissue thickness compensator, and / or with body fluids to expand or inflate the tissue thickness compensator 70130. As the legs deform against the anvil, the legs of each staple can capture a portion of the fabric thickness compensator 70130 and a portion of the tissue T within each staple 70128 and apply a compressive force to the fabric T. As shown in Figures 521 and 522, the fabric thickness compensator 70130 can compensate for the thickness of the fabric. T tissue captured within each staple 70128.
With reference to Figure 526, a surgical instrument 70200 may comprise an anvil 70205 comprising an upper tissue thickness compensator 70210 and a staple cartridge 70215 comprising a lower tissue thickness compensator comprising an outer layer 70220 and a layer interior 70225. The upper fabric thickness compensator 70210 can be positioned on a first side of the objective fabric and the lower fabric thickness compensator can be positioned on a second side of the fabric. The upper fabric thickness compensator 70210 may comprise ORC, the outer layer of the lower fabric thickness compensator may comprise a hydrogel having ORC particles incorporated therein, and the inner layer of the lower fabric thickness compensator may comprise ORC, for example.
With reference to Figures 529 to 531, a surgical instrument 70400 may comprise a staple cartridge 70405 and an anvil 70410. The staple cartridge 70405 may comprise a tissue thickness compensator 70415 including the bioabsorbable foam. The bioabsorbable foam may comprise an encapsulation which comprises an encapsulated component 70420. The bioabsorbable foam may comprise ORC and the encapsulated component may comprise a medicament, for example. The tissue thickness compensator 70415 of the anvil 70410 may comprise an inner layer 70425 and an outer layer 70430. The inner layer 70425 may comprise a bioabsorbable foam, and the outer layer 70430 may comprise a hydrogel, optionally comprising reinforcing materials, for example. During an illustrative firing sequence, with reference primarily to Figure 530, the slider 70435 may first come into contact with the staple 70440A and begin to raise the staple upwards. As the slider 70435 is further advanced distally, the slider 70435 may begin to raise the staples 70440B-D, and any subsequent clips, in a sequential order. The slider 70435 can urge the staples 70440 upwards so that the legs of the staples come into contact with the opposite anvil 70410 and deform to the desired shape. With respect to the firing sequence illustrated in Figure 530, staples 70440A-C have been moved to their fully fired positions, staple 70440D is in the process of firing, and staple 70420E is still in its non-fired position. The encapsulated component 70470 can be broken by the staple legs during the illustrative firing sequence. The encapsulated component 70420 may flow from the encapsulation around the staple legs to come into contact with the T-tissue. In various circumstances, additional compression of the tissue thickness compensator may squeeze additional medication out of the package. The medication can treat the tissue immediately and can reduce tissue bleeding.
In various circumstances, a surgeon, or other clinician, can supply a fluid to the tissue thickness compensator to fabricate a Fabric thickness compensator comprising at least one medicament stored and / or absorbed therein. A staple cartridge and / or the anvil may comprise a port configured to provide access to the tissue thickness compensator. With reference to Figure 532B, a staple cartridge 70500 may comprise a port 70505 at a distal end thereof, for example. Port 70505 can be configured to receive a needle 70510, such as a fenestrated needle shown in Figure 532A. The clinician can insert a needle 70510 through the port 70505 into the tissue thickness compensator 70515 to deliver the fluid to the tissue thickness compensator 70515. The fluid may comprise a medicament and a hydrogel precursor, for example. As described above, the fluid can be released from the tissue thickness compensator to the tissue when the tissue thickness compensator is broken and / or compressed. For example, the medicament can be released from the fabric thickness compensator 70515 as the tissue thickness compensator 70515 biodegrades.
Referring now to Figure 216, a staple cartridge, such as the staple cartridge 10000, for example, may comprise a support portion 10010 and a compressible tissue thickness compensator 10020. Referring now to FIGS. 218 to 220 , the support portion 10010 may comprise a surface of the cover 10011 and a plurality of staple cavities 10012 defined within the support portion 10010. Each staple pocket 10012 may be sized and configured to removably store a staple therein, such as a staple 10030, for example. The staple cartridge 10000 may further comprise a plurality of staple drivers 10040 each of which may be configured to support one or more staples 10030 within the staple pockets 10012 when the staples 10030 and the staple drivers 10040 are in contact with the stapler 10000. their positions not fired. For example, with reference primarily to Figures 224 and 225, each staple pusher 10040 may comprise one or more bases or channels, 10041, for example, which may be configured to support the staples and limit relative movement between staples 10030 and staples 10030. staple drivers 10040. Referring again to Figure 218, the staple cartridge 10000 may further comprise a staple trigger slider 10050 that can be moved from a proximal end 10001 to a distal end 10002 of the staple cartridge for the purpose of sequentially raising the staple drivers 10040 and staples 10030 from their non-fired positions towards an anvil positioned opposite the staple cartridge 10000. With reference primarily to Figures 218 and 220, each staple 10030 may comprise a base 10031 and one or more legs 10032 extending from the base 10031, where each staple may have at least one form of substantially one U and substantially one V, for example. The staples 10030 may be configured such that the tips of the staple legs 10032 are recessed with respect to the surface of the cover 10011 of the support portion 10010 when the staples 10030 are in their non-fired positions. The staples 10030 may be configured, such that the tips of the staple legs 10032 are flush with respect to the surface of the cover 10011 of the support portion 10010 when the staples 10030 are in their non-fired positions. The staples 10030 may be configured so that the tips of the staple legs 10032, or at least some portion of the staple legs 10032, extend above the surface of the cover 10011 of the support portion 10010 when the staples 10030 they are in their non-fired positions. In such cases, the staple legs 10032 may extend and may be incorporated within the tissue thickness compensator 10020 when the staples 10030 are in their non-fired positions. For example, the staple legs 10032 may extend above the surface of the cover 10011 by approximately 1.9 mm (0.075"), for example. The staple legs 10032 may extend above the surface of the cover 10011 in a distance between about 0.64 mm (0.025") and about 3.18 mm (0.125"), for example. In addition to the foregoing, the fabric thickness compensator 10020 may comprise an uncompressed thickness between about 2.0 mm (0.08") and about 3.18 mm (0.125"), for example.
In operation, in addition to the foregoing and with reference primarily to Figure 233, an anvil, such as the anvil, 10060, for example, can be moved to a closed position opposite the staple cartridge 10000. As described in more detail below , the anvil 10060 can position the tissue against the tissue thickness compensator 10020 and compressing the fabric thickness compensator 10020 against the surface of the cover 10011 of the support portion 10010, for example. Once the anvil 10060 has been properly positioned, the staples 10030 can be deployed, as further illustrated in Figure 233. As mentioned above, the staple trigger slider 10050 can be moved from the proximal end 10001 of the staple cartridge 10000 towards the distal end 10002, as illustrated in Figure 234. As the slider 10050 advances, the slider 10050 may come into contact with the staple drivers 10040 and raise the staple drivers 10040 upwardly within the staple cavities. 10012. The slider 10050 and the staple drivers 10040 each may comprise one or more sloped, or sloping surfaces, which may cooperate to move the staple drivers 10040 upward from their non-fired positions. For example, with reference to Figures 221 to 225, each staple driver 10040 may comprise at least one inclined surface 10042 and the slider 10050 may comprise one or more inclined surfaces 10052 that may be configured, such that the inclined surfaces 10052 may sliding below the sloping surface 10042 as the slider 10050 advances distally within the staple cartridge. As staple drivers 10040 are raised upwardly within their respective staple pockets 10012, staple drivers 10040 can raise staples 10030 upward, such that staples 10030 can emerge from their staple pockets 10012 to through apertures in the staple cover 10011. During an illustrative shot sequence, with reference primarily to FIGS. 227 to 229, the slider 10050 may first come into contact with the staple 10030a and begin to raise the staple 10030a upwards. As the slider 10050 further advances distally, the slider 10050 may begin to raise the staples 10030b, 10030c, 10030d, 10030e, and 10030f, and any other subsequent clips, in a sequential order. As illustrated in Figure 229, the slider 10050 can urge the staples 10030 upwards, such that the legs 10032 of the staples come into contact with the opposite anvil, are deformed to a desired shape, and eject therefrom the support portion 10010. In various circumstances, the slider 10030 may move several staples upward at the same time as part of a firing sequence. With respect to the firing sequence illustrated in Figure 229, staples 10030a and 10030b have been moved to their fully fired positions and ejected from support portion 10010, staples 10030c and 10030d are in the process of being fired and at least they are partially contained within the support portion 10010, and the staples 10030e and 10030f are still in their non-fired positions.
As discussed above, and with reference to Figure 235, the staple legs 10032 of the staples 10030 may extend above the surface of the cover 10011 of the support portion 10010 when the staples 10030 are in their non-fired positions. With respect to in addition to this firing sequence illustrated in Figure 229, staples 10030e and 10030f are illustrated in their non-fired position and their staple legs 10032 extend above the surface of the cover 10011 and within the tissue thickness compensator 10020. The tips of the staple legs 10032, or any other portion of the staple legs 10032 may not protrude through a contact surface with the upper fabric 10021 of the fabric thickness compensator 10020 when the staples 10030 are in their non-fired positions. When the staples 10030 move from their non-fired positions to their fired positions, as illustrated in Figure 229, the tips of the staple legs can protrude through the contact surface with the tissue 10032. staple legs 10032 can comprise sharp tips that can cut and penetrate the fabric thickness compensator 10020. The tissue thickness compensator 10020 can comprise a plurality of openings that can be configured to receive the staple legs 10032 and allow the legs of staple 10032 are slid with respect to the fabric thickness compensator 10020. The support portion 10010 may further comprise a plurality of guides 10013 extending from the surface of the cover 10011. The guides 10013 may be positioned adjacent to the openings of the staple cavities in the surface of the cover 10011, in such a way that the staple legs 10032 can be supported at least partially The guide 10013 can be positioned at a proximal end and / or at a distal end of an aperture of the staple cavities. A first guide 10013 can be positioned at a first end of each opening of the staple cavities and a second guide 10013 can be positioned at a second end of each opening of the staple cavities, such that each first guide 10013 can support a first staple leg 10032 of a staple 10030 and each second guide 10013 can support a second leg staple 10032 staple. With reference to Figure 235, each guide 10013 may comprise a groove or groove, such as spline 10016, for example, within which a staple leg 10032 may be slidably received. Each guide 10013 may comprise a cross member, a projection, and / or a peak that may extend from the surface of the cover 10011 and may extend within the tissue thickness compensator 10020. As described in more detail below, the cross members, projections, and / or spikes may reduce relative movement between the tissue thickness compensator 10020 and the support portion 10010. The tips of the staple legs 10032 may be positioned within the guides 10013 and may not extend above the surfaces. of the guides 10013 when the staples 10030 are in their non-fired position. In at least such a mode, the guides 10013 can define a guide height and the staples 10030 may not extend above this guide height when in their non-fired position.
A fabric thickness compensator, such as the fabric thickness compensator 10020, for example, may comprise a single sheet of material. A fabric thickness compensator may comprise a continuous sheet of material that can cover the entire surface of the top cover 10011 of the support portion 10010 or, alternatively, cover less than the entire surface of the cover 10011. The sheet of material can cover the openings of the staple cavities in the support portion 10010 while, as an alternative, the sheet of material may comprise openings that can be aligned, or at least partially aligned, with the openings of the staple pockets. A tissue thickness compensator can comprise multiple layers of material. Referring now to Figure 217, a tissue thickness compensator may comprise a compressible core and a shell surrounding the compressible core. A wrapper 10022 may be configured to removably clamp the compressible core to the support portion 10010. For example, the support portion 10010 may comprise one or more projections, such as projections 10014 (FIG. 220), for example, which extend from this, which can be received within one or more openings and / or slots, such as openings 10024, for example, defined in the envelope 10022. Projections 10014 and openings 10024 can be configured, such that projections 10014 they can retain the envelope 10022 to the support portion 10010. The ends of the projections 10014 can be deformed, such as by a thermal staking process, for example, in order to enlarge the ends of the projections 10014 and, as a result, limiting the relative movement between the envelope 10022 and the support portion 10010. The envelope 10022 may comprise one or more perforations 10025 which can be easily the release of the envelope 10022 from the support portion 10010, as illustrated in Figure 217. Referring now to Figure 226, a compensator The thickness of fabric may comprise a sheath 10222 including a plurality of openings 10223, wherein the openings 10223 may be aligned, or at least partially aligned, with the openings of the staple cavities in the supporting portion 10010. The core of the compensator The thickness of fabric may further comprise openings that align, or at least partially align, with the openings 10223 in the wrapper 10222. Alternatively, the core of the tissue thickness compensator may comprise a continuous body and may extend below of the openings 10223 in such a manner that the continuous body covers the openings of the staple cavities in the surface of the cover 10011.
As described above, a tissue thickness compensator may comprise a wrapper that removably holds a compressible core to the support portion 10010. For example, with reference to FIG. 218, a staple cartridge may further comprise retaining clips 10026 that can be configured to prevent the wrapper, and the compressible core, from prematurely separating from the support portion 10010. Each retaining clip 10026 may comprise apertures 10028 that can be configured to receive projections 10014 extending from the support portion 10010, such that the retaining clips 10026 can be retained to the support portion 10010. Each of the retaining clips 10026 can comprise at least a portion of the tray 10027 that can extend below the portion of support 10010 and can support and retain staple drivers 10040 within the support portion 10010. As described above, a tissue thickness compensator can be removably attached to support portion 10010 by staples 10030. More particularly, as described above, the legs of staples 10030 can extend within of the fabric thickness compensator 10020 when the staples 10030 are in their non-fired position and, as a result, removably hold the fabric thickness compensator 10020 to the support portion 10010. The legs of the staples 10030 can be in contact with the side walls of their respective staple pockets 10012 where, due to friction between the staple legs 10032 and the side walls, the staples 10030 and the tissue thickness compensator 10020 can be retained in position until they staples 10030 are deployed from the staple cartridge 10000. When staples 10030 are deployed, the tissue thickness compensator 10020 can be to be captured within the staples 10030 and held against the stapling tissue T. When the anvil is thereafter moved to an open position to release the tissue T, the support portion 10010 can be separated from the tissue thickness compensator 10020 which has been removed. fastened to the tissue. An adhesive can be used to removably support the fabric thickness compensator 10020 to the support portion 10010. A two part adhesive can be used wherein a first part of the adhesive can be placed on the surface of the cover 10011 and a second part of the adhesive can be placed in the fabric thickness compensator 10020, such that, when the fabric thickness compensator 10020 is placed against the surface of the cover 10011, the first part can come into contact with the second part to activate the adhesive and removably attach the fabric thickness compensator 10020 to the support portion 10010. Any other means could be used. suitable for removably retaining the tissue thickness compensator to the supporting portion of a staple cartridge.
In addition to the above, the slider 10050 can be advanced from the proximal end 10001 to the distal end 10002 to fully deploy all the staples 10030 contained within the staple cartridge 10000. Referring now to FIGS. 258 to 262, the slider 10050 can be advanced distally within a longitudinal cavity 10016 within the support portion 10010 by a trigger member, or knife bar, 10052 of a surgical stapler. In operation, the staple cartridge 10000 can be inserted into a staple cartridge channel in a clamp of the surgical stapler, such as the staple cartridge channel 10070, for example, and the firing member 10052 can advance in contact with the slider 10050, as illustrated in Figure 258. As the slider 10050 advances distally through the firing member 10052, the slider 10050 may come into contact with the most proximal staple pusher or impellers, 10040 and fire, or eject , the staples 10030 from the cartridge body 10010, as described above. As illustrated in Figure 258, the firing member 10052 may further comprise a cutting edge 10053 that can advance distally through a groove. for knife at the support portion 10010 as the staples 10030 are fired. A corresponding knife slot can extend through the anvil positioned opposite the staple cartridge 10000, such that the cutting edge 10053 can extend between the staple cartridge 10000. anvil and the support portion 10010 and cutting the tissue and the tissue thickness compensator positioned therebetween. In various circumstances, the slider 10050 can advance distally by the firing member 10052 until the slider 10050 reaches the distal end 10002 of the staple cartridge 10000, as illustrated in Figure 260. At that point, the firing member 10052 can retreat proximally. The slider 10050 can be retracted proximally with the firing member 10052 but, with reference now to Figure 261, the slider 10050 can be left behind at the distal end 10002 of the staple cartridge 10000 when the firing member 10052 is retracted. the firing member 10052 has been sufficiently retracted, the anvil can be opened again, the tissue thickness compensator 10020 can be separated from the support portion 10010, and the remaining non-implanted portion of the spent staple cartridge 10000, which includes the portion of 10010 support, can be removed from the 10070 staple cartridge channel.
After the spent staple cartridge 10000 has been removed from the staple cartridge channel, in addition to the above, a new staple cartridge 10000, or any other suitable staple cartridge, can be inserted into the staple cartridge channel 10070. In addition to the above, the staple cartridge channel 10070, the firing member 10052, and / or the staple cartridge 10000 may comprise auxiliary elements that can prevent the firing member 10052 from being advanced distally a second time, or a subsequent time, without a new, or untriggered, staple cartridge 10000 positioned in the staple cartridge channel 10070 More particularly, with reference again to Figure 258, as the firing member 10052 advances in contact with the slider 10050 and, when the slider 10050 is in its non-fired proximal position, a support tip 10055 of the limb member 10050 shot 10052 may be positioned on and / or on a support flange 10056 on the slider 10050, such that the firing member 10052 is kept in a sufficient upward position to prevent a blockade, or a bar, 10054 extending from the firing member 10052 falls into a defined blocking recess within the staple cartridge channel. Because the lock 10054 will not fall into the locking recess, under such circumstances, the lock 10054 may not abut a distal side wall 10057 of the locking recess as the firing member 10052 advances. As the firing member 10052 pushes the slider 10050 distally, the firing member 10052 can be supported in its upward firing position due to the support tip 10055 resting on the support flange 10056. When the firing member 10052 retracts relative to the glider 10050 , as described above and illustrated in Figure 261, the firing member 10052 can be pulled down from its upward position because the support tip 10055 no longer rests on the support shoulder 10056 of the glider 10050. For example , the surgical staple may comprise a spring 10058, and / or any other suitable pressure element, which may be configured to press the firing member 10052 to its downward position. Once the firing member 10052 has completely retracted, as illustrated in Figure 262, the firing member 10052 can not advance distally through the spent staple cartridge 10000 once again. More particularly, the firing member 10052 can not be maintained in its upper position by the glider 10050 because the glider 10050, at this point in the sequence of operation, has been left behind at the distal end 10002 of the staple cartridge 10000. Thus, as mentioned above, in the event that the firing member 10052 advances again without replacing the staple cartridge , the locking bar 10054 will come into contact with the side wall 10057 of the locking recess, which will prevent the firing member 10052 from advancing distally within the staple cartridge 10000 once again. Stated another way, once the spent staple cartridge 10000 has been replaced with a new staple cartridge, the new staple cartridge will have a proximally positioned slider 10050 which can keep the firing member 10052 in its upper position and allow the firing member 10052 advances distally once again.
As described above, the slider 10050 can be configured to move the staple drivers 10040 between a first, non-fired position and a second position, fired for the purpose of ejecting the staples 10030 from the support portion 10010. staples 10040 may be contained within the staple pockets 10012 after the staples 10030 have been ejected from the support portion 10010. The support portion 10010 may comprise one or more retention features that can be configured to block the staple drivers 10040 are ejected, or peeled, from the staple pockets 10012. Alternatively, the slider 10050 may be configured to eject the staple drivers 10040 from the support portion 10010 with the staples 10030. For example, the staple drivers 10040 may comprise a bioabsorbable and / or biocompatible material, such as Ultem, for example. The staple drivers may be attached to the staples 10030. For example, a staple driver may be molded on and / or around the base of each staple 10030, such that the driver integrally forms with the staple. U.S. patent application no. of series 11 / 541,123, entitled SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE T, HEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME, filed on September 29, 2006, is incorporated herein by reference in its entirety.
In various circumstances, in addition to the foregoing, a compressible tissue thickness compensator may move, twist, and / or deviate relative to the underlying rigid support portion of a staple cartridge. The support portion, and / or any other suitable portion of the staple cartridge, may comprise one or more elements configured to limit the relative movement between the tissue thickness compensator and the support portion. As described above, at least a portion of the staples 10030 may extend above the surface of the cover 10011 of the support portion 10010 where, under certain circumstances, with reference now to Figures 263 and 264, the lateral forces applied to a tissue thickness compensator 10120, for example, can be counteracted by the staples 10030 and / or the crosspieces 10013 extending from the support portion 10010, for example. In various circumstances, staples 10030 may be inclined and / or bent within staple pockets 10012 while counteracting lateral movement of fabric thickness compensator 10120 where the staple cavities 10012 and the staples 10030 can be sized and configured to maintain the relative alignment between the legs 10032 of the staples 10030 and the forming cavities 10062 on the opposite anvil 10060, such that the staples 10000 are correctly formed during the forming process of the staples 10030. the Staples. The staples 10030 and / or the cross members 10013 can be configured to prevent or at least limit the lateral distortion within the tissue thickness compensator 10020, as illustrated in Figure 264. For example, the staples 10030 and / or the crosspieces 10013, for example, they can be configured to tension, or limit the lateral and / or longitudinal movement of a surface, first, or in contact with tissue 10021 of the tissue thickness compensator relative to a second, or lower, surface 10029. A cartridge of staples, and / or a channel of staple cartridges in which positioning the staple cartridge, may comprise at least one member to minimize distortion, which may extend upward to limit lateral and / or longitudinal movement, or distortion, of a tissue thickness compensator. A wrap that at least partially surrounds a fabric thickness compensator, as discussed above, can also prevent, or at least limit, the lateral and / or longitudinal movement, or distortion, of the fabric thickness compensator.
Referring again to Figures 263 and 264, a fabric thickness compensator, such as the fabric thickness compensator 10120, for example, may comprise a core 10128 and a liner 10122. The liner 10122 and the compressible core 10128 may comprise different materials or, alternatively, the same material. In any case, the liner 10122 may have a greater density than the core 10128. In circumstances where the liner 10122 comprises the upper part of the fabric thickness compensator 10120, the tips of the lug legs 10032 may be incorporated into the liner 10122. Where a liner comprises the lower portion of the fabric thickness compensator 10120, the lug legs 10032 may extend through the liner and into the core. In any case, the lining of the fabric thickness compensator may help to maintain the staple legs 10032 in alignment with the forming cavities 10062 of the anvil 10060. The liner 10122 may comprise a density that is approximately 10% greater than the density of core 10128, approximately 20% greater than the density of the core 10128, approximately 30% greater than core density 10128, approximately 40% greater than core density 10128, approximately 50% greater than core density 10128, approximately 60% greater than core density 10128 , approximately 70% greater than the core density 10128, approximately 80% greater than the core density 10128, approximately 90% greater than the core density 10128, and / or approximately 100% greater than the core density 10128, for example. The liner 10122 may comprise a density that is greater than the density of the core 10128 and less than two times the density of the core 10128, for example. The liner 10122 may comprise a density that is more than twice the density of the core 10128, for example. In addition to the above, the liner 10122 and the core 10128 can be formed, or manufactured, simultaneously. For example, a fluid comprising any suitable material described in the present description can be poured into a plate or a mold and, while the fluid is solidified, the fluid can form a coating, or layer, having a greater density than the rest of the body. material. Multiple layers within a material can be formed by using a process in which one or more subsequent layers of material are poured onto a previously cured layer. Two or more layers can be glued together with an adhesive, for example. Two or more layers may be joined together by one or more fasteners and / or one or more mechanical interlacing elements, for example. For example, adjacent layers can be connected to each other by one or more dovetail joints, for example. The coating may comprise a sealed surface that can prevent, or at least limit, the flow of fluid therethrough. Alternatively, the coating may comprise a porous open cell structure, for example.
In addition to the above, the liner can be cut from the fabric thickness compensator. The fabric thickness compensator can be cut from a larger block of material such that the fabric thickness compensator does not comprise a coating. For example, the fabric thickness compensator may be comprised of a homogeneous, or at least substantially homogeneous, material comprising large pores, for example.
A staple cartridge may comprise a plurality of staple cavities each containing a staple positioned therein, wherein the staple pockets may be arranged in a plurality of rows, and, wherein an anvil positioned opposite the staple cartridge may comprise a plurality of forming cavities corresponding to the staple cavities in the staple cartridge. In other words, the anvil may comprise a plurality of rows of forming cavities wherein each forming cavity may be positioned opposite a staple pocket in the staple cartridge. Each forming cavity may comprise two forming trays which are configured to receive the staple legs 10032 of a staple 10030, wherein each forming trough is configured to receive a staple leg 10032 and form or bend the staple leg 10032 in the direction of the other staple leg 10032, for example. In various circumstances, the legs 10032 may fail to enter or enter incorrectly into the forming trays and, as a result, the staple legs 10032 may be poorly formed during the firing sequence. An anvil may comprise a set, or grid, of shaping cavities which are each configured to receive and form a staple leg. For example, the set of forming cavities may comprise a number of forming cavities that exceed the number of staples contained in the staple cartridge. A staple cartridge may comprise six longitudinal rows of staple cavities, for example, wherein the anvil may comprise six rows of forming cavities aligned with the six rows of staple cavities and, in addition, the forming cavities positioned between the rows of conformation cavities. For example, on one side of the anvil, the anvil may comprise a first row of forming cavities that can be positioned on a first row of staple cavities, a second row of forming cavities that can be positioned on a second row of staple cavities. which is adjacent to the first row of staple cavities and, in addition, a row of shaping cavities that is positioned between the first row of shaping cavities and the second row of shaping cavities. Referring now to Figures 276 to 279, an anvil 10260 can comprise six rows of shaping cavities 10261 that can be configured to be placed on six corresponding rows of staple cavities in the staple cartridge 10200. For example, the rows of cavities of intermediate shaping 10262 may be positioned between and / or adjacent to the rows of shaping cavities 10261. Referring now to Figures 277, 278, and 280, each forming cavity 10261 and 10262 may comprise two forming buckets, wherein each bucket The formation can comprise a distal portion 10263 that can be configured to shape or bend a staple leg 10032 proximally and a proximal portion 10264 that can be configured to shape or bend a staple leg 10032 distally. In other various circumstances, staples 10030 can be formed in a variety of other ways. For example, a staple 10030 may be formed such that one leg 10032 is formed outwardly and the other leg 10032 is formed inwardly (Figure 281), or in such a manner that both legs 10032 are formed outwardly (Figure 282). ) depending on, one, in which forming pans staple legs 10032 enter and / or, two, if legs 10032 enter proximal portion 10263 or distal portion 10064 of each forming pail, for example.
In addition to the above, each forming cavity 10261 and / or forming cavity 10262 may comprise a triangular or diamond-like shape, for example. Each distal portion 10263 and / or each proximal portion 10264 of the shaping cavities may comprise a triangular shape, wherein, for example, the triangular shapes of the distal portions 10263 and the proximal portions 10264 may be arranged such that they have vertices. that point in opposite directions. The anvil may comprise a set of forming cavities substantially square, for example. For example, the shaping surface of each square-shaped cavity may comprise an arcuate surface extending between the sides of the square. The anvil may comprise a set of circular or spherical holes, for example. In addition to the above, the forming cavities 10261 can be positioned along one or more lines and, similarly, the forming cavities 10262 can be further positioned along one or more lines. Alternatively, the shaping cavities 10261 and / or the shaping cavities 10262 can be arranged in one or more circular rows. For example, the shaping cavities 10261 may be arranged along a primary circumference and the shaping cavities 10262 may be arranged along a different circumference. The primary circumference and the different circumference may be concentric, or at least substantially concentric. The shaping cavities 10262 may be arranged along an inner circumference positioned radially inward with respect to the primary circumference and / or an outer circumference positioned radially outward with respect to the primary circumference, for example. The primary circumference can be defined by a primary diameter, the inner circumference can be defined by an inner diameter, and the outer circumference can be defined by an outer diameter. For example, the inner diameter may be shorter than the primary diameter and the outer diameter may be longer than the primary diameter.
As described above, an anvil can move from an open position to a closed position for the purpose of compressing the tissue against the tissue thickness compensator of a staple cartridge, such as the tissue thickness compensator 10020, for example. In various circumstances, the fabric thickness compensator may be positioned adjacent to the staple cartridge support portion before the tissue thickness compensator is positioned relative to the tissue. The tissue thickness compensator 10020 may be in a position, where it abuts the support portion 10018 before the anvil moves to its closed position. Alternatively, the fabric thickness compensator 10020 may be in a position where there is a gap between the fabric thickness compensator 10020 and the support portion 10018. For example, the anvil may displace the fabric and the tissue thickness compensator 10020 down until the tissue thickness compensator 10020 abuts the support portion 10018 where, at such a point, the anvil can move to its closed position and generate compression within the tissue. In the event that a surgeon is not satisfied with the placement of the tissue between the anvil and the staple cartridge, the surgeon can open the anvil, adjust the position of the anvil and the staple cartridge, and close the anvil once more. Due to such positioning and repositioning of the staple cartridge relative to the tissue, under various circumstances, the distal end of the tissue thickness compensator 10020 can be dislodged from the support portion 10010, for example. In some such circumstances, the distal end of the tissue thickness compensator 10020 may come into contact with the fabric and peel off, or roll relative to the support portion 10010. As described in greater detail below, a staple cartridge may comprise one or more elements configured to removably retain a thickness compensator of tissue to an underlying support portion of the staple cartridge.
Referring now to Figure 265, a staple cartridge 10300 may comprise a support portion 10310, a fabric thickness compensator 10320 supported by the support portion 10310, and a distal end 10302 including a tip 10303 configured to hold removably a distal end 10325 of the fabric thickness compensator 10320 in its position. The tip 10303 may comprise a groove 10305 configured to receive the distal end 10325 of the tissue thickness compensator 10320. The distal end 10325 may be compressed, or fitted, within the groove 10305, such that the distal end 10325 may be held in place. its place while the staple cartridge 10300 is positioned relative to the tissue. For example, the slot 10305 can be oriented in a direction that is parallel, or at least substantially parallel, to the surface of the cover 10311 of the support portion 10310. The slot 10305 can be horizontal with respect to the surface of the cover 10311 Alternatively, with reference now to Figure 266, a staple cartridge 10400 may comprise a support portion, a tissue thickness compensator 10420 supported by the support portion, and a distal end 10402 including a tip 10403 configured to hold removably the distal end 10425 of the thickness compensator of fabric 10420 in its position. The distal end 10425 may comprise a projection extending therefrom and the tip 10403 may comprise a vertical slot 10405 configured to receive the projection of the distal end 10425. The distal end 10425, and / or the projection extending therefrom, may compressing, or engaging, within the slot 10405, such that the distal end 10425 can be held in place while the staple cartridge 10400 is positioned relative to the tissue. The fabric thickness compensator 10420 may comprise a groove, such as slot 10429, for example, which can be configured to receive at least a portion of the tip 10403 therein. The slot 10405 can be oriented in a direction that is perpendicular, or at least substantially perpendicular, to the surface of the cover 10411 of the support portion. Referring now to Figure 267, a staple cartridge 10500 may comprise a support portion, a tissue thickness compensator 10520 supported by the support portion, and a distal end 10502 including a tip configured to removably contain the Distal end 10525 of tissue thickness compensator 10520 in position. The tip may comprise a vertical groove 10505 configured to receive the distal end 10525 of the tissue thickness compensator 10520. The distal end 10525 may be compressed, or be fitted into the groove 10505, such that the distal end 10525 may be held in place. place while the staple cartridge 10500 is positioned relative to the tissue.
Referring again to Figure 265, the fabric thickness compensator 10320 may comprise an upper surface 10324 which it can be positioned above the top surface 10304 of the tip 10303. Another illustrative embodiment in which the top surface of a tissue thickness compensator is positioned above the tip of the staple cartridge is illustrated in Figure 238, wherein the surface upper 10721 of fabric thickness compensator 10720 is positioned above top surface 10004 of tip 10003, for example. In use, with reference once more to Figure 265, the fabric may slide over the top surface 10304 of the tip 10303 and, in some circumstances, the tissue may come into contact with the distal end 10325 of the fabric thickness compensator 10320 and can apply a force to the fabric thickness compensator 10320 which tends to detach the fabric thickness compensator 10320 from the support portion 10310. In the embodiments described in the present disclosure, this release force can be resisted by the end portion. distal 10325 fitted within the tip 10303. In any case, once the tissue is properly positioned relative to the staple cartridge 13000, the anvil can be rotated in a closed position to compress the tissue and the tissue thickness compensator 10320 into against the support portion 10310. For example, the anvil can be rotated in a position where the anvil comes into contact with the upper surface. 10304 of tip 10303 and, as a result, prevents the anvil from rotating further. In various circumstances, because the upper surface 10324 of the fabric thickness compensator 10320 is positioned above the upper surface 10304 of the tip 10303, the upper surface 10324 can be pushed downward toward the support portion 10310 while the anvil is closed and, in some circumstances, the upper surface 10324 can be pushed under the upper surface 10304 of the tip 10303, for example. After the staples contained in the staple cartridge 10300 are deployed and the fabric thickness compensator 10320 is cut, as described in the present description, the support portion 10310 and the tip 10303 can move out of the tissue thickness compensator 10320 in such a manner that the distal end 10325 of the fabric thickness compensator 10320 can slide out of the slot 10305.
As described above, an anvil, such as the anvil 10060, for example, can be rotated to a closed position where the anvil 10060 comes into contact with the upper surface of the tip 10004 of a staple cartridge, such as the cartridge Staples 10000, for example. Once the anvil reaches its closed position, the amount by which a tissue thickness compensator, such as the tissue thickness compensator 10020, for example, is compressed, will depend, among other things, on the uncompressed thickness, or height, the fabric thickness compensator and the thickness of the fabric. Referring now to Figures 236 and 237, a fabric thickness compensator 10920 may comprise an upper surface that is level, or at least substantially at the same level, with the upper surface 10004 of the tip 10003. In such cases, the Top surface of the fabric thickness compensator 10920 can be pushed under the upper surface 10004 of the tip 10003. Referring now to Figures 241 and 242, a tissue thickness compensator, such as the fabric thickness compensator 10820, for example, may comprise an upper surface 10821 which is positioned below the upper surface of the tip 10004 before the tissue thickness compensator 10820 is compressed by the tissue T and the anvil 10060. In the circumstances where the T fabric is relatively thin, as illustrated in Figures 239 and 240, the fabric thickness compensator 10920 can be subjected to a relatively small compression. With reference now to Figures 241 and 242, the fabric thickness compensator 10820 can undergo a greater compression when the tissue T is relatively thicker. In the circumstances where the fabric T has both thin sections and thicker sections, as illustrated in Figures 243 and 244, the fabric thickness compensator 10820 can be compressed a larger amount when positioned under the thicker tissue T and a smaller amount when positioned under the thinnest tissue T, for example. In this way, as described above, the fabric thickness compensator can compensate for different tissue thicknesses.
Referring now to Figures 268 to 270, a surgical stapling instrument may comprise, one, a cartridge channel 16670 that is configured to receive a staple cartridge 16600 and, two, an anvil 16660 that is rotatably coupled to the channel. of cartridges 16670. The staple cartridge 16600 may comprise a support portion 16610 and a tissue thickness compensator 16620, wherein a distal end 16625 of the fabric thickness compensator 16620 may be removably attached to the support portion 16610 by a tip 16603 at distal end 16602 of staple cartridge 16600. Tip 16603 may comprise a groove 16605 and may be comprised of a flexible material. In use, with reference primarily to Figure 269, the tip 16603 can flex downward to expand the opening of the slot 16605. The tip 16603 can comprise notches or cutouts 16606 that can be configured to allow the tip 16603 to flex downwardly. In any case, under various circumstances, the expanded opening of the groove 16605 can facilitate insertion of the distal end 16625 of the fabric thickness compensator 16620 into the groove 16605. Once the fabric thickness compensator 16620 is properly positioned, the tip 16603 can be released and, due to the flexibility of the material comprising tip 16603, tip 16603 can return, or at least substantially return, to its non-flexed condition and trap distal end 16625 of tissue thickness compensator 16620 against the surface of cover 16611, as illustrated in Figure 270. In use, similar to the foregoing, distal end 16625 can be removed from slot 16605 when support portion 16610 moves away from the stapled tissue. In various circumstances, the flexible tip 16603 may be configured to deflect as the fabric thickness compensator 16620 is separated from the support portion 16610. Referring again to Figure 270, the fabric thickness compensator 16620 may comprise a surface upper 16621 which aligns, or at least substantially aligns, with an upper surface 16604 of the tip 16603.
With reference to Figure 271, a surgical stapling instrument may comprise, one, a channel 10770 configured to receive a staple cartridge 10700 and, two, an anvil 10760 rotatably coupled to the channel 10770. The staple cartridge 10700 may comprise a support portion 10710 and a fabric thickness compensator 10720. The fabric thickness compensator 10720 can be held in position by a tip sheath 10703 that can be slid over the support portion 10710. With reference primarily to Figure 272, the tip case 10703 may comprise one or more side slots 10707 that can be configured to removably receive one or more tie rails extending along the support portion 10710, for example. The fabric thickness compensator 10720 can be positioned between the side slots 10707. The tip sleeve 10703 can further comprise a distal end 10702 and a cavity 10706 defined at the distal end 10702, wherein the cavity 10706 can also be configured to receive at least a portion of the support portion 10710, for example, in this. In use, the tip sheath 10703 can slide over the support portion 10710 in a distal to proximal direction. The fabric thickness compensator 10720 can be removably mounted to the tip sleeve 10703 such that, after the staples are fired through the fabric thickness compensator 10720, the fabric thickness compensator 10720 can be separated from the sleeve 10703 while the support portion 10710 and the tip sleeve 10703 move away from the fabric thickness compensator 10720.
The upper surface 10721 of the fabric thickness compensator 10720 can be positioned below the upper surface 10704 of the tip 10703.
Referring now to Figures 273 and 274, a surgical stapling instrument may comprise, one, a staple cartridge channel 11070 configured to receive a 11000 staple cartridge and, two, an anvil 11060 rotatably coupled to the channel 11070. The staple cartridge 11000 may comprise a support portion 11010 and a fabric thickness compensator 11020. The fabric thickness compensator 11020 may be maintained in the correct position by one or more longitudinal rails 11019 which extend from the cover 11011 of the support portion 11010. The longitudinal rails 11019 can be embedded within the fabric thickness compensator 11020. With reference mainly to Figure 274, the fabric thickness compensator 11020 can comprise a longitudinal recess 11029. which can be configured to receive the longitudinal rails 11019. For example, the recess 11029 can be sized and configured to receive the rails 11019 in a press fit arrangement, for example. Such elements, in addition to the above, can be configured to avoid, or at least limit, the relative lateral movement between the fabric thickness compensator 11020 and the support portion 11010 and, in addition, limit the premature release of the tissue thickness compensator. 11020 of the support portion 11010, for example. Referring now to Figure 275, a surgical stapling instrument may comprise, one, a staple cartridge channel 11170 configured to receive a staple cartridge 11100 and, two, an anvil 11160 rotatably coupled to the channel. 11170. The staple cartridge 11100 may comprise a support portion 11110 and a fabric thickness compensator 11120. The fabric thickness compensator 11120 may be held in place by one or more longitudinal rows of peaks, or teeth, 11119 extending from the cover 11111 of the support portion 11110. The longitudinal rows of peaks 11119 may be incorporated within the fabric thickness compensator 11120.
With respect to Figure 273, in addition to the above, the fabric thickness compensator 11020 of the staple cartridge 11000 can be progressively released from the support portion 11010 while the staples are ejected from the staple pockets 10012 defined therein. More particularly, in addition to the above, the staples positioned in the staple pockets 10012 can be sequentially ejected between the proximal end 11001 of the staple cartridge 11000 and the distal end 11002 of the staple cartridge 11000 such that, while the staples are being ejected, the staples staples can apply an upward pressing force to the fabric thickness compensator 11020 which acts to push the fabric thickness compensator 11020 out of the rails 11019. In such circumstances, the proximal end 11006 of the fabric thickness compensator 11020 can be released. of the support portion 11010 while the staples are ejected from the most proximal staple cavities 10012. The tissue thickness compensator 11020 can then be progressively released from the support portion 11010 while the staples are progressively expelled from the support portion 11010 between the proximal end 11001 and the distal end 11002 of the staple cartridge 11000. When the staples positioned within the most distal staple pockets 10012 are expelled from the support portion 11010, the distal end 11007 of the fabric thickness compensator 11020 can be released from the support portion 11010. With respect to to Figure 275, the fabric thickness compensator 11120 can be progressively released from the peaks 11119 extending from the support portion 11110 while the staples are progressively ejected from the staple cartridge between the proximal end 11101 and the distal end 11102.
As described above, a fabric thickness compensator can be progressively released from the support portion of a staple cartridge while the staples are progressively expelled from the support portion and come into contact with the tissue thickness compensator. Staple legs, such as staple legs 10032, for example, may be able to pass through the tissue thickness compensator without releasing the tissue thickness compensator from the support portion. In such cases, the fabric thickness compensator can be kept engaged with the support portion until the bases of the staples, such as the bases 10031, come into contact with the tissue thickness compensator and push it upward. However, the cross members and / or other retaining features that extend from the support portion, for example, may oppose the release of the tissue thickness compensator from the support portion. As described in greater detail below, a support portion may comprise retention features that can be configured to progressively release a tissue thickness compensator from the support portion while the staples are progressively fired from the staple cartridge. Referring now to Figure 283, a staple cartridge, such as staple cartridge 11200, may comprise, for example, a support portion 11210 including retainer features 11213 that can be configured to removably maintain a thickness compensator. fabric 11220 (Figure 284) to support portion 11210. Retaining features 11213 may be positioned at the ends of each staple pocket 11212, for example, wherein each retainer feature 11213 may comprise a guide groove 11216 defined therein, which is configured to slidably receive a staple leg 10032 of a staple 10030. In such cases, both the staple legs 10032 and the retaining features 11213 can be configured to removably retain the fabric thickness compensator 11220 at the support portion 11210. In use, with reference now to Figure 284, the staple drivers 10040 contained within the p Support portion 11210 can be urged upward by a slider 10050, as described above, wherein the staple drivers 10040 can be configured to come into contact with the retainer features 11213, at least partially separating the retention features 11213 from the portion of support 11210, and to move retaining features 11213 outward and away from staples 10030 and staple pockets 11212. When retention features 11213 are separated from support portion 11210 and / or move outwardly, as illustrated in Figure 284, the retainer features 11213 may no longer be able to retain the fabric thickness compensator 11220 to the support portion 11210 and, as a result, the compensator fabric thickness 11220 can be released from the support portion 11210. Similar to the above, the fabric thickness compensator 11220 can be progressively released from the support portion 11210 while the staples 10030 are progressively ejected from the staple cartridge in the direction to an anvil, such as anvil 11260, for example. The staple drivers 10040 may come into contact with the retaining features 11213 when the upper surfaces of the staple drivers 10040 are coplanar, or at least substantially coplanar, with the surface of the cover 11211 of the support portion 11210, for example . In such cases, the fabric thickness compensator 11220 can be released from the support portion 11210 at the same time and / or just before the staples 10030 are formed to their fully formed, or fully fired configuration. For example, with reference primarily to Figure 285, the impellers 10040 may be overdriven, such that they are pushed over the surface of the cover 11211 to completely form the staples 10030 and, during the overdrive process, break the characteristics of retainer 11213 away from support portion 11210. Referring again to Figure 284, retainer features 11213 may extend above or protrude into staple pockets 11212 before separating or moving toward outside so that the impellers 10040 can come into contact with the holding features 11213 just as the impellers 10040 reach the cover surface 11211. In any case, once the fabric thickness compensator 11220 is released from the portion of Support 11210, now with reference to Figure 285, the support portion 11210 can move away from the implant thickness compensator 11220 implanted.
As described above, a compressible tissue thickness compensator of a staple cartridge can be progressively released from a support portion, or body of the cartridge, of the staple cartridge while the staples are being fired, or deployed, from the staple cartridge. In various circumstances, such release may comprise a progressive distension of the tissue thickness compensator from the support portion where, in some circumstances, a complete separation of the tissue thickness compensator from the support portion can not occur until it is opened the anvil and the support portion move away from the implanted tissue thickness compensator. Referring now to Figure 289, a staple cartridge, such as staple cartridge 11300, for example, may comprise a fabric thickness compensator 11320 that is removably retained to a support portion 11310. The support portion 11310 may comprise a plurality of retention members 11313 extending therefrom which are configured to removably compress and hold the longitudinal sides of the fabric thickness compensator 11320 to the support portion 11310. For example, each member retention 11313 may comprise an inwardly oriented channel or a slot 11316 that can be configured to receive the longitudinal sides of the fabric thickness compensator 11320 therein. In various circumstances, a plurality of retention members 11313 may extend along a first longitudinal side of the support portion 11310 and a plurality of retention members 11313 may extend along a second longitudinal side of the support portion. 11310 wherein, in certain circumstances, retention members 11313 can be configured to prevent, or at least limit, the relative lateral movement between the fabric thickness compensator 11320 and the support portion 11310 and, moreover, to avoid, or at least limiting, the premature release of the fabric thickness compensator 11320 from the support portion 11310. The retention members 11313 can be formed integrally with the support portion 11310 and, with reference to Figure 290, the retention members 11313 can be configured to separate, or at least partially separate, from the support portion 11310 in order to allow the compensator of fabric thread 11320 is separated from support portion 11310, as illustrated in Figure 291, for example. The anvil, such as the anvil 11360, for example, can be configured to compress the fabric thickness compensator 11320 and, in response to the pressure generated within the fabric thickness compensator 11320, the fabric thickness compensator 11320 can be laterally expanded. to at least partially detach, or disengage, the retention members 11313 from the fabric thickness compensator 11320.
The advance of a cutting member, which was described above, through the anvil 11360 and the staple cartridge 11300 can deploy the staples contained therein and, simultaneously, compress the anvil 11360 and the staple cartridge 11300 closer together. that it can apply an added compression pressure to the fabric thickness compensator 11320 and thus cause the retention members 11313 to separate sequentially while the cutting member passes through the staple cartridge 11300.
Referring now to Figures 292 to 294, a staple cartridge, such as staple cartridge 11400, for example, may comprise a fabric thickness compensator 11420 removably attached to a support portion 11410. The staple cartridge 11400 may comprise one or more retainer bars 11413 that can be configured to hold the longitudinal sides of the fabric thickness compensator 11420 to the surface of the cover 11411. For example, each retainer bar 11413 may comprise opposing arms 11418 that can define a channel 11416 between these. In such cases, one of the arms 11418 can be configured to extend above the fabric thickness compensator 11420 and the other arm 11418 can be configured to extend below a rim 11419 extending from the support portion 11410. With reference primarily to the Figure 292, channel 11416 of each retaining bar 11413 can be sized and configured to apply a compressive force to the longitudinal sides of the fabric thickness compensator 11420 before the staple cartridge 11400 is used. During use, with reference mainly to Figure 293, the cartridge of Staples 11400 can be positioned within a channel of staple cartridges and, once staple cartridge 11400 is properly positioned, an anvil, such as anvil 11460, for example, can move in a position where it can compress the compensator fabric thickness 11420. Similar to the above, the fabric thickness compensator 11420, when compressed, may expand laterally, or outwardly, and, as a result, separate the retainer bars 11413 from the staple cartridge 11400. Alternatively, the closure of the anvil 11460 may not separate, or may not completely separate, the retainer bars 11413 from the staple cartridge. For example, the advancement of a firing bar, as described above, through staple cartridge 11400 can deploy staples 10030 from support portion 11410 and, simultaneously, compress anvil 11460 and staple cartridge 11400 closer one of the other to apply a compression force to the fabric thickness compensator 11420 which is sufficient to cause the fabric thickness compensator 11420 to laterally expand and separate the detents 11413 from the staple cartridge 11400. Once the retention bars 11413 are separated from the staple cartridge 11400, with reference to Figure 294, the support portion 11410 can move away from the implanted tissue thickness compensator 11420 and be removed from the surgical site. In certain alternative embodiments, with reference now to Figure 295, a staple cartridge 11400 'may comprise detents 11413' which, similar to the foregoing, may comprise arms 11418 'extending therefrom. For example, each of arms 11418 'may comprise a bevel of locking wedge 11417 'which can be configured to removably engage retaining bars 11413' to staple cartridge 11400 '. More particularly, the support portion 11410 'of the staple cartridge 11400' may comprise recesses 11419 'which, in cooperation with the locking wedge bevels 11417', may be configured to removably retain the retainer bars 11413 'to the cartridge staples 11400 and inhibiting tissue thickness compensator 11420 from prematurely separating from support portion 11410 '. During use, similar to the above, the holding bars 11413 'can be separated from the staple cartridge 11400' when a sufficient compression force is applied to the fabric thickness compensator 11420, for example.
In various circumstances, as described above and with reference again to Figures 259 and 260, the slider 10050 of the staple cartridge 10000 and the trigger member 10052 of a surgical stapling instrument can be moved from the proximal end 10001 of the staple cartridge. staples 10000 to the distal end 10002 (FIG. 219) of the staple cartridge 10000 to deploy the staples 10030 from the support portion 10010. In at least one such circumstance, each staple 10030 can move from a non-tripped position to a tripped position. and ejecting from the support portion 10010 to capture the entire tissue thickness compensator 10020 against the tissue positioned between the anvil 10060 and the staple cartridge 10000. In certain circumstances, a surgeon may not need to shoot all the staples 10030 from the staple cartridge 10000 and the surgeon can stop the progression of the slider 10050 and the firing rod 10052 at a point positioned between the proximal end 10001 and the distal end 10002 of the staple cartridge 10000. In such circumstances, the tissue thickness compensator 10020 may only be partially implanted in the tissue T and, to separate the non-implanted portion of the tissue thickness compensator 10020 from the support portion 10010, the surgeon may pull the support portion 10010 away from the tissue thickness compensator 10020 partially implanted such that the non-implanted portion detaches or detaches from the support portion 10010. While such embodiments are suitable under various circumstances, an improvement is illustrated in Figures 300 to 302, wherein a tissue thickness compensator , such as the fabric thickness compensator 11520 of the staple cartridge 11500, for example, may comprise a plurality of segments with ectates that can be configured to separate from each other. For example, the fabric thickness compensator 11520 may comprise a first segment 11520a, or more proximally, a second segment 11520b removably connected to the first segment 11520a, a third segment 11520c removably connected to the second segment 11520b, a fourth segment 11520d removably connected to the third segment 11520c, and a fifth segment 11520e removably connected to the fourth segment 11520d, for example. The fabric thickness compensator 11520 may comprise at least one thin section 11529 positioned between any of the two adjacent segments 11520a-11520e that can be configured to define a predetermined break or point of separation in which the segments of the fabric thickness compensator can be separated from each other. The fabric thickness compensator may include any suitable arrangement of perforations, thin sections, and / or any other means for creating a separation point within the tissue thickness compensator. With reference principally to Figure 301, an anvil 11560 is illustrated in a closed position and the firing member 10052 is illustrated as advancing partially through the staple cartridge 11500, such that the staples 10030 underlying the first segment 11520a, the second segment 11520b, and the third segment 11520c are triggered to capture the fabric thickness compensator 11520 against the tissue T. In such a position, the firing member 10052 still does not advance to deploy the staples 10030 underlying the fourth segment 11520d and the fifth segment 11520e, for example. Referring now to Figure 302, the anvil 11560 moves to an open position and the support portion 11510 of the staple cartridge 11500 moves away from the portion of the fabric thickness compensator 11520 that is implanted. As illustrated in Figure 302, the thin section 11529 (Figure 300) positioned between the third segment 11520c and the fourth segment 11520d allows the non-implanted portion of the fabric thickness compensator 11520 to be separated from the implanted portion.
In addition to the above, a staple cartridge may comprise a plurality of fasteners configured to removably hold a tissue thickness compensator to a supporting portion of the staple cartridge. The support portion may comprise a plurality of openings defined in the surface of the cover, for example, wherein the fasteners may extend through the tissue thickness compensator and may be detachably retained in the openings of the support portion. In use, the fasteners can be progressively released from the support portion while the staples are progressively expelled from the support portion. For example, the fasteners can be implanted with the tissue thickness compensator and the fasteners can be composed of at least one bioabsorbable material, for example. The fasteners can be separated from the support portion after the tissue thickness compensator is at least partially implanted and while the support portion moves away from the implanted tissue thickness compensator. Referring now to Figures 323 to 325, a staple cartridge, such as staple cartridge 11600, for example, may comprise a fabric thickness compensator 11620 removably mounted to a support portion 11610 by a plurality of fasteners. 11613. Each fastener 11613 may comprise a first end 11618 embedded within and / or coupled with the fabric thickness compensator 11620, a second end 11618 coupled with the support portion 11610, and a connect 11616 connecting the first end 11618 to the second end 11618. end 11618. The fasteners 11613 may extend through a blade slot 11615 defined in the support portion 11610. In use, the firing member 10052, which was described above, may move a knife edge to through the knife groove 11615 in the support portion 11610 and cutting the fasteners 11613 to release the fabric thickness compensator 11620 from the support portion 11610. For example, the firearm 10052 can be advanced from a proximal end 11601 of the staple cartridge 11600 to a distal end 11602 of the staple cartridge 11600 in order to, one, advance the slider 10050 distally and progressively shoot the staples 10030, as described above and, two, progressively cut and / or break the fasteners 11613 to progressively release the fabric thickness compensator 11620 from the support portion 11610. Similar to the foregoing, the fabric thickness compensator 11620 may comprise a plurality of removable segments 11620a-11620e which may each be attached to the portion of support 11610 by one or more fasteners 11613, for example. In the event that the firing member 10052 is stopped between the proximal end 11601 and the distal end 11602 of the staple cartridge 11600, as illustrated in Figure 324, the fasteners 11613 can assist in holding the non-implanted portion of the compensator of fabric thickness 11620 to the support portion 11610 after the anvil 11660 is opened and the support portion 11610 moves away from the tissue T, as illustrated in Figure 325. In addition to the foregoing, the cutting edge 10053 of the member 10052 can be configured to cut and / or break fasteners 11613. In certain alternative embodiments, with reference now to Figures 327 and 328, a staple deployment slider, such as slider 11650, for example, may comprise an edge 11653 blade that can be configured for cutting the connectors 11616 of the fasteners 11613 while the slider 11650 traverses the staple cartridge 11600. For example, each connector 11616 may comprise a cylindrical member extending between the T-shaped ends 11618 of the fasteners 11613, wherein the blade edge 11653 may comprise a concave profile 11653 that can be configured to receive cylindrical connector 11616, for example.
As described above, a staple cartridge can be loaded into a staple cartridge channel of a surgical stapling instrument. In various circumstances, a surgeon, or other clinician, may insert the staple cartridge into the staple cartridge channel by placing a force down on the staple cartridge to lock the staple cartridge in place. In some such circumstances, the physician may place his thumb, for example, on the upper surface of the staple cartridge to apply such force downwardly. The upper surface of the staple cartridge may comprise the upper surface of a tissue thickness compensator wherein, as described above, the tissue thickness compensator may be compressible and the downward force applied to the tissue thickness compensator may cause that the tissue thickness compensator is compressed to the point where the clinician's thumb comes into contact with the tips of the staples stored within the support portion. A staple cartridge applicator can be used to insert a staple cartridge into a staple cartridge channel that can be configured to prevent, or at least limit, the ability for the clinician to touch the staples in the cartridge of staples. After the staple cartridge is properly positioned within the staple cartridge channel, as described in more detail below, the applicator can be separated from the staple cartridge.
Referring now to Figures 305 and 306, a staple cartridge applicator may comprise a rigid cover, such as the cover 10080, for example, which may be connected to a staple cartridge 10000. In addition to the foregoing, the cover 10080 may configured to prevent, or at least inhibit, the clinician's thumb, for example, from coming in contact with the tips of the staples 10030 positioned within the staple cartridge 10000 when the staple cartridge 10000 is inserted into a channel of the staple cartridge. Staples Referring now to Figures 307 and 308, the cover 10080 may extend over the top surface 10021, or at least a portion of the top surface 10021, of the fabric thickness compensator 10020 and may include, one, a bottom surface 10081 that it may extend over and / or abut the fabric thickness compensator 10020 and, two, an upper surface 10082 which may provide a pushing surface for the clinician to apply a downward force to it, for example. In use, the clinician can take a handle portion 10084 from the cover 10080, align the support portion 10010 of the staple cartridge 10000 with the staple cartridge channel, and at least partially insert the staple cartridge 10000 into the staple cartridge. staple cartridge. Thereafter, the clinician can completely seat the staple cartridge 10000 in the staple cartridge channel by applying force down to the upper surface 10082 of the cover 10880 which can transmit the downward force directly to the support portion 10010. For example, the cover 10080 may comprise the proximal supports 10087 which may extend downward and come into contact with the surface of cover 10011 of the support portion. The cover 10080 may further comprise a distal support portion 10083 which may be configured to abut the tip 10003. When a downward force is applied to the cover 10080, the downward force may be transmitted through the proximal support 10087 and / or the distal support portion 10083 without transmitting, or at least substantially not transmitting, the downward force to the support portion 10010 through the tissue thickness compensator 10020. In various circumstances, as a result of the foregoing, the physician may Do not come into direct contact with the tissue thickness compensator 10020. In addition, as a result of the foregoing, the cover 10080 may not compress, or at least substantially compress, the fabric thickness compensator 10020 as the staple cartridge is inserted into the staple cartridge channel 10000. A cover may comprise any suitable number of supports that are configured to transmit a downward force to the support portion without transmitting, or at least transmitting substantially, the downward force through the tissue thickness compensator. The supports may extend around the distal end, the proximal end, and / or the longitudinal sides of the tissue thickness compensator. The supports can be extended through the thickness compensator of tissue. For example, the supports may extend through openings in the tissue thickness compensator and abut the cover of the support portion. At least some of the supports may not contact the cover before the downward force is applied to the cover; however, the cover can be configured to flex, or move, downward, until the supports come into contact with the cover of the support portion. At such a point, the downward flexing, or movement, of the cover can be prevented, or at least substantially prevented, from further flexing.
As described above, the cover 10080 can be attached to the staple cartridge 10000 and can be used to manipulate the position of the staple cartridge 10000. The cover 10080 can comprise any suitable number of clamping members that can be configured to removably hold the cover 10080 to the support portion 10010 of the staple cartridge 10000, for example. For example, the cover 10080 may further comprise one or more retention members, such as the latch arms 10088 and / or 10089, for example. The latch arms 10089 can be configured to extend around the sides of the tip 10003 and engage the lower surface 10009 (Fig. 306) of the tip 10003. Similarly, the latch arms 10088 can extend around the sides of the lattice projections. lock 10008 extending from the support portion 10010 and engaging the lower surfaces of the locking projections 10008. These latching arms may be configured to place the cover 10080 over the area or region in which the staples are stored.
In the case of the support portion 10010. In any case, once the staple cartridge 10000 is properly positioned, the cover 10080 can be separated from the staple cartridge 10000. The doctor can apply an upward lifting force on the handle 10084 for separating the distal end of the cover 10080 from the distal end 10002 of the staple cartridge 10000. For example, the latch arms 10088 and 10089 may flex outwardly while the handle 10084 is raised upwardly such that the latch arms 10088 and 10089 may flex around locking projections 10008 and tip 10003, respectively. Thereafter, the proximal end of the cover 10080 may be raised away from the proximal end 10001 of the staple cartridge and the cover 10080 may move away from the staple cartridge 10000.
Referring now to Figures 309 and 310, a staple cartridge applicator, such as the staple cartridge applicator 10680, for example, can be configured to position an upper tissue thickness compensator, such as the tissue thickness compensator. 10690, for example, in relation to an anvil, in addition to positioning a staple cartridge, such as staple cartridge 10600, for example, within a staple cartridge channel. Similar to the foregoing, the applicator 10680 may comprise latching arms 10688 that can be removably coupled with the locking projections 10608 extending from a supporting portion 10610 of the staple cartridge 10600 such that the applicator 10680 can be held in place. position on a fabric thickness compensator 10620 of staple cartridge 10600. Top fabric thickness compensator 10690 can be removably attached to staple cartridge applicator 10680, such that the anvil of a surgical instrument, such as anvil 10060, for example, it can be closed on the applicator 10680, couple the fabric thickness compensator 10690, and separate the tissue thickness compensator 10690 from the applicator 10680. The tissue thickness compensator 10690 and / or the anvil 10060 can comprise one or more retaining features that can be configured to removably attach the fabric thickness compensator 10690 to the anvil 10060. For example, the fabric thickness compensator 10690 may comprise a longitudinal rail 10695, for example, extending from the upper surface 10691 of the fabric thickness compensator 10690 that can be received within a longitudinal knife groove 10065 defined within the anvil 10060. The fabric thickness compensator 10690 and the longitudinal rail 10695 may be comprised of any suitable compressible material, such as those described in the application of this patent, for example, wherein the longitudinal rail 10695 may be compressed and / or fitted into the groove. for blade 10065, for example. Once the anvil 10060 engages with the fabric thickness compensator 10690, the anvil 10060 can return to an open position and, under such circumstances, the fabric thickness compensator 10690 can be separated from the applicator 10680. Thereafter, the applicator 10680 can be separated from the staple cartridge 10600 of such so that the anvil 10060 and the staple cartridge 10600 can be positioned relative to the tissue to be stapled and / or cut. In use, a staple deployment slider, such as slider 10050 (FIG. 236), for ple, may advance distally through the staple cartridge 10600 by a trigger member 10052 (FIG. 236), for ple, to eject the staples. of staple cartridge 10060, as described above. While the staples are deformed, each staple can capture a portion of the fabric thickness compensator 10690 against the upper surface of the fabric and a portion of the fabric thickness compensator 10620 against the lower surface of the fabric. At the same time, the firing member 10052 can advance a knife edge 10053 (FIG. 236) through the fabric thickness compensator 10620 and / or the fabric thickness compensator 10690 wherein, the knife edge 10053 can advance to through the longitudinal rail 10695 to cut the rail 10695 and progressively separate the fabric thickness compensator 10690 from the anvil 10060. After the clips are deployed, the anvil 10060 can be reopened and moved away from the implanted tissue thickness compensator 10690 and, similarly, the support portion 10610 of the staple cartridge 10600 can move away from the implanted tissue thickness compensator 10620. In addition to the above, the fabric thickness compensator 10620 and / or the fabric thickness compensator 10690 may comprise a plurality of demountable segments that can be configured to separating from each other in the event that only portions of the fabric thickness compensators 10620 and 10690 are implanted by the staples.
In addition to the above, the applicator 10680 may comprise one or more retention features that can be configured to removably hold the tissue thickness compensator 10690 to the applicator 10680. For ple, with reference primarily to FIG. 310, the applicator 10680 may comprising a longitudinal retaining rail 10685 which can be configured to be received in a longitudinal retention groove 10694 defined in the bottom surface 10692 of the fabric thickness compensator 10690 in the form of press fit, for ple. In various circumstances, the retaining rail 10685 and the retaining groove 10694 can be configured to retain the fabric thickness compensator 10690 to the applicator 10680 until a sufficient upward lifting force is applied by the anvil 10060 to the tissue thickness compensator. 10690, as described above. For ple, retaining rail 10685 extending from applicator 10680 may further comprise end stops 10686 positioned at the proximal and distal ends of retaining rail 10685 that can be configured to prevent, or at least limit, movement relative longitudinal between the fabric thickness compensator 10690 and the applicator 10680. With reference again to Figure 310, one or more adhesives, such as the longitudinal adhesive strips 10693, for ple, can be positioned on the contact surface 10691 of the compensator of thickness of fabric 10690 such that, when the anvil 10060 comes into contact with the fabric thickness compensator 10690, as described above, the adhesive may removably attach the fabric thickness compensator 10690 to the anvil 10060. One or more adhesives may to be used in addition to or instead of the compressible retention characteristics described above, for ple. One or more adhesives may be used to removably attach a tissue thickness compensator to a staple cartridge applicator. Referring now to Figure 310A, cover 10080, for ple, may include one or more adhesive pads 12185 that can be configured to removably retain a top fabric thickness compensator, such as the fabric thickness compensator 12190, for example, to the top surface 10082 of the cover 10080. For example, similar to the embodiments described above, an anvil may be closed on the fabric thickness compensator 12190 to engage the longitudinal retention rail 12195 of the tissue thickness compensator 12190. A release mechanism can be positioned between the fabric thickness compensator 12190 and the cover 10080 that can be used to break the adhesive bonds that hold the fabric thickness compensator 12190 to the cover 10080 and separate the tissue thickness compensator 12190 of the cover 10080. The release mechanism may comprise a pull tab 12196 and a circular instrument 12197, wherein the circular instrument 12197 may comprise the first and second ends that are attached to the tongue of the device. traction 12196. The circular instrument 12197 may comprise a suture, for example, which may define a perimeter circumscribing the adhesive pads 12185 such that, when the pull tab 12196 is pulled distally, the suture may slide between the tissue thickness compensator 12190 and cover 10080 and contact fabric pads 12185. In such circumstances, the suture can at least one, separate the adhesive pads 12185 from the fabric thickness compensator 12190, separate the adhesive pads 12185 from the cover 10080, and / or cutting the adhesive pads 12185, for example.
Referring now to Figure 311, a staple cartridge may comprise a support portion 10710, for example, which, similar to the foregoing, may comprise a longitudinal blade slot 10715 extending therethrough. For example, a staple cartridge applicator, such as applicator 10780, for example, may comprise a longitudinal retention and alignment member 10786 that may extend in knife slot 10715 in support portion 10710. Retention member 10786 can be configured to be coupled to the side walls of the knife slot 10715 by press fit, for example, such that the applicator 10780 can be detachably retained to the support portion 10710. Although not illustrated, a first portion of a fabric thickness compensator can be positioned on a first side of the retaining member 10786 and a second portion of the tissue thickness compensator can be positioned on a second, or opposite, side of the retaining member 10786. Similar to the above, the first and second portions of the tissue thickness compensator can be mounted on the support portion 10710 of the staple cartridge through the retaining members 10013, for example. In addition, similar to the foregoing, a top fabric thickness compensator 10790 can be removably mounted to the applicator 10780 through a longitudinal retention member 10785 extending from the loading surface 10782 of the applicator 10780, wherein the Retention 10785 can be pressurized in a removable manner in a longitudinal groove 10794 defined in the lower surface 10792 of the fabric thickness compensator 10790, for example. Also similar to the foregoing, the fabric thickness compensator 10790 may further comprise a longitudinal retention member 10795 extending from the upper surface 10791 of the fabric thickness compensator 10790 which can be detachably retained in the groove for longitudinal blade 10065 defined in anvil 10060, for example. For example, the longitudinal retention member 10795 may comprise a wedge-shaped cross section comprising an upper portion that is larger than a lower portion, wherein the lower portion may attach the retention member 10795 to the fabric thickness compensator 10790 , for example.
Referring now to Figures 312 and 313, a staple cartridge 10800 comprising a support portion 10810 and a tissue thickness compensator 10820 can be loaded into a channel of staple cartridges. with a 10880 staple cartridge applicator, for example. Similar to the above, the staple cartridge applicator 10880 can also be configured to place an upper fabric thickness compensator 10890, for example, in relation to an anvil, such as the anvil 10060, for example, such that, when the anvil 10060 is closed, the anvil 10060 can contact and engage the fabric thickness compensator 10890. The fabric thickness compensator 10890 can comprise a plurality of retaining legs 10895 extending from the upper surface 10891 of the thickness compensator of 10890 fabric that can be configured to engage the anvil 10060 and removably retain the fabric thickness compensator 10890 to the anvil 10060. For example, the legs 10895 may be arranged in a longitudinal row, wherein each leg 10895 may comprise at least one foot configured to enter and engage in the knife slot 10065 defined in the anvil 10060. Some of the feet of the legs 10895 may extend in one direction while other feet can extend in another direction. Some of the feet can extend in opposite directions. In any case, once the anvil 10060 engages with the tissue thickness compensator 10890, now referring to FIGS. 313 and 314, the anvil 10060 can be reopened and the physician can move the staple cartridge applicator 10880 away. of the fabric thickness compensators 10820 and 10890. Thereafter, with reference to Figure 314A, the upper fabric thickness compensator 10890 can be positioned on a first side of the target fabric and the fabric thickness compensator 10820, which can comprise a thickness compensator lower fabric, can be positioned on a second side of the fabric. After the fabric thickness compensators 10820 and 10890 are properly positioned, with reference now to Figure 314B, a knife edge of a trigger member, such as the knife edge 10053, for example, can advance through the tissue and the fabric thickness compensators. Referring now to Figure 318, a staple cartridge applicator, such as applicator 12280, for example, may comprise a fabric thickness compensator 12290 detachably mounted thereto which may, similar to the foregoing, be inserted into a staple cartridge channel, as illustrated in FIG. 319, and coupled by the anvil 10060 when the anvil 10060 moves to a closed position. For example, the fabric thickness compensator 12290 may comprise a plurality of retaining members 12295 extending upwardly from the upper surface 12291 of the fabric thickness compensator 12290 wherein each retaining member 12295 may comprise a plurality of flexible legs. 12296 which can be configured to be inserted in the knife slot 10065 in the anvil 10060. With reference primarily to Figures 321 and 322, the flexible legs 12296 of each retaining member 12295 can be separated by a spacing 12298 such that, while the legs 12296 are inserted into the knife slot 10065, the legs 12296 can flex inwardly and then flex flexibly outwardly once the enlarged feet of the flexible legs 12296 pass through the knife slot 10065. The enlarged feet of the flexible legs 12296 can flex backward opposite retention flanges 12297 which are defined on the anvil 10060 and, as a result of the interaction of the legs and flanges 12296 and 12297, the tissue thickness compensator 12290 can be retained by the anvil 10060. Thereafter, the staple cartridge applicator 12280 can be moved away from the fabric thickness compensator 12290, as illustrated in Figure 320. In use, once the fabric thickness compensator 12290 is implanted against the tissue by means of deployed staples of the staple cartridge 10000, for example, the anvil 10060 can be reopened and, while the anvil 10060 moves away from the implanted tissue thickness compensator 12290, the legs 12296 of the retaining members 12995 can flex inwardly so that they can be removed from the knife groove 10065.
Referring now to Figures 315 and 316, a fabric thickness compensator, such as the fabric thickness compensator 11990, for example, can be loaded longitudinally on an anvil, such as anvil 11960, for example. More particularly, the fabric thickness compensator 11990 may comprise one or more longitudinal rails 11995 that can be inserted into a distal opening in a knife groove 11965 of the anvil 11960 and then pushed proximally until the tissue thickness compensator 11990 has settled. Correctly on anvil 11960. For example, each rail 11995 may comprise a longitudinal retention foot 11996 which can be positioned behind a longitudinal retention flange 11997 which at least partially defines the knife recess 11965, for example. As illustrated in Figure 316, the feet 11996 can extend in opposite directions to be positioned behind the retaining flanges 11997 positioned on opposite sides of the knife slot 11965. A longitudinal spacing 11998 can be defined between the rails 11995 that can be configured to allow the rails 11995 to flex inwardly. facing each other when the fabric thickness compensator 11990 is separated from the anvil 11960. Referring now to Figure 317, a fabric thickness compensator, such as the fabric thickness compensator 12090, for example, can comprise one or more lock arms 12098 that can extend around the sides of an anvil, such as anvil 12060, for example. In use, the locking arms 12098 can couple the anvil 12060 and removably retain the tissue thickness compensator 12090 to the anvil 12060. For example, the anvil 12060 can comprise one or more notches, or lock supports 12097, for example , which can each be configured to receive a foot extending from a locking arm 12098. In use, the arms 12098 can flex outwards and separate from the anvil 12060 when the anvil 12060 moves away from the tissue thickness compensator 12090 afterwards. that the tissue thickness compensator 12090 is implanted, at least partially.
As described above, a surgical stapling instrument may comprise a staple cartridge channel configured to receive a staple cartridge, an anvil rotatably coupled to the staple cartridge channel, and a trigger member comprising a staple edge. blade that is movable relative to the anvil and the staple cartridge channel. In use, a staple cartridge can be positioned within the staple cartridge channel and, after the staple cartridge is at least partially expended, the staple cartridge can be removed from the staple cartridge channel and replaced with a new staple cartridge. Staples In some such embodiments, the staple cartridge channel, the anvil, and / or the trigger member of the surgical stapling instrument can be reused with the replacement staple cartridge. Alternatively, a staple cartridge may comprise a part of an assembly of the disposable loading unit which may include a staple cartridge channel, an anvil, and / or a trigger member, for example, that can be replaced together with the cartridge of staples as part of replacing the assembly of the disposable loading unit. Some assemblies of disposable loading units are described in United States patent application no. of series 12 / 031,817, entitled END EFFECTOR COUPLING ARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT, which was filed on February 15, 2008, the complete description of which is incorporated herein by reference. Referring now to Figure 370, a disposable loading unit, such as the disposable loading unit 12500, for example, may comprise a support portion 12510, an anvil 12560 rotatably coupled to the support portion 12510, and a elongated stem 12570 extending from the support portion 12510. Similar to the staple cartridges described herein, the support portion 12510 may comprise a plurality of staple cavities 10012 and a staple, such as staple 10030, for example, positioned in each staple pocket 10012, for example. The disposable loading unit 12500 may further comprise a firing member 12552 that can advance distally to move the anvil 12560 from an open position, as illustrated in Figure 370, to a closed position. The disposable loading unit 12500 may further comprise a fabric thickness compensator 12520 positioned and / or attached to the support portion 12510, wherein, when the anvil 12560 is in its closed position, the anvil 12560 can be positioned opposite the fabric thickness compensator 12520 and, the anvil 12560 can at least partially compress the fabric thickness compensator 12520 when the anvil 12560 is in its closed position. In any case, the firing member 12552 may advance further to eject the staples from the support portion 12510. While the staples are being expelled, the staples may be deformed by the anvil 12560 and trap at least a portion of the fabric thickness compensator 12520 in this. Thereafter, the firing member 12552 can be retracted proximally, the anvil 12560 can be reopened, and the support portion 12510 can move away from the implanted tissue thickness compensator 12520.
In addition to the foregoing, the fabric thickness compensator 12520 can be removably mounted to the support portion 12510.
For example, the support portion 12510 may comprise a longitudinal retention rail 12526 mounted on each side thereof where each rail 12526 may comprise one or more openings 12528 that can be configured to receive at least a portion of the fabric thickness compensator 12520 therein. Once the fabric thickness compensator 12520 is at least partially impregnated, the fabric thickness compensator 12520 can be removed from the openings 12528 while the support portion 12510 moves away. Referring now to Figures 371 to 373, a disposable loading unit 12600 may comprise a support portion 12610, a fabric thickness compensator 12620 removably mounted to the support portion 12610, and one or more retention rails 12626 that can be configured to extend below the weight compensator. fabric thickness 12620 and assemble the fabric thickness compensator 12620 to the support portion 12610. Each retaining rail 12626 may comprise a plurality of retaining hooks 12628, for example, that can be coupled to the support portion 12610 through retention grooves 12614, for example, which are defined in the support portion 12610. In use, for example, the fabric thickness compensator 12620 may be configured to separate from the retention rails 12626 after the tissue thickness compensator 12620 is at least partially impinged and the support portion 12610 moves away from the tissue thickness compensator 12620. Referring now to the Figures 374 to 376, a disposable loading unit 12700 may comprise one or more retention rails 12726 each which may comprise a lower bar 12725 which may extend below the fabric thickness compensator 12720 and an upper bar 12727 which may extend over the surface 12621 Superior Compensator fabric thickness 12620. The fabric thickness compensator 12620 can be at least partially compressed between the upper bars 12727 and the lower bars 12725, such that the retaining rails 12726 can removably hold the fabric thickness compensator 12620 with relation to support portion 12610. For example, each retaining rail 12726 may comprise one or more retaining hooks 12728 that can be engaged with support portion 12610 to retain retaining rails 12726 to support portion 12610.
Referring now to Figures 377 and 378, a disposable loading unit 12800 may comprise a retaining member 12822 that can be configured to mount a tissue thickness compensator 12620 to the support portion 12610. For example, the retaining member 12822 it may comprise a sheet of material positioned against the cover surface 12611 of the support portion, wherein the fabric thickness compensator 12620 may be attached to the sheet of material by at least one adhesive, for example. The retaining member 12822 may further comprise a longitudinal retaining rail 12825 configured to extend downwardly within a blade slot 12615 defined in the support portion 12610. For example, the retaining rail 12825 may be sized and configured to such that it is compressed between the side walls of the knife groove 12615. In use, the firing member 12552 may comprise a knife edge that can pass through the knife groove 12615 while the firing member 12552 advances distally and cross section the tissue thickness compensator 12620 and retaining rail 12825 longitudinally. Further, in use, the staples expelled from the support portion 12610 can penetrate the retaining member 12822, the fabric thickness compensator 12820, and the fabric positioned between the tissue thickness compensator 12820 and the anvil 12560. Retention 12822 may comprise a biocompatible and / or bioabsorbable material. The retaining member 12822 may be comprised of a sufficiently compressible material to comprise a tissue thickness compensator underlying the fabric thickness compensator 12620. Referring now to Figures 379 to 381, a disposable loading unit 12900 may comprise a unit of load including a lower portion 12922 that can be removably attached to the support portion 12610, an upper portion 12990 removably attachable to the anvil 12560, and a flexible joint 12991 connecting the lower portion 12922 and the upper portion 12990 Similar to the above, a longitudinal retaining rail 12825 may extend downwardly from the lower portion 12922 and in the knife slot 12615 defined in the support portion 12610 such that the lower portion 12922 may be removably retained to the support portion 12610. Similarly, a longitudinal retention rail 12995 may extend upwardly. it went from the upper portion 12990 in a knife slot defined in the anvil 12560 in such a way that the upper portion 12990 can be detachably retained to the anvil 12560. As illustrated in Figures 380 and 381, a tissue thickness compensator 12620 can be mounted on the lower portion 12922 of the load assembly, in where, to place the tissue thickness compensator 12620 relative to the support portion 12610, a physician could flex the upper portion 12990 and the lower portion 12922 in the direction of one another, place the loading unit between the anvil 12560 and the support portion 12610, and releasing the flexed load assembly such that it can flexibly expand and press the upper portion 12990 against the anvil 12560 and the lower portion 12922 against the support portion 12610. Referring now to Figures 382 to 384 , the loading unit may further comprise one or more retaining hooks, such as the retaining hooks 12994, for example, extending therefrom which can be configured to removably connect the upper portion 12990 to the anvil 12560 and / or releasably connecting the lower portion 12922 to the support portion 12610.
Referring now to Figure 385, a disposable loading unit 15900, for example, may comprise an anvil 15960 and a staple cartridge channel 15970, wherein the staple cartridge channel 15970 may rotate relative to the anvil 15960. For example, anvil 15960 may not be able to rotate. The fabric can be positioned between the anvil 15960 and the staple cartridge channel 15970 and, thereafter, the staple cartridge channel 15970 can be rotated in the tissue direction to hold the tissue against the anvil. For example, the disposable loading unit 15900 may further comprise a fabric thickness compensator 15920 that can be configured to come into contact with the fabric.
As discussed above and with reference to Figure 332, a staple cartridge, such as the staple cartridge 10000, for example, may comprise a support portion 10010 and a tissue thickness compensator 10020, wherein a plurality of staples 10030 may be stored at least partially in the support portion 10010 and may extend to the fabric thickness compensator 10020 when the staples 10030 are in their non-fired position. The tips of the staples 10030 do not protrude from the tissue thickness compensator 10020 when the staples 10030 are in their non-fired positions. While the clips 10030 move from their non-fired positions to their positions fired by the staple drivers 10040, as discussed above, the tips of the staples 10030 can penetrate through the fabric thickness compensator 10020 and / or penetrate through of the top layer, or liner, 10022. In certain alternative embodiments, the tips of the staples 10030 may protrude through the upper surface of the fabric thickness compensator 10020 and / or of the liner 10022 when the staples 10030 are in place. position not triggered. In any case, staples 10030, while extending upwardly away from support portion 10010 before unfolding, may be tilted and / or biased relative to the support portion, as also discussed above. Referring now to Figure 329, a staple cartridge, such as the staple cartridge 13000, for example, may comprise a plurality of guide members, or retainers that may be configured to limit relative movement between the cartridge support portion 13010. from 13000 staples and staple tips positioned on them. With reference principally to Figure 330, the staple cartridge 13000 may comprise a fabric thickness compensator 13020 mounted on a support portion 13010 and, additionally, a plurality of pads 13022 attached to the upper surface 13021 of the tissue thickness compensator. 13020. Each pad 13022 may comprise a plurality of openings 13029 defined therein which may be configured to slidably receive and / or guide the legs 13022 of a staple 13030 therein. Additionally or in place of the openings, a pad may comprise any suitable opening such as a groove, guide, and / or groove, for example, which may be configured to slidably receive and / or guide the legs 13022. As illustrated in FIG. Figure 330, the tips of the staple legs 13032 can be positioned within the openings 13029 when the staples 13030 are in their non-fired positions. For example, the tips of the staple legs 13032 may protrude above the pads 13022 when the staples are in their non-fired position. Alternatively, the tips of the staple legs 13032 can be positioned just below the pads 13022 when the staples 13030 are in their non-fired positions such that, when the staples 13030 move upwardly through the tissue thickness compensator 13020, the staple legs 13032 can enter the openings 13029 of the pads 13022 and slide therethrough. When the legs 13032 of the staples 13030 are positioned within the pads, lateral and / or longitudinal movement of the staple legs 13032 can be limited without impeding the upward movement of staple legs 13032 when staples 13030 are deployed. When staples 13030 unfold, with reference now to Figure 331, staple legs 13032 can slide upwardly through pads 13022 to penetrate tissue T , coming into contact with an anvil positioned opposite the staple cartridge 13030, and deforming downward to capture the tissue T and the tissue thickness compensator 13030 therein.
In addition to the above, the pads 13022 can be attached to the fabric thickness compensator 13020 by using at least one biocompatible and / or bioabsorbable adhesive, for example. The pads 13022, and / or a retainer member extending from each pad, can be incorporated at least partially within the fabric thickness compensator 13020. For example, the fabric thickness compensator 13020 can comprise cavities defined therein that they configure to at least partially receive a pad 13022. The fabric thickness compensator 13020 can be integrally molded, or formed around the pads 13022 during a molding manufacturing process. The pads 13022 can comprise discrete retainers that can move independently of one another. With reference principally to Figure 330, each pad 13022 may comprise interlocking and / or locking features that can be configured to allow and, to some extent, limit relative lateral and longitudinal movement between the pads 13022. For example, each pad 13022 may comprising a projection 13026 and one or more recesses 13027, for example, wherein the projection 13026 of a first pad 13022 can be positioned within and / or aligned with respect to the recesses 13027 of the second and third adjacent pads 13022. Adjacent packs 13022 can be spaces that can allow the pads 13022 to move or slide relative to the another until they come in contact with an adjacent pad 13022. The pads 13022 may be weakly interconnected. The pads 13022 can be removably connected to each other. For example, the pads 13022 can be manufactured as a sheet of interconnected pads wherein, when sufficient force is applied to the sheet, one or more of the pads 13022 can be released from the others. Referring again to Figure 329, a first sheet 13024 of pads 13022 can be positioned on a first side of a longitudinal slot 13025 and a second sheet 13024 of pads 13022 can be positioned on a second side of slot 13025. In addition to the above, the longitudinal groove 13025 extending through the fabric thickness compensator 13020 can be configured to facilitate the passage of a knife edge of a firing member through the fabric thickness compensator 13020 and, while the firing member thus passes. , the firing member can apply a compressive force to the blades 13024 and separate or remove at least some of the pads 13022.
The pads 13022 can be composed of a biocompatible and / or bioabsorbable plastic, for example. The pads 13022 can be composed of a solid material, a semi-solid material, and / or a material flexible, for example. The pads 13022 may be incorporated within a tissue thickness compensator such that the pads 13022 move with the tissue thickness compensator. For example, the pads 13022 may be sufficiently flexible, such that they can flex with the top surface of the tissue thickness compensator. The pads 13022 may be configured to remain incorporated in the tissue thickness compensator while, alternatively, the pads 13022 may be configured to come out, or separate, from the tissue thickness compensator. The pads 13022 may comprise a top surface that is flush with the top surface of the tissue thickness compensator. The upper surfaces of the pads 13022 can be positioned above and / or below the top surface of the tissue thickness compensator. The upper surfaces of the pads 13022 can be arranged in such a way that they are visible during visualization of the upper surface of the tissue thickness compensator while, as an alternative, the upper surfaces of the pads 13022 can be positioned below a layer of the tissue thickness compensator, for example. The guide features can be molded on the upper surface of a tissue thickness compensator, for example. For example, the fabric thickness compensator may not comprise a composite material and may comprise a unitary piece of material, for example.
Referring now to Figure 338, a staple cartridge may comprise a tissue thickness compensator and a top coat or layer, for example. For example, one or more pads, or retainers 13622, for example, may be incorporated in the liner 13621. Each retainer 13622 may comprise one or more openings 13629 defined therein that can be configured to receive the staple legs 13032 of the staples 13030 in these when the staples 13030 are in their non-fired position, as illustrated in Figure 338. In use, in addition to the above, the staple legs 10032 can slide through the openings 13629 when the staples 13030 are displaced from their position. not fired to its fired position until the bases 13031 of the staples 13030 come into contact with the fabric thickness compensator 13620 and compress at least a portion of the fabric thickness compensator 13620 against the lower surfaces of the pads 13622, for example . Referring now to Figure 333, a staple cartridge may comprise a fabric thickness compensator 13120 and a coating or top layer, 13122, for example. For example, the fabric thickness compensator 13120 may comprise conical bulges, projections, and / or protrusions 13128, for example, which may extend upwardly from the upper surface 13121 of the fabric thickness compensator 13120. Projections 13128 may be configured to receiving and wrapping the tips of the staple legs 13032 of the staples 13030 when the staples 13030 are in their non-fired position, as illustrated in FIG. 333. The top layer 13122 may further comprise conical bulges, projections, and / or protrusions 13129 that may be aligned, or at least substantially aligned, with the projections 13128. In use, the staple legs 10032 may penetrate projections 13128 and 13129 and emerge from the fabric thickness compensator 13120. Referring now to Figure 337, a staple cartridge may comprise a fabric thickness compensator 13520 and a top coat, 13522, for example. For example, the liner 13522 may comprise conical bulges, projections, and / or protrusions 13529, for example, which may extend upwardly from the top surface 13521 of the fabric thickness compensator 13520. Similar to the foregoing, the projections 13529 may be configured for receiving and wrapping the tips of the staple legs 13032 of the staples 13030 when the staples 13030 are in their non-fired position, as illustrated in FIG. 337. In use, the staple legs 10032 can penetrate the projections 13529 and emerge of the cladding 13522.
Referring now to Figure 334, a staple cartridge may comprise a fabric thickness compensator 13220 and a top coat, 13222, for example. For example, the fabric thickness compensator 13220 may comprise conical holes and / or recesses 13128, for example, which may extend downwardly on the upper surface 13221 of the fabric thickness compensator 13220. The tips of the staple legs 13032 may extending through the recesses 13128 when the staples 13030 are in their non-fired position, as illustrated in Figure 334. The top layer 13222 can also comprise conical holes and / or recesses 13229 that can be aligned, or at least substantially aligned, with the recesses 13228. Referring now to Figure 335, a staple cartridge it may comprise a fabric thickness compensator 13320 and a coating or top layer, 13322, for example. For example, the liner 13320 may comprise thick portions 13329 that may extend downwardly on the upper surface 13321 of the fabric thickness compensator 13320. In various circumstances, the thick portions 13329 may be configured to receive at least a portion of the staple legs. 13032 of the staples 13030 in these when staples 13030 are in their non-fired position, as illustrated in Figure 335. In such cases, the thick portions 13429 can hold the staple legs 13032 in place, such that the legs 13032 align, or at least substantially align, with the shaping cavities of the legs 13032. staples of an anvil positioned opposite the fabric thickness compensator 13320. Referring now to Figure 336, a staple cartridge may comprise a fabric thickness compensator 13420 and a top coat, 13433, for example. For example, the liner 13422 may comprise thick portions 13429 that may extend upwardly from the upper surface 13421 of the fabric thickness compensator 13420. In various circumstances, the thick portions 13429 may be configured to receive at least a portion of the staple legs. 13032 of staples 13030 in these when staples 13030 are in their position not triggered, as illustrated in Figure 336. In such cases, the thick portions 13429 can hold the staple legs 13032 in place, such that the legs 13032 align, or at least substantially align, with the recesses 13032. staple conformation of an anvil positioned opposite the tissue thickness compensator 13420.
In various embodiments, with reference now to Figures 339 and 340, a staple cartridge may comprise a tissue thickness compensator 13720 and a coating or top layer, 13721, for example. For example, the fabric thickness compensator 13720 may comprise pyramidal and / or stepped bulges, projections, and / or protrusions 13728, for example, which may extend upwardly from the upper surface 13721 of the tissue thickness compensator 13720. The projections 13728 can be configured to receive and wrap the tips of the staple legs 13032 of the staples 13030 when the staples 13030 are in their non-fired position, as illustrated in Figure 340. Similarly, the upper layer 13721 can comprise pyramidal bulges and / or staggered, projections, and / or protrusions 13729 that can be aligned, or at least substantially aligned, with the projections 13728. The liner 13721 may further comprise one or more teeth 13727 extending upwardly from the projections 13729 that they can be configured to engage the tissue positioned against the top layer 13721 and prevent, or at least limit, movement lateral and / or longitudinal relative between the fabric, the upper layer 13721, and / or the tips of the staple legs 13032. In use, the staple legs 13032 can penetrate projections 13728 and 13729 and emerge from the tissue thickness compensator 13720 when staples 13030 move from their non-fired positions to their fired positions. Referring now to Figures 341 and 342, a staple cartridge may comprise a fabric thickness compensator 13820 and a top coat or layer, 13821, for example. For example, the fabric thickness compensator 13820 may comprise pyramidal and / or stepped bulges, projections, and / or protrusions 13828, for example, which may extend upwardly from the top surface 13821 of the fabric thickness compensator 13820. The projections 13828 may be configured to receive and wrap the tips of the staple legs 13032 of the staples 13030 when the staples 13030 are in their non-fired position, as illustrated in FIG. 342. Similarly, the upper layer 13821 may comprise pyramidal bulges and / or staggered, projections, and / or protrusions 13829 that can be aligned, or at least substantially aligned, with the projections 13828. The top layer 13821 may further comprise one or more teeth 13827 extending downwardly in the thickness compensator of fabric 13820 that can be configured to prevent, or at least limit, the relative lateral and / or longitudinal movement between the top layer and 13821 fabric thickness compensator 13820, for example. In use, the staple legs 10032 can penetrate the projections 13828 and 13829 and emerge from the fabric thickness compensator 13820 when the staples 13030 move from their non-fired positions and their fired positions.
Referring now to Figure 343, a staple cartridge may comprise a tissue thickness compensator, such as tissue thickness compensator 13920, for example, which may include ridges 13923 and valleys 13924 defined therein, wherein, valleys 13924 may be defined between ridges 13923. Each ridge 13923 may comprise the same height, substantially the same height, or different heights. Similarly, each valley 13924 may comprise the same depth, substantially the same depth, or different depths. A plurality of staples 13030 can be stored at least partially within the tissue thickness compensator 13920, such that the tips of the staples 13030 can be positioned within the ridges 13923. For example, the staple legs 13032 of the staples 13030 can not protrude from the fabric thickness compensator 13920 and / or a coating or upper layer, 13921 attached to the fabric thickness compensator 13920, for example, when the staples 13030 are stored in their non-fired position. Ridges 13923 and / or valleys 13924 may extend laterally through the staple cartridge. For example, the staple cartridge may comprise a slot for a longitudinal blade, wherein ridges 13923 and valleys 13924 may extend in a direction that is transverse and / or perpendicular to the blade slot. In various circumstances, the ridges 13923 can be configured to hold the tips of the staple legs 13032 in place until the staples 13030 move from their non-fired position to their position. shot. In various embodiments, with reference now to Figure 344, a fabric thickness compensator, and / or a covering covering a tissue thickness compensator, may comprise ridges and / or longitudinal valleys. For example, a tissue thickness compensator may comprise an upper surface defined by ridges 14023 and valleys 14024, where valleys 14024 may be defined between ridges 14023, for example. The fabric thickness compensator may comprise a liner 14021 which may include a plurality of openings 14029 defined therein which can be configured to receive a staple leg 13032. Openings 14029 can be defined at ridges 14023, where the tips the staple legs 13032 can be positioned below the peaks 14028 of ridges 14029, positioned flush with peaks 14028, and / or positioned above peaks 14028. Additionally or instead of the above, openings 14029 can be defined in the valleys 14024, for example. Each opening may be surrounded, or at least partially surrounded, by a relief, for example, which may strengthen the coating and / or the fabric thickness compensator surrounding the openings. In any case, in addition to the foregoing, the liner 14021 may be connected to a fabric thickness compensator in any suitable manner, which includes the use of at least one adhesive, for example.
As described above and with reference again to Figure 233, a surgical stapling instrument may comprise an anvil, such as anvil 10060, for example, that can be moved between a position open and a closed position for compressing the tissue T against the tissue thickness compensator 10020 of a staple cartridge 10000, for example. In various circumstances, the anvil 10060 can be rotated in the direction of the staple cartridge 10000 until its downward movement is stopped by some portion of the staple cartridge 10000 and / or a portion of the channel, where the staple cartridge 10000 is positioned. In at least one such circumstance, the anvil 10060 can be rotated downwards until its downward movement is resisted by the tip 10003 of the staple cartridge 10000 and / or the tissue T positioned intermediate between the tip 10003 and the staple cartridge 10000 In some circumstances, the anvil 10060 can sufficiently compress the tissue thickness compensator 10020 to allow the tissue T to come in contact with the tips of the staples 10030. In certain circumstances, depending on the thickness of the tissue T, the anvil 10060 can compress the tissue thickness compensator 10020 sufficiently in such a manner that the anvil 10060 comes into contact with the staples 10030 at the moment when the anvil 10060 reaches its fully closed position. Stated differently, in such circumstances, the anvil 10060 may deform the staples 10030 before the firing member 10052 advances toward the staple cartridge 10000 to fire the staples 10030. Such circumstances may be acceptable in certain embodiments; however, with reference now to Figures 358 and 359, other embodiments are contemplated wherein a distal space fastener element, such as element 10059, for example, can be used to limit the distance at which the anvil 10060 can be closed before the bar 10052 shot advance in the staple cartridge 10000. The element 10059 can extend upwardly from the upper surface 10021 of the fabric thickness compensator 10020, such that the downward movement of the anvil 10060 can be stopped while the tissue T is compressed against the element 10059 and a resistance force is generated between them. In use, as described above, the firing member 10052 can advance distally in the staple cartridge 10000 in the direction of the distal end 10002 of the staple cartridge 10000 to eject the staples 10030 from the support portion 10010. Simultaneously, the firing member 10052 can couple the anvil 10060 and place the anvil 10060 at a desired distance from the cover surface 10011 (FIG. 218) of the support portion 10010 on the staples 10030 formed. In this way, the firing member 10052 can control the distance, or space, between the contact surface with the anvil tissue 10060 and the cover surface 10011 at a particular location, where this particular location can advance distally while the firing member 10052 advances distally. In various circumstances, this distance of space may be shorter than the space between the anvil 10060 and the cover surface 10011 which is controlled or dictated by the distal space fastener 10059 at the distal end of the tissue thickness compensator 10020 With reference now to Figure 359, the blade edge 10053 of the firing member 10052 can be configured to cross-section the distal space fastener 10059 when the firing member 10052 reaches the distal end of the compensator of fabric thickness 10020 such that, after the element 10059 is cross-sectioned, the firing member 10052 can pull the anvil 10060 downward toward the support portion 10010 and close the space at the desired height of space when staples 10030 are fired at the distal end of staple cartridge 10000. In certain alternative embodiments, a distal space fastener can be configured to fold while the firing member approaches the distal end of the staple cartridge. For example, the distal space fastener may comprise a column that can provide anvil resistance, as described above and, then, be suddenly bent once the buckling strength of the space fastener is reached when the trigger member approaches the distal end of the staple cartridge. This buckling force can be approximately 44 N (10 Ibf), for example. A space fastener can be configured to drop downwardly into the cover of the support portion when a force greater than a predetermined amount is applied to the space fastener, for example. Alternatively, the distal space can be controlled by the tip of the staple cartridge. For example, downward movement of the anvil 10060 may be limited by the tip until the firing member reaches the distal end of the cartridge, where, at such a point, the compression force applied to the tip may cause the tip to fold . The tip may comprise a cavity defined by walls of the cavity which may allow the cavity to be fold once the compression force applied to it exceeds a predetermined force. For example, the cavity can be defined by folding walls.
As described above, an anvil, such as the anvil 10060, for example, can move between an open position and a closed position to compress a tissue thickness compensator between the anvil and the supporting portion of a staple cartridge. Under certain circumstances, with reference now to Figures 360 and 361, the tissue thickness compensator of a staple cartridge, such as the fabric thickness compensator 14120 of the staple cartridge 14100, for example, may be laterally expanded and / or longitudinally when the fabric thickness compensator 14120 is compressed against a support portion 14110 of the staple cartridge 14100. The ends and / or sides of the fabric thickness compensator 14120 may not be constrained by the support portion 14110 and / or the anvil 10060 and, as a result, the fabric thickness compensator 14120 can expand in those directions without generating a compression pressure, or at least an undesirable compression pressure, within the fabric thickness compensator 14120. In such cases, a member trigger, such as the firing member 10052 (FIG. 236), for example, passing through the tissue thickness compensator 14120 may not be unduly hindered by a p undesirable compression pressure within the fabric thickness compensator 14120, for example. Alternatively, with reference again to Figure 360, the distal end 14125 of the tissue thickness compensator 14120 may be limited by the tip 14103 of the staple cartridge 14100, example. In this particular embodiment, similar to the foregoing, the distal end 14125 of the fabric thickness compensator 14120 may be limited by the tip 14103 to reduce the possibility that the fabric thickness compensator 14120 prematurely separates from the support portion 14110 In any case, as a result of the foregoing, a large internal pressure may be generated within the distal end 14125 which may impede the advancement of the firing member 10052, especially when the firing member 10052 reaches the distal end 14125. More particularly, in certain circumstances, the firing member 10052 can push, channel, and / or move the fabric thickness compensator 14120 distally while transversally severing the fabric thickness compensator 14120 and, as a result, an even larger internal pressure can be created within the distal end 14125 of the fabric thickness compensator 14120. In order to dissipate, at least partially, this pressure within the tissue thickness compensator 14120, the tip 14103 may comprise a flexible material that can allow the tip 14103 to be flex in the distal direction, for example, and create additional space for the fabric thickness compensator 14120. Referring now to Figures 362 and 363, the tip of a staple cartridge may comprise a distally slidable portion. More particularly, the tip 14203 of the staple cartridge 14200 may comprise a slidable portion 14204 that can be slidably connected to the tip 14203 in such a manner that, when the anvil 10060 is closed and / or the firing member 10052 advances at the end distal staple cartridge 14200, the slidable portion 14204 can slide distally and create additional space for the fabric thickness compensator 14200 and at least partially relieve the internal pressure therein. One of the tip 14203 and the slidable portion 14204 may comprise one or more rails and the other between the tip 14203 and the slidable portion 14204 may comprise one or more channels configured to slidably receive the rails therein. The channels and rails can be configured to cooperatively limit the movement of the slidable portion 14204 to a longitudinal distal path, for example.
In various circumstances, in addition to the above, certain staples, such as the most distal staples within a staple cartridge, for example, may capture a larger portion of a tissue thickness compensator than the proximal staples within the staple cartridge. . In such circumstances, as a result, a great clamping pressure can be applied to the tissue captured within the distal staples as compared to the proximal staples. These circumstances may arise when at least a portion of the tissue thickness compensator is displaced and / or accumulated at the distal end of the staple cartridge during use, as described above, even though the tissue thickness compensator may be composed of a substantially homogeneous material having a substantially constant thickness. In various circumstances, it may be desired for certain staples to apply a higher clamping pressure to the tissue than other staples wherein a support portion and / or a tissue thickness compensator can be constructed and arranged for check that staples can apply the upper clamping pressure to the tissue and that staples can apply a lower clamping pressure to the tissue. Referring now to Figure 364, a staple cartridge 14300 may comprise a support portion 14310 and, additionally, a fabric thickness compensator 14320 positioned on the cover surface 14311 of the support portion. 14310. In comparison with other embodiments described in this application comprising a support portion 14310 having a flat, or at least substantially flat, cover surface, the cover surface 14311 can be inclined and / or reduced between the distal end 14305 and the proximal end 14306 of the support portion 14310. The cover surface 14311 of the support portion 14310 may comprise a height of the cover at its distal end 14305 that is shorter than the height of the cover at its proximal end 14306. For example, the staples 10030 at the distal end of the staple cartridge 14300 can extend above the cover surface 14311 a greater distance than the staples 10030 at the proximal end. In various alterative embodiments, the cover surface of a support portion may comprise a height at its distal end that is higher than its height at its proximal end. Referring again to Figure 364, the fabric thickness compensator 14320 may comprise a thickness that is different along the longitudinal distance thereof. The fabric thickness compensator 14320 may comprise a thickness at its distal end 14325 that is thicker than its proximal end 14326, for example. For example, the fabric thickness compensator 14322 may comprise a lower surface 14322 that can be inclined or reduced to adjust, or at least substantially adjust, the sloping or reduced cover surface 14311 of the support portion 14310. As a result, the top, or contact, surface 14321 of the thickness compensator of woven fabric 14320 may comprise a flat, or at least substantially flat, surface on which the fabric T can be positioned. In any case, as the fabric thickness compensator 14320 is thicker at its distal end 14325, the distal staples 10030 can capture a larger portion of the fabric thickness compensator 14320 in these than the proximal staples 10030 and, as a result, the distal staples 10030 can apply a greater compressive force to the tissue T, especially when the distance of space between the anvil 10060 and the cover surface 14311 is constant, or at least substantially constant, at the proximal and distal ends of the staple cartridge. In certain circumstances, however, the anvil 10060 may not reach a fully closed position and, as a result, the space distance between the anvil 10060 and the cover surface 14311 may be larger at the distal end of the staple cartridge 14300 than in the proximal end. In various circumstances, the distal staples 10030 may not be completely formed and, as a result, the distal staples 10030 may not apply the desired clamping pressure to the tissue T. In the embodiments in which the tissue thickness compensator is thicker in the tissue. At the distal end of the staple cartridge, the tissue thickness compensator can compensate for the deformation of the staples and apply sufficient pressure to the tissue T.
Referring now to Figure 365, a staple cartridge, such as the staple cartridge 14400, for example, may comprise a support portion 14410 and, additionally, a tissue thickness compensator 14420 positioned on the cover surface 14411 of the support portion 14410. Similar to the above, the cover surface 14411 may be inclined and / or reduced such that the distal end 14405 of the support portion 14410 may have a height of the cover that is shorter than the height of the cover at the proximal end 14406, for example. The fabric thickness compensator 14420 may comprise a constant, or at least substantially constant, thickness along the length thereof and, as a result, the top, or tissue contacting surface 14421 of the fabric thickness compensator 14420 it can equal, or at least substantially equal, the contour of the cover surface 14411. The staples 10030 of the staple cartridge 14400 can be fully incorporated within the tissue thickness compensator 14420 and the support portion 14410 when the staples 10030 are in its position not triggered. The staples 10030 positioned at the proximal end of the staple cartridge 14400 can be fully integrated within the tissue thickness compensator 14420 and the support portion 14410 when the staples 10030 are in their non-fired position while, due to the reduced slope of the cover 14411 and upper surface 14421, the tips of certain staples 10030, which includes staples 10030 positioned at the distal end of staple cartridge 14400, may protrude through the upper surface 14421 of tissue thickness compensator 14420 when staples 10030 are in their non-fired position.
As described above, a fabric thickness compensator may comprise a single material, wherein the entire fabric thickness compensator may have the same material properties, or at least substantially the same, such as density, stiffness, the resistance index, the hardness, and / or the elasticity, for example, everywhere. Alternatively, with reference now to Figure 368, a fabric thickness compensator, such as the fabric thickness compensator 14520, for example, may comprise a plurality of materials or layers of materials. Fabric thickness compensator 14520 may comprise a first, or middle, layer 14520a, second, or intermediate layers 14520b attached to first layer 14520a on opposite sides thereof, and a third, or outer layer 14520c attached to each of the layers. second layers 14520b. The intermediate layers 14520b can be attached to the central layer 14520a by using at least one adhesive and, similarly, the outer layers 14520c can be joined to the second layers 14520 by using at least one adhesive. Additionally or in lieu of an adhesive, the layers 14520a-14520c may be held together by one or more interlacing features and / or fasteners, for example. In any case, the inner layer 14520a can comprise a first material having a first set of a second material having a second set of properties of the materials, the intermediate layers 14520b can comprising a set of properties of the materials, and the outer layers 14520c may be comprised of a third material having a third set of properties of the materials, for example. These sets of material properties may include density, stiffness, strength index, hardness, and / or elasticity, for example. A staple cartridge may comprise six rows of staples 10030, for example, wherein a row of staples 10030 may be positioned at least partially on each of the outer layers 14520c and each of the inner layers 14520b, for example, and wherein two rows of staples 10030 can be positioned at least partially with the inner layer 14520a. In use, similar to the above, the staples 10030 can be ejected from the staple cartridge in such a manner that the staple legs 10032 of the staples 10030 penetrate the upper surface 14521 of the fabric thickness compensator 14520, penetrate the tissue positioned against the top surface 14521 by an anvil and then come into contact with the anvil in such a way that the legs 10032 are deformed to capture the fabric thickness compensator 14520 and the tissue within the staples 10030. In addition, similar to the above, the compensator Fabric thickness 14520 can be transected transversely by a firing member while the firing member advances through the staple cartridge. For example, the trigger member can cross-section the inner layer 14520a, and the tissue, along a path defined by an axis 14529, for example.
In addition to the above, the rows of staples 10030 positioned within the inner layer 14520a may comprise the rows of staples that are closer to the edges of the cross-sectioned fabric. Correspondingly, the staple rows 10030 that are positioned within the outer layers 14520c may comprise staple rows that are further away from the edges of the cross-sectioned fabric. The first material comprising the inner layer 14520a may comprise a density that is greater than the density of the second material comprising the intermediate layers 14520b and, similarly, the density of the second material may be greater than the density of the third material comprising the layers external 14520c, for example. In various circumstances, as a result, larger compression forces can be created within the staples 10030 positioned within the inner layer 14520a compared to the compression forces generated within the staples 10030 positioned within the intermediate layers 14520b and the outer layers. 14520c. Similarly, larger compression forces can be created within the staples 10030 positioned within the intermediate layers 14520b, as compared to the compression forces created within the staples 10030 positioned within the outer layers 14520c, for example. Alternatively, the first material comprising the inner layer 14520a may comprise a density that is smaller than the density of the second material comprising the intermediate layers 14520b and, similarly, the density of the second material may be less than the density of the second material. density of the third material comprising the outer layers 14520c, for example. In various circumstances, as a result, within the staples 10030 positioned within the outer layers 14520c larger compression forces can be created as compared to the compression forces created within the staples 10030 positioned within the intermediate layers 14520b and the inner layer 14520a. Similarly, larger compression forces can be created within the staples 10030 positioned within the intermediate layers 14520b, as compared to the compression forces created within the staples 10030 positioned within the inner layer 14520a, for example. Alternatively, any other suitable arrangement of layers, materials, and / or material properties could be used. In any case, the layers 14520a-14520c of the fabric thickness compensator 14520 can be configured to remain joined together after being implanted. Alternatively, layers 14520a-14520c of fabric thickness compensator 14520 can be configured to separate from one another after implantation. For example, the layers 14520a-14520c may be joined by using one or more bioabsorbable adhesives that can initially hold the layers together and then allow the layers to release to each other over time.
As described above, a fabric thickness compensator of a staple cartridge, such as the fabric thickness compensator 14520, for example, may comprise a plurality of longitudinal layers. Alternatively, with reference now to Figure 369, a Staple cartridge may comprise a fabric thickness compensator, such as the fabric thickness compensator 14620, for example, which may comprise a plurality of horizontal layers. For example, the fabric thickness compensator 14620 may comprise a first, or lower, layer 14620a, a second, or intermediate layer, 14620b attached to the lower layer 14620a, and a third, or higher, layer 14620c attached to the intermediate layer. 14620b. The first layer 14620a may comprise a flat, or substantially planar bottom surface 14626a and a triangular, or pyramid top surface 14625a, for example. For example, the second layer 14620b may comprise a triangular or pyramidal bottom surface 14626b, which can be configured to match and adjoin the upper surface 14625a of the first layer 14620a. Similarly to the foregoing, the second layer 14620b may comprise a triangular or pyramidal upper surface, 14625b which may equal and abut a triangular, or pyramid, bottom surface 14626c of the third layer 14620c, for example. The upper surface of the third layer 14626c may comprise a contact surface with the flat, or at least substantially flat, fabric 14621. In addition, similar to the foregoing, the fabric thickness compensator 14620 may be configured to store at least six rows of fabric. staples, such as staples 10030, for example, in these, wherein a firing member can cross-section the fabric thickness compensator 14620 between the two rows of innermost staples along a path extending through the staple. axis 14629, for example. Similary to the foregoing, each layer 14620a, 14620b, and 14620c may comprise a different material that may comprise different properties of the material and, as a result of the triangular, or pyramidal, configuration of the layers 14620a-14620c, the fabric thickness compensator 14620 You can have different global properties in several places within this. For example, the outermost rows of staples 10030 can capture more of the third layer 14620c than of the first layer 14620a therein while the innermost rows of the staples 10030 can capture less of the third layer 14620c than the first layer 14620a and, as a result, the fabric thickness compensator 14620 can compress the captured tissue within the outermost staples 10030 differently than the fabric captured within the innermost staples 10030, for example, even though the tissue thickness compensator 14620 may have the same total thickness, or at least substantially the same, through it.
Referring now to Figure 286, a tissue thickness compensator of a staple cartridge, such as the tissue thickness compensator 14720 of the staple cartridge 14700, for example, may comprise voids, cavities, channels, and / or grooves. , for example, defined herein that the thickness of the fabric thickness compensator 14720 may vary. In at least one such embodiment, the fabric thickness compensator 14720 may be positioned against the cover surface 14711 of a support portion 14710 of the staple cartridge 14700 in such a way that the voids 14723 defined in the bottom surface 14722 of the fabric thickness compensator 14720 can cover certain staple cavities 10012, but not others. The voids 14723 may extend transversely to the knife groove 14715 of the support portion 14710, perpendicular to the knife groove 14715, and / or parallel to the knife groove 14715, for example. The voids 14723 may define a pattern of footprints on the bottom surface 14722 of the fabric thickness compensator 14720. In any case, when the staples, such as staples 10030, for example, are deployed from the support portion 14710, referenced now to Figures 287 and 288, certain staples 10030 may capture the fabric thickness compensator 14720 within a region containing a vacuum 14723, while other staples 10030 may capture the tissue thickness compensator 14720 within an intermediate positioned region. between voids 14723. Additionally or instead of the above, the fabric thickness compensator 14720 can comprise voids, cavities, channels, and / or grooves, for example, which are defined on the upper surface, or contact with the fabric 14721. Referring now to Figures 366 and 367, a staple cartridge 14800 may comprise a fabric thickness compensator 14820 which may include a plurality of fingerprint. s 14823 extending from at least one between, upwardly from an upper surface 14821 of the tissue thickness compensator 14820, inwardly toward a central groove 14825, and / or distally toward the distal end of the 14800 staple cartridge , for example. For example, the tracks 14823 can be separated by channels, grooves, and / or grooves, such as channels 14824, for example. In various circumstances, as a result of the above, the total thickness of the Fabric thickness compensator may vary between rows and / or vary between staples within a row of staples. In certain circumstances, the tracks, or thick portions, can be constructed and arranged in such a way that they can flow in a desired direction, such as inwards, for example, when the tissue thickness compensator is compressed.
Referring now to Figure 303, a staple cartridge, such as the staple cartridge 14900, for example, may comprise a support portion 14910 and, additionally, a tissue thickness compensator 14920 positioned against the support portion 14910. Similar to the previous, the support portion 14910 may comprise staple drivers that can be raised upward by a staple-out slider to elevate the staples, such as staples 10030, for example, at least partially positioned within the support portion 14910 in the direction to an anvil, such as the anvil 10060, for example, positioned opposite the staple cartridge 14900. The support portion 14910 may comprise six rows of staple cavities, such as two outer rows of staple cavities, two inner rows of cavities of staples, and two intermediate rows of staple cavities positioned intermediate between the inner rows and the outer rows, for example, wherein the anvil 10060 may comprise six rows of forming cavities 10062 aligned, or at least substantially aligned with the cavities of Staples The inner rows of staple cavities may include staple drivers 14940a positioned therein, the intermediate rows of staple cavities may include staple drivers 14940b positioned in these, and the outer rows of the staple cavities may include staple drivers 14940c positioned therein, wherein each of the staple drivers 14940a may include a base 14949a configured to support a staple 10030, wherein each of the staple drivers 14940a includes a base 14949a. staple drivers 14940b may include a 14949b base configured to support a staple 10030, and wherein each of the staple drivers 14940c may include a base 14949c configured to support a staple 10030. In its non-fired positions, that is, when the staple drivers 14940a-14940c are seated in the drive brackets 14926 which extend below the support portion 14910, the bases 14949a of the staple drivers 14940a can be positioned closer to the anvil 10060 than the bases 14949b of the staple drivers 14940b and the bases 14949c of the staple drivers 14940c. In such a position, a first forming distance can be defined between the bases 14949a and the forming cavities 10062 positioned on the bases 14949a, a second forming distance can be defined between the bases 14949b and the forming cavities 10062 positioned on the bases 14949b, and a third shaping distance can be defined between the bases 14949c and the shaping cavities 10062 positioned on the bases 14949c, wherein the first shaping distance can be shorter than the second shaping distance and the second shaping distance can be more short than the third conformation distance, for example. When staple drivers 14940a-14940c move from their non-fired positions (Figure 303) to their fired positions, each Staple pusher 14940a-14940c can move up an equal, or at least substantially equal distance in the direction of anvil 10060 by the staple deployment slider in such a manner that first impellers 14940a propel their respective staples 10030 to a first formed height , the second impellers 14940b propel their respective staples 10030 to a second formed height, and the third impellers 14940c propel their respective staples 10030 to a third formed height, wherein the first height formed may be shorter than the second height formed and the second height formed. height formed may be shorter than the third height formed, for example. Various other embodiments are provided, wherein the first staple drivers 14940a move up a first distance, the second staple drivers 14940b move up a second distance, and the third staple drivers 14940c move up a third distance , where one or more of the first distance, the second distance, and the third distance may be different.
Referring again to Figure 303, the cover surface 14911 of the support portion 14910 may vary in height with respect to the contact surface with the 10061 anvil fabric 10060. This variation in height may occur laterally and, the height of the cover surface 14911 surrounding the inner rows of staple cavities may be higher than the cover surface 14911 surrounding the outer rows of the staple pockets, for example. The bottom surface 14922 of the fabric thickness compensator 14920 can be configured to equaling or at least substantially equalizing the cover surface 14911 of the support portion 14910. In addition to the foregoing, the fabric thickness compensator 14920 may also vary in thickness, wherein, the top surface, or contact with the fabric 14921 of the fabric thickness compensator 14920 can be tilted in from the outside or the side edges thereof. For example, as a result of the foregoing, the fabric thickness compensator 14920 may be thinner in a region positioned on the inner rows of staple cavities., and thicker in a region positioned on the outer rows of the staple cavities, for example. Referring now to Figure 304, the cover surface of a support portion 15010 may comprise a stepped deck surface, for example, wherein the highest steps of the stepped surface may surround the inner rows of staple pockets, and the lower steps of the stepped surface may surround the outer rows of staple cavities, for example. For example, steps that have an intermediate height may surround the intermediate rows of staple cavities. A fabric thickness compensator, such as the fabric thickness compensator 15020, for example, may comprise a bottom surface that can match and abut the cover surface of the support portion 15010. The top, or contact, surface the fabric 15021 of the fabric thickness compensator may comprise an arc, parabolic, and / or curved surface, for example, which may extend from a first lateral side of the fabric. tissue thickness compensator 15020 to a second side side of the fabric thickness compensator 15020 with a vertex aligned, or at least substantially aligned, with the center of the staple cartridge 15000, for example. Referring now to Figure 299, a staple cartridge 15300, for example, may comprise a support portion 15310, a plurality of staple drivers 15340 movably positioned within the staple cavities defined in the support portion 15310, and a fabric thickness compensator 15320 positioned above the cover surface 15311 of the support portion 15310. The staple cartridge 15300 may further comprise one or more lower tray portions 15326 that can be attached to the support portion. 15310 and extending around the lower portion of the support portion 15310 and supporting the impellers 15340, and the staples 15330, in their non-fired positions. While a staple display slider advances through the staple cartridge, the slider can also be supported by the lower tray portions 15326 while the slider lifts the staple drivers 15340 and staples 15330 upwardly through the tissue thickness compensator. 15320. Fabric thickness compensator 15320 may comprise a first, or inner 15322a portion positioned on an inner row of staple pockets, a second portion, or intermediate portion 15322b positioned on an intermediate row of staple pockets, and a third portion. portion, or outer 15322c positioned over a row of staple cavities, wherein the inner portion 15322a it may be thicker than the intermediate portion 15322b and the intermediate portion 15322b may be thicker than the outer portion 15322c, for example. The fabric thickness compensator 15320 can comprise longitudinal channels, for example, defined therein that can create the thinner portions 15322b and 15322c of the fabric thickness compensator 15320. Alternatively, the longitudinal channels can be defined on the upper surface and / or the bottom surface of a tissue thickness compensator. The upper surface 15321 of the fabric thickness compensator 15320 may comprise a flat, or at least substantially flat, surface, for example.
Referring now to Figure 296, a staple cartridge may comprise a fabric thickness compensator, such as the fabric thickness compensator 15120, for example, which may comprise a plurality of portions having different thicknesses. The fabric thickness compensator 15120 may comprise a first, or inner, portion 15122a which may have a first thickness, second, or intermediate portions, 15122b extending from the first portion 15122b which may each have a second thickness, and third portions portions, or exteriors, 15122c extending from the second portions 15122b which may each have a third thickness. For example, the third thickness may be thicker than the second thickness and the second thickness may be thicker than the first thickness, for example, although any of the suitable thicknesses could be used in various other embodiments. The 15122a-15122c portions of the thickness compensator of fabric 15120 can comprise steps having different thicknesses. Similar to the above, a staple cartridge may comprise several rows of staples 10030 and a plurality of staple drivers having different heights that can deform staples 10030 at different heights formed. In addition, similar to the above, the staple cartridge may comprise first staple drivers 15140a which can drive the staples 10030 supported thereon at a first formed height, second staple drivers 15140b which can drive the staples 10030 supported thereon to a second one. height formed, and third staple drivers 15140c that can drive staples 10030 supported on them at a third height formed, wherein the first height formed may be shorter than the second height formed and the second height formed may be shorter than the third height formed, for example. As illustrated in Figure 296, each staple 10030 may comprise the same height, or substantially the same, not formed, or not fired. In certain other embodiments, with reference now to Figure 296A, the first impellers 15140a, the second impellers 15140b, and / or the third impellers 15140c can support unformed staples having different heights. For example, first staple drivers 15140a can support staples 15130a having a first non-formed height, second staple drivers 15140b can support staples 15130b having a second non-formed height, and third staple drivers 15140c can support staples 15130c that have a third height not formed, where the first height not formed can be shorter than the second height not formed and the second height not formed may be shorter than the third height not formed, for example. Referring again to Figure 296A, the tips of the staples 15130a, 15130b, and / or 15130c may be, or at least be substantially in the same plane, while, as an alternative, the tips of the staples, 15130a, 15130b , and / or 15130c may not be in the same plane. Referring now to Figure 297, a staple cartridge can include a fabric thickness compensator 15220 having a plurality of portions having different thickness that can be implanted against tissue T by staples 15130a, 15130b, and 15130c, as shown in FIG. described earlier. In at least one embodiment, with reference now to Figure 298, the staples 15130a, 15130b, and / or 15130c can be deformed at different heights formed, where the first staples 15130a can be formed at a first formed height, the second staples 15130b can formed at a second formed height, and the third staples 15130c may be formed at a third height formed, and wherein the first height formed may be shorter than the second height formed and the second height formed may be shorter than the third height formed , for example. Other embodiments are contemplated wherein staples 15130a, 15130b, and 15130c may be formed at any suitable formed height and / or any relative formed height.
As described above, the anvil of a surgical stapling instrument can move between an open position and a closed position. In such circumstances, the surface of contact with the anvil tissue can move in its final position, or formation, while the anvil move to its closed position. Once the anvil is in its closed position, the contact surface with the tissue may not be adjustable again. Alternatively, with reference now to Figure 351, a surgical stapler, such as surgical stapler 15500, for example, may comprise an anvil channel 15560 and an adjustable tissue contact anvil adjustment plate 15561 positioned within the surgical channel. anvil 15560. In such cases, the anvil plate 15561 can be raised and / or lowered into the anvil channel 15560 in order to adjust the position of the contact surface with the tissue of the anvil plate 15561 relative to a cartridge Staples positioned opposite of the anvil plate 15561. The surgical stapler 15500 may comprise an adjustment slide 15564 which, with reference to FIGS. 356 and 357, may slide intermediate between the anvil channel 15560 and the anvil plate 15561 with the purpose of controlling the distance between the anvil plate 15561 and the staple cartridge. Referring again to Figures 351 and 352, the surgical stapler 15500 may further comprise an impeller 15562 coupled to the adjusting slide 15564 that can slide proximally with the purpose of sliding the adjustment slide 15564 proximally and / or sliding distally with the objective of sliding the adjustment slide 15564 distally. Referring again to Figures 356 and 357, the pusher 15562 can slide between two or more predefined positions in order to adjust the anvil plate 15561 between two or more positions, respectively. Such predefined positions can be demarcated on the surgical stapler 15500 as demarcations 15563 (Figure 351), for example. With reference to Figure 357, the adjustment slide 15564 may comprise a plurality of support surfaces, such as the first support surface 15565a, the second support surface 15565b, and the third support surface 15565c, for example, which can aligning with a plurality of plate positioning surfaces, such as the first positioning surface 15569a, the second positioning surface 15569b, and the third positioning surface 15569c, respectively, in the rear part of the anvil plate 15561 to position the anvil plate 15561 in a first position. In order to place the anvil plate 15561 in a second position, the pusher 15562 and the slide 15564 can slide proximally, for example, to realign the bearing surfaces 15565a-15565c of the slide 15564 relative to the positioning surfaces 15569a -15569c of the anvil plate 15561. More particularly, with reference to Figure 356, the slide 15564 can slide distally, such that the first support surface 15565a of the slide 15564 can be positioned behind the second positioning surface 15569b of the anvil plate 15561 and in such a way that the second support surface 15565b of the slide 15564 can be positioned behind the third positioning surface 15569c of the anvil plate 15561 to move the anvil plate 15561 closer to the staple cartridge . When the anvil plate 15561 moves from its first position to its second position, under such circumstances, the adjustable anvil plate 15561 can still compress plus the tissue T positioned between the anvil plate 15561 and the staple cartridge. In addition to the above, the formed height of the staples can be controlled by the position of the anvil plate 15561 relative to the staple cartridge while the forming cavities defined in the anvil plate 15561 move closer and / or further from the staple cartridge when the anvil plate 15561 is adjusted. Although only two positions are described above, the slide 15564 can slide in an appropriate number of positions to move the anvil plate 15561 closer and / or away from the staple cartridge. In any case, once the anvil plate 15561 is properly positioned, a staple deployment slider 15550 can slide distally into the staple cartridge to raise staple drivers 15540 and staples 15530 in the direction of anvil plate 15561 and staple tissue T, as illustrated in FIG. 354. Similar surgical staplers are described in the application U.S. Patent No. of series 13 / 036,647, entitled SURGICAL STAPLING INSTRUMENT, which was filed on February 28, 2011, the description of which is incorporated in its entirety as a reference in the present description.
Referring now to Figure 353, a staple cartridge can be positioned within a staple cartridge channel 15570 of surgical stapler 15500 which may comprise a tissue thickness compensator, such as tissue thickness compensator 15520, for example. . When the anvil plate 15561 moves in the direction of the staple cartridge, as described above, the anvil plate 15561 can compress the fabric thickness compensator 15520 and / or the tissue T positioned intermediate between the anvil plate 15561 and the fabric thickness compensator 15520. While the staples 15530 are deployed from the staple cartridge, with reference to the Figure 355, the staples 15530 can compress and implant the fabric thickness compensator 15520 against the tissue T. When the anvil plate 15561 is positioned against the slide 15564 and the tissue is still not positioned between the anvil plate 15561 and the compensator Fabric thickness 15520, a space may be defined between anvil plate 15561 and upper surface 15521 of fabric thickness compensator 15520 when anvil plate 15561 is in a first position. When the anvil plate 15561 is moved to a second position, the anvil plate 15561 can come into contact with the fabric thickness compensator 15520. Alternatively, when the anvil plate 15561 is positioned against the slide 15564 and the tissue still not positioned between the anvil plate 15561 and the fabric thickness compensator 15520, a space can be defined between the anvil plate 15561 and the top surface 15521 of the fabric thickness compensator 15520 when the anvil plate 15561 is in a first position and / or a second position. For example, the anvil plate 15561 may not come into contact with the fabric thickness compensator 15520. In other alternative embodiments, when the anvil plate 15561 is positioned against the slide 15564 and the tissue is still not positioned between the plate anvil 15561 and the fabric thickness compensator 15520, the anvil plate 15561 may come into contact with the upper surface 15521 of the fabric thickness compensator 15520 regardless of whether the anvil plate 15561 is in a first position and / or a second position, for example . Although only two positions of the anvil plate 15611 are described in the present description, the anvil plate 15611 can be positioned, or indexed, in any suitable number of positions.
As a result of the foregoing, a surgical stapling instrument may comprise means for adjusting the height formed of the staples that may, in various circumstances, compensate for different tissue thicknesses. Additionally, the surgical stapling instrument may comprise other means for compensating the different thicknesses of tissue and / or thickness variations within the tissue, for example. For example, the anvil plate 15561 can be adjusted up or away from the opposite staple cartridge to increase the formed, or fired, height of the staples. Correspondingly, the anvil plate 15561 can be adjusted downward, or in the direction, to the opposite staple cartridge to decrease the formed, or fired, height of the staples. The adjustment of the anvil plate 15561, for example, can adjust the space between the forming cavities defined in the anvil plate 15561 and the fired height of the staple drivers or, more specifically, the triggered height of the impeller bases. of staples, for example. Even with such a capacity to adjust the height of the staples formed to take into account the thicker and / or thinner fabric, for example, a compensator of Fabric thickness can also compensate for thicker and / or thinner fabric and / or compensate for variations in thickness in the fabric, as described above. In such cases, a surgeon may be provided with various means of compensation within the same surgical stapling instrument.
As described above and illustrated in various embodiments, a surgical stapling instrument can use a staple cartridge having a linear array of staple and staple cavities, wherein a trigger member can advance distally through the staple cartridge to unfold the staples from the staple cavities. A staple cartridge may comprise rows of staple cavities, and staples that are curved. Referring now to Figures 345 and 346, a surgical stapling instrument, such as stapler 15600, for example, may comprise one or more circular or annular rows of staple cavities defined in a circular or annular support portion 15610. Such rows of circular staples may comprise a circular row of inner staple cavities 15612 and a circular row of outer staple cavities 15613, for example. For example, the circular rows of the staple cavities may surround a circular opening 15615 or annular defined in the stapler 15600 that can accommodate a circular or annular knife movably positioned therein. In use, the fabric can be positioned against the cover surface 15611 of the support portion 15610 and an anvil (not illustrated) can be mounted to the surgical stapler 15600 through an impeller that extends through and / or is positioned inside the opening 15615 in such a way that, when the impeller is actuated, the anvil can be clamped in the direction of the support portion 15610 and compress the tissue against the cover surface 15611. Once the tissue is compressed sufficiently, the staples positioned within the staple cavities 15612 and 15613 can be ejected from the support portion 15610 and through the tissue such that the staples can come into contact with the anvil and deform sufficiently to capture tissue therein. While the staples are fired and / or after the staples are fired, the circular blade can advance and cross-section the tissue. After that, the anvil can move away from the support portion 15610 and / or separate from the surgical stapler 15600 in such a manner that the anvil and the surgical stapler 15600 can be removed from the surgical site. Such surgical staplers 15600 and such surgical techniques can be used to join two portions of a large intestine, for example. In various circumstances, the circular staple lines can be configured to hold the portions of the large intestine together while the tissue is recovered and, at the same time, allow the portions of the large intestine to expand flexibly. Similar surgical stapling instruments and surgical techniques are described in U.S. Pat. 5,285,945, entitled SURGICAL ANASTOMOSIS STAPLING INSTRUMENT, granted on February 15, 1994, the disclosure of which is incorporated in its entirety as a reference in the present description.
In addition to the above, a tissue thickness compensator can be positioned against and / or attached to the support portion 15610 of the surgical stapler 15600, for example. The tissue thickness compensator may comprise a circular or annular ring of material comprising an inner radius and an outer radius, for example. In certain circumstances, the fabric may be positioned against this ring of material and, when the anvil is used to move the fabric toward the support portion 15610, the tissue thickness compensator may be compressed between the tissue and the surface of the fabric. cover 15611. During use, the staples may be fired through the tissue thickness compensator and the tissue such that the staples may come into contact with the anvil and deform to its fired position to capture portions of tissue and the compensator Thickness of tissue inside the staples. In various circumstances, in addition to the above, the ring of material comprising the tissue thickness compensator must be sufficiently flexible to allow the portions of the large intestine surrounding the staple lines to expand. Referring again to Figures 345 and 346, a fabric thickness compensator 15620 may comprise a circular or annular flexible inner ring 15624, for example, which may define a circular opening 15625 or annular. The inner ring 15624 can be configured such that it is not captured within the staples deployed from the surgical stapler 15600; rather, the inner ring 15624 can be positioned radially inward with respect to the inner row of the staple pockets 15612. For example, the Fabric thickness compensator 15620 may comprise a plurality of labels, such as inner labels 15622 and outer labels 15623, for example, extending therefrom, such that labels can be at least partially captured within the staples, while they are deformed More particularly, with reference primarily to Figure 345, each inner tag 15622 may comprise a head that is positioned over a staple pocket 15612 that is defined in the surgical stapler 15600 where the head can be attached to the inner ring 15624 by a neck 15626 , for example, and, similarly, each outer tag 15623 may comprise a head that is positioned over a staple pocket 15613 defined in the surgical stapler 15600, wherein the head may be attached to the inner ring 15624 by a neck 15627, for example. The heads of the inner tags 15622 and the outer tags 15623 may comprise any suitable shape, such as round, oval, and / or elliptical, for example. The collars 15626 and / or 15627 can also comprise any suitable shape, wherein the collars 15627 connecting the heads of the external tags 15623 to the inner ring 15624 can be configured to extend between the adjacent inner staple pockets 15612 in the support portion 15610 , such that the collars 15627 are not captured within the staples deployed from the internal staple cavities 15612.
Referring now to Figures 347 and 348, a flexible fabric thickness compensator 15720 may comprise a flexible outer ring circular or annular 15724, for example. The outer ring 15724 can be configured such that it is not captured within staples deployed from the surgical stapler 15600; rather, the outer ring 15724 can be positioned radially outwardly relative to the outer row of the staple pockets 15613. For example, the fabric thickness compensator 15720 can comprise a plurality of labels, such as inner labels 15622 and labels external 15623, for example, extending from it, in such a way that labels can be captured at least partially within the staples, while deforming. More particularly, with reference primarily to Figure 347, each inner tag 15622 may comprise a head that is positioned over a staple pocket 15612 that is defined in the surgical stapler 15600, where the head can be attached to the outer ring 15724 by a neck 15726, for example, and, similarly, each outer tag 15623 may comprise a head that is positioned over a staple pocket 15613 defined in the surgical stapler 15600, wherein the head can be attached to the outer ring 15724 by a neck 15727, for example . The heads of the inner tags 15622 and the outer tags 15623 may comprise any suitable shape, such as round, oval, and / or elliptical, for example. The collars 15726 and / or 15727 may also comprise any suitable shape, wherein the collars 15726 connecting the heads of the inner tags 15622 to the outer ring 15724 may be configured to extend between the adjacent outer staple pockets 15613, such that the 15726 necks are not captured inside the unfolded staples of the outer staple cavities 15613. In certain alternative embodiments, a tissue thickness compensator may comprise a flexible circular or annular inner ring, a circular or annular flexible outer ring and, additionally, a plurality of labels that can be connected to the inner ring and / or the outer ring. Certain labels can be connected to the inner ring and some other labels can be connected to the outer ring. At least some of the labels can be connected to both the inner ring and the outer ring. In any case, in addition to the above, the inner ring 15624 of the fabric thickness compensator 15620, the outer ring 15724 of the fabric thickness compensator 15720, and / or any other suitable fabric thickness compensator, can be configured to flexibly expand and / or contract to accommodate the expansion and / or contraction of tissue that is implanted against. In addition, although several embodiments are described herein as comprising circular or annular support rings, a tissue thickness compensator may comprise any support structure in a form suitable for the connection of the labels thereto. In addition to the above, the circular blade that is advanced by the surgical stapler to cut the captured tissue between the anvil and the support portion can also cut the reinforcing material. The blade can separate the inner support ring from the labels by cutting the necks of these, for example.
In addition to the above, a fabric thickness compensator may comprise removable and / or relatively movable positions that can be configured to allow the tissue thickness compensator to expand and / or contract for the purpose of accommodating the movement of the tissue against which it is implanted. Referring now to Figures 349 and 350, a circular or annular tissue thickness compensator 15820 can be positioned against and / or supported by the cover surface 15611 of the surgical stapler 15600 that can be maintained in an unexpanded position (FIG. 349) while implanted against the fabric and, after the fabric thickness compensator 15820 is implanted, the fabric thickness compensator 15820 can be configured to expand outwardly, as illustrated in Figure 350. The thickness compensator of fabric 15820 can comprise a plurality of arcuate portions 15822 that can be connected together by an inner ring 15824, for example. The arcuate portions 15822 may be separated from each other by the joints 15828. In at least one other form of embodiment, the arcuate portions 15822 may be connected together where, for example, an array of perforations may allow the arcuate portions 15822 to be separated from each other. . In any case, the arcuate portions 15822 may each comprise interlock features, such as projections 15826 and notches 15823, for example, which may cooperate to limit relative movement between the arched portions 15822 before the thickness compensator is implanted. of fabric 15820. In addition to the above, each arcuate portion 15822 may be connected to the inner ring 15824 by one or more connectors 15827, for example, which may be configured to removably maintain the arcuate portions 15822 in position. After the staples, such as staples 10030, for example, stored inside the Support portion 15610 is used to implant the fabric thickness compensator 15620 against tissue, with reference primarily to Figure 350, connectors 15827 may be separated from inner ring 15824 and allow fabric thickness compensator 15820 to expand at least. partially to accommodate movement within the underlying tissue. In various circumstances, all of the arcuate portions 15822 can be separated from the inner ring 15824, while, in other circumstances, only some of the arcuate portions 15822 can be separated from the inner ring 15824. In certain alternative embodiments, the arcuate portions 15822 can be connected by sections flexible that can allow the arcuate portions 15822 to move relative to one another but not to separate from each other. For example, the flexible sections may not receive staples therein and may be configured to stretch and / or contract to accommodate the relative movement of the arcuate portions 15822. In Figures 349 and 350, the fabric thickness compensator 15820 may comprise eight portions. arched 15822, for example. Alternatively, a fabric thickness compensator may comprise any suitable number of arcuate portions, such as two or more arcuate portions, for example.
In addition to the foregoing, a tissue thickness compensator 15620, 15720, and / or 15820, for example, may be configured to compensate for thicker and / or thinner tissue captured between the anvil and the support portion 15610 of the surgical instrument 15600. Similar to the above, the formed, or triggered, height of the staples can be adjusted by moving the anvil in direction a, and / or away from the support portion 15610. More particularly, the anvil can move closer to the support portion 15610 to decrease the formed height of the staples, whereas, correspondingly, the anvil can move further away from the support portion 15610 for increasing the height formed of the staples. In such cases, as a result, a surgeon can adjust the anvil away from the support portion 15610 to take the coarse tissue into account and toward the support portion 15610 to take the thin tissue into account. In various other circumstances, the surgeon may decide not to adjust the anvil at all and rely on the tissue thickness compensator to account for the thinnest and / or thickest tissue. As a result, the surgical instrument 15600 may comprise at least two means for compensating different thicknesses and / or variations in tissue thickness.
As described above, a tissue thickness compensator can be attached to a support portion of a staple cartridge. The lower surface of the fabric thickness compensator may comprise one between a layer of hooks or a layer of circular instruments while one surface of cover on the support portion may comprise the other between the layer of hooks and the layer of circular instruments. For example, the hooks and circular instruments may be configured to engage with each other and removably retain the tissue thickness compensator to the support portion. Each hook may comprise an enlarged head extending from a neck, for example. A plurality of pads comprising the circular instruments, for example, may be attached to the surface bottom of the fabric thickness compensator, while a plurality of pads comprising the hooks may be attached to the cover surface of the support portion. The support portion may comprise one or more openings and / or recesses, for example, which may be configured to receive an insert therein comprising hooks and / or circular instruments. Additionally or in lieu of the foregoing, a fabric thickness compensator can be removably mounted to an anvil through the use of such hook and circular instrument arrangements, for example. Hooks and circular instruments may comprise fibrous surfaces, for example.
As described above, a staple cartridge may comprise a support portion and a tissue thickness compensator attached to the support portion. As described above, in addition, the support portion may comprise a longitudinal groove configured to receive a cutting member therein and the fabric thickness compensator may comprise a retaining member that can be retained in the longitudinal groove. Referring now to Figure 386, a staple cartridge 16000 may comprise a support portion 16010 that includes a cover surface 16011 and a longitudinal groove 16015. The staple cartridge 16000 may further comprise a fabric thickness compensator 16020 positioned above the cover surface 16011. The fabric thickness compensator, may include a longitudinal retaining member 16025 extending downwardly within the longitudinal groove 16015. For example, the retainer member 16025 may pressed into groove 16015 in such a way that the interaction between retaining member 16025 and groove 16015 can withstand relative movement between support portion 16010 and tissue thickness compensator 16020. Body of tissue thickness compensator 16020 it can be composed of a first material and the retaining member 16025 can be composed of a second or different material. The body of the fabric thickness compensator 16020 may comprise a material having a first hardness and the retaining member 16025 may comprise a material having a second hardness, wherein the second hardness may be greater than the first hardness, for example. In use, the staples 10030 can be pushed up by staple drivers 10040, such that the tips of the staples 10030 can push through the body of the tissue thickness compensator 16020 and emerge from the tissue contacting surface 16021 and capturing in at least a portion of the tissue thickness compensator 16020 against the target tissue. A cutting member passing through the slot 16015 can cross-section the retaining member 16025 while the clips 10030 are deployed. Once the tissue thickness compensator 16020 is implanted, the retaining member 16025 can be removed from the slot 16015. Alternatively, the body of the tissue thickness compensator 16020 can be configured to separate from retaining member 16025.
Referring now to Figures 387 and 389, a staple cartridge 17000 may comprise a support portion 17010 that includes a cover surface 17011 and a longitudinal groove 17015. The staple cartridge 17000 may further comprise a fabric thickness compensator 17020 positioned above the cover surface 17011. The fabric thickness compensator 17020 may include a retainer member longitudinal 17025 extending downwardly into the longitudinal slot 17015. For example, the retaining member 17025 can be pressed into the slot 17015 in such a way that the interaction between the retaining member 17025 and the slot 17015 can withstand the relative movement between the support portion 17010 and the fabric thickness compensator 17020. The retainer member 17025 can extend through the entire fabric thickness compensator 17020 to the upper surface 17021 thereof, wherein the body portions 17024 of the compensator of fabric thickness 17020 may be attached to opposite sides of retaining member 17025. For example, member d The retention 17025 can also be configured to withstand lateral deflection, for example, of the fabric thickness compensator 17020. The body portions 17024 can be composed of a first material and the retaining member 17025 can be composed of a second or different material. The body portions 17024 can be composed of a material having a first hardness and the retaining member 17025 can be composed of a material having a second hardness, wherein the second hardness can be higher than the first hardness, for example. In addition to the foregoing, a cutting member passing through the slot 17015 can cross-section the retaining member 17025 while deploying the staples 10030. Once the tissue thickness compensator 17020 is implanted, the retention member 17025 can be removed from the slot 17015. Alternatively, the body portions 17024 can be configured to separate from the retention member 17025.
Referring now to Figure 388, a staple cartridge 18000 may comprise a support portion 18010 that includes a cover surface 18011 and a longitudinal groove 18015. The staple cartridge 18000 may further comprise a fabric thickness compensator 18020 positioned above the cover surface 18011. The fabric thickness compensator 18020 may include a longitudinal retaining member 18025 extending downwardly within the longitudinal slot 18015. For example, the retainer member 18025 may be pressed into the slot 18015 in such a way that the interaction between the retainer member 18025 and the groove 18015 can withstand relative movement between the holder portion 18010 and the fabric thickness compensator 18020. The retainer member 18025 can extend through the entire fabric thickness compensator 18020 to the upper surface 18021 of this, wherein the body portions 18024 of the co Fabric thickness moulder 18020 may be attached to opposite sides of retaining member 18025. Retaining member 18025 may comprise an enlarged portion 18026 that can be received in a cavity 18016 that is defined in slot 18015. For example, the enlarged portion 18026 can resist the removal of retention member 18025 from slot 18015.
The fabric thickness compensator may comprise an extrudable, fuseable and / or moldable composition comprising at least one of the synthetic and / or non-synthetic materials described in the present disclosure. The tissue thickness compensator may comprise a film or sheet comprising two or more layers. The fabric thickness compensator can be obtained by using conventional methods, such as, for example, mixing, fusing, combining, spraying, wicking, solvent evaporation, immersion, brushing, vapor deposition, extrusion, calendering, casting, molding and the like. In extrusion, an opening may be in the form of a matrix comprising at least one opening for imparting a shape to the emerging extruded product. In calendering, an opening may comprise a line of contact between two rollers. Conventional molding methods may include, but are not limited to, blow molding, injection molding, foam injection, compression molding, thermoforming, extrusion, foam extrusion, film blowing, calendering, spinning, solvent welding, coating methods, such as dip coating and spin coating, solution casting and film casting, plastisol processing (including knife coating, roller coating and casting), and combinations thereof. In injection molding, an opening may comprise a tip and / or channels / corridors and / or cavities and mold features. In compression molding, the composition can be placed in a mold cavity, heated to a suitable temperature, and formed by exposure to compression under a relatively high pressure. In casting, the composition may comprise a liquid or suspension that can be poured or otherwise provided in, on and / or around a mold or object to replicate the characteristics of the mold or object. After melting, the composition can be dried, cooled and / or cured to form a solid.
A method of manufacturing a fabric thickness compensator can generally comprise providing a fabric thickness compensator composition, fluidizing the composition so that it is capable of flowing, and forming the composition in the melt, semi-melt, or plastic state in a layer and / or film having the desired thickness. With reference to Figure 527A, a tissue thickness compensator can be manufactured by dissolving a hydrogel precursor in an aqueous solution, dispersing biocompatible particles and / or fibers therein, providing a mold having biocompatible particles therein, providing the solution in the mold, contacting an activator and the solution, and curing the solution to form the tissue thickness compensator comprising an outer layer comprising biocompatible particles and an inner layer comprising biocompatible particles incorporated therein. As shown in Figure 527A, a biocompatible layer 70250 can be provided at the bottom of a mold 70260, and an aqueous solution of a hydrogel precursor 70255 having biocompatible particles 70257 disposed therein can be provided to the mold 70260, and the aqueous solution can be cured to form a compensator of fabric thickness having a first layer comprising a biocompatible material, such as ORC, for example, and a second layer comprising a hydrogel having biocompatible fibers, such as ORC fibers, disposed therein. The tissue thickness compensator it may comprise a foam comprising an outer layer comprising biocompatible particles and an inner layer comprising biocompatible particles incorporated therein. A tissue thickness compensator can be manufactured by dissolving a sodium alginate in water, dispersing ORC particles in it, providing a mold having ORC particles in it, pouring the solution into the mold, spraying or infusing calcium chloride to come into contact with the solution to initiate the crosslinking of the sodium alginate, lyophilize the hydrogel to form the tissue thickness compensator comprising an outer layer comprising ORC and an inner layer comprising a hydrogel and ORC particles incorporated therein.
With reference to Figure 527B, a method of manufacturing a three-layer fabric thickness compensator may generally comprise dissolving a first hydrogel precursor in a first aqueous solution, dispersing biocompatible particles and / or fibers in the first aqueous solution, provide a mold 70260 having a first layer 70250 of biocompatible particles therein, provide the first aqueous solution in the mold, contact an activator and the first aqueous solution, cure the first aqueous solution to form a second layer 70255, dissolve a second hydrogel precursor in a second aqueous solution, provide the second aqueous solution in the mold, cure the second aqueous solution to form a third layer 70265. A three layer fabric thickness compensator can be manufactured by dissolving a sodium alginate in water to form a first aqueous solution, dispersing ORC particles in the first aqueous solution, providing a mold having a first layer of ORC particles in it, pouring the first aqueous solution into the mold, spraying or infusing calcium chloride to come in contact with the first aqueous solution to initiate the cross-linking of sodium alginate, lyophilizing the first aqueous solution to form a second layer comprising a hydrogel having OCR particles incorporated therein, dissolving the sodium alginate in water to form a second aqueous solution, pouring the second aqueous solution into the mold, spraying or infusing calcium chloride to come into contact with the second aqueous solution to initiate the cross-linking of the sodium alginate, lyophilize the second aqueous solution to form a third layer comprising a hydrogel.
A method of manufacturing a tissue thickness compensator comprising at least one medicament stored and / or absorbed therein that can generally comprise providing a tissue thickness compensator and bringing the tissue thickness compensator and the tissue thickness compensator into contact with one another. medication to retain the medication in the tissue thickness compensator. A manufacturing method of a tissue thickness compensator comprising an antibacterial material it can comprise providing a hydrogel, drying the hydrogel, swelling the hydrogel in an aqueous solution of silver nitrate, contacting the hydrogel and a sodium chloride solution to form the tissue thickness compensator having antibacterial properties. The tissue thickness compensator may comprise silver dispersed therein.
With reference to Figure 533, a method for manufacturing a fabric thickness compensator may comprise coextrusion and / or bonding. The fabric thickness compensator 70550 may comprise a laminate comprising a first layer 70555 and a second layer 705f¾3 sealing by sealing an inner layer 70565 comprising a hydrogel, for example. The hydrogel may comprise a dry film, a dry foam, a powder, and / or granules, for example. The hydrogel may comprise superabsorbent materials, such as, for example, polyvinyl pyrrolidone, carboxymethyl cellulose, propyl poly acrylate sulful. The first and / or second layers can be made in line by feeding the raw materials of the first and second layers, respectively, in an extruder from a hopper, and thereafter, supplying the first and second layers. The raw materials of the inner layer 70565 can be added to a hopper of an extruder. The raw materials can be mixed and compounded in a dispersed manner at a high temperature within the extruder. As the raw materials leave the matrix 70570 in an opening, the inner layer 70565 can be deposited on a surface of the first layer 70555. The fabric thickness compensator can comprise a foam, film, powder, and / or granule. The first and Second layers 70555 and 70560 can be placed in face-to-face relationship. The second layer 70560 can be aligned with the first layer 70555 in a face to face relationship by a roller 70575. 70555 The first layer may be adhered to the second layer 70560, wherein the first and second layers 70555, 70560 can physically capture inner layer 70565. The layers may be joined together under slight pressure, by virtue of conventional calender bonding processes, and / or by the use of adhesives, for example, to form the fabric thickness compensator 70550. As shown in FIG. Figure 407, the first and second layers 70555 and 70560 can be joined together through a lamination process by using a grooved roll 70580, for example. As a result of the foregoing, the inner layer 70565 may be contained and / or sealed by the first and second layers 70555 and 70560 which may collectively form an outer layer, or barrier. The outer layer can prevent or reduce moisture from coming into contact with the inner layer 70565 until the outer layer is broken.
With reference to Figure 390, an end effector 12 for a surgical instrument 10 (Figure 1) can be configured to receive a fixation cartridge unit, such as staple cartridge 20000, for example. As illustrated in Figure 390, the staple cartridge 20000 can be configured to fit into a cartridge channel 20072 of a clamp 20 070 of the end effector 12. Alternatively, the staple cartridge 20000 may be integral with the end effector 12 such that the staple cartridge 20000 and the end effector 12 are formed as a single-unit construction unity. The staple cartridge 20000 may comprise a first body portion, such as the rigid support portion 20010, for example. The staple cartridge 20000 may also comprise a second body portion, such as a compressible portion or tissue thickness compensator 20020, for example. Alternatively, the fabric thickness compensator 20020 may not comprise an integral part of the staple cartridge 20000, but may be positioned in any other way relative to the end effector 12. For example, the tissue thickness compensator 20020 may be attached to a anvil 20060 of the end effector 12 or can be retained in any other way in the end effector 12. With reference to Figure 407 the staple cartridge may further comprise retention clips 20126 which can be configured to inhibit the tissue thickness compensator 20020 of prematurely separating from the support portion of 20010. The reader will appreciate that the fabric thickness compensators described herein may be installed or otherwise coupled with a variety of end effectors and that such embodiments are within the scope of the present invention. description.
Similar to the tissue thickness compensators described in the present description, reference is now made to Figure 407, the tissue thickness compensator can be released or uncoupled with the surgical end effector 12. For example, the rigid support portion 20010 of the staple cartridge 20000 can remain coupled with the channel of the clamping cartridge 20072 of the end effector clamp 20070, while the tissue thickness compensator 20020 is decoupled from the support portion rigid 20010. Fabric thickness compensator 20020 can be released from end effector 12 after staples 20030 (Figures 407 to 412) are deployed from staple cavities 20012 in rigid support portion 2010, similar to various embodiments described in FIG. the present description. The staples 20030 can be fired from the staple pockets 20012 in such a way that staples 20030 couple the tissue thickness compensator 20020. In addition, similar to various embodiments described in the present description, reference is generally made to FIGS. 392, 411 and 412, a staple 20030 can capture a portion of the tissue thickness compensator 20020 together with the stapled tissue T. The fabric thickness compensator 20020 may be deformable and the portion of the fabric thickness compensator 20020 that is captured within a fired staple 20030 may be compressed. Similar to the fabric thickness compensators described in the present description, the thickness compensator Fabric 20020 can compensate for the different thicknesses, compressibilities, and / or fabric densities T captured within each staple 20030. In addition, as also described in the present description, the fabric thickness compensator 20020 can compensate for spaces created by staples malformed 20030.
The tissue thickness compensator 20020 can be compressible between the non-compressed height (s) and the compressed height (s). With reference to Figure 407, the fabric thickness compensator 20020 may have an upper surface 20021 and a lower surface 20022. The height of the tissue thickness compensator may be the distance between the upper surface 20021 and the lower surface 20022. The uncompressed height of the fabric thickness compensator 20020 may be the distance between the upper surface 20021 and the lower surface 20022 when minimal or no force is applied to the tissue thickness compensator 20020, that is, when the tissue thickness compensator is not compressed 20020. The compressed height of the fabric thickness compensator 20020 may be the distance between the upper surface 20021 and the lower surface 20022 when a force is applied to the fabric thickness compensator 20020, such as when a fired staple 20030 captures a portion of the tissue compensator 20020. tissue thickness 20020, for example. The tissue thickness compensator 20020 may have a distal end 20025 and a proximal end 20026. As illustrated in Figure 407, the uncompressed height of the tissue thickness compensator 20020 may be uniform between the distal end 20025 and the proximal end. 20026 of the fabric thickness compensator 20020. Alternatively, the uncompressed height can vary between the distal end 20025 and the proximal end 20026. For example, the upper surface 20021 and / or the lower surface 20022 of the tissue thickness compensator 20020 can inclining and / or staggering relative to each other in such a way that the uncompressed height varies between the proximal end 20026 and the distal end 20025. The uncompressed height of the tissue thickness compensator 20020 may be approximately 2.0 mm (0.08 inches), for example. Alternatively, the uncompressed height of the compensator Fabric thickness 20020 may vary between about 0.64 mm (0.025 inches) and about 2.5 mm (0.10 inches), for example.
As described in greater detail in the present description, the fabric thickness compensator 20020 can be compressed at different compressed heights between the proximal end 20026 and the distal end 20025 thereof. Alternatively, the fabric thickness compensator 20020 can be compressed uniformly over the entire length thereof. The compressed height (s) of the fabric thickness compensator 20020 may depend on the geometry of the end effector 12, the characteristics of the tissue thickness compensator 20020, the coupled tissue T and / or Staples 20030, for example. The compressed height of the tissue thickness compensator 20020 can be related to the tissue space in the end effector 12. When the anvil 20060 is clamped to the staple cartridge 20000, the tissue space can be defined between an upper cover surface 20011 (Figure 407) of the staple cartridge 20000 and a tissue contacting surface 20061 (Figure 390) of the anvil 20060, for example. The tissue space can be approximately 0.64 mm (0.025 inches) or approximately 2.5 mm (0.100 inches), for example. The tissue space can be about 0.750 millimeters or about 3500 millimeters, for example. The compressed height of the tissue thickness compensator 20020 may be equal or substantially equal to the tissue space, for example. When the tissue T is placed within the tissue space of the end effector 12, the compressed height of the Fabric thickness compensator may be smaller to accommodate tissue T. For example, where the fabric space is approximately 0.750 millimeters, the compressed height of the fabric thickness compensator may be approximately 0.500 millimeters. When the tissue space is approximately 3,500 millimeters, the compressed height of the tissue thickness compensator of 20020 can be about 2.5 mm, for example. In addition, the fabric thickness compensator 20020 may comprise a minimum compressed height. For example, the minimum compressed height of the fabric thickness compensator 20020 may be approximately 0.250 millimeters. The tissue space defined between the cover surface of the staple cartridge and the contact surface with the anvil tissue may be the same, or at least substantially equal, at the uncompressed height of the tissue thickness compensator, for example.
Referring mainly to Figure 391, the fabric thickness compensator 20020 may comprise a fibrous, non-woven material 20080 including fibers 20082. The fabric thickness compensator 20020 may comprise a felt or felt-like material. The fibers 20082 in the non-woven material 20080 can be fastened together by any means known in the art, including, but not limited to, needle piercing, thermal bonding, hydroentanglement, ultrasonic bonding, chemical bonding, and fusion-blown union. In addition, the layers of non-woven material 20080 can be joined together mechanically, thermally or chemically to form the fabric thickness compensator 20020. As described in greater detail in the present description, the fibrous, non-woven material 20080 may be compressible, which may enable compression of the fabric thickness compensator 20020. The tissue thickness compensator 20020 may further comprise a non-compressible portion. . For example, the fabric thickness compensator 20020 may comprise a compressible nonwoven material 20080 and a non-compressible portion.
Still with reference principally to Figure 391, the non-woven material 20080 may comprise a plurality of fibers 20082. At least some of the fibers 20082 in the non-woven material 20080 may be enshrined fibers 20086. The crimped fibers 20086 may be, for example , crimped, twisted, twisted, bent, deformed, spirally, curled and / or arched within the non-woven material 20080. As described in more detail in the present description, the crimped fibers 20086 may be formed in any suitable manner in such a manner that the deformation of the crimped fibers 20086 generates a spring load or restoring force. The 20086 crimped fibers can be formed into heat to form a coiled or substantially coiled form. The 20086 crimped fibers can be formed from unbonded fibers 20084. For example, the unbonded fibers 20084 can be wound around a hot mandrel to form a substantially coiled shape.
The fabric thickness compensator 20020 may comprise a homogenous absorbable polymer matrix. The homogenous absorbable polymer matrix may comprise a foam, gel, and / or film, by example. In addition, the plurality of fibers 20082 can be dispersed throughout the homogenous absorbable polymer matrix. At least some of the fibers 20082 in the homogenous absorbable polymer matrix may be 20086 crimped fibers, for example. As described in more detail in the present description, the homogenous absorbable polymer matrix of the fabric thickness compensator 2002 can be compressible.
With reference to Figures 394 and 395, the bonded fibers 20086 can be randomly dispersed through at least a portion of the non-woven material 20080. For example, crimped fibers 20086 can be randomly dispersed through the non-woven material 20080 in such a way that a portion of the non-woven material 20080 comprises more 20086 crimped fibers than other portions of the 20080 non-woven material., the 20086 crimped fibers can be assembled in 20085a, 20085b, 20085c, 20085d and 20085e fiber agglomerations, for example, in the 20080 non-woven material. The shape of the 20086 crimped fibers can cause the interlacing of 20086 fibers during the manufacture of the fibers. non-woven material 20080; the entanglement of the crimped fibers 20086 can, in turn, lead to the formation of fiber agglomerations 20085a, 20085b, 20085c, 20085d and 20085e. Additionally or alternatively, the crimped fibers 20086 can be randomly oriented along the non-woven material 20080.
For example, with reference to Figure 391, a first crimped 20086a fiber can be oriented in a first direction, a second fiber crimped 20086b can be oriented in a second direction, and a third crimped fiber 20086c can be oriented in a third direction.
The crimped fibers 20086 can be systematically distributed and / or arranged along at least a portion of the non-woven material 20080. For example, with reference now to Figure 396, the crimped fibers 20186 can be positioned in an arrangement 20185, in FIG. that a plurality of crimped fibers 20186a are disposed in a first direction and a plurality of crimped fibers 20186b are disposed in a second direction. The crimped fibers 20186 may overlap such that they intertwine or interconnect with each other. The crimped fibers 20186 can be organized systematically such that a crimped fiber 20186a is substantially parallel to another crimped fiber 20186a. Yet another crimped fiber 20186b can be substantially transverse to some crimped fibers 20186a. The crimped fibers 20186a can be substantially aligned with a first axis Y and the crimped fibers 20186b can be substantially aligned with a second axis X. In some cases, the first axis Y can be perpendicular or substantially perpendicular to the second axis X, for example.
With reference mainly to Figure 397, the crimped fibers 20286 may be arranged in an array 20285. Each crimped fiber 20286 may comprise a longitudinal axis defined between a first end 20287 and a second end 20289 of the crimped fiber 20286. The crimped fibers 20186 may Distribute systematically in the non-woven material 20080 such that a first end 20287 of a crimped fiber 20286 is placed adjacent a second end 20289 of another crimped fiber 20286. In another example, with reference now to Figure 398, a fiber arrangement 20385 it may comprise a first crimped fiber 20386a oriented in a first direction, a second crimped fiber 20386b oriented in a second direction, and a third crimped fiber 20386c oriented in a third direction, for example. A single pattern or arrangement of crimped fibers 20286 can be repeated throughout the entire non-woven material 20080. The crimped fibers can be arranged in different patterns throughout the entire non-woven material 20080. In a further alternative, the non-woven material 20080 may comprise at least one pattern of crimped fibers, as well as a plurality of crimped fibers randomly oriented and / or randomly distributed.
Referring again to Figure 391, the plurality of fibers 20082 in the non-woven material 20080 may comprise at least some unbonded fibers 20084. The unbonded fibers 20084 and the bonded fibers 20086 in the non-woven material 20080 may be interlaced or interconnected. The ratio of fibers bonded 20086 to unbonded fibers 20084 can be about 25: 1, for example. In another example, the ratio of bonded fibers 20086 to unbonded fibers 20084 can be about 1:25, for example. Alternatively, the ratio of fibers bonded 20086 to unbonded fibers 20084 may be about 1: 1, for example. As described in more detail In the present description, the number of crimped fibers 20086 per unit volume of non-woven material 20080 can affect the restoring force generated by the non-woven material 20080 when the non-woven material 20080 is deformed. As also described in more detail in presently, the restoring force generated by the non-woven material 20080 may also depend, for example, on the material, shape, size, position and / or orientation of the crimped and non-crimped fibers 20086, 20084 on the non-woven material 20080 The fibers 20082 of the nonwoven material 20080 may comprise a polymer composition. The polymer composition of the 20082 fibers may comprise non-absorbable polymers, absorbable polymers, or combinations thereof. The absorbable polymers can include biocompatible, bioabsorbable elastomeric polymers. In addition, the polymer composition of the 20082 fibers may comprise synthetic polymers, non-synthetic polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. For example, fibers 20082 may comprise a poly (glycolide-L-lactide) copolymer 90/10, such as, for example, the copolymer commercially available from Ethicon, Inc. under the trade designation "VICRYL (polyglactic 910)". Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharide, glycoprotein, elastin, proteoglycans, gelatin, collagen and regenerated oxidized cellulose (ORC). Similar to polymer compositions in the compensator of fabric thickness described in the present disclosure, the polymer composition of the 20082 fibers may include varied amounts of absorbent polymers, non-absorbent polymers, synthetic polymers, and / or non-synthetic polymers, for example, as a function of percent weight.
The bonded fibers 20086 of the nonwoven material 20080 may comprise a first polymeric composition and the unbonded fibers 20084 of the nonwoven material 20080 may comprise a different polymer composition. For example, the bonded fibers 20086 can comprise synthetic polymer (s), such as, for example, poly (glycolide-L-lactide) 90/10, while non-linked fibers 20084 can comprise polymer (s) not synthetic (s), such as, for example, oxidized regenerated cellulose. Alternatively, the bonded fibers 20086 and the unbonded fibers 20084 may comprise the same polymer composition.
As described herein, the bonded fibers 20086 and the unbonded fibers 20084 can be fixed together, for example, by needle punching, thermal bonding, hydroentanglement, ultrasonic bonding, chemical bonding, and meltblown bonding. The 20086 crimped fibers comprising synthetic polymers such as, for example, "VICRYL (polyglactic 910)", and the non-crimped fibers 20084 comprising regenerated oxidized cellulose can be punched together with needle to form the non-woven material 20080. The non-woven material 20080 may comprise about 5% to 50% by weight of "VICRYL (polyglactic 910)" fibers bonded 20086 and about 5% to 50% by weight of cellulose fibers (ORC) regenerated oxidized not crimped 20084, for example. When the non-woven material 20080 comes into contact with the T-fabric, the unbonded ORC fibers 20084 can rapidly react with plasma in the tissue to form a gelatinous mass, for example. The formation of the gelatinous ORC mass can be instantaneous or almost instantaneous upon contact with the tissue. In addition, after formation of the gelatinous ORC mass, the "VICRYL (polyglactic 910)" 20086 crimp fibers can remain dispersed throughout the 20080 non-woven material. For example, the 20086 crimped fibers can be suspended in the gelatinous ORC mass. While the gelatinous ORC mass is bioabsorbed, the "VICRYL (polyglactic 910)" fibers bonded 20086 can exert an elastic recovery force on the adjacent tissue, as described in greater detail in the present description. In addition, the fabric may begin to cure around the "VICRYL (polyglactic 910)" fibers and / or the formed staples 30030, as also described in greater detail in the present description.
With reference principally to Figures 407 to 410, the holder portion 20010 of the staple cartridge 20000 may comprise a cartridge body 20017, an upper cover surface 20011, and a plurality of staple cavities 20012. Each staple pocket 20012 may defining an opening in the cover surface 20011. A staple 10030, for example, can be removably positioned in each staple pocket 20012. A single staple 20030 is disposed in each staple pocket 20012. With reference primarily to FIGS. 411 and 412 and similar to the staples described in the present description, each staple 20030 may comprise a base 20031 that has a first end 20035 and a second end 20036. A staple leg 20032 can extend from the first end 20035 of the base 20031 and another staple leg 20032 can extend from the second end 20036 of the base 20031. With reference again to the Figures 407-410, prior to deployment of the staples 20030, the base 20031 of each staple 20030 can be supported by a staple driver 20040 positioned within the rigid support portion 20010 of the staple cartridge 20000. Also prior to the staple deployment 20030, the legs 20032 of each staple 20030 can be contained at least partially within a staple pocket 20012.
The staples 20030 can be deployed between an initial position and a triggered position. For example, with reference primarily to Figure 410, staples 20030 may be in an initial position (staples 20030e, 20030f), a partially triggered or intermediate position (staples 20030c, 20030d), or a fired position (staples 20030a, 20030b) . The impeller 20040 can incite the staples between the initial position and the triggered position. For example, the base 20031 of each staple 20030 can be supported by an impeller 20040. The legs 20032 of a staple (staples 20030e, 20030f in Figure 409, for example) can be placed within a staple pocket 20012. As the staple cavity 20012 firing member or staple firing glider 20050 is moved from proximal end 20001 to distal end 20002 of staple cartridge 20000, an inclined surface 20051 on slider 20050 may come into contact with an inclined surface 20042 on an impeller 20040 for unfolding the staple 20030 positioned above the impeller in contact 20040. The staples 20030 can be deployed between an initial position and a fired position so that the legs 20032 move through the non-woven material 20080 of the tissue thickness compensator 20020, penetrate in the upper surface 20021 of the fabric thickness compensator 20020, they penetrate the tissue T, and come into contact with an anvil 20060 (Figure 390) positioned opposite the staple cartridge 2000 in the end effector 12. The staple legs 20032 can deforming against the anvil 20060 and the legs 20032 of each staple 20030 may capture a portion of the nonwoven material 20080 and a portion of the tissue T.
In the fired configuration (Figures 411 and 412), each staple 20030 can apply a compressive force to the tissue T and the fabric thickness compensator 20020 captured within the staple 20030. With reference primarily to FIGS. 409 and 410, the legs 20032 of each staple 20030 can be deformed downward toward the base 20031 of the staple 20030 to form a staple capture zone 20039. The staple capture zone 20039 can be the area in which the T tissue and the thickness compensator Fabric 20020 can be captured by a fired staple 20030. In various circumstances, the staple capture area 20039 can be defined between the internal surfaces of the deformed legs 20032 and the inner surface of the base 20031 of a 20030 staple. capture area 20039 for a staple 20030 may depend on several factors such as the length of the legs, the diameter of the legs, the width of the base, and / or the degree to which the legs deform, for example.
When a nonwoven material 20080 is captured in a staple capture area 20039, the captured portion of the nonwoven material 20080 can be compressed. The compressed height of the 20080 nonwoven material captured in a staple capture zone 20039 can vary within the cartridge of staples 20000 as a function of the T-tissue in the same staple capture area 20039. For example, where the T-tissue is thinner, the staple capture area 20039 may have more space for the 20080 non-woven material and as a result , the nonwoven material 20080 may not be compressed as much as it would be if the T fabric were thicker. When the tissue T is thicker, the nonwoven material 20080 can be further compressed to accommodate the thicker tissue T, for example. For example, with reference to Figure 411, the non-woven material 20080 may be compressed to a first height in a first staple capture area 20039a, a second height in a second staple capture area 20039b, a third height in a third staple capture area 20039c, a fourth height in a fourth staple capture area 20039d, and a fifth height in a fifth staple capture area 20039e, for example. Similarly, as illustrated in Figure 412, the nonwoven material 20080 can be compressed to a first height in the first staple capture area 20039a, a second height in the second staple capture area 20039b, a third height in the third staple capture area. staple capture area 20039c, and a fourth height in the fourth catch area of staple 20039d. Alternatively, the compressed height of the non-woven material 20080 may be uniform throughout the staple cartridge 20010.
An applied force can move the nonwoven material 20080 from an initial non-compressed configuration to a compressed configuration. In addition, the non-woven material 20080 can be flexible, such that, when compressed, the non-woven material 20080 can generate a restoring or elastic recovery force. When deformed, the non-woven material 20080 may seek to recover from the compressed or deformed configuration. As the nonwoven material 20080 seeks to recover, it can exert a restoring or elastic recovery force on the fabric also captured in the staple capture area 30039, as described in greater detail in the present description. When the applied force is subsequently removed, the restoring force can cause the non-woven material to recover from the compressed configuration. The non-woven material can be recovered 20080 at the initial configuration, uncompressed, or can be recovered to a configuration substantially similar to the initial, uncompressed configuration. The deformation of the nonwoven material 20080 can be elastic. The deformation of the nonwoven material may be partially elastic and partially plastic.
When a portion of the non-woven material 20080 is compressed in a staple capture zone 20039, the fibers bonded 20086 in that portion of the non-woven compensator 20039 may also be compressed or otherwise deformed. The amount of crimped fiber 20086 that is deformed may correspond to the amount that the captured portion of the fiber is compressed. nonwoven material 20080. For example, with reference to Figure 392, the non-woven material 20080 can be captured by the unfolded staples 20030. When the non-woven material 20080 is further compressed by an unfolded staple 20030, the average strain of the crimped fibers 20086 may be longer. Further, when the non-woven material 20080 is less compressed by a deployed staple, the average crimped fiber strain 20086 may be smaller. Similarly, with reference to Figures 411 and 412, in a staple capture area 20039d, where the non-woven material 20080 is further compressed, the 20086 crimped fibers can, on average, deform more in that staple capture area 20039d . Furthermore, in a staple capture area 20039a where the non-woven material 20080 is compressed less, the 20086 crimped fibers can, on average, be deformed less in that staple capture area 20039a.
The ability of the non-woven material 20080 to recover from the deformed configuration, i.e., the flexibility of the non-woven material 20080, can be a function of the flexibility of the bonded fibers 20086 in the non-woven material 20080. The bonded fibers 20086 can be deformed elastically. The deformation of the crimped fibers 20086 can be partially elastic and partially plastic. The compression of each 20086 crimped fiber can cause the compressed crimped fibers 20086 to generate a restoration or elastic recovery force. For example, the compressed crimped fibers 20086 can generate a restoring force while the 20086 fibers seek to recover from their compressed configuration. The 20086 fibers may seek to return to their initial configuration, uncompressed or to a substantially similar configuration. The 20086 crimped fibers may seek to partially return to their initial configuration. Only a portion of the bonded fibers 20086 in the nonwoven material 20080 can be flexible. When a 20086 crimped fiber is composed of a linear elastic material, the restoring force of the compressed crimped fiber 20086 can be a function of the amount of crimped fiber 20086 being compressed and the fiber bundle strength index 20086, by example. The index of strength of the crimped fiber 20086 can, at least, depend on the orientation, the material, the shape and / or the size of the crimped fiber 20086, for example.
The bonded fibers 20086 in the nonwoven material 20080 may comprise a uniform strength index. Alternatively, the index of strength of the bonded fibers 20086 may vary in the non-woven material 20080. When a 20086 crimped fiber having a large strength index is compressed a lot, the crimped fiber 20086 may generate a large restoration force. When a 20086 crimped fiber that has the same high strength index is compressed less, the 20086 crimped fiber can generate a smaller restoring force. The sum of restoring forces generated by the compressed crimped fibers 20086 in the non-woven material 20080 can generate a combined restoring force along the non-woven material 20080 of the fabric thickness compensator 20020. The non-woven material 20080 can exert the combined restoration force on the tissue T captured within a staple fired 20030 with the compressed nonwoven material 20080.
In addition, the number of crimped fibers 20086 per unit volume of non-woven material 20080 can affect the strength index of the non-woven material 20080. For example, the flexibility in a non-woven material 20080 can be low when the number of fibers bonded 20086 per unit volume of nonwoven material 20080 is low, for example; the flexibility of the non-woven material 20080 can be greater when the number of fibers bonded 20086 per unit volume of non-woven material 20080 is greater, for example; and the flexibility of the nonwoven material 20080 may be greater even when the number of fibers bonded 20086 per unit volume of nonwoven material 20080 is even greater, for example. When the flexibility of the non-woven material 20080 is low, such as when the number of fibers bonded 20086 per unit volume of non-woven material 20080 is low, the combined restoring force exerted by the fabric thickness compensator 20020 on the captured fabric T can also be low. When the flexibility of the non-woven material 20080 is greater, such as when the number of fibers bonded 20086 per unit volume of non-woven material 20080 is greater, the aggregate restoration force exerted by the fabric thickness compensator 20020 on the captured fabric T can also be greater.
With reference principally to Figure 393, a nonwoven material 20080 'of a tissue thickness compensator 20020' may comprise a therapeutic agent 20088, such as a medicament and / or pharmaceutically active agent, for example. The nonwoven material 20080 'can deliver a therapeutically effective amount of the therapeutic agent 20088. For example, the therapeutic agent 20088 can be released while absorbing the nonwoven material 20080'. The therapeutic agent 20088 can be released into the fluid, such as blood, for example, passing over or through the nonwoven material 20080 '. Examples of therapeutic agents 20088 may include, but are not limited to, hemostatic agents and medicaments such as, for example, fibrin, thrombin, and / or oxidized regenerated cellulose (ORC); anti-inflammatory drugs such as, for example, diclofenac, aspirin, naproxen, sulindac, and / or hydrocortisone; antibiotic and antimicrobial drugs or agents such as, for example, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol; and anticancer agents such as, for example, cisplatin, mitomycin, and / or adriamycin. The therapeutic agent 20088 may comprise a biological agent, such as a stem cell, for example. The fibers 20082 of the non-woven material 20080 'may comprise the therapeutic agent 20088. Alternatively, the therapeutic agent 20088 may be added to the non-woven material 20080' or otherwise integrated into the tissue thickness compensator 20020 '.
Mainly with reference to Figures 399 to 399B, a fabric thickness compensator 20520 for an end effector 12 (Figure 390) may comprise a plurality of springs or coiled fibers 20586. As in the crimped fibers 20086 described herein description, the twisted fibers 20586 can be, for example, crimped, twisted, twisted, bent, deformed, spirally, crimped, and / or arched within the fabric thickness compensator 20520. The twisted fibers 20586 can be wound around a mandrel to form a coiled or substantially coiled shape. The threaded fibers 20586 can be randomly oriented and / or randomly distributed along the fabric thickness compensator 20520. Alternatively, the threaded fibers 20586 can be systematically arranged and / or evenly distributed along the fabric thickness compensator 20520. For example , with reference to Figure 399, the threaded fibers 20586 may comprise a longitudinal axis between a first end 20587 and a second end 20589 of the coiled fiber 20586. The longitudinal axes of the coiled fibers 20520 in the fabric thickness compensator 20520 may be parallel or substantially parallel. The first end 20587 of each coiled fiber 20520 can be positioned along a first longitudinal side 20523 of the fabric thickness compensator 20520 and the second end 20589 of each coiled fiber 20586 can be positioned along a second longitudinal side 20524 of the compensator of fabric thickness 20520. In such an arrangement, the twisted fibers 20586 can laterally traverse the tissue thickness compensator. Alternatively, the twisted fibers 20586 may traverse longitudinally or diagonally the tissue thickness compensator 20520.
As in the crimped fibers 20086 described in the present disclosure, the twisted fibers 20586 may comprise a polymer composition. The crimped fibers 20586 may be at least partially elastic such that the deformation of the crimped fibers 20586 generates a restoring force. The polymeric composition of the coiled fibers 20586 may comprise polycaprolactone (PCL), for example, such that the enrobed fibers 20586 are not soluble in a chlorophyll solvent. With reference to Figure 399A, coiled springs or fibers 20520 can be retained in a compensating material 20580. Compensating material 20580 can keep coiled fibers 20586 in a loaded position such that coiled fibers 20586 exert a spring load in, or within the compensation material 20580. The compensation material 20580 can keep the coiled fibers 20586 in a neutral position, where the coiled fibers 20586 do not exert a spring load on, or within the compensation material 20580. The material compensation 20580 may be bioabsorbable and, may comprise a foam, such as, for example, polyglycolic acid (PGA) foam. In addition, the compensation material 20580 can be soluble in a chlorophyll solvent, for example. The fabric thickness compensator may comprise coiled fibers 20586 comprising polycaprolactone (PCL) and compensation material 20580 comprising polyglycolic acid foam (PGA), for example, such that the coiled fibers 20520 are not soluble. in a chlorophyll solvent while the compensation material 20580 is soluble in the chlorophyll solvent. The compensation material 20580 can be at least partially elastic, such that the compression of the compensation material 20580 generates a restoring force. In addition, with reference to Figure 399B, the compensation material 20580 of the tissue thickness compensator 20520 may comprise a therapeutic agent 20588, such as stem cells, for example. The compensation material 20580 can deliver a therapeutically effective amount of the therapeutic agent 20588 while the compensation material 20580 is absorbed.
Similar to the fabric thickness compensator 20020 described in the present description, the fabric thickness compensator 20520 can be compressible. For example, while staples 20030 (Figures 407 to 410) are deployed from an initial position to a fired position, staples 20030 can be attached to a portion of the tissue thickness compensator. 20520. A staple 20030 can capture a portion of the fabric thickness compensator 20520 and the adjacent tissue T. The staple 20030 can apply a compressive force to the captured portion of the fabric thickness compensator 20520 and the tissue T such that the compensator Fabric thickness 20520 is compressed from an uncompressed height to a compressed height. Compression of the fabric thickness compensator 20520 may result in a corresponding deformation of the coiled fiber 20586 therein. As described in greater detail in the present description, the deformation of each coiled fiber 20586 can generate a restoration force that may depend on the flexibility of the coiled fiber, for example, the amount of coiled fiber 20586 that is deformed and / or the coiled fiber 20586 resistance index. The strength of the twisted fiber 20586 can at least depend on the orientation, the material, the shape and / or the size of the twisted fiber 20586, for example The deformation of the twisted fibers 20586 in the fabric thickness compensator 20520 can generate forces of restoration along the entire fabric thickness compensator 20520. The fabric thickness compensator 20520 can exert the aggregate restoration force generated by the deformed twisted fibers 20586 and / or the flexible compensation material 20586 in the captured tissue T in staples fired 20030.
Mainly with reference to Figures 400 and 401, a tissue thickness compensator 20620 for an end effector 12 may comprise a plurality of spring turns 20686. As in the crimped fibers 20086 and the coiled fibers 20586 described herein Description, spring coils 20686 may be, for example, crimped, twisted, twisted, bent, deformed, spiral, crimped and / or arcuate within tissue thickness compensator 20620. Similar to the fibers and rolls described in FIG. present description, spring coils 20686 may comprise a polymer composition. In addition, the spring coils 20686 can be at least partially elastic in such a way that the deformation of the spring coils 20686 generates a force of restoration. The spring turns 20686 may comprise a first end 20687, a second end 20689, and a longitudinal axis therebetween. With reference to Figure 400, the first end 20686 of a spring coil 20686 can be positioned at or near a proximal end 20626 of the tissue thickness compensator and the second end 20689 of the same spring coil 20686 can be positioned at or near of a distal end 20625 of the tissue thickness compensator 20620 so that the spring coil 20686 longitudinally traverses the tissue thickness compensator 20620, for example. Alternatively, the twisted fibers 20686 can traverse laterally or diagonally the tissue thickness compensator 20620.
The tissue thickness compensator 20620 may comprise an outer film 20680 which at least partially surrounds at least one spring coil 20686. With reference to Figure 400, the outer film 20680 may extend around the perimeter of multiple spring coils 20686 in the fabric thickness compensator 20620. Alternatively, the outer film 20680 can completely encapsulate the spring turns 20686 or at least one spring coil 20686 in the fabric thickness compensator 20620. The outer film 20680 can retain the spring turns 20686 in the end effector 12. The outer film 20680 may contain the spring turns 20686 in a loaded position such that the spring turns 20686 generate a spring load and exert an elastic restoring force on the outer film 20680. Alternatively, the outer film 20680 can retain the spring turns 20686 in a neutral position. The tissue thickness compensator 20620 may also comprise a filler material 20624. The filler material 20624 may be retained in and / or around the spring coils 20686 by the outer film 20680. The filler material 20624 may comprise a therapeutic agent 20688, similar to the therapeutic agents described in the present disclosure. In addition, the filler material 20624 can support the spring turns 20686 within the tissue thickness compensator 20620. The filler material 20624 can be compressible and at least partially flexible, such that filler material 20624 contributes to the strength of restoration or elastic recovery generated by the tissue thickness compensator 20620, as described in greater detail in the present description.
Similar to the fabric thickness compensators described in the present description, the fabric thickness compensator 20620 may be compressible. While staples 20030 (Figures 407 to 410) are deployed from an initial position to a fired position, staples 20030 can be attached to a portion of tissue thickness compensator 20620. Each staple 20030 can capture a portion of the tissue thickness compensator. 20620 together with the adjacent tissue T. The staple 20030 can apply a compressive force to the captured portion of the fabric thickness compensator 20620 and the captured tissue T such that the tissue thickness compensator 20620 is compressed between a height not compressed and a compressed height. The compression of the fabric thickness compensator 20620 can result in a corresponding deformation of the spring turns 20686 retained in this (Figure 401). As described in greater detail in the present description, the deformation of each of the turns of the spring 20686 can generate a restoring force which depends on the flexibility of the spring turns 20686, for example, the amount that the spring coil 20686 is deformed and / or the resistance index of the spring coil 20686. The resistance index of a spring coil 20686 may, at least, depend on the material, shape and / or dimensions of the spring coil 20686, for example . In addition, depending on the flexibility of the filler material 20624 and the outer film 20680, the compression of the filler material 20624 and / or the outer film 20680 may also generate restoration forces. The addition of restoration forces generated by at least the deformed spring turns 20686, the filler material 20624 and / or the outer film 20680 in the fabric thickness compensator 20620 can generate restoring forces along the thickness compensator of fabric 20620. The fabric thickness compensator 20620 can exert the aggregate restoration force generated by the deformed spring turns 20686 on the captured tissue T in a 20030 fired staple.
Primarily with reference to Figures 402 to 404, a fabric thickness compensator 20720 for an end effector 12 may comprise a plurality of spring turns 20786. Similar to the coiled fibers and springs described in the present disclosure, the coils of spring 20786 may be, for example, crimped, twisted, curled, bent, deformed, spirally curled, and / or arched within the tissue thickness compensator 20720. The turns of the spring 20786 may be at least partially elastic such that the deformation of the spring turns 20786 generates a force of restoration. In addition, the spring coils 20786 may comprise a first end 20787, a second end 20789, and a longitudinal axis therebetween. With reference primarily to Figure 404, the first end 20787 of the spring coil 20786 can be positioned at or near a proximal end 20726 of the tissue thickness compensator 20720 and the second end 20789 of spring coil 20786 can be positioned at or near a distal end 20725 of tissue thickness compensator 20720 so that spring coil 20786 longitudinally traverses tissue thickness compensator 20720. Spring coil 20786 can extend longitudinally in two parallel rows in the fabric thickness compensator 20720. The tissue thickness compensator 20720 can be positioned in an end effector 12 such that a slider 20050 (Figure 390) or cutting element 20052 can be moved along of a slot 20015 between the parallel rows of turns of spring 20786. Alternatively, the turns of spring 20786 can traverse laterally or diagonally the tissue thickness compensator 20720.
Referring again to Figure 404, the spring coils 20786 may be retained or incorporated in a compensation material 20780. The compensation material 20780 may be bioabsorbable and may comprising foam, such as, for example, polyglycolic acid (PGA) foam. The compensation material of 20780 can be flexible, in such a way that the deformation of the compensation material 20780 generates an elastic recovery force. The compensation material 20780 can be soluble in a chlorophyll solvent, for example. For example, the fabric thickness compensator may comprise spring turns 20786 comprising polycaprolactone (PCL) and compensation material 20780 comprising polyglycolic acid (PGA) foam such that spring coils 20786 are not soluble in a chlorophyll solvent while the compensation material 20780 is soluble in a chlorophyll solvent, for example. The compensation material 20780 can be at least partially flexible in such a way that the deformation of the compensation material 20780 generates a spring load or restoration force.
The fabric thickness compensator 20720 may comprise interwoven yarns 20790, which may extend between the parallel rows of the spring turns 20786. For example, with reference to Figure 404, a first interwoven yarn 20790 may traverse the two parallel rows diagonally of spring coils 20786 and a second interwoven thread 20790 can also diagonally traverse the two parallel rows of spring coils 20786. The first and second interwoven strands 20790 can be interlocked. The interwoven yarns 20790 can be crisscrossed multiple times along the length of the fabric thickness compensator 20720. The interwoven yarns 20790 can maintain the spring turns 20786 in a configuration loaded in such a way that the spring coils 20786 are maintained in a substantially flat position in the fabric thickness compensator 20720. The interwoven yarns 20790 running through the fabric thickness compensator 20720 can be directly attached to the spring coils 20786. Alternatively , the interwoven threads 20790 may be coupled to the spring turns 20786 through a support 20792 extending through each spring coil 20786 along the longitudinal axis thereof.
As described in more detail in the present description, a staple cartridge 20000 may comprise a slot 20015 configured to receive a translation slider 20050 comprising a cutting element 20052 (FIG. 390). While the slider 20050 moves along the slot 20015, the slider 20050 can eject the clips 20030 from the holding cavities 20012 in the staple cartridge 20000 and the cutting element 20052 can simultaneously or almost simultaneously cut the tissue T. Referring again to Figure 404, while the cutting element 20052 moves, it can also cut the interwoven yarns 20790 that intersect between the parallel rows of spring turns 20786 in the fabric thickness compensator 20720. While the woven yarns 20790 are cut, each spring coil 20786 can be released from its loaded configuration so that each spring coil 20786 returns from the substantially flat loaded position to an expanded position in the fabric thickness compensator 20720.
When a spring coil 20786 is expanded, the compensation material 20780 surrounding the coil 20786 may also expand.
While staples 20030 (Figures 407 to 410) are deployed from an initial position to a fired position, staples 20030 can be attached to a portion of tissue thickness compensator 20720 and tissue thickness compensator 20720 can expand, or attempt to expand , within the staples 20030 and can apply a compressive force to the fabric T. At least one staple 20030 can capture a portion of the tissue thickness compensator 20720, together with the adjacent tissue T. The staple 20030 can apply a compressive force to the captured portion of the tissue thickness compensator 20720 and the captured tissue T, such that the tissue thickness compensator 20720 is compressed between a height not compressed and a compressed height. Compression of the fabric thickness compensator 20720 can result in a corresponding deformation of the spring turns 20786 and the compensation material 20780 retained therein. As described in greater detail in the present description, the deformation of each spring coil 20786 may generate a restoring force which may depend on the flexibility of the spring coil, for example, the amount the spring coil 20786 deforms and / or the resistance index of the spring coil 20786. The resistance index of a spring coil 20786 may, at least, depend on the orientation, material, shape and / or size of the spring coil 20786 , for example. The sum of the restoration forces generated by at least the spring turns Deformed 20786 and / or compensating material 30380 in the fabric thickness compensator 20720 can generate restoration forces along the fabric thickness compensator 20720. The fabric thickness compensator 20720 can exert the aggregate restoration force generated by the deformed spring turns 20786 in the fabric thickness compensator 20720 on the captured tissue T and the fired clips 20030.
Primarily with reference to Figures 405 and 406, a tissue thickness compensator 20820 for a surgical end effector 12 may comprise a spring coil 20886. Similar to the fibers and coils described in the present disclosure, the coil 20886 may be, for example, crimped, twisted, coiled, bent, deformed, spiral, curved, and / or arcuate within the tissue thickness compensator 20820. The spring coil 20886 may comprise a polymeric composition and may be at least partially elastic , in such a way that the deformation of the spring coil 20886 generates an elastic recovery force. Further, the spring coil 20886 may comprise a first end 20887 and a second end 20889. With reference to Figure 405, the first end 20887 may be positioned at or near a proximal end 20826 of the tissue thickness compensator 20820 and the second end 20889 may be positioned at or near a distal end 20825 of tissue thickness compensator 20820. Spring coil 20886 may snake or wriggle from proximal end 20825 to distal end 20826 of tissue thickness compensator 20820.
Referring again to Figure 405, the spring coil 20886 may be retained or incorporated in a compensation material 20880. The compensation material 20880 may be bioabsorbable and, may comprise a foam, such as, for example, polyglycolic acid foam ( PGA). The compensation material 20880 can be soluble in a chlorophyll solvent, for example. The tissue thickness compensator may comprise spring turns 20886 comprising polycaprolactone (PCL) and compensation material 20880 comprising polyglycolic acid (PGA) foam, for example, so that the spring coil 20886 is not soluble in a chlorophyll solvent while the compensation material 20880 is soluble in a chlorophyll solvent. The compensation material 20880 can be at least partially flexible in such a way that the deformation of the compensation material 20880 generates a spring load or restoration force.
Similar to the fabric thickness compensators described in the present description, for example, the fabric thickness compensator 20820 may be compressible. The compression of the fabric thickness compensator 20820 can result in a deformation of at least a portion of the spring coil 20886 retained or incorporated in the compensation material 20880 of the fabric thickness compensator 20820. As described in more detail in In the present description, the deformation of the spring coil 20886 can generate restoring forces which may depend on the flexibility of the spring coil 20886, the amount the spring coil 20886 deforms, and / or the coil resistance index. spring 20886, for example.
The sum of restoring forces generated by the deformed spring turn 20886 and / or the deformed compensation material 20880 can generate restoring forces along the fabric thickness compensator 20820. The fabric thickness compensator 20820 can exert the force of restoration added in the captured tissue T in the staples fired 20030.
Referring now to Figure 413, a surgical end effector 12 may comprise a tissue thickness compensator 30020 having at least one tubular element 30080. The tissue thickness compensator 30020 may be retained in the surgical end effector 12. As described in more detail in the present description, a clamping element in the end effector 12 can be implemented in such a way that the clamping element moves to a fired position and deforms at least a portion of the tubular element 30080 in the tissue thickness compensator 30020. The reader will appreciate that fabric thickness compensators comprising at least one tubular element as described herein may be installed or otherwise coupled with a variety of surgical end effectors and such embodiments are within the scope of the present invention.
Still with reference to Figure 413, the fabric thickness compensator 30020 can be positioned in relation to the anvil 30060 of the end effector 12. Alternatively, the fabric thickness compensator 30020 can be positioned relative to an element cartridge unit. holding, such as staple cartridge 30000, end effector 12. The staple cartridge 30000 can be configured to fit into a cartridge channel 30072 of a bracket 30070 of end effector 12. For example, tissue thickness compensator 30020 can removably fasten to staple cartridge 30000. Tubular element 30080 Fabric thickness compensator 30020 can be positioned adjacent an upper cover surface 30011 of a rigid support portion 30010 of the staple cartridge 30000. The tubular member 30080 can be fixed to the upper cover surface 30011 by an adhesive or by a wrapper, similar to at least one of the wraps described herein (e.g., Figure 218). The fabric thickness compensator 30020 may be an integral part of a unit comprising the staple cartridge 30000 such that the staple cartridge 30000 and the tissue thickness compensator 30020 are formed as a single unit construction. For example, the staple cartridge 30000 may comprise a first body portion, such as the rigid support portion 30010, and a second body portion, such as the fabric thickness compensator 30020, for example.
With reference to Figures 413 to 415, the tubular element 30080 in the fabric thickness compensator 30020 may comprise an elongated portion 30082 having at least one lumen 30084 extending at least partially therethrough. With reference principally to Figure 415, the elongated portion 30082 of the tubular member 30080 may comprise woven or braided strands 30090, as described in greater detail in the present disclosure. Alternatively, the elongated portion 82 it may comprise a solid structure, such as an extrusion of polymers, instead of woven strands 30090. The elongated portion 30082 of the tubular element 30080 may comprise a thickness. The thickness of the elongate portion 30082 can be substantially uniform along the length and around the diameter thereof; in other cases, the thickness may vary. The elongate portion 30082 may be lengthened such that the length of the elongated portion 30082 is greater than the diameter of the elongated portion 30082, for example. The elongated portion may comprise a length of about 30.5 mm (1.20 inches) to about 66.0 mm (2.60 inches) and a diameter of about 2.5 mm (0.10 inches) to approximately 3.81 mm (0.15 inches), for example. The length of the tubular element 20080 may be about 35.6 mm (1.40 inches), for example, and the diameter of the tubular element 20080 may be about 3.18 mm (0.125 inches), for example. In addition, the elongated portion 30082 may define a substantially circular or elliptical cross-sectional shape, for example. Alternatively, the cross-sectional shape may comprise a polygonal shape, such as, for example, a triangle, a hexagon and / or an octagon. Referring again to Figure 413, the tubular element 30080 may comprise a first distal end 30083 and a second proximal end 30085. The cross-sectional shape of the elongated portion 30082 may narrow at the first and / or second end 30083, 30085, wherein at least one end 30083 can be closed and / or sealed, 30085 of the tubular member 30080. Alternatively, a lumen 30084 may continue through the distal ends 30083, 30085 of the tubular member 30080 such that the ends 30083, 30085 are open.
The tubular element 30080 may comprise a single central lumen 30084 extending at least partially through the elongate portion 30084. The lumen 30084 may extend through the entire length of the elongate portion 30084. In a further alternative, the tubular element 30080 may comprise multiple lumens 30084 extending through it. The lumens 30084 extending through the tubular element 30080 can be circular, semicircular, wedge-shaped, and / or combinations thereof. A tubular member 30080 may also comprise support bands that can form a modified "T" or "X" shape, for example, within lumen 30084. The dimensions, lumen (s), and / or support band (s) within of the tubular element 30080 can define the shape of the cross section of the tubular element 30080. The shape of the cross-section of the tubular element 30080 may be consistent along the length thereof, alternatively, the cross-sectional shape of the tubular element 30080 may vary along the length of the east. As described in more detail in the present description, the cross-sectional shape of the tubular member 30080 can affect the compressibility and flexibility of the tubular member 30080.
The tubular element 30080 may comprise a vertical diameter and a horizontal diameter; the dimensions of these can selected according to the arrangement of the tubular element 30080 in the end effector 12, the dimensions of the end effector 12, including the tissue gap of the end effector 12, and the expected geometry of the staple capture areas 30039. For example, the vertical diameter of the tubular element 30080 can be related to the expected height of a formed staple. In such cases, the vertical diameter of the tubular element 30080 can be selected in such a way that the vertical diameter can be reduced from about 5% to about 20% when the tubular element 30080 is captured within a formed staple 30030. For example, a tubular element 30080 having a vertical diameter of about 2.5 mm (0.100 inches) can be used for staples having an expected formed height of about 2.0 mm (0.080 inches) to about 2.4 mm (0.095 inches). As a result, the vertical diameter of the tubular element 30080 can be reduced from about 5% to about 20% when captured within the formed staple 30030, even when no T tissue is captured therein. When tissue T is captured within the formed staple 30030, the compression of the tubular element 30080 may be even greater. The vertical diameter may be uniform along the length of the tubular element 30080 or, alternatively, the vertical diameter may vary along the length thereof.
The horizontal diameter of the tubular member 30080 can be greater than, equal to, or less than the vertical diameter of the tubular member 30080 when the tubular member 300080 is in a non-deformed configuration or recovered. For example, with reference to Figure 414, the horizontal diameter may be approximately three times greater than the vertical diameter, for example. In some cases, the horizontal diameter may be approximately 10 mm (0.400 inches) and the vertical diameter may be approximately 3.18 mm (0.125 inches), for example. Alternatively, with reference now to Figure 416, the horizontal diameter of a tubular element 31080 can be equal or substantially equal to the vertical diameter of the tubular element 31080 when the tubular element 31080 is in a non-deformed or recovered configuration. In some cases, the horizontal diameter may be approximately 3.18 mm (0.125 inches) and the vertical diameter may also be approximately 3.18 mm (0.125 inches), for example. The tubular element 30080 may comprise a vertical diameter of approximately 3.18 mm (0.125 inches), a horizontal diameter of approximately 10 mm (0.400 inches), and a length of approximately 36 mm (1400 inches). As described in greater detail in the present description, when a force A is applied to the tubular element 30080 and / or 31080, the tubular element can be deformed in such a way that it can change the geometry of the cross section, which includes the horizontal diameters and vertical Referring again to Figures 413 to 415, the tubular member 30080 in the fabric thickness compensator of 30020 may be deformable. All tubular element 30080 can be deformable. For example, tubular element 30080 may be deformable from the proximal end 30083 to the distal end 30085 of the elongate portion 30082 and around the entire circumference thereof. Alternatively, only a portion of the tubular element 30080 may be deformable. For example, only an intermediate length of the elongated portion 30082 and / or only a portion of the circumference of the tubular element 30080 can be deformable.
When a compression force is applied to a contact point in the elongate portion 30082 of the tubular member 30080, the contact point may change, which may alter the cross-sectional dimensions of the tubular member 30080. For example, with reference again to Figure 414, the tubular element 30080 may comprise a top vertex 30086 and bottom vertex 30088 of the elongated portion 30082. In the initial, undeformed configuration, the tubular element 30080 may comprise non-deformed cross-sectional dimensions, including a vertical diameter not deformed between the upper vertex 30086 and the lower vertex 30088. When a compression force A is applied to the upper vertex 30086, the tubular element 30080 can be moved to a deformed configuration. In the deformed configuration, the cross-sectional dimensions of the tube 30080 may be altered. For example, the tube 30086 may comprise a deformed vertical diameter between the upper vertex 30086 and the lower vertex 30088, which may be smaller than the vertical diameter not deformed . With reference to Figure 416, the horizontal diameter of the deformed tube 30080 can be lengthened, for example, when the tubular element 30080 moves from a non-deformed configuration to a deformed configuration. The dimensions of the deformed cross section of the deformed tube 30080 can at least depend on the position, the angular orientation, and / or the magnitude of the applied force A. As described in more detail in the present description, the deformation of an element tubular 30080 can generate a restoration or elastic recovery force that may depend on the flexibility of the tubular element 30080.
With reference still to Figure 414, the tubular element 30080 can generate a restoring or elastic recovery force when compressed. In such cases, as described in the present description, the tubular element 30080 can move from an initial undeformed configuration to a deformed configuration when a force A is applied to a contact point in the elongated portion 30082 of the tubular element 30080. When the applied force A is removed, the deformed tube 30080 can be recovered from the deformed configuration. The deformed tube 30080 can be recovered to the initial configuration, not deformed or can be recovered to a configuration substantially similar to the initial configuration, not deformed. The ability of the tubular member 30080 to recover from a deformed configuration refers to the flexibility of the tubular member 30080.
Referring again to Figure 414, a tubular element 30080 can exert a restoring or elastic recovery force. The restoring force can be generated by the tubular element 30080 when an applied force A is exerted on the tubular element 30080, for example, by a staple 30030 (Figures 417 and 418), as described in more detail in the present description. An applied force A can alter the cross-sectional dimensions of the tubular element 30080. Furthermore, in the elastic linear materials, the restoring force of each deformed portion of the tubular element 30080 can be a function of the deformed dimensions of the tubular element 30080 and the resistance index of the portion of the tubular element 30080. The resistance index of a tubular element 30080 can at least depend on the orientation, the material, the geometry of the cross section and / or the dimensions of the tubular element 30080, for example . The tubular element 30080 in a tissue thickness compensator 30020 may comprise a uniform resistance index. Alternatively, the resistance index may vary along the length and / or around the diameter of the tubular member 30080. When a portion of a tubular member 30080 having a first resistance index is compressed a lot, the tubular element 30080 may generate a great restoration force. When a portion of the tubular member 30080 having the same first resistance index is compressed less, the tubular member 30080 can generate a smaller restoring force.
Referring again to Figure 413, the tubular member 30080 in the fabric thickness compensator 30020 may comprise a polymeric composition. The elongate portion 30082 of the tubular member 30080 may comprise the polymer composition. In addition, the polymer composition may comprise at least partially elastic material of such that the deformation of the tubular element 30080 generates a restoring force. The polymer composition may comprise nonabsorbent polymers, absorbent polymers, or combinations thereof, for example. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. The absorbent polymers can include biocompatible, bioabsorbable, elastomeric polymers, for example. In addition, the polymeric composition of the tubular member 30080 may comprise synthetic polymers, non-synthetic polymers, or combinations thereof, for example. The polymeric composition of the tubular member 30080 may include varied amounts of absorbent polymers, non-absorbent polymers, synthetic polymers, and / or non-synthetic polymers, for example, as a function of weight percentage.
With reference to Figure 413 and 414, the tubular member 30080 may comprise a therapeutic agent 30098 such as a pharmaceutically active agent or medicament, for example. The therapeutic agent 30098 can be retained in the lumen 30084 of the tubular element 30080. The elongated portion 30082 can encapsulate or partially encapsulate the therapeutic agent 30098. Additionally or alternatively, the polymer composition of the elongated portion 30082 can comprise the therapeutic agent 30098. The element tubular 30080 can release a therapeutically effective amount of the therapeutic agent 30098. The therapeutic agent 30098 can be released while the tubular element 30080 is absorbs For example, the therapeutic agent 30098 can be released into the fluid (such as blood) that passes over or through the tubular element 30080. In a further alternative, the therapeutic agent 30098 can be released when a staple 30030 (FIGS. 417 and 418) pierces the tubular element 30080 and / or when the cutting element 30052 in the staple trigger slider 30050 (FIG. 413) cuts a portion of the tubular element 30080, for example. Examples of therapeutic agents 30098 may include, but are not limited to, hemostatic agents and medicaments such as, for example, fibrin, thrombin, and / or oxidized regenerated cellulose (ORC), anti-inflammatory drugs such as, for example, diclofenac, aspirin, naproxen, sulindac, and / or hydrocortisone, antibiotics and antimicrobial drugs or agents such as, for example, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol, anticancer agents such as, for example, cisplatin, mitomycin, and / or adriamycin, and / or biological, such as, for example, stem cells.
Referring again to Figures 413, 417 and 418, fasteners such as staples 30030, for example, can be unfolded from a staple cartridge 30000 such that staples 30030 are attached to a tissue thickness compensator 30020 and apply a force A to a tubular element 32080 therein. As described herein, the application of a force A to the tubular member 30080 can cause deformation of the tubular member 30080. Similar to the end effectors 12 described herein, the rigid support portion 30010 of the staple cartridge 30000 it may comprise a cartridge body 30017, a cover surface 30011, and a plurality of staple cavities 30012 therein. Each staple pocket 30012 can define an opening in the cover surface 30011 and a staple 30030 can be removably positioned in a staple pocket 30012 (FIG. 433). With reference mainly to Figures 417 and 418, each staple 30030 can comprise a base 30031 and two staple legs 30032 extending from the base 30031. Prior to the implementation of the staples 30030, the base 30031 of each staple 30030 can be supported by a staple driver 30040 (FIG. 433) ) positioned within the rigid support portion 30010 of the staple cartridge 30000. Also prior to the deployment of the staples 30030, the legs 30032 of each staple 30030 can at least partially be contained within the staple pocket 30012 (FIG. 433).
As described in greater detail in the present description, staples 30030 can be deployed between an initial position and a triggered position. For example, a staple trigger slider 30050 may be coupled to an impeller 30040 (FIG. 433) to move at least one staple 30030 between the initial position and the triggered position. With reference principally to Figure 417, the staple 30030 can be moved to a fired position, where the legs 30032 of the staple 30030 engage a tubular member 32080 of a tissue thickness compensator 32020, penetrate the tissue T, and enter contact with an anvil 30060 (Figure 433) positioned in front of the staple cartridge 30000 in the surgical end effector 12. staple forming cavities 30062 on the anvil 30060 can bend the legs of the staple 30032 in such a manner that the staple 3030 catches a portion of the tubular element 32080 and a portion of the tissue T in a staple capture area 30039. As shown in FIG. described in greater detail in the present description, at least one staple leg 30032 can pierce the tubular element 32080 of the fabric thickness compensator 32020 when the staple 30030 moves between the initial position and the triggered position. Alternatively, the legs of the staples 30032 can move around the perimeter of the tubular element 32080 in such a manner that the staple legs 30032 prevent piercing the tubular element 32080. Similar to the fasteners described in the present description, the legs 30032 of each staple 30030 may deform downward to the base 30031 of staple 30030 to form a staple capture area 30039 therebetween. The staple capture area 30039 may be the area in which the tissue T and a portion of the fabric thickness compensator 32020 may be captured by a staple staple 30030. In the fired position, each staple 30030 may apply a compression force to the staple. tissue T and fabric thickness compensator 32020 captured within staple capture area 30039 of staple 30030.
Still referring to Figure 417, when the tubular member 32080 is captured in a staple capture area 30039, the captured portion of the tubular member 32080 can be deformed, as described in the present disclosure. In addition, the tubular element 32080 can deform to different configurations deformed into different staple capture areas 30039 depending on, for example, the thickness, compressibility, and / or density of the T tissue captured in that same staple capture area 30039. The tubular element 32080 in the tissue thickness compensator 32080 it may extend longitudinally through successive staple capture zones 30039. In such an arrangement, the tubular element 32080 may be deformed to different deformed configurations in each staple capture area 30039 along a row of staples 30030. Referred now to Figure 418, the tubular elements 33080 in a fabric thickness compensator 33020 can be disposed laterally in the staple capture areas 30039 along a row of fired staples 30030. The tubular elements 33080 can be retained by a flexible cover 33210 In such arrangements, tubular elements 33080 and flexible cover 33210 can deform to different deformed configurations in each zone 30039. For example, where the T tissue is thinner, the tubular elements 33080 can be compressed less and where the T fabric is thicker, the tubular elements 33080 can be further compressed to accommodate the thicker fabric T. Alternatively, the deformed dimensions of the tubular elements 33080 can be uniform throughout the length and / or width of the fabric. Fabric thickness compensator 33020.
With reference to Figures 419 to 421, a tubular element 34080 in a fabric thickness compensator 34020 may comprise a plurality of strands 34090. With reference principally to Figure 419, the 34090 strands can be woven or braided into a tubular net 34092 forming the tubular element 34080. The tubular net 34092 formed by the strands 34090 can be substantially hollow. The strands 34090 of the tubular member 34080 can be solid strands, tubular strands, and / or some other suitable shape. For example, with reference to Figure 420, a single strand 34090 of the tubular net 34092 may be a tube. With reference to Figure 422, a strand 34090 may comprise at least one lumen 34094 extending therethrough. The number, geometry and / or dimensions (s) of the 34094 lumens can determine the shape of the cross section of the thread 34090. For example, a thread 34090 can comprise circular lumen (s), lumen (s) semicircular (en), wedge-shaped lumen (s), and / or combinations thereof. A strand 34090 may also comprise support bands 34096 which may form a modified form of "T" or "X", for example. At least the diameter of the strand 34090, the lumen (s) extending therethrough, and the support band (s) may characterize the shape of the cross section of a strand. 34090. The shape of the cross section of each strand 34090, as described in greater detail in the present description, may affect the restoration or elastic recovery force generated by the 34090 strand and the corresponding restoring or elastic recovery force generated. by the tubular element 34080.
With reference to Figure 423, a tubular network of strands 34090 may be deformable. The tubular net 34092 can produce or contribute to the deformability and / or flexibility of the tubular element 34080. For example, the strands 34090 of the tubular net 34092 may be woven together in such a way that the strands 34090 are configured to slide and / or bend relative to one another. When a force is applied to the elongated portion 34082 of the tubular member 34080, the strands 34090 therein can slide and / or bend such that the tubular net 34092 moves to a deformed configuration. For example, still with reference to Figure 423, a staple 30030 can compress the tubular net 34092 and the captured tissue T in a staple capture area 34039 which can cause the strands 34090 of the tubular net 34092 to slide and / or double one in relation to the other. The upper vertex 34086 of the tubular net 34092 can move towards the lower vertex 34088 of the tubular net 34092 when the tubular net 34092 is compressed to the deformed configuration to accommodate the captured tissue T in a staple capture area 30039. In various circumstances , the tubular network 34092 captured in a perforated staple 30030 will seek to recover its undeformed configuration and can apply a restoring force to the captured tissue T. In addition, portions of the 34092 tubular network positioned between the staple capture areas 30039, i.e. , not captured within a perforated staple 30030, may also be deformed due to deformation of the adjacent portions of the tubular network 34092 that are within the staple capture areas 30039. Where the tubular network 34092 is deformed, the tubular network 34092 may seek to recover or partially recover from the deformed configuration. The portions of the 34092 tubular network can be recovered to their Initial configurations and other portions of the 34092 tubular network can only partially recover and / or remain fully compressed.
Similar to the description of the tubular elements in the present description, each strand 34090 may be, furthermore, deformable. In addition, the deformation of a strand 34090 can generate a restoring force that depends on the flexibility of each strand 34090. With reference mainly to Figures 420 and 421, each strand 34090 of a tubular net 34092 can be tubular. Alternatively, each strand 34090 of a tubular net 34092 may be solid. In a further alternative, the tubular network 34092 may comprise at least one tubular strand 34090, at least one solid strand 34090, at least one strand in the form of "X" or "T" 34090, and / or a combination thereof.
The strands 34090 in the tubular element 34080 may comprise a polymer composition. The polymer composition of a strand 34090 may comprise nonabsorbable polymers, absorbable polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. The absorbable polymers can include biocompatible, bioabsorbable elastomeric polymers, for example. In addition, the polymer composition of the 34090 strand may comprise synthetic polymers, non-synthetic polymers, and / or combinations thereof. The polymer composition of the 34090 strand may include varied amounts of polymers absorbables, non-absorbable polymers, synthetic polymers, and / or non-synthetic polymers, for example, weight percent.
Strands 34090 in tubular member 34080 may further comprise a therapeutic agent 34098 (Figure 420) such as a pharmaceutically active agent or medicament, for example. The strand 34090 can deliver a therapeutically effective amount of the therapeutic agent 34098. The therapeutic agent 34098 can be released while the tubular strand 34090 is absorbed. For example, the therapeutic agent 30098 can be released into the fluid, such as blood, for example, passing above or through the thread 34090. In a further alternative, the therapeutic agent 34098 can be released when a staple 30030 pierces the thread 34090 and / or when the cutting element 30052 in the staple trigger slider 30050 (FIG. 413) cuts a portion of the tubular network 34092, for example. Examples of therapeutic agents 34098 may include, but are not limited to, hemostatic agents and drugs, such as, for example, fibrin, thrombin, and / or oxidized regenerated cellulose (ORC); anti-inflammatory drugs, such as, for example, diclofenac, aspirin, naproxen, sulindac, and / or hydrocortisone; antibiotic and antimicrobial agents or drugs, such as, for example, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol, anticancer agents, such as, for example, cisplatin, mitomycin , and / or adriamycin; and / or biological, such as, for example, stem cells.
With reference to Figures 424 and 425, a tubular element 35080 may comprise multiple layers 350100 of strands 35090. The tubular member 35080 may comprise multiple layers 35100 of tubular networks 34092. With reference to Figure 424, the tubular element 35080 may comprise a first layer 35100a and second layer 35100b of strands 35090, for example. Referring now to Figure 425, a tubular member 35180 of a tissue thickness compensator 35120 may comprise a third layer 35100c of strands 35090, for example. On the other hand, different layers 35100 in the tubular element 35180 can comprise different materials. Each layer 35100a, 35100b, 35100c can be bioabsorbable, wherein, each layer 35100a, 35100b, 35100c may comprise a different polymer composition. For example, the first layer 35100a may comprise a first polymer composition; the second layer 35100b may comprise a second polymer composition; and the third layer may comprise 35100c a third polymeric composition. In such cases, the layers 35100a, 35100b, 35100c of the tubular member 35180 can be bioabsorbable at different speeds. For example, the first layer 35100a can absorb rapidly, the second layer 35100b can absorb slower than the first layer 35100a, and the third layer 35100c can absorb more slowly than the first layer 35100a and / or the second layer 35100b. Alternatively, the first layer 35100a can absorb slowly, the second layer 35100b can absorb faster than the first layer 35100a, and the third layer 35100c can absorb faster than the first layer 35100a and / or the second layer 35100b.
Similar to the strands 34090 described in the present description, the strands 35090 in the tubular element 35180 may comprise a medicament 35098. Referring again to Figure 424, to control the elution or release of the medicament (s) 35098, the first layer 35100a of strands 35090 comprising a medicament 35098a can be bioabsorbable at a first rate and the second layer 35100b of strands 35090 comprising a medicament 30098b can be bioabsorbed at a second velocity. For example, the first layer 35100a can absorb rapidly to allow a rapid initial release of the drug 35098a and the second layer 35100b can absorb slower to allow controlled release of the drug 30098b. The medicament 35098a in the strands 35090 of the first layer 30100a may be different from the medicament 35098b in the strands 35090 of the second layer 35100b. For example, the strands 35090 in the first layer 35100a may comprise oxidized regenerated cellulose (ORC) and the strands 35090 in the second layer 35100b may comprise a solution comprising hyaluronic acid. In such cases, the initial absorption of the first layer 35100a can release oxidized regenerated cellulose to help control bleeding while the subsequent absorption of the second layer 35100b can release a solution comprising hyaluronic acid in order to help prevent adhesion of the tissue . Alternatively, the layers 35100a, 35100b may comprise the same medicament 35098a, 35098b. For example, with reference again to Figure 425, strands 35090 in layers 35100a, 35100b and 35100c may comprise an anti-cancer agent, such as, for example, cisplatin. In addition, the first layer 35100a can absorb rapidly to allow a rapid initial release of cisplatin, the second layer 35100b can absorb slower to allow a controlled release of cisplatin, and the third layer 35100c can absorb slower to allow a more extended release controlled cisplatin.
With reference to Figures 426 and 427, a fabric thickness compensator 36020 may comprise an overmold material 36024. The overmoulding material 36024 may be formed outside a tubular member 36080, within a tubular member 36080, or both inside and outside of a tubular element 36080. With reference to Figure 426, the overmolding material 36024 can be co-extruded both inside and outside the tubular member and 36080, the tubular member 36080 may comprise a tubular network 36092 of strands 36090. Similar to the polymer composition described In the present description, the overmoulding material 36024 may comprise polyglycolic acid (PGA), poly (lactic acid) (PLA), and / or any other suitable elastomeric, biocompatible and bioabsorbable polymers, for example. In addition, the overmolding material 36024 can be non-porous in such a way that the overmolding material 36024 forms a fluid impermeable layer in the tubular member 36080. The overmold material 36024 can define a lumen 36084 therethrough.
In connection with the above discussion, the tubular member 36080 and / or the strands 36090 in the tubular network 36092 may comprise a therapeutic agent 36098. With reference still to Figures 426 and 427, a material 36024 non-porous overmold may contain the medicament 36098 within an inner lumen 36084a. Alternatively or additionally, the non-porous overmolding material 36024 may contain the medicament 36098 within an intermediate lumen 36084b, such as, for example, the intermediate lumen 36084b containing the tubular network 36092 of strands 36090 comprising medicament. Similar to the above, the tubular element 36080 can be positioned relative to the staple pockets 30012 and a cutting element 30052 in the staple cartridge 30000 (FIG. 413). For example, the deployment of the staples 30030 and / or the translation of the cutting element 30052 can be configured to pierce or break the non-porous overmolding material 36024 in such a way that the medicament 36098 contained in at least one lumen 36084 of the tubular element 30080 can be released from lumen 30084. With reference to Figure 428, a tubular member 37080 may comprise a non-porous film 37110. The non-porous film 37110 may at least partially surround a tubular network 37092 or a first layer 37100a and a second layer 37100b of tubular networks 30092 to provide a cover impervious to similar fluids. to the overmold material 36024 described in the present description.
As described in the present description, a tubular element may comprise at least one of a bioabsorbable material, a therapeutic agent, a plurality of strands, a tubular network, the tubular network layers, an overmold material, a non-porous film, or combinations of these. For example, with reference to Figure 429, a tubular element 38080 it may comprise an overmolding material 38024 and a plurality of strands 38090 positioned through a central lumen 38084 of the tubular element 38080. The strands 38090 may comprise a therapeutic agent 38098. Alternatively, for example, with reference to Figure 430, an element tubular 39080 may comprise an overmold material 39024 and a therapeutic agent 39098 positioned in a central lumen 39084 of the tubular member 39080, for example. At least one of the tubular member 39080 and the overmold material 39024 may comprise a fluidic therapeutic agent 39098.
Referring again, principally, to Figure 413, the tubular member 30080 can be positioned relative to the rigid support portion 30010 of the staple cartridge 30000. The tubular member 30080 can be positioned longitudinally adjacent the rigid support portion 30010. The element tubular 30080 may be substantially parallel or aligned with a longitudinal groove or cavity 30015 in the rigid support portion 30010. The tubular member 30080 may be aligned with the longitudinal groove 30015 such that a portion of the tubular member 30080 is superimposed on a portion of the tubular element 30080. the longitudinal slot 30015. In such cases, a cutting element 30052 in the staple firing glider 30050 can cut a portion of the tubular element 30080 while the cutting edge 30052 moves along the longitudinal groove 30015. Alternatively, the Tubular element 30080 can be positioned longitudinally on a first or a second side of the longitudinal slot 30015. In a further alternative, the tubular element 30080 can be positioned relative to the rigid support portion 30010 of the staple cartridge 30000 such that the tubular member 30080 laterally or diagonally passes through at least a portion of the rigid support portion 30010.
With reference to Figure 431 for example, a fabric thickness compensator 40020 may comprise multiple tubular elements 40080. The tubular elements 40080 may comprise different lengths, cross-sectional shapes, and / or materials, for example. In addition, the tubular elements 40080 can be positioned relative to the rigid support portion 40010 of the staple cartridge 30000 in such a manner that the tubular shafts of the tubular elements 40080 are parallel to each other. The tubular shafts of the tubular elements 40080 can be longitudinally aligned in such a way that a first tubular element 40080 is positioned within another tubular element 40080. Alternatively, the parallel tubular elements 40080 can longitudinally traverse the staple cartridge 30000, for example. In a further alternative, the parallel tubular elements 40080 can pass laterally or diagonally through the staple cartridge 30000. Alternatively, the non-parallel tubular elements 40080 can be angularly oriented relative to each other in such a way that their tubular shafts intersect and / or They are not parallel to each other.
With reference to Figures 431 to 434, a fabric thickness compensator 40020 can have two tubular elements 40080; a first tubular element 40080a can be positioned longitudinally on a first side of the longitudinal slot 30015 in the rigid support portion 30010 and a second tubular element 40080b can be positioned longitudinally on a second side of the longitudinal slot 30015. Each tubular element 40080 may comprise a tubular network 40092 of strands 40090. The staple cartridge 30000 may comprise a total of six rows of staple cavities 30012, wherein three rows of staple cavities 30012 are positioned on each side of the longitudinal slot 30015, for example. In such cases, the cutting edge 30052 on the translation staple gun 30050 may not be necessary to cut a portion of the tubular member 40080.
Similarly, with reference now to Figures 435 to 436, a fabric thickness compensator 41020 can comprise two tubular elements 41080a, 41080b longitudinally disposed in the staple cartridge 30000. Similar to the previous one, staples 30030 of three rows of cavities of staple 30012 can couple a tubular member 41080a and staples 30030 from three different rows of staple cavities 30012 can couple another tubular member 41080b. Referring still to Figures 435 to 436, the unfolded staples 30030 may involve the tubular member 40080 at different locations through the cross section of the tubular member 40080. As described in the present description, the elastic recoverability and the corresponding Restorative force exerted by the tubular member 41080 may depend on the cross-sectional shape of the tubular member 41080, among other things. A staple 30030 positioned in a staple capture area 30039 located on or near an arched portion of the tubular element 41080 may experience a greater restoring force than a staple 30030 in a staple capture area 30039 positioned near an unbowed portion. Similarly, a staple 30030 positioned in the staple capture area 30039 in the non-arched portion of the tubular member 41080 may experience a restoration force less than the restoring force experienced by a staple 30030 positioned on or near the arcuate portion of the element. tubular 30080. In other words, the arcuate portions of a tubular member 41080 may have a higher strength index than the non-arched portion of the tubular member 41080 due to the possibility that a greater amount of resilient material may be captured by staples 30030 a along said portions. As a result, reference is made principally to Figure 436, the restoring force generated by the fabric thickness compensator 41020 may be greater near the staples 30030a and 30030c and less close to the staple 30030b in the tubular member 30080a. Correspondingly, the restoring force generated by the fabric thickness compensator 41020 may be greater near the staples 30030d and 30030f than near the staple 30030e in the tubular element 30080b.
Referring again to Figures 431 to 434, the cross-sectional geometries of the strands 40090 comprising the tubular net 40092 may be selected to provide a desired elastic recovery capacity and the corresponding restoring force exerted by the tubular net 40092. For example , with reference again to the Figure 432, strands 40090a positioned in arcuate portions of the tubular element 40080 may comprise X-shaped cross sections, while strands 40090b positioned in non-arcuate portions of tubular member 40080 may comprise tubular cross-sections. The strands 40090a and 40090b comprising different cross-sectional geometries may be woven together to form the tubular net 40092. Alternatively, the strands 40090a and 40090b may be bonded together with an adhesive, for example. With reference to Figures 433 and 434, the different cross-section geometries of the strands 40090 in the tubular member 40080 can optimize the restoration force experienced in the staple capture areas 30039 through the staple cartridge 30000. The geometries of Specific cross-sections can be selected in such a way that the elastic recovery constant in the staple capture areas 30039 is balanced or substantially equalized through the staple cartridge.
With reference to Figure 437, the tubular elements 41080a, 41080b of a fabric thickness compensator 41120 can be held together by a contiguous portion 41126. Although the translation cutting member 30052 can be configured to pass between the tubular elements 41080a and 41080b, the cutting element 30052 may be needed to cut at least a portion of the contiguous portion 41126. The contiguous portion 41126 may comprise a soft material, such as, for example, a foam or gel, which is easily cut by the translational cutting member 30052. The contiguous portion 41026 can securely Removable compensator tissue thickness 41120 to the surgical end effector 12. The contiguous portion 41126 can be fixed to the upper cover surface 30011 of the rigid support portion 30010 such that the contiguous portion 41126 remains retained in the surgical end effector 12 after that the tubular elements 41080a, 41080b are released from this.
With reference to Figures 438 to 439, a fabric thickness compensator 42020 can comprise multiple tubular elements 42080 such that the number of tubular elements 42080 is the same as the number of rows of staple cavities 30012 in the staple cartridge 30000, for example. The staple cartridge 30000 can comprise six rows of staple cavities 30012 and the fabric thickness compensator 42020 can comprise six tubular elements 42080. Each tubular member 42080 can be substantially aligned with a row of staple cavities 30012. When staples 30030 ejected from a row of staple cavities 30012, each staple 30030 of that row can pierce the same tubular element 42080 (Figure 439). The deformation of a tube 42080 can have little or no impact on the deformation of an adjacent tube 42080. Accordingly, the tubular elements 42080 can exert a substantially discrete and personalized resilient recovery force in the staple capture areas 30039 through the staple cartridge width 30030. When staples 30030 fired from multiple rows of staple cavities 30012 couple the same tubular element 35080 (FIG. 436), it can less deformation of the tubular element 35080 is customized, for example, deformation of a tubular element 35080 in a staple capture area 30039 in a first row can affect the deformation of said tubular element 35080 in the staple capture area 30039 in another row. The transverse cutting edge 30052 can prevent the tubular elements 42080 from breaking. Alternatively, with reference to Figure 440, a fabric thickness compensator 43020 may comprise more than six tubular elements 43080, such as, for example, seven elements In addition, the tubular elements 43080 can be arranged symmetrically or non-symmetrically in the end effector 12. When an odd number of tubular elements 43080 are arranged longitudinally and symmetrically in the end effector 12, the translational cutting element 30052 can be configured to cut the middle tubular element covering the longitudinal channel 30015.
With reference to Figure 441, a fabric thickness compensator 44020 may comprise a central tubular member 44080b that is at least partially aligned with the longitudinal slot 30015 in the rigid support portion 33010 of the staple cartridge 30000. The thickness compensator woven 44020 may further comprise at least one peripheral tubular member 44080a, 44080c located on one side of the longitudinal groove 30015. For example, the fabric thickness compensator 44020 may comprise three tubular elements 44080: a first peripheral tubular member 44080a may be longitudinally positioned on a first side of the longitudinal slot 30015 of the staple cartridge 30000, a central tubular member 44080b can be positioned substantially along and / or aligned with the longitudinal slot 30015, and a second peripheral tubular element 44080c can be positioned longitudinally on a second side of longitudinal slot 30015. Central tubular element 44080b can comprise a horizontal diameter that is substantially elongated relative to vertical diameter. The central tubular member 44080b, and / or any other tubular member, may overlap multiple rows of staple pockets 30012. Referring still to Figure 441, the central tubular member 44080b may overlap four rows of cleat cavity staples 30012 and each peripheral tubular element 44080a, 44080c may overlap a single row of staple cavities 30012, for example. Alternatively, the central tubular member 44080b may overlap less than four rows of staple pockets 30012, such as, for example, two rows of staple pockets 30012, for example. Further, peripheral tubular elements 44080a, 44080c may overlap more than one row of staple pockets 30012, such as, for example, two rows of staple pockets 30012. Referring now to Figure 442, a central tubular member 44180b of a Fabric thickness compensator 44120 may comprise a therapeutic agent 44198 in a lumen 44184 of central tubular member 44180b. The central tubular member 44180b and / or at least one peripheral tubular member 44080a, 44080c may comprise the therapeutic agent 44198 and / or any other suitable therapeutic agent.
With reference to Figure 443, the fabric thickness compensator 44220 may comprise a cover 44224, which may be similar to the overmold material 32024 described in the present disclosure. The cover 44224 retains multiple tubular elements 44080 in position in end effector 12. Cover 44224 may be co-extruded with tubular elements 44080. Tubular elements 44080 may comprise a 44092 string tubing 44090. Similar to the polymer compositions described herein description, cover 44224 may comprise polyglycolic acid (PGA), poly (lactic acid) (PLA), and / or any other biocompatible, bioabsorbable, elastomeric polymers, suitable, for example. In addition, the cover 44224 can be non-porous in such a way that the cover 44224 forms a fluid impermeable layer in the fabric thickness compensator 44220, for example. In addition to the discussion in the present disclosure, the tubular member 44080 and / or the strands 44090 in the tubular network 44092 may comprise a therapeutic agent 44098. The non-porous cover 44224 may contain the therapeutic agent 44098 within the tissue thickness compensator. As described in the present description, the tubular member 44080 can be positioned relative to the staple pockets 30012 and a cutting element 30052 in the staple cartridge 30000. For example, the deployment of the staples 30030 and / or the translation of the staples 30030. cutting element 30052 may be configured to pierce or break the non-porous cover 44224 in such a manner that the therapeutic agent 44198 contained therein may be released from the tissue thickness compensator 44020.
With reference to Figure 444, a thickness compensator of woven 44320 may comprise a central tubular element 44380b which It comprises a tubular net 44392. The tubular net 44392 may have a non-woven portion or a space 44381 which is substantially aligned with the longitudinal slot 30015 of the rigid support portion 30010. In such cases, a woven portion of the tubular net 44092 of the tubular element 44380b does not overlap the longitudinal slot 30015. Accordingly, the cutting element 30052 in the translation staple slide slider 30052 can be moved along the longitudinal slot 30015 without cutting an overlap a tissue portion of the tubular network 44392. Although staples 30030c and 30030d positioned adjacent space 44381 in tubular member 44380b may receive less support from tubular network structure 44392, additional features may provide support to those staples 30030 and / or additional restoration force in the region of staple capture 30039 of this. For example, as described in more detail in the present description, additional tubular elements, support belts, springs and / or propping material can be positioned at least one of the tubular element in and out 44380b near the space 44381, for example.
Referring now to Figures 445 to 448, a fabric thickness compensator 45020 may comprise multiple tubular members 45080 laterally traversing the staple cartridge 30000. The tubular members 45080 may be positioned perpendicular to the rows of staple pockets 30012 and / or to the longitudinal axis of the rigid support portion 30010 of the staple cartridge 30000. With reference to Figure 445, the tubular elements 45080 can pass through the longitudinal groove 30015 in the staple cartridge 30000 in such a manner that the cutting element 30052 in the staple trigger slider 30050 is configured to cut the tubular elements 45080 while the staple trigger slider 30050 is moved along the longitudinal slot 30015. Alternatively, with reference now to Figure 446, the fabric thickness compensator 46020 may comprise two sets of tubular elements traversing laterally 46080. The first set of laterally traversing tubular elements 46080a may be positioned on a first side of the longitudinal groove 30015 and the second set of tubular elements traversing laterally 46080b can be positioned on a second side of the longitudinal slot 30015. In such an arrangement, the cutting element 30052 can be configured to pass between the two sets of tubular elements 46080 without cutting a portion of the tubular elements 46080. Alternatively, the cutting element 30052 can cut at least one tubular element 46080 passing through the longitudinal groove 30015, while at least another tubular element 46080 does not pass through the longitudinal slot 30015 and is not cut by the cutting element 30052.
Since tubular elements 45080 laterally traverse staple cartridge 30000, with reference to Figures 447 and 448, a staple 30030 can couple at least one tubular member 45080 in each staple capture area 30039. In such an arrangement, each tubular element 45080 can provide a discrete restoration force throughout the length of staple cartridge 30000. For example, with reference mainly to Figure 448, the tubular elements 45080 positioned near the proximal end of the fabric thickness compensator 45020 where the fabric is thicker can be compressed much compared to the tubular elements 45080 positioned near the distal end of the tissue thickness compensator 45020 where the tissue is thinner. As a result, the tubular elements 45080 positioned closer to the proximal end of the fabric thickness compensator 45020 can provide a restoration force greater than the restoration force that could be generated by the tubular elements 46080 positioned closer to the distal end of the thickness compensator of fabric 45020. Further, still with reference to Figure 448, the deformation of a tube 45080 may have little or no impact on the deformation of an adjacent tube 45080. Accordingly, the tubular elements 45080 may exert an elastic recovery force substantially discrete and personalized in the staple capture areas 30039 along the length of the staple cartridge 30030. When multiple staples 30030 fired from a single row of staple cavities 30012 couple the same tubular element 35080 the deformation of the element can be customized less tubular 35080. For example, the deformation of an element to tubular 35080 in the staple capture area 30039 may affect the deformation of said tubular element 35080 in another staple capture area 30039.
In a further alternative, with reference to Figures 449 to 454, the tubular elements 47080 of the tissue thickness compensator 47020 it can diagonally traverse the staple cartridge 30000. The tubular elements 47080 can traverse the longitudinal slot 30015 of the staple cartridge 30000 in such a way that the cutting element 30052 in the staple trigger slider 30050 is configured to cut the tubular elements traversing diagonally 47080 while the staple firing glider 30052 moves along the longitudinal groove 30015. Alternatively, the fabric thickness compensator 47020 may comprise two sets of tubular elements traversing diagonal 47080. A first set of tubular elements diagonally crossing 47080 can be positioned on a first side of the longitudinal groove 30015 and a second set of tubular elements running diagonally 47080 can be positioned on a second side of the longitudinal groove 30015. In such an arrangement, the cutting element 30052 can pass between the two sets of tubular elements 47080 and can n or cut any tubular element 47080.
With reference still to Figures 449 to 452, diagonally spaced tubular elements 47080 can be positioned in staple cartridge 30,000 so that a space is defined between tubular elements 47080. A space between adjacent tubular elements 47080 can provide space for the horizontal expansion of the tubular elements 47080 when a compressive force is applied to these, such as, for example, by the T fabric captured within the staple capture area 30039 of the formed staple 30030. The tubular elements 47080 can be connected through a space by a film or sheet of material 47024. The material sheet can be positioned on at least one of the cover surface 30011 of the rigid support portion 30010 and / or the tissue contacting side of the tubular elements 47080.
With reference to Figures 453 and 454, at least one diagonally spaced tubular member 47080 can be positioned relative to staple pockets 30012 in staple cartridge 30000 such that tubular member 47080 is positioned between legs 30032 of staples 30030 deployed from multiple rows of staples. staple cavities 30012. Since the staples 30030 move from the initial position to the fired position, as described in more detail in the present description, the legs 30032 of the staple can remain positioned around the tubular member 47080. In addition, the staples they can be deformed in such a way that the staple legs 30032 wrap around the perimeter of the tubular element 47080, for example. In such an arrangement, the staples 30030 can be configured to move to the fired or formed position without piercing the tubular member 47080. The movement of the staple legs 30032 around the tubular member 47080 could, in some cases, prevent the accidental release of an agent. therapeutic 47098 retained in this. The selected angular orientation of each tubular member 47080 relative to the longitudinal slot 30015 of the staple cartridge 30000 may depend on the position of the staple pockets 30012 in the staple cartridge 30000. For example, the tubular elements 47080 may be positioned in a An angle of approximately forty-five (45) degrees relative to the longitudinal slot 30015 of the staple cartridge 30000.
Alternatively, the tubular elements 47080 can be posed at an angle of fifteen (15) to seventy-five (75) degrees relative to the longitudinal slot 30015 of the staple cartridge 30000, for example.
Similar to the descriptions throughout the present disclosure, multiple tubular elements in a tissue thickness compensator may be connected by a bonding agent, sheath, belts, overmolding, compensating material, and / or any other suitable bonding adhesive or structure , for example. With reference to Figures 455 to 457, a flexible cover 48024 can surround or encapsulate tubular elements 48080 in a fabric thickness compensator 48020. The flexible cover 48024 can restrict the tubular elements 48080 in the end effector 12 and can hold each element tubular 48080 in position, such as, for example, in longitudinal alignment with a row of staple cavities 30012. The fabric thickness compensator 48020 may comprise six tubular elements 48080, for example. The flexible cover 48024 can be sufficiently deformable and flexible to contain the tubular elements 48020 enclosed therein while allowing deformation and recovery of the tubular elements 48080. Furthermore, the flexible cover 48024 can tautly surround the tubular elements 48080 and it can remain tightly coupled with the tubular elements 48080 while deforming and / or recovering.
With reference to Figure 456, prior to deployment of the staples 30030, the anvil 30060 can be rotated or rotated downward to compressing the fabric thickness compensator 48020 and the tissue T between the anvil 30060 and the staple cartridge 30000. The compression of the fabric thickness compensator 48020 may include a corresponding compression of the flexible cover 48024 and the tubular elements 48020 therein. While the tubular elements 48020 are deformed, the flexible cover 48024 can similarly deform. The tubular elements 48020 can be compressed uniformly across the width of the staple cartridge 30000 and the flexible cover 48024 can similarly experience a uniform compression through the tubular elements 48080. With reference to Figure 457, when the anvil 30060 is opened after the staples 30030 are deployed from the staple cartridge 30000, the tubular elements 48080 can be recovered or partially recovered from the compressed configurations (FIG. 456). A tubular element 48080 can be recovered in such a way that the tubular element 48080 returns to its initial undeformed configuration. A tubular element 48080 can be partially recovered in such a way that the tubular member 48080 partially returns to its initial undeformed configuration. For example, the deformation of the tubular element 48080 may be partially elastic and partially plastic. While the tubular elements 48080 are recovered, the flexible cover 48024 can remain tightly coupled with each tubular element 48080. The tubular elements 48080 and the flexible cover 48024 can be recovered to such a degree that the tubular elements 48080 and the 578 T-woven fill the staple capture areas 30039 while the tubular elements 48080 exert an appropriate restoring force on the tissue T in these. With reference to Figure 458, as an alternative, a fabric thickness compensator 48120 comprising six tubular elements 48180 retained in a flexible cover 48124 can be positioned on the anvil 30060 of the end effector 12, for example.
With reference to Figures 459 to 462, a fabric thickness compensator 49020 may comprise a tubular member 49080 longitudinally positioned along the longitudinal axis of the anvil 30060. The tissue thickness compensator 49020 may be secured to the anvil 30060 of the end effector 12 for a compressible compensation material 49024. In addition, the compressible compensation material 49024 may surround or encapsulate the tubular member 49080. Similar to the descriptions in the present disclosure, the tubular member 49080 may comprise at least one therapeutic agent 49098 which may be released by absorption of various components of the thickness compensator No. 49020, perforation of the tubular member 49080 by means of staples 30030 from the staple cartridge 30000, and / or by the cutting element 30052.
With reference to Figure 460, a staple cartridge 30000 may comprise staples 30030 positioned in staple pockets 30012, wherein, prior to deployment of the staples 30030, the anvil 30060 and the tissue thickness compensator of 49020 attached thereto can turn to the staple cartridge 30000 and compress the T tissue captured between them. He The tubular element 49080 of the fabric thickness compensator 49020 can be uniformly deformed along the length of the staple cartridge 30000 by the rotary anvil 30060 (FIG. 460). With reference to Figures 461 and 462, the staple trigger slider 30050 can travel along the longitudinal slot 30015 in the staple cartridge 30000 and couple each pusher 30040 positioned under a staple 30030 in a staple pocket 30010, wherein each coupled driver 30040 can fire or eject the staple 30030 from the staple pocket 30012. When the anvil 30060 releases pressure on the tissue T and the fabric thickness compensator 49020, the fabric thickness compensator 49020, which includes the tubular member 49080 and the compressible compensation material 49024 may be recovered or partially recovered from the compressed configuration (Figure 460) to a retrieved configuration (Figures 461 and 462). The tubular member 49080 and the compressible compensation material 49024 can be recovered to such an extent that the fabric thickness compensator 49020 and the tissue T fill the staple capture areas 30039 while the tissue thickness compensator 49020 exerts a force of restoration in the captured tissue T.
With reference to Figures 463 to 465, two tissue thickness compensators 50020a, 50020b can be positioned in the end effector 12 of a surgical instrument. For example, a first fabric thickness compensator 50020a can be connected to staple cartridge 30000 in lower clamp 30070 and a second fabric thickness compensator 50020b can be attached to anvil 30060. The first fabric thickness compensator 50020a it may comprise a plurality of tubular elements 50080 longitudinally disposed and retained in a first compensating material 50024a. At least one tubular member 50080 may comprise a therapeutic agent 50098, similar to the therapeutic agents described in the present disclosure. The first compensation material 50024a may be deformable or substantially rigid. In addition, the first compensation material 50024a may contain the tubular elements 50080 in position relative to the staple channel 30000. For example, the first compensation material 50024a may contain each tubular member 50080 in longitudinal alignment with a row of staple cavities 30012 The second fabric thickness compensator 50020b may comprise the first compensation material 50024a, a second compensation material 50024b and / or a third compensation material 50024c. The second and third compensation material 50024b, 50024c may be deformable or substantially rigid.
The anvil 30060 can rotate and apply a compressive force to the fabric thickness compensators 50020a, 50020b and the tissue T between the anvil 30060 and the staple cartridge 30000. Neither the first fabric thickness compensators 50020a nor the second thickness compensators of tissue 50020b need to be compressible. Alternatively, at least one component of the first fabric thickness compensators 50020a and / or the second fabric thickness compensators 50020b can be compressible. When staples 30030 are fired from the cartridge staples 30000, now referring to Figures 464 and 465, each staple 30030 it can pierce a tubular element 50080 retained in the first fabric thickness compensator 50020a. As shown in Figure 464, such therapeutic agent 50098 retained in tubular member 50080 can be released when a staple 30030 passes through tubular member 50080. When released, therapeutic agent 50098 can coat staple legs 30032 and tissue T surrounding staple staple 30030. Staples 30030 can also pierce second fabric thickness compensator 50020b when staples 30030 are fired from staple cartridge 30000.
With reference to Figures 466 to 469, a fabric thickness compensator 51020, representative of any of the fabric thickness compensators described in the present description, may comprise at least one tubular member 51080 laterally traversing the tissue thickness compensator. 51020. For example, with reference to Figure 466, the fabric thickness compensator 51020 can be positioned in relation to the staple cartridge 30000 in such a way that a first end 51083 of the laterally traversing tubular element 51080 can be positioned close to a first longitudinal side of the staple cartridge 30000 and a second end 51085 of the laterally traversing tubular member 51080 can be positioned near a second longitudinal side of the staple cartridge 30000. The tubular member 51080 may comprise a capsule shape, for example. As illustrated in Figure 467, the tubular member 51080 can be pierced between the first end 51083 and the second end 51085 and, the tubular member 51080 can be drilled at or near the center 51087 of the tubular element 51080. The element Tubular 51080 may comprise a polymeric composition, such as a biocompatible, bioabsorbable, elastomeric polymer, for example. In addition, with reference again to Figure 466, the fabric thickness compensator 51020 may comprise a plurality of tubular elements that traverse laterally 51080. Thirteen tubular elements 51080 may be disposed laterally in the fabric thickness compensator 51020, for example.
Referring again to Figure 466, the fabric thickness compensator 51020 may further comprise a compensation material 51024 which at least partially surrounds the tubular elements 51080. The compensation material 51024 may comprise a bioabsorbable polymer, such as, for example, lyophilized polysaccharide, glycoprotein, elastin, proteoglycans, gelatin, collagen, and / or oxidized regenerated cellulose (ORC). The compensation material 51024 may contain the tubular elements 51080 in position in the fabric thickness compensator 51020. In addition, the compensation material 51024 may be secured to the upper cover surface 30011 of the rigid support portion 30010 of the staple cartridge 30000 in such a manner that the compensation material 51020 is securely positioned in the end effector 12. The compensation material 51024 may comprise at least one drug 51098.
Still with reference to Figure 466, the laterally positioned tubular elements 51080 can be positioned relative to the cutting element 30052 in such a way that the transverse cutting member 30052 is configured to cut the tubular elements 51080. The cutting element can be cut 30052 tubular elements 51080 at or near the perforation in these. When the tubular elements 51080 are cut into two halves, the cut portions of the tubular elements 51080 may be configured to swell or expand, as illustrated in Figure 468. For example, the tubular member 51080 may comprise a hydrophilic substance 51099 which can be be released and / or exposed when the tubular member 51080 is cut. Further, when the hydrophilic substance 51099 comes into contact with the body fluids in the tissue T, the hydrophilic substance 51099 may attract the fluid, which may cause the tubular member 51080 swells or expands. While the tubular member 51080 expands, the compensation material 51024 surrounding the tubular member 51080 can be displaced or adjusted to accommodate the swollen tubular member 51080. For example, when the compensation material 51024 comprises gelatin, the gelatin can be moved to accommodate the swollen tubular elements 51080. With reference now to Figure 469, the expansion of the tubular elements 51080 and the displacement of the compensation material 51024 can cause a corresponding expansion of the tissue thickness compensator 51020.
Similar to other fabric thickness compensators discussed throughout the present description, the fabric thickness compensator 51020 can be deformed or compressed by an applied force. In addition, the fabric thickness compensator 51020 can be sufficiently flexible such that it produces an elastic restoring force when deformed by applied force and can subsequently be recovered or recover partially when the applied force is removed. When the fabric thickness compensator 51020 is captured in a staple capture area 30039, the staples 30030 can deform the fabric thickness compensator 51020. For example, the staples 30030 can deform the tubular elements 51080 and / or the staple material. compensation 51024 of the fabric thickness compensator 51020 which are captured within the perforated staple 30030. The non-captured portions of the fabric thickness compensator 51020 may also be deformed due to deformation in the staple capture areas 30039. When deformed, the fabric thickness compensator 51020 may seek to recover from the deformed configuration. Such a recovery can occur before the hydrophilic expansion of the tubular element 51080, simultaneously with the hydrophilic expansion of the tubular element 51080, and / or after the hydrophilic expansion of the tubular element 51080. While the tissue thickness compensator 51020 seeks to recover , this can exert a restoring force on the tissue also captured in the staple capture area 30039, as described in greater detail in the present description.
At least one of the tubular elements 51080 and / or the compensation material 51024 in the tissue thickness compensator 51020 may comprise a therapeutic agent 51098. When the tubular member 51080 containing a therapeutic agent 51098 is cut, the therapeutic agent 51098 contained within the tubular elements 51080 can be released. In addition, when the compensation material 51024 comprises the therapeutic agent 51098, therapeutic agent 51098 can be released while absorbing the bioabsorbable compensation material 51024. The tissue thickness compensator 51020 can provide a rapid initial release of therapeutic agent 51098 followed by a controlled release of therapeutic agent 51098. For example, the tissue thickness compensator 51020 can provide an initial rapid release of the therapeutic agent 51098 from the tubular elements 51080 to the tissue T along the cutting line when the tubular elements 51080 comprising the therapeutic agent 51098 are cut. the bioabsorbable compensation material 51024 comprising the therapeutic agent 51098 is absorbed, the tissue thickness compensator 51020 can provide a prolonged and controlled release of the therapeutic agent 51098. At least some of the therapeutic agents 51098 can remain in the tubular element 51080 during a short period of time before the therapeutic agent 51098 flows into the compensation material 51024. Alternatively, at least some of the therapeutic agents 51098 can remain in the tubular element 51080 until the tubular member 51080 is absorbed. The therapeutic agent 51098 released from the tubular element 51080 and the compensation material 51024 can be the same. Alternatively, tubular element 51080 and compensating material 51024 may comprise different therapeutic agents or different combinations of therapeutic agents, for example.
Referring still to Figure 469, the end effector 12 can cut the tissue T and shoot the staples 30030 on the cut tissue T almost simultaneously or in rapid succession. In such cases, a staple 30030 can be deployed in the tissue T immediately after the cutting element 30052 breaks the tubular element 51080 adjacent to the tissue T. In other words, the staples 30030 can couple the fabric thickness compensator 51020 immediately after or simultaneously with the swelling of the tubular element 51080 and the expansion of the fabric thickness compensator 51020. The fabric thickness compensator 51020 can grow continuously or expand after staples 30030 are fired into tissue T. When staples 30030 are deployed, staples 30030 can be configured to pierce tubular elements 51080. In such cases, therapeutic agents 51098 still retained in cut tubular elements 51080 can be released from the tubular elements 51080 and, may cover the legs 30031 of the staples 30030.
With reference to Figure 470, the fabric thickness compensator 51020 can be manufactured by a molding technique, for example. A frame, or a mold, 51120 may comprise a first longitudinal side 51122 and a second longitudinal side 51124. Each longitudinal side 51124 may comprise one or more notches 51130, each which may be configured to receive the first or second end 50183, 50185 of a tubular element 51080. The first end 50183 of the tubular element 51080 can be positioned in a first notch 51130a on the first side longitudinal 51122 and second end 50183 of tubular element 51080 can be positioned in a second groove 51130b on second longitudinal side 51124 such that tubular member 51080 laterally traverses frame 51120. Notch 51180 may comprise a semicircular groove, which can fit securely the first or second end 50183, 50185 of the tubular element 51080 therein. The first notch 51130a can be positioned directly opposite the second notch 51130b and the tubular member 51080 can be positioned perpendicular, or at least substantially perpendicular, to the longitudinal axis of the frame 51120. Alternatively, the first notch 51130a can be displaced from the second notch 51130b of such so that the tubular element 51080 is angularly positioned relative to the longitudinal axis of the frame 51120. In a further alternative, at least one tubular element 51080 can be positioned longitudinally within the frame 51120 in such a manner that the tubular element extends between the lateral sides 51126 , 51128 of the frame 51120. Furthermore, at least one tubular element can be positioned angularly in the frame between two notches on the side sides 51126, 51128 of the frame and / or between a notch in a lateral side 51126 and a notch in a longitudinal side 51124 , for example. The frame 51120 may comprise a support flange 51136, which can support the tubular elements 51080 positioned within the frame 51120.
The frame 51120 may comprise notches 51130 to accommodate twelve tubular elements 51080, for example. The notches of the 51130 frame can be filled with tubular elements 51080 while, alternatively, less than all of the notches 51130 can be filled. At least one tubular element 51080 can be positioned in the frame 51120. As an example, at least half of the notches 51130 can receive tubular elements 51080. Once the tubular elements 51080 are positioned in the frame 51120, the compensation material 51024 can be added to the frame 51120. The compensation material 51024 can be fluidic when it is added to the frame 51120. For example, the The compensation material 51024 can be poured into the frame 51120 and can flow around the tubular elements 51080 positioned therein. With reference to Figure 471, the fluid compensation material 51024 can flow around the tubular member 51080 supported by the notches 51130 in the frame 51120. After the compensation material 51024 cures, or at least heals sufficiently, with reference now to the Figure 472, the fabric thickness compensator 51020 comprising the compensation material 51024 and the tubular elements 5180 can be removed from the frame 51120. The fabric thickness compensator 51020 can be cut out. For example, the excess compensation material 51024 can be removed from the fabric thickness compensator 51020 in such a way that the longitudinal sides of the compensation material are substantially flat. In addition, with reference to Figure 473, the first and second ends 50183, 50185 of the tubular elements 51080 can be compressed, or closed, to seal the element tubular 51080. The ends can be closed before the tubular elements 51080 are placed in the frame 51120. Alternatively, the cutting process can sever the ends 51083, 51085 and a thermal stacking process can be used to seal and / or close the ends 51083 , 51085 of the tubular elements 51080.
Referring again to Figure 470, a stiffening pin 51127 may be positioned within each tubular element 51080. For example, the stiffening pin 51127 may extend through a longitudinal lumen of the tubular element 51080. The stiffening pin 51127 may extend beyond each tubular element 51080 in such a way that the stiffening pin 51127 can be positioned in the notches 51130 in the frame 51120. In embodiments having stiffening pins 51127, the stiffening pins 51127 can support the tubular elements 51080 when the material of compensation 51204 is poured into the frame 51120 and while the fluid compensating material 51024 flows around the tubular elements 51080, for example. Once the compensation material 51024 cures, solidifies, and / or lyophilizes or sufficiently cures, solidifies, and / or lyophilizes the fabric thickness compensator 51020 can be removed from the frame 51120 and the reinforcement pins 51127 can be removed from the lumens of the tubular elements 51080. The tubular elements 51080 can then be filled with medicaments, for example. After the tubular elements 51080 are filled with medicines, the fabric thickness compensator 51020 can be trimmed, which includes the ends 51083, 51085 of the tubular elements 51080, for example. The fabric thickness compensator 51020 can be die cut, for example, and / or sealed by heat and / or pressure, for example.
As described in the present description, the fabric thickness compensator 52020 may comprise multiple tubular elements 51080. Referring now to Figure 474, the tubular elements 51080 may comprise different material properties, dimensions and geometries. For example, a first tubular member 51080a may comprise a first thickness and a first material and a second tubular member 51080b may comprise a second thickness and a second material. At least two tubular elements 51080 in the fabric thickness compensator 52020 may comprise the same material. Alternatively, each tubular element 51080 in the fabric thickness compensator 5202 may comprise different materials. Similarly, at least two tubular elements 51080 in the tissue thickness compensator may comprise 52020 the same geometry. Alternatively, each tubular element 51080 in the fabric thickness compensator 52020 may comprise different geometries.
Referring now to Figures 537 to 540, a fabric thickness compensator 51220 may comprise at least one tubular member 51280 laterally traversing the fabric thickness compensator 51220.
With reference to Figure 537, the fabric thickness compensator 51220 can be positioned relative to the anvil 30060 of the end effector 12.
The fabric thickness compensator 51220 can be fixed to a surface of anchoring 30061 of anvil 30060 of end effector 12, for example. With reference principally to Figure 538 the tubular element 51280 may comprise a capsule shape, for example. The tubular element 51280 may comprise a polymeric composition, such as a biocompatible, bioabsorbable, elastomeric polymer, for example.
Referring again to Figure 537, the fabric thickness compensator 51220 may further comprise a compensating material 51224 which at least partially surrounds the tubular elements 51280. The compensating material 51224 may comprise a bioabsorbable polymer, such as, for example, lyophilized polysaccharide, glycoprotein, elastin, proteoglycans, gelatin, collagen, and / or oxidized regenerated cellulose (ORC), for example. Similar to the above, the compensation material 51024 may contain the tubular elements 51280 in position in the fabric thickness compensator 51220. Furthermore, the compensation material 51224 may be fixed to the anchoring surface 30061 of the anvil 30060 in such a way that the compensation material 51220 is securely positioned in end effector 12. Compensating material 51224 may comprise at least one medicament.
Still with reference to Figure 537, the laterally positioned tubular elements 51280 can be positioned relative to the cutting element 30252 in a translatory slide 30250 in such a way that the translatable cutting element 30252 is configured to cut the elements tubular 51280. The cutting element can cut 30252 the elements tubular 51280 at or near the center of each tubular element 51280, for example. When the tubular elements 51280 are cut into two halves, the cut portions of the tubular elements 51280 can be configured to swell or expand, as illustrated in Figure 537. With reference primarily to Figure 539, a tubular element 51280 can comprise a hydrophilic substance 51099 that can be released and / or exposed when the tubular member 51280 is cut. Further, with reference now to Figure 540, when the hydrophilic substance 51099 comes into contact with the body fluids in the tissue T, the hydrophilic substance 51099 can attract the fluid, which can cause the tubular element 51280 to swell or expand. While the tubular member 51280 expands, the compensating material 51224 surrounding the tubular member 51280 can be displaced or adjusted to accommodate the swollen tubular member 51280. For example, when the compensating material 51224 comprises gelatin, the gelatin can be displaced to accommodate the swollen tubular element 51280. Referring again to Figure 537, the expansion of the tubular elements 51280 and the displacement of the compensating material 51224 may cause a corresponding expansion of the tissue thickness compensator 51220.
Similar to other fabric thickness compensators discussed throughout the present description, the fabric thickness compensator 51220 can be deformed or compressed by an applied force. In addition, the fabric thickness compensator 51220 can be sufficiently flexible in such a way as to produce an elastic recovery force when deformed by the force applied and, subsequently, can be recovered or partially recovered when the applied force is removed. When the fabric thickness compensator 51220 is captured in a staple capture area 30039 (FIG. 417), the staples 30030 can deform the tissue thickness compensator 51220. For example, the staples 30030 can deform the tubular elements 51280 and / or the compensation material 51224 of the fabric thickness compensator 51220 captured within the perforated staple 30030. The non-captured portions of the fabric thickness compensator 51220 can also be deformed due to deformation in the staple capture areas 30039. When deformed, the fabric thickness compensator 51220 can seek to recover from the deformed configuration. A recovery of this type can occur before the hydrophilic expansion of the tubular element 51280, simultaneously with the hydrophilic expansion of the tubular element 51280, and / or after the hydrophilic expansion of the tubular element 51280. While the tissue thickness compensator 51220 seeks to recover , this can exert a restoring force on the tissue also captured in the staple capture area 30039, as described in greater detail in the present description.
With reference to Figures 475 to 478, a fabric thickness compensator 52020 may comprise one or more tubular elements 52080 laterally traversing the fabric thickness compensator 52020, similar to at least one tissue thickness compensator described in the present description. . The fabric thickness compensator 52020 can comprising multiple tubular elements that traverse laterally 52080. The fabric thickness compensator 52020 may further comprise one or more sheets of material 52024 that hold or retain at least one tubular member 52080 in the fabric thickness compensator 52020. One or more sheets of material 52024 can be positioned above and / or below the tubular elements 52080 and can safely hold each tubular member 52080 in the fabric thickness compensator 52020. With reference primarily to Figure 475, the fabric thickness compensator may comprise a first sheet of material 52024a and a second sheet of material 52024b. The tubular elements 52080 can be positioned between the first and second sheets of material 52024a, 52024b. In addition, still with reference to Figure 475, the material sheet 52024b can be fixed to the upper cover surface 30011 of the rigid support portion of the staple cartridge 30000 in such a way that the fabric thickness compensator 52020 is positioned from securely in the end effector 12. Alternatively, one or more of the sheets of material 52024 can be secured to the anvil 30060 or otherwise retained in the end effector 12.
With reference principally to Figure 476, the fabric thickness compensator 52020 can be porous and / or permeable. For example, sheet material 52024 may comprise a plurality of openings 52026. Openings 52026 may be substantially circular. The openings 52036 may be visible in sheet material 52024. Alternatively, the 52036 openings can be microscopic. Still referring to Figure 476, the tubular elements 52080 may comprise a plurality of openings 26, as well. With reference to Figure 477, a fabric thickness compensator 52120 may comprise a sheet of material 52124 comprising a plurality of non-circular openings 52126. For example, the openings 52126 may comprise a diamond shape and / or with slots. Alternatively, with reference to Figure 478, a tissue thickness compensator 52220 may comprise a tubular element 52280 comprising a permeable tubular net 52292. The sheet of material 52224 may comprise a biocompatible, bioabsorbable elastomeric polymer and may comprise a medicament, example.
In any of the fabric thickness compensators described in the present disclosure, at least one tubular element 52080 can be configured to swell or expand, as illustrated in Figures 479A to 479D. For example, with reference to Figure 479A, the tubular elements 52080 can be positioned between the first and second sheet material 52024a, 52024b in the fabric thickness compensator 52020. When fabric thickness compensator 52020 comes into contact with the fabric T, as illustrated in Figure 479B, the fabric thickness compensator 52020 can be expanded. For example, the tubular elements 52080 may comprise a hydrophilic substance 52099 that expands when exposed to fluid in and / or on the T-fabric. In addition, the sheet of material 52024 and the tubular elements 52080 may be permeable, as described in US Pat. the present description, in such a way that the fluid from the tissue T can penetrate the fabric thickness compensator 52020 which thus allows the fluid to come in contact with the hydrophilic substance 52099 within the tubular elements 52080. While the tubular elements 52080 expand , the material sheet 52024 surrounding the tubular elements 52080 can be displaced or adjusted to accommodate the swollen tubular elements 52080. Similar to various fabric thickness compensators discussed throughout the present disclosure, the expanded fabric thickness compensator 52020 it can be deformed or compressed by an applied force, such as, for example, a compressive force applied by the fired clips, as illustrated in Figure 479C. In addition, the fabric thickness compensator 52020 can be sufficiently flexible such that it produces an elastic restoring force when deformed by the applied force and can be subsequently recovered when the applied force is removed. Referring now to Figures 479D and 479E, the fabric thickness compensator 52020 can be recovered to different configurations in the different staple capture area 30039 to suitably accommodate the captured tissue T.
With reference to Figures 480 to 485, a fabric thickness compensator 53020 may comprise a plurality of tubular elements in vertical position 53080. Each tubular element 53080 may comprise a tubular axis that is substantially perpendicular to the upper cover surface 30011 of the rigid support portion 30010 of staple cartridge 30000. In addition, the first end of each element tubular 53080 can be positioned adjacent the upper cover surface 30011, for example. The tubular elements 53080 may be deformable and may comprise an elastomeric polymer, for example. As illustrated in Figure 481, tubular elements 53080 can be compressed when captured in a staple capture area 30039 with the stapled tissue T. A tubular element 53080 can comprise an elastic material such that deformation of the tubular element 53080 generates a recovery force while the tubular element 53080 seeks to recover of the deformed configuration. The deformation of the tubular element 53080 may be at least partially elastic and at least partially plastic. The tubular element 53080 can be configured to act as a spring by virtue of an applied force and can be configured not to bend. With reference to Figure 482, the tubular elements 53080 can be substantially cylindrical. With reference to Figure 483, a tubular member 53180 may comprise a buckling region 53112. The tubular member 53180 may be configured to deform or bend in the buckling region 53112 when a compression force is applied thereto. The tubular element 53180 can be deformed elastically and / or in plastic form and then designed to suddenly bend in the buckling region 53112 under a pre-selected buckling force.
With reference principally to Figure 484, a first tubular element 53080 can be positioned at a first end of a staple pocket 30012 and another tubular element 53080 can be positioned at a second end of the staple pocket 30012. As illustrated in Figure 482, the tubular element 53080 may comprise a lumen 53084 extending therethrough. Referring again to Figure 481, when the staple 30030 moves from the initial position to the triggered position, each staple leg 30032 can be configured to pass through a lumen 53084 of each tubular element 53080. Alternatively, with reference primarily to Figure 485, the tubular elements in vertical position 54080 can be arranged in a tissue thickness compensator 54020 in such a way that the tubular elements 54080 abut or come into contact with each other. In other words, tubular elements 54080 can be grouped or accumulated. The tubular elements 54080 can be arranged systematically in the fabric thickness compensator 54020; however, as an alternative, tubular elements 54080 can be arranged randomly.
Referring again to Figures 480, 484, and 485, the fabric thickness compensator 53020 may also comprise a sheet of material 53024 that holds or retains the tubular elements 53080 in the fabric thickness compensator 53020. The sheet of material 53024 it can be positioned above and / or below the tubular elements 53080 and can safely hold each tubular element 53080 in the fabric thickness compensator 53020. The tissue thickness compensator 53020 can comprise a first and a second sheet of material 53024 The tubular elements 53080 can be positioned between the first and the second material sheets 53024. In addition, the material sheet 53024 can be fixed to the upper cover surface 30011 of the rigid support portion of the staple cartridge 30000 in such a way that the fabric thickness compensator 53020 is securely positioned in the end effector 12. Alternatively, a sheet of material 53024 can be secured to anvil 30060 or otherwise retained in end effector 12. Sheet of material 53024 can be sufficiently deformable such that sheet of material 53024 is deformed while the springs 55080 inside the tissue thickness compensator deform.
With reference to Figures 486 and 487, a fabric thickness compensator 55020 may comprise at least one spring 55080 that is sufficiently flexible such that it is capable of producing an elastic restoring force when deformed. With reference principally to Figure 486, the fabric thickness compensator 55020 may comprise a plurality of springs 55080, such as, for example, three rows of springs 55080. The springs 55080 may be arranged in a systematic and / or random manner in the compensator of fabric thickness 55020. Spring 55080 may comprise an elastomeric polymer, for example. The shape of springs 55080 can allow the deformation of these. The springs 55080 may deform from an initial configuration to a deformed configuration. For example, when a portion of the fabric thickness compensator 55020 is captured in a staple capture area 30039, the springs 55080 may deform in and / or around the staple capture area. 30039. The springs 55080 can be bent or collapsed under a compression force applied by a fired staple 30030 and the springs 55080 can generate a restoring force which is a function of the resistance index of the deformed spring 55080 and / or the amount that the spring 55080 is deforms, for example. The spring 55080 may act as a sponge under a compressive force applied by a fired staple 30030. In addition, the spring 55080 may comprise a compensating material, as described in greater detail throughout the present description.
The fabric thickness compensator 55020 may further comprise one or more sheets of material 55024 that hold or retain at least one spring 55080 in the fabric thickness compensator 55020. The sheets of material 55024 may be positioned above and / or below the springs 55080 and can securely retain the springs 55080 in the fabric thickness compensator 55020. The fabric thickness compensator 55020 may comprise a first sheet of material 55024a and a second sheet of material 55024b. The tubular elements 52080 can be positioned between the first and second sheets of material 55024a, 55024b. With reference principally to Figure 487, the fabric thickness compensator 55020 may further comprise a third sheet of material 55024c positioned adjacent the first or second sheet of material 55024a, 55024b. At least one sheet of material 55024 can be secured to the upper cover surface 30011 of the rigid support portion of the staple cartridge 30000, such that the fabric thickness compensator 55020 is positioned from securely in the end effector 12. Alternatively, at least one sheet of material 55024 can be secured to the anvil 30060 or in any other manner be retained in the end effector 12.
Referring now to Figure 487, when a staple 30030 is fired from the staple cartridge 30000 (FIG. 485), the staples 30030 can be attached to the tissue thickness compensator 55020. The staple 30030 fired can capture the tissue T and a portion of the fabric thickness compensator 55020 in the staple capture area 30039. The springs 55080 can be deformable in such a way that the tissue thickness compensator 55020 is compressed when captured by a perforated staple 30030. The springs 55080 can be positioned between the fired staples 30030 in the fabric thickness compensator 55020. Alternatively, at least one spring 55080 can be captured within the staple capture area 30039.
With reference to Figure 488, a fabric thickness compensator 60020 can comprise at least two compensation layers 60022. The fabric thickness compensator 60020 can comprise a plurality of compensation layers 60022 that can be stacked on top of each other, positioned sideways to side, or a combination of these. As described in more detail in the present description, the compensation layers 60022 of the fabric thickness compensator 60020 may comprise different geometrical and / or material properties, for example. In addition, as described in more detail in the present description, there may be cavities and / or channels between the compensation layers stacked adjacent 60022. By For example, a fabric thickness compensator 62020 can comprise six compensation layers 62022a, 62022b, 62022c, 62022d, 62022e, 62022f, which can be stacked adjacent one on top of the other (Figure 503).
With reference to Figures 489, 490, and 492 to 497, a fabric thickness compensator may comprise a first compensating layer 60122a and a second compensating layer 60122b. The first compensation layer 60122a can be stacked adjacent to the second compensation layer 60122b. Adjacently stacked compensation layers 60122 can be separated by a gap or cavity 60132. Referring primarily to Figure 489, a fabric thickness compensator 60120 may also comprise at least one cantilevered or support beam 60124 positioned between the first and second compensation layers 60122a, 60122b. The support 60124 can be configured to position the first compensation layer 60122a relative to the second compensation layer 60122b in such a way that the compensation layers 60122 are separated by the separation space 60132. As described in greater detail in the present description , the deformation of the support 60124 and / or the compensation layers 60122a, 60122b, for example, can reduce the gap 60132.
The support bar of a fabric thickness compensator can comprise several geometries and dimensions. For example, the support bar can be a simple I-bar, a single-curved support bar centered 60124 (Figure 489), a single curve support bar offset 60224 (Figure 490), an elliptical support bar 60324 (Figure 492), a multicurve support bar 60424 (Figure 493), and / or a symmetrical double cantilever support bar 60524 (Figure 494). In addition, with reference now to Figures 489, 495, and 496, a support bar 60624 may be thinner than at least one compensating layer 60122 (Figure 495), a support bar 60724 may be thicker than at least one compensation layer 60122 (Figure 496), and / or a support bar 60124 can be substantially the same thickness as at least one compensation layer 60122 (Figure 489), for example. The material, geometry and / or dimensions of the support bar 60124, for example, can affect the deformability and elastic recoverability of the fabric thickness compensator 60120.
Still referring to Figure 489, the compensating layers 60122 and the support bars 60124 of the fabric thickness compensator 60120 can comprise different materials, such as, for example, structural material, biological material, and / or electrical material, for example. example. For example, at least one compensation layer 60122 may comprise a polymer composition. The polymer composition may comprise at least partially elastic material such that the deformation of the compensating layer 60122 and / or 60124 of the support bar can generate an elastic restoring force. The polymer composition of the compensation layer 60122 may comprise nonabsorbent polymers, absorbent polymers, or combinations thereof. The absorbent polymers can include polymers elastomeric biocompatible, bioabsorbable, for example. Besides, the The polymer composition of the compensation layer 60122 may comprise synthetic polymers, non-synthetic polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharide, glycoprotein, elastin, proteoglycan, gelatin, collagen, and oxidized regenerated cellulose (ORC). The polymer composition of the compensation layers 60122 may include varied amounts of absorbent polymers, non-absorbent polymers, synthetic polymers and non-synthetic polymers, for example, as a function of weight percentage. Each compensation layer 60022 in the fabric thickness compensator 60120 may comprise a different polymer composition or, alternatively, at least two compensation layers 60122 may comprise the same polymer composition.
Referring again to Figure 488, at least one compensating layer 60022 may comprise a therapeutic agent 60098 such as a medicament or pharmaceutically active agent, for example. The compensation layer 60022 can deliver a therapeutically effective amount of the therapeutic agent 60098. The therapeutic agent 60098 can be released while the compensation layer 60022 is absorbed. Examples of therapeutic agents 60098 can include, but are not limited to, hemostatic agents and drugs, such as, for example, fibrin, thrombin, and oxidized regenerated cellulose (ORC), anti-inflammatory drugs, such as, for example, diclofenac, aspirin, naproxen, sulindac, and / or hydrocortisone antibiotic and antimicrobial drugs or agents, such as, for example, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol, and / or anticancer agents, such as, for example, cisplatin, mitomycin, adriamycin. The therapeutic agent 60098 may comprise a biological agent, such as a stem cell, for example. Each compensation layer 60022 in a tissue thickness compensator 60020 may comprise a different therapeutic agent 60098 or, alternatively, at least two compensation layers 60022 may comprise the same therapeutic agent 60098. A compensation layer 60022 comprising a therapeutic agent 60098 , such as a biological one, for example, can be lined between two structural compensation layers 60022 comprising a polymeric composition, such as, for example, polyglycolic acid (PGA) foam, for example. A compensating layer 60022 can also comprise an electrically conductive material, such as, for example, copper.
Referring again to Figure 503, the compensation layers 62022 in the fabric thickness compensator 62020 may have different geometries. When the layers 62022 are positioned adjacently in the fabric thickness compensator 62020, the compensation layers 62022 can form at least one three-dimensional conduit 62032 between the layers 62022. For example, when a second compensation layer 62022b comprising a channel is positioned above a layer third layer substantially flat 62022c, to the channel and the flat surface of the third compensation layer 62022c can define a three-dimensional conduit 62032a therebetween. Similarly, for example, when a fifth compensation layer 62022e comprising a channel is positioned below a fourth compensation layer 62022d comprising a corresponding channel, the channels can form a three-dimensional conduit 62032b defined by the channels in the compensation layers. stacked adjacent 62022d, 62022e. The conduits 62032 can direct therapeutic agents and / or body fluids while the fluids flow through the tissue thickness compensator 62020.
With reference to Figure 499, a fabric thickness compensator 61020 may comprise compensation layers 61022, such as layers 60122a and 21022b, configured to receive staples 30030 deployed from staple cartridge 20000 (Figure 498). While a staple 30030 moves from an initial position to a triggered position, the geometry of at least one compensating layer 61022 can guide the legs of the staples 30032 to the triggered position. At least one compensating layer 61022 may comprise openings 61030 extending therethrough, wherein the openings 61030 may be arranged to receive the legs of the staples 30032 of the unfolded staples 30030 when the staples 30030 are fired from the staple cartridge 20000 (Figure 498), as described in greater detail in the present description. Alternatively, with reference again to Figure 503, the staple legs 30032 can pierce through at least one layer of compensation, such as compensation layer 62022f, for example, and can be received through openings 62030 in at least one compensation layer, such as, for example, compensation layer 62022a.
With reference principally to Figure 499, the fabric thickness compensator 60120 may comprise at least one support tab 61026 in one of the compensation layers 61022a, 61022b. The support tab 61026 may protrude into the gap 61032 defined between the adjacent compensation layers, such as the space 61032 between the first compensation layer 61020a and the second compensation layer 61020b. The support tab 61026 may protrude from a longitudinal side of a first compensating layer 61022a. In addition, the support tab 61026 may extend along the length of the longitudinal side or only along a portion thereof. At least one support tab 61026 can protrude from two longitudinal sides of the compensation layer 61022a, 61022b. In addition, the adjacently positioned compensation layers 61022a, 61022b may comprise corresponding support tabs 60126, such that the support tab 60126 extending from the first compensating layer 60122a may at least partially align with the support tab 60126 that extends from the second compensation layer 60122b. Referring again to Figure 497, a fabric thickness compensator 60820 may comprise a limiting plate 60828 between adjacent compensation layers 60122a, 60122b. The limiter plate 60828 can be positioned in the space 60132 defined between the first compensation layer 60122a and the second compensation layer 60122b, for example. As described in more detail in the present description, the support tab (s) 61026 and / or the limiting plate (s) 60828 can control the deformation and / or deflection of a support 60124 and / or compensation layers 60122a, 60122b.LL GO.
As described in the present description, the compensation layers 60022 of the fabric thickness compensator 60020 may comprise different materials, geometries and / or dimensions. Said 60020 fabric thickness compensators can be assembled by a variety of fabrication techniques. With reference mainly to Figure 488, the fabric thickness compensator 60022 can be manufactured by stereolithography (SLA), lithography, or screen printing processes. For example, a stereolithography manufacturing process can create a fabric thickness compensator 60020 in which each compensation layer 60022 comprises different materials and / or geometric characteristics. For example, an ultraviolet light in a stereolithography machine can draw the geometry of a first compensation layer 60022, such that the first compensation layer 60022 comprising a first material, geometry and / or dimensions is cured by ultraviolet light . The ultraviolet light can subsequently draw the geometry of a second compensation layer 60022, such that the second compensation layer 60022 comprising a second material, geometry and / or dimensions is cured by ultraviolet light. A stereolithography machine can draw layers of compensation 60022 one on top of the other, side by side, or a combination of these. In addition, compensation layers 60022 can be drawn such that cavities 60132 exist between adjacent compensation layers 60022. Because a stereolithography machine can create very thin layers having unique geometries, a fabric thickness compensator 60020 manufactured by A stereolithography process can comprise a very complex three-dimensional geometry.
With reference to Figure 498, the tissue thickness compensator 60920 can be positioned in the end effector 12 of a surgical instrument 10 (Figure 1). The fabric thickness compensator 60920 can be positioned relative to the staple cartridge 20000 of the end effector 12. For example, the fabric thickness compensator 60920 can be removably secured to the staple cartridge 20000. At least one compensation layer 60922 of the fabric thickness compensator 60920 can be positioned adjacent the upper cover surface 20011 (Figure 408) of the staple cartridge 20000. For example, a second compensating layer 60922b can be fixed to the upper cover surface 20011 by an adhesive or by an envelope, similar to at least one of the wraps described herein (Figure 218). The fabric thickness compensator 60920 can be integrated into the staple cartridge 20000 in such a manner that the staple cartridge 20000 and the tissue thickness compensator 60920 are formed as a single unit construction. For example, staple cartridge 20000 may comprise a first body portion, such as rigid support portion 20010 (Figure 408), and a second body portion, such as the fabric thickness compensator 60920.
Still with reference to Figure 498, the fabric thickness compensator 60920 may comprise a first portion of the compensator 60920a and a second portion of the compensator 60920b. The first portion of the compensator 60920a can be positioned on a first longitudinal side of the staple cartridge 20000 and the second portion of the compensator 60920b can be positioned on a second longitudinal side of the staple cartridge 20000. When the tissue thickness compensator 60920 is positioned relative to to the staple cartridge 20000, the longitudinal slot 20015 (FIG. 407) in the rigid support portion 20010 (FIG. 407) may extend between the first portion of the compensator 60920a and the second portion of the compensator 60920b. When the cutting element 20052 in the staple trigger slider 20050 (Figure 407) is translated through the end effector 12, the cutting element 20052 can pass through the longitudinal slot 20015 between the first portion of the compensator 60920a and the second portion of the compensator 60920b without cutting a portion of the fabric thickness compensator 60920, for example. Alternatively, the cutting element 20052 can be configured to cut a portion of the fabric thickness compensator 60920.
Referring now to Figure 491, a tissue thickness compensator 63020 can be configured to fit the end effector 12 'of a circular surgical instrument. The thickness compensator Fabric 62030 can comprise a first compensation layer circular 63022a and a second circular compensation layer 63022b. The second compensation layer 63022b can be positioned on a circular top cover surface 20011 'of a circular staple cartridge 20000', wherein the second compensation layer 63022b can comprise a geometry corresponding to the geometry of the cover surface 20011 ' . For example, the cover surface 20011 'may comprise a stepped portion and the second compensation layer 63022b may comprise a corresponding stepped portion. The fabric thickness compensator may further comprise at least one support 63024 and / or support tabs 63026, for example, which extends around the tissue thickness compensator 63020.
Referring again to Figure 499, the fired staples 30030 may be configured to engage the fabric thickness compensator 60920. As described throughout the present description, a fired staple 30030 may capture a portion of the fabric thickness compensator 60920 and the fabric T and applying a compressive force to the fabric thickness compensator 60920. Further, with reference primarily to Figures 500 to 502, the fabric thickness compensator 60920 may be deformable. As described in the present description, a first compensating layer 60920a can be separated from a second compensating layer 60920b by a gap 60932. With reference to Figure 500, prior to compression of the fabric thickness compensator 60920, the space 60932 can comprise a first distance. When a compression force A is applied to the fabric thickness compensator 60920 and the tissue T, for example, by a perforated staple 30030 (FIG. 499), the support 60924 can be configured to deform. Referring now to Figure 501, the single curve support bar 60924 can be bent under the compression force A such that the gap 60932 between the first compensation layer 60920a and the second compensation layer is reduced to a second distance 60920b. With reference principally to Figure 502, the first and second compensation layers 60922a, 60922b can also be deformed under the compression force A. The support tabs 60926 can control the deformation of the compensation layers 60920. For example, the tabs of Support 60926 can prevent excessive bending of the compensation layers 60920 by supporting the longitudinal sides of the compensation layer 60920 when they come into contact with one another. The support tabs 60926 can also be configured to be bent or tilted under the compression force A. Additionally or alternatively, the limiting plate 60128 (Figure 497) which is described in greater detail in the present description, can limit the deformation of the layers of compensation 60920 when the compensation layers 60920 and / or the support tabs 60926 come into contact with the limiting plate 60128.
In addition, similar to various fabric thickness compensators described in the present disclosure, the fabric thickness compensator 60920 can generate a resilient restoration or recovery force when deformed. The restoration force generated by the compensator the thickness of deformed fabric can, at least, depend on the orientation, dimensions, material, and / or geometry of the fabric thickness compensator 60920, as well as the deforming amount of the fabric thickness compensator 60920 by the applied force. In addition, at least a portion of the fabric thickness compensator 60920 can be flexible, such that the fabric thickness compensator 60920 generates a spring load or restoring force when deformed by a perforated staple 30030. The support 60924 can comprising an elastic material and / or at least one compensating layer 60922 may comprise an elastic material in such a way that the fabric thickness compensator 60920 is flexible.
Referring now to Figure 504, an end effector of a surgical stapling instrument can comprise a first clamp and a second clamp, wherein at least one of the first clamp and the second clamp can be configured to move relative to the other. . The end effector may comprise a first clamp including a staple cartridge channel 19070 and a second clamp including an anvil 19060, wherein the anvil 19060 can be rotated toward and / or from the staple cartridge channel 19070, for example . The staple cartridge channel 19070 can be configured to receive a staple cartridge 19000, for example, that can be detachably retained within the staple cartridge channel 19070. The staple cartridge 19000 can comprise a cartridge body 19010 and a compensator of fabric thickness 19020, where the fabric thickness compensator 19020 can be attached in a removable to cartridge body 19010. Referring now to Figure 505, cartridge body 19010 may comprise a plurality of staple cavities 19012 and a staple 19030 positioned within each staple pocket 19012. In addition, staples 19030 may be supported by staple drivers 19040 positioned within the cartridge body 19010, wherein a slider and / or a trigger member, for example, can be advanced through the staple cartridge 19000 to raise the staple drivers 19040 up into the cavities of staples 19012, as illustrated in Figure 506, and eject staples 19030 from staple cavities 19012.
With reference principally to Figures 504 and 505, the fabric thickness compensator 19020 can comprise flexible members 19022 and a container 19024 which encapsulates flexible members 19022. The container 19024 can be sealed and can define a cavity containing an internal atmosphere having a pressure that is different from the surrounding atmospheric pressure. The pressure of the inner atmosphere may be greater than the pressure of the surrounding atmosphere, while, alternatively, the pressure of the inner atmosphere may be less than the pressure of the surrounding atmosphere. When the container 19024 contains a pressure less than the pressure of the surrounding atmosphere, the side wall of the container 19024 can enclose a vacuum. In such cases, the vacuum can cause the container 19024 to distort, collapse and / or collapse where the flexible members 19022 positioned within the container 19024 can be flexibly compressed within the container 19024. When the vacuum is made in the container 19024, the flexible members 19022 can deviate or deform downward and can be held in position by the side walls of the container 19024 in a compressed or vacuum packed state.
Flexible member 19022 and container 19024 are composed of biocompatible materials. Flexible member 19022 and / or container 19024 may be composed of bioabsorbable materials such as PLLA, PGA, and / or PCL, for example. The flexible member 19022 can be composed of a flexible material. The flexible member 19022 may also comprise structural flexibility. For example, the flexible member 19022 may be in the form of a hollow tube.
In addition to the foregoing, the fabric thickness compensator 19020 can be positioned against or adjacent to the cover surface 19011 of the cartridge body 19010. When the staples 19030 are at least partially fired, with reference now to FIG. 19030 staples can pierce or break container 19024. Container 19024 can comprise a central portion 19026 that can be positioned over a cutting slot 19016 of cartridge body 19010 in such a way that, when a cutting member 19080 is advanced to impact the T tissue positioned between the staple cartridge 19000 and the anvil 19060, the cutting member 19080 can also cut the central portion 19026 of the container 19024 to pierce or thus break the container 19024. In any case, once the container 19024 is broken , the internal atmosphere inside the container 19024 can match with the atmosphere surrounding the fabric thickness compensator 19020 and allowing flexible members 19022 to flex flexibly to recover, or at least partially recover, their undistorted and / or non-flattened configuration. In such circumstances, the flexible members 19022 may apply a pressing force to the tissue T captured within the deformed staples 19020. More specifically, after being deformed by the forming surfaces of the cavities 19062 defined in the anvil 19060, the legs of the legs 190 19030 staples can capture the fabric Ty and at least a portion of a flexible member 19022 within the staples 19030 such that, when the container 19024 breaks, the fabric thickness compensator 19020 can compensate for the thickness of the tissue T captured within the fabric. the staples 19030. For example, when the tissue T captured within a staple 19030 is thinner, a flexible member 19022 captured within that staple 19030 can expand to fill the voids within staple 19030 and apply sufficient compression force to the staple 19030. tissue T. Accordingly, when the T tissue captured within a 19030 staple is thicker, a flexible member 19022 captured inside from that 19030 staple can remain compressed to make room for the thicker tissue within the 19030 staple and, in the same way, apply sufficient compression force to the T tissue.
When the container 19024 is perforated, as indicated above, the flexible members 19022 can expand in an attempt to flexibly return to their original configuration. In certain circumstances, the portion of flexible members 19022 that is captured within the staples 19030 may not be able to return to its original form without distorting. In In such circumstances, the flexible members 19022 may comprise a spring that can apply a compressive force to the tissue T captured within the staples 19030. A flexible member 19022 can emulate a linear spring, wherein the compression force applied by the flexible member 19022 is linearly proportional to the amount, or distance, in which the flexible member 19022 remains offset within the staple 19030. Alternatively, a flexible member 19022 may emulate a non-linear spring wherein the compression force applied by the flexible member 19022 is not linearly proportional to the amount, or distance, in which the flexible member 19022 remains offset within the staple 19030.
With reference principally to Figures 507 and 508, a staple cartridge 19200 may comprise a tissue thickness compensator 19220 which may comprise one or more sealed containers 19222 therein. Each of the containers 19222 can be sealed and can contain an indoor atmosphere. The pressure of the inner atmosphere within a sealed container 19222 may exceed the atmospheric pressure while, alternatively, the pressure of the inner atmosphere within a sealed container 19222 may be less than the atmospheric pressure. When the pressure of the inner atmosphere within a container 19222 is lower than the atmospheric pressure, the container 19222 can be described as containing a vacuum. One or more of the containers 19222 can be wrapped or contained in an outer shell, package, wrapper, and / or film 19224, for example, where The fabric thickness compensator 19220 can be positioned above a cover surface 19011 of the cartridge body 19010. Each container 19222 may be fabricated from a tube having a circular, or at least substantially circular, cross section, for example, having a closed end and an open end. A vacuum can be made at the open end of the tube and, when a sufficient vacuum is reached within the tube, the open end can be closed and sealed. For example, the tube can be composed of a polymeric material, for example, where the open end of the tube can be heated to close and seal it. In any case, the vacuum within each container 19222 can pull the side walls of the tube inwardly and flexibly distort and / or flatten the tube. The containers 19222 are illustrated in a state at least partially flattened in Figure 508.
When the staples 19030 are in their non-fired position, as illustrated in Figure 508, the tips of the staples 19030 can be positioned further in the tissue thickness compensator 19220. For example, staples 19030 can be positioned within their respective staples. staple cavities 19012 in such a manner that the staples 19030 do not come into contact with the containers 19222 until the staples 19030 move from the non-fired positions, illustrated in FIG. 508, to their fired positions, illustrated in FIG. 509. wrapping 19224 of fabric thickness compensator 19220 can protect containers 19220 from being punctured prematurely by staples 19030. When staples 19030 are at least partially fired, with reference now to Figure 509, legs of staples 19030 can pierce or break the containers 19222. In such circumstances, the indoor atmospheres within the containers 19222 can be matched to the atmosphere surrounding the containers 19222 and flexibly expanded to recover, or at least partially recover, their configuration without distortion and / or flattening. In such circumstances, the perforated containers 19222 may apply a pressing force to the tissue captured within the deformed staples 19030. More specifically, after being deformed by the forming surfaces of the cavities 19062 defined in the anvil 19060, the legs of the staples 19030 can capture tissue T and at least a portion of a container 19222 within staples 19030 in such a way that, when the containers 19222 are broken, the containers 19222 can compensate for the thickness of the T tissue captured within the staples 19030. For example, when the tissue T captured within a staple 19030 is thinner, a container 19222 captured within that staple 19030 can be expanded to filling the voids within the staple 19030 and, at the same time, applying a sufficient compression force for the tissue T. Accordingly, when the T tissue captured within a 19030 staple is thicker, a container 19222 captured within that staple 19030 can remain compressed to make room for the thicker tissue within the 19030 staple and, at the same time, apply sufficient compression force for the T tissue.
When the containers 19222 are perforated, as indicated above, the containers 19222 may extend in an attempt to flexibly return to their original configuration. The portion of the containers 19222 that It is captured within the 19030 staples may not be able to return to its original shape without distorting. In such circumstances, the container 19222 can comprise a spring that can apply a compressive force to the tissue T captured within the staples 19030. A container 19222 can emulate a linear spring wherein the compression force applied by the container 19222 is linearly proportional to the amount, or distance, in which the container 19222 remains offset within the staple 19030. Alternatively, a container 19222 can emulate a non-linear spring, wherein the compression force applied by the container 19222 is not linearly proportional to the amount, or distance, in which the container 19222 remains offset within the staple 19030. The containers 19222 may be hollow and empty when in their closed configuration. Alternatively, each of the containers 19222 may define a cavity and may also include at least one medicament contained therein. The containers 19222 can be composed of at least one medicament that can be released and / or bioabsorbed, for example.
The containers 19222 of the tissue thickness compensator 19220 can be arranged in any suitable manner. As illustrated in Figure 507, the staple cavities 19012 defined in the body of the cartridge 19010 and the staples 19030 positioned in the staple cavities 19012 can be arranged in rows. As illustrated, the staple cavities 19012 can be arranged in six linear, longitudinal rows, for example; however, any suitable arrangement of staple cavities 19012 could be used. As also illustrated in Figure 507, the tissue thickness compensator 19220 can comprise six containers 19222 where each of the containers 19222 can be aligned with, or positioned on, a row of staple pockets 19012. Each of the staples 19030 within a row of staple pockets 19012 can be configured to pierce the same container 19222. In certain situations, some of the staple legs of the staples 19030 may not puncture container 19222 positioned thereon; however, when the container 19222 defines a continuous internal cavity, for example, the cavity can be sufficiently pierced by at least one of the staples 19030 to allow the pressure of the atmosphere of the internal cavity to equalize with the atmospheric pressure surrounding the chamber. container 19222. Referring now to Figure 514, a tissue thickness compensator may comprise a container, such as container 19222 ', for example, which may extend in a direction that is transverse to a line of staples 19030. For example , a container 19222 'can extend through multiple rows of staples. Referring now to Figure 515, a fabric thickness compensator 19220"may comprise a plurality of containers 19222" extending in a direction that is perpendicular, or at least substantially perpendicular, to a line of staples 19030. For example, some of the containers 19222"may be pierced by the staples 19030, while others may not be pierced by the staples 19030. The containers 19222" may extend from one side to the other or through a cutting path in which a cutting member could break and section the containers 19222", for example.
As described above, a tissue thickness compensator of a staple cartridge, such as tissue thickness compensator 19220, for example, may comprise a plurality of sealed containers 19222, for example. As also described above, each of the sealed containers 19222 may comprise a separate internal atmosphere. The containers 19222 can have different internal pressures. For example, a first container 19222 may comprise an internal vacuum having a first pressure and a second container 19222 may comprise an internal vacuum having a second, different pressure, for example. For example, the amount of distortion or flattening of a container 19222 may be a function of the vacuum pressure of the internal atmosphere contained therein. For example, a container 19222 having a larger vacuum may be distorted or flattened by a larger amount compared to a container 19222 having a smaller vacuum. The cavity of a container may be segmented into two or more sealed, separate cavities, wherein each sealed, separate cavity may comprise a separate internal atmosphere. For example, some of the staples within a row of staples can be configured and arranged to pierce a first defined cavity in the container while other staples within the row of staples can be configured and arranged to pierce a second cavity defined in the container, for example. In such cases, especially when the staples in a row of staples are sequentially fired from one end of the row of staples to the other, as described above, one of the cavities may remain intact and It can maintain its internal atmosphere when another cavity is broken. The first cavity may have an inner atmosphere having a first vacuum pressure and the second cavity may have an internal atmosphere having a second different vacuum pressure, for example. A cavity that remains intact can maintain its internal pressure until the container bioabsorbs to create a release of timed pressure.
Referring now to Figures 510 and 511, a fabric thickness compensator, such as the fabric thickness compensator 19120, for example, may be attached to an anvil 19160. Similar to the foregoing, the fabric thickness compensator 19120 may comprise a container 19124 and a plurality of flexible members 19122 positioned therein. Also similar to the above, vessel 19124 may define a cavity containing an inner atmosphere having a pressure that is lower or higher than the pressure of the atmosphere surrounding the tissue thickness compensator 19120. When the interior atmosphere within the container 19124 comprises a vacuum, the container 19124 and the flexible members 19122 positioned therein can be distorted, collapsed, and / or flattened by the pressure difference between the vacuum in the container 19124 and the atmospheric pressure outside the container 19124. In use, the Anvil 19160 can be moved to a closed position in which it is positioned opposite the staple cartridge 19100 and in which a tissue engaging surface 19121 in the container 19124 can couple the positioned tissue T 19100 staples. In use, the trigger member 19080 can be advanced distally to trigger the staples 19030, as described above and, at the same time, cut the tissue T. The tissue thickness compensator 19120 can further comprise an intermediate portion 19126 which can be aligned with a cutting groove that is defined in the anvil 19160 where, when the firing member 19080 is advanced distally through the tissue thickness compensator 19120, the firing member 19080 can pierce or break the container 19124 In addition, similar to the foregoing, the trigger member 19080 can raise the staple drivers 19040 upward and trigger the staples 19030 in such a manner that the staples 19030 can come into contact with the anvil 19160 and deform in their deformed configuration, as is illustrated in Figure 512. When the staples are fired 19030, the staples 19030 can pierce the tissue T and then pierce or tear the container 19124 from such ma The flexible members 19122 positioned within the container 19124 can be expanded at least partially, as described above.
In addition to the foregoing, a tissue thickness compensator may be composed of a biocompatible material. The biocompatible material, such as a foam, may comprise tackifiers, surfactants, fillers, crosslinking agents, pigments, dyes, antioxidants and other stabilizers and / or combinations thereof to provide desired properties to the material. A biocompatible foam It may comprise a surfactant agent. The surfactant agent can applied to the surface of the material and / or dispersed within the material. Without wishing to be bound to any particular theory, the surfactant applied to the biocompatible material can reduce the surface tension of the fluids in contact with the material. For example, the surfactant can reduce the surface tension of the water in contact with the material to accelerate the penetration of water into the material. Water can act as a catalyst. The surfactant agent can increase the hydrophilicity of the material.
The surfactant may comprise an anionic surfactant, a cationic surfactant, and / or a nonionic surfactant. Examples of surfactants include, but are not limited to, polyacrylic acid, metallose, methyl cellulose, ethyl cellulose, propyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octylphenyl ether, ether polyoxyethylene oleyl, polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether, polyoxyethylene nonylphenyl ether, poly dialkylphenoxy (ethyleneoxy) ethanol, and polyoxamers, and combinations thereof. The surfactant may comprise a copolymer of polyethylene glycol and polypropylene glycol. The surfactant may comprise a phospholipid surfactant. The phospholipid surfactant can provide antibacterial stabilizing properties and / or disperse other materials in the biocompatible material. The tissue thickness compensator may comprise at least one medicament. The fabric thickness compensator may comprise one or more of the natural materials, non-synthetic materials, and / or synthetic materials that are described in the present disclosure. He Fabric thickness compensator may comprise a biocompatible foam comprising gelatin, collagen, hyaluronic acid, oxidized regenerated cellulose, polyglycolic acid, polycaprolactone, polylactic acid, polydioxanone, polyhydroxyalkanoate, polygallecapron, and combinations thereof. The tissue thickness compensator may comprise a film comprising at least one medicament. The tissue thickness compensator may comprise a biodegradable film comprising at least one medicament. The medicament may comprise a liquid, gel, and / or a powder. The medicaments may comprise anticancer agents, such as, for example, cisplatin, mitomycin, and / or adriamycin.
The tissue thickness compensator may comprise a biodegradable material to provide controlled elution of the at least one medicament while degrading the biodegradable material. The degradable biodegradable material can decompose, or lose structural integrity, when the biodegradable material comes into contact with an activator, such as, for example, an activating fluid. The activating fluid may comprise saline solution or any other electrolyte solution, for example. The biodegradable material may come into contact with the activating fluid by conventional techniques, including, but not limited to, spraying, dipping, and / or brushing. In use, for example, a surgeon may immerse an end effector and / or a staple cartridge comprising the tissue thickness compensator comprising at least one medicament in an activating fluid comprising a salt solution, such as chloride. of sodium, calcium chloride, and / or potassium chloride. The tissue thickness compensator can release the medication while the tissue thickness compensator degrades. Elution of the drug from the tissue thickness compensator can be characterized by a rapid initial elution rate and a slower sustained elution rate.
A tissue thickness compensator, for example, may be composed of a biocompatible material which may comprise an oxidizing agent. The oxidizing agent may be an organic peroxide and / or an inorganic peroxide. Examples of oxidizing agents may include, but are not limited to, hydrogen peroxide, urea peroxide, calcium peroxide, and magnesium peroxide, and sodium percarbonate. The oxidizing agent may comprise oxidizing agents based on peroxygen and hypohalite-based oxidizing agents, such as, for example, hydrogen peroxide, hypochlorous acid, hypochlorites, hypocodites, and percarbonates. The oxidizing agent may comprise chlorites of alkali metals, hypochlorites and perborates, such as, for example, sodium chlorite, sodium hypochlorite and sodium perborate. The oxidizing agent may comprise vanadate. The oxidizing agent may comprise ascorbic acid. The oxidizing agent may comprise an active oxygen generator. A tissue scaffold may comprise the biocompatible material comprising an oxidizing agent.
The biocompatible material may comprise a liquid, gel, and / or a powder. The oxidizing agent may comprise microparticles and / or nanoparticles, for example. For example, the oxidizing agent can be ground into microparticles and / or nanoparticles. The oxidizing agent can be incorporated into the biocompatible material by suspending the oxidizing agent in a polymer solution. The oxidizing agent can be incorporated into the biocompatible material during the lyophilization process. After lyophilization, the oxidizing agent can bind to the cell walls of the biocompatible material to interact with the tissue at the time of contact. The oxidizing agent may not chemically bind to the biocompatible material. A dry percarbonate powder can be incorporated into a biocompatible foam to provide a prolonged biological effect by the slow release of oxygen. A dry percarbonate powder can be incorporated into a polymer fiber in a non-woven structure to provide a biological effect prolonged by the slow release of oxygen. The biocompatible material may comprise an oxidizing agent and a medicament, such as, for example, doxyelin and ascorbic acid.
The biocompatible material may comprise a quick release oxidizing agent and / or a slower sustained release oxidizing agent. The elution of the oxidizing agent from the biocompatible material can be characterized by a rapid initial elution rate and a slower sustained elution rate. The oxidizing agent can generate oxygen when the oxidizing agents come into contact with body fluids, such as, for example, water. Examples of bodily fluids may include, but are not limited to, blood, plasma, peritoneal fluid, cerebrospinal fluid, urine, lymphatic fluid, synovial fluid, vitreous humor, saliva, gastrointestinal luminal content, and / or bile. Without wishing to link to any particular theory, the oxidizing agent can reduce cell death, improve tissue viability and / or maintain the mechanical strength of the tissue to the tissue that can be damaged during cutting and / or stapling. The biocompatible material may comprise at least one microparticle and / or nanoparticles. The biocompatible material may comprise one or more of the natural materials, non-synthetic materials, and synthetic materials described in the present disclosure. The biocompatible material may comprise particles having an average diameter of about 10 nm to about 100 nm and / or about 10 mm to about 100 mm, such as, for example, 45-50 nm and / or 45-50 pm. The biocompatible material may comprise biocompatible foam comprising at least one microparticle and / or nanoparticle incorporated therein. The microparticle and / or nanoparticle may not chemically bind to the biocompatible material. The microparticle and / or nanoparticle can provide a controlled release of the drug. The microparticle and / or nanoparticle may comprise at least one medicament. The microparticle and / or nanoparticle may comprise a hemostatic agent, an antimicrobial agent, and / or an oxidizing agent, for example. The tissue thickness compensator may comprise a biocompatible foam comprising a hemostatic agent comprising oxidized regenerated cellulose, an antimicrobial agent comprising doxyielin and / or Gentamicin, and / or an oxidizing agent comprising a percarbant. The microparticle and / or nanoparticle can provide a controlled release of the drug for up to three days, for example.
The microparticle and / or nanoparticle can be incorporated into the biocompatible material during a manufacturing process. For example, a biocompatible polymer, such as, for example, a PGA / PCL, may come into contact with a solvent, such as, for example, dioxane to form a mixture. The biocompatible polymer can be ground to form particles. The dried particles, with or without ORC particles, can be contacted with the mixture to form a suspension. The suspension can be lyophilized to form a biocompatible foam comprising PGA / PCL having dry particles and / or ORC particles incorporated therein.
The fabric thickness compensators or layers described herein may be comprised of an absorbable polymer, for example. A tissue thickness compensator can be composed of foam, film, fibrous tissue, fibrous non-woven PGA, PGA / PCL (po) i (glycolic acid-co-caprolactone)), PLA / PCL (poly (lactic acid-co-polycaprolactone) )), PLLA / PCL, PGA / TMC (poly (glycolic acid-co-trimethylene carbonate)), PDS, PEPBO or other absorbable polyurethane, polyester, polycarbonate, polyorthoesters, polyanhydrides, polyesteramides, and / or polyoxaesters, for example. A tissue thickness compensator can be composed of PGA / PLA (poly (glycolic acid-co-lactic acid)) and / or PDS / PLA (poly (p-dioxane-co-lactic acid)), for example. A tissue thickness compensator may be composed of an organic material, for example. A tissue thickness compensator can be composed of carboxymethyl cellulose, sodium alginate, cross-linked hyaluronic acid, and / or oxidized regenerated cellulose, for example. The compensator of Thickness of fabric may comprise a durometer in the range of 3-7 Shore A (30-50 Shore 00) with a maximum stiffness of 15 Shore A (65 Shore 00), for example. The fabric thickness compensator can experience 40% compression under 13 N (3 Ibf) load, 60% compression under 27 N (6 Ibf) load, and / or 80% compression under 89 N (20 Ibf) of loading, for example. One or more gases, such as air, nitrogen, carbon dioxide, and / or oxygen, for example, can be bubbled through and / or contained within the tissue thickness compensator. A fabric thickness compensator may comprise beads in it comprising between about 50% and about 75% of the stiffness of the material comprising the fabric thickness compensator.
The tissue thickness compensator may comprise hyaluronic acid, nutrients, fibrin, thrombin, platelet-rich plasma, sulfasalazine (Azulfidine®-5ASA + linked diazo Sulphapyridine)) -profarmaceutical-bacterial colony (azorreductase), Mesalamine (5ASA with different configurations of prodrug for delayed release), Asacol® ((5ASA + Eudragit-S coated - pH> 7 (coating solution)), Pentasa® (5ASA + coated ethylcellulose - time / pH dependent release), Mesasal® (5ASA + Eudragit-L coated - pH> 6), Olsalazine (5ASA + 5ASA - bacterial colony (azorreductase)), Balsalazide (5ASA + 4Aminobenzoyl-B-alanine) - bacterial colony (azorreductase)), granulated mesalamine, Lialda (delayed and SR formulation of mesalamine), HMPL-004 (mixture of herbs that can inhibit TNF- alpha, interleukin-1 beta, and nuclear activation kappa B), CCX282-B (oral chemokine receptor antagonist that interferes with trafficking of T lymphocytes in the intestinal mucosa), rifaximin (broad spectrum antibiotic not absorbed), Infliximab, murine chimeric (monoclonal antibody directed against TNF-alpha approved to reduce signs / symptoms and maintain clinical remission in adult / pediatric patients with moderate / severe luminal and fistulizing Crohn's disease who have an inadequate response to conventional therapy) , Adalimumab, total human IgG1 (anti-TNF-alpha monoclonal antibody - approved to reduce the signs / symptoms of Crohn's disease, and for the induction and maintenance of clinical remission in adult patients with moderate / severe Crohn's disease active with inadequate response to conventional therapies, or that become intolerant to infliximab), Certolizumab pegoll, humanized anti-TNF Fab '(fragment of monoclonal antibody linked to polyethylene glycol - approved to reduce the signs / symptoms of Crohn's disease and for the induction and maintenance of the response in adult patients with moderate / severe disease with inadequate response to conventional therapies), Natalizumab, first non-TNF inhibitor -alfa (biological compound approved for Crohn's disease), the humanized IgG4 monoclonal antibody (directed against alpha-4 integrin - approved by the FDA to induce and maintain clinical response and remission in patients with moderate / severe disease with evidence of inflammation and that have an inadequate response or are unable to tolerate conventional Crohn's and TNF-alpha inhibitors), concomitant immunomodulators potentially given with Infliximab, Azathioprine 6-Mercaptopurine (inhibitor of the synthesis of purines - prodrug), methotrexate (binds the enzyme dihydrofolate reductase (DHFR) that participates in the synthesis of tetrahydrofolate, inhibits all the purine synthesis), the therapy of Allopurinol and Thioprine, PPI, H2 for the suppression of acid to protect the healing line, C-Diff-Flagyl, vancomycin (fecal translocation treatment, probiotics, repopulation of the normal endoluminal flora), and / or rifaximin (treatment of bacterial overgrowth (notable hepatic encephalopathy), not absorbed in the Gl tract with action on intraluminal bacteria), for example.
As described in the present description, a fabric thickness compensator can compensate for variations in the thickness of tissue that is captured within the staples ejected from a staple cartriand / or contained within a line of staples, for example. Stated in any other way, certain staples within a staple line can capture thick portions of the fabric while other staples within the staple line can capture thin portions of tissue. In such circumstances, the fabric thickness compensator can assume different heights or thicknesses within the staples and apply a compressive force to the tissue captured within the staples, regardless of whether the captured tissue is thick or thin. A tissue thickness compensator can compensate for variations in fabric hardness. For example, certain staples within a line of staples can capture large portions tissue squeezables while other staples within the staple line can capture portions of tissue that are less compressible. In such circumstances, the fabric thickness compensator can be configured to assume a smaller height within the staples that capture tissue having a lower compressibility, or higher hardness, and, correspondingly, a larger height within the staples that capture tissue. which have a higher compressibility, or lower hardness, for example. In any case, a fabric thickness compensator, regardless of whether it compensates for variations in fabric thickness and / or variations in fabric hardness, for example, may be referred to as a 'tissue compensator' and / or as a 'compensator', for example.
The devices described in the present description can be designed to be discarded after a single use, or they can be designed to be used multiple times. In any case, however, the device can be repaired to reuse it at least after one use. The repair may include any combination of disassembly steps of the device, followed by cleaning or replacement of particular parts, and subsequent assembly. Particularly, the device can be disassembled, and any number of parts or particular parts of the device can be selectively replaced or removed in any combination. After cleaning and / or replacement of particular parts, the device can be reassembled for later use in a reconditioning center, or by a surgical team, immediately before a surgical procedure. People with It will be appreciated from experience in the art that for the reconditioning of a device a variety of techniques can be used to disassemble, clean / replace, and reassemble. Both the use of such techniques and the reconditioned device are within the scope of the present application.
Preferably, the invention described in the present description will be processed before surgery. First, a new or used instrument is obtained and cleaned, if necessary. The instrument can be sterilized afterwards. In a sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic bag or TYVEK. Then, the container and instrument are placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays or high-energy electrons. Radiation removes bacteria in the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container keeps the instrument sterile until it opens at the medical center.
Any patent, publication or other description material, in whole or in part, which is said to be incorporated by reference in the present description is incorporated in the present description only to the extent that the incorporated materials are not in conflict with the definitions, declarations or another existing description material that is disclosed in the present description. As such, and to the extent necessary, the description as set forth, explicitly, in the present invention replaces any conflicting material incorporated in the present invention as a reference. Any material, or portion thereof, that is incorporated as reference in the present invention, but which is in conflict with the definitions, statements or other described material incorporated that are set forth in this description will only be incorporated to the extent that no conflict arises between that incorporated material and the existing described material.
While it has been described that this invention has illustrative designs, the present invention can be modified further provided that those modifications are within the spirit and scope of the description. Therefore, this application is intended to cover any variation, use or adaptation of the invention provided that they are based on the general principles indicated therein. In addition, this application is intended to cover all deviations of the present invention that may arise within the practice known or customary in the matter to which the present invention pertains.

Claims (21)

NOVELTY OF THE INVENTION CLAIMS
1. A tissue thickness compensator comprising: a biocompatible material; a first component; and a second component; wherein the first component and the second component are adapted to form a reaction product to expand the tissue thickness compensator.
2. The fabric thickness compensator according to claim 1, further characterized in that it additionally comprises an encapsulated component comprising one of the first component and second component, wherein the other of the first component and second component is incorporated into the biocompatible material.
3. The fabric thickness compensator according to claim 1, further characterized in that the first component comprises a hydrophilic material incorporated in the biocompatible material and the second component is a body fluid.
4. The fabric thickness compensator according to claim 1, further characterized in that it comprises a first encapsulated component comprising the first component and a second encapsulated component comprising the second component.
5. The tissue thickness compensator according to claim 4, further characterized in that the biocompatible material comprises at least one encapsulation comprising the first encapsulated component and the second encapsulated component.
6. The tissue thickness compensator according to claim 4, further characterized in that the first encapsulated component is configured to release the first component when the first encapsulated component is broken, and the second encapsulated component is configured to release the second component when the second component is formed. Encapsulated component breaks.
7. The tissue thickness compensator according to any preceding claim, further characterized in that the biocompatible material comprises albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, blood serum, starch, poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polycarbonate, polyhydroxyethyl methacrylate, poly ( vinylpyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly (amino acid), copolymer (ether-ester), polyalkylene oxalate, polyamide, poly (iminocarbonate), polyoxamate, polyorthoester, polyphosphazene or a combination of the foregoing.
8. The tissue thickness compensator according to claim 1, further characterized in that the reaction product is formed in situ upon contacting the first component and the second component.
9. The fabric thickness compensator according to any preceding claim, further characterized in that the reaction product is a fluid swellable composition.
10. The fabric thickness compensator according to any of claims 1 and 4 to 9, further characterized in that the first component comprises a first hydrogel precursor, the second component comprises a second hydrogel precursor, and the reaction product comprises a hydrogel .
11. The tissue thickness compensator according to any preceding claim, further characterized in that the first component and second component are independently selected from albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, blood serum, starch, poly (lactic acid), poly (glycolic acid), polycarbonate, poly (hydroxybutyrate), poly (phosphakine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polyhydroxyethyl methacrylate, poly (vinylpyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly (amino acid), copolymer (ether-ester), polyalkylene oxalate, polyamide, poly (iminocarbonate), polyoxaester, polyorthoester, polyphosphazene or a combination of the foregoing.
12. The fabric thickness compensator according to any preceding claim, further characterized in that it comprises an outer layer comprising a water impermeable material and an inner layer comprising the biocompatible material and at least one of the first component and second component.
13. The fabric thickness compensator according to claim 12, further characterized in that the water-impermeable material comprises poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyester, polyethylene glycol, polyalkylene, polyacrylamide, polycarbonate, polyhydroxyethyl methacrylate, poly (vinylpyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly (amino acid), copoly (ether-ester), polyalkylene oxalate , polyamide, poly (iminocarbonate), polyoxaester, polyorthoester, polyphosphazene or a combination of the foregoing.
14. The fabric thickness compensator according to any preceding claim, further characterized in that the biocompatible material comprises a reinforcing material incorporated therein, and wherein the reinforcing material comprises a mesh, a fiber, a particle, a powder, or a combination of the above.
15. The fabric thickness compensator according to claim 14, further characterized in that the reinforcement material it comprises collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, oxy cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitana, chitosan, alginate, poly (lactic acid), poly (glycolic acid), poly ( hydroxybutyrate), poly (phosphazine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polyhydroxyethyl methyl acrylate, polyvinyl pyrrolidone, polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polycaprolactone, polypropylene, aliphatic polyester, glycerol, poly (amino acid), copoly (ether ester), polyalkylene oxalate, polyamide, poly (iminocarbonate), polyalkylene oxalate, polyoxaester, polyorthoester, polyphosphazene or a combination of the foregoing.
16. The tissue thickness compensator according to any preceding claim, further characterized in that it comprises a hemostatic agent, an anti-inflammatory agent, an antibiotic agent, an antimicrobial agent, an anti-adherent agent, an anticoagulant agent, a medicament, a pharmaceutically active agent, or a combination of the above.
17. A selected article of an anvil of a stapling apparatus and a staple cartridge for a stapling apparatus, the article comprising: the fabric thickness compensator of claim 1, the tissue thickness compensator comprising: an outer layer that comprises a non-porous material; an inner layer comprising a porous material, a first encapsulated component comprising said first component and a second encapsulated component comprising said second component.
18. The article according to claim 17, further characterized in that: the outer layer comprises polyglycolic acid, polylactic acid, polydioxanone, polyhydroxyalkanoate, polyglecaprona, polycaprolactone, or a combination thereof; the porous material comprises regenerated oxicellulose, the first component comprises a first hydrogel precursor, and the second component comprises a second hydrogel precursor; and wherein the reaction product is a hydrogel and the first hydrogel precursor and second hydrogel precursor are adapted to form said hydrogel to expand the tissue thickness compensator when the first encapsulated component and second encapsulated component are broken.
19. The article according to claim 17 or claim 18, further characterized in that the article defines at least part of a staple forming path to be followed by a staple from the cartridge to an anvil or from a cartridge to the anvil as the case may be, and wherein the first and second components encapsulated they align with the staple formation path so that a staple following that path pierces or otherwise breaks the encapsulations.
20. A method for forming in situ a tissue thickness compensator that is expanded by using the tissue thickness compensator of claim 4, the method comprising: breaking the first encapsulated component and the second encapsulated component to allow the in situ reaction of the first encapsulated component and second encapsulated component to form said reaction product; wherein the reaction product expands the tissue thickness compensator to compensate for different tissue thicknesses.
21. The method according to claim 20, further characterized in that: the tissue thickness compensator comprises: an outer layer comprising polyglycolic acid, polylactic acid, polydioxanone, polyhydroxyalkanoate, polyglecaprona, polycaprolactone, or a combination of the foregoing; and an inner layer comprising regenerated oxicellulose; the first encapsulated component comprises a first hydrogel precursor; the second encapsulated component comprises a second hydrogel precursor; and the reaction product comprises a hydrogel.
MX2014011667A 2012-03-28 2013-03-27 Expandable tissue thickness compensator. MX2014011667A (en)

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US13/433,098 US9301753B2 (en) 2010-09-30 2012-03-28 Expandable tissue thickness compensator
PCT/US2013/033997 WO2013148762A2 (en) 2012-03-28 2013-03-27 Expandable tissue thickness compensator

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JP2015513955A (en) 2015-05-18
RU2014143212A (en) 2016-05-20
CN104321021A (en) 2015-01-28
JP6193350B2 (en) 2017-09-06
BR112014024306A2 (en) 2017-06-20

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