BR112016028736B1 - STAPLER CARTRIDGE FOR USE WITH A SURGICAL STAPLER - Google Patents

Abstract

DEVICES FOR SEALING FABRIC CLAMPS. The present invention relates to an auxiliary composite material and methods of using an auxiliary composite material to reinforce a staple line. In general, the auxiliary composite material can be used to maintain a seal in the fabric and prevent tearing of the stapled fabric. This auxiliary composite material can be attached to the grip of a surgical stapler and can be implanted into the tissue along with the staples. In some embodiments, the auxiliary composite material may be sized and shaped so that a portion of the material extends laterally outside the staple line and distributes stress to the fabric outside the staple line. In certain aspects, the sealant can be applied to the staple line and auxiliary composite material in a variety of ways to seal the fabric and/or prevent fabric leaks from forming.

Description

FIELD

[001] The present invention relates to methods and devices for reinforcing a staple line.

BACKGROUND

[002] Surgical staplers are used in surgical procedures to seal, divide, and/or transverse tissue in the body by closing openings in tissue, blood vessels, ducts, shunts, or other objects or body parts involved in the specific procedure. Openings may be naturally occurring, such as passageways in blood vessels, airways, or an internal lumen or organ such as the stomach, or may be formed by the surgeon during a surgical procedure, such as by puncturing tissue or blood vessels to form a bypass or an anastomosis, or by cutting tissue during a stapling procedure.

[003] Most staplers have a handle with an elongated flexible or rigid shank having a pair of opposing jaws formed on one end thereof, for gripping and forming staples therebetween. At least one of the opposing jaws is movable with respect to the other jaw. In the case of laparoscopic surgery, one jaw is often fixed and the other is movable. On some devices (eg, an open linear stapler), the opposing jaws can be separated by the operator and reassembled to provide the relative movement necessary for tissue placement. Staples are typically contained in a staple cartridge, which can house multiple rows of staples and is often released in one of two jaws for ejection of staples at the surgical site. During use, the jaws are positioned so that the object to be stapled is placed between the jaws and the staples are ejected and formed when the jaws are closed and the device is triggered. Some staplers include a knife configured to pass between the rows of staples in the staple cartridge to cut lengthwise the stapled fabric between the stapled rows. Device placement, manipulation of device components or systems, and other device actuations such as articulation, triggering, etc., can be achieved in a variety of ways, such as electromechanically, mechanically, or hydraulically.

[004] Although surgical staplers have been improved over the years, a number of problems can arise. Although rare, as illustrated in Figure 1, one problem is that leakage can occur when the S-clamps form H tears when penetrating a T-fabric or other object, on which the S-clamps are arranged. Blood, air, gastrointestinal fluids, and other fluids can enter the H tears formed by the S-clamps, even after the S-clamps are fully formed. The T tissue to be treated can also become inflamed due to manipulations and deformation that can occur during stapling. In addition, staples, as well as other objects and materials implanted during stapling procedures, generally do not have the same characteristics as the tissue where they are being implanted. For example, staples and other objects and materials may not have the natural flexibility of the tissue in which they are implanted. One skilled in the art will recognize that it is normally desirable for the fabric to retain as much of its natural characteristics as possible after the staples are released.

[005] Consequently, there remains a need for methods and devices to place an implant in the patient.

SUMMARY

[006] A staple cartridge for use with a surgical stapler is provided and may include a cartridge frame and auxiliary material. The cartridge structure may have a plurality of staple cavities configured to position staples therein. The auxiliary material may be coupled to the cartridge structure and configured to be detached therefrom as the staples are released from the cartridge structure and into the fabric. The auxiliary material may include a solid central portion sized and formed to substantially correspond to the cartridge structure, and a wing portion extending along at least two sides of the solid central portion such that the wing portion extends beyond the lateral boundary of the cartridge structure in a direction transverse to a longitudinal axis of the cartridge structure.

[007] The solid central portion of the auxiliary material can vary in numerous ways. For example, the solid central portion of the auxiliary material may be formed substantially rectangular. In certain aspects, the solid central portion may include opposing first and second edges. In other aspects, the wing portion may extend along opposite first and second edges of the auxiliary material. During use, the solid central portion can be configured to reinforce a seal around the staples when the auxiliary material and staples are coupled to the fabric.

[008] The wing portion can have several characteristics. For example, the wing portion may include rounded corners. In another example, the wing portion may have a mesh structure. In certain aspects, the wing portion may have a plurality of apertures formed therein. In use, the wing portion may be configured to distribute or otherwise change a stress or strain present in the fabric beyond the staple line when the auxiliary material is disposed on the fabric.

[009] The wing and solid portions can be formed from various materials. In certain aspects, the wing and solid portions may be formed from a single polymer. In certain aspects, the wing and solid portions may be formed from more than one material or material type. In certain aspects, the wing and solid portions may be formed from different materials. In other aspects, the wing portion may be more flexible than the solid central portion of the auxiliary material.

[0010] An end actuator for a surgical instrument is provided, and may include first and second jaws, the first jaw having a cartridge structure removably affixed thereto, and the cartridge structure having a plurality of clamp cavities configured to accommodate the staples in them. The second jaw may include an anvil with a plurality of aperture-forming clips formed therein, at least one of the first and second jaws being movable relative to the other jaw. The end actuator may include a bracket having a width greater than a width of at least one of the cartridge structure and anvil, and the bracket having a compressible central region configured to form a seal around a clamp, and a strain relief region adjacent to the compressible region. The strain relief region may have a plurality of openings formed therein, and the strain relief region may extend from at least two sides of the central region. In use, the holder can be releasably retained on at least one of the cartridge structure and the anvil, and can be configured to be released therefrom upon application of the clamps from the cartridge structure and into the region. support compressible.

[0011] The end actuator can vary in numerous ways. In certain aspects, the plurality of openings include slits. When the support and staples are implanted in the fabric, the plurality of slits extend parallel to the longitudinal axes of the staples. In other aspects, the plurality of openings are separated so that the strain relief region is more flexible along a lateral portion thereof than a portion of the strain relief region adjacent to the compressible region. In other aspects, the plurality of openings are formed and separated so that the strain-relief region is more flexible along a longitudinal portion thereof than a portion of the strain-relief region adjacent to the compressible region.

[0012] A method of implanting a tissue reinforcement material into tissue is provided, and includes engaging the tissue between a cartridge assembly and an anvil of a surgical stapler in a surgical field, at least one of the cartridge assembly and the an anvil having a fabric reinforcing material releasably retained therein. The fabric reinforcement material may include a compressible core region configured to seal around a staple, and a flexible support region adjacent the core region that defines an edge of the fabric reinforcement material. Operating the surgical stapler can eject staples from the cartridge assembly to form a line of staples through the core and into the tissue to retain tissue reinforcement material in the surgical field.

[0013] The method may vary in any number of ways. For example, operating the surgical stapler can eject the staples through the central region and does not eject the staples through the flexible support region of the tissue reinforcement material. In certain aspects, the cartridge assembly and anvil may be inserted into the surgical field with the flexible support region folded around at least one of the cartridge assembly and anvil. Operating the surgical stapler can advance a cutting element through the tissue reinforcement material and release the tissue reinforcement material from the surgical stapler. In certain aspects, actuating the surgical stapler advances the cutting member through the central region of the tissue reinforcement material.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The invention will be more widely understood from the detailed description presented together with the accompanying drawings, in which:

[0015] Figure 1 is a side view of damaged stapled fabric;

[0016] Figure 2 is a perspective view of one embodiment of an auxiliary material, as described herein, that is attached to stapled fabric;

[0017] Figure 3 is a perspective view of a prior art surgical instrument that can be used with one or more auxiliary materials;

[0018] Figure 4 is an exploded perspective view of an end actuator and a distal end of a rod of the instrument of Figure 3;

[0019] Figure 5 is a perspective view of an electron beam component of the instrument of Figure 3;

[0020] Figure 6 is a perspective view of another prior art surgical instrument that can be used with one or more auxiliary materials;

[0021] Figure 7 is a perspective view of another prior art surgical instrument that can be used with one or more auxiliary materials;

[0022] Figure 8 is a perspective view of the end actuator insertion element of Figure 4;

[0023] Figure 9 is a side view of a prior art end actuator having an implantable staple cartridge therein;

[0024] Figure 10 is a side view of the embodiment of Figure 6;

[0025] Figure 11 is a cross-sectional view of the end actuator of Figure 9;

[0026] Figure 12 is a top view of the staple cartridge of the anastomotic stapling instrument of figure 7;

[0027] Figure 13 is a diagrammatic representation of staple lines installed using a prior art surgical stapling instrument;

[0028] Figure 14 is a top view of a prior art staple cartridge having a stapling pattern;

[0029] Figure 15 is a side view of an end actuator with a staple cartridge loaded with an auxiliary material;

[0030] Figure 16 is a cross-sectional view of the end actuator of Figure 4 in a triggered condition;

[0031] Figure 17A is a perspective view of the auxiliary material having a central portion and a wing portion, the auxiliary material being coupled to a cartridge assembly;

[0032] Figure 17B is a perspective view of an auxiliary material stapled to the fabric;

[0033] Figure 18 is a perspective view of another exemplary embodiment of a suture anchor.

[0034] Figure 19A is a perspective view of an auxiliary material having edge protrusions configured to distribute a stress on the fabric beyond a row of staples;

[0035] Figure 19B is a perspective view of another auxiliary material having edge protrusions, the auxiliary material being stapled to the fabric;

[0036] Figure 20 is a perspective view of an auxiliary material that includes an outer region with a plurality of cuts formed therein;

[0037] Figures 21A to 21C are side views of the auxiliary material that has modified external regions;

[0038] Figure 21D is a side cross-sectional view of the auxiliary material stapled to a lumen of the body;

[0039] Figure 22A is a perspective view of the auxiliary material having first and second layers and atraumatic woven edges;

[0040] Figure 22B is a side view of the auxiliary material of Figure 22A showing the first and second layers;

[0041] Figure 22C is a side view of the auxiliary material of Figure 22A absorbing a fluid between the first and second layers;

[0042] Figure 23A is a perspective view of the auxiliary material having a varying thickness in a lateral direction;

[0043] Figure 23B is an end view of an anvil and cartridge assembly, and two auxiliary materials of varying thicknesses, a first auxiliary material associated with the anvil and a second auxiliary material associated with the cartridge assembly;

[0044] Figure 23C is an end view of the anvil and cartridge assembly of Figure 23B, having first and second auxiliary materials coupled thereto;

[0045] Figure 23D is a side view of the first and second auxiliary materials stapled to the fabric;

[0046] Figure 24A is a side view of the auxiliary material having surface features formed therein to penetrate and hold the fabric;

[0047] Figure 24B is a side view of another auxiliary material that has surface features to penetrate and hold the fabric;

[0048] Figure 24C is an end view of four rows of auxiliary material, each row of auxiliary material having a surface feature attached to a fabric;

[0049] Figure 24D is a side view of an auxiliary material having surface features penetrated into the fabric;

[0050] Figure 25A is a side view of another exemplary auxiliary material having a plurality of sharp surface features for penetrating tissue;

[0051] Figure 25B is a side view of the auxiliary material of Figure 24A, having the surface features piercing the fabric;

[0052] Figure 26A is a perspective view of a cartridge assembly having an auxiliary material for detachable coupling to a distal end of the cartridge assembly;

[0053] Figure 26B is a side view of the cartridge assembly and an anvil of a surgical stapler holding tissue, with the auxiliary material of Figure 26A extending beyond the distal end of the cartridge assembly;

[0054] Figure 26C is a side view of the cartridge and anvil assembly of Figure 26B, applying staples through the auxiliary material and tissue;

[0055] Figure 27A is a perspective view of the auxiliary material having protuberances configured to mate with corresponding depressions formed in a cartridge assembly;

[0056] Figure 27B is a perspective view of the auxiliary material having a single protrusion configured to mate with a corresponding depression formed in a cartridge assembly;

[0057] Figure 28A is an end view of an auxiliary material extending around a cartridge assembly, and having first and second side edges coupled to the cartridge assembly;

[0058] Figure 28B is an end view of the auxiliary material and cartridge assembly of Figure 27A, and a cutting element being advanced through the cartridge assembly for releasing auxiliary material from the cartridge assembly;

[0059] Figure 29A is a perspective view of a cartridge assembly that includes suturing an auxiliary material to the cartridge assembly;

[0060] Figure 29B is a perspective view of the cartridge assembly and auxiliary material of Figure 29A, the suture separated from the cartridge assembly to release the auxiliary material;

[0061] Figure 30A is a perspective view of a surgical stapler shaft that includes an auxiliary material coupled thereto;

[0062] Figure 30B is a side view of the rod of Figure 30A showing the attachment points for fixing the auxiliary material on the rod;

[0063] Figure 30C is a perspective view of an actuator that can be inserted into the rod, and that has a plurality of lateral extension portions;

[0064] Figure 30D is a perspective view of the auxiliary material for attachment to the rod;

[0065] Figure 30E is a partial top view of the shank of Figure 30A with a stapler cutting member in a first retracted position;

[0066] Figure 30F is a partial top view of the rod of Figure 30A, with the cutting member in a second forward position, which releases the auxiliary material from the rod;

[0067] Figure 31A is an end view of a cartridge assembly, an auxiliary material, and an insertion tool for attaching the auxiliary material to the cartridge assembly;

[0068] Figure 31B is an end view of the insertion tool pressing the auxiliary material against the cartridge assembly of Figure 31A;

[0069] Figure 31C is an end view of the cartridge assembly of Figure 31A, having the auxiliary material affixed thereto and after the insertion tool has been removed from the cartridge assembly;

[0070] Figure 32A is an exemplary kit that includes a retention tool and a surgical stapler, the retention tool being configured to wrap the auxiliary material around a cartridge/anvil assembly;

[0071] Figure 32B is a side view of the holding tool of Figure 32A, being advanced proximally along a longitudinal axis of the anvil and cartridge assembly;

[0072] Figure 32C is a perspective view of the retaining tool and stapler of Figure 32A, the retaining tool being in a more proximal position;

[0073] Figure 33A is a perspective view of an end actuator of a stapler that has an auxiliary material attached thereto, and positioned above a trocar;

[0074] Figure 33B is a perspective view of the end actuator of Figure 33A, which has auxiliary material wrapped around the end actuator as the end actuator is inserted through the trocar;

[0075] Figure 34A is an end view of a cartridge and anvil assembly of a surgical stapler having a multilayer auxiliary material coupled thereto;

[0076] Figure 34B is a side view of three auxiliary materials stapled to the fabric, and having portions overlapping each other;

[0077] Figure 34C is a perspective view of a first auxiliary material, and a second auxiliary material stapled to the fabric, and having first and second overlapping portions;

[0078] Figure 35A is a perspective view of the first and second auxiliary materials stapled to the fabric, and having a sealant applied to an outer surface of the first auxiliary material;

[0079] Figure 35B is a side view of the first and second auxiliary materials of Figure 35A stapled to fabric;

[0080] Figure 35C is a side view of the first and second auxiliary materials of Figure 35A, which have a sealant applied to a space below an outer surface of the auxiliary material;

[0081] Figure 35D is a side view of the first and second auxiliary materials of Figure 35A in an expanded position;

[0082] Figure 36A is a perspective view of a system for spraying a sealant, which includes a container and an applicator tool that extends through a trocar and into the patient;

[0083] Figure 36B is a perspective view of the applicator tool of Figure 36A releasing sealant to a line of staples in the fabric;

[0084] Figure 36C is a perspective view of the sprayed sealant of Figure 36A, hardened at the staple line;

[0085] Figure 37A is a perspective view of another exemplary system for spraying a sealant and releasing a sealant sprayed directly into a patient through a trocar and into the patient; and

[0086] Figure 37B is a perspective view of the trocar of Figure 37A, applying sealant sprayed onto tissue at and beyond the staple line.

DETAILED DESCRIPTION

[0087] Certain exemplifying modalities will now be described to provide a general understanding of the principles of structure, function, fabrication and use of the devices and methods disclosed here. One or more examples of such embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are exemplary, non-limiting embodiments, and that the scope of such devices and methods is defined solely by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the devices and methods described herein. Additionally, in the present description, similarly numbered components of the various embodiments generally have similar characteristics when these components are of a similar nature and/or serve a similar purpose.

[0088] Reference throughout the specification to "several modalities", "some modalities", "one modality" or "the modality", or the like, means that a feature, structure or characteristic described in conjunction with the modality is included in at least one modality. Thus, the appearance of the expressions "in several modalities", "in some modalities", "in a modality" or "in the modality", or similar, in places throughout the descriptive report is not necessarily referring to the same modality . In addition, specific features, structures or features can be combined in any suitable way in one or more modalities. Therefore, the specific features, structures or characteristics illustrated or described in conjunction with one modality may be combined, in whole or in part, with the structures of the features or characteristics of one or more other modality, without limitation. Such modifications and variations are intended to be included within the scope of the methods, apparatus, devices and systems described herein.

[0089] The terms "proximal" and "distal" are used in the present invention with reference to a physician who manipulates the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the physician, and the term "distal" refers to the portion located away from the physician. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "upwards" and "downwards" may be used in the present invention in connection with the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

[0090] It may be desirable to use one or more biological materials and/or synthetic materials collectively mentioned in the present invention as "ancillary materials" in conjunction with surgical instruments to help improve surgical procedures. These biological materials may be derived from animal and/or human sources. One skilled in the art may refer to these types of materials as support materials as well as auxiliary materials.

[0091] Various exemplifying devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. In some embodiments, the devices and methods are provided for open surgical procedures, and in other embodiments, the devices and methods are provided for laparoscopic, endoscopic, and other minimally invasive surgical procedures. Devices can be triggered directly by a human user or remotely under the direct control of a robot or similar manipulation tool. However, one of skill in the art will understand that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications. Those skilled in the art will also understand that the various instruments presented herein can be inserted into a body in any way, such as through a natural orifice, through an incision or perforation formed in the tissue, or through an access device such as a cannula. to exchange, &c. For example, the functional portions or end actuator portions of instruments can be inserted directly into a patient's body, or they can be inserted through an access device that has a working channel through which the end actuator can be advanced. and the elongated shaft of a surgical instrument.

[0092] Surgical instrument end actuators, as described herein, may be configured to apply one or more synthetic materials and/or biological materials, collectively referred to in the present invention as "auxiliary materials," to a surgical site to assist to improve surgical procedures. These biological materials may be derived from animal and/or human sources. While a variety of different end actuators can benefit from the use of auxiliary materials, in some exemplary embodiments the end actuator can be a surgical stapler. When used in conjunction with a surgical stapler, the auxiliary material(s) may be disposed between and/or in the stapler's jaws, included in a staple cartridge disposed in the jaws, or placed another way near the clamps. When the staples are positioned, the ancillary materials can remain at the treatment site with the staples, in turn, generating several benefits. In some cases, the material(s) may be used to help seal the holes formed by the staples as they are placed in tissue, blood vessels, and other objects or body parts. Tissue reinforcement may be necessary to prevent staples from tearing the tissue if the tissue is diseased, it is healing from another treatment such as irradiation, drugs such as chemotherapy, or other tissue property change. In some cases, the auxiliary material(s) can minimize tissue movement at and around the staple perforation sites that can occur from tissue deformation that occurs after the staple is punctured. stapling (e.g. lung inflation, gastrointestinal tract distention, etc.). It will be recognized by one skilled in the art that a puncture site of the staple can serve as a stress concentration and that the size of the hole created by the staple will grow when the tissue around it is placed under tension. Restricting tissue movement around these perforation sites can minimize the size of holes that can grow under tension. In some cases, the auxiliary material(s) may be configured to absorb beneficial fluids, e.g. sealants, blood, glues, which further promote healing, and in some cases , the auxiliary material(s) may be configured to degrade to form a gel, e.g. a sealant, which further promotes curing. In some cases, the helper may transport materials that, when placed in a humid environment (e.g. blood, water, saline, or other body fluids) form a sealant to create a seal (e.g., human-derived fibrinogen and thrombin or animal can be lyophilized into a powder which, when mixed with water, creates a sealant). Additionally, the materials can help reduce inflammation, promote cell growth and otherwise enhance healing.

[0093] Figure 2 illustrates an embodiment of an auxiliary material that includes a porous support 30 that can be attached to a tissue T to be treated by a surgical stapler and that remains in the treatment site with staples 70. The support 30 can be made of one or more absorbent materials and may be printed, pressed, cut, patterned, woven, cast, blown, comprised of composite structures and/or methods or otherwise shaped to facilitate absorption, reinforcement, application and/or retention of beneficial fluids such as sealants, glues, blood, etc. Absorption and/or retention of beneficial fluids, for example a fibrin sealant 40, at the treatment site can help to prevent leakage and further strengthen the support 30.

surgical stapling instrument

[0094] While various surgical instruments may be used in conjunction with the ancillary materials disclosed herein, Figures 1 and 3 illustrate a non-limiting exemplary embodiment of a surgical stapler 10 suitable for use with one or more ancillary materials. As shown, the instrument 10 includes a handle assembly 12, a stem 14 extending distally from a distal end 12d of the handle assembly 12, and an attachment portion 50 detachably coupled to a distal end 14d of the handle assembly 12. rod 14. As the illustrated embodiment is a surgical stapler, a distal end 16d of the attachment portion 16 includes an end actuator 50 having jaws 52, 54, although other types of end actuators can be used with the rod 14, cable assembly 12 and associated components. As shown, the surgical stapler includes first and second jaws 52, 54 opposite the first lower jaw 52, including an elongated channel 56 (Figure 4) configured to support a staple cartridge 60, and the second upper jaw 54 having a surface 58 (Figures 3, 4 and 6) facing the lower jaw 52 and which is configured to function as an anvil to help deploy the staples of a staple cartridge. Jaws 52, 54 are configured to move relative to each other to secure tissue or other objects disposed therebetween, and an axial drive assembly 80 (Figure 11) can be configured to traverse at least a portion of the actuator. end cap 50 to eject staples into tight tissue. In various embodiments, a knife blade 81 may be associated with the axial drive assembly 80 to cut the fabric during the stapling process. At least one of the opposing upper and lower jaws 52, 54 will be movable with respect to the other upper and lower jaws 52, 54. At least one of the opposing upper and lower jaws 52, 54 may be fixed or otherwise immobilized. In some embodiments, both the upper and lower jaws 52, 54 will be movable.

[0095] Operation of end actuator 50 and drive assembly 80 may begin with the entry of a clinician into cable assembly 12. Cable assembly 12 can have many different configurations designed to handle and operate the associated end actuator to him. In the illustrated embodiment, the handle assembly 12 has a pistol handle-like housing 18 with various mechanical components disposed therein to operate various aspects of the instrument. For example, handle assembly 12 may include a knob 26 mounted adjacent a distal end 12d thereof, which may facilitate rotation of stem 14 and/or end actuator 50 relative to handle assembly 12 about of a longitudinal axis L of the rod 14. The cable assembly 12 may additionally include clamping components as part of a locking system actuated by a clamping trigger 22 and triggering components as part of the triggering system which are actuated by means of a firing trigger 24. The firing and clamping triggers 22, 24 can be forced into an open position with respect to a stationary cable 20, for example, by a torsion spring. Movement of the clamping trigger 22 towards the stationary handle 20 can trigger the clamping system, described below, which can cause the jaws 52, 54 to close towards each other and thus clamp the fabric therebetween. Movement of firing trigger 24 can trigger the firing system, described below, which can cause staples to be ejected from a staple cartridge disposed therein and/or advance of knife blade 81 to cut tissue captured between the jaws. 52, 54. A person skilled in the art will recognize different configurations of components of a triggering system, mechanical or otherwise, that can be used to eject staples and/or cut tissue, and thus no explanation is necessary. detailed of the same.

[0096] As shown in detail in Figure 4, the end actuator 50 of the illustrated embodiment is a surgical stapling instrument having a first lower jaw 52, which serves as a cartridge or carrier assembly, and a second upper jaw 54 opposite that serves as an anvil. The staple cartridge 60, having a plurality of staples 70 therein, is supported on a staple track 57, which, in turn, is supported within the cartridge channel of the lower jaw 52. The upper jaw 54 has a plurality of staple forming pockets 66 (Figure 11), each of which is positioned above a corresponding staple of the plurality of staples 70 contained within the staple cartridge 60. Upper jaw 54 can be connected to lower jaw 52 in a variety of ways, although in the illustrated embodiment, upper jaw 54 has a pivoting proximal end 54p that is pivotally received within a proximal end 56p of clamp channel 56, just distal to its engagement with shank 14. When upper jaw 54 is pivoted to down, the upper jaw 54 moves the surface of the anvil 58 and the staple forming pockets 66 formed therein move to the opposite staple cartridge 60.

[0097] Various clamping components can be used to effect the opening and closing of the jaws 52, 54 to selectively clamp the tissue between them. In the illustrated embodiment, the pivoting end 54p of the upper jaw 54 includes a closure element 54c distal to its pivotal connection with the clamp channel 56. In this way, a closure tube 82, the distal end of which includes a horseshoe 80 which engages this closing member 76, selectively imparts an opening movement to the anvil 54 during proximal longitudinal movement and a closing movement to the anvil 54 during the distal longitudinal movement of the closing tube 78 sliding over the rod structure 82 in response to the closing actuator 22. It will be appreciated by one skilled in the art that the opening and closing of the end actuator 50 can be effected by a relative movement of the lower jaw 52 relative to the upper jaw 54, a relative movement of the upper jaw 54 relative to the lower jaw 52, or by the movement of both jaws 52, 54 relative to each other.

[0098] The firing components of the illustrated embodiment may include a firing bar 84, as shown in Figure 5, having an electron beam 86 at a distal end thereof. The firing bar 84 is encompassed within the rod 14, for example, a longitudinal slot of the firing bar 14s of the rod 14, and guided by a firing movement from the handle 12. The actuation of the firing trigger 24 can affect distal movement of electron beam 86 through at least a portion of end actuator 50 to thereby trigger clips 70 contained within clip cartridge 60. In the illustrated embodiment, guides 85 projecting from a distal end of the clip electron beam 86 can engage a wedge slider 90 which, in turn, can push staple drivers 92 upward through staple cavities 68 formed in staple cartridge 60. Clip holders 92 apply an upward force to each plurality of clips 70 within the cartridge 60 to thereby push the clips 70 up against the anvil surface 58 of the upper jaw 54 and to create shaped clips. 70'.

[0099] In addition to triggering staples, the electron beam 86 can be configured to facilitate closing of jaws 52, 54, spacing between upper jaw 54 from staple cartridge 60, and/or tissue cutting captured between the jaws 52, 54. In particular, a pair of top pins 87 and a pair of bottom pins 89 may engage with one or both of the upper and lower jaws 52, 54 to compress the jaws 52, 54 into towards each other as the firing bar 84 advances through the end actuator 50. Simultaneously, a knife 81 extending between the top and bottom pins 87, 89 can be configured to cut the tissue captured between the jaws 52, 54.

[00100] During use, the surgical stapler can be placed in a cannula or port and placed in a surgical site. A tissue to be cut and stapled can be placed between the jaws 52, 54 of the surgical stapler 10. Features of the stapler 10, such as the rotary knob 24 and drive lever 26, can be performed as desired by the clinician to target a location. desired on the jaws 52, 54 at the surgical site and the tissue relative to the jaws 52, 54. After proper positioning is achieved, the trigger 22 can be pulled toward the stationary handle 20 to trigger the firing system. Trigger 22 may cause components of the firing system to function so that control rod 82 advances distally through at least a portion of rod 14 so that jaws 52, 54 collapse together to grip tissue disposed therebetween. and/or drive the trigger assembly 80 distally by at least a portion of the end actuator 50. Thereafter, the trigger 24 may be pulled toward the stationary handle 20 to cause the triggering system components to operate in such a manner. such that the trigger bar 84 and/or the electron beam 86 are advanced distally through at least a portion of the end actuator 50 to trigger the clamps 70 and, optionally, sever the captured tissue between the jaws 52, 54 .

[00101] Another embodiment of a surgical instrument 100 is illustrated in Figure 6. Like the surgical instrument 10, the surgical instrument 100 includes a handle assembly 112 with a stem 114 extending distally therefrom and having an actuator end cap 150 at a distal end thereof for tissue treatment. The upper and lower jaws 154, 152 of the end actuator 150 may be configured to capture tissue therebetween, staple the tissue by firing staples from a cartridge 160 positioned in the lower jaw 154, and/or create an incision in the tissue. In this embodiment, an attachment portion 116 at a proximal end of the stem 114 may be configured to enable removable connection of the stem 114 and end actuator 150 to the cable assembly 112. In particular, the corresponding features 125 of the attachment portion 116 may pair with complementary matching features 123 of the cable assembly 112. Matching features 123, 125 may be configured to be coupled together via, for example, a snap-fit coupling, a bayonet-style coupling, etc., although any of the corresponding complementary features and any type of coupling features may be used to detachably couple the rod 114 to the cable assembly 112. Although the entire rod 114 of the illustrated embodiment is configured to be removable from the cable assembly 112, in some cases In other embodiments, the attachment portion 116 may be configured to allow separation of only a distal portion of the ha Stem 114. Removable coupling of stem 114 and/or end actuator 150 may enable selective attachment of an end actuator 150 for a particular procedure and/or reuse of cable assembly 112 for multiple different procedures.

[00102] Cable assembly 112 may have one or more features thereon for manipulating and operating end actuator 150. By way of non-limiting example, a rotary knob mounted on a distal end 126 of cable assembly 112 may facilitate rotation of stem 114 and/or end actuator 150 relative to cable assembly 112. Cable assembly 112 may additionally include clamping components as part of a trigger-actuated clamping system 122 and triggering components as part of a trigger system that may also be actuated by trigger 122. Thus, in some embodiments, movement of trigger 122 toward a stationary handle 120 through a first range of motion may drive fasteners to cause the opposing jaws 152, 154 approach each other to a closed position. Further movement of trigger 122 toward stationary handle 120 through a second range of motion can drive trigger components to cause staples to eject from staple cartridge 160 and/or advance a knife to cut tissue. captured between claws 152, 154.

[00103] Another embodiment of a surgical instrument 200 is illustrated in Figure 7. Like the surgical instruments 10 and 100, the surgical instrument 200 includes a handle assembly 212 with a shank 214 extending distally therefrom and having an end actuator 250 at a distal end thereof for tissue treatment. End actuator 250 may include a cartridge assembly 252 and anvil 254, each having a tissue-contacting surface 260p, 260d that is substantially circular in shape. Cartridge assembly 252 and anvil 254 may be coupled by a rod 262 extending from anvil 254 to cable assembly 212 of stapler 200, and manipulation of an actuator 222 on cable assembly 220 may retract and displace the shank 262 for moving the anvil 254 with respect to the cartridge assembly 252. In one embodiment, the shank 262 may be formed of first and second portions (not shown) configured to releasably couple to allow the anvil 254 to be detached from the cartridge assembly 252, allowing greater flexibility in positioning the anvil 254 and cartridge assembly 252 in one body. For example, the first portion of the stem may be disposed within the cartridge assembly 252 and extends distally out of the cartridge assembly 252, terminating in a corresponding distal feature. The second portion of the stem 214 may be disposed within the anvil 254 and extend proximally outside the cartridge assembly 252, terminating in a proximal corresponding feature. In use, the corresponding proximal and distal features may be coupled together to allow the anvil 254 and cartridge assembly 252 to move relative to each other. The anvil 254 and cartridge assembly 252 can perform various functions and can be configured to capture tissue together, staple tissue from the staple firing of a staple cartridge 252, and/or can create an incision in the tissue. In general, the cartridge assembly 252 can house a cartridge containing the staples and can position the staples against the anvil 254 to form a circular pattern of staples around the circumference of a tubular organ of the body.

[00104] The cable assembly 212 of the stapler 200 may have several actuators disposed thereon which can control the movement of the stapler. For example, the cable assembly 212 may have a knob 226 disposed thereon to facilitate positioning of the end effector 250 by means of rotation and/or a trigger 222 for actuating the end actuator 250. The trigger 222 through a first range of motion can drive components of a stapling system in order to join the jaws, i.e., move the anvil 254 toward the cartridge assembly 252. The movement of the trigger 222 through a second range of motion. Movements can drive components of an unloading system to cause the staples of the staple cartridge assembly 252 to position and/or cause a knife to move to cut the captured tissue between the cartridge assembly 252 and the anvil 254.

[00105] The illustrated embodiment of a surgical stapler 10, 100 and 200 features one of many different configurations and associated methods of use that may be used in conjunction with the disclosures provided herein. While the illustrated modalities are all configured for use in minimally invasive procedures, it will be appreciated that instruments configured for use in open surgical procedures, e.g., open linear staplers, as described in the U.S. patent. No. 8,317,070, may be used in conjunction with the descriptions provided herein. Further details on illustrated embodiments, as well as additional exemplary embodiments of surgical staplers, components thereof, and their related methods of use, which may be used in accordance with the present disclosure, include the devices, components, and methods provided in the U.S. publication. No. 2013/0256377, in U.S. Patent No. 8,393,514, in U.S. Patent No. 8,317,070 in U.S. Patent No. 7,143,925 in U.S. Patent Application Serial No. 14/074,884, entitled "Sealing Materials for Use in Surgical Procedures", and was filed on November 8, 2013, in the U.S. patent application. No. 14/074,810 entitled "Hybrid Adjunct Materials for Use in Surgical Stapling" and filed November 8, 2013, in the U.S. patent application. No. 14/075,438 entitled "Positively Charged Implantable Materials and Method of Forming the Same" and filed November 8, 2013, in the U.S. patent application. No. 14/075,459 entitled "Tissue Ingrowth Materials and Method of Using the Same" and filed November 8, 2013, in the U.S. patent application. No. 14/074,902 entitled "Hybrid Adjunct Materials for Use in Surgical Stapling" and filed November 8, 2013, in the U.S. patent application. No. 14/226,142 entitled "Surgical Instrument Comprising a Sensor System" and filed March 26, 2014, each of which is incorporated herein by reference in its entirety.

End actuator variations

[00106] The end actuators of the surgical stapling instruments described herein may have one or more features to adjust the amount of compression applied to tissue captured by the end actuator. In some embodiments, the end actuator can be configured to create a desired compression profile in the tissue captured therein, for example, a profile that helps minimize bleeding, tearing, and/or leakage of the treated tissue. By way of non-limiting example, the desired fabric compression profile can be obtained using variations in a gap between the upper and lower jaws of the end actuator and/or variations in the orientation, size, and/or shape of the clamps. applied to the tissue by the end actuator. As described in detail in this document, auxiliary material(s) used in conjunction with such an end actuator may be configured to assist in creating the desired tissue compression profile and/or to accommodate characteristics used to create the desired tissue compression profile.

[00107] Any of these variations described in the present invention can be used alone or together to provide the desired tissue compression profile. Although exemplary end actuators and components thereof are described in conjunction with a specific surgical instrument, for example, instruments 10, 100, and 200, it will be appreciated that end actuators and components thereof may be configured for use. with other modalities of surgical instruments, as described here.

[00108] In some embodiments, a staple cartridge disposed within an end actuator of a surgical stapling instrument may have a first portion configured to compress tissue captured by the end actuator more than a second portion when the actuator end is in a closed position. The first portion of the cartridge may be spaced longitudinally and/or laterally from the second portion to create a desired compression gradient. For example, as shown in Figures 4 and 8, the staple cartridge 60 may have a graduated tissue contact surface. In particular, cartridge 60 may have an inner tissue-contacting surface 62 and outer tissue-contacting surfaces 64 that extend upward to a higher height than the inner tissue-contacting surface 62. Thus, when the upper jaw 54 is in the closed position and close to the cartridge 60, the anvil surface 58 can be configured to compress the outer surfaces 64 more than the inner surface 62, due to the higher height of the outer surfaces 64. In In some circumstances, including circumstances where the tissue positioned between the anvil surface 58 and the cartridge 60 has a constant, or at least substantially constant, thickness, the pressure generated within the tissue may be greater in the outer portions of the end actuator 50 than in the internal portions of end actuator 50. Considering that the compression gradient generated by cartridge 60 varies in a graduated manner, it will be appreciated by one skilled in the art. the technique that a compression gradient can be generated within the tissue by a gradual increase in height of various portions of the cartridge 60. It will also be understood that a compression gradient can be obtained by varying the height of the anvil surface 58, for example alone or in combination with variations in height of cartridge 60, and that variations in height may be spaced laterally and/or longitudinally along end actuator 50.

[00109] In some embodiments, one or more auxiliary materials affixed to an end actuator of a surgical stapling instrument may be used to create a desired compression profile in the tissue captured by the end actuator. Referring now to Figure 9, a compressible and implantable staple cartridge 360 may be formed from one or more auxiliary materials, as described herein, and may be configured to be accommodated within an end actuator of a surgical instrument, for example. example, an end actuator 350. Cartridge 360 may have a height that decreases from a higher height H1 at a distal end 360d thereof, to a lower height H2 at a proximal end 360p thereof. In this manner, when an upper jaw 354 of end actuator 350 is in the closed position proximate to cartridge 360, an upper jaw 354 of end actuator 350 can be configured to compress distal end 360d more than proximal end 360p. Although the compression gradient created in the tissue captured by the cartridge 360 decreases linearly from the distal end 360d to the proximal end 360p, it will be appreciated by one skilled in the art that any compression gradient can be created by different shapes of the cartridge 360. In one embodiment, a thickness of cartridge 360 can vary across its width, similar to cartridge 360.

[00110] In some embodiments, staples contained within a staple cartridge of an end actuator can be configured to create a desired compression profile within the tissue captured by the staples. The desired compression profile can be created in the stapled fabric, for example, where the staples within the staple cartridge have different unformed staple heights. As shown in Figure 10, an unformed height H of the exemplary clip 70 can be measured from a base 74 of the clip 70 to a top, or tip, of the legs 72a, 72b of the clip 70. Referring now to Figure 11, which illustrates a cross-section of end actuator 350, a first clamp group 370a may have a first clamp height H1 that is higher than the second clamp height H2 of a second clamp group 370b. The first group of staples 370a may be positioned in a first portion of the staple cartridge 360, for example in an outer portion, and the second group of staples 370b may be positioned in a second portion of the staple cartridge 360, for example in an inner portion. In the illustrated embodiment, the cartridge 360, and therefore the compression gradient, may be configured to be symmetrical about a slot 367 configured to receive a cutting instrument, e.g., electron beam 86, therethrough. It will be appreciated by one of skill in the art that the first and second groups of clips 370a, 370b may be arranged in any pattern, and may be spaced laterally and/or longitudinally along the cartridge 360. In certain embodiments, a plurality of staple groups, where each group has a different staple height. In at least one of these embodiments, a third group having an intermediate staple height may be positioned in cartridge body 2110 at an intermediate position between the first group of staples and the second group of staples. In various embodiments, each staple in a row of staples in the staple cartridge may comprise a different staple height. In at least one embodiment, the tallest staple of a row of staples may be positioned over a first end of a row of staples, and the shortest staple may be positioned at an opposite end of the row of staples. In at least one of these embodiments, staples arranged in an intermediate position between the tallest staple and the shortest staple may be arranged so that the heights of the staples decrease between the tallest staple and the shortest staple, for example.

[00111] Similarly, the staples within the staple cartridge can have different crown widths to create a desired compression profile in the stapled fabric. As shown in Figure 10, the crown width W of the exemplary clip 70 can be measured from one side of the base 74 of the clip 70 to an opposite side. As with the variations in staple height H described above, variations in staple width W may be spaced across the staple cartridge so as to create a plurality of groups of staples dispersed longitudinally and/or laterally along the cartridge. By way of non-limiting example, Figure 12 illustrates a staple cartridge 260 for use with the surgical instrument 200, and which has staples 270 therein with different crown widths W. The staple cartridge 260 houses three groups of staples 270a. , 270b, 270C, each having different widths W1, W2, and W3, respectively, although any number of groups of staples is possible. As shown, groups of staples 270a, 270b, 270c may be arranged in circumferential rows, with staples 270c having the greatest width W1 and positioned on an outermost edge of the cartridge 260, and staples 270a having the smallest width W3 and positioned on an innermost edge of the 260 cartridge. In other embodiments, staples that have the largest crown width can be positioned close to an innermost edge of a cartridge, and staples that have a smaller crown width may be positioned close to the innermost edge of a cartridge. an outer edge of the cartridge. In still other embodiments, the staples along the same line may have different crown widths.

[00112] Additionally or alternatively, it may be possible to create a desired tissue compression profile by creating different heights of formed (end) staples. Figure 13 illustrates an exemplary embodiment of formed staple lines 470' installed using a surgical stapling instrument as described herein and configured to apply staples 470' having different formed heights, as well as cutting tissue to create, thus, a cut line 494. As shown in Figure 13, the formed heights F1 of a first group of staples 470a' in a first row that is furthest from the cut line 494 are greater than the formed heights F3 of a third group. of staples 470c' in a third row which is closer to the cut line 494. A second group of staples 470b' in a second row which is formed between the first and third rows may have staples 470b' with a formed height F2 which lies up between the heights F1, F3. In other embodiments, the formed heights of the staples may decrease from an innermost row to an outermost row. In other applications, it may be desirable for the formed heights of the staples in a single row to increase (or decrease) from staple to staple.

[00113] Again with reference to Figure 11, the differences in the formed heights of the clamps can be obtained by, for example, changing a clamp formation distance A. The formation distances A1, A2 can be measured from a base of clips 370a, 370b, respectively, within the cartridge 360, and an apex of a forming pocket 366 corresponding to the anvil surface 358 when the upper jaw 354 is in the closed position. In one embodiment, for example, a first staple formation distance A1 is different from a second staple formation distance A2. Due to the fact that the forming distance A1 is greater than the forming distance A2, the staples 370a are not compressed as much as the staples 370b, which can change the formed heights of the staples 370a, 370b. In particular, greater amounts of compression, corresponding to smaller forming distances, can result in clamps with smaller formed (end) heights. It will be understood that similar results can be achieved in any desired pattern.

[00114] Varying tissue compression gradients can be obtained through patterns in the orientation of staples within a staple cartridge, for example, by the patterns illustrated in Figures 14 and 15. In the embodiment shown in Figure 14, the staple cartridge 560 may include at least one first staple cavity 568a and at least one second staple cavity 568b for storing staples 570 therein. The first cavity 568a may be located on the first side side 563 of the cartridge 560, and the second cavity 568b may be located on a second side side 565 of the cartridge 560, the first and second side sides 563, 565 being separated by a slot 567 configured to receive a cutting instrument, for example the electron beam 86, therethrough. First cavity 568a may define a first longitudinal axis 569a and second cavity 568b may define a second longitudinal axis 569b. In the illustrated embodiment, the first axis 569a is perpendicular, or substantially perpendicular, to the second axis 569b. In other embodiments, the first axis 569a can be transverse to the second axis 569b, so that the axes 569a, 569b can create an acute or obtuse angle to each other. In still other embodiments, the first axis 569a may be parallel to, or substantially parallel to, the second axis 569b. In some embodiments, at least a portion of the clip cavities 568a, 568b may overlap, so that clips 570 therein may be interlocked when formed. Cartridge 560 may have a plurality of each of first and second cavities 568a, 568b, which may be arranged in any pattern on the first and second sides 563, 565 of cartridge 560, for example, in rows extending along both sides 563, 565 of cartridge 560 along a longitudinal axis Lc of cartridge 560. Staples 570 housed within pockets 568a, 568b may be implanted into tissue in a pattern determined by the orientation and positioning of pockets 568a, 568b. Cartridge 560, for example, can be used to implant staples 570 that have different orientations than staples 570 on opposite sides of an incision line created by a surgical instrument carrying cartridge 560.

[00115] In other embodiments, for example the embodiment of a cartridge 660 illustrated in Figure 15, clip cavities 668a and 668b that have different orientations may both be arranged on a single lateral side of the cartridge 660. As shown in Figure 15, a axis 669a of first staple cavity 668a is perpendicular, or substantially perpendicular, to an axis 669b of second staple cavity 668b, both of which are disposed on each of first and second side sides 663, 665 of cartridge 660. In others embodiments, the axes 669a, 669b may form an acute or obtuse angle to each other, or may be parallel to each other. A plurality of first and second cavities 668a, 668b may be aligned in adjacent rows along a longitudinal axis Lc' of cartridge 660 on each of lateral sides 663, 665 of cartridge 660. In this embodiment, clips 670 housed within the Cavities 668a, 668b can be implanted into tissue in a symmetrical pattern around an incision line by a surgical instrument loading cartridge 660. More details on staple patterns, as well as additional modalities of such patterns, can be found. in US Publication No. 2011/0192882, incorporated herein by reference in its entirety.

Exemplary compositions for auxiliary materials

[00116] Regardless of the configuration of the surgical instrument, the present invention features the use of implantable materials, for example, biological materials and/or synthetic materials, collectively "auxiliary materials", in conjunction with the instrument's operations. As shown in Figures 12 and 16, the end actuator 50 may include at least one piece of auxiliary material 200, 30' positioned between the first and second jaw members 52, 54 and which may be retained in one of the support 56 and/or anvil portion 58. In use, the patient's layer and tissue may be captured by the staples when the staples are fired. Then, the layer can be separated from the surgical stapler and can remain on the patient when the stapler is removed from the patient. Exemplary devices and methods for attaching one or more auxiliary materials to an end actuator of a surgical instrument can be found in US Publication No. 2013/0256377, and in US Publication No. 2013/0153641, incorporated herein in full, reference title.

[00117] The auxiliary material used in conjunction with the descriptions presented here can have any number of configurations and properties. Generally, they can be formed from a bioabsorbable material, a biofragmentable material, and/or a material that can be decomposed in another way, for example, so that the auxiliary material can be absorbed, fragmented, and/or decomposed during the process. of cure. In at least one embodiment, the auxiliary material may be configured to degrade over time to form a gel, e.g. a sealant, to aid in wound healing. In at least one embodiment, the ancillary material can include a therapeutic drug that can be configured to be released over time to help the tissue heal, for example. In accordance with other different embodiments, the auxiliary materials may include a non-absorbable material and/or non-decomposable material, for example.

[00118] Some particularly advantageous auxiliary materials may include porous polymer scaffolds which may be configured so that they decompose, for example, upon exposure to water, so that the water attacks a polymer bond in the material. The degraded material can be configured to gel over a wound site to thereby coat injured tissue, e.g. soft tissue wounds, which can generally aid in compression, sealing and/or creating an environment at the wound site that promotes tissue healing. In particular, such degradable polymers can enable the fabric itself to become the weight-bearing component. In some embodiments, the degraded material may include chemotactic agents that attract natural healing compounds to the wound site. Polymer scaffolds can be configured to have a desired rate of degradation, for example minutes to hours after attachment to tissue, in order to aid the healing process almost immediately after attachment. For more details on porous polymer scaffolds as described herein, see Q. Chen et al., Elastomeric biomaterials for tissue engineering, Progress in Polymer Science 38 (2013) 584 to 671, incorporated herein in full by reference.

[00119] In some embodiments, the porous polymer scaffolds described herein may be physically cross-linked, which may enable the polymer to be formed into various complicated three-dimensional shapes, e.g., fibers, sheets, films, etc., having any porosity. desired, surface-to-volume ratio, and mechanical properties. The scaffold can be formed into a desired shape by various methods, for example by extrusion, wet spinning, electrospinning, thermally induced phase separation (TIPS), salt leaching/freeze-drying, etc. Where the scaffold is formed into a film or sheet, the film or sheet can be of any thickness desired, for example in the range of about 50 to 750 μm or in the range of about 1 to 3 mm, depending on the desired application.

[00120] One embodiment of a porous polymer scaffold includes multiple layers, each of which may play different roles in wound healing. In an exemplary embodiment, the framework includes three layers. The first layer can be made of polyester carbonate urethane urea (PECUU), the second layer can be made of poly(ester urethane) urea (PEUU), and the third layer can be made of poly(carbonate urethane) urea ) (PCUU), lysine triisocyanate (LTI) or hexamethylene diisocyanate (HDI). One skilled in the art will appreciate that the properties of each layer can be optimized to achieve desired results and performance. In some embodiments, the desired properties of the scaffold can be obtained by mixing or copolymerizing the third layer or copolymerized material with different polymers or copolymers. By way of non-limiting examples, the third layer material may be blended with a polyester copolymer, for example polycaprolactone (PCL), PGA polyglycolic acid, poly(D,L-lactic acid) (PDLLA), PGA and/or polyethylene glycol (PEG). Where the third layer material is blended with either a polyester copolymer or PEG, the ratio of polyester to PEG in the third layer can be about 50:50. In another exemplifying embodiment, PCL can be present in a range of about 60 to 70% weight/volume, PGA can be present in a range of about 20 to 30% weight/volume, PEG may be present in a range of about 50% weight/volume, and PDLLA may be present in a range of about 10% weight/volume.

[00121] The three-layer film can be set to degrade almost immediately after bonding to tissue, e.g. about 1 to 2 hours after bonding, despite the fact that each of the three layers can be set to degrade. degrade differently to have different healing benefits. The order, amount and thickness of each layer can vary, and can be adapted to create the desired degradation and/or compression ratios. In some embodiments, the first, second, and third layer may be formed on a base material or substrate, for example, on PCL, which may be configured to assist in the mechanical compression of the injured tissue.

[00122] Another exemplary embodiment of a porous polymer framework can be synthesized from poly(hydroxyalkanoate) (PHA). In an exemplary embodiment, PHA can be produced from a variety of microorganisms, for example Gram-negative or Gram-positive bacteria, or can be synthesized, for example, similar to the production of Biopol®, available from Zeneca's London, United Kingdom. Because PHAS are very fast to dissolve, PHA scaffolds can begin to degrade within 20 to 30 minutes after attachment to tissue by contact with heat and/or water. Where the PHA scaffold has a higher molecular weight, the degradation time may be longer, for example in the range of about 30 minutes to about 10 hours. PHA can be formed into a very thin film, for example a film having a thickness of less than 0.1 mm, for example in the range between 50 and 750 μm. In some embodiments, the PHA may be copolymerized and/or blended with one or more additional materials. As a non-limiting example, PHA can be copolymerized with hydroxyl-valerate (HV), hydroxyl-butyrate (HB) and/or hydroxyl-hexanoate (HH), which can reduce the level of crystallinity and/or brittleness of the product. PHA. In other embodiments, the PHA can be blended with one or more thermoplastics, e.g. poly(lactic acid) (PLA), PGA, PCL, starch, etc., to thereby customize a molecular weight and resulting mechanical properties. of the framework. In certain aspects, one or more of the polymers may be a thermoplastic polymer.

[00123] In other embodiments, the scaffold may be synthesized from poly(polyol sebacate) (PPS), for example from poly(glycerol sebacate) (PGS). Such structures may be particularly biocompatible and may provide an additional advantage of reducing the risk of infection as well as promoting healing. Other exemplary modalities can be synthesized from xylitol-based elastomers, e.g. polyxylitol sebacates (PXSs), which can provide structural stability over a clinically necessary period and/or can enter the metabolic pathway slowly without causing fluctuations. rapid changes in blood glucose levels. Scaffolds made from PXSs can be formed into a thicker film, to thereby provide greater compression to the wound site, and can be configured to degrade within a range of about 10 hours to 8 days after fixation. Still other exemplary embodiments can be synthesized from poly(glycerol-co-acrylate sebacate) (PGSA), which can promote tissue growth in the scaffold, particularly when formed as a fiber and/or can serve as an antibacterial agent. PGSA scaffolds can be useful as a replacement for surgical sutures and staples and/or can serve as a waterproof sealant for hollow organ anastomoses (e.g. ducts, intestine, etc.), 2D mesh grafts (e.g. (e.g. treatment of hernias, ulcers, burns, etc.), and/or wound bandages (e.g. hemostatic patches, etc.). PGSA can be combined with glycerol, which may allow the scaffold to last longer in situ, for example up to 20 days.

[00124] In yet another embodiment, the scaffold can be produced from poly(ε-caprolactone) (PCL), which can be blended with silk fibroin (SF) which can be formed into a very thin film. The PCL/SF mixture may have highly biocompatible properties and/or may improve cell adhesion and/or proliferation to the scaffold. For example, when implanted in tissue, the scaffold can release fibroin into the tissue to promote faster healing, almost immediate hemostasis, and/or attract fibroblasts in greater quantities. The PCL component may additionally assist in the healing process by mechanically compressing the injured tissue. A higher PCL content can provide better mechanical properties, although a higher SF content can provide better degradation properties. In general, the PCL content can be in a range of about 50 to 90% weight/volume and the SF content can be in a range of about 10 to 50% weight/volume. More details on the properties and fabrication methods for scaffolds made from PCL and SF can be found in Jun Sik Lim et al., Fabrication and Evaluation of Poly(epsilon-caprolactone)/Silk Fibroin Blend Nanofibrous Scaffold, Biopolymers 97: 265 a 275 (2012) incorporated herein by reference in its entirety.

[00125] In still other embodiments, the scaffold may include a gelatin-coated PCL. The framework can be laid out in one or more layers, for example with PCL serving as a substrate. PCL may function to increase the mechanical strength of the scaffold and/or may support fibroblast adhesion and cell proliferation. More details on the properties and fabrication methods for scaffolds made of gelatin-coated PCL can be found in Pengcheng Zhao et al., Biodegradable fibrous scaffolds composed of gelatin coated poly(ε-caprolactone) prepared by coaxial electrospinning, J. Biomed Mater Res 83A: 372 to 382 (2007 ) incorporated herein by reference in its entirety.

[00126] Table 1 below describes exemplary molecular weight ranges, with approximate absorption times, and average dimensions of films produced from the aforementioned porous polymer backbone materials. It will be appreciated by one of skill in the art that the ranges provided in Table 1 are not intended to limit the same, and that a molecular weight of any of the polymers described herein can be altered to obtain the desired degradation properties. Table 1.

[00127] Other suitable auxiliary materials include absorbable polyurethanes, for example, polyurethanes derived from absorbable aromatic isocyanates which may be similar to methylene bis(phenyl isocyanate) (MDI) and chain-extending diols. Absorbable polyurethanes can be configured to degrade hydrolytically into safe, biocompatible products on hydrolysis. Some non-limiting examples of hydrolysable aromatic isocyanates that can be used to form absorbable polyurethanes include glycolate-diisocyanate, caprolactone-diisocyanate, glycolate-ethylene glycol-glycolate, glycolate-diethylene glycol-glycolate, lactate-diethylene glycol-lactate, acid triester glycolic acid with trimethylpropane and glycolic acid tetraester with pentaerythritol.

[00128] Another particularly advantageous auxiliary material which may be used in conjunction with the descriptions provided herein are the materials forming the multilayer bandages disclosed in the U.S. publication. No. 2006/0257458, incorporated herein in its entirety, which are particularly suitable for absorbing and retaining fluids when compressed, for example, by clamping. More particularly, some non-limiting examples of synthetic materials that may be used in conjunction with the descriptions provided herein include a biodegradable synthetic absorbable polymer, such as a polydioxanone film, marketed under the trademark PDS®, or with a film of polyglycerol sebacate (PGS) or other biodegradable films formed from PGA (polyglycolic acid, marketed under the trade name Vicryl), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (polyhydroxyalkanoate), PGCL (polyglecaprone 25, marketed under the tradename Monocryl), PANACRYL (Ethicon, Inc., Somerville, N.J, USA), Polyglactin 910, Polyglyconate, PGA/TMC (polyglycolate-trimethylene carbonate marketed under the tradename Biosyn), polyhydroxybutyrate (PHB) , poly(vinylpyrrolidone) (PVP), Polyvinyl alcohol (PVA), or a copolymerization mixture of PGA, PCL, PLA, PDS monomers. Blends and/or copolymers of any of the aforementioned materials can be adapted to have a desired molecular weight and/or degradation rate.

[00129] Some non-limiting examples of biological materials that can be used in conjunction with the descriptions presented here include platelet-poor plasma (PPP), platelet-rich plasma (PRP), starch, chitosan, alginate, fibrin, thrombin, polyssa - caride, cellulose, collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalin adhesive, oxidized cellulose, mussel-based adhesive, polyamino acid, agarose, polyetheretherketone, amylose, hyaluronan, hyaluronic acid, whey protein, cellulose gum, starch, gelatin, silk, or other material suitable to be mixed with biological material and introduced to the wound or defect site, including combinations of materials, or any material evident to those skilled in the art in view of the descriptions presented herein. Biological materials can be derived from a variety of sources, including a patient in which the biological material is to be implanted, a person other than the patient in which the biological material is to be implanted, or other animals.

[00130] Further descriptions regarding synthetic materials or polymers and biological materials that can be used in conjunction with the descriptions presented herein can be found in US Patent Application Publication No. 2012/7,772,352, US Patent Application Publication No. 2014/016819, US patent application series no. 2006/0257458, US patent application series no. 2012/0080335, US Patent Application Serial No. 2012/0083835, US Patent Application Serial No. 2013/0256372, US Patent Application Serial No. 2013/0256365, US Patent Application Serial No. 2013/0256376, US Patent Application Serial No. US Patent Serial No. 13/710,931 entitled "Electrosurgical End Effector with Tissue Tacking Features" and filed December 11, 2012, and US Patent Application Serial No. 13/763,192 entitled "Multiple Thickness Implantable Layers for Surgical Stapling Devices" " and filed on February 8, 2013, each of which is incorporated herein by reference in their entirety.

Auxiliaries that have strain relief features

[00131] A tissue aid can have various configurations, but can generally be configured to contact tissue as tissue is clamped between a cartridge assembly and an anvil of a surgical stapler. An advantage of fabric aids is their propensity to prevent or minimize leaks, such as liquid or gas leaks. Tissue aids can perform this function by one or more of the following mechanisms: filling the holes or breaks that occur at the puncture sites of the staple; restriction of tissue movement around puncture sites to prevent an increase in staple hole size and/or tissue tearing; and minimizing the elongation gradients that occur between the tissues confined within the staple line and the free tissue adjacent the staple line.

[00132] In certain aspects, the auxiliary material may be used to distribute compressive clamping force over tissue, absorb and retain beneficial fluids at the treatment site, enhance staple acquisition, and/or promote hemostasis. In some embodiments, a first piece of auxiliary material may be affixed to a cartridge assembly, and a second piece of auxiliary material may be affixed to an anvil; however, any suitable amount of auxiliary materials may be situated within the end actuator.

[00133] The fabric aid may include various features, and may be formed from various materials to assist in sealing the fabric at the staple line and/or to prevent the formation of fabric leaks. For example, a fabric aid may have a central region configured to be positioned over the fabric and connected thereto by staples. The fabric auxiliary may additionally include an outer region, also referred to in the present invention as a wing region or wing portion, which may be positioned outside of a staple line when the auxiliary is stapled to the fabric. The wing portion can help more evenly distribute tension and/or minimize stress gradients across the tissue as the tissue deforms or otherwise expands and contracts during normal bodily functions. In some embodiments, a sealant may be used in conjunction with the auxiliary to help seal the stapled tissue. The sealant may be introduced into a patient in a first liquid state, and may be configured to change to a second hardened or solid state after a predetermined amount of time. When the sealant is in the first liquid state, the sealant can flow into the auxiliary and/or staple line, and then be hardened therein, thus facilitating complete sealing of the fabric. The auxiliary and the sealant can therefore cooperate to provide a better and more complete seal of the staple line than if only the fabric auxiliary or the sealant were used.

[00134] Exemplary aids that have central and wing regions are shown implanted in the tissue in Figures 17A and 17B. As shown in Figure 17A, an auxiliary 1000 may include a central region 1002 for receiving the clips therethrough, and a wing portion 1004 adjacent the central region 1002. The central region 1002 of the auxiliary 1000 may be sized and formed to correspond to a size and shape of a cartridge assembly 52 and/or an anvil (not shown). For example, Figure 17A illustrates an auxiliary 1000 that has a central region 1002 that corresponds in size and shape to a tissue-contacting surface on the cartridge assembly 52. That is, the central region 1002 can be substantially equal in size to the contact surface with the fabric. The central region 1002 of the auxiliary 1000 shown in Figure 17A may have a substantially rectangular elongated shape defined by the proximal and distal edges 1002p, 1002d, and the first and second side edges 1002a, 1002b. The proximal edge 1002p of the central region 1002 may terminate in a corresponding proximal feature 1006 for coupling to a distal end 14d of a shank 14 of a stapler 10. At least two of the three remaining edges of the central region 1002 may include a wing portion 1004 which extends around it and forms a perimeter of the auxiliary 1000. For example, as shown in Figure 17A, the wing portion 1004 of the auxiliary 1000 may extend around the first and second side edges 1002a, 1002b, and may extend distally beyond the distal edge 1002d of the central region 1002. In one embodiment, the auxiliary 1000 is sized and positioned in the cartridge assembly 52 such that it can be separated by a cutting member in the stapler during use. In fact, a distal region of the wing portion 1004 is always clipped. As shown, the wing portion 1004 can have a modified structure that is different from a structure of the central region 1002. In the illustrated embodiment, the central region 1002 can be substantially solid, for example, a film, and the wing portion 1004 can be be a mesh. As shown in Figure 17B, when auxiliary 1000 is stapled to fabric T, central region 1002 may have one or more rows/lines of staples 1008 extending therethrough, and wing portion 1004 may extend laterally outward. from staples 1008. As shown, auxiliary 1000 stapled to fabric T includes half of the auxiliary shown in Figure 17A, due to the fact that the cutting member on the stapler cuts the fabric while staples 1008 are applied thereto. The 1004 mesh wing portion can flex as the fabric expands and contracts, and more evenly distributes stress (or minimizes a gradient of stress) across a larger area of the fabric than the included auxiliary 1000 alone. in the central region 1002. For example, the wing portion 1004 can expand and contract in a direction transverse to the longitudinal axis LC of the central region 1002. This can help to prevent the formation of pressure points that can create leaks in the stapled fabric after repeated expansion and contraction of tissue. In certain aspects, the mesh may be formed from fibers of the same film material as the central region 1002, extending in a crisscross pattern. The longitudinal axis of half of the L1 fibers may be arranged at an angle θ1 of about 45 degrees to the longitudinal axis LC of the central region 1002 as shown, and a longitudinal axis L2 of the other half of the fibers may be arranged at an angle θ2 of about 45 degrees to the longitudinal axis LC of the central region 1002, or may be positioned at other angles to the central region 1002. As will be appreciated by one skilled in the art, the wing portion 1004 of the auxiliary 1000 may be formed using various known manufacturing techniques, such as laser cutting or punching shapes such as squares, circles, diamonds, out of the film to produce a mesh wing region and solid core region 1002. Two identical auxiliaries 1000 , 1000' may be stapled to fabric, as shown in Figure 17B, and in certain aspects, these auxiliaries 1000, 1000' may be of substantially the same size, shape, and configuration.

[00135] Another embodiment of an auxiliary 1010 is shown in Figure 18 and also includes a central region and a wing region. In this embodiment, a wing portion 1014 has a plurality of apertures 1018 formed therein which allow the wing portion 1014 to flex with the T fabric during expansion and contraction of the T fabric. The apertures 1018 can be of various sizes, shapes, and configurations, and may be circular, oval, rectangular, etc., and may be positioned at various locations along the wing portion 1014. In the illustrated embodiment, apertures 1018 are slots positioned in multiple rows, the rows being substantially parallel to the axis. longitudinal axis LC of a central region 1012. A longitudinal axis of the slots 1018 may be parallel to a longitudinal axis LS of the clamps 1008. The number of longitudinal rows and the number of openings 1018 arranged in each row may vary. In the illustrated embodiment, a row adjacent to the central region 1012 may have fewer openings 1018 than a row adjacent to an outermost edge 1014a of the wing portion 1014. For example, the row adjacent to the central region 1012 may have about three openings 1018 formed therein, while the row adjacent to the outermost edge 1014a of the wing portion 1014 may have about four openings 1018 formed therein. In this way, the flexibility of the wing portion 1014 can increase from the central region 1012 to the side edge, and can further facilitate the distribution of stress along the fabric T.

[00136] Figures 19A and 19B illustrate another embodiment of a fabric aid that has wings for distributing stress across the fabric. Figure 19A illustrates an auxiliary 1020 having a central region 1022 and a wing region 1024, both regions being formed from a plurality of layers. As in previous embodiments, the central region 1022 may have a substantially rectangular shape. A layer of top material may define the central region 1022, and both regions 1022, 1024 may be formed from a plurality of layers. The central region 1022 may be substantially rectangular in shape, but may be formed in other ways. As shown in Figure 19A, a top material layer 1026t may define the core region, and may be formed from a flexible material such as PDS®, PGA, Neoveil®, ORC, or other biologically active polymers and material structures. derivative, or combinations of the materials described herein. Material geometry and structure (material thickness, fiber orientation, polymer chain orientation, hole patterns, etc.) can be used to create desired isotropic or anisotropic strain characteristics. A bottom material layer 1026b may also be substantially flexible, and in certain aspects, may have greater flexibility than the top layer 1026t. Bottom layer 1026b may have a shape that corresponds to a shape of top layer 1026t, and is shown to have a substantially rectangular shape. The bottom layer 1026b may have a greater surface area than the top layer 1026t, so that the bottom layer 1026b extends beyond the side edges of the top layer 1026t. As shown, the side edges of the bottom layer 1026b may be cup-shaped, having a plurality of semicircular protuberances 1028 along the wing portion 1024. These semicircular protuberances may be spaced equal distances along the edges. , or they can be separated into groups of two, three, four, and the groups of protuberances can be arranged at equal distances from each other along the edge. When auxiliary 1020 is stapled to fabric, top layer 1026t of material 1026t will be positioned outside of, and will not come into direct contact with, fabric, while bottom layer 1026b will come into direct contact with fabric. Additionally, the bulges can be positioned away from the rows of staples, and can distribute the stress along the T fabric to prevent leaks from forming. Bottom layer 1062b may be formed from a flexible material, such as PDS®, PGA, Neoveil®, ORC, or other biologically derived material polymers and structures, or combinations described herein. Material geometry and structure (material thickness, fiber orientation, polymer chain orientation, hole patterns, etc.) can be used to create desired isotropic or anisotropic strain characteristics. In one embodiment, at least one of the top layer 1062t and the bottom layer 1062b comprises at least partially PDS® to aid in the attachment of adjacent layers. In one embodiment, both the top layer 1062t and the bottom layer 1062b are created from absorbable materials.

[00137] Auxiliary material can be constructed in several ways. For example, the auxiliary material may be formed from a continuous material. That is, as shown in Figure 19B, auxiliary 1020 may include a single layer in the central region 1022 and wing portion 1024 that has a plurality of protrusions 1024 for distributing a stress. In other aspects, the helper may include more than two layers of material. For example, one or more intermediate layers of material (not shown) may be positioned between the top layer and the bottom layer, and may be more rigid than the top and bottom layers. The layers can be coupled together using known manufacturing techniques such as lamination, adhesives, etc. The protrusions 1028 on the wing portion 1024 of the auxiliary may also be formed using known manufacturing techniques, such as laser cutting, stamping, punching, etc.

[00138] Another exemplary auxiliary is shown in Figure 20 and includes a wing region that has varying geometry. As shown, an auxiliary 1020' may have a wing region 1024' that extends around a perimeter of the central region 1022' and may have a plurality of surface features 1028' formed therein and evenly spaced along from the 1024' wing region. Surface features 1028' may have a generic boomerang-like shape, and may include an elbow 1023' and first and second arms 1025', 1027' extending therefrom. As shown in Figure 20, the elbow 1023' may be positioned along the edges 1022a', 1022b', 1022c' of the central region 1022', while the terminal ends 1025t', 1027t' of the arms 1025', 1027' may be positioned at an outer edge of the 1024' wing region. In this way, the thickness of the wing region 1024' in a direction transverse to a longitudinal axis of the central region 1022' may vary, and a thickness of the wing region 1024' in a direction parallel to the longitudinal axis of the central region 1022' may also vary. vary. These surface features 1028' can be formed by removing a portion of the auxiliary material 1020' using known manufacturing techniques such as laser cutting, stamping, punching, etc.

[00139] Figures 21A to 21C illustrate an auxiliary material that includes wing portions with modified edges. For example, a wing portion 1034 of an auxiliary 1030 of Figure 21A may have an outer edge in the shape of a sine wave with peaks 1034p and valleys 1034v along its length, so that the wing portion 1034 is atraumatic and not increases the likelihood of leaks forming in the fabric. A wing portion 1034' of Figure 21B includes a first material 1036' forming a central region 1032' and the wing portion 1034' the wing portion 1034' having curved edges that curl and extend towards the central region 1032'. , and back toward the edge forming an oblong opening 1035'. In certain aspects, a second material 1038' is disposed in the teardrop-shaped oblong openings 1035', such as being laminated to the first material 1036' to form the auxiliary 1030'. A thickness of this second material 1038' may vary from a thickness of the first material 1036'. For example, the thickness of the second material 1038' may be less than the thickness of the first material 1036', as shown. A wing portion 1034'' of Figure 21C may have a plurality of apertures 1035'' formed therein, as triangular-shaped apertures, which may form protuberances 1038'' similar to the protuberances 1028 shown in Figure 19B, but the protuberances 1038'' ' may have corners instead of rounded edges. The auxiliaries 1030, 1030', 1030'' of Figures 21A to 21C may be formed from different materials, such as any flexible or extensible polymeric material described herein. In use, any of the auxiliaries 1030, 1030', 1030'' may be stapled to the fabric and any of the respective wing portions may extend beyond the staple line. As shown in Figure 21D, auxiliary 1030 can be stapled to fabric T and the wing portion 1034 can be positioned outside the staples 1008 that form a row of staples, and the center portion 1032 can be positioned inside the row of staples. . In certain respects, as the fabric expands and contracts, the aids may extend or flex in a direction transverse to the rows of staples, or they may be configured to extend in multiple directions, such as along an outer surface of the fabric. T, as shown. One skilled in the art will appreciate that the edges of the wing portions may be formed in ways other than those of the illustrated embodiments.

[00140] Figures 22A to 22C illustrate another embodiment of auxiliary material that includes a wing portion with modified edges. As shown in Figure 22A, an auxiliary material 1040 may be woven. A central region 1042 of the auxiliary 1040 may be formed from a woven material of higher density than a material woven into a wing portion 1044 of the auxiliary 1040. In other aspects, a less dense woven material may enclose a denser woven material. on all sides, as shown in Figure 22B. In both embodiments, the wing portion 1044 may have smooth, atraumatic edges 1046 that are less likely to puncture or otherwise damage the tissue, and cause holes to form therein. Auxiliary 1040 can be configured to drain and/or absorb liquid therein. For example, in the embodiment of Figure 22C, a top layer 1048V of material from an auxiliary 1040' is shown positioned over a bottom layer 1048b' with liquid 1047' draining through the top layer of material and into a space between the top and bottom layers 1048b\ 1048V. These auxiliary materials can be formed from various woven materials known in the art, such as ETHISORB® (Ethicon, Inc, of Somerville, NJ, USA). In one embodiment, the central region 1042 may be a film comprising a solid but deformable absorbable material.

[00141] An auxiliary material for use with a stapler that deploys staples of varying thickness is shown in Figures 23A through 23D. As shown, a thickness of an auxiliary 1050 can vary from a central axis 1056 to an outer edge of the auxiliary 1050, in a lateral direction indicated by the arrows. That is, the auxiliary 1050 may have a decrease/taper in thickness from the central axis 1056 of the auxiliary 1050 to the outer edge thereof in the lateral direction. As in previous embodiments, the auxiliary material 1050 may include a central region 1052 and a wing portion 1054. The auxiliary 1050 may include an elongated slot 1058 formed along the central axis 1056 of the auxiliary 1050, and having a size and shape that correspond to a size and shape of a cutting member (not shown). In the illustrated embodiment, the elongated slot 1058 is substantially rectangular in shape. Figures 23B and 23C provide end views of a cartridge assembly 52 and anvil 54 that have a varying thickness in the lateral direction so that the stapler 10 can dispense staples (not shown) of different heights. As shown, a thickness TO of anvil 54 near the slit of the cutting member can be greater than a thickness TE of anvil 54 near its side edge. Auxiliary 1050 may be coupled to cartridge assembly 52 and/or anvil 54, with at least the central region 1052 of auxiliary 1050 directly in contact with tissue-contacting surface 60, 58 of cartridge assembly 52/anvil 54 The tissue contacting surface 58 of anvil 54 may include one or more attachment points 1057 attaching auxiliary 1050 to anvil 54, as shown. Wing portion 1054 of auxiliary 1050 can be folded around cartridge assembly 52 and/or anvil 54, and affixed thereto, as will be described in more detail below. Thus, a tissue-contacting surface 1053 of the first auxiliary 1050 may be substantially flat, and may be arranged in parallel with a tissue-contacting surface 1053' of the second auxiliary 1050' disposed in the cartridge assembly 52. When auxiliaries 1050, 1050' are stapled to the fabric, as shown in Figure 23D, the wing portion of the auxiliary 1050 may be disposed between the staples 1008, and extends towards a cutting end TE of the fabric T, while a second portion of auxiliary 1050 can extend away from the cut end TE end of the T fabric and distributes stress on the T fabric, similar to the wing portions described above. Auxiliary 1050' may have similarly positioned portions 1052', 1054' as shown.

[00142] Any of the auxiliary materials may include various features to increase the friction between the auxiliary material and the fabric to ensure that the auxiliary material remains in a desired position. For example, aids 1060, 1060' in Figures 24A and 24B include a plurality of teeth 1061, 1061' formed on a tissue-contacting surface thereof, and terminating at points 1063, 1063' which can penetrate tissue. As shown, the plurality of teeth 1061, 1061' may be spaced at equal distances from each other in the lateral direction of auxiliary 1060, 1060'. Teeth 1061, 1061' can be formed on auxiliary 1060, 1060' using various known manufacturing techniques, such as through compression molding, cutting/stamping, drilling, etc. For example, the auxiliary 1060 of Figure 24A may be compression molded, while the auxiliary 1060' of Figure 24B may be formed by stamping slots 1065' in the material to form the teeth 1061'. The gaps between the teeth 1061, 1061' can penetrate the fabric T and create a lock that prevents slippage of the auxiliary 1060, 1060', as in Figure 24C, which illustrates multiple rows of auxiliaries 1060'. In another embodiment shown in Figure 25A, the auxiliary 1060'' may include a plurality of micropillars 1063'' formed on a tissue contacting surface thereof, the micropillars 1063'' being formed as needles configured to penetrate tissue T. Teeth 1063 and/or micro abutments 1063" may penetrate directly into tissue T, as shown in Figures 24D and 25B, and thus prevent auxiliary 1060, 1060'' from slipping relative to clamps 1008 as tissue T expands and expands. In certain aspects, the micro abutments 1063'' may have a diameter D1 in the range of about 0.01 to 0.50 mm, and a height H1 in the range of about 0.05 to 0.50 mm.

[00143] Another embodiment of an auxiliary material is shown in figures 26A to 26C. In this embodiment, an auxiliary material such as the auxiliary 1000 of Figures 17A and 17B is used in conjunction with an end extension member 1070 that can be coupled to an anvil 54 and/or a cartridge assembly 52 of a surgical stapler 10. As shown in Figure 26A, a distal end 1004d of auxiliary 1000, i.e., distal end 1004d of wing portion 1004, may terminate at or near a more distal end 52d of cartridge assembly 52. As shown in Figure 26B, a distal end 1004d of auxiliary 1000, i.e., distal end 1004d of wing portion 1004, may terminate at or near a more distal end 54d of anvil 54. End extension element 1070 may be added over the assembly of cartridge 52 and/or anvil 54 for replacing or supplementing a distal portion of auxiliary material 1000. A proximal end 1070p of end extension member 1070 may have a cutout 1072 formed in the m and sized so as not to obstruct or cover a slot formed in the anvil 54 to receive a cutting member (not shown). Cutout 1072 may define first and second arms 1074a, 1074b that can be releasably coupled to distal end 54d along anvil 54 along a curved portion of anvil 54 that is distal to the anvil-contacting surface. anvil tissue 54 in various ways, such as through the use of an adhesive. The most distal end 1070d of the end extension member 1070 may be substantially rounded. A mechanism for releasing a distal portion 1076 of the butt extension 1070 from the proximal end 1070p of the butt extension 1070 may also be provided. In certain aspects, the release mechanism may consist of a perforation 1078 that extends transversely to a longitudinal axis LN of the end extension element 1070. In use, an auxiliary 1000 may be positioned over the anvil 54, and the element The end extension element 1070 may also be coupled to the anvil 54. The anvil 54 and cartridge assembly 52 may clamp the tissue T together, and a portion of the auxiliary 1000 may extend distally beyond the end extension element 1070. , as shown in Figure 26B. That is, the distal end 1070d of the end extension element 1070 may be positioned distal to the distal end 1004d of the auxiliary 1000. The anvil 54 and cartridge assembly 52 may apply staples 1008 through the T-fabric and through the auxiliary 1000, while the wing region 1004 of the auxiliary 1000 does not include clips 1008 extending therethrough. The wing region 1004 of the auxiliary 1000 may be in direct contact with the fabric T, and the end extension element 1070 may be positioned above the wing region 1004. In certain aspects, the end extension element 1070 may be a semi-flexible material, and may be used in conjunction with auxiliary 1000 to help relieve stress on the T-tissue and/or provide strength to auxiliary 1000. In use, the distal end of the end extension element 1070 may be removed from the anvil 54 and/or cartridge before, during, and/or after the tissue T is stapled.

[00144] While auxiliary characteristics described above have been illustrated as separate embodiments, an auxiliary may have any combination of characteristics described above.

Mechanisms for attaching and releasing auxiliaries from an end actuator

[00145] Various mechanisms can be used to attach and then release an auxiliary that has wings from an end actuator, for example, a cartridge assembly 52 and an anvil 54. While the embodiments described below include features formed in an anvil 54, any of these features may be formed in a cartridge assembly 52 for mating an auxiliary to the cartridge assembly 52. Figures 27A to 27B illustrate an auxiliary material 1000', 1000'' having keyed mating features to corresponding engagement features formed on an anvil 54. More specifically, Figure 27A shows an auxiliary 1000' having a plurality of cylindrical protuberances 1003' formed on a surface 1007' that is oriented away from a tissue-contacting surface 1005' from auxiliary 1000'. While Figure 27A illustrates three cylindrical protuberances 1003' spaced along an axis parallel to a longitudinal axis LA of the anvil 54, any number of protuberances 1003' may be formed at various locations along the auxiliary 1000'. A side surface 54L of anvil 54 may have a plurality of depressions 53 configured to receive the plurality of protuberances 1003' of auxiliary 1000' thereon. In one embodiment, the height (not shown) of the cylindrical protuberances 1003' may vary, and may range from about 0.25 to 1.00 mm, the height measured perpendicular to the surface 1007' of the auxiliary 1000'. The protrusions 1003' formed on the auxiliary 1000' can be of other sizes and shapes. As shown in Figure 27B, in another embodiment, an auxiliary 1000'' may have a single elongated rectangular protuberance 1003'' that extends parallel to the longitudinal axis LA of anvil 54. A side surface of anvil 54 may also include an elongated rectangular depression. 53' to receive rectangular protuberance 1003'' therein when auxiliary 1000'' is folded around anvil 54. A height (not shown) of rectangular protuberance 1003'' may also vary, but may be substantially the same. range than the height of the cylindrical protuberances 1003' described above. While only a first side surface 54L of anvil 54 is shown in Figures 27A and 27B, one skilled in the art will observe that identical protuberance(s) can be formed on a second surface. side (not shown) of anvil 54. Similarly, identical depression(s) may be formed on a second side surface (not shown) of auxiliaries 1000', 1000''.

[00146] An auxiliary can be attached to an anvil/cartridge assembly in other ways. As shown in Figures 28A and 28B, a suture thread 1003''' may couple the auxiliary to the anvil 54. The suture 1003''' may extend from the first lateral surface 54L of the anvil 54 along the contact surface with the fabric of the auxiliary, and up to the second side surface 55L of the anvil 54. The first and second depressions 53''', 55''' may be formed in the first and second side surfaces of the anvil 54, and a first terminal end of suture 1003''' may be received in the first depression 53''', and a second terminal end may be received in the second depression 55'''. A suture length 1003''' and/or a size of depressions 53''', 55''' can be selected so that suture 1003''' is tightened when the terminal ends of suture 1003''' are positioned in depressions 53''', 55'''. As a cutting member 59 advances through anvil 54 during and/or after staples 1008 are applied to tissue T, as shown in Figure 28B, cutting member 59 may cut suture 1003''', causing the ends to suture ends 1003''' slide out of depressions 53''', 55''' and thereby release auxiliaries from the anvil. Figures 29A and 29B illustrate the suture cord 1003''' that extends around an anvil 54 and couples a multilayer aid 1020 to the anvil 54. As in the previous embodiment, advancement of the cutting member (not shown) relative to the anvil 54. to anvil 54 may cut suture 1003''' and release suture 1003''' from depressions 53''', 55''' in anvil 54 to release auxiliary 1020. As will be appreciated by one skilled in the art, any number of suture strands can be used to connect the auxiliary to a cartridge assembly 52 and an anvil 54, and the depressions formed therein can be varied as long as they are configured to receive a portion of the suture therein.

[00147] Figures 30A to 30B illustrate other mechanisms for attaching an auxiliary to an anvil/cartridge assembly. In this embodiment, anvil 54 includes a surgical stapler 10 that includes a cutting element 59 that can advance into slot 61, called here longitudinal track, and can move between proximal and distal ends 61p, 61d of track 61. A driver 1081 that includes first and second elongate elements (not shown) may be disposed on longitudinal track 61, as in Figure 30B. Three cylindrical protuberances (not shown) extend from the elongate elements and into depressions 53'''', 55'''' formed on both side surfaces of the anvil 54, but there may be any number of protuberances spaced along the of the trigger and which has several other formats. As shown in Figure 30C, a first driver 1081a may be generally elongated, and may have a plurality of protuberances 1083, such as three protuberances 1083, oriented transversely to the longitudinal axis of the driver, the protuberances 1083 having a cylindrical. A wing portion 1080 of auxiliary material 1084 may be disposed around a lateral surface of support 54, and may include a plurality of protrusions 1083' oriented transversely to the longitudinal axis LA of anvil 54 when auxiliary material 1080 is coupled. at the same. As shown in Figure 30D, the auxiliary material 1080 may have a first set of protrusions 1083' for engagement with the first side surface of anvil 54, and a second set of protrusions 1083'' for engagement with the second side surface of anvil 54. Prior to use, the first driver 1081a may be positioned on a first side wall of the rail 61, and the second driver 1081b may be positioned on a second side wall of the rail 61. A proximal end of each driver 1081a, 1081b may have a portion angled 1085p, 1087p so that when drivers 1081a, 1081b are arranged on rail 61, a width W1 between drivers 1081a, 1081b at a proximal end of rail 61 is greater than a width W2 between drivers 1081a, 1081b at and/or distal to the protuberances 1083', the width being measured transversely to the longitudinal axis LA of the anvil 54, as shown in Figure 30E. Additionally, the width W2 between drivers 1081a, 1081b distal to the proximal end 61p of the rail 61 can be less than the width WC of the cutting member 59. In this way, the cutting member 59 can be advanced towards the distal end 54d of the anvil 54 and can increase a width between drivers 1081a, 1081b and protrusions 1083 can push corresponding protuberances 1083' on auxiliary 1080 out and away from the anvil, as in Figure 30F, thus releasing the auxiliary from anvil 54. In certain aspects , auxiliary 1080 can be forced into a substantially flat configuration, so that when cutting member 59 advances into rail 61 and exerts a force on drivers 1081a, 1081b, auxiliary 1080 is better able to be released from of the anvil 54.

[00148] A loading mechanism for loading an auxiliary into an anvil/cartridge assembly is shown in Figures 31A through 31B. The loading mechanism 1090 can be of various sizes, shapes, and configurations, and can include a first curved arm 1092a and a second curved arm 1092b, which have a radius of curvature that corresponds to the radius of curvature of the first and second side surfaces 54L, 55L of the anvil 54, and the arms 1092a, 1092b may terminate at angled features 1093a, 1093b which can be gripped by a user. The loading mechanism 1090 may have a flat base 1094 from which each of the first and second curved arms 1092a, 1092b extend. The base 1094 of the loading mechanism 1090 may additionally include a rail extension 1094e that extends perpendicular to the base 1094 and is disposed along the central longitudinal axis of the loading mechanism 1090 for insertion into the slot of the cutting member 54s. on anvil 54, as shown in Figure 31B. A first inner surface 1094a of the loading mechanism 1090 may be defined by the first curved arm 1092a and a first portion of the base 1094 of the first arm 1092a to the extent of the rail, as shown in Figure 31A. Likewise, the second inner surface 1094b of the loading mechanism 1090 may be defined by the second curved arm 1092b and a second base portion 1094 from the second arm 1092b to the track extension 1094e. In this way, the loading mechanism 1090 can be generally shaped like an anvil 54. An auxiliary 1000 having a central region 1002 and a wing region 1004 can be positioned and sandwiched between internal surfaces of the loading mechanism. 1090 and the tissue contacting surface of the anvil 54, as shown in Figure 31B, the loading mechanism 1090 squeezing the anvil 54 as shown. Rail extension 1094e can facilitate achieving a snug fit between loading mechanism 1090, auxiliary 1000, and anvil 54, without any substantial gap between them. After the auxiliary 1000 is coupled to the anvil 54, such as through the use of any of the clamping mechanisms described herein, such as the clamping mechanisms 1052, the loading mechanism 1090 can be removed from the anvil 54. This can be accomplished, for example, by pressing the angular features 1093a, 1093b of the curved arms 1092a, 1092b from each other, leaving the anvil 54 loaded with the auxiliary 1000, as in Figure 31C.

[00149] Another exemplary charging mechanism is shown in Figures 32A to 32C. A 1090' loading mechanism can be packaged as a kit along with a stapler end actuator. Alternatively, the loading mechanism 1090' can be packaged separately. As shown in Figure 32A, the anvil 54 and cartridge assembly 52 of the end actuator 50 may include auxiliary material 1000 preloaded thereon, or, in another embodiment not illustrated, auxiliary material 1000 may be affixed to the anvil 54 and to the cartridge assembly 52 after being removed from the package 1100. This loading mechanism 1090' may be configured to wrap the wing portion 1004 of the auxiliary 1000 around the side surfaces 54L, 53L of the anvil/cartridge assembly 54, 52 , such that the wing portion is passively coupled to the anvil/cartridge assembly 54, 52. As shown in Figure 32B, the loading mechanism 1090' can be configured to contact the central region (not shown) of the auxiliary. 1000 against the fabric contacting surface of the anvil/cartridge assembly 54, 52 and, if necessary, can be configured to form the wing portion (not shown) around the anvil 54. The loading mechanism 1090' pod and being formed from a single molded material having an upper retaining portion 1104 and a lower retaining portion 1102, the retaining portions having a channel (not shown) sized and formed to receive the anvil/cartridge assembly 54, 52 in them. The shape of the channel may be substantially similar to the shape of the loading mechanism 1090 previously described, and may include any of the features thereof, such as the length of the track. The upper and lower retaining portions 1104, 1102 may be disposed at an angle θL with respect to each other, the angle being in the range of about 10 to 40 degrees. A support member 1106 can extend between a lower surface of the upper retaining portion 1104 and an upper surface of the lower retaining portion 1102, so that the angle θL between the retaining portions 1102, 1104 is fixed. Support element 1106 may be a substantially solid element, as shown, in order to provide rigidity to loading mechanism 1090'. A first end of the support member 1106 may terminate in a gripping member 1108, and the gripping feature 1108 may have first and second flat surfaces 1108a, 1108b configured to be gripped by a user, such as between a thumb and finger of a user. The grip feature 1108 may further include one or more surface features 1110 to increase friction between the user's fingers. A longitudinal axis of the handle element 1108 may be oriented perpendicular to the longitudinal axis of the stapler 10, or may be parallel to the longitudinal axis of the stapler 10. In use, a user may hold the distal handle feature 1108 and position the distal ends 1102d, 1104d of the retaining portions adjacent the proximal ends 52p, 54P of the cartridge assembly 52 and the anvil 54. A user may advance the distal end of the loading mechanism 1090' toward the proximal end of the end actuator 50 as shown. in Figure 32B, and retaining portions 1102, 1104 can slide along the anvil/cartridge assembly 54, 52 and force auxiliary material 1000 around the side surfaces thereof, as shown in Figure 32C. This can temporarily clamp the wing region 1004 along the side surfaces of the cartridge assembly 52 and anvil 54. With the wing region 1004 in place, a user can retract the loading mechanism 1090' in the opposite direction, distally away from the end actuator 50, leaving end actuator 50 ready for insertion into a patient. While reference is made to a single auxiliary material 1000 loaded into anvil 54, auxiliary material 1000' may be similarly loaded into cartridge assembly 52. Auxiliary material 1000, such as the material shown in Figures 32A through 32C, may be a shape memory material, such that auxiliary 1000 is oriented to a substantially straight configuration. That is, when the end actuator 50 is positioned within the patient, the wing regions can automatically move back to their substantially straight configuration before being applied by the end actuator 50 to the tissue.

Application of aids to a patient

[00150] End actuators that have one or more auxiliaries attached thereto can be applied to various areas of a patient, such as a chest cavity, stomach, etc. As will be appreciated by one of skill in the art, an aid may be delivered through an access port, such as a trocar that extends into the patient. Any of the aids of the present invention may include features that assist in releasing the aid into a patient's body. For example, Figure 33A illustrates an auxiliary 1000 having a solid central region 1002 and a mesh wing region 1004 coupled to an anvil 54 of a surgical stapler 10. While a single auxiliary 1000 is shown coupled to anvil 54, another auxiliary 1000' may be coupled to cartridge assembly 52 prior to insertion of end actuator 50 into a patient's body. A distal portion of auxiliary 1000, such as a distal portion 1004d of wing region 1004, may be configured to guide proximal portions 1004p of wing region 1004 around the side surfaces (not shown) of anvil 54 so as to reduce the width of the auxiliary material, as shown in Figure 33b. This can facilitate the insertion of the end actuator 50 and auxiliary 1000 into an access port, such as a port 1202 formed into a trocar 1200, due to the fact that an anvil width/cartridge assembly 54, 52 including auxiliary 1000 it will have a width slightly equal to that of the anvil/cartridge assembly 54, 52 without the helper. In certain aspects, this distal portion 1004d of the wing region 1004 may be formed from a material more rigid than the remainder of the portions of the wing region 1004 to help guide the auxiliary material 1000 into the port 1202.

Stapling aids into the fabric

[00151] An auxiliary material may include features that facilitate multiple staple discharges along the fabric. Figure 34A illustrates an embodiment 1300 of an end actuator 50 having first and second auxiliary materials 1400, 1400, first auxiliary material 1400 being coupled to anvil 54, and second auxiliary material 1400' being coupled to cartridge assembly 52 As shown, each of the auxiliary materials 1400, 1400' may include multiple layers, and the layers may be of various widths in the direction transverse to a longitudinal axis (not shown) of the anvil/cartridge assembly 54, 52. tissue contact layer 1402, 1402' of each auxiliary 1400, 1400' may be positioned adjacent to tissue (not shown) when tissue is clamped between anvil 54 and cartridge assembly 52. In certain aspects, the first layer Fabric contact pads 1402, 1402' may be formed from a material configured to seal around a row of staples, such as an elastomeric material. The first tissue-contacting layer 1402, 1402' may have a width W5 in a direction transverse to the longitudinal axis LA of the anvil 54, which is substantially equal to a width WA of the anvil 54, or the width W5 of the first layer. 1402 may be smaller than the width WA of the anvil 54. As shown in Figure 34A, the first tissue contacting layer 1402 may include a first portion 1402a positioned on a first side of the slit of the cutting member 54s, and a second portion 1402b positioned on a second side of the slot of the cutting member 54s, rather than being formed from a continuous piece of material. In other aspects, the first layer 1402 may be a single piece of continuous material. A second layer 1406, 1406' may be positioned closer to the fabric contacting surface of the anvil 54, and may be formed from a substantially rigid material. As shown, a width W6 of the second layer 1406 may be greater than the width WA of the anvil 54. This second layer 1406, 1406' may help to prevent stretching of the fabric T near the staples 1008. A third layer 1408, 1408' may be positioned closest to the fabric contacting surface of the anvil 54, so that the second layer 1406, 1406' is disposed between the first and third layers 1402, 1402' and 1408, 1408'. The third layer, 1408, 1408' may have a width W7, which is greater than the width WA of the anvil 54, but less than the width W6 of the second layer 1406, as shown. This third layer 1408, 1408' may be semi-rigid to help relieve stress on the T fabric as the T fabric expands and contracts. A longitudinal length of the layers can also vary, the length being measured in the direction transverse to the widths. Preferably, the third layer 1408, 1408' has a longer length measured along the longitudinal axis of the anvil 54, compared to a longitudinal length of each of the first and second layers 1402, 1402, 1406, 1406'. As shown in Figure 34B, multiple auxiliaries 1400, 1400\1400" may be sequentially applied to the fabric in a row, and the longitudinal lengths of the layers may result in regions 1410a, 1410b where the first layer 1402 of an auxiliary 1400 overlaps a first layer 1402' of another auxiliary 1400' In this way, clips 1008 can still penetrate through these overlapping regions even though several, e.g. three or more layers 1402, 1406, 1408 have been positioned. Figure 33C illustrates two auxiliaries 1400, 1400' stapled onto the fabric T at an angle of about 90 degrees thereto, the first auxiliary 1400 having a first terminal end, and the second auxiliary 1400' having a second and final end. terminal end. The first and second terminal ends form an overlapping region 1410a as shown. These auxiliaries 1400, 1400' can be used to allow the user to apply auxiliaries to accommodate various fabric geometries. These multilayer helpers 1400, 1400' can be varied in countless ways. While layers 1402, 1406, 1408 can be of various thicknesses, in the illustrated embodiment the second layer 1406 has a thickness less than one thickness each of the first and third layers 1402, 1408. For example, the first layer 1402 can be in the range of about 3 to 15 mm, the second layer can be in the range of about 5 to 20 mm, and the third layer 1408 can be in the range of about 3 to 20 mm. In certain aspects, these layers 1402, 1404, 1406 and 1402, 1404, 1406' may be laminated together prior to being coupled to the anvil/cartridge assembly 54, 52. In certain aspects, layers 1406 and 1406' may comprise at least partially, an absorbable material such as PDS®.

Reinforce the fabric with sealant and auxiliaries

[00152] Any of the aids of the present invention can be used in conjunction with a seal to help maintain a seal around the staples as tissue expands and contracts after surgery. A sealant can have different formulations and different viscosity and cure behavior. In general, a sealant can be produced from a biocompatible and bioabsorbable material, which can be configured to change from a first liquid state to a second liquid state through a curing process, such as a polymerization reaction. The first state can be a softened state, e.g. a fluid, a gel, a foam, etc., and the second state can be a hardened state, e.g. a solid, a rigid element, etc. When the sealant is in the first, softened state, the sealant can flow through the manifold and into the sealing clamp, as described in more detail below. The sealant may change from the first softened state to the second hardened state after a predetermined amount of time. In certain aspects, the sealant may be made from biological materials. In some embodiments, the sealant may aid wound healing, through the release of various chemical compounds, during and/or after the sealant cures in a patient's body. By way of non-limiting example, the sealant can be configured to deliver a therapeutic drug, such as wound healing promoters (eg, transforming growth factor beta, etc.), antibacterial agents (eg, triclosan, ionized silver, etc.), and other agents known over time, to help tissue heal near the sealant's site in the body. In one embodiment, a fibrin sealant may include two reactive components combined immediately prior to delivery to a patient, such as thrombin and a biologically active component (BAC2), fibrinogen and Factor XIII. In certain aspects, the components may be supplied in a 5:1 volumetric ratio of BAC2 to thrombin. In an alternative embodiment, the material may be fibrin sealant commercially available under the tradename Evicel®. In another embodiment, the sealant may be blood, such as autologous blood.

[00153] Figure 35A illustrates the auxiliary of Figure 17B, which has a sealant 1500 applied thereto. As shown, sealant 1500 can be applied so as to substantially cover the center 1002 and wing 1004 portions of auxiliary 1000, or, in another embodiment (not shown), sealant 1500 can be selectively applied only over the center region 1002, and not over wing region 1004.

[00154] Sealant 1500 can be applied to an auxiliary in other ways, and need not be applied to an external surface of the auxiliary 1000. For example, Figure 35B illustrates multi-layer auxiliaries 1700, 1700' stapled to fabric T. Layers 1702 , 1704 may be formed from a variety of materials, but in the illustrated embodiment they include a first layer 1702 of fibrous backbone positioned adjacent the fabric T, and a second layer 1704 consisting of an elastic film. An application tool 1706 having an injection needle 1708 may have a sealant 1500 disposed therein and which may penetrate the first layer 1702 of fibrous armature. Sealant 1500 can be applied to that first layer 1702, as in Figure 35C, and injection needle 1708 can be removed from the patient's body. Sealant 1500 may bond directly to the fabric T and/or may be held in tight juxtaposition to the fabric by layer 1704, and, as in other embodiments, may have a wing region 1704, 1704' that distributes a stress on the fabric beyond the 1008 staples in the staple line. When the sealant is Evicel®, the material forms a fibrin clot from fibrinogen. Without losing the principles, other seals form a hardened sealing structure through different mechanisms that are useful for sealing leakage routes. The combination of sealant 1500 and auxiliary material 1700 can prevent leaks from forming as the T fabric expands and contracts. Helpers 1700' and layers 1702', 1704' may be substantially similar to helper 1700 and layers 1702, 1704 described above.

[00155] A sealant can be used to reinforce fabric in other ways. For example, Figures 36A through 36C illustrate sealant 1500 being delivered to a patient's chest cavity 1800. As shown in Figure 35A, a system 1900 for applying a sealant 1500 may include a container or tube 1902 for receiving components A, B, C of a sealant 1500 therein. In certain aspects, components A, B, C may include an acid solubilized collagen A, fibrinogen B, and thrombin C. A 1200 trocar may extend through an 1904 incision formed in a 1906 patient and into the 1800 chest cavity. An applicator tool 1908 may have a stem 1910 extending through the trocar 1200, a distal end 1910d of the stem 1910 terminating in the chest cavity. A cable assembly can be formed at a proximal end 1910p of the rod 1900 and can be configured to be picked up by a user. Cable assembly 1912 may be a pistol grip cable assembly, and may include one or more actuators, such as lever 1914 that can be pivoted to actuate device 1908. Tube 1902 and applicator tool 1908 may be coupled together. in various ways, such as through a tube 1916. This tube 1916 may be substantially flexible to facilitate movement of the applicator tool 1908 during a procedure. Tube 1902 can have a second tube 1918 coupled thereto and connected to a source of gas S, so that gas 1920 can be applied to tube 1902. Gas 1920 can include, by way of non-limiting example, CO2, O2, etc. In certain respects, the gas source S may be a continuous gas source, such as a continuous source of CO2 available in the operating rooms of a hospital. One or more valves (not shown) may be arranged on tube 1916, cable assembly 1912, stem 1910, or any other part of system 1900, and may be selectively opened and closed by activating the actuator, such as by turning the valve 1914 in cable assembly 1912. For example, one valve can control the inflow of gas 1920 into tube 1902, and another valve can control the release of sealant 1500 in the applicator tool 1908. After the T fabric is stapled, such as by applying one or more staple cartridges over lung tissue, the distal end 1910d of the applicator shaft 1910 1908 may be positioned close to the staples 1008, as in Figure 36B. Preferably, the distal end 1910d of the applicator tool 1908 is positioned about 5 to 30 mm from a row of staples, depending on the size of the region to be coated. A user can take handle assembly 1912 from applicator tool 1008 and activate actuator 1914, such as by moving pivot lever 1914 proximally. This can open a valve arranged in system 1900 and begin to release gas 1920 to tube 1902 to spray sealant 1500 so that it forms encapsulated droplets of liquid which can be sprayed directly onto fabric T as shown. In this manner, sealant 1500 can be applied to the fabric along the staple line, as shown in Figure 36C. Sealant 1500 can harden therein, forming hardened regions 1500 h facilitating the formation and maintenance of a seal along the clamps 1008. Sealant 1500 can also be applied over an auxiliary rather than directly onto the T fabric, like any other one of the auxiliaries described here. As one skilled in the art will appreciate, the sealant can be applied to any portion of the fabric, such as just the fabric in the staple line and/or beyond the staple line.

[00156] This detection can be done in several ways. For example, a system 1900' for applying a sealant 1500 is provided in Figure 37A, and includes many of the features of Figure 36A, including a gas source, tube, etc. However, in this embodiment, the system provides a sealant 1500 sprayed directly through the trocar 1200, and does not include an applicator tool. In this embodiment, the system need not include valves, and the application of gas 1920 to tube 1902 can simply be controlled using a valve at the gas source. The release of gas in tube 1902 can spray sealant 1500, but instead of forming encapsulated liquid droplets, gas 1920 can be applied at a higher pressure and rate to create sealant fog 1600. As shown in Figure 37B , this 1500 mist of sealant can spread throughout the patient's chest cavity and can harden on all tissue surfaces, such as forming hardened regions 1500 h along all surfaces of the patient's lungs.

[00157] In an embodiment in which the sealant is blood, such as autologous blood, blood may be drawn from the patient and applied to the adjunct material. By way of non-limiting example, the adjunct material may be ORC, a known hemostatic agent, and application of blood to the adjunct ORC will cause a clot to form, resulting in an effective sealing structure. One skilled in the art will appreciate that blood such as autologous blood can be applied to a variety of adjunct materials to provide an improved sealing structure. Furthermore, one skilled in the art will appreciate that the volume of blood applied to the adjunct will vary depending on a number of factors, including the type and location of tissue, as well as the age and condition of the patient, and the identity of the patient. adjunct. In general, however, when the adjunct is an ORC material, blood can be applied in an amount in the range of about 5 to 10 cc per row of staples used to affix the adjunct to tissue.

reprocessing

[00158] The devices described here may be designed to be discarded after a single use, or they may be designed to be used multiple times. In either case, however, the device may be refurbished for reuse after at least one use. Overhaul can include any combination of the steps of disassembling the device, followed by cleaning or replacing specific parts and subsequent reassembly. In particular, the device can be disassembled and any number of specific parts or parts of the device can be selectively replaced or removed, in any combination. Upon cleaning and/or replacement of specific parts, the device can be reassembled for subsequent use at the refurbishment facility or by a surgical team, immediately prior to a surgical procedure. Those skilled in the art will understand that refurbishing a device can use a variety of techniques to disassemble, clean/replace, and reassemble. The use of such techniques and the resulting refurbished device are within the scope of this application.

[00159] In some embodiments, the devices described herein may be processed prior to surgery. First, a new or used instrument, which may include an adjunct material, is obtained and, if necessary, cleaned. The instrument can then be sterilized. In some embodiments, the instrument may be dried, for example, in an oven, together with a desiccant item, which may have a greater affinity for moisture than the adjunct material. In a sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag or a metal bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. Radiation kills bacteria on the instrument and container. In another sterilization technique, the instrument is placed in a first container, such as a plastic or TYVEK bag, which has a vapor permeable backing. The first container can then be packaged in a second container, for example a metal pouch, which can be left open. The first and second containers, together with the instrument, can be subjected to ethylene oxide sterilization. The second container can then be sealed to prevent exposure to moisture. Prior to sealing, a desiccant item may be included in at least one of the first and second containers to prevent further alteration to one or more device components. In both techniques, the sterilized materials can then be stored in the sterile container (or containers) to keep the materials sterile until the container (or containers) is opened at the medical facility.

[00160] Those skilled in the art will understand other features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited are expressly incorporated herein by reference.

Claims (7)

1. A staple cartridge (52) for use with a surgical stapler, comprising: a cartridge body having a plurality of staple cavities configured to position staples therein; and, an auxiliary composite material (1000) fitted to the cartridge body and configured to be removed therefrom when the staples are implanted from the cartridge body into tissue, the auxiliary composite material (1000) including a solid central portion (1002) sized and shaped to match the cartridge body, and a tab portion (1004) extending along at least two sides of the solid central portion (1002) so that the tab portion (1004) extends plus a lateral contour of the cartridge body in a direction transverse to the longitudinal axis of the cartridge body; characterized in that the flap portion (1004) has a mesh structure, wherein the flap portion (1004) is more flexible than the solid central portion (1002) of the auxiliary composite material (1000) and is configured to distributing a tension in the fabric beyond the staple line when the auxiliary composite material (1000) is disposed in the fabric. 2. Device according to claim 1, characterized in that the solid central portion (1002) is configured to reinforce a seal around the clamps when the auxiliary compound material (1000) and the clamps are coupled to the tissue. 3. Device according to claim 1 or 2, characterized in that the solid central portion (1002) of the auxiliary compound material (1000) is rectangular in shape. 4. Device according to claim 1, 2 or 3, characterized in that the solid central portion (1002) includes first and second opposing edges (1002a, 1002b). Device according to claim 4, characterized in that the flap portion (1004) extends along the first and second opposing edges (1002a, 1002b) of the solid central portion (1002). Device according to any one of claims 1 to 5, characterized in that the flap portion (1004) includes rounded corners. Device according to any one of claims 1 to 6, characterized in that the solid and tab portions (1002, 1004) are formed from a single polymer.

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