CN113693658A

CN113693658A - End effector including barbed staples

Info

Publication number: CN113693658A
Application number: CN202111039864.0A
Authority: CN
Inventors: E·A·谢林; T·W·阿伦霍尔特; M·J·文德利; F·E·谢尔顿四世
Original assignee: Ethicon Endo Surgery Inc
Current assignee: Ethicon Endo Surgery Inc
Priority date: 2014-02-24
Filing date: 2015-01-21
Publication date: 2021-11-26
Also published as: BR112016018601B1; JP2017506142A; RU2016137803A3; CA2940136A1; JP6545719B2; CA2940136C; BR112016018601A2; MX2016010955A; RU2016137803A; AU2015219502A1; RU2676520C2; CN106232027A; AU2015219502B2

Abstract

An end effector for fastening tissue includes a cartridge having a longitudinal row of staple cavities and a plurality of staples removably stored in the staple cavities. The staple includes a base, a pair of legs extending from the base, and a plane formed by the pair of legs, wherein at least one of the legs has a barb extending therefrom. The barb extends 360 degrees from the leg around the leg, wherein the barb extends beyond a plane formed by the leg. The end effector further comprises an anvil configured to deform the staples; and a plurality of staple drivers movable within the lumen, the staple drivers configured to lift the staples toward the anvil. The end effector further comprises a firing member configured to lift the staple driver system toward the anvil, the firing member comprising a first portion configured to engage the anvil and a second portion configured to engage the cartridge. The firing member is configured to relatively position the anvil and the cartridge.

Description

End effector including barbed staples

This application is a divisional application of international application entering the chinese national phase with filing date of 2015, 1-21, international application number PCT/US2015/012156, national application number 201580021222.4, entitled "staple cartridge including barbed staples".

Technical Field

The present invention relates to surgical instruments and, in various arrangements, to surgical stapling and cutting instruments and staple cartridges therefor that are designed to staple and cut tissue.

Drawings

The features and advantages of the present invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a front left perspective view of a surgical stapling and severing instrument having a handle portion;

FIG. 2 is a perspective view of a split knife and firing bar ("E-beam") of the surgical stapling and severing instrument of FIG. 1;

FIG. 3 is a perspective view of a wedge sled of a staple cartridge of the staple applying assembly;

FIG. 4 is a longitudinal cross-sectional view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator and an anvil in a closed position showing the staples moving from an unfired position to a fired position during a first sequence;

FIG. 5 is another cross-sectional view of the anvil and staple cartridge of FIG. 4 showing the anvil in an open position after completion of the firing sequence;

FIG. 6 is an exploded perspective view of the tissue thickness compensator and cartridge assembly;

FIG. 7 is a partial cross-sectional view of the staple cartridge assembly of FIG. 6 showing the unfired staples positioned in the staple cavities of the staple cartridge body and partially embedded in the tissue thickness compensator;

FIG. 8 is a partial cross-sectional view of the staple cartridge assembly of FIG. 6, showing fired staples ejected from the staple cavities of the staple cartridge body and formed against the anvil, and further showing a tissue thickness compensator and tissue captured within the staple entrapment areas of the formed staples;

FIG. 9 is a partial perspective view of an end effector of a surgical fastening instrument with portions removed for illustration and other portions shown in cross-section; further, the cutting member of the end effector is shown in a partially advanced position;

FIG. 10 is a partial cross-sectional end view of the end effector of FIG. 9 showing patient tissue captured between an anvil and a tissue thickness compensator of the end effector; further, staples removably stored within the cartridge body of the end effector are shown in an unfired position and the cutting member of the end effector is shown in an undeployed position adjacent to the tissue thickness compensator;

FIG. 11 is a partial cross-sectional end view of the end effector of FIG. 9, with the staples shown in a fired position and the cutting member shown in a partially advanced position wherein patient tissue has been at least partially transected;

FIG. 12 is a partial cross-sectional end view of the end effector of FIG. 9 showing staples in a fired position and a cutting member in an advanced position wherein at least a portion of the tissue thickness compensator has been transected by the cutting member;

FIG. 13 is a perspective view of a fastener cartridge including a tissue thickness compensator;

fig. 14 is a cross-sectional view of the tissue thickness compensator of fig. 13, showing a cutting member positioned relative to a proximal end of the tissue thickness compensator;

FIG. 15 is an exploded view of a tissue thickness compensator assembly;

FIG. 16 is a perspective view of a tissue thickness compensator component layer;

FIG. 17 is a cross-sectional view of the tissue thickness compensator assembly of FIG. 15;

FIG. 18 is a cutaway perspective view of an assembled tissue thickness compensator assembly and a mold for assembling the same;

FIG. 19 is a perspective view of the assembled tissue thickness compensator assembly of FIG. 18;

FIG. 20 is a perspective view of a tissue thickness compensator assembly and a mold for assembling the same;

FIG. 21 is a perspective view of a tissue thickness compensator assembly and a mold for assembling the same;

FIG. 22 is a cutaway perspective view of the tissue thickness compensator assembly of FIG. 21 and the mold of FIG. 21 for assembling the same;

FIG. 23 is a perspective view of an end effector including a tissue thickness compensator;

FIG. 24 is a perspective view of the end effector and tissue thickness compensator of FIG. 23 and a modifying member modifying the tissue thickness compensator;

FIG. 25 is a perspective view of the end effector of FIG. 23 including the modified tissue thickness compensator of FIG. 24;

FIG. 26 is a cutaway perspective view of a tissue thickness compensator;

FIG. 27 is a cut-away perspective view of a mold for modifying the tissue thickness compensator of FIG. 26;

FIG. 28 is a cutaway perspective view of the tissue thickness compensator of FIG. 26 after modification by the mold of FIG. 27;

FIG. 29 is a cutaway perspective view of a tissue thickness compensator;

FIG. 30 is a cut-away perspective view of a mold for modifying the tissue thickness compensator of FIG. 29;

FIG. 31 is a cutaway perspective view of the tissue thickness compensator of FIG. 29 after modification by the mold of FIG. 30;

FIG. 32 is a cutaway perspective view of a tissue thickness compensator;

FIG. 33 is a cut-away perspective view of a mold for modifying the tissue thickness compensator of FIG. 32;

FIG. 34 is a cutaway perspective view of the tissue thickness compensator of FIG. 32 after modification by the mold of FIG. 33;

FIG. 35 is a cutaway perspective view of a tissue thickness compensator comprising a first height;

FIG. 36 is a cutaway perspective view of the tissue thickness compensator of FIG. 35 being modified to change the first height to the second height;

FIG. 37 is a cross-sectional view of a mold for modifying the tissue thickness compensator of FIG. 35;

FIG. 38 is a cutaway perspective view of a tissue thickness compensator;

FIG. 39 is a cutaway perspective view of the tissue thickness compensator of FIG. 38 after modification;

FIG. 40 is a graph illustrating the effect of compressive force on the elastic ratio of a tissue thickness compensator;

FIG. 41 is a cutaway perspective view of a tissue thickness compensator;

FIG. 42 is a cutaway perspective view of a space creator for modifying the tissue thickness compensator of FIG. 41;

FIG. 43 is a cutaway perspective view of the tissue thickness compensator of FIG. 41 after modification by the space creator of FIG. 42;

FIG. 44 is a partial cross-sectional elevation view, partially broken away to show, of a fastener cartridge for use with a surgical instrument including a firing member in accordance with at least one embodiment;

FIG. 45 is a partial cross-sectional elevation view showing the tissue thickness compensator of the fastener cartridge of FIG. 44 being removed from the fastener cartridge and the firing member of FIG. 44 shown in a locked state;

FIG. 46 is a partial perspective view of the tissue thickness compensator of FIG. 45;

FIG. 47 is a partial perspective view of a tissue thickness compensator according to at least one embodiment;

FIG. 48 is a partial cross-sectional elevation view, with portions broken away, of an end effector of a surgical instrument including a fastener cartridge having the tissue thickness compensator of FIG. 47, a sled, and a firing member supported by the sled;

FIG. 49 is a partial cross-sectional elevation view of the end effector of FIG. 48, showing the firing member in a partially fired position;

FIG. 50 is a partial cross-sectional elevation view of the end effector of FIG. 48, showing the tissue thickness compensator removed from the fastener cartridge and the firing member in a locked state;

FIG. 51 is a partial perspective view, with portions broken away, of a fastener cartridge according to at least one embodiment;

FIG. 52 is a perspective view of a slide of the fastener cartridge of FIG. 51;

FIG. 53 is a partial perspective view of the fastener cartridge of FIG. 51;

FIG. 54 is a front view of a slider according to at least one embodiment;

FIG. 55 is a perspective view of a slider, shown in an unlocked configuration, in accordance with at least one embodiment;

FIG. 56 is a perspective view of the slider of FIG. 55 shown in a locked configuration;

FIG. 57 is a partial cross-sectional elevation view of the sled of FIG. 55 positioned within a fastener cartridge, showing the sled in its unlocked configuration, a firing member supported by the sled, and a tissue thickness compensator of the fastener cartridge engaged with the sled;

FIG. 58 is a partial cross-sectional elevation view of the tissue thickness compensator of FIG. 57 being removed from the fastener cartridge of FIG. 57 placing the sled of FIG. 55 in its locked configuration and the firing member of FIG. 57 in a locked state;

fig. 59 is a partial cross-sectional elevation view, with portions removed, of a slider positioned at a proximal end of a fastener cartridge in accordance with at least one embodiment;

FIG. 60 is a partial cross-sectional elevation view of the sled of FIG. 59 shown at the distal end of the fastener cartridge;

FIG. 61 is a perspective view of a slider according to at least one embodiment;

FIG. 62 is an illustration showing a staple including a plurality of barbs, wherein the staple is shown in an unformed configuration and a deformed configuration, in accordance with at least one embodiment;

FIG. 63 is an elevational view of a staple including a plurality of barbs positioned within a staple cavity in an unfired position in accordance with at least one embodiment;

FIG. 64 is an elevation view of a staple including a plurality of barbs in accordance with at least one embodiment;

FIG. 65 is an elevation view of a staple including a plurality of barbs in accordance with at least one embodiment;

FIG. 66 is an elevation view of a staple including a plurality of barbs in accordance with at least one embodiment;

FIG. 67 is an elevation view of a staple including a plurality of barbs in accordance with at least one embodiment;

FIG. 68 is an elevational view of a staple including a plurality of barbs positioned within a staple cavity in an unfired position in accordance with at least one embodiment;

FIG. 69 is a plan view of the staple and staple cavity of FIG. 68;

FIG. 70 is a partial perspective view of a barbed staple leg according to at least one embodiment;

FIG. 71 is a partial perspective view of a barbed staple leg of the staple of FIG. 68;

FIG. 71A is a cross-sectional plan view of the barbed staple leg of FIG. 71;

FIG. 72 is a partial perspective view of a barbed staple leg according to at least one embodiment; and is

FIG. 73 is a partial perspective view of a barbed staple leg according to at least one embodiment.

Detailed Description

The applicant of the present application also owns the following identified U.S. patent applications, each of which is hereby incorporated by reference in its entirety:

U.S. patent application Ser. No. 12/894,311 (now U.S. patent publication 2012/0080496) entitled "SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS";

U.S. patent application Ser. No. 12/894,340 entitled "SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS" (now U.S. patent publication 2012/0080482);

U.S. patent application Ser. No. 12/894,327 entitled "JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS" (now U.S. patent publication 2012/0080499);

U.S. patent application Ser. No. 12/894,351 entitled "SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS" (now U.S. patent publication 2012/0080502);

U.S. patent application Ser. No. 12/894,338 (now U.S. patent publication 2012/0080481) entitled "IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT";

U.S. patent application Ser. No. 12/894,369 entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING ASUPPORT RETAINER" (now U.S. patent publication 2012/0080344);

U.S. patent application Ser. No. 12/894,312 entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS" (now U.S. patent publication 2012/0080479);

U.S. patent application serial No. 12/894,377 (now U.S. patent 8,393,514) entitled "SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE";

U.S. patent application Ser. No. 12/894,339 entitled "SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL ARRANGEMENT" (now U.S. patent publication 2012/0080500);

U.S. patent application Ser. No. 12/894,360 entitled "SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM" (now U.S. patent publication 2012/0080484);

U.S. patent application Ser. No. 12/894,322 (now U.S. patent publication 2012/0080501), entitled "SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS";

U.S. patent application Ser. No. 12/894,350 entitled "SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES" (now U.S. patent publication 2012/0080478);

U.S. patent application Ser. No. 12/894,383 entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS" (now U.S. patent publication 2012/0080345);

U.S. patent application serial No. 12/894,389 entitled "compact FASTENER CARTRIDGE" (now U.S. patent publication 2012/0080335);

U.S. patent application serial No. 12/894,345 entitled "FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT" (now U.S. patent publication 2012/0080483);

U.S. patent application serial No. 12/894,306 entitled "COLLAPSIBLE FASTENER CARTRIDGE" (now U.S. patent publication 2012/0080332);

U.S. patent application Ser. No. 12/894,318 entitled "FASTENER SYSTEM composition A PLURALITY OF CONNECTED RETENTION MATRIX ELEMENTS" (now U.S. patent publication 2012/0080480);

U.S. patent application Ser. No. 12/894,330 entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX" (now U.S. patent publication 2012/0080503);

U.S. patent application Ser. No. 12/894,361 (now U.S. Pat. No. 8,529,600), entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX";

U.S. patent application Ser. No. 12/894,367 entitled "FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (now U.S. patent publication 2012/0080485);

U.S. patent application Ser. No. 12/894,388 entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER" (now U.S. Pat. No. 8,474,677);

U.S. patent application Ser. No. 12/894,376 entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES" (now U.S. patent publication 2012/0080486);

U.S. patent application Ser. No. 13/097,865 entitled "SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS" (now U.S. patent publication 2012/0080488);

U.S. patent application Ser. No. 13/097,936 entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER" (now U.S. patent publication 2012/0080339);

U.S. patent application Ser. No. 13/097,954 entitled "STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION" (now U.S. patent publication 2012/0080340);

U.S. patent application Ser. No. 13/097,856 entitled "STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE PORTION THEREOF" (now U.S. patent publication 2012/0080336);

U.S. patent application Ser. No. 13/097,928 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING DEACABLE PORTIONS" (now U.S. patent publication 2012/0080490);

U.S. patent application Ser. No. 13/097,891 entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN ADJUSTABLE ANVIL" (now U.S. patent publication 2012/0080489);

U.S. patent application Ser. No. 13/097,948 (now U.S. patent publication 2012/0083836), entitled "STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION";

U.S. patent application serial No. 13/097,907 entitled "compact STAPLE CARTRIDGE asset" (now U.S. patent publication 2012/0080338);

U.S. patent application Ser. No. 13/097,861 entitled "TISSUE THICKNESS COMPENSATOR COMPATINING PORTIONS HAVING DIFFERENT PROPERTIES" (now U.S. patent publication 2012/0080337);

U.S. patent application Ser. No. 13/097,869 (now U.S. patent publication 2012/0160721), entitled "STAPLE CARTRIDGE LOADING ASSEMBLY";

U.S. patent application Ser. No. 13/097,917 entitled "COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS" (now U.S. patent publication 2012/0083834);

U.S. patent application Ser. No. 13/097,873 entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION" (now U.S. patent publication 2012/0083833);

U.S. patent application Ser. No. 13/097,938 entitled "STAPLE CARTRIDGE composite curable resin compositions" (now U.S. patent publication 2012/0080491);

U.S. patent application Ser. No. 13/097,924 entitled "STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR" (now U.S. patent publication 2012/0083835);

U.S. patent application Ser. No. 13/242,029 entitled "SURGICAL STAPLER WITH FLOATING ANVIL" (now U.S. patent publication 2012/0080493);

U.S. patent application Ser. No. 13/242,066 (now U.S. patent publication 2012/0080498), entitled "CURVED END EFFECTOR FOR A STAPLING INSTRUMENTS";

U.S. patent application Ser. No. 13/242,086 entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK" (now U.S. patent publication 2013/0075450);

U.S. patent application serial No. 13/241,912 (now U.S. patent publication 2013/0075448), entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT";

U.S. patent application serial No. 13/241,922 entitled "SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS" (now U.S. patent publication 2013/0075449);

U.S. patent application Ser. No. 13/241,637 (now U.S. patent publication 2012/0074201) entitled "SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTION MOTIONS";

U.S. patent application Ser. No. 13/241,629 (now U.S. patent publication 2012/0074200), entitled "SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR";

U.S. patent application Ser. No. 13/433,096 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES" (now U.S. patent publication 2012/0241496);

U.S. patent application Ser. No. 13/433,103 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS" (now U.S. patent publication 2012/0241498);

U.S. patent application Ser. No. 13/433,098 entitled "EXPANDABLE TISSUE THICKNESS COMPENSATOR" (now U.S. patent publication 2012/0241491);

U.S. patent application Ser. No. 13/433,102 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR" (now U.S. patent publication 2012/0241497);

U.S. patent application Ser. No. 13/433,114 entitled "RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR" (now U.S. patent publication 2012/0241499);

U.S. patent application Ser. No. 13/433,136 entitled "TISSUE THICKNESS COMPENSATOR COMPISING AT LEAST ONE MEDICAMENT" (now U.S. patent publication 2012/0241492);

U.S. patent application Ser. No. 13/433,141 entitled "TISSUE THICKNESS COMPENSATOR COMPATINING CONTROLLED RELEASE AND EXPANSION" (now U.S. patent publication 2012/0241493);

U.S. patent application Ser. No. 13/433,144 (now U.S. patent publication 2012/0241500), entitled "TISSUE THICKNESS COMPENSATOR COMPISING FIBERS TO PRODUCE A RESILIENT LOAD";

U.S. patent application Ser. No. 13/433,148 entitled "TISSUE THICKNESS COMPENSATOR COMPISING STRUCTURE TO PRODUCE A RESILIENT LOAD" (now U.S. patent publication 2012/0241501);

U.S. patent application Ser. No. 13/433,155 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING RESILINT MEMBERS" (now U.S. patent publication 2012/0241502);

U.S. patent application Ser. No. 13/433,163 entitled "METHOD FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS" (now U.S. patent publication 2012/0248169);

U.S. patent application Ser. No. 13/433,167 entitled "TISSUE THICKNESS COMPENSATORS" (now U.S. patent publication 2012/0241503);

U.S. patent application Ser. No. 13/433,175 entitled "laminated TISSUE THICKNESS COMPENSATOR" (now U.S. patent publication 2012/0253298);

U.S. patent application Ser. No. 13/433,179 entitled "TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS" (now U.S. patent publication 2012/0241505);

U.S. patent application serial No. 13/763,028 entitled "ADHESIVE FILM LAMINATE" (now U.S. patent publication 2013/0146643);

U.S. patent application Ser. No. 13/433,115 (now U.S. patent publication 2013/0256372) entitled "TISSUE THICKNESS COMPENSATOR COMPLEMENTING CAPSULES DEFINING A LOW PRESSURE ENVIRONMENT";

U.S. patent application Ser. No. 13/433,118 entitled "TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS" (now U.S. patent publication 2013/0256365);

U.S. patent application Ser. No. 13/433,135 entitled "Movable Membrane FOR USE WITH A TISSUE THICKNESS COMPENSATOR" (now U.S. patent publication 2013/0256382);

U.S. patent application Ser. No. 13/433,140 entitled "TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME" (now U.S. patent publication 2013/0256368);

U.S. patent application Ser. No. 13/433,129 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS" (now U.S. patent publication 2013/0256367);

U.S. patent application Ser. No. 11/216,562 (now U.S. Pat. No. 7,669,746) entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS";

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U.S. patent application Ser. No. 11/711,979 (now U.S. Pat. No. 8,317,070) entitled "SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS";

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U.S. patent application Ser. No. 11/711,977 entitled "SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTS MULTIPLE WIRE DIAMETER STAPLES" (now U.S. Pat. No. 7,673,781);

U.S. patent application Ser. No. 11/712,315 (now U.S. Pat. No. 7,500,979) entitled "SURGICAL STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR WEDGE CAMS FOR DRIVING STAPLE DRIVERS";

U.S. patent application Ser. No. 12/038,939 (now U.S. Pat. No. 7,934,630) entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS";

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U.S. patent application Ser. No. 13/118,278 (now U.S. patent publication 2011/0290851), entitled "ROBOTIC-CONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS";

U.S. patent application Ser. No. 13/369,629 entitled "ROBOTIC-CONTROLLED CABLE-BASED SURGICAL END EFFECTORS" (now U.S. patent publication 2012/0138660);

U.S. patent application Ser. No. 12/695,359 (now U.S. Pat. No. 8,464,923) entitled "SURGICAL STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENT FORMED HEIGHTS";

U.S. patent application Ser. No. 13/072,923 (now U.S. Pat. No. 8,567,656) entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS";

U.S. patent application Ser. No. 13/766,325 entitled "LAYER OF MATERIAL FOR A SURGICAL END EFFECTOR" (now U.S. patent publication 2013/0256380);

U.S. patent application Ser. No. 13/763,078 entitled "ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR" (now U.S. patent publication 2013/0256383);

U.S. patent application Ser. No. 13/763,094 entitled "LAYER composition laminated adhesive MEMBERS" (now U.S. patent publication 2013/0256377);

U.S. patent application Ser. No. 13/763,106 entitled "END EFFECTOR COMPRISING A DISTAL TISSUE ABUTMENT MEMBER" (now U.S. patent publication 2013/0256378);

U.S. patent application Ser. No. 13/433,147 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS" (now U.S. patent publication 2013/0256369);

U.S. patent application Ser. No. 13/763,112 entitled "SURGICAL STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES" (now U.S. patent publication 2013/0256379);

U.S. patent application Ser. No. 13/763,035 entitled "ACTUATOR FOR RELEASING A TISSUE THICKNESS COMPENSATOR FROM A FASTENER CARTRIDGE" (now U.S. patent publication 2013/0214030);

U.S. patent application Ser. No. 13/763,042 (now U.S. patent publication 2013/0221063), entitled "RELEABLE TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGE HAVING THE SAME";

U.S. patent application Ser. No. 13/763,048 entitled "FASTENER CARTRIDGE COMPRISING A RELEABLE TISSUE THICKNESS COMPENSATOR" (now U.S. patent publication 2013/0221064);

U.S. patent application Ser. No. 13/763,054 entitled "FASTENER CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING A TISSUE THICKNESS COMPENSATOR";

U.S. patent application Ser. No. 13/763,065 entitled "FASTENER CARTRIDGE COMPRISING A RELEASABLE ATTACHED TISSUE THICKNESS COMPENSATOR" (now U.S. patent publication 2013/0221065);

U.S. patent application Ser. No. 13/763,021 entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE COVER";

U.S. patent application serial No. 13/763,095 (now U.S. patent publication 2013/0161374), entitled "LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES";

U.S. patent application Ser. No. 13/463,147 (now U.S. patent publication 2013/0292398), entitled "IMPLANTABLE ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES";

U.S. patent application Ser. No. 13/763,192 (now U.S. patent publication 2013/0146642), entitled "MULTIPLE THICKNESESS IMPLANTABLE LAYERS FOR SURGICAL STAPLING DEVICES";

U.S. patent application Ser. No. 13/763,161 entitled "RELEABLE LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVING THE SAME" (now U.S. patent publication 2013/0153641);

U.S. patent application Ser. No. 13/763,177 (now U.S. patent publication 2013/0146641) entitled "ACTUATOR FOR RELEASING A LAYER OF MATERIAL FROM A SURGICAL END EFFECTOR";

U.S. patent application Ser. No. 13/763,037 entitled "STAPLE CARTRIDGE COMPRISING A COMPRESSIBLE PORTION";

U.S. patent application Ser. No. 13/433,126 entitled "TISSUE THICKNESS COMPENSATOR COMPISING TISSUE INGROWTH FEATURES" (now U.S. patent publication 2013/0256366);

U.S. patent application Ser. No. 13/433,132 (now U.S. patent publication 2013/0256373) entitled "DEVICES AND METHODS FOR ATTACHING titanium catalyst TO minor catalyst systems".

U.S. patent application Ser. No. 13/851,703 entitled "FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR INCLUDING OPENNING GS THEREIN";

U.S. patent application Ser. No. 13/851,676 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A CUTTING MEMBER PATH";

U.S. patent application serial No. 13/851,693 entitled "FASTENER CARTRIDGE assets"; and

U.S. patent application Ser. No. 13/851,684 entitled "FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR AND A GAP SETTING ELEMENT".

The applicant of the present application also owns the following patent applications, filed on the same day as the present application and each incorporated herein by reference in its entirety:

U.S. patent application Ser. No. __________ (attorney docket number END7439USNP) entitled "STAPLE CARTRIDGE INCLUDING A BARBED STAPLE";

U.S. patent application Ser. No. __________ (attorney docket number END7440USNP) entitled "STAPLE CARTRIDGE INCLUDING A BARBED STAPLE";

U.S. patent application Ser. No. __________ entitled "IMPLANTABLE LAYERS COMPRISING A PRESSED REGION" (attorney docket number END7349 USNP/130323);

U.S. patent application Ser. No. __________ (attorney docket No. END7348USNP/130324) entitled "IMPLANTABLE LAYERS AND METHODS FOR ALTERING ONE OR MORE PROPERTIES OF IMPLANTABLE LAYERS FOR USE WITH FASTENING INSTRUMENTS";

U.S. patent application Ser. No. __________ (attorney docket No. END7347USNP/130325) entitled "IMPLANTABLE LAYERS AND METHODS FOR MODIFYING THE SHAPE OF THE IMPLANTABLE LAYERS FOR USE WITH A SURGICAL FASTENING INSTRUMENT";

U.S. patent application serial No. __________ entitled "IMPLANTABLE LAYER ASSEMBLIES" (attorney docket number END7346 USNP/130326);

U.S. patent application Ser. No. __________ entitled "IMPLANTABLE LAYERS COMPRISING A PRESSED REGION" (attorney docket number END7345 USNP/130327); and

U.S. patent application Ser. No. __________ entitled "FASTENING SYSTEM COMPRISING A FIRING MEMBER LOCKOUT" (attorney docket number END7350 USNP/130328).

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention 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 present invention.

The terms "comprises" (and any form of comprising, such as "comprising" and "comprising)", "having" (and any form of having, such as "has" and "having)", "comprising" (and any form of containing, such as "comprises" and "comprising)", and "containing" (and any form of containing, such as "containing" and "containing") are open-ended verbs, and thus a surgical system, device, or apparatus "comprising", "having", "containing", or "containing" one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. But is not limited to having only one or more of these features.

The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion away from the clinician. It will also be appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein in connection with the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, one of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein may be used in a number of surgical procedures and applications, including, for example, in conjunction with open surgery. With continued reference to the present detailed description, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein may be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture formed in tissue, and the like. The working portion or end effector portion of the instrument can be inserted directly into the patient or can be inserted through an access device having a working channel through which the end effector and elongate shaft of the surgical instrument can be advanced.

Turning to the drawings, wherein like numbers denote like parts throughout the several views, fig. 1 illustrates an exemplary surgical stapling and severing instrument 8010 suitable for use with a tissue thickness compensator assembly, as described in greater detail below. The surgical stapling and severing instrument 8010 can include an anvil 8014 that can be repeatedly opened and closed about its pivotal attachment to the elongate staple channel 8016. The staple applying assembly 8012 can comprise an anvil 8014 and a channel 8016, wherein the assembly 8012 can be attached proximally to an elongate shaft 8018 that forms an implement portion 8022. When the staple applying assembly 8012 is closed, or at least substantially closed, the implement portion 8022 can present a sufficiently small cross-section that is suitable for insertion of the staple applying assembly 8012 through a trocar. In various circumstances, the assembly 8012 can be manipulated by a handle 8020 connected to the shaft 8018. The handle 8020 can include user controls such as a knob 8030 that rotates the elongate shaft 8018 and staple applying assembly 8012 about the longitudinal axis of the shaft 8018. The closure trigger 8026 can be pivoted in front of the pistol grip 8036 to close the staple applying assembly 8012. For example, when the closure trigger 8026 is clamped, the closure release button 8038 can be presented outwardly on the handle 8020 such that the release button 8038 can be depressed to release the closure trigger 8026 and open the staple applying assembly 8012. A firing trigger 8034, which can pivot in front of the closure trigger 8026, can cause the staple applying assembly 8012 to simultaneously sever and staple tissue clamped therein. In various circumstances, multiple firing strokes can be employed using the firing trigger 8034 to reduce the amount of force required to be applied by the surgeon's hand per stroke. In certain embodiments, the handle 8020 can include one or more rotatable indicator wheels, such as a rotatable indicator wheel 8041 that can indicate the progress of firing. If desired, a manual firing release lever 8042 may allow the firing system to retract before full firing travel is complete, and further, in the event of a stuck and/or failed firing system, the firing release lever 8042 may allow a surgeon or other clinician to retract the firing system. Additional details regarding the surgical stapling and severing instrument 8010 and other surgical stapling and severing instruments suitable for use with the present disclosure are described, for example, in U.S. patent application 13/851,693 entitled "FASTENER CARTRIDGE ASSEMBLY" filed on 27.3.2013, the entire disclosure of which is incorporated herein by reference. In addition, powered surgical stapling and severing instruments may also be used with the present disclosure. See, for example, U.S. patent application publication 2009/0090763a1 entitled "POWERED SURGICAL STAPLING DEVICE," filed on 8.8.2008, the entire disclosure of which is incorporated herein by reference.

In connection with fig. 2 and 3, a firing assembly, such as firing assembly 9090, can be used with the surgical stapling and severing instrument 8010 to advance a wedge sled 9126 comprising a plurality of wedges 9204 that are configured to deploy staples from the staple applying assembly 8012 into tissue captured between the anvil 8014 and the elongate staple channel 8016. In addition, an E-beam 9102 at a distal portion of the firing assembly 9090 can facilitate separate closure and firing, as well as spacing the anvil 8014 from the elongate staple channel 8016 during firing. The E-beam 9102 can include a pair of top pins 9110, a pair of middle pins 9112 that can follow portions 9218 of the wedge sled 9126, and a bottom pin or foot 9114, as well as a sharp cutting edge 9116, which can be configured to sever captured tissue as the firing assembly 9090 is advanced distally. In addition, the proximally projecting integrally formed top guide 9118 and middle guide 9120 that cradle each vertical end of the cutting edge 9116 may further define a tissue staging area 9122, thereby helping to guide tissue to the sharp cutting edge 9116 prior to severing the tissue. The intermediate guide 9120 can also be used to engage and fire the staple applying assembly 8012 through a stepped central member 9124 that abuts a wedge sled 9126 (fig. 2) that effects staple formation by the staple applying assembly 8012.

In various instances, a staple cartridge can include a means for compensating for the thickness of tissue captured within staples deployed from the staple cartridge. Referring to fig. 4, a staple cartridge, such as staple cartridge 10000, for example, can be used with a surgical stapling and severing instrument 8010 and can include a rigid first portion, such as the support portion 10010, and a compressible second portion, such as the tissue thickness compensator 10020. The support portion 10010 can comprise a cartridge body and a plurality of staple cavities 10012. The staples 10030 can be removably positioned within each staple cavity 10012, for example. Referring primarily to fig. 4 and 5, each staple 10030 can comprise a base 10031 and one or more legs 10032 extending from the base 10031. Prior to deployment of the staples 10030, the bases 10031 of the staples 10030 can be supported by staple drivers positioned within the support portion 10010 and, at the same time, the legs 10032 of the staples 10030 can be at least partially contained within the staple cavities 10012. In various circumstances, the staples 10030 can be deployed between an unfired position and a fired position such that the legs 10032 move through the tissue thickness compensator 10020, penetrate a top surface of the tissue thickness compensator 10020, penetrate the tissue T, and contact an anvil positioned opposite the staple cartridge 10000. As the legs 10032 are deformed against the anvil, the legs 10032 of each staple 10030 can capture a portion of the tissue thickness compensator 10020 and a portion of the tissue T within each staple 10030 and apply a compressive force to the tissue. Further to the above, the legs 10032 of each staple 10030 can be deformed downwardly toward the base 10031 of the staple to form a staple entrapment area in which the tissue T and the tissue thickness compensator 10020 can be captured. In various circumstances, a staple entrapment area can be defined between the inner surface of the deformed leg 10032 and the inner surface of the base 10031. The size of the staple entrapment area may depend on several factors, such as the length of the legs, the diameter of the legs, the width of the base, and/or the degree of deformation of the legs.

In use, further to the above and referring primarily to fig. 4, an anvil, such as anvil 8014, of the surgical stapling and severing instrument 8010 can be moved into a closed position opposite the staple cartridge 10000 by pressing on the closure trigger 8026 to advance the E-beam 9102. The anvil 8014 can position the tissue against the tissue thickness compensator 10020 and, in various circumstances, compress the tissue thickness compensator 10020 against the support portion 10010, for example. Once the anvil 8014 has been properly positioned, the staples 10030 can be deployed, as also shown in fig. 4. In various instances, as described above, a staple firing sled 10050, which is similar in many respects to the sled 9126 (see fig. 3), can be moved from the proximal end toward the distal end 10002 of the staple cartridge 10000, as shown in fig. 5. As the firing assembly 9090 is advanced, the sled 10050 can contact the staple drivers 10040 and lift the staple drivers 10040 upwardly within the staple cavities 10012. In at least one example, the sled 10050 and the staple drivers 10040 can each comprise one or more ramps or inclined surfaces that can cooperate to move the staple drivers 10040 upwardly from their unfired positions. As the staple drivers 10040 are lifted upwardly within their respective staple cavities 10012, the staple drivers 10040 can lift the staples 10030 upwardly such that the staples 10030 can emerge from their staple cavities 10012. In various circumstances, as part of the firing sequence, the sled 10050 can move several staples upward simultaneously.

As described above and referring to fig. 5, when the staples 10030 are in their unfired positions, the staple legs 10032 of the staples 10030 can extend into the compensator 10020 beyond the support portion 10010. In various circumstances, the tips of the staple legs 10032, or any other portion of the staple legs 10032, may not protrude through the top tissue-contacting surface 10021 of the tissue thickness compensator 10020 when the staples 10030 are in their unfired positions. In certain instances, the tips of the staple legs 10032 can comprise sharpened tips that are capable of cutting into and penetrating the tissue thickness compensator 10020.

In various circumstances, it may be preferable to prevent and/or limit friction between the tissue thickness compensator and the staples. Referring now to fig. 6-8, a tissue thickness compensator 20220 for use with a staple cartridge assembly 20200 can comprise a plurality of clearance holes 20224 extending at least partially through the tissue thickness compensator 20220. In various instances, the staple cartridge assembly 20200 can include a staple cartridge body 20210 and a tissue thickness compensator 20220 releasably secured relative to the staple cartridge body 20210. The cartridge body 20210 can comprise, for example, a cartridge deck 20211 and staple cavities 20212 defined through the cartridge deck 20211 and into the body of the staple cartridge body 20210. The staples 20230 can, for example, be removably positioned in the staple cavities 20212. Tissue thickness compensator 20220 can comprise a tissue contacting surface 20221 (fig. 7) and a platform contacting surface 20222 (fig. 6). The deck-contacting surface 20222 can be releasably positioned against, for example, the deck 20211 of the cartridge body 20210, and the tissue-contacting surface 20221 can be positioned against, for example, tissue T to be stapled. The clearance hole 20224 may extend through the platform contact surface 20222 and into the tissue thickness compensator 20220 and may include holes, slits, gaps, bores, openings, and/or cleared paths, for example, within the tissue thickness compensator 20220.

Referring primarily to fig. 7 and 8, the staples 20230 can be positioned in the staple cavities 20212 of the cartridge body 20210. Each staple 20230 can include a base 20231 and a pair of staple legs 20232, which can extend from the base 20231, for example. Each staple leg 20232 may extend from opposite ends of the base 20231. Referring primarily to fig. 7, one or more of the clearance holes 20224 in the tissue thickness compensator 20220 can comprise an opening in the platform contact surface 20222. The opening of the clearance hole 20224 can be aligned with a corresponding staple leg 20232 positioned in the staple cavity 20212. For example, when the tissue thickness compensator 20220 is fixed relative to the cartridge body 20210, the individual staple legs 20232 can be aligned with the openings of the individual clearance holes 20224. In some cases, the staple legs 20232 can extend into each clearance hole 20224 such that at least a portion of the staples 20230 are embedded, for example, in the tissue thickness compensator 20220. For example, referring primarily to fig. 7, staple 20230 can include a first staple leg 20232a and a second staple leg 20232 b. In addition, the tissue thickness compensator 20220 can comprise, for example, a first clearance hole 20224a aligned with the first staple leg 20232a and a second clearance hole 20224b aligned with the second staple leg 20232 b. Prior to deployment of the staple 20230, for example, the first staple leg 20232a may extend partially through the first clearance hole 20224a and the second staple leg 20232b may extend partially through the second clearance hole 20224 b. The tissue thickness compensator 20220 can include additional clearance holes 20224 that are not aligned with the staple legs 20232, for example. In certain instances, the staple cartridge assembly 20200 can include additional staples 20230 and/or staple legs 20232 that are not aligned with the clearance holes 20224, for example.

The staples 20230 can be moved from an unfired configuration (fig. 7) to a fired configuration (fig. 8). Each staple 20230 can move along a staple axis when moving between an unfired configuration and a fired configuration. When in the unfired configuration, the staple legs 20232 can extend from the staple cavities 20212 and into, for example, the tissue thickness compensator 20220. For example, when the staples 20230 are in an unfired configuration, the staple legs 20232 can be partially embedded in the tissue thickness compensator 20220. Further, for example, at least a portion of the staple legs 20232 can be aligned with and/or positioned within the clearance holes 20224 of the tissue thickness compensator 20220 when the staples are in an unfired configuration. In other instances, when in the unfired configuration, the staple legs 20232 can be positioned entirely within the staple cavities 20212 and can be aligned with the clearance holes 20224 positioned, for example, above the cartridge deck 20211 (fig. 6).

During the firing stroke, the staples 20230 can be moved from an unfired configuration (fig. 7) to a fired configuration (fig. 8), as described herein. A staple driver 20240 can be positioned within each staple cavity 20212. The staple drivers 20240 within each staple cavity 20212 can be urged toward the cartridge deck 20211 (fig. 6), e.g., to drive the staples 20230 into the tissue T and toward an anvil 20260 (fig. 8), which can be similar in many respects to other anvils described herein, e.g., anvil 8014 (fig. 1). As each staple 20230 moves from the unfired configuration to the fired configuration, the staple legs 20232 can be moved through the clearance holes 20224 in the tissue thickness compensator 20220. The clearance hole 20224 can have a predetermined trajectory within the tissue thickness compensator 20220. For example, clearance hole 20224 can extend along an axis that is perpendicular and/or substantially perpendicular to tissue-contacting surface 20221 (fig. 7) and/or platform-contacting surface 20222 (fig. 6) of tissue thickness compensator 20220. In other instances, the clearance hole 20224 can extend along an axis oriented at an oblique angle relative to, for example, the tissue-contacting surface 20221 and/or the platform-contacting surface 20222 of the tissue thickness compensator 20220. In some cases, a set of clearance holes 20224 can be parallel. In some cases, for example, all of the clearance holes 20224 within the tissue thickness compensator 20220 can be parallel. Clearance hole 20224 can include a partially curved track and/or a partially linear track. Other characteristics and features of clearance hole 20224 are described in more detail in U.S. patent application 13/851,693 entitled "FASTENER CARTRIDGE ASSEMBLY" filed on 3/27 of 2013, the entire disclosure of which is incorporated herein by reference. Methods and techniques for modifying a tissue thickness compensator to include clearance holes, such as clearance hole 20224, are described in more detail below.

Referring now to fig. 9-12, an end effector 22090 of a surgical instrument similar in many respects to the surgical instrument 8010 can comprise, for example, a first jaw having a fastener cartridge assembly 22000 and a second jaw having an anvil 10060. The first jaw can comprise a staple cartridge channel 10070, which can be configured to removably receive the cartridge assembly 22000. Alternatively, the staple cartridge channel 10070 and cartridge assembly 22000 can comprise an integral unit. In various circumstances, the anvil 10060 can be moved between an open position and a closed position (fig. 9-12). In the open position of the anvil 10060, for example, the anvil 10060 can be positioned on a first side of tissue T (fig. 10-12) of a patient, and the cartridge assembly 22000 can be positioned on a second, or opposite, side of the tissue T. When the anvil 10060 is moved into its closed position, the anvil 10060 can compress the tissue T against the cartridge assembly 22000. Alternatively, the first jaw, including the cartridge assembly 22000, can be moved relative to the anvil 10060. A firing member 10052, which is similar in many respects to firing assembly 9090 (fig. 3), can be advanced distally from the proximal end 22001 of cartridge assembly 22000 toward the distal end 22002 of cartridge assembly 22000 to eject fasteners, such as staples 22030 removably stored in cartridge body 22010 of cartridge assembly 22000, as firing member 10052 is advanced from proximal end 22001 toward distal end 22002 of cartridge assembly 22000.

As further described above, the staples 22030 can be supported by staple drivers 10040 that are movably positioned within the staple cavities 22012 defined in the cartridge body 22010. Further, the firing member 10052 can be configured to advance the staple firing sled 10050 distally within the cartridge body 22010 as the firing member 10052 is moved from the proximal end 22001 toward the distal end 22002. In such instances, the staple firing sled 10050 can be configured to lift the staple drivers 10040, and the staples 22030 supported thereon, toward the anvil 10060. In essence, further to the above, the staple drivers 10040 can move the staples 22030 from an unfired position (fig. 10) to a fired position (fig. 11 and 12), wherein the staples 22030 can contact the anvil 10060 and deform between an undeformed configuration (fig. 10) and a deformed configuration (fig. 11 and 12). The anvil 10060 can comprise forming pockets 10062 that can be configured to receive and deform the staples 22030. The staples 22030 can be the same as or similar to, for example, the staples 10030 and/or any other staples disclosed herein, and thus, the staples 22030 are not described in greater detail herein. However, the reader will note that the staples 22030 comprise any suitable shape and/or suitable dimensions, such as width and/or height, for example, in their undeformed configuration and/or their deformed configuration. For example, in certain instances, when the staples 22030 are in their unfired position, the staples 22030 can comprise a height that does not extend above the deck surface 22011 of the cartridge body 22010, while in other instances, when the staples 22030 are in their unfired position, the staples 22030 can comprise a height wherein the legs of the staples 22030 extend upwardly from the deck surface 22011 such that the legs of the staples 22030 are at least partially embedded in the tissue thickness compensator 22010 of the cartridge assembly 22000.

With continued reference to the embodiment shown in fig. 9-12, further to the above, the cartridge assembly 22000 can comprise a cartridge body 22010 and a tissue thickness compensator 22020. In various circumstances, the cartridge body 22010 can be similar in many respects to the support portion 10010, for example, and accordingly, many of such aspects are not repeated herein for the sake of brevity. Moreover, the tissue thickness compensator 22020 can be similar to the tissue thickness compensator 10020, for example, in many respects. Further to the above, the firing member 10052 can comprise a cutting portion 10053 that can be configured to transect tissue positioned between the anvil 10060 and the tissue thickness compensator 22020 as the firing member 10052 is advanced distally. Thus, in various circumstances, the firing member 10052 can be configured to simultaneously fire the staples 22030 to staple and sever tissue T. In some instances, the firing process may at least partially cause the cutting process. In other words, the cutting process may lag the firing process. In such cases, a portion of tissue T may be sutured and then incised.

As shown in fig. 9-12, the cartridge body 22010 can comprise a cartridge knife slot 22015 which can be configured to receive a portion of the firing member 10052 as the firing member 10052 is advanced distally. Further to the above, the anvil 10060 can comprise an anvil knife slot 10065 that can be configured to receive a portion of the firing member 10052 as the firing member 10052 is advanced distally. In various instances, the tissue thickness compensator 22020 can comprise a tissue thickness compensator knife slot 22025 that can be aligned with the anvil knife slot 10065 and the cartridge knife slot 22015 such that the firing member 10052 can pass through the cartridge knife slot 22015, the anvil knife slot 10065, and the tissue thickness compensator knife slot 22025 simultaneously. In various circumstances, the anvil knife slot 10065 can extend above the tissue thickness compensator knife slot 22025 such that the cutting portion 10053 of the firing member 10052 can pass through the cartridge knife slot 22015, the anvil knife slot 10065, and the tissue thickness compensator knife slot 22025 simultaneously. The tissue thickness compensator knife slot 22025 can define a tissue thickness compensator knife path of the cutting portion 10053, wherein the tissue thickness compensator knife path can be parallel to the anvil knife path and the cartridge knife path. In various instances, the tissue thickness compensator blade path can be longitudinal, and in some instances, the tissue thickness compensator blade path can be curved. Further to the above, curved end effectors and curved fastener cartridges are disclosed in U.S. patent application publication 2008/0169329. The entire disclosure of U.S. patent application serial No. 11/652,164 (now U.S. patent application publication 2008/0169329), entitled "CURVED END effect FOR a SURGICAL STAPLING DEVICE," filed on 11/1 of 2007 is hereby incorporated by reference herein. In such cases, the tissue thickness compensator can be curved. In at least one such embodiment, the tissue thickness compensator can be curved to match the curvature of the cartridge body of the fastener cartridge. Methods and techniques for modifying a tissue thickness compensator to include a knife slot, such as knife slot 22025, are described below.

Further to the above, referring primarily to fig. 9, the tissue thickness compensator blade slot 22025 can extend between a first stapling portion 22021a, which can be stapled by a first set of staples 22030, and a second stapling portion 22021b, which can be stapled by a second set of staples 22030. The knife slot 22025 can releasably connect the first suture portion 22021a to the second suture portion 22021 b. In use, as shown in fig. 9, the cutting portion 10053 can be advanced distally through the knife slot 22025 to transect the knife slot 22025 and separate the first suture portion 22021a from the second suture portion 22021 b. In certain instances, the knife slot 22025 can comprise a plurality of connectors or bridges 22026 that can connect the first and

second suture portions

22021a, 22021b prior to being transected by the cutting portion 10053. In various instances, the connector 22026 can have the same thickness as the first and/or

second suture portions

22021a, 22021b, at least when the tissue thickness compensator 22020 is in an uncompressed state. In at least one such instance, the connector 22026, the first suture portion 22021a, and/or the second suture portion 22021b can be integrally and unitarily formed from a flat or at least substantially flat piece of material, for example. In various other instances, the first sewn portion 22021a may comprise a first thickness, the second sewn portion 22021b may comprise a second thickness, and the connector 22026 may comprise a third thickness, wherein one or more of the first thickness, the second thickness, and the third thickness may be different than the other thicknesses.

Knife slot 22025 can also include, for example, a hole defined therein, such as hole 22024. For example, the hole 22024 may be elongated and may extend longitudinally along the knife slot 22025. In various other instances, the holes in the knife slot 22025 can comprise any suitable arrangement. In some cases, the aperture 22024 may comprise a perforation positioned in the middle of the connector 22026, which may be formed using, for example, a laser cutting operation. In some cases, the holes 22024 can be cut from a sheet of material to form the tissue thickness compensator 22020 such that the holes 22024 and connectors 22026 are arranged, for example, in an alternating arrangement. In other instances, the tissue thickness compensator 22020 can be molded with the hole 22024 already formed therein. In various instances, one or more of the holes 22024 can comprise, for example, a through hole. In various instances, one or more of the holes 22024 can include, for example, clearance holes. In some cases, one or more of the holes 22024 may not include a through hole and instead may have a reduced thickness, such as knife slot 22025. Methods and techniques for modifying a tissue thickness compensator to include apertures, such as aperture 22024, are described below.

Further to the above, referring again to fig. 9-11, when the anvil 10060 is in the open position, patient tissue can be positioned between the anvil 10060 of the end effector 22090 and the tissue thickness compensator 22020 of the cartridge assembly 22000. As the anvil 10060 is moved into the closed position, a bottom or tissue-contacting surface 10063 of the anvil 10060 can contact the tissue T and push the tissue T toward the deck surface 22011 of the cartridge body 22010. The tissue T can contact the top surface or tissue contacting surface 22021 of the tissue thickness compensator 22020 wherein when the anvil 10060 is moved into its closed position, the anvil 10060 can press the tissue T against the tissue thickness compensator 22020 and, as further described above, compress the tissue thickness compensator 22020 against the deck surface 22011 of the cartridge body 22010. In various instances, the tissue thickness compensator 22020 can comprise a bottom surface 22029, which can abut the platform surface 22011. In some instances, a gap can exist between the bottom surface 22029 and the platform surface 22011 before the tissue thickness compensator 22020 is compressed against the cartridge body 22010. In such instances, the tissue thickness compensator 22020 can first be translated toward the cartridge body before being compressed against the cartridge body 22010. As the tissue thickness compensator 22020 is compressed against the cartridge body 22010, the first suture portion 22021a and/or the second suture portion 22021b of the tissue thickness compensator 22020 can move laterally under various circumstances. For example, the first suture portion 22021a and/or the second suture portion 22021b can be moved laterally away from the cartridge knife slot 22015. In various circumstances, the connector 22026 can be configured to inhibit such lateral movement between the first suture portion 22021a and the second suture portion 22021 b. In various circumstances, referring primarily to fig. 11, the connector 22026 can be configured to stretch to allow some relative lateral movement between the first and

second stapling portions

22021a, 22021b when the anvil 10060 is closed. With the anvil 10060 reopened, the connector 22026 can be configured to resiliently return, or at least substantially return, to its unstretched configuration and, as a result, laterally pull back the first and

second stapling portions

22021a, 22021b toward their initial positions shown in fig. 10. Further, when the anvil 10060 is moved into its closed position, the anvil 10060 can compress the tissue T. In such cases, the tissue T may flow at least partially into the aperture 22024.

Upon viewing fig. 10-12, the reader will recognize that the knife slot 22025 of the tissue thickness compensator 22020 includes less material along its longitudinal length than the first and/or

second suture portions

22021a, 22021 b. In other words, a longitudinal cross-section through the first suture portion 22021a and/or the second suture portion 22021b will transect a first amount of material, while a longitudinal cross-section through the knife slot 22025 will transect a second amount of material that is less than the first amount of material.

Once the anvil 10060 has been properly positioned, further to the above, the firing member 10052 can be advanced distally to fire the staples, as shown in fig. 11, and incise the tissue T and the connector 22026, as shown in fig. 12. Further, the tissue thickness compensator incising force, the tissue thickness compensator resistance, and/or the tissue resistance can blunt the cutting portion 10053 of the firing member 10052. The blunt blade may not be able to transect the tissue T and/or the tissue thickness compensator 22020, for example, according to a preferred manner. Referring primarily to fig. 12, the cutting portion 10053 can comprise, for example, a first blade zone 10053a, a second blade zone 10053b, and/or a third blade zone 10053c, wherein the first blade zone 10053a is positioned vertically above the second blade zone 10053b, and wherein the second blade zone 10053b is positioned vertically above, for example, the third blade zone 10053 c. The cutting portion 10053 may include any suitable number and/or location of knife-edge regions, with the knife-edge regions shown in fig. 12 being selected for discussion purposes. Further to the above, the first blade region 10053a can be configured to transect tissue T, while the second blade region 10053b can be configured to transect tissue thickness compensator 22020. As a result, first blade region 10053a may experience the tissue incising forces and/or tissue resistance described above. Such forces may wear or dull the first blade region 10053a at a first rate. The second blade zone 10053b can experience the tissue thickness compensator incising force and/or the tissue thickness compensator resistance described above. Such forces may wear or dull the second blade edge region 10053b at a second rate. In various cases, the second rate may be different from the first rate.

Turning now to fig. 13 and 14, the fastener cartridge 22400 can include a tissue thickness compensator 22420, which can include a first stapling section 22421a and a second stapling section 22421b connected by a knife slot 22425. The knife slot 22425 may include an angled longitudinal connector 22426. The angled longitudinal connectors 22426 may extend between a proximal end 22401 of the knife slot 22425 and a distal end 22402 of the knife slot 22425. In some instances, the angled longitudinal connectors 22426 may extend the entire length of the knife slot 22425, while in other instances, the angled longitudinal connectors 22426 may extend less than the length of the knife slot 22425. The angled longitudinal connectors 22426 may extend between a top surface 22428 of the tissue thickness compensator 22420 and a bottom surface 22429 of the tissue thickness compensator 22420. In some cases, the angled longitudinal connectors 22426 may extend the entire distance between the top and

bottom surfaces

22428 and 22429, while in other cases, the angled longitudinal connectors 22426 may extend less than the distance between the top and

bottom surfaces

22428 and 22429. In various instances, the proximal ends of the longitudinal connectors 22426 may extend from the top surface 22428 of the tissue thickness compensator, while the distal ends of the longitudinal connectors 22426 may extend from the bottom surface 22429. Alternatively, the distal ends of the longitudinal connectors 22426 may extend from the top surface 22428 of the tissue thickness compensator, while the proximal ends of the longitudinal connectors 22426 may extend from the bottom surface 22429. In various instances, the longitudinal connector 22426 can comprise a thin bridge (i.e., less than the entire thickness of the tissue thickness compensator 22420) or a series of thin bridges that can, for example, join the first stapling section 22421a, which can be stapled by the first set of staples 22030, to the second stapling section 22421b, which can be stapled by the second set of staples 22030. These thin, angled bridges and/or longitudinal connectors 22426 can distribute wear over the second blade edge region 10053b, rather than concentrating it in one point. In various circumstances, as a result, for example, the wear occurring on the second blade region 10053b can be equal to or nearly equal to the wear occurring at the first blade region 10053 a.

Referring now to fig. 15-17, an example tissue thickness compensator assembly 1000 can comprise a first layer 1002 and a second layer 1004 attachable to the first layer 1002. The tissue thickness compensator assembly 1000 can be used with a surgical instrument, such as the surgical instrument 8010 (fig. 1). In addition, the tissue thickness compensator assembly 1000 can be used in a similar manner to the tissue thickness compensator 22020 of the cartridge assembly 22000 of the end effector 22090 and can replace the tissue thickness compensator 22020 (fig. 9). For example, the second layer 1004 of the tissue thickness compensator assembly 1000 can include a first portion 1006 that can be positioned on the deck surface 22011 on a first side of the cartridge knife slot 22015 in a similar manner as the first suture portion 22021a, and a second portion 1008 that can be positioned on the deck surface 22011 on a second side of the cartridge knife slot 22015 opposite the first side in a similar manner as the second suture portion 22021b (fig. 9-11). In various instances, the first and

second portions

1006, 1008 of the second layer 1004 can be spaced apart and can include a gap 1010 therebetween, which can include a knife path for the cutting portion 10053 of the firing member 10052 and can extend at least partially over the cartridge knife slot 22015 when the tissue thickness compensator assembly 1000 is assembled with the cartridge end effector 22090. In some cases, first layer 1002 can be configured to couple first portion 1006 and second portion 1008 and extend at least partially over gap 1010, e.g., as shown in fig. 17.

In use, tissue T can be captured between the anvil 10060 and the tissue contacting surface 1012 of the first layer 1002. As the firing member 10052 is advanced, a first set of staples 20030 can be deployed to staple the first portion 1006 and a second set of staples can be deployed to staple the second portion 1008. The first and second groups of staples can be configured to penetrate the first platform contact surface 1007 and the second platform contact surface 1009 of the second layer 1004, then penetrate the tissue contact surface 1012 of the first layer, and then penetrate the captured tissue T to contact the pockets 10062 of the anvil 10060, respectively. Further, advancement of the firing member 10052 can cause the cutting portion 10053 to advance distally through the gap 1010 of the tissue thickness compensator assembly 1000. The cut portion 10053 can traverse the first layer 1002 while advancing through the gap 1010, thereby separating the first portion 1006 and the second portion 1008 of the second layer 1004.

Referring again to fig. 17, the first layer 1002 of the tissue thickness compensator assembly 1000 can comprise a first height H1, the first portion 1006 of the second layer 1004 can comprise a second height H2, and the second portion 1008 of the second layer 1004 can comprise a third height H3. In some cases, as shown in fig. 17, second height H2 and third height H3 may be the same or substantially the same. In other cases, second height H2 may be different than third height H3. In some cases, first height H1 may be less than second height H2 and/or third height H3, as shown in fig. 17. The first layer 1002 of the tissue thickness compensator assembly 1000 can comprise a first density, the first portion 1006 of the second layer 1004 can comprise a second density, and the second portion 1008 of the second layer 1004 can comprise a third density. In some cases, as shown in fig. 17, the second density and the third density may be the same or substantially the same. In other cases, the second density may be different from the third density and/or different from the first density of the first layer 1002. The material composition of the first portion 1006 and the second portion 1008 may be the same or at least substantially the same. In other cases, the material compositions of the first and

second portions

1006, 1008 may be different from each other and/or may be different from the material composition of the first layer 1002.

As described above, repeated use of the cutting portion 10053 to cut the tissue T and the tissue thickness compensator material can dull the cutting portion 10053. To slow the blunting process, it may be desirable to reduce the tissue thickness compensator material cut by the cutting portion 10053. An additional benefit may be a reduction in the force required to advance the firing member 10052 distally during the firing stroke. To reduce passivation of the cut portion 10053, the first layer 1002 can comprise, at least in part, a thin film, for example. In such cases, the first height H1 may be significantly less than the second height H2 and the third height H3, as shown in fig. 17. In some cases, the first layer 1002 may have a uniform or substantially uniform height therethrough, as shown in fig. 17. In other cases, the gap bridge portion 1014 of the first layer 1002 can extend at least partially over the gap 1010 and can be thinner than the remainder of the first layer 1002. The cut portion 10053 can intersect the gap bridge portion 1014 of the first layer 1002 while advancing through the gap 1010 between the first portion 1006 and the second portion 1008 of the second layer 1004, which can reduce the resistance experienced by the cut portion 10053 and/or slow the blunting of the cut portion 10053. In any event, the first layer 1002 can be configured to maintain coupled engagement with the first and

second portions

1006, 1008 of the second layer 1004 prior to being transected, and present the cut portion 10053 with reduced resistance as the cut portion 10053 is advanced to transect the first layer 1002.

To further reduce blunting of the cutting portion 10053 and/or reduce the resistance experienced by the cutting portion 10053, the gap bridge 1014 can include a perforated segment 1016 along the knife path defined by the gap 1010, as shown in fig. 16. The perforated section 1016 may include a plurality of perforations 1018 that may be cut into the first layer 1002 prior to, for example, assembling the first layer 1002 to the second layer 1004. As the cut portion 10053 is advanced through the knife path defined by the gap 1010, the perforations 1018 may reduce the interaction between the cut portion 10053 and the first layer 1002, which may slow the blunting of the cut portion 10053 and/or reduce the resistance experienced by the cut portion 10053.

In various instances, as described in greater detail below, the tissue thickness compensator assembly 1000 can be constructed of one or more biocompatible materials. In some cases, the first layer 1002 can be composed of, for example, a biocompatible support material and/or plastic material, such as Polydioxanone (PDS) and/or polyglycolic acid (PGA), and the second layer 1004 can be composed of, for example, a bioabsorbable foam material and/or a compressible hemostatic material, such as Oxidized Regenerated Cellulose (ORC). In some cases, the first layer 1002 can be a film comprising, for example, a bioabsorbable material such as polyglycolic acid (PGA) sold under the trade name Vicryl, polylactic acid (PLA or PLLA), Polydioxanone (PDS), Polyhydroxyalkanoate (PHA), poliglecaprone 25(PGCL) sold under the trade name Monocryl, Polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL. In some cases, the first portion 1006 and/or the second portion 1008 of the second layer 1004 can be comprised of, for example, a lyophilized foam comprising polylactic acid (PLA) and/or polyglycolic acid (PGA). In some cases, the first portion 1006 and/or the second portion 1008 of the second layer 1004 can be constructed of a biocompatible foam, which can include a porous open-cell foam and/or a porous closed-cell foam.

Referring again to fig. 15 and 17, the first layer 1002 can be at least partially disposed on the second layer 1004 such that the second layer 1004 can be positioned between the first layer 1002 and the deck surface 22011 (fig. 9) when the tissue thickness compensator assembly 1000 is assembled with the end effector 22090 (fig. 9). In other instances, the first layer 1002 can be positioned under the first portion 1006 and the second portion 1008 (not shown) such that when the tissue thickness compensator assembly 1000 is assembled with the end effector 22090 (fig. 9), the first layer 1002 can be positioned between the second layer 1004 and the platform surface 22011 (fig. 9). In any case, the first layer 1002 may be attached to the first contact surface 1020 of the first portion 1006 and the second contact surface 1022 of the second portion 1008 of the second layer 1004. The first layer 1002 may be attached to the second layer 1004 by a thermal compression process that involves the application of heat and/or pressure, as described in more detail below. In other cases, the first layer 1002 can be attached to the second layer 1004 by, for example, a biocompatible adhesive material such as fibrin and/or protein hydrogel. The present disclosure contemplates other ways for attaching the first layer 1002 to the second layer 1004.

Referring now to fig. 21 and 22, the first layer 1002 may be at least partially embedded in the first portion 1006 and/or the second portion 1008 of the second layer 1004. In such cases, the tissue thickness compensator assembly 1000 can be prepared using a mold 1024, for example as shown in fig. 21. In various instances, an organic solution comprising a polymer, such as polylactic acid (PLA) and/or polyglycolic acid (PGA), can be poured into the mold 1024. The first layer 1002 can be immersed in an organic solution. As shown in fig. 22, center shelf 1026 and center beam 1027 of mold cover 1028 may sandwich first layer 1002 therebetween to ensure that first layer 1002 remains immersed in the organic solution, which may then be lyophilized using, for example, conventional lyophilization techniques and/or any other suitable technique. After completion of the lyophilization process and/or any other suitable process, the mold cover 1028 can be removed and the tissue thickness compensator assembly 1000 can be retrieved from the mold 1028.

As shown in fig. 21, the first layer 1002 of the tissue thickness compensator 1000 can be positioned partially within the first portion 1006 and the second portion 1008 of the second layer 1004. In some cases, first layer 1002 may be positioned partially within one of first portion 1006 and second portion 1008 and attached to a top surface or a bottom surface of the other of first portion 1006 and second portion 1008.

In some cases, when cover 1028 and mold 1024 are in a closed configuration, central beam 1027 and shelf 1026 may extend at least partially along an axis parallel or substantially parallel to first platform contact surface 1007 and/or second platform contact surface 1009, as shown in fig. 22. In such cases, first layer 1002 may be embedded in first portion 1006 and/or second portion 1008 such that first layer 1002 is positioned or substantially positioned in a parallel or substantially parallel relationship with first platform contact surface 1007 and/or second platform contact surface 1009. In other instances, although not shown, the central beam 1027 and shelf 1026 may extend at least partially along an axis that is at an oblique angle to the first platform contact surface 1007 and/or the second platform contact surface 1008 when the cover 1028 and the mold 1024 are in a closed configuration. In such cases, first layer 1002 may be embedded in first portion 1006 and/or second portion 1008 such that first layer 1002 is positioned or substantially positioned at an oblique angle relative to first platform contact surface 1007 and/or second platform contact surface 1009. The present disclosure contemplates other techniques for partially embedding first layer 1002 in first portion 1006 and/or second portion 1008.

Referring now to fig. 18 and 19, a tissue thickness compensator assembly 1033 is shown that is similar in many respects to the tissue thickness compensator assembly 1000 and the tissue thickness compensator 20020. The tissue thickness compensator assembly 1033 can include a first portion 1006 and a second portion 1008 that can be spaced apart and detachably coupled together by a plurality of bridge members or connectors 1030 that can extend across a gap 1010 between the first portion 1006 and the second portion 1008. Additionally, some or all of the connectors 1030 of the tissue thickness compensator assembly 1033 can be partially embedded in the first and

second portions

1006, 1008, as shown in fig. 19. Further, some or all of the connectors 1030 may include a first end positioned within the first portion 1006, a second end positioned within the second portion 1008, and a gap bridge 1032 therebetween. The gap bridge portion 1032 may extend across the gap 1010 between the first portion 1006 and the second portion 1008, as shown in fig. 19. The connectors 1030 may be spaced apart along the length of the gap 1010 to detachably couple the first portion 1006 to the second portion 1008.

In some cases, connectors 1030 may be evenly distributed along an axis extending along gap 1010, as shown in fig. 19. In other cases, although not shown, the connectors 1030 may be unevenly distributed along an axis extending along the gap 1010. The cutting portion 10053 can be configured to transect the gap bridge portion 1032 of the connector 1030 as the cutting portion 10053 is advanced between the first portion 1006 and the second portion 1008 through the knife path defined by the gap 1010. Where the connectors 1030 are unevenly distributed along an axis extending along the first and second portions 1006, in at least one instance, the connectors 1030 can be disposed at a distal segment of the gap 1010 at a greater frequency and/or closer to one another than at a proximal segment of the gap 1010, such that the cutting portions 10053 can experience increased resistance when advancing along a knife path defined by the gap 1010. In other instances, the connectors 1030 can be disposed at a greater frequency and/or closer to each other at the proximal segment of the gap 1010 than at the distal segment of the gap 1010, e.g., such that the cutting portions 10053 can experience reduced resistance when advanced along the knife path defined by the gap 1010.

In some cases, the connector 1030 may extend or substantially extend in a single plane that may be parallel or substantially parallel to the first platform contact portion 1007 and/or the second platform contact portion 1009, as shown in fig. 19. In other instances, although not shown, the connectors 1030 may extend or substantially extend along multiple planes that may be parallel or substantially parallel to each other and/or parallel or substantially parallel to the first platform contact portion 1007 and/or the second platform contact portion 1009.

Further to the above, some or all of the gap bridging portions 1032 of the connectors 1030 may be thinner than the remainder of their respective connectors 1030 to present the cut portion 10053 with reduced resistance as the cut portion 10053 is advanced to transect the connector 1030 while maintaining the coupled engagement of the first and

second portions

1006, 1008 of the second layer 1004. For example, some or all of the connectors 1030 may include a dog-bone shape having thicker ends that terminate within the first and

second portions

1006, 1008 of the second layer 1004 and a thinner central portion extending therebetween. In some cases, connectors 1030 may each be comprised of a length of suture that may be comprised of a bioabsorbable material, such as polyglycolic acid (PGA) sold under the trade name Vicryl, polylactic acid (PLA or PLLA), Polydioxanone (PDS), Polyhydroxyalkanoate (PHA), poliglecaprone 25(PGCL) sold under the trade name Monocryl, Polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL.

Referring again to fig. 18, the tissue thickness compensator component 1033 can be prepared using a mold 1034. An organic solution comprising a polymer, such as polylactic acid (PLA) and/or polyglycolic acid (PGA), may be poured into the mold 1034. The connector 1030 may be immersed in an organic solution. As shown in fig. 18, one or more of the connectors 1030 may each be clamped in one or more dedicated slots 1040 on the central frame 1036 by one or more beams 1039 extending from the mold cover 1038 and configured for mating engagement with the slots 1040 when the mold cover 1038 and the mold 1034 are in the closed configuration to ensure that the connectors 1030 remain submerged in the organic solution. The slots 1040 may be sized to receive, or at least partially receive, the bridge portions 1032, which may be secured by the beams 1039 when the die cover 1038 and the die 1034 are in a closed configuration. The end of the connector 1030 extending from the gap bridge 1032 may be free floating in the organic solution. Alternatively, the end of the connector 1030 may be secured to the side of the mold 1034, for example. In some cases, connector 1030 may be stretched in an organic solution between the sides of mold 1034. In other cases, the connector 1030 may be loosely held between the sides of the mold 1034 to extend through the organic solution, for example, in a non-linear manner.

As further described above, in each case, the organic solution can then be lyophilized using conventional lyophilization techniques and/or any other suitable technique. After the lyophilization process is complete, the mold cover 1036 can be removed and the tissue thickness compensator assembly 1033 can be recovered from the mold 1034. As shown in fig. 19, the resulting tissue thickness compensator assembly 1033 includes a connector 1030 positioned partially within the first and

second portions

1006, 1008. The present disclosure contemplates other techniques for partially embedding the connector 1030 in the first portion 1006 and/or the second portion 1008. The reader will appreciate that the connector 1030 may be positioned closer to or further from the

platform contact surfaces

1007 and 1009 by varying the height of the centerpost 1038 and/or the depth of the slot 1040.

Referring now to fig. 20, a tissue thickness compensator assembly 1042 is illustrated that is similar in many respects to tissue thickness compensator assembly 1033, tissue thickness compensator assembly 1000, and/or tissue thickness compensator 20020. The tissue thickness compensator assembly 1042 can include a first portion 1006 and a second portion 1008 that can be spaced apart and detachably coupled together by a continuous flexible member 1044, which can be formed by a plurality of bridge members or connectors 1046 that can extend across the gap 1010 between the first and

second portions

1006 and 1008. The continuous flexible member 1044 may include a first end 1048, a second end 1050, and a flexible portion 1052 extending between the first end 1048 and the second end 1050. The flexible portion 1052 may be configured to extend through the first and

second portions

1006, 1008 several times, for example in a zig-zag pattern, to form a connector 1046, as shown in fig. 20. The flexible portion 1052 may be passed through the distal segment 1054 of the first portion 1006 and the distal segment 1056 of the second portion 1008 in a first direction to form a first gap bridge 1046a across the gap 1010. Flexible portion 1052 may then be cycled in a second direction opposite the first direction and through second portion 1008 proximal to distal segment 1056 and through first portion 1006 proximal to distal segment 1054, forming a second gap bridge 1046b proximal to first gap bridge 1046 a. Additional

gap bridging portions

1046c and 1046d may be formed across the gap 1010, for example, in the same manner, as shown in fig. 20.

In some instances, the continuous flexible member 1044 can comprise and can be composed of suture material such as polyglycolic acid (PGA) sold under the trade name Vicryl, polylactic acid (PLA or PLLA), Polydioxanone (PDS), Polyhydroxyalkanoate (PHA), poliglecaprone 25(PGCL) sold under the trade name Monocryl, Polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL. In some cases, the tissue thickness compensator assembly 1042 can be assembled after the first and

second portions

1006, 1008 have been fabricated, for example, by lyophilization. In some cases, a needle (not shown) may be attached to the first end 1048 of the continuous flexible member 1044 and may pass through the first portion 1006 and the second portion 1008, for example, in a zig-zag pattern to couple the first portion 1006 to the second portion 1008, as described above. First end 1048 and/or second end 1050 of continuous flexible member 1044 may be secured to a sidewall of first portion 1006 and/or second portion 1008 by tying one or more knots at, for example, first end 1048 and/or second end 1050. The knot may abut a sidewall of the first portion 1006 and/or the second portion 1008 to prevent the flexible portion 1052 from untwisting relative to the first portion 1006 and/or the second portion 1008. In other instances, the first and

second portions

1006, 1008 of the tissue thickness compensator assembly 1042 can be formed around the continuous flexible member 1044. In such cases, as shown in fig. 20, the continuous flexible member 1044 may be disposed in a mold 1062, for example, in a zigzag pattern with slots 1064 defined in the side walls 1066 and slots 1068 defined in the central shelf 1070. An organic solution comprising a polymer, such as polylactic acid (PLA) and/or polyglycolic acid (PGA), may be poured into the mold 1062 until the continuous flexible member 1044 is submerged in the organic solution. Mold cap 1072 may be used to ensure that continuous flexible member 1044 remains submerged in the organic solution, which is then lyophilized using conventional lyophilization techniques and/or any other suitable technique. After, for example, passing first end 1048 through opening 1053 and passing second end 1050 through opening 1055, first end 1048 and second end 1050 of continuous flexible member 1044 may be secured at

openings

1053 and 1055, respectively, of mold 1062 by tying one or more knots at first end 1048 and second end 1050. The knot may abut against a sidewall of the mold 1062 to prevent the continuous flexible member 1044 from untwisting relative to the mold 1066. After the tissue thickness compensator has been removed from the mold, in various circumstances, portions of the continuous flexible member 1044 (such as

portions

1048, 1050, and/or 1052) may then be cut and removed from the tissue thickness compensator. The present disclosure contemplates other techniques for assembling the tissue thickness compensator assembly 1042.

In some cases, when excessive force or pressure is applied to a tissue thickness compensator assembly (such as tissue thickness compensator assembly 1042), it can be damaged. For example, pressure can be applied to a tissue thickness compensator assembly (such as tissue thickness compensator assembly 1042) when the tissue thickness compensator assembly 1042 is loaded onto a staple cartridge (such as staple cartridge 10000). The tissue thickness compensator assembly 1042 can be fitted with a pressure or force sensitive member that can provide warning feedback to the user whether the pressure experienced by the tissue thickness compensator assembly exceeds a threshold. For example, a pressure or force sensitive membrane may be attached to the tissue thickness compensator assembly 1042 and may be configured to change color when subjected to a pressure that exceeds a threshold. In some cases, a pressure or force sensitive membrane may be disposed over first portion 1006 and/or second portion 1008 and may be attached thereto by, for example, an adhesive. The pressure or force sensitive membrane can be biocompatible to allow for implantation of the pressure or force sensitive membrane into a patient with the tissue thickness compensator assembly 1042.

Referring now to fig. 23-25, a surgical end effector 1100 is shown. The end effector 1100 is similar in many respects to the various end effectors disclosed elsewhere herein, such as end effector 22090 (fig. 9). As shown in fig. 23, end effector 1100 can comprise, for example, a staple cartridge assembly 1102 that is similar in many respects to staple cartridge assembly 20200 (fig. 6). Additionally, the end effector 1100 can include a tissue thickness compensator 1104, e.g., similar in many respects to other tissue thickness compensators disclosed elsewhere in this document, such as tissue thickness compensator 22020 (fig. 9), tissue thickness compensator 20220 (fig. 6), and/or tissue thickness compensator 10020 (fig. 4).

Further to the above, the end effector 1100 may include a tissue thickness compensator 1104, wherein the tissue thickness compensator 1104 may be prepared using conventional lyophilization techniques and/or any other suitable technique. In at least one example, the tissue thickness compensator 1104 can be prepared by dissolving a polymer, such as polylactic acid (PLA) and/or polyglycolic acid (PGA), in an organic solvent and lyophilizing the solution. The tissue thickness compensator 1104 may be constructed of a biocompatible foam, which may include, for example, a porous open cell foam and/or a porous closed cell foam.

Further to the above, the tissue thickness compensator 1104 can be altered or modified for use in surgery. For example, after completion of the lyophilization process, the tissue thickness compensator 1104 can be contacted with the modification member 1106 to modify the tissue thickness compensator 1104 for use in a particular surgical procedure. In some cases, the modification may be made after assembling the tissue thickness compensator 1104 with the end effector 1100, as shown in fig. 23-35. For example, as shown in fig. 23, the tissue thickness compensator 1104 can be releasably assembled to the cartridge assembly 1102 and modified when assembled with the cartridge assembly 1102. In other cases, the modification can be made prior to assembling the tissue thickness compensator 1104 with the end effector 1100. In at least one example, the modification may be performed as a separate step during manufacturing. In yet another example, the modification may be made during a surgical procedure.

As described in more detail below, the modification process may involve modifying a surface or surfaces of the tissue thickness compensator 1104. In some cases, the modification process may involve modifying one or more portions of the tissue thickness compensator 1104. One or more portions may be modified in a single modification process. Alternatively, the plurality of portions may each be modified separately in a continuous modification process. In some cases, the modification process may include a thermal compression process that may be used to change the shape, size, dimension, and/or porosity of at least a portion of the tissue thickness compensator 1104. Further, the modification process can include a means for creating a space within one or more portions of the tissue thickness compensator 1104.

Referring again to fig. 23-25, in some cases, the portion 1107 of the tissue thickness compensator 1104 (fig. 23) can be modified by a thermal compression process that can include transforming the portion 1107 into a glassy state, bonding the portion 1107 to the modifying member 1106, applying pressure to the portion 1107 while the portion 1107 is in the glassy state, and allowing the portion 1107 to cool below the glassy state while the modifying member 1106 is still bonded to the portion 1107. The modifying member 1106 may be used to maintain pressure on the portion 1107 for a period of time sufficient to form a resulting modified portion 1108 (fig. 25). Notably, the transition of the material to the glassy state can be a reversible transition from a relatively hard state to a relatively molten or flexible state in response to an increase in the temperature of the material to a glass transition temperature. The glass transition temperature of the material may be a particular temperature, or in some cases a range of temperatures. The tissue thickness compensator modification process described herein exploits this phenomenon by: modifying the tissue thickness compensator while the tissue thickness compensator is in a glass flexible state, and then cooling the tissue thickness compensator below the glass transition temperature while maintaining the modification.

As further described above, referring again to fig. 23-25, the portion 1107 of the tissue thickness compensator 1004 can transition to a glassy state by: at least portion 1107 is heated to a temperature greater than or equal to the glass transition temperature of the material from which portion 1107 is composed, but below its melting temperature. For example, the tissue thickness compensator 1104 may be composed of polyglycolic acid (PGA), and in such cases, the portion 1107 may transition to a glassy state by: the portion 1107 is heated to a temperature greater than or equal to the glass transition temperature of polyglycolic acid (PGA) but below its melting temperature. In various instances, the glass transition temperature of polyglycolic acid (PGA) may be in the range of, for example, 35-40 deg.C, and its melting temperature may be in the range of, for example, 225-230 deg.C. In at least one example, the portion 1107 of the tissue thickness compensator 1104 can be heated to a temperature greater than or equal to 35 ℃ but less than 225 ℃ in order to transition the portion 1107 to a glassy state. In another example, the portion 1107 may transition to a glassy state by: portion 1107 is heated to a temperature, for example, greater than or equal to 40 ℃ but less than 200 ℃.

As further described above, the modification member 1106 can then be used to apply pressure to the portion 1107 while the portion 1107 is in a glassy state. The portion 1107 may exit the glassy state by, for example, cooling the portion 1107 to a temperature below 35 ℃. The pressure can be maintained for a period of time sufficient to allow the tissue thickness compensator 1104 to remain or at least partially remain modified by the modifying member 1106.

In certain embodiments, the pressure may be maintained for a period of time of about 30 seconds to about 8 hours, for example, during the time in the glassy state and/or for a period of time of about 30 seconds to about 8 hours, for example, after exiting the glassy state. In at least one example, the pressure may be maintained for about 10 minutes during the time in the glassy state and for about 10 minutes after exiting the glassy state. The present disclosure contemplates other time periods for maintaining pressure.

In some cases, the modifying member 1106 may be used to apply pressure to the portion 1107 before the portion 1107 transitions to a glassy state. In some cases, the modification member 1106 can apply pressure to the portion 1107 as the portion 1107 is heated to reach a glassy state, as the portion 1107 is in a glassy state, and/or as the portion 1107 transitions or cools to a temperature below a glassy state. In some cases, the pressure applied to the portion 1107 may gradually increase toward a threshold value, such as when the temperature of the portion 1107 gradually increases to cause the portion 1107 to transition toward a glassy state. In some cases, the pressure applied to the portion 1107 may be removed, gradually removed, or at least partially reduced as the portion 1107 exits the glassy state, before the portion 1107 exits the glassy state, and/or after the portion 1107 exits the glassy state.

In some cases, the modification member 1106 can also be a heat source for transforming the portion 1107 of the tissue thickness compensator 1104 into a glassy state. For example, the modification member 1106 can include a cylindrical distal portion 1110, as shown in fig. 24, which can include a heating coil (not shown). The user can energize the heating coil and engage the portion 1107 of the tissue thickness compensator 1104 with the modification member 1106 to heat the portion 1107 to a temperature greater than or equal to the glass transition temperature of the material composition of the portion 1107. Once the desired temperature is reached, the modifying member may be pressed against portion 1107, as shown in fig. 24. Alternatively, the modifying member 1106 may be pressed against the portion 1107 before the modifying member reaches the desired temperature. As described above, the pressure can be maintained for a period of time sufficient to allow the tissue thickness compensator 1104 to remain or at least partially remain with the modification applied by the modifying member 1106. In addition, the heating coils of the modification member 1106 may be turned off to cool the temperature of the portion 1107 below the glass transition temperature. The modifying member may then be removed. In some cases, the pressure applied by the modifying member 1106 may be initiated and maintained throughout the glassy state before the portion 1107 enters the glassy state. In some cases, the pressure applied by the modifying member 1106 may be removed while the portion 1107 is in a glassy state.

As shown in fig. 23-25, the modification member 1106 can be configured to change the shape, size, dimension, density, spring rate, and/or porosity of the portion 1107 of the tissue thickness compensator 1104. For example, the modified portion 1108 may include a substantially concave top surface 1114 having a reduced height H1, while the remainder of the tissue thickness compensator 1104 may remain a substantially flat top surface including an initial height H that is greater than the reduced height H1, as shown in fig. 25. As described above, the modification member 1106 can include a cylindrical distal portion 1110. In such cases, the curvature of the resulting concave surface 1114 may depend in part on the curvature of the cylindrical distal portion 1110 of the modification member 1106 that is in contact with the portion 1107 of the tissue thickness compensator 1104 during the modification process. Further, the modified portion 1108 may have a lower new porosity than the unmodified portion 1107, which may be caused at least in part by the compressive force applied to the portion 1107 by the modifying member 1106 during the modification process, as described above. In other words, pressure applied to the portion 1107 during the modification process may cause material redistribution, wherein a cross-section through the modified portion 1108 prior to the modification process may have a greater material density than a similar cross-section through the portion 1107. Further, the modified portion 1108 may have a different spring rate than the remainder of the tissue thickness compensator 1104, which may be caused in part by changes in density and porosity achieved by the modified portion 1108 during the modification process, as described in more detail below. In at least one instance, the spring rate of the modified portion 1108 can be less than or greater than the spring rate of the unmodified portion 1107.

Referring now to fig. 26-34, the tissue thickness compensator can be modified prior to assembly with an end effector, such as end effector 22090 (fig. 9). In some cases, as shown in fig. 27, 30, and 33, the mold may be used to modify the tissue thickness compensator using a hot pressing process, as described above. For example, as shown in fig. 26-28, the tissue thickness compensator 1120 can be modified to include a longitudinal slot 1122. The tissue thickness compensator 1120 may be similar in many respects to other tissue thickness compensators described elsewhere, such as the tissue thickness compensator 22020 (fig. 9). For example, as with compensator 22020, compensator 1120 can be used with end effector 22090. Further, the longitudinal slot 1122 may be similar in many respects to the knife slot 22025. For example, like the knife slot 22025, the slot 1122 can define a tissue thickness compensator knife path for the cutting portion 10053 between the first and

second stapling portions

1124a, 1124 b. Further, the first and

second stapling portions

1124a, 1124b may be similar in many respects to the first and

second stapling portions

22021a, 22021b (fig. 9) and 22021b, respectively, of the tissue thickness compensator 22020. Additionally, the slot 1122 can be configured to releasably connect the first and

second suture portions

1124a, 1124b such that, when used with the end effector 22090, the cutting portion 10053 can be advanced distally through the slot 1122 to transect the slot 1122 and separate the first and

second suture portions

1124a, 1124 b.

Referring again to fig. 26-28, the tissue thickness compensator 1120 can be prepared using conventional lyophilization techniques and/or any other suitable technique. In addition, the tissue thickness compensator 1120 can be modified or altered to form a slot 1122 therethrough. Similar to the tissue thickness compensator 1104, the tissue thickness compensator 1120 can be at least partially composed of a material having a glass transition temperature and can be modified by transforming the material into a glassy state. In one example, the tissue thickness compensator 1120 can be heated in an oven (not shown) to a temperature greater than or equal to the glass transition temperature of the material composition of the tissue thickness compensator 1120 but less than the melting temperature thereof. As shown in fig. 27, a die 1126 including a central beam 1128 may be used to form slot 1122 by: the central beam 1128 is inserted into the tissue thickness compensator 1120 while the tissue thickness compensator 1120 is in a glassy state. While the central beam 1128 remains inserted into the tissue thickness compensator 1120, the tissue thickness compensator 1120 may then be allowed to cool to a temperature below the glass transition temperature. In some cases, the central beam 1128 may be removed from the tissue thickness compensator 1120 while the tissue thickness compensator 1120 is in its glassy state.

In some cases, a cooling medium may be used to actively cool the tissue thickness compensator 1120. In some cases, a fan may be used to generate an air flow over the tissue thickness compensator 1120 while the tissue thickness compensator 1120 is in the mold 1126 and/or after the tissue thickness compensator 1120 has been removed from the mold. In some cases, the refrigeration process may be used to cool the tissue thickness compensator 1120 while the tissue thickness compensator 1120 is in the mold 1126 and/or after the tissue thickness compensator 1120 has been removed from the mold. The central beam 1128 may be removed after the tissue thickness compensator 1120 has transitioned out of the glassy state. The central beam 1128 can remain inserted into the tissue thickness compensator 1120 for a period of time sufficient to allow the tissue thickness compensator 1120 to maintain, or at least substantially maintain, the space occupied by the central beam 1128. In certain examples, the central beam 1128 may remain inserted for a period of about 30 seconds to about 8 hours, for example, during the time in the glassy state and/or for a period of about 30 seconds to about 8 hours, for example, after exiting the glassy state. In at least one example, the central beam 1128 may remain inserted for about 10 minutes during the time in the glassy state and for about 10 minutes after exiting the glassy state. The present disclosure contemplates other time periods for maintaining the central beam 1128 within the tissue thickness compensator 1120.

Further to the above, as shown in fig. 28, the pressure applied by the center beam 1128 during the modification process may result in an increased material density at the portion 1130 of the tissue thickness compensator 1120. Portion 1130 may connect first and second stitched

portions

1124a, 1124b, providing additional stability to slot 1122. In some cases, mold 1126 may include an edge modifier, such as

edge modifiers

1132a and 1132b, which may modify tissue thickness compensator 1120 during the modification process to produce modified

edges

1134a and 1134b, respectively, as shown in fig. 28.

Referring again to fig. 26-28, a significant amount of material may need to be removed from the tissue thickness compensator 1120 to form the slots 1122. In such cases, the central beam 1128 can be heated to a temperature greater than the melting temperature of the material composition of the tissue thickness compensator 1120. After inserting the heated central beam 1128 into the tissue thickness compensator 1120, the central beam 1128 can melt through the tissue thickness compensator 1120, thereby creating a space for the slot 1122 within the tissue thickness compensator 1120, as shown in FIG. 28. In some cases, it may be desirable to gradually increase the pressure applied by the central beam 1128 against the tissue thickness compensator 1120 to gradually insert the central beam 1128 into the tissue thickness compensator 1120.

In some cases, it may be desirable to increase the material density of one or more surfaces of the tissue thickness compensator. As shown in fig. 29-31, the tissue thickness compensator 1140 can be modified or altered such that the surface 1142 of the tissue thickness compensator 1140 can comprise a higher material density than the remainder of the tissue thickness compensator 1140, which in some cases can be achieved after lyophilization. The tissue thickness compensator 1140 can be similar in many respects to other tissue thickness compensators described elsewhere, such as tissue thickness compensator 22020 (fig. 9) and/or tissue thickness compensator 1120 (fig. 26). The surface modifying agent 1144 may be used to modify the surface 1142 of the tissue thickness compensator 1140 using a thermal compression process that is similar in many respects to the thermal compression process used to modify the tissue thickness compensator 1104 and/or the tissue thickness compensator 1120, as described above. For example, the tissue thickness compensator 1140 may be at least partially constructed of a material comprising a glass transition temperature and may be modified after being converted to a glassy state.

As described above, a tissue thickness compensator (such as tissue thickness compensator 1140) can be converted to a glassy state, wherein the tissue thickness compensator is heated to a temperature greater than or equal to the glass transition temperature but less than the melting temperature of the material composition of the tissue thickness compensator 1140. While the tissue thickness compensator 1140 is in a glassy state, the surface modifier 1144 can be pressed against the surface 1142. The pressure applied by surface modifier 1144 may compress surface 1142, thereby increasing the material density of surface 1142. The increase in material density may be maintained by surface 1142 by: the surface 1142 is cooled to a temperature below the glass transition temperature.

In certain instances, the pressure applied by surface modifier 1144 against surface 1142 may be maintained for a period of time of about 30 seconds to about 8 hours, for example, during the time in the glassy state and/or for a period of time of about 30 seconds to about 8 hours, for example, after exiting the glassy state. In at least one example, the pressure may be maintained for about 10 minutes during the time in the glassy state and for about 10 minutes after exiting the glassy state. The present disclosure contemplates other time periods for maintaining the pressure applied by surface modifying agent 1144 against surface 1142.

In some cases, a fan may be used to generate an air flow over tissue thickness compensator 1140 when tissue thickness compensator 1140 is in contact with modifier 1144 and/or after tissue thickness compensator 1140 has been removed from modifier 1144. In some cases, a refrigeration process can be used to cool tissue thickness compensator 1140 while tissue thickness compensator 1140 is in contact with modifier 1144 and/or after tissue thickness compensator 1140 has been removed from modifier 1144. After the tissue thickness compensator 1140 has transitioned out of the glassy state, the surface modifying agent 1144 may, in various circumstances, disengage from the tissue thickness compensator 1140. In some cases, the surface modifying agent 1144 can include a heating element that can be used to increase the temperature of the surface 1142 to a temperature greater than or equal to the glass transition temperature of the material composition of the tissue thickness compensator 1140, as described above.

Referring again to fig. 30, surface modifying agent 1144 may include a flat or at least substantially flat contact surface 1146 for contacting, for example, surface 1142. In other cases, the contact surface 1146 can have various textures, such as protrusions that can extend into the surface 1142 of the tissue thickness compensator 1140 during the modification process. In some cases, surface modifying agent 1144 may be used to apply pressure to surface 1142 of tissue thickness compensator 1140 before the tissue thickness compensator 1140 transitions to a glassy state. In some cases, the surface modifying agent 1144 can apply pressure to the surface 1142 when the tissue thickness compensator 1140 is heated to reach a glassy state, when the tissue thickness compensator 1140 is in a glassy state, and/or when the tissue thickness compensator 1140 is transitioned or cooled to a temperature below a glassy state. In some cases, the pressure applied to surface 1142 by surface modifying agent 1144 may gradually increase toward a threshold value, for example, as the temperature of tissue thickness compensator 1140 gradually increases to cause tissue thickness compensator 1140 to transition toward a glass state. In some cases, the pressure applied to surface 1142 may be removed, gradually removed, or at least partially reduced as tissue thickness compensator 1140 exits the glassy state, before tissue thickness compensator 1140 exits the glassy state, and/or after tissue thickness compensator 1140 exits the glassy state.

In some cases, the tissue thickness compensator 1140 can be modified or altered to include a skin or dense outer layer. In some cases, the resulting skin or dense outer layer may include texture, such as protrusions that may extend into the surface 1142 of the tissue thickness compensator 1140. In some cases, the contact surface 1146 of the surface modifying agent 1144 can be heated to a temperature greater than or equal to the melting temperature of the material composition of the tissue thickness compensator 1140. The surface modifying agent 1144 and/or the tissue thickness compensator 1140 can be moved to bring the surface 1142 of the tissue thickness compensator 1140 into contact with the heated contact surface 1146 of the surface modifying agent 1144, thereby melting, or at least substantially melting, the surface 1142. The surface modifier 1144 and the tissue thickness compensator 1140 can then be separated to allow the modified surface 1142 to cool below its melting temperature, which can form a skin or dense outer layer onto the tissue thickness compensator 1140.

In some cases, the contact surface 1146 of the surface modifying agent 1144 may be heated prior to contact with the surface 1142. In other cases, the contact surface 1146 of the surface modifying agent 1144 may be heated after contact with the surface 1142.

In some cases, the contact surface 1146 of the surface modifying agent 1144 may remain in contact with the surface 1142 of the tissue thickness compensator 1140 for a period of time sufficient to cause the surface 1142 to flow into the desired geometry. Such time periods may range, for example, from about 30 seconds to about 8 hours, other time periods being contemplated by the present disclosure. Such a period of time may be sufficient to locally affect and/or melt the material of the tissue thickness compensator 1140 and cause it to flow into the new geometry. As described herein, such new geometries may be specified by the tools used to manufacture the tissue thickness compensator 1140.

In some cases, the surface 1142 of the tissue thickness compensator 1140 can be cooled or actively cooled to a temperature below the melting temperature of the tissue thickness compensator 1140 prior to separating the surface modifying agent 1144 from the tissue thickness compensator 1140. In other cases, the surface 1142 of the tissue thickness compensator 1140 can be cooled or actively cooled to a temperature below the melting temperature of the tissue thickness compensator 1140 after separating the surface modifying agent 1144 from the tissue thickness compensator 1140.

Further to the above, the modified surface 1142 can comprise a density, for example, about 10% greater than the density of the remainder of the tissue thickness compensator 1140, about 20% greater than the density of the remainder of the tissue thickness compensator 1140, about 30% greater than the density of the remainder of the tissue thickness compensator 1140, about 40% greater than the density of the remainder of the tissue thickness compensator 1140, about 50% greater than the density of the remainder of the tissue thickness compensator 1140, about 60% greater than the density of the remainder of the tissue thickness compensator 1140, about 70% greater than the density of the remainder of the tissue thickness compensator 1140, about 80% greater than the density of the remainder of the tissue thickness compensator 1140, about 90% greater than the density of the remainder of the tissue thickness compensator 1140, and/or about 100% greater than the density of the remainder of the tissue thickness compensator 1140. In various instances, the surface 1142 can include a density, for example, greater than the density of the remainder of the tissue thickness compensator 1140 and less than twice the density of the remainder of the tissue thickness compensator 1140. In various instances, the modified surface 1142 can include a density, for example, greater than twice the density of the remainder of the tissue thickness compensator 1140.

Referring now to fig. 32-34, the tissue thickness compensator 1150 can be modified to include a plurality of apertures 1152 that can extend at least partially through the tissue thickness compensator 1150. The tissue thickness compensator 1150 may be similar in many respects to other tissue thickness compensators described herein, such as tissue thickness compensator 20220 (fig. 6). As with the compensator 20220, the compensator 1150 can be used with the cartridge assembly 20200 (fig. 6), and the bore 1152 can be similar in many respects to a clearance bore 20224 that extends at least partially through the tissue thickness compensator 20220. For example, like the hole 20224, when the tissue thickness compensator 1150 is assembled with the cartridge assembly 20200, the holes 1152 can be aligned with corresponding staple legs 20232 (fig. 7) such that the staple legs 20232 can move through the clearance holes 1152 in the tissue thickness compensator 1150 as the staple legs 20232 move from an unfired configuration to a fired configuration, as described in more detail above.

As further described above, referring again to fig. 32-34, the tissue thickness compensator 1150 can be prepared using conventional lyophilization techniques and/or any other suitable technique. In some cases, a polymer having a glass transition temperature (e.g., polylactic acid (PLA) and/or polyglycolic acid (PGA)) can be dissolved in an organic solvent to form a solution, which can be lyophilized to produce the tissue thickness compensator 1150. Further, the tissue thickness compensator 1150 can be modified after lyophilization using a thermal compression process that is similar in many respects to the thermal compression process used to modify the tissue thickness compensator 1104, the tissue thickness compensator 1120, and/or the tissue thickness compensator 1140, as described above. For example, once the tissue thickness compensator 1150 transitions to a glassy state, the tissue thickness compensator 1150 can be modified to include an aperture 1152.

As described above, a tissue thickness compensator, such as tissue thickness compensator 1150, can be transformed to a glassy state by heating in an oven (not shown) to a temperature greater than or equal to the glass transition temperature but less than the melting temperature of the material composition of the tissue thickness compensator 1150. A mold 1154 comprising a plurality of posts, dowels, pins, and/or protrusions (such as pins 1156) may be used to form the aperture 1152 by: the needle 1156 is inserted into the tissue thickness compensator 1150 while the tissue thickness compensator 1150 is in a glassy state. While the needle 1156 remains inserted into the tissue thickness compensator 1150, the tissue thickness compensator 1150 can then be cooled to a temperature below the glass transition temperature. In some cases, the needle 1156 can be removed from the tissue thickness compensator 1150 while the tissue thickness compensator 1150 is in a glassy state. In some cases, a fan may be used to generate an air flow over the tissue thickness compensator 1150 when the tissue thickness compensator 1150 is engaged with the needle 1156 and/or after the tissue thickness compensator 1150 has been disengaged from the needle 1156. In some cases, a refrigeration process can be used to cool the tissue thickness compensator 1150 as the tissue thickness compensator 1150 is engaged with the needle 1156 and/or after the tissue thickness compensator 1150 has been disengaged from the needle 1156. In various instances, the needle 1156 can be removed after the tissue thickness compensator 1150 transitions out of the glassy state. The needle 1156 can remain inserted into the tissue thickness compensator 1150 for a period of time sufficient to allow the tissue thickness compensator 1150 to remain, or at least substantially remain, in the space defining the aperture 1152 occupied by the needle 1156.

In certain examples, the needle 1156 may remain inserted for a period of about 30 seconds to about 8 hours, for example, during the time in the glassy state and/or for a period of about 30 seconds to about 8 hours, for example, after exiting the glassy state. In at least one example, the needle 1156 may remain inserted for about 10 minutes during the time it is in the glassy state and for about 10 minutes after exiting the glassy state. The present disclosure contemplates other time periods for maintaining insertion of the needle 1156 into the tissue thickness compensator 1150.

In some cases, the needle 1156 may be removed from the tissue thickness compensator 1150 before the tissue thickness compensator 1150 transitions out of the glassy state. In other cases, the needle 1156 may be gradually removed over time. For example, the needle 1156 may be partially removed from the tissue thickness compensator 1150 prior to the tissue thickness compensator 1150 transitioning out of the glassy state. After the tissue thickness compensator 1150 has transitioned out of the glassy state, the needle 1156 can then be completely removed from the tissue thickness compensator 1150. The reader will appreciate that the greater the depth of insertion of the needle 1156 into the tissue thickness compensator 1150, the greater the depth of the corresponding aperture 1152 that can be formed in the tissue thickness compensator 1150.

Referring again to fig. 32-34, in some cases, the needle 1156 can be heated to a temperature greater than or equal to the melting temperature of the material composition of the tissue thickness compensator 1150. Additionally, the needle 1156 can be inserted into the tissue thickness compensator 1150 to form an aperture 1152 by melting or at least partially melting through the region of the tissue thickness compensator 1150 that receives the needle 1156. In various circumstances, the needle 1156 can be heated prior to insertion into the tissue thickness compensator 1150. In various circumstances, the needle 1156 can be heated after insertion into the tissue thickness compensator 1150. In various circumstances, the needle 1156 can gradually heat up as the needle 1156 is inserted into the tissue thickness compensator 1150.

In some cases, the needle 1156 may remain positioned within the tissue thickness compensator 1150 for a period of time sufficient to allow the molten material of the tissue thickness compensator 1150 to flow into the desired geometry. Such time periods may range, for example, from about 30 seconds to about 8 hours, other time periods being contemplated by the present disclosure. Such a period of time may be sufficient to locally affect and/or melt the material of the tissue thickness compensator 1150 and cause it to flow into the new geometry. As described herein, such new geometries may be specified by the tools used to manufacture the tissue thickness compensator 1150.

In some cases, the tissue thickness compensator 1150 can be cooled or actively cooled to a temperature below the melting temperature of the tissue thickness compensator 1150 prior to separating the needle 1156 from the tissue thickness compensator 1150. In other cases, the tissue thickness compensator 1150 can be cooled or actively cooled to a temperature below the melting temperature of the tissue thickness compensator 1150 after separating the needle 1156 from the tissue thickness compensator 1150.

Referring again to fig. 32-34, needles 1156 can be arranged in rows extending longitudinally along the length of mold 1154, which rows can correspond to rows of staples in a staple cartridge, such as staple cartridge assembly 20200 (fig. 6). For example, as shown in fig. 33, the needles 1156 may be arranged in six rows, which may be configured to form six rows of holes 1152, which may be configured to receive six rows of staples 20230 (fig. 7). In some cases, as shown in fig. 33, the rows of needles 1156 may be arranged in two sets that are spaced apart and configured to be received in the two

portions

1158 and 1160 of the tissue thickness compensator 1150, thereby forming two sets of apertures 1152 separated by an intermediate portion 1162. When the tissue thickness compensator 1150 is assembled with the staple cartridge assembly 20200, the intermediate portion 1162 can be positioned at least partially over the knife slot 22015 (fig. 6). In use, the firing member 10052 (fig. 10) can be advanced distally to push the staple legs 20232 (fig. 8) through the apertures 1152 in the

portions

1158 and 1160 and advance the cutting portion 10053 (fig. 10) to transect the middle portion 1162 and separate the

portions

1158 and 1160.

Referring again to fig. 32-34, the aperture 1152 can be configured to extend within the tissue thickness compensator 1150 and terminate at a depth within the tissue thickness compensator 1150. The apertures 1152 may comprise a uniform depth, as shown in fig. 34. In other cases, the wells 1152 may include different depths (not shown). For example, a first row of apertures 1152 may include a first depth, and a second row of apertures 1152 may include a second depth different from the first depth, while a third row of apertures 1152 may include a third depth different from the first and second depths. The depth of the aperture 1152 may be determined, at least in part, by the height of the corresponding pin 1156. For example, a first row of needles 1156 comprising a first height and a second row of needles 1156 comprising a second height greater than the first height may form a first row of holes 1152 comprising a first depth and a second row of holes 1152 comprising a second depth greater than the first depth.

Referring again to fig. 32-34, the needle 1156 can be configured to define a track for the aperture 1152 within the tissue thickness compensator 1150. In some cases, the needles 1156 can extend along an axis that is perpendicular and/or substantially perpendicular to a mold surface 1164 of the mold 1154, as shown in fig. 33. Inserting the needles 1156 into the tissue thickness compensator 1150 while maintaining a parallel relationship between the mold surface 1164 and the surface 1166 of the tissue thickness compensator 1150 can result in a perpendicular and/or substantially perpendicular trajectory for the apertures 1152 being defined relative to the surface 1166 of the tissue thickness compensator 1150, as shown in fig. 34. In other instances, the needles 1156 can extend from the mold surface 1164 at an oblique angle (not shown) and/or the insertion trajectory of the needles 1156 into the tissue thickness compensator 1150 can be angled such that the needles 1156 can define a non-perpendicular trajectory for the holes 1152 relative to the surface 1166 of the tissue thickness compensator 1150. In some cases, the set of needles 1156 can be parallel and/or substantially parallel to each other, as shown in fig. 33, resulting in the set of apertures 1152 can be parallel and/or substantially parallel to each other, as shown in fig. 24. In other cases, although not shown, a set of non-parallel needles may extend from the mold surface 1164 and may create non-parallel holes when inserted into the tissue thickness compensator 1150. In some cases, the needle 1156 can be configured to form an aperture in the tissue thickness compensator 1150, which can include a partially curved trajectory and/or a partially linear trajectory. For example, the needles 1156 can extend from the mold surface 1164 in partially curved trajectories and can be inserted into the tissue thickness compensator 1150 to form holes in the tissue thickness compensator 1150 with corresponding partially curved trajectories.

Referring again to fig. 32-34, some or all of the needles 1156 may include a blunt distal end 1168, as shown in fig. 33. In other cases, some or all of the needles 1156 can include a sharp distal end (not shown). Some or all of the needles 1156 may comprise a cylindrical or at least substantially cylindrical shape, for example, as shown in fig. 33. Other shapes are also contemplated by the present disclosure.

In various circumstances, one or more of the needles 1156 extending from the mold surface 1164 may not be able to be inserted through the entire thickness of the tissue thickness compensator 1150. In some cases, one or more of the needles 1156 extending from the mold surface 1164 may be capable of being inserted through the entire thickness of the tissue thickness compensator 1150 to form openings and/or holes extending through the entire thickness of the tissue thickness compensator 1150. In some cases, one or more of the needles 1156 extending from the mold surface 1164 can be inserted through a first side of the tissue thickness compensator 1150 and exit through, for example, a second side of the tissue thickness compensator 1150 that can be opposite the first side. In some cases, one or more of the needles 1156 can include a length that is greater than the entire thickness of the tissue thickness compensator 1150 to facilitate insertion of the one or more needles 1156 through the entire thickness of the tissue thickness compensator 1150.

Referring now to fig. 35-37, it may be necessary to re-size the tissue thickness compensator. For example, one or more dimensions of the tissue thickness compensator can be adjusted to correspond to dimensions of the staple cartridge to provide a better fit to the staple cartridge when the tissue thickness compensator is assembled with the staple cartridge. In some cases, the tissue thickness compensator 1170 can be resized by changing its height from a first height H1 as shown in fig. 35 to a second height H2 as shown in fig. 36. The tissue thickness compensator 1170 can be similar in many respects to other tissue thickness compensators described herein, such as tissue thickness compensator 22020 (fig. 9), tissue thickness compensator 1140 (fig. 29), and/or tissue thickness compensator 1150 (fig. 32). For example, as with compensator 22020, compensator 1170 can be used with end effector 22090 (fig. 9).

In various instances, referring again to fig. 35-37, the tissue thickness compensator 1170 can be prepared using conventional lyophilization techniques and/or any other suitable technique. In some cases, the tissue thickness compensator 1170 can be resized using, for example, a hot pressing process and a die 1172, as shown in fig. 37. Mold 1172 can include a receiver 1174 configured to receive tissue thickness compensator 1170 and an adjustment member 1176 configured to be partially inserted into receiver 1174. The tissue thickness compensator 1170 can be resized as the tissue thickness compensator 1170 transitions into a glassy state. In one embodiment, the tissue thickness compensator 1170 can be heated in an oven (not shown) to a temperature greater than or equal to the glass transition temperature of the material composition of the tissue thickness compensator 1170, but less than the melting temperature thereof. In another embodiment, the receiver 1174 and/or the conditioning member 1176 can include a heating element for transitioning the tissue thickness compensator 1170 to a glassy state. The adjustment member 1176 can then be inserted into the receiver 1174 a distance H3, for example as shown in fig. 37, thereby compressing the tissue thickness compensator 1170 and reducing its height from a first height H1 to a second height H2. In some cases, the adjustment member 1176 can be inserted into the receiver 1174 before the tissue thickness compensator 1170 enters the glassy state or just as the tissue thickness compensator 1170 enters the glassy state. The adjustment member 1176 can be held against the tissue thickness compensator 1170 to compress the tissue thickness compensator 1170 for a period of time sufficient to allow the tissue thickness compensator 1170 to maintain, or at least substantially maintain, the second height H2, as shown in fig. 36. While under compression from the adjustment member 1176, the tissue thickness compensator 1170 can then be cooled to a temperature below the glass transition temperature. After the tissue thickness compensator 1170 transitions out of the glassy state, the adjustment member 1176 can be retracted. In some cases, the adjustment member 1176 can be retracted before the tissue thickness compensator 1170 exits the glassy state. In some cases, the above-described resizing process can be used to change another dimension of the tissue thickness compensator 1170, such as the length or width of the tissue thickness compensator 1170. In some cases, these dimensions may be modified simultaneously or sequentially.

In certain examples, the compression from the conditioning member 1176 may be maintained for a period of time of about 30 seconds to about 8 hours, for example, during the time in the glassy state and/or for a period of about 30 seconds to about 8 hours, for example, after exiting the glassy state. In at least one example, the compression from the conditioning member 1176 may be maintained for about 10 minutes during the time in the glassy state and for about 10 minutes after exiting the glassy state. The present disclosure contemplates a period of time for maintaining the compression applied by the adjustment member 1176 against the tissue thickness compensator 1170.

In some cases, the adjustment member 1176 can be used to apply pressure to the tissue thickness compensator 1170 before the tissue thickness compensator 1170 transitions to a glassy state. In some cases, the adjustment member 1176 can apply pressure to the tissue thickness compensator 1170 when the tissue thickness compensator 1170 is heated to reach a glassy state, when the tissue thickness compensator 1170 is in a glassy state, and/or when the tissue thickness compensator 1170 transitions or cools to a temperature below a glassy state. In some cases, the pressure applied to the tissue thickness compensator 1170 may gradually increase toward a threshold value, such as when the temperature of the tissue thickness compensator 1170 gradually transitions toward a glass state. In some cases, the pressure applied to the tissue thickness compensator 1170 may be removed, gradually removed, or at least partially reduced as the tissue thickness compensator 1170 exits the glassy state, before the tissue thickness compensator 1170 exits the glassy state, and/or after the tissue thickness compensator 1170 exits the glassy state.

The reader will appreciate that the different molds used in the modification process described above (such as

molds

1144, 1154, and/or 1172) are illustrative examples. Other mold designs and configurations can also be used to manipulate the tissue thickness compensator in a variety of ways. Furthermore, the forces involved in manipulating the tissue thickness compensator need not be only compressive forces. For example, the tension may also be used to modify, reshape and/or size the tissue thickness compensator in a manner similar to those described above. For example, the tissue thickness compensator 1170 can also be stretched using a pulling force to reduce its height from a first height H1 (fig. 35) to a second height H2 (fig. 36), e.g., using a modification process similar in many respects to the modification process described above. In some cases, a combination of tensile and compressive forces may be used to manipulate the tissue thickness compensator during the modification process.

Referring again to fig. 35-37, the porosity of the tissue thickness compensator may need to be modified for use in surgery. The tissue thickness compensator can comprise, for example, a porous open cell foam and/or a porous closed cell foam. Conventional lyophilization techniques may provide some control over the porosity of the tissue thickness compensator, but such control may not be easily reproducible and may require additional fine adjustments that are not available through conventional lyophilization techniques. As shown in fig. 35-37, the height of the tissue thickness compensator 1170 can be changed from a first height H1 (fig. 35) to a second height H2 (fig. 36) using, for example, the modification process described above. In addition, the same and/or similar modification processes can also be used to modify the porosity of the tissue thickness compensator 1170. For example, the tissue thickness compensator 1170 can have a first porosity (fig. 35) prior to the modification process and a second porosity (fig. 36) after the modification process is completed, as described above. The change in porosity can be due, at least in part, to the compressive force and/or energy applied to the tissue thickness compensator 1170 by the adjustment member 1176 during the modification process described above.

Further to the above, the tissue thickness compensator 1170 can include a plurality of apertures 1180. For example, some or all of the apertures 1180 may vary in location, size, and/or shape as a result of the modification process described above. For example, one or more of the apertures 1180 may include a spherical or substantially spherical shape prior to the modification process, which may be changed to an elliptical or substantially elliptical shape as a result of the modification process. In at least one example, one or more of the apertures 1180 may include a first size prior to the modification process and a second size different from the first size as a result of the modification process. In some cases, as described in more detail below, the porosity change may be limited to one or more regions or zones of the tissue thickness compensator 1170.

Further, in some cases, a change in porosity of the tissue thickness compensator 1170 can be accompanied by a change in density of the tissue thickness compensator 1170. In other words, as the adjustment member 1176 is advanced against the tissue thickness compensator 1170, the compressive force may reduce the space occupied by the tissue thickness compensator 1170, causing a redistribution of material and/or pores, which may cause an increase in the density of the tissue thickness compensator 1170 and/or a decrease in its porosity. In some cases, as described in more detail below, the density change may be limited to one or more regions or zones of the tissue thickness compensator 1170.

Further to the above, a change in porosity and/or density of the tissue thickness compensator 1170 can cause a change in the spring rate of the tissue thickness compensator 1170. When the tissue thickness compensator is deployed against tissue captured by staples, such as staples 20230 (fig. 8), the elastic ratio of the tissue thickness compensator can affect its ability to compensate for tissue thickness, as described in more detail above. In addition, the elastic ratio of the tissue thickness compensator can also affect its ability to apply pressure against the tissue captured by the staple with the tissue thickness compensator. In other words, a change in the elastic ratio of the tissue thickness compensator can change the pressure exerted by the tissue thickness compensator against the tissue captured by the staples. Fine control of the elastic ratio of the tissue thickness compensator can be advantageous since different tissue types can respond more aggressively to certain pressures.

As shown in fig. 35-37, the tissue thickness compensator 1170 can include a first spring rate (fig. 35) that can be changed or modified using the modification process described above to a second spring rate (fig. 36) that is different than the first spring rate. For example, as described above, the adjustment member 1176 can be advanced against the tissue thickness compensator 1170 while the tissue thickness compensator 1170 is in a glassy state. In response, the tissue thickness compensator 1170 can be compressed, which results in a change in the spring rate of the tissue thickness compensator 1170. The adjustment member 1176 can remain in the advanced position for a period of time sufficient to allow the tissue thickness compensator 1170 to maintain, or at least substantially maintain, the change in elastic ratio. In addition, the tissue thickness compensator 1170 can be cooled below the glass transition temperature of its material composition while maintaining the pressure applied by the adjustment member 1176 against the tissue thickness compensator 1170.

In certain instances, the adjustment member 1176 may be maintained in the advanced position against the tissue thickness compensator 1170 for a period of about 30 seconds to about 8 hours, for example, during the time in the glassy state and/or for a period of about 30 seconds to about 8 hours, for example, after exiting the glassy state. In at least one example, the adjustment member 1176 can be maintained in the advanced position against the tissue thickness compensator 1170 for about 10 minutes during the time in the glassy state and for about 10 minutes after exiting the glassy state, for example. The present disclosure contemplates other time periods for maintaining the adjustment member 1176 in the advanced position against the tissue thickness compensator 1170.

In some cases, the adjustment member 1176 can be used to apply pressure to the tissue thickness compensator 1170 to change the elastic ratio of the tissue thickness compensator 1170 before the tissue thickness compensator 1170 transitions to a glassy state. In some cases, the adjustment member 1176 can apply pressure to the tissue thickness compensator 1170 when the tissue thickness compensator 1170 is heated to reach a glassy state, when the tissue thickness compensator 1170 is in a glassy state, and/or when the tissue thickness compensator 1170 transitions or cools to a temperature below a glassy state. In some cases, the pressure applied to the tissue thickness compensator 1170 may gradually increase toward a threshold value, such as when the temperature of the tissue thickness compensator 1170 gradually increases to transition the tissue thickness compensator 1170 toward a glass state. In some cases, the pressure applied to the tissue thickness compensator 1170 may be removed, gradually removed, or at least partially reduced as the tissue thickness compensator 1170 exits the glassy state, before the tissue thickness compensator 1170 exits the glassy state, and/or after the tissue thickness compensator 1170 exits the glassy state.

Referring again to fig. 35-40, the tissue thickness compensator 1170 can be fabricated with a natural spring rate using conventional lyophilization techniques and/or any other suitable technique. As described above, the elastic ratio of the tissue thickness compensator 1170 can affect its ability to apply pressure against tissue captured by the stapled tissue thickness compensator 1170. The above-described modification process can be used to adjust the natural spring rate of the tissue thickness compensator 1170 to adjust its ability to apply pressure against tissue captured by the stapled tissue thickness compensator 1170. In some cases, the natural spring rate of the tissue thickness compensator 1170 may increase from a first spring rate at point a (fig. 40) to a second spring rate that includes and is at most the maximum spring rate at point B (fig. 40). In some cases, such an increase in the elastic ratio of the tissue thickness compensator 1170 can be achieved by: the adjustment member 1176 is used to apply a compressive force to the tissue thickness compensator 1170 while the tissue thickness compensator 1170 is in a glassy state, as explained in the modification process above. As shown in FIG. 40, point B represents the maximum elastic yield of the tissue thickness compensator 1170. Thus, any additional compression applied by the adjustment member 1176 to the tissue thickness compensator 1170 at point B that exceeds the threshold compression may result in a reduction in the spring rate of the modified tissue thickness compensator 1170. For example, as shown in fig. 40, the spring rate at point C is less than the spring rate at point B, even though the compressive force applied by the adjustment member 1176 to the tissue thickness compensator 1170 at point C is greater than the compressive force applied at point B.

As described above, one or more processes can be used to affect the spring rate and/or any other characteristics of materials used in connection with, for example, fastener cartridges and/or surgical fastening instruments. The elastic ratio and/or any other properties of the material may change throughout the modification process. In some cases, such a change may be gradual, while in other cases, the change may be abrupt. In various instances, one or more of the steps of the modification process may result in an increase in the elastic ratio of the material, while one or more steps may result in a decrease in the elastic ratio of the material. Finally, the net change in the spring rate may be measured when the comparison between the initial spring rate before the modification process begins and the subsequent spring rate after the modification process is completed. In various instances, the material may have a varying spring rate after the material has been heated and then cooled.

In some cases, it may be desirable to apply one or more of the above-described modification procedures to the tissue thickness compensator. For example, a first modification process can be used to modify the porosity of the tissue thickness compensator, as described above with respect to the tissue thickness compensator 1170. A second modification process, subsequent to the first modification process, can be used to alter the surface of the tissue thickness compensator, as described above with respect to tissue thickness compensator 1140. Further, a third modification process can be used to modify the tissue thickness compensator to include longitudinal slots similar to the longitudinal slots 1122 of the tissue thickness compensator 1120. In yet a fourth modification, the tissue thickness compensator can be modified to include an aperture similar to aperture 1152 of tissue thickness compensator 1150. The reader will appreciate that some of the above-described modifications may be combined or grouped in a single modification process. For example, the mold may be designed to include the pins 1156 of the mold 1154 and the central beam 1128 of the mold 1126. Other modified arrangements are contemplated by the present disclosure.

Referring now to fig. 38 and 39, a tissue thickness compensator, such as tissue thickness compensator 1190, can be changed or modified to include portions having different spring rates, porosities, and/or densities using one or more of the above-described modification processes. In some cases, the tissue thickness compensator 1190 may be modified to include a gradient pore morphology (i.e., the size of the small pores gradually increases in one direction across the thickness of the tissue thickness compensator 1190 into large pores) using one or more of the modification procedures described above. Such morphology is more desirable for tissue growth or hemostatic behavior. In addition, the gradient may also be combined with a varying bioabsorption profile. A short-term absorption profile may be more suitable for achieving hemostasis, while a long-term absorption profile may achieve better tissue healing without leakage.

Referring again to fig. 38 and 39, the tissue thickness compensator 1190 can have one or more region geometries that are different from the remainder of the tissue thickness compensator 1196. For example, as shown in fig. 38, the tissue thickness compensator 1190 may comprise one or more protruding portions, such as protruding portion 1196. Additionally, the tissue thickness compensator 1190 can comprise a first elastic ratio, a first porosity, and/or a first density that is uniform or at least substantially uniform across the tissue thickness compensator 1190 comprising one or more zone geometries, as shown in fig. 38. In some cases, the tissue thickness compensator 1190 may be altered or modified using one or more of the modification processes described above to alter or modify one or more zone geometries and/or cause local changes in, for example, the first elastic ratio, the first porosity, and/or the first density. The modified tissue thickness compensator 1190 may comprise one or more modified regions having an elasticity ratio, porosity, and/or density that differs from the first elasticity ratio, first porosity, and/or first density, respectively, of the other modified regions and/or of the remainder of the tissue thickness compensator 1190. In some cases, the resulting one or more modified regions may correspond to one or more region geometries. For example, as shown in fig. 39, the tissue thickness compensator 1190 can be altered or modified to be level or at least substantially level with the protruding portion 1196 and form a flat or at least substantially flat surface 1198, for example. The modified tissue thickness compensator 1190 may include a first portion 1192 having a first spring rate, a first porosity, and/or a first density and a second portion 1194 having a second spring rate, a second porosity, and/or a second density that are different than the first spring rate, the first porosity, and/or the first density, respectively. Second portion 1194 may correspond to protruding portion 1196 and may be caused to be horizontal, or at least substantially horizontal, with protruding portion 1196 to form a flat, or at least substantially flat, surface 1198, for example. In certain aspects, the geometry of the protruding portion 1196 prior to modification of the tissue thickness compensator 1190 reflects, matches, or is similar to the geometry of the second portion 1194 after the tissue thickness compensator 1190 has been modified.

Referring again to fig. 37-39, a die 1172 can be used to alter or modify the tissue thickness compensator 1190 in a manner similar to the tissue thickness compensator 1170. For example, the tissue thickness compensator 1190 can be heated in the receiver 1174 to a temperature greater than or equal to the glass transition temperature of the material composition of the tissue thickness compensator 1190 but less than the melting temperature thereof. In some cases, the adjustment member 1176 can be advanced against the protruding portion 1196 while the tissue thickness compensator 1190 is in a glassy state, thereby compressing the protruding portion 1196 and rearranging its geometry to form the second portion 1194, as shown in fig. 39. Further to the above, the adjustment member 1176 can be configured to maintain compression against the protrusion portion 1196 for a period of time sufficient to allow the tissue thickness compensator 1190 to remain, or at least substantially remain, with the modification applied by the adjustment member 1176. While under compression from the adjustment member 1176, the tissue thickness compensator 1190 may be cooled or may be actively cooled to a temperature below its glass transition temperature. After the tissue thickness compensator 1190 transitions out of the glassy state, the adjustment member 1190 may retract. The tissue thickness compensator 1190 can retain, or at least substantially retain, the second portion 1194, as shown in fig. 39. In some cases, the adjustment member 1176 can apply pressure to the protruding portion 1196 when the tissue thickness compensator 1190 is heated to reach a glassy state, when the tissue thickness compensator 1190 is in a glassy state, and/or when the tissue thickness compensator 1190 transitions or cools to a temperature below the glassy state. In some cases, the pressure applied to the protruding portion 1196 of the tissue thickness compensator 1190 may gradually increase toward a threshold value, such as when the temperature of the tissue thickness compensator 1190 gradually increases to cause the tissue thickness compensator 1190 to transition toward a glass state. In some instances, the pressure applied to the protruding portion 1196 of the tissue thickness compensator 1190 may be removed, gradually removed, or at least partially reduced as the tissue thickness compensator 1190 exits the glassy state, before the tissue thickness compensator 1190 exits the glassy state, and/or after the tissue thickness compensator 1190 exits the glassy state.

Referring now to fig. 41-43, a tissue thickness compensator, such as tissue thickness compensator 1200, can be prepared using conventional lyophilization techniques and/or any other suitable technique. Additionally, the tissue thickness compensator 1200 can be modified or altered for use in, for example, surgery. The tissue thickness compensator 1200 can be similar in many respects to other tissue thickness compensators, such as tissue thickness compensator 22020 (fig. 9) and/or tissue thickness compensator 1120 (fig. 26). For example, as with the tissue thickness compensator 22020, the tissue thickness compensator 1200 can be used with the end effector 22090. Further, as shown in fig. 41-43, the tissue thickness compensator 1200 can be modified to include a longitudinal slot 1202 that, like the knife slot 22025, can define a tissue thickness compensator knife path for the cutting portion 10053 between the first and

second stapling portions

1204a, 1204 b. Further, the first and

second suture portions

1204a, 1204b can be similar in many respects to the first and

second suture portions

22021a, 22021b (fig. 9) of the tissue thickness compensator 22020. In addition, the slot 1202 can be configured to releasably connect the first and

second stapling portions

1204a, 1204b such that, when used with the end effector 22090, the cutting portion 10053 can be advanced distally through the slot 1202 to transect the slot 1202 and separate the first and

second stapling portions

1204a, 1204 b.

Referring again to fig. 41-43, the tissue thickness compensator 1200 can be modified prior to assembly with an end effector, such as end effector 22090 (fig. 9). Alternatively, the tissue thickness compensator 1200 can be modified after it has been assembled with the end effector. As described above, the tissue thickness compensator 1200 can be prepared using conventional lyophilization techniques and/or any other suitable technique. The space creator 1206 may be used to modify the tissue thickness compensator 1200 during the thermal compression process, as shown in fig. 41-43. For example, the space creator 1206 can be heated to a temperature greater than or equal to the melting temperature of the material composition of the tissue thickness compensator 1200. The space creator 1206 can then be aligned with and inserted into the tissue thickness compensator 1200 to form the longitudinal slot 1202. The space creator 1206 may melt through the tissue thickness compensator 1200 to create space for the longitudinal slot 1202. The space creator 1206 can be retracted after a desired depth within the tissue thickness compensator 1200 is reached. In some cases, the thermal compression process may be repeated by reinserting the heated space creator 1206 through the tissue thickness compensator 1200 to widen the space created for the longitudinal slot 1202.

Referring again to fig. 41-43, the space creator 1206 may comprise a hot wire. For example, the space creator 1206 may comprise a thin, tensioned wire, which may be made of, for example, nichrome or stainless steel, or a thicker wire that is preformed into a desired shape. The hot wire may be heated to a desired temperature by electrical resistance. As the hot wire of the space creator 1206 passes through the material of the tissue thickness compensator 1200, heat from the hot wire may vaporize the material just prior to contact. In some cases, the hot wire may have a cylindrical or substantially cylindrical shape, as shown in FIG. 42. The depth of the longitudinal slot 1202 may depend in part on the insertion depth of the space creator 1206 through the tissue thickness compensator 1200, and the width of the longitudinal slot 1202 may depend in part on the diameter of the hot wire of the space creator 1206.

In some cases, the space creator 1206 may be partially inserted through the entire thickness of the tissue thickness compensator. In some cases, the space creator 1206 can be inserted completely through the entire thickness of the tissue thickness compensator 1200 to form openings, holes, and/or slots that extend through the entire thickness of the tissue thickness compensator 1200. In some cases, the space creator 1206 may be inserted through a first side of the tissue thickness compensator 1200 and exit through, for example, a second side of the tissue thickness compensator 1200, which may be opposite the first side.

A number of processes are disclosed herein that utilize thermal energy to modify a tissue thickness compensator. Such a process may be referred to as a felting process. In some cases, the felting process may also utilize the application of compressive and/or tensile forces to the tissue thickness compensator. In other cases, the felting process may not utilize the application of compressive and/or tensile forces to the tissue thickness compensator. In either case, the felting process disclosed herein may also be used, for example, to modify and appropriately implant layers and/or support materials.

In various instances, the tissue thickness compensator component can comprise a polymer composition. The polymer composition may comprise one or more synthetic polymers and/or one or more non-synthetic polymers. The synthetic polymer may comprise a synthetic absorbable polymer and/or a synthetic non-absorbable polymer. In various instances, the polymer composition can comprise, for example, a biocompatible foam. The biocompatible foam may comprise, for example, a porous open cell foam and/or a porous closed cell foam. Biocompatible foams may have a uniform pore morphology, or may have a gradient pore morphology (i.e., small pores gradually increasing in size across the thickness of the foam in one direction to large pores). In various instances, the polymeric composition can include one or more of a porous scaffold, a porous matrix, a gel matrix, a hydrogel matrix, a solution matrix, a filamentous matrix, a tubular matrix, a composite matrix, a membrane matrix, a biostable polymer, and a biodegradable polymer, and combinations thereof. For example, the tissue thickness compensator assembly may comprise a foam reinforced by a filamentous matrix, or may comprise a foam with an additional hydrogel layer that stretches in the presence of bodily fluids to provide further compression on the tissue. In various instances, the tissue thickness compensator component can also be comprised of a material and/or a coating on the second or third layer that stretches in the presence of bodily fluids to provide further compression on the tissue. Such layers may be hydrogels, which may be synthetic and/or natural-derived materials, and may be, for example, biodurable and/or biodegradable. In some cases, the tissue thickness compensator component may be reinforced with, for example, a fibrous nonwoven material or a fibrous mesh-type element that can provide additional flexibility, stiffness, and/or strength. In each case, the tissue thickness compensator component has a porous morphology that exhibits a gradient structure, e.g., small pores on one surface and larger pores on the other surface. Such morphology is more desirable for tissue growth or hemostatic behavior. In addition, the gradient may also be combined with a varying bioabsorption profile. A short-term absorption profile may be more suitable for achieving hemostasis; while a long-term absorption profile may achieve better tissue healing without leakage.

Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and Oxidized Regenerated Cellulose (ORC). Examples of synthetic absorbable polymers include, but are not limited to, poly (lactic acid) (PLA), poly (L-lactic acid) (PLLA), Polycaprolactone (PCL), polyglycolic acid (PGA), poly (trimethylene carbonate) (TMC), polyethylene terephthalate (PET), Polyhydroxyalkanoate (PHA), copolymers of glycolide and epsilon-caprolactone (PGCL), copolymers of glycolide and trimethylene carbonate, poly (glycerol sebacate) (PGS), polydioxanone, poly (orthoesters), polyanhydrides, polysaccharides, poly (ester-amides), tyrosine-based polyarylates, tyrosine-based polyiminocarbonates, tyrosine-based polycarbonates, poly (D, L-lactide-urethanes), poly (B-hydroxybutyric acid), poly (E-caprolactone), polyethylene glycol (PEG), poly [ di (carboxyphenoxy) phosphazene ], (N-methyl-ethyl-o-hydroxy-butyrate), poly (N-methyl-co-ethyl-n-propyl-ethyl-methyl-co-propyl-ethyl-propyl-ethyl-co-propyl-ethyl-methyl-carbonate (L-propyl-ethyl-propyl-co-propyl-ethyl-propyl-co-propyl-ethyl-propyl-carbonate (ethyl-co-propyl-butyl-ethyl-propyl-ethyl-co-ethyl-co-propyl-co-propyl-co-ethyl-propyl-co-propyl-butyl-co-butyl-co-butyl-co-carbonate(s) with poly(s) poly (p-butyl-co-butyl-co-butyl-ethyl-co-butyl-esters) s, poly(s) with poly(s) s, poly (s-esters, poly(s) and poly (s-esters with poly (p-esters, poly (p-co-esters) s) and poly (p-esters, and poly(s) s-esters with poly(s) s-esters, and poly (p-esters with poly(s) s-esters, and (p-esters, and(s) and (p-esters with poly(s) and/s, and/s) and/s, poly (amino acids), pseudo-poly (amino acids), absorbable polyurethanes, and combinations thereof. In various instances, the polymeric composition can comprise, for example, about 50% to about 90% PLLA by weight of the polymeric composition, and about 50% to about 10% PCL by weight of the polymeric composition. In at least one embodiment, the polymeric composition may comprise, for example, about 70% by weight PLLA, and about 30% by weight PCL. In various instances, the polymer composition can comprise, for example, about 55% to about 85% PGA by weight of the polymer composition, and 15% to 45% PCL by weight of the polymer composition. In at least one embodiment, the polymer composition may comprise, for example, about 65% by weight PGA, and about 35% by weight PCL. In various instances, the polymer composition can comprise, for example, from about 90% to about 95% PGA by weight of the polymer composition, and from about 5% to about 10% PLA by weight of the polymer composition.

In various instances, the synthetic absorbable polymer may comprise a bioabsorbable, biocompatible elastomeric copolymer. Suitable bioabsorbable, biocompatible elastomeric copolymers include, but are not limited to, copolymers of epsilon-caprolactone and glycolide (the mole ratio of epsilon-caprolactone to glycolide is preferably from about 30:70 to about 70:30, preferably from 35:65 to about 65:35, and more preferably from 45:55 to 35: 65); elastomeric copolymers of epsilon-caprolactone and lactide (including L-lactide, D-lactide, blends thereof or lactic acid copolymers) (the mole ratio of epsilon-caprolactone to lactide is preferably from about 35:65 to about 65:35, and more preferably from 45:55 to 30: 70); elastomeric copolymers of p-dioxanone (1, 4-dioxan-2-one) and lactide (including L-lactide, D-lactide, and lactic acid) (the molar ratio of p-dioxanone to lactide is preferably from about 40:60 to about 60: 40); elastomeric copolymers of epsilon-caprolactone and p-dioxanone (the mole ratio of epsilon-caprolactone to p-dioxanone is preferably from about 30:70 to about 70: 30); an elastomeric copolymer of p-dioxanone and trimethylene carbonate (the molar ratio of p-dioxanone to trimethylene carbonate is preferably from about 30:70 to about 70: 30); elastomeric copolymers of trimethylene carbonate and glycolide (preferably in a mole ratio of trimethylene carbonate to glycolide of from about 30:70 to about 70: 30); elastomeric copolymers of trimethylene carbonate and lactide (including L-lactide, D-lactide, blends thereof or lactic acid copolymers) (the molar ratio of trimethylene carbonate to lactide is preferably from about 30:70 to about 70: 30); and blends thereof. In one embodiment, the elastomeric copolymer is a copolymer of glycolide and epsilon-caprolactone. In another embodiment, the elastomeric copolymer is a copolymer of lactide and epsilon-caprolactone.

The disclosures of U.S. Pat. No. 5,468,253, entitled "ELASTOMERIC MEDICAL DEVICE", published at 21.11.1995 and U.S. Pat. No. 6,325,810, entitled "FOAM BUTTRESS FOR STAPLING APPATUS", published at 4.12.2001, are hereby incorporated by reference in their entireties.

In various instances, the synthetic absorbable polymer may, for example, include one or more of the following: 90/10 poly (glycolide-L-lactide) copolymer commercially available under the trade name VICRYL (polyglutic 910) from Ethicon, inc, polyglycolide commercially available under the trade name DEXON from American Cyanamid co, polydioxanone commercially available under the trade name PDS from Ethicon, inc, poly (glycolide-trimethylene carbonate) random block copolymer commercially available under the trade name MAXON from American Cyanamid co, 75/25 poly (glycolide-E-caprolactone-poliglecaprone 25) copolymer commercially available under the trade name MONOCRYL from Ethicon.

Examples of synthetic non-absorbable polymers include, but are not limited to, polyurethane foams, polypropylene (PP), Polyethylene (PE), polycarbonate, polyamides, such as nylon, polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), Polystyrene (PS), polyester, Polyetheretherketone (PEEK), Polytetrafluoroethylene (PTFE), Polychlorotrifluoroethylene (PTFCE), polyvinyl fluoride (PVF), Fluorinated Ethylene Propylene (FEP), polyacetal, polysulfone, and combinations thereof. Synthetic non-absorbable polymers may include, but are not limited to, foamed elastomers and porous elastomers, such as silicone, polyisoprene, and rubber. In each case, the synthetic polymer may include expanded polytetrafluoroethylene (ePTFE) commercially available under the trade name GORE-TEX Soft Tissue Patch from W.L.Gore & Associates, Inc., and copolyether ester polyurethane foam commercially available under the trade name NASPORE from Polynics.

The polymer composition of the tissue thickness compensator component can be characterized by, for example, percent porosity, pore size, and/or hardness. In various instances, the polymer composition can have a percent porosity of, for example, from about 30% to about 99% by volume. In certain instances, the polymer composition can have a percent porosity of, for example, about 60% to about 98% by volume. In various instances, the polymer composition can have a percent porosity of, for example, from about 85% to about 97% by volume. In at least one embodiment, the polymeric composition may comprise, for example, about 70% by weight PLLA and about 30% by weight PCL, and may include, for example, about 90% porosity by volume. In at least one such embodiment, therefore, the polymer composition will comprise about 10% copolymer by volume. In at least one embodiment, the polymer composition may comprise, for example, about 65% by weight PGA and about 35% by weight PCL, and may have a porosity percentage of, for example, about 93% to about 95% by volume. In various instances, the polymer composition can include a porosity of greater than 85% by volume. The polymer composition can have a pore size of, for example, about 5 microns to about 2000 microns. In various instances, the polymer composition can have a pore size, for example, between about 10 microns to about 100 microns. In at least one such embodiment, the polymeric composition can comprise, for example, a copolymer of PGA and PCL. In certain instances, the polymer composition can have a pore size, for example, between about 100 microns to about 1000 microns. In at least one such embodiment, the polymeric composition can comprise, for example, a copolymer of PLLA and PCL. According to certain aspects, the hardness of a polymer composition may be expressed in terms of shore hardness, which may be defined as the resistance of a material to permanent indentation as measured by a durometer (such as shore durometer). To evaluate the Durometer value of a given material, the material was pressed with a Durometer pin according to ASTM procedure D2240-00, entitled "Standard Test Method for Rubber Property-Durometer Hardness" (which is incorporated herein by reference in its entirety). The durometer indenter foot may be pressed into the material for a sufficient period of time (such as 15 seconds), in which case the reading is then taken on a suitable scale. Depending on the type of scale used, a reading of 0 may be obtained when the indenter foot has fully penetrated the material, and a reading of 100 may be obtained when the material has not been penetrated. The readings are dimensionless. In each case, hardness can be determined according to ASTM D2240-00 using any suitable scale, such as a class A and/or OO class scale. In various instances, the polymer composition of the tissue thickness compensator assembly can have a shore a hardness value, for example, from about 4A to about 16A, which is from about 45OO to about 65OO in the shore OO range. In at least one such embodiment, the polymeric composition can comprise, for example, a PLLA/PCL copolymer or a PGA/PCL copolymer. In various instances, the polymer composition of the tissue thickness compensator component can have a shore a hardness value of less than 15A. In various instances, the polymer composition of the tissue thickness compensator component can have a shore a hardness value of less than 10A. In various instances, the polymer composition of the tissue thickness compensator component can have a shore a hardness value of less than 5A. In certain instances, the polymeric material can have a shore OO composition value of, for example, about 35OO to about 75 OO.

In various instances, the polymer composition can have at least two of the above identified properties. In various instances, the polymer composition can have at least three of the above identified properties. The polymer composition can have, for example, a porosity of 85% to 97% by volume, a pore size of 5 microns to 2000 microns, and a shore a hardness value of 4A to 16A, and a shore OO hardness value of 45OO to 65 OO. In at least one embodiment, for example, the polymeric composition may comprise 70% PLLA by weight of the polymeric composition and 30% PCL by weight of the polymeric composition and have a porosity of 90% by volume, a pore size of 100 microns to 1000 microns, and a shore a hardness value of 4A to 16A, and a shore OO hardness value of 45OO to 65 OO. In at least one embodiment, for example, the polymeric composition may comprise 65% PGA by weight of the polymeric composition and 35% PCL by weight of the polymeric composition, and have a porosity of 93% to 95% by volume, a pore size of 10 microns to 100 microns, and a shore a hardness value of 4A to 16A, and a shore OO hardness value of 45OO to 65 OO.

In various instances, the polymer composition can comprise a pharmaceutically active agent. The polymer composition may release a therapeutically effective amount of the pharmaceutically active agent. In various instances, the pharmaceutically active agent may be released when the polymer composition is desorbed/absorbed. In various instances, the pharmaceutically active agent can be released into a fluid, such as blood, flowing over or through the polymer composition. Examples of pharmaceutically active agents may include, but are not limited to, hemostatic agents and drugs, such as fibrin, thrombin, and Oxidized Regenerated Cellulose (ORC); anti-inflammatory agents such as diclofenac, aspirin, naproxen, sulindac, and hydrocortisone; antibiotics and antimicrobial drugs or agents, such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, chloramphenicol; and anticancer agents, such as cisplatin, mitomycin, doxorubicin.

Various methods for altering a tissue thickness compensator are disclosed herein. Such methods can be used to alter any suitable layer used, for example, with a fastener cartridge and/or a surgical fastening instrument. Such layers may comprise less than one hundred percent dense compositions that may be formed using any suitable process. For example, such processes may include, for example, extrusion, injection molding, weaving, lyophilization, gas foaming, and/or melt blowing processes. Some processes may produce foam, while others may not; in any event, however, it is contemplated that all such embodiments may be used with all embodiments disclosed herein.

In various embodiments, referring to fig. 44-46, an end effector of a surgical fastening instrument, such as end effector 100, can be configured to capture, fasten, and/or incise tissue. The end effector 100 can comprise a fastener cartridge 110, and additionally a firing member 140 that can be advanced through the fastener cartridge 110 to deploy staples removably stored within the staple cartridge 110 into tissue captured within the end effector 100. In various circumstances, the firing member 140 can be advanced from a proximal position (fig. 44) toward the distal end of the end effector 100 to simultaneously deploy staples and transect tissue. There are, however, some instances where it may not be necessary to advance the firing member 140 toward the distal end of the end effector 100. For example, the fastener cartridge 110 of the end effector 100 can be removable and/or replaceable, and advancement within the end effector 100 may not be required for the firing member 140 in instances in which the fastener cartridge 110 is not positioned within the end effector 100. With the firing member 140 advanced through the end effector 100 without the fastener cartridge being positioned within the end effector 100, the knife edge 142 of the firing member 140 can incise tissue captured within the end effector 100 without simultaneously fastening the tissue. Similarly, where a fastener cartridge positioned within the end effector 100 has been previously used, or extended, and at least some of the fasteners have been deployed from the fastener cartridge, it may not be necessary for the firing member 140 to be advanced within the end effector 100. With the firing member 140 advanced through the end effector 100 while the pre-extended fastener cartridge is positioned within the end effector 100, the knife edge 142 of the firing member 140 can incise tissue captured within the end effector without simultaneously fastening the tissue. In various embodiments, the end effector 100 can include one or more lockout systems that can prevent the firing member 140 from being advanced distally when a fastener cartridge is not present within the end effector 100 and/or when a fastener cartridge positioned within the end effector 100 has been at least partially extended. Various locking systems are disclosed in U.S. patent 6,988,649 entitled "SURGICAL STAPLING INSTRUMENT HAVING ASPENT CARTRIDGE LOCKOUT" and published on 24.1.2006. The entire disclosure of U.S. patent 6,988,649 entitled "SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT" is incorporated herein by reference.

Referring again to fig. 44-46, the fastener cartridge 110 can comprise a cartridge body and a tissue thickness compensator 120, wherein, further to the above, the tissue thickness compensator 120 can be implanted against tissue captured by the end effector 100 via fasteners removably stored within the cartridge body. The tissue thickness compensator 120 can be positioned above a top surface or deck of the cartridge body, wherein staples 180 removably stored within staple cavities defined in the cartridge body can be ejected from the staple cavities by, for example, a firing member (such as sled 130 and/or firing member 140). In certain embodiments, the fastener cartridge 110 can further comprise a driver configured to support the staples 180 and to transmit movement of the sled 130 to the staples 180 in order to move the staples 180 between the unfired and fired positions. In various circumstances, the staples 180 can be at least partially embedded in the tissue thickness compensator 120 when the staples 180 are in their unfired position, and in some instances, the staples 180 can hold the tissue thickness compensator 120 in place over the cartridge deck when the staples 180 are in their unfired position. With the tissue thickness compensator 120 moved relative to the cartridge body and/or the staples 180 prior to deployment of the staples 180 into the tissue, in some instances, the tissue thickness compensator 120 can move the staples 180 relative to or away from their preferred positions. Furthermore, with the tissue thickness compensator 120 removed from the cartridge 110 prior to deployment of the staples 180, the cartridge 110 may no longer be suitable for its original intended use. In view of the above, as discussed in greater detail below, the end effector 100 can comprise a lockout that can be configured to prevent the firing member 140 and/or sled 130 from advancing distally to deploy the staples 180 if the tissue thickness compensator 120 is removed from, or becomes at least partially disengaged from, the cartridge body prior to the staples 180 being deployed.

Referring again to fig. 44-46, the tissue thickness compensator 120 can comprise (a) a body 121 configured to be captured by the staples 180, and (b) a locking pin 122 extending from the body 121. In various circumstances, when the tissue thickness compensator 120 is not removed from, or substantially moved from, a suitable position above the cartridge body deck, the locking pin 122 can comprise a first end 123 embedded in the body 121 and a second end 124 positioned intermediate the firing member 140 and sled 130. In such a position, the second end 124 of the locking pin 122 may be positioned intermediate a shoulder or shelf 134 defined on the sled 130 and a protrusion 144 extending distally from the firing bar 140. In other words, when the lockout pin 122 is positioned intermediate the sled 130 and the firing bar 140, the lockout pin 122 and the sled 130 can cooperate to support the firing bar 140 in an unlocked position above a lockout shoulder 112 defined in the fastener cartridge 110 such that, when a distal firing force is applied to the firing bar 140, the firing bar 140 can advance the sled 130 distally to fire the staples 180. When the tissue thickness compensator 120 is removed from the cartridge 110 and/or substantially disengaged from a desired position relative to the cartridge body, referring primarily to fig. 45, the lockout pin 122 may no longer be positioned intermediate the sled 130 and the firing member 140 and/or may not be able to support the firing member 140 in its unlocked position (fig. 44). In such circumstances, the firing member 140 can become positioned in the locked position such that distal advancement of the firing member 140 is prevented by the locking shoulder 112. In at least one such instance, the end effector 100 can further comprise a biasing member, such as a spring, for example, configured to bias the firing member 140 into its locked state. In some instances, the biasing member may bias the firing member 140 into contact with the sled 130, for example, without the need for a lockout pin 122 positioned therebetween, which may comprise a lockout position of the firing member 140.

As a result of the above, the cartridge 110 may become inoperable if the tissue thickness compensator 120 is prematurely removed from the cartridge 110. In such instances, the locking pin 122 can comprise a fuse that deactivates the cartridge 110 with the tissue thickness compensator 120 removed prior to distal advancement of the firing member 140. In various instances, the locking pin 122 can comprise a key that maintains the cartridge 110 in an unlocked state when the key is positioned between the sled 130 and the firing member 140 and allows the cartridge 110 to enter a locked state with the tissue thickness compensator 120 removed from the cartridge 110 prior to the firing member 140 advancing distally, i.e., prior to the firing member 140 beginning its firing stroke. When the firing member 140 is in its locked state and cannot be advanced distally, the knife edge 142 of the firing member 140 cannot incise the tissue captured within the end effector 100. Further, in such circumstances, the firing member 140 cannot advance the sled 130 distally to fire the staples 180. Thus, when the tissue thickness compensator 120 is not positioned or properly positioned on the cartridge 110, the tissue thickness compensator lock can prevent the tissue captured within the end effector 100 from being incised and stapled. With the firing member 140 advanced distally before the tissue thickness compensator 120 is removed or disengaged, the firing member 140 can complete the firing stroke of the end effector 100 or at least a portion of the firing stroke thereof. In such instances, the sled 130 is advanced distally such that the one or more ramps 132 defined on the sled 130 can lift the staples 180 and the knife edge 142 of the firing member 140 can cut into the tissue thickness compensator 120 and/or tissue captured within the end effector 100. In some instances, the firing member 140 may contact the locking pin 122 and displace it away as the firing member 140 is advanced distally. In such cases, the locking pin 122 may be flexible. In various instances, the locking pin 122 may be constructed of, for example, a bioabsorbable material and/or a biocompatible material. In certain instances, the firing member 140 may incise the locking pin 122 as the firing member 140 advances distally. In any event, once the firing member 140 has been at least partially advanced, the purpose of the locking pin 122 may become obsolete. In other words, the tissue thickness compensator lock can be used as an initial check to verify that the tissue thickness compensator is present within the end effector, and once the initial check has been completed, the firing stroke of the end effector can be performed.

Referring again to fig. 47-50, the end effector 200 can comprise an anvil 260, and additionally a fastener cartridge 210 comprising a cartridge body 214 and a tissue thickness compensator 220, wherein, further to the above, the tissue thickness compensator 220 can be implanted against tissue captured by the end effector 200 by fasteners removably stored within the cartridge body 214. The tissue thickness compensator 220 can be positioned above a top surface or deck 211 of the cartridge body 214, wherein staples removably stored within staple cavities defined in the cartridge body 214 can be ejected from the staple cavities by, for example, a firing member (such as sled 230 and/or firing member 240). In certain embodiments, the fastener cartridge 210 can further comprise a driver configured to support the staples and to transmit movement of the sled 230 to the staples in order to move the staples between the unfired and fired positions. In various instances, the staples can be at least partially embedded in the tissue thickness compensator 220 when the staples are in their unfired positions, and in some instances, the staples can hold the tissue thickness compensator 220 in place when the staples are in their unfired positions. With the tissue thickness compensator 220 moved relative to the cartridge body 214 and/or staples prior to deployment of the staples into the tissue, in some instances, the tissue thickness compensator 220 can move the staples relative to or away from their preferred positions. Further, with the tissue thickness compensator 220 removed from the cartridge 210 prior to staple deployment, the cartridge 210 may no longer be suitable for its original intended use. In view of the above, as discussed in greater detail below, the end effector 200 can comprise a lockout that can be configured to prevent the firing member 240 and/or sled 230 from advancing distally to deploy staples if the tissue thickness compensator 220 is removed from, or becomes at least partially disengaged from, the cartridge body 214 prior to staples being deployed.

Referring again to fig. 44-46, the tissue thickness compensator 220 can comprise (a) a body 221 configured to be captured by a staple, and (b) a ring or tether 222 extending from the body 221. In various instances, referring primarily to fig. 47, the ring 222 can include end portions at least partially embedded in the body 221 and a middle portion extending between the end portions that can be releasably engaged with the slider 230. In some cases, the loop 222 may comprise, for example, a suture or a flexible thread. In some cases, the ring 222 can be constructed of, for example, a bioabsorbable material and/or a biocompatible material. Referring primarily to fig. 48, the slider 230 may include a longitudinal body portion 236, a hook 238 extending from the body portion 236, and a slot 237 defined between the body portion 236 and the hook 238. As shown in fig. 48, when the tissue thickness compensator 220 is positioned over the cartridge deck 211, the ring 222 is positioned within the slot 237 and the sled 230 and firing member 240 are in an unfired position. As also shown in fig. 48, a distal projection 244 extending from the firing member 240 is positioned against and/or on a support shoulder 234 defined on the sled 230 that retains the firing member 240 in an unlocked position, i.e., in a position in which distal movement of the firing member 240 will be impeded, or at least substantially impeded, by a lockout shoulder 212 defined in the end effector 200 when a firing motion is applied to the firing member 240. Thus, when the sled 230 holds the firing member 240 in its unlocked position, referring to fig. 49, the firing member 240 will slide past the lockout shoulder 212 to advance the sled 230 distally, fire staples removably stored within the cartridge body 214, and incise the tissue thickness compensator and tissue positioned within the end effector 200 with the knife edge 242. As shown in fig. 49, as the slider 230 is advanced distally, the loop 222 can slide out of the slot 237 defined in the slider 230.

With the tissue thickness compensator 220 removed from the cartridge 210 or moved substantially from a position above the deck 211 of the cartridge 210, referring now to fig. 50, the tissue thickness compensator 220 can pull the sled 230 distally such that the firing member 240 is no longer supported by the sled 230. More specifically, the ring 222 of the tissue thickness compensator 220 positioned within the slot 237 can pull the sled 230 distally from its unfired position such that the support shoulder 234 is no longer positioned under the distal protrusion 244 of the firing member 240. In such instances, the firing member 240 may be displaced downward into a locked position, wherein distal movement of the firing member 240 may be impeded by the lockout shoulder 212. In certain instances, the end effector 200 can further include a biasing member, such as a spring, that can bias the firing member 240 into its locked state. When the firing member 240 is in its locked state, the firing member 240 cannot move distally to advance the sled 230, fire staples from the cartridge body 210, and/or incise tissue captured within the end effector 200. While the sled 230 can advance distally when the tissue thickness compensator 220 is removed from the cartridge 210, in various circumstances the sled 230 may not advance sufficiently to deploy staples from the cartridge 210. When the user of the surgical instrument recognizes that the firing member 240 is in the locked state, the user can remove the staple cartridge 210 from the end effector 200 and replace it with, for example, the staple cartridge 210 with the tissue thickness compensator 220 properly positioned above the deck 211 and the sled 230 not yet advanced distally from its unfired position. Other embodiments are contemplated wherein the staple cartridge is not removable from the end effector, in such embodiments, the end effector can be completely replaced with the tissue thickness compensator removed from the staple cartridge and/or the firing member brought into a locked state.

Turning now to fig. 51-53, the staple cartridge 310 can comprise a cartridge body 314 and a sled 330 movably positioned within the cartridge body 314. Similar to the above, the cartridge body 314 can comprise, for example, a plurality of fastener cavities, such as fastener cavity 316, and, for example, a longitudinal slot, such as knife slot 318, defined therein. The slider 330 may include a central body portion 336 slidably positioned within the knife slot 318 and a hook 338 extending from the central body portion 336. Referring primarily to fig. 51, the tissue thickness compensator 320 of the cartridge 310 can comprise a body portion 321 and a catch 322 extending from the body portion 321, wherein the catch 322 can be releasably retained in a slot 337 defined between the hook 338 and the central body portion 336 when the sled 330 is in its unfired or unextended position. Similar to the above, the fastener 322 can comprise an end 323 mounted within the body 321 and can extend proximally from the body 321 of the tissue thickness compensator 320, wherein with the tissue thickness compensator 320 removed from the cartridge body 314, for example, the fastener 322 can pull the sled 330 distally such that the support shoulder 334 defined in the central body portion 336 can no longer support a firing member (such as the firing member 240) thereon and such that the firing member can enter a locked state. In various circumstances, a user of the surgical instrument can attempt to reassemble or reposition the tissue thickness compensator 320 over the deck 311 of the cartridge body 314; however, since repositioning of the tissue thickness compensator 320 will not reset the sled 330, the firing member 340 will remain in the locked state. Thus, such an arrangement may prevent the cartridge 310 from being used if it has been tampered with.

In various instances, referring again to fig. 51-53, at least a portion of a hook 338 defined therebetween extending from the slider 330 and/or the central portion 336 of the slot 337 can extend above the platform 311. In some instances, at least a portion of the hook 338 defined therebetween extending from the slider 330 and/or the central portion 336 of the slot 337 can extend above the knife slot 318. In such embodiments, the fasteners 322 can easily slide into the slots 337 when the tissue thickness compensator 320 is assembled to the cartridge body 314. In certain instances, the fasteners 322 can be positioned above or against the deck surface 311 of the cartridge body 314. In various circumstances, referring primarily to fig. 53, the cartridge body 314 can comprise depressions or pockets 319 defined therein within which the hooks 338 can be positioned when the sled 330 is in its unfired or unextended position. In such embodiments, the top of the hook 338 may be positioned below the platform surface 311. In various instances, the pockets 319 can further include one or more sloped surfaces 313 defined in a distal end of the pockets 319 and extending downward from the land surface 311. In some cases, catch 322 may abut sloped surface 313 as slider 330 is advanced distally, in which case hook 338 may then be separated from catch 322. In various circumstances, the recesses 319 can be configured to facilitate assembly of the fasteners 322 to the sled 330 when the tissue thickness compensator 320 is assembled to the cartridge body 314. In various embodiments, the slot 337 can extend longitudinally and can include a closed distal end and an open proximal end, wherein the catch 322 can slide into the slot 337 from the open proximal end. In the event that the tissue thickness compensator 320 is not prematurely removed or disengaged from the cartridge 314, the sled 330 can be advanced distally such that the fasteners 322 exit the slots 337 through the distal ends thereof and such that the ramps 332 defined on the sled 330 can eject the staples from the staple cartridge 310.

In various instances, at least one adhesive may be used to adhere the tissue thickness compensator to the sliding member. In such cases, the adhesive attachment between the tissue thickness compensator and the sled can be strong enough to allow the tissue thickness compensator to pull the sled distally if the tissue thickness compensator is removed from the cartridge. When the sled is advanced distally by the firing member as part of the firing stroke, the adhesive attachment between the tissue thickness compensator and the sled may fail, allowing the sled to slide distally relative to the tissue thickness compensator. In various instances, the tissue thickness compensator can be bonded to the sliding member using a thermal welding process and/or a thermoforming process. In such cases, the bond between the tissue thickness compensator and the sled can be strong enough to allow the tissue thickness compensator to pull the sled distally if the tissue thickness compensator is removed from the cartridge. When the sled is advanced distally by the firing member as part of the firing stroke, the engagement between the tissue thickness compensator and the sled may fail, thereby allowing the sled to slide distally relative to the tissue thickness compensator.

In some cases, for example, the loop, fastener, and/or label may be integrally formed with the tissue thickness compensator. In various instances, for example, the loop, fastener, and/or label can comprise a material that is integral with the tissue thickness compensator. In some cases, additional layers may be attached to the tissue thickness compensator. In various instances, the layer may include a mounting portion that engages the slider.

Turning now to fig. 54, similar to the above, the sled 430 can include a central body portion 436, and additionally a plurality of ramps 432 configured to eject, for example, staples removably stored within the cartridge body. Also similar to above, the body portion 436 may include a hook 438 extending therefrom, wherein a slot 437 may be defined between the body portion 436 and the hook 438. In some instances, the slot 437 can include a closed distal end 437a and an open proximal end 437 d. In various instances, the slot 437 can also include a first portion 437b extending in a first direction and a second portion 437c extending in a second direction. In some cases, the first portion 437b can extend along a longitudinal axis and the second portion 437 can extend along a second axis that is transverse to the longitudinal axis. In at least one such case, the second portion 437c can extend at an angle relative to the first portion 437 b.

Turning now to fig. 55-58, the slider assembly 530 can include a first portion 535, and additionally a second portion 536 that can move relative to the first portion 535 between an unlocked position (fig. 55 and 57) and a locked position (fig. 56 and 58). The first portion 535 can include (a) a central portion configured to slide within a longitudinal slot, such as a knife slot 518 defined in the staple cartridge 510, and (b) a plurality of ramps 532 configured to eject staples removably stored within the cartridge 510. A central portion of the first portion 535 can include a first slot 533a and a second slot 533b defined therein. The first and

second slots

533a and 533b may be configured to receive

pins

531a and 531b, respectively, extending from the second portion 536. The first pin 531a can be configured to slide within the first slot 533a, and the second pin 531b can be configured to slide within the second slot 533b, so as to allow the second portion 536 to rotate relative to the first portion 535. In various instances, the first pin 531a can be closely received within the first slot 533a such that the first slot 533a can constrain movement of the first pin 531a along the first path, and similarly, the second pin 531b can be closely received within the second slot 533b such that the second slot 533b can constrain movement of the second pin 531b along the second path. Referring primarily to fig. 57, the second portion 536 of the slider assembly 530 can include an arm configured to slide within the knife slot 518, wherein the arm can include a support shoulder 534 defined on a proximal end thereof and a hook 538 defined on a distal end thereof. Similar to the above, the support shoulder 534 can be configured to support the firing member 240, e.g., in an unlocked position, when the sled assembly 530 is in the proximal unfired position and the tissue thickness compensator 220 is positioned, e.g., over or against the deck surface 511 of the cartridge 510. Also similar to the above, the hooks 538 can be configured to releasably retain the loops 222 of the tissue thickness compensator 220 such that upon removal and/or substantial displacement of the tissue thickness compensator 220 from the cartridge body, the loops 222 can pull on the second portion 536 to pivot the second portion 536 into its locked position, as shown in fig. 58. In such a locked position of the second portion 536, the support shoulder 534 may no longer support the distal projection 244 of the firing member 240, and the firing member 240 may drop downward into its locked position. As shown in fig. 58, rotation of the second portion 536 into its locked position can move the support shoulder 534 distally and/or downward away from the firing member 240. As also shown in fig. 58, the firing member 240 can include a lock 541 extending from opposing sides thereof that can be configured to abut the lock shoulder 212 when the firing member 240 is in its locked position. When the firing member 240 is held in its unlocked position by the sled assembly 530, the lock 541 may not contact the lockout shoulder 212 and the firing member 240 may be advanced through the cartridge 510.

In various circumstances, as described above, a portion of the staple driving sled can extend above the deck surface of the cartridge body. For example, referring again to fig. 52 and 54, for example, the hook 338 of the slider 330 (fig. 52) and/or the hook 438 of the slider 430 may extend above the platform surface. In such instances, the hook 338 and/or the hook 438 may translate distally over the deck surface and, in some instances, contact a tissue thickness compensator positioned against or over the deck surface. In certain instances, the hooks 338 and/or the hooks 438 can lift the tissue thickness compensator upwardly away from the cartridge body and facilitate gradual release of the tissue thickness compensator from the cartridge. For example, the hook 338 and/or the hook 438 can begin at the proximal end of the tissue thickness compensator and move toward the distal end of the tissue thickness compensator in order to initially lift the proximal end of the tissue thickness compensator and then gradually lift it away from the cartridge deck until the distal end of the tissue thickness compensator is ultimately lifted away from the cartridge body. In other instances, as discussed in more detail further below, it may be preferable for the portion of the sled that contacts the tissue thickness compensator to deflect downward and/or otherwise not interfere with the tissue thickness compensator as the sled advances distally.

Turning now to fig. 59 and 60, the staple cartridge 610 can comprise a cartridge body 614, a tissue thickness compensator 620 releasably retained to the cartridge body 614, and a sled 630 configured to longitudinally traverse the cartridge body 614 and eject staples removably stored therein. The sled 630 can include a main body portion 635 having a plurality of ramp surfaces defined thereon, a support shoulder 634, and an arm 636 extending from the body portion 635. In various instances, the arm 636 can be assembled to the main body portion 635. For example, the arm 636 may include a first end embedded in the main body portion 635, for example, and a second end including a hook 638. In various instances, the arm 636 can comprise a cantilevered beam extending from the main body portion 635. In some cases, the arm 636 can be constructed of a material that is resilient and/or flexible, for example. Similar to the above, the slot 637 can be defined between the hook 638 and the arm 636, which can be configured to releasably retain a portion of the tissue thickness compensator 620 when the sled 630 is in its proximal, unfired position. For example, with the tissue thickness compensator 620 pulled away from the cartridge body 614, the tissue thickness compensator 620 can pull the sled 630 distally away from the firing member such that the firing member enters into a locked state.

In various instances, further to the above, at least a portion of the arm 636, such as the hook 638, can extend above the deck surface 611 of the cartridge body 614. In some instances, the arms 636 can engage loops extending from the tissue thickness compensator 620, for example, when the sled 630 is in its proximal position (fig. 59), and the arms 636 can disengage from the loops as the sled 630 is advanced distally. As the sled 630 advances distally, in some instances, the arms 636 may contact the body portion 621 of the tissue thickness compensator 620 and flex downward. In various circumstances, as the sled 630 is advanced distally, the deflected arms 636 can slide within the longitudinal knife slots 618 defined in the cartridge body 614. In some instances, referring to fig. 60, the distal end of the longitudinal slot 618 can be defined by a nose wall or roof 619, wherein when the sled 630 reaches the distal end 617 of the cartridge 610, the arm 636 can slide under the nose wall 619 such that the firing stroke of the end effector can be completed. In some cases, the arm 636 may not be deflected downward or substantially deflected downward by the tissue thickness compensator 620, wherein when the arm 636 reaches the end of the longitudinal slot 618, the arm 636 may contact the nose wall 618 and flex downward to slide thereunder, as shown in fig. 60. In various circumstances, as a result, the flexible arm 636 can allow the firing stroke to complete and the sled 630 to park at the distal end of the cartridge.

Turning now to fig. 61, a slider, such as slider assembly 730, for example, can include a main body portion 735 and a movable arm 736. Similar to the above, the main body portion 735 can include one or more staple drive ramps 732 and a support shoulder 734 configured to support the firing member in the unlocked position, as described above. The arm 736 may include a first end that may be pivotally and/or rotatably mounted to the main body portion 735, and a second end that includes a hook 738 configured to releasably engage with a tissue thickness compensator, as described above. As the sled assembly 730 advances distally, the hooks 738 can separate from the tissue thickness compensator; however, the upper surface of the hooks 738 may remain in contact with the bottom surface of the tissue thickness compensator. In such instances, the arm 736 can pivot, for example, downward into the knife slot 318 in order to slide under the tissue thickness compensator. More specifically, the arm 736 is pivotable from a raised or convex uppermost position (fig. 61) to a lowered or concave position. In various instances, the slider assembly 730 can further include a resilient biasing member, such as a spring 731, for example, configured to bias the arm 736 into its raised position. When the arm 736 has been rotated downwardly into its lowered position, the spring 731 may apply a biasing force to the arm 736, which is transferred into the tissue thickness compensator. In some cases, the spring 731 may be positioned intermediate the arm 736 and the frame portion 733 defined on the main body portion 735. In various instances, the spring 731 can comprise, for example, a cantilever spring or a leaf spring extending from the arm 736. The cantilever spring can be configured to flex and/or slide along, for example, the frame portion 731 when the arm 736 is pushed downward. In various embodiments, the main body portion 735 can also include a stop shoulder 739, for example, which can limit the upward rotation or travel of the arm 736. In any event, similar to the above, the arm 736 may be configured to rotate downward when it contacts the roof 619 and allows the firing stroke to complete.

In various instances, a staple can include a base and one or more legs extending from the base. In some cases, a staple may include a base having a first end and a second end, a first leg extending from the first end, and a second leg extending from the second end. In some cases, the staple may be formed from a continuous line including a first leg, a base, and a second leg. The first end of the continuous wire may comprise a tip of the first staple leg and the second end of the continuous wire may comprise a tip of the second staple leg. One such staple, staple 800, is shown, for example, in fig. 62. The staple 800 may include a base 802, a first staple leg 804 extending from a first end of the base 802, and a second staple leg 804 extending from a second end of the base 802. The first staple leg 804 can include a first tip 806, and similarly, the second staple leg 804 can include a second tip 806. In various instances, the tip 806 can be configured to penetrate tissue, such as tissue T shown in fig. 62, for example. In some cases, the tip 806 may be sharp and may be formed by, for example, a molding process. In various embodiments, the wire may be constructed of, for example, titanium and/or stainless steel.

In various embodiments, staple 800 may be U-shaped, or at least substantially U-shaped, for example, when it is in its unformed configuration. In such embodiments, the legs 804 of the peg 800 may be parallel to each other or at least substantially parallel to each other. Further, in such embodiments, the legs 804 may be perpendicular, or at least substantially perpendicular, to the base 802. In certain embodiments, the staple 800 may be V-shaped, or at least substantially V-shaped, for example, when it is in its unformed configuration. In such embodiments, the legs 804 of the peg 800 are not parallel to each other; instead, the legs 804 may extend in a non-parallel direction. Further, in such embodiments, one or both of the legs 804 are not perpendicular to the base 802, wherein one or both of the legs 804 may extend in a direction oblique to the base 802. In various circumstances, the legs 804 can extend or splay outward relative to the center or centerline of the staple. In any event, the staples 800 can be removably stored within the staple cartridge, ejected from the staple cartridge to penetrate tissue, as shown in FIG. 62, and then contact an anvil positioned on the opposite side of the tissue. The anvil may be configured to deform the staples 800 into any suitable shape, such as a B-form configuration, for example, as also shown in fig. 62. Various shaped staple configurations, such as a B-form configuration, can define a tissue entrapment area, such as tissue entrapment area 807, configured to entrap tissue within the staple.

As described above, the staples can be removably stored within a cavity defined in the cartridge body. A cartridge body 810 is shown in fig. 63, which can comprise one or more staple cavities 812 defined therein. Referring to fig. 63, 68, and 69, each staple cavity 812 may include a first end 814 and a second end 814. In certain embodiments, such as embodiments comprising a longitudinal end effector, for example, the first end 814 can comprise a proximal end of the staple cavity 812 and the second end 814 can comprise a distal end of the staple cavity 812. In various instances, a staple may be positioned within a staple cavity 812 such that a first leg 804 of the staple 800 is positioned in a first end 814 of the staple cavity 812 and a second leg 804 is positioned in a second end 814. In various instances, a staple cavity width can be defined between the ends 814 of the staple cavity 812. The base 802 of the staple may be defined by a base width that is equal to or shorter than, for example, the staple cavity width. In some cases, the staple can have a staple width that can be defined between the tips 806 of the staple legs 804. In some embodiments, the staple width may be equal to the staple cavity width. In various embodiments, the staple width can be wider than the staple cavity width. In such embodiments, the legs 804 can be in contact with the ends 814 of the staple cavities 812 and can be resiliently biased inward by the ends 814 when the staples are positioned within the staple cavities 812. As the staples are lifted upward out of the staple cavities 812, the legs 804 may resiliently spread outward as they emerge from the staple cavities 812. For example, the staples can be positioned within the staple cavities 812 such that the tips 806 of the staple legs 804 do not extend above the top surface or deck of the cartridge body 810 when the staples are in their unfired or unretained position. In such a position, the tip 806 can be positioned flush with or recessed below the deck 811 of the cartridge body 810. Alternatively, the tips 806 of the legs 804 can extend at least partially above the deck 811 of the cartridge body 810. In any event, as the staple is lifted upward, the staple tip 806 may appear above the platform 811 and spread outward as the legs 804 emerge from the cavity 812. At some point during the lifting of the staples, the legs 804 may no longer be in contact with the ends 814 of the staple cavities 812 and the legs 804 may no longer be biased inward by the sidewalls of the staple cavities 812.

In various instances, the anvil can comprise one or more pockets configured to receive the tips 806 of the staple legs 804 as the staples 800 are ejected from the staple cartridge. The anvil pockets can be configured, for example, to flip or bend the staple legs 804 inwardly toward one another. In other instances, the anvil pockets can be configured to, for example, evert or bend the staple legs 804 outwardly away from one another. However, in some cases, one or more of the staple legs of a staple may miss the staple pockets and may not deform properly. In some cases, one or more of the staple legs may not contact the anvil and may not deform at all. In either case, the staples may not properly capture and/or hold the tissue within their tissue entrapment areas. In addition, malformed or unformed staples may not be able to apply the desired compressive pressure to the tissue. In some cases, malformed or unformed staples may not remain in the tissue and may become dislodged from the tissue.

Referring again to fig. 62, staple 800, and/or various other staples disclosed herein, can include one or more barbs extending therefrom. In various instances, the barbs can be configured to engage tissue captured within and/or around the staples. In some cases, the barbs can help retain the staples within the tissue, particularly when the staples have been deformed or unformed. The peg 800 may include barbs extending from one or both of the legs 804. For example, each leg 804 can include one or more barbs 808 facing outward from the center of the staple 800 and/or one or more barbs 809 facing inward toward, for example, the center of the staple 800. In some cases, barbs 808 may extend away from tissue entrapment area 807 and/or barbs 809 may extend toward or into tissue entrapment area 807. As shown in fig. 62, two of the legs 804 of staple 800 may include barbs 808 and barbs 809. In some cases, staple leg 804 can include barb 808, but not barb 809. Staple 820 is shown in fig. 63, including barb 808, but not barb 809. In some cases, staple legs 804 can include barbs 809 but not barbs 808. Staples 830,840,850,860 and 870 are shown in fig. 64, 65, 66, 67, and 68, respectively, and include barbs 809 but not barbs 808. In some embodiments, for example, the first leg 804 of the staple can include a barb 808, and the second leg 804 of the staple can include a barb 809.

In various instances, the legs 804 and the base 802 of the staple can define a staple plane when the staple is in an unformed configuration. Barbs 808 may extend outwardly from legs 804 in the plane of such staples. Similarly, barbs 809 may extend inwardly from legs 804 in such a plane. In some cases, staples can include barbs extending transversely relative to the plane of such staples. Other embodiments are contemplated in which the legs 804 and the base 802 do not lie or lie entirely within a single plane. In such embodiments, the barbs may extend in any suitable direction. In various embodiments, referring now to fig. 67, a staple, such as staple 860, for example, can include barbs 803 extending from the base 802. In various circumstances, barbs 803 can extend inwardly toward tissue entrapment area 807 of staples 860. In some cases, barbs 803 may extend outwardly away from tissue entrapment area 807. As shown in fig. 67, the barb 803 may extend within the staple plane defined by the leg 804 and the base 802. In some cases, barbs 803 may extend transversely relative to the plane of such staples. Various exemplary barb configurations are discussed in further detail below.

In various instances, the staple legs 804 can include an array of barbs 808 extending along their entire length. In some cases, staple legs 804 can include an array of barbs 808 that extend along less than their entire length. By way of example, referring to fig. 62, the legs 804 of the staple 800 each include an array of barbs 808 that extend along less than the entire length of the legs 804. Similarly, referring to FIG. 63, the legs 804 of the staple 820 each include an array of barbs 808 that extend along less than the entire length of the legs 804. Referring to the staple 800, for example, an array of barbs 808 may extend along each of the legs 804 from the base 802 of the staple 800 toward the tip 806 of the leg 804. As shown in fig. 62, the array of barbs 808 may not extend to the tip 806 of the leg 804. In various instances, the array of barbs 808 can extend along, for example, half or about half of the length of the leg 804; however, any suitable length of the barb array may be used. For example, the array of barbs 808 may extend along less than half of the length of the leg 804 or more than half of its length. In some embodiments, an array of barbs 808 may extend along each of the legs 804 from the tip 806 of the leg 804 toward the base 802. In such embodiments, the array of barbs 808 may not extend to the base 802. In some embodiments, the leg 804 may include an array of barbs 808 that do not extend to the tip 806 or base 802 of the leg 804. In certain embodiments, the leg 804 may include more than one array of barbs 808.

In various instances, further to the above, the staple legs 804 can include an array of barbs 809 extending along the entire length thereof. By way of example, referring to fig. 64, the legs 804 of the staple 830 each include an array of barbs 809 that extend along the entire length of the legs 804. In some cases, the staple legs 804 can include an array of barbs 809 that extend along less than their entire length. By way of example, referring to FIG. 65, the legs 804 of the staple 840 each include an array of barbs 809 that extend along less than the entire length of the legs 804. Similarly, referring to FIG. 68, the legs 804 of the staple 870 each include an array of barbs 809 that extend along less than the entire length of the legs 804. Referring to the staple 840, for example, an array of barbs 809 can extend along each of the legs 804 from the base 802 of the staple 840 toward the tip 806 of the leg 804. As shown in fig. 65, the array of barbs 809 may not extend to the tip 806 of the leg 804. In various instances, the array of barbs 809 can extend along, for example, half or about half of the length of the legs 804; however, any suitable length of the barb array may be used. For example, the array of barbs 809 may extend along less than half of the length of the leg 804 or more than half of its length. In some embodiments, an array of barbs 809 can extend along each of the legs 804 from the tip 806 of the leg 804 toward the base 802. In such embodiments, the array of barbs 809 may not extend to the base 802. In some embodiments, as shown in fig. 66, the leg 804 can include an array of barbs 809 that do not extend to the tip 806 or base 802 of the leg 804. In certain embodiments, the leg 804 can include more than one array of barbs 809.

Various barb configurations are shown in fig. 70-73, but any suitable barb configuration may be used. Referring to fig. 70, the staple leg 804 can include at least one barb 809, for example. In various instances, the barbs 809 can comprise prongs. The prongs may include a first surface 809a and a second surface 809b that may extend from the perimeter 805 of the legs 804. The first surface 809a may include, for example, an inclined surface, a convex surface, and/or a concave surface. The second surface 809b can comprise, for example, a flat or at least substantially flat surface. In various instances, the first surface 809a and the second surface 809b can converge, for example, at an edge 809 c. Barbs 809 may be formed using any suitable process. For example, the barbs 809 may be formed using a stamping process. In at least one embodiment, a shaping die, for example, can be used to impact the perimeter 805 of the wire including the legs 804 in order to disrupt or disturb enough material to form the barbs 809. In various instances, the barbs may include, for example, any suitable point or burr. In various embodiments, barbs 809 can be tapered. In various instances, the barbs 809 can include a base adjacent the perimeter 805 that is thicker than the tips of the barbs 809.

Referring now to fig. 68, 69, 71 and 71A, the staple leg 804 may include at least one barb 879, for example. In at least one embodiment, barbs 879 can extend around a portion of the perimeter 805 of the staple legs 804. In various instances, barbs 879 can include a first surface 879a and a second surface 879b that can extend from the perimeter 805 of the staple legs 804. The first surface 879a may include, for example, an inclined surface, a convex surface, and/or a concave surface. The second surface 879b can comprise, for example, a flat or at least substantially flat surface. In various instances, the first surface 879a and the second surface 879b can converge at an edge 879c, for example. In various instances, the edge 879c can be arcuate, for example. Barbs 879 can be formed using any suitable process. For example, barbs 879 can be formed using a stamping process. In at least one embodiment, a forming die, for example, can be used to impinge the perimeter 805 of the wire including the legs 804 in order to disrupt or interfere with sufficient material to form the barbs 879. Referring primarily to fig. 71A, the wire including legs 804 may be defined by a diameter 801 and barbs 879 may be defined by a diameter larger than diameter 801. Accordingly, the line including the legs 804 may be defined by a radius, and the barbs 879 may be defined by a radius that is greater than the line radius. In various embodiments, barbs 879 can be tapered. In various instances, the barbs 879 can include a base adjacent the perimeter 805 that is thicker than the tip of the barbs 879.

Referring now to fig. 72, the staple legs 804 can include at least one barb 889, for example. In at least one embodiment, the barbs 889 can extend around the entire perimeter 805 of the staple legs 804. In various instances, the barbs 889 can include a first surface 889a and a second surface 889b that can extend from the perimeter 805 of the staple legs 804. The first surface 889a may include, for example, a sloped surface, a convex surface, and/or a concave surface. The second surface 889b can comprise, for example, a planar or at least substantially planar surface. In various instances, the first surface 889a and the second surface 889b can converge at, for example, an edge 889 c. In various instances, the edge 889c can be arcuate, for example. Barbs 889 may be formed using any suitable process. For example, barbs 889 may be formed using a stamping process. In at least one embodiment, a shaping mold, for example, can be used to impact the perimeter 805 of the line including the legs 804 in order to disrupt or interfere with sufficient material to form the barbs 889. The wire comprising the legs 804 may be defined by a wire diameter, and the barbs 889 may be defined by a diameter larger than the wire diameter. Accordingly, the line including the legs 804 may be defined by a radius, and the barbs 889 may be defined by a radius greater than the line radius. In various embodiments, barbs 889 can be tapered. In various instances, barb 889 can include a base adjacent perimeter 805 that is thicker than the tip of barb 889.

Referring now to fig. 73, the staple legs 804 can include at least one barb 899, for example. In various instances, the barbs 899 may include prongs. The prongs may include a first surface 899a and a second surface 899b that may extend from the periphery of the legs 804. The first surface 899a may include, for example, a sloped surface, a convex surface, and/or a concave surface. The second surface 899b may include, for example, a flat or at least substantially flat surface. In various instances, the first surface 899a and the second surface 899b can converge at, for example, an edge 899 c. The barbs 899 may be formed using any suitable process. For example, the barbs 899 may be formed using a stamping process. In at least one embodiment, a forming die, for example, may be used to impinge the periphery of the line including the legs 804 so as to disrupt or interfere with sufficient material to form the barbs 899. In various embodiments, the wire comprising the staple may comprise one or more flat sides. In at least one embodiment, the wire may include opposing flat sides 895, for example. In at least one such embodiment, the flat side 895 can be formed as a cylindrical wire. In some cases, the wire may maintain one or more cylindrical surfaces in addition to the flat side 895. In various instances, the barbs may include, for example, any suitable point or burr. In various embodiments, barbs 899 may be tapered. In various instances, the barb 899 can include a base adjacent the periphery of the leg 804 that is thicker than the tip of the barb 899.

In various instances, the legs of the staple may define a staple plane. The base of the staple may or may not be positioned in the staple plane. In either case, one or more barbs extending from the legs and/or the base can extend in the staple plane and/or parallel with respect to the staple plane. In some cases, one or more barbs extending from the legs and/or the base can extend outwardly from the plane of the staple. One or more barbs extending from the legs and/or the base may extend transversely relative to the staple plane. In various instances, the barbs can extend circumferentially around the staple legs. Such barbs may extend in and out of the staple plane. In some cases, the barbs may extend around the entire perimeter of the staple legs. In some cases, the barbs may extend less than 360 degrees around the staple legs. Barbs extending in the plane of the staple can readily control the tissue in the plane of the staple. Barbs extending outwardly from the plane of the staples can facilitate control of tissue beyond the plane of the staples. The staples and/or staple legs can include one or more barbs extending in the plane of the staple and one or more barbs extending outwardly from the plane of the staple.

Referring again to FIG. 62, the barbs extending from the staple legs 804 can be configured to retain the staple legs 804 within tissue. As described above, in some instances, the staple legs 804 can be misshapen and/or unformed by the anvil, and the staple legs 804 can remain within the tissue due to the one or more barbs extending therefrom. In various instances, the barbs can be configured to entrap tissue within the tissue entrapment area of the staple. In some cases, the barbs can be configured to hold tissue against the base 802. In such cases, the barbs may apply a compressive force or pressure to the tissue. As described above in connection with the embodiments shown in fig. 70-73, the barbs may include, for example, sloped, convex, and/or concave top surfaces, such as

surfaces

809a,879a,889a, and/or 899 a. The top surface of the barbs can be configured to facilitate insertion of the staple legs 804 and barbs into and/or through tissue. As also described above in connection with the embodiments shown in fig. 70-73, the barbs may include, for example, flat or at least substantially flat bottom surfaces, such as

surfaces

809b,879b,889b and/or 899 b. The bottom surface of the barbs can be configured to inhibit removal of the barbs and staple legs 804 from tissue. As a result of the above, in some cases, the top surface of the barb may be configured to pierce tissue, while the bottom surface of the barb may be configured to abut tissue. In various instances, the tips 806 of the staple legs 804 can be configured to puncture a hole in tissue, while the staple legs 804 and barbs extending therefrom can be configured to resiliently spread the hole such that the tissue can flow around the barbs and back below the bottom surfaces of the barbs as the staple legs 804 are pushed through the tissue.

In certain embodiments, a first barb may extend from the first leg 804 of the staple and a second barb may extend from the second leg 804 of the staple. In various instances, the first and second barbs can be located at the same, or at least substantially the same, distance between the bases 802. In some cases, the first and second barbs may be positioned at the same, or at least substantially the same, vertical distance from the base 802. As described above, the staple legs 804 can include an array of barbs extending along the length of the staple legs 804. In various embodiments, referring primarily to fig. 62, a staple can include a first leg 804 having a first array of barbs and a second leg 804 having a second array of barbs, wherein the first array of barbs and the second array of barbs can be configured to cooperatively retain the staple within tissue. In various embodiments, the barbs from the first array and the barbs from the second array can comprise a pair of barbs configured to engage tissue at the same vertical distance from, for example, the base 802. In various instances, a staple may include more than one pair of barbs. In some cases, each of the pairs of barbs may be configured to engage tissue at different vertical distances from the base 802. In such cases, the staples may be adapted for use with different tissue thicknesses. For example, when the staple is used to staple thin tissue, one pair of barbs or less than all of the barb pairs may engage the thin tissue. If staples are used to staple thick tissue, however, additional pairs or all pairs of barbs may engage the tissue. In certain embodiments, the barbs extending from the legs 804 can be arranged in a pattern of tissue thickness or a range of tissue thicknesses that are stapled by staples. For example, referring again to fig. 62,

barbs

808 and 809 can be selectively positioned along leg 804 such that they are positioned within and/or adjacent to tissue captured within the staple. In some instances, the portions of the staple legs 804 deformed by or in contact with the anvil may not include barbs extending therefrom. In at least some instances, the array of barbs extending from the inwardly facing sides of the staple legs 804 can be longer than the array of barbs extending from the outwardly facing sides of the staple legs 804. In other instances, the array of barbs extending from the inwardly facing side of the staple legs 804 can be shorter than the array of barbs extending from the outwardly facing side of the staple legs 804. In yet another instance, the array of barbs extending from the inwardly facing side of the staple legs 804 can be as long as the array of barbs extending from the outwardly facing side of the staple legs 804.

As discussed above, if the staple legs 804 are misshapen and/or inadvertently unformed, the barbs extending from the staple legs 804 can help to retain the staples within tissue. However, certain situations are envisioned in which a staple including one or more of the barbs disclosed herein is inserted into tissue and remains intentionally unformed. In any event, a staple including one or more of the barbs disclosed herein can be used to staple thick tissue. More specifically, in some instances, the presence of thick and/or dense tissue between the staple cartridge and the anvil and/or within the staples can prevent the staples from fully forming or closing. For example, the staples may not be fully closed in the B-form configuration, or the staples may not be fully closed. In such cases, the barbs of the unclosed staples may inhibit or prevent tissue from being pulled out of the staples, for example. An array of barbs extending along the length of the staple legs can allow the legs to remain in the tissue regardless of the thickness of the tissue.

Various embodiments are contemplated in which at least one barbed staple, such as barbed staple 800, for example, is removably stored within a staple cartridge, such as staple cartridge 22000 shown in fig. 10-12. Certain embodiments are contemplated in which the staple cartridge includes only barbed staples, while other embodiments are contemplated in which barbed and unbarbed staples are used. For example, a first row of staples can comprise barbed staples, while a second row of staples can comprise unbarbed staples. In some cases, staples stored within a staple cartridge can have the same or substantially the same unformed height. With reference at least to a U-shaped and/or V-shaped staple, for example, the unformed height of the staple may be defined as the vertical distance between the bottom of the base of the staple and the tips of the legs of the staple. Such measurements may be taken before the staples are inserted into the staple cartridge, while the staples are removably stored within the staple cartridge, and/or before the staples are deformed against the anvil. In some cases, barbed staples disposed in a first row in the staple cartridge may have a first unformed height, and barbed staples disposed in a second row in the staple cartridge may have a second unformed height. The barbed staples in the third row in the staple cartridge may have a first unformed height, a second unformed height, or a third unformed height. The barbed staples of the first, second, and/or third rows may be positioned on the same side of a knife slot or on opposite sides of a knife slot defined in the staple cartridge. In use, barbed staples removably stored in the staple cartridge may be formed to the same formed height or to different formed heights. The formed height of a staple can be defined as the total vertical distance of the staple after it has been deformed against the anvil. With reference at least to staples that have been deformed into the B-form, for example, the formed height of the staple can be measured between the bottom of the base of the staple and the uppermost portion of the legs of the staple. In some cases, barbed staples disposed in a first row in the staple cartridge may be deformed to a first formed height, and barbed staples disposed in a second row in the staple cartridge may be deformed to a second formed height. The barbed staples in the third row in the staple cartridge may have a first formed height, a second formed height, or a third formed height. The barbed staples of the first, second, and/or third rows may be positioned on the same side of a knife slot defined in the staple cartridge or on opposite sides of the staple cartridge. As the reader will appreciate, the staples shown in fig. 10-12 have been deformed to different formed heights. Barbed staples 800 may be used, for example, in staple cartridges and/or stapling instruments that form rows of staples having different formed heights. The first row of barbed staples 800 may be deformed to a first formed height and the second row of barbed staples 800 may be deformed to a second formed height. In various circumstances, the third row of barbed staples 800 may be deformed to a third formed height. In some cases, barbed staples 800 that deform to different heights may begin at the same or substantially the same unformed height. In some cases, barbed staples 800 that deform to different formed heights may begin at different unformed heights. Various configurations can be used to form the staples to different formed heights. For example, the movable drivers that support the staples can support the staples at different distances relative to the anvil. In some cases, the anvil can include staple forming pockets having different depths. In various instances, the staple drivers can include a cradle configured to support the base of the staples and push the staples upward toward forming pockets defined in the anvil. The formed height of the staples can be determined by the distance between the bottom surface of the stand and the top surface of the forming pocket. U.S. patent 8,317,070 entitled "SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS," published on 11, 27/2012, is incorporated by reference in its entirety. In some instances, the deck of the staple cartridge can include a stepped surface, as shown in FIG. 1. The staple cavities of the first row may be defined in a first step and the staple cavities of the second row may be defined in a second step, wherein the first and second steps may be vertically offset from each other. For example, the first step may be positioned vertically above the anvil or closer to the anvil than the second step. In some cases, the wall may be positioned between the first step and the second step. In some cases, the deck of the staple cartridge can include a first step, a second step positioned vertically above the first step, and a third step positioned vertically above the second step. Various embodiments are contemplated wherein the deck of the staple cartridge comprises any suitable number of steps and any suitable number of walls between the steps. For example, a first row of staple cavities may be defined in a first step, a second row of staple cavities may be defined in a second step, and/or a third row of staple cavities may be defined in a third step. For example, a first row of staple cavities may comprise staples having a first unformed height, a second row of staple cavities may comprise staples having a second unformed height, and/or a third row of staple cavities may comprise staples having a third unformed height. Various embodiments are contemplated wherein the staple cartridge includes any suitable number of staple rows having different unformed heights. For example, staples in a first row of staple cavities can be deformed to a first formed height, staples in a second row of staple cavities can be deformed to a second formed height, and/or a third row of staple cavities can be deformed to a third formed height. Various embodiments are contemplated wherein the staple cartridge comprises any suitable number of rows of staples that are deformed to different formed heights. In addition to or instead of having different formed staple heights, the end effector of the stapling instrument can have different tissue gaps. For example, referring generally to fig. 10 and 11, a gap can be defined between the cartridge deck surface 22011 of the staple cartridge and the anvil tissue compression surface 10063 of the anvil. The gap may be configured to receive tissue T. The gap may also be configured to receive a tissue thickness compensator; however, barbed staples may or may not be used with a tissue thickness compensator, and the discussion provided with respect to barbed staples may be applicable in either case. In any event, the reader will appreciate that the anvil tissue compression surface 10063 is stepped. The anvil tissue compression surface 10063 comprises a first portion positioned vertically above a second portion. When the anvil and staple cartridge of the end effector are in a closed state, as shown in fig. 11, a first gap distance is defined between an outer portion of the anvil tissue compression surface 10063 and the cartridge deck surface 22011 and a second, different gap distance is defined between an inner portion of the anvil tissue compression surface 10063 and the cartridge deck surface 22011. The first gap distance is shown as being greater than the second gap distance, but it is possible that the first gap distance is shorter than the second gap distance. Tissue compressed between the anvil and the staple cartridge at a shorter gap distance may be more compressed than tissue at a larger gap distance. For example, the barbs of barbed staple 800 may engage tissue differently depending on whether the tissue is positioned in a shorter tissue gap or a larger tissue gap. More specifically, tissue compressed within a shorter tissue gap may seek more re-expansion after it is released from the end effector than tissue compressed within a larger tissue gap, and the barbs of the barbed staples may inhibit or resist such re-expansion, depending on their configuration and/or location on the barbs. In other cases, the barbs may be configured and/or positioned so as not to inhibit or resist re-deployment of tissue. As the reader will appreciate, the anvil tissue compression surface 10063 is stepped and the cartridge deck surface is flat, or at least substantially flat, and thus, the difference in tissue gap defined within the end effector varies with the height of the stepped anvil surface. Other embodiments are contemplated. For example, the anvil tissue compression surface may be flat or at least substantially flat, and the cartridge deck surface may be stepped. In other cases, both the anvil tissue compression surface and the cartridge deck surface may be stepped. In any event, different gap distances can be defined between the anvil tissue compression surface and the cartridge deck surface. Although two gap distances have been shown in fig. 10 and 11, more than two gap distances are possible, such as three gap distances. Referring to fig. 10 and 11, a first longitudinal row of forming pockets can be disposed within a first portion of the end effector having a first tissue gap distance, and a second longitudinal row of forming pockets can be disposed within a second portion of the end effector having a second tissue gap distance that is different than the first tissue gap distance. In some cases, the end effector can include a third longitudinal row of forming pockets disposed within a third portion of the end effector having a third tissue gap distance that is different from the first and second tissue gap distances. In some cases, the end effector can include a third longitudinal row of forming pockets disposed within a third portion of the end effector having a tissue gap distance that is the same as the first tissue gap distance or the second tissue gap distance. The reader will appreciate that the end effectors may have different tissue gap distances and/or different formed staple heights. The end effector may have one, the other, or both. In some cases, shorter formed staple heights can be associated with shorter tissue gap distances, while larger formed staple heights can be associated with larger tissue gap distances. In other instances, shorter formed staple heights can be associated with larger tissue gap distances, while larger formed staple heights can be associated with shorter tissue gap distances. Further to the above, the staple may have a U-shaped configuration in its unformed state. The U-shaped staple may comprise a base and two staple legs extending from the base, wherein the staple legs extend to each other in parallel directions. As further described above, the staple may include a V-shaped configuration in its unformed state. The V-shaped configuration can include a base and two legs extending from the base, wherein the legs extend in non-parallel directions.

Various embodiments described herein are described in the context of a linear end effector and/or linear fastener cartridge. Such embodiments and their teachings can be applied to non-linear end effectors and/or non-linear fastener cartridges, such as rounded and/or contoured end effectors. For example, various end effectors, including non-linear end effectors, are disclosed in U.S. patent application serial No. 13/036,647 entitled "SURGICAL STAPLING INSTRUMENT" (now U.S. patent application publication 2011/0226837), filed on 28.2.2011, which is hereby incorporated by reference in its entirety. Additionally, U.S. patent application serial No. 12/893,461 (now U.S. patent application publication 2012/0074198), entitled "STAPLE CARTRIDGE," filed on 9/29/2012, is hereby incorporated by reference in its entirety. U.S. patent application serial No. 12/031,873 (now U.S. patent 7,980,443), entitled "END effects FOR a minor CUTTING AND STAPLING INSTRUMENT," filed on 15.2.2008, is also hereby incorporated by reference in its entirety. The entire disclosure of U.S. patent 7,845,537 entitled "SURGICAL INSTRUMENTS HAVING RECORDING CAPABILITIES", published 12, 7.2010, is incorporated herein by reference. The entire disclosure of U.S. application serial No. 13/118,241 (now U.S. patent application publication 2012/0298719), entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," filed 5/27/2011 is incorporated herein by reference.

The devices disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the device may be reconditioned for reuse after at least one use. The reconditioning may include any combination of the following steps: disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, the device may be disassembled, and any number of the particular pieces or parts may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular parts, the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting reconditioned device are all within the scope of the present invention.

Preferably, the invention described herein will be treated before surgery. First, a new or used instrument is obtained and cleaned as needed. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK 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. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container keeps the instrument sterile until the container is opened in a medical facility.

Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein is only incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

While this invention has been described as having an exemplary design, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

Claims

1. An end effector for fastening tissue, comprising:

a cartridge comprising a longitudinal row of staple cavities;

a plurality of staples removably stored in said staple cavities, wherein each said staple comprises:

a base;

a pair of legs extending from the base; and

a plane formed by the pair of legs, wherein at least one of the legs comprises at least two barbs, each of the barbs extending 360 degrees circumferentially around the leg and beyond the plane formed by the leg such that each of the barbs extends within and outward from the plane formed by the leg, and wherein each of the legs comprises a tip configured to pierce tissue;

an anvil configured to deform the staples;

a plurality of staple drivers movable within said lumen, said plurality of staple drivers configured to lift said staples toward said anvil; and

a firing member configured to lift the staple driver system toward the anvil, wherein the firing member comprises a first portion configured to engage the anvil and a second portion configured to engage the cartridge, and wherein the firing member is configured to relatively position the anvil and the cartridge,

wherein each said barb comprises a first surface and a second surface extending from and around a portion of the perimeter of a staple leg and extending beyond the plane formed by the staple leg, wherein the first plane and the second plane converge at an arcuate edge, and

wherein the first surface of one barb of the at least two barbs converges with the second surface of an adjacent barb of the at least two barbs.

2. The end effector of claim 1, wherein said firing member comprises a knife edge.

3. The end effector of claim 1, wherein said firing member comprises at least one ramped surface configured to lift said driver toward said anvil.

4. The end effector of claim 1, wherein tips of the staple legs are flush with or recessed below a deck of a cartridge body of the cartridge when the staples are in their unfired or un-lifted positions.

5. The end effector of claim 1, wherein said base includes at least one barb extending therefrom.

6. The end effector of claim 5, wherein the barbs extending from the base extend transversely relative to a plane formed by the staple legs.