WO2013148762A2 - Expandable tissue thickness compensator - Google Patents

Expandable tissue thickness compensator Download PDF

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Publication number
WO2013148762A2
WO2013148762A2 PCT/US2013/033997 US2013033997W WO2013148762A2 WO 2013148762 A2 WO2013148762 A2 WO 2013148762A2 US 2013033997 W US2013033997 W US 2013033997W WO 2013148762 A2 WO2013148762 A2 WO 2013148762A2
Authority
WO
WIPO (PCT)
Prior art keywords
staple
thickness compensator
tissue thickness
staple cartridge
view
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2013/033997
Other languages
English (en)
French (fr)
Other versions
WO2013148762A3 (en
Inventor
Jeffrey L. Aldridge
Chunlin Yang
Charles J. Scheib
Christopher W. Widenhouse
William B. Ii Weisenburgh
John L. Stammen
Mark H. Ransick
Stephanie A. MUTCHLER
Gary W. Knight
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Endo Surgery Inc
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 US13/532,824 external-priority patent/US9307989B2/en
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Priority to CN201380027745.0A priority Critical patent/CN104321021B/zh
Priority to MX2014011667A priority patent/MX376566B/es
Priority to BR112014024306-9A priority patent/BR112014024306B1/pt
Priority to RU2014143212A priority patent/RU2648884C2/ru
Priority to JP2015503485A priority patent/JP6193350B2/ja
Publication of WO2013148762A2 publication Critical patent/WO2013148762A2/en
Publication of WO2013148762A3 publication Critical patent/WO2013148762A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/10—Surgical instruments, devices or methods for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105—Wound clamp magazines
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Definitions

  • the present invention relates to surgical instruments and to surgical cutting and stapling instruments and staple cartridges therefor that are designed to cut and staple tissue.
  • a tissue thickness compensator comprising:
  • first component and second component are adapted to form a reaction product to expand the tissue thickness compensator.
  • tissue thickness compensator of Embodiment 1 further comprising an encapsulated component comprising one of the first component and second component, wherein the other of the first component and second component is embedded in the biocompatible material.
  • tissue thickness compensator of Embodiment 1 wherein the first component comprises a hydrophilic material embedded in the biocompatible material and the second component is a bodily fluid.
  • tissue thickness compensator of Embodiment 1 comprising a first encapsulated component comprising the first component and a second encapsulated component comprising the second component.
  • tissue thickness compensator of Embodiment 4 wherein the biocompatible material comprises at least one encapsulation comprising the first encapsulated component and the second encapsulated component.
  • tissue thickness compensator of Embodiment 4 wherein the first encapsulated component is configured to release the first component when the first encapsulated component is ruptured, and the second encapsulated component is configured to release the second component when the second encapsulated component is ruptured.
  • biocompatible material comprises albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, serum, starch, poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phosphazine), polyester, polyethylene glycol, polyalkyleneoxide, polyacrylamide, polycarbonate, polyhydroxyethylmethylacrylate, 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
  • tissue thickness compensator of Embodiment 1 wherein the reaction product is formed in situ by contacting the first component and the second component.
  • the reaction product is a fluid-swellable composition.
  • tissue thickness compensator of any one of Embodiments 1 and 4-9, wherein the first component comprises a first hydrogel precursor, the second component comprises a second hydrogel precursor, and the reaction product comprises a hydrogel.
  • tissue thickness compensator of any preceding Embodiment, wherein 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, serum, starch, poly(lactic acid), poly(glycolic acid), polycarbonate, poly(hydroxybutyrate), poly(phosphazine), polyester, polyethylene glycol, polyalkyleneoxide, polyacrylamide, polyhydroxyethylmethylacrylate, poly(vinylpyrrolidone), polyvinyl alcohol, poly(caprolactone), poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly( amino acid), copoly( ether-ester), polyalkylene oxalate, polyamide, poly(iminocarbonate), polyox
  • tissue thickness compensator of any preceding Embodiment, comprising 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.
  • tissue thickness compensator of Embodiment 12 wherein the water impermeable material comprises poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate),
  • tissue thickness compensator of Embodiment 14 wherein the reinforcement material comprises collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose,
  • tissue thickness compensator of any preceding Embodiment comprising a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, an anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a medicament, a pharmaceutically active agent, or a combination of the foregoing.
  • An article selected from an anvil of a stapling apparatus and a staple cartridge for a stapling apparatus comprising:
  • the tissue thickness compensator of Embodiment 1 comprising:
  • an inner layer comprising a porous material, a first encapsulated component comprising said first component and a second encapsulated component comprising said second component.
  • the outer layer comprises polyglycolic acid, polylactic acid, polydioxanone, polyhydroxyalkanoate, poliglecaprone, polycaprolactone, or a combination thereof;
  • the porous material comprises oxidized regenerated cellulose
  • the first component comprises a first hydrogel precursor
  • the second component comprises a second hydrogel precursor
  • 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 ruptured.
  • Embodiment 17 or Embodiment 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 are aligned with the staple-forming path so that a staple following that path punctures or otherwise ruptures the encapsulations.
  • reaction product expands the tissue thickness compensator to compensate for different tissue thicknesses.
  • the tissue thickness compensator comprises:
  • an outer layer comprising polyglycolic acid, polylactic acid, polydioxanone, polyhydroxyalkanoate, poliglecaprone, polycaprolactone, or a combination of the foregoing; and an inner layer comprising oxidized regenerated cellulose;
  • the first encapsulated component comprises a first hydrogel precursor
  • the second encapsulated component comprising a second hydrogel precursor; and the reaction product comprises a hydrogel.
  • FIG. 1 is a cross-sectional view of a surgical instrument embodiment
  • FIG. 1 A is a perspective view of one embodiment of an implantable staple cartridge
  • FIGS. IB- IE illustrate portions of an end effector clamping and stapling tissue with an implantable staple cartridge
  • FIG. 2 is a partial cross-sectional side view 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;
  • FIG. 3 is another partial cross-sectional side view of the end effector of FIG. 2 in a closed position
  • FIG. 4 is another partial cross-sectional side view of the end effector of FIGS. 2 and 3 as the knife bar is starting to advance through the end effector;
  • FIG. 5 is another partial cross-sectional side view of the end effector of FIGS. 2-4 with the knife bar partially advanced therethrough;
  • FIG. 6 is a perspective view of an alternative staple cartridge embodiment installed in a surgical cutting and stapling device
  • FIG. 7 is a top view of the surgical staple cartridge and elongated channel of the device depicted in FIG. 6;
  • FIG. 8 is a top view of another surgical staple cartridge embodiment installed in an elongated channel of an end effector
  • FIG. 9 is a bottom view of an anvil
  • FIG. 10 is a partial perspective view of a plurality of staples forming a portion of a staple line
  • FIG. 1 1 is another partial perspective view of the staple line of FIG. 10 with the staples thereof after being formed by being contacted by the anvil of the surgical cutting and stapling device;
  • FIG. 12 is a partial perspective view of alternative staples forming a portion of another staple line;
  • FIG 13 is a partial perspective view of alternative staples forming a portion of another staple line
  • FIG. 14 is a partial perspective view of alternative staples forming a portion of another staple line embodiment
  • FIG. 15 is a cross-sectional view of an end effector supporting a staple cartridge
  • FIG. 16 is a cross-sectional view of the elongated channel portion of the end effector of FIG. 15 after the implantable staple cartridge body portion and staples have been removed therefrom;
  • FIG. 17 is a cross-sectional view of an end effector supporting another staple cartridge
  • FIGS. 18A-18D diagram the deformation of a surgical staple positioned within a collapsible staple cartridge body in accordance with at least one embodiment
  • FIG. 19 A is a diagram illustrating a staple positioned in a crushable staple cartridge body
  • FIG. 19B is a diagram illustrating the crushable staple cartridge body of FIG. 19A being crushed by an anvil
  • FIG. 19C is a diagram illustrating the crushable staple cartridge body of FIG. 19A being further crushed by the anvil
  • FIG. 19D is a diagram illustrating the staple of FIG. 19 A in a fully formed configuration and the crushable staple cartridge of FIG. 19A in a fully crushed condition;
  • FIG. 20 is a diagram depicting a staple positioned against a staple cartridge support surface and illustrating potential relative movement therebetween;
  • FIG. 21 is a cross-sectional view of a staple cartridge support surface comprising a slot, or trough, configured to stabilize the base of the staple of FIG. 20;
  • FIG. 22 is a cross-sectional view of a staple comprising an overmolded crown and a slot, or trough, configured to receive a portion of the crown in accordance with at least one alternative embodiment
  • FIG. 23 is a top view of a staple cartridge in accordance with at least one embodiment comprising staples embedded in a collapsible staple cartridge body;
  • FIG. 24 is an elevational view of the staple cartridge of FIG. 23;
  • FIG. 25 is an elevational view of a staple cartridge in accordance with at least one embodiment comprising a protective layer surrounding staples positioned within a collapsible staple cartridge body;
  • FIG. 26 is a cross-sectional view of the staple cartridge of FIG. 25 taken along line 26-26 in FIG. 25;
  • FIG. 27 is an elevational view of a staple cartridge in accordance with at least one embodiment comprising staples at least partially extending outside of a collapsible staple cartridge body and a protective layer surrounding the staple cartridge body;
  • FIG. 28 is a cross-sectional view of the staple cartridge of FIG. 27 taken along line 28-28 in FIG. 27;
  • FIG. 29 is a partial break-away view of a staple cartridge in accordance with at least one embodiment comprising staples at least partially embedded in a collapsible staple cartridge body, the staples being at least partially positioned in a staple cavity void in the staple cartridge body;
  • FIG. 30 is a cross-sectional view of the staple cartridge of FIG. 29 taken along line 30-30 in FIG. 29;
  • FIG. 31 is a partial break-away view of a staple cartridge in accordance with at least one embodiment
  • FIG. 32 is a partial break-away view of a staple cartridge in accordance with at least one embodiment comprising staples at least partially embedded within a collapsible staple cartridge body and an alignment matrix connecting the staples and aligning the staples with respect to each other;
  • FIG. 33 is a cross-sectional view of the staple cartridge of FIG. 32 taken along line 33-33 in FIG. 32;
  • FIG. 34 is partial cut-away view of an inner layer of a compressible staple cartridge body
  • FIG. 35 is a diagram illustrating the inner layer of FIG. 34 compressed between a transfer plate and a support plate
  • FIG. 36 is a diagram illustrating staples being inserted into the compressed inner layer of FIG. 35;
  • FIG. 37 is a diagram of the support plate of FIG. 35 being removed away from the inner layer;
  • FIG. 38 is a diagram of a subassembly comprising the inner layer of FIG. 34 and the staples of FIG. 36 being inserted into an outer layer;
  • FIG. 39 is a diagram illustrating the outer layer of FIG. 38 being sealed to form a sealed staple cartridge
  • FIG. 40 is a cross-sectional view of the sealed staple cartridge of FIG. 39;
  • FIG. 41 is a cross-sectional view of a staple cartridge and staple cartridge channel in accordance with at least one embodiment
  • FIG. 42 is a diagram illustrating a portion of the staple cartridge of FIG. 41 in a deformed state
  • FIG. 43 is an elevational view of an end effector of a surgical stapler comprising an anvil in an open position and a staple cartridge positioned within a staple cartridge channel;
  • FIG. 44 is an elevational view of the end effector of FIG. 43 illustrating the anvil in a closed position and the staple cartridge compressed between the anvil and the staple cartridge channel;
  • FIG. 45 is an elevational view of the end effector of FIG. 43 illustrating the staple cartridge of FIG. 43 positioned within the staple cartridge channel in an alternative manner;
  • FIG. 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 buttress material attached to an anvil;
  • FIG. 47 is a cross-sectional view of the end effector of FIG. 46 illustrating the anvil in a closed position
  • FIG. 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;
  • FIG. 49 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler
  • FIG. 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;
  • FIG. 51 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler;
  • FIG. 52 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising inclined tissue-contacting surfaces;
  • FIG. 53 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler comprising inclined tissue-contacting surfaces;
  • FIG. 54 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a support insert configured to support a staple cartridge;
  • FIG. 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;
  • FIG. 56 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a stepped compressible cartridge body;
  • FIG. 57 is a cross-sectional view of another alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a stepped compressible cartridge body;
  • FIG. 58 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge comprising a curved tissue-contacting surface;
  • FIG. 59 is a cross-sectional view of an alternative embodiment of an end effector of a surgical stapler comprising a staple cartridge having an inclined tissue-contacting surface;
  • FIG. 60 is a cross-sectional view of a compressible staple cartridge comprising staples and at least one medicament stored therein;
  • FIG. 61 is a diagram illustrating the compressible staple cartridge of FIG. 60 after it has been compressed and the staples contained therein have been deformed;
  • FIG. 62 is a partial cut-away view of a staple cartridge in accordance with at least one embodiment
  • FIG. 63 is a cross-sectional view of the staple cartridge of FIG. 62;
  • FIG. 64 is a perspective view of an implanted staple cartridge in accordance with at least one alternative embodiment
  • FIG. 65 is a cross-sectional view of the implanted staple cartridge of FIG. 64;
  • FIG. 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;
  • FIG. 67 is a perspective view of an alternative embodiment of a staple cartridge comprising an outer layer of the staple cartridge being assembled to an inner layer;
  • FIG. 68 is a cross-sectional view of an alternative embodiment of a staple cartridge comprising a plurality of staples, a compressible layer, and a pledget layer;
  • FIG. 69 is a perspective view of the pledget layer of FIG. 68;
  • FIG. 70 is a perspective view of a pledget singulated from the pledget layer of FIG. 68 and a staple aligned with a groove in the pledget;
  • FIG. 71 is a perspective view of two connected pledgets from the pledget layer of FIG. 68;
  • FIG. 72 is a perspective view of a pledget support frame of the pledget layer of FIG. 68 being removed from the singulated pledgets;
  • FIG. 73 is an exploded perspective view of an alternative embodiment of a compressible staple cartridge comprising staples therein and a system for driving the staples against an anvil;
  • FIG. 73 A is a partial cut-away view of an alternative embodiment of the staple cartridge of FIG. 73;
  • FIG. 74 is a cross-sectional view of the staple cartridge of FIG. 73;
  • FIG. 75 is an elevational view of a sled configured to traverse the staple cartridge of FIG.
  • FIG. 76 is a diagram of a staple driver which can be lifted toward the anvil by the sled of FIG. 75;
  • FIG. 77 is a break-away view of a staple cartridge in accordance with at least one alternative embodiment comprising staples positioned within staple drivers;
  • FIG. 78 is a cross-sectional view of the staple cartridge of FIG. 77 positioned within a staple cartridge channel;
  • FIG. 79 is a cross-sectional view of the staple cartridge of FIG. 77 illustrating an anvil moved into a closed position and staples contained within the staple cartridge deformed by the anvil;
  • FIG. 80 is a cross-sectional view of the staple cartridge of FIG. 77 illustrating the staples moved upwardly toward the anvil;
  • FIG. 81 is a perspective view of an alternative embodiment of a staple cartridge comprising straps connecting the flexible sides of the staple cartridge;
  • FIG. 82 is a perspective view of a sled and cutting member assembly
  • FIG. 83 is a diagram of the sled and cutting member assembly of FIG. 82 being used to lift the staples of the staple cartridge of FIG. 77;
  • FIG. 84 is a diagram illustrating a sled configured to engage and lift staples toward an anvil and a lock-out system configured to selectively permit the sled to move distally;
  • FIGS. 85A-85C illustrate the progression of a staple being inserted into a staple crown
  • FIG. 86 is a cross-sectional view of a staple cartridge comprising a support pan or retainer
  • FIG. 87 is a partial cross-sectional view of a compressible staple cartridge in accordance with at least one alternative embodiment
  • FIG. 88 is a diagram illustrating the staple cartridge of FIG. 87 in an implanted condition
  • FIG. 89 is a partial cut-away view of a compressible staple cartridge in accordance with at least one alternative embodiment
  • FIG. 90 is a partial cross-sectional view of the staple cartridge of FIG. 89;
  • FIG. 91 is a diagram illustrating the staple cartridge of FIG. 89 in an implanted condition
  • FIG. 92 is a partial cross-sectional view of a crushable staple cartridge in accordance with at least one alternative embodiment
  • FIG. 93 is a partial cut-away view of a collapsible staple cartridge in accordance with at least one embodiment comprising a plurality of collapsible elements
  • FIG. 94 is a perspective view of a collapsible element of FIG. 93 in an uncollapsed state
  • FIG. 95 is a perspective view of the collapsible element of FIG. 94 in a collapsed state
  • FIG. 96A is a partial cross-sectional view of an end effector of a surgical stapling instrument comprising a jaw, a staple cartridge channel positioned opposite the jaw, and a staple cartridge positioned within the staple cartridge channel, wherein the jaw comprises a retention matrix attached thereto;
  • FIG. 96B is a partial cross-sectional view of the end effector of FIG. 96 A illustrating the jaw being moved toward the staple cartridge channel, the staple cartridge being compressed by the anvil and the retention matrix, and a staple at least partially extending through tissue positioned intermediate the retention matrix and the staple cartridge;
  • FIG. 96C is a partial cross-sectional view of the end effector of FIG. 96 A illustrating the jaw in a final position and the retention matrix engaged with the staple of FIG. 96B;
  • FIG. 96D is a partial cross-sectional view of the end effector of FIG. 96 A illustrating the jaw and the staple cartridge channel being moved away from the implanted staple cartridge and retention matrix;
  • FIG. 97 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising a plurality of retention members configured to engage a fastener leg extending therethrough;
  • FIG. 98 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising six retention members;
  • FIG. 99 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising eight retention members;
  • FIG. 100 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising a plurality of retention members configured to engage a fastener leg extending therethrough;
  • FIG. 101 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising six retention members;
  • FIG. 102 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising eight retention members;
  • FIG. 103 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising a plurality of retention members that have been stamped from a sheet of metal;
  • FIG. 104 is a perspective view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment comprising a plurality of apertures extending around the perimeter of the retention aperture;
  • FIG. 105 is a top view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment
  • FIG. 106 is a top view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment
  • FIG. 107 is a top view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment
  • FIG. 108 is a top view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment
  • FIG. 109 is a top view of a retention aperture of a retention matrix in accordance with at least one alternative embodiment
  • FIG. 1 10 is a top view of a retention aperture of a retention matrix comprising a retention tab extending into the retention aperture in accordance with at least one embodiment
  • FIG. I l l is a top view of a retention aperture of a retention matrix comprising a retention tab extending into the retention aperture in accordance with at least one alternative embodiment
  • FIG. 1 12 is a perspective view of a fastening system comprising a plurality of staples, a retention matrix engaged with the staples, and an alignment matrix configured to align the staples;
  • FIG. 1 13 is a perspective view of the retention matrix of FIG. 1 12;
  • FIG. 1 14 is a perspective view of the alignment matrix of FIG. 1 12;
  • FIG. 1 15 is a partial top view of the retention matrix of FIG. 1 12 engaged with the staples of FIG. 1 12;
  • FIG. 1 16 is a partial bottom view of the retention matrix of FIG. 1 12 engaged with the staples of FIG. 1 12;
  • FIG. 1 17 is a partial elevational view of the fastening system of FIG. 1 12;
  • FIG. 1 18 is a partial perspective view of the fastening system of FIG. 1 12;
  • FIG. 1 19 is a partial cross-sectional view of the retention matrix of FIG. 1 12 engaged with the staples of FIG. 1 12;
  • FIG. 120 is a partial cross-sectional view of the fastening system of FIG. 1 12;
  • FIG. 121 is a perspective view of the fastening system of FIG. 1 12 further comprising protective caps assembled to the legs of the staples;
  • FIG. 122 is a bottom perspective view of the fastening system arrangement of FIG. 121 ;
  • FIG. 123 is a partial perspective view of the fastening system arrangement of FIG. 121 ;
  • FIG. 124 is a partial cross-sectional view of the fastening system arrangement of FIG. 121 ;
  • FIG. 125 is an elevational view of an end effector in accordance with at least one embodiment comprising a jaw in an open position, a retention matrix and a plurality of protective caps positioned in the jaw, and a staple cartridge positioned in a staple cartridge channel;
  • FIG. 126 is an elevational view of the end effector of FIG. 125 in a closed position
  • FIG. 127 is an elevational view of the end effector of FIG. 125 in a fired position;
  • FIG. 128 is an elevational view of the retention matrix and protective caps of FIG. 125 assembled to the staple cartridge of FIG. 125;
  • FIG. 129 is a detail view of the arrangement of FIG. 128;
  • FIG. 130 is an elevational view of the end effector of FIG. 125 illustrating the jaw in an open position with thinner tissue positioned between the retention matrix and the staple cartridge;
  • FIG. 131 is an elevational view of the end effector of FIG. 125 illustrating the jaw in a closed position against the thinner tissue of FIG. 130;
  • FIG. 132 is an elevational view of the end effector of FIG. 125 illustrating the jaw in a fired position to capture the thinner tissue of FIG. 130 between the retention matrix and the staple cartridge;
  • FIG. 133 is an elevational view of the retention matrix and the protective caps of FIG. 125 assembled to the staple cartridge of FIG. 125 with the thin tissue of FIG. 130 positioned therebetween;
  • FIG. 134 is a detail view of the arrangement of FIG. 133;
  • FIG. 135 is a cross-sectional view of a protective cap positioned on the tip of a staple leg in accordance with at least one alternative embodiment
  • FIG. 136 is a perspective view of a plurality of protective caps embedded within a sheet of material
  • FIG. 137 is a perspective view of a jaw comprising a plurality of recesses configured to receive a plurality of protective caps therein;
  • FIG. 138 is a detail view of a portion of a jaw comprising a sheet covering the protective caps positioned within the jaw of FIG. 137;
  • FIG. 139 is a cross-sectional view of a protective cap positioned on a tip of a staple leg in accordance with at least one alternative embodiment wherein the protective cap comprises an interior forming surface;
  • FIG. 140 is another cross-sectional view of the protective cap of FIG. 139 illustrating the staple leg being deformed against the forming surface
  • FIG. 141 is a top view of an alternative embodiment of a retention matrix comprising a plurality of connected matrix elements
  • FIG. 142 is a top view of an alternative embodiment of a retention matrix comprising a plurality of connected matrix elements
  • FIG. 143 is a top view of an alternative embodiment of a retention matrix comprising a plurality of connected matrix elements
  • FIG. 144 is a top view of an alternative embodiment of an array of retention matrices comprising a plurality of connected matrix elements
  • FIG. 145 is a top view of an alternative embodiment of a retention matrix comprising a plurality of connected matrix elements
  • FIG. 146 is a partial exploded view of a jaw comprising a retention matrix including a compressible cover
  • FIG. 147 is a detail view of the retention matrix of FIG. 146;
  • FIG. 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 medicaments;
  • FIG. 149 is a diagram illustrating staple legs which have pierced the cells of FIG. 148 as they are being engaged with the retention matrix;
  • FIG. 150 is a partial cross-sectional view of a fastening system comprising a retention matrix including a compressible layer;
  • FIG. 151 is an elevational view of a fastener cartridge insertion assembly comprising a holder, a first fastener cartridge, and a second fastener cartridge;
  • FIG. 152 is an elevational view of an end effector of a surgical stapler comprising a first jaw and a second jaw, the second jaw being illustrated in an open configuration;
  • FIG. 153 is an elevational view of the end effector of FIG. 152 illustrating the second jaw in a closed configuration and the fastener cartridge insertion assembly of FIG. 151 being used to load the first jaw with the first cartridge and the second jaw with the second cartridge;
  • FIG. 154 is an elevational view of the loaded end effector of FIG. 153 illustrating the cartridge insertion assembly removed from the end effector, the second jaw in an open configuration once again, and tissue positioned intermediate the first jaw and the second jaw;
  • FIG. 155 is an elevational view of the loaded end effector of FIG. 154 in a fired configuration
  • FIG. 156 is an elevational view of the first cartridge and the second cartridge in an implanted condition
  • FIG. 157 is an elevational view of the end effector of FIG. 152 illustrating a portion of the first cartridge still engaged with the first jaw in accordance with at least one embodiment
  • FIG. 158 is an elevational view of an alternative embodiment of a fastener cartridge insertion assembly comprising a holder, a first fastener cartridge, and a second fastener cartridge;
  • FIG. 159 is an elevational view of the fastener cartridge insertion assembly of FIG. 158 being used to load a first jaw of an end effector with the first cartridge and a second jaw with the second cartridge;
  • FIG. 160 is a cross-sectional view of the loaded end effector of FIG. 159;
  • FIG. 161 is a perspective view of a surgical stapler comprising a bottom jaw and a top jaw in accordance with at least one embodiment illustrated with portions of the surgical stapler removed;
  • FIG. 162 is a perspective view of the surgical stapler of FIG. 161 with the top jaw removed;
  • FIG. 163 is a perspective view of a slidable anvil system of the top jaw of the surgical stapler of FIG. 161 comprising a first slidable anvil and a second slidable anvil;
  • FIG. 164 is an end view of the slidable anvil system of FIG. 163;
  • FIG. 165 is a top view of the slidable anvil system of FIG. 163;
  • FIG. 166 is a diagram illustrating the slidable anvil system of FIG. 163 in an unfired condition
  • FIG. 167 is a diagram illustrating the first slidable anvil of the slidable anvil system of FIG. 163 in an unfired position and staples positioned within the bottom jaw in an undeployed position;
  • FIG. 168 is a diagram illustrating the staples in the bottom jaw in a deployed
  • FIG. 169 is a diagram illustrating the first group of staples of FIG. 168 deformed to a fully deformed state
  • FIG. 170 is a diagram illustrating the second slidable anvil of the slidable anvil system of FIG. 163 being pushed distally to deform a second group of staple legs;
  • FIG. 171 is a partial perspective view of an anvil comprising a plurality of forming pockets in at least one embodiment;
  • FIG. 172 is a cross-sectional end view of the anvil of FIG. 171 ;
  • FIG. 173 is a diagram illustrating a first step in manufacturing the forming pockets of
  • FIG. 171
  • FIG. 174 is a diagram illustrating a second step in manufacturing the forming pockets of FIG. 171 ;
  • FIG. 175 is a top view of the forming pocket arrangement of the anvil of FIG. 171 ;
  • FIG. 176 is a diagram illustrating a first step of a manufacturing process for producing an anvil
  • FIG. 177 is a diagram illustrating a second step in the manufacturing process of FIG. 176;
  • FIG. 178 is a diagram illustrating a third step in the manufacturing process of FIG. 176;
  • FIG. 179 is a left front perspective view of a surgical stapling and severing instrument with a handle portion including a link triggered automatic retraction and a ratcheting manual retraction mechanism;
  • FIG. 180 is a right aft perspective view of the surgical stapling and severing instrument of FIG. 179 with a portion of an elongate shaft cut away and a right half shell of a handle housing removed to expose an automatic end-of- firing travel retraction mechanism and a manual firing retraction mechanism;
  • FIG. 181 is a right aft perspective disassembled view of the handle portion and an elongate shaft of the surgical stapling and severing instrument of FIG. 179;
  • FIG. 182 is a right aft perspective view of the surgical stapling and severing instrument of FIG. 31 with a right half shell and outer portions of the implement portion removed to expose the closure and firing mechanisms in an initial state;
  • FIG. 183 is a right side view in elevation of the partially disassembled surgical stapling and severing instrument of FIG. 182;
  • FIG. 184 is a right aft perspective view of the partially disassembled surgical stapling and severing instrument of FIG. 182 with a closure mechanism closed and clamped and the side pawl firing mechanism completing a first stroke and with a manual retraction mechanism removed to expose a distal link of the linked rack that triggers automatic retraction of the firing mechanism;
  • FIG. 185 is a right aft perspective view of the partially disassembled surgical stapling and severing instrument of FIG. 183 with the side pawl firing mechanism disengaged and the distal link approaching automatic retraction;
  • FIG. 186 is left side view in elevation of the partially disassembled surgical stapling and severing instrument of FIG. 183 in an initial state of end effector open and anti -backup mechanism engaged;
  • FIG. 187 is a left side detail view of the right half shell and an anti-backup release lever of the handle portion of FIG. 186;
  • FIG. 188 is a left side detail view in elevation of the disassembled surgical stapling and severing instrument of FIG. 179 with the closure trigger clamped, the firing trigger performing a final stroke and the distal link positioned to trip automatic retraction;
  • FIG. 189 is a left side detail in elevation of the disassembled surgical stapling and severing instrument of FIG. 188 immediately after the distal link has actuated and locked forward the anti-backup release lever, allowing the linked rack to retract;
  • FIG. 190 is a right disassembled perspective view of the idler and aft gears and manual retraction lever and ratcheting pawl of a manual retraction mechanism of the surgical stapling and severing instrument of FIG. 179;
  • FIG. 191 is a right perspective view of the manual retraction mechanism of FIG. 190 with the manual retraction lever partially cut away to expose a smaller diameter ratchet gear on the aft gear engaging the ratcheting pawl;
  • FIG. 192 is a partially disassembled left side view in elevation of a surgical stapling and severing instrument of FIG. 179 with the anti -backup mechanism engaged to a fully fired linked rack that is disconnected from a combination tension/compression spring prior to actuation of the manual retraction lever of FIG. 190;
  • FIG. 193 is a partially disassembled left side view in elevation of the surgical stapling and severing instrument of FIG. 192 with hidden portions of the anti -backup release lever, aft gear, and manual firing release lever shown in phantom;
  • FIG. 194 is a partially disassembled left side view in elevation of the surgical stapling and severing instrument of FIG. 193 after actuation of the manual firing release lever has manually retracted the link rack;
  • FIG. 195 is a partially disassembled left side view in elevation of the surgical stapling and severing instrument of FIG. 194 with the linked rack omitted depicting the manual firing release lever disengaging the anti-backup mechanism;
  • FIG. 196 is a left side detail view of an alternative anti-backup release lever and handle housing for the surgical stapling and severing instrument of FIG. 179;
  • FIG. 197 is a left perspective disassembled view of the alternative anti-backup release lever, aft gear axle, and automatic retraction cam wheel of FIG. 196;
  • FIG. 198 is a right side view in elevation of the alternative anti-backup release mechanism of FIG. 196 with the linked rack in a retracted position and the anti -backup release lever proximally positioned with the anti-backup plate engaged to the firing rod;
  • FIG. 198A is a right detail side view in elevation of the aft gear, automatic retraction cam wheel and distal-most link of FIG. 198;
  • FIG. 199 is a right side view in elevation of the anti-backup release mechanism of FIG.
  • FIG. 199A is a right detail side view in elevation of the aft gear, automatic retraction cam wheel and a second link of FIG. 199;
  • FIG. 200 is a right side view in elevation of the anti-backup release mechanism of FIG.
  • FIG. 200A is a right detail side view in elevation of the aft gear, automatic retraction cam wheel and third link of FIG. 200;
  • FIG. 201 is a right detail side view in elevation of the anti-backup release mechanism of FIG. 200 after a third firing and final stroke;
  • FIG. 201 A is a right detail side view in elevation of the aft gear, automatic retraction cam wheel and proximal-most fourth link of FIG. 201 ;
  • FIG. 202 is a right side view in elevation of the automatic release mechanism of FIG. 201 after a further firing stroke causes the automatic retraction cam wheel to distally slide and lock the anti-backup release lever, disengaging the anti-backup mechanism;
  • FIG. 203 is a left, front perspective view of an open staple applying assembly with a right half portion of a replaceable staple cartridge included in a staple channel;
  • FIG. 204 is an exploded perspective view of the staple applying assembly of FIG. 203 with a complete replaceable staple cartridge and an nonarticulating shaft configuration;
  • FIG. 205 is a perspective view of a two-piece knife and firing bar ("E-beam") of the staple applying assembly of FIG. 203;
  • FIG. 206 is a perspective view of a wedge sled of a staple cartridge of a staple applying assembly;
  • FIG. 207 is a left side view in elevation taken in longitudinal cross section along a center line line 207-207 of the staple applying assembly of FIG. 203;
  • FIG. 208 is a perspective view of the open staple applying assembly of FIG. 203 without the replaceable staple cartridge, a portion of the staple channel proximate to a middle pin of two- piece knife and firing bar, and without a distal portion of a staple channel;
  • FIG. 209 is a front view in elevation taken in cross section along line 209-209 of the staple applying assembly of FIG. 203 depicting internal staple drivers of the staple cartridge and portions of the two-piece knife and firing bar;
  • FIG. 210 is a left side view in elevation taken generally along the longitudinal axis of line 207-207 of a closed staple applying assembly of FIG. 203 to include center contact points between the two-piece knife and wedge sled but also laterally offset to show staples and staple drivers within the staple cartridge;
  • FIG. 21 1 is a left side detail view in elevation of the staple applying assembly of FIG. 210 with the two-piece knife retracted slightly more as typical for staple cartridge replacement;
  • FIG. 212 is a left side detail view in elevation of the staple applying assembly of FIG. 21 1 with the two-piece knife beginning to fire, corresponding to the configuration depicted in FIG. 210;
  • FIG. 213 is a left side cross-sectional view in elevation of the closed staple applying assembly of FIG. 210 after the two-piece knife and firing bar has distally fired;
  • FIG. 214 is a left side cross-sectional view in elevation of the closed staple applying assembly of FIG. 213 after firing of the staple cartridge and retraction of the two-piece knife;
  • FIG. 215 is a left side cross-sectional detail view in elevation of the staple applying assembly of FIG. 214 with the two-piece knife allowed to drop into a lockout position;
  • FIG. 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 in accordance with at least one embodiment of the invention
  • FIG. 217 is a partially exploded view of the staple cartridge of FIG. 216;
  • FIG. 218 is a fully exploded view of the staple cartridge of FIG. 216;
  • FIG. 219 is another exploded view of the staple cartridge of FIG. 216 without a warp covering the tissue thickness compensator;
  • FIG. 220 is a perspective view of a cartridge body, or support portion, of the staple cartridge of FIG. 216;
  • FIG. 221 is a top perspective view of a sled movable within the staple cartridge of FIG.
  • FIG. 222 is a bottom perspective view of the sled of FIG. 221 ;
  • FIG. 223 is an elevational view of the sled of FIG. 221 ;
  • FIG. 224 is a top perspective view of a driver configured to support one or more staples and to be lifted upwardly by the sled of FIG. 221 to eject the staples from the staple cartridge;
  • FIG. 225 is a bottom perspective view of the driver of FIG. 224;
  • FIG. 226 is a wrap configured to at least partially surround a compressible tissue thickness compensator of a staple cartridge
  • FIG. 227 is a partial cut away view of a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrated with staples being moved from an unfired position to a fired position during a first sequence;
  • FIG. 228 is an elevational view of the staple cartridge of FIG. 227;
  • FIG. 229 is a detail elevational view of the staple cartridge of FIG. 227;
  • FIG. 230 is a cross-sectional end view of the staple cartridge of FIG. 227;
  • FIG. 231 is a bottom view of the staple cartridge of FIG. 227;
  • FIG. 232 is a detail bottom view of the staple cartridge of FIG. 227;
  • FIG. 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 being moved from an unfired position to a fired position during a first sequence;
  • FIG. 234 is another cross-sectional view of the anvil and the staple cartridge of FIG. 233 illustrating the anvil in an open position after the firing sequence has been completed;
  • FIG. 235 is a partial detail view of the staple cartridge of FIG. 233 illustrating the staples in an unfired position;
  • FIG. 236 is a cross-sectional elevational view of a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator illustrating the staples in an unfired position;
  • FIG. 237 is a detail view of the staple cartridge of FIG. 236;
  • FIG. 238 is an elevational 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 unfired position;
  • FIG. 239 is an elevational 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 unfired position and tissue captured between the anvil and the tissue thickness compensator;
  • FIG. 240 is a detail view of the anvil and staple cartridge of FIG. 239;
  • FIG. 241 is an elevational 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 unfired position illustrating thicker tissue positioned between the anvil and the staple cartridge;
  • FIG. 242 is a detail view of the anvil and staple cartridge of FIG. 241 ;
  • FIG. 243 is an elevational view of the anvil and staple cartridge of FIG. 241 illustrating tissue having different thicknesses positioned between the anvil and the staple cartridge;
  • FIG. 244 is a detail view of the anvil and staple cartridge of FIG. 241 as illustrated in FIG. 243;
  • FIG. 245 is a diagram illustrating a tissue thickness compensator which is compensating for different tissue thickness captured within different staples
  • FIG. 246 is a diagram illustrating a tissue thickness compensator applying a compressive pressure to one or more vessels that have been transected by a staple line;
  • FIG. 247 is a diagram illustrating a circumstance wherein one or more staples have been improperly formed
  • FIG. 248 is a diagram illustrating a tissue thickness compensator which could compensate for improperly formed staples
  • FIG. 249 is a diagram illustrating a tissue thickness compensator positioned in a region of tissue in which multiple staples lines have intersected;
  • FIG. 250 is a diagram illustrating tissue captured within a staple;
  • FIG. 251 is a diagram illustrating tissue and a tissue thickness compensator captured within a staple
  • FIG. 252 is a diagram illustrating tissue captured within a staple
  • FIG. 253 is a diagram illustrating thick tissue and a tissue thickness compensator captured within a staple
  • FIG. 254 is a diagram illustrating thin tissue and a tissue thickness compensator captured within a staple
  • FIG. 255 is a diagram illustrating tissue having an intermediate thickness and a tissue thickness compensator captured within a staple
  • FIG. 256 is a diagram illustrating tissue having another intermediate thickness and a tissue thickness compensator captured within a staple
  • FIG. 257 is a diagram illustrating thick tissue and a tissue thickness compensator captured within a staple
  • FIG. 258 is a partial cross-sectional view of an end effector of a surgical stapling instrument illustrating a firing bar and staple-firing sled in a retracted, unfired position;
  • FIG. 259 is another partial cross-sectional view of the end effector of FIG. 258 illustrating the firing bar and the staple-firing sled in a partially advanced position;
  • FIG. 260 is a cross-sectional view of the end effector of FIG. 258 illustrating the firing bar in a fully advanced, or fired, position;
  • FIG. 261 is a cross-sectional view of the end effector of FIG. 258 illustrating the firing bar in a retracted position after being fired and the staple-firing sled left in its fully fired position;
  • FIG. 262 is a detail view of the firing bar in the retracted position of FIG. 261 ;
  • FIG. 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 therein;
  • FIG. 264 is another partial cross-sectional view of the end effector of FIG. 263 illustrating the staples at least partially moved and/or rotated relative to an anvil positioned opposite the staple cartridge;
  • FIG. 265 is a partial cross-sectional view of an end effector of a surgical stapling instrument in accordance with at least one embodiment
  • FIG. 266 is a partial cross-sectional view of an end effector in accordance with at least one alternative embodiment
  • FIG. 267 is a partial cross-sectional view of an end effector in accordance with another alternative embodiment
  • FIG. 268 is a perspective view of an end effector of a surgical stapling instrument in accordance with at least one embodiment
  • FIG. 269 is a partial cross-sectional view of the end effector of FIG. 268 illustrated in a flexed condition
  • FIG. 270 is a partial cross-sectional view of the end effector of FIG. 269 in a released condition
  • FIG. 271 is a perspective view of an end effector comprising a tissue thickness compensator sock
  • FIG. 272 is a rear perspective of the tissue thickness compensator sock in FIG. 271 ;
  • FIG. 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;
  • FIG. 274 is a perspective view of the tissue thickness compensator of FIG. 273;
  • FIG. 275 is a perspective view of an end effector comprising a plurality of teeth extending from a support portion and a tissue thickness compensator engaged therewith;
  • FIG. 276 is a perspective view of an anvil comprising a pocket array in accordance with at least one embodiment
  • FIG. 277 is a partial detail view of the anvil of FIG. 276;
  • FIG. 278 is a partial longitudinal cross-sectional view of the anvil of FIG. 276;
  • FIG. 279 is a transverse cross-sectional view of the anvil of FIG. 276;
  • FIG. 280 is an elevational view of a fired staple comprising a substantially B-shaped configuration
  • FIG. 281 is an elevational view of a fired staple comprising one leg deformed inwardly and one leg deformed outwardly;
  • FIG. 282 is an elevational view of a fired staple comprising both legs formed outwardly;
  • FIG. 283 is a partial perspective view of a support portion of a staple cartridge comprising detachable and/or displaceable staple leg guides; [0300] FIG. 284 is a partial cross-sectional view of the staple cartridge of FIG. 283 illustrating staples being deployed from the staple cartridge;
  • FIG. 285 is a detail view of the cross-sectional view of FIG. 284 after the staple cartridge has been fired;
  • FIG. 286 is an exploded view of a staple cartridge including a tissue thickness compensator comprising voids defined therein;
  • FIG. 287 is a diagram illustrating the tissue thickness compensator of FIG. 286 implanted against tissue
  • FIG. 288 is another diagram illustrating the tissue thickness compensator of FIG. 286 implanted against tissue
  • FIG. 289 is a cross-sectional perspective view of a staple cartridge comprising lateral retention members extending from a support portion thereof configured to hold a tissue thickness compensator in position;
  • FIG. 290 is a cross-sectional view of the staple cartridge of FIG. 289 being utilized to staple tissue;
  • FIG. 291 is another cross-sectional view of the staple cartridge of FIG. 289 illustrating the support portion being moved away from the implanted tissue thickness compensator;
  • FIG. 292 is a cross-sectional perspective view of a staple cartridge comprising lateral retention members configured to hold a tissue thickness compensator to a support portion;
  • FIG. 293 is a cross-sectional view of the staple cartridge of FIG. 292 being utilized to staple tissue;
  • FIG. 294 is another cross-sectional view of the staple cartridge of FIG. 292 illustrating the support portion being moved away from the implanted tissue thickness compensator;
  • FIG. 295 is a cross-sectional detail view of a retainer holding a tissue thickness compensator to a support portion of a staple cartridge in accordance with at least one
  • FIG. 296 is partial cut-away view of a staple cartridge comprising staple drivers having different heights in accordance with at least one embodiment
  • FIG. 296A is a diagram illustrating the staple drivers of FIG. 296 and staples having different unfired heights supported thereon;
  • FIG. 297 is a diagram illustrating a tissue thickness compensator comprising a varying thickness, staple drivers having different heights, and staples having different unformed heights;
  • FIG. 298 is a diagram illustrating the staples and the tissue thickness compensator of FIG. 297 implanted to tissue;
  • FIG. 299 is a partial cross-sectional view of a staple cartridge comprising a tissue thickness compensator comprising a varying thickness in accordance with at least one embodiment
  • FIG. 300 is a cross-sectional view of an end effector of a surgical stapling instrument in an open configuration
  • FIG. 301 is cross-sectional view of the end effector of FIG. 300 illustrated in a partially- fired configuration
  • FIG. 302 is a cross-sectional view of the end effector of FIG. 300 illustrated in a reopened configuration
  • FIG. 303 is a cross-sectional view of an end effector of a surgical stapling instrument comprising staple drivers having different heights and a contoured deck surface in accordance with at least one embodiment
  • FIG. 304 is a cross-sectional view of an end effector of a surgical stapling instrument comprising staple drivers having different heights and a stepped deck surface in accordance with at least one embodiment
  • FIG. 305 is a perspective view of a staple cartridge being loaded into an effector of a surgical stapling instrument utilizing a staple cartridge applicator;
  • FIG. 306 is a bottom perspective view of the staple cartridge applicator of FIG. 305;
  • FIG. 307 is a side view of the staple cartridge applicator of FIG. 305 assembled to a staple cartridge
  • FIG. 308 is a cross-sectional view of the assembly of FIG. 307;
  • FIG. 309 is a perspective view of a staple cartridge applicator assembly further including an upper tissue thickness compensator positioned on the top surface of the staple cartridge applicator in accordance with at least one embodiment
  • FIG. 310 is an exploded view of the upper tissue thickness compensator and the staple cartridge applicator of FIG. 309;
  • FIG. 31 OA is an exploded view of a staple cartridge applicator assembly comprising a pull member configured to detach an upper tissue thickness compensator adhered to the staple cartridge applicator;
  • FIG. 31 1 is a partial exploded view of a staple cartridge applicator assembly in accordance with at least one alternative embodiment
  • FIG. 312 is a perspective view of a staple cartridge applicator assembly comprising an upper tissue thickness compensator including a plurality of retention features extending therefrom and a staple cartridge comprising a lower tissue thickness compensator;
  • FIG. 313 is an elevational view of the staple cartridge applicator assembly of FIG. 312 positioned within a staple cartridge channel and an anvil being closed onto the staple cartridge applicator assembly;
  • FIG. 314 is an elevational view of the anvil of FIG. 313 in a re-opened position and the staple cartridge applicator of FIG. 312 being removed from the end effector;
  • FIG. 314A is a cross-sectional view of tissue positioned intermediate the upper tissue thickness compensator and the lower tissue thickness compensator of FIG. 312;
  • FIG. 314B is a cross-sectional view illustrating the upper tissue thickness compensator and the lower tissue thickness compensator stapled to the tissue and severed by a cutting member;
  • FIG. 315 is a diagram illustrating a tissue thickness compensator being inserted into an anvil in accordance with at least one embodiment
  • FIG. 316 is a cross-sectional view of the tissue thickness compensator of FIG. 315;
  • FIG. 317 is an exploded view of a tissue thickness compensator and an anvil in accordance with at least one alternative embodiment
  • FIG. 318 is a perspective view of staple cartridge applicator assembly comprising an upper tissue thickness compensator configured to be attached to an anvil in accordance with at least one embodiment
  • FIG. 319 is an elevational view of the staple cartridge applicator assembly of FIG. 318 positioned within a staple cartridge channel and an anvil being moved toward the upper tissue thickness compensator;
  • FIG. 320 illustrates the staple cartridge applicator of FIG. 318 being removed from the end effector after the upper tissue thickness compensator has been engaged with the anvil;
  • FIG. 321 is a cross-sectional end view of the anvil being moved toward the upper tissue thickness compensator of FIG. 318;
  • FIG. 322 is a cross-sectional end view of the anvil engaged with the upper tissue thickness compensator
  • FIG. 323 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a segmentable tissue thickness compensator attached to a support portion of the staple cartridge by a plurality of fasteners;
  • FIG. 324 is a cross-sectional view of the end effector of FIG. 323 illustrating a firing member in a partially-fired position
  • FIG. 325 is a cross-sectional view of the end effector of FIG. 323 illustrating the support portion being moved away from the partially-implanted tissue thickness compensator;
  • FIG. 326 is a partial perspective view of the support portion of FIG. 323;
  • FIG. 327 is a perspective view of a staple- deploying sled in accordance with at least one embodiment
  • FIG. 328 is an elevational view of the sled of FIG. 327;
  • FIG. 329 is a perspective view of an end effector of a surgical stapling instrument comprising a staple cartridge including a tissue thickness compensator and a plurality of staple guides positioned on the tissue thickness compensator;
  • FIG. 330 is a partial cross-sectional view of the tissue thickness compensator and the staple guides of FIG. 329 in an unfired configuration
  • FIG. 331 is a partial cross-sectional view of the tissue thickness compensator and the staple guides of FIG. 329 in a fired configuration
  • FIG. 332 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator and a support portion in accordance with at least one embodiment
  • FIG. 333 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position;
  • FIG. 334 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 335 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 336 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 337 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 338 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 339 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 340 is a detail view of a region surrounding a tip of the staple of FIG. 339;
  • FIG. 341 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 342 is a detail view of a region surrounding a tip of the staple of FIG. 341 ;
  • FIG. 343 is a partial cross-sectional view of a tissue thickness compensator, a staple guide layer, and a staple in an unfired position in accordance with at least one alternative embodiment
  • FIG. 344 is a perspective view of a staple guide layer and a plurality of staples in an unfired position in accordance with at least one alternative embodiment
  • FIG. 345 is an end view of a tissue thickness compensator configured to be used with a circular surgical stapler
  • FIG. 346 is a perspective view of the tissue thickness compensator and the circular surgical stapler of FIG. 345;
  • FIG. 347 is an end view of a tissue thickness compensator configured to be used with a circular surgical stapler in accordance with at least one alternative embodiment
  • FIG. 348 is a perspective view of the tissue thickness compensator and the circular surgical stapler of FIG. 347;
  • FIG. 349 is an end view of a tissue thickness compensator configured to be used with a circular surgical stapler
  • FIG. 350 is an end view of the tissue thickness compensator of FIG. 349 in a partially expanded configuration
  • FIG. 351 is an elevational view of a surgical stapling instrument comprising a staple cartridge in accordance with at least one embodiment;
  • FIG. 352 is an end view of the surgical stapling instrument of FIG. 351 positioned relative to tissue;
  • FIG. 353 is an end view of the surgical stapling instrument of FIG. 351 further comprising a tissue thickness compensator positioned between the staple cartridge and the tissue;
  • FIG. 354 is a partial perspective view of staples deployed into tissue from the surgical stapling instrument of FIG. 351 without a tissue thickness compensator;
  • FIG. 355 is a partial perspective view of staples deployed into tissue from the surgical stapling instrument of FIG. 351 with a tissue thickness compensator;
  • FIG. 356 is a partial cross-sectional view of the end effector of the surgical stapling instrument of FIG. 351 comprising an anvil plate in a first position;
  • FIG. 357 is a partial cross-sectional view of the end effector of the surgical stapling instrument of FIG. 351 illustrating the anvil plate of FIG. 356 in a second position;
  • FIG. 358 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a gap setting element;
  • FIG. 359 is a perspective view illustrating a firing member cutting the gap setting element of FIG. 358 at the end of firing stroke of the firing member;
  • FIG. 360 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a flexible nose;
  • FIG. 361 is a cross-sectional view of the end effector of FIG. 360 illustrating the nose in a flexed configuration
  • FIG. 362 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge including a slidable portion;
  • FIG. 363 is a cross-sectional view of the end effector of FIG. 362 illustrating the slidable portion slid distally;
  • FIG. 364 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a support portion comprising an inclined deck surface and a tissue thickness compensator comprising a varying thickness;
  • FIG. 365 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a support portion comprising an inclined deck surface and a tissue thickness compensator comprising a uniform thickness;
  • FIG. 366 is a perspective view of a staple cartridge comprising a tissue thickness compensator having a varying thickness;
  • FIG. 367 is an end view of the staple cartridge of FIG. 366;
  • FIG. 368 is a cross-sectional perspective view of a tissue thickness compensator comprising longitudinal layers
  • FIG. 369 is a cross-sectional perspective view of a tissue thickness compensator comprising a plurality of layers in accordance with at least one alternative embodiment
  • FIG. 370 is a perspective view of a disposable loading unit comprising retention members configured to releasably hold a tissue thickness compensator thereto;
  • FIG. 371 is a perspective view of a tissue thickness compensator including retention members configured to releasably hold the tissue thickness compensator to a disposable loading unit;
  • FIG. 372 is a perspective view of the tissue thickness compensator of FIG. 371 attached to a disposable loading unit;
  • FIG. 373 is an end view of the disposable loading unit of FIG. 372;
  • FIG. 374 is a perspective view of a tissue thickness compensator including retention members configured to releasably hold the tissue thickness compensator to a disposable loading unit;
  • FIG. 375 is a perspective view of the tissue thickness compensator of FIG. 374 attached to a disposable loading unit;
  • FIG. 376 is an end view of the disposable loading unit of FIG. 375;
  • FIG. 377 is a perspective view of a tissue thickness compensator including a retention member configured to releasably hold the tissue thickness compensator to a disposable loading unit;
  • FIG. 378 is a perspective view of the tissue thickness compensator of FIG. 377 attached to a disposable loading unit;
  • FIG. 379 is a perspective view of a tissue thickness compensator applicator positioned within an effector of a disposable loading unit
  • FIG. 380 is a top perspective view of the tissue thickness compensator applicator of FIG. 379;
  • FIG. 381 is a bottom perspective view of the tissue thickness compensator applicator of FIG. 379;
  • FIG. 382 is a perspective view of a tissue thickness compensator applicator positioned within an effector of a disposable loading unit in accordance with at least one alternative embodiment
  • FIG. 383 is a top perspective view of the tissue thickness compensator applicator of FIG. 382;
  • FIG. 384 is a bottom perspective view of the tissue thickness compensator applicator of FIG. 382;
  • FIG. 385 is an elevational view of a disposable loading unit including a pivotable jaw configured to support a staple cartridge;
  • FIG. 386 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator attached to a support portion of the staple cartridge in accordance with at least one embodiment
  • FIG. 387 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator attached to a support portion of the staple cartridge in accordance with at least one embodiment
  • FIG. 388 is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator attached to a support portion of the staple cartridge in accordance with at least one embodiment
  • FIG. 389 is a perspective view of the tissue thickness compensator of FIG. 387;
  • FIG. 390 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 391 is a detail view of nonwoven material of the tissue thickness compensator of FIG. 390;
  • FIG. 392 is an elevational view depicting the tissue thickness compensator of FIG. 390 implanted against tissue and released from the end effector;
  • FIG. 393 is a detail view of nonwoven material of a tissue thickness compensator according to at least one embodiment
  • FIG. 394 is a schematic depicting clusters of randomly oriented crimped fibers according to at least one embodiment
  • FIG. 395 is a schematic depicting a cluster of randomly oriented crimped fibers according to at least one embodiment
  • FIG. 396 is a schematic depicting an arrangement of crimped fibers according to at least one embodiment
  • FIG. 397 is a schematic depicting an arrangement of crimped fibers according to at least one embodiment
  • FIG. 398 is a schematic depicting an arrangement of crimped fibers according to at least one embodiment
  • FIG. 399 is a plan cross-sectional view of coiled fibers in a tissue thickness compensator according to at least one embodiment
  • FIG. 399A is a plan cross-sectional view of the coiled fibers of FIG. 399;
  • FIG. 399B is a cross-sectional detail view of the tissue thickness compensator of FIG.
  • FIG. 400 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 401 is a diagram depicting deformation of the tissue thickness compensator of FIG. 400.
  • FIG. 402 is a schematic of woven suture for a tissue thickness compensator depicting the woven suture in a loaded configuration according to at least one embodiment
  • FIG. 403 is a schematic of the woven suture of FIG. 402 depicting the woven suture in a released configuration
  • FIG. 404 is a plan view of a tissue thickness compensator having the woven suture of FIG. 402 in an end effector of a surgical instrument;
  • FIG. 405 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 406 is a partial plan view of the tissue thickness compensator of FIG. 405;
  • FIG. 407 is an exploded view of the fastener cartridge assembly of the end effector and tissue thickness compensator of FIG. 390;
  • FIG. 408 is a partial cross-sectional view of the fastener cartridge assembly of FIG. 407 depicting unfired, partially fired, and fired fasteners;
  • FIG. 409 is an elevational view of the fastener cartridge assembly of FIG. 407 depicting a driver firing fasteners from staple cavities of the fastener cartridge assembly into the tissue thickness compensator;
  • FIG. 410 is a detail view of the fastener cartridge assembly of FIG. 409;
  • FIG. 41 1 is an elevational view of the tissue thickness compensator of FIG. 390 and tissue captured within fired fasteners;
  • FIG. 412 is an elevational view of the tissue thickness compensator of FIG. 390 and tissue captured within fired fasteners;
  • FIG. 413 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 414 is a diagram depicting deformation of a deformable tube of the tissue thickness compensator of FIG. 413;
  • FIG. 415 is a detail view of the deformable tube of the tissue thickness compensator of FIG. 413;
  • FIG. 416 is a diagram depicting deformation of a deformable tube of a tissue thickness compensator according to at least one embodiment
  • FIG. 417 is an elevational view of a tissue thickness compensator comprising a tubular element implanted against tissue according to at least one embodiment
  • FIG. 418 is an elevational view of a tissue thickness compensator comprising tubular elements implanted against tissue according to at least one embodiment
  • FIG. 419 is a partial perspective view of a deformable tube comprising a tubular lattice according to at least one embodiment
  • FIG. 420 is an elevational view of a tubular strand of the deformable tube of FIG. 419.
  • FIG. 421 is an elevational view of the deformable tube of FIG. 419;
  • FIG. 422 is an elevational view of multiple tubular strands for the deformable tube of FIG. 419 according to various embodiments;
  • FIG. 423 is an elevational view of the tubular lattice of FIG. 419 implanted against tissue;
  • FIG. 424 is a partial perspective view of a deformable tube according to at least one embodiment
  • FIG. 425 is a partial perspective view of a deformable tube according to at least one embodiment
  • FIG. 426 is a partial perspective view of a deformable tube according to at least one embodiment
  • FIG. 427 is an elevational view of the deformable tube of FIG. 426;
  • FIG. 428 is a partial perspective view of a deformable tube according to at least one embodiment
  • FIG. 429 is a partial perspective view of a deformable tube according to at least one embodiment
  • FIG. 430 is a partial perspective view of a deformable tube according to at least one embodiment
  • FIG. 431 is a perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 432 is an elevational view of a tubular element of the tissue thickness compensator of FIG. 431 ;
  • FIG. 433 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 431 depicting the end effector in an undamped configuration
  • FIG. 434 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 431 depicting the end effector in a clamped and fired configuration;
  • FIG. 435 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 436 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 435 depicting the end effector in a clamped and fired configuration
  • FIG. 437 is an elevational cross-sectional view of a tissue thickness compensator in the end effector of a surgical instrument according to at least one embodiment
  • FIG. 438 is a cross-sectional elevational view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 439 is a cross-sectional elevational view of the tissue thickness compensator and the end effector of FIG. 438 depicting the end effector in a clamped and fired configuration;
  • FIG. 440 is a perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 441 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 442 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 443 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 444 is an elevational cross-sectional view of a tissue thickness compensator positioned in 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
  • FIG. 446 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
  • FIG. 447 is a partial elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 445 depicting the end effector in an undamped configuration
  • FIG. 448 is a partial elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 445 depicting the end effector in a clamped configuration
  • FIG. 449 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 450 is an elevational view of the tissue thickness compensator and the end effector of FIG. 449;
  • FIG. 451 is a perspective view of the tissue thickness compensator and the end effector of FIG. 449 depicting the anvil of the end effector moving towards a clamped configuration;
  • FIG. 452 is an elevational view of the tissue thickness compensator and the end effector of FIG. 449 depicting the end effector in a clamped configuration
  • FIG. 453 is an elevational cross-sectional view of tubular elements of the tissue thickness compensator of FIG. 449 in an undeformed configuration
  • FIG. 454 is an elevational cross-sectional view of tubular elements of the tissue thickness compensator of FIG. 449 in a deformed configuration
  • FIG. 455 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 456 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 455 depicting the end effector in a clamped configuration
  • FIG. 457 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 455 depicting the end effector in a fired and partially undamped configuration
  • FIG. 458 is a perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 459 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument according to at least one embodiment
  • FIG. 460 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 459 depicting the end effector in a clamped configuration
  • FIG. 461 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 459 depicting the end effector in a fired and partially undamped configuration
  • FIG. 462 is a detail view of the tissue thickness compensator and the end effector of FIG. 461 ;
  • FIG. 463 is an elevational cross-sectional view of a tissue thickness compensator clamped in an end effector of a surgical instrument depicting deployment of staples by a staple- firing sled according to at least one embodiment
  • FIG. 464 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 463 depicting the end effector in a clamped configuration
  • FIG. 465 is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 463 depicting the end effector in a fired configuration
  • FIG. 466 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 467 is a perspective view of a tubular element of the tissue thickness compensator of FIG. 466;
  • FIG. 468 is a perspective view of the tubular element of FIG. 467 severed between a first and second end;
  • FIG. 469 is a perspective view of the tissue thickness compensator of FIG. 466 depicting a cutting element severing the tissue thickness compensator and staples engaging the tissue thickness compensator;
  • FIG. 470 is perspective view of a frame configured to make the tissue thickness compensator of FIG. 466 according to at least one embodiment;
  • FIG. 471 is an elevational cross-sectional view of the frame of FIG. 470 depicting the tissue thickness compensator of FIG. 466 curing in the frame;
  • FIG. 472 is an elevational cross-sectional view of the tissue thickness compensator removed from the frame of FIG. 471 and prepared for trimming by at least one cutting instrument;
  • FIG. 473 is an elevational cross-sectional view of the tissue thickness compensator of FIG. 472 after at least one cutting instrument has trimmed the tissue thickness compensator;
  • FIG. 474 is an elevational cross-sectional view of the tissue thickness compensator formed in the frame of FIG. 471 depicting severable tubes having various cross-sectional geometries;
  • FIG. 475 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 476 is a detail view of the tissue thickness compensator of FIG. 475 according to at least one embodiment
  • FIG. 477 is a partial perspective view of a tissue thickness compensator according to at least one embodiment
  • FIG. 478 is a partial perspective view of a tissue thickness compensator according to at least one embodiment
  • FIG. 479A is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 475 depicting the end effector in an undamped configuration
  • FIG. 479B is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 475 depicting the end effector in a clamped configuration
  • FIG. 479C is an elevational cross-sectional view of the tissue thickness compensator and the end effector of FIG. 475 depicting the end effector in a clamped and fired configuration;
  • FIG. 479D is an elevational cross-sectional view of the tissue thickness compensator of FIG. 475 captured in fired staples;
  • FIG. 479E is an elevational cross-sectional view of the tissue thickness compensator of FIG. 475 captured in fired staples depicting further expansion of the tissue thickness compensator;
  • FIG. 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;
  • FIG. 481 is a partial elevational view of the tissue thickness compensator of FIG. 480 captured in a fired staple;
  • FIG. 482 is an elevational view of a deformable tube of the tissue thickness compensator of FIG. 480;
  • FIG. 483 is an elevational view of a deformable tube according to at least one
  • FIG. 484 is a perspective cross-sectional view of the tissue thickness compensator of FIG. 480;
  • FIG. 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
  • FIG. 486 is a perspective view of a tissue thickness compensator according to at least one embodiment
  • FIG. 487 is a partial elevational cross-sectional view of the tissue thickness compensator of FIG. 486 depicting a fastener engaged with tissue and with the tissue thickness compensator;
  • FIG. 488 is a perspective cross-sectional view of a tissue thickness compensator according to at least one embodiment
  • FIG. 489 is an elevational view of a tissue thickness compensator according to at least one embodiment
  • FIG. 490 is an elevational view of a tissue thickness compensator according to at least one embodiment
  • FIG. 491 is an elevational view of a tissue thickness compensator positioned in a circular end effector of a surgical instrument according to at least one embodiment
  • FIG. 492 is an elevational view of a tissue thickness compensator according to at least one embodiment
  • FIG. 493 is an elevational view of a tissue thickness compensator according to at least one embodiment
  • FIG. 494 is an elevational view of a tissue thickness compensator according to at least one embodiment
  • FIG. 495 is an elevational view of a tissue thickness compensator according to at least one embodiment
  • FIG. 496 is an elevational view of a tissue thickness compensator according to at least one embodiment
  • FIG. 497 is a partial perspective view of a tissue thickness compensator according to at least one embodiment
  • FIG. 498 is a partial perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument according to at least one embodiment
  • FIG. 499 is a partial perspective view of a tissue thickness compensator with a fastener positioned in the apertures thereof according to at least one embodiment
  • FIG. 500 is a partial perspective view of the tissue thickness compensator of FIG. 498 depicting the tissue thickness compensator in an undeformed configuration
  • FIG. 501 is a partial perspective view of the tissue thickness compensator of FIG. 498 depicting the tissue thickness compensator in a partially deformed configuration
  • FIG. 502 is a partial perspective view of the tissue thickness compensator of FIG. 498 depicting the tissue thickness compensator in a deformed configuration
  • FIG. 503 is a perspective view of a tissue thickness compensator according to at least one embodiment
  • FIG. 504 is a perspective view of an end effector of a stapling instrument comprising an anvil and a staple cartridge in accordance with at least one embodiment
  • FIG. 505 is a cross-sectional view of the end effector of FIG. 504 illustrating staples positioned within the staple cartridge in an unfired state and a tissue thickness compensator comprising a sealed vessel in an unpunctured state, wherein the vessel is depicted with portions thereof removed for the purposes of illustration;
  • FIG. 506 is a cross-sectional view of the end effector of FIG. 504 illustrating the staples of FIG. 505 in an at least partially fired state and the vessel in an at least partially punctured state;
  • FIG. 507 is a perspective view of an end effector of a stapling instrument comprising an anvil and a staple cartridge in accordance with at least one embodiment
  • FIG. 508 is a cross-sectional view of the end effector of FIG. 507 illustrating staples positioned within the staple cartridge in an unfired state and sealed vessels positioned within a tissue thickness compensator of the staple cartridge in an unpunctured state, wherein the vessels are depicted with portions thereof removed for the purposes of illustration;
  • FIG. 509 is a cross-sectional view of the end effector of FIG. 507 illustrating the staples of FIG. 508 in an at least partially fired state and the vessels in the staple cartridge in an at least partially punctured state;
  • FIG. 510 is a perspective view of an end effector of a stapling instrument comprising an anvil and a sealed vessel attached to the anvil in accordance with at least one alternative embodiment wherein the vessel is depicted with portions thereof removed for the purposes of illustration;
  • FIG. 51 1 is a cross-sectional view of the end effector of FIG. 510 illustrating staples at least partially fired from a staple cartridge and the vessels attached to the anvil in an at least partially punctured state;
  • FIG. 512 is a cross-sectional view of the vessel attached to the anvil of FIG. 510 illustrated in an expanded state
  • FIG. 513 is a detail view of the vessel attached to the anvil of FIG. 512 illustrated in an expanded state
  • FIG. 514 illustrates a vessel extending in a direction transverse to a line of staples
  • FIG. 515 illustrates a plurality of vessels extending in directions which are transverse to a line of staples
  • FIG. 516 is a cross-sectional view of a staple cartridge in accordance with various embodiments.
  • FIG. 517 is a partial cross-section view of FIG. 516 in an implanted condition
  • FIG. 518A is a partial perspective view of a tissue thickness compensator prior to expansion
  • FIG. 518B is a partial perspective view of a tissue thickness compensator of FIG. 518 during expansion
  • FIG. 519 is a partial perspective view of a tissue thickness compensator comprising a fluid swellable composition according to various embodiments
  • FIG. 520 is a cross-sectional view of tissue positioned adjacent a tissue thickness compensator according to various embodiments; [0548] FIG. 521 is a partial cross-sectional view of FIG. 520 after the staple cartridge has been fired;
  • FIG. 522 is a diagram illustrating the tissue thickness compensator of FIG. 520 implanted adjacent the tissue
  • FIG. 523 is a partial perspective view of a tissue thickness compensator according to various embodiments.
  • FIG. 524 is a perspective view of a jaw configured to receive the tissue thickness compensator of FIG. 523;
  • FIG. 525 is a partial cross-sectional view of a staple cartridge illustrating staples being deployed from the staple cartridge
  • FIG. 526 is a perspective view of an upper tissue thickness compensator and a lower tissue thickness compensator positioned within an effector of a disposable loading unit;
  • FIG. 527A is a cross-sectional view of the lower tissue thickness compensator of FIG. 526 being manufactured in a mold in accordance with various embodiments;
  • FIG. 527B is a cross-sectional view of a trilayer tissue thickness compensator being manufactured in a mold in accordance with various embodiments
  • FIG. 528 is a cross-sectional view of an anvil comprising a tissue thickness compensator comprising reinforcement material in accordance with various embodiments;
  • FIG. 529 is cross-sectional view of a tissue positioned intermediate the upper tissue thickness compensator and lower tissue thickness compensator in accordance with various embodiments;
  • FIG. 530 is a cross-sectional view of FIG. 529 illustrating staples being deployed from the staple cartridge
  • FIG. 531 is a cross-sectional view of FIG. 529 after the staple cartridge has been fired
  • FIG. 532A illustrates a needle configured to deliver a fluid to a tissue thickness compensator attached to a staple cartridge according to various embodiments
  • FIG. 532B is a cross-sectional view of a staple cartridge comprising a tissue thickness compensator configured to receive the needle of FIG. 532A;
  • FIG. 533 illustrates a method of manufacturing a tissue thickness compensator according to various embodiments
  • FIG. 534 is a diagram and a method of forming an expanding thickness compensator according to various embodiments
  • FIG. 535 illustrates a micelle comprising a hydrogel precursor
  • FIG. 536 is a diagram of a surgical instrument comprising a tissue thickness compensator and fluids that may be delivered to the tissue thickness compensator according to various embodiments.
  • FIG. 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.
  • FIG. 538 is a perspective view of a tubular element of the tissue thickness compensator of FIG. 537.
  • FIG. 539 is a perspective view of the tubular element of FIG. 538 depicting the tubular element severed into two halves and fluid contacting the hydrophilic substance within each half.
  • FIG. 540 is a perspective view of a half of the severed tubular element of FIG. 539 depicting expansion of the severed tubular element.
  • any article or product disclosed or claimed herein may exist alone, or in combination with, or as an integral part of any other article or product so disclosed with which it is compatible.
  • the particular features, structures, or characteristics illustrated or described in connection with one article, product or method may be combined, in whole or in part, with the features structures, or characteristics of one or more other compatible articles, products or methods without limitation. Such modifications and variations are included within the scope of the present invention.
  • proximal and distal are used herein with reference to a clinician manipulating the handle portion of the surgical instrument.
  • proximal referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician.
  • distal referring to the portion located away from the clinician.
  • spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings.
  • surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
  • FIG. 1 depicts a surgical instrument 10 that is capable of practicing several unique benefits.
  • the surgical stapling instrument 10 is designed to manipulate and/or actuate various forms and sizes of end effectors 12 that are operably attached thereto.
  • the end effector 12 includes an elongated channel 14 that forms a lower jaw 13 of the end effector 12.
  • the elongated channel 14 is configured to support an "implantable" staple cartridge 30 and also movably support an anvil 20 that functions as an upper jaw 15 of the end effector 12.
  • the elongated channel 14 may be fabricated from, for example, 300 & 400 Series, 17-4 & 17-7 stainless steel, titanium, etc. and be formed with spaced side walls 16.
  • the anvil 20 may be fabricated from, for example, 300 & 400 Series, 17-4 & 17-7 stainless steel, titanium, etc. and have a staple forming undersurface, generally labeled as 22 that has a plurality of staple forming pockets 23 formed therein. See FIGS. IB- IE.
  • the anvil 20 has a bifurcated ramp assembly 24 that protrudes proximally therefrom.
  • An anvil pin 26 protrudes from each lateral side of the ramp assembly 24 to be received within a corresponding slot or opening 18 in the side walls 16 of the elongated channel 14 to facilitate its movable or pivotable attachment thereto.
  • implantable staple cartridge 30 has a body portion 31 that consists of a compressible hemostat material such as, for example, oxidized regenerated cellulose ("ORC") or a bio-absorbable foam in which lines of unformed metal staples 32 are supported.
  • a compressible hemostat material such as, for example, oxidized regenerated cellulose ("ORC") or a bio-absorbable foam in which lines of unformed metal staples 32 are supported.
  • the entire cartridge may be coated or wrapped in a biodegradable film 38 such as a polydioxanon film sold under the trademark PDS® or with a Polyglycerol sebacate (PGS) film or other biodegradable films formed from PGA (Polyglycolic acid, marketed under the trade mark Vicryl), PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under the trademark Monocryl) or a composite of PGA, PCL, PLA, PDS that would be impermeable until ruptured.
  • PGA Polyglycolic acid, marketed under the trade mark Vicryl
  • PCL Polycaprolactone
  • PLA or PLLA Polylactic acid
  • PHA polyhydroxyalkanoate
  • PGCL poliglecaprone 25, sold under the trademark Monocryl
  • the body 31 of 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 corresponding staple forming pockets 23 in the anvil when the anvil 20 is driven into forming contact with the staple cartridge 30.
  • the end effector 12 is manipulated to capture or clamp 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 moving the anvil 20 in a path that is substantially parallel to the elongated channel 14 to bring the staple forming surface 22 and, more particularly, the staple forming pockets 23 therein into substantially simultaneous contact with the upper face 36 of the staple cartridge 30.
  • the legs 34 of the staples 32 contact a corresponding staple forming pocket 23 in anvil 20 which serves to bend the staple legs 34 over to form the staples 32 into a "B shape". Further movement of the anvil 20 toward the elongated channel 14 will further compress and form the staples 32 to a desired final formed height "FF".
  • FIGS. IB- IE The above-described staple forming process is generally depicted in FIGS. IB- IE.
  • FIG. 1 B illustrates the end effector 12 with target tissue "T" between the anvil 20 and the upper face 36 of the implantable staple cartridge 30.
  • FIG. 1 C illustrates the initial clamping position of the anvil 20 wherein the anvil has 20 been closed onto the target tissue "T” to clamp the target tissue "T” between the anvil 20 and the upper face 36 of the staple cartridge 30.
  • FIG. ID illustrates the initial staple formation wherein the anvil 20 has started to compress the staple cartridge 30 such that the legs 34 of the staples 32 are starting to be formed by the staple forming pockets 23 in the anvil 20.
  • FIG. 1 B illustrates the end effector 12 with target tissue "T" between the anvil 20 and the upper face 36 of the implantable staple cartridge 30.
  • FIG. 1 C illustrates the initial clamping position of the anvil 20 wherein the anvil has 20 been closed onto the target tissue "T” to clamp the
  • IE illustrates the staple 32 in its final formed condition through the target tissue "T” with the anvil 20 removed for clarity purposes.
  • the surgeon will move the anvil 20 to the open position to enable the cartridge body 31 and the staples 32 to remain affixed to the target tissue while the end effector 12 is being withdrawn from the patient.
  • the end effector 12 forms all of the staples simultaneously as the two jaws 13, 15 are clamped together.
  • the remaining "crushed" body materials 31 act as both a hemostat (the ORC) and a staple line reinforcement (PGA, PDS or any of the other film compositions mentioned above 38).
  • implantable staple cartridges are distinguishable from prior cartridge arrangements that remain positioned within the end effector in their entirety after they have been fired.
  • the end effector 12 is configured to be coupled to an elongated shaft assembly 40 that protrudes from a handle assembly 100.
  • the end effector 12 (when closed) and the elongated shaft assembly 40 may have similar cross-sectional shapes and be sized to operably pass through a trocar tube or working channel in another form of access instrument.
  • the term "operably pass” means that the end effector and at least a portion of the elongated shaft assembly may be inserted through or passed through the channel or tube opening and can be manipulated therein as needed to complete the surgical stapling procedure.
  • the jaws 13 and 15 of the end effector 12 may provide the end effector with a roughly circular cross-sectional shape that facilitates its passage through a circular passage/opening.
  • the end effectors of the present invention, as well as the elongated shaft assembly embodiments could conceivably be provided with other cross- sectional shapes that could otherwise pass through access passages and openings that have non- circular cross-sectional shapes.
  • an overall size of a cross-section of a closed end effector will be related to the size of the passage or opening through which it is intended to pass.
  • one end effector for example, may be referred to as a "5mm" end effector which means it can operably pass through an opening that is at least approximately 5mm in diameter.
  • the elongated shaft assembly 40 may have an outer diameter that is substantially the same as the outer diameter of the end effector 12 when in a closed position.
  • a 5mm end effector may be coupled to an elongated shaft assembly 40 that has 5mm cross-sectional diameter.
  • a 10mm end effector may be attached to an elongated shaft that has a 5mm cross- sectional diameter.
  • the elongated shaft assembly 40 may have a 10mm (or larger) cross- sectional diameter, but may also be able to actuate a 5mm or 10mm end effector. Accordingly, the outer shaft 40 may have an outer diameter that is the same as or is different from the outer diameter of a closed end effector 12 attached thereto.
  • the elongated shaft assembly 40 extends distally from the handle assembly 100 in a generally straight line to define a longitudinal axis A-A.
  • the elongated shaft assembly 40 may be approximately 9-16 inches (229-406mm) long.
  • the elongated shaft assembly 40 may be provided in other lengths and, as an alternative, may have joints therein or be otherwise configured to facilitate articulation of the end effector 12 relative to other portions of the shaft or handle assembly as will be discussed in further detail below.
  • the elongated shaft assembly 40 includes a spine member 50 that extends from the handle assembly 100 to the end effector 12.
  • the proximal end of the elongated channel 14 of the end effector 12 has a pair of retention trunnions 17 protruding therefrom that are sized to be received within corresponding trunnion openings or cradles 52 that are provided in a distal end of the spine member 50 to enable the end effector 12 to be removably coupled the elongated shaft assembly 40.
  • the spine member 50 may be fabricated from, for example, 6061 or 7075 aluminum, stainless steel, titanium, etc.
  • the handle assembly 100 comprises a pistol grip-type housing that may be fabricated in two or more pieces for assembly purposes.
  • the handle assembly 100 as shown comprises a right hand case member 102 and a left hand case member (not illustrated) that are molded or otherwise fabricated from a polymer or plastic material and are designed to mate together.
  • Such case members may be attached together by snap features, pegs and sockets molded or otherwise formed therein and/or by adhesive, screws, etc.
  • the spine member 50 has a proximal end 54 that has a flange 56 formed thereon.
  • the flange 56 is configured to be rotatably supported within a groove 106 formed by mating ribs 108 that protrude inwardly from each of the case members 102, 104.
  • Such arrangement facilitates the attachment of the spine member 50 to the handle assembly 100 while enabling the spine member 50 to be rotated relative to the handle assembly 100 about the longitudinal axis A-A in a 360° path.
  • the spine member 50 passes through and is supported by a mounting bushing 60 that is rotatably affixed to the handle assembly 100.
  • the mounting bushing 60 has a proximal flange 62 and a distal flange 64 that define a rotational groove 65 that is configured to rotatably receive a nose portion 101 of the handle assembly 100 therebetween.
  • the spine member 50 is non-rotatably pinned to the mounting bushing 60 by a spine pin 66.
  • a rotation knob 70 is attached to the mounting bushing 60.
  • the rotation knob 70 has a hollow mounting flange portion 72 that is sized to receive a portion of the mounting bushing 60 therein.
  • the rotation knob 70 may be fabricated from, for example, glass or carbon filled Nylon, polycarbonate, Ultem®, etc. and is affixed to the mounting bushing 60 by the spine pin 66 as well.
  • an inwardly protruding retention flange 74 is formed on the mounting flange portion 72 and is configured to extend into a radial groove 68 formed in the mounting bushing 60.
  • the surgeon may rotate the spine member 50 (and the end effector 12 attached thereto) about longitudinal axis A-A in a 360° path by grasping the rotation knob 70 and rotating it relative to the handle assembly 100.
  • the anvil 20 is retained in an open position by an anvil spring 21 and/or another biasing arrangement.
  • the anvil 20 is selectively movable from the open position to various closed or clamping and firing positions by a firing system, generally designated as 109.
  • the firing system 109 includes a "firing member" 1 10 which comprises a hollow firing tube 1 10.
  • the hollow firing tube 1 10 is axially movable on the spine member 50 and thus forms the outer portion of the elongated shaft assembly 40.
  • the firing tube 1 10 may be fabricated from a polymer or other suitable material and have a proximal end that is attached to a firing yoke 1 14 of the firing system 109.
  • the firing yoke 1 14 may be over-molded to the proximal end of the firing tube 1 10.
  • other fastener arrangements may be employed.
  • the firing yoke 1 14 may be rotatably supported within a support collar 120 that is configured to move axially within the handle assembly 100.
  • the support collar 120 has a pair of laterally extending fins that are sized to be slidably received within fin slots formed in the right and left hand case members.
  • the support collar 120 may slide axially within the handle housing 100 while enabling the firing yoke 1 14 and firing tube 1 10 to rotate relative thereto about the longitudinal axis A-A.
  • a longitudinal slot is provided through the firing tube 1 10 to enable the spine pin 66 to extend therethrough into the spine member 50 while facilitating the axial travel of the firing tube 1 10 on the spine member 50.
  • the firing system 109 further comprises a firing trigger 130 which serves to control the axial travel of the firing tube 1 10 on the spine member 50. See FIG. 1. Such axial movement in the distal direction of the firing tube 1 10 into firing interaction with the anvil 20 is referred to herein as "firing motion".
  • the firing trigger 130 is movably or pivotally coupled to the handle assembly 100 by a pivot pin 132.
  • a torsion spring 135 is employed to bias the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 to an un- actuated "open" or starting position.
  • FIG. 1 A torsion spring 135 is employed to bias the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 to an un- actuated "open" or starting position.
  • the firing trigger 130 has an upper portion 134 that is movably attached to (pinned) firing links 136 that are movably attached to (pinned) the support collar 120.
  • movement of the firing trigger 130 from the starting position (FIG. 1) toward an ending position adjacent the pistol grip portion 107 of the handle assembly 100 will cause the firing yoke 1 14 and the firing tube 1 10 to move in the distal direction "DD".
  • Movement of the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 (under the bias of the torsion spring 135) will cause the firing yoke 1 14 and firing tube 1 10 to move in the proximal direction "PD" on the spine member 50.
  • the present invention may be employed with different sizes and configurations of implantable staple cartridges.
  • the surgical instrument 10 when used in connection with a first firing adapter 140, may be used with a 5mm end effector 12 that is approximately 20mm long (or in other lengths) which supports an implantable staple cartridge 30.
  • Such end effector size may be particularly well-suited, for example, to complete relatively fine dissection and vascular transactions.
  • the surgical instrument 10 may also be employed, for example, in connection with other sizes of end effectors and staple cartridges by replacing the first firing adapter 140 with a second firing adapter.
  • the elongated shaft assembly 40 may configured to be attached to only one form or size of end effector.
  • the present invention may also have an end effector locking assembly for locking the firing trigger 130 in position after an end effector 12 has been attached to the spine member 50.
  • the end effector locking assembly 160 includes a retention pin 162 that is movably supported in the upper portion 134 of the firing trigger 130.
  • the firing tube 1 10 must initially be advanced distally to the coupled position wherein the first firing adapter 140 retains the retention trunnions 17 of the end effector 12 in the trunnion cradles 52 in the spine member 50. The surgeon advances the firing adapter 140 distally to the coupled position by pulling the firing trigger 130 from the starting position toward the pistol grip 107.
  • the retention pin 162 is moved distally until the firing tube 1 10 has advanced the first firing adapter 140 to the coupled position at which point the retention pin 162 is biased into a locking cavity 164 formed in the case member.
  • the pin 162 may 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” onto the spine member 50.
  • the surgeon cannot inadvertently continue to actuate the firing trigger 130 to start to form staples 32 in the end effector 12 without intentionally biasing the retention pin 162 out of the locking cavity 164.
  • the surgeon releases the firing trigger 130 when in the coupled position it is retained in that position by the retention pin 162 to prevent the firing trigger 130 from returning to the starting position and thereby releasing the end effector 12 from the spine member 50.
  • the present invention may further include a firing system lock button 137 that is pivotally attached to the handle assembly 100.
  • the firing system lock button 137 has a latch 138 formed on a distal end thereof that is oriented to engage the firing yoke 1 14 when the firing release button is in a first latching position.
  • a latch spring 139 serves to bias the firing system lock button 137 to the first latching position.
  • the latch 138 serves to engage the firing yoke 1 14 at a point where the position of the firing yoke 1 14 on the spine member 50 corresponds to a point wherein the first firing adapter 140 is about to distally advance up the clamping ramp 28 on the anvil 20. It will be understood that, as the first firing adapter 140 advances axially up the clamping ramp 28, the anvil 20 will move in a path such that its staple forming surface portion 22 is substantially parallel to the upper face 36 of the staple cartridge 30.
  • the staple forming process is commenced by first depressing the firing system lock button 137 to enable the firing yoke 1 14 to be further moved distally on the spine member 50 and ultimately compress the anvil 20 into the staple cartridge 30.
  • the surgeon continues to actuate the firing trigger 130 towards the pistol grip 107 thereby driving the first staple collar 140 up the corresponding staple forming ramp 29 to force the anvil 20 into forming contact with the staples 32 in the staple cartridge 30.
  • the firing system lock button 137 prevents the inadvertent forming of the staples 32 until the surgeon is ready to start that process. In this example, the surgeon must depress the firing system lock button 137 before the firing trigger 130 may be further actuated to begin the staple forming process.
  • the surgical instrument 10 may be solely used as a tissue stapling device if so desired.
  • the present invention may also include a tissue cutting system, generally designated as 170.
  • the tissue cutting system 170 comprises a knife member 172 that may be selectively advanced from an un-actuated position adjacent the proximal end of the end effector 12 to an actuated position by actuating a knife advancement trigger 200.
  • the knife member 172 is movably supported within the spine member 50 and is attached or otherwise protrudes from a knife rod 180.
  • the knife member 172 may be fabricated from, for example, 420 or 440 stainless steel with a hardness of greater than 38HRC (Rockwell Hardness C-scale) and have a tissue cutting edge 176 formed on the distal end 174 thereof and be configured to slidably extend through a slot in the anvil 20 and a centrally disposed slot 33 in the staple cartridge 30 to cut through tissue that is clamped in the end effector 12.
  • the knife rod 180 extends through the spine member 50 and has a proximal end portion which drivingly interfaces with a knife transmission that is operably attached to the knife advance trigger 200.
  • the knife advance trigger 200 is attached to pivot pin 132 such that it may be pivoted or otherwise actuated without actuating the firing trigger 130.
  • a first knife gear 192 is also attached to the pivot pin 132 such that actuation of the knife advance trigger 200 also pivots the first knife gear 192.
  • a firing return spring 202 is attached between the first knife gear 192 and the handle housing 100 to bias the knife advancement trigger 200 to a starting or un-actuated position.
  • the knife transmission also include a second knife gear 194 that is rotatably supported on a second gear spindle and in meshing engagement with the first knife gear 192.
  • the second knife gear 194 is in meshing engagement with a third knife gear 196 that is supported on a third gear spindle.
  • Also supported on the third gear spindle 195 is a fourth knife gear 198.
  • the fourth knife gear 198 is adapted to drivingly engage a series of annular gear teeth or rings on a proximal end of the knife rod 180.
  • such arrangement enables the fourth knife gear 198 to axially drive the knife rod 180 in the distal direction "DD" or proximal direction “PD” while enabling the firing rod 180 to rotate about longitudinal axis A-A with respect to the fourth knife gear 198. Accordingly, the surgeon may axially advance the firing rod 180 and ultimately the knife member 172 distally by pulling the knife advancement trigger 200 towards the pistol grip 107 of the handle assembly 100.
  • the present invention may further include a knife lockout system 210 that prevents the advancement of the knife member 172 unless the firing trigger 130 has been pulled to the fully fired position. Such feature will therefore prevent the activation of the knife advancement system 170 unless the staples have first been fired or formed into the tissue.
  • various implementations of the knife lockout system 210 comprise a knife lockout bar 21 1 that is pivotally supported within the pistol grip portion 107 of the handle assembly 100.
  • the knife lockout bar 21 1 has an activation end 212 that is adapted to be engaged by the firing trigger 130 when the firing trigger 130 is in the fully fired position.
  • the knife lockout bar 21 1 has a retaining hook 214 on its other end that is adapted to hookingly engage a latch rod 216 on the first cut gear 192.
  • a knife lock spring 218 is employed to bias the knife lockout bar 21 1 to a "locked" position wherein the retaining hook 214 is retained in engagement with the latch rod 216 to thereby prevent actuation of the knife advancement trigger 200 unless the firing trigger 130 is in the fully fired position.
  • the surgeon may depress the firing trigger release button 167 to enable the firing trigger 130 to return to the starting position under the bias of the torsion spring 135 which enables the anvil 20 to be biased to an open position under the bias of spring 21.
  • the surgeon may withdraw the end effector 12 leaving the implantable staple cartridge 30 and staples 32 behind.
  • the surgeon will return the anvil 20 to the closed position by activating the firing trigger 130 to enable the end effector 12 to be withdrawn out through the passage or working channel.
  • the surgeon activates the knife advancement trigger 200 in the above-described manner to drive the knife bar 172 through the target tissue to the end of the end effector. Thereafter, the surgeon may release the knife advancement trigger 200 to enable the firing return spring 202 to cause the firing transmission to return the knife bar 172 to the starting (un-actuated) position. Once the knife bar 172 has been returned to the starting position, the surgeon may open the end effector jaws 13, 15 to release the implantable cartridge 30 within the patient and then withdraw the end effector 12 from the patient.
  • such surgical instruments facilitate the use of small implantable staple cartridges that may be inserted through relatively smaller working channels and passages, while providing the surgeon with the option to fire the staples without cutting tissue or if desired to also cut tissue after the staples have been fired.
  • Various unique and novel embodiments of the present invention employ a compressible staple cartridge that supports staples in a substantially stationary position for forming contact by the anvil.
  • the anvil is driven into the unformed staples wherein, for example, the degree of staple formation attained is dependent upon how far the anvil is driven into the staples.
  • Such an arrangement provides the surgeon with the ability to adjust the amount of forming or firing pressure applied to the staples and thereby alter the final formed height of the staples.
  • surgical stapling arrangements can employ staple driving elements which can lift the staples toward the anvil. Such embodiments are described in greater detail further below.
  • the amount of firing motion that is applied to the movable anvil is dependent upon the degree of actuation of the firing trigger. For example, if the surgeon desires to attain only partially formed staples, then the firing trigger is only partially depressed inward towards the pistol grip 107. To attain more staple formation, the surgeon simply compresses the firing trigger further which results in the anvil being further driven into forming contact with the staples.
  • forming contact means that the staple forming surface or staple forming pockets have contacted the ends of the staple legs and have started to form or bend the legs over into a formed position.
  • the degree of staple formation refers to how far the staple legs have been folded over and ultimately relates to the forming height of the staple as referenced above.
  • the anvil 20 moves in a substantially parallel relationship with respect to the staple cartridge as the firing motions are applied thereto, the staples are formed substantially simultaneously with substantially the same formed heights.
  • FIGS. 2 and 3 illustrate an alternative end effector 12" that is similar to the end effector 12' described above, except with the following differences that are configured to accommodate a knife bar 172'.
  • the knife bar 172' is coupled to or protrudes from a knife rod 180 and is otherwise operated in the above described manner with respect to the knife bar 172.
  • the knife bar 172' is long enough to traverse the entire length of the end effector 12" and therefore, a separate distal knife member is not employed in the end effector 12".
  • the knife bar 172' has an upper transverse member 173 ' and a lower transverse member 175' formed thereon.
  • the upper transverse member 173 ' is oriented to slidably transverse a corresponding elongated slot 250 in 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 disengagement slot (not shown) is also provide din the anvil 20" such that when the knife bar 172' has been driven to an ending position with thin end effector 12", the upper transverse member 173 ' drops through the corresponding slot to enable the anvil 20" to move to the open position to disengage the stapled and cut tissue.
  • the anvil 20" may be otherwise identical to anvil 20 described above and the elongated channel 14" may be otherwise identical to elongated channel 14 described above.
  • the anvil 20" is biased to a fully open position (FIG. 2) by a spring or other opening arrangement (not shown).
  • the anvil 20" is moved between the open and fully clamped positions by the axial travel of the firing adapter 150 in the manner described above.
  • the surgeon may then advance the knife bar 172" distally in the manner described above. If the surgeon desires to use the end effector as a grasping device to manipulate tissue, the firing adapter may be moved proximally to allow the anvil 20" to move away from the elongated channel 14" as represented in FIG. 4 in broken lines.
  • the unique and novel features of the various surgical staple cartridges and the surgical instruments of the present invention enable 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 for receiving the tissue cutting member therethrough.
  • the staples in one line may be substantially parallel with the staples in adjacent line(s) of staples, but offset therefrom.
  • one or more lines of staples may be non-linear in nature. That is, the base of at least one staple in a line of staples may extend along an axis that is substantially transverse to the bases of other staples in the same staple line.
  • the lines of staples on each side of the elongated slot may have a zigzag appearance.
  • Such non-linear staple arrangements may attain better tissue fastening results with fewer staples than various linear staple arrangements employed in prior staple cartridges.
  • FIG. 6 illustrates use of a surgical staple cartridge embodiment 900 in an end effector embodiment 612'.
  • an embodiment of the surgical staple cartridge 900 has a cartridge body 902 that has a centrally disposed elongated slot 904 extending through a proximal end 903 to an area adjacent a distal end 905.
  • the elongated slot 904 is configured to permit a knife body to axially move therethrough during a tissue cutting operation in the manner described above.
  • the cartridge body 902 consists of a compressible hemostat material such as, for example, oxidized regenerated cellulose ("ORC") or a bio-absorbable foam fabricated from, for example, PGA (Polyglycolic acid, sold under the trademark Vicryl), PCL (polycaprolactone), PLA or PLLA (Polyactic acid), PDS (Polydioxanone), PHA
  • PGA Polyglycolic acid, sold under the trademark Vicryl
  • PCL polycaprolactone
  • PLA polycaprolactic acid
  • PDS Polydioxanone
  • the cartridge body 902 may be fabricated from other materials that serve to support the unformed staples 922 in a desired orientation such that they may be compressed as the anvil 910' is brought into contact therewith.
  • the staple cartridge 900 is implantable and is left attached to the stapled tissue after the stapling procedure has been completed.
  • the entire cartridge 900 may be coated or wrapped in a biodegradable film 906 such as a polydioxanon film sold under the trademark PDS® or with a Polyglycerol sebacate (PGS) film or other biodegradable films fabricated from, for example, PGA (Polyglycolic acid, marketed under the trade mark Vicryl), PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under the trademark Monocryl) or a composite of PGA, PCL, PLA, PDS that would be impermeable until ruptured.
  • the cartridge body 902 of staple cartridge 900 is sized to be removably supported within the elongated channel of the end effector 612'.
  • the surgical staple cartridge 900 operably supports a first line 920 of staples 922 on one lateral side 907 of the elongated slot 904 and a second line 930 of staples 922 on the other lateral side 909 of the elongated slot 904.
  • the staples 922 may be fabricated from a metal material such as, for example, Titanium, Titanium alloys ( e.g., 6AI-4V Titanium, 3al-2.5V Titanium), Stainless Steel, etc. and have a staple base 924 and two upstanding staple legs 926 protruding therefrom. Each staple leg 926 may have a tissue-piercing tip 928 formed thereon.
  • the staple base 924 of at least one staple 922 overlaps the staple base of another staple 922.
  • the staple base 924 of each staple 922 overlaps the staple bases 924 of two adjacent staples 922, except for the base 924 of the last staple 922 on each end of the first staple line 920. See FIG. 10.
  • the first staple line 920 has a substantially non-linear shape. More particularly, when viewed from above, the first staple line 920 has a substantially zigzag appearance.
  • the anvil 90 has two sequential longitudinal staple forming pockets 912 that each has a substantial zigzag shape that corresponds to the shape of the first line 920 of staples 922 such that, when the anvil 910 is brought into forming contact with the staples 922, the legs 926 thereof are formed as shown in FIG. 1 1.
  • the distal leg of one staple shares the same pocket as the proximal leg of the next staple longitudinally.
  • Such arrangement allows for a denser pocket pattern, even to a point where the staples themselves interact (e.g., are folded over one another).
  • prior staple pocket arrangements in general, there has to be between 0.005 and 0.015 inches of metal/space from one set of pockets to the next.
  • This embodiment of the present invention has a spacing arrangement from 0 to 0.02 inches of
  • Another staple forming pocket arrangement may comprise a common staple forming pocket.
  • common staple forming pocket means that one forming pocket can form all of the staples in a single line of staples as opposed to prior anvil designs wherein a discrete forming pocket is provided for each leg of each staple to be formed.
  • FIG. 12 illustrates yet another staple embodiment 922' wherein the base 924' has an offset portion 929 to facilitate a tighter overlap of the bases 924'.
  • the staple cartridge 900 has a second line 930 of staples 922 supported on a second lateral side 909 of the elongated slot 904.
  • the second line 930 of staples 922 is substantially identical to the first line 920 of staples 922.
  • the anvil 910 has a second common staple forming pocket 912 that corresponds to the second line of staples 930 for forming contact therewith.
  • the second line 930 of staples 922 may differ from the first line 920 of staples in shape and, perhaps, number of staples.
  • FIG. 8 illustrates a surgical staple cartridge 900' that is substantially identical to the staple cartridge 900 described above, with the exception of the lines 920', 930' of staples 922 supported therein.
  • the line 920' of staples 922 are arranged relative to each other such that a base axis S-S of at least one staple base 924 is substantially transverse to the base axis S-S of the staple base 924 of at least one other adjacent staple 922.
  • Such predetermined pattern of staples when viewed from above, comprises a substantially zigzag arrangement.
  • the respective bases 924 of staples 922 may additionally have a base support member 927 overmolded thereon as shown.
  • the base support member 927 may be fabricated from, for example, non-absorbable plastic such as Polyether ether ketone "PEEK” or absorbable plastic such as, for example, Polyglycolic acid “PGA", Polylactic acid “PLA” or “PLLA”, Polydioxanone “PDS”, PCL (polycapro lactone), PHA (polyhydroxyalkanoate), Polyglycerol sebacate (PGS), PGCL (poliglecaprone 25, sold under the trademark Monocryl) or various composite mixes of PGS, PDS, PLA, PGA, and PCL.
  • the base support members 927 facilitate interlocking between the staples without making the staples themselves overlap.
  • FIG. 14 employs a staple line 920" wherein the legs 926 of adjacent staples 922 are coupled together by a coupler portion 929 molded or otherwise attached thereto.
  • Each coupler portion 929 may be fabricated from, 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
  • Such staple line 920" has substantial zigzag appearance when viewed from above. While the various surgical staple cartridge embodiments 900, 900' have been explained with reference to use with the end effector 612', it will be understood that the staple cartridges 900, 900' may be effectively employed with the various other end effectors and surgical instruments described hereinabove, with appropriate staple forming pocket arrangements being provided in the anvils of those instruments in order to achieved the desired amount of staple formation upon movement of the anvils into forming contact with the staples.
  • FIGS. 15 and 16 illustrate another surgical staple cartridge 940 embodiment supported in an elongated channel 14 of a surgical instrument 10.
  • the surgical staple cartridge 940 includes a cartridge body 942 that has a centrally disposed elongated slot 944 extending at least partially therethrough.
  • the elongated slot 944 is configured to permit a knife body of the surgical instrument 10 to axially move therethrough during a tissue cutting operation in the manner described above.
  • the cartridge body 942 consists of a compressible hemostat material such as, for example, oxidized regenerated cellulose ("ORC”) or a bio-absorbable foam of the types described above or below in which lines 946, 948, 950, 952 of unformed staples 922 are supported.
  • ORC oxidized regenerated cellulose
  • the entire cartridge 940 may be coated or wrapped in a biodegradable film 954 such as a polydioxanon film sold under the trademark PDS® or with a Polyglycerol sebacate (PGS) film or other biodegradable films fabricated from, for example, PGA (Polyglycolic acid, marketed under the trade mark Vicryl), PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under the trademark Monocryl) or a composite of PGA, PCL, PLA, PDS that would be impermeable until ruptured.
  • PGA Polyglycolic acid, marketed under the trade mark Vicryl
  • PCL Polycaprolactone
  • PLA or PLLA Polylactic acid
  • PHA polyhydroxyalkanoate
  • PGCL poliglecaprone 25, sold under the trademark Monocryl
  • the cartridge 940 further includes a cartridge support member 960 that is coupled to the cartridge body 942.
  • the cartridge support member 960 may be fabricated from a rigid material such as, for example, Titanium, Stainless Steel, Aluminum, any alloy of the foregoing, etc. and may be partially embedded within the cartridge body 942.
  • the cartridge support member 960 may be held in place by, for example, film 954.
  • sporadic use of cyanoacylate could be used to "glue" the two components together.
  • the cartridge body 942 may be heated and "welded” or "fused” to the cartridge support member 960.
  • the cartridge support member 960 forms at least a portion of the bottom surface of the cartridge body 942 for mating with the elongated channel 14.
  • the cartridge support member 960 has one or more snap features 962 protruding therefrom for releasably coupling the cartridge support member 960 to the elongated channel 14.
  • Other forms of snap features/fastener arrangements may be employed for releasably coupling the cartridge support member 960 to the elongated channel 14.
  • the cartridge support member 960 has a series of support ridges 964, 966, 968, 970, 972, 974, 976 formed thereon to provide some lateral support to the bases 924 of the staples 922 in the staple lines 946, 948, 950, 952 as shown in FIG. 15.
  • the support ridges are substantially coextensive with the staple lines.
  • FIG. 17 illustrates an alternative staple cartridge embodiment 940' that is substantially identical to cartridge 940, except for the inclusion of upstanding fin portions 978, 979, 980, 981 , 982, 983 that protrude from the support ridges 964, 966, 968, 970, 972, 976, respectively to provide additional lateral support to the staples 922.
  • the fin portions may be integrally formed with the cartridge support member 960 and have a height that is about 1 ⁇ 2 or less of the height of the cartridge.
  • any standing features supporting the foam cannot extend above the maximum compression height of the foam.
  • the cartridge is designed, for example, to compress to 1/3 of its original height when fired, the fins would between 66% of the uncompressed height, all the way down to 10% of uncompressed height.
  • the anvil 20 is opened and the end effector 12 is pulled away from the stapled tissue.
  • the cartridge body 942 remains fastened to the stapled tissue and is then separated from the cartridge support member 960 which remains coupled to the elongated channel 14.
  • the cartridge support member 960 is provided with a color that differs from the color of the material comprising the cartridge body 942 as well as the color of the elongated channel 14. Such arrangement provides the surgeon with an easily recognizable indication that no staple cartridge is present within the end effector.
  • the surgeon will not inadvertently attempt to reinsert/use the end effector without first installing a new staple cartridge therein. To do so, the surgeon simply disconnects the snap features of the cartridge support member 960 from the elongated channel 14 to enable the cartridge support member 960 of a new staple cartridge 940 to be placed therein. While the staple cartridges 940, 940' have been explained with reference to surgical instrument 10, it will be understood that those cartridges may be effectively employed with many of the other surgical instrument embodiments disclosed herein without departing from the spirit and scope of the present invention.
  • a staple cartridge can comprise a cartridge body and a plurality of staples stored within the cartridge body.
  • the staple cartridge can be introduced into a surgical site and positioned on a side of the tissue being treated.
  • a staple-forming anvil can be positioned on the opposite side of the tissue.
  • the anvil can be carried by a first jaw and the staple cartridge can be carried by a second jaw, wherein the first jaw and/or the second jaw can be moved toward the other.
  • a staple cartridge or at least a portion of a staple cartridge, can be implanted with the staples.
  • a staple cartridge can comprise a cartridge body which can be compressed, crushed, and/or collapsed by the anvil when the anvil is moved from an open position into a closed position.
  • the staples positioned within the cartridge body can be deformed by the anvil.
  • the jaw supporting the staple cartridge can be moved toward the anvil into a closed position. In either event, the staples can be deformed while they are at least partially positioned within the cartridge body.
  • a compressible staple cartridge such as staple cartridge 1000, for example, can comprise a compressible, implantable cartridge body 1010 and, in addition, a plurality of staples 1020 positioned in the compressible cartridge body 1010, although only one staple 1020 is depicted in FIGS. 18A-18D.
  • FIG. 18A illustrates the staple cartridge 1000 supported by a staple cartridge support, or staple cartridge channel, 1030, wherein the staple cartridge 1000 is illustrated in an uncompressed condition.
  • the anvil 1040 may or may not be in contact with the tissue T.
  • the anvil 1040 can be moved from an open position into contact with the tissue T as illustrated in FIG. 18B and position the tissue T against the cartridge body 1010. Even though the anvil 1040 can position the tissue T against a tissue-contacting surface 1019 of staple cartridge body 1010, referring again to FIG. 18B, the staple cartridge body 1010 may be subjected to little, if any, compressive force or pressure at such point and the staples 1020 may remain in an unformed, or unfired, condition.
  • the staple cartridge body 1010 can comprise one or more layers and the staple legs 1021 of staples 1020 can extend upwardly through these layers.
  • the cartridge body 1010 can comprise a first layer 101 1 , a second layer 1012, a third layer 1013, wherein the second layer 1012 can be positioned intermediate the first layer 101 1 and the third layer 1013, and a fourth layer 1014, wherein the third layer 1013 can be positioned intermediate the second layer 1012 and the fourth layer 1014.
  • the bases 1022 of the staples 1020 can be positioned within cavities 1015 in the fourth layer 1014 and the staple legs 1021 can extend upwardly from the bases 1022 and through the fourth layer 1014, the third layer 1013, and the second layer 1012, for example.
  • Each deformable leg 1021 can comprise a tip, such as sharp tip 1023, for example, which can be positioned in the second layer 1012, for example, when the staple cartridge 1000 is in an uncompressed condition.
  • the tips 1023 may not extend into and/or through the first layer 101 1 , wherein, the tips 1023 may not protrude through the tissue-contacting surface 1019 when the staple cartridge 1000 is in an uncompressed condition.
  • the sharp tips 1023 may be positioned in the third layer 1013, and/or any other suitable layer, when the staple cartridge is in an uncompressed condition.
  • a cartridge body of a staple cartridge may have any suitable number of layers such as less than four layers or more than four layers, for example.
  • the first layer 101 1 can be comprised of a buttress material and/or plastic material, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example, and the second layer 1012 can be comprised of a bioabsorbable foam material and/or a compressible haemostatic material, such as oxidized regenerated cellulose (ORC), for example.
  • PDS polydioxanone
  • PGA polyglycolic acid
  • the second layer 1012 can be comprised of a bioabsorbable foam material and/or a compressible haemostatic material, such as oxidized regenerated cellulose (ORC), for example.
  • PDS polydioxanone
  • PGA polyglycolic acid
  • One or more of the first layer 101 1 , the second layer 1012, the third layer 1013, and the fourth layer 1014 may hold the staples 1020 within the staple cartridge body 1010 and, in addition, maintain the staples 1020 in alignment with one another.
  • the third layer 1013 can be comprised of a buttress material, or a fairly incompressible or inelastic material, which can be configured to hold the staple legs 1021 of the staples 1020 in position relative to one another. Furthermore, 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 though the second layer 1012 and the fourth layer 1014 can be comprised of a compressible foam or elastic material.
  • the staple tips 1023 of the staple legs 1021 can be at least partially embedded in the first layer 101 1.
  • the first layer 101 1 and the third layer 1013 can be configured to co-operatively and firmly hold the staple legs 1021 in position.
  • the first layer 101 1 and the third layer 1013 can each be comprised of a sheet 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), poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example, and the second layer 1012 and the fourth layer 1014 can each be comprised of at least one haemostatic material or agent.
  • PGA polyglycolic acid
  • Vicryl polylactic acid
  • PDS polydioxanone
  • PHA polyhydroxyalkanoate
  • PGCL poliglecaprone 25
  • PCL polycaprolactone
  • the second layer 1012 and the fourth layer 1014 can each be comprised of at least one hae
  • the second layer 1012 can be substantially more compressible than the first layer 101 1.
  • the second layer 1012 can be about twice as compressible, about three times as compressible, about four times as compressible, about five times as compressible, and/or about ten times as compressible, for example, as the first layer 101 1.
  • the second layer 1012 may compress about two times, about three times, about four times, about five times, and/or about ten times as much as first layer 101 1 , for a given force.
  • the second layer 1012 can be between about twice as compressible and about ten times as compressible, for example, as the first layer 101 1.
  • the second layer 1012 can comprise a plurality of air voids defined therein, wherein the amount and/or size of the air voids in the second layer 1012 can be controlled in order to provide a desired compressibility of the second layer 1012.
  • the third layer 1013 can be compressible
  • the fourth layer 1014 can be substantially more compressible than the third layer 1013.
  • the fourth layer 1014 can be about twice as compressible, about three times as compressible, about four times as compressible, about five times as compressible, and/or about ten times as compressible, for example, as the third layer 1013.
  • the fourth layer 1014 may compress about two times, about three times, about four times, about five times, and/or about ten times as much as third layer 1013, for a given force.
  • the fourth layer 1014 can be between about twice as compressible and about ten times as compressible, for example, as the third layer 1013.
  • the fourth layer 1014 can comprise a plurality of air voids defined therein, wherein the amount and/or size of the air voids in the fourth layer 1014 can be controlled in order to provide a desired compressibility of the fourth layer 1014.
  • the compressibility of a cartridge body, or cartridge body layer can be expressed in terms of a compression rate, i.e., a distance in which a layer is compressed for a given amount of force.
  • a compression rate i.e., a distance in which a layer is compressed for a given amount of force.
  • a layer having a high compression rate will compress a larger distance for a given amount of compressive force applied to the layer as compared to a layer having a lower compression rate.
  • the second layer 1012 can have a higher compression rate than the first layer 101 1 and, similarly, the fourth layer 1014 can have a higher compression rate than the third layer 1013.
  • the second layer 1012 and the fourth layer 1014 can be comprised of the same material and can comprise the same compression rate.
  • the second layer 1012 and the fourth layer 1014 can be comprised of materials having different compression rates.
  • the first layer 101 1 and the third layer 1013 can be comprised of the same material and can comprise the same compression rate.
  • the anvil 1040 As the anvil 1040 is moved toward its closed position, the anvil 1040 can contact 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 can push the top surface, or tissue-contacting surface 1019, of the cartridge body 1010 downwardly toward the staple cartridge support 1030.
  • the staple cartridge support 1030 can comprise a cartridge support surface 1031 which can be configured to support the staple cartridge 1000 as the staple cartridge 1000 is compressed between the cartridge support surface 1031 and the tissue-contacting surface 1041 of anvil 1040. Owing 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.
  • 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 101 1 of cartridge body 1010, pierce the tissue T, and enter into forming pockets 1042 in the anvil 1040.
  • the tips 1023 can contact the walls defining the forming pockets 1042 and, as a result, the legs 1021 can be deformed or curled inwardly, for example, as illustrated in FIG. 18C.
  • the bases 1022 of the staples 1020 can be in contact with or supported by the staple cartridge support 1030.
  • the staple cartridge support 1030 can comprise a plurality of support features, such as staple support grooves, slots, or troughs 1032, for example, which can be configured to support the staples 1020, or at least the bases 1022 of the staples 1020, as the staples 1020 are being deformed.
  • the cavities 1015 in the fourth layer 1014 can collapse as a result of the compressive force applied to the staple cartridge body 1010.
  • the staple cartridge body 1010 can further comprise one or more voids, such as voids 1016, for example, which may or may not comprise a portion of a staple positioned therein, that can be configured to allow the cartridge body 1010 to collapse.
  • the cavities 1015 and/or the voids 1016 can be configured to collapse such that the walls defining the cavities and/or walls deflect downwardly and contact the cartridge support surface 1031 and/or contact a layer of the cartridge body 1010 positioned underneath the cavities and/or voids.
  • FIG. 18B and FIG. 18C Upon comparing FIG. 18B and FIG. 18C, it is evident that the second layer 1012 and the fourth layer 1014 have been substantially compressed by the compressive pressure applied by the anvil 1040. It may also be noted that the first layer 101 1 and the third layer 1013 have been compressed as well. As the anvil 1040 is moved into its closed position, the anvil 1040 may continue to further compress the cartridge body 1010 by pushing the tissue-contacting surface 1019 downwardly toward the staple cartridge support 1030. As the cartridge body 1010 is further compressed, the anvil 1040 can deform the staples 1020 into their completely-formed shape as illustrated in FIG. 18D. Referring to FIG.
  • the legs 1021 of each staple 1020 can be deformed downwardly toward the base 1022 of each staple 1020 in order to capture at least a portion of the tissue T, the first layer 101 1 , the second layer 1012, the third layer 1013, and the fourth layer 1014 between the deformable legs 1021 and the base 1022.
  • FIGS. 18C and 18D it is further evident that the second layer 1012 and the fourth layer 1014 have been further substantially compressed by the compressive pressure applied by the anvil 1040. It may also be noted upon comparing FIGS. 18C and 18D that the first layer 101 1 and the third layer
  • the cartridge body 1010 can be implanted with the staples 1020.
  • the implanted cartridge body 1010 can support the tissue along the staple line.
  • a haemostatic agent, and/or any other suitable therapeutic medicament, contained within the implanted cartridge body 1010 can treat the tissue over time.
  • a haemostatic agent can reduce the bleeding of the stapled and/or incised tissue while a bonding agent or tissue adhesive can provide strength to the tissue over time.
  • the implanted cartridge body 1010 can be comprised of materials such as ORC (oxidized regenerated cellulose), extracellular proteins such as collagen, polyglycolic acid (PGA) which is marketed under the trade name Vicryl, poly lactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
  • the cartridge body 1010 can comprise an antibiotic and/or anti-mi crobial material, such as colloidal silver and/or triclosan, for example, which can reduce the possibility of infection in the surgical site.
  • the layers of the cartridge body 1010 can be connected to one another.
  • the second layer 1012 can be adhered to the first layer 101 1
  • the third layer 1013 can be adhered to the second layer 1012
  • the fourth layer 1014 can be adhered to the third layer 1013 utilizing at least one adhesive, such as fibrin and/or protein hydrogel, for example.
  • the layers of the cartridge body 1010 can be connected together by interlocking mechanical features.
  • the first layer 101 1 and the second layer 1012 can each comprise corresponding interlocking features, such as a tongue and groove arrangement and/or a dovetail joint arrangement, for example.
  • the second layer 1012 and the third layer 1013 can each comprise corresponding interlocking features while the third layer 1013 and the fourth layer
  • each staple cartridge 1000 can comprise one or more rivets, for example, which can extend through one or more layers of the cartridge body 1010.
  • each rivet can comprise a first end, or head, positioned adjacent to the first layer 101 1 and a second head positioned adjacent to the fourth layer 1014 which can be either assembled to or formed by a second end of the rivet.
  • the rivets can compress the cartridge body 1010 such that the heads of the rivets can be recessed relative to the tissue- contacting surface 1019 and/or the bottom surface 1018 of the cartridge body 1010, for example.
  • the rivets can be comprised of a bioabsorbable material, such as polyglycolic acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
  • the layers of the cartridge body 1010 may not be connected to one another other than by the staples 1020 contained therein.
  • the frictional engagement between the staple legs 1021 and the cartridge body 1010 can hold the layers of the cartridge body 1010 together 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 can comprise a roughened surface or rough coating which can increase the friction forces between the staples 1020 and the cartridge body 1010.
  • a surgical instrument can comprise a first jaw including the staple cartridge support 1030 and a second jaw including the anvil 1040.
  • the staple cartridge 1000 can comprise one or more retention features which can be configured to engage the staple cartridge support 1030 and, as a result, releasably retain the staple cartridge 1000 to the staple cartridge support 1030.
  • the staple cartridge 1000 can be adhered to the staple cartridge support 1030 by at least one adhesive, such as fibrin and/or protein hydrogel, for example.
  • the second jaw can be moved into a closed position opposite the first jaw, for example, such that the first and second jaws can be inserted through a trocar into a surgical site.
  • the trocar can define an approximately 5mm aperture, or cannula, through which the first and second jaws can be inserted.
  • the second jaw can be moved into a partially-closed position intermediate the open position and the closed position which can allow the first and second jaws to be inserted through the trocar without deforming the staples 1020 contained in the staple cartridge body 1010.
  • the anvil 1040 may not apply a compressive force to the staple cartridge body 1010 when the second jaw is in its partially-closed intermediate position while, alternatively, the anvil 1040 can compress the staple cartridge body 1010 when the second jaw is in its partially-closed intermediate position.
  • 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 into contact with the staples 1020 and/or such that the staples 1020 are deformed by the anvil 1040.
  • the second jaw can be opened once again and the anvil 1040 and the staple cartridge 1000 can be positioned relative to the targeted tissue as described above.
  • an end effector of a surgical stapler can comprise an implantable staple cartridge 1 100 positioned intermediate an anvil 1 140 and a staple cartridge support 1 130.
  • the anvil 1 140 can comprise a tissue-contacting surface 1 141
  • the staple cartridge 1 100 can comprise a tissue-contacting surface 1 1 19
  • the staple cartridge support 1 130 can comprise a support surface 1 131 which can be configured to support the staple cartridge 1 100.
  • the anvil 1 140 can be utilized to position the tissue T against the tissue contacting surface 1 1 19 of staple cartridge 1 100 without deforming the staple cartridge 1 100 and, when the anvil 1 140 is in such a position, the tissue-contacting surface 1 141 can be positioned a distance 1 101a away from the staple cartridge support surface 1 131 and the tissue-contacting surface 1 1 19 can be positioned a distance 1 102a away from the staple cartridge support surface 1 131. Thereafter, as the anvil 1 140 is moved toward the staple cartridge support 1 130, referring now to FIG. 19B, the anvil 1 140 can push the top surface, or tissue-contacting surface 1 1 19, of staple cartridge 1 100 downwardly and compress the first layer 1 1 1 1 and the second layer 1 1 12 of cartridge body 1 1 10.
  • the second layer 1 1 12 can be crushed and the legs 1 121 of staples 1 120 can pierce the first layer 1 1 1 1 and enter into the tissue T.
  • the staples 1 120 can be at least partially positioned within staple cavities, or voids, 1 1 1 15 in the second layer 1 1 12 and, when the second layer 1 1 12 is compressed, the staple cavities 1 1 15 can collapse and, as a result, allow the second layer 1 1 12 to collapse around the staples 1 120.
  • the second layer 1 1 12 can comprise cover portions 1 1 16 which can extend over the staple cavities 1 1 15 and enclose, or at least partially enclose, the staple cavities 1 1 15. FIG.
  • the second layer 1 1 12 can comprise one or more weakened portions which can facilitate the collapse of the second layer 1 1 12.
  • Such weakened portions can comprise score marks, perforations, and/or thin cross-sections, for example, which can facilitate a controlled collapse of the cartridge body 1 1 10.
  • the first layer 1 1 1 1 can comprise one or more weakened portions which can facilitate the penetration of the staple legs 1 121 through the first layer 1 1 1 1.
  • Such weakened portions can comprise score marks, perforations, and/or thin cross-sections, for example, which can be aligned, or at least substantially aligned, with the staple legs 1 121.
  • the anvil 1 140 When the anvil 1 140 is in a partially closed, unfired position, referring again to FIG. 19A, the anvil 1 140 can be positioned a distance 1 101a away from the cartridge support surface 1 131 such that a gap is defined therebetween. This gap can be filled by the staple cartridge 1 100, having a staple cartridge height 1 102a, and the tissue T. As the anvil 1 140 is moved downwardly to compress the staple cartridge 1 100, referring again to FIG. 19B, the distance between the tissue contacting surface 1 141 and the cartridge support surface 1 131 can be defined by a distance 1 101b which is shorter than the distance 1 101 a.
  • the gap between the tissue-contacting surface 1 141 of anvil 1 140 and the cartridge support surface 1 131 may be larger than the original, unde formed staple cartridge height 1 102a.
  • the second layer 1 1 12 can continue to collapse and the distance between the staple legs 1 121 and the forming pockets 1 142 can decrease.
  • the distance between the tissue- contacting surface 1 141 and the cartridge support surface 1 131 can decrease to a distance 1 101c which may be greater than, equal to, or less than the original, undeformed cartridge height 1 102a.
  • the anvil 1 140 can be moved into a final, fired position in which the staples 1 120 have been fully formed, or at least formed to a desired height.
  • the tissue-contacting surface 1 141 of anvil 1 140 can be a distance 1 l Old away from the cartridge support surface 1 131 , wherein the distance 1 101 d can be shorter than the original, undeformed cartridge height 1 102a.
  • the staple cavities 1 1 15 may be fully, or at least substantially, collapsed and the staples 1 120 may be completely, or at least substantially, surrounded by the collapsed second layer 1 1 12. In various circumstances, the anvil 1 140 can be thereafter moved away from the staple cartridge 1 100.
  • the cartridge body 1 1 10 can at least partially re- expand in various locations, i.e., locations intermediate adjacent staples 1 120, for example.
  • the crushed cartridge body 1 1 10 may not resiliently re-expand.
  • the formed staples 1 120 and, in addition, the cartridge body 1 1 10 positioned intermediate adjacent staples 1 120 may apply pressure, or compressive forces, to the tissue T which may provide various therapeutic benefits.
  • each staple 1 120 can comprise staple legs 1 121 extending therefrom.
  • staples 1 120 are depicted as comprising two staple legs 1 121 , various staples can be utilized which can comprise one staple leg or, alternatively, more than two staple legs, such as three staple legs or four staple legs, for example.
  • each staple leg 1 121 can be embedded in the second layer 1 1 12 of the cartridge body 1 1 10 such that the staples 1 120 are secured within the second layer 1 1 12.
  • the staples 1 120 can be inserted into the staple cavities 1 1 15 in cartridge body 1 1 10 such that the tips 1 123 of the staple legs 1 121 enter into the cavities 1 1 15 before the bases 1 122.
  • the tips 1 123 can be pressed into the cover portions 1 1 16 and incise the second layer 1 1 12.
  • the staples 1 120 can be seated to a sufficient depth within the second layer 1 1 12 such that the staples 1 120 do not move, or at least substantially move, relative to the second layer 1 1 12.
  • the staples 1 120 can be seated to a sufficient depth within the second layer 1 1 12 such that the bases 1 122 are positioned or embedded within the staple cavities 1 1 15.
  • the bases 1 122 may not be positioned or embedded within the second layer 1 1 12. Referring again to FIG. 19 A, the bases 1 122 may extend below the bottom surface 1 1 18 of the cartridge body 1 1 10.
  • the bases 1 122 can rest on, or can be directly positioned against, the cartridge support surface 1 130.
  • the cartridge support surface 1 130 can comprise support features extending therefrom and/or defined therein wherein, for example, the bases 1 122 of the staples 1 120 may be positioned within and supported by one or more support grooves, slots, or troughs, 1 132, for example, in the staple cartridge support 1 130, as described in greater detail further below.
  • the bases 1 122 of the staples 1 120 can be positioned directly against the support surface 1 131 of staple cartridge support 1 130.
  • the staple bases 1 122 comprise circular or arcuate bottom surfaces 1 124, for example, the staple bases 1 122 may move or slide along the staple cartridge support surface 1 131. Such sliding can occur when the anvil 1 140 is pressed against the tips 1 123 of the staple legs 1 121 during the staple forming process.
  • the staple cartridge support 1 130 can comprise one or more support slots 1 132 therein which can be configured to eliminate, or at least reduce, the relative movement between the staple bases 1 122 and the cartridge support surface 1 131.
  • each support slot 1 132 can be defined by a surface contour which matches, or at least substantially matches, the contour of the bottom surface of the staple positioned therein.
  • the bottom surface 1 124 of the base 1 122 depicted in FIG. 21 can comprise a circular, or at least substantially circular, surface and the support slot 1 132 can also comprise a circular, or at least substantially circular, surface.
  • the surface defining the slot 1 132 can be defined by a radius of curvature which is greater than or equal to a radius of curvature which defines bottom surface 1 124.
  • the slots 1 132 may assist in preventing or reducing relative sliding movement between the staples 1 120 and the staple cartridge support 1 130, the slots 1 132 may also be configured to prevent or reduce relative rotational movement between the staples 1 120 and the staple cartridge support 1 130. More particularly, the slots 1 132 can be configured to closely receive the bases 1 122 in order to prevent or reduce the rotation of the staples 1 120 about axes 1 129, for example, such that the staples 1 120 do not rotate or twist when they are being deformed.
  • each staple 1 120 can be formed from a round, or an 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.
  • the staple cartridge support 1 130 can comprise corresponding non-circular slots, such as rectangular slots, for example, configured to receive the bases of such staples.
  • each staple 1 120 can comprise a crown, such as a crown 1 125, for example, overmolded onto a base 1 122 wherein each crown 1 125 can be positioned within a support slot in the staple cartridge support 1 130.
  • each crown 1 125 can comprise a square and/or rectangular cross-section, for example, which can be configured to be received within square and/or rectangular slots 1 134, for example, in the staple cartridge support 1 130.
  • the crowns 1 125 can be comprised of a bioabsorbable plastic, such as polyglycolic acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
  • PHA polyhydroxyalkanoate
  • PGCL poliglecaprone 25
  • PCL polycaprolactone
  • PGA polyhydroxyalkanoate
  • PLA polyhydroxyalkanoate
  • PDS polycaprolactone
  • PHA polycaprolactone
  • PCL polycaprolactone
  • the slots 1 134 can further comprise lead-ins, or bevels, 1 135 which can be configured to facilitate the insertion of the crowns 1 125 into the slots 1 134.
  • the bases and/or crowns of the staples 1 120 may be positioned within the slots 1 134 when the staple cartridge 1 100 is assembled to the staple cartridge support 1 130.
  • the crowns 1 125 of the staples 1 120 may be aligned with the slots 1 134 when the staple cartridge 1 100 is assembled to the staple cartridge support 1 130. For example, the crowns 1 125 may not enter into the slots 1 134 until a compressive force is applied to the staple legs 1 121 and the bases and/or crowns of the staples 1 120 are pushed downwardly into the slots 1 134.
  • a staple cartridge such as staple cartridge 1200, for example, can comprise a compressible, implantable cartridge body 1210 comprising an outer layer 121 1 and an inner layer 1212. Similar to the above, the staple cartridge 1200 can comprise a plurality of staples 1220 positioned within the cartridge body 1210. Each staple 1220 can 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 seated to a depth in which the bases 1222 of the staples 1220 abut and/or are positioned adjacent to the bottom surface 1218 of the inner layer 1212, for example. In FIGS.
  • the inner layer 1212 does not comprise staple cavities configured to receive a portion of the staples 1220 while, as an alternative, the inner layer 1212 can comprise such staple cavities.
  • 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 collapse when a compressive load is applied thereto.
  • the inner layer 1212 can be comprised of a lyophilized foam comprising polylactic acid (PLA) and/or polyglycolic acid (PGA), for example.
  • the ORC may be commercially available under the trade name Surgicel and can comprise a loose woven fabric (like a surgical sponge), loose fibers (like a cotton ball), and/or a foam
  • the inner layer 1212 can be comprised of a material including medicaments, such as freeze-dried thrombin and/or fibrin, for example, contained therein and/or coated thereon which can be water-activated and/or activated by fluids within the patient's body, for example.
  • the freeze-dried thrombin and/or fibrin can be held on a Vicryl (PGA) matrix, for example.
  • PGA Vicryl
  • the activatable medicaments can be unintentionally activated when the staple cartridge 1200 is inserted into a surgical site within the patient, for example.
  • the outer layer 121 1 can be comprised of a water impermeable, or at least substantially water impermeable, material such that liquids do not come into contact with, or at least substantially contact, the inner layer 1212 until after the cartridge body 1210 has been compressed and the staple legs have penetrated the outer layer 121 1 and/or after the outer layer 121 1 has been incised in some fashion.
  • the outer layer 121 1 can be comprised of a buttress material and/or plastic material, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example.
  • PDS polydioxanone
  • PGA polyglycolic acid
  • the outer layer 121 1 can comprise a wrap which surrounds the inner layer 1212 and the staples 1220. More particularly, the staples 1220 can be inserted into the inner layer 1212 and the outer layer 121 1 can be wrapped around the subassembly comprising the inner layer 1212 and the staples 1220 and then sealed.
  • a staple cartridge such as staple cartridge 1300, for example, can comprise a compressible, implantable cartridge body 1310 including an outer layer
  • the staple cartridge 1300 can further comprise staples 1320 positioned within the cartridge body 1310 wherein each staple 1320 can comprise a base 1322 and one or more legs 1321 extending therefrom. Similar to staple cartridge 1200, the bases 1322 of staples 1320 can extend below the bottom surface 1318 of the inner layer
  • the outer layer 131 1 can be sufficiently flexible so as to envelop each staple base 1322 such that the outer layer 131 1 conforms to the contour of the bases 1322.
  • the outer layer 121 1 can be sufficiently rigid such that it extends around the bases 1222 without conforming to each base 1222.
  • the outer layer 131 1 can be positioned intermediate the bases 1322 of staples 1320 and a staple cartridge support surface, such as support surfaces 1031 or 1 131 , for example, supporting the staple cartridge 1300.
  • the outer layer 131 1 can be positioned intermediate the bases 1322 and support slots, such as slots 1032 or 1 132, for example, defined in the staple cartridge support surface.
  • the outer layer 131 1 can be configured to limit the movement of the bases 1322 and/or increase the coefficient of friction between the bases 1322 and the staple cartridge support surface and/or support slots in order to reduce relative movement therebetween.
  • the outer layer of a staple cartridge such as staple cartridge 1400, for example, may not entirely surround the staples positioned therein.
  • an outer layer 141 1 of a compressible, implantable cartridge body 1410 may be assembled to the inner layer 1412 before the staple legs 1421 of staples 1420 are inserted into the cartridge body 1410.
  • the bases 1422 of staples 1420 may extend outside of the outer layer 141 1 and, for example, the bases 1422 may be positioned directly into the support slots 1032 or 1 132 within the staple cartridge support surfaces 1031 or 1 131 , for example.
  • the staple legs 1421 may incise the outer layer 141 1 when they are inserted therethrough.
  • the holes created by the staple legs 1421 may closely surround the staple legs 1421 such that very little, if any, fluid can leak between the staple legs 1421 and the outer layer 141 1 which can reduce the possibility of, or prevent, the medicament contained within the staple cartridge body 1410 from being activated and/or leaking out of the cartridge body 1410 prematurely.
  • the legs 1221 of the staples 1220 can be embedded within the cartridge body 1210 and the bases 1222 of staples 1220 may extend outwardly from the bottom surface 1218 of the inner layer 1212. Further to the above , the inner layer 1212 may not comprise staple cavities configured to receive the staples 1220.
  • a staple cartridge such as staple cartridge 1500, for example, may comprise a compressible, implantable cartridge body 1510 comprising staple cavities 1515 which can be configured to receive at least a portion of the staples 1520 therein.
  • a top portion of the staple legs 1521 of the staples 1520 may be embedded in the inner layer 1512 while a bottom portion of the staple legs 1521 , and the bases 1522, may be positioned within the staple cavities 1515.
  • the bases 1522 may be entirely positioned in the staple cavities 1515 while, the bases 1522 may at least partially extend below the bottom surface 1518 of the inner layer 1512.
  • a staple cartridge 1600 may comprise staples 1620 positioned within staple cavities 1615 in a compressible, implantable cartridge body 1610 wherein at least a portion of the staples 1620 are not enclosed by the outer layer 161 1.
  • each staple 1620 can comprise staple legs 1621 which are at least partially embedded in the inner layer 1612 and, in addition, bases 1622 which extend outwardly around the outer layer 161 1.
  • a staple cartridge such as staple cartridge 1700, for example, can comprise a compressible, implantable cartridge body 1710 and a plurality of staples 1720 at least partially positioned within the cartridge body 1710.
  • the cartridge body 1710 can comprise an outer layer 171 1 , an inner layer 1712, and, in addition, an alignment matrix 1740 which can be configured to align and/or retain the staples 1720 in position within the cartridge body 1710.
  • the inner layer 1712 can comprise a recess 1741 which can be configured to receive the alignment matrix 1740 therein.
  • the alignment matrix 1 140 can be press-fit within the recess 1741 and/or otherwise suitably secured to the inner layer 1712 utilizing at least one adhesive, such as fibrin and/or protein hydrogel, for example.
  • the recess 1741 can be configured such that the bottom surface 1742 of alignment matrix 1740 is aligned, or at least substantially aligned, with the bottom surface 1718 of the inner layer 1712.
  • the bottom surface 1742 of the alignment matrix can be recessed with respect to and/or extend from the bottom 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 matrix 1740.
  • the alignment matrix 1740 can further comprise a plurality of apertures and/or slots, for example, extending therethrough which can be configured to receive the staple legs 1721 therein.
  • each aperture can be configured to closely receive a staple leg 1721 such that there is little, if any, relative movement between the staple leg
  • the alignment matrix apertures may not extend entirely through the alignment matrix 1740 and the staple legs 1721 may be required to incise the alignment matrix 1740 as the staple legs 1721 are pushed therethrough.
  • the alignment matrix 1740 can be comprised of a molded plastic body which can be stiffer or less compressible than the inner layer 1712 and/or the outer layer 171 1.
  • the alignment matrix 1740 can be comprised of a plastic material and/or any other suitable material, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example.
  • PDS polydioxanone
  • PGA polyglycolic acid
  • the alignment matrix 1740 can be assembled to the inner layer 1712 and the staple legs 1721 can thereafter be inserted through the alignment matrix 1740 and embedded into the inner layer 1712.
  • the bottom surface 1742 of the alignment matrix 1740 can comprise one or more grooves, slots, or troughs, for example, which can be configured to at least partially receive the bases
  • the outer layer 171 1 can then be placed around the subassembly comprising the inner layer 1712, the alignment matrix 1740, and the staples
  • the outer layer 171 1 can be placed around a subassembly comprising the inner layer 1712 and the alignment matrix 1740 wherein the staples 1720 can be thereafter inserted through the outer layer 171 1 , the alignment matrix 1740, and the inner layer 1712.
  • the inner layer 1712, the alignment matrix 1740, and/or the outer layer 171 1 can be configured to retain the staples 1720 in position until and/or after they are deformed by an anvil as described above.
  • the alignment matrix 1740 can serve to hold the staples 1720 in place before the staple cartridge 1700 is implanted within a patient and, in addition, secure the tissue along the staple line after the staple cartridge 1700 has been implanted.
  • the staples 1720 may be secured within the alignment matrix 1740 without being embedded in the inner layer 1712 and/or the outer layer 171 1 , for example.
  • a staple cartridge such as staple cartridge 1800, for example, can be assembled by compressing an inner layer 1812, inserting staples, such as staples 1820, for example, into the inner layer 1812, and wrapping the inner layer 1812 with an outer layer 181 1.
  • a compressible inner layer 1812 is illustrated as comprising a plurality of staple cavities 1815 defined therein, although other embodiments are envisioned in which the inner layer 1812 does not comprise staple cavities, as described above.
  • the compressible inner layer 1812 can be positioned intermediate a transfer plate 1850 and a support plate 1860 and compressed between the compression surfaces
  • the top and bottom surfaces of the inner layer 1812 can be compressed toward one another and, in response thereto, the inner layer 1812 can bulge outwardly in the lateral directions.
  • the inner layer 1812 can be compressed to a height which is approximately one -third of its original height, for example, and can have a height or thickness between approximately 0.06" and approximately 0.08" in its compressed state, for example.
  • the transfer plate 1850 can further comprise a plurality of staples, such as staples 1820, for example, positioned within a plurality of staple wells 1853.
  • the transfer plate 1850 can further comprise a plurality of drivers 1851 which can be configured to push the staples 1820 upwardly and out of the staple wells 1853.
  • the drivers 1851 can be utilized to push the staple legs 1821 of the staples 1820 into and through the compressed inner layer 1812.
  • the drivers 1851 can be configured such that the top surfaces thereof are positioned flush, or at least nearly flush, with the compression surface 1852 of the transfer plate 1850 when the staples 1820 have been fully deployed from the staple wells
  • the support plate 1860 can comprise a plurality of receiving apertures 1861 which can be configured to receive the staple legs 1821 , or at least the tips of the staple legs 1821 , after they are pushed through the inner layer 1812.
  • the receiving apertures 1861 may be necessitated where the inner layer 1812 has been compressed to a height which is shorter than the height of the staples 1820 and, thus, when the staples 1820 have been fully ejected from the staple wells 1853, the staple legs 1821 may protrude from the top surface of the compressed inner layer 1812.
  • the inner layer 1812 may be compressed to a height which is taller than the height of the staples 1820 and, as a result, the receiving apertures 1861 in support plate 1860 may be unnecessary.
  • the support plate 1860 can be moved away from the transfer plate 1850 in order to allow the inner layer 1812 to decompress.
  • the inner layer 1812 can resiliently re- expand to its original, or at least near-original, uncompressed height.
  • the height of the inner layer 1812 can 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 top surface of the inner layer 1812.
  • the receiving apertures 1861 can be configured to hold the staple legs 1821 in position at least until the support plate 1860 has been sufficiently moved away such that the legs 1821 are no longer positioned within the receiving apertures 1861. In such circumstances, the receiving apertures 1861 can assist in maintaining the relative alignment of the staples 1820 within the inner layer 1812 as it re-expands.
  • the inner layer 1812 and the staples 1820 positioned therein can comprise a subassembly 1801 which, referring now to FIG. 38, can be inserted into an outer layer 181 1 , for example.
  • the outer layer 181 1 can comprise a cavity 1802 defined therein which can be configured to receive the subassembly 1801 therein.
  • a tool such as pliers 1855, for example, can be utilized to pull the outer layer 181 1 onto the subassembly 1801.
  • the outer layer 181 1 can be sealed.
  • the outer layer 181 1 can be sealed utilizing the application of heat energy to a portion thereof.
  • the outer layer 181 1 can be comprised of a plastic material wherein the open end of the outer layer 181 1 can be heat-staked by one or more heated elements, or irons, 1856 in order to bond and/or seal the perimeter of the open end of the outer layer 181 1 together.
  • heated elements or irons
  • a staple cartridge can be positioned within and/or secured to a staple cartridge attachment portion.
  • a staple cartridge attachment portion can comprise a staple cartridge channel, such as 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, therein.
  • the staple cartridge channel 1930 can comprise a bottom support surface 1931 , a first lateral support wall 1940, and a second lateral support wall 1941.
  • the staple cartridge 1900 can be positioned within the staple cartridge channel 1930 such that the staple cartridge 1900 is positioned against and/or adjacent to the bottom support surface 1931 and positioned intermediate the first lateral support wall 1940 and the second lateral support wall 1941.
  • the first lateral support wall 1940 and the second lateral support wall 1941 can define a lateral gap therebetween.
  • the staple cartridge 1900 can comprise a lateral width 1903 which is the same as and/or wider than the lateral gap defined between the support walls 1940 and 1941 such that a compressible, implantable cartridge body 1910 of the staple cartridge 1900 can fit securely between the walls 1940 and 1941.
  • the lateral width 1903 of the staple cartridge 1900 can be shorter than the gap defined between the first and second side walls 1940 and 1941.
  • the walls 1940 and 1941 and the bottom support surface 1931 can be defined by a stamped metal channel while, at least a portion of the lateral support wall 1940 and/or lateral support wall 1941 can be comprised of a flexible material, such as an elastomeric material, for example.
  • the first side wall 1940 and the second side wall 1941 of the staple cartridge channel 1930 can each be comprised of a rigid portion 1933 extending upwardly from the bottom support surface 1931 and a flexible portion 1934 extending upwardly from the rigid portions 1933.
  • the cartridge body 1910 of staple cartridge 1900 can be comprised of one or more compressible layers, such as first layer 191 1 and second layer 1912, for example.
  • first layer 191 1 and second layer 1912 for example.
  • the side portions of the cartridge body 1910 can expand laterally.
  • the staple cartridge 1930 is comprised of 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 stress, can be developed within the cartridge body 1910.
  • the flexible side walls can be configured to flex laterally and permit the side portions of the cartridge body 1910 to expand laterally, thereby reducing the internal pressure, or stress, generated within the cartridge body 1910.
  • the cartridge channel does not comprise lateral side walls, or comprises lateral sidewalls which are relatively shorter than the staple cartridge, the side portions of the staple cartridge may expand laterally uninhibited, or at least substantially uninhibited.
  • a staple cartridge channel 2030 can comprise lateral sidewalls 2040 and 2041 which can be entirely comprised of a flexible material, such as an elastomeric material, for example.
  • the staple cartridge channel 2030 can further comprise lateral slots 2033 extending along the sides of the bottom support surface 2031 of the staple cartridge channel 2030 which can be configured to receive and secure at least a portion of the lateral sidewalls 2040 and 2041 therein.
  • the lateral side walls 2040 and 2041 can be secured in the slots 2033 via a snap-fit and/or press-fit arrangement, or the lateral side walls 2040 and 2041 can be secured in the slots 2033 by one or more adhesives.
  • the sidewalls 2040 and 2041 may be detachable from the bottom support surface 2031 during use. In any event, a compressible, implantable cartridge body 2010 can be detached and/or disengaged from the lateral side walls 2040 and 2041 when the cartridge body 2010 is implanted with the staples 2020.
  • a surgical instrument can comprise a shaft 2150 and an end effector extending from the distal end of the shaft 2150.
  • the end effector can comprise, similar to the above, a staple cartridge channel 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.
  • the staple cartridge 2100 can comprise a compressible, implantable cartridge body 21 10 and a plurality of staples 2120 positioned in the cartridge body 21 10.
  • the staple cartridge channel 2130 can comprise, one, a bottom support surface 2131 against which the staple cartridge 2100 can be positioned, two, a distal end 2135 and, three, a proximal end 2136.
  • the staple cartridge 2100 can comprise a first end 2105 which can be positionable in the distal end 2135 of the staple cartridge channel 2130 and a second end 2106 which can be positionable in the proximal end 2136 of the staple cartridge channel 2130.
  • the distal end 2135 of the staple cartridge channel 2130 can comprise at least one distal retention feature, such as a retention wall 2137, for example, and, similarly, the proximal end 2136 can comprise at least one proximal retention feature, such as a retention wall 2138, for example.
  • the distal retention wall 2137 and the proximal retention wall 2138 can define a gap therebetween which can be equal to or less than the length of the staple cartridge 2100 such that the staple cartridge 2100 can fit securely within the staple cartridge channel 2130 when the staple cartridge 2100 is inserted therein.
  • a staple cartridge such as staple cartridge 1200, for example, can comprise a flat, or at least substantially flat, tissue-contacting surface 1219.
  • the staple cartridge body 1210 of staple cartridge 1200 can comprise a first end 1205 which can be defined by a first height, or thickness, 1207 and a second end 1206 which can be defined by a second height, or thickness, 1208, wherein the first height 1207 can be equal to, or at least substantially equal to, the second height 1208.
  • the cartridge body 1210 can comprise a constant, or at least substantially constant, height, or thickness, between the first end 1205 and the second end 1206.
  • the tissue-contacting surface 1219 can be parallel, or at least substantially parallel, to the bottom surface 1218 of the cartridge body 1210.
  • the first end 2105 of the cartridge body 21 10 of staple cartridge 2100 can be defined by a first height 2107 which is different than a second height 2108 of the second end 2106.
  • the first height 2107 is larger than the second height 2108, although the second height 2108 could be larger than the first height 2107 in alternative embodiments.
  • the height of the cartridge body 21 10 can decrease linearly and/or geometrically between the first end 2105 and the second end 2106.
  • the tissue-contacting surface 21 19, which extends between the first end 2105 and the second end 2106 can be oriented along an angle defined therebetween.
  • the tissue-contacting surface 21 19 may not be parallel to the bottom surface 21 18 of the cartridge body 21 10 and/or parallel to the support surface 2131 of the staple cartridge channel 2130.
  • the anvil 2140 can comprise a tissue-contacting surface 2141 which can 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 FIG. 44.
  • the anvil 2140 can be configured to compress the first end 2105 of the staple cartridge 2100 more than the second end 2106 owing to the taller height of the first end 2105 and the shorter height of the second end 2106.
  • the pressure generated within the tissue T and the cartridge 2100 can be greater at the distal end of the end effector than the proximal 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, 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 more compressed than the tissue T positioned intermediate the proximal end 2146 of the anvil 2140 and the second end 2106 of the staple cartridge 2100.
  • a pressure gradient can be generated within the 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 can decrease linearly from the distal end of the end effector 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.
  • the tissue T positioned intermediate the staple cartridge 2100 and the anvil 2140 may not have a constant thickness throughout. In at least one such
  • the tissue T positioned between the proximal end 2146 of the anvil 2140 and the second end 2106 of the staple cartridge 2100 may 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.
  • the thicker tissue T may be generally positioned above the shorter proximal end 2106 of the staple cartridge 2100 and the thinner tissue T may be generally positioned above the taller distal end 2105.
  • the firing collar 2152 of the shaft 2150 can be advanced distally along the shaft spine 2151 such that the firing collar 2152 engages the cam portion 2143 of the anvil 2140 and rotates the anvil 2140 toward the staple cartridge 2100 as illustrated in FIG. 44.
  • the tissue T may be compressed between the tissue-contacting surfaces 21 19 and 2141 and, even though the height of the staple cartridge 2100 may not be constant between the proximal and distal ends of the end effector, the pressure or compressive forces applied to the tissue T may be constant, or at least substantially constant, thereacross.
  • the cumulative, or summed, height 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, thereacross.
  • the staple cartridge 2100 can comprise an
  • the height of the staple cartridge 2100 at the first end 2105 thereof may be higher than the height of the staple cartridge 2100 at the second end 2106 thereof.
  • the staple cartridge 2100 and/or the staple cartridge channel 2130 can comprise one or more alignment and/or retention features which can be configured to assure that the staple cartridge 2100 can only be positioned within the staple cartridge channel 2130 in one orientation, i.e., an orientation in which the first end 2105 is positioned in the distal end 2135 of the staple cartridge channel 2130 and the second end 2106 is positioned in the proximal end 2136.
  • the staple cartridge 2100 and/or the staple cartridge channel 2130 can comprise one or more alignment and/or retention features which can be configured to permit the staple cartridge 2100 to be positioned within the staple cartridge channel 2130 in more than one orientation.
  • 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 in the proximal end 2136 of the staple cartridge channel 2130 and the second end 2106 can be positioned in the distal end 2135.
  • the shorter height of the staple cartridge 2100 can be positioned proximate the distal retention wall 2137 and the taller height of the staple cartridge 2100 can be positioned proximate to the proximal retention wall 2138.
  • the staple cartridge 2100 can be suitably arranged to apply a constant, or at least substantially constant, clamping pressure to tissue T having a thicker portion within the distal end of the end effector and a thinner portion within the proximal end of the end effector.
  • the staple cartridge 2100 can be selectively oriented within the staple cartridge channel 2130.
  • the alignment and/or retention features of the staple cartridge 2100 can be symmetrical and a surgeon can selectively orient the staple cartridge 2100 within the staple cartridge channel 2130 in the orientations depicted in FIG. 43 and FIG. 45, for example.
  • the implantable cartridge body 21 10 can comprise a longitudinal axis 2109 which, when the staple cartridge 2100 is positioned in the staple cartridge channel 2130, can extend between the proximal and distal ends of the end effector.
  • the thickness of the cartridge body 21 10 can generally decrease and/or generally increase between the first end 2105 and the second end 2106 along the longitudinal axis 2109.
  • the distance, or height, between the bottom surface 21 18 and the tissue-contacting surface 21 19 can generally decrease and/or generally increase between the first end 2105 and the second end 2106.
  • the thickness of the cartridge body 21 10 can both increase and decrease along the longitudinal axis 2109.
  • the thickness of the cartridge body 21 10 can comprise one or more portions which increase in thickness and one or more portions which can decrease in thickness.
  • the staple cartridge 2100 can comprise a plurality of staples 2120 positioned therein. In use, as described above, the staples 2120 can be deformed when the anvil 2140 is moved into a closed position. Each staple 2120 can have the same, or at least substantially the same, height. 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 tallest leg of the staple, for example.
  • a staple cartridge can comprise a first group of staples having a first staple height which are positioned in a first portion of a compressible cartridge body and a second group of staples having a second staple height which are positioned in a second portion of the compressible cartridge body.
  • the first staple height can be taller than the second staple height and the first group of staples can be positioned in the first end 2105 of the staple cartridge 2100 while the second group of staples can be positioned in the second end 2106.
  • the taller first group of staples can be positioned in the second end 2106 of the staple cartridge 2100 while the shorter second group of staples can be positioned in the first end 2105.
  • a plurality of staple groups each group having a different staple height, can be utilized.
  • a third group having an intermediate staple height can be positioned in the cartridge body 21 10 intermediate the first group of staples and the second group of staples.
  • Each staple within a staple row in the staple cartridge can comprise a different staple height.
  • the tallest staple within a staple row can be positioned on a first end of a staple row and the shortest staple can be positioned on an opposite end of the staple row.
  • the staples positioned intermediate the tallest staple and the shortest staple can be arranged such that the staple heights descend between the tallest staple and the shortest staple, for example.
  • an end effector of a surgical stapler can 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 can 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 can comprise a cartridge support surface 2231 and a plurality of staple support slots, such as support slots 2232a and 2232b, for example, defined therein.
  • the staple cartridge 2200 can comprise two outer rows of staples 2220a and two inner rows of staples 2220b, wherein the support slots 2232a can be configured to support the staples 2220a and the support slots 2232b can be configured to support the staples 2220b.
  • the anvil 2240 can comprise a plurality of staple forming pockets 2242 defined therein which can be configured to receive and deform the staples 2220a and 2220b when the anvil 2240 is moved toward the staple cartridge 2200.
  • the bottom surfaces of the support slots 2232a can be a first distance 2201a away from the top surfaces of the staple forming pockets 2242 while the bottom surfaces of the support slots 2232b can be a second distance 2201b away from the top surfaces of the staple forming pockets 2242.
  • the support slots 2232b are positioned closer to the anvil 2240 owing to the raised step in the support surface 2231 in which they are defined. Owing to the different distances 2201a and 2201b, the outer rows of staples 2220a and the inner rows of staples 2220b can be deformed to different formed heights. In various circumstances, staples deformed to different formed heights can apply different clamping pressures or forces to the tissue T being stapled.
  • the staples can begin with different unformed staple heights.
  • the outer staples 2220a can have an initial, unformed height which is greater than the initial, unformed height of the inner staples 2220b.
  • the inner staples 2220b which have a shorter unformed height than the outer staples 2220a, can also have a shorter formed height than the outer staples 2220b.
  • the inner staples 2220b may have a taller unformed height than the outer staples 2220a yet have a shorter deformed staple height than the outer staples 2220a.
  • the anvil 2240 can be moved into a closed position, as illustrated in FIG. 47, in order to compress the cartridge body 2210 and deform the staples 2220a and 2220b.
  • a surgical stapler comprising the end effector depicted in FIGS 46 and 47, for example, can further comprise a cutting member which can be configured to transect the tissue T positioned intermediate the anvil 2240 and the staple cartridge 2200.
  • the anvil 2240, the staple cartridge channel 2230 and/or the staple cartridge 2200 can define a slot configured to slidably receive a cutting member therein.
  • the anvil 2240 can comprise a slot portion 2249
  • the staple cartridge channel 2230 can comprise a slot portion 2239
  • the staple cartridge 2200 can comprise a slot portion 2203 which can be aligned, or at least substantially aligned, with one another 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 toward 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 be moved independently of the staple deformation process.
  • the cutting member can be advanced at the same time that the staples are being deformed. In any event, the cutting member can be configured to incise the tissue along a path positioned intermediate the inner rows of staples 2220b.
  • the inner staples 2220b can be formed to a shorter height than the outer staples 2220a wherein the inner staples 2220b can apply a larger clamping pressure or force to the tissue adjacent to the cut line created by the cutting member.
  • the larger clamping pressure or force created by the inner staples 2220b can provide various therapeutic benefits such as reducing bleeding from the incised tissue T while the smaller clamping pressure created by the outer staples 2220a can provide flexibility within the stapled tissue.
  • the anvil 2240 can further comprise at least one piece of buttress material, such as buttress material 2260, for example, attached thereto.
  • the legs of the staples 2220a, 2220b can be configured to incise the buttress material 2260 and/or pass through apertures in the buttress material 2260 when the staple cartridge 2200 is compressed by the anvil 2240 and thereafter contact the staple forming pockets 2242 in the anvil 2240.
  • the legs of the staples 2220a, 2220b can contact and/or incise the buttress material 2260 once again.
  • the buttress material 2260 can improve the hemostasis of and/or provide strength to the tissue being stapled.
  • the bottom surface of the cartridge body 2210 can comprise a stepped contour which matches, or at least substantially matches, the stepped contour of the cartridge support surface 2231.
  • the bottom surface of the cartridge body 2210 can deform to match, or at least substantially match, the contour of the cartridge support surface 2231.
  • an end effector can comprise a staple cartridge 2300 positioned therein.
  • the staple cartridge 2300 can comprise a compressible, implantable body 2310 comprising an inner layer 2312 and an outer layer 231 1 wherein, further to the above, the outer layer 231 1 can be comprised of a water impermeable material.
  • the outer layer 231 1 can extend around the staples 2220a, 2220b and can be positioned intermediate the staples 2220a, 2220b and the support slots 2232a, 2232b, respectively.
  • FIG. 49 an end effector, similar to the end effector depicted in FIG.
  • the compressible, implantable cartridge body 2410 of staple cartridge 2400 can comprise an inner layer 2412 and an outer layer 241 1 ; however; the cartridge body 2410 may not comprise a cutting member slot therein.
  • the cutting member may be required to incise the inner layer 2412 and/or the outer layer 241 1 , for example, as it is advanced through the staple cartridge.
  • an end effector of a surgical stapler can comprise an anvil 2540, a staple cartridge channel 2530, and a staple cartridge 2500 positioned in the staple cartridge channel 2530.
  • the staple cartridge 2500 can comprise a compressible, implantable cartridge body 2510, outer rows of staples 2220a, and inner rows of staples 2220b.
  • the staple cartridge channel 2530 can comprise a flat, or an at least substantially flat, cartridge support surface 2531 and staple support slots 2532 defined therein.
  • the anvil 2540 can comprise a stepped surface 2541 and a plurality of staple forming pockets, such as forming pockets 2542a and 2542b, for example, defined therein.
  • the forming pockets 2542a and the support slots 2532 can define a distance therebetween which is greater than the distance between the forming pockets 2452b and the support slots 2532.
  • the anvil 2540 can further comprise a piece of buttress material 2560 attached to the stepped surface 2541 of the anvil 2540.
  • the buttress material 2560 can conform, or at least substantially conform, to the stepped surface 2541.
  • the buttress material 2560 can be removably attached to the surface 2541 by at least one adhesive, such as fibrin and/or protein hydrogel, for example.
  • the cartridge body 2510 can also comprise a stepped profile which, parallels, or at least substantially parallels, the stepped surface 2541 of the anvil 2540.
  • the anvil 2540 can comprise steps 2548 extending toward the staple cartridge 2500 wherein the steps 2548 can comprise a step height which equals, or at least substantially equals, the step height of the steps 2508 extending from the cartridge body 2510.
  • the amount of the compressible cartridge body 2510 that can be captured in the first staples 2220a can be different than the amount of the compressible cartridge body 2510 that can be captured in the second staples 2220b, for example.
  • an end effector can comprise an anvil 2640, a staple cartridge channel 2530, and a staple cartridge 2600 positioned therebetween.
  • the staple cartridge 2600 can comprise a compressible, implantable cartridge body 2610 including an inner layer 2612, an outer layer 261 1 , and a plurality of staples, such as staples 2220a and 2200b, for example, positioned therein.
  • the anvil 2640 can comprise a plurality of staple forming pockets 2642 in surface 2641 and the staple cartridge channel 2530 can comprise a plurality of staple forming slots 2532 defined in the support surface 2531. As illustrated in FIG.
  • the anvil surface 2641 can be parallel, or at least substantially parallel, to the cartridge support surface 2531 wherein each forming pocket 2642 can be positioned an equal, or at least substantially equal, distance away from an opposing and corresponding staple support slot 2532.
  • the staple cartridge 2600 can comprise staples having the same, or at least substantially the same, initial, unformed staple height and, in addition, the same, or at least substantially the same, formed staple height.
  • the outer rows of staples can comprise staples 2220a and the inner rows of staples can comprise staples 2220b wherein, as discussed above, the staples 2220a and 2220b can have different unformed staple heights.
  • the staples 2220a and 2220b can be formed such that they have the same, or at least substantially the same, formed staple height.
  • the formed outer staples 2220a and the inner staples 2220b may have the same, or at least substantially the same, amount of compressible cartridge body 2610 contained therein; however, as the outer staples 2220a have a taller unformed staple height than the inner staples 2220b and may have the same formed staple height nonetheless, a greater clamping pressure can be generated in the outer staples 2220a than the inner staples 2220b, for example.
  • an end effector of a surgical stapler can comprise an anvil 2740, a staple cartridge channel 2530, and a staple cartridge 2700 positioned within the staple cartridge channel 2530.
  • the staple cartridge 2700 can comprise a compressible, implantable cartridge body 2710 comprising an inner layer 2712, an outer layer 271 1 , 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.
  • the cartridge body 2710 can comprise a center portion 2708 and side portions 2709, wherein the center portion 2708 can comprise a thickness which is greater than the thickness of the side portions 2709.
  • the thickest portion of the cartridge body 2710 can be located at the center portion 2708 while the thinnest portion of the cartridge body 2710 can be located at the side portions 2709.
  • the thickness of the cartridge body 2710 can decrease gradually between the center portion 2708 and the side portions 2709.
  • the thickness of the cartridge body 2710 can decrease linearly and/or geometrically between the center portion 2708 and the side portions 2709.
  • the tissue-contacting surface 2719 of cartridge body 2710 can comprise two inclined, or angled, surfaces which slope downwardly from the center portion 2708 toward the side portions 2709.
  • the anvil 2740 can comprise two inclined, or angled, surfaces which parallel, or at least substantially parallel, the inclined tissue-contacting surfaces 2719.
  • the anvil 2740 can further comprise at least one piece of buttress material 2760 attached to the inclined surfaces of the anvil 2740.
  • the inner rows of staples in the staple cartridge 2700 can comprise the taller staples 2220a and the outer rows of staples can comprise the shorter staples 2220b.
  • the taller staples 2220a can be positioned within and/or adjacent to the thicker center portion 2708 while the staples 2220b can be positioned within and/or adjacent to the side portions 2709.
  • the taller staples 2220a can capture more material of the implantable cartridge body 2710 than the shorter staples 2220b. Such circumstances could result in the staples 2220a applying a greater clamping pressure to the tissue T than the staples 2220b.
  • the taller staples 2220a may capture more material of the cartridge body 2710 therein than the shorter staples 2220b, the taller staples 2220a may have a taller formed staple height than the shorter staples 2220b owing to the inclined arrangement of the staple forming pockets 2742a and 2742b.
  • Such considerations can be utilized to achieve a desired clamping pressure within the tissue captured by the staples 2220a and 2220b wherein, as a result, the clamping pressure in the staples 2220a can be greater than, less than, or equal to the clamping pressure applied to the tissue by the staples 2220b, for example.
  • the shorter staples 2220b can be positioned within and/or adjacent to the thicker center portion 2708 of the cartridge body 2710 and the taller staples 2220a can be positioned within and/or adjacent to the thinner side portions 2709.
  • the staple cartridge 2700 may comprise additional rows of staples, such as staple rows positioned intermediate the inner and outer rows of staples, for example.
  • the intermediate staple rows can comprise staples having an unformed staple height which is intermediate the unformed staple heights of the staples 2220a and 2220b and a formed staple height which is intermediate the formed staple heights of the staples 2220a and 2220b, for example.
  • an end effector of a surgical stapler can comprise an anvil 2840, a staple cartridge channel 2530, and a staple cartridge 2800 positioned within the staple cartridge channel 2530.
  • the staple cartridge 2800 can comprise a compressible, implantable cartridge body 2810 comprising an inner layer 2812, an outer layer 281 1 , 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.
  • the cartridge body 2810 can comprise a center portion 2808 and side portions 2809, wherein the center portion 2808 can comprise a thickness which is less than the thickness of the side portions 2809.
  • the thinnest portion of the cartridge body 2810 can be located at the center portion 2808 while the thickest portion of the cartridge body 2810 can be located at the side portions 2809.
  • the thickness of the cartridge body 2810 can increase gradually between the center portion 2808 and the side portions 2809.
  • the thickness of the cartridge body 2810 can increase linearly and/or geometrically between the center portion 2808 and the side portions 2809.
  • the tissue-contacting surface 2819 of cartridge body 2810 can comprise two inclined, or angled, surfaces which slope upwardly from the center portion 2808 toward the side portions 2809.
  • the anvil 2840 can comprise two inclined, or angled, surfaces which parallel, or at least substantially parallel, the inclined tissue-contacting surfaces 2819.
  • the anvil 2840 can further comprise at least one piece of buttress material 2860 attached to the inclined surfaces of the anvil 2840.
  • the outer rows of staples in the staple cartridge 2800 can comprise the taller staples 2220a and the inner rows of staples can comprise the shorter staples 2220b.
  • the taller staples 2220a can be positioned within and/or adjacent to the thicker side portions 2809 while the staples 2220b can be positioned within and/or adjacent to the center portion 2808.
  • the taller staples 2220a can capture more material of the implantable cartridge body 2810 than the shorter staples 2220b.
  • the staple cartridge channel 2230 can comprise a stepped support surface 2231 which can be configured to support the staples 2220a and 2220b at different heights with respect the anvil 2240.
  • the staple cartridge channel 2230 can be comprised of metal and the steps in the support surface 2231 may be formed in the support surface 2231 by a grinding operation, for example.
  • an end effector of a surgical instrument can comprise a staple cartridge channel 2930 comprising a support insert 2935 positioned therein.
  • the staple cartridge channel 2930 can be formed such that it has a flat, or at least substantially flat, support surface 2931 , for example, which can be configured to support the insert 2935 which comprises the stepped surfaces for supporting the staples 2220a and 2220b of the staple cartridge 2200 at different heights.
  • the insert 2935 can comprise a flat, or at least substantially flat, bottom surface which can be positioned against the support surface 2931.
  • the insert 2935 can further comprise support slots, grooves, or troughs 2932a and 2932b which can be configured to support the staples 2220a and 2220b, respectively, at different heights.
  • the insert 2935 can comprise a knife slot 2939 defined therein which can be configured to permit a cutting member to pass therethrough.
  • the staple cartridge channel 2930 can be comprised of the same material as or a different material than the support insert 2935.
  • the staple cartridge channel 2930 and the support insert 2935 can both be comprised of metal, for example, while, as an alternative, the staple cartridge channel 2930 can be comprised of metal, for example, and the support insert 2935 can be comprised of plastic, for example.
  • the support insert 2935 can be fastened and/or welded into the staple cartridge channel 2930.
  • the support insert 2935 can be snap-fit and/or press-fit into the staple cartridge channel 2930.
  • the support insert 2935 can be secured in the staple cartridge channel 2930 using an adhesive.
  • an end effector of a surgical stapler can comprise an anvil 3040, a staple cartridge channel 3030, and a compressible, implantable staple cartridge 3000 positioned in the staple cartridge channel 3030.
  • the anvil 3040 can comprise a plurality of staple-forming pockets 3042 defined therein and a knife slot 3049 which can be configured to slidably receive a cutting member therein.
  • the staple cartridge channel 3030 can comprise a plurality of staple support slots 3032 defined therein and a knife slot 3039 which can also be configured to slidably receive a cutting member therein.
  • the staple cartridge 3000 can comprise a first layer 301 1 , a second layer 3012, and a plurality of staples, such as staples 3020a and 3020b, for example, positioned therein.
  • the staples 3020a can comprise an unformed staple height which is taller than the unformed staple height of the staples 3020b.
  • the first layer 301 1 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 a rate which is higher than the second compressible material while, alternatively, the first compressible material can be compressed at a rate which is lower than the second compressible material.
  • the first compressible material can be comprised of a resilient material which can comprise a first spring rate and the second compressible material can be comprised of a resilient material which can comprise a second spring rate which is different than the first spring rate.
  • the first compressible material can comprise a spring rate which is greater than the spring rate of the second compressible material.
  • the first compressible material can comprise a spring rate which is less than the spring rate of the second compressible material.
  • the first compressible layer can comprise a first stiffness and the second compressible layer can comprise a second stiffness, wherein the first stiffness is different than the second stiffness.
  • the first compressible layer can comprise a stiffness which is greater than the stiffness of the second compressible layer.
  • the first compressible layer can comprise a stiffness which is less than the stiffness of the second compressible layer.
  • the second layer 3012 of the staple cartridge 3000 can comprise a constant, or at least substantially constant, thickness across the width thereof.
  • the first layer 301 1 can comprise a thickness which varies across the width thereof.
  • the first layer 301 1 can comprise one or more steps 3008 which can increase the thickness of the cartridge body 3010 in certain portions of the cartridge body 3010, such as the center portion, for example.
  • the shorter staples 3020b can be positioned in or aligned with the steps 3008, i.e., the thicker portions of the cartridge body 3010, and the taller staples 3020a can be positioned in or aligned with the thinner portions of the cartridge body 3010.
  • the stiffness of the cartridge body 3010 can be greater along the inner rows of staples 3020b than the outer rows of staples 3020a.
  • the first layer 301 1 can be connected to the second layer 3012.
  • the first layer 301 1 and the second layer 3012 can comprise interlocking features which can retain the layers 301 1 and 3012 together.
  • the first layer 301 1 can comprise a first laminate and the second layer 3012 can comprise a second laminate, wherein the first laminate can be adhered to the second laminate by one or more adhesives.
  • the staple cartridge 3000 can comprise a knife slot 3003 which can be configured to slidably receive a cutting member therein. [0657] Referring now to FIG.
  • a staple cartridge 3100 can comprise a compressible, implantable cartridge body 31 10 comprising a single layer of compressible material and, in addition, a plurality of staples, such as staples 3020b, for example, positioned therein.
  • the thickness of the cartridge body 31 10 can vary across the width thereof.
  • the cartridge body 31 10 can comprise steps 3108 extending along the side portions thereof.
  • a staple cartridge 3200 can comprise a compressible, implantable cartridge body 3210 comprising a single layer of compressible material and, in addition, a plurality of staples, such as staples 3020b, for example, positioned therein.
  • the thickness of the cartridge body 3210 can vary across the width thereof.
  • the cartridge body 3210 can comprise steps 3208 extending along the center portion thereof.
  • a staple cartridge 3300 can comprise a compressible, implantable cartridge body 3310 wherein, similar to the above, the thickness of the cartridge body 3310 can vary across the width thereof. The thickness of the cartridge body 3310 can increase geometrically between the side portions and the center portion of the cartridge body 3310.
  • the thickness of the cartridge body 3310 can be defined by an arcuate or curved profile and can comprise an arcuate or curved tissue-contacting surface 3319.
  • the thickness of the cartridge body 3310, and the contour of the tissue-contacting surface 3319, can be defined by one radius of curvature or, alternatively, by several radiuses of curvature, for example.
  • a staple cartridge 3400 can comprise a compressible, implantable cartridge body 3410 wherein the thickness of the cartridge body 3410 can increase linearly, or at least substantially linearly, between the side portions and the center portion of the cartridge body 3410.
  • a staple cartridge 3500 can comprise a compressible, implantable cartridge body 3510 and a plurality of staples 3520 positioned therein.
  • the implantable cartridge body 3510 can comprise a first inner layer 3512, a second inner layer 3513, and an outer layer 351 1.
  • the first inner layer 3512 can comprise a first thickness and the second inner layer 3513 can comprise a second thickness wherein the second inner layer 3513 can be thicker than the first inner layer 3512.
  • the first inner layer 3512 can be thicker than the second inner layer 3513.
  • the first inner layer 3512 can have the same, or at least substantially the same, thickness as the second inner layer 3513.
  • Each staple 3520 can comprise a base 3522 and one or more deformable legs 3521 extending from the base 3522.
  • Each leg 3521 can comprise a tip 3523 which is embedded in the first inner layer 351 1 and, in addition, each base 3522 of the staples 3520 can be embedded in the second inner layer 3512.
  • the first inner layer 3512 and/or the second inner layer 3513 can comprise at least one medicament stored therein and the outer layer 351 1 can encapsulate and seal the first inner layer 3512 and the second inner layer 3513 such that the medicament does not flow out of the staple cartridge body 3510 until after the outer layer 351 1 has been punctured by the staples 3520.
  • an anvil can be pushed downwardly against tissue positioned against the tissue-contacting surface 3519 of staple cartridge 3500 such that the cartridge body 3510 is compressed and the surface 3519 is moved downwardly toward, and at least partially below, the staple tips 3523 such that the tips 3523 rupture or puncture the outer layer 351 1.
  • the at least one medicament M can flow out of the cartridge body 3510 around the staple legs 3521.
  • additional compression of the cartridge body 3510 can squeeze additional medicament M out of the cartridge body 3510 as illustrated in FIG. 61.
  • the outer layer 351 1 can comprise a water impermeable, or at least substantially impermeable, wrap which can configured to, one, keep the medicament from prematurely flowing out of the staple cartridge 3500 and, two, prevent fluids within a surgical site, for example, from prematurely entering into the staple cartridge 3500.
  • 3512 can comprise a first medicament stored, or absorbed, therein and the second inner layer
  • the 3513 can comprise a second medicament stored, or absorbed, therein, wherein the second medicament can be different than the first medicament.
  • An initial compression of the cartridge body 3510, which causes the rupture of the outer layer 351 1 can generally express the first medicament out of the first inner layer 3512 and a subsequent compression of the cartridge body 3510 can generally express the second medicament out of the second inner layer 3513.
  • portions of the first medicament and the second medicament may be expressed simultaneously although a majority of the medicament that is initially expressed can be comprised of the first medicament and a majority of the medicament subsequently expressed thereafter can be comprised of the second medicament.
  • the first inner layer 3512 can be comprised of a more compressible material than the second inner layer 3513 such that the initial compression forces or pressure, which can be lower than the subsequent compression forces or pressure, can cause a larger initial deflection within the first inner layer 3512 than the second inner layer 3513. This larger initial deflection within the first inner layer 3512 can cause a larger portion of the first medicament to be expressed from the first inner layer 3512 than the second medicament from the second inner layer 3513.
  • the first inner layer 3512 can be more porous and/or more flexible than the second inner layer 3513.
  • the first inner layer 3512 can comprise a plurality of pores, or voids, 3508 defined therein and the second inner layer 3513 can comprise a plurality of pores, or voids, 3509 defined therein wherein the pores 3508 can be configured to store the first medicament in the first inner layer 3512 and the pores 3509 can be 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 the pores 3509 within the second inner layer 3513 can be selected so as to provide a desired result described herein.
  • the outer layer 351 1 , the first inner layer 3512, and/or the second inner layer 3513 can 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
  • the outer layer 351 1 can be comprised of a third bioabsorbable material, wherein the first bioabsorbable material, the second bioabsorbable material, and/or the third bioabsorbable material can be comprised of different materials.
  • the first bioabsorbable material can be bioabsorbed at a first rate
  • the second bioabsorbable material can be bioabsorbed at a second rate
  • the third bioabsorbable material can be bioabsorbed at a third rate, wherein the first rate, the second rate, and/or the third rate can be different.
  • a rate can be defined as the amount of material mass that is absorbed by a patient's body over a unit of time.
  • the bodies of different patients may absorb different materials at different rates and, thus, such rates may be expressed as average rates in order to account for such variability.
  • a faster rate may be a rate in which more mass is bioabsorbed for a unit of time than a slower rate.
  • the first inner layer 3512 and/or the second inner layer 3513 can be comprised of a material which bioabsorbs faster than the material comprising the outer layer 351 1.
  • the first inner layer 3512 and/or the second inner layer 3513 can be comprised of a bioabsorbable foam, tissue sealant, and/or haemostatic material, such as oxidized regenerated cellulose (ORC), for example
  • the outer layer 351 1 can be comprised of a buttress material and/or plastic material, such as polyglycolic acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
  • the first inner layer 3512 and/or the second inner layer 3513 can immediately treat the tissue and can reduce bleeding from the tissue, for example, wherein the outer layer 3514 can provide longer-term structural support and can be bioabsorbed at a slower rate.
  • the outer layer 351 1 can buttress or structurally reinforce 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 which can be bioabsorbed 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 sustained release of the same therapeutic material and/or a different therapeutic material.
  • the rate in which a therapeutic material can be released from a layer 3512, 3513 can be a function of the bioabsorbability of the substrate layer in which the medicament is absorbed or dispersed.
  • the substrate comprising the first inner layer 3512 can be bioabsorbed faster than the substrate comprising the second inner layer 3513 and, as a result, a medicament can be release from the first inner layer 3512 faster than the second inner layer 3513, for example.
  • one or more of the layers 351 1 , 3512, and 3513 of the cartridge body 3510 can be adhered to one another by at least one adhesive, such as fibrin and/or protein hydrogel, for example.
  • the adhesive can be water soluble and can be configured to release the connection between the layers as the staple cartridge 3500 is being implanted and/or some time thereafter.
  • the adhesive can be configured to bioabsorb faster than the outer layer 351 1 , the first inner layer 3512, and/or the second inner layer 3513.
  • a staple cartridge such as staple cartridge 3600, for example, can comprise a cartridge body 3610 including a compressible first layer 361 1 , a second layer 3612 attached to the first layer 361 1 , and a removable compressible layer 3613 attached to the second layer 3612.
  • the first layer 361 1 can be comprised of a compressible foam material
  • the second layer 3612 can comprise a laminate material adhered to the first layer 361 1 utilizing one or more adhesives
  • the third layer 3613 can comprise a compressible foam material removably adhered to the second layer 3612 utilizing one or more adhesives, for example.
  • the staple cartridge 3600 can further comprise a plurality of staples, such as staples 3620, for example, positioned in the cartridge body 3610.
  • each staple 3620 can comprise a base 3622 positioned in the third layer 3613 and one or more deformable legs 3621 extending upwardly from the base 3622 through the second layer 3612 and into the first layer 361 1 , for example.
  • the top surface 3619 of the staple cartridge body 3610 can be pushed downwardly by an anvil until the staple legs 3621 penetrate through the top surface 3619 and the targeted tissue and contact the anvil. After the staple legs 3621 have been sufficiently deformed, the anvil can be moved away from the staple cartridge 3600 such that the compressible layers thereof can at least partially re-expand.
  • the third layer 3613 can be comprised of an absorbent material, such as protein hydrogel, for example, which can draw blood away from the stapled tissue.
  • the third layer 3613 can be comprised of a haemostatic material and/or tissue sealant, such as freeze-dried thrombin and/or fibrin, for example, which can be configured to reduce the bleeding from the tissue.
  • the third layer 3613 may provide a structural support to the first layer 361 1 and the second layer 3612 wherein the third layer 3613 may be comprised of a bioabsorbable material and/or a non- bioabsorbable material.
  • the third layer 3613 can be detached from the second layer 3612 after the staple cartridge 3610 has been implanted.
  • the surgeon can elect whether to remove the third layer 3613 of 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 361 1 can be comprised of a first foam material and the third layer 3613 can be comprised of a second foam material which can be different than the first foam material.
  • the first foam material can have a first density and the second foam material can have a second density wherein the first density can be different than the second density.
  • the second density can be higher than the first density wherein, as a result, the third layer 3613 may be less compressible, or have a lower compression rate, than the first layer 361 1.
  • the first density can be higher than the second density wherein, as a result, the first layer 361 1 may be less compressible, or have a lower compression rate, than the third layer 3613.
  • a staple cartridge 3700 can comprise a cartridge body 3710 comprising a first compressible foam layer 371 1 , a second layer 3712 attached to the first layer 371 1 , and a detachable third compressible foam layer 3713 removably attached to the second layer 3712.
  • the third layer 3713 can comprise a plurality of staple receiving slots, or cut-outs, 3709 which can each be configured to receive at least a portion of a staple 3620, such as a staple base 3622, for example, therein.
  • the staples 3620 can be configured to slide within the staple receiving slots 3709 or, stated 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 targeted tissue and compressed by an anvil, for example.
  • the receiving slots 3709 can be configured such that there is clearance between the staples 3620 and the side walls of the receiving slots 3709. For example, as a result of the above, the staples 3620 may not capture a portion of the third layer 3713 therein when the staples 3620 are deformed, as illustrated in FIGS. 64 and 65.
  • the ends of the staple receiving slots 3709 adjacent to 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.
  • the third layer 3713 can comprise one or more perforations and/or score marks 3708, for example, which can be configured to permit the third layer 3713 to be removed from the second layer 3712 in two or more pieces as illustrated in FIG. 64. In FIG. 64, one of the pieces of the third layer 3713 is illustrated as being removed by a tool 3755.
  • the perforations 3708 can be arranged along a line positioned intermediate a first row of staples and a second row of staples.
  • the bases 3622 of the staples 3620 can be positioned within the receiving slots 3709 wherein, the side walls of the receiving slots 3709 can be configured to contact and releasable retain the staple legs 3621 in position.
  • the third layer 3713 can comprise an elongated slot surrounding all of the staples within a staple line.
  • a staple cartridge comprising four staple rows for example, can comprise an elongate slot aligned with each staple row in the bottom layer of the staple cartridge.
  • at least a portion of the staple cartridge 3600 and/or the staple cartridge 3700 can be implanted within a patient and at least a portion of the staple cartridge can be removable from the patient.
  • the first layer 371 1 and the second layer 3712 can be captured within the staples 3620 and can be implanted with the staples 3620, whereas the third layer 3713 can be optionally removed or detached from the staple cartridge 3700.
  • the 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 various therapeutic benefits.
  • the detached staple cartridge portion can be removed from the surgical site through a trocar, such as a trocar having a 5 mm aperture, for example.
  • a cartridge body can comprise more than one layer that can be removed.
  • the cartridge body 3710 can comprise a fourth layer wherein the third layer of 3713 of the cartridge body 3710 can be comprised of a haemostatic material and the fourth layer can be comprised of a support layer.
  • a surgeon can remove the support layer and then elect whether to remove the haemostatic layer, for example.
  • a staple cartridge such as staple cartridge 3800, for example, can comprise a cartridge body 3810 including an outer layer 381 1 and an inner layer 3812.
  • the inner layer 3812 can be comprised of a compressible foam material and the outer layer 381 1 can be at least partially wrapped around the inner layer 3812.
  • the outer layer 381 1 can comprise a first portion 381 1 a configured to be positioned on a first side of the inner layer 3812 and a second portion 381 lb configured to be positioned on a second side of the inner layer 3812 wherein the first portion 381 1a and the second portion 381 lb can be connected by a flexible hinge, such as hinge 3809, 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 in order to secure the portions of the outer layer 381 1 thereto.
  • the outer layer 381 1 can comprise one or more fastening members extending therefrom.
  • the outer layer 381 1 can comprise a plurality of deformable legs 3821 extending from one side of the outer layer 381 1 which can be seated in the compressible inner layer 3812.
  • the legs 3821 may not protrude from the second side of the inner layer 3812 or , alternatively, the legs 3821 may at least partially protrude from the inner layer 3812.
  • the legs 3821 can be configured to pierce the inner layer 3812 and the second portion 381 lb of the outer layer 381 1.
  • the second portion 381 lb of the outer layer 381 1 can comprise apertures, such as apertures 3808, for example defined therein which can be configured to receive the staple legs 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.
  • the knife slot 3803 may not extend entirely through the thickness of the cartridge body 3810 and, as a result, the cutting member may incise the cartridge body 3810 as it is moved relative thereto.
  • a staple cartridge 3900 can comprise, similar to staple cartridge 3800, a cartridge body 3910 including an inner layer 3812 and an outer layer 381 1 , wherein the outer layer 381 1 can comprise a first portion 381 l a positioned adjacent to the first side of the inner layer 3812 and a second portion 381 1b positioned adjacent to the second side of the inner layer 3812. Similar to the above, the outer layer 381 1 can comprise one or more fastening members extending therefrom.
  • the outer layer 381 1 can comprise a plurality of deformable legs 3921 extending from one side of the outer layer 381 1 which can be seated in the compressible inner layer 3812.
  • Each deformable leg 3921 can comprise at least one hook or barb 3923 protruding therefrom which can be configured to engage the second portion 381 1b of the outer layer 381 1 and, as a result, retain the outer layer 381 1 to the inner layer 3812.
  • the barbs 3923 can be configured to protrude from the second side of the inner layer 3812 and extend through the apertures 3808 in the second portion 381 lb of the outer layer 381 1 such that the barbs 3923 can engage the outside surface of the outer layer 381 1 and lock the outer layer 381 1 to the inner layer 3812.
  • the inner layer 3812 may be at least partially compressed in order to cause the barbs to protrude therefrom and enter into the apertures 3808.
  • the staple cartridge 3900 can be at least partially pre- compressed when it is inserted into a staple cartridge, for example.
  • at least a portion of the legs 3921 can be embedded within the first portion 381 la of the outer layer 381 1 wherein, the outer layer 381 1 can be comprised of a plastic material, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example, and the plastic material can be overmolded around at least a portion of the legs 3921.
  • PDS polydioxanone
  • PGA polyglycolic acid
  • a staple cartridge such as staple cartridge 4000, for example, can comprise a cartridge body 4010 including a compressible first layer 401 1 and a second layer 4012 and, in addition, a plurality of staples 4020 positioned within the cartridge body 4010.
  • each staple 4020 can comprise a base 4022 and at least one deformable leg 4023 extending from the base 4022.
  • the staple cartridge 4000 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 staple cartridge channel 4030.
  • the second layer 4012 can comprise a layer of pledgets 4060 interconnected to one another by a pledget support frame 4061.
  • the pledgets 4060 and the pledget support frame 4061 can be comprised of a molded plastic material, such as polyglycolic acid (PGA), for example.
  • PGA polyglycolic acid
  • Each pledget 4060 can comprise one or more apertures or slots 4062 which can be configured to receive a staple leg 4021 extending therethrough as illustrated in FIGS. 70 and 71.
  • Each pledget 4060 can further comprise a receiving slot 4063 defined therein which can be configured to receive a base 4022 of a staple 4020.
  • the pledgets 4060 and/or pledget support fame 4061 can comprise a plurality of score marks, perforations, or the like which can be configured to allow the pledgets 4060 to become detached from the pledget support frame 4061 at a desired location.
  • one or more pledgets 4060 can be connected to one another along a line comprising perforations and/or score marks 4064, for example.
  • the compressible foam layer 401 1 can be positioned against the targeted tissue T and the cartridge body 4010 can be compressed by the anvil 4040 such that the anvil 4040 can deform the staples 4020.
  • the staple legs 4021 of each staple 4020 can capture the tissue T, a portion of the first layer 401 1 , and a pledget 4060 within the deformed staple.
  • the pledget support frame 4061 can be detached from the pledgets 4060 and/or the pledgets 4060 can be detached from one another.
  • the pledgets 4060 can be detached from the frame 4061 and/or each other when the staples 4020 are being deformed by the anvil 4040 as described above.
  • the staples of a staple cartridge can be fully formed by an anvil when the anvil is moved into a closed position.
  • the staples of a staple cartridge such as staple cartridge 4100, for example, can be deformed by an anvil when the anvil is moved into a closed position and, in addition, by a staple driver system which moves the staples toward the closed anvil.
  • the staple cartridge 4100 can comprise a compressible cartridge body 41 10 which can be comprised of a foam material, for example, and a plurality of staples 4120 at least partially positioned within the compressible cartridge body 41 10.
  • the staple driver system can comprise a driver holder 4160, a plurality of staple drivers 4162 positioned within the driver holder 4160, and a staple cartridge pan 4180 which can be configured to retain the staple drivers 4162 in the driver holder 4160.
  • the staple drivers 4162 can be positioned within one or more slots 4163 in the driver holder 4160 wherein the sidewalls of the slots 4163 can assist in guiding the staple drivers 4162 upwardly toward the anvil.
  • the staples 4120 can be supported within the slots 4163 by the staple drivers 4162 wherein, the staples 4120 can be entirely positioned in the slots 4163 when the staples 4120 and the staple drivers 4162 are in their unfired positions.
  • the staples 4120 can extend upwardly through the open ends 4161 of slots 4163 when the staples 4120 and staple drivers 4162 are in their unfired positions.
  • the bases of the staples 4120 can be positioned within the driver holder 4160 and the tips of the staples 4120 can be embedded within the compressible cartridge body 41 10.
  • Approximately one-third of the height of the staples 4120 can be positioned within the driver holder 4160 and approximately two-thirds of the height of the staples 4120 can be positioned within the cartridge body 41 10.
  • the staple cartridge 4100 can further comprise a water impermeable wrap or membrane 41 1 1 surrounding the cartridge body 41 10 and the driver holder 4160, for example.
  • the staple cartridge 4100 can be positioned within a staple cartridge channel, for example, and the anvil can be moved toward the staple cartridge 4100 into a closed position.
  • the anvil can contact and compress the compressible cartridge body 41 10 when the anvil is moved into its closed position.
  • the anvil may not contact the staples 4120 when the anvil is in its closed position.
  • the anvil may contact the legs of the staples 4120 and at least partially deform the staples 4120 when the anvil is moved into its closed position.
  • the staple cartridge 4100 can further comprise one or more sleds 4170 which can be advanced longitudinally within the staple cartridge 4100 such that the sleds 4170 can sequentially engage the staple drivers 4162 and move the staple drivers 4162 and the staples 4120 toward the anvil.
  • the sleds 4170 can slide between the staple cartridge pan 4180 and the staple drivers 4162.
  • the upward movement of the staples 4120 toward the anvil can initiate and complete the forming process and deform the staples 4120 to their fully formed, or at least desired, height.
  • the sleds 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 in the proximal end of the staple cartridge 4100 are fully formed before the staples 4120 positioned in the distal end of the staple cartridge 4100 are fully formed.
  • the sleds 4170 can each comprise at least one angled or inclined surface 471 1 which can be configured to slide underneath the staple drivers 4162 and lift the staple drivers 4162 as illustrated in FIG. 76.
  • the staples 4120 can be formed in order to capture at least a portion of the tissue T and at least a portion of the compressible cartridge body 41 10 of the staple cartridge 4100 therein.
  • the anvil and the staple cartridge channel 4130 of the surgical stapler can be moved away from the implanted staple cartridge 4100.
  • the cartridge pan 4180 can be fixedly engaged with the staple cartridge channel 4130 wherein, as a result, the cartridge pan 4180 can become detached from the compressible cartridge body 41 10 as the staple cartridge channel 4130 is pulled away from the implanted cartridge body 41 10.
  • the cartridge pan 4180 can comprise opposing side walls 4181 between which the cartridge body 41 10 can be removably positioned.
  • the compressible cartridge body 41 10 can be compressed between the side walls 4181 such that the cartridge body 41 10 can be removably retained therebetween during use and releasably disengaged from the cartridge pan 4180 as the cartridge pan 4180 is pulled away.
  • the driver holder 4160 can be connected to the cartridge pan 4180 such that the driver holder 4160, the drivers 4162, and/or the sleds 4170 can remain in the cartridge pan 4180 when the cartridge pan 4180 is removed from the surgical site.
  • the drivers 4162 can be ejected from the driver holder 4160 and left within the surgical site.
  • the drivers 4162 can be comprised of a bioabsorbable material, such as polyglycolic acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
  • PGA polyglycolic acid
  • PDS polydioxanone
  • PHA polyhydroxyalkanoate
  • PGCL poliglecaprone 25
  • the drivers 4162 can be attached to the staples 4120 such that the drivers 4162 are deployed with the staples 4120.
  • each driver 4162 can comprise a trough configured to receive the bases of the staples 4120, for example, wherein, the troughs can be configured to receive the staple bases in a press-
  • the driver holder 4160 and/or the sleds 4170 can be ejected from the cartridge pan 4180.
  • the sleds 4170 can slide between the cartridge pan 4180 and the driver holder 4160 such that, as the sleds 4170 are advanced in order to drive the staple drivers 4162 and staples 4120 upwardly, the sleds 4170 can move the driver holder 4160 upwardly out of the cartridge pan 4180 as well.
  • the driver holder 4160 and/or the sleds 4170 can be comprised of a bioabsorbable material, such as polyglycolic acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
  • PGA polyglycolic acid
  • Vicryl polylactic acid
  • PDS polydioxanone
  • the sleds 4170 can be integrally formed and/or attached to a drive bar, or cutting member, which pushes the sleds 4170 through the staple cartridge 4100. In such cases, the sleds 4170 may not be ejected from the cartridge pan 4180 and may remain with the surgical stapler while, in other embodiments in which the sleds 4170 are not attached to the drive bar, the sleds 4170 may be left in the surgical site.
  • the compressibility of the cartridge body 41 10 can allow thicker staple cartridges to be used within an end effector of a surgical stapler as the cartridge body 41 10 can compress, or shrink, when the anvil of the stapler is closed.
  • taller staples such as staples having an approximately 0.18" staple height, for example, could be used, wherein approximately 0.12" of the staple height can be positioned within the compressible layer 41 10 and wherein the compressible layer 41 10 can have an uncompressed height of approximately 0.14", for example.
  • a staple cartridge such as staple cartridge 4200, for example, can comprise a compressible cartridge body 4210, a plurality of staples 4220 positioned therein, and a plurality of flexible lateral support members 4234.
  • the staple cartridge 4200 can be positioned intermediate an anvil 4240 and a staple cartridge channel 4230 wherein, the lateral support members 4234 can be attached to the staple cartridge channel 4230.
  • the anvil 4240 is moved downwardly to compress the cartridge body 4210 and at least partially deform the staples 4220, as illustrated in FIG. 79, the side portions of the cartridge body 4210 can bulge laterally and push the lateral support members 4234 outwardly.
  • the lateral support members 4234 can be attached to the cartridge body 4210 and, when the cartridge body 4210 bulges laterally as described above, the lateral support members 4234 can detach from the cartridge body 4210 as illustrated in FIG. 79.
  • the lateral support members 4234 can be adhered to the cartridge body 4210 utilizing at least one adhesive, such as fibrin and/or protein hydrogel, for example. Similar to the above, the closing of the anvil 4240 may only partially deform the staples 4220, wherein the formation of the staples 4220 can be completed by the advancement of one or more sleds 4270 through the staple cartridge 4200 as illustrated in FIG. 80. Referring now to FIGS.
  • the sleds 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.
  • the cutting member 4280 can comprise a cutting element, or knife, 4283, which can be advanced through the tissue T and/or the compressible cartridge body 4210.
  • the cutting member 4280 can comprise camming members 4282 which can travel along the outside surfaces of the jaws 4230 and 4240 and move or hold the jaws in position.
  • the staples 4220 can be formed into their final shapes at the same time, or at least substantially the same time, as the tissue T is incised.
  • the sleds 4270 can be positioned distally with respect to the knife 4283 such that the tissue T is only incised when the proceeding portion of the tissue has been fully stapled, for example.
  • the sleds 4270 can comprise separate slidable members which are advanced together by the cutting member 4280.
  • the sleds 4270 can be contained within the staple cartridge 4200 and the cutting member 4280 can be advanced into the staple cartridge 4200 by a firing bar 4281 such that the cutting member 4280 engages the sleds 4270 and advances the sleds 4270 distally.
  • the sleds 4270 can be connected to one another.
  • each sled 4270 can comprise an angled surface, or cam, 4271 which can be configured to lift the staples 4220 aligned within a staple row.
  • the angled surfaces 4271 can be integrally formed with the cutting member 4280.
  • each staple 4200 can comprise a base, at least one deformable member extending from the base, and a crown 4229 overmolded onto 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 sled 4270, for example.
  • the crowns 4229 of staples 4220 can be configured such that the angled surfaces 4271 of the sleds 4270 can slide underneath and directly contact the crowns 4229 without a staple driver positioned therebetween.
  • each crown 4229 can comprise at least one co-operating angled or inclined surface which can be engaged by an angled surface 4271 of the sleds 4270 such that the co-operating angled surfaces can drive the staples 4220 upwardly when the sleds 4270 are slid underneath the staples 4220.
  • a staple cartridge such as staple cartridge 4300, for example, can comprise a compressible body 4310 and a plurality of staples 4320 positioned within the compressible body 4310. Similar to the above, the staple cartridge 4300 can comprise flexible
  • the flexible lateral supports 4334 can be connected together by one or more struts, or connection members, 4335 which can be configured to hold the lateral supports 4334 together.
  • the connection members 4335 can be configured to prevent, or at least inhibit, the lateral supports 4334 from becoming prematurely detached from the cartridge body 4310.
  • the connection members 4335 can be configured to hold the lateral supports 4334 together after the staple cartridge 4300 has been compressed by an anvil. In such cases, the lateral supports 4334 can resist the lateral bulging, or displacement, of the lateral portions of the cartridge body 4310.
  • a cutting member such as cutting member 4280, for example, can be configured to transect the connection members 4335 as the cutting member 4280 is moved distally within the cartridge body 4310.
  • the cutting member 4280 can be configured to push one or more sleds, such as sleds 4270, for example, distally in order to form the staples 4320 against an anvil.
  • the sleds 4270 can lead the cutting edge 4283 such that the cutting member 4280 does not transect a connection member 4335 until the staples 4320 adjacent to that connection member 4335 have been fully formed, or at least formed to a desired height.
  • connection members 4335 in co-operation with the lateral supports 4334, can prevent, or at least reduce, the lateral movement of the compressible cartridge body 4310 and, concurrently, prevent, or at least reduce, the lateral movement of the staples 4320 positioned within the cartridge body 4310.
  • the connection members 4335 can hold the staples 4320 in position until after they are deformed and the connection members 4335 can be thereafter cut to release the lateral portions of the cartridge body 4310.
  • the lateral 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 staple cartridge 4300 has been implanted.
  • the lateral supports 4334 can be comprised of an implantable material and can be left within a surgical site.
  • connection members 4335 can be positioned intermediate the cartridge body 4310 and the tissue T and, after the connection members 4335 have been detached from the lateral supports 4334, the connections members 4335 can remain implanted in the patient.
  • the connection members 4335 can be comprised of an implantable material and the connection members 4335 can be comprised of the same material as the lateral supports 4334, for example.
  • connection members 4335 and/or lateral supports 4334 can be comprised of a flexible bioabsorbable material such as polyglycolic acid (PGA) which is marketed under the trade name Vicryl, poly lactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
  • the connection member can comprise a sheet of material connecting the lateral supports 4334.
  • the staple cartridge can comprise connection members extending across the top surface of the cartridge body 4310 and, in addition, connection members extending around the bottom surface of the cartridge body 4310.
  • a staple cartridge can comprise staples, such as staples 4420, for example, which can comprise a wire portion inserted into a crown portion.
  • the wire portion can be comprised of metal, such as titanium and/or stainless steel, for example, and/or plastic, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example.
  • the crown portion can be comprised of metal, such as titanium and/or stainless steel, for example, and/or plastic, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example.
  • each staple 4420 can comprise a base 4422 and deformable legs 4421 extending from the base 4422 wherein the crown portion of each staple 4420 can comprise a crown 4429 which can be configured to receive at least a portion of a base 4422 therein.
  • the legs 4421 of the wire portion can be inserted into an opening 4426 in a crown 4429 wherein the opening 4426 can be configured to guide the legs 4421 into a base chamber 4427.
  • the wire portion can be further inserted into the crown 4429 such that the legs 4421 exit the base chamber 4427 and the base 4422 of the wire portion enters into the base chamber 4427.
  • the base chamber 4427 can be configured such that the wire portion is rotated within the crown 4429 as the base 4422 enters into the base chamber 4427 such that the staple legs 4421 are pointed in an upward, or at least substantially upward, direction.
  • the crown 4429 can comprise exit holes 4425 which can be configured to receive the staple legs 4421 therein.
  • a surgical stapler can comprise a sled 4470 configured to transverse the staple cartridge 4400 and staple cartridge channel 4430 and move the staples 4420 contained within the cartridge body 4410 toward an anvil.
  • the sled 4470 can be moved from a proximal end of the staple cartridge channel 4430 to a distal end of the cartridge channel 4430 in order to implant the cartridge body 4410 and the staples 4420.
  • the sled 4470 can be retracted or returned to the proximal end of the cartridge channel 4430 and another staple cartridge 4400 can be inserted into the cartridge channel 4430.
  • the surgical stapler may comprise one or more lock-out features which can prevent the sled 4470 from being advanced distally once again without a new staple cartridge 4400 being positioned within the cartridge channel 4430.
  • the staple cartridge channel 4430 can comprise a lock-out shoulder 4439 which can be configured to prevent, or at least limit, the distal movement of the sled 4470.
  • the sled 4470 can be configured to abut the shoulder 4439 unless the sled 4470 is at least partially lifted upwardly over the shoulder 4439 by a lift feature 4428, for example, extending between the proximal-most staples 4420 within a staple cartridge 4400. Stated another way, absent the presence of the proximal-most staples 4420 in a new staple cartridge 4400, the sled 4470 cannot be advanced. Thus, when an expended staple cartridge 4400 is present within the cartridge channel 4430, or no staple cartridge 4400 is present in the cartridge channel 4430 at all, the sled 4470 cannot be advanced within the cartridge channel 4430.
  • a staple cartridge such as staple cartridge 4500, for example, can be positioned within a staple cartridge channel 4530 and can comprise a compressible cartridge body 4510, a plurality of staples 4520 positioned within the cartridge body 4510, and a cartridge pan, or retainer, 4580.
  • the compressible cartridge body 4510 can comprise an outer layer 451 1 and an inner layer 4512 wherein, the outer layer 451 1 can sealingly enclose the inner layer 4512.
  • the outer layer 451 1 can extend between the inner layer 4512 and the cartridge pan 4580.
  • the outer layer 451 1 may only partially surround the inner layer 4512 and, for example, the outer layer 451 1 and the cartridge pan 4580 can co-operate to encompass, or at least substantially encompass, the inner layer 4512.
  • the staples 4520 can be supported by the cartridge pan 4580 wherein the cartridge pan 4580 can comprise one or more staple support channels configured to support the staples 4520.
  • the cartridge pan 4580 can be attached to the cartridge body 4510 wherein, for example, the cartridge body 4510 can be compressed laterally between opposing side walls of the cartridge pan 4580.
  • the side walls of the cartridge pan 4580 can support the cartridge body 4510 laterally and, for example, the cartridge pan 4580 can comprise one or more walls, or fins, 4582 extending upwardly from the bottom support 4583 into the cartridge body 4510.
  • the cartridge body 4510 can comprise one or more slots, or channels, therein which can be configured to receive and/or interlock with the walls 4582.
  • the walls 4582 can extend partially, or almost entirely, through the cartridge body 4510.
  • the walls 4582 can 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 pan 4580 can comprise co-operating retention features which can provide a snap-fit between the cartridge pan 4580 and the cartridge body 4510.
  • the staple cartridge 4500 can be positioned within the cartridge channel 4530 such that the cartridge pan 4580 is positioned against and/or attached to the cartridge channel 4530.
  • the cartridge pan 4580 can be detachably coupled 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 pan 4580 can detach from the cartridge channel 4530 and can be implanted with the cartridge body 4510.
  • the cartridge pan 4580 can be comprised of a bioabsorbable material such as polyglycolic acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
  • PGA polyglycolic acid
  • Vicryl polylactic acid
  • PDS polydioxanone
  • PHA polyhydroxyalkanoate
  • PCL poliglecaprone 25
  • PCL polycaprolactone
  • the surgical stapler can further comprise a firing mechanism and/or driver which can be slid intermediate the staple cartridge channel 4530 and a bottom drive surface on the cartridge pan 4580 which can be configured to lift or eject the cartridge pan 4580 from the cartridge channel 4530.
  • the cartridge body 4510 can be detachably coupled to the cartridge pan 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 detach from the cartridge pan 4580.
  • the cartridge pan 4580 can remain fixedly engaged with the cartridge channel 4530 such that the cartridge pan 4580 is removed from the surgical site with the cartridge channel 4530.
  • the surgical stapler can further comprise a firing mechanism and/or driver which can be slid intermediate the staple cartridge pan 4580 and a bottom drive surface on the cartridge body 4510 which can be configured to lift or eject the cartridge body 4510 from the cartridge pan 4580.
  • the staple cartridge 4500 can further comprise staple drivers positioned intermediate the cartridge pan 4580 and the staples 4520 such that, as the firing mechanism is slid distally, the staple drivers and the staples 4520 can be driven upwardly toward the anvil.
  • the staple drivers can be at least partially embedded within the compressible cartridge body 4510.
  • the staple cartridge 4500 can comprise a lock-out feature which can be configured to prevent, or at least limit, the distal movement of a cutting member unless an unfired staple cartridge 4500 has been positioned within the staple cartridge channel 4530.
  • the staple cartridge pan 4580 can comprise a surface which lifts the cutting member upwardly and over a locking surface within the staple cartridge channel 4530, for example. In the event that a staple cartridge 4500 comprising a cartridge pan 4580 is not present in the cartridge channel 4530, the cutting member cannot be advanced.
  • the proximal-most staples, and/or any other suitable staples, within a staple cartridge 4500 can comprise a lifting surface which can sufficiently lift the cutting member over the locking surface.
  • various portions of the staple cartridge 4500 can be comprised of materials having different colors.
  • a surgeon may be able to visually identify when an unfired and/or fired staple cartridge is present in the staple cartridge channel 4530.
  • the outer layer 451 1 of the cartridge body 4510 may have a first color
  • the cartridge pan 4580 may have a second color
  • the staple cartridge channel 4530 may have a third color.
  • the surgeon may know that an unfired cartridge 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 4500 is present in the staple cartridge channel 4530 and that the remaining cartridge pan 4580 needs to 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.
  • a staple cartridge such as staple cartridge 4600, for example, can comprise a compressible, implantable cartridge body 4610 and a plurality of staples 4620 positioned therein.
  • the cartridge body 4610 can comprise an outer layer 461 1 and an inner layer 4612.
  • the inner layer 4612 can comprise a plurality of pockets, such as pockets, or cavities, 4615, for example, defined therein which can facilitate the collapse of the cartridge body 4610.
  • the inner layer 4612 can comprise a corrugated, or honeycomb-configured, lattice which can be configured to withstand a compressive force, or pressure, as long as the compressive force, or pressure, does not exceed a certain threshold value.
  • the inner layer 4612 can deform at a linear, or at least substantially linear, rate with respect to the compressive force, or pressure, being applied. After the compressive force, or pressure, has exceeded the threshold value, the inner layer 4612 can suddenly succumb to large deflections and collapse, or buckle, as a result of the compressive load.
  • the lattice of the inner layer 4612 can be comprised of a plurality of sub-layers 4612a which can be connected together. Each sub-layer 4612a can comprise a plurality of alternating furrows and ridges, or waves, which can be aligned with the alternating furrows and ridges of an adjacent sub-layer 4612a.
  • the furrows of a first sub-layer 4612a can be positioned adjacent to the ridges of a second sub-layer 4612a and, similarly, the ridges of the first sub-layer 4612a can be positioned adjacent to the furrows of the second sub-layer 4612a.
  • the adjacent sublayers 4612a can be adhered to one another and/or the outer layer 461 1 by at least one adhesive, such as fibrin and/or protein hydrogel, for example.
  • FIG. 88 illustrates the staple cartridge 4600 after the cartridge body 4610 has been collapsed and the staples 4620 have been deformed in order to capture and hold tissue T against the cartridge body 4610.
  • a staple cartridge such as staple cartridge 4700, for example, can comprise a compressible, implantable cartridge body 4710 and a plurality of staples 4720 positioned within the cartridge body 4710.
  • the cartridge body 4710 can comprise an outer layer 471 1 and an inner layer 4712, wherein the inner layer 4712 can comprise a plurality of sub-layers 4712a.
  • each sub-layer 4712a can comprise alternating furrows 4717 and ridges 4718 which can be aligned with one another to define pockets, or cavities, 4715 therebetween.
  • the furrows 4717 and/or the ridges 4718 can extend along axes which are parallel to one another and/or parallel to a longitudinal axis 4709.
  • the staples 4720 can be aligned in a plurality of staple rows which can extend along axes which are parallel to one another and/or parallel to the longitudinal axis 4709.
  • the staples 4620 contained in the cartridge body 4600 can extend along axes which are traverse or perpendicular with respect to the axes defined by the furrows and ridges of the sub-layers 4612a. Referring again to FIGS.
  • the staples 4720 can extend through the furrows 4717 and the ridges 4718 wherein friction forces between the staples 4720 and the sub-layers 4712a can hold the staples 4720 within the cartridge body 4710.
  • the plurality of sub-layers 4712a can be comprised of a buttress material and/or plastic material, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example, which can be configured to hold the staples 4720 in an upright orientation, for example, and/or hold the staples 4720 in alignment with respect to each other as illustrated in FIGS. 89 and 90.
  • FIG. 91 illustrates the staple cartridge 4700 after the cartridge body 4710 has been collapsed and the staples 4720 have been deformed in order to capture and hold tissue T against the cartridge body 4710.
  • the cartridge body 4710 can resiliently or elastically collapse when it is compressed.
  • the waves formed within each sub-layer 4712a by the furrows 4717 and the ridges 4718 can be flattened, or at least substantially flattened, when the cartridge body 4710 is compressed which can collapse, or at least substantially collapse, the cavities 4715 defined therebetween.
  • the cartridge body 4710, or at least portions of the cartridge body 4710 can resiliently or elastically re-expand after the compressive force, or pressure, has been removed from the cartridge body 4710.
  • connections between the furrows 4717 and the ridges 4718 of adjacent sub-layers 4712a can remain intact, or at least substantially intact, when the cartridge body 4710 is compressed such that, after the compression force has been removed from the cartridge body 4710, the sub-layers 4712a can bias themselves away from each other and, as a result, at least partially re-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 re-expand after the compressive force, or pressure, has been removed from the cartridge body 4710.
  • a staple cartridge such as staple cartridge 4800
  • a staple cartridge can comprise a crushable cartridge body 4810 comprising an outer layer 481 1 and an inner layer 4812, wherein the inner layer 4812 can comprise a corrugated, honeycomb-configured, lattice having a plurality of pockets, or cavities, 4815 defined therein.
  • the walls defining the lattice of inner layer 4812 can comprise one or more weakened, or thin, cross-sections 4819 which can be configured to allow the walls defining the lattice to break when the cartridge body 4810 is compressed. In such circumstances, the cartridge body 4810 can be crushed when the staple cartridge 4800 is implanted.
  • a staple cartridge such as staple cartridge 4900, for example, can comprise a cartridge body 4910 comprising an outer layer 491 1 and a plurality of collapsible elements 4912 positioned intermediate top and bottom portions of the outer layer 491 1 , for example.
  • the staple cartridge 4900 can further comprise a plurality of staples 4920, wherein each staple 4920 can be positioned in a collapsible element 4912.
  • each collapsible element 4912 can comprise a first portion 4912a, a second portion 4012b, and a third portion 4012c which can co-operate to define a cavity 4915 therein which is configured to receive a staple 4920.
  • 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 in order to compress the cartridge body 4910. As the tissue contacting surface 4919 is moved downwardly, the collapsible elements 4912 can collapse.
  • each collapsible element 4912 can collapse into a corresponding first portion 4912a and, similarly, the third portion 4912c of each collapsible element 4912 can collapse into a corresponding second portion 4912b.
  • the staples 4920 positioned within the collapsible elements 4912 can be deformed, as illustrated in FIG. 95.
  • each collapsible element 4912 can be frictionally engaged and/or press-fit within a corresponding first portion 4912a such that, once the compressive force applied to the collapsible element 4912 exceeds the retention force retaining the first portion 4912a and the second portion 4912b in their extended position (FIG. 94), the first portion 4912a and the second portion 4912b can begin to slide relative to one another.
  • each collapsible element 4912 can be frictionally engaged and/or press-fit within a corresponding second portion 4912b such that, once the compressive force applied to the collapsible element 4912 exceeds the retention force retaining the second portion 4912b and the third portion 4912c in their extended position (FIG. 94), the second portion 4912b and the third portion 4912c can begin to slide relative to one another.
  • a staple cartridge can comprise a plurality of staples therein.
  • Such staples can be comprised of a metal wire deformed into a substantially U- shaped configuration having two staple legs.
  • staples can 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 can comprise a round, or at least substantially round, cross-section.
  • the staple wires can comprise any other suitable cross-section, such as square and/or rectangular cross-sections, for example.
  • the staples can be comprised of plastic wires.
  • the staples can be comprised of plastic-coated metal wires.
  • a cartridge can comprise any suitable type of fastener in addition to or in lieu of staples.
  • a fastener can comprise pivotable arms which are folded when engaged by an anvil.
  • Two-part fasteners could be utilized.
  • a staple cartridge can comprise a plurality of first fastener portions and an anvil can comprise a plurality of second fastener portions which are connected to the first fastener portions when the anvil is compressed against the staple cartridge.
  • a sled or driver can be advanced within a staple cartridge in order to complete the forming process of the staples.
  • a sled or driver can be advanced within an anvil in order to move one or more forming members downwardly into engagement with the opposing staple cartridge and the staples, or fasteners, positioned therein.
  • a staple cartridge can comprise four rows of staples stored therein.
  • the four staple rows can be arranged in two inner staple rows and two outer staple rows.
  • an inner staple row and an outer staple row can be positioned on a first side of a cutting member, or knife, slot within the staple cartridge and, similarly, an inner staple row and an outer staple row can be positioned on a second side of the cutting member, or knife, slot.
  • the staple cartridge may not comprise a cutting member slot; however, such a staple cartridge may comprise a designated portion configured to be incised by a cutting member in lieu of a staple cartridge slot.
  • the inner staple rows can be arranged within the staple cartridge such that they are equally, or at least substantially equally, spaced from the cutting member slot.
  • the outer staple rows can be arranged within the staple cartridge such that they are equally, or at least substantially equally, spaced from the cutting member slot.
  • a staple cartridge can comprise more than or less than four rows of staples stored within a staple cartridge.
  • a staple cartridge can comprise six rows of staples.
  • the staple cartridge can comprise three rows of staples on a first side of a cutting member slot and three rows of staples on a second side of the cutting member slot.
  • a staple cartridge may comprise an odd number of staple rows.
  • a staple cartridge may comprise two rows of staples on a first side of a cutting member slot and three rows of staples on a second side of the cutting member slot.
  • the staple rows can comprise staples having the same, or at least substantially the same, unformed staple height.
  • one or more of the staple rows can comprise staples having a different unformed staple height than the other staples.
  • the staples on a first side of a cutting member slot may have a first unformed height and the staples on a second side of a cutting member slot may have a second unformed height which is different than the first height, for example.
  • an end effector of a surgical stapler can comprise a cartridge attachment portion, such as staple cartridge channel 5030, for example, a fastener cartridge removably positioned in the staple cartridge channel 5030, such as staple cartridge 5000, for example, and a jaw 5040 positioned opposite the staple cartridge 5000 and the staple cartridge channel 5030.
  • the staple cartridge 5000 can 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medicinal Preparation (AREA)
  • Prostheses (AREA)
  • Manufacture Of Porous Articles, And Recovery And Treatment Of Waste Products (AREA)
PCT/US2013/033997 2012-03-28 2013-03-27 Expandable tissue thickness compensator Ceased WO2013148762A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN201380027745.0A CN104321021B (zh) 2012-03-28 2013-03-27 可扩展的组织厚度补偿件
MX2014011667A MX376566B (es) 2012-03-28 2013-03-27 Compensador expansible de grosor de tejido.
BR112014024306-9A BR112014024306B1 (pt) 2012-03-28 2013-03-27 Compensador de espessura de tecido
RU2014143212A RU2648884C2 (ru) 2012-03-28 2013-03-27 Расширяемый компенсатор толщины ткани
JP2015503485A JP6193350B2 (ja) 2012-03-28 2013-03-27 拡張可能な組織厚コンペンセーター

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US13/433,098 US9301753B2 (en) 2010-09-30 2012-03-28 Expandable tissue thickness compensator
US13/433,098 2012-03-28
US13/433,115 US9204880B2 (en) 2012-03-28 2012-03-28 Tissue thickness compensator comprising capsules defining a low pressure environment
US13/532,820 US9314247B2 (en) 2012-03-28 2012-06-26 Tissue stapler having a thickness compensator incorporating a hydrophilic agent
US13/532,824 US9307989B2 (en) 2012-03-28 2012-06-26 Tissue stapler having a thickness compensator incorportating a hydrophobic agent

Publications (2)

Publication Number Publication Date
WO2013148762A2 true WO2013148762A2 (en) 2013-10-03
WO2013148762A3 WO2013148762A3 (en) 2013-12-05

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Application Number Title Priority Date Filing Date
PCT/US2013/033997 Ceased WO2013148762A2 (en) 2012-03-28 2013-03-27 Expandable tissue thickness compensator
PCT/US2013/034077 Ceased WO2013148817A1 (en) 2012-03-28 2013-03-27 Tissue thickness compensator comprising capsules defining a low pressure environment
PCT/US2013/033999 Ceased WO2013148764A2 (en) 2012-03-28 2013-03-27 Tissue thickness compensator comprising a reservoir
PCT/US2013/046540 Ceased WO2014004205A1 (en) 2012-03-28 2013-06-19 Tissue stapler having a thickness compensator incorporating a hydrophilic agent
PCT/US2013/046549 Ceased WO2014004208A1 (en) 2012-03-28 2013-06-19 Tissue stapler having a thickness compensator incorporating a bioabsorbable hydrophobic material

Family Applications After (4)

Application Number Title Priority Date Filing Date
PCT/US2013/034077 Ceased WO2013148817A1 (en) 2012-03-28 2013-03-27 Tissue thickness compensator comprising capsules defining a low pressure environment
PCT/US2013/033999 Ceased WO2013148764A2 (en) 2012-03-28 2013-03-27 Tissue thickness compensator comprising a reservoir
PCT/US2013/046540 Ceased WO2014004205A1 (en) 2012-03-28 2013-06-19 Tissue stapler having a thickness compensator incorporating a hydrophilic agent
PCT/US2013/046549 Ceased WO2014004208A1 (en) 2012-03-28 2013-06-19 Tissue stapler having a thickness compensator incorporating a bioabsorbable hydrophobic material

Country Status (7)

Country Link
US (4) US9204880B2 (enExample)
EP (4) EP2656793B1 (enExample)
JP (2) JP2015521524A (enExample)
CN (2) CN104582592B (enExample)
BR (1) BR112014032693B1 (enExample)
RU (2) RU2639035C2 (enExample)
WO (5) WO2013148762A2 (enExample)

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US20120241491A1 (en) 2012-09-27
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WO2013148764A3 (en) 2013-12-12
BR112014032693B1 (pt) 2022-07-12

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