Methods for altering implantable layers for use with surgical fastening instruments
Abstract
A staple cartridge is disclosed which includes a cartridge body, a plurality of staples removably stored, at least partially, within the cartridge body, and an implantable layer. The implantable layer can include a first portion, a second portion spaced apart from the first portion, and a third portion intermediate the first portion and the second portion, the third portion including a pressed region.
Term
8.4 yearsto projected expiry
Projected expiry 24 February 2035, counted from filing; an application has no term until it is granted.
- Priority
- Filed
- Published
- Today
- Projected expiry
13 claims: 7 independent, 6 dependent
- 1Patent claims Zastrzeżenia patentowe 1. A method of changing a tissue thickness compensator (1104, 1120, 1140, 1150, 1190, 1200), the method comprising the steps of:1. Sposób zmiany kompensatora grubości tkanki (1104, 1120, 1140, 1150, 1190, 1200), który to sposób obejmuje etapy: obtaining a biocompatible polymer including a glass transition temperature and a melting point;uzyskanie biokompatybilnego polimeru obejmującego temperaturę zeszklenia i temperaturę topnienia;dissolving said biocompatible polymer in a solvent to form a solution;and lyophilizing said solution to obtain a tissue thickness compensator (1104, 1120, 1140, 1150, 1190, 1200) having a thickness and including a tissue contact surface (1114) and a plaque contact surface, said tissue contact surface (1114) and said plate-engaging surface are opposed to each other and separated by said thickness, said tissue thickness compensator (1104, 1120, 1140, 1150, 1190, 1200) is compressible in the thickness direction to compensate for the thickness of the tissue captured in staples disposed from a surgical staple cartridge (1102) wherein at least one of said surfaces (1114, 1142, 1166) is at least partially made of a material with a glass transition temperature and melting point;rozpuszczanie wymienionego biokompatybilnego polimeru w rozpuszczalniku z wytworzeniem roztworu;i liofilizację wspomnianego roztworu w celu uzyskania kompensatora grubości tkanki (1104,1120, 1140, 1150, 1190, 1200) mającego grubość i zawierającego powierzchnię (1114) stykającą się z tkanką i powierzchnię stykającą się z płytką, przy czym wspomniana powierzchnia stykająca się z tkanką (1114) i wspomniana powierzchnia stykająca się z płytką są przeciwne do siebie i oddzielone wspomnianą grubością, przy czym wspomniany kompensator grubości tkanki (1104, 1120, 1140, 1150, 1190, 1200) jest ściśliwy w kierunku grubości, aby skompensować grubość tkanki uchwyconą w zszywkach rozmieszczonych z chirurgicznego wkładu zszywek (1102), w którym co najmniej jedna z wymienionych powierzchni (1114, 1142, 1166) jest co najmniej częściowo wykonana z materiału o temperaturze zeszklenia i temperaturze topnienia;heating said surface (1114, 1142, 1166) to a temperature higher than said glass transition temperature and lower than said melting point;ogrzewanie wspomnianej powierzchni (1114, 1142, 1166) do temperatury wyższej niż wspomniana temperatura zeszklenia i niższej niż wspomniana temperatura topnienia;manipulating said surface (1114, 1142, 1166);manipulowanie wspomnianą powierzchnią (1114, 1142, 1166);allowing said manipulated surface (1114, 1142, 1166, 1198) to cool below said glass transition temperature;and releasing said surface (1114,1142, 1166,1198). pozostawienie wspomnianej manipulowanej powierzchni (1114, 1142, 1166, 1198) do schłodzenia poniżej wspomnianej temperatury zeszklenia;i uwalnianie wspomnianej powierzchni (1114,1142, 1166,1198).
- 4The method according to p. 1, further comprising the step of actively cooling said manipulated surface (1114, 1142, 1166) below said glass transition temperature. 4. Sposób według zastrz. 1, obejmujący dodatkowo etap aktywnego chłodzenia wspomnianej manipulowanej powierzchni (1114, 1142, 1166) poniżej wspomnianej temperatury zeszklenia.
- 8The method according to p. The apparatus of 7, wherein said plurality of projections (1156) are arranged in rows. 8. Sposób według zastrz. 7, w którym wspomniane wiele występów (1156) jest rozmieszczonych w rzędach.
- 9The method according to p. Wherein said plurality of projections (1156) include a plurality of pins (1156), wherein said space creator comprises a surface (1164), and wherein each of said plurality of pins (1156) extends from said surface (1164) parallel to each other. 9. Sposób według zastrz. 7, w którym wspomniane wiele występów (1156) zawiera wiele kołków (1156), w których wspomniany kreator przestrzeni zawiera powierzchnię (1164), i w której każdy ze wspomnianych wielu kołków (1156) rozciąga się od wspomnianej powierzchni (1164) równolegle do siebie.
- 11The method according to p. 5, further comprising the step of actively cooling said biocompatible foam to below said glass transition temperature. 11. Sposób według zastrz. 5, obejmujący dodatkowo etap aktywnego chłodzenia wspomnianej biokompatybilnej pianki do powrotu poniżej wspomnianej temperatury zeszklenia. Ethicon LLC, Portoryko Ethicon LLC, Puerto Rico Pełnomocnik:Proxy: ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 G. G. ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 ΕΡ2 910 198 Bl ΕΡ2 910 198 Bl Z-16380/17 Z-16380/17 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 4/39 4/39 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Ζ-16380/17 Ζ-16380/17 20232α ^ 20260 20232α^20260 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 22090 22090 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 22090 22090 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 22090 22090 ΕΡ2 910 198 Bl ΕΡ2 910 198 Bl Z-16380/17 Z-16380/17 1 0/39 1 0/39 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Ζ-16380/17 Ζ-16380/17 1 1 /39 1 1 /39 CN CN ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17
- 1212/39 12/39 1000 1000 ΕΡ 2 910 198 BI ΕΡ 2 910 198 BI Ζ-16380/17 Ζ-16380/17
- 131 3/39 1 3/39 FIG. 18 FIG. 18 ΕΡ2 910 198 Bl ΕΡ2 910 198 Bl Z-16380/17 Z-16380/17 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 1 5/39 1 5/39 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 100 100 ΕΡ 2 910 198 BI ΕΡ 2 910 198 BI Ζ-16380/17 Ζ-16380/17 101 101 1 7/39 1 7/39 FIG. 25 FIG. 25 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Ζ-16380/17 Ζ-16380/17 102 102 EP 2 910 198 B1 EP 2 910 198 BI Z-16380/17 Z-16380/17 103 103 ΕΡ2 910 198 Bl ΕΡ2 910 198 Bl Z-16380/17 Z-16380/17 104 104 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 105 105 -1176 -1176 1180 1180 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 106 106 (spring stiffness) compression force (sztywność sprężyny) siła sprężania EP 2 910 198 B1 EP 2 910 198 BI Z-16380/17 Z-16380/17 107 107 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Ζ-16380/17 Ζ-16380/17 108 108 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 109 109 25/39 25/39 FIG. 47 FIG. 47 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 200 200 ΕΡ2 910 198 BI ΕΡ2 910 198 BI 111 111 Z-16380/17 Z-16380/17 200 200 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Ζ-16380/17 Ζ-16380/17 112 112 200 200 G. 50 G. 50 ΕΡ 2 910 198 BI ΕΡ 2 910 198 BI Ζ-16380/17 Ζ-16380/17 113 113 EP 2 910 198 B1 EP 2 910 198 BI Z-16380/17 Z-16380/17 114 114 30/39 30/39 ΕΡ2 910 198 Bl ΕΡ2 910 198 Bl Z-16380/17 Z-16380/17 115 115 EP 2 910 198 B1 EP 2 910 198 BI Z-16380/17 Z-16380/17 116 116 32/39 32/39 FIG. 57 FIG. 57 FIG. 58 FIG. 58 ΕΡ2 910 198 BI ΕΡ2 910 198 BI 117 117 Z-16380/17 Z-16380/17 33/39 33/39 FIG. 60 FIG. 60 FIG. 59 FIG. 59 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 118 118 34/39 34/39 FIG. 61 FIG. 61 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 119 119 800 800 ΕΡ2 910 198 BI ΕΡ2 910 198 BI Z-16380/17 Z-16380/17 908 ^908 ^908 ^908 908 ^908 ^908 ^908 ΕΡ2 910 198 BI ΕΡ2 910 198 BI 121 121 Z-16380/17 Z-16380/17 FIG. 68 FIG. 68 EP 2 910 198 B1 EP 2 910 198 BI Z-16380/17 Z-16380/17 122 122 EP 2 910 198 B1 EP 2 910 198 BI Z-16380/17 Z-16380/17 123 123
Independent claims7
347 paragraphs in 4 sections, as filed
Description
BACKGROUND
[0001] The present invention relates to methods of varying the thickness of an compensator tissue as defined in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0002] The features and advantages of the present invention, and how to achieve them, will be 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 figures, in which:
FIG. 1 is a left front perspective view of a surgical stapling and cut-off instrument with a handle portion;
FIG. 2 is a perspective view of the two-piece knife and e-beam ("E-beam) of the surgical stapling and severing instrument of FIG. 1;
FIG. 3 is a perspective view of the wedge slide of the staple cartridge of the staple application unit;
FIG. 4 is a longitudinal cross-sectional view of the anvil in a closed position and a staple cartridge including a rigid support portion and a compressible tissue thickness compensator, illustrated by staples displaced from the unfired position to the fired position during the first sequence;
FIG. 5 is another cross-sectional view of the anvil and the staple cartridge of FIG. 4 illustrating the anvil in the open position upon completion of the firing sequence;
FIG. 6 is an exploded perspective view of the tissue thickness compensator and the staple cartridge assembly;
FIG. 7 is a partial cross-sectional view of the staple cartridge assembly of FIG. 6 illustrating unexpected staples inserted into the staple recesses 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, illustrating fired staples ejected from the staple recesses of the staple cartridge body and formed relative to the anvil, and further illustrating a tissue thickness compensator and tissue gripped in the staple retention area of the formed staple;
FIG. 9 is a partial perspective view of the surgical stapling instrument gripper illustrated with some portions removed and other portions illustrated in cross section; in addition, the gripper cutting member is shown in a partially extended position;
FIG. 10 is a partial cross-sectional view of the gripper of FIG. 9, illustrated with the patient's tissue gripped between the anvil and the gripper tissue thickness compensator; furthermore, the staples removably stored in the body of the gripper cartridge are illustrated in an unfired position and the gripper cutting member is shown in an unfolded position which is proximate the tissue thickness compensator;
FIG. 11 is a partial cross-sectional view of the gripper of FIG. 9, illustrated with the staples in the deployed position and the cutting member in a partially extended position in which the patient's tissue has been at least partially cut across;
FIG. 12 is a partial cross-sectional view of the gripper of FIG. 9, illustrated with the staples in the deployed position and the cutting member in the extended position, wherein at least a portion of the tissue thickness compensator has been cut across by the cutting member;
FIG. 13 is a perspective view of a fastening element insert including a tissue thickness compensator;
FIG. 14 is a cross-sectional view of the tissue thickness compensator of FIG. 13 illustrating a cutting member positioned relative to the proximal end of the tissue thickness compensator. FIG. 15 is an exploded view of the tissue thickness compensator assembly;
FIG. 16 is a perspective view of a layer of tissue thickness compensator assembly;
FIG. 17 is a cross-sectional view of the tissue thickness compensator assembly of FIG. 15;
FIG. 18 is a cross-sectional perspective view of the assembled tissue thickness compensator assembly and mold for assembly thereof;
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 mounting it;
FIG. 21 is a perspective view of a tissue thickness compensator assembly and a mold for mounting thereof;
FIG. 22 is a perspective cross-sectional view of the tissue thickness compensator assembly of FIG. 21 and the mold of FIG. 21 for their assembly;
FIG. 23 is a perspective view of a gripper including a tissue thickness compensator; FIG. 24 is a perspective view of the gripper and tissue thickness compensator of FIG. 23 and a modifying member that modifies the tissue thickness compensator;
FIG. 25 is a perspective view of the gripper of FIG. 23 including the modified tissue thickness compensator of FIG. 24;
FIG. 26 is a perspective cross-sectional view of a tissue thickness compensator;
FIG. 27 is a perspective cross-sectional view of a mold for modifying the tissue thickness compensator of FIG. 26;
FIG. 28 is a perspective cross-sectional view of the tissue thickness compensator of FIG. 26 after being modified by the mold of FIG. 27;
FIG. 29 is a perspective cross-sectional view of a tissue thickness compensator;
FIG. 30 is a perspective cross-sectional view of a mold for modifying the tissue thickness compensator of FIG. 29;
FIG. 31 is a perspective cross-sectional view of the tissue thickness compensator of FIG. 29 after modification with the mold of FIG. thirty;
FIG. 32 is a perspective cross-sectional view of a tissue thickness compensator;
FIG. 33 is a perspective cross-sectional view of the mold for modifying the tissue thickness compensator of FIG. 32;
FIG. 34 is a perspective cross-sectional view of the tissue thickness compensator of FIG. 32 after modification with the mold of FIG. 33;
FIG. 35 is a perspective cross-sectional view of a tissue thickness compensator including a first height;
FIG. 36 is a perspective cross-sectional view of the tissue thickness compensator of FIG. After modified to change the first height to the second height;
FIG. 37 is a perspective cross-sectional view of the mold for modifying the tissue thickness compensator of FIG. 35;
FIG. 38 is a perspective cross-sectional view of a tissue thickness compensator;
FIG. 39 is a perspective cross-sectional view of the tissue thickness compensator of FIG. 38 after modification;
FIG. 40 is a graph illustrating the effect of compressive forces on specific deflection of the tissue thickness compensator spring;
FIG. 41 is a perspective cross-sectional view of a tissue thickness compensator;
FIG. 42 is a perspective cross-sectional view of the space wizard for modifying the tissue thickness compensator of FIG. 41;
FIG. 43 is a perspective cross-sectional view of the tissue thickness copensator of FIG. 41 after being modified by the space wizard of FIG. 42;
FIG. 44 is a partial cross-sectional view of a fastening element cartridge for use with a surgical instrument including a firing member according to at least one embodiment illustrated with parts removed;
FIG. 45 is a partial cross-sectional elevational view showing the tissue thickness compensator of the fastener insert of FIG. 44 removed from the fastening element cartridge and firing member of FIG. 44, shown locked; FIG. 46 is a fragmentary perspective view of the tissue thickness compensator of FIG. 45; FIG. 47 is a fragmentary perspective view of a tissue thickness compensator in accordance with at least one embodiment;
FIG. 48 is a partial cross-sectional view of a surgical instrument gripper including a fastening element insert including the tissue thickness compensator of FIG. 47, a sled and a firing member supported by a sled illustrated with parts removed; FIG. 49 is a partial cross-sectional view of the gripper of FIG. 48 illustrating the launch member in a partial firing position;
FIG. 50 is a partial cross-sectional view of the gripper of FIG. 48 illustrating the tissue thickness compensator removed from the fastening element cartridge and the firing member in a locked state;
FIG. 51 is a fragmentary perspective view of an insert of fasteners according to at least one embodiment illustrated with parts removed;
FIG. 52 is a perspective view of the slide of the fastener cartridge of FIG. 51;
FIG. 53 is a fragmentary perspective view of the fastener cartridge of FIG. 51;
FIG. 54 is an elevation view of a sled in accordance with at least one embodiment;
FIG. 55 is a perspective view of a sled according to at least one embodiment illustrated in an unlocked configuration;
FIG. 56 is a perspective view of the sled of FIG. 55 shown in a locked configuration;
FIG. 57 is a partial cross-sectional view of the sled of FIG. 55 cartridge insertion means illustrating the sled in its unlocked configuration, a firing member supported by the sled, and a tissue thickness compensator of the fastening element insert coupled to the sled;
FIG. 58 is a partial cross-sectional view of the tissue thickness compensator of FIG. 57 of the removed fasteners of FIG. 57, which placed 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 view of a sled positioned at the proximal end of a fixture cartridge according to at least one embodiment illustrated with parts removed;
FIG. 60 is a partial cross-sectional view of the sled of FIG. 59 of fastening elements illustrated at the distal end of the cartridge;
FIG. 61 is a perspective view of a sled in accordance with at least one embodiment;
FIG. 62 is a diagram illustrating a staple including a plurality of barbs according to at least one embodiment wherein the staple is shown in a non-formed formation and a deformed formation;
FIG. 63 is an elevation view of a staple including a plurality of barbs according to at least one embodiment, wherein the staple is positioned within the staple cavity in the non-fired position;
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 elevation view of a staple including a plurality of barbs according to at least one embodiment wherein the staple is positioned within the staple cavity in an unfired position;
FIG. 69 is an elevational view of the staple and the staple bay of FIG. 68;
FIG. 70 is a partial perspective view of a leg of a barbed staple in accordance with at least one embodiment;
FIG. 71 is a fragmentary perspective view of a staple leg with the barbed staple of FIG. 68;
FIG. 71A is a cross-sectional view of the staple of FIG. 71;
FIG. 72 is a fragmentary perspective view of a leg of a barbed staple in accordance with at least one embodiment; and
FIG. 73 is a partial perspective view of a leg of a barbed staple in accordance with at least one embodiment.
DETAILED DESCRIPTION
[0003] The applicant of the present application also has the related United States patent applications indicated below:
United States Patent Application Serial No. 12 / 894,311 entitled SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT ODCINEKS; now United States Patent Publication No. 2012/0080496;
United States Patent Application Serial No. 12 / 894,340, entitled SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS; now United States Patent Publication No. 2012/0080482;
United States Patent Application Serial No. 12 / 894,327, entitled JAW
CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS; now US patent publication
2012/0080499;
United States Patent Application Serial No. 12 / 894,351, entitled SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS; now United States Patent Publication No. 2012/0080502;
United States Patent Application Serial No. 12 / 894,338 entitled IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT; now United States Patent Publication No. 2012/0080481;
United States Patent Application Serial No. 12 / 894,369, entitled IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER; now United States Patent Publication No. 2012/0080344;
United States Patent Application Serial No. 12 / 894,312 entitled IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS; now United States Patent Publication No. 2012/0080479;
United States Patent Application Serial No. 12 / 894,377 entitled SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE; now US Patent No. 8,393,514;
United States Patent Application Serial No. 12 / 894,339, entitled SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL ARRANGEMENT; now United States Patent Publication No. 2012/0080500;
United States Patent Application Serial No. 12 / 894,360, entitled SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM; now United States Patent Publication No. 2012/0080484;
United States Patent Application Serial No. 12 / 894,322, entitled SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS; now United States Patent Publication No. 2012/0080501;
United States Patent Application Serial No. 12 / 894,350, entitled SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES; now United States Patent Publication No. 2012/0080478;
United States Patent Application Serial No. 12 / 894,383 entitled IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS; now United States Patent Publication No. 2012/0080345;
United States Patent Application Serial No. 12 / 894,389, entitled COMPRESSIBLE FASTENER CARTRIDGE; now United States Patent Publication No. 2012/0080335;
United States Patent Application Serial No. 12 / 894,345, entitled FASTENERS
SUPPORTED BY A FASTENER CARTRIDGE SUPPORT; now US patent publication
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United States Patent Application Serial No. 12 / 894,306 entitled COLLAPSIBLE FASTENER CARTRIDGE; now United States Patent Publication No. 2012/0080332;
United States Patent Application Serial No. 12 / 894,318 entitled FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTION MATRIX MEMBERS; now United States Patent Publication No. 2012/0080480;
United States Patent Application Serial No. 12 / 894,330, entitled FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX; now United States Patent Publication No. 2012/0080503;
United States Patent Application Serial No. 12 / 894,361 entitled FASTENER SYSTEM COMPRISING A RETENTION MATRIX; now US Patent No. 8,529,600;
United States Patent Application Serial No. 12 / 894,367, entitled FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION MATRIX; now United States Patent Publication No. 2012/0080485;
United States Patent Application Serial No. 12 / 894,388, entitled FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER; now US Patent No. 8,474,677;
United States Patent Application Serial No. 12 / 894,376, entitled FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES; now United States Patent Publication No. 2012/0080486;
United States Patent Application Serial No. 13 / 097,865 entitled SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS; now United States Patent Publication No. 2012/0080488;
United States Patent Application Serial No. 13 / 097,936, entitled TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER; now United States Patent Publication No. 2012/0080339;
United States Patent Application Serial No. 13 / 097,954 entitled STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION; now United States Patent Publication No. 2012/0080340;
United States Patent Application Serial No. 13 / 097,856, entitled STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE PORTION THEREOF; now United States Patent Publication No. 2012/0080336;
United States Patent Application Serial No. 13 / 097,928, entitled TISSUE
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United States Patent Application Serial No. 13 / 097,891, entitled TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN ADJUSTABLE ANVIL; now United States Patent Publication No. 2012/0080489;
United States Patent Application Serial No. 13 / 097,948 entitled STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION; now United States Patent Publication No. 2012/0083836;
United States Patent Application Serial No. 13 / 097,907 entitled COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY; now United States Patent Publication No. 2012/0080338;
United States Patent Application Serial No. 13 / 097,861 entitled TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERTIES; now United States Patent Publication No. 2012/0080337;
United States Patent Application Serial No. 13 / 097,869, entitled STAPLE CARTRIDGE LOADING ASSEMBLY; now US Patent Publication No. 2012/0160721;
United States Patent Application Serial No. 13 / 097,917 entitled COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS; now United States Patent Publication No. 2012/0083834;
United States Patent Application Serial No. 13 / 097,873 entitled STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION; now United States Patent Publication No. 2012/0083833;
United States Patent Application Serial No. 13 / 097,938 entitled STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS; now United States Patent Publication No. 2012/0080491;
United States Patent Application Serial No. 13 / 097,924 entitled STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR; now United States Patent Publication No. 2012/0083835;
United States Patent Application Serial No. 13 / 242,029 entitled SURGICAL STAPLER WITH FLOATING ANVIL; now United States Patent Publication No. 2012/0080493;
United States Patent Application Serial No. 13 / 242,066, entitled CURVED END EFFECTOR FOR A STAPLING INSTRUMENT; now United States Patent Publication No. 2012/0080498;
United States Patent Application Serial No. 13 / 242,086, entitled STAPLE
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United States Patent Application Serial No. 13 / 241,912 entitled STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT; now United States Patent Publication No. 2013/0075448;
United States Patent Application Serial No. 13 / 241,922 entitled SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS; now United States Patent Publication No. 2013/0075449;
United States Patent Application Serial No. 13 / 241,637, entitled SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FORGENERATING MULTIPLE ACTUATION MOTIONS; now United States Patent Publication No. 2012/0074201;
United States Patent Application Serial No. 13 / 241,629, entitled SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR; now United States Patent Publication No. 2012/0074200;
United States Application Serial No. 13 / 433,096 entitled TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES; now United States Patent Publication No. 2012/0241496;
United States Application Serial No. 13 / 433,103 entitled TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS; now United States Patent Publication No. 2012/0241498;
United States Application Serial No. 13 / 433,098 entitled EXPANDABLE TISSUE THICKNESS COMPENSATOR; now United States Patent Publication No. 2012/0241491; United States Application Serial No. 13 / 433,102, entitled TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR; now US Patent Publication No. 2012/0241497;
United States Application Serial No. 13 / 433,114 entitled RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR; now United States Patent Publication No. 2012/0241499;
United States Application Serial No. 13 / 433,136 entitled TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONE MEDICAMENT; now United States Patent Publication No. 2012/0241492;
United States Application Serial No. 13 / 433,141 entitled TISSUE THICKNESS
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United States Application Serial No. 13 / 433,144, entitled TISSUE THICKNESS
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United States Application Serial No. 13 / 433,148 entitled TISSUE THICKNESS
COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD; now US Patent Publication No. 2012/0241501;
United States Application Serial No. 13 / 433,155 entitled TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS; now US Patent Publication No. 2012/0241502;
United States Application Serial No. 13 / 433,163 entitled METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS; now United States Patent Publication No. 2012/0248169;
United States Application Serial No. 13 / 433,167 entitled TISSUE THICKNESS COMPENSATORS; now United States Patent Publication No. 2012/0241503;
United States Application Serial No. 13 / 433,175, entitled LAYERED TISSUE THICKNESS COMPENSATOR; now United States Patent Publication No. 2012/0253298; United States Application Serial No. 13 / 433,179 entitled TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS; now United States Patent Publication No. 2012/0241505;
United States Application Serial No. 13 / 763,028 entitled ADHESIVE FILM LAMINATE; now US Patent Publication No. 2013/0146643;
United States Application Serial No. 13 / 433,115, entitled TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING A LOW PRESSURE ENVIRONMENT; now US Patent Publication No. 2013/0256372;
United States Application Serial No. 13 / 433,118, entitled TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS; now United States Patent Publication No. 2013/0256365;
United States Application Serial No. 13 / 433,135, entitled MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR; now US Patent Publication No. 2013/0256382;
United States Application Serial No. 13 / 433,140, entitled TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME; now United States Patent Publication No. 2013/0256368;
United States Application Serial No. 13 / 433,129, entitled TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS; now US Patent Publication No. 2013/0256367;
United States Application Serial No. 11 / 216,562, entitled STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS, now US Patent No. 7,669,746;
United States Application Serial No. 11 / 714,049, entitled SURGICAL STAPLING
DEVICE WITH ANVIL HAVING STAPLE FORMING POCKETS OF VARYING DEPTHS, now US Patent Publication No. 2007/0194082;
United States Application Serial No. 11 / 711,979, entitled SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS, now US Patent No. 8,317,070;
United States Application Serial No. 11 / 711,975, entitled SURGICAL STAPLING DEVICE WITH STAPLE DRIVERS OF DIFFERENT HEIGHT, now US Patent Publication No. 2007/0194079;
US Application Serial No. 11 / 711,977, entitled SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTS MULTIPLE WIRE DIAMETER STAPLES, now US Patent No. 7,673,781;
United States Application Serial No. 11 / 712,315 entitled SURGICAL STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR WEDGE CAMS FOR DRIVING STAPLE DRIVERS, now US Patent No. 7,500,979;
United States Application Serial No. 12 / 038,939, entitled STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS, now US Patent No. 7,934,630;
United States Application Serial No. 13 / 020,263 entitled SURGICAL STAPLING SYSTEMS THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS, now US Patent Publication No. 2011/0147434;
United States Application Serial No. 13 / 118,278, entitled ROBOTICALLYCONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS, now US Patent Publication No. 2011/0290851;
United States Application Serial No. 13 / 369,629, entitled ROBOTICALLYCONTROLLED CABLE-BASED SURGICAL END EFFECTORS, now US Patent Publication No. 2012/0138660;
United States Application Serial No. 12 / 695,359, entitled SURGICAL STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENT FORMED HEIGHTS, now US Patent No. 8,464,923;
United States Application Serial No. 13 / 072,923, entitled STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS, now US Patent No. 8,567,656;
United States Application Serial No. 13 / 766,325, entitled LAYER OF MATERIAL FOR A SURGICAL END EFFECTOR; now US Patent Publication No. 2013/0256380;
United States Application Serial No. 13 / 763,078 entitled ANVIL LAYER
ATTACHED TO A PROXIMAL END OF AN END EFFECTOR; now US patent publication
No. 2013/0256383;
United States Application Serial No. 13 / 763,094 entitled LAYER COMPRISING DEPLOYABLE ATTACHMENT MEMBERS; now US Patent Publication No. 2013/0256377;
United States Application Serial No. 13 / 763,106 entitled END EFFECTOR COMPRISING A DISTAL TISSUE ABUTMENT MEMBER; now US Patent Publication No. 2013/0256378;
United States Application Serial No. 13 / 433,147 entitled TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS; now US Patent Publication No. 2013/0256369;
United States Application Serial No. 13 / 763,112, entitled SURGICAL STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES; now US Patent Publication No. 2013/0256379;
United States Application Serial No. 13 / 763,035 entitled ACTUATOR FOR RELEASING A TISSUE THICKNESS COMPENSATOR FROM A FASTENER CARTRIDGE; now US Patent Publication No. 2013/0214030;
United States Application Serial No. 13 / 763,042, entitled RELEASABLE TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGE HAVING THE SAME; now US Patent Publication No. 2013/0221063;
United States Application Serial No. 13 / 763,048 entitled FASTENER CARTRIDGE COMPRISING A RELEASABLE TISSUE THICKNESS COMPENSATOR; now US Patent Publication No. 2013/0221064;
United States Application Serial No. 13 / 763,054 entitled FASTENER CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING A TISSUE THICKNESS COMPENSATOR;
United States Application Serial No. 13 / 763,065 entitled FASTENER CARTRIDGE COMPRISING A RELEASABLY ATTACHED TISSUE THICKNESS COMPENSATOR; now US Patent Publication No. 2013/0221065;
United States Application Serial No. 13 / 763,021 entitled STAPLE CARTRIDGE COMPRISING A RELEASABLE COVER;
United States Application Serial No. 13 / 763,078 entitled ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR; now US Patent Publication No. 2013/0256383;
United States Application Serial No. 13 / 763,095 entitled LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES; now US Patent Publication No. 2013/0161374;
United States Application Serial No. 13 / 463,147 entitled IMPLANTABLE
ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES; now US patent publication
No. 2013/0292398;
United States Application Serial No. 13 / 763,192 entitled MULTIPLE THICKNESS IMPLANTABLE LAYERS FOR SURGICAL STAPLING DEVICES; now US Patent Publication No. 2013/0146642;
United States Application Serial No. 13 / 763,161 entitled RELEASABLE LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVING THE SAME; now US Patent Publication No. 2013/0153641;
United States Application Serial No. 13 / 763,177, entitled ACTUATOR FOR RELEASING A LAYER OF MATERIAL FROM A SURGICAL END EFFECTOR; now United States Patent Publication No. 2013/0146641;
United States Application Serial No. 13 / 763,037 entitled STAPLE CARTRIDGE COMPRISING A COMPRESSIBLE PORTION;
United States Application Serial No. 13 / 433,126 entitled TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES; now United States Patent Publication No. 2013/0256366;
United States Application Serial No. 13 / 433,132, entitled DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS; now US Patent Publication No. 2013/0256373. United States Application Serial No. 13 / 851,703 entitled FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR INCLUDING OPENINGS THEREIN;
United States Application Serial No. 13 / 851,676, entitled TISSUE THICKNESS COMPENSATOR COMPRISING A CUTTING MEMBER PATH;
United States Application Serial No. 13 / 851,693 entitled FASTENER CARTRIDGE ASSEMBLIES; and
United States Application Serial No. 13 / 851,684, entitled FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR AND A GAP SETTING MEMBER.
[0004] Document US2007027553 A1 discloses an exemplary method of changing a tissue thickness compensator. Certain illustrative embodiments will now be described to provide a general understanding of the principles of the structure, operation, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are shown in the accompanying drawings. It will be understood by those skilled in the art that the devices and methods detailed herein and illustrated in the accompanying drawings are non-limiting illustrative embodiments and that the scope of various embodiments of the present invention is defined solely in the claims. Features illustrated or described in conjunction with one illustrative embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present invention.
[0005] The terms "include (and any form include, such as" includes and "contain)," have (and any form are, such as "is and" are), "include (and any form include, such as" includes and "include) and" contain (and in any form to include, such as "contain and" contain) are open-ended liniking verbs. As a result, a surgical system, device or apparatus that "includes," has, "includes or" includes one or more members has the one or more members, but is not limited to just the one or more members. Likewise, a member of a system, device or apparatus that "comprises," has, "includes or" includes one or more features, has the one or more features, but is not limited to just that one or more features.
[0006] The terms "proximal and" distal are used herein to refer to a practitioner manipulating the grip portion of a surgical instrument. The term "proximal" refers to the part closest to the practitioner and "distal" refers to the part remote from the practitioner. It should additionally be noted that with reference to the drawings, spatial terms such as "vertical," horizontal, "top, and" bottom may be used herein for convenience and clarity. However, surgical instruments are used in many orientations and positions and these terms are not intended to be limiting and / or absolute.
[0007] Various exemplary devices and methods for performing laparoscopic and minimally invasive surgical procedures have been provided. However, one skilled in the art will readily appreciate that various methods and devices disclosed herein may be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures. Throughout this detailed description, those skilled in the art will also appreciate that various devices disclosed herein may be freely inserted into the body, e.g., through a natural orifice, through an incision or puncture hole formed in tissue, etc. The operative parts or parts of the instrument gripper may be inserted directly into the patient's body or may be introduced through an access device that has a tool passage through which the gripper and the longitudinal shaft of the surgical instrument can be extended.
[0008] Referring to the drawings in which like numerals designate like components in several views, FIG. 1 illustrates an exemplary surgical stapling and severing tool 8010 suitable for use with a tissue thickness compensator assembly, as described in more detail below. The surgical stapling and severing tool 8010 can include an anvil 8014 that can be re-opened and closed about pivoting to elongate staple channel 8016. The staple application assembly 8012 may include an anvil 8014 and a channel 8016, wherein the staple assembly 8012 may be secured adjacent an elongated shaft 8018 forming part 8022 of the tool. When the staple applying assembly 8012 is closed or at least substantially closed, tool portion 8022 may have a sufficiently small cross-section to accommodate the staple applying assembly 8012 through a trocar. In various circumstances, assembly 8012 may be operated with a handle 8020 connected to shaft 8018. Handle 8020 may include user control members such as a pivot knob 8030 that rotates longitudinal shaft 8018, and a staple application assembly 8012 about the longitudinal axis of shaft 8018. A trigger. the closure 8026, which can swing from pistol grip 8036 to close the staple application 8012. The closure release button 8038 may be externally visible on the handle 8020 when the closure trigger 8026 is squeezed so that the closure release button 8038 may be released to unlock the closure trigger 8026 and open, for example, the staple application assembly 8012. The firing trigger 8034, which may swing in front of the closing trigger 8026, can cause the staple application assembly 8012 to simultaneously cut and stitch tissue pinched therein. In various circumstances, multiple firing strokes may be performed with the 8034 fire trigger to reduce the force required for the surgeon's hand to apply per stroke. In some embodiments, handle 8020 may include one or more rotatable indicator wheels, such as, for example, rotatable indicator wheel 8041, which can indicate the progress of a fire. The manual firing release lever 8042 may allow the firing system to be retracted before the full firing movement is complete, if desired, and in addition, the firing release lever 8042 may allow the surgeon or other practitioner to retract the firing system in the event that the firing system fails and / or fails. Additional details regarding the 8010 surgical stapling and severing instrument and other surgical stapling and severing instruments suitable for use with the present disclosure are described, for example, in U.S. Patent Application No. 13 / 851,693, entitled "FASTENER CARTRIDGE ASSEMBLY, and filed on March 27, 2013. r. Additionally, surgically powered stapling and severing tools may also be used in the present disclosure. See, for example, U.S. Patent Application Publication No. 2009/0090763 A1 entitled POWERED SURGICAL STAPLING DEVICE, filed August 8, 2008.
[0009] Referring to FIG. 2 and 3, a launch assembly, such as, for example, a launch assembly 9090 may be used with the surgical stapling and severing tool 8010 to advance a wedge slide 9126 that includes a plurality of wedges 9204 configured to dispense staples from the staple assembly 8012 into tissue caught between the anvil 8014 and the longitudinal staple channel 8016. Additionally, the E-beam 9102 downstream of the firing assembly 9090 may facilitate separate closure and firing as well as the distance of the anvil 8014 from the elongated staple channel 8016 during firing. The E-beam 9102 can include a pair of top pins 9110, a pair of center pins 9112 that can follow a portion 9218 of a wedge slide 9126, and a bottom pin or foot 9114, as well as a sharp cutting edge 9116 that can be shaped to sever grappled tissue when launch assembly 9090 is advanced further. Additionally, the integrally formed and proximal top guide 9118 and center guide 9120 enclosing each vertical end of cutting edge 9116 can further define a tissue displacement area 9122 to assist in guiding tissue to sharp cutting edge 9116 prior to cutting it. The center guide 9120 may also serve to engage and fire the staple application assembly 8012 by abutting the stepped center member 9124 of the wedge slide 9126 (FIG. 2), which causes the staples to be formed by the staple applying unit 8012.
[0010] In various circumstances, the staple cartridge may include members for compensating for the thickness of the tissue captured in the staples disposed from the staple cartridge. Referring to FIG. 4, for example, a staple cartridge, such as, for example, staple 10000, may be used with the surgical stapling and severing instrument 8010, and may include a rigid first portion such as, for example, a support portion 10010, and a compressible second portion, such as , for example, tissue thickness compensator 10020. Support portion 10010 may include a cartridge body and a plurality of staple cavities 10012. For example, staple 10030 may be removably inserted into each staple cavity 10012. Referring primarily to FIG. 4 and 5, each staple 10030 can include a base 10031 and one or more legs 10032 extending from base 10031. Prior to disposing of the staples 10030, the staple bases 10031 can be supported by staple driving members located within the support portion 10010, and at the same time the legs 10032 of staples 10030 can be at least partially contained within the staple cavities 1005. In various circumstances, the staples 10030 may be positioned between the unexpected position and the fired position such that the legs 10032 travel through the tissue thickness compensator 10020, penetrate the top surface of the tissue compensator 10020, penetrate the tissue T, and contact the anvil positioned opposite the staple cartridge | 10,000. As the legs 10032 are deformed against the anvil, the legs 10032 of each staple 10030 can grasp a portion of the tissue thickness compensator 10020 and a portion of the tissue T within each staple 10030 and apply a compressive force to the tissue. In addition to the above, the legs 10032 of each staple 10030 may be deformed downward toward the staple base 10031 to form a staple retention area in which tissue T and tissue thickness compensator 10020 can be gripped. In various circumstances, the staple retention area may be defined between the inner surfaces of the deformed legs 10032 and the inner surface of the base 10031. The size of the staple retention 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 extent to which the legs are are deformed, for example.
[0011] In use, in addition to the above, and referring principally to FIG. 4, an anvil, such as the anvil 8014 of the surgical suturing and cutting tool 8010, can be moved to the closed position opposite to the staple cartridge 10000 by pressing the closure trigger 8026 to advance the beam a-E 9102. The anvil 8014 can position tissues relative to the tissue thickness compensator 10020 and, under various circumstances, compress the tissue thickness compensator 10020, for example, with the support portion 10010. Once the anvil 8014 is properly positioned, the staples 10030 can be positioned, as also illustrated in FIG. 4. Under various circumstances, as noted above, the staple firing carriage 10050, which is similar in many respects to the sled 9126 (see FIG. 3), can be advanced from the proximal end of the staple cartridge 10000 towards the distal end 10002 as shown in FIG. 5. When the firing assembly 9090 is advanced, the carriage 10050 may contact the staple driving members 10040 and lift the staple driving members 10040 upward in the staple cavities 10012. In at least one example, the slide 10050 and the staple driving members 10040 may each include one or more ramps or inclined surfaces that may cooperate to move the staple driving members 10040 upward from their unexploited positions. When the staple driving members 10040 are raised in their respective staple cavities 10012, the staple driving members 10040 can lift the staples 10030 upward such that the staples 10030 can exit their staple cavities 10012. In various circumstances, carriage 10050 may advance several staples up at the same time as part of the firing sequence.
[0012] As discussed above and referring to FIG. 5, the legs of the staples 10032 of the staples 10030 may extend into the compensator 10020 beyond the support portion 10010 when the staples 10030 are in their unfired positions. Under various circumstances, the ends of the staple legs 10032, or any other portions of the staple legs 10032, may not protrude through the tissue engaging surface 10021 of the tissue thickness compensator 10020 when the staples 10030 are in their unfired positions. In some circumstances, the ends of the staple legs 10032 may include sharp ends that may cut and penetrate the tissue thickness compensator 10020.
[0013] In various circumstances, it may be advantageous to prevent and / or limit the frictional forces between the tissue thickness compensator and the staple. Referring now to FIG. 6-8, a tissue thickness compensator 20220 for use with the staple cartridge assembly 20200 may include a plurality of through-holes 20224 extending at least partially through the tissue thickness compensator 20220. In various circumstances, the staple cartridge 2020 assembly may include a staple cartridge body 20210 and a tissue thickness compensator 20220 releasably attached to the staple cartridge body 20210. Cartridge body 20210 may include a staple cartridge 20211 and a plurality of staple recesses 20210 formed by the cartridge base plate 20211 and into the staple cartridge body 20210, for example. Staples 20230 may, for example, be detachably inserted into staple recesses 20212. Tissue thickness compensator 20220 may include a tissue engaging surface 20221 (FIG. 7) and a baseplate engaging surface 20222 (FIG. 6). The surface contacting the base plate 20222 may be, for example, releasably provided on the base plate 20211 of the cartridge body 20210, and the tissue engaging surface 20221 may be provided, for example, on the suturing tissue T. Through-holes 20224 may extend across the plate engaging surface 20222 and the tissue thickness compensator
20220 and may include holes, slots, gaps, bores, openings, and / or via paths, for example, within tissue thickness compensator 20220.
[0014] Referring mainly to FIG. 7 and 8, staples 20230 may be positioned within the staple recesses 20212 of cartridge body 20210. Each staple 20230 may include a base 20231 and a pair of staple legs 20232 that may extend from base 20231. Each staple leg 20232 may extend from opposite ends of base 20231 Referring mainly to FIG. 7, one or more ports 20224 in tissue thickness compensator 20220 may include an opening in the surface contacting base plate 20222. Through opening 20224 may align with a corresponding leg of staple 20232 that is received within staple cavity 20212. For example, one staple leg 20232 can align with single through hole 20224 when tissue thickness compensator 20220 is attached to cartridge body 20210. Under some circumstances, a staple leg 20232 may extend into each through hole 20224 such that at least a portion of the staple 20230 is embedded in, for example, tissue thickness compensator 20220. For example, referring primarily to FIG. 7, staple 20230 may include a first staple leg 20232a and a second staple leg 20232b. Additionally, the tissue thickness compensator 20220 may include, for example, first through hole 20224a aligned with first staple leg 20232a and second through hole 20224b aligned with second staple leg 20232b. Prior to disposing staple 20230, first staple leg 20232a may extend partially through first through hole 20224a and second staple leg 20232b may, for example, extend partially through second through hole 20224b. Tissue thickness compensator 20220 may include, for example, additional through holes 20224 that are not aligned with the staple legs 20232. In some circumstances, the staple cartridge assembly 20200 may include additional staples 20230 and / or staple legs 20232 that do not align with the holes. through ports 20224, for example.
[0015] Staples 20230 can be advanced from the unexpanded formation (FIG. 7) into the fired formation (FIG. 8). Each staple 20230 is moveable along the axis of the staples as it travels between the unfired formation and the fired formation. In the unexploited configuration, staple legs 20232 may extend from, for example, staple recesses 20212 and into tissue thickness compensator 20220. The staple legs 20232 may be partially embedded in the tissue thickness compensator 20220 when the staples 20230 are in, for example, a non-fired configuration. Additionally, at least a portion of the staple legs 20232 may be aligned with and / or inserted into the through holes 20224 of the tissue thickness compensator 20220 when the staples are in, for example, a non-fired configuration. In other circumstances, staple legs 20232 may be positioned completely within staple recess 20212 when in the non-fired configuration, and may be aligned with through holes 20224 located above cartridge base plate 20211 (FIG. 6), for example.
[0016] Staples 20230 are able to advance from the unexpanded formation (FIG. 7) to the fired formation (FIG. 8) during the firing stroke, as described herein. The staple driver 20240 may be disposed in each staple cavity 20212. The staple driver 20240 within each staple cavity 20212 may be biased towards the cartridge base plate 20211 (FIG. 6), for example, to guide the staple 20230 into the tissue T and into the anvil. 20260 (FIG. 8), which may be similar in many respects to other anvils described herein, such as, for example, the anvil 8014 (FIG. 1). As each staple 20230 moves from the unexpired form to the fired form, the legs of the staples 20232 may move through the through holes 20224 in the tissue thickness compensator 20220. The ports 20224 may have a predetermined trajectory in the tissue thickness compensator 20220. For example, the ports 20224 may extend along an axis that is perpendicular to and / or substantially perpendicular to the tissue engaging surface 20221 (FIG. 7) and / or the base deck surface 20222 (FIG. 6) of the tissue thickness compensator 20220. In other circumstances, the through holes 20224 may extend along an axis that is oriented at an oblique angle to the tissue engaging surface 20221 and / or the baseplate contact surface 20222 of tissue thickness compensator 20220, for example. Under some circumstances, group of ports 20224 may be parallel. In some circumstances, all of the through holes 20224 of the tissue thickness compensator 20220 may be parallel, e.g. Through holes 20224 may include a partially curved trajectory and / or a partially linear trajectory. Other features and features of through-holes 20224 are described in more detail in United States Patent Application No. 13 / 851,693 entitled "FASTENER CARTRIDGE ASSEMBLY, filed on March 27, 2013. Methods and techniques for modifying the tissue thickness compensator to accommodate ports, such as ports 20224, for example, are described in more detail below.
[0017] Referring now to FIG. 9-12, a gripper 22090 of a surgical instrument similar in many respects to the surgical instrument 8010, for example, may include a first jaw including a fastener cartridge assembly 22000 and a second jaw including an anvil 10060. The first jaw may include a staple cartridge passage 10070 that may be shaped. for removably receiving a cartridge assembly 22000. Alternatively, the staple cartridge channel 10070 and cartridge assembly 22000 may include an integral unit. Under various circumstances, the anvil 10060 can be moved between an open position and a closed position (FIGS. 9-12). In the open position of the anvil 10060, the anvil 10060 can be positioned on the first side of patient T tissue (FIG. 10-12) and the cartridge assembly
22,000 it can be placed on the opposite or opposite side of the tissue T, for example. When the anvil 10060 is moved to the 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. The firing member 10052, which is in many respects similar to the launch assembly 9090 ( FIG. 3), may be moved farther from the proximal end 22001 of cartridge assembly 22000 toward the distal end 22002 of cartridge assembly 22000 to discard fasteners, such as, for example, staples 22030 for, jointly stored in the cartridge body 22010 of cartridge assembly 22000 as the firing member 10052 is advanced from the proximal end 22001 towards the distal end 22002 of the cartridge assembly 22000.
[0018] In addition to the above, staples 22030 may be supported by staple driving members 10040 that are movably inserted into staple recesses 2252 defined in the cartridge body 22010. Additionally, the firing member 10052 may be configured to move the staple firing sled 10050 further within the body. cartridge 22010 as the firing member 10052 is advanced from the proximal end 22001 towards the distal end 22002. In such circumstances, the staple firing carriage 10050 may be configured to lift the staple drive members 10040 and the staples 22030 supported thereon toward the anvil 10060. In general, in addition to the above, the staple driving members 10040 can advance the staples 22030 from the unfired position (FIG. 10) to the fired position (FIG. 11 and 12), in which staples 22030 can contact the anvil 10060 and be deformed between the undistorted form (FIG. 10) and a deformed configuration (FIGS. 11 and 12). The anvil 10060 may include forming pockets 10062 that may be configured to receive and deform staples 22030. Staples 22030 may be the same or similar to staples 10030, for example, and / or any other staples disclosed herein, and as such, staples 22030 are not described in more detail here. The reader will appreciate, however, that staples 22030 may include any suitable shape and / or suitable dimensions such as width and / or height, for example in their non-deformed configuration and / or in their deformed configuration. For example, staples 22030 may, under certain circumstances, include a height that does not extend above the surface of the base plate 22011 of cartridge body 22010 when the staples 22030 are in their non-fired positions, while in other circumstances, staples 22030 may include a height at which the legs. the staples 22030 extend upward from the surface of the base plate 22011 when the staples 22030 are in their non-fired positions so that the staple legs 22030 are at least partially embedded in the tissue thickness compensator 22010 of the cartridge assembly 22000.
[0019] With further reference to the embodiment illustrated in FIG. 9-12, in addition to the above, cartridge assembly 22000 can include a cartridge body 22010 and a tissue thickness compensator 22020. In various circumstances, the cartridge body 22010 may be similar to the support portion 10010, e.g., in many respects and consequently many of the these considerations are not repeated here for the sake of brevity. Additionally, the tissue thickness compensator 22020 may be similar to the tissue thickness compensator 10020 in many respects, for example. In addition, the launch member 10052 may include a cutting portion 10053, which may be configured to cut tissue disposed between the anvil 10060 and the tissue thickness compensator 22020 as the launch member 10052 is moved distally. In various circumstances, as a result, the firing member 10052 may be configured to simultaneously fire the staples 22030 to stitch the tissue T and cut the tissue T. Under some circumstances, the firing process may at least partially lead to a cutting process. In other words, the cutting process may delay the firing process. Under such circumstances, a portion of the T tissue may be sutured and then incised. [0020] As shown in FIG. 9-12, the cartridge body 22010 may include a cartridge knife slot 22015, which may be configured to receive portions of the firing member 10052 as the firing member 10052 is advanced further. In addition to the above, the anvil 10060 may include an anvil knife slot 10065, which may be configured to receive portions of the launch member 10052 when the launch member 10052 is advanced. In various circumstances, the tissue thickness compensator 22020 may include a tissue thickness compensator knife slot 22025 that can align with the anvil knife slot 10065 and cartridge knife slot 22015 such that the firing member 10052 can pass through the cartridge knife slot 22015, anvil knife slot 10065, and knife gap of the tissue thickness compensator 22025. Under various circumstances, an anvil knife slot 10065 may extend over a tissue thickness compensator knife slot 22025 such that a cutting portion 10053 of firing member 10052 can pass through a cartridge knife slot 22015, anvil knife slot 10065, and a tissue thickness compensator slot 22025 simultaneously. Tissue thickness compensator knife slot 22025 may define a tissue thickness compensator knife path for cutting portion 10053, wherein the tissue thickness compensator knife path may be parallel to the anvil knife path and the cartridge knife path. In various circumstances, the tissue thickness compensator knife path may be oblong, while under certain circumstances the tissue thickness compensator knife path may be curved. In addition to the above, curved grippers and curved fastener inserts are disclosed in United States Patent Application No. 2008/0169329. The entire disclosure of United States Patent Application Serial No. 11 / 652,164, entitled CURVED END EFFECTOR FOR A SURGICAL STAPLING DEVICE, filed on January 11, 2007, now United States Patent Publication No. 2008/0169329, is hereby cited. Under such circumstances, the tissue thickness compensator may be curved. In at least one such embodiment, the tissue thickness compensator may be curved to match the curvature of the cartridge body, the insert of the fasteners. Methods and techniques for modifying the tissue thickness compensator to include a knife gap, such as, for example, knife gap 22025 are described below.
[0021] In view of the foregoing, referring primarily to FIG. 9, the knife slot of the tissue thickness compensator 22025 may extend between the first suturing portion 2202la that may be sutured by the first group of staples 22030 and the second suturing portion 22021b that may be sewn by the second group of staples 22030. The knife slot 22025 may detachably engage the first portion. stitching 2202la with the second suturing portion 22021b. In use, as shown in FIG. 9, the cutting portion 10053 can be moved distally through the knife slot 22025 to cut the knife slot 22025 and separate the first suturing portion 22021a and the second suturing portion 22021b. In some circumstances, the knife slot 22025 can include a plurality of links or bridges 22026 that can connect the first seaming portion 2202la and the second stapling portion 2202lb prior to being cut by cutting portion 10053. Under various circumstances, fasteners 22026 may be the same thickness as the first suture portion 2202 Ia and / or the second suture portion 2202lb, at least while the tissue thickness compensator 22020 is in an uncompressed state. In at least one such situation, the fasteners 22026, the first seam portion 2202la and / or the second seam portion 2202lb may be uniformly and integrally formed from a flat, or at least substantially flat, piece of fabric, for example. In various other circumstances, the first stitching portion 2202la may include a first thickness, the second stitching portion 2202lb may include a second thickness, and fasteners 22026 may include a third thickness, with one or more of the first thickness, the second thickness, and the third thickness being different from other thicknesses.
[0022] The knife slot 22025 may further include, for example, holes, such as holes 22024, for example, defined therein. For example, the holes 22024 can be elongated and can extend along the knife slot 22025. In a variety of other circumstances, the holes in the knife slot 22025 can include any suitable arrangement. In some circumstances, the holes 22024 may include perforations located indirectly on the connectors 22026, which may be formed, for example, using a laser cutting operation. In some circumstances, holes 22024 may be cut from the sheet of material to form a tissue thickness compensator 22020 such that holes 22024 and connectors 22026 are arranged, for example, in an alternating pattern. In other instances, tissue thickness compensator 22020 may be formed with openings 22024 already formed therein. In various circumstances, one or more of the holes 22024 may include, for example, through holes. In various circumstances, one or more of the holes 22024 may, for example, include through holes. In some circumstances, one or more of the holes 22024 may not include the through holes and may instead include, for example, reducing the thickness of the knife slot 22025. Methods and techniques for modifying the tissue thickness compensator to accommodate holes, such as, for example, holes 22024. described below.
[0023] In addition to the above, referring again to FIG. 9-11, patient tissue may be positioned between the anvil 10060 of the gripper 22090 and the tissue thickness compensator 22020 of the cartridge assembly 22000 when the anvil 10060 is in the open position. When the anvil 10060 is moved to the closed position, the bottom surface or tissue contact surface 10063 of the anvil 10060 may contact the tissue T and push the tissue T towards the base plate 22011 surface of the cartridge body 22010. The tissue T may contact the top surface or tissue contacting surface 22021 of the tissue thickness compensator 22020, wherein as the anvil 10060 is moved to its closed position, the anvil 10060 may press the tissue T against the tissue thickness compensator 22020 and, in addition to above, compress the tissue thickness compensator 22020 against the surface of the cartridge 22011 of the cartridge body 22010. In various circumstances, the tissue thickness compensator 22020 may include a bottom surface 22029 that may adjoin the base plate surface 22011. In some circumstances, there may be a gap between the bottom surface 22029 and the base plate surface 22011 before the tissue thickness compensator 22020 compresses against the cartridge body. 22010. Under such circumstances, the tissue thickness compensator 22020 may first move toward the cartridge body 22010 before being compressed against it. When the tissue thickness compensator 22020 is compressed against the cartridge body 22010, under various circumstances, the first suturing portion 22021a and / or the second suturing portion 22021b of the tissue thickness compensator 22020 may move sideways. For example, the first suturing portion 2202la and / or the second suturing portion 22021b may move laterally from the knife slot of cartridge 22015. In various circumstances, fasteners 22026 may be configured to block such lateral movement between the first suturing portion 2202la and the second suturing portion 2202lb . In various circumstances, referring primarily to FIG. 11, the fasteners 22026 may be stretched to allow some relative lateral movement between the first seaming portion 2202la and the second suturing portion 2202lb when the anvil 10060 is closed. When the anvil 10060 is reopened, the fasteners 22026 may be formed to resiliently return, or at least substantially return, to their unstretched formation and, consequently, pull the first suturing portion 22021a and the second suturing portion 22021b back toward their original positions. , illustrated in FIG. 10. Additionally, the anvil 10060 can compress the tissue T as the anvil 10060 is moved to its closed position. Under such circumstances, the tissue T may at least partially flow into the openings 22024.
[0024] Referring to FIG. 10-12, the reader will appreciate that the knife slot 22025 of the tissue thickness compensator 22020 contains less material along its longitudinal length than the first suturing portion 2202la and / or the second suturing portion 2202lb. In other words, a longitudinal cross-section through the first seam portion 2202la and / or the second seam portion 2202lb will cut the first amount of material, while a longitudinal cross-section through the knife slot 22025 will cut a second amount of material that is less than the first amount of material.
[0025] Once the anvil 10060 is properly positioned, in addition to the above, the firing member 10052 may be moved further to fire the staples as shown in FIG. 11 and incise the T tissues and connectors 22026 as shown in FIG. 12. In addition, the tissue thickness compensator bias force, tissue incision force, tissue thickness compensator drag force, and / or tissue resisting force may blunt cutting portion 10053 of firing member 10052. The blunt knife may not be able to cut the tissue T and / or the tissue thickness compensator 22020, for example, in an advantageous manner. Primarily referring to FIG. 12, the cutting portion 10053 may include, for example, a first knife edge strip 10053a, a second knife edge strip 10053b, and / or a third knife edge strip 10053c, the first knife edge strip 10053a being positioned vertically over the second knife edge strip 10053b, and in which the second knife edge band 10053b is positioned vertically over the third knife edge band 10053c, for example. The cutting portion 10053 may include any suitable number and / or location of the knife edge strips, with the knife edge strips shown in FIG. 12 were selected for discussion. In addition to the above, the first knife edge band 10053a may be shaped to cut tissue T, while the second knife edge band 10053b may be shaped to cut the tissue thickness compensator 22020. As a result, the first knife edge strip 10053a may experience a tissue incision force and / or a tissue drag force discussed above. Such forces may wear or blunt the first strip of the knife edge 10053a at first speed. The second knife edge strip 10053b may experience the compression force of the tissue thickness compensator and / or the drag force of the tissue thickness compensator discussed above. Such forces may wear or blunt the second strip of knife edge 10053b at a second speed. In various circumstances, the second speed may be different from the first speed.
[0026] Turning now to FIG. 13 and 14, insertion of fasteners 22400 may include a tissue thickness compensator 22420, which may include a first suture portion 22421a and a second suture portion 22421b, which are connected by a knife slot 22425. Knife slot 22425 may include an angular link 22426. Angled longitudinal link 22426 may extend between the proximal end 22401 of the knife slot 22425 and the distal end 22402 of the knife slot 22425. In some circumstances, angled elongate connector 22426 may extend the entire length of knife slot 22425, while in other circumstances, angled elongate connector 22426 may extend less than the length of knife slot 22425. Angled elongate connector 22426 may extend between top surface 22428 tissue thickness compensator 22420 and lower surface 22429 tissue thickness compensator 22420. In some circumstances, angular elongate link 22426 may extend the full length between top surface 22428 and bottom surface 22429, while in other circumstances, angular elongate link 22426 may extend less than the distance between top surface 22428 and bottom surface 22429. In various circumstances, the proximal end of the longitudinal link 22426 may extend from the top surface 22428 of the tissue thickness compensator, while the distal end of the elongated link 22426 may extend from the bottom surface 22429. Alternatively, the distal end of the longitudinal link 22426 may extend from the top surface 22428 of the compensator. tissue thickness, while the proximal end of the elongate link 22426 may extend from the bottom surface 22429. In various circumstances, elongate connector 22426 may include a thin bridge (i.e., less than the full thickness of the tissue thickness compensator 22420) or a series of thin bridges that connect to the first suture portion 22421a that can be sewn by the first group of staples 22030 to the second suture portion. 22421b, which may be stapled by the second group of staples 22030, for example. These thin angled mosquitoes and / or spike 22426 can distribute wear in the second edge zone 10053b of the blade rather than concentrating it in one location. In various circumstances, as a result, the wear occurring at the second edge zone of the knife 10053b may be equal to or closer to that of, for example, the wear occurring in the first edge zone of the blade 10053a, for example.
[0027] Referring now to FIG. 15-17, an exemplary tissue thickness compensator assembly 1000 may include a first layer 1002 and a second layer 1004 for engagement with the first layer 1002. A tissue thickness compensator assembly 1000 may be used with a surgical instrument, such as, for example, surgical instrument 8010 (FIG. 1). . In addition, the tissue thickness compensator assembly 1000 may be used in a similar manner and may replace the tissue thickness compensator 22020 of the gripper cartridge 22000 assembly 22090 (FIG. 9). For example, the second layer 1004 of the tissue thickness compensator assembly 1000 may include a first portion 1006 that may be positioned over the deck surface 22011 on the first side of the knife cartridge slot 22015 in a manner similar to the first suture portion 22021a and second portion 1008 that may be positioned on the deck. deck surface 22011 on the second side opposite the first side of the knife insert slot 22015 in a similar manner to the second suturing portion 22021b (FIG. 9-11). In various instances, the first portion 1006 and the second portion 1008 of the second layer 1004 may be spaced apart and may include a slot 1010 therebetween which may include a knife path for the cutting portion 10053 of the firing member 10052 and may extend at least one partially over the slot 22015 of the cartridge. of the knife as the tissue thickness compensator assembly 1000 is assembled with the cartridge gripper 22090. In some instances, the first layer 1002 may be configured to join the first portion 1006 and the second portion 1008 and extend at least partially over the gap 1010 as shown, for example, in FIG. 17.
[0028] In use, tissue T may be trapped between the anvil 10060 and the surface
1012 contacting the tissue of the first layer 1002. As the firing member 10052 is advanced, the first group of staples 20030 may be used to stitch the first portion 1006 and the second group of staples may be positioned to stitch the second portion.
1008. The first and second groups of staples may be configured to pass through the first deck contact surface 1007 and the second deck contact surface 1009 respectively, and then through the tissue contact surface 1012 of the first layer, and then the gripped tissue T to contact the pockets 10062. anvil 10060. In addition, movement of the firing member 10052 may cause the cutting portion 10053 to move further through the slot 1010 from the tissue thickness compensator assembly 1000. The cutting portion 10053 may cut the first layer 1002 while passing through the slit 1010, thereby separating the first portion 1006 and the second portion 1008 of the second layer 1004.
[0029] Referring again to FIG. 17, the first layer 1002 of the tissue thickness compensator assembly 1000 may include a first height H1, a first portion 1006 of the second layer 1004 may include a second height H2, and a second portion 1008 of the second layer 1004 may include a third height H3. Under certain circumstances, as shown in FIG. 17, the second height H2 and the third height H3 may be the same or substantially the same. In other circumstances, the second height H2 may be different from the third height H3. Under some circumstances, the first height H1 may be less than the second height H2 and / or the third height H3 as illustrated in FIG. 17. The first layer 1002 of the tissue thickness compensator assembly 1000 may include a first density, the first portion 1006 of the second layer 1004 may include a second density, and a second portion 1008 of the second layer 1004 may include a third density. In some circumstances, as shown in FIG. 17, the second density and the third density may be the same or substantially the same. In other circumstances, the second density may be different from the third density and / or different from the first density of the first layer 1002. The material compositions of the first portion 1006 and the second portion 1008 may be the same or at least substantially the same. In other circumstances, the material compositions of the first portion 1006 and the second portion 1008 may differ from each other and / or may be different from the material composition of the first layer 1002.
[0030] As described above, repeated use of cutting portion 10053 to cut tissue T and tissue thickness compensator material may blunt cutting portion 10053. To slow the blunting process, it may be desirable to reduce the tissue thickness compensator material that is cut by cutting portion 10053. An additional benefit may be to reduce the forces needed to move the firing member 10052 farther on the firing stroke. To reduce the dullness of the cutting portion 10053, the first layer 1002 may be comprised at least partially of a thin film, for example. In such circumstances, the first height H1 may be significantly less than the second height H2 and the third height H3 as illustrated in FIG. 17. Under certain circumstances, the first layer 1002 may include a uniform or substantially uniform height, as shown in FIG. 17. In other circumstances, the bridging portion 1014 of the gap of the first layer 1002 may extend at least partially over the gap 1010 and may be thinner than the remainder of the first layer 1002. The cutting portion 10053 may intersect the gap-bridging portion 1014 of the first layer 1002 while traversing the gap 1010 between the first portion 1006 and the second portion 1008 of the second layer 1004, which may reduce drag that occurred in cutting portion 10053 and / or slow down blunting of cut portion 10053. In any event, the first layer 1002 may be configured to maintain engaging engagement with the first portion 1006 and second portion 1008 of the second layer 1004 prior to cutting it, and to present cutting portion 10053 with reduced resistance as cutting portion 10053 is advanced to intersect the first layer 1002.
[0031] To further reduce dullness of the cutting portion 10053 and / or reduce the drag felt by cutting portion 10053, the gap-bridging portion 1014 may include a perforated portion 1016 along a knife path defined by the slot 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 folding the first layer 1002 into the second layer 1004, for example. The perforations 1018 can reduce the interaction between cutting portion 10053 and first layer 1002 as cutting portion 10053 is advanced through the knife path defined by slot 1010, which can slow down blunting of cutter 10053 and / or reduce drag experienced by cutting portion 10053.
[0032] Under various circumstances, as described in more detail below, the tissue thickness compensator assembly 1000 may be comprised of one or more biocompatible materials. In some circumstances, the first layer 1002 may consist of a biocompatible pushing material and / or a plastic such as polydioxanone (PDS) and / or polyglycolic acid (PGA) and the second layer 1004 may consist of a bioabsorbable foam material and / or a compressible material. a hemostatic agent such as, for example, oxidized regenerated cellulose (ORC). In some circumstances, the first layer 1002 may be a thin layer containing a bioabsorbable material such as polyglycolic acid (PGA) which is sold under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA). polyglecaprone 25 (PGCL), which is sold under the trade name Monocryl, polycaprolactone (PCL) and / or a composite of PGA, PLA, PDS, PHA, PGCL and / or PCL, for example. In some circumstances, the first portion 1006 and / or the second portion 1008 of the second layer 1004 may consist of a freeze-dried foam containing, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA). In some circumstances, the first portion 1006 and / or the second portion 1008 of the second layer 1004 may consist of a biocompatible foam, which may include an open-cell porous foam and / or a closed-cell porous foam.
[0033] Referring again to FIG. 15 and 17, the first layer 1002 may be at least partially disposed over the second layer 1004 such that the second layer 1004 may be sandwiched between the first layer 1002 and the deck surface 22011 (FIG. 9) when the
1000 the tissue thickness compensator is assembled with the gripper 22090 (FIG. 9). In other circumstances, the first layer 1002 may be located beneath the first portion 1006 and the second portion 1008 (not shown) such that the first layer 1002 may be sandwiched between the second layer 1004 and the deck surface 22011 (FIG. 9) when the assembly 1000 is a tissue thickness compensator is mounted with gripper 22090 (FIG. 9). In any event, the first layer 1002 may be attached to the first contacting surface 1020 of the first portion 1006 and the second contacting 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 stamping process involving the application of heat and / or pressure. as described in more detail below. In other circumstances, the first layer 1002 may be attached to the second layer 1004 with a biocompatible adhesive material such as, for example, fibrin and / or a protein hydrogel. Other means for attaching the first layer 1002 to the second layer 1004 are contemplated in the present disclosure.
[0034] Referring now to FIG. 21 and 22, the first layer 1002 may be at least partially embedded in the first portion 1006 and / or second portion 1008 of the second layer 1004. In such circumstances, tissue thickness compensator assembly 1000 may be prepared using a mold 1024, for example, as shown in FIG. . 21. In various instances, an organic solution containing a polymer such as, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA) can be poured into mold 1024. The first layer 1002 can be immersed in an organic solution. As shown in FIG. 22, middle shelf 1026 and middle beam 1027 of mold cover 1028 can grip the first layer 1002 therebetween to ensure that first layer 1002 remains immersed in the organic solution, which can then be lyophilized using conventional freeze-drying techniques and / or, for example, any other suitable techniques. Upon completion of the lyophilization process and / or any other suitable process, mold cover 1028 may be removed and tissue thickness compensator assembly 1000 may be recovered from mold 1028.
[0035] As shown in FIG. 21, the first layer 1002 of the tissue thickness compensator 1000 may be partially positioned within the first portion 1006 and second portion 1008 of the second layer 1004. In some circumstances, the first layer 1002 may be partially positioned within one of the first portion 1006 and the second portion 1008 and secured to the surface. the top or bottom surface of the second of the first portion 1006 and the second portion 1008.
[0036] In some circumstances, the center beam 1027 and the ledge 1026 may at least partially extend along an axis that is parallel or substantially parallel to the first deck contact surface 1007 and / or the second deck contact surface 1009 when the cover 1028 is in a closed configuration with the mold. 1024, as shown in FIG. 22. In such circumstances, the first layer 1002 may be embedded in the first portion 1006 and / or the second portion 1008 such that the first layer 1002 is positioned or substantially parallel to or substantially parallel to the first deck contact surface 1007 and / or second deck contact surface 1009. . In other circumstances, although not shown, center beam 1027 and ledge 1026 may at least partially extend along an axis that is at an oblique angle with respect to the first deck contact surface 1007 and / or second deck contact surface 1008 when cover 1028 is in the closed position. configuration with form 1024. In such circumstances, the first layer 1002 may be embedded in the first portion 1006 and / or the second portion 1008 such that the first layer 1002 is positioned or substantially at an oblique angle to the first deck contact surface 1007 and / or the second deck contact surface 1008. Other techniques for partially descending the first layer 1002 into the first portion 1006 and / or the second portion 1008 are contemplated in this disclosure.
[0037] Referring now to FIG. 18 and 19, a tissue thickness compensator assembly 1033 is illustrated that is similar in many respects to a tissue thickness compensator assembly 1000 and a tissue thickness compensator assembly 20020. The tissue thickness compensator assembly 1033 may include a first portion 1006 and a second portion 1008 that may be spaced apart and releasably connected together by a plurality of bridging members or connectors 1030 that may extend through the gap 1010 between the first portion 1006 and the second portion 1008. Additionally, some or all of the fasteners 1030 of the tissue thickness compensator assembly 1033 may be partially embedded in the first portion 1006 and second portion 1008, as illustrated in FIG. 19. Additionally, some or all of the connectors 1030 may include a first end disposed in the first portion 1006, a second end disposed in the second portion 1008, and a bridging portion 1032 of the gap therebetween. The gap bridging portion 1032 may extend through the gap 1010 between the first portion 1006 and the second portion 1008 as shown in FIG. 19. Connectors 1030 may be spaced apart along the length of the slot 1010 to separately engage the first portion 1006 with the second portion 1008.
[0038] In some circumstances, the connectors 1030 may be uniformly distributed along an axis extending along the slot 1010 as shown in FIG. 19. In other circumstances, although not shown, connectors 1030 may be unevenly spaced along an axis extending along the slot 1010. The cutting portion 10053 may be configured to cut portions 1032 of the bridging connectors 1030 as the cutting portion 10053 is moved between the first portion 1006 and the second portion 1008 through the knife path defined through the slot 1010. Where the connectors 1030 are unevenly spaced along an axis extending along the first portion 1006 and the second portion, in at least one instance, the connectors 1030 may be spaced more frequently and / or closer to each other in the distal portion of the slot 1010 than in the proximal portion of the slot 1010 such that that the cutting portion 10053 may experience increasing resistance as it is moved along the path of the knife defined by the slot 1010. In other circumstances, the connectors 1030 may be spaced more frequently and / or closer together at the proximal portion of the slot 1010 than at the distal portion of the slot 1010 such that the cutting portion 10053 may encounter diminishing resistance as it is moved along, for example, along a knife path defined by slot 1010.
[0039] In some circumstances, the connectors 1030 may extend or substantially extend in a single plane which may be parallel or substantially parallel to the first deck contacting portion 1007 and / or the second deck contacting portion 1009 as shown in FIG. 19. In other circumstances, although not shown, the connectors 1030 may extend or substantially extend along a plurality of planes that may be parallel or substantially parallel to each other and / or to the first deck contacting portion 1007 and / or the second deck contacting portion 1009.
Additionally, some or all of the portions 1032 bridging the slot of the links 1030 may be thinner than their respective links 1030 to present the cutting portion 10053 of reduced resistance as the cutting portion 10053 is moved to intersect the links 1030, maintaining engaging engagement with the first portion. 1006 and the second portion 1008 of the second layer 1004. For example, some or all of the connectors 1030 may be skeleton shaped with thicker ends ending at first portion 1006 and second portion 1008 of the second layer 1004 and thinner middle portions extending therebetween. In some circumstances, the 1030 fittings may be made of a piece of seam, which may be comprised of a bioabsorbable material such as polyglycolic acid (PGA), which is sold under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglycaprone (PGCL), which is sold under the trade name Monocryl, polycaprolactone (PCL) and / or a composite of PGA, PI_A, PDS, PHA, PGCL and / or PCL, for example.
[0041] Referring again to FIG. 18, the tissue thickness compensator assembly 1033 can be fabricated with mold 1034. An organic solution containing a polymer such as, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA) can be poured into mold 1034. The connectors 1030 can be immersed in the organic solution. . As shown in FIG. 18, one or more fittings 1030 may each be trapped in one or more dedicated slots 1040 on the middle shelf 1036 by one or more beams 1039 extending from mold cover 1038 and configured to mate with slots 1040 when mold cover 1038 is in position. closed configuration with mold 1034 to ensure that fittings 1030 remain immersed in the organic solution. The slots 1040 may be sized to receive or at least partially receive the bridging portions 1032 that may be secured by the beams 1039 when the mold cover 1038 is in a closed configuration with the mold 1034. The ends of the connectors 1030 extending from the gap bridging portions 1032 are freely movable. swim in an organic solution. Alternatively, the ends of the connectors 1030 may be secured to the sides of the mold 1034, for example. In some circumstances, the connectors 1030 may extend in organic solution between the sides of the mold 1034. In other circumstances, the connectors 1030 may be loosely retained between the sides of the mold 1034 to extend through the organic solution in a non-linear manner, for example.
[0042] Additionally, in various instances, the organic solution may 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 fasteners 1030 partially disposed in first portion 1006 and second portion 1008. Other techniques for partially seating the fasteners 1030 into the first portion 1006 and / or the second portion 1008 are contemplated by the present disclosure. The reader will appreciate that the fasteners 1030 can be located closer to or farther from the deck contacting surfaces 1007 and 1009 by varying the height of the center shelf 1038 and / or the depth of the slots 1040.
[0043] Referring now to FIG. 20, tissue thickness compensator assembly 1042 is illustrated, which may be similar in many respects to tissue thickness compensator assembly 1033, tissue thickness compensator assembly 1000, and / or tissue thickness compensator 20020. Tissue thickness compensator assembly 1042 can include a first portion 1006 and a second portion 1008 that may be spaced apart and releasably connected together by a continuous flexible member 1044 that may define a plurality of bridging members or connectors 1046 that may extend through the gap 1010 between. the first portion 1006 and the second portion 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 shaped to extend through the first portion 1006 and the second portion 1008 several times, e.g. in a zigzag pattern to form the connectors 1046, as shown in FIG. 20. The flexible portion 1052 may be passed in a first direction through a distal portion 1054 of the first portion 1006 and a distal portion 1056 of the second portion 1008 to form a first portion 1046a that bridges a slot through the slot 1010. The flexible portion 1052 may then be looped and passed in a second direction opposite the first direction through the second portion 1008 closer to the distal portion 1056 and through the first portion 1006 closer to the distal portion 1054, thereby forming a second portion 1046b bridging the gap closer to the first portion. 1046a that bridges the slot. Additional bridging slot portions 1046c and 1046d, for example, may be formed in the same manner in slot 1010 as shown in FIG. 20. [0044] In some circumstances, the continuous flexible member 1044 may include a seam and may consist of a seam material such as polyglycolic acid (PGA), which is sold under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS). , polyhydroxyalkanoate (PHA), polyglecaprone (PGCL), which is sold under the trade name Monocryl, polycaprolactone (PCL) and / or a composition of PGA, PI_A, PDS, PHA, PGCL and / or PCL, for example. Under some circumstances, the tissue thickness compensator assembly 1042 may be assembled after the first portion 1006 and second portion 1008 have been manufactured, for example, by lyophilization. In some circumstances, a needle (not shown) may be attached to the first end 1048 of the continuous flexible member 1044 and may be passed through the first portion 1006 and the second portion 1008, e.g., in a zigzag pattern to connect the first portion 1006 to the second portion 1008, such as described above. The first end 1048 and / or second end 1050 of the continuous flexible member 1044 may be attached to the side walls of the first portion 1006 and / or second portion 1008 by tying, for example, one or more knots at the first end 1048 and / or second end 1050. The knots may rest against the side walls of the first portion 1006 and / or the second portion 1008 to prevent the flexible portion 1052 from unraveling relative to the first portion 1006 and / or the second portion 1008. In other circumstances, the first portion 1006 and the second portion 1008 of the tissue thickness compensator assembly 1042 may be formed around the continuous flexible member 1044. Under such circumstances, as illustrated 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 by side walls 1066 and slots 1068 defined in center shelf 1070. An organic solution containing a polymer such as, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA) can be poured into mold 1062 until the continuous flexible member 1044 is immersed in the organic solution. A mold lid 1072 can be used to ensure that the continuous flexible member 1044 remains immersed in the organic solution, which can then be lyophilized using conventional lyophilization techniques and / or any other suitable technique. First end 1048 and second end 1050 of continuous flexible member 1044 may be secured to openings 1053 and 1055 of mold 1062, respectively, by tying at one or more knots at first end 1048 and second end 1050, such as after passing first end 1048 through the opening 1053 and second end 1050 through opening 1055. The knots may abut the side walls of mold 1062 to prevent the continuous flexible member 1044 from unraveling with respect to mold 1066. After the tissue thickness compensator is removed from the mold, in various instances, portions of the continuous flexible member 1044, e.g., portions 1048, 1050 and / or 1052, for example, may then be cut and removed from the tissue thickness compensator. Other techniques for assembling tissue thickness compensator assembly 1042 are contemplated by the present disclosure.
[0045] Under some circumstances, a tissue thickness compensator assembly, such as a tissue thickness compensator assembly 1042, may be compromised when excessive force or pressure is applied to it. For example, pressure may be applied to a tissue thickness compensator assembly, such as, for example, tissue thickness compensator assembly 1042 as the tissue thickness compensation assembly 1042 is loaded onto a staple cartridge, such as, for example, a 10,000 staple cartridge. Tissue thickness compensator assembly 1042 may be equipped with a pressure or force sensitive member that can provide a feedback to the user if the pressure experienced by the tissue thickness compensator assembly exceeds a threshold. For example, a pressure or pressure sensitive film may be attached to the tissue thickness compensator assembly 1042 and may be shaped to change color upon experiencing a pressure above the threshold. In some circumstances, a pressure or force sensitive film may be provided on the first portion 1006 and / or the second portion 1008 and may be attached thereto, for example, with an adhesive. The pressure or force sensitive foil may be biocompatible to allow implantation of the pressure or force sensitive foil with the tissue thickness compensator assembly 1042 within the patient.
[0046] Referring now to FIG. 23-25, the surgical gripper 1100 is shown. The gripper 1100 is similar in many respects to the various grippers elsewhere disclosed herein, such as, for example, gripper 22090 (FIG. 9). As shown in FIG. 23, the gripper 1100 may include a staple cartridge assembly 1102 that is similar, for example, in many respects to the staple cartridge 20200 assembly 20 (FIG. 6). Additionally, the gripper 1100 may include a tissue thickness compensator 1104 that is similar in many respects to the other tissue thickness compensators disclosed elsewhere in this document, such as, for example, a tissue thickness compensator 22020 (FIG. 9), a tissue thickness compensator 20220 (FIG. 6), and / or tissue thickness compensator 10020 (FIG. 4).
[0047] In addition, the gripper 1100 may include a tissue thickness compensator 1104, wherein the tissue thickness compensator 1104 may be manufactured using conventional freeze-drying techniques and / or any other suitable techniques. In at least one example, tissue thickness compensator 1104 can be formed by dissolving a polymer such as, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA) in an organic solvent and lyophilizing the solution. Tissue thickness compensator 1104 may be comprised of a biocompatible foam which may include, for example, an open-cell porous foam and / or a closed-cell porous foam.
[0048] In addition, the tissue thickness compensator 1104 may be altered or modified for use in a surgical procedure. For example, after the lyophilization process is complete, the tissue thickness compensator 1104 may be contacted with modifying member 1106 to modify the tissue thickness compensator 1104 for use in a particular surgical procedure. Under some circumstances, modification may occur after the tissue thickness compensator 1104 has been assembled with the gripper 1100, as illustrated in FIG. 23-35. For example, as shown in FIG. 23, the tissue thickness compensator 1104 may be removably mounted to the cartridge assembly 1102 and modified during assembly with the cartridge assembly 1102. In other circumstances, modification may occur prior to folding the tissue thickness compensator 1104 with the gripper 1100. In at least one example, the modification may be performed as a separate step during manufacture. In yet another example, the modification can be performed during a surgical procedure.
[0049] As described in more detail below, the modification process may include modifying the surface or multiple surfaces of the tissue thickness compensator 1104. In some circumstances, the modification process may include modifying one or more portions of the tissue compensator 1104. One or more parts may be modified in a single modification process. Alternatively, each of the plurality of parts may be individually modified in subsequent modification processes. In some circumstances, the modification process may include a thermal stamping process that may be used to change the shape, size, dimensions, and / or porosity of at least a portion of the tissue thickness compensator 1104. Additionally, the modification process may include means for creating spaces within one or more portions of the tissue thickness compensator 1104.
[0050] Referring again to FIG. 23-25, under some circumstances, portion 1107 (FIG. 23) of the tissue thickness compensator 1104 may be modified by a thermal stamping process, which may include moving portion 1107 to a glass transition state, engaging portion 1107 with modifying member 1106, applying pressure to portion 1107 while it is in a glass transition state, and allowing portion 1107 to open. cooling below the glass transition state, while modifying member 1106 is still coupled to portion 1107. Modifier 1106 may be used to maintain pressure on portions 1107 for a period of time sufficient to form a resulting modified portion 1108 (FIG. 25). Of note, the transition of the material to the glass transition can be a reversible transition from relatively hard to relatively molten or elastic in response to an increase in the temperature of the material to the glass transition temperature. The glass transition temperature of a material can be a specific temperature or, in some cases, a temperature range. The tissue thickness compensator modification process described herein takes advantage of this phenomenon by modifying the tissue thickness compensator while the tissue thickness compensator is in a flexible glass transition state and then allows the tissue thickness compensator to cool below the glass transition temperature while maintaining the modification.
[0051] In this regard, referring again to FIG. 23-25, portion 1107 of the tissue thickness compensator 1004 can be converted to a glass transition state by heating at least portion 1107 to a temperature greater than or equal to the glass transition temperature of the material that comprises portion 1107 but less than the melting point of the same. For example, the tissue thickness compensator 1104 can be composed of polyglycolic acid (PGA), and under such circumstances, portion 1107 can be converted to a glass transition by heating portion 1107 to a temperature that is greater than or equal to the glass transition temperature of polyglycolic acid (PGA). but lower than its melting point. In various instances, the glass transition temperature of polyglycolic acid (PGA) may, for example, be in the range of 35-40 ° C, and for example, its melting point may be in the range of 225-230 ° C. In at least one example, a portion 1107 of the tissue thickness compensator 1104 may be heated to a temperature that is greater than or equal to 35 ° C, but less than 225 ° C in order to transition portion 1107 to a glass transition state. In another example, for example, portion 1107 can be converted to a glass transition by heating portion 1107 to a temperature that is greater than or equal to 40 ° C but less than 200 ° C.
[0052] Additionally, modifying member 1106 may then be used to apply pressure to portion 1107 while portion 1107 is in a vitrified state. Part 1107 can leave the glass transition state, for example by cooling part 1107 to a temperature below 35 ° C. The pressure may be maintained for a period of time sufficient to allow the tissue compensator 1104 to retain or at least partially maintain the modification imposed by modifying member 1106.
[0053] In some examples, the pressure may be maintained for a period of from about 30 seconds to about 8 hours, such as during the glass transition time, and / or for a period of from about 30 seconds to about 8 hours, such as after recovery from the glass transition. In at least one example, the pressure can be held for about 10 minutes during the glass transition and for about 10 minutes after the glass transition. Other pressure holding times are contemplated in this disclosure.
[0054] In some circumstances, modifying member 1106 may be used to apply pressure to portion 1107 prior to portion 1107 becoming a glass transition. Under certain circumstances, modifying member 1106 may apply pressure to portion 1107 while portion 1107 is heated to reach a glass transition state while portion 1107 is in a glass transition state, and / or while portion 1107 is transformed or cooled to a temperature below the glass transition state. Under some circumstances, pressure on portion 1107 may be gradually increased toward the threshold as the temperature of portion 1107 is gradually increased to, for example, move portion 1107 toward the glass transition state. In some circumstances, the pressure applied to portion 1107 may be removed, gradually removed, or at least partially reduced as portion 1107 exits the glass transition state, before portion 1107 exits the glass transition state and / or after portion 1107 leaves the glass transition state.
[0055] Under some circumstances, modifying member 1106 may also be a heat source until the tissue thickness compensator portion 1107 1104 passes to the glass transition state. For example, the modifying member 1106 may include a cylindrical distal portion 1110 as shown in FIG. 24, which may include a heating coil (not shown). The user may energize the heating coil and couple portion 1107 of the tissue thickness compensator 1104 with modifying member 1106 to heat portion 1107 to a temperature that is greater than or equal to the glass transition temperature of the material composition of portion 1107. Once the desired temperature is reached, the modifying member may be pressed against the portion. 1107 as shown in FIG. 24. Alternatively, modifying member may be pressed against portion 1107 before modifying member 1106 is at the desired temperature. As described above, the pressure may be maintained for a period of time sufficient for the tissue thickness compensator 1104 to retain or at least partially retain the modification imposed by modifying member 1106. Additionally, the heating coil of modifying member 1106 may be turned off so that the temperature of portion 1107 drops below temperature. glazing. The modifier member can then be deleted.
Under certain circumstances, pressure exerted by modifying member 1106 may be initiated before portion 1107 enters the glass transition state and will be maintained throughout the glass transition state. Under some circumstances, the pressure exerted by modifying member 1106 may be released while portion 1107 is in a vitrified state.
[0056] As shown in FIG. 23-25, modifying member 1106 may be shaped to change the shape, size, dimensions, density, elasticity, and / or porosity of portion 1107 of the tissue thickness compensator 1104. For example, modified portion 1108 may include a substantially concave top surface 1114 with a diminished height H1, while the remainder of the tissue thickness compensator 1104 may maintain a substantially flat top surface containing the original height H that is greater than the reduced height H1 as shown in FIG. 25. As described above, modifying member 1106 may include a cylindrical distal portion 1110. Under such circumstances, the curvature of the resulting concave surface 1114 may, in part, be dependent on the curvature of the cylindrical portion 1110 of modifying member 1106 in contact with portion 1107 of the tissue compensator 1104 during the modification process. Additionally, the modified portion 1108 may have a new lower porosity compared to the unmodified portion 1107, which may result, at least in part, from compressive forces applied to portion 1107 by modifying member 1106 during the modification process as described above. In other words, the pressure exerted on part 1107 during the modification process can result in a material redistribution in which the section through the modified portion 1108 may have a greater material density than a similar section through the portion 1107 prior to the modification process. Additionally, the modified portion 1108 may include a different spring rate from the remainder of the tissue thickness compensator 1104, which may be partly due to changes in density and porosity obtained by the modified portion 1108 during the modification process, as described in greater detail below. In at least one instance, the specific spring deflection of the modified portion 1108 may be less or greater than the specific spring deflection of unmodified portion 1107.
[0057] Referring now to FIG. 26-34, the tissue thickness compensator may be modified prior to assembly with a gripper, such as, for example, gripper 22090 (FIG. 9). Under certain circumstances, as shown in FIG. 27, 30 and 33, the mold can be used to modify the tissue thickness compensator by a thermal stamping process as described above. For example, as shown in FIG. 26-28, the tissue thickness compensator 1120 may be modified to include the longitudinal slot 1122. Tissue thickness compensator 1120 may be similar in many respects to the other tissue thickness compensators described elsewhere, such as, for example, tissue thickness compensator 22020 (FIG. 9). For example, like compensator 22020, compensator 1120 may be used with gripper 22090. Additionally, longitudinal slot 1122 may be similar in many respects to knife slot 22025. For example, like knife slot 22025, slot 1122 may define the knife path of the tissue thickness compensator for cutting portion 10053 between the first suturing portion 1124a and the second suturing portion 1124b. In addition, the first suturing portion 1124a and the second suturing portion 1124b may be similar in many respects to the first suturing portion 22021a (FIG. 9) and the second suturing portion 22021b (FIG. 9), respectively, of a tissue thickness compensator 22020. Additionally, the slot 1122 may be configured to detachably engage the first suturing portion 1124a and the second suturing portion 1124b such that in use with the gripper 22090, the cutting portion 10053 can be advanced distally through the slot 1122 to cut the slot 1122 and separate the first suturing portion. 1124a and the second suture portion 1124b.
[0058] Referring again to FIG. 26-28, the tissue thickness compensator 1120 may be made using conventional lyophilization techniques and / or any other suitable technique. Additionally, the tissue thickness compensator 1120 may be modified or altered to create a through gap 1122. Like tissue thickness compensator 1104, tissue thickness compensator 1120 may include at least a portion of the material containing glass transition temperature and may be modified by the material entering a glass transition state. In one example, the tissue thickness compensator 1120 may be heated in an oven (not shown) to a temperature greater than or equal to the glass transition temperature of the tissue thickness compensator material composition 1120 but less than the melting point of the same material. A mold 1126 including a center beam 1128 as shown in FIG. 27 may be used to form slot 1122 by inserting the center beam 1128 into the tissue thickness compensator 1120 while the tissue thickness compensator 1120 is in a vitrified state. The tissue thickness compensator 1120 can be allowed to cool to a temperature below the glass transition temperature, while the center beam 1128 remains inserted into the tissue thickness compensator 1120. In some cases, the middle beam 1128 may be removed from the tissue thickness compensator 1120 while the tissue thickness compensator 1120 is in a vitrified state.
[0059] In some circumstances, a cooling agent may be used to actively cool the tissue compensator 1120. In some instances, the fan may be used to generate air flow through the tissue thickness compensator 1120 while the tissue thickness compensator 1120 is in the mold 1126 and / or after the tissue thickness compensator 1120 is removed from the mold. In some cases, the cooling 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 center beam 1128 may be removed after the tissue thickness compensator 1120 has passed from the glass transition state. The center beam 1128 may remain inserted into the tissue thickness compensator 1120 for a period of time sufficient to allow the tissue thickness compensator 1120 to hold, or at least substantially preserve, the space occupied by the center beam 1128. In some examples, center beam 1128 may remain inserted for a time from about 30 seconds to about 8 hours, for example, during the glass transition time, and / or for a time from about 30 seconds to about 8 hours, for example, after recovery from the glass transition state. . In at least one example, center beam 1128 may remain inserted for about 10 minutes during the glass transition and for about 10 minutes after recovery from the glass transition. Other periods of time for maintaining the center beam 1128 within the tissue thickness compensator 1120 are contemplated by the present disclosure.
[0060] In addition, as shown in FIG. 28, the pressure exerted by the center beam 1128 during the modification process may result in an increased material density in the portion 1130 of the tissue thickness compensator 1120. The portion 1130 may join the first suturing portion 1124a and the second suturing portion 1124b, thereby providing additional stability to the slot 1122. Under some circumstances, mold 1126 may include edge modifiers, such as, for example, 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 illustrated in FIG. 28.
[0061] Referring again to FIG. 26-28, it may be desirable to remove a significant amount of material from the tissue thickness compensator 1120 to form gap 1122. In such circumstances, the center beam 1128 may be heated to a temperature greater than the melting point of the tissue thickness Compensator material composition 1120. Upon insertion of the heated center beam 1128 into the tissue thickness compensator 1120, the center beam 1128 can melt through the tissue thickness compensator 1120, thereby creating a space for a slot 1122 within the tissue thickness compensator 1120 as illustrated in FIG. 28. In some circumstances, it may be desirable to gradually increase the pressure applied by the middle beam 1128 on the tissue thickness compensator 1120 to gradually insert the middle beam 1128 into the tissue thickness compensator 1120.
[0062] In some circumstances, 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 may be modified or changed such that surface 1142 of the tissue thickness compensator 1140 may include a higher material density than the remainder of the tissue thickness compensator 1140, which may be achieved in some circumstances after lyophilization. The tissue thickness compensator 1140 may be similar in many respects to the other tissue thickness compensators described elsewhere, such as, for example, the tissue thickness compensator 22020 (FIG. 9) and / or the tissue thickness compensator 1120 (FIG. 26). The surface modifier 1144 may be used to modify the surface 1142 of the tissue thickness compensator 1140 using a thermal stamping process that is similar in many respects to the thermal stamping processes 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 composed at least in part of a material having a glass transition temperature and may be modified after it has entered the glass transition state.
[0063] As described above, a tissue thickness compensator, such as a tissue thickness compensator 1140, can be converted to a glass transition state in which it is heated to a temperature greater than or equal to the glass transition temperature of the tissue thickness material composition, the compensator 1140, but less than its own. melting temperature. The surface modifier 1144 can be pressed against the surface 1142 while the tissue thickness compensator 1140 is in a vitrified state. The pressure exerted by the surface modifier 1144 can compress surface 1142, thereby increasing the material density of surface 1142. The increase in material density can be maintained by surface 1142 by allowing surface 1142 to cool below the glass transition temperature.
[0064] In some instances, the pressure exerted by the surface modifier 1144 on the surface 1142 may be maintained for a time from about 30 seconds to about 8 hours, such as during the glass transition and / or for a time from about 30 seconds to about 8 hours. for example after coming out of the glass transition state. In at least one example, the pressure can be held for about 10 minutes during the glass transition and for about 10 minutes after the glass transition. Other holding times for the pressure exerted by the surface modifier 1144 on the surface 1142 are contemplated by the present disclosure.
[0065] In some instances, a fan may be used to create airflow through the tissue thickness compensator 1140 while the tissue thickness compensator 1140 contacts the modifier 1144 and / or after removal of the tissue thickness compensator 1140 from the tissue thickness modifier 1144. In some cases, the cooling process may be used to cool the tissue thickness compensator 1140 while the tissue thickness compensator 1140 is in contact with the modifier 1144 and / or after the tissue thickness compensator 1140 has been removed from the modifier 1144. After the tissue thickness compensator 1140 has passed from the glass transition state. , in various instances, the surface modifier 1144 may be detached from the tissue thickness compensator 1140. In some circumstances, the surface modifier 1144 may include a heating member that may be used to increase the temperature of surface 1142 to a temperature greater than or equal to the glass transition temperature of the material composition ion tissue thickness compensator 1140 as described above.
[0066] Referring again to FIG. 30, the surface modifier 1144 may include, for example, a flat or at least substantially planar abutting surface 1146 for contacting surface 1142. In other circumstances, the contacting surface 1146 may include various textures, such as, for example, protrusions that may extend into the surface. 1142 compensator 1140 tissue thickness during the modification process. Under some circumstances, the surface modifier 1144 may be used to apply pressure to the surface 1142 of the tissue thickness compensator 1140 before the tissue thickness compensator 1140 is transitioned to the glass transition state. Under certain circumstances, the surface modifier 1144 may apply pressure to the surface 1142, while the tissue thickness compensator 1140 is heated to reach a glass transition state, while the tissue thickness compensator 1140 is in a glass transition state, and / or when the tissue thickness compensator 1140 is transitioning from the glass transition state. or is cooled to a temperature below the glass transition. Under certain circumstances, the pressure exerted by the surface modifier 1144 on the surface 1142 may be gradually increased towards the threshold as the temperature of the tissue thickness compensator 1140 is gradually increased, for example to move the tissue thickness compensator 1140 to a glass transition state. Under certain circumstances, the pressure applied to surface 1142 may be removed, progressively removed, or at least partially reduced as the tissue thickness compensator 1140 recovers from the glass transition, before tissue thickness compensator 1140 recovers from the glass transition and / or after tissue thickness compensator 1140 recovers. glazing.
[0067] In some circumstances, the tissue thickness compensator 1140 may be modified or changed to include skin or a dense outer layer. In some circumstances, the resulting skin or dense outer layer may include a texture, such as, for example, protrusions that may extend to surface 1142 of the tissue thickness compensator 1140. In some cases, the contacting surface 1146 of the surface modifier 1144 may be heated to a temperature greater than or equal to the melting point of the tissue thickness compensator material composition 1140. The surface modifier 1144 and / or the tissue thickness compensator 1140 may be moved to bring surface 1142 of the tissue thickness compensator 1140 into contact with the heated contact surface 1146 of the surface modifier 1144, thereby melting or at least substantially melting the surface 1142. The surface modifier 1144 and tissue thickness compensator 1140 can then be separated to allow the modified surface 1142 to cool below its melting point, which may form a skin or a dense outer layer on the tissue thickness compensator 1140.
[0068] In some instances, the contacting surface 1146 of the surface modifier 1144 may be heated prior to contacting the surface 1142. In other instances, the contacting surface 1146 of the surface modifier 1144 may be heated upon contacting the surface 1142.
[0069] In some instances, the contacting surface 1146 of the surface modifier 1144 may remain in contact with the surface 1142 of the tissue thickness compensator 1140 for a time sufficient to allow surface 1142 to flow to the desired geometry. For example, such time may be from about 30 seconds to about 8 hours; other periods are considered by this disclosure. This time may be sufficient to locally affect and / or melt the tissue thickness compensator material 1140 and bring it to a new geometry. As described herein, such new geometry may be recommended by the tooling used to fabricate the tissue thickness compensator 1140.
[0070] In some instances, surface 1142 of tissue thickness compensator 1140 may be allowed to cool or may be actively cooled to below the melting point of tissue thickness compensator 1140 prior to separating the surface modifier 1144 from the tissue thickness compensator 1140. In other instances, surface 1142 of tissue thickness compensator 1140 may be allowed to cool, or may be actively cooled to a temperature below the melting point of tissue thickness compensator 1140 after the surface modifier 1144 is separated from the tissue thickness compensator 1140.
Additionally, the modified surface 1142 can reach a density that is, for example, about 10% greater than that of the rest of the tissue thickness compensator 1140, about 20% more than the rest of the tissue thickness compensator 1140, about 30% greater than the rest of the tissue thickness compensator 1140. compensator 1140 tissue thickness, about 40% greater than the density of the rest of the compensator 1140 tissue thickness, about 50% greater than the density of the rest of the compensator 1140 tissue thickness, approx. 60% greater than the rest of the 1140 tissue thickness compensator, approx. 70% greater than the rest of the 1140 tissue thickness compensator, approx. 80% greater than the rest of the 1140 tissue thickness compensator, approx. 90% greater than the remainder of the 1140 tissue thickness compensator and / or about 100% greater than the remainder of the tissue thickness compensator 1140 in density. Under various circumstances, the modified surface 1142 may include a density that is, for example, greater than that of the remainder of the tissue thickness compensator 1140 and less than twice the density of the remainder of the tissue thickness compensator 1140. Under various circumstances, the modified surface 1142 may include, for example, a density that is more than twice as dense as the remainder of the tissue thickness compensator 1140.
[0072] Referring now to FIG. 32-34, the tissue thickness compensator 1150 may be modified to include a plurality of openings 1152 that may extend at least partially through the tissue thickness compensator 1150. The tissue thickness compensator 1150 may be similar in many respects to the other tissue thickness compensators described herein. document, such as, for example, tissue thickness compensator 20220 (FIG. 6). Like compensator 20220, compensator 1150 may be used with cartridge assembly 20200 (FIG. 6) and openings 1152 may be similar in many respects to exit holes 20224 extending at least partially through tissue thickness compensator 20220. For example, openings 20224, similarly. how holes 1152 can align with corresponding staple legs 20232 (FIG. 7), when the tissue thickness compensator 1150 is assembled with the cartridge assembly 20200 so that the staple legs 20232 can move through the exit holes 1152 in the tissue thickness Compensator 1150 as the staple legs 20232 move from the unfired configuration to the fired configuration as described above in more detail. .
[0073] In this regard, referring again to FIG. 32-34, the tissue thickness compensator 1150 may be made using conventional lyophilization techniques and / or any other suitable technique. In some circumstances, a polymer with a glass transition temperature, such as, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA), can be dissolved in an organic solvent to form a solution that can be lyophilized to provide a 1150 tissue thickness compensator. In addition, the tissue thickness compensator 1150 may be modified after lyophilization using a thermal stamping process which is similar in many respects to the thermal stamping processes used to modify, for example, tissue thickness compensator 1104, tissue thickness compensator 1120, and / or tissue thickness compensator 1140. as described above. For example, the tissue thickness compensator 1150 may be modified to include holes 1152 when the tissue thickness compensator 1150 is converted to a glass transition.
[0074] As described above, a tissue thickness compensator, such as, for example, tissue thickness compensator 1150 can be converted to a glass transition state by heating 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 1150 but less than. its melting point. A mold 1154 having a plurality of posts, pins, pins, and / or protrusions, such as, for example, needles 1156, may be used to form holes 1152 by inserting needles 1156 into the tissue thickness compensator 1150, while the tissue thickness compensator 1150 is in a condition. vitrified. Thereafter, the tissue compensator 1150 may be allowed to cool to a temperature below the glass transition temperature while the needles 1156 remain inserted into the tissue thickness compensator 1150. In some instances, needles 1156 can be removed from the tissue compensator 1150 while the tissue thickness compensator 1150 is in a vitrified state. In some instances, a fan may be used to generate airflow through the tissue thickness compensator 1150 while the tissue thickness compensator 1150 is coupled to the needles 1156 and / or after the tissue thickness compensator 1150 is disconnected from the needles 1156. In some instances, the cooling process may be used to cool the tissue compensator 1150 while the tissue compensator 1150 is coupled to the needles 1156 and / or after the tissue compensator 1150 is disconnected from the needles 1156. In various instances, the needles 1156 may be removed after the tissue thickness compensator has passed through. 1150 from the glass transition state. The needles 1156 may remain inserted into the tissue compensator 1150 for a time sufficient to allow the tissue compensator 1150 to retain, or at least substantially maintain, the spaces defining the openings 1152 that are occupied by the needles 1156. [0075] In some examples, the needles 1156 may remain inserted for a time from about 30 seconds to about 8 hours, e.g., during the glass transition and / or for example, from about 30 seconds to about 8 hours after recovery from the glass transition. . In at least one example, needles 1156 may remain inserted for about 10 minutes during the glass transition time and for about 10 minutes after recovery from the glass transition. Other holding times of the needles 1156 inserted into the tissue thickness compensator 1150 are contemplated by the present disclosure.
[0076] Under some circumstances, the needles 1156 may be removed from the tissue thickness compensator 1150 before the tissue thickness compensator 1150 has passed from the glass transition state. In other circumstances, the needles 1156 may be gradually removed over time. For example, the needles 1156 may be partially removed from the tissue thickness compensator 1150 before the tissue thickness compensator 1150 passes from the glass transition state. The needles 1156 can then be completely removed from the tissue thickness compensator 1150 after the tissue thickness compensator 1150 has passed from the glass transition state. The reader will appreciate that the greater the insertion depth of the needles 1156 into the tissue thickness compensator 1150, the greater the depth of the respective openings 1152 that may be formed in the tissue thickness compensator 1150.
[0077] Referring again to FIG. 32-34, in some instances, needles 1156 may be heated to a temperature greater than or equal to the melting point of the tissue thickness compensator material composition 1150. Additionally, needles 1156 may be inserted into tissue thickness compensator 1150 to form openings 1152 by melting, or at least partially fusing, through areas of tissue thickness compensator 1150 that receive needles 1156. In various instances, the needles 1156 may be heated prior to insertion into the tissue compensator 1150. In various instances, the needles 1156 may be heated after they have been inserted into the tissue thickness compensator 1150. In various instances, the needles 1156 may be gradually heated as the needles 1156 are inserted into the tissue thickness compensator 1150.
[0078] In some instances, the needles 1156 may remain within the tissue thickness compensator 1150 for a time sufficient to allow molten material of the tissue thickness compensator 1150 to flow to the desired geometry. Such a period of time may, for example, be from about 30 seconds to about 8 hours; other periods are considered by this disclosure. This period of time may be sufficient to locally interact and / or melt the tissue thickness compensator 1150 material and bring it to a new geometry. As described herein, such new geometry may be recommended by the tooling used to manufacture the tissue thickness compensator 1150.
[0079] In some instances, the tissue compensator 1150 may be allowed to cool or may be actively cooled to a temperature below the melting point of the tissue compensator 1150 before separating the needles 1156 from the tissue compensator 1150. In other instances, the tissue compensator 1150 may be allowed to cool or may be actively cooled to below the melting point of the tissue compensator 1150 after the needles 1156 have been separated from the tissue compensator 1150.
[0080] Referring again to FIG. 32-34, the needles 1156 may be arranged in rows extending along a length of the mold 1154, which may correspond to the rows of staples in a staple cartridge, such as, for example, a staple cartridge assembly 20200 (FIG. 6). For example, as shown in FIG. 33, the needles 1156 can be arranged in six rows, which can be shaped to form six rows of holes 1152, which can be shaped to receive six rows of staples 20230 (FIG. 7). Under certain circumstances, as shown in FIG. 33, the rows of needles 1156 may be arranged in two groups that are spaced apart and configured to receive in two portions 1158 and 1160 a tissue thickness compensator 1150, thereby forming two groups of holes 1152 separated by an intermediate portion 1162. Intermediate portion 1162 may be located at least partially over the knife slot of cartridge 22015 (FIG. 6) when the tissue thickness compensator 1150 is assembled with the staple cartridge unit 20200. In use, the launch member 10052 (FIG. 10) can be moved further to push the staple legs 20232 (FIG. 8) through the openings 1152 in portions 1158 and 1160 and further advance cutting portion 10053 (FIG. 10) to cut the intermediate portion 1162. and the separation of parts 1158 and 1160.
[0081] Referring again to FIG. 32-34, the openings 1152 may be shaped to extend within 1150 of the tissue thickness compensator and terminate a certain depth within the tissue thickness compensator 1150. The openings 1152 may have equal depths, as shown in FIG. 34. In other circumstances, holes 1152 may include varying depths (not shown). For example, the first row of holes 1152 may include a first depth and the second row of holes 1152 may include a second depth other than the first depth, yet the third row of holes 1152 may include a third depth other than the first depth and the second depth. The depth of the holes 1152 may be defined, at least in part, by the heights of the respective needles 1156. For example, a first row of needles 1156 including a first height and a second row of needles 1156 having a second height greater than the first height may form a first row of holes 1152 including a first depth and a second row of holes 1152 having a second depth that is greater than the first depth.
[0082] Referring again to FIG. 32-34, needles 1156 may be configured to define a trajectory for openings 1152 within tissue thickness compensator 1150. Under some circumstances, the needles 1156 may extend along an axis that is perpendicular and / or substantially perpendicular to the surface of the mold 1164 of the mold 1154, as illustrated in FIG. 33. Inserting the needles 1156 into the tissue thickness compensator 1150 while maintaining a parallel relationship between the surface 1164 of the mold and the surface 1166 of the tissue compensator 1150 can create a perpendicular and / or substantially perpendicular trajectory for the openings 1152 relative to the surface 1166 of the tissue compensator 1150, as illustrated in FIG. 34. In other circumstances, the needles 1156 may extend from the mold surface 1164 at an oblique angle (not shown) and / or the trajectory of the needles 1156 into the tissue thickness compensator 1150 may be such that the needles 1156 may define a non-perpendicular trajectory for the holes 1152 with respect to surface 1166 of the 1150 tissue compensator. Under some circumstances, the group of needles 1156 may be parallel and / or substantially parallel to each other, as shown in FIG. 33, resulting in a group of holes 1152 that may be parallel and / or substantially parallel to each other, as illustrated in FIG. 24. In other circumstances, although not illustrated, the group of non-parallel needles may extend from the mold surface 1164 and may produce non-parallel holes when tissue is inserted into the compensator 1150. In some circumstances, needles 1156 may be configured to form openings in tissue thickness compensator 1150 that may include a partially curved trajectory and / or a partially linear trajectory. For example, the needles 1156 may extend from the mold surface 1164 in a partially curved trajectory and may be inserted into the tissue compensator 1150 to form openings within the tissue thickness compensator 1150 with a corresponding partially curved trajectory.
[0083] Referring again to FIG. 32-34, some or all of the needles 1156 may include blunt distal ends 1168, as illustrated in FIG. 33. In other circumstances, some or all of the 1156 needles may have sharp distal ends (not shown). Some or all of the needles 1156 may include cylindrical or at least substantially cylindrical shapes, for example, as illustrated in FIG. 33. Other shapes are also considered in this disclosure.
[0084] In various instances, one or more needles 1156 protruding from the mold surface 1164 may not be inserted through the full thickness of the tissue compensator 1150. In some instances, one or more needles 1156 extending from the mold surface 1164 may be inserted through the full thickness of the tissue compensator 1150 to create holes and / or holes that extend through the full thickness of the tissue thickness compensator 1150. In some instances, one or more needles 1156 protruding from the mold surface 1164 may be inserted through the first side of the tissue compensator 1150 and out through the second side of the tissue compensator 1150, which may be opposite the first side, for example. In some instances, one or more of the needles 1156 may have a length greater than the full thickness of the tissue compensator 1150 to facilitate insertion of the one or more needles 1156 through the full thickness of the tissue thickness compensator 1150.
[0085] Referring now to FIG. 35-37, it may be desirable to resize the tissue thickness compensator. For example, one or more dimensions of the tissue thickness compensator may be matched with the dimensions of the staple cartridge to provide a better fit with the staple cartridge when the tissue thickness compensator is assembled with the staple cartridge. Under some circumstances, the tissue thickness compensator 1170 may be changed by changing its height from the first height HI as shown in FIG. 35, to the second height H2, as shown in FIG. 36. Tissue thickness compensator 1170 may be similar in many respects to other tissue thickness compensators described herein, such as, for example, tissue thickness compensator 22020 (FIG. 9), tissue thickness compensator 1140 (FIG. 29), and / or tissue thickness compensator 1150. (FIG. 32). For example, like the compensator 22020, the compensator 1170 may be used with the gripper 22090 (FIG. 9).
[0086] In various instances, referring again to FIG. 35-37, the tissue thickness compensator 1170 may be made using conventional lyophilization techniques and / or any other suitable technique. In some instances, the tissue thickness compensator 1170 may be altered, as shown in FIG. 37, using a thermal stamping process and mold 1172, for example. Mold 1172 can include a receiver 1174 configured to receive a tissue thickness compensator 1170 and an adjustment member 1176 that can be partially inserted into receiver 1174. The tissue thickness compensator 1170 can be changed when the tissue thickness compensator 1170 is converted to a glass transition state. In one embodiment, the tissue thickness compensator 1170 may be heated in an oven (not shown) to a temperature greater than or equal to the glass transition temperature of the tissue thickness compensator material composition 1170 but less than the melting point of the same material. In another embodiment, receiver 1174 and / or regulating member 1176 may include a heating member for conveying tissue thickness compensator 1170 to the glass transition state. Control member 1176 can then be inserted into receiver 1174 over a distance H3, for example, as shown in FIG. 37, thereby compressing the tissue thickness compensator 1170 and reducing its height from the first height H1 to the second height H2. In some instances, the regulating member 1176 may be inserted into the receiver 1174 before the tissue thickness compensator 1170 enters the glass transition state or so when the tissue thickness compensator 1170 enters the glass transition state. The adjuster 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 H 2 as shown in FIG. 36. The tissue thickness compensator 1170 can then be allowed to cool to below the glass transition temperature while being compressed by the control member 1176. After the tissue thickness compensator 1170 has moved from the glass transition state, the control member 1176 can be retracted. In some cases, the regulating member 1176 may be retracted before the tissue thickness compensator 1170 is clear of the glass transition state. Under some circumstances, the resizing process described above may be used to change a different dimension of the tissue thickness compensator 1170, such as the length or width of the tissue thickness compensator 1170. In some circumstances, these dimensions may be modified simultaneously or modified sequentially.
[0087] In some examples, the compression by the control member 1176 can be maintained for a period of from about 30 seconds to about 8 hours, for example, during the glass transition and / or for a period of from about 30 seconds to about 8 hours. , for example after coming out of the glass transition state. In at least one example, compression from the regulating member
1176 it can be held for about 10 minutes during the glass transition and for about minutes after recovery from the glass transition. Other periods of time to maintain the compression imposed by the adjusting member 1176 against the tissue thickness compensator 1170 are contemplated by the present disclosure.
[0088] In some circumstances, the adjusting member 1176 may be used to apply pressure to the tissue thickness compensator 1170 before the tissue thickness compensator 1170 is transferred to the glass transition state. Under some circumstances, the adjusting member 1176 may apply pressure to the tissue thickness compensator 1170 while the tissue thickness compensator 1170 is heated to achieve glass transition, while the tissue thickness compensator 1170 is in a vitrified state and / or when the tissue thickness compensator 1170 is reshaped. or cooled to below the glass transition state. Under some circumstances, the pressure on the tissue thickness compensator 1170 may gradually increase towards the threshold as the temperature of the tissue thickness compensator 1170 is gradually transformed into a glass transition state, for example. Under some circumstances, the pressure applied to the tissue thickness compensator 1170 may be removed, progressively removed, or at least partially reduced as the tissue thickness compensator 1170 recovers from the glass transition, before the tissue thickness compensator 1170 comes out of glass transition and / or after tissue thickness 1170 is equalized. from the glass transition state.
[0089] The reader will appreciate that the various forms used in the modification processes described above, such as, for example, forms 1144, 1154 and / or 1172, are illustrative examples. Other mold designs and configurations may also be used to manipulate tissue thickness compensators in a variety of ways. Additionally, the forces involved in manipulating the tissue thickness compensator require more than just compressive forces. For example, tensile forces may also be used to modify, resize and / or resize the tissue thickness compensator in a similar manner to those described above. For example, the tissue thickness compensator 1170 may be stretched by tensile forces to reduce its height from the first height H1 (FIG. 35) to the second height H 2 (FIG. 36), for example, using a modification process that is similar in many aspects of the modification processes described above. Under certain circumstances, combinations of tensile and compressive forces may be used to manipulate the tissue thickness compensator during the modification process.
[0090] Referring again to FIG. 35-37, it may be desirable to modify the porosity of the tissue thickness compensator for use in a surgical procedure. The tissue thickness compensator may include, for example, a porous open-cell foam and / or a porous closed-cell foam. Traditional lyophilization techniques may provide some control over the porosity of the tissue thickness compensator, but such control may not be readily reproducible and may require additional minor adjustments that may not be achievable with traditional lyophilization techniques. As shown in FIG. 35-37, the height of the tissue thickness compensator 1170 may be varied from a first height H1 (FIG. 35) to a second height H 2 (FIG. 36), for example, using the modification process described above. Additionally, the porosity of the tissue thickness compensator 1170 may also be modified using the same and / or a similar modification process. For example, the tissue thickness compensator 1170 may include a first porosity (FIG. 35) prior to the modification process and a second porosity (FIG. 36) after completion of the modification process, as described above. The change in porosity may be attributed, at least in part, to the compressive forces and / or energy applied to the tissue thickness compensator 1170 by the adjusting member 1176 during the modification process described above.
[0091] In addition, the tissue thickness compensator 1170 may include a plurality of pores 1180. Some or all of the pores 1180 may be altered in position, size, and / or shape, for example, as a result of the modification process described above. For example, one or more of the pores 1180 may be spherical or substantially spherical prior to the modification process, which may be changed to an oval or substantially oval shape through the modification process. In at least one example, one or more of the pores 1180 may have a fist size prior to the modification process and a second size different from the first size through the modification process. Under certain circumstances, as described in more detail below, the changes in porosity may be located in one or more regions or zones of the tissue thickness compensator 1170.
[0092] Additionally, under certain circumstances, a change in the porosity of the tissue thickness compensator 1170 may be accompanied by a change in the density of the tissue thickness compensator 1170. In other words, as the adjusting member 1176 is moved against the tissue thickness compensator 1170, the compressive forces can reduce the space occupied by the tissue thickness compensator 1170, thereby redistributing the material and / or pores, which can lead to an increase in the density of the tissue thickness compensator 1170 and / or or reducing its porosity. Under certain circumstances, as described in more detail below, the density variation may be located to one or more regions or zones of the tissue thickness compensator 1170. [0093] Additionally, changing the porosity and / or density of the tissue thickness compensator 1170 may cause the specific spring deflection of the tissue thickness compensator 1170 to change. The modulus of elasticity of the tissue thickness compensator can affect its ability to compensate for tissue thickness when the tissue thickness compensator is deployed over the tissue captured by staples, such as, for example, staples 20230 (FIG. 8) as described above in more detail. In addition, the specific deflection of the tissue thickness compensator spring may also affect its ability to apply pressure to the tissue captured by the tissue thickness compensator with a staple. In other words, changing the specific spring deflection of the tissue thickness compensator can change the pressure exerted by the tissue thickness compensator on the tissue captured by the staple. Since different tissue types may respond more positively to certain pressures, good control of the elasticity of the tissue thickness compensator can be beneficial.
[0094] As shown in FIG. 35-37, the tissue thickness compensator 1170 may include a first specific spring deflection (FIG. 35), which may be changed or modified to a second specific spring deflection (FIG. 36) different from the first specific spring deflection using the modification process described above. For example, as described above, the adjuster 1176 can be moved to the tissue thickness compensator 1170 while the tissue thickness compensator 1170 is in a vitrified state. In response, tissue thickness compressor 1170 may be compressed, which may alter the specific spring deflection of tissue thickness compensator 1170. Adjustment member 1176 can be held in the extended position for a period of time sufficient to allow the tissue thickness compensator 1170 to maintain, or at least substantially preserve, vary the specific spring deflection. Additionally, the tissue thickness compensator 1170 can be allowed to cool below the glass transition temperature of its material composition while maintaining the pressure exerted by the control member 1176 against the tissue thickness compensator 1170.
[0095] In some instances, the control member 1176 can be maintained in a position relative to the tissue thickness compensator 1170 for a period of from about 30 seconds to about 8 hours, such as during a glass transition and / or for from about 30 seconds to about 8 hours, for example after recovery from the glass transition state. In at least one example, control member 1176 can be held in a position relative to the tissue thickness compensator 1170 for about 10 minutes during the glass transition and for about 10 minutes after recovery from the glass transition. Other periods of holding the control member 1176 in an extended position relative to the tissue thickness compensator 1170 are contemplated by the present disclosure.
[0096] In some circumstances, the adjusting member 1176 may be used to apply pressure to the tissue thickness compensator 1170 to alter the specific spring deflection of the tissue thickness compensator 1170 before the tissue thickness compensator 1170 is transferred to the glass transition state. Under some circumstances, the adjusting member 1176 may apply pressure to the tissue thickness compensator 1170 while the tissue thickness compensator 1170 is heated to achieve glass transition, while the tissue thickness compensator 1170 is in a vitrified state and / or when the tissue thickness compensator 1170 is reshaped. or cooled to below the glass transition state. Under some circumstances, the pressure applied to the tissue thickness compensator 1170 may gradually increase towards the threshold as the temperature of the tissue thickness compensator 1170 is gradually increased to move, e.g., the tissue thickness compensator 1170 towards the glass transition state. Under some circumstances, the pressure applied to the tissue thickness compensator 1170 may be removed, progressively removed, or at least partially reduced as the tissue thickness compensator 1170 recovers from the glass transition state, before the tissue thickness compensator 1170 emerges from the glass transition state and / or after the compensator.
1170 tissue thickness recovers from the glass transition state.
[0097] Referring again to FIG. 35-40, tissue thickness compensator 1170 may be manufactured with native spring travel using conventional freeze-drying techniques and / or any other suitable technique. As described above, the specific spring deflection of the tissue thickness compensator 1170 may affect its ability to apply pressure to the tissue captured by the tissue thickness compensator 1170 with the staple. The modification process described above may be used to adjust the native spring deflection of the tissue thickness compensator 1170 to accommodate its ability to apply pressure to the tissue captured by the tissue thickness compensator 1170 by the staple. Under certain circumstances, the tissue thickness native spring travel 1170 may be increased from the first specific spring travel at point A (FIG. 40) to the second specific deflection of the female spring and to the maximum specific spring deflection at point B (FIG. 40). Under certain circumstances, such an increase in the specific spring deflection of the tissue thickness compensator 1170 may be achieved by applying compressive forces to the tissue thickness compensator 1170 using the adjuster 1176 while the tissue thickness compensator 1170 is in a vitrified state, as explained in the modification process described above. As shown in FIG. 40, point B represents the maximum elastic performance of the tissue thickness compensator 1170. As such, any additional compression applied by the adjusting member 1176 to the tissue thickness compensator 1170 beyond the compression threshold at point B may cause the specific spring deflection of the modified tissue thickness compensator 1170 to decrease. For example, as shown in FIG. 40, the specific spring deflection at point C is less than the specific spring deflection at point B, even when the compressive force applied by the adjusting member 1176 to the tissue thickness compensator 1170 at point C is greater than the compressive force applied at point B.
[0098] As discussed above, one or more processes may be used to influence the spring rate and / or any other property of the material used in, for example, a fastener cartridge and / or a surgical fastening tool. The specific spring deflection and / or any other material property may change during the modification process or processes. Such a change may be gradual in some circumstances, while in other circumstances the change may be sudden. In various instances, one or more steps in the modification process may increase the specific spring rate of the material to increase, while one or more steps may reduce the specific spring rate of the material. Ultimately, the net change in specific spring deflection can be measured as a comparison of the original specific spring deflection before starting the modification process and the subsequent specific spring deflection after completion of the modification process. In various instances, the material may contain an altered specific spring deflection after the material is heated and then cooled.
[0099] In some circumstances, it may be desirable to apply one or more of the above-described modification processes to the tissue thickness compensator. For example, the first modification process may be used to modify the porosity of the tissue thickness compensator as described above in relation to the tissue thickness compensator 1170. The second modification process, after the first modification process, may be used to change the surface of the tissue thickness compensator as described above in relation to the tissue thickness compensator 1140. In addition, the third modification process may be used to modify the tissue thickness compensator to include a longitudinal slot similar to the longitudinal slot 1122 of the tissue thickness compensator 1120. In yet a fourth modification process, the tissue thickness compensator may be modified to include holes similar to the holes 1152 of the tissue compensator 1150. The reader will understand that some of the above-mentioned modifications can be combined or grouped into a single modification process. For example, a mold may be designed comprising the needles 1156 of the mold 1154 and a center beam 1128 of the mold 1126. Other modifications are contemplated by this disclosure.
[0100] Referring now to FIG. 38 and 39, a tissue thickness compensator, such as a tissue thickness compensator 1190, may be altered or modified with one or more of the modification processes described above to include parts with different specific spring deflections, porosities, and / or densities. In some circumstances, the tissue thickness compensator 1190 may be modified using one or more of the modification processes described above to account for the pore gradient morphology (i.e., small pores gradually increasing in size to large pores throughout the thickness of the tissue compensator 1190 in one direction). Such morphology could be more optimal for tissue growth or hemostatic behavior. In addition, the gradient can also be compositional with a varying biological absorption profile. A short-term absorption profile may be more favorable than hemostasis, while a long-term absorption profile may help better tissue healing without leakage.
[0101] Referring again to FIG. 38 and 39, tissue thickness compensator 1190 may include one or more zone geometries that differ from the rest of the tissue thickness compensator 1196. For example, as illustrated in FIG. 38, the tissue thickness co mpensator 1190 may include one or more protruding portions, such as, for example, protruding portion 1196. Additionally, the tissue thickness compensator 1190 may include a uniform, or at least substantially uniform, first modulus, first porosity, and / or first density through a tissue thickness compensator 1190 including one or more zone geometries, as shown in FIG. 38. In some circumstances, 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 induce localized changes, such as first spring deflection, first porosity, and / or first density. The modified tissue thickness compensator 1190 may include one or more modified zones with different specific spring deflections, porosities and / or densities from other modified zones and / or first specific spring deflection, first porosity and / or first density, respectively, the remainder of the tissue thickness compensator 1190. In some circumstances, the resulting one or more modified zones may correspond to one or more zone geometries. For example, as shown in FIG. 39, the tissue thickness compensator 1190 may be altered or modified to level, or at least substantially level, protruding portion 1196 and form, for example, a flat or at least substantially flat surface 1198. The modified tissue thickness compensator 1190 may include a first portion 1192 including a first spring rate, a first porosity, and / or a first density and a second portion 1194 including a second spring rate, a second porosity, and / or a second density, which may differ from the first spring rate, respectively. proper spring, first porosity and / or first density. Second portion 1194 may correspond to protruding 1196 and may result from aligning or at least substantially aligning protruding 1196 to form, for example, a flat or at least substantially flat surface 1198. In some respects, the geometry of protruding 1196 prior to modifying tissue compensator 1190 maps, conforms to resembles or resembles the geometry of the second portion 1194 after the tissue thickness compensator 1190 has been modified.
[0102] Referring again to FIG. 37-39, the tissue thickness compensator 1190 can be altered or modified with the mold 1172 in a similar manner to the tissue thickness compensator 1170. For example, the tissue thickness compensator 1190 may be heated in the receiver 1174 to a temperature greater than or equal to the glass transition temperature of the tissue thickness compensator material composition 1190 but less than its melting point. Under some circumstances, the adjustment member 1176 can be moved over the protruding portion 1196 while the tissue thickness compensator 1190 is vitrified, thereby compressing the protruding portion 1196 and changing its geometry to form a second portion 1194 as shown in FIG. 39. Additionally, the adjusting member 1176 may be configured to maintain a compression against the protruding portion 1196 for a period of time sufficient to allow the tissue thickness compensator 1190 to maintain or at least substantially retain the modification imposed by the adjusting member 1176. Tissue thickness compensator 1190 may be allowed to cool or may be actively cooled to a temperature below its glass transition temperature while being compressed by adjusting member 1176. After tissue thickness compensator 1190 has passed from the glass transition state, adjusting member 1190 can be retracted. Tissue thickness compensator 1190 may retain or at least substantially retain the second portion 1194 as illustrated in FIG. 39. Under some circumstances, the regulating member 1176 may apply pressure to the protruding portion 1196 while the compensator
1190 the tissue thickness is heated to reach the glass transition state while the tissue thickness compensator 1190 is in the glass transition state and / or while the tissue thickness compensator 1190 is transformed or cooled to a temperature below the glass transition state. Under some circumstances, the pressure applied to the protruding portion 1196 of the tissue thickness compensator 1190 may gradually increase towards the threshold as the temperature of the tissue thickness compensator 1190 is gradually increased to move the tissue thickness compensator 1190 towards the glass transition state, for example. Under certain circumstances, the pressure applied to the protruding portion 1196 of tissue thickness compensator 1190 may be removed, progressively removed, or at least partially reduced as tissue thickness compensator 1190 recovers from glass transition, before tissue compensator 1190 emerges from glass transition and / or after compensator 1190 exits. tissue thickness from the glass transition state.
[0103] Referring now to FIG. 41-43, a tissue thickness compensator, such as a tissue thickness compensator 1200, may be prepared using conventional lyophilization techniques and / or any other suitable technique. Additionally, the tissue thickness compensator 1200 may be modified or changed in, for example, surgery. The tissue thickness compensator 1200 may be similar in many respects to other tissue thickness compensators, such as, for example, the tissue thickness compensator 22020 (FIG. 9) and / or the tissue thickness compensator 1120 (FIG. 26). For example, like the tissue thickness compensator 22020, the tissue thickness compensator 1200 may be used with the gripper 22090. In addition, as illustrated in FIG. 41-43, the tissue thickness compensator 1200 may be modified to include an elongated slot 1202 which, like knife slot 22025, may define the knife path of the tissue thickness compensator for cutting portion 10053 between the first suturing portion 1204a and the second suturing portion 1204b. In addition, the first seaming portion 1204a and the second suturing portion 1204b may be similar in many respects to the first seaming portion 2202la (FIG. 9) and the second suturing portion 2202lb (FIG. 9) of the tissue thickness compensator 22020. In addition, the slot 1202 may be configured to detachably engage the first suturing portion 1204a and the second suturing portion 1204b such that in use with the gripper 22090, the cutting portion 10053 can be advanced distally through the slot 1202 to cut the slit 1202 and separate the first suturing portion. 1204a and the second stitching portion 1204b.
[0104] Referring again to FIG. 41-43, the tissue thickness compensator 1200 may be modified prior to assembly with a gripper, such as gripper 22090 (FIG. 9). Alternatively, the tissue thickness compensator 1200 may be modified after collapsing with the gripper. As described above, the tissue thickness compensator 1200 may be prepared using conventional lyophilization techniques and / or any other suitable technique. The space wizard 1206 may be used to modify the tissue thickness compensator 1200 in a thermal stamping process, as illustrated in FIG. 41-43. For example, the space creator 1206 may be heated to a temperature greater than or equal to the melting point of the tissue thickness compensator material composition 1200. The space wizard 1206 may then be aligned and inserted into the tissue thickness compensator 1200 to form a longitudinal slot. The space wizard 1206 may melt through the tissue thickness compensator 1200 to create space for the longitudinal slot 1202. The space wizard 1206 may be retracted after the desired depth in tissue thickness compensator 1200 has been reached. Under some circumstances, the thermal stamping process may be repeated by repositioning the heated space forming device 1206 through the tissue thickness compensator 1200 to expand the space created for the longitudinal gap 1202.
[0105] Referring again to FIG. 41-43, space wizard 1206 may contain hot wire. For example, the space wizard 1206 may include a thin, taut metal wire which may be made of, for example, nichrome or stainless steel, or a thicker wire preformed into a desired shape. The hot wire can be heated by electrical resistance to the desired temperature. As the hot space wizard wire 1206 passes through the tissue thickness compensator material 1200, heat from the hot wire may evaporate the material just prior to contact. Under certain circumstances, the hot wire may have a cylindrical or substantially cylindrical shape as shown in FIG. 42. The depth of the longitudinal slot 1202 may in part depend on the depth of insertion of the space creator 1206 through the tissue thickness compensator 1200, and the width of the longitudinal slot 1202 may in part depend on the diameter of the hot wire of the space creator 1206.
[0106] In some instances, the space wizard 1206 may be partially inserted through the full thickness of the tissue thickness compensator. In some instances, the space wizard 1206 may be completely inserted through the full thickness of the tissue thickness compensator 1200 to create holes, holes, and / or gaps extending through the entire thickness of the tissue thickness compensator 1200. In some cases, the space wizard 1206 may be inserted through the first side of the tissue thickness compensator 1200 and exited through the second side of the tissue thickness compensator 1200, which may for example be opposite the first side.
[0107] Disclosed herein are a number of processes that use thermal energy to modify the tissue thickness compensator. Such processes may be called felting processes. In some instances, the felting process may also use the application of compressive and / or tensile forces to the tissue thickness compensator. In other instances, the felting process may not utilize the application of compressive and / or tensile forces to the tissue thickness compensator. In any event, the felting processes disclosed herein can also be used to modify and, for example, the corresponding implantable layer and / or the plunging material.
[0108] In various circumstances, the tissue thickness compensator may comprise a polymer composition. The polymer composition may include one or more synthetic polymers and / or one or more non-synthetic polymers. The synthetic polymer may include a synthetic absorbable polymer and / or a synthetic non-absorbable polymer. Under various circumstances, the polymer composition may include a biocompatible foam, for example. The biocompatible foam can include porous, open-cell foams and / or porous, closed-cell foams, for example. A biocompatible foam can have a uniform pore morphology or it can have a pore morphology gradient (that is, small pores gradually increase in size to large pores along the thickness of the foam in one direction). In various circumstances, the polymer composition may comprise one or more of a porous scaffold, a porous matrix, a gel matrix, a hydrogel matrix, a solution matrix, a continuous fiber matrix, a tubular matrix, a composite matrix, a membrane matrix, a biostable polymer, and a biodegradable polymer, and combinations of them. For example, the tissue thickness compensator assembly may include a foam reinforced by a filamentous matrix or may include a foam having an additional layer of hydrogel that expands in the presence of body fluids to further provide tissue compression. Under various circumstances, the tissue thickness compensator assembly may also consist of a coating on the material and / or a second or third layer that expands in the presence of body fluids to further provide tissue compression. Such a layer may be a hydrogel which may be a material of synthetic and / or natural origin and may be biopersistent and / or biodegradable, for example. In some circumstances, the tissue thickness compensator assembly may be reinforced with non-woven fibrous materials or mesh-like fibrous elements, for example, which may provide additional flexibility, stiffness and / or strength. In various circumstances, a tissue thickness compensator assembly that has a porous morphology that has a gradient structure, such as, for example, small pores on one surface and larger pores on the other surface. Such morphology may be more optimal for the tissue to grow or maintain hemostasis. Moreover, the gradient could also be a composition with a different biological absorption profile. The short-term absorption profile can be beneficial to solve hemostasis while the long-term absorption profile can solve the treatment of tissue without leakage.
[0109] Examples of non-synthetic polymers include, but are not limited to, lifted polysaccharide, glycoprotein, proteoglycans, elastin, gelatin, collagen, and oxidized regenerated cellulose (ORC). Examples of absorbable synthetic 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), copolymer of glycolide and ε-caprolactone (PGCL), copolymer of glycolide and trimethylene carbonate, poly (glycerol sebacate) (PGS), polydioxanone, poly (orthoesters), poly anhydrides (ester-amides), tyrosine-based polyarylates, tyrosine-based polyiminocarbonates, tyrosine-based polycarbonates, poly (D, L-lactide-urethane), poly (B-hydroxybutyrate), poly (E-caprolactone), polyethylene glycol (PEG), poly [( carboxylatophenoxy) phosphazene], poly (amino acids), pseudopoly (amino acids), assimilable polyurethanes and combinations thereof. Under various circumstances, the polymer composition may contain from about 50% to about 90% by weight of the PLLA polymer composition and about 50% to about 10% by weight of the PCL polymer composition, for example. In at least one circumstance, the polymer composition may contain about 70% by weight PLLA and about 30% by weight polycaprolactone, for example. Under various circumstances, the polymer composition may contain from about 55% to about 85% by weight of the PGA polymer composition and 15% to 45% by weight of the PCL polymer composition, for example. In at least one circumstance, the polymer composition may contain about 65% by weight of PGA and about 35% by weight of polycaprolactone, for example. In various circumstances, the polymer composition may contain from about 90% to about 95% by weight of the PGA polymer composition and about 5% to about 10% by weight of the PLA polymer composition, for example.
[0110] In various circumstances, the resorbable synthetic polymer may include a bioavailable, biocompatible elastomeric copolymer. Suitable biocompatible, biocompatible elastomeric copolymers include, but are not limited to, copolymers of ε-caprolactone and glycolide (preferably the molar ratio of ε-caprolactone to glycolide is 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 ε-caprolactone and lactide, including Lactide, D-lactide, and blends thereof, or copolymers of lactic acid (preferably having a molar ratio of ε-caprolactone to lactide ranging from about 35:65 to about 65:35, and more preferably 45 : 55 to 30:70) elastomeric copolymers of p-dioxanone (1,4-dioxan-2-one) and lactide including L-lactide, D-lactide and lactic acid (preferably with a molar ratio of p-dioxanone to lactide from about 40:60 up to about 60:40); elastomeric copolymers of ε-caprolactone and p-dioxanone (preferably having a molar ratio of ε-caprolactone to p-dioxanone ranging from about 30:70 to about 70:30); elastomeric copolymers of p-dioxanone and trimethylene carbonate (preferably having a molar ratio of p-dioxanone to trimethylene carbonate ranging from about 30:70 to about 70:30); elastomeric copolymers of trimethylene carbonate and glycolide (preferably having a mole ratio of trimethylene carbonate to glycolide from about 30:70 to about 70:30); elastomeric copolymers of trimethylene carbonate and lactide including Lactide, D-lactide, blends thereof or lactic acid copolymers (preferably having a mole ratio of trimethylene carbonate to lactide ranging from about 30:70 to about 70:30) and blends thereof. In one instance, the elastomeric copolymer is a copolymer of glycolide and εcaprolactone. In another circumstance, the elastomeric copolymer is a copolymer of lactide and εcaprolactone.
[0111] US Patent No. 5,468,253, describes an Elastomeric Medical Device that was issued November 21, 1995 and in US Patent No. 6,325,810, entitled Foam Buttress for
Stapling Apparatus, which was released on December 4, 2001.
[0112] Under various circumstances, the absorbable synthetic polymer may include one or more of the 90/10 poly (glycolide-L-lactide) copolymer commercially available from Ethicon, Inc. under the trade designation VICRYL (polyglactic 910), a polyglycolide commercially available from American Cyanamid Co. under the trade designation DEXON, a polydioxanone, commercially available from Ethicon, Inc. under the trade designation PDS, a random block copolymer of poly (glycolide-trimethylene carbonate) commercially available from American Cyanamid Co. under the trade designation ΜΑΧΟΝ, a 75/25 poly (glycolide-εcaprolactone) copolymer, commercially available from Ethicon, Inc. under the trade designation MONOCRYL, for example.
[0113] Examples of non-absorbable synthetic polymers include, but are not limited to, expanded polypropylene polyurethane (PP), polyethylene (PE), polycarbonate, polyamide such as nylon, polyvinyl chloride (PVC), polymethylmethacrylate (PMMA), polystyrene (PS ), polyester, polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCE), polyvinylfluoride (PVF), fluorinated ethylene propylene (FEP), polyacetal, polysulfone, and combinations thereof. Nonabsorbable synthetic polymers can include, but are not limited to, expanded elastomers and porous elastomers such as, for example, silicone, polyisoprene, and rubber. Under various circumstances, the synthetic polymers may include expanded polytetrafluoroethylene (ePTFE), commercially available from WL Gore & Associates, Inc. under the trade designation Gore-Tex Soft Tissue Patch and Polyganics co-polyether urethane foam commercially available under the trade designation NASOPORE.
[0114] The polymer composition of the tissue thickness compensator assembly may be characterized by percentage porosity, pore size and / or hardness, for example. In various circumstances, the polymer composition may exhibit a porosity percentage from about 30 vol.% To about 99 vol.%, For example. In some circumstances, the polymer composition may have a porosity percentage of from about 60 vol.% To about 98 vol.%, For example. Under various circumstances, the polymer composition may have a porosity percentage from about 85 vol.% To about 97 vol.%, For example. In at least one embodiment, the polymer composition may contain about 70% by weight of PLLA and about 30% by weight of PCL, for example, and may have about 90% porosity, for example, by volume. In at least one such embodiment, therefore, the polymer composition will contain about 10% by volume of copolymer. In at least one circumstance, the polymer composition may contain about 65% by weight of PGA and about 35% by weight of PCL, for example, it may have a porosity percentage from about 93% by volume to about 95% by volume, for example. In various circumstances, the polymer composition may have greater than 85% porosity by volume. The polymer composition may have a pore size of from about 5 microns to about 2000 microns, for example. In various circumstances, the polymer composition may have a pore size of from about 10 micrometers to about 100 micrometers, for example. In at least one such embodiment, the polymer composition may include a copolymer of PGA and PCL, for example. In some circumstances, the polymer composition may have a pore size of from about 100 microns to about 1000 microns, for example. In at least one such embodiment, the polymer composition may include a copolymer of PLLA and PCL, for example. In accordance with certain aspects, the hardness of the polymer composition may be expressed in terms of Shore hardness, which may be defined as the permanent footprint resistance of the material as determined by a durometer such as a Shore durometer. In order to determine the durometer value for a given material, pressure is applied to the material with the foot of the indenter in accordance with ASTM D2240-00 Procedure, entitled "Standard Test Method for Rubber Property-Durometer Hardness. The foot of the durometer indenter may be applied to the material for a suitable period of time, for example 15 seconds, for example, in which a reading is taken from a suitable scale. Depending on the type of scale used, a reading of 0 may be obtained when the indenter foot completely penetrates the material, and a reading of 100 may be obtained when there is no material permeation. This reading is dimensionless. In various circumstances, the hardness tester may be specified according to any suitable scale, such as a Type A scale and / or Type OO, for example according to ASTM D2240-00. Under various circumstances, the tissue thickness compensator polymer composition may have a Shore A hardness value of from about 4 A to about 16 A, for example, which is about 45 OO to about 65 OO Shore OO. In at least one such embodiment, the polymer composition may comprise a PLLA / PCL copolymer or a PGA / PCL copolymer, for example. Under various circumstances, the tissue thickness compensator polymer composition may have a Shore A hardness value of less than 15 A. Under various circumstances, the tissue thickness compensator polymer composition may have a Shore A hardness value of less than 10 A. Under various circumstances, the polymer composition of a tissue thickness compensator assembly may have a Shore a value of less than 5A. In some circumstances, the polymeric material may have a Shore OO value of the composition from about 35O to about 75O, for example.
[0115] In various circumstances, the polymer composition may contain at least two of the above-identified properties. Under various circumstances, the polymer composition may contain at least three of the above-identified properties. The polymer composition may have a porosity of 85% to 97% by volume, a pore size of 5 micrometers to 2,000 micrometers, and a Shore A hardness value of 4 A to 16 A, and a Shore hardness OO of 45 OO to 65 OO on example. In at least one circumstance, the polymer composition may contain 70% by weight of PLLA polymer composition and 30% by weight of PCL polymer composition with a porosity of 90% by volume, pore size from 100 micrometers to 1000 micrometers Shore A hardness value of 4 A 16 A and a Shore hardness value OO from 45O to 65OO, for example. In at least one circumstance, the polymer composition may contain 65% by weight of the PGA polymer composition and 35% by weight of the PCL polymer composition with a porosity of 93% to 95% by volume, a pore size of micrometers to 100 micrometers, and a Shore A hardness value of from 4 A to 16 A and a Shore hardness value OO of 45 00 to 65 00, for example.
[0116] In various circumstances, the polymer composition may contain a pharmaceutically active agent. The polymer composition can release a therapeutically effective amount of a pharmaceutically active agent. In various circumstances, the pharmaceutically active agent can be released when the polymer composition is desorbed / absorbed. In various circumstances, the pharmaceutically active agent may be released into a fluid, such as, for example, blood by passing by or through the polymer composition. Examples of pharmaceutically active agents may include, but are not limited to, hemostatic agents and drugs such as, for example, fibrin, thrombin, and oxidized regenerated cellulose (ORC); anti-inflammatory drugs such as, for example, diclofenac, aspirin, naproxen, sulindac and hydrocortisone; an antibiotic and an antibacterial drug or agents such as, for example, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, chloramphenicol; and anti-tumor agents such as, for example, cisplatin, mitomycin, adriamycin.
[0117] Various methods of changing the tissue thickness compensator are disclosed herein. Such methods may be used to alter any suitable layer for use with a fastener cartridge and / or surgical fastening tool, for example. Such a layer may contain less than one hundred percent thick composition which may be made using any suitable process. For example, such processes may include, for example, extrusion, injection molding, weaving, freeze drying, gas foaming, and / or melt-blow processes. Some processes may produce foam while other processes may not produce foam; however, in each case, all such embodiments are contemplated for use in all of the embodiments disclosed herein.
[0118] In various embodiments, referring to FIG. 44-46, the gripper of a surgical fixation tool, such as, for example, gripper 100 may be configured to grip, fix, and / or cut tissue. The gripper 100 may include a holding member cartridge 110, and in addition, a firing member 140 that is movable by the holding member cartridge 110 to arrange staples removably stored in the staple cartridge 110 in the tissue captured in the gripper 100. In various instances, the launch member 140 may be moved from the proximal position (FIG. 44) towards the distal end of the gripper 100 to simultaneously dispose of the staples and cut the tissue. There are, however, certain circumstances in which it may not be desirable to move the launch member 140 toward the distal end of the gripper 100. For example, the attachment element 110 of the gripper 100 may be removable and / or replaceable, and, in the event that the attachment element 110 is not retained in the gripper 100, it may not be desirable for the firing member 140 to be moved into the gripper 100. In the event that the firing member 140 were to pass through the gripper 100 without an insert of fastening elements in the gripper 100, the knife edge 142 of the firing member 140 may incise the tissue captured in the gripper 100 without simultaneously attaching the tissue. Similarly, in the event that the fastening element insert positioned within the gripper 100 has previously been used or worn out and at least some of the fastening elements have been removed from the fastening cartridge, it may not be desirable for the firing member 140 to be moved within the gripper 100. In the event that the firing member 140 was to be advanced by the gripper 100 with the previously used holding cartridge positioned within the gripper 100, the edge of the knife 142 of the firing member 140 may incise the gripped tissue in the gripper without securing the tissue at the same time. In various embodiments, the gripper 100 may include one or more locking systems that may prevent further movement of the firing member 140 when the attachment member 140 is not present in the gripper 100 and / or when the attachment member insert is placed in the gripper 100 at least. partially worn out. Various locking systems are disclosed in the US patent No. 6,988,649, entitled SURGICAL STAPLING INSTRUMENT HAVING SPENT CARTRIDGE LOCKOUT, and issued January 24, 2006. The entire disclosure of US Patent No. 6,988,649, entitled SURGICAL STAPLING INSTRUMENT HAVING SPENT CARTRIDGE LOCKOUT is cited herein.
[0119] Referring again to FIG. 44-46, the insertion of fasteners 110 may include a cartridge body and a tissue thickness compensator 120, wherein the tissue thickness compensator 120 may be implanted against the tissue gripped by the gripper 100 by fasteners removably stored in the cartridge body. Tissue thickness compensator 120 may be positioned above the top surface or deck of the cartridge body wherein staples 180 removably retained in the staple cavities defined in the cartridge body can be ejected from the staple cavities by a firing member such as a sled 130 and / or a firing member 140. , e.g. In some embodiments, the fastener cartridge 110 may further include drive means configured to support the staples 180 and transmit the movement of the sled 130 to the staples 180 to move the staples 180 between the non-fired position and the fired position. In various instances, the staples 180 may be at least partially embedded in the tissue thickness compensator 120 when the staples 180 are in their non-fired positions and, in some cases, the staples 180 may hold the tissue thickness compensator 120 in position above the fastener cartridge when the staples 180 are in position. in their non-firing position. In the event that the tissue thickness compensator 120 was to be moved relative to the cartridge body and / or staples 180 prior to inserting the staples 180 into the tissue, in some cases, the tissue thickness compensator 120 may move the staples 180 relative to or away from their preferred positions. Additionally, in the event that the tissue thickness compensator 120 was to be removed from the cartridge 110 prior to the insertion of the staples 180, the cartridge 110 may no longer be fit for the originally intended use. In view of the above, as discussed in more detail below, the gripper 100 may include an interlock configured to prevent further movement of the launch member 140 and / or sled 130 to arrange the staples 180 in the event that the tissue thickness compensator 120 is removed or at least partially pushed out of the way. cartridge body before inserting 180 staples.
[0120] Referring again to FIG. 44-46, the tissue thickness compensator 120 may include one body 121 configured to be captured by staples 180 and two a locking pin 122 extending from the body 121. In various instances, the locking pin 122 may include a first end 123 embedded in the body 121 and a second end 124 positioned indirectly on the firing member 140 and on the sled 130 when the tissue thickness compensator 120 has not been removed or substantially moved out of position above the deck of the cartridge body. In such a position, the second end 124 of the locking pin 122 may be positioned indirectly in a flange or shelf 134 formed on the sled 130 and a protrusion 144 extending outwardly from the launch rod 140. Alternatively depicted, when the locking pin 122 is positioned indirectly on the slide 130 and the launch rod 140, the locking pin 122 and the slide 130 can cooperate to support the firing rod 140 in the unlocked position over the locking arm 112 defined on the fastener insert 110 such that as further firing force is applied to the fire rod 140, the firing rod 140 may advance the slide 130 further to fire the staples 180. When the tissue thickness compensator 120 has been removed from the cartridge 110 and / or sufficiently displaced from the desired position with respect to the cartridge body, referring primarily to FIG. 45, the locking pin 122 may no longer be indirectly positioned on the sled 130 and launch member 140 and / or may otherwise not be able to hold the launch member 140 in its open position (FIG. 44). In such circumstances, the firing member 140 may be set in a locked position to prevent further movement of the firing member 140 by the locking arm 112. In at least one of such situations, the gripper 100 may further include a biasing member such as, for example, a spring configured to bias the firing member. 140 to the locked state. Under some circumstances, the biasing member may, for example, bias the firing member 140 into contacting the slide 130, for example, without a locking pin 122 therebetween, which may include the locked position of the firing member 140.
[0121] As a result, the cartridge 110 may fail if the tissue thickness compensator 120 is prematurely removed from the cartridge 110. In such circumstances, the locking pin 122 may include a fuse that deactivates the cartridge 110 in the event that the thickness compensator 120 is removed before it is removed. the launch member 140 will be moved further. In various circumstances, locking pin 122 may include a key that keeps cartridge 110 unlocked when the key is positioned between carriage 130 and firing member 140, and allows cartridge 110 to enter a locked state when tissue thickness compensator 120 is removed from cartridge 110. before the firing member 140 is advanced further, i.e., before the firing member 140 begins its firing motion.
When the firing member 140 is in the locked state and cannot be moved further, the knife edge 142 of the firing member 140 is unable to incise the tissue trapped in the gripper 100. Additionally, in such circumstances, the firing member 140 cannot advance the slide 130 further to fire 180 staples. Thus, locking of the tissue thickness compensator may prevent the tissue captured in the gripper 100 from being cut and sutured when the tissue thickness compensator 120 is not positioned or properly seated on the pad 110. In the event that the firing member 140 is advanced distal before the tissue thickness compensator 120 removed or displaced, the launch member 140 may complete the fire stroke, or at least a portion of the fire stroke, of the gripper 100. In such cases, the slide 130 is moved a distance such that one or more ramps 132 defined on the slide 130 can pick up the staples 180 and that the edge of knife 142 of the launch member 140 can cut the tissue thickness compensator 120 and / or the tissue captured in the gripper 100. Under some circumstances, the launch member 140 may contact the locking pin 122 and move it out of the way as the launch member 140 is moved on. In such circumstances, the locking pin 122 may be flexible. In various instances, the locking pin 122 may be, for example, made of a bio-absorbable material and / or a biocompatible material. Under some circumstances, the launch member 140 may notch the locking pin 122 as the launch member 140 is moved distally. In any event, the target of locking pin 122 may become obsolete when firing member 140 is at least partially extended. In other words, the lock of the tissue thickness compensator can serve as a preliminary check to verify that the tissue thickness compensator is present in the gripper and, after the initial check is performed, the gripper firing stroke can be performed.
[0122] Referring again to FIG. 47-50, the gripper 200 may include an anvil 260, and a further insertion of fasteners 210 including a cartridge body 214 and a tissue thickness compensator 220 wherein, in addition to the above, a tissue thickness compensator 220 may be implanted against tissue gripped by gripper 200 by means of fasteners removably stored in the cartridge body 214. Tissue thickness compensator 220 may be positioned above the top surface or deck 211 of cartridge body 214, wherein removable staples retained in staple cavities defined in cartridge body 214 may be ejected from the tab cavities by a firing member such as a sled 230 and / or a member. firing 240, for example. In some embodiments, the fastener cartridge 210 may further include driving members configured to support the staples and transmit the movement of the sledge 230 to the staples for moving the staples between the unfired position and the fired position. In various instances, the staples may be at least partially embedded in the tissue thickness compensator 220 when the staples are in their non-fired positions, and, in some cases, the staples may hold the tissue thickness compensator 220 in position when the staples are in their unfired position. In the event that the tissue thickness compensator 220 is moved relative to the cartridge body 214 and / or the staples prior to the insertion of the staples into the tissue, in some instances the tissue thickness compensator 220 may move the staples relative to or out of their preferred positions. Additionally, in the event that the tissue thickness compensator 220 is removed from the cartridge 210 prior to unfolding the staples, the cartridge 210 may no longer be fit for its originally intended use. In view of the above, as discussed in more detail below, the gripper 200 may include an interlock configured to prevent further movement of the launch member 240 and / or sled 230 to arrange the staples in the event that the tissue thickness compensator 220 is removed or at least partially pushed out of the way. cartridge body 214 prior to disposing of the staples.
[0123] Referring again to FIG. 44-46, the tissue thickness compensator 220 may include one body 221 configured to be gripped by staples and two a loop or tether 222 extending from body 221. In various instances, referring primarily to FIG. 47, the loop 222 may include ends that are at least partially seated in the body 221 and an intermediate portion extending between ends that may be releasably engaged with the sled 230. In some instances, loop 222 may, for example, include a seam or elastic thread. In some instances, loop 222 may, for example, consist of a bio-absorbable material and / or a biocompatible material. Referring mainly to FIG. 48, the carriage 230 may include an elongated body portion 236, a hook 238 extending from the body portion 236, and a slot 237 formed between the body portion 236 and the hook 238. As shown in FIG. 48, the loop 222 is located in the slot 237 with the tissue thickness compensator 220 positioned above the cartridge deck 211 and the carriage 230 and the firing member 240 in the unexploited position. As also illustrated in FIG. 48, a distal protrusion 244 extending from the launch member 240 is positioned opposite and / or above a support arm 234 defined on sled 230 that holds the launch member 240 in an unlocked position, i.e. In a position where further movement of the firing member 240 will not be hindered or at least significantly impeded by the locking arm 212 defined in the gripper 200 when the firing motion is applied to the firing member 240. Thus, as the slide 230 retains the firing member 240 in its position, unlocked position with reference to FIG. 49, the launch member 240 will move past the locking arm 212 to advance the carriage 230 further, shoot the staples removably stored in the cartridge body 214, and incise the tissue thickness compensator and tissue gripper 200 with the edge of the knife 242. As shown in FIG. 49, the loop 222 may slide out of the slot 237 defined on the sled 230 as the sled 230 is advanced further.
[0124] In the event that the tissue thickness compensator 220 is removed from the cartridge 210 or substantially shifted from the appropriate position above deck 211 of cartridge 210, referring now to FIG. 50, the tissue thickness compensator 220 may pull the sled 230 in the distal direction such that the firing member 240 is no longer supported by the sled 230. Specifically, the loop 222 of the tissue thickness compensator 220 disposed in the slot 237 may pull the slide 230 further from its unexploited position such that the support arm 234 is no longer positioned under the distal protrusion 244 of the launch member 240. Under such circumstances, the firing member 240 may slide into position. down to a locked position in which further movement of the firing member 240 may be impeded by the locking arm 212. Under some circumstances, gripper 200 may additionally include a biasing member, such as a spring, that may bias the firing member 240 into a locked state. When the firing member 240 is in the locked state, the firing member 240 cannot be moved any further to advance the slide 230, shoot staples from the cartridge body 210, and / or cut the tissue captured in gripper 200. Although the carriage 230 may be advanced further as the tissue thickness compensator 220 is removed from the cartridge 210, the carriage 230, under various circumstances, may not be unfolded sufficiently to remove the staples from the cartridge 210. When the user of the surgical instrument recognizes that the firing member 240 is in a locked state, the user may remove the staple cartridge 210 from the gripper 200 and replace it with, for example, a staple cartridge 210 where the tissue thickness compensator 220 is properly seated on deck 211 and carriage 230 is not have been moved farther from its unused position. Other embodiments are contemplated in which the staple insert is not removable from the gripper; in such embodiments, the gripper may be completely replaced in the event that the tissue thickness compensator is removed from the staple cartridge and / or the firing member enters the locked state.
[0125] Turning now to FIG. 51-53, the staple cartridge 310 may include a cartridge body 314 and a carriage 330 movably positioned within the cartridge body 314. As above, the cartridge body 314 may include a plurality of mounting recesses, such as, for example, recesses 316, and a longitudinal slot such as, for example, a knife slot 318 defined therein. The carriage 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 mainly to FIG. 51, insert tissue thickness compensator 320 310 may include a body portion 321 and a detent 322 extending from a body portion 321, wherein the detent 322 may be releasably retained in a gap 337 formed between the hook 338 and a central body portion 336. When sled 330 is in the unfired or fired position. As above, the detent 322 may include ends 323 mounted in body 321 and may extend proximal to body 321 of the tissue thickness compensator 320, in which, in the event that the tissue thickness compensator 320 is removed from the cartridge body 314, for example, the tab 322 can pull the sledge 330 further such that the support arm 334 defined in the central portion 336 of the body is no longer able to support a launch member such as launch member 240. for example on it, and so that the firing member may enter the locked state. In various instances, the user of the surgical instrument may attempt to reassemble or reposition the tissue thickness compensator 320 on the deck 311 of the cartridge body 314; however, the firing member 340 will still remain in the locked state since repositioning the tissue thickness compensator 320 will not reset the slide 330. Thus, such an arrangement may prevent the use of cartridge 310 if it has previously been tampered with.
[0126] In various instances, referring again to FIG. 51-53, at least a portion of the hook 338 extending from the central portion 336 of the sled 330 and / or the slot 337 formed therebetween may extend above deck 311. In some cases, at least a portion of the hook 338 extending from the central portion 336 of the slide 330 and / or the slot 337 defined therebetween may extend above the knife gap 318. In such embodiments, the detent 322 may be easily slipped into the slot 337 when the tissue thickness compensator 320 is assembled with the cartridge body 314. In some instances, the detent 322 may be located above or relative to the deck surface 311 of the cartridge body 314. In various instances referring mainly to FIG. 53, the cartridge body 314 may include a recess or recess 319 defined therein, within which the hook 338 may be positioned when the carriage 330 is in an unexpired or fired position. In such an embodiment, the top portion of hook 338 may be positioned below deck surface 311. In various instances, pocket 319 may additionally include one or more sloped surfaces 313 that define the distal end of pocket 319 and extend downwardly from deck surface 311. In some instances, the detent 322 may abut the sloped surfaces 313 when the sled 330 is extended a distance and, under such circumstances, the catch 338 may then separate from the catch 322. In various instances, the recess 319 may be shaped to facilitate mounting of the sled fastener 322 to the sled 330 when the tissue thickness compensator 320 is assembled with the cartridge body 314. In various embodiments, the slot 337 may extend longitudinally and may include a closed distal end, an open proximal end in which the detent 322 may be inserted into the slot 337 from the open proximal end. In the event that the tissue thickness compensator 320 is not prematurely removed or removed from the insert 314, the sled 330 may be moved a distance so that the detent 322 extends from the slot 337 through its distal end and so that the ramps 332 defined on the sled 330 can advance. staples from a cartridge of 310 staples.
[0127] In various instances, the tissue thickness compensator may be adhered to the sled by at least one adhesive. In such cases, the adhesive bond between the tissue thickness compensator and the slide may be strong enough to allow the tissue thickness compensator to extend the slide distal in the event that the tissue thickness compensator is removed from the cartridge. When the slide is advanced by the firing member on the firing stroke, the adhesive bond between the tissue thickness compensator and the slide may fail, allowing the slide to slide further relative to the tissue thickness compensator. In various instances, the tissue thickness compensator may be bonded to the sled using a heating process and / or a thermoforming process. In such cases, the bond between the tissue thickness compensator and the slide may be strong enough to allow the tissue thickness compensator to extend the slide distal in the event that the tissue thickness compensator is removed from the cartridge. As the slide is advanced by the firing member on the firing stroke, bonding between the tissue thickness compensator and the slide may fail, allowing the slide to slide further relative to the tissue thickness compensator.
[0128] In some instances, the loop, tab and / or tab may, for example, be formed integral with the tissue thickness compensator. In various instances, the loop, tab and / or tab may, for example, comprise a unitary piece of material with a tissue thickness compensator. In some cases, an additional layer can be attached to the tissue thickness compensator. This layer, in various cases, may include a securing portion coupled to the slide.
[0129] Turning now to FIG. 54, carriage 430 may include, like the above, a central portion 436 of the body, in addition a plurality of ramps 432 that are configured to advance staples removably stored in the cartridge body, for example. Similar to the above, the body portion 436 may include an extending hook 438 in which a gap 437 may be formed between the body portion 436 and the hook 438. In some instances, the slot 437 may include a closed distal end 437a and an open proximal end 437d. In various instances, the slot 437 may further include a first portion 437b extending in the first direction and a second portion 437c extending in the second direction. In some instances, the first portion 437b may extend along the longitudinal axis and the second portion 437c may extend along a second axis that is transverse to the longitudinal axis. In at least one such case, second portion 437c may extend at an angle with respect to first portion 437b.
[0130] Turning now to FIG. 55-58, the sled assembly 530 may include a first portion 535, and further, a second portion 536 that is movable with respect to the first portion 535 between an unlocked position (FIGS. 55 and 57) and a locked position (FIGS. 56 and 58). First portion 535 may include one central portion configured to slide in a longitudinal slot, such as a knife slot 518 defined in, for example, staple cartridge 510, and two, plurality of ramps 532 configured to release staples releasably stored in cartridge 510. a portion of the first portion 535 may include a first slot 533a and a second slot 533b defined therein. The first slot 533a and the second slot 533b may be formed to receive pins 53a and 53lb extending from the second portion 536. The first pin 53a may be configured to slide in the first socket 533a and the second pin 531b may be configured to slide in. the second slot 533b to allow the second portion 536 to pivot relative to the first portion 535. In various instances, the first pin 531a may be closely seated within the first hole 533a such that the first slot 533a may restrict the movement of the first pin 531a along the first path and, similarly, the second pin 531b may be closely seated within the second slot 533b such that the second slot 533b may limit the movement of second pin 531b along the second track. Referring mainly to FIG. 57, second portion 536 of sled assembly 530 may include an arm configured to slide through knife slot 518, wherein the arm may include a support arm 534 defined at the proximal end thereof and a hook 538 defined at the distal end thereof. Similar to the above, support arm 534 may be configured to support firing member 240, e.g., in an unlocked position, when sled assembly 530 is in a proximal, non-fired position and tissue thickness compensator 220, e.g., is positioned over and / or on the deck area 511 of the insert 510. As above, the hook 538 may be configured to releasably hold the loop 222 of the tissue thickness compensator 220 so that in the event that the tissue thickness compensator 220 were to be removed and / or substantially displaced with respect to the cartridge body, the loop 222 could pull over the second portion 536. to rotate second portion 536 to its locked position as illustrated in FIG. 58. In this locked position of second portion 536, support arm 534 may no longer support distal projection 244 of launch member 240, and launch member 240 may drop down to its locked position. As shown in FIG. 58, rotation of the second portion 536 to its locked position can move support arm 534 further and / or down from the launch member 240. As also shown in FIG. 58, the launch member 240 may include an interlock 541 extending from opposite sides thereof, which may be shaped to abut the locking arm 212 when the launch member 240 is in its locked position. When firing member 240 is held in its unlocked position by sled assembly 530, locks 541 may not be in contact with locking protrusion 212 and firing member 240 may be slid by cartridge 510.
[0131] In various instances, as discussed above, a portion of the staple driven sled may extend above the deck surface of the cartridge body. For example, referring again to FIG. 52 and 54, a sled hook 338 330 (FIG. 52) and / or a sled hook 438 430, for example, may extend above the deck surface. In such instances, the hook 338 and / or the hook 438 may extend beyond the deck surface and, in some cases, contact a tissue thickness compensator located on or above the deck surface. In some instances, the hook 338 and / or the hook 438 can lift the tissue thickness compensator away from the cartridge body and facilitate progressive removal of the tissue thickness compensator from the pad. For example, hook 338 and / or hook 438 may begin at the proximal end of the tissue thickness compensator and move towards the distal end of the tissue thickness compensator to initially lift the proximal end of the tissue thickness compensator, then progressively move it away from the cartridge until the distal end of the tissue thickness compensator. the thickness of the tissue will eventually be lifted from the cartridge body. In other instances, as discussed in more detail below, it may be preferable that the portion of the sled contacting the tissue thickness compensator deflects downward and / or otherwise not interfering with the tissue thickness compensator as the sled is moved a distance.
[0132] Turning now to FIG. 59 and 60, the staple cartridge 610 may include a cartridge body 614, a tissue thickness compensator 620 releasably releasable into the cartridge body 614, and a carriage 630 configured to longitudinally advance the cartridge body 614 and to retrieve staples removably stored therein. The carriage 630 may include a main body portion 635 having a plurality of ramp surfaces defined therein, a support arm 634, and an arm 636 extending from the body portion 635. In various instances, the arm 636 may be assembled with the main body portion 635. For example, the arm 636 may include a first end embedded in the main body 635 and a second end including a hook 638, for example. In various instances, the arm 636 may include a cantilever beam extending from the main body portion 635. In some instances, the arm 636 may be comprised of, for example, resilient and / or flexible material. Similar to the above, a slot 637 may be defined between the detent 638 and the arm 636, which may be configured to releasably hold a portion of the tissue thickness compensator 620 when the slide 630 is in its proximal, non-fired position. In the event that the tissue thickness compensator 620 is pulled out of the cartridge body 614, the tissue thickness compensator 620 may pull the slide 630 away from the firing member such that the firing member enters a locked state.
[0133] In various instances above the above, at least a portion of the arm 636, such as the hook 638, may, for example, extend above the deck surface 611 of the cartridge body 614. In some instances, arm 636 may engage a loop, e.g., extending from tissue compensator 620 when sled 630 is in its proximal position (FIG. 59), and as sled 630 is advanced further, arm 636 may disengage from the tissue compensator 620. loop. As the slide 630 is moved further, in some instances, arm 636 may contact a portion of the body 621 of the tissue thickness compensator 620 and bend downward. In various instances, deflected arm 636 may slide in the knife longitudinal slot 618 defined in the cartridge body 614 as the slide 630 is extended further. In some instances, referring to FIG. 60, the distal end of the longitudinal slot 618 may be defined by the nose wall or the roof 619 in which, when the sled 630 reaches the distal end 617 of the cartridge 610, the arm 636 can slide under the nose wall 619 so that the gripper firing stroke can be completed. In some instances, the arm 636 may not be deflected or substantially deflected downward by the tissue thickness compensator 620, in which, as arm 636 reaches the end of the longitudinal slot 618, arm 636 may contact the nasal wall 618 and bend downward to slide. as shown in FIG. 60. As a result, flexible arm 636 under various circumstances may allow the firing stroke to be completed and the sled 630 parked at the distal end of the cartridge.
[0134] Turning now to FIG. 61, e.g., a sled, e.g., sled assembly 730, may include a main body portion 735 and a moveable arm 736. As above, main body portion 735 may include one or more staple-pick-up ramps 732 and an arm support 734 configured to support the launch member in the frame. unlocked position as described above. Arm 736 may include a first end pivotally and / or pivotally mounted to the main body portion 735 and a second end including a hook 738 configured to releasably engage a tissue thickness compensator as described above. As sled assembly 730 is extended further, hook 738 may disengage from the tissue thickness compensator; however, the upper surface of the hook 738 may be in contact with the lower surface of the tissue thickness compensator. Under such circumstances, arm 736 may pivot downward into knife slot 318, for example, to slide under the tissue thickness compensator. In particular, arm 736 can pivot from a raised or upper position (FIG. 61) to a lowered or lower position. In various instances, sled assembly 730 may further include a resilient biasing member, such as, for example, a spring 731 configured to bias arm 736 into its raised position. When arm 736 is pivoted down to the lowered position, spring 731 can apply a biasing force to arm 736 that is transferred to the tissue thickness compensator. In some cases, spring 731 may be positioned between arm 736 and a frame portion 733 formed on main body portion 735. In various instances, spring 731 may include a cantilever spring or a leaf spring, for example, extending from arm 736. When arm 736 is biased downward, the cantilever spring may be shaped to bend and / or slide along the frame portion 731, for example. In various embodiments, main body portion 735 may further include, for example, a stop arm 739 that may restrict the upward or moving movement of arm 736. In any event, as above, the arm 736 may be configured to pivot downward as it contacts the roof 619 and allows the stroke to end.
[0135] In various instances, the staple can include a base and one or more legs extending from the base. In some instances, the staple may include a base including a first end and a second end, a first arm extending from the first end, and a second arm extending from the second end. In some cases, the staple may be formed from a continuous wire that includes a first leg, a base, and a second leg. The first end of the continuous wire may include the tip of the first leg of the stapler, and the second end of the continuous wire may include the tip of the second leg of the stapler. One such staple, i.e., a staple 800, is shown in FIG. 62 for example. The staple 800 may include a base 802, a first staple leg 804 extending from the first end of the base 802, and a second staple leg 804 extending from the second end of the base 802. The first staple arm 804 may include a first end 806, and similarly, the second staple base 804 may include a second end 806. In various instances, the tips 806 may be configured to penetrate tissue, such as the tissue T shown in FIG. 62 for example. In some instances, tips 806 may be sharp and may be formed, for example, by a flaring process. In various embodiments, the wire may consist of, for example, titanium and / or stainless steel.
[0136] In various embodiments, staple 800 may be, for example, U-shaped or at least substantially U-shaped when in its unformed configuration. In such embodiments, the legs 804 of the staple 800 may be parallel or at least substantially parallel to each other. Additionally, in such embodiments, legs 804 may be perpendicular, or at least substantially perpendicular, to base 802. In some embodiments, staple 800 may be, for example, V-shaped, or at least substantially V-shaped when in its unformed configuration. In such embodiments, the legs 804 of the staple 800 are not parallel to each other; rather, legs 804 may protrude in non-parallel directions. Additionally, in such embodiments, one or both of the legs 804 are not perpendicular to the base 802, and one or both of the legs 804 may extend in directions that are oblique to the base 802. In various instances, the legs 804 may protrude or extend. outward from the center or centerline of the staple. In any event, the staple 800 may be removably stored in the staple cartridge ejected from the staple cartridge for tissue penetration, as illustrated in FIG. 62, and then comes into contact with an anvil located on the opposite side of the tissue. The anvil may be shaped to deform the staple 800 into any suitable shape, such as, for example, a B-shape, as also illustrated in FIG. 62. Various forms of staple configurations, such as, for example, a B-shape, may define a tissue retention area, such as a tissue retention area 807, configured, for example, to retain tissue in a staple.
[0137] As discussed above, the staple may be removably stored in a cavity defined in the cartridge body. A cartridge body 810 is shown in FIG. 63, which may include 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 including a longitudinal end of the gripper, for example, first end 814 may include a proximal end of the staple recess 812 and the second end 814 may include a distal end of the staple recess 812. In various instances, a staple may be positioned within the staple cavity 812 such that the first staple leg 804 is located at the first end 814 of the staple cavity 812 and the second leg 804 is located at the second end 814. In various instances, the width of the staple cavity may be defined between the ends 814 of the staple cavity 812. The staple base 802 may be defined by the width of the staple base, which may be equal to or less than the width of the staple recess, for example. In some instances, the staple may include a staple width which may be defined between the peaks 806 of the staple legs 804. In some embodiments, the width of the staple may be equal to the width of the staple recess. In various embodiments, the width of the staple may be wider than the width of the staple recess. In such embodiments, the legs 804 may contact the ends 814 of the staple cavity 812 and may be resiliently biased in an inward direction by the ends 814 when the staple is inserted into the staple cavity 812. When the staple is lifted up from the staple cavity 812, the legs 804 may resiliently extend outward as they exit from the staple cavity 812. For example, a staple may be positioned within the staple cavity 812 such that the tops 806 of the staple legs 804 do not extend above the top surface or base plate of the cartridge body 810 when the staple is in its unfired or un-raised position. In such a position, the apexes 806 may be aligned with or below the base plate 811 of the cartridge body 810. Alternatively, the tops 806 of the legs 804 may at least partially extend above the base plate 811 of the cartridge body 810. Whenever the staple is lifted upward, the staple tips 806 may extend over the base plate 811 and extend outward as the legs 804 exit the cavity 812. At some point while lifting the staple, the legs 804 may no longer be in contact with the ends 814 of the staple cavity 812 and the legs 804 can no longer be biased inwardly by the side walls of the staple cavity 812.
[0138] In various instances, the anvil may include one or more pockets configured to receive the tops 806 of staples 804 when the staple 800 is ejected from the staple cartridge. The anvil pockets may be configured to pivot or bend, for example, the legs of the staples 804 inward toward each other. In other instances, the anvil pockets may be configured to pivot or bend, for example, the legs of the staples 804 outwardly away from each other. In some cases, however, one or more of the legs of the staple may not be in contact with the anvil and may not be deformed at all. In any event, the staple may inappropriately grasp and / or retain the tissue in its tissue retention area. Additionally, poorly formed or unshaped staples may not be able to exert the desired compressive pressure on the tissue. In some cases, poorly formed or unformed staples may not be retained in the tissue and may be removed from the tissue.
[0139] Referring again to FIG. 62, staple 800, and / or various other staples disclosed herein may include one or more barbs protruding therefrom. In various instances, the barbs may be shaped to engage the tissue gripped within and / or surrounding the staple. In some cases, barbs can help retain the staples in the tissue, especially when the staple has been poorly formed or unformed. The staple 800 may include barbs extending from one or both of the legs 804. For example, each leg 804 may include one or more barbs 808 that point outward away from the center of staple 800 and / or one or more barbs 809 that point inward toward the center of staple 800, for example. In some instances, barbs 808 may extend from tissue stop area 807 and / or barbs 809 may extend toward or into tissue stop area 807. As shown in FIG. 62, both staple legs 804, staples 800 may include barbs 808 and barbs 809. In some instances, staple legs 804 may include barbs 808 but not barbs 809. Staple 820 is depicted in FIG. 63, which includes barbs 808 but not barbs 809. In some instances, the staple legs 804 may include barbs 809, but not barbs 808. Staples 830, 840, 850, 860, and 870 are shown in FIG. 64, 65, 66, 67, and 68, which include barbs 809 but not barbs 808. In some embodiments, the first staple leg 804 may include barbs 808, while the second staple leg 804 may include barbs 809, for example.
[0140] In various instances, the legs 804 and the staple base 802 may define the plane of the staple when the staple has an unformed configuration. The barbs 808 may extend outwardly from the legs 804 in such a staple plane. Similarly, the barbs 809 may extend inwardly from the legs 804 in such a plane. In some instances, a staple can include barbs that extend transversely to such a plane of stitching. Other embodiments may be envisaged in which the legs 804 and base 802 do not or completely lie in one plane. In such embodiments, the barbs may protrude in any suitable direction. In various embodiments, referring now to FIG. 67, a staple, such as staple 860, may, for example, include barbs 803 extending from base 802. In various instances, barbs 803 may extend inward toward the tissue retention area 807 of staple 860. In some instances, barbs 803 may extend outwardly from the tissue arrest area 807. As illustrated in FIG. 67, barbs 803 may extend in the plane of the staple defined by the legs 804 and base 802. In some instances, barbs 803 may extend transversely to such a seaming plane. Various exemplary barb designs are discussed in more detail below.
[0141] In various instances, the staple leg 804 may include an array of barbs 808 that extends along its entire length. In some instances, the staple leg 804 can include a barbed arrangement 808 that extends along less than its entire length. By way of example only, referring to FIG. 62, each leg 804 of staple 800 includes a barbed array 808 that extends along less than the entire length of the leg 804. Similarly, with reference to FIG. 63, each of the legs 804 of staple 820 includes a bar pattern 808 that extends along less than the entire length of the leg 804. With respect to staple 800, for example, bar pattern 808 may extend along each leg 804 from the base 802 of staple 800 in. towards the tops 806 of the legs 804. As shown in FIG. 62, the barb arrays 808 may not extend to the tips 806 of the legs 804. In various instances, the barb arrays 808 may extend, for example, to half or approximately half the length of the legs 804; however, any suitable length of the barbed arrangements may be used. For example, the barb patterns 808 may extend along less than half or more than half the length of the legs 804. In some embodiments, the bar pattern 808 may extend along each of the legs 804 from the tops 806 of the legs 804 toward the base 802. In such embodiments, the bar pattern 808 may not extend to the base 802. In some embodiments, the leg 804 may include a bar pattern 808 that does not extend to the apex 806 of the leg 804 or base 802. In some embodiments, the leg 804 may contain more than one arrangement of barbs 808.
[0142] In various instances, in addition to the above, the staple leg 804 may include an array of barbs 809 that extends along its entire length. By way of example only, referring to FIG. 64, the legs 804 of staple 830 include a barb pattern 809 that extends along the entire length of the legs 804. In some instances, the staple leg 804 may include a barb pattern 809 that extends less than its full length. By way of example only, referring to FIG. 65, each of the legs 804 of the staple 840 includes a barbed arrangement 809 that extends less than the full length of the legs 804. Similarly, referring to FIG. 68, each leg 804 of staple 870 includes an array of barbs 809 that extends less than the full length of the legs 804. With respect to staple 840, for example, the array of barbs 809 may extend along each of the legs 804 from the base 802 of staple 840 in. towards the tops 806 of the legs 804. As shown in FIG. 65, the barr patterns 809 may not extend to the tips 806 of the legs 804. In various instances, the barr patterns 809 may extend along, for example, half or approximately half the length of the legs 804; however, any suitable length of the barbed arrangements may be used. For example, the barb arrays 809 may extend along less than half or more than half the length of the legs 804. In some embodiments, the bar pattern 809 may extend along each of the legs 804 from the tops 806 of the legs 804 toward the base 802. In such embodiments, the bar pattern 809 may not extend into the base 802. In some embodiments, as illustrated in FIG. 66, leg 804 may include a bar pattern 809 that does not extend to the apex 806 of leg 804 or base 802. In some embodiments, leg 804 may include more than one barb pattern 809.
[0143] Various barbar configurations are shown in FIG. 70-73, although any suitable barb design may be used. Referring to FIG. 70, the staple leg 804 may include, for example, at least one barb 809. In various instances, the barb 809 may include a tooth. The tooth may include a first surface 809a and a second surface 809b that may extend from the circumference 805 of the staple leg 804. First surface 809a may include, for example, a sloped surface, a convex surface, and / or a concave surface. Second surface 809b may include, for example, a flat or at least substantially flat surface. In various instances, the first surface 809a and the second surface 809b may converge at an edge 809c, for example. The barb 809 may be formed using any suitable process. For example, a barb 809 may be formed using an extrusion process. In at least one embodiment, for example, a shaping die may be used to punch out the circumference 805 of the wire containing the leg 804 to swell or induce enough material to form a barb 809. In various instances, the barb may, for example, include any suitable tab or hitch protrusion. In various embodiments, the barb 809 may be tapered. In various instances, barb 809 may include a base adjacent to perimeter 805 that is thicker than the tip of barb 809.
[0144] Referring now to FIG. 68, 69, 71 and 71A, the staple leg 804 may include, for example, at least one barb 879. In the at least one embodiment, the barb 879 may extend about a portion of the circumference 805 of the staple leg 804. In various instances, the barb 879 may include a first face 879a and a second face 879b that may extend from the perimeter 805 of the staple leg 804. First surface 879a may include a sloped surface, a convex surface, and / or a concave surface, for example. Second surface 879b may include, for example, a flat or at least substantially flat surface. In various instances, the first surface 879a and the second surface 879b may converge at an edge 879c, for example. In various instances, the edge 879c may be arcuate, for example. The barb 879 may be formed using any suitable process. For example, a barb 879 can be formed using an extrusion process. In at least one embodiment, for example, a shaping die may be used to punch out the circumference 805 of the wire including the leg 804 to swell or puff enough material to form a barb 879. Referring primarily to FIG. 71A, the wire including the leg 804 may be defined by a diameter 801 and the barb 879 may be defined by a diameter that is greater than the diameter 801. Accordingly, the wire including leg 804 may be defined by a radius and the barb 879 may be defined by a radius. which is larger than the radius of the wire. In various embodiments, the barb 879 may be tapered. In various instances, barb 879 may include a base adjacent to perimeter 805 that is thicker than the tip of barb 879.
[0145] Referring now to FIG. 72, the staple leg 804 may include, for example, at least one barb 889. In at least one embodiment, the barb 889 may extend about a portion of the circumference 805 of the staple leg 804. In various instances, the barb 879 may include a first face 889a and a second face 889b that may extend from the circumference 805 of the staple leg 804. First surface 889a may include, for example, a sloped surface, a convex surface, and / or a concave surface. Second surface 889b may include, for example, a flat or at least substantially flat surface. In various instances, the first surface 889a and the second surface 889b may converge at an edge 889c, for example. In various instances, the edge 889c may be, for example, arcuate. The barb 879 may be formed using any suitable process. For example, barbs 889 may be formed using an extrusion process. In at least one embodiment, for example, a shaping die may be used to pierce the perimeter 805 of the wire including the leg 804 to swell or puff enough material to form a barb 889. Referring primarily to FIG. 71A, the wire including the leg 804 may be defined by a diameter 801 and the barb 879 may be defined by a diameter that is greater than the diameter 801. Accordingly, the wire including leg 804 may be defined by a radius and the barb 889 may be defined by a radius. which is larger than the radius of the wire. In various embodiments, the barb 879 may be tapered. In various instances, barb 889 may include a base adjacent to perimeter 805 that is thicker than the tip of barb 879.
[0146] Referring now to FIG. 73, the base leg 804 may include, for example, at least one barb 899. In various instances, barb 899 may include a tooth. The tooth may include a first face 899a and a second face 899b that may extend from the circumference of the staple leg 804. First surface 899a may include, for example, a sloped surface, a convex surface, and / or a concave surface. Second surface 899b may, for example, include a planar or at least substantially planar surface. In various instances, the first surface 899a and the second surface 899b may converge at an edge 899c, for example. The barb 899 may be formed using any suitable process. For example, a barb 899 may be formed using an extrusion process. In at least one embodiment, a shaping die, for example, may be used to punch out the circumference of the wire including the leg 804 to swell or ruffle enough material to form a barb 899. In various embodiments, the wire including the staple may include one or more flat sides. In at least one embodiment, the wire may include, for example, opposing flat sides 895. In at least one such embodiment, the flat sides 895 may be formed into a cylindrical wire. In some instances, the wire may retain one or more cylindrical surfaces in addition to the flat sides 895. In various instances, the barb may, for example, include any suitable lug or tab. In various embodiments, the barb 899 may be tapered. In various instances, barb 899 may include a base adjacent to the periphery of leg 804 that is thicker than the tip of barb 899.
[0147] In various instances, the legs of the staple may define the plane of the staple. The base of the staple may or may not be positioned in the plane of the staple. In any event, one or more barbs extending from the legs and / or the base may extend in and / or run parallel to the plane of the staples. In some cases, one or more barbs extending from the legs and / or the base may extend outwardly from the plane of the staples. One or more barbs extending from the legs and / or the base may extend transversely to the plane of the staples. In various instances, the barb may protrude circumferentially around the staple leg. Such a burr may extend inward and outwardly from the plane of the staples. In some cases, the barb may extend all the way around the staple leg. In some cases, the barb may extend less than 360 degrees around the staple leg. A barb extending in the staple plane can easily guide the tissue within the staple plane. A barb extending outward from the staple plane can easily guide the tissue outside the staple plane. The staple and / or a staple leg may include one or more barbs extending in the staple plane and one or more barbs extending outwardly from the staple plane.
[0148] Referring again to FIG. 62, the barbs extending from the staple leg 804 may be configured to retain the staple leg 804 in the tissue. As outlined above, the staple legs 804 may in some cases be malformed and / or not formed by the anvil, and due to the protruding barb or barbs, the staple leg 804 may still be retained in tissue. In various instances, the barbs may be configured to trap tissue in the region of the staple tissue retention. In some instances, the barbs may be configured to hold the tissue against the base 802. In such instances, the barbs may apply a compressive force or pressure to the tissue. As discussed above in connection with the embodiments shown in FIG. 70-73, the barb may include a sloped, convex and / or concave top surface, such as, for example, surfaces 809a, 879a, 889a, and / or 899a. The top surfaces of the barbs may be shaped to facilitate insertion of the barbs and legs 804 into and / or through the tissue. As also discussed above in connection with the embodiments shown in FIG. 70-73, the barb may include a flat or at least substantially flat bottom surface, such as, for example, surfaces 809b, 879b, 889b and / or 899b. The lower surfaces of the burrs may be shaped to inhibit the removal of burrs and legs 804 from the tissue. As a result of the above, in some circumstances, upper surfaces of the barbs may be shaped to pierce tissue, while lower surfaces of the barbs may be shaped to adhere to tissue. In various circumstances, the tip 806 of the staple legs 804 may be shaped to punch a hole in the tissue, while the staple legs 804 and the barbs extending therefrom may be shaped to elastically expand the opening so that tissue may flow around the barb when the legs 804. the staples are pushed through the tissue and flow back under the bottom surfaces of the barbs.
[0149] In some embodiments, the first barb may extend from the first staple leg 804 and the second bar may extend from the second staple leg 804. In various instances, the first bar and the second bar may be located the same or at least substantially the same distance from the base 802. In some instances, the first barb and the second barb may be the same distance or at least substantially the same vertical distance from base 802. As discussed above, the staple leg 804 may include an array of barbs extending along the length of the staple leg 804. In various embodiments, referring primarily to FIG. 62, the staple may include a first leg 804 having a first barb array and a second leg 804 including a second barb array, the first barb array and the second barb array may be configured to cooperate in retaining tissue in the staple. In various embodiments, the barbs of the first array and the barbs of the second array may include a pair of barbs configured to engage tissue at the same vertical distance from base 802, for example. In various instances, the staple may contain more than one pair of barbs. In some instances, each pair of barbs may be configured to engage tissue at a different vertical distance from the base 802. In such circumstances, a staple may be suitable for use with varying thicknesses of tissue. For example, when a staple is used to suture thin tissue, one pair of barbs, or less than all pairs of barbs, may engage the thin tissue. However, if this staple was used to suture thick tissue, additional pairs of barbs, or all pairs of barbs, may engage the tissue. In some embodiments, the barbs extending from the legs 804 may be positioned in a manner consistent with the thickness of the tissue or the range of tissue thickness that can be sutured by the staple. For example, referring again to FIG. 62, the barbs 808 and 809 can be selectively positioned along the legs 804 such that they are positioned within and / or adjacent to the tissue captured within the staple. In some cases, the portions of the staple legs 804 that are deformed by or come into contact with the anvil may not include the barbs projecting therefrom. In at least some instances, the pattern of barbs extending from the inward side of the staple legs 804 may be longer than the pattern of barbs extending from the outward side of the staple legs 804. In other instances, the pattern of barbs extending from the inward side of the staple legs 804 may be shorter than the pattern of barbs extending from the outward side of the staple legs 804. In still other instances, the set of barbs extending from the inward side of the staple legs 804 may be the same length as the array of barbs extending from the outward side of the staple legs 804.
[0150] As discussed above, the barbs extending from the staple legs 804 may assist in retaining the staple in the tissue if the staple legs 804 are badly formed and / or inadvertently unshaped. However, certain circumstances are contemplated when a staple including one or more barbs disclosed herein is inserted into the tissue and remains intentionally unformed. In any event, staples including one or more of the barbs disclosed herein may be useful in suturing thick tissue. More specifically, in some instances, the presence of thick and / or dense tissue between the staple cartridge and the anvil and / or the presence of thick and / or dense tissue within the staple may prevent the staple from fully forming or closing. For example, the staple may not be fully closed in the B-shape, or the staple may not be fully closed at all. In such cases, burrs of unsealed staples can, for example, block or prevent tissue from being pulled out of the staple. The arrangement of barbs extending along the length of the barbed staple leg may allow the leg to remain in the tissue, regardless of the thickness of the tissue.
[0151] Various embodiments are contemplated in which at least one barbed staple, such as, for example, a barbed staple 800, is removably stored in a staple cartridge, such as the staple cartridge 22000 shown in FIG. 1012, for example. Certain embodiments are envisaged in which the staple cartridge only includes barbed staples, while other embodiments are envisaged that use barbed and unbarbed staples. For example, the first row of staples may include barbed staples, while the second row of staples may include unbarbed staples. In some instances, the staples stored in the staple cartridge may be the same or substantially the same unformed height. At least with respect to U-shaped and / or V-shaped staples, the unformed height of the staple may be defined as the vertical distance between the underside of the staple base and the tips of the staple legs. Such measurement may be made prior to insertion of the staples into the staple cartridge, when the staples are removably stored in the staple cartridge, and / or before the staples are deformed against the anvil. In some instances, barbed staples positioned in the first row of the staple cartridge may include a first unformed height, and barbed staples positioned in the second row of the staple cartridge may include a second unformed height. The barbed staples in the third row of the staple cartridge may include a first unformed height, a second unformed height, or a third unformed height. The first row, second row and / or third row of barbed staples may be positioned on the same side of the knife slot defined in the staple cartridge or on opposite sides of the knife slot. In use, barbed staples removably retained in the staple cartridge can be formed to the same forming height or to different forming heights. The staple formation height can be defined as the total vertical distance of the staple after it has been deformed against the anvil. At least with respect to a staple that has been deformed to form B, for example, the staple formation height may be measured between the bottom of the staple base and the top of the staples. In some instances, barbed staples positioned in the first row in the staple cartridge may be deformed to a first forming height and barbed staples positioned in the second row in the staple cartridge may be deformed to a second forming height. The barbed staples in the third row of the staple cartridge may include a first forming height, a second forming height, or a third forming height. The first row, second row and / or third row of barbed staples may be positioned on the same side of the 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 forming heights. Barbed staples 800 may, for example, be used in staple inserts and / or stapling tools that create rows of staples with different forming heights. The first row of barbed staples 800 can be deformed to the first forming height and the second row of barbed staples 800 can be deformed to the second forming height. In various instances, the third row of barbed staples 800 may be deformed to a third forming height. In some cases, barbed staples 800 deformed to different heights may start at the same, or at least substantially the same, forming height. In some cases, barbed staples 800 deformed to different forming heights may start at different unformed heights. Different designs can be used to create staples for different forming heights. For example, the movable staple support drivers may support the staples at various distances relative to the anvil. In some instances, the anvil can include pockets that form staples of varying depths. In various instances, the staple drivers may include a cradle configured to support the base of the staple and push the staple upward toward a forming pocket defined in the anvil. The staple forming height may be determined by the distance between the lower surface of the cradle and the upper surface of the forming pocket. United States Patent No. 8,317,070 entitled SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS, issued November 27, 2012, is referenced herein. In some instances, the staple cartridge base plate may include stepped surfaces, as illustrated in FIG. 1. The first row of staples can be defined in the first step and the second row of staple cavities can be defined in the second step, the first step and the second step being vertically offset with respect to each other. For example, the first step may be vertically above or closer to the anvil than the second step. In some cases, you can define a face between the first and second steps. In some instances, the staple cartridge base plate may include a first step, a second step positioned vertically above the first step, and the third step is positioned vertically above the second step. Various embodiments are envisaged in which the base plate of the staple cartridge includes any suitable number of steps and any suitable number of walls between the steps. The first row of staple cavities can be defined in the first step, the second row of staples can be defined in the second step, and / or the third row of staples can be defined in the third step, for example. The first row of staple cavities may include staples having a first non-formed height, and the second row of staple cavities may include staples having a second non-formed height, and / or the third row of staple recesses may include staples having a third non-formed height, for example. Various embodiments are envisaged in which the staple cartridge comprises any suitable number of rows of staples having different unformed heights. The staples in the first row of the staple cartridge can be deformed to the first formed height, the staples in the second row of staple cavities can be deformed to the second forming height and / or the third row of staple cavities can be deformed to, for example, a third forming height. Various embodiments are envisaged in which the staple insert comprises any suitable number of rows of staples that are deformed to different forming heights. In addition to or instead of having different staple forming heights, the stapler gripper may have different tissue gaps. For example, referring generally to FIG. 10 and 11, a gap may be defined between the base plate surface 22011 of the staple cartridge and the tissue pressing surface 10063 against the anvil anvil. This gap may be configured to receive T tissue. The gap may also be configured to receive a tissue thickness compensator; however, the barbed staple may or may not be used with a tissue thickness compensator, and the discussion provided in relation to barbed staples may apply to both circumstances. In any event, the reader will appreciate that the anvil tissue compression surface 10063 is stepped. The anvil tissue compression surface 10063 includes a first portion disposed vertically over the second portion. When the anvil and the gripper's staple cartridge are in a closed state, as shown in FIG. 11, a first gap distance is defined between the outer anvil tissue compression surface 10063 and the cartridge base plate surface 22011, and a second, different gap distance is defined between the inner anvil tissue compression surface 10063 and the cartridge base plate surface 22011. The first gap distance is shown to be greater than the second gap distance, but it is possible for the first gap distance to be shorter than the second gap distance. Tissue pinched between the anvil and the staple cartridge in the shorter gap distance can be compressed more than tissue in the greater gap distance. For example, barbed staple barbs 800 may engage tissue differently depending on whether the tissue is positioned in a shorter tissue gap or a larger tissue gap. In particular, tissue compressed in a shorter tissue gap may attempt to re-enlarge upon release from the gripper than tissue compressed in a larger tissue gap, and barbs of the barbed staple may inhibit or prevent re-enlargement depending on their configuration and / or position on burrs. In other instances, the barbs may be shaped and / or positioned so as not to inhibit or resist tissue re-expansion. As will be appreciated by the reader, the anvil tissue compression surface 10063 is stepped and the cartridge surface is flat or at least substantially flat, so that the difference in tissue gaps formed in the gripper is a function of the height of the stepped anvil surface. Other embodiments are envisaged. For example, the anvil tissue pressing surface may be flat or at least substantially flat and the surface of the staple cartridge may be stepped. In other instances, both the anvil tissue compression surface and the base plate surface of the insert may be stepped. In any event, different gap distances may be defined between the anvil tissue compression surface and the surface of the cartridge base plate. Although the two gap distances are illustrated in FIG. 10 and 11, more than two gap distances are possible, for example three gap distances. With further reference to FIG. 10 and 11, a first longitudinal row of forming pockets may be located in a first gripper portion having a first tissue break distance, and a second longitudinal row of forming pockets may be located in a second longitudinal row of forming pockets having a second tissue break distance that is different from the first tissue break distance. In some instances, the gripper may include a third longitudinal row of forming pockets disposed in the third gripper portion having a third tissue distance that is different from the first tissue break distance and the second tissue break distance. In some instances, the gripper may include a third longitudinal row of forming pockets disposed in the third gripper portion having a tissue break distance that is the same as the first tissue break distance or the second tissue break distance. The reader will appreciate that the gripper may have different tissue break distances and / or different staple formation heights. The gripper can have one, the other, or both. In some instances, shorter staple formation heights may be associated with shorter tissue gap distances, while greater staple formation heights may be associated with longer tissue gap distances. In other instances, shorter staple formation heights may be associated with greater tissue gap distances, while greater staple formation heights may be associated with shorter tissue gap distances. In addition, the staple may include a U-shape in its unshaped state. The U-shaped staple may include a base and two staple legs extending from the base, the staple legs extending in parallel directions relative to each other. Also in addition to the above, the staple may include a V-shaped formation in its unshaped state. The V-shaped configuration may include a base and two staple legs extending from the base, with the staple legs extending in directions that are not parallel.
[0152] Various embodiments described herein are described in the context of linear grippers and / or linear fastener inserts. Such embodiments and their teaching can be applied to non-linear grippers and / or non-linear inserts of fastening elements such as, for example, round and / or profiled grippers. For example, various grippers, including non-linear grippers, are disclosed in United States Patent Application No. 13 / 036,647, filed February 28, 2011, entitled SURGICAL STAPLING INSTRUMENT, now United States Patent Publication No. 2011/0226 837. Additionally, patent application
US No. 12 / 893,461, filed September 29, 2012, entitled STAPLE CARTRIDGE, now US Patent Publication No. 2012/0074198, is herein incorporated by reference. United States Patent Application No. 12 / 031,873, filed February 15, 2008, entitled END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT, now United States Patent No. 7,980,443, also referenced herein. The entire disclosure of United States Patent No. 7,845,537 entitled SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES, filed on December 7, 2010, is contemplated. The entire disclosure of U.S. Patent Application Serial No. 13 / 118,241, entitled SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S. Patent Application Publication No. 2012/0298719, filed May 27, 2011, is considered herein.
[0153] The devices disclosed herein may be designed to be disposed of after a single use, or may be designed to be used multiple times. In both cases, however, the device can be regenerated for reuse after at least one use. Reconditioning can involve any combination of the steps of disassembling the device followed by cleaning or replacing individual components and then reassembling. In particular, the device may be disassembled and any number of individual components or parts of the device may be selectively replaced or removed in any combination. After cleaning and / or replacing individual components, the device can be reassembled for subsequent use at a recovery facility or by a surgical team immediately prior to surgery. Those skilled in the art will appreciate that reconditioning the device can employ a variety of disassembly, cleaning / replacement, and reassembly techniques. The use of such techniques and the resulting reconditioned device is within the scope of this application.
[0154] Preferably, the invention described herein will be processed prior to surgery. First, a new or used tool is obtained and cleaned if necessary. The tool can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic bag or TYVEK. The container and tool are then placed in a radiation field that can penetrate the container, such as gamma rays, X rays, or high energy electrons. The radiation kills the bacteria on the instrument and in the container. The sterile instrument can then be stored in a sterile container. The sealed container keeps the instrument sterile until it is opened in a medical facility.
Ethicon LLC, Puerto Rico
Proxy:
ΕΡ 2 910 198 BI
Z-16380/17
Contents4
93 sheets
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131 members in 11 offices
Priority claims22
| Document | Office | Kind | Date |
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| 201414187384 | United States of America | A | |
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| 201414187390 | United States of America | A | |
| 201414187395 | United States of America | A | |
| 201414187400 | United States of America | A | |
| 15156366 | European Patent Office (EPO) | A | |
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Numbers
- Publication
- 2910198
- Publication, DOCDB
- 2910198
- Publication, EPODOC
- PL2910198T
- Application
- 15156366
- Application, DOCDB
- 15156366
- Application, EPODOC
- PL20150156366T
Titles2
- English
- METHODS FOR ALTERING IMPLANTABLE LAYERS FOR USE WITH SURGICAL FASTENING INSTRUMENTS
- Polish
- SPOSOBY ZMIENIANIA WSZCZEPIALNYCH WARSTW DO UŻYCIA Z CHIRURGICZNYMI NARZĘDZIAMI ŁĄCZĄCYMI
Classification
- CPC, 26
- A61B17/07207
- B29C67/20
- A61B17/0644
- A61B17/07292
- A61B2017/00004
- A61B2017/00526
- A61B2017/07242
- A61B2017/07278
- A61B2017/07285
- B29K2995/0056
- B29L2031/7546
- B29K2105/04
- A61B17/064
- A61B2017/07235
- A61B2017/07257
- A61B2017/07264
- A61B2017/07271
- A61B17/072
- A61B17/068
- A61B17/105
- A61L31/04
- A61L31/146
- B29C43/00
- B29C43/52
- A61B2017/0688
- B29C55/00
- IPC, 2
- A61B17 064
- A61B17 072