JP2015516838A - Tissue thickness compensator composed of multiple materials - Google Patents

Abstract

In various embodiments, the tissue thickness compensator (22770) can include a plurality of fibers (22773, 22774). In at least one embodiment, such fibers include a plurality of first fibers (22773) composed of a first material and a plurality of second fibers (22774) composed of a second material. be able to. The tissue thickness compensator can include multiple layers, each layer being composed of one or more agents. For example, certain embodiments are disclosed herein for making a tissue thickness compensator that includes fibers.

Description

  The present invention relates to surgical instruments and, in various embodiments, to surgical cutting and stapling instruments and staple cartridges for surgical cutting and stapling instruments designed to cut and staple tissue.

The following is a non-exhaustive list of embodiments of the invention that are claimed or may be claimed.
1. A compensator attachable to the anvil of the coupling device, wherein the anvil comprises a forming surface,
A first layer composed of a first fiber and a second fiber, wherein the first fiber is composed of a first material, the second fiber is composed of a second material, A first layer, wherein the material is different from the second material, wherein the first and second fibers are present in the first layer according to a first ratio;
A second layer composed of a first fiber and a second fiber, wherein the first fiber and the second fiber are present in the second layer according to a second ratio, and the first ratio is A second layer different from the second ratio;
A compensator comprising: an attachment portion configured to be attached to an anvil.
2. The compensator of embodiment 1, wherein the first material comprises oxidized regenerated cellulose and the second material comprises an absorbent polymer.
3. Embodiment 1 or 2 wherein the first ratio of the first fibers to the second fibers is about 4: 1, and the second ratio of the first fibers to the second fibers is about 1: 4. The compensator described.
4). Embodiment 4. The compensator of embodiment 1 or 3, wherein the first layer comprises a tissue contacting surface and the second material comprises oxidized regenerated cellulose.
5. Embodiments 1 to 4 wherein in the first layer, the second fibers are woven into the first fibers and in the second layer, the first fibers are woven into the second fibers. Compensation sweater as described in 1.
6). The compensator of embodiment 1, further comprising a drug absorbed within the first fiber.
7). A compensator attachable to the anvil of the coupling device, wherein the anvil comprises a forming surface,
An absorbent outer layer comprising a first drug adapted to be absorbed primarily during the first stage of the healing process;
An absorbent intermediate layer comprising a second agent adapted to be absorbed primarily during the second stage of the healing process;
A compensator comprising: an inner layer comprising a third drug adapted to be absorbed primarily during the third stage of the healing process.
8). Embodiment 8. The compensator of embodiment 7, wherein the first agent comprises a hemostatic material, the second agent comprises an anti-inflammatory material, and the third agent comprises a collagen material.
9. The compensator according to embodiment 7 or 8, wherein the first agent comprises a hemostatic material, the second agent comprises an antimicrobial material, and the third agent comprises a collagen material.
10. The compensator according to any of embodiments 7-9, wherein the at least one intermediate layer comprises an annular layer surrounding the inner layer and the outer layer comprises an annular layer surrounding the at least one intermediate layer.
11. The compensator according to any one of embodiments 7-10, wherein the first healing stage at least partially overlaps with the second healing stage, and the second healing stage at least partially overlaps with the third healing stage. sweater.
12 The compensator according to embodiment 11, wherein the first healing stage partially overlaps with the third healing stage.
13. A method of manufacturing a tissue thickness compensator comprising:
Obtaining a fiber comprising a substrate and a drug;
Preparing a solution of a first liquid and a second liquid;
Mixing the fibers into the solution;
Injecting the solution into the mold;
Lyophilizing the solution.
14 Embodiment 14. The method of embodiment 13, wherein the fibers are obtained by coating a substrate with a drug.
15. Embodiment 14. The method of embodiment 13, wherein the fibers are obtained by extruding the substrate and drug simultaneously.
16. Embodiment 14. The method of embodiment 13, wherein the fibers are obtained by impregnating a substrate with a drug.
17. Embodiments according to any of embodiments 13-16, wherein the solution is lyophilized by placing a mold in the vacuum chamber, reducing the pressure in the vacuum chamber, and lowering the temperature in the vacuum chamber. The method described.
18. Embodiment 18. The method of any one of embodiments 13-17, further comprising allowing the fibers to settle to the bottom of the mold prior to lyophilizing the solution.
19. 19. The method of any one of embodiments 13-18, wherein the material sheet is produced by lyophilization of the solution and the method further comprises tearing the material sheet.

The features and advantages of the present invention, as well as the manner in which they are realized, will become more apparent and the invention itself will be more fully understood by reference to the following description of embodiments of the invention in conjunction with the accompanying drawings. .
1 is a cross-sectional view of one embodiment of a surgical instrument. 1 is a perspective view of one embodiment of an implantable staple cartridge. FIG. FIG. 6 shows portions of an end effector clamping and stapling tissue with an implantable staple cartridge. FIG. 6 shows portions of an end effector clamping and stapling tissue with an implantable staple cartridge. FIG. 6 shows portions of an end effector clamping and stapling tissue with an implantable staple cartridge. FIG. 6 shows portions of an end effector clamping and stapling tissue with an implantable staple cartridge. FIG. 10 is a partial side cross-sectional view of another end effector coupled to a portion of a surgical instrument with an end effector supporting a surgical staple cartridge and an anvil in an open position. FIG. 3 is another partial cross-sectional side view of the end effector of FIG. 2 in a closed position. FIG. 4 is another partial cross-sectional side view of the end effector of FIGS. 2 and 3 as the knife bar begins to advance through the end effector. FIG. 5 is another partial cross-sectional side view of the end effector of FIGS. 2-4 with the knife bar partially advanced through the interior. FIG. 6 illustrates a surgical staple deformation positioned within a foldable staple cartridge body in accordance with at least one embodiment. FIG. 6 illustrates a surgical staple deformation positioned within a foldable staple cartridge body in accordance with at least one embodiment. FIG. 6 illustrates a surgical staple deformation positioned within a foldable staple cartridge body in accordance with at least one embodiment. FIG. 6 illustrates a surgical staple deformation positioned within a foldable staple cartridge body in accordance with at least one embodiment. It is a figure which shows the staple determined in the crushing-type staple cartridge main body. FIG. 7B illustrates the crushable staple cartridge body of FIG. 7A being crushed by an anvil. FIG. 7B illustrates the crushable staple cartridge of FIG. 7A being further crushed by an anvil. FIG. 7B illustrates the staple of FIG. 7A in a fully formed state and the crushable staple cartridge of FIG. 7A in a fully crushed state. FIG. 3 is a top view of a staple cartridge according to at least one embodiment comprising staples embedded in a foldable staple cartridge body. FIG. 9 is an elevational view of the staple cartridge of FIG. 8. FIG. 7 is an exploded perspective view of an alternative embodiment of a compressible staple cartridge with staples therein and a system for driving the staples against the anvil. FIG. 11 is a partial cutaway view of an alternative embodiment of the staple cartridge of FIG. 10. FIG. 11 is a cross-sectional view of the staple cartridge of FIG. 10. FIG. 11 is an elevational view of a sled configured to traverse the staple cartridge of FIG. 10 and move the staples toward the anvil. FIG. 13 is a view of a staple driver that can be lifted toward the anvil by the sled of FIG. 1 is a perspective view of a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator for use with a surgical stapling instrument, according to at least one embodiment of the invention. FIG. FIG. 15 is a partially exploded view of the staple cartridge of FIG. 14. FIG. 15 is a complete exploded view of the staple cartridge of FIG. 14. FIG. 15 is another exploded view of the staple cartridge of FIG. 14 without a wrap covering the tissue thickness compensator. FIG. 15 is a perspective view of a cartridge main body, that is, a supporting portion of the staple cartridge of FIG. 14. FIG. 15 is a top perspective view of a sled that can be moved within the staple cartridge of FIG. 14 for deploying staples from the staple cartridge. FIG. 20 is a bottom perspective view of the thread of FIG. 19. FIG. 20 is an elevation view of the thread of FIG. 19. FIG. 20 is a top perspective view of a driver configured to support one or more staples and to be raised up by the sled of FIG. 19 for firing staples from a staple cartridge. FIG. 23 is a bottom perspective view of the driver of FIG. 22. A wrap configured to at least partially surround a compressible tissue thickness compensator of a staple cartridge. FIG. 3 is a partial cutaway view of a staple cartridge with a rigid support portion and a compressible tissue thickness compensator showing the staple moving from a non-fired position to a fired position during a first sequence. FIG. 26 is an elevational view of the staple cartridge of FIG. 25. FIG. 26 is a detailed elevation view of the staple cartridge of FIG. 25. FIG. 26 is a cross-sectional end view of the staple cartridge of FIG. 25. FIG. 26 is a bottom view of the staple cartridge of FIG. 25. FIG. 26 is a detailed bottom view of the staple cartridge of FIG. 25. Longitudinal direction of a staple cartridge comprising a closed anvil and a rigid support portion and a compressible tissue thickness compensator showing the staple moving from the non-fired position to the fired position during the first sequence It is sectional drawing. FIG. 32 is another cross-sectional view of the anvil and staple cartridge of FIG. 31 showing the anvil in an open position after the firing sequence is complete. FIG. 32 is a partial detail view of the staple cartridge of FIG. 31 showing the staples in a non-fired position. FIG. 3 is a cross-sectional elevation view of a staple cartridge with a rigid support portion and a compressible tissue thickness compensator showing the staple in a non-fired position. FIG. 35 is a detailed view of the staple cartridge of FIG. 34. 1 is an elevational view of a staple cartridge with an anvil in an open position and a rigid support portion and a compressible tissue thickness compensator showing the staple in an unfired position. FIG. Staple cartridge comprising a staple in a non-fired position and an anvil in a closed position showing tissue captured between the anvil and the tissue thickness compensator, and a rigid support portion and a compressible tissue thickness compensator FIG. FIG. 38 is a detailed view of the anvil and staple cartridge of FIG. 37. Stand of staple cartridge comprising a staple in a non-fired position, and an anvil in a closed position, showing a thicker tissue captured between the anvil and staple cartridge, and a rigid support portion and a compressible tissue thickness compensator FIG. FIG. 40 is a detailed view of the anvil and staple cartridge of FIG. 39. FIG. 40 is an elevational view of the anvil and staple cartridge of FIG. 39 showing tissue having different thicknesses disposed between the anvil and the staple cartridge. FIG. 42 is a detailed view of the anvil and staple cartridge of FIG. 39, as shown in FIG. FIG. 5 shows a tissue thickness compensator that corrects for different tissue thicknesses captured in different staples. FIG. 6 shows a tissue thickness compensator applying compression pressure to one or more vessels cut by a staple line. It is a figure which shows the condition where one or more staples are poorly formed. It is a figure which shows the structure | tissue thickness compensator which can correct | amend a poorly formed staple. FIG. 6 is a diagram illustrating a tissue thickness compensator disposed in a tissue region where a plurality of staple lines intersect. FIG. 3 shows tissue captured in a staple. FIG. 6 shows tissue and tissue thickness compensator captured within a staple. FIG. 3 shows tissue captured in a staple. FIG. 6 shows a thick tissue and tissue thickness compensator captured within a staple. FIG. 6 shows a thin tissue and tissue thickness compensator captured within a staple. FIG. 6 shows a tissue having an intermediate thickness captured in a staple and a tissue thickness compensator. FIG. 5 shows a tissue having another intermediate thickness captured within a staple and a tissue thickness compensator. FIG. 6 shows a thick tissue and tissue thickness compensator captured within a staple. FIG. 5 is a partial cross-sectional view of an end effector of a surgical stapling instrument showing the firing bar and staple firing thread in a retracted, non-fired position. FIG. 57 is another partial cross-sectional view of the end effector of FIG. 56 showing the firing bar and staple firing sled in a partially advanced position. FIG. 57 is a cross-sectional view of the end effector of FIG. 56 showing the firing bar fully advanced, ie, in the firing position. FIG. 57 is a cross-sectional view of the end effector of FIG. 56 showing the firing bar in a retracted position after firing and the staple firing thread remaining in the fully fired position. FIG. 60 is a detailed view of the firing bar in the retracted position of FIG. 59. 1 is a cross-sectional perspective view of one embodiment of a cutting blade being advanced distally within an end effector of a surgical instrument to incise tissue. FIG. FIG. 62 is a cross-sectional side view illustrating features on the cutting blade of FIG. 61 configured to direct the material in the tissue thickness compensator to the tissue. FIG. 10 is a cross-sectional perspective view of an alternate embodiment of a cutting blade being advanced distally within an end effector of a surgical instrument to incise tissue. 12 is a cross-sectional perspective view of another alternative embodiment of a cutting blade being advanced distally within an end effector of a surgical instrument to incise tissue. FIG. FIG. 67 is a cross-sectional side view illustrating features on the cutting blade of FIG. 64 configured to mix the material from the second tissue thickness compensator with the material in the first tissue thickness compensator. FIG. 65 is a front view illustrating features on the cutting blade of FIG. 64 configured to mix the material from the second tissue thickness compensator with the material in the first tissue thickness compensator. FIG. 65 is a top cross-sectional view showing features on the cutting blade of FIG. 64 configured to mix the material from the second tissue thickness compensator with the material in the first tissue thickness compensator. 12 is a cross-sectional perspective view of another alternative embodiment of a cutting blade being advanced distally within an end effector of a surgical instrument to incise tissue. FIG. FIG. 69 is a cross-sectional side view illustrating features on the cutting blade of FIG. 68 configured to spread the material contained within the tissue thickness compensator. FIG. 69 is a side cross-sectional view of the cutting blade of FIG. 68 spreading the material. FIG. 6 is a partially cutaway perspective view of a tissue thickness compensator, according to at least one embodiment. Figure 2 shows the drug loaded in the tissue thickness compensator. FIG. 72 is a cross-sectional end view of a tube disposed within the tissue thickness compensator of FIG. 71, including a drug contained therein. FIG. 72 shows the tissue thickness compensator of FIG. 71 positioned and compressed against the patient's tissue. FIG. 72 is a cross-sectional end view of an end effector of a surgical stapling instrument showing staples being fired through the tissue thickness compensator of FIG. 71. It is the graph which showed melt | dissolution of the capsule contained in a structure | tissue thickness compensator. The capsule includes a plurality of drug layers. FIG. 77 shows the first or outer layer of the capsule of FIG. 76 being dissolved. FIG. 77 shows the second layer of the capsule of FIG. 76 being dissolved. FIG. 77 shows the third layer of the capsule of FIG. 76 being dissolved. FIG. 77 shows the fourth or inner layer of the capsule of FIG. 76 being dissolved. FIG. 6 is a partial cutaway view of a staple cartridge according to at least one embodiment comprising a tissue thickness compensator with a plurality of vertical capsules. FIG. 82 is a perspective view of the vertical capsule of FIG. 81. FIG. 82 is a partial cutaway view of the staple cartridge of FIG. 81 showing the staples included in an internal unfired position. FIG. 84 is a cross-sectional side view of the staple cartridge of FIG. 81 showing the staple of FIG. 83 moving from a non-fired position to a fired position. FIG. 4 is a partial cutaway view of a tissue thickness compensator with a vertical capsule positioned therein, according to at least one embodiment. FIG. 5 is a partial cutaway view of a tissue thickness compensator with a plurality of capsules having openings defined therein. A surgical stapling instrument comprising a plurality of staples in a non-fired position and a plurality of penetrating members configured to rupture a capsule or tube contained within a tissue thickness compensator according to at least one embodiment. It is a section end view of an end effector. FIG. 88 is an elevational view of the staple of FIG. 87 in a non-fired configuration. FIG. 89 is an elevational view of the staple of FIG. 88 in a firing configuration. FIG. 88 is an elevation view of the penetrating member of FIG. 87. FIG. 88 is a cross-sectional end view of the end effector of FIG. 87 showing the staple and penetrating member in a fired position. FIG. 89 is a cross-sectional side view of the end effector of FIG. 87 showing the staple and penetrating member moving from a non-fired position to a fired position. FIG. 10 is a top cutaway view of a staple cartridge according to at least one embodiment including a tissue thickness compensator with a plurality of capsules positioned therein. FIG. 94 is a detailed view of the staple cartridge of FIG. 93. FIG. 94 is a cross-sectional end view of the staple cartridge of FIG. 93 positioned within an end effector showing staples contained within the staple cartridge in a firing position. FIG. 96 is a cross-sectional end view of the staple cartridge of FIG. 93 of the end effector of FIG. 95 showing the cutting member advanced through the capsule of the tissue thickness compensator. 1 is a perspective view of a tissue thickness compensator with a longitudinal member, according to at least one embodiment. FIG. FIG. 98 is a cross-sectional view of a mold configured to produce the tissue thickness compensator of FIG. 97. FIG. 99 is a cross-sectional end view of the mold of FIG. 98 showing the longitudinal members of FIG. 97 positioned therein; FIG. 99 is a cross-sectional end view of the mold of FIG. 98 showing the tissue thickness compensator material being injected into the mold of FIG. FIG. 3 is a cutaway perspective view of a tissue thickness compensator, according to at least one embodiment. FIG. 6 is a perspective view of a support member configured to be embedded in a tissue thickness compensator, according to at least one embodiment. FIG. 3 is a cutaway perspective view of a tissue thickness compensator, according to at least one embodiment. FIG. 104 is a cross-sectional end view showing a mold for manufacturing the tissue thickness compensator of FIG. 103. FIG. 104 is a cross-sectional view of the tissue thickness compensator of FIG. 103. FIG. 105 is a side cross-sectional view of the mold of FIG. 104. FIG. 3 is a cross-sectional end view of a tissue thickness compensator, according to at least one embodiment. FIG. 6 is a cross-sectional end view of another tissue thickness compensator, according to at least one embodiment. FIG. 3 is a detail view of a scaffold material for a tissue thickness compensator, according to at least one embodiment. FIG. 3 is a detailed view of an unexpanded tissue thickness compensator according to at least one embodiment. FIG. 111 is a detailed view of the tissue thickness compensator of FIG. 110 in an expanded state. FIG. 3 is a cutaway perspective view of a tissue thickness compensator, according to at least one embodiment. FIG. 6 is a partially cutaway perspective view of a tissue thickness compensator being manufactured in a mold, according to at least one embodiment. FIG. 6 is a cross-sectional perspective view of a tissue thickness compensator, according to at least one alternative embodiment. FIG. 6 is a cross-sectional end view of a tissue thickness compensator according to at least one alternative embodiment. FIG. 6 is a partial perspective view of a tissue thickness compensator according to at least one alternative embodiment. 1 is an elevational view of an end effector of a surgical stapling instrument comprising a tissue thickness compensator, according to at least one embodiment. FIG. FIG. 118 is an exploded view of the tissue thickness compensator of FIG. 117, wherein the tissue thickness compensator includes multiple layers. FIG. 5 is a cross-sectional view of layers of a tissue thickness compensator. FIG. 6 is a cross-sectional view of another layer of a tissue thickness compensator. FIG. 118 is a partial cross-sectional elevation view of the tissue thickness compensator of FIG. 117 positioned between an anvil of a surgical stapling instrument and a staple cartridge. FIG. 118 is another partial cross-sectional elevation view of the tissue thickness compensator of FIG. 117 ejected from a staple cartridge and captured within a staple deformed by an anvil of a surgical stapling instrument. FIG. 122 is another partial cross-sectional elevation view of the tissue thickness compensator of FIG. 117 attached to tissue by the staple of FIG. 122; FIG. 6 is a perspective view of a layer of tissue thickness compensator, according to at least one alternative embodiment. FIG. 125 is a perspective view of an end effector of a surgical stapling instrument comprising a tissue thickness compensator including the layers of FIG. 124; FIG. 6 is a partial perspective view of a tissue thickness compensator according to at least one alternative embodiment. FIG. 127 is a perspective view of an end effector of a surgical stapling instrument comprising the tissue thickness compensator of FIG. 126; FIG. 3 is a perspective view of a plurality of coated fibers. 1 is a perspective view illustrating an extrusion process for making coated fibers and / or coated filaments that can be torn into coated fibers. FIG. 1 is a cross-sectional perspective view of a coated fiber. FIG. 5 is a perspective view illustrating a coating process that utilizes a carrier fluid configured to deposit material on and / or within a fiber. FIG. 129 is a perspective view of a staple cartridge including a tissue thickness compensator containing the fibers of FIG. 128; FIG. 6 is a partially cutaway perspective view of a tissue thickness compensator, according to at least one embodiment. 2 is a cross-sectional view of a drug encased in a hydrophilic material, according to at least one embodiment. FIG. FIG. 134 is a perspective view of the tissue thickness compensator of FIG. 133 positioned within an end effector of a surgical instrument. FIG. 134 is a partially cutaway perspective view of the drug of FIG. 134 being exposed to liquid so that the drug can exude from the tissue thickness compensator of FIG. 133. 3 is a partial perspective view of a tissue thickness compensator, according to at least one embodiment. FIG. FIG. 138 is a partial perspective view of the tissue thickness compensator of FIG. 137 after being exposed to a liquid. FIG. 138 is a perspective view of an end effector including the tissue thickness compensator of FIG. 137 attached to an anvil. FIG. 135 is a partially cutaway perspective view of a tissue thickness compensator comprising the agent of FIG. 134 and the fibers of FIG. 128. FIG. 6 is a partial perspective view of a staple cartridge with a tissue thickness compensator including a plurality of capsules. FIG. 142 is a side view of the staple cartridge of FIG. 141. 141 shows the capsule of FIG. 141 being placed in a mold. 141 shows the capsule of FIG. 141 resting on the bottom of the mold of FIG. 142 shows the compensator body material being poured onto the capsule of FIG. 141 illustrates an embodiment in which the capsule of FIG. 141 is denser than the compensator body material and remains on the bottom of the mold of FIG. 141 illustrates an embodiment where the capsule of FIG. 141 is less dense than the compensator body material and can float to the top of the mold of FIG. 143. 14 shows an alternative embodiment of a mold comprising a plurality of recesses or dimples configured to receive the capsule of FIG. 6 is a cross-sectional end view of an end effector of a surgical stapling instrument with a tissue thickness compensator positioned over a staple cartridge, according to at least one embodiment. FIG. 149 is a cross-sectional end view of the end effector of FIG. 149 showing staples fired from the staple cartridge and extending through the tissue thickness compensator of FIG. 149; Figure 2 shows a mold and a plurality of drug capsules located within the mold. FIG. 3 is a cross-sectional end view of a mold showing the compensator body material being injected into the mold to form a tissue thickness compensator. FIG. 157 is a perspective view of the tissue thickness compensator of FIG. 152 attached to an anvil of a surgical stapling instrument. 158 is a cross-sectional view of a mold configured to form the tissue thickness compensator of FIG. 157 showing the first layer being injected into the mold. FIG. 156 is a cross-sectional view of the mold of FIG. 154 showing the capsule positioned in the first layer. FIG. FIG. 157 is a cross-sectional view of the mold of FIG. 154 showing the second layer being injected over the capsule. 1 is a perspective view of a tissue thickness compensator, according to at least one embodiment. FIG. 158 is a perspective view of the tissue thickness compensator of FIG. 157 positioned within an end effector of a surgical stapling instrument. FIG. 162 is a perspective view of a compensator body of the tissue thickness compensator of FIG. 162. FIG. 159 is a perspective view of a longitudinal opening defined in the compensator body of FIG. 159; FIG. FIG. 161 shows the capsule positioned within the longitudinal opening of FIG. 160. FIG. 3 is a perspective view of an end effector of a surgical stapling instrument including a tissue thickness compensator, according to at least one embodiment. 166 is a perspective view of a compensator body of the tissue thickness compensator of FIG. 166. FIG. FIG. 167 is a perspective view of a plurality of lateral openings defined in the compensator body of FIG. 163; FIG. 167 shows the capsule positioned within the lateral opening of FIG. 164; FIG. 3 is a perspective view of an end effector of a surgical stapling instrument including a tissue thickness compensator, according to at least one embodiment. 1 is a perspective view of a vertical mold configured to produce a tissue thickness compensator. FIG. 167 is a perspective view of a capsule positioned in the mold of FIG. 167; FIG. 167 is a perspective view of the capsule of FIG. 168 positioned within the mold of FIG. 167; 167 is a perspective view of a cover positioned against the mold of FIG. 167 and the compensator body material positioned within the mold. FIG. 170 is a perspective view of the mold of FIG. 167 shown with the cover of FIG. 170 removed. FIG. 6 shows a staple cartridge comprising a tissue thickness compensator and a tissue thickness compensator mat, according to at least one embodiment. 172 is a partial bottom perspective view of the tissue thickness compensator mat of FIG. 172; FIG. 172 is a partial top perspective view of the tissue thickness compensator mat of FIG. 172; FIG. 173 is a partial cross-sectional view of the staple cartridge of FIG. 172 being fired by a firing member; FIG. In this figure, the staple cartridge is shown without the tissue thickness compensator positioned on top. 175 is a top view of the tissue thickness compensator mat of FIG. 172 being incised by a cutting member engaged with the firing member of FIG. 175; FIG. In this figure, the staple cartridge is shown without the tissue thickness compensator positioned on top. 175 is a top view of the tissue thickness compensator mat of FIG. 172 being incised by a cutting member engaged with the firing member of FIG. 175; FIG. In this figure, the staple cartridge is shown with a tissue thickness compensator positioned on top. FIG. 6 is a plan view of a circular staple cartridge according to at least one alternative embodiment with a circular tissue thickness compensator mat. FIG. 6 illustrates a mold with a plurality of cavities configured to simultaneously form a tissue thickness compensator on a plurality of staple cartridge bodies. 179 shows the staple cartridge body positioned within the cavity of FIG. 179 and one or more sheets disposed over the cartridge body. 179 shows the sheet of FIG. 180 secured in place within the mold of FIG. 179 shows an elongated tube member wrapped around a plurality of column supports in the mold of FIG. 180 shows the sheet of FIG. 180 covered over the staple cartridge body of FIG. 179 and secured in place. 182 shows the tube member of FIG. 182 in place on the sheet of FIG. 179 shows the compensator body material being injected into the mold of FIG. 179 shows the cutting die positioned over the mold of FIG. 186 shows the compensator body material of FIG. 185 and the cutting die moved down to cut the sheet of FIG. 179 shows the cutting die moved away from the mold of FIG. 189 is a cross-sectional end view of a tissue thickness compensator fabricated by the manufacturing process outlined in FIGS. 179-188, according to at least one embodiment. FIG. FIG. 3 is a top view of a staple cartridge with a tissue thickness compensator, according to at least one embodiment. FIG. 190 is a perspective view of the staple cartridge of FIG. 190. FIG. 190 is a diagram illustrating the manufacture of the tissue thickness compensator of the staple cartridge of FIG. 190; FIG. 4 is a view of a roller flattening tubing to form a tissue thickness compensator, according to at least one embodiment. FIG. 6 is an illustration of a roller forming a tissue thickness compensator, according to at least one alternative embodiment. 196 is a partial perspective view of a staple cartridge including a tissue thickness compensator made by the process shown in FIG. 194. FIG. 196 is a cross-sectional elevation view of a staple deployed from the staple cartridge of FIG. 195; FIG. 196 is a cross-sectional end view of a staple deployed from the staple cartridge of FIG. 195;

  Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations detailed herein illustrate, in one form, specific embodiments of the invention, and such illustrations should not be construed as limiting the scope of the invention in any way. .

The applicant of this application also owns US patent applications identified below, the entire contents of each of which are incorporated herein by reference.
US patent application Ser. No. 12 / 894,311, titled “SURGICAL INSTRUMENTS WITH RECONFIGURE SHAFFT SEGMENTS” (Attorney Docket No. END 6734 USNP / 100058),
US Patent Application No. 12 / 894,340, Title “SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLENS AND SURGICAL STALPING INSTRUMENTS WITH COMMAND STA
US patent application Ser. No. 12 / 894,327, titled “JAW CLOSER ARRANGEMENTS FOR SURGITAL INSTRUMENTS” (Attorney Docket No. END6736USNP / 100060),
US patent application Ser. No. 12 / 894,351, title “SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS 100 / Ag.
U.S. Patent Application No. 12 / 894,338, titled "IMPLANTABLE FASTENER CARTRIGAGE HAVING A NON-UNIFORM ARRANGEMENT" (Attorney Docket No. END6840USNP / 100525),
US patent application Ser. No. 12 / 894,369, titled “IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER” (Attorney Docket No. END6841USNP / 100526),
US patent application Ser. No. 12 / 894,312, title “IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS” (Attorney Docket No. END6842USNP / 100527),
US patent application Ser. No. 12 / 894,377, titled “SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE” (Attorney Docket No. END6843USNP / 100528),
U.S. Patent Application No. 12 / 894,339, titled "SURGICAL STAPLING INSTRUMENT WITH COMPACT ACTULATION CONTROL ARRANGEMENT" (Attorney Docket No. END6847USNP / 100532),
US patent application Ser. No. 12 / 894,360, titled “SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM” (Attorney Docket No. END6848USNP / 100533),
US patent application Ser. No. 12 / 894,322, title “SURGICAL STAPLING INSTRUMENT WITH INTERCHANGABLE STARL CARTRIDGE ARRANGEMENTS” (Attorney Docket No. END6849USNP / 100534),
U.S. Patent Application No. 12 / 894,350, entitled "SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTUATION MOTIONS WHEN A CARTRIDGE IS NOT PRESENT" (Attorney Docket No. END6855USNP / 100540),
US patent application Ser. No. 12 / 894,383, titled “IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIO ABSORBABLE LAYERS” (Attorney Docket No. END6856USNP / 100541),
US patent application Ser. No. 12 / 894,389, titled “COMPRESSABLE FASTENER CARTRIDGE” (Attorney Docket No. END6857USNP / 100542),
US patent application Ser. No. 12 / 894,345, titled “FASTENERS SUPPORTED BY A FASTNER CARTRIDGE SUPPORT” (Attorney Docket No. END6858USNP / 100543),
US patent application Ser. No. 12 / 894,306, titled “COLLAPSIBLE FASTENER CARTRIDGE” (Attorney Docket No. END6859USNP / 100544),
US patent application Ser. No. 12 / 894,318, title “FASTENER SYSTEM COMPRISING A PLULARITY OF CONNECTED RETENTION MATRIX ELEMENTS” (Attorney Docket No. END6860USNP / 100546),
US patent application Ser. No. 12 / 894,330, titled “FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX” (Attorney Docket No. END6861 USNP / 100547),
US patent application Ser. No. 12 / 894,361, title “FASTENER SYSTEM COMPRISING A RETENTION MATRIX” (Attorney Docket No. END 6862 USNP / 100548),
US patent application Ser. No. 12 / 894,367, title “FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION MATRIX” (Attorney Docket No. END 6863USNP / 100549),
US patent application Ser. No. 12 / 894,388, titled “FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER” (Attorney Docket No. END 6864 USNP / 100550),
US patent application Ser. No. 12 / 894,376, entitled “FASTENER SYSTEM COMPRISING A PLULARITY OF FASTENER CARTRIDGES” (Attorney Docket No. END6865USNP / 100551),
U.S. Patent Application No. 13 / 097,865, titled "SURGICAL STAPLLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS" (Attorney Docket No. END6735 USCIP1 / 100059CIP1),
US Patent Application No. 13 / 097,936, titled “TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER” (Attorney Docket No. END6736USCIP1 / 100060CIP1),
US Patent Application No. 13 / 097,954, titled “STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIVE POTION” (Attorney Docket No. END6840USCIP1 / 100525CIP1),
US Patent Application No. 13 / 097,856, title "STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN COMPRESIBLE PORTION THEREOF" (Attorney Docket No. END6841USCIP1 / 100526CIP1),
US Patent Application No. 13 / 097,928, title “TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORATIONS” (Attorney Docket No. END6842USCIP1 / 100527CIP1),
US Patent Application No. 13 / 097,891, title “TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLERS COMPRISING AN ADJUSTABLE ANVIL” (Attorney Docket No. END6843USCIP1 / 100528CIP1),
US Patent Application No. 13 / 097,948, title “STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISPORTION” (Attorney Docket No. END 6847 USCIP1 / 1003 CIP1),
US Patent Application No. 13 / 097,907, Title “COMPRESSABLE STAPLE CARTRIDGE ASSEMBLY” (Attorney Docket No. END6848 USCIP1 / 1003533CIP1),
U.S. Patent Application No. 13 / 097,861, title "TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERIES" (Attorney Docket No. END6849USCIP1 / 100534CIP1),
US Patent Application No. 13 / 097,869, Title “STAPLE CARTRIDGE LOADING ASSEMBLY” (Attorney Docket No. END6855 USCIP1 / 100540CIP1),
U.S. Patent Application No. 13 / 097,917, titled "COMPRESSABLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS" (Attorney Docket No. END6856USCIP1 / 100541CIP1),
US Patent Application No. 13 / 097,873, title “STAPLE CARTRIDGE COMPRISING A RELEASABLE POTION” (Attorney Docket No. END6857USCIP1 / 100542CIP1),
US Patent Application No. 13 / 097,938, Title “STAPLE CARTRIDGE COMPRISING COMPRESIBLE DISTORTION RESISTANT COMPONENTS” (Attorney Docket No. END6858USCIP1 / 100543CIP1),
US Patent Application No. 13 / 097,924, entitled “STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR” (Attorney Docket No. END6859USCIP1 / 100544CIP1),
US patent application No. 13 / 242,029, titled “SURGICAL STAPLER WITH FLOATING ANVIL” (Attorney Docket No. END6841USCIP2 / 100526CIP2),
US Patent Application No. 13 / 242,066, title "CURVED END EFFECTOR FOR A STAPLING INSTRUMENT" (Attorney Docket No. END6841USCIP3 / 100526CIP3),
US Patent Application No. 13 / 242,086, titled “STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK” (Attorney Docket No. END7020USNP / 110374),
US Patent Application No. 13 / 241,912, entitled “STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT” (Attorney Docket No. END7019 USNP / 110375),
US Patent Application No. 13 / 241,922, title “SURGICAL STAPLIER WITH STATIONARY STAY DRIVERS” (Attorney Docket No. END 7013 USNP / 110377),
US Patent Application No. 13 / 241,637, Title “SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATION MULTIPACTION ACTION MOTIONS” (Attorney Docket No. END6888USNP3 / 110378),
And US patent application Ser. No. 13 / 241,629, entitled “SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULABLE END EFFECTOR” (Attorney Docket No. END6888USNP2 / 110379).

The applicant of this application also owns the US patent applications identified below, filed on the same day as this specification, the entire contents of each of which are incorporated herein by reference.
US application _____________________________________ Title, TISSUE THICKNESS COMPENSATOR COMPRISING A PLARITY OF CAPSULES (Attorney Docket Number END 6864 USCIP1 / 100550CIP1),
US application _________, title “TISSUE THICKNESS COMPENSATOR COMPRISING A PLULARITY OF LAYERS” (Attorney Docket No. END 6864 USCIP2 / 100550CIP2),
US application ________, title "EXPANDABLE TISSUE TICHKNESS COMPENSATOR" (Attorney Docket No. END6843USCIP2 / 100528CIP2),
US Application No. _________, title “TISSUE THICKNESS COMPENSOR COMPRISING A RESERVOIR” (Attorney Docket No. END6843USCIP3 / 100528CIP3),
US application ______________________________________, Title “RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR” (Attorney Docket Number END6843USCIP4 / 100528CIP4),
US application _________, title “TISSUE THICKNESS COMPENSOR COMPRISING AT Least ONE MEDIACAMENT” (Attorney Docket Number END6843USCIP5 / 100528CIP5),
US Application No. _________, title “TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION” (Attorney Docket No. END6843USCIP6 / 100528CIP6),
US Application No. _________, title “TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD” (Attorney Docket Number END6843USCIP7 / 100528CIP7),
US application ________, title "TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD" (Attorney Docket No. END6843USCIP8 / 100528CIP8),
US application _________, title “TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS” (Attorney Docket No. END6843USCIP9 / 100528CIP9),
US application ________, title "METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS" (Attorney Docket No. END6843USCIP10 / 100528CP10),
US application _________, title “TISSUE THICKNESS COMPENSATORS” (Attorney Docket No. END6843USCIP11 / 100528CP11),
US Application No. ________, title “LAYERED TISSUE THICKNESS COMPENSATOR” (Attorney Docket No. END6843USCIP12 / 100528CP12),
US application ________________________________________ Title, TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS (Attorney Docket Number END6843USCIP13 / 100528CP13),
US Application No. _________, title “TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFING A LOW PRESSURE ENVIRONMENT” (Attorney Docket No. END7100USNP / 110601),
US application _________, title “MOVABLE MEMBER FOR US WITH A TISSUE THICKNESS COMPENSATOR” (Attorney Docket No. END7107USNP / 110603),
US application _____________________________________ Title, TISSUE THICKNESS COMPENSATOR COMPRISING A PLARITY OF MEDICAMENTS (Attorney Docket Number END7102USNP / 110604),
United States application ______________________________________________, title "TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME"
US Application No. _________, title “TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS” (Attorney Docket No. END7104USNP / 110606),
U.S. Application No. ________ No., entitled "TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES" (Attorney Docket No. END7105USNP / 110607), and U.S. Application No. ________ No., entitled "DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS (Attorney Docket No. END7106USNP / 110608).

  Certain exemplary embodiments are described below to provide a general understanding of the principles of structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the devices and methods specifically described herein and shown in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are encompassed within the scope of the invention.

  Any of the methods disclosed or claimed herein for manufacturing, forming or separately manufacturing an article or product may be used to manufacture, form or separately manufacture all or part of the subject article or product. Otherwise, if such a method is used to manufacture, form or otherwise produce a portion of the subject article or product, the remainder of the article or product will produce, form or otherwise produce the article or product. Can be fabricated in any manner, including utilizing any of the other methods disclosed and claimed herein, and the various parts so fabricated can be combined in any way. Similarly, any article or product disclosed or claimed herein is alone or in combination, or any other article or product so disclosed that is compatible with the article or product. Can exist as part. Accordingly, each individual feature, structure, or characteristic illustrated or described in connection with one article, product, or method is equivalent to one or more other compatible article, product, or method features, structures, or characteristics. , In whole or in part, without limitation. Such modifications and variations are encompassed within the scope of the invention.

  It is to be understood that certain embodiments of the present invention or certain articles, products or methods may include certain structures, characteristics or features, as disclosed herein in connection with individual figures or otherwise. The reader will understand that the structure, properties, or characteristics of can be implemented in the subject article, product, or method in any compatible combination. In particular, such disclosure of a number of any structures, properties or features is disclosed in combination with all of those structures, properties or features, except in the case of structures, properties or features disclosed as alternatives to each other. That will be understood as well. Where such structures, characteristics or features are disclosed as alternatives to one another, it will be understood that it discloses those alternatives as a replacement for one another.

  The terms “proximal” and “distal” are used herein with reference to the clinician operating the handle portion of the surgical instrument. The term “proximal” refers to the portion closest to the clinician, and the term “distal” refers to the portion located away from the clinician. It is further appreciated that for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “top”, and “bottom” may be used herein in connection with the drawings. It will be. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.

  Various exemplary devices and methods for performing laparoscopic and minimally invasive surgery are provided. However, the reader will readily appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications, including when used in connection with open surgery. Will do. As the “Mode for Carrying Out the Invention” herein progresses, the various instruments disclosed herein may be used in any way, such as through natural openings, through incisions or puncture holes formed in tissue. The reader will further recognize that the technique can be inserted into the body. The functional or end effector portion of the instrument may be inserted directly into the patient's body or may be inserted through an access device having a functional channel capable of advancing the end effector and elongated shaft of the surgical instrument. .

  Turning to the drawings, like reference numerals indicate like components throughout the several views. FIG. 1 illustrates a surgical instrument 10 that can implement several inherent advantages. Surgical stapling instrument 10 is designed to manipulate and / or actuate end effectors 12 of various forms and sizes that are operably attached to instrument 10. In FIGS. 1-1E, for example, the end effector 12 includes an elongate channel 14 that forms a lower jaw 13 of the end effector 12. The elongate channel 14 is configured to support the “implantable” staple cartridge 30 and to movably support the anvil 20 that functions as the upper jaw 15 of the end effector 12.

  The elongate channel 14 may be made of, for example, 300 & 400 series, 17-4 & 17-7 stainless steel, titanium, etc., and spaced apart side walls 16 may be formed. Anvil 20 may be made of, for example, 300 & 400 series, 17-4 & 17-7 stainless steel, titanium, etc., and is generally labeled 22 with a plurality of staple forming pockets 23 formed therein. It may have a lower surface for forming staples. See Figures 1B-1E. In addition, the anvil 20 has a bifurcated ramp assembly 24 protruding proximally therefrom. The anvil pin 26 is tilted to be received within a corresponding slot or opening 18 in the side wall 16 of the elongated channel 14 to facilitate movable or pivotable attachment to the slot or opening 18. It protrudes from each side surface of 24.

  Various forms of implantable staple cartridges can be utilized with the surgical instruments disclosed herein. Specific staple cartridge configurations and structures are described in further detail below. However, in FIG. 1A, an implantable staple cartridge 30 is shown. The staple cartridge 30 has a body portion 31 of compressible hemostatic material, such as oxidized regenerated cellulose (“ORC”) or bioabsorbable foam, in which a line of unformed metal staples 32 is supported. Have. The entire cartridge is sold under the trade name PDS®, which is impervious until it breaks to prevent the staples from being affected and the hemostatic material from being activated during the introduction and positioning process. Polydioxanone film, polyglycerol sebacate (PGS) film, or PGA (polyglycerol acid marketed under the trade name Vicryl), PCL (polycaprolactone), PLA, or PLLA (polylactic acid), PHA (polyhydroxyalkano) Or other biodegradable films formed from PGA, PCL, PLA, PDS composites, or PGCL (Polygrecapron 25 sold under the trade name Monocryl) or Can be coated. The body 31 of the staple cartridge 30 is shown such that each staple 32 therein is aligned with a corresponding staple forming pocket 23 in the anvil as the anvil 20 forms contact with the staple cartridge 30. As such, it is sized to be removably supported within the elongated channel 14.

  In use, once the end effector 12 is positioned adjacent to the target tissue, the end effector 12 captures or clamps the target tissue between the upper surface 36 of the staple cartridge 30 and the staple forming surface 22 of the anvil 20. To be operated. In order to bring the staple forming surface 22, and more particularly the internal staple forming pocket 23, into contact with the top surface 36 of the staple cartridge 30 at substantially the same time, the staple 32 is anviled in a path substantially parallel to the elongated channel 14. Formed by moving 20. As the anvil 20 continues to move into the staple cartridge 30, the staple 32 in the corresponding staple forming pocket 23 of the anvil 20 functions to fold the staple legs 34 to form the staples 32 in a "B" shape. The leg part 34 contacts. Further movement of the anvil 20 into the elongate channel 14 further compresses the staple 32 to form the desired final formed height “FF”.

  The above staple forming process is shown generally in FIGS. For example, FIG. 1B shows the end effector 12 with the target tissue “T” between the anvil 20 and the top surface 36 of the implantable staple cartridge 30. FIG. 1C shows the initial clamping position of the anvil 20 with the anvil 20 closed on the target tissue “T” to clamp the target tissue “T” between the anvil 20 and the top surface 36 of the staple cartridge 30. . FIG. 1D shows the initial staple formation where the anvil 20 begins to compress the staple cartridge 30 so that the legs 34 of the staple 32 begin to be formed by the staple forming pockets 23 of the anvil 20. FIG. 1E shows the staple 32 in its final formed state through the target tissue “T” with the anvil 20 removed for clarity purposes. Once the staple 32 is formed and clamped to the target tissue “T”, the surgeon will leave the cartridge body 31 and staple 32 secured to the target tissue while the end effector 12 is withdrawn from the patient. In order to make this possible, the anvil 20 will be moved to the open position. The end effector 12 forms all of the staples simultaneously when the two jaws 13, 15 are clamped together. The remaining “crushed” body material 31 serves as both a hemostatic agent (ORC) and a staple line reinforcement (PGA, PDS or any of the other film compositions 38 described above). Further, since the staple 32 does not need to leave the cartridge body 31 during the formation, the possibility that the staple 32 is abnormally formed during the formation is minimized. As used herein, the term “implantable” means that in addition to staples, the cartridge body material supporting the staples can also remain in the patient and ultimately be absorbed by the patient's body. Means. Such implantable staple cartridges are distinct from conventional cartridge configurations that remain entirely positioned within the end effector after firing.

  In various embodiments, the end effector 12 is configured to be coupled to an elongate shaft assembly 40 that projects from the handle assembly 100. End effector 12 (when closed) and elongate shaft assembly 40 may have a similar cross-sectional shape and are sized to operably pass through a trocar tube or functional channel in another form of access device. Also good. As used herein, the term “operably passing” means that at least a portion of the end effector and elongate shaft assembly can be inserted or passed through a channel or tube opening, and surgical stapling. It means that it can be manipulated internally as needed to complete the surgery. When in the closed position, the jaws 13 and 15 of the end effector 12 can provide the end effector with a generally circular cross-sectional shape that facilitates passage of the end effector's circular passages / openings. However, the end effector and elongate shaft assembly of the present invention can be provided with other cross-sectional shapes that can separately pass through access passages and openings having non-circular cross-sectional shapes, if conceivable. Thus, the overall size of the closed end effector cross-section will be related to the size of the passage or opening through which the end effector is intended to pass. Thus, an end effector may be referred to as a “5 mm” end effector, meaning that the end effector can operably pass through an opening that is at least about 5 mm in diameter, for example.

  The elongate shaft assembly 40 may have an outer diameter that is substantially the same as the outer diameter of the end effector 12 when in the closed position. For example, a 5 mm end effector may be coupled to an elongate shaft assembly 40 having a 5 mm cross-sectional diameter. However, as the “DETAILED DESCRIPTION” of this specification proceeds, it will become apparent that the present invention can be effectively used in connection with different sizes of end effectors. For example, a 10 mm end effector may be attached to an elongate shaft having a cross sectional diameter of 5 mm. Conversely, for those applications where an access opening or passage of 10 mm or more is provided, the elongate shaft assembly 40 may have a cross-sectional diameter of 10 mm (or greater), but 5 mm or 10 mm. The end effector can also be actuated. Accordingly, the outer shaft 40 can have an outer diameter that is the same as or different from the outer diameter of the closed end effector 12 attached thereto.

  As shown, the elongate shaft assembly 40 extends generally straight distally from the handle assembly 100 to define a longitudinal axis AA. For example, the elongate shaft assembly 40 may be about 9-16 inches long. However, the elongate shaft assembly 40 can be provided in other lengths or have joints on the inside, or the end effector 12 relative to other parts of the shaft or handle assembly, as described in more detail below. Can be configured separately to facilitate the articulation of The elongate shaft assembly 40 includes a spine member 50 that extends from the handle assembly 100 to the end effector 12. The proximal end of the elongated channel 14 of the end effector 12 is a corresponding trunnion opening or receptacle provided in the distal end of the spine member 50 so that the end effector 12 can be removably coupled to the elongated shaft assembly 40. A pair of retaining trunnions 17 project from a proximal end sized to be received within the platform 52. The spine member 50 may be made of, for example, 6061 or 7075 aluminum, stainless steel, titanium, or the like.

  The handle assembly 100 comprises a pistol grip type housing that can be made of two or more parts for assembly purposes. For example, the handle assembly 100 as shown comprises a right hand case member 102 and a left hand case member (not shown) that are molded or separately made from a polymer or plastic material and designed to fit together. Such case members may be attached to each other by snap function, pegs and sockets molded or separately formed therein and / or by adhesives, screws, and the like. Spine member 50 has a proximal end 54 having a flange 56 formed thereon. The flange 56 is configured to be rotatably supported in a groove 106 formed by a fitting rib 108 protruding inward from each of the case members 102 and 104. Such a configuration allows the spine member 50 to rotate in a 360 ° path about the longitudinal axis AA relative to the handle assembly 100, while at the same time attaching the spine member 50 to the handle assembly 100. make it easier.

  As can further be seen in FIG. 1, the spine member 50 passes through and is supported by a mounting bushing 60 that is rotatably attached to the handle assembly 100. The mounting bushing 60 has a proximal flange 62 and a distal flange 64 that define a rotation groove 65 configured to rotatably receive the nose portion 101 of the handle assembly 100 therebetween. Such a configuration allows the mounting bushing 60 to rotate about the longitudinal axis AA relative to the handle assembly 100. The spine member 50 is non-rotatably pinned to the mounting bushing 60 by a spine pin 66. In addition, a rotation knob 70 is attached to the attachment bushing 60. For example, the rotary knob 70 has a hollow mounting flange portion 72 sized to receive a portion of the mounting bushing 60 therein. The rotary knob 70 may be made of, for example, glass or carbon-filled nylon, polycarbonate, Ultem (registered trademark), and the like, and is similarly fixed to the mounting bushing 60 by a spine pin 66. In addition, an inwardly projecting retaining flange 74 is formed on the mounting flange portion 72 and is configured to extend into a radial groove 68 formed in the mounting bushing 60. Accordingly, the surgeon grasps the rotation knob 70 and rotates it relative to the handle assembly 100 to cause the spine member 50 (and the end effector 12 attached thereto) to 360 ° about the longitudinal axis AA. It can be rotated in the path.

  Anvil 20 is maintained in the open position by anvil spring 21 and / or other biasing configurations. Anvil 20 is selectively movable from an open position to various closed or clamping and firing positions by a firing system, generally designated 109. Firing system 109 includes a “firing member” 110 and a hollow firing tube 110. The hollow firing tube 110 is axially movable on the spine member 50 and thus forms the exterior of the elongate shaft assembly 40. The firing tube 110 may be made from a polymer, or other suitable material, and may have a proximal end that is attached to the firing yoke 114 of the firing system 109. For example, the firing yoke 114 may be overmolded to the proximal end of the firing tube 110. However, other fastener arrangements may be utilized.

  As seen in FIG. 1, the firing yoke 114 may be rotatably supported within a support collar 120 that is configured to move axially within the handle assembly 100. The support collar 120 has a pair of laterally extending fins that are slidably received in fin slots formed in the right hand case member and the left hand case member, respectively. It is a size. Thus, the support collar 120 may be slidable axially within the handle housing 100 while the firing yoke 114 and the firing tube 110 rotate relative to the longitudinal axis AA. to enable. In accordance with the present invention, an elongated slot is provided through the launch tube 110 to allow the spine pin 66 to extend through and into the spine member 50 while the launch tube 110 on the spine member 50 is extended. Facilitates axial movement.

  The firing system 109 further includes a firing trigger 130 that functions to control the axial movement of the firing tube 110 on the spine member 50. Please refer to FIG. Such axial movement in the distal direction of the launch tube 110 that interacts with the anvil 20 for launch is referred to herein as “fire motion”. As seen in FIG. 1, the firing trigger 130 is movably or pivotally coupled to the handle assembly 100 by a pivot pin 132. A torsion spring 135 is utilized to bias the firing trigger 130 from the pistol grip portion 107 of the handle assembly 100 to an inoperative “release” or starting position. As seen in FIG. 1, the firing trigger 130 has an upper portion 134 that is movably attached (pinned) to a firing link 136 that is movably attached (pinned) to the support collar 120. Accordingly, movement of the firing trigger 130 from the firing position (FIG. 1) to an end position adjacent to the pistol grip portion 107 of the handle assembly 100 moves the firing yoke 114 and the firing tube 110 in the distal direction “DD”. . Movement of the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 (by biasing the torsion spring 135) causes the firing yoke 114 and the firing tube 110 to move proximally in the spine member 50 in the “PD” direction.

  The present invention can be utilized with implantable staple cartridges of different sizes and configurations. For example, the surgical instrument 10 is used with a 5 mm end effector 12 of approximately 20 mm length (or other length) that supports the implantable staple cartridge 30 when used with the first firing adapter 140. obtain. Such end effector sizes are particularly suitable, for example, to complete relatively fine incisions and vessel transections. However, as described in more detail below, the surgical instrument 10 can also be utilized with other sized end effectors and staple cartridges, for example, by replacing the first firing adapter 140 with a second firing adapter. Can be done. As an additional alternative, the elongate shaft assembly 40 may be configured to be attached to an end effector of only one shape or size.

  One method of removably coupling the end effector 12 to the spine member 50 is described. The joining process is initiated by inserting the retaining trunnion 17 on the elongated channel 14 into the trunnion cradle 52 of the spine member 50. Thereafter, the surgeon advances the firing trigger 130 toward the pistol grip 107 of the housing assembly 100 and advances the firing tube 110 and the first firing adapter 140 distally beyond the proximal end portion 47 of the elongated channel 14. Thereby holding the trunnion 17 on each of these cradles 52. Such a position of the first firing adapter 140 over the trunnion 17 is referred to herein as a “coupled position”. The present invention may also include an end effector securing assembly for securing the firing trigger 130 in place after the end effector 12 is attached to the spine member 50.

  More specifically, one embodiment of the end effector fixation assembly 160 includes a retaining pin 162 that is movably supported within the upper portion 134 of the firing trigger 130. As described above, the firing tube 110 is initially advanced distally to a coupled position where the first firing adapter 140 retains the retaining trunnion 17 of the end effector 12 within the trunnion cradle 52 of the spine member 50. Must-have. The surgeon advances the firing adapter 140 distally to the coupled position by pulling the firing trigger 130 from the starting position to the pistol grip 107. When the firing trigger 130 is initially actuated, the retaining pin 162 moves distally until the firing tube 110 advances the first firing adapter 140 to the coupled position, at which point the retaining pin 162 is It is biased into a fixed cavity 164 formed in the case member. Optionally, when the retaining pin 162 enters the locking cavity 164, the pin 162 may produce an audible “click” or other sound, and a tactile sense that the end effector 12 is “locked” to the spine member 50. Instructions may be provided to the surgeon. In addition, the surgeon will not inadvertently actuate the firing trigger 130 and begin to form the staple 32 in the end effector 12 unless the retention pin 162 is intentionally biased from the locking cavity 164. Similarly, when the surgeon releases the firing trigger 130 when it is in the coupled position, it is held in this position by the retaining pin 162 and the firing trigger 130 is returned to the starting position, thus causing the end effector 12 to move the spine member 50. To prevent the release.

  The present invention may further include a firing system locking button 137 pivotally attached to the handle assembly 100. In one form, the firing system locking button 137 has a latch 138 formed on its distal end that engages the firing yoke 114 when the firing release button is in the first latching position. Directed to. As can be seen in FIG. 1, the latch spring 139 functions to bias the firing system locking button 137 to the first latching position. In various situations, the latch 138 corresponds to the position of the firing yoke 114 on the spine member 50 where the first firing adapter 140 begins to advance distally up the clamping ramp 28 on the anvil 20. In that respect, it functions to engage the firing yoke 114. As the first firing adapter 140 extends axially advancing the clamping ramp 28, the anvil 20 is routed such that its staple forming surface portion 22 is substantially parallel to the top surface 36 of the staple cartridge 30. Moving.

  When the end effector 12 is coupled to the spine member 50, the stapling process is initiated by first pressing the firing system locking button 137, and the firing yoke 114 is further moved distally on the spine member 50 to provide a final result. Thus, the anvil 20 is pressed against the staple cartridge 30. After pressing the firing system locking button 137, the surgeon continues to actuate the firing trigger 130 in the direction of the pistol grip 107, thereby driving the first staple collar 140 up the corresponding staple forming ramp 29 and the anvil. 20 is formed in contact with the staples 32 in the staple cartridge 30. The firing system locking button 137 prevents inadvertent formation of the staple 32 until the surgeon is ready for the process. In this embodiment, the surgeon must press the firing system lock button 137 before the firing trigger 130 is further actuated to begin the stapling process.

  The surgical instrument 10 can simply be used as a tissue stapling device if desired, if desired. However, the present invention may also include a tissue cutting system, generally designated as 170. In at least one form, the tissue cutting system 170 includes a knife member 172 that operates from a non-actuated position adjacent the proximal end of the end effector 12 to an activated position by actuating the knife advance trigger 200. You can move forward selectively. The knife member 172 is movably supported and attached within the spine member 50 or protrudes from the knife rod 180 by another method. Knife member 172 may be made of, for example, 420 or 440 stainless steel having a hardness of more than 38 HRC (Rockwell hardness C scale) and has a tissue cutting edge 176 formed on its distal end 174; It extends slidably through a slot in the anvil 20 and a slot 33 located in the center of the staple cartridge 30 and cuts through the tissue clamped in the end effector 12. The knife rod 180 extends through the spine member 50 and has a proximal end portion operatively joined to the knife transmitter that is operably attached to the knife advance trigger 200. The knife advance trigger 200 is attached to the drive pin 132 so that it can be pivoted or otherwise actuated without activating the firing trigger 130. In accordance with the present invention, the first knife gear 192 is also attached to the pivot pin 132 so that actuation of the knife advance trigger 200 also pivots the first knife gear 192. The firing return spring 202 is mounted between the first knife gear 192 and the handle housing 100 and biases the knife advance trigger 200 to a start or inoperative position.

  The knife transmitter further includes a second knife gear 194 rotatably supported on the second gear spindle and in meshing engagement with the first knife gear 192. The second knife gear 194 meshes with the third knife gear 196 supported on the third gear spindle. The fourth knife gear 198 is also supported on the third gear spindle 195. The fourth knife gear 198 is adapted to engage in driving with a series of annular gear teeth or rings on the proximal end of the knife rod 180. Such an arrangement allows the fourth knife gear 198 to drive the knife rod 180 axially in the distal direction “DD” or the proximal direction “PD”, while the firing rod 180 is in the fourth knife gear. 198 allows rotation about the longitudinal axis AA. Accordingly, the surgeon can advance the firing rod 180 axially and ultimately advance the knife member 172 distally by pulling the knife advance trigger 200 toward the pistol grip 107 of the handle assembly 100. .

  The present invention further includes a knife lockout system 210 that prevents the advancement of the knife member 172 except when the firing trigger 130 is pulled to the full firing position. Such a feature thus prevents operation of the knife advancement system 170 except when the staple is first fired or formed into tissue. As seen in FIG. 1, various implementations of the knife lockout system 210 include a knife lockout bar 211 that is pivotally supported within the pistol grip portion 107 of the handle assembly 100. The knife lockout bar 211 has an actuation end 212 that is adapted to engage the firing trigger 130 when the firing trigger 130 is in the fully fired position. In addition, the knife lockout bar 211 has a retaining hook 214 at the other end, which is adapted to engage the latch rod 216 on the first cutting gear 192. The knife locking spring 218 is utilized to bias the knife lockout bar 211 to the “locked” position, and the retaining hook 214 is maintained in engagement with the latch rod 216, thereby causing the firing trigger 130 to move. Actuation of knife advance trigger 200 is prevented except when in the fully fired position.

  After the staple has been “fired” (formed) into the target tissue, the surgeon presses the fire trigger release button 167 to allow the fire trigger 130 to return to the starting position by the biasing force of the torsion spring 135; As a result, the anvil 20 is biased to the open position by the biasing force of the spring 21. When in the open position, the surgeon may pull the end effector 12 leaving behind the implantable staple cartridge 30 and staples 32. In applications where the end effector is inserted through a path, working channel, etc., the surgeon places the anvil 20 in a closed position by activating the firing trigger 130 to allow the end effector 12 to be retracted through the path or working channel. return. However, if the surgeon desires to cut the target tissue after staple firing, the surgeon activates the knife advance trigger 200 in the manner described above to drive the knife bar 172 through the target tissue to the end effector end. . The surgeon then releases the knife advance trigger 200 so that the firing return spring 202 allows the firing transmitter to return the knife bar 172 to the starting (inactive) position. Once the knife bar 172 has returned to the starting position, the surgeon opens the end effector jaws 13, 15 to release the implantable cartridge 30 within the patient and then withdraws the end effector 12 from the patient. Thus, such surgical instruments can be inserted through relatively small working channels and pathways, while allowing the surgeon to fire the staples without cutting the tissue or, if desired, after the staples have been fired. Tissue also facilitates the use of small implantable staple cartridges that offer the option of cutting.

  Various unique and novel embodiments of the present invention utilize a compressible staple cartridge that supports staples in a substantially static position in contact with the anvil. The anvil is driven against unformed staples, where, for example, the degree of staple formation achieved depends on how far the anvil has been driven against the staples. Such a configuration provides the surgeon with the ability to adjust the degree of forming or firing pressure applied to the staples, thereby changing the height of the final formed staples. In the present invention, the surgical stapling arrangement can employ a staple drive element that can lift the staples toward the anvil. These are further detailed below.

  Optionally, with respect to the above, the amount of firing motion applied to the movable anvil depends on the differential degree of the firing trigger. For example, if the surgeon wants to obtain a partially formed staple, the firing trigger is only partially pressed inwardly toward the pistol grip 107. To obtain further staple formation, the surgeon simply compresses the firing trigger further, thereby driving the anvil further into greater contact with the staples. As used herein, the term “contacting” means that a staple forming surface or staple forming pocket contacts the end of a staple leg and begins to form or bend into the position where the leg is formed. means. The degree of staple formation refers to how much the staple leg has been folded, and thus relates to the height of staple formation described above. Those skilled in the art further recognize that the anvil 20 moves in a substantially parallel relationship with the staple cartridge as the firing motion is applied thereto, so that the staples are formed at substantially the same, substantially the same forming height. Understand what will be done.

  Figures 2 and 3 illustrate another end effector 12 "similar to the end effector 12 'described above, but including the following differences configured to fit the knife bar 172'. Knife bar 172 ′ is coupled to or protrudes from knife rod 180 and is otherwise manipulated in the manner described above with respect to knife bar 172. However, in this embodiment, the knife bar 172 'is long enough to traverse the entire length of the end effector 12 "and therefore no separate distal knife member is utilized with the end effector 12". Knife bar 172 'has an upper transverse member 173' and a lower transverse member 175 'formed thereon. The upper cross member 173 'is oriented to slidably traverse the corresponding elongate slot 250 of the anvil 20 ", and the lower cross member 175' is an elongate slot of the elongate channel 14" of the end effector 12 ". Directed to cross 252. A disengagement slot (not shown) is also provided in the anvil 20 ″ so that when the knife bar 172 ′ is driven to the end position with the thin end effector 12 ″, the upper transverse member 173 ′ is lowered through the corresponding slot. Then, the anvil 20 '' moves to the open position and disengages from the stapling and cut tissue. The anvil 20 ″ may be otherwise identical to the anvil 20 described above, and the elongated channel 14 ″ may be otherwise identical to the elongated channel 14 described above.

  In these embodiments, the anvil 20 '' is biased to the fully open position (FIG. 2) by a spring or other opening configuration (not shown). The anvil 20 "moves between the open position and the fully clamped position by the axial movement of the firing adapter 150 in the manner described above. Once the firing adapter 150 has been advanced to the fully clamped position (FIG. 3), the surgeon may then advance the knife bar 172 ″ distally in the manner described above. When the surgeon uses the end effector as a grasping device for manipulating tissue, the firing adapter is moved proximally to allow the anvil 20 '' to move away from the elongated channel 14 ''. (Represented by the dashed line in FIG. 4). In this embodiment, as the knife bar 172 ″ moves distally, the upper transverse member 173 ′ and the lower transverse member 175 ′ pull the anvil 20 ″ and the elongated channel 14 ″ together, and the knife bar 172 ″. As the needle advances distally through the end effector 12 '', the desired staple formation is achieved. Please refer to FIG. Thus, in this embodiment, staple formation occurs simultaneously with tissue cutting, but the staples themselves may be formed sequentially as the knife bar 172 "is driven in the distal direction.

  The unique and novel features of the various surgical staple cartridges and surgical instruments of the present invention allow the staples of these cartridges to be configured in one or more linear or non-linear lines. A plurality of such staple lines may be provided on either side of the elongated slot centrally disposed within the staple cartridge for receiving a tissue cutting member therethrough. In one configuration, for example, staples on one line are substantially parallel to staples on adjacent lines of staples, but may be offset therefrom. As an additional alternative, one or more staple lines may have non-linear properties. That is, the base of at least one staple in the staple line may extend along an axis that is substantially transverse to the other staple base in the same staple line. For example, the staple line on each side of the elongated slot may have a zigzag appearance.

  According to the present invention, the staple cartridge can include a cartridge body and a plurality of staples housed in the cartridge body. In use, the staple cartridge can be incorporated at the surgical site and on the side of the tissue being processed. In addition, the staple forming anvil may be located on the opposite side of the tissue. The anvil can be held by the first jaw, the staple cartridge can be held by the second jaw, and the first jaw and / or the second jaw can move toward each other. Once the staple cartridge and anvil are positioned relative to the tissue, the staple can be fired from the staple cartridge body, and the staple can penetrate the tissue and contact the spleating anvil. Once the staples are deployed from the staple cartridge body, the staple cartridge body may then be removed from the surgical site. The staple cartridge or at least a portion of the staple cartridge can be embedded with the staples. For example, as described in more detail below, a staple cartridge can include a cartridge body that can be compressed, crushed, and / or folded by the anvil as the anvil moves from an open position to a closed position. As the cartridge body is compressed, crushed, and / or folded, staples positioned within the cartridge body can be deformed by the anvil. Alternatively, the jaws that support the staple cartridge can move toward the anvil and into the closed position. In any case, the staples can be deformed when they are at least partially positioned within the cartridge body. In some cases, the staples may not be ejected from the staple cartridge, and in other cases, the staples may be ejected from the staple cartridge along with a portion of the cartridge body.

  6A-6D, a compressible staple cartridge, such as, for example, a staple cartridge 1000, is positioned within a compressible, implantable cartridge body 1010, and in addition, a compressible cartridge body 1010. Although a plurality of staples 1020 may be included, only one staple 1020 is shown in FIGS. 6A illustrates a cartridge 1000 supported by a staple cartridge support, or staple cartridge channel 1030, which is illustrated in an uncompressed state. In such an uncompressed state, the anvil 1040 may or may not be in contact with the tissue T. In use, the anvil 1040 may move from the open position into contact with the tissue T and position the tissue T relative to the cartridge body 1010 as seen in FIG. 6B. Referring again to FIG. 6B, the anvil 1040 can position the tissue T relative to the tissue contacting surface 1019 of the staple cartridge body 1010, but the staple cartridge body 1010 may apply compressive force or pressure at such time ( The staple 1020 may be in a non-formed or unfired state (if received). As illustrated in FIGS. 6A and 6B, the staple cartridge body 1010 may include one or more layers, and the staple legs 1021 of the staples 1020 may extend upwardly through these layers. The cartridge body 1010 may include a first layer 1011, a second layer 1012, and a third layer 1013, and the second layer 1012 is positioned between the first layer 1011, the third layer 1013, and the fourth layer 1014. The third layer 1013 may be positioned between the second layer 1012 and the fourth layer 1014. The base 1022 of the staple 1020 may be positioned within the cavity 1015 of the fourth layer 1014, and the staple legs 1021 extend upward from the base 1022 through the fourth layer 1014, the third layer 1013, and the second layer 1012. May be. Optionally, each deformable leg 1021 may include a tip, eg, a sharp tip 1023, which is positioned on the second layer 1012 when, for example, the staple cartridge 1000 is in an uncompressed state. May be. For example, the tip 1023 may not extend into and / or through the first layer 1011 and the tip 1023 may not protrude through the tissue contacting surface 1019 when the staple cartridge 1000 is in an uncompressed state. There is. When the staple cartridge is in an uncompressed state, the sharp tip 1023 may be positioned in the third layer 1013 and / or any other suitable layer. Alternatively, the cartridge body of the staple cartridge may have any suitable number of layers, for example, 3 layers or less, or 5 layers or more.

  Optionally, as described in more detail below, the first layer 1011 may comprise a buttress material and / or a plastic material, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), The bilayer 1012 may comprise a bioabsorbable foam material and / or a compressible hemostatic material, such as oxidized regenerated cellulose (ORC). Optionally, one or more of the first layer 1011, the second layer 1012, the third layer 1013, and the fourth layer 1014 may hold the staple 1020 within the staple cartridge body 1010, in addition to holding the staple 1020. , May be kept in alignment with each other. The third layer 1013 may be composed of a buttress material, or a highly incompressible or inelastic material, which may be configured to hold the staple legs 1021 of the staples 1020 in place relative to each other. . Further, the second layer 1012 and the fourth layer 1014 disposed on both sides of the third layer 1013 may be used even though the second layer 1012 and the fourth layer 1014 may comprise a compressible foam or elastic material. The movement of the staple 1020 can be stabilized or reduced. A part of the staple tip 1023 of the staple leg 1021 may be embedded in the first layer 1011. For example, the first layer 1011 and the third layer 1013 can be configured to hold the staple legs 1021 in place in a coordinated and secure manner. Each of the first layer 1011 and the third layer 1013 is a sheet of bioabsorbable plastic such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxy sold under the trade name Vicryl. May include alkanoate (PHA), polygrecapron 25 (PGCL), polycaprolactone (PCL), and / or complexes of PGA, PLA, PDS, PHA, PGCL and / or PCL sold under the trade name Monocryl. The second layer 1012 and the fourth layer 1014 may each include at least one hemostatic material or drug.

  The first layer 1011 can be compressible and the second layer 1012 is substantially more compressible than the first layer 1011. For example, the second layer 1012 may be about 2 times compressible, about 3 times compressible, about 4 times compressible, about 5 times compressible, and / or about 10 times compressible than the first layer 1011. In other words, the second layer 1012 may be compressed about twice, about three times, about four times, about five times, and / or about ten times the first layer 1011 with a predetermined force. The second layer 1012 may be compressible from about 2 times to about 10 times that of the first layer 1011. The second layer 1012 may include a plurality of voids defined therein, and the amount and / or size of the voids in the second layer 1012 is controlled to provide the desired compressibility of the second layer 1012. Can be done. Similar to the above, the third layer 1013 may be compressible, and the fourth layer 1014 may be substantially more compressible than the third layer 1013. For example, the fourth layer 1014 may be about 2 times compressible, about 3 times compressible, about 4 times compressible, about 5 times compressible, and / or about 10 times compressible than the third layer 1013. In other words, the fourth layer 1014 may be compressed about twice, about three times, about four times, about five times, and / or about ten times the third layer 1013 with a predetermined force. The fourth layer 1014 may be compressible from about 2 times to about 10 times that of the third layer 1013. The fourth layer 1014 may include a plurality of voids defined therein, and the amount and / or size of the voids in the fourth layer 1014 is controlled to provide the desired compressibility of the fourth layer 1014. Can be done. In various situations, the compressibility of a cartridge body, or a layer of a cartridge body, can be expressed in terms of compressibility (ie, the distance that a layer is compressed at a predetermined amount of force). For example, a layer with a high compressibility compresses a greater distance at a given amount of compressive force applied to the layer compared to a layer with a lower compressibility. That is, the second layer 1012 may have a higher compression ratio than the first layer 1011, and similarly the fourth layer 1014 may have a higher compression ratio than the third layer 1013. The second layer 1012 and the fourth layer 1014 can include the same material and can include the same compressibility. The second layer 1012 and the fourth layer 1014 may be composed of materials having different compressibility. Similarly, the first layer 1011 and the third layer 1013 may include the same material and may include the same compression rate. The first layer 1011 and the third layer 1013 may include materials having different compression rates.

  As illustrated in FIG. 6C, when the anvil 1040 moves to the closed position, the anvil 1040 can contact the tissue T and apply a compressive force to the tissue T and the staple cartridge 1000. In such a situation, the anvil 1040 can push the top or tissue contacting surface 1019 of the cartridge body 1010 downward toward the staple cartridge support 1030. The staple cartridge support 1030 may include a cartridge support surface 1031 that is stapled as the staple cartridge 1000 is compressed between the cartridge support surface 1031 and the tissue contacting surface 1041 of the anvil 1040. Can be configured to support. Due to the pressure applied by the anvil 1040, the cartridge body 1010 can be compressed and the anvil 1040 can come into contact with the staples 1020. More specifically, due to compression of the cartridge body 1010 and downward movement of the tissue contacting surface 1019, the tips 1023 of the staple legs 1021 penetrate the first layer 1011 of the cartridge body 1010, penetrate the tissue T, and the anvil 1040. May enter into the formation pocket 1042 of the device. As the cartridge body 1010 is further compressed by the anvil 1040, the tip 1023 can contact the wall defining the forming pocket 1042, resulting in the legs 1021 as illustrated, for example, in FIG. 6C. It can be deformed or curved inward. As can also be seen in FIG. 6C, when the staple leg 1021 is deformed, the base 1022 of the staple 1020 may contact or be supported by the staple cartridge support 1030. Optionally, as will be described in more detail below, the staple cartridge support 1030 may comprise, for example, a plurality of support mechanisms (such as staple support grooves, slots, or troughs 1032) that are used by the staples 1020. When deformed, the staple 1020 or at least the base 1022 of the staple 1020 may be configured to be supported. As also illustrated in FIG. 6C, the cavity 1015 of the fourth layer 1014 can be folded as a result of the compressive force applied to the staple cartridge body 1010. In addition to cavity 1015, staple cartridge body 1010 may further include one or more voids, such as void 1016, which may or may not include a portion of staples positioned therein. This can be configured to allow the cartridge body 1010 to be folded. Cavity 1015 and / or cavity 1016 is a cartridge body in which the wall defining the cavity and / or wall is bent downward to contact cartridge support surface 1031 and / or be positioned below the cavity and / or cavity. It is configured to collapse in contact with 1010 layers.

  Comparing FIGS. 6B and 6C, it is clear that the second layer 1012 and the fourth layer 1014 are substantially compressed by the compression pressure applied by the anvil 1040. It can be seen that the first layer 1011 and the third layer 1013 have been similarly compressed. As the anvil 1040 is moved to its closed position, the anvil 1040 may continue to compress the cartridge body 1010 further by pushing the tissue contacting surface 1019 downward toward the staple cartridge support 1030. As illustrated in FIG. 6D, as the cartridge body 1010 is further compressed, the anvil 1040 may deform the staples 1020 into their fully formed shapes. Referring to FIG. 6D, the leg 1021 of each staple 1020 has a tissue T, a first layer 1011, a second layer 1012, a third layer 1013, and a fourth between the deformable leg 1021 and the base 1022. To capture at least a portion of the layer 1014, it can be deformed downward toward the base 1022 of each staple 1020. Comparing FIGS. 6C and 6D, it is clear that the second layer 1012 and the fourth layer 1014 are substantially compressed by the compression pressure applied by the anvil 1040. Similarly, it should be noted that the first layer 1011 and the third layer 1013 were further compressed when comparing FIGS. 6C and 6D. After the staple 1020 is fully or at least fully formed, the anvil 1040 may be lifted away from the tissue T, and the staple cartridge 1030 may be moved away from the staple cartridge 1000 and / or separated therefrom. May be. As shown in FIG. 6D, as a result of the above, the cartridge body 1010 can be implanted with staples 1020. In various situations, the implanted cartridge body 1010 may support tissue along a staple line. In some situations, the hemostatic agent and / or any other suitable therapeutic agent contained within the implanted cartridge body 1010 may treat the tissue over time. As noted above, hemostatic agents can reduce bleeding of stapled and / or incised tissue, while binders or tissue adhesives can provide strength to tissue over time. The embedded cartridge body 1010 is made of, for example, ORC (oxidized regenerated cellulose), extracellular protein such as collagen, polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS) sold under the trade name Vircyl. , Polyhydroxyalkanoate (PHA), polygrecapron 25 (PGCL), polycaprolactone (PCL) and / or a complex of PGA, PLA, PDS, PHA, PGCL and / or PCL sold under the trade name Monocryl The material may be included. In some situations, the cartridge body 1010 may include antibiotic and / or antimicrobial agents, such as colloidal silver and / or triclosan, which can reduce the likelihood of infection at the surgical site. .

  The layers of the cartridge body 1010 can be connected to each other. For example, the second layer 1012 may be bonded to the first layer 1011 and the third layer 1013 is bonded to the second layer 1012 using at least one adhesive such as fibrin and / or protein hydrogel. The fourth layer 1014 may be adhered to the third layer 1013. Although not illustrated, the layers of the cartridge body 1010 can be coupled together by a coupling mechanical mechanism. For example, the first layer 1011 and the second layer 1012 can each include a corresponding coupling mechanism, such as, for example, a tongue and groove configuration and / or a dovetail configuration. Similarly, the second layer 1012 and the third layer 1013 may each include a corresponding coupling mechanism, while the third layer 1013 and the fourth layer 1014 may each include a corresponding coupling mechanism. Although not illustrated, the stapling cartridge 1000 can include, for example, one or more rivets that can extend through one or more layers of the cartridge body 1010. For example, each rivet is adjacent to a first layer 1014 that can be assembled or formed by a first end or head positioned adjacent to the first layer 1011 and a second end of the rivet. A positioned second head may be included. Due to the compressible nature of the cartridge body 1010, the rivet may compress the cartridge body 1010 so that the head of the rivet is depressed relative to the tissue contacting surface 1019 and / or the bottom surface 1018 of the cartridge body 1010, for example. Have For example, rivets are polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA) sold under the trade name Vircyl, polygrecapron sold under the trade name Monocryl. 25 (PGCL), polycaprolactone (PCL), and / or bioabsorbable materials such as PGA, PLA, PDS, PHA, PGCL and / or PCL composites. The layers of the cartridge body 1010 may not be connected to each other except by the staples 1020 contained therein. For example, frictional engagement between the staple legs 1021 and the cartridge body 1010 can hold the layers of the cartridge body 1010 together so that once the staples are formed, the layers can be captured within the staples 1020. . At least a portion of the staple legs 1021 may comprise a non-planarized surface or a non-planar coating, which may include a frictional force between the staple 1020 and the cartridge body 1010.

  As described above, the surgical instrument may include a first jaw that includes a staple cartridge 1030 and a second jaw that includes an anvil 1040. Optionally, as described in more detail below, the staple cartridge 1000 may include one or more retention mechanisms, which may be configured to engage the staple cartridge support 1030, resulting in The staple cartridge 1000 is releasably held on the staple cartridge support 1030. The staple cartridge 1000 can be adhered to the staple cartridge support 1030 by at least one adhesive, such as, for example, fibrin and / or protein hydrogel. In use, in at least one situation, particularly in laparoscopic and / or endoscopic surgery, for example, the second jaw may be moved to a closed position opposite the first jaw, whereby the first and second jaws are moved. It can be inserted through the trocar into the surgical site. For example, the trocar may define an approximately 5 mm opening or cannula through which the first and second jaws can be inserted. The second jaw can be moved to a partially closed position intermediate between the open and closed positions, which does not deform the staples 1020 contained within the staple cartridge body 1010 through the first trocar. And allowing the second jaw to be inserted. For example, when the second jaw is in its partially closed intermediate position, the anvil 1040 may not apply compressive force to the staple cartridge body 1010 and when the second jaw is in its partially closed intermediate position. The anvil 1040 can compress the staple cartridge body 1010. Even though the anvil 1040 can compress the staple cartridge body 1010 when in the intermediate position, the anvil 1040 is in contact with the staple 1020 and / or the staple 1020 is in the anvil 1040. Therefore, the staple cartridge body 1010 may not be sufficiently compressed. Once the first and second jaws are inserted through the trocar into the surgical site, the second jaws may be opened again, and the anvil 1040 and staple cartridge 1000 are relative to the target tissue as described above. May be positioned.

  With reference to FIGS. 7A-7D, the end effector of the surgical stapler may include an implantable staple cartridge 1100 positioned intermediate the anvil 1140 and the staple cartridge support 1130. Similar to the above, the anvil 1140 may include a tissue contacting surface 1141, the staple cartridge 1100 may include a tissue contacting surface 1119, and the staple cartridge support 1130 may include a supporting surface 1131. This is configured to support the staple cartridge 1100. Referring to FIG. 7A, the anvil 1140 can be used to position the tissue T relative to the tissue contacting surface 1119 of the staple cartridge 1100 without deforming the staple cartridge 1100, when the anvil 1140 is in such a position. The tissue contacting surface 1141 can be positioned at a distance 1101a from the staple cartridge support surface 1131 and the tissue contacting surface 1119 can be positioned at a distance 1102a from the staple cartridge supporting surface 1131. Thereafter, the anvil 1140 is moved toward the staple cartridge support 1130, and referring to FIG. 7B, the anvil 1140 pushes the top or tissue contacting surface 1119 of the staple cartridge 1100 downward, and the first layer 1111 of the cartridge body 1110. And the second layer 1112 can be compressed. Referring to FIG. 7B, when the layers 1111 and 1112 are compressed, the second layer 1112 may collapse and the legs 1121 of the staple 1120 may pass through the first layer 1111 and into the tissue T. For example, the staple 1120 can be positioned at least partially within the staple cavities or voids 1115 of the second layer 1112 such that when the second layer 1112 is compressed, the staple cavities 1115 are folded, resulting in the second layer 1112 being The staple 1120 is folded around. The second layer 1112 may include a cover portion 1116 that extends over the staple cavity 1115 and may surround or at least partially surround the staple cavity 1115. FIG. 7B illustrates the cover portion 1116 being collapsed down into the staple cavity 1115. The second layer 1112 may include one or more weakened portions, which may facilitate the second layer 1112 to be folded. Optionally, such weakened portions may include, for example, scribed lines, perforations, and / or thin cross sections, which may facilitate controlled folding of the cartridge body 1110. The first layer 1111 may include one or more weakened portions, which may facilitate penetration of the staple legs 1121 through the first layer 1111. Optionally, such weakened portions may include, for example, scribed lines, perforations, and / or thin cross sections, which may be aligned with or at least substantially aligned with the staple legs 1121. .

  Referring again to FIG. 7A, when the anvil 1140 is in a partially closed, unfired position, the anvil 1140 is positioned at a distance 1101a from the cartridge support surface 1131 such that a gap is defined therebetween. Can be. The void may be filled with a staple cartridge 1100 having a staple cartridge height 1102a and tissue T. Referring again to FIG. 7B, when the anvil 1140 is moved downward to compress the staple cartridge 1100, the distance between the tissue contacting surface 1141 and the cartridge support surface 1131 may be defined by a distance 1101b that is shorter than the distance 1101a. In various situations, the gap between the tissue contacting surface 1141 of the anvil 1140 and the cartridge support surface 1131, defined by the distance 1101b, may be larger than the original undeformed staple cartridge height 1102a. Referring now to FIG. 7C, as the anvil 1140 is moved closer to the cartridge support surface 1131, the second layer 1112 continues to fold and the distance between the staple legs 1121 and the forming pocket 1142 may decrease. Similarly, the distance between the tissue contacting surface 1141 and the cartridge support surface 1131 may decrease to 1101c, which is greater than or equal to the original undeformed cartridge height 1102a. Or it may be smaller. Referring to FIG. 7D, the anvil 1140 can be moved to a final firing position where the staples 1120 are fully formed or at least formed to a desired height. In such a position, the tissue contacting surface 1141 of the anvil 1140 may be a distance 1101d from the cartridge support surface 1131, which may be shorter than the original undeformed cartridge height 1102a. As also illustrated in FIG. 7D, the staple cavity 1115 is fully or at least substantially folded, and the staple 1120 is completely or at least substantially surrounded by the folded second layer 1112. . In various situations, the anvil 1140 may then move away from the staple cartridge 1100. Once the anvil 1140 is disengaged from the staple cartridge 1100, the cartridge body 1110 can be at least partially re-expanded at various positions (ie, for example, intermediate positions of staples adjacent to the staple 1120). The crushed cartridge body 1110 may not elastically re-expand. The formed staple 1120 and, in addition, the cartridge body 1110 positioned in the middle of adjacent staples 1120 may apply pressure or compressive force to the tissue T, which provides various therapeutic effects. obtain.

  As noted above, referring again to FIG. 7A, each staple 1120 may include a staple leg 1121 extending therefrom. Staple 1120 is shown as including two staple legs 1121, but includes one staple leg, or alternatively more than two staple legs, eg, three staple legs, or four staple legs. Various staples may be used. As illustrated in FIG. 7A, each staple leg 1121 may be embedded in the second layer 1112 of the cartridge body 1110 such that the staple 1120 is secured within the second layer 1112. The staple 1120 may be inserted into the staple cavity 1115 of the cartridge body 1110 such that the leading end 1123 of the staple leg 1121 enters the cavity 1115 before the base 1122. After the tip 1123 is inserted into the cavity 1115, the tip 1123 is pushed into the cover portion 1116 to cut through the second layer 1112. Staples 1120 may be installed to a sufficient depth within the second layer 1112 such that the staple 1120 does not move or at least substantially does not move relative to the second layer 1112. The staple 1120 can be positioned at a sufficient depth within the second layer 1112 such that the base 1122 is positioned or embedded within the staple cavity 1115. Alternatively, the base 1122 may not be positioned or embedded within the second layer 1112. Referring back to FIG. 7A, the base 1122 may extend below the bottom surface 1118 of the cartridge body 1110. Base 1122 can be located on or directly relative to cartridge support surface 1130. The cartridge support surface 1130 may include a support mechanism extending therefrom and / or defined therein, for example, the base 1122 of the staple 1120 may be staple cartridge support as described in more detail below. The body 1130 may be positioned within or supported by one or more support grooves, slots, or troughs 1132.

  With reference now to FIGS. 8 and 9, a staple cartridge, such as, for example, a staple cartridge 1200, may include a compressible, implantable cartridge body 1210 that includes an outer layer 1211 and an inner layer 1212. Similar to the above, the staple cartridge 1200 may include a plurality of staples 1220 positioned within the cartridge body 1210. Optionally, each staple 1220 can include a base 1222 and one or more staple legs 1221 extending therefrom. For example, the staple legs 1221 can be inserted into the inner layer 1212 and installed, for example, at a depth such that the base 1222 of the staple 1220 is positioned adjacent and / or adjacent to the bottom surface 1218 of the inner layer 1212. . In FIGS. 8 and 9, the inner layer 1212 does not include a staple cavity configured to receive a portion of the staple 1220; alternatively, the inner layer 1212 may include such a staple cavity. In addition to the above, the inner layer 1212 may include a compressible material, such as, for example, bioabsorbable foam and / or oxidized regenerated cellulose (ORC), which causes the cartridge body 1210 to have a compressive load therein. It may be configured to allow it to be folded when applied. The inner layer 1212 may be composed of a lyophilized foam containing, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA). The ORC may be marketed under the trade name Surgicel and may comprise a loosely knitted fabric (such as a surgical sponge), a loose fiber (such as a cotton ball), and / or foam. The inner layer 1212 can be activated with, for example, water and / or lyophilized thrombin contained therein and / or applied thereto, eg, activated by a body fluid of a patient, and / or It can be composed of a pharmaceutical-containing material, such as fibrin. For example, lyophilized thrombin and / or fibrin can be retained on a Vicryl (PGA) matrix. However, in certain circumstances, an activatable pharmaceutical can be unintentionally activated when the staple cartridge 1200 is inserted, for example, into a surgical site within a patient's body. Referring again to FIGS. 8 and 9, the outer layer 1211 can be composed of a water impermeable, or at least substantially water impermeable material, thereby compressing the cartridge body 1210 and causing the staple legs to become the outer layer 1211. The liquid does not contact or at least substantially does not contact the inner layer 1212 after penetrating and / or after the outer layer 1211 has been cut in some manner. The outer layer 1211 may be composed of a buttress material and / or a plastic material such as, for example, polydioxanone (PDS) and / or polyglycolic acid (PGA). Outer layer 1211 may include a wrap that surrounds inner layer 1212 and staples 1220. More specifically, the staple 1220 may be inserted into the inner layer 1212 and the outer layer 1211 may be wound around a subassembly that includes the inner layer 1212 and the staple 1220 and then sealed.

  As described herein, the staples of the staple cartridge can be completely formed by the anvil when the anvil is moved to the closed position. Alternatively, referring to FIGS. 10-13, staples of a staple cartridge, such as, for example, staple cartridge 4100, are staples that move by an anvil as the anvil moves to a closed position, plus moving the staples toward the closed anvil. It can be modified by the driver system. Staple cartridge 4100 may include a compressible cartridge body 4110 that may include, for example, foam material and a plurality of staples 4120 positioned at least in part within compressible cartridge body 4110. The staple driver system may include a driver holder 4160, a plurality of staple drivers 4162 positioned within the driver holder 4160, and a staple cartridge pan 4180 that may be configured to hold the staple drivers 4162 in the driver holder 4160. For example, the staple driver 4162 may be positioned in one or more slots 4163 of the driver holder 4160, and the sidewalls of the slots 4163 may assist in guiding the staple driver 4162 upward toward the anvil. Staple 4120 may be supported in slot 4163 by staple driver 4162, and staple 4120 may be fully positioned in slot 4163 when staple 4120 and staple driver 4162 are in their unfired positions. . Alternatively, at least a portion of the staple 4120 may extend upward through the open end 4161 of the slot 4163 when the staple 4120 and staple driver 4162 are in their unfired positions. For example, referring now to FIG. 11, the base of the staple 4120 may be positioned within the driver holder 4160 and the tip of the staple 4120 may be embedded within the compressible cartridge body 4110. Approximately 1/3 of the height of the staple 4120 may be positioned in the driver holder 4160, and approximately 2/3 of the staple 4120 may be positioned in the cartridge body 4110. Referring to FIG. 10A, staple cartridge 4100 may further comprise a water permeable wrap or membrane 4111 that surrounds cartridge body 4110 and driver holder 4160, for example.

  In use, the staple cartridge 4100 can be positioned, for example, within a staple cartridge channel, and the anvil can be moved toward the staple cartridge 4100 to a closed position. The anvil can contact and compress the compressible cartridge body 4110 when the anvil is moved to its closed position. The anvil may not contact the staple 4120 when the anvil is in its closed position. The anvil may contact the legs of the staple 4120 and at least partially deform the staple 4120 as the anvil is moved to its closed position. In any case, the staple cartridge 4100 may further include one or more sleds 4170, which may be advanced longitudinally within the staple cartridge 4100 so that the sled 4170 is continuous. Engaging with staple driver 4162, staple driver 4162 and staple 4120 can be moved toward the anvil. The sled 4170 can slide between the staple cartridge pan 4180 and the staple driver 4162. When the anvil closure initiates the forming process of the staples 4120, the upward movement of the staples 4120 toward the anvil completes the forming process and the staples 4120 are fully formed or at least to the desired height. And can be transformed. If the anvil closure is not deforming the staple 4120, the upward movement of the staple 4120 toward the anvil initiates and completes the forming process, and the staples 4120 are fully formed or at least as desired. Can be transformed to height. The sled 4170 can be advanced from the proximal end of the staple cartridge 4100 to the distal end of the staple cartridge 4100 such that the staple 4120 positioned within the proximal end of the staple cartridge 4100 is distant from the staple cartridge 4100. The staple 4120 positioned at the leading edge is fully formed before it is fully formed. Referring to FIG. 12, the sleds 4170 can each include at least one angled or inclined surface 4711 that slides under the staple driver 4162, as illustrated in FIG. And can be configured to lift the staple driver 4162.

  In addition to the above, the staple 4120 may be formed to capture at least a portion of the tissue T and at least a portion of the compressible cartridge body 4110 of the staple cartridge 4100 therein. After the staple 4120 is formed, the surgical stapler anvil and staple cartridge channel 4130 may be moved away from the implanted staple cartridge 4100. In various situations, the cartridge pan 4180 can be secured to the staple cartridge channel 4130 so that the cartridge pan 4180 can be compressed when the staple cartridge channel 4130 is pulled away from the implanted cartridge body 4110. The cartridge body 4110 can be removed. Referring again to FIG. 10, the cartridge pan 4180 can include opposing sidewalls 4181 between which the cartridge body 4110 can be removably attached. For example, the compressible cartridge body 4110 is releasably retained between the sidewalls 4181 between the side walls 4181 during use and releasably disengaged from the cartridge pan 4180 when the cartridge pan 4180 is pulled away. So that it can be compressed. For example, the driver holder 4160 can be connected to the cartridge pan 4180 such that the driver holder 4160, driver 4162, and / or sled 4170 can remain on the cartridge pan 4180 when the cartridge pan 4180 is removed from the surgical site. . Driver 4162 can be ejected from driver 4160 and left in the surgical site. For example, the driver 4162 may be polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), sold under the trade name Vircyl, It may be composed of bioabsorbable materials such as capron 25 (PGCL), polycaprolactone (PCL), and / or PGA, PLA, PDS, PHA, PGCL and / or PCL composites. Driver 4162 may be attached to staple 4120 such that driver 4162 is deployed with staple 4120. For example, each driver 4162 may include a trough configured to receive the base of staple 4120, for example, and the trough is configured to receive a staple device by way of a pressure fit and / or snap fit. Can be done.

  Further to the above, driver holder 4160 and / or sled 4170 can be ejected from cartridge pan 4180. For example, the sled 4170 may slide between the cartridge pan 4180 and the driver holder 4160 so that the sled 4170 advances as the sled 4170 drives the staple driver 4162 and staple 4120 upward. Similarly, the sled 4170 can also move the driver holder 4160 upward to the outside of the cartridge pan 4180. For example, the driver holder 4160 and / or thread 4170 may be polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), trade name Monocryl sold under the trade name Vircyl. May contain bioabsorbable materials such as polygrecapron 25 (PGCL), polycaprolactone (PCL), and / or composites of PGA, PLA, PDS, PHA, PGCL and / or PCL. The sled 4170 may be integrally formed and / or attached to the driver bar or cutting member, which pushes the sled 4170 through the staple cartridge 4100. In such cases, the sled 4170 may not be ejected from the cartridge pan 4180 and may remain with the surgical stapler, but in other cases where the sled 4170 is not attached to the drive bar. May remain at the surgical site. In any case, in addition to the above, the compressibility of the cartridge body 4110 allows the thicker staple cartridge to be used within the end effector of the surgical stapler when the cartridge body 4110 can be compressed or contracted when the staple anvil is closed. May be able to be done. As a result of staples that are at least partially deformed upon anvil closure, higher staples may be used, such as, for example, staples having approximately 4.6 mm (0.18 "), approximately 3.0 mm ( A staple height of 0.12 ") may be positioned within the compressible layer 4110, which has an uncompressed height of, for example, approximately 3.6 mm (0.14"). Can do.

  As described herein, a staple cartridge can have a plurality of staples therein. Optionally, such a staple may be composed of a metal wire that is deformed into a substantially U-shaped configuration having two staple legs. Alternatives are envisaged where the staples may comprise different configurations such as two or more wires joined together having three or more staple legs. The wire used to form the staple may include a round or at least substantially round cross section. The staple wire may include any other suitable cross section, such as, for example, a square and / or rectangular cross section. The staple may include a plastic wire. Staples can include plastic-coated metal wires. In accordance with the present invention, the cartridge can include any suitable type of fastener in addition to or instead of staples. For example, such fasteners may comprise a pivotable arm that can be folded when engaged with an anvil. A fastener that is divided into two parts may be utilized. For example, the staple cartridge may comprise a plurality of first fastening portions, and the anvil includes a plurality of second fastening portions that are connected to the first fastening portion when the anvil is compressed against the staple cartridge. There is a case to prepare. As described above, the thread or driver may be advanced within the staple cartridge to complete the staple forming process. The sled or driver may be advanced within the anvil to move one or more forming members downwardly to engage opposing staple cartridges and staples or fasteners positioned therein.

  As described herein, a staple cartridge can include four rows of staples stored therein. The four staple rows can be configured into two inner staple rows and two outer staple rows. For example, the inner staple row and the outer staple row may be positioned on a first side of a cutting member or knife slot in the staple cartridge, and similarly, the inner staple row and the outer staple row may be in the cutting member or knife slot. May be positioned on the second side. The staple cartridge may not include a cutting member slot, but such a staple cartridge may include a designated portion configured to be incised by the cutting member instead of the staple cartridge slot. The inner staple rows may be arranged within the staple cartridge such that they are evenly or at least substantially evenly spaced from the cutting member slots. Similarly, other staple rows may be arranged within the staple cartridge such that they are evenly or at least substantially evenly spaced from the cutting member slots. According to the present invention, the staple cartridge may comprise 5 or more rows, or 3 or less rows of staples stored in the staple cartridge. The staple cartridge can comprise six rows of staples. For example, the staple cartridge may comprise three rows of staples on the first side of the cutting member slot and three rows of staples on the second side of the cutting member slot. The staple cartridge includes an odd number of staple rows. For example, the staple cartridge may comprise two rows of staples on the first side of the cutting member slot and three rows of staples on the second side of the cutting member slot. The staple rows may comprise the same or at least substantially the same unformed staple height. Alternatively, the one or more staple rows may comprise staples having a different non-formed staple height than the other staples. For example, the staple on the first side of the cutting member slot has a first non-forming height and the second side of the cutting member slot has a second non-forming height, for example, Different from the first height.

  Optionally, as described above, the staple cartridge may comprise a cartridge body having a plurality of staple cavities defined therein. The cartridge body can comprise a deck and a deck upper surface, and each staple cavity can define an opening in the deck surface. As described above, staples can be placed in each staple cavity such that they are stored in the cartridge body until fired therefrom. The staples can be received within the cartridge body before firing from the cartridge body so that the staples do not protrude above the deck surface. Because the staples are located below the deck surface, in such cases, the damage to the staples and / or the possibility of premature contact with the target tissue can be reduced. In various situations, the staple is between a non-fired position that does not protrude from the cartridge body and a fired position that emerges from the cartridge body and can contact an anvil disposed relative to the staple cartridge. Can move. The anvil, and / or the forming pocket defined within the anvil, can be located at a predetermined distance above the deck surface so that when the staple is deployed from the cartridge body, the staple has a predetermined forming height. It will be transformed. In some situations, the thickness of the tissue captured between the anvil and the staple cartridge can vary, so that thicker tissue may be captured within a particular staple, while more Thin tissue may be trapped within other specific staples. In any case, the clamping pressure or clamping force exerted on the tissue by the staples can vary with the staples, or, for example, at one end of a staple row and the other end of the staple row. There is a possibility of changing between certain staples. In certain circumstances, the gap between the anvil and the staple cartridge deck can be controlled such that the staples apply a predetermined minimum clamping pressure within each staple. However, in some such situations, there may still be significant fluctuations in clamping pressure within different staples. A surgical stapling instrument is disclosed in US Pat. No. 7,380,696 (issued June 3, 2008), the entire disclosure of which is incorporated herein by reference. An exemplary multi-stroke handle for surgical stapling and cutting instruments is a co-pending and co-pending US patent application Ser. No. 10 / 374,026, the entire disclosure of which is incorporated herein by reference. Details are described in “SURGICAL STAPLING INSTRUMENT INCORPORATION A MULTISTROKE FIRING POSITION INDICATOR AND RETRATION MECHANSIM”. Other applications consistent with the present invention include, for example, co-pending and co-pending US patent application Ser. No. 10 / 441,632 “SURGICAL STAPLING INSTRUMENT HAVING SEPARATE, the entire disclosure of which is incorporated herein by reference. DISTINCT CLOSEING AND FIRING SYSTEMS ".

  As described herein, the staple cartridge may comprise means for correcting for the thickness of tissue captured within the staple deployed from the staple cartridge. Referring to FIG. 14, a staple cartridge (eg, staple cartridge 10000) includes a rigid first portion (eg, support portion 10010) and a compressible second portion (eg, tissue thickness compensator 10020). May be included. Referring primarily to FIG. 16, the support portion 10010 can comprise a cartridge body, a deck upper surface 10011, and a plurality of staple cavities 10012, similar to the above, each staple cavity 10012 defining an opening in the deck surface 10011. obtain. For example, staples 10030 can be removably disposed within each staple cavity 10012. For example, each staple 10030 can include a base 10031 and one or more legs 10032 extending from the base 10031. Before the staple 10030 is deployed, the bottom surface 10031 of the staple 10030 can be supported by a staple driver disposed within the support portion 10010 and at the same time the legs 10032 of the staple 10030, as will also be described in detail below. Can be at least partially contained within the staple cavity 10012. Staple 10030 is an anvil in which legs 10032 move through tissue thickness compensator 10020, penetrate the upper surface of tissue thickness compensator 10020, enter tissue T, and are positioned relative to staple cartridge 10000. It can be deployed between an unfired position and a fired position to make contact. As the leg 10032 strikes and deforms against the anvil, the leg 10032 of each staple 10030 captures and compresses a portion of the tissue thickness compensator 10020 and a portion of the tissue T within each staple 10030. You can apply power. Further to the above, the leg 10032 of each staple 10030 can be deformed downward toward the bottom surface 10031 of the staple to form a staple capture region 10039, where the tissue T and tissue thickness compensator 10020 are Can be captured. In various situations, the staple capture region 1000039 can be defined between the inner surface of the deformed leg 10032 and the inner surface of the bottom surface 10031. The size of the staple capture area may depend on several factors such as, for example, leg length, leg diameter, bottom width, and / or degree of leg deformation.

  Previously, surgeons often had to select the appropriate staple with the appropriate staple height for the tissue to which it was applied. For example, the surgeon could select long staples for use with thick tissue and short staples for use with thin tissue. However, in some situations, the tissue to which the staples are applied does not have a uniform thickness, and some staples have not been able to achieve the desired firing shape. For example, FIG. 48 shows a long staple used for thin tissue. Referring now to FIG. 49, when a tissue thickness compensator (eg, tissue thickness compensator 10020) is used with thin tissue, even a large staple can form the desired firing shape.

  Thanks to the compressibility of the tissue thickness compensator, the tissue thickness compensator can correct the thickness of the tissue captured within each staple. More specifically, referring now to FIGS. 43 and 44, a tissue thickness compensator (e.g., tissue thickness compensator 10020) can be used to detect the thickness and / or tissue captured in the staple capture region 10039. Or, depending on the type, each staple 10030 may occupy a larger portion and / or a smaller portion of the staple capture area 10039. For example, when thinner tissue T is captured in the staple 10030, the tissue thickness compensator 10020 is a larger portion of the staple capture area 10030 than when the thicker tissue T is captured in the staple 10030. Can occupy. Correspondingly, if a thicker tissue T is captured in the staple 10030, the tissue thickness compensator 10020 will capture the staple capture region 100039 as compared to a thinner tissue T captured in the staple 10030. Can occupy a smaller part. In this way, the tissue thickness compensator can compensate for thinner and / or thicker tissue, compressing independently or at least substantially independent of the tissue thickness captured within the staple. Pressure can be applied to the tissue. In addition to the above, the tissue thickness compensator 10020 can correct for various types or compressibility of tissue captured in different staples 10030. Referring now to FIG. 44, the tissue thickness compensator 10020 can apply a compressive force against the vascular tissue T that may include the tube V, so that the blood passing through the less compressible tube V While restricting flow, the desired compression pressure can be applied to the surrounding tissue T. In various circumstances, in addition to the above, the tissue thickness compensator 10020 can also correct malformed staples. Referring to FIG. 45, misforming of various staples 10030 may result in a larger staple capture region 1000039 defined within such staples. Due to the elasticity of the tissue thickness compensator 10020, and referring now to FIG. 46, the tissue thickness compensator 10020 disposed within the malformed staple 10030 is defined within such a malformed staple 10030. Even when the staple capture area 1000039 is increased, sufficient compression pressure can still be applied to the tissue T. In various situations, for example, the tissue thickness compensator 10020 in the middle of adjacent staples 10030 can be biased against the tissue T by the properly formed staples 10030 surrounding the poorly formed staples 10030, so that Compressive pressure can be applied to the surrounding tissue and / or tissue captured within the malformed staple 10030. In various situations, the tissue thickness compensator can correct for different tissue densities that can be caused by, for example, calcification, fibrous regions, and / or previously stapled or treated tissue.

  In accordance with the present invention, a fixed (non-changeable) tissue spacing can be defined between the support portion and the anvil so that the staples are dependent on the thickness of the tissue captured within the staples. Instead, it can be deformed to a predetermined height. When the tissue thickness compensator is used in such a case, the tissue thickness compensator can be adapted to the tissue captured between the anvil and the support portion staple cartridge, and the tissue thickness compensator Thanks to this, the tissue thickness compensator can apply additional compression pressure to the tissue. 50 to 55, the staple 10030 is formed at a predetermined height H. With respect to FIG. 50, the tissue thickness compensator is not used and the tissue T occupies the entire staple capture area 10039. With reference to FIG. 57, a portion of the tissue thickness compensator 10020 is captured within the staple 10030, compressing the tissue T and occupying at least a portion of the staple capture region 10039. Referring now to FIG. 52, thin tissue T has been captured within the staple 10030. In this embodiment, for example, the compressed tissue T has a height of about 2 / 9H and the compressed tissue thickness compensator 10020 has a height of about 7 / 9H. Referring now to FIG. 53, tissue T having an intermediate thickness is captured within staple 10030. In this embodiment, for example, the compressed tissue T has a height of about 4 / 9H and the compressed tissue thickness compensator 10020 has a height of about 5 / 9H. Referring now to FIG. 54, tissue T having an intermediate thickness has been captured within staple 10030. In this embodiment, for example, the compressed tissue T has a height of about 2 / 3H and the compressed tissue thickness compensator 10020 has a height of about 1 / 3H. Referring now to FIG. 53, thick tissue T has been captured within the staple 10030. In this embodiment, for example, the compressed tissue T has a height of about 8 / 9H and the compressed tissue thickness compensator 10020 has a height of about 1 / 9H. In various situations, the tissue thickness compensator can be, for example, about 10% of staple capture height, about 20% of staple capture height, about 30% of staple capture height, and about 40% of staple capture height. About 50% of the staple catch height, about 60% of the staple catch height, about 70% of the staple catch height, about 80% of the staple catch height, and / or about 90% of the staple catch height. The compression height can be included.

  Staple 10030 may comprise any suitable unformed height. Staple 10030 may comprise an unformed height of about 2 mm to about 4.8 mm, for example. The staple 10030 may be, for example, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.4 mm, about 3.5 mm, about 3.8 mm, about 4.0 mm, about 4.1 mm, and / or about It may include an unformed height of 4.8 mm. The height H at which the staple can be deformed can be defined by the distance between the deck surface 10011 of the support portion 10010 and the anvil relative thereto. The distance between the deck surface 10011 and the tissue contacting surface of the anvil can be, for example, about 2.5 mm (0.097 ″). The height H also depends on the depth of the forming pocket defined in the anvil. The forming pocket can have a depth measured, for example, from the tissue contacting surface, and optionally, as described in detail below, the staple cartridge 10000 can further include a staple driver, which is Staples 10030 can be lifted toward the anvil and staples can be lifted (or “overdriven”) onto the deck surface 10011. In such a case, the height H at which the staple 10030 is formed can also be defined by the distance over which the staple 10030 is overdriven. For example, the staple 10030 may be overdriven, for example, about 0.71 mm (0.28 "), thereby forming the staple 10030, for example, to a height of about 4.80 mm (0.189"). obtain. Staple 10030 may be formed, for example, at a height of about 0.8 mm, about 1.0 mm, about 1.5 mm, about 1.8 mm, about 2.0 mm, and / or about 2.25 mm. Staples can be formed, for example, to a height of about 2.25 mm to about 3.0 mm. Further to the above, the height of the staple capture region can be determined by the staple formation height and the width (or diameter) of the wires that make up the staple. The height of the staple capture area 10037 of the staple 10030 can be the staple formation height H minus twice the diameter width of the wire. The staple wire can include, for example, a diameter of about 0.23 mm (0.0089 ″). The staple wire can be, for example, about 0.18 mm (0.0069 ″) to about 0.30 mm (0.0119 ″). For example, the forming height H of the staple 10030 may be, for example, about 4.8 mm (0.189 ") and the staple wire diameter is about 0.23 mm (0.0089"). This may result in a staple capture height of about 0.171 ". Further to the above, the tissue thickness compensator can be configured to have an uncompressed (or pre-deployed) height and be deformed to one of a plurality of compressed heights. The tissue thickness compensator can comprise, for example, an uncompressed height of about 3.18 mm (0.125 ″). The tissue thickness compensator can be, for example, about 2.0 mm (0.080 ″) or greater. May have an uncompressed height. The tissue thickness compensator may include an uncompressed (or pre-deployed) height that is higher than the unfired height of the staples. The uncompressed (or pre-deployment) height of the tissue thickness compensator is, for example, about 10%, about 20%, about 30%, about 40%, about 50%, about 50% higher than the height of unfired staples. It may be 60%, about 70%, about 80%, about 90%, and / or about 100% higher. The uncompressed (or pre-deployment) height of the tissue thickness compensator may be, for example, up to about 100% higher than the height of unfired staples. The uncompressed (or pre-deployment) height of the tissue thickness compensator may be, for example, 100% or more higher than the height of unfired staples. The tissue thickness compensator may comprise an uncompressed height equal to the unfired height of the staples. The tissue thickness compensator may comprise an uncompressed height that is less than the unfired height of the staples. The uncompressed (or pre-deployment) height of the thickness compensator is, for example, about 10%, about 20%, about 30%, about 40%, about 50%, about 60, than the unfired height of the staple. %, About 70%, about 80%, and / or about 90% smaller. The compressible second portion may have an uncompressed height that is higher than the uncompressed height of the tissue T to be stapled. The tissue thickness compensator may have an uncompressed height equal to the uncompressed height of the tissue T to be stapled. The tissue thickness compensator may have an uncompressed height that is lower than the uncompressed height of the tissue T to be stapled.

  As described above, the tissue thickness compensator can be compressed into a plurality of formed staples regardless of whether the tissue captured in the staples is thick or thin. For example, the staples in the staple line (row) can be deformed such that the capture area of each staple includes a height of, for example, about 2.0 mm, and the tissue T and tissue thickness compensator are within this height. Can be compressed. In certain circumstances, for example, tissue T may include a compressed height of about 1.75 mm in the staple capture area, while tissue thickness compensators may have a compressed height of about 0.25 mm in the staple capture area. This results in a total staple capture area height of about 2.0 mm. In certain circumstances, for example, tissue T may include a compression height of about 1.50 mm in the staple capture area, while tissue thickness compensators have a compression height of about 0.50 mm in the staple capture area. This results in a total staple capture area height of about 2.0 mm. In certain circumstances, for example, the tissue T may include a compressed height of about 1.25 mm in the staple capture area, while the tissue thickness compensator has a compression height of about 0.75 mm in the staple capture area. This results in a total staple capture area height of about 2.0 mm. In certain circumstances, for example, tissue T may include a compression height of about 1.0 mm in the staple capture area, while tissue thickness compensator may have a compression height of about 1.0 mm in the staple capture area. This results in a total staple capture area height of about 2.0 mm. In certain circumstances, for example, tissue T may include a compression height of about 0.75 mm in the staple capture area, while tissue thickness compensators may have a compression height of about 1.25 mm in the staple capture area. This results in a total staple capture area height of about 2.0 mm. In certain circumstances, for example, tissue T may include a compression height of about 1.50 mm in the staple capture area, while tissue thickness compensators have a compression height of about 0.50 mm in the staple capture area. This results in a total staple capture area height of about 2.0 mm. In certain circumstances, for example, tissue T may include a compression height of about 0.25 mm in the staple capture area, while tissue thickness compensators may have a compression height of about 1.75 mm in the staple capture area. This results in a total staple capture area height of about 2.0 mm.

  Further to the above, the tissue thickness compensator may include an uncompressed height that is less than the fired height of the staple. The tissue thickness compensator may comprise an uncompressed height equal to the staple firing height. The tissue thickness compensator may comprise an uncompressed height that is higher than the firing height of the staples. For example, the uncompressed height of the tissue thickness compensator is, for example, about 110% of the height of the formed staple, about 120% of the height of the formed staple, about 130% of the height of the formed staple, About 140% of the formed staple height, about 150% of the formed staple height, about 160% of the formed staple height, about 170% of the formed staple height, and the formed staple height. About 180% of the formed staple height, and / or about 200% of the formed staple height. The tissue thickness compensator may comprise an uncompressed height that is more than twice as high as the fired height of the staples. The tissue thickness compensator can include, for example, a compressed height of about 85% to about 150% of the height of the formed staples. Optionally, as described above, the tissue thickness compensator can be compressed to between an uncompressed thickness and a compressed thickness. The compressed thickness of the tissue thickness compensator is, for example, about 10% of the uncompressed thickness, about 20% of the uncompressed thickness, about 30% of the uncompressed thickness, and the uncompressed thickness. About 40%, about 50% of the uncompressed thickness, about 60% of the uncompressed thickness, about 70% of the uncompressed thickness, about 80% of the uncompressed thickness, and / or uncompressed Can be about 90% of the thickness. The uncompressed thickness of the tissue thickness compensator can be, for example, about 2 times, about 10 times, about 50 times, and / or about 100 times the compressed thickness. The compressed thickness of the tissue thickness compensator can be about 60% to about 99% of the uncompressed thickness. The compressed thickness of the tissue thickness compensator may be at least 50% thicker than the compressed thickness. The compressed thickness of the tissue thickness compensator may be up to 100 times greater than the compressed thickness. The compressible second portion may be elastic or at least partially elastic and may bias the tissue T against the deformed leg of the staple. For example, the compressible second portion can elastically expand between the tissue T and the bottom surface of the staple to press the tissue T against the staple legs. As will be described in detail below, the tissue thickness compensator can be placed intermediate the tissue T and the deformed staple legs. In various situations, as a result of the above, the tissue thickness compensator can be configured to fill any gaps in the staple capture area.

  Tissue thickness compensator is, for example, biocompatible, bioabsorbable, bioresorbable, biodurable, biodegradable, compressible, fluid absorbable, expandable, self-expandable, bioactive, medicinal, A material characterized by one or more properties such as pharmacological activity, antiadhesive, hemostatic, antibacterial, bactericidal, antiviral, nutritional, adhesive, permeable, hydrophilic, and / or hydrophobic. May be included. According to the present invention, a surgical instrument comprising an anvil and a staple cartridge contains at least one of a hemostatic agent such as fibrin and thrombin, an antibiotic agent such as doxycp1, and an agent such as matrix metalloproteinases (MMPs). A tissue thickness compensator associated with the anvil and / or staple cartridge may be provided.

  The tissue thickness compensator may include synthetic and / or non-synthetic materials. The tissue thickness compensator may comprise a polymer composition comprising one or more synthetic polymers and / or one or more non-synthetic polymers. The synthetic polymer may include an absorbable synthetic polymer and / or a non-absorbable synthetic polymer. The polymer composition may include, for example, a biocompatible foam. Biocompatible foams can include, for example, porous open cell foams and / or porous closed cell foams. The biocompatible foam may have a uniform pore morphology or a gradient pore morphology (ie, a gradual increase in size from small to large pores in one direction throughout the foam thickness). You may have. The polymer composition comprises a porous scaffold, a porous matrix, a gel matrix, a hydrogel matrix, a solution matrix, a fibrous matrix, a tubular matrix, a composite matrix, a membrane matrix, a biostable polymer, a biodegradable polymer, and these One or more of the combinations may be included. For example, a tissue thickness compensator may include a foam reinforced with a fibrous matrix or may include a foam with an additional hydrogel layer that swells in the presence of body fluid to provide additional pressure to the tissue. Good. In accordance with the present invention, the tissue thickness compensator can also be comprised of a coating on the material and / or a second or third layer that expands in the presence of body fluid to provide further compression on the tissue. Such a layer may be, for example, a hydrogel that may be a synthetic and / or naturally derived material, and may be biodurable and / or biodegradable. The tissue thickness compensator may comprise a microgel or a nanogel. Hydrogels may include carbohydrate-derived microgels and / or nanogels. The tissue thickness compensator may be reinforced with, for example, a fibrous nonwoven material or a fibrous mesh type element, which can provide additional flexibility, stiffness, and / or strength. In accordance with the present invention, the tissue thickness compensator has a porous morphology, which exhibits, for example, a gradient structure with small pores on one surface and large pores on the other surface. Such a configuration may be more optimal for tissue ingrowth or hemostasis procedures. Furthermore, this gradient can be configured with various bioabsorbable profiles. A short-term absorption profile may be preferred for coping with hemostasis, while a long-term absorption profile can provide better tissue healing without leaks.

  Examples of non-synthetic materials include freeze-dried polysaccharides, glycoproteins, bovine pericardium, collagen, gelatin, fibrin, fibrinogen, elastin, proteoglycan, keratin, albumin, hydroxyethylcellulose, cellulose, oxidized cellulose, oxidized regeneration Cellulose (ORC), hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitin, chitosan, casein, alginic acid, and combinations thereof include, but are not limited to.

  Examples of absorbent synthetic materials include 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, copolymer of (PGCL) glycolide and trimethylene carbonate, poly (glycerol sebacate) (PGS), poly (dioxanone) (PDS) , Polyester, poly (orthoester), polyoxaester, polyetherester, polycarbonate, polyamide ester, polyanhydride, polysaccharide, poly (ester-amide), tyrosine polyarylate, polyamine, tyrosine polymer Imino carbonate, tyrosine polycarbonate, poly (D, L-lactide-urethane), poly (hydroxybutyrate), poly (B-hydroxybutyrate), poly (E-caprolactone), polyethylene glycol (PEG), poly [bis (Carboxylatphenoxy) phosphazene] poly (amino acid), pseudopoly (amino acid), absorbent polyurethane, poly (phosphazine), polyphosphazene, polyalkylene oxide, polyacrylamide, polyhydroxyethylmethyl acrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly (Caprolactone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerol, copoly (ether-ester), polyalkylene oxalate, polyamide, poly Examples include, but are not limited to, li (imino carbonate), polyalkylene oxalate, and combinations thereof. The polyester may be selected from the group consisting of polylactic acid, polyglycolide, trimethylene carbonate, polydioxanone, polycaprolactone, polybutaester, and combinations thereof.

  Absorbent synthetic polymers are described, for example, by Ethicon, Inc. 90/10 poly (glycolide-L-lactide) copolymer, American Cyanamid Co., commercially available under the trade name VICRYL (polyglactic 910). Commercially available under the trade name DEXON from Ethicon, Inc. Commercially available under the trade name PDS from American Cyanamid Co. One or more of poly (glycolide-trimethylene carbonate) random block copolymers commercially available under the trade name MAXON from 75/25 poly (glycolide-E-caprolactone-polyglycaprolactone 25) copolymers commercially available from Ethicon under the trade name MONOCRYL May be included.

  Examples of non-absorbing synthetic materials include polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate, polyamide such as nylon, polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), polystyrene (PS), polyester, Polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCCE), polyvinyl fluoride (PVF), fluorinated ethylene propylene (FEP), polyacetal, polysulfone, silicon, and combinations thereof However, it is not limited to these. Synthetic non-absorbable polymers can include, but are not limited to, foamed elastomers and porous elastomers such as, for example, silicone, polyisoprene, and rubber. Synthetic polymers are described in W.W. L. Gore & Associates, Inc. May include expanded polytetrafluoroethylene (ePTFE) commercially available under the trade name GORE-TEX Soft Tissue Patch, and co-polyether ester urethane foams available under the trade name NASOPORE from Polyganics.

  The polymer composition may comprise, for example, a polymer composition of about 50% to about 90% by weight PLLA and a polymer composition of about 50% to about 10% by weight PCL. The polymer composition may comprise, for example, about 70% by weight PLLA and about 30% by weight PCL. The polymer composition may include, for example, a polymer composition of about 55 wt% to about 85 wt% PGA, and a polymer composition of 15 wt% to 45 wt% PCL. The polymer composition may comprise, for example, about 65% by weight PGA and about 35% by weight PCL. The polymer composition may comprise, for example, from about 90% to about 95% by weight PGA polymer composition and from about 5% to about 10% PLA polymer composition.

  The absorbable synthetic polymer may comprise a bioabsorbable and biocompatible elastomeric copolymer. Suitable bioabsorbable and biocompatible elastomeric copolymers include (preferably about 30:70 to about 70:30, preferably 35:65 to about 65:35, more preferably 45:55 to 35:65. A copolymer of ε-caprolactone and glycolide (preferably having a molar ratio of ε-caprolactone to glycolide) of (preferably from about 35:65 to about 65:35, more preferably from 45:55 to 30:70). An elastomeric copolymer of ε-caprolactone (with a caprolactone molar ratio) and L-lactide, D-lactide, blends thereof, or lactides including lactic acid copolymers (preferably from about 40:60 to about 60:40). P-dioxanone (having a molar ratio of p-dioxanone to lactide) (1,4-dioxane-2) ON) and an elastomeric copolymer of L-lactide, D-lactide, and lactide including lactic acid, preferably having a molar ratio of ε-caprolactone to p-dioxanone of about 30:70 to about 70:30. An elastomeric copolymer of caprolactone and p-dioxanone, preferably having an molar ratio of p-dioxanone to trimethylene carbonate of from about 30:70 to about 70:30, an elastomeric copolymer of p-dioxanone and trimethylene carbonate; An elastomeric copolymer of trimethylene carbonate and glycolide (preferably having a molar ratio of trimethylene carbonate to glycolide of from about 30:70 to about 70:30), preferably from about 30:70 to about 70:30 lactide Trimethyle against Elastomeric copolymers of trimethylene carbonate (with a molar ratio of carbonate) and L-lactide, D-lactide, blends thereof, or lactides including lactic acid copolymers, as well as blends thereof. . The elastomeric copolymer may be a copolymer of glycolide and ε-caprolactone. Alternatively, the elastomeric copolymer is a copolymer of lactide and ε-caprolactone.

  US Patent No. 5,468,253 “ELASTOMERIC MEDICAL DEVICE” (issued November 21, 1995) and US Pat. No. 6,325,810 “FOAM BUTTRESS FOR STAPLING APPARATUS” (December 4, 2001) Each of which is incorporated herein by reference in its entirety.

  The tissue thickness compensator may include an emulsifier. Examples of emulsifiers include water soluble polymers such as polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyethylene glycol (PEG), polypropylene glycol (PPG), PLURONICS, TWEENS, polysaccharides, and combinations thereof. However, it is not limited to these.

  The tissue thickness compensator may include a surfactant.

  Examples of surfactants include polyacrylic acid, metalose, methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octylphenyl Ethers, polyoxyethylene oleyl ethers, polyoxyethylene sorbitan monolaurates, polyoxyethylene stearyl ethers, polyoxyethylene nonylphenyl ethers, dialkylphenoxy poly (ethyleneoxy) ethanols, and polyoxamers may be mentioned but are not limited to these. .

  The polymer composition may include a pharmacologically active agent. The polymer composition can release a therapeutically effective amount of the pharmacologically active agent. The pharmacologically active agent may be released as the polymer composition is released / absorbed. The pharmacologically active agent may be released into a fluid such as blood that passes over or through the polymer composition. Examples of pharmacologically active agents include anti-inflammatory agents such as hemostatic agents and drugs such as fibrin, thrombin, and oxidized regenerated cellulose (ORC), such as diclofenac, aspirin, naproxen, sulindac, and hydrocortisone, such as Antibiotics and antibacterial drugs or agents such as, triclosan, silver ion, ampicillin, gentamicin, polymyxin B, chloramphenicol, and anti-cancer agents such as, but not limited to, cisplatin, mitomycin, adriamycin, and the like.

  The polymer composition may include a hemostatic material. Tissue thickness compensators include poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (caprolactone), poly (dioxanone), polyalkylene oxide, copoly (ether-ester), collagen, gelatin, Thrombin, fibrinogen, fibrinogen, fibronectin, elastin, albumin, hemoglobin, ovalbumin, polysaccharide, hyaluronic acid, chondroitin sulfate, hydroxyethyl starch, hydroxyethylcellulose, cellulose, oxidized cellulose, hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitin , Chitosan, agarose, maltose, maltodextrin, alginic acid, coagulation factor, methacrylate, polyurethane, cyanoacrylate , Platelet agonist, vasoconstrictor, alum, calcium, RGD peptide, protein, protamine sulfate, ε-aminocaproic acid, ferric sulfate, ferric sulfate, ferric chloride, zinc, zinc chloride, aluminum chloride, sulfuric acid Hemostatic materials including aluminum, aluminum acetate, permanganate, tannin, bone wax, polyethylene glycol, fucans, and combinations thereof may be included. The tissue thickness compensator may be characterized by hemostasis.

  The polymer composition of the tissue thickness compensator can be characterized, for example, by percent porosity, pore size, and / or hardness. The polymer composition may have, for example, a percent porosity of about 30% to about 99% by volume. The polymer composition may have, for example, a percent porosity of about 60% to about 98% by volume. The polymer composition may have, for example, a percent porosity of about 85% to about 97% by volume. The polymer composition may include, for example, about 70% by weight PLLA and about 30% by weight PCL, and can have, for example, a porosity of about 90% by volume. For example, as a result, the polymer composition will contain about 10% by volume of the copolymer. The polymer composition may include, for example, about 65% by weight PGA and about 35% by weight PCL, and can have a percent porosity of, for example, about 93% to about 95% by volume. The polymer composition may have a porosity greater than 85% by volume. The polymer composition can have a pore size of, for example, from about 5 micrometers to about 2000 micrometers. The polymer composition may have a pore size of, for example, from about 10 micrometers to about 100 micrometers. For example, the polymer composition can include, for example, a copolymer of PGA and PCL. The polymer composition may have, for example, a pore size of about 100 micrometers to about 1000 micrometers. For example, the polymer composition can include, for example, a copolymer of PLLA and PCL.

  According to a particular embodiment, the hardness of the polymer composition can be expressed in terms of Shore hardness, which can be defined as the resistance to permanent depression of the material, as measured, for example, by a durometer such as a Shore durometer. In order to evaluate the durometer value of a given material, pressure is applied to the material at the durometer indenter foot according to ASTM procedure D2240-00 “Standard Test Method for Rubber Property-Durometer Hardness”. The durometer indenter foot may be applied to the material for a sufficient amount of time, for example 15 seconds, and this measurement is taken on an appropriate scale. Depending on the type of scale used, a reading of 0 is obtained when the indenter foot is fully penetrated into the material and a reading of 100 is obtained when no penetration into the material has occurred. This reading is dimensionless. The durometer can be determined by any suitable scale, such as type A and / or type OO, according to ASTM D2240-00. The polymer composition of the tissue thickness compensator may, for example, have a Shore A hardness value of about 4A to about 16A, which is about 45 OO to about 65 OO in the Shore OO range. For example, the polymer composition can include, for example, PLLA / PCL copolymer or PGA / PCL copolymer. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 15A. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 10A. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 5A. The polymeric material may have a Shore OO composition value of, for example, about 35 OO to about 75 OO.

  The polymer composition may have at least two of the properties described above. The polymer composition may have at least three of the properties described above. The polymer composition has a porosity of 85% to 97% by volume, a pore size of 5 micrometers to 2000 micrometers, and a Shore A hardness of 4A to 16A, and a Shore OO hardness value of 45 OO to 65 OO. Can do. The polymer composition includes, for example, 70% by weight PLLA polymer composition and 30% by weight PCL polymer composition, 90% by volume porosity, 100 micron to 1000 micron pore size, and 4A It may have a Shore A hardness value of ˜16A and a Shore OO hardness value of 45 OO to 65 OO. The polymer composition includes, for example, a polymer composition of 65% by weight PGA and a polymer composition of 35% by weight PCL, with a porosity of 93% to 95% by volume and a pore size of 10 to 100 micrometers. You may have a size, and a Shore A hardness value of 4A-16A, and a Shore OO hardness value of 45OO-65OO.

  The tissue thickness compensator may include a material that expands. As noted above, the tissue thickness compensator may include a compressed material that expands when not compressed or deployed, for example. The tissue thickness compensator may include a self-expanding material formed in situ. The tissue thickness compensator includes at least one precursor selected to spontaneously crosslink when in contact with at least one of the other precursor (s), water, and / or body fluid. But you can. In accordance with the present invention, the first precursor may be in contact with one or more other precursors to form an expandable and / or swellable tissue thickness compensator. The tissue thickness compensator may comprise a fluid swellable composition, such as, for example, a water swellable composition. The tissue thickness compensator may include a gel containing water.

  The tissue thickness compensator may comprise a biodegradable foam with an encapsulating portion containing dry hydrogel particles or granules embedded therein. While not wishing to be bound by any particular theory, the foam enclosure is formed by contacting an aqueous solution of a hydrogel precursor and an organic solution of a biocompatible material to form the foam. obtain. Aqueous solutions and organic solutions can form micelles. Aqueous and organic solutions may be dried to encapsulate the dried hydrogel particles or granules within the foam. For example, a hydrogel precursor, such as a hydrophilic polymer, can be dissolved in water to form a micelle dispersion. The aqueous solution can be contacted with an organic solution of dioxane containing poly (glycolic acid) and polycaprolactone. Aqueous and organic solutions can be lyophilized to form biodegradable foams with dried hydrogel particles or granules dispersed therein. While not wishing to be bound by any particular theory, it is believed that the micelles form an encapsulant in which the dried hydrogel particles or granules are dispersed within the foam structure. The enclosure may be ruptured and the dried hydrogel particles or granules may expand in contact with a fluid such as a body fluid.

  Optionally, as described above, the tissue thickness compensator may comprise an initial thickness and an expanded thickness. The initial thickness of the tissue thickness compensator is, for example, about 0.001% of the expanded thickness, about 0.01% of the expanded thickness, about 0.1% of the expanded thickness, About 1% of the expanded thickness, about 10% of the expanded thickness, about 20% of the expanded thickness, about 30% of the expanded thickness, about 40% of the expanded thickness; About 50% of the expanded thickness, about 60% of the expanded thickness, about 70% of the expanded thickness, about 80% of the expanded thickness, and / or about the expanded thickness It can be 90%. The expanded thickness of the tissue thickness compensator can be, for example, about 2 times, about 5 times, about 10 times, about 50 times, about 100 times, about 200 times, about 300 times, about 400 times than the initial thickness. It can be about 500 times, about 600 times, about 700 times, about 800 times, about 900 times, and / or about 1,000 times thicker. The initial thickness of the tissue thickness compensator is up to 1% of the expanded thickness, up to 5% of the expanded thickness, up to 10% of the expanded thickness, and maximum of the expanded thickness. It can be 50%. The expanded thickness of the tissue thickness compensator is at least 50% thicker than the initial thickness, at least 100% thicker than the initial thickness, at least 300% thicker than the initial thickness, and at least 500% thicker than the initial thickness. be able to. As described above, in various situations, as a result of the above, the tissue thickness compensator can be configured to fill any gaps in the staple capture area.

  As noted above, the tissue thickness compensator may include a hydrogel. Hydrogels may include homopolymer hydrogels, copolymer hydrogels, multipolymer hydrogels, interpenetrating polymer hydrogels, and combinations thereof. Hydrogels may include microgels, nanogels, and combinations thereof. The hydrogel may generally include a hydrophilic polymer network capable of absorbing and / or retaining fluid. Hydrogels may include non-crosslinked hydrogels, crosslinked hydrogels, and combinations thereof. The hydrogel may include chemical crosslinks, physical crosslinks, hydrophobic segments, and / or water insoluble segments. The hydrogel may be chemically cross-linked by polymerization, low molecular cross-linking, and / or polymer-polymer cross-linking. Hydrogels may be physically cross-linked by ionic interactions, hydrophobic interactions, hydrogen bonding interactions, steric complexation, and / or supramolecular chemistry. The hydrogel may be substantially insoluble by cross-linking, hydrophobic segments, and / or water-insoluble segments, but may be swellable and / or swellable by absorbing and / or retaining fluid. The precursor may crosslink with endogenous material and / or tissue.

  The hydrogel may include an environmentally responsive hydrogel (ESH). The ESH may include a material having fluid swellability with respect to environmental conditions. Environmental conditions can include, but are not limited to, physical conditions, biological conditions, and / or chemical conditions of the surgical site. The hydrogel may swell or shrink in response to, for example, temperature, pH, electric field, ionic strength, enzyme and / or chemical reaction, electrical and / or magnetic stimulation, and other physiological and environmental variables. The ESH may include multifunctional acrylates, hydroxyethyl methacrylate (HEMA), elastic acrylates, and related monomers.

  A tissue thickness compensator comprising a hydrogel may comprise at least one of the non-synthetic and synthetic materials described above. The hydrogel may include a synthetic hydrogel and / or a non-synthetic hydrogel. The tissue thickness compensator may include multiple layers. The plurality of layers may include a porous layer and / or a non-porous layer. For example, the tissue thickness compensator may include a non-porous layer and a porous layer. In another example, the tissue thickness compensator may include a porous layer intermediate the first non-porous layer and the second non-porous layer. In another example, the tissue thickness compensator may include a non-porous layer intermediate the first porous layer and the second porous layer. The non-porous layer and the porous layer can be positioned in any order relative to the surface of the staple cartridge and / or anvil.

  Examples of non-synthetic materials include albumin, alginic acid, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, serum, and starch Can be mentioned, but is not limited thereto. The cellulose may include hydroxyethyl cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, and combinations thereof. The collagen may include bovine pericardium. The carbohydrate may comprise a polysaccharide, such as a lyophilized polysaccharide. The protein may include glycoproteins, proteoglycans, and combinations thereof.

  Examples of synthetic materials include poly (lactic acid), poly (glycolic acid), poly (hydroxybutyric acid), poly (phosphazine), polyester, polyethylene glycol, polyethylene oxide, polyethylene oxide-co-polypropylene oxide, co-polyethylene oxide, Polyalkylene oxide, polyacrylamide, polyhydroxyethyl methyl acrylate, poly (vinyl pyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerol, poly (amino acid) ), Copoly (ether-ester), polyalkylene oxalate, polyamide, poly (iminocarbonate), polyoxaester, polyorthoester, polyphosphatase , And combinations thereof may include, but are not limited to. The non-synthetic materials described above may be prepared synthetically using conventional methods, for example, synthetic hyaluronic acid.

The hydrogel may be made from one or more hydrogel precursors. The precursor may include monomers and / or macromers. The hydrogel precursor may comprise an electrophilic functional group and / or a nucleophilic electrophilic functional group. In general, electrophiles can react with nucleophiles to form bonds. The term “functional group” as used herein refers to an electrophilic or nucleophilic group capable of reacting with each other to form a bond. Examples of electrophilic functional groups include N-hydroxysuccinimide (“NHS”), sulfosuccinimide, carbonyldiimidazole, sulfonyl chloride, aryl halide, sulfosuccinimidyl ester, N-hydroxysuccinimidyl ester, Succinimidyl esters such as cinimidyl succinate and / or succinimidyl propionate, isocyanate thiocyanate, carbodiimide, benzotriazole carbonate, epoxide, aldehyde, maleimide, imide ester, and combinations thereof. It is not limited to these. The electrophilic functional group may include a succinimidyl ester. Examples of nucleophilic functional _{groups, -NH 2, -SH, -OH,} -PH 2, and -CO-NH-NH ₂ include, but are not limited to.

  The hydrogel may be formed from a single precursor or multiple precursors. The hydrogel may be formed from a first precursor and a second precursor. The first hydrogel precursor and the second hydrogel precursor may form a hydrogel in situ and / or in vivo upon contact. Hydrogel precursors can generally refer to polymers, functional groups, macromolecules, small molecules, and / or crosslinkers that can participate in a reaction to form a hydrogel. The precursor may comprise a homogeneous, heterogeneous, or phase separated solution in a suitable solvent, such as, for example, water or a buffer. The buffer may have a pH of about 8 to about 12, such as about 8.2 to about 9, for example. Examples of the buffer include, but are not limited to, a borate buffer. The precursor (s) may be in the form of an emulsion. According to the present invention, the first precursor can react with the second precursor to form a hydrogel. The first precursor may spontaneously crosslink when in contact with the second precursor. According to the present invention, the first electrophilic functional group set of the first precursor can react with the second nucleophilic functional group set of the second precursor. When precursors are mixed in an environment that allows reaction (eg, with respect to pH, temperature, and / or solvent), the functional groups can react with each other to form a covalent bond. A precursor may be crosslinked when at least some of the precursors react with two or more other precursors.

  Tissue thickness compensators include potassium 3-sulfopropyl acrylate (“KSPA”), sodium acrylate (“NaA”), N- (tris (hydroxylmethyl) methyl) acrylamide (“Trisacryl”), and 2 -It may comprise at least one monomer selected from the group consisting of acrylamido-2-methyl-1-propanesulfonic acid (AMPS). The tissue thickness compensator may comprise a copolymer comprising two or more monomers selected from the group consisting of KSPA, NaA, Trisacryl, aMPS. The tissue thickness compensator may include homopolymers derived from KSPA, NaA, Trisacryl, and AMPS. The tissue thickness compensator may include a hydrophilic modifying monomer that is copolymerizable with the tissue thickness compensator. The hydrophilic modifying monomer may include methyl methacrylate, butyl acrylate, cyclohexyl acrylate, styrene, styrene sulfonic acid.

The tissue thickness compensator may include a cross-linking agent. Crosslinking agents are ethylene glycol diacrylate or dimethacrylate, di- -, tri - or tetra-ethylene glycol diacrylate or dimethacrylate, allyl (meth) acrylate, C 2 _-C 8 _- alkylene acrylate or dimethacrylate, divinyl ether, divinyl Sulfone, di- and trivinylbenzene, trimethylolpropane triacrylate or trimethacrylate, pentaerythritol tetraacrylate or tetramethacrylate, bisphenol A diacrylate or dimethacrylate, methylenebisacrylamide or bismethacrylamide, ethylenebisacrylamide or ethylenebismethacrylamide , Low molecular weight di- or polyvinyl crosslinkers, such as triallyl phthalate or diallyl phthalate May be included. The cross-linking agent may include N, N′-methylenebisacrylamide “MBAA”).

  The tissue thickness compensator comprises an isocyanate functional macromer, an amine and / or sulfhydryl functional macromer optionally comprising an acrylate and / or methacrylate functional hydrogel, a biocompatible photoinitiator, an alkyl-cyanoacrylate, an amine functional macromer. Optional succinimidyl ester functional macromers, epoxy functional macromers optionally including amine functional macromers, mixtures of proteins and / or polypeptides and aldehyde crosslinkers, Genipin, water soluble carbodiimides, anionic polysaccharides and poly It may contain at least one of the valent cations.

  The tissue thickness compensator may include unsaturated organic acid monomers, acrylic substituted alcohols, and / or acrylamide. Tissue thickness compensators include methacrylic acid, acrylic acid, glycerol acrylate, glycerol methacrylate, 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, 2-dimethylaminoethyl methacrylate, N-vinylpyrrolidone, methacrylamide, and / or Alternatively, poly (ethylene glycol) (n) dimethacrylic acid may be included.

  The tissue thickness compensator may include a reinforcing material. The reinforcing material may include at least one of the non-synthetic material and the synthetic material described above. Reinforcing materials are collagen, gelatin, fibrinogen, fibrinogen, elastin, keratin, albumin, hydroxyethylcellulose, cellulose, oxidized cellulose, hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitin, chitosan, alginic acid, poly (lactic acid), poly (lactic acid) Glycolic acid), poly (hydroxybutyric acid), poly (phosphadine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polyhydroxyethyl methyl acrylate, poly (vinyl pyrrolidone), polyvinyl alcohol, poly (caprolactone), poly (dioxanone) ), Polyacrylic acid, polyacetate, polycaprolactone, polypropylene, aliphatic polyester, glycerol, Li (amino acids), copoly (ether - ester), polyalkylene oxalates, polyamides, poly (imino carbonates), polyalkylene oxalates, polyoxaesters, polyorthoesters, polyphosphazenes, and may include a combination thereof.

  The tissue thickness compensator may include a layer that includes a reinforcing material. The porous layer and / or non-porous layer of the tissue thickness compensator may include a reinforcing material. For example, the porous layer may include a reinforcing material and the non-porous layer may not include a reinforcing material. The reinforcing layer may include an inner layer between the first non-porous layer and the second non-porous layer. The reinforcing layer may include an outer layer of a tissue thickness compensator. The reinforcing layer may include the outer surface of the tissue thickness compensator.

  The reinforcing material may comprise mesh, monofilament, multifilament braid, fiber, mat, felt, particles, and / or powder. The reinforcing material may be incorporated into the layer of tissue thickness compensator. The reinforcing material may be incorporated into at least one of the non-porous layer and the porous layer. The mesh comprising the reinforcing material may be formed using conventional techniques such as knitting, weaving, touching, and / or nip ring, for example.

  According to the present invention, the plurality of reinforcing materials may be oriented in a random direction and / or a common direction. The common direction may be, for example, one of parallel to the staple line and perpendicular to the staple line. For example, monofilament and / or multifilament braids may be oriented in a random and / or common direction. Monofilament and multifilament braids may be associated with non-porous layers and / or porous layers. The tissue thickness compensator may include a plurality of reinforcing fibers oriented in a random direction within the non-porous layer. The tissue thickness compensator may include a plurality of reinforcing fibers oriented in a common direction within the non-porous layer.

  The fibers may form a nonwoven material such as, for example, a mat and felt. The fibers may have any suitable length such as, for example, 0.1 mm to 100 mm and 0.4 mm to 50 mm. The reinforcing material may be ground into a powder. The powder may have a particle size of, for example, 10 micrometers to 1 cm. The powder may be incorporated into a tissue thickness compensator.

  The tissue thickness compensator may be formed in situ. The hydrogel may be formed in situ. Tissue thickness compensators can be formed in situ by covalent, ionic, and / or hydrophobic bonds. Physical (non-covalent) crosslinking can result from complex formation, hydrogen bonding, desolvation, van der Waals interactions, ionic bonding, and combinations thereof. Chemical (covalent) crosslinking includes free radical polymerization, condensation polymerization, anionic or cationic polymerization, step growth polymerization, electrophilic-nucleophilic reaction, and combinations thereof, It can be realized by any of a number of mechanisms.

  Optionally, the in situ formation of the tissue thickness compensator is physically separated until contacted in situ and / or in response to environmental conditions to react with each other to form a hydrogel, 2 Reacting two or more precursors may be included. In situ polymerizable polymers may be prepared from precursor (s) that can react to form a polymer at the surgical site. The tissue thickness compensator may be formed by a cross-linking reaction of the precursor (s) in situ. The precursor may include an initiator capable of initiating a polymerization reaction for the formation of an in situ tissue thickness compensator. The tissue thickness compensator may include a precursor that can be activated upon application to create a cross-linked hydrogel. In situ formation of the tissue thickness compensator may include activating at least one precursor to form a bond to form the tissue thickness compensator. Optionally, activation includes at a surgical site including but not limited to temperature, pH, electric field, ionic strength, enzyme and / or chemical reaction, electrical and / or magnetic stimulation, and other physiological and environmental variables. It may be achieved by changes in physical conditions, biological conditions, and / or chemical conditions. The precursor may contact outside the body and be introduced to the surgical site.

  The tissue thickness compensator may comprise one or more enclosures, i.e. cells, which may be configured to store at least one component therein. The enclosure may be configured to store the hydrogel precursor therein. The enclosure may be configured, for example, to store two components therein. The enclosure may be configured to store the first hydrogel precursor and the second hydrogel precursor therein. The first enclosure may be configured to store the first hydrogel precursor therein, and the second enclosure may be configured to store the second hydrogel precursor therein. As described above, the encapsulation is aligned with, or at least substantially aligned with, the staple legs such that the encapsulation legs puncture and / or otherwise tear when the staple legs contact the encapsulation. Can be done. When the staple is deployed, the enclosure can be compressed, crushed, folded and / or otherwise torn. After the enclosure is ruptured, the component (s) stored therein can flow out of the enclosure. Components stored therein may contact other components, layers of tissue thickness compensator, and / or tissue. Other components may flow from the same or different enclosures provided to the tissue thickness compensator layer and / or provided to the surgical site by the clinician. As a result of the above, the component (s) stored within the enclosure can provide for the expansion and / or swelling of the tissue thickness compensator.

  The tissue thickness compensator may include a layer that includes an encapsulation. The enclosure may comprise voids, pockets, domes, tubes and combinations thereof associated with the layers. The enclosing portion may include a void in the layer. The layer can include two layers that can be attached to each other, and an enclosure can be defined between the two layers. The enclosure may comprise a dome on the surface of the layer. For example, at least a portion of the enclosure may be located in a dome that extends upward from the layer. The enclosure may comprise a pocket formed in the layer. The first part of the enclosure may comprise a dome and the second part of the enclosure may comprise a pocket. The enclosure may comprise a tube embedded in the layer. The tube may include non-synthetic and / or synthetic materials as described herein, such as PLA. The tissue thickness compensator may comprise a bioabsorbable foam, such as ORC, that includes a PLA tube embedded therein, and the tube may encapsulate, for example, a hydrogel. The enclosure may comprise separate cells that are not connected to each other. One or more of the enclosures can be in fluid communication with each other, eg, via one or more paths, conduits, and / or channels that extend through the layers.

  The rate of release of the component from the enclosure can be, for example, tissue thickness compensator thickness, tissue thickness compensator composition, component size, component hydrophilicity, and / or between components. It may be controlled by physical and / or chemical interactions, tissue thickness compensator compositions, and / or surgical instruments. The layer can comprise one or more thin sections or weakened portions, such as, for example, partial perforations, and the thin sections or weakened portions can facilitate incision of the layer and tearing of the enclosure. . Partial perforations may not extend completely through the layer, and in some cases the perforations may extend completely through the layer.

  Optionally, the anvil may comprise a tissue thickness compensator that includes an encapsulated component that includes at least one microsphere particle. The tissue thickness compensator may comprise an enclosure that includes a first encapsulated component and a second encapsulated component. The tissue thickness compensator may comprise an encapsulant that includes a first encapsulated microsphere particle and a second encapsulated microsphere particle.

  The tissue thickness compensator may be suitable for use with surgical instruments. As noted above, the tissue thickness compensator can be associated with a staple cartridge and / or an anvil. The tissue thickness compensator can be configured in any shape, size and / or dimension suitable for attachment to a staple cartridge and / or anvil. As described above, the tissue thickness compensator can be releasably attached to the staple cartridge and / or the anvil. The tissue thickness compensator can be any mechanical and / or chemical that is capable of maintaining the tissue thickness compensator in contact with the staple cartridge and / or anvil before and during the stapling process. By means, it can be attached to a staple cartridge and / or an anvil. After the staples have penetrated the tissue thickness compensator, the tissue thickness compensator can be removed or released from the staple cartridge and / or anvil. As the staple cartridge and / or anvil moves away from the tissue thickness compensator, the tissue thickness compensator can be removed or released from the staple cartridge and / or anvil.

  Referring now to FIG. 14, a staple cartridge such as, for example, a staple cartridge 10000 can include a support portion 10010 and a compressible tissue thickness compensator 10020. With reference now to FIGS. 16-18, the support portion 10010 can comprise a deck surface 10011 and a plurality of staple cavities 10012 defined within the support portion 10010. Each staple cavity 10012 may be sized and configured to removably store staples, such as staples 10030, for example. Staple cartridge 10000 can further comprise a plurality of staple drivers 10040, each of which has one or more staples 10030 in staple cavity 10012 when staple 10030 and staple driver 10040 are in a non-fired position. It can be configured to support. For example, referring primarily to FIGS. 22 and 23, each staple driver 10040 can include, for example, one or more cradle, or trough 10040, that supports the staples and staples 10030 and staples. It can be configured to limit relative movement with the driver 10040. Referring again to FIG. 16, the staple cartridge 10000 can further comprise a staple firing thread 10050 that can move the staple driver 10040 and the staple 10030 from their unfired positions against the staple cartridge 10000. The staple cartridge can be moved from the proximal end 10001 to the distal end 10002 for sequential lifting toward the positioned anvil. Referring primarily to FIGS. 16 and 18, each staple 10030 can include a base 10031 and one or more legs 10032 extending from the base 10031, each staple being substantially U-shaped, for example. It can be at least one of shape and substantially V-shaped. The staple 10030 can be configured such that the tips of the staple legs 10032 are hidden from the deck surface 10011 of the support portion 10010 when the staple 10030 is in the non-fired position. The staple 10030 can be configured such that the tips of the staple legs 10032 are flush with the deck surface 10011 of the support portion 10010 when the staple 10030 is in the non-fired position. The staple 10030 can be configured such that the tips of the staple legs 10032 or at least some portions of the staple legs 10032 extend onto the deck surface 10011 of the support portion 10010 when the staples 10030 are in the non-fired position. . In such cases, when the staple 10030 is in the non-fired position, the staple legs 10032 can extend into the tissue thickness compensator 10020 and can be embedded within the tissue thickness compensator 10020. For example, the staple legs 10032 can extend, for example, about 1.9 mm (0.075 ") on the deck surface 10011. The staple legs 10032 can be, for example, about 0.64 mm (about 0.64 mm). 0.025 ") to about 3.25 mm (0.125"). Further to the above, tissue thickness compensator 10020 can be, for example, about 2.0 mm (0.08 "). An uncompressed thickness of ˜about 3.18 mm (0.125 ″) can be provided.

  In use, and with reference primarily to FIG. 31 above, an anvil, such as anvil 10060, for example, can be moved to the opposite closed position of staple cartridge 10000. As described in more detail below, the anvil 10060 can position tissue relative to the tissue thickness compensator 10020, eg, the tissue thickness compensator 10020 relative to the deck surface 10011 of the support portion 10010. Can be compressed. Once the anvil 10060 is suitably positioned, staples 10030 can be deployed, as also shown in FIG. Optionally, as described above, the staple firing sled 10050 can be moved from the proximal end 10001 of the staple cartridge 10000 toward the distal end 10002, as shown in FIG. As the thread 10050 advances, the thread 10050 can contact the staple driver 10040 and lift the staple driver 10040 upward within the staple cavity 10012. The sled 10050 and the staple driver 10040 can each comprise one or more slopes, i.e., sloped surfaces, that can cooperate to move the staple driver 10040 upward from the unfired position. For example, referring to FIGS. 19-23, each staple driver 10040 can comprise at least one inclined surface 10042 and the sled 10050 can comprise one or more inclined surfaces 10052 and canted. Surface 10052 may be configured such that inclined surface 10052 can slide under inclined surface 10042 as sled 10050 advances distally within the staple cartridge. As the staple driver 10040 is lifted upward within each staple cavity 10012, the staple driver 10040 can lift the staple 10030 upward so that the staple 10030 passes through the opening of the staple deck 10011. 10012 can appear. During the exemplary firing sequence, primarily referring to FIGS. 25-27, the sled 10050 can first contact the staple 10030a and begin to lift the staple 10030a upward. As the sled 10050 is advanced further distally, the sled 10050 can begin to lift the staples 10030b, 10030c, 10030d, 10030e, and 10030f, and any other subsequent staples in turn. As shown in FIG. 27, the sled 10050 can drive the staple 10030 upward so that the staple legs 10032 contact the opposing anvil and are deformed to the desired shape, from the support portion 10010. It is injected. In various situations, the sled 10030 can simultaneously move several staples upward as part of the firing sequence. For the firing sequence shown in FIG. 27, the staples 10030a and 10030b have been moved to the fully fired position and fired from the support portion 10010, and the staples 10030c and 10030d are at least partially in firing. Contained within support portion 10010, staples 10030e and 10030f are still in a non-fired position.

  As described above, with reference to FIG. 33, the staple legs 10032 of the staple 10030 can extend onto the deck surface 10011 of the support portion 10010 when the staple 10030 is in the unfired position. Further, for this firing sequence shown in FIG. 27, staples 10030e and 10030f are shown in the unfired position, and their staple legs 10032 extend onto the deck surface 10011 and into the tissue thickness compensator 10020. When the staple 10030 is in the non-fired position, the tip of the staple leg 10032, or any other portion of the staple leg 10032, protrudes past the tissue contacting upper surface 10021 of the tissue thickness compensator 10020. I can't. As the staple 10030 moves from the non-fired position to the fired position, the tips of the staple legs can protrude past the tissue contacting surface 10032 as shown in FIG. The tip of staple leg 10032 may include a sharp tip, which can incise and penetrate tissue thickness compensator 10020. The tissue thickness compensator 10020 may include a plurality of openings that receive the staple legs 10032 such that the staple legs 10032 slide relative to the tissue thickness compensator 10020. Can be configured to do so. Support portion 10010 may further comprise a plurality of guides 10013 extending from deck surface 10011. The guide 10013 can be positioned adjacent to the staple cavity opening in the deck surface 10011 such that the staple legs 10032 can be at least partially supported by the guide 10013. Guide 10013 may be located at the proximal and / or distal end of the staple cavity opening. According to the present invention, the first guide 10013 can be disposed at the first end of each staple cavity opening, the second guide 10013 can be disposed at the second end of each staple cavity opening, Accordingly, each first guide 10013 can support the first staple leg 10032 of the staple 10030, and each second guide 10013 can support the second staple leg 10032 of the staple. Referring to FIG. 33, each guide 10013 can include a groove or slot (eg, groove 10016) in which staple legs 10032 can be slidably received. Optionally, each guide 10013 may include a non-slip, protrusion, and / or spike that may extend from the deck surface 10011, which may extend into the tissue thickness compensator 10020. As described in detail below, anti-slip, protrusions, and / or spikes can reduce relative movement between the tissue thickness compensator 10020 and the support portion 10010. The tips of the staple legs 10032 can be disposed within the guide 10013 and cannot extend over the upper surface of the guide 10013 when the staple 10030 is in the unfired position. For example, the guide 10013 defines a guide height, and the staple 10030 cannot extend beyond this guide height when in the unfired position.

  In accordance with the present invention, a tissue thickness compensator (eg, tissue thickness compensator 10020) can be constructed from a single sheet of material. The tissue thickness compensator can include one continuous sheet of material that can cover the entire deck upper surface 10011 of the support portion 10010 or can cover a smaller area than the entire deck surface 10011. While the sheet of material may cover the staple cavity opening of the support portion 10010, alternatively, the sheet of material may include an opening, which is aligned with, or at least partially, the staple cavity opening. Can be matched. According to the present invention, the tissue thickness compensator can be composed of multiple layers of material. Referring now to FIG. 15, a tissue thickness compensator can include a compressible core and a wrap that encloses the compressible core. The wrap 10022 may be configured to releasably hold the compressible core relative to the support portion 10010. For example, the support portion 10010 includes one or more protrusions (eg, protrusion 10014 (FIG. 18)) extending therefrom, which may include one or more openings defined in the wrap 10022 and / or It may be received in a slot (eg, opening 10024). The protrusion 10014 and the opening 10024 can be configured such that the protrusion 10014 can secure the wrap 10022 to the support portion 10010. The ends of the protrusions 10014 can be deformed, for example, by a thermal caulking process or the like, thereby enlarging the ends of the protrusions 10014 and consequently limiting the relative movement between the wrap 10022 and the support portion 10010. it can. As shown in FIG. 15, the wrap 10022 includes one or more perforations 10025, which may facilitate peeling the wrap 10022 from the support portion 10010. Referring now to FIG. 24, the tissue thickness compensator can include a wrap 10222 that includes a plurality of openings 10223 that are aligned, or at least partially aligned, with staple cavity openings in the support portion 10010. Can do. The core of the tissue thickness compensator may also include openings, which may be aligned with, or at least partially aligned with, the opening 10223 of the wrap 10222. Alternatively, the core of the tissue thickness compensator can comprise a continuum that can extend below the opening 10223 such that the continuum covers the staple cavity opening in the deck surface 10011. .

  Optionally, as described above, the tissue thickness compensator can include a wrap that releasably holds the compressible core relative to the support portion 10010. For example, referring to FIG. 16, the staple cartridge may further include a retaining clip 10026, which can be configured to prevent the wrap and compressible core from prematurely disengaging from the support portion 10010. Optionally, each retaining clip 10026 can include an opening 1000028, which can be configured to receive a protrusion 10014 extending from the support portion 10010, such that the retaining clip 10026 can be secured to the support portion 10010. . Each retaining clip 10026 can include at least one dished portion 10027 that can extend below the support portion 10010 to hold the staple driver 10040 within the support portion 10010. As described above, the tissue thickness compensator can be removably attached to the support portion 10010 by staples 10030. More specifically, as also described above, when the staple 10030 is in the non-fired position, the legs of the staple 10030 can extend into the tissue thickness compensator 10020, resulting in a tissue thickness compensator. Sweater 10020 can be releasably retained on support portion 10010. The legs of the staples 10030 can be in contact with the sidewalls of each staple cavity 10012, and the staples 10030 can be deployed from the staple cartridge 10000 due to friction between the staple legs 10032 and the sidewalls. 10030 and tissue thickness compensator 10020 can be held in place. When the staple 10030 is deployed, the tissue thickness compensator 10020 can be captured within the staple 10030 and held against the stapled tissue T. When the anvil is then moved to the open position to release the tissue T, the support portion 10010 secured to the tissue can move away from the tissue thickness compensator 10020. An adhesive can be used to removably hold the tissue thickness compensator 10020 to the support portion 10010. A two-component adhesive can be used, the first adhesive component can be placed on the deck surface 10011 and the second adhesive component can be placed on the tissue thickness compensator 10020, thereby increasing the tissue thickness. When the compensator 10020 is positioned relative to the deck surface 10011, the first component contacts the second component to activate the adhesive and the tissue thickness compensator 10020 is removed from the support portion 10010. Can be combined. Optionally, any other suitable means can be used to releasably hold the tissue thickness compensator to the support portion of the staple cartridge.

  Further to the above, the thread 10050 can be advanced from the proximal end 10001 to the distal end 10002 to fully deploy all the staples 10030 contained within the staple cartridge 10000. Referring now to FIGS. 56-60, the sled 10050 can be advanced distally within the longitudinal cavity 10016 in the support portion 10010 by the firing member (or knife bar) 10052 of the surgical stapler. In use, the staple cartridge 10000 is inserted into a staple cartridge channel (eg, staple cartridge channel 10070) within the jaws of the surgical stapler, which causes the firing member 10052 to advance into the sled 10050 as shown in FIG. Can touch. As sled 10050 is advanced distally by firing member 10052, sled 10050 can contact the most proximal staple driver (or driver 10040) to fire or eject staple 10030 from cartridge body 10010 as described above. Can do. As shown in FIG. 56, the firing member 10052 can further include a cutting edge 10053, which can be advanced distally through the knife slot of the support portion 10010 when the staple 10030 is fired. In accordance with the present invention, a corresponding knife slot can extend through an anvil disposed relative to staple cartridge 10000 such that cutting edge 10053 extends between the anvil and support portion 10010. Existing tissue and tissue thickness compensator in between can be cut. In various situations, the sled 10050 can be advanced distally by the firing member 10052 until the sled 10050 reaches the distal end 10002 of the staple cartridge 10000, as shown in FIG. At that point, the firing member 10052 can be retracted proximally. The sled 10050 can be retracted proximally at the firing member 10052, but referring now to FIG. 59, the sled 10050 can be moved toward the distal end 10002 of the staple cartridge 10000 when the firing member 10052 is retracted. Can be left behind. When the firing member 10052 is fully retracted, the anvil reopens, the tissue thickness compensator 10020 moves away from the support portion 10010, and the remaining unimplanted portion (including the support portion 10010) of the consumed staple cartridge 10000 is stapled. It can be removed from the cartridge channel 10070.

  After the consumed staple cartridge 10000 is removed from the staple cartridge channel, a new staple cartridge 10000, or any other suitable staple cartridge, can be inserted into the staple cartridge channel 10070 in addition to the above. Further to the above, the staple cartridge channel 10070, firing member 10052, and / or staple cartridge 10000 can constitute a cooperating function, which is a new (or unfired) disposed in the staple cartridge channel 10070. The firing member 10052 may be prevented from advancing distally a second time (or subsequent) without the staple cartridge 10000). More specifically, referring again to FIG. 56, when the firing member 10052 is advanced to contact the sled 10050 and the sled 10050 is in the proximal non-firing position, the support nose 10055 of the firing member 10052 is 10050 support shelf 10056 can be positioned above and / or above, so that the firing member 10052 is held in a sufficiently upper position, and a lock (or beam) 10054 extending from the firing member 10052 is a staple cartridge. It can be prevented from falling into a locking recess defined in the channel. If the lock 10054 does not fall into the lock recess, in such a situation, the lock 10054 does not contact the distal sidewall 10057 of the lock recess as the firing member 10052 is advanced. As the firing member 10052 pushes the sled 10050 distally, the firing member 10052 can be supported in the upper firing position thanks to the support nose 10055 riding on the support shelf 10056. When the firing member 10052 is retracted with respect to the sled 10050, as described above and as shown in FIG. 59, the support nose 10055 is no longer on the support shelf 10056 of the sled 10050, and the firing member 10052 It can fall downward from the upper position. For example, the surgical staple can include a spring 10058 and / or any other suitable biasing component, which can be configured to bias the firing member 10052 to a lower position. Once the firing member 10052 is fully retracted, the firing member 10052 cannot be advanced again distally through the used staple cartridge 10000, as shown in FIG. More specifically, the firing member 10052 cannot be held in the up position by the sled 10050 because the sled 10050 is left at the distal end 10002 of the staple cartridge 10000 at this point in the sequence of operations. Thus, as described above, when the firing member 10052 is advanced again without replacement of the staple cartridge, the lock beam 10054 contacts the side wall 10057 of the locking recess, thereby causing the firing member 10052 to again move relative to the staple cartridge 10000. Prevents advancement in the distal direction. In other words, if the used staple cartridge 10000 is replaced with a new staple cartridge, the new staple cartridge has a sled 10050 disposed proximally, which can hold the firing member 10052 in the upper position, The firing member 10052 can again be advanced in the distal direction.

  As described above, the sled 10050 can be configured to move the staple driver 10040 between a first unfired position and a second fired position to fire the staple 10030 from the support portion 10010. it can. After the staple 10030 is fired from the support portion 10010, the staple driver 10040 can be received within the staple cavity 10012. Support portion 10010 may constitute one or more retention mechanisms, which may be configured to prevent staple driver 10040 from being fired or dropped from staple cavity 10012. Alternatively, the thread 10050 can be configured to fire the staple driver 10040 from the support portion 10010 within the staple 10030. For example, the staple driver 10040 can be constructed from a bioabsorbable and / or biocompatible material (eg, Ultem, etc.). A staple driver can be attached to the staple 10030. For example, a staple driver can be molded on and / or around the bottom surface of each staple 10030 such that the driver is molded integrally with the staple. U.S. Patent Application No. 11 / 541,123 "SURGICAL STAPLES HAVING COMPRESIBLE OR CRUSSHABLE MEMBERS FOR SECURING TISSUE THEHERE AND STAPLING INSTRUMENTS FOR DEPLOYING DAY 9 Incorporated into.

  As described above, a surgical stapling instrument receives a staple cartridge, an anvil rotatably coupled to the staple cartridge channel, and a firing member including a knife edge movable relative to the anvil and the staple cartridge channel. A staple cartridge channel configured to: In use, the staple cartridge is disposed within the staple cartridge channel, and after the staple cartridge is at least partially consumed, the staple cartridge can be removed from the staple cartridge channel and replaced with a new staple cartridge. For example, the staple cartridge channel, anvil, and / or firing member of a surgical stapling instrument can be reused with a replacement staple cartridge. Alternatively, the staple cartridge can include a portion of a disposable loading unit assembly, which can include staple cartridge channels, anvils, and / or firing members, for example, a disposable loading unit. As part of the assembly replacement, it can be replaced with the staple cartridge. A specific disposable mounting unit assembly is disclosed in U.S. Patent Application No. 12 / 031,817 "END EFFECTOR COUPLING ARRANGEMENTS FOR A SURGICAL CUTING AND STAPLING INSTRUMENT" (filed February 15, 2008), the entire disclosure. Is incorporated herein by reference.

  The tissue thickness compensator can comprise an extrudable, castable and / or moldable composition comprising at least one of the synthetic and / or non-synthetic materials described herein. The tissue thickness compensator can comprise a film or sheet comprising two or more layers. The tissue thickness compensator can be obtained using conventional methods such as mixing, blending, compounding, spraying, wicking, solvent evaporation, dipping, brushing, vapor deposition, extrusion, calendering, casting, molding, etc. . In extrusion, the opening can be in the form of a die with at least one opening to impart shape to the exiting extrudate. In calendering, the opening can include a nip between two rolls. Conventional molding methods include blow molding, injection molding, foam injection, compression molding, thermoforming, extrusion, foam extrusion, film blowing, calendering, spinning, solvent welding, dip coating and spin coating, and solution casting. And film casting, plastisol treatment (including knife coating, roller coating and casting), and combinations thereof, but are not limited to these. In injection molding, the openings can include nozzles and / or channels / runners and / or molding cavities and functions. In compression molding, the composition can be positioned in a molding cavity, heated to a suitable temperature, and molded by exposure to compression under relatively high pressure. In casting, the composition can include a liquid or slurry that can be injected or otherwise provided in and on and / or around the mold or object to replicate the characteristics of the mold or object. After casting, the composition can be dried, cooled, and / or cured to form a solid.

  In accordance with the present invention, a method of manufacturing a tissue thickness compensator comprising at least one agent stored and / or absorbed therein comprises providing a tissue thickness compensator and the tissue thickness compensator. It can generally include contacting the tissue thickness compensator and the drug to maintain the drug. The method of manufacturing a tissue thickness compensator containing antibacterial materials includes preparing a hydrogel, drying the hydrogel, swelling the hydrogel in an aqueous solution of silver nitrate, forming a tissue thickness compensator with antibacterial properties Contacting with a solution of hydrogel and sodium chloride to do so. The tissue thickness compensator can include silver dispersed therein.

  Referring now to FIG. 71, a tissue thickness compensator 21020 can comprise a compensator body 21022 and a plurality of capsules or tubes 21024 positioned therein. Each of the tubes 21024 can include a cavity 21026 defined within the tube that can include one or more agents therein. As described in more detail below, the tissue thickness compensator 21020 can be manufactured, for example, by placing a tube 21024 in a mold and forming a compensator body 21022 around the tube 21024. One or more of the tubes 21024 are placed in the mold so that the tube 21024 can be enclosed in the compensator body 21022 after the compensator body 21022 has solidified, lyophilized, and / or cured, for example. A drug can be placed in the tube 21024. Alternatively, referring now to FIG. 72, the tissue thickness compensator 21120 is a compensator in which one or more agents can be loaded into the tube 21124 after the compensator body 21122 is formed around the tube 21124. There can be a plurality of capsules or tubes 21124 positioned within the body 21122. For example, the tissue thickness compensator 21120 can include a port 21123 that can be in fluid communication with the tube 21124 and that can be configured, for example, to allow one or more medications to be pressed into the tube 21124 using a syringe 21125. it can. In some situations, a surgeon or other clinician can load one or more drugs into the tube 21124 just prior to the tissue thickness compensator 21120 being inserted into the patient. These can be particularly useful when the tissue thickness compensator 21120 is expected or required to have a long shelf life or shelf life.

  Referring now to FIG. 73, the compensator body 21022 of the tissue thickness compensator 21020 can be composed of, for example, a bioabsorbable material. The compensator body 21022 may be composed of any suitable material such as, for example, PGA and / or PCL. Tube 21024 can be comprised of any suitable bioabsorbable material, for example. Tube 21024 may be composed of any suitable material such as, for example, hyaluronic acid, gelatin, PDS, and / or oxidized regenerated cellulose (ORC). The one or more medicaments 21025 contained within the cavity 21026 can include a fluid, such as doxycycline, for example. For example, each of the tubes 21024 can be sealed such that the drug 21025 can be stored within the tube 21024 until at least a portion of the tube 21024 is, for example, dissolved and / or bioabsorbed. In use, referring now to FIG. 74, the tube 21024 can be exposed to bodily fluids, such as blood, for example, but bodily fluids can contact the tube 21024 and dissolve the tube 21024. Referring to FIG. 75, body fluid may be squeezed out of tissue T when tissue T and tissue thickness compensator 21020 are compressed, for example, by anvil 21060 and / or a plurality of staples 21030. In accordance with the present invention, a bioabsorbable wrap can be utilized to surround or at least partially surround the compensator body 21022. For example, the wrap can be composed of, for example, hyaluronic acid and / or ORC.

  Referring now to FIG. 77, a capsule, or tube 21224, can comprise a plurality of layers 21224a-21224d, for example. Each tube 21224 can comprise, for example, an outer or first layer 21224a, a second layer 21224b, a third layer 21224c, and an inner layer 21224d. The outer layer 21224a can be made of a hemostatic material such as thrombin, for example. The second layer 21224b can be composed of antibacterial and / or antibiotic materials, such as doxycycline and / or gentamicin, for example. The third layer 21224c may be composed of anti-inflammatory materials, such as, for example, diclofenac and / or NSAIDSs. Inner layer 21224d may be composed of a material that affects healing, such as, for example, a powdered collagen synthetic material. Referring again to FIG. 77, the tube 21224 is such that the outer layer 21224a is dissolved or at least substantially dissolved before the second layer 21224b is dissolved or at least partially dissolved. Can be structured and prepared. Referring to FIG. 76, the outer layer 21224a can begin to dissolve as soon as it is exposed to body fluids. This point in time is indicated as time t0. The outer layer 21224a can be completely dissolved in minutes, hours, and / or days, and at the time indicated as time t1, the material comprising the outer layer 21224a can reach maximum efficacy or concentration. At some later time, outer layer 21224a may be completely or at least substantially dissolved by the time indicated by time t2.

  When the outer layer 21224a is dissolved, body fluid can reach the second layer 21224b and can begin to at least partially dissolve the second layer 21224b. Similar to the above, the second layer 21224b can be completely dissolved in minutes, hours, and / or days, and at the time indicated as time t3, the material comprising the second layer 21224b is the largest. Efficacy or concentration can be reached. In various situations, body fluid passes through the outer layer 21224a to reach the second layer 21224b so that the outer layer 21224a and the second layer 21224b can begin to dissolve simultaneously, or at least substantially simultaneously. be able to. In any case, it will be apparent to the reader that the time t1 at which the material comprising the outer layer 21224a reaches its maximum potency or concentration can occur before time t3. At some later time, the second layer 21224b may be completely or at least substantially dissolved by the time indicated by time t5. As will be apparent to the reader, time t5 may occur after time t2. When the second layer 21224b is being dissolved, body fluid can reach the third layer 21224c and can begin to at least partially dissolve the third layer 21224c. Similar to above, the third layer 21224c can be completely dissolved in minutes, hours, and / or days, and at the time indicated as time t6, the material comprising the third layer 21224c is the largest. Efficacy or concentration can be reached. In various circumstances, body fluid reaches the third layer 21224c so that the outer layer 21224a, the second layer 21224b, and / or the third layer 21224c can begin to dissolve simultaneously, or at least substantially simultaneously. To pass through the outer layer 21224a and the second layer 21224b. In any case, it will be apparent to the reader that the time t3 for the material comprising the second layer 21224b to reach its maximum potency or concentration can occur before time t6. At some later time, the third layer 21224c may be completely or at least substantially dissolved by the time indicated by time t8. As will be apparent to the reader, time t8 may occur after time t5.

  When the third layer 21224c is dissolved, body fluid can reach the fourth layer 21224d and begins to at least partially dissolve the fourth layer 21224d at the time indicated by time t4. Can do. As above, the fourth layer 21224b can be completely dissolved in minutes, hours, and / or days, and at the time indicated as time t7, the material comprising the fourth layer 21224d is at most Potency or concentration can be reached. In various situations, the bodily fluid may be the The fourth layer 21224d can be passed through the outer layer 21224a, the second layer 21224b, and the third layer 21224c. In any case, it will be apparent to the reader that the time t6 when the material comprising the third layer 21224c reaches its maximum potency or concentration can occur before time t7. At some later time, the fourth layer 21224d may be completely or at least substantially dissolved by the time indicated by time t9. As will be apparent to the reader, time t9 may occur after time t8. Optionally, the above results can result in a gradual release of the drug.

  Referring now to FIGS. 81 and 83, a staple cartridge 21300 can comprise a cartridge body 21310 with a plurality of staple cavities 2112, and a plurality of staples 21330 positioned therein. The staple cartridge 21300 includes a tissue thickness compensator 21320 that can include a compensator body 21322 positionable relative to the cartridge body 21310, as well as a plurality of separate capsules 21324 positioned within the compensator body 21322. Can be further provided. Capsules 21324 can be oriented vertically, and when staples 21330 are in a non-fired configuration, each capsule 21324 can be positioned between staple legs 21322 of staples 21330, as shown in FIG. For example, the staple legs 21322 can extend at least partially into the tissue thickness compensator 21320 when the staples 21330 are in the unfired position without rupturing the capsule 21324. As the staple 21330 moves from the non-fired position to the fired position, referring now to FIG. 84, the staple 21330 can tear the capsule 21324, thereby releasing at least one drug stored therein. can do. More specifically, when the staple 21330 is lifted upward so that the staple legs 21332 can be bent or deformed downward and inward toward the capsule 21324 positioned therebetween, the staple 21330 becomes an anvil 21060. Can be deformed by forming pockets 21062 defined therein. The staples 21330 can be lifted upward by a firing system comprising a driver 21340 and a sled 21345, and the sled 21345 passes through the staple cartridge 21000 in the longitudinal direction and sequentially raises and fires the staple driver 21340 and the staple 21330 positioned at the top. Can be configured as such. In any case, the staple legs 21332 penetrate the capsule 21324 so that the internal cavity 21326 defined in the capsule 21324 can be destroyed and one or more drugs contained in the internal cavity 21326 can flow out of it. And / or can be crushed. The one or more agents can include, for example, one or more powders and / or fluids contained therein. The staple cartridge 21300 can further include a cutting member 21380 that can be advanced distally by the sled 21345 to traverse the tissue T positioned between the staple cartridge 21300 and the anvil 21060, for example. The cutting member 21380 can be configured to pass through a knife slot 21314 defined in the cartridge body 21310, such as 1 for such a capsule 21324 such that the cutting member 21380 can traverse the capsule 21324. One or more capsules may be located in and / or above knife slot 21314. In any case, the tissue thickness compensator 21320 can be constructed of, for example, hyaluronic acid and positioned at the top and / or bottom of the cartridge body 21322 that can stabilize the cartridge body 21322 and / or staples 21330. A layer 21321 may be further provided. For example, the cutting member 21380 can be configured to traverse the layer 21321 when the cutting member 21380 is advanced through the staple cartridge 21300 as described above.

  Referring now to FIG. 85, the tissue thickness compensator 21420 can comprise a compensator body 21422 and a plurality of capsules 21444 positioned therein. Similar to the above, each capsule 21444 can include a sealed cavity 21446 that can be configured to releasably store one or more medicaments therein. Each capsule 21444 can include, for example, a conical and / or tapered end 21447. For example, the tapered end 21447 can be utilized to hold the capsule 21444 in place while the cartridge body 21422 is formed around it. In accordance with the present invention, the mold is adapted to receive and secure the tapered end 21447 so that the mold can hold the capsule 21444 in place when the compensator material is injected around the capsule 21444. A plurality of openings and / or recesses may be provided. Further to the above, for example, during use, the capsule 21444 does not rupture or rupture until the staple is fired into and / or through the tissue thickness compensator 21420 during use. At the same time, capsule 21444 may be positioned and prepared.

  Alternatively, referring now to FIG. 86, the tissue thickness compensator 21520 can comprise a plurality of capsules 21524 positioned within the compensator body 21522. The capsules 21524 can each include one or more openings 21528 defined in their outer walls, the openings 21528 configured to allow one or more medicaments 21525 to flow out of the cavities 21526 defined in the capsules 21524. obtain. Aperture 21528 can be sized and configured to control the rate at which drug 21525 exits cavity 21526. For example, the large opening 21528 can allow fast release of the drug 21525, and the small opening 21528 can allow slow release of the drug 21525, for example. The outer wall of each capsule 21524 may be composed of a tube having a closed and / or sealed end 21527. The outer wall of the capsule 21524 can be composed of, for example, one or more bioabsorbable polymers, and the end 21527 can be closed and closed using, for example, a heat staking process, a thermal welding process, and / or a laser welding process. And / or can be sealed. The outer wall or shell of the capsule 21524 can be manufactured using an injection molding process in which one or more drugs are positioned within the shell through one or more open ends of the shell after the shell is formed. Can be done. The open end or end of the shell can then be covered using, for example, a polymer solution. If the wall of the capsule 21524 is composed of a bioabsorbable material, the opening 21528 defined therein can grow over time. For example, the rate at which drug 21525 is released from cavity 21526 can increase over time.

  The compensator body 21522 may be composed of, for example, gelatin and may be manufactured into a foam material using, for example, a freeze drying process. The capsule 21524 can be inserted into the compensator body 21522, for example, the compensator body 21522 can be formed with an opening configured to receive the capsule 21524. For example, a layer or film may be subsequently placed on the compensator body 21522 to cover or surround the inner capsule 21524. Capsule 21524 can be positioned within the mold and compensator material can be formed at least partially around capsule 21524 to form compensator body 21522. In any case, the compensator body 21552 is configured to align and orient the tissue thickness compensator 21520 with the cartridge body of the staple cartridge so that the capsule 21524 is positioned in the desired position. One or more key or scale functions can be included.

  Referring now to FIG. 87, the surgical stapling system can include a staple cartridge 21600 and an anvil 21060, which can be positioned on the opposite side of the tissue T. As with other staple cartridges disclosed herein, staple cartridge 21600 can include a cartridge body 21310 with a plurality of staple cavities 2112, and a plurality of staples 21330 positioned therein. In use, referring to FIG. 91, the staple 21330 is moved from the non-fired position to the fired position by the driver 21340 so that the staple 21330 deforms against the anvil 21060 or more specifically deforms within the forming pocket 21062. Can be lifted up. When the staples 21330 are fired, the staples 21330 are attached to the tissue T and anvil 21060 before the staples 21330 are deformed between their non-fired configuration (FIG. 88) and their fired configuration (FIG. 89). The resulting tissue thickness compensator 21620 can be penetrated. Staples 21330 can be composed of any suitable material, such as, for example, stainless steel and / or titanium, and can be configured to apply a compression or clamping force against tissue thickness compensator 21620 and tissue T. As shown in FIG. 87, staples 21330 can be prepared in multiple rows, and one staple 21330 can be positioned in each staple cavity 21112. Staple cartridge 21300 may be configured to engage and penetrate tissue T, tissue thickness compensator 21620, and / or one or more drug capsules positioned within, for example, tissue thickness compensator 21620. A member 21635 (FIG. 90) may further be provided. For example, penetrating member 21635 may be positioned within staple cavity 2112, and penetrating member 21635 may be fired or ejected from staple cavity 2112, by driver 21340. Further to the above, some staple cavities 2112, 312 of the staple cartridge 21600 can comprise staples 21330 positioned therein, and the remaining staple cavities 2112, comprising penetrating members 21635 positioned therein. be able to. Staple cartridge 21600 includes several rows of staple cavities 2112, with only staples 21330 positioned therein, several rows with only penetrating members 21635 positioned therein, and / or staples 21330 and penetrating members 21635. There can be several columns with both located inside. As shown, with reference to FIG. 91, the four rows inside the staple cavity 21112 may only comprise the staples 21330, and the outside row of the staple cavities 2112, with both the staples 21330 and the penetrating members 21635 inside. You may prepare. Staples 21330 and penetrating members 21635 in the outer rows of staple cavities 2112, for example, may be prepared in an alternating arrangement. Referring now to FIG. 92, the staple 21330 and penetrating member 21635 include, for example, a pattern including two staples 21330 followed by a penetrating member 21635, followed by two more staples 21330, followed by a penetrating member 21635, and so on. You may be prepared with.

  Referring primarily to FIG. 90, each penetrating member 21635 can include a base 21638 and legs 21638 that extend upward from opposite sides of the base 21638. Referring now to FIG. 91, the drivers 21340 can each include a trough 21348 that can be configured to receive and support the base 21638 of the penetrating member 21635. When the driver 21340 is pushed upward by the sled 21345, now referring to FIG. 92, the sled 21345 can fire the staple 21330 and the penetrating member 21635 in sequence. Referring now to FIG. 91, the staple 21330 may strike the anvil 21060 and deform, while the penetrating member 21635 may not contact the anvil 21060. Referring primarily to FIG. 90, one or both of the legs 21636 of each penetrating member 21635 can be configured to penetrate the tissue T and / or tissue thickness compensator 21620, and, for example, There may be provided at least one barb 21737 that may be configured to maintain the leg 21636 with the tissue T and / or tissue thickness compensator 21620. No tissue thickness compensator may be used. The legs 21636 of the penetrating member 21635 may not be long enough to pass completely through the tissue T, as well as touch the anvil 21060. The legs 21636 may contact the anvil 21060 and may be long enough to be deformed to different configurations.

  The penetrating member 21635 may be made of a material different from that of the staple 21330. The penetrating member 21635 can be composed of at least one bioabsorbable polymer such as, for example, PGA. The penetrating member 21635 can each include at least one agent, such as, for example, an antibacterial agent, an anti-inflammatory agent, a pain medication, and / or an MMP inhibitor. The penetrating member 21635 can be located, for example, within the staple line so that when the penetrating member 21635 is dissolved and / or bioabsorbed, the penetrating member 21635 is within the staple line and / or adjacent to the staple line. Thus, one or more drugs can be supplied to the tissue T. The penetrating member 21635 can be coated with one or more agents. The penetrating member 21635 can include one or more agents embedded within a structural substrate comprising the penetrating member 21635. Some penetrating members 21635 may be composed of a first structural substrate and / or a first agent, and the remaining penetrating members 21635 may be, for example, a second, ie different structural substrate and / or second, That is, it can be composed of different drugs. The penetrating member 21635 can be manufactured using, for example, an injection molding process.

  93 and 94, a staple cartridge 21700 includes a cartridge body 21710 and a tissue thickness compensator 21720 positioned on or adjacent to the deck surface 21711 of the cartridge body 21710. be able to. Similar to the above, the cartridge body 21710 can include a plurality of staple cavities 2112, and a plurality of staples positioned therein. Cartridge body 21710 can also include a slot 21714 therein that can be configured to receive a cutting member, such as, for example, cutting member 21380 (FIG. 95). In use, as shown in FIG. 95, the cutting member 21380 can be configured to traverse the tissue T positioned between the anvil 21060 and the staple cartridge 21700. Referring again to FIGS. 93 and 94, the tissue thickness compensator 21720 can comprise a compensator body 21722 and a plurality of drug packets 21724, or capsules, positioned within the compensator body 21722. The capsule 21724 can be positioned and prepared within the compensator body 21722 so that the capsule 21724 is over a slot 21714 defined in the cartridge body 21710. In use, referring primarily to FIG. 96, the cutting member 21380 can be configured to incise the capsule 21724 as the cutting member 21380 is advanced through the staple cartridge 21700. For example, capsule 21724 can be sealed before being cut by cutting member 21380, and one or more medicaments contained therein can be released after capsule 21724 is opened. Depending on the position of the capsule 21724 on the slot 21714, one or more agents may be released onto the portion of tissue T traversed by the cutting member 21380. The one or more agents contained within the capsule 21724 can include a biological agent in the form of a powder, for example. One or more agents within capsule 21724 can include, for example, oxidized regenerated cellulose, alginic acid, and / or calcium.

  Referring again to FIGS. 93 and 94, the capsule 21724 can contain the same medication therein. Alternatively, one or more of the capsules 21724 can contain one or more different agents therein. The first plurality of capsules 21724 can include a first agent therein, and the second plurality of capsules 21724 can include a second agent therein. For example, the capsules 21724 can be prepared in an alternating arrangement, for example, along the longitudinal path of the cutting member 21380, so that, for example, the capsules containing the second drug after the capsules 21724 containing the first drug. 21724 can follow, followed by capsule 21724 containing the first agent, and so on. Cutting member 21380 may be configured to mix the first agent and the second agent as cutting member 21380 advances through staple cartridge 21300. Referring again to FIGS. 93 and 94, the tissue thickness compensator 21720 can include one or more channels 21726 extending outwardly from the respective capsules 21724. The channel 21726 can move within the tissue T positioned relative to the tissue thickness compensator 21720 and the tissue thickness compensator 21720 after the capsule 21724 has been cut. Can be configured. Capsule 21724 may be configured not to rupture when a compressive load is applied to capsule 21724 by anvil 21060. 93 and 96, the cartridge body 21710 can include a plurality of recesses 21715 that can each be configured to receive at least a portion of the capsule 21724 therein. For example, the recess 21715 may be configured to allow the capsule 21724 to slide downward within the recess 21715 when a compressive load is applied to the capsule 21724 so that the capsule 21724 may not rupture. Alternatively, one or more of the capsules 21724 can be configured to rupture only when a specific compressive force applied to the capsule 21724 is met or exceeded. For example, the capsule 21724 can be configured to withstand the clamping pressure applied by the anvil 21060, but the compression pressure applied to the capsule 21724 by, for example, the cutting member 21380 advancing through the staple cartridge 21700 is increased. Sometimes it can burst. Capsule 21724 can include a lubricant therein that can facilitate movement of cutting member 21380 as cutting member 21380 is advanced and / or retracted within staple cartridge 21700.

  Referring now to FIG. 97, a tissue thickness compensator 21820 can comprise a compensator body 21822 and a longitudinal tube 21824 extending therethrough. Similar to the above, the tube 21824 can include a longitudinal cavity 21826 defined therein and one or more agents 21825 positioned within the cavity 21826. The longitudinal tube 21824 can further include one or more support legs 21827 extending outwardly from the tube that can be configured to support the tube 21824. For example, referring now to FIG. 98, support legs 21827 can support the tube 21824 within the mold 21890 while the compensator body 21822 is formed around the tube 21824. Referring now to FIGS. 99 and 100, the material comprising the compensator body 21822, such as PGA and / or PCL, for example, is injected around the tube 21824, followed by, for example, lyophilization, foaming, and the like. It can be solidified. Referring again to FIG. 98, the material making up the compensator body 21822 can be injected into the cavity 21891 surrounding the tube 21824, which can subsequently be closed by the cover 21892. Referring to FIG. 97, the end of the support leg 21827 may not be covered by the injected material and may be flush with the bottom surface 21821 of the compensator body 21822. Support legs 21827 and / or tube 21824 may be comprised of a soluble and / or bioabsorbable material such as, for example, gelatin, hyaluronic acid, PDS, and / or ORC. The legs 21827 can be quickly dissolved, for example, by body fluids and / or saline, leaving a channel or passage extending between the outer periphery and the interior of the tissue thickness compensator 21820. Such a passage may be created so that one or more medications 21825 positioned within the tube 21824 can be rapidly dissolved and / or absorbed. Alternatively, for example, the tissue thickness compensator 21920 can comprise a compensator body 21922 and a tube 21924 with a plurality of support legs 21927, as shown in FIG. Referring to FIG. 102, the support legs 21927 can be part of a larger support network or structural grid 21928 that can extend through the compensator body 21922.

  Referring again to FIG. 97, the legs 21827 extending from the tube 21824 can also include one or more medicaments therein. When the leg 21827 is dissolved and / or absorbed as described above, one or more drugs in the leg 21827 can provide a first drug response to the stapling and / or incised tissue. , One or more medications 21825 in tube 21824 can provide a second or subsequent medication response. Referring now to FIGS. 103 and 105, the tissue thickness compensator 22020 can include a compensator body 22022 and a longitudinal drug tube 2024 extending through the compensator body 22022. Similar to the above, the tube 22024 can define a longitudinal cavity 22026a that includes one or more agents 22025a positioned therein. Also similar to the above, the tube 22024 can include a plurality of longitudinal leg supports 22027 that can extend along the length of the tube 22024. Optionally, each of the leg supports 22027 can define longitudinal cavities, such as, for example, cavities 22026b and 22026c, each of these cavities, respectively, one or more such as, for example, drugs 22025b and 22025c. Of drugs. The leg support 22027 can be composed of a material that can be quickly dissolved and / or absorbed so that the drugs 22025b and 22025c can be quickly released. The support leg 22027 and tube 22024 can then be further dissolved and / or absorbed so that the drug 22025a can subsequently be released. Drugs 22025a, 22025b, and / or 22025c may be composed of the same material. Alternatively, medications 22025a, 22025b, and / or 22025c can be composed of different materials. Agents 22025b and 22025c can be composed of the same material (s), and these materials can be different from the material (s) that comprise agent 22025a.

  Further to the above, the tubes 22024, legs 22027, and / or cavities 22026a-22026c defined therein may be manufactured using an injection molding process. Tubes 22024, legs 22027, and / or cavities 22026a-22026c can be manufactured using, for example, an extrusion process, and as a result, such features can comprise a continuous cross section along their length. . By such a process, the tube 22024 and the leg 22027 can be integrally formed. Drugs 22025a-22025c can then be located within cavities 22026a-22026c, respectively. Each of the drugs 22025a-22025c may be comprised of, for example, one or more powders and / or one or more fluids. Referring now to FIG. 106, the ends 22029 of the cavities 22026a-22026c may be sealed to contain the medicaments 22025a-22025c therein. In any case, the tube 22024 can subsequently be positioned in a mold, such as the mold 21890 described above, and the material comprising the compensator body 22022 can be tissue thickness compensator 22020 as shown in FIG. Can be injected around tube 22024. Various alternatives are shown in FIGS. 107 and 108. Referring to FIG. 107, a tissue thickness compensator 22120 can comprise a compensator body 22122 and a plurality of longitudinal tubes 22124 connected to each other. Each of the tubes 22124 can define longitudinal cavities 22126, which can each include one or more medicaments 22125 therein. The longitudinal cavities 22126 may not be in fluid communication with each other, or one or more of the longitudinal cavities 22126 may be in fluid communication with each other. Similar to the above, the compensator 22120 can further comprise legs 22127 that extend downwardly from the tube 22124 and can each comprise a longitudinal cavity 22126 and at least one medicament 22125 therein. Tube 22124 and / or support leg 22127 can be constructed of a material that can be configured to dissolve and / or bioabsorb at different rates. For example, the support legs 22127 can be constructed of a material that can be dissolved and / or bioabsorbed at a faster rate than the material comprising the tube 22124, for example. Referring now to FIG. 108, the tissue thickness compensator 22220 can include a compensator body 22222 and a longitudinal tube 22224, which can include a plurality of support legs 22227 extending from the tube. . A single longitudinal cavity 22226 can be defined in the tube 22224 and can extend into the support legs 22227. Similar to the above, the cavity 22226 can include one or more medicaments 22225 positioned therein.

  Referring again to FIG. 97, the support legs 21827 can be composed of one or more materials that can be configured to absorb fluid, such as, for example, blood and / or saline. Support legs 21827 may be configured to wick fluid to tube 21824 and one or more medications 21825 contained within the tube. By such wicking, the drug 21825 can be dissolved and / or bioabsorbed early in the healing process. The ends of the support legs 21827 may not be covered by the compensator body 21822 and may be exposed to fluid. This wicking step can occur by capillary action, for example, regardless of the orientation of the tissue thickness compensator 21820.

  Referring now to FIG. 112, the tissue thickness compensator 22320 can comprise a compensator body 22322 and a plurality of tubes 22324 positioned therein. The compensator body 23222 may be composed of a regenerative tissue scaffold foam, such as, for example, a cell-free biomatrix, Omentum Scaffold Material, and / or ACell. Omentum Scaffold Material can include a hydrophilic foam made from a skeletonized net, and in some cases can be compressible. When exposed to fluid, the Omentum Scaffold Material expands and can apply pressure to tissue located relative to the Omentum Scaffold Material. ACell is a regenerative product that provides an extracellular matrix or scaffold network to promote cell growth and migration. The tissue scaffold comprising the compensator body 22322 can be loaded with, for example, stem cells, PRP, or growth factors. The tissue scaffold that makes up the compensator body 22322 may be coated, for example, on a collagen matrix. The tissue scaffold matrix of the compensator body 22322 can be composed of a fiber matrix, and the fiber matrix can be composed of randomly oriented fibers. In some situations, a fiber matrix composed of randomly oriented fibers may not provide the desired elasticity or elasticity within the compensator body 22322. To compensate for this, the randomly oriented fibers can be composed of a hydrophilic material and / or expand after exposure to a liquid to provide the desired elasticity to the fiber matrix and / or the desired compressive force to the tissue. It can be coated with a hydrophilic material that can be configured to provide. In various situations, the fiber matrix may not be exposed to the liquid until the fiber matrix has been captured to the tissue by the plurality of staples as described above. For example, the compensator body 22322 includes a liquid-impermeable wrap that can be torn, punctured, and / or incised so that, during use, liquid can enter the compensator body 22322 and access the hydrophilic fibers during use. Can be provided. In any case, when liquid is absorbed into the scaffold matrix trapped within the staple, the scaffold matrix applies compressive pressure to the tissue similarly captured within the staple, and over time the tissue ingrowth into the scaffold matrix. Can be expanded to accommodate.

  Further to the above, the tube 22324 of the tissue thickness compensator 22320 can be comprised of a degradable material that can be configured to dissolve and / or bioresorb. Similar to the above, each tube 22324 may include a sealed inner cavity with one or more drugs therein, in addition to reach the drug stored in the tube 22324. One or more support legs 22327 may be provided that may be configured to break down and provide a channel or flow path for the liquid. Such disassembly of the support legs 22327 may take time and as a result, the drug contained in the tube 22324 may not be released immediately. In a sense, a period of time may be required for the fluid to disassemble the leg 22327, so that the leg 22327 functions as a fuze designed to delay the release of the drug in the tube 22324. Can do. Thus, in various situations, a leg 22327 having a long length and / or a thick cross-section can provide a large delay, and a leg 22327 having a short length and / or a thin cross-section can provide a small delay. Can do. The tube 22324 can be composed of a material that dissolves quickly and / or slowly, but in either case, the degradation of the tube 22324 over time can delay the release of one or more drugs contained within the tube 22324. Can occur. According to the present invention, the first tube 22324 may be composed of a first material that decomposes at a first rate, and the second tube 22324 is a second, that is, a second material that decomposes at a different rate. Can be configured. In such a case, the first drug contained in the first tube 22324 can be released before the second drug contained in the second tube 22324, for example. The first tube 22324 can cause the first tube 22324 to break down faster than the second tube 22324, and the drug contained in the first tube 22334 can be, for example, before the drug in the second tube 22324. Can have an outer wall thinner than the second tube 22324, which can be released to As a result of the above, the first tube 22324 can be configured to release the first drug at a first time point and the second tube 22324 can be configured to release the second drug at a second, i.e., later time point. The third tube 22324 can be configured to release the third medicament at a third, ie, later, time point, for example.

  Referring now to FIGS. 113 and 114, the tissue thickness compensator 22420 can comprise a compensator body 22422 and a sealed passage tube 22424 positioned within the compensator body 22422. Similar to above, the canal 22424 can define a longitudinal cavity 22426 and one or more medicaments 22425 positioned within the longitudinal cavity 22426. When the tissue thickness compensator 22420 is compressed, i.e., flattened, as shown in FIG. 114, the vessel 22424 may rebound or attempt to maintain its original undeformed shape. The trachea 22424 can be elastic. For example, the conduit 22424 can include an elastic spring member positioned within the compensator body 22422. The canal 22424 may be configured to change shape without tearing. For example, the conduit 22424 can be disassembled as described herein, for example, when exposed to liquid.

  Referring now to FIG. 115, the tissue thickness compensator 22520 can include a compensator body 22522 and a plurality of sealed passages 22524a-22524c. Each of the ducts 22524a-22524c defines a perimeter configured to increase, maximize, and / or optimize the surface area of the duct in contact with a liquid, such as, for example, blood and / or saline. Can do. In various situations, a vessel with a large surface area can be exposed to a large amount of liquid and as a result can be dissolved and / or bioabsorbed at a fast rate. Correspondingly, a vessel with a small surface area can be exposed to a small amount of liquid and as a result can be dissolved and / or bioabsorbed at a slow rate. The ducts 22524a to 22524c can be composed of, for example, gelatin, hyaluronic acid, PDS, and / or ORC. Similar to the above, the conduits 22524a-22524c can be resilient and can provide a rebound or elastic biasing force. Referring now to FIG. 116, the tissue thickness compensator 22620 can include a compensator body 22622 and a plurality of resilient layered members 22624 positioned within the compensator body 22622. Each of the laminar members 22624 can include a sealed inner channel that includes one or more drugs positioned therein.

  Referring now to FIG. 117, the end effector of a surgical stapling instrument can comprise an anvil 21060 and a staple cartridge 22700. The anvil 21060 can comprise a tissue thickness compensator 22770 attached to the anvil 21060, and the staple cartridge 22700 can comprise a cartridge body 22710 and a tissue thickness compensator 22720. Referring now to FIG. 118, tissue thickness compensator 22770 can include multiple layers, and an alternative is contemplated where tissue thickness compensator can include more than two layers. The compensator 22720 can comprise a first layer 22771 and a second layer 22773. Optionally, one or more of the layers of the tissue thickness compensator can comprise a woven material. The first layer 22771 may be composed of a plurality of first yarns 22773 made of a first material and a plurality of second yarns 22774 made of a second, ie different material. Similarly, the second layer 22773 may be composed of a plurality of first yarns 22773 and a plurality of second yarns 22774. The concentration of the first yarn 22773 and the second yarn 22774 of the first layer 22771 may be the same as the concentration of the first yarn 22773 and the second yarn 22774 of the second layer 22773. The concentration of the first yarn 22773 and the second yarn 22774 of the first layer 22771 is as described in more detail below, of the first yarn 22773 and the second yarn 22774 of the second layer 22773. It can be different from the concentration.

  Further to the above, the first yarn 22773 may be composed of a bioabsorbable polymer such as PGA, PDS, PCL and / or PLA, and the second yarn 22774 may be composed of, for example, oxidized regenerated cellulose ( ORC). The first layer 22771 can include an outer layer of tissue thickness compensator 22770 and can comprise a tissue contacting surface. The first layer 22771 can include more first threads 22773 than the second threads 22774. For example, the first layer 22771 can include, for example, a ratio of about 80% of the first yarn 22773 to about 20% of the second yarn 22774. The first layer 22771 can be, for example, a ratio of about 60% first yarn 22773 to about 40% second yarn 22774, about 67% first yarn 22773 to about 33% second yarn 22774. A ratio of about 70% of the first thread 22773 to the second thread 22774 of about 30%, a ratio of about 75% of the first thread 22773 to the second thread 22774 of about 25%, and / or A ratio of about 90% of the first yarn 22773 to about 10% of the second yarn 22774 may be included.

  Further to the above, the first yarn 22773 may be composed of a material that dissolves, bioabsorbs and / or changes state at a slower rate than the material comprising the second yarn 22774. For example, the second thread 22774 can be composed of, for example, an ORC thread that can change from a solid to a gel when exposed to a liquid, and the ORC thread is responsive to a solid when exposed to, for example, platelets. Can change from gel to gel. However, in such a case, the first layer 22773 can be composed largely of bioabsorbable polymer yarns that can react to the liquid much more slowly than the ORC yarns, thus the first layer 22773 is It can be contacted multiple times with tissue or fluid without losing its overall shape and structure. That said, the ORC fibers of the first layer 22773 can react when first contacted with the liquid and / or tissue, but the ORC gel is at least partially or mostly in the first layer 22773. Can be maintained within.

  The second layer 22773 may include an inner layer of tissue thickness compensator 22770 and may not include a direct tissue contacting surface. The second layer 22773 can include fewer first threads 22773 than the second threads 22774. For example, the second layer 22773 can include, for example, a ratio of about 20% of the first yarn 22773 to about 80% of the second yarn 22774. The second layer 22773 may comprise, for example, a ratio of about 40% first yarn 22773 to about 60% second yarn 22774, about 33% first yarn 22773 to about 67% second yarn 22774. A ratio of about 30% of the first yarn 22773 to the second yarn 22774 of about 70%, a ratio of about 25% of the first yarn 22773 to the second yarn 22774 of about 70%, and / or A ratio of about 10% first yarn 22773 to about 90% second yarn 22774 may be included.

  Further to the above, the second layer 22773 can include, for example, more ORC yarns than bioabsorbable polymer yarns. The second layer 22773 can include more ORC yarns than the first layer 22771. Since the second layer 22773 is not an outer layer, the liquid must first pass through the first layer 22771 before contacting the second layer 22773, and immediately contact the second layer 22773. I can't. In such a case, the second layer 22773 can include a high density of ORC yarns because the ORC yarn of the second protected layer 22773 does not immediately turn into a gel. Even though the ORC yarn of the second layer 22773 turns into a gel upon contact with the liquid, the ORC gel retains its general shape at least initially as described above and provides a supporting mesh for the second layer 22773 A first layer 22771 that can be included in the tissue thickness compensator 22770. ORC fibers and bioabsorbable fibers can be utilized, but optionally other suitable materials can be utilized.

  Further to the above, and referring now to FIGS. 121-123, tissue thickness compensator 22770 can be positioned midway between anvil 21060 and tissue T, before staple 21330 is fired from staple cartridge 22700. The tissue thickness compensator 22770 can be compressed against the tissue T. After staple 21330 has been fired to capture tissue T and tissue thickness compensator 22720 and 22770 therein, cartridge body 22710 of anvil 21060 and staple cartridge 22700 moves away from compensator 22720 and 22770 and tissue T. And can be removed from the surgical site. Referring now to FIG. 119, the tissue thickness compensator layer 22871 can include, for example, a woven yarn 22873 that can comprise an elongated or flattened cross-section. Referring now to FIG. 120, the tissue thickness compensator layer 22971 can include, for example, a woven yarn 22973 that can comprise a round cross-section.

  Various alternatives are shown in FIGS. Referring now to FIG. 125, the end effector of the surgical stapling instrument can include an anvil 21060 and a tissue thickness compensator 22770 ′ positioned on the anvil 21060. Referring to FIG. 124, the tissue thickness compensator 22270 'can include a layer 22771' that can include a plurality of first fibers 22773 'woven with a plurality of second fibers 22774'. For example, the first fiber 22773 'can be configured to dissolve and / or bioabsorb at a faster rate than the second fiber 22774'. A void, opening, and / or pocket may be defined between the first fiber 22773 'and the second fiber 22773 "that may allow liquid to flow through the layer 22771'. Referring now to FIG. 127, the end effector of the surgical stapling instrument can comprise a tissue thickness compensator 22770 ″ attached to the anvil 21060. Referring to FIG. 126, the tissue thickness compensator 22770 ″ can include a woven layer of yarn 22771 ″ that can be embedded and / or wrapped within the substrate 22773 ″. Although the yarn 22771 "may be exposed, alternatively, at least a portion of the substrate 22773" may have to be dissolved and / or bioabsorbed before the yarn 22771 "is exposed. For example, the material making up the substrate 22773 "can be filled into any voids, openings, or pockets defined between the threads 22771".

  Referring now to FIG. 132, the staple cartridge 23000 can comprise a tissue thickness compensator 23020. As described herein, a tissue thickness compensator can be manufactured utilizing, for example, a lyophilization process. For example, a solution containing PGA and / or PCL can be injected into the mold and the solution can be allowed to grow into an open cell foam, for example under a vacuum atmosphere and / or low temperature. For example, the PGA material can be present in the solution, for example, according to a weight ratio of about 64/36 to the PLA material. Referring to FIG. 128, fibers and / or filaments 23021 can be mixed into a solution, for example. The PGA fibers can be distributed, for example, before the solution is injected into the mold so that the PGA fibers can be distributed uniformly or at least substantially uniformly, for example, throughout the tissue thickness compensator 23020. And can be dispersed in the solution. In other situations, the PGA fibers can be placed, for example, in solution and / or directly in the mold so that the PGA fibers can settle or settle, for example, toward the bottom of the mold. In other situations, the PGA fibers can be configured to float to the top of the solution. In any case, a solvent, such as a dioxane solvent, that can assist in the lyophilization process can be present in the solution. The dioxane solvent may not react with the PGA fibers in the solution, or at least substantially unreacted.

  Further to the above, the fibers 23021 can be coated with one or more agents in and / or prior to being mixed with the solution. Referring to FIG. 130, each fiber 23021 can include a substrate 23022 that can be at least partially coated with a coating 23023 utilizing any suitable manufacturing process. Referring to FIG. 129, the fibers 23021 can be manufactured utilizing an extrusion process in which at least one drug coating is placed, for example, on a PGA substrate. They can be particularly useful for drugs that can withstand the high temperatures of the extrusion process. Referring to FIG. 131, the fibers 23021 can be coated and / or impregnated with a drug utilizing a carrier fluid such as, for example, supercritical carbon dioxide. In any case, drug-coated fibers 23021 can be mixed with the solution so that the fibers 23021 are embedded within the tissue thickness compensator 23020. In various situations, as a result, the coating of fibers 23021 can begin to dissolve and elute one or more agents contained therein. The fibers 23021 positioned near the periphery of the tissue thickness compensator 23020 can begin to dissolve before the fibers 23021 positioned near the interior of the tissue thickness compensator 23020. In such a case, the melted fibers 23021 can leave multiple cavities, ie, a network of cavities, within the tissue thickness compensator 23020, and such cavities can be separated within the tissue thickness compensator 23020. Cell or tissue ingrowth. The tissue thickness compensator can include a plurality of first fibers that can dissolve at a faster rate than the plurality of second fibers. For example, the first fibers can include, for example, gamma irradiated PGA fibers. Optionally, gamma irradiated PGA fibers can dissolve faster than non-gamma irradiated PGA fibers, for example.

  Optionally, one or more colorants can be added to the above solution so that a tissue thickness compensator made from the solution can have a suitable color. It may be desirable for the tissue thickness compensator to have a color that contrasts with its surrounding environment. For example, the tissue thickness compensator can be, for example, green and / or blue.

  Referring now to FIGS. 133 and 135, the tissue thickness compensator 23120 can comprise a compensator body 23122 and a plurality of drug particles 23121 distributed throughout the compensator body 23122. The compensator body 23122 can be composed of a hydrophobic material. For example, the compensator body 23122 can be composed of a material including, for example, PCL / PGA, and the PCL and PGA can be present in the material according to a weight ratio of 65/35. Referring now to FIG. 134, drug particles 23121 can be encapsulated and / or incorporated, for example, in a casing or shell 23124 comprised of a hydrophilic material, eg, doxycycline, percarbonate, and / or phosphorus ascorbate. One or more drugs 23123 can be included, such as acid esters. The shell 23124 can be composed of, for example, low molecular weight gelatin, hyaluronic acid, and / or CMC. Drug 23121 can be manufactured as microparticles that can be distributed within the solution and can be injected into the mold if the solution can be subsequently lyophilized, for example, as described above. Once the tissue thickness compensator 23120 is exposed to liquid during use, fluid 23129 (FIG. 136) can enter the compensator body 23122, eg, dissolve the hydrophilic shell 23124 of the drug particle 23121. And / or can be absorbed. Referring now to FIG. 139, the tissue thickness compensator 23220 includes a first layer 23222 and a second or outer layer 23224 that can include, for example, a plurality of coated drug particles 23221 dispersed therein. Can be included. Similar to the above, the particles 23221 can be dissolved and / or absorbed from the second layer 23224, for example, leaving the second layer 23224, for example, leaving an opening or capillary pathway 23225. Referring now to FIG. 140, the tissue thickness compensator 23320 can comprise a compensator body 23322 that includes, for example, a plurality of drug particles 23121 and a plurality of fibers 23021 distributed therein.

  Referring now to FIGS. 141 and 142, the staple cartridge 23400 can comprise a cartridge body 23410 and, for example, a tissue thickness compensator 23420 positioned on the cartridge body 23410. The tissue thickness compensator 23420 can comprise a plurality of capsules 23421 positioned within the compensator body 23422. Capsule 23421 may be manufactured using, for example, an emoulism or spin disk process, and capsule 23421 may include, for example, solid and / or liquid biometric microspheres. Capsule 23421 can include one or more adhesives that can aid in secure tissue sealing when released from capsule 23421. Capsule 23421 can include, for example, a hemostatic agent. In any case, the capsules 23421 can be distributed within the compensator body 23422 by any suitable means. Referring now to FIG. 143, the capsule 23421 can be placed, for example, in a molding cavity 21189 defined in the mold 21890, and the capsule 23421 can rest on the bottom 21893 of the mold 21890. Referring to FIG. 144, the mold 21890 can be vibrated so that the capsule 23421 can form a uniform or at least substantially uniform layer on the bottom 21893. Referring now to FIG. 145, the material making up the compensator body 23422 can be injected into the molding cavity 21891 with the capsule 23421. The capsule 23421 can be denser than the compensator body material, so that the capsule 23421 can remain at the bottom 21893 of the mold 21890, as shown in FIG. For example, referring to FIG. 148, the bottom 21893 of the mold 21890 can include a plurality of recesses, indentations, and / or dimples 21899 that can be configured to receive the capsule 23421. Alternatively, referring to FIG. 147, the capsule 23421 can be less dense than the compensator body material and can float to the top of the mold 21890. Optionally, as described in more detail below, the density of capsules 23421 can be selected such that capsules 23421 can float within the compensator body material.

  After the mixture comprising the capsule 23421 and the compensator body material is suitably injected into the mold 21890, the mixture can be subjected to, for example, a lyophilization process to form the tissue thickness compensator 23420. For example, the capsule 23421 can be fixed or freeze-dried in place within the compensator body 23422. Then, referring again to FIG. 141, the tissue thickness compensator 23420 can be removed from the mold 21890 and subsequently assembled to the cartridge body 23410 of the staple cartridge 23400. As shown in FIG. 141, the tissue thickness such that the capsule 23421 defines or is positioned adjacent to the tissue contacting surface or epidermis 23425 of the tissue thickness compensator 23420. The compensator 23420 can be positioned and prepared. The capsule 23421 can be at least partially constructed of a hydrophilic material that can be rapidly dissolved and / or bioabsorbed, for example, after the tissue thickness compensator 23420 is positioned relative to the tissue, for example. Each of the capsules 23421 may be composed of multiple layers of material that can be dissolved and / or bioabsorbed over time. For example, the outer layer of the capsule 23421 can be dissolved and / or bioabsorbed to expose a second, ie, inner layer, including a second agent that can be subsequently dissolved and / or bioabsorbed, for example. Can be included. Some of the capsules 23421 may be incised by the cutting member as it is advanced distally to incise the tissue and / or tissue thickness compensator 23420 as described elsewhere herein. Can be located. Capsule 23421 can, for example, reduce the density of tissue thickness compensator 23420, which can reduce the force or energy required to advance the cutting member through tissue thickness compensator 23420.

  As described above, the tissue thickness compensator 23420 can comprise a capsule 23421 positioned on one or more sides or epidermis of the compensator body 23422. Similarly, as described above, the tissue thickness compensator 23420 can include capsules 23421 dispersed within the compensator body 23422. For example, the capsule 23421 can have a compensator body material of the same density so that the capsule 23421 can float within the compensator body material. The capsule 23421 can be dispersed or homogenized in the compensator body material, and the mixture can be subsequently cooled before the capsule 23421 settles or at least substantially settles to the bottom of the mold.

  Referring now to FIG. 149, the tissue thickness compensator 23520 can comprise a shell 23522 and a plurality of movable elements 23524 positioned within the shell 23522. The shell 23322 can define an enclosed and / or sealed space, such as, for example, a cavity 23523 in which the movable element 23524 can move. The movable elements 23254 can be, for example, spherical and can be configured to slide and / or roll with respect to each other, for example. The tissue thickness compensator 23520 can be positioned over the cartridge body 21310 of the staple cartridge, and the staples 21330 can be fired from the staple cartridge through the tissue thickness compensator 23520, as shown in FIG. . In various situations, the movable element 23524 moves to the side of the fired staple 21330 through the tissue thickness compensator 23520 so that the element 23524 may not be torn during the firing process. Can be configured as follows. For example, the shell 23522 is constructed of a resilient material that can be configured to bend and / or shift to accept movement of the movable element 23524 and dynamically redistribute internally generated forces. be able to. Shell 23522 can enclose the media. For example, the media can include, for example, one or more powders, liquids, gases, fluids, and / or gels in which the movable element 23524 can move. The movable element 23524 can be composed of, for example, a soluble and / or bioabsorbable material and one or more agents contained therein. For example, such an arrangement can be configured to provide delayed and / or sustained release of one or more drugs. Alternatively, although not shown, the tissue thickness compensator 23520 can be positioned between the tissue T and the anvil 21060, for example. In any case, the tissue thickness compensator 23520 can include an enclosed “bean bag” arrangement. The shell 23522 may be configured to not rupture, or at least not substantially rupture, for example, until a cutting member such as the cutting member 21380 passes. At that point, one or more of the movable elements 23524 can flow out of the shell 23522.

  Referring now to FIG. 153, the tissue thickness compensator 23620 can include a compensator body 23622 and a plurality of capsules 23624 contained at least partially therein. Referring now to FIG. 151, a mold 23690 can be utilized to manufacture the tissue thickness compensator 23620. For example, a plurality of spherical capsules 23624 can be positioned in a cavity 23691 defined in the mold 23690, and the lateral movement of the capsules 23624 in the mold 23690 can be determined, for example, by the side wall 23694 of the mold 23690, and the lateral Can be restrained or stopped by a lateral stopper 23669 extending between the side walls 23694 of The lateral side wall 23694 and the lateral stop 23669 can define a plurality of pockets in which the capsule 23624 can be positioned and contained. The capsule 23624 can be configured to rest on the bottom surface 23699 of the mold 23690. Alternatively, referring to FIGS. 151 and 152, the mold 23690 may be configured to suspend the capsule 23624 so that the capsule 23624 does not contact the bottom surface 23699 of the mold 23690. 23,692 may further be provided. For example, the longitudinal support 23699 can be positioned on the bottom surface 23699, but alternatively, referring to FIG. 152, the longitudinal support 23692 can be positioned on the lateral support 23693.

  Referring again to FIGS. 151 and 152, the material comprising the compensator body 23622 may be injected into the cavity 23691 of the mold 23690 such that the capsule 23624 is at least substantially surrounded by the material. Referring primarily to FIG. 153, each portion of the capsule 23624 can protrude from the compensator body 23622 of the tissue thickness compensator 23620. For example, the lateral support 23669 and / or the longitudinal support 23692 can be withdrawn from the mold 23691 during and / or after the compensator body 23622 has undergone a lyophilization process. At that point, the capsule 23624 can be suspended within the compensator body 23622 without structural support. Alternatively, lateral support 23669 and / or longitudinal support 23699 may be left in the compensator body 23622. For example, the lateral support 23669 and / or the longitudinal support 23699 can be comprised of, for example, a bioabsorbable material. The support 23692 and / or the support 23693 can comprise, for example, an elastic member positioned within the compensator body 23622 that can increase the elasticity of the compensator body 23622.

  Referring now to FIG. 157, a tissue thickness compensator 23720 can comprise a compensator body having first and second portions 23722a and 23722b, and at least one capsule 23724 positioned therebetween. . The tissue thickness compensator 23720 can be manufactured using a mold 21890, for example. Referring now to FIG. 154, a first material can be injected into the mold 21890 to form the first portion 23722a of the compensator body. Referring now to FIG. 155, the capsule 23724 can be positioned on the first portion 23722a. Capsule 23724 may be positioned on first portion 23722a after a period of time and / or after the first material has undergone, for example, a lyophilization process. Referring now to FIG. 156, a second material can be injected into the mold 21890 to form the second portion 23722b of the compensator body. After a period of time and / or after the second material has undergone a lyophilization process, for example, the tissue thickness compensator 23720 is removed from the mold 21890 and associated with, for example, a staple cartridge 23700 as shown in FIG. Can be used. The second material may be different from the first material, but alternatively, the second material may be the same as the first material. In either case, the first material and / or the second material can be composed of a bioabsorbable material, and the capsule 23724 can be composed of, for example, at least one agent.

  Referring now to FIG. 162, a staple cartridge 23800 can comprise a tissue thickness compensator 23820, which can comprise a compensator body 23822 and a longitudinal capsule 23824 positioned therein. Referring now to FIGS. 159 and 160, a longitudinal opening 23821 may be formed in the compensator body 23822 by any suitable process, such as, for example, a mechanical drilling process and / or a laser drilling process. Once the longitudinal opening 23821 is formed, the longitudinal capsule 23824 can be positioned within the longitudinal opening 23821 as shown in FIG. Referring now to FIG. 166, the staple cartridge 23900 can comprise a tissue thickness compensator 23920 that can comprise a compensator body 23922 and a plurality of lateral capsules 23924 positioned therein. Referring now to FIGS. 163 and 164, a lateral opening 23921 may be formed in the compensator body 23922 by any suitable process, such as, for example, a mechanical drilling process and / or a laser drilling process. Once the lateral opening 23291 is formed, a plurality of lateral capsules 23924 can be positioned within the lateral opening 23922 as shown in FIG.

  FIGS. 167-171 illustrate an alternative method of manufacturing the tissue thickness compensator 23820 utilizing the vertical mold 24090. FIG. Referring primarily to FIG. 167, the mold 24090 can comprise a cavity 24091 defined by a side wall 24092 and a bottom wall 24093. Referring to FIG. 168, the end wall 24093 includes an opening 24094 that can be configured to receive the end of the longitudinal capsule 23824 and hold the capsule 23824 in an upright position, as shown in FIG. it can. Referring now to FIG. 170, the open side of the cavity 24091 is then closed by a cover 24095 so that the material comprising the compensator body 23822 can be injected into the cavity 24091 through the open end of the mold 24090. And / or can be sealed. The tissue thickness compensator 23820 can be removed from the mold 24090 after the material comprising the compensator body has been solidified, cured, and / or lyophilized, for example.

  Referring now to FIG. 172, the staple cartridge 24100 is positioned on top of the cartridge body 24110, the tissue thickness compensator mat 24170 positioned relative to the deck surface 24111 of the cartridge body 24110, and the tissue thickness compensator mat 24170. A localized tissue thickness compensator 24120 can be provided. The tissue thickness compensator 24120 and the tissue thickness compensator mat 24170 can vary in thickness of tissue captured in staples, such as staples 21330 (FIG. 175), fired from the staple cartridge 24100, together or It can be corrected alone. Referring primarily to FIGS. 172 and 173, the compensator mat 24170 is securely received within a knife slot 24114 defined in the cartridge body 24110 in addition to a bottom surface 24171 configured to contact the deck surface 24111. A mounting flange or rail 24174 extending from the bottom surface 24171 can be provided. The compensator mat 24170 can further comprise a plurality of packets 24172 that can extend across the compensator mat 24170. For example, each of the packets 24172 may be defined along a transverse axis that is perpendicular and / or perpendicular to the longitudinal axis defined by the knife slot 24114, as shown in FIG. The compensator mat 24170 can include multiple layers in which a packet 24172 can be defined. For example, the layer can be composed of, for example, PDS and / or collagen. Each packet 24172 may be configured to store therein one or more agents, such as, for example, doxycycline, an aggregating agent, and / or an antimicrobial material.

  Referring again to FIG. 175, the tissue thickness compensator mat 24170 can be positioned relative to the cartridge body 24110 such that the packet 24172 is on the staple cavity 21112 defined in the cartridge body 24110. More specifically, each packet 24172 can be positioned and prepared to extend between staple legs 21332 of staples 21330. The compensator mat 24170 can include a plurality of openings and / or through-holes that can be configured to receive the ends of the staples 21330, for example. These through holes may be located adjacent to the packet 24172, for example. As shown in FIG. 175, the staple 21330 may be configured to capture the packet 24172 therein as the staple 21330 moves from the non-fired position to the fired position. For example, staple 21330 and packet 24172 can be configured and prepared such that packet 24172 is not punctured or torn while staple 21330 is fired. In such a case, the packet 24172 can provide elastic or compressive pressure to the tissue T captured within the staple 21330, and can occupy a void between the tissue T and the staple 21330, for example. Referring again to FIG. 176, the packet 24172 is incised by the cutting member 21380 as the cutting member 21380 advances through the knife slot 24114, tissue T, and / or compensator mat 24170 defined in the cartridge body 24110. obtain. It will be apparent to the reader that the tissue thickness compensator 24120 is not shown in FIGS. 175 and 176. Various embodiments are contemplated in which the staple cartridge 24100 includes a tissue thickness compensator mat 24170 and does not include the tissue thickness compensator 24120; alternatively, referring now to FIG. 177, the staple cartridge 24100 is For example, both a tissue thickness compensator mat 24170 and a tissue thickness compensator 24120 can be provided.

  An alternative embodiment of a staple cartridge is shown in FIG. According to the present invention, the circular staple cartridge 24200 can comprise, for example, a circular cartridge body 24210 with a plurality of staple cavities 2112, prepared concentrically. For example, the staple cartridge 24200 can further comprise a circular tissue thickness compensator mat 24270 positioned in the cartridge body 24210, and the compensator mat 24270 can comprise, for example, a packet 24272 extending radially outward. it can. Similar to above, the packet 24272 can extend in the direction above the staple cavity 2112, so that the packet 24272 can extend between the legs of the staple 21330 positioned within the staple cavity 21112. Also similar to the above, the staple 21330 can be configured to capture the packet 24272 therein when the staple 21330 is fired from the staple cartridge 24200.

  Referring now to FIG. 189, the staple cartridge 24300 can include a cartridge body 24310 and a tissue thickness compensator 24320 that includes a compensator body 24322 and a plurality of tubular members 24324 positioned within the compensator body 24322. it can. For example, the staple cartridge 24300 can further comprise, for example, a tissue thickness compensator layer or sheet 24370 disposed between the tissue thickness compensator 24320 and the cartridge body 24310. Referring now to FIG. 179, a plurality of staple cartridges 24300 can be manufactured simultaneously using a mold 24390. The mold 24390 can include a plurality of cavities 24391 that can each be configured to receive a cartridge body 24310, as shown in FIG. One or more large sheets of material that make up the tissue thickness compensator layer 24370 can then be placed over the cartridge body 24310. The mold 24390 can include a plurality of upwardly extending support pins or posts 24392 such that the post 24392 can pierce the seat 24370 as shown in FIGS. 181 and 183. Can be positioned and subsequently pushed down. Referring now to FIGS. 182 and 184, elongated tube (s) 24324 may be wrapped between posts 24392 such that tube 24324 passes over each cartridge body 24310 at least once. Tube 24324 may be wrapped between posts 24392 such that tube 24324 passes over each cartridge body 24310, for example, six times. The tube 24324 can rest on the sheet 24370 and the tube 24324 can be tightly wrapped between the posts 24392 so that the tube 24324 can be pinched and suspended on the sheet 24370. Once the tube 24324 is suitably positioned, referring primarily to FIG. 185, the material comprising the compensator body 24322 can be injected into the top of the sheet 24370 in the mold 24390. The sheet 24370 can be configured to protect, ie mask, the cartridge body 24310 to prevent the compensator body material 24322 from entering, for example, the staple cavities 2112, defined in the cartridge body 24310. In accordance with the present invention, a sufficient amount of compensator body material 24322 can be injected into the mold such that the compensator body material 24322 covers the elongated tube 24322.

  Further to the above, the compensator body material 24322 can subsequently be hardened, solidified, and / or lyophilized, for example, to form a tissue thickness compensator 24320 on top of the cartridge body 24310. Referring now to FIG. 186, a cutting die 24395 can be utilized to cut the compensator body material 24322, the tissue thickness compensator sheet 24370, and the elongated tube 24322. Referring now to FIG. 187, the cutting die 24395 can comprise a plurality of cutting blades 24396 that can be configured to separate and separate the tissue thickness compensator 24320 and the tissue thickness compensator sheet 24370 from each other. The cutting die 24395 can be configured to remove any excess material between the separated tissue thickness compensator 24320 and the tissue thickness compensator sheet 24370, as shown in FIG. 188. A well 24397 can be provided. Cutting die 24935 and / or any other suitable die may comprise, for example, one or more heating elements that may be configured to seal the ends and / or shelves of tissue thickness compensator 24320. Can do. Tube 24324 may be filled with one or more fluids. In such cases, the cutting blade 24396 may be configured to incise the tube 24324 and simultaneously seal the end of the tube portion contained within the tissue thickness compensator 24320. The plurality of staple cartridges 24300 can then be removed from the mold.

  Referring now to FIGS. 190 and 191, the staple cartridge 24400 can comprise a cartridge body 24410 that can be configured to removably store a plurality of staples therein. In addition, the staple cartridge 24400 can further comprise a tissue thickness compensator 24420. The tissue thickness compensator 24420 can comprise a compensator body comprised of a plurality of layers 24422, and the layer 24422 can be comprised of, for example, a cellulose film. As shown in FIG. 192, material 24424 can be positioned between two or more adjacent layers 24422, which can separate adjacent layers 24422 from each other. Material 24424 can include a polyblend biomedics extrusion, and material 24424 can include, for example, a hemostatic material, an anti-inflammatory material, and / or an antibiotic material. Referring now to FIG. 192, the material 24424 can be applied to the layer 24422 by a dispenser 24490, for example, in a wave pattern, and the material 24424 can be positioned over one or more staple cavities defined in the cartridge body 24410. As such, the wave pattern can be configured. In such cases, the material 24424 can be captured in staples ejected from the staple cavity and can provide a resilient biasing force to the similarly captured tissue in the staples. In any case, one or more of the layers 24422 can be vacuum formed and / or heat sealed, for example, over the material 24424 to create a tissue thickness compensator 24420. The tissue thickness compensator 22420 can then be cut to a predetermined length. Various embodiments are contemplated in which a tissue thickness compensator 22420 is positioned relative to the staple cartridge deck surface and another tissue thickness compensator 22420 is positioned relative to the anvil.

  Referring now to FIG. 195, the staple cartridge 24600 can include one or more tissue thickness compensators 24620 positioned over the cartridge body 24610. Referring primarily to FIG. 194, each tissue thickness compensator 24620 can comprise a plurality of layers 24622 and a compressible or collapsible member 24624 positioned between the layers 24622. The collapsible member 24624 can comprise a corrugated member comprising a plurality of pockets defined therein, and one or more medications can be stored in the pockets. For example, a first agent can be placed in a pocket on the first side of the corrugated member and a second agent can be placed in a pocket on the second side of the corrugated member, for example. The tissue thickness compensator 24620 can be formed when the layer 24622 and the compressible member 24624 are compressed together, for example, by a roller 24590. Referring now to FIG. 193, the tissue thickness compensator 24520 may be formed from a tube material that has been rolled by a roller 24590 into a partially flattened shape, for example. Referring now to FIGS. 196 and 197, the staple 21330 positioned within the cartridge body 24610 is positioned such that the staple 21330 can capture at least a portion of the tissue thickness compensator 24620 therein. Can be injected from. In such a case, the compressible member 24624 can be configured to apply a resilient biasing force against the tissue T also captured within the staple 21330. The layer 24622 of the tissue thickness compensator 24620 may be similarly configured to apply a resilient biasing force against the tissue T. Staples 21330 can puncture the pockets of corrugated member 24624 and can release one or more medicaments contained therein.

  The tissue thickness compensator may include a substance inside. Examples of the substance include an aggregating agent, a pharmaceutical agent, and / or an anti-inflammatory agent. The substance may be a liquid, but may take other forms such as, for example, a solid and / or a gel. For a surgical instrument that includes such a tissue thickness compensator, it may be advantageous for the surgical instrument to have the ability to direct material from the tissue thickness compensator. For example, the material can be directed from the tissue thickness compensator to the incised and stapled tissue. In another example, the first tissue thickness compensator can include a first material, the second thickness compensator can include a second material, and the first and second materials are Can be mixed with surgical instruments. As another example, the materials can be directed away from each other, for example, to a staple cartridge of a surgical instrument and / or to an anvil.

  FIGS. 390-391 illustrate a cutting blade 19000 including a cutting edge 19016, a staple cartridge 19002, an anvil 19008, a first tissue thickness compensator 19004 positioned on the staple cartridge 19002, and a second positioned on the anvil 19008. 1 shows a surgical stapling system with a tissue thickness compensator 19006. In use, the cutting blade 19000 moves distally in the direction of arrow D to cut the patient tissue T and the first and second tissue thickness compensators 19004 and 19006. The first tissue thickness compensator 19004 includes the substance S contained therein, and the second tissue thickness compensator 19006 includes the substance S ′ contained therein. The first tissue thickness compensator 19004 includes an encasement containing the substance S therein. The container may include a film material that is opened by a cutting blade 19000 that cuts the film, and the substance S is released when the film is opened. The second tissue thickness compensator 19006 may comprise a similar volume, and the second material S ′ when the volume of the second tissue thickness compensator 19006 is cut open by the cutting blade 19000. Can be released. As the blade 19000 moves distally, the guides 19030 and 19022 can direct or displace the substances S and S 'from the first and second tissue thickness compensators 19004 and 19006, respectively. For example, the substances S and S ′ may be directed to the incised tissue T. The blade 19000 may be coupled to the shaft 19012 and the shaft 19012 may also be connected to an actuation mechanism that moves the blade 19000 in the distal direction D and in the proximal direction indicated by the arrow P.

  The guide 19030 may direct the substance S from the first tissue thickness compensator 19004 to the incised tissue T. A mirror image of guide 19030 may be located on the opposing surface of blade 19000. Guide 19030 may include two ridges 19032 and 19034 that define channel C therebetween. When the surgical stapler is positioned relative to the tissue T, the distal end 19035 of the channel C can be positioned proximal to the first tissue thickness compensator 19004 and the proximal end 19037 of the channel C is It can be located proximal to the tissue T. In use, as the cutting blade 19000 moves in the distal direction D, the substance S from the first tissue thickness compensator 19004 enters the channel C at the distal end 19035 and flows through the channel C; Exit channel C at the proximal end 19037 proximal of tissue T.

  A guide 19022 may direct the substance S 'from the second tissue thickness compensator 19006 to the dissected tissue T. The guide 19022 includes a protrusion 19025 having an inclined surface 19023. As shown in FIG. 61, the protrusion 19025 may penetrate or cut through the second tissue thickness compensator 19006 to release the substance S '. As the blade 19000 moves distally D, the tilted surface 19025 can direct the substance S 'to the tissue T.

  As materials S and S 'are directed to tissue T, materials S and S' may be mixed. Substances S and S 'may be different and may react when mixed. For example, substances S and S 'may react chemically when mixed to form a new substance S ". The new substance S ″ can be, for example, a pharmaceutical agent, an antibiotic, an aggregating agent, and / or any other suitable type of substance. After the blade 19000 has suitably advanced in the distal direction D, the blade 19000 may return by moving proximally P, and the proximal movement of the blade 19000 may further mix the substances S and S ′. .

  Alternatively, guides 19022 and 19030 may be configured to direct materials S and S ′ away from tissue T. For example, the guide 19030 may be configured to direct the substance S to the staple cartridge 19002 and the guide 19022 may be configured to direct the substance S ′ to the anvil 19008. For example, when the first tissue thickness compensator 19004 is held on the staple cartridge 19002 with an adhesive at, for example, the joint 19005, the second tissue thickness compensator 19906 is adhered at the joint 19007, for example. Such an arrangement may be advantageous when held on the anvil 19008 by the agent. Substances S and S ′ may dissolve or neutralize the adhesive, thereby at least partially releasing first and second tissue thickness compensators 19004 and 19006 from staple cartridge 19002 and anvil 19008, respectively. To do.

  FIG. 63 shows an alternative guide 19030 ′ in which the channel C ′ is defined by a recess or groove in the surface of the blade 19014. The channel C 'may comprise a single channel or a plurality of channels.

  FIGS. 64-67 illustrate another surgical stapling system that includes a cutting blade 19060 and cutting edge 19056, a first tissue thickness compensator 19004, and a second tissue thickness compensator 19006. The blade 19060 may comprise a first protrusion 19062 on the first side of the blade 19060, the first protrusion 19062 being an orifice that leads from the first side of the blade 19060 to the second side of the blade 19060. 19064 is defined. The first protrusion 19062 and the first orifice 19064 may be aligned with the first tissue thickness compensator 19004. In use, as the blade 19060 moves distally, at least a portion of the material S of the first tissue thickness compensator 19004 can pass through the first orifice 19064. Optionally, the contour of the first protrusion 19062 can direct the substance S to the second side of the blade 19060 and / or to the tissue T.

  The blade 19060 may also include a second protrusion 19066 on the second side of the blade 19060, the second protrusion being an orifice that leads from the second side of the blade 19060 to the first side of the blade 19060. 19068 is defined. The second protrusion 19066 and the second orifice may be aligned with the second tissue thickness compensator 19006. In use, at least a portion of the material S ′ of the tissue thickness compensator 19006 can pass through the second orifice 19068 as the blade 19060 moves distally. Optionally, the contour of the second protrusion 19066 can direct the substance S ′ to the first side of the blade 19060 and / or to the tissue T.

  Referring primarily to FIGS. 64 and 65, the shaft 19059 may include surface features, such as dimples 19070, that can increase the turbulence and / or displacement of the substances S and S ′. This increased turbulence and / or displacement can, for example, bring most of the substances S and S 'into contact with each other. The dimple 19070 can be positioned proximal to the orifices 19064 and 19068. When the blade 19000 is advanced distally, the dimple 19070 can be downstream of the orifices 19064 and 19068, while when the blade 19000 is retracted proximally, the dimple 19070 can be upstream of the orifices 19064 and 19068.

  FIGS. 68-70 show another surgical stapler with a blade 19100 and cutting edge 19108, a first tissue thickness compensator 19120, and a second tissue thickness compensator 19122. FIG. The first tissue thickness compensator 19120 can include a first material S and a second material S '. For example, the first substance S can be included in the first container as described above. The second material S 'can be proximal to the first volume and / or can be placed in a second volume that can surround the first volume. The second tissue thickness compensator 19122 can include a third material S ″. The second tissue thickness compensator 1922 can include a fourth material S '' '. The third substance S "and the fourth substance S" "may be placed in a container such as the container described above. The blade 19100 may comprise a textured surface 19110 on the first side 19102 of the blade 19100 on which the substances S, S ′, S ″, and S ″ ″ can spread. Another textured surface may be located on the opposing second side (not shown) of blade 19100. The textured surface 19110 can comprise a series of disturbing features, such as grooves, that are cut, scored, etched, and / or separately formed on the first surface 19102. The disturbing features may also comprise a series of raised features, such as raised portions, on the first surface 19102, for example. As shown in FIGS. 68-70, the disturbing features of the textured surface 19110 may include a regularly repeating pattern of disturbing features. The disturbing features may also be arranged in a non-repeating pattern or randomly arranged.

  The blade 19100 may also include a second surface 19104 positioned proximal to the first surface 19102. The second surface 19104 can be raised relative to the first surface 19102. The joint between the first surface 19102 and the second surface 19104 can define a third surface 19106, which is at a constant angle with respect to the longitudinal axis of the blade 19100. The position may be determined by: Movement of the blade 19100 in the distal direction D can result in the first end 19107 of the third surface 19106 leading ahead of the second end 19109 of the third surface 19106. As a result, as shown in FIG. 70, the third surface 19106 can direct the materials S and S 'from the first tissue thickness compensator 19120 to the dissected tissue T. A surface 19105, similar to the second surface 19104, may be located on the opposing second side of the blade 19100.

  The blade 19100 shown in FIGS. 68-70 may be used in a surgical instrument that includes the first and second tissue thickness compensators 19004 and 19006 shown in FIGS. As described above, the textured surface 19110 may be mixed with the materials S and S ′ from the tissue thickness compensators 19004 and 19006, respectively, so that the materials S and S ′ can be mixed and positioned in the vicinity of the tissue T. And S ′ can be distributed on the first surface 19102 of the blade.

  The blade 19100 shown in FIGS. 68-70 may also be used in a surgical instrument that includes the first tissue thickness compensator 19120 and the second tissue thickness compensator 19122 shown in FIGS. The first tissue thickness compensator 19120 may include an internal portion 19121 that includes the first material S. Material S may be released from the inner portion 19121 when the first tissue thickness compensator 19120 is cut by the cutting edge 19108 of the blade 19100. As the blade 19100 moves relative to the tissue thickness compensator 19120, the material S may be spread over the textured surface 19110, and the third surface 19106 can direct the material S to the tissue T. . As described above, the first tissue thickness compensator 19120 may include the second material S ′ outside the inner portion 19121. When the first tissue thickness compensator 19120 is cut by the cutting edge 19108 of the blade 19100, both the first material S and the second material S ′ are distributed on the textured surface 19110. Good. The distribution on the textured surface 19110 may mix the first material S and the second material S '. When mixed, the first material S and the second material S 'may react, for example, chemically react to form a new material. The third surface 19106 may direct the first material S and the second material S ′ to the tissue. As described above, the second tissue thickness compensator 19122 may include a third material S ″. When the second tissue thickness compensator 19122 is cut by the cutting edge 19108 of the blade 19100, the third substance S ″ may be distributed on the textured surface 19110 and the textured surface. At 19110, it may be mixed with the first substance S and / or the second substance S ′ and directed to the tissue T. As described above, the second tissue thickness compensator 19122 may include a fourth material S ″ ″. When the second tissue thickness compensator 19122 is cut by the cutting edge 19108 of the blade 19100, the third material S ″ and the fourth material S ′ ″ are distributed on the textured surface 19110. May be mixed with the first material S, the second material S ′, and / or each other at the textured surface 19110 and directed to the tissue T.

  Further to the above, the tissue thickness compensator can be composed of a biocompatible material. Biocompatible materials, such as foams, are tackifiers, surfactants, fillers, crosslinkers, pigments, dyes, antioxidants and other stabilizers and / or these to provide the desired properties to the material. May be included. The biocompatible foam may include a surfactant. Surfactants may be applied to the surface of the material and / or dispersed within the material. While not wishing to be bound by any particular theory, surfactants applied to biocompatible materials can reduce the surface tension of fluids in contact with the material. For example, surfactants can reduce the surface tension of water in contact with the material in order to accelerate water penetration into the material. Water may act as a catalyst. Surfactants may increase the hydrophilicity of the material.

  Surfactants can include anionic surfactants, cationic surfactants, and / or nonionic surfactants. Examples of surfactants include polyacrylic acid, metalose, methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octylphenyl Ethers, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether, polyoxyethylene nonylphenyl ether, dialkylphenoxy poly (ethyleneoxy) ethanol, and polyoxamers, and combinations thereof, It is not limited to these. The surfactant may comprise a copolymer of polyethylene glycol and polypropylene glycol. The surfactant may include a phospholipid surfactant. The phospholipid surfactant may provide antimicrobial stabilizing properties and / or may disperse other materials in the biocompatible material.

  The tissue thickness compensator may include at least one drug. The tissue thickness compensator may include one or more of the natural materials, non-synthetic materials, and / or synthetic materials described herein. Tissue thickness compensator is biocompatible, including gelatin, collagen, hyaluronic acid, oxidized regenerated cellulose, polyglycolic acid, polycaprolactone, polylactic acid, polydioxanone, polyhydroxyalkanoate, polygrecapron, and combinations thereof It may contain a form. The tissue thickness compensator may comprise a film containing at least one drug. The tissue thickness compensator may comprise a biodegradable film containing at least one drug. The medicament can include a liquid, a gel, and / or a powder. The agent may include an anticancer agent, such as, for example, cisplatin, mitomycin, and / or adriamycin.

  The tissue thickness compensator may include a biodegradable material to provide controlled elution of at least one drug as the biodegradable material is degraded. When the biodegradable material comes into contact with an active agent, such as, for example, an active agent fluid, the biodegradable material may degrade or lose structural integrity. The activator fluid can include, for example, saline or any other electrolyte solution. The biodegradable material can be contacted with the active agent fluid by conventional techniques including, but not limited to, spraying, dipping, and / or brushing. In use, for example, a surgeon includes a salt solution, such as sodium chloride, calcium chloride, and / or potassium chloride, with a staple cartridge with an end effector and / or a tissue thickness compensator containing at least one agent. It may be immersed in an activator fluid. As the tissue thickness compensator disintegrates, the tissue thickness compensator may release the drug. Drug dissolution from the tissue thickness compensator may be characterized by a rapid initial dissolution rate and a slow sustained dissolution rate.

  In accordance with the present invention, the tissue thickness compensator can be comprised of a biocompatible material that can include, for example, an oxidizing agent. The oxidizing agent may be an organic peroxide and / or an inorganic peroxide. Examples of oxidizing agents can include, but are not limited to, hydrogen peroxide, urea peroxide, calcium peroxide, and magnesium peroxide, and sodium percarbonate. The oxidant may include peroxygen oxidants and hypohalite oxidants such as, for example, hydrogen peroxide, hypochlorous acid, hypochlorite, hypocodeites, and percarbonates. Oxidizing agents may include alkali metal chlorites, hypochlorites, and perborates, such as, for example, sodium chlorite, sodium hypochlorite, and sodium perborate. The oxidizing agent may include vanadate. The oxidizing agent may include ascorbic acid. The oxidizing agent may include an active oxygen generator. According to the present invention, the tissue scaffold may comprise a biocompatible material including, for example, an oxidant.

  Biocompatible materials can include liquids, gels, and / or powders. The oxidizing agent can include, for example, microparticles and / or nanoparticles. For example, the oxidizing agent may be milled into fine particles and / or nanoparticles. The oxidizing agent may be incorporated into the biocompatible material by suspending the oxidizing agent in the polymer solution. The oxidizing agent may be incorporated into the biocompatible material during the lyophilization process. The oxidant may be attached to the cellular wall of the biocompatible material after lyophilization so that it interacts with the tissue upon contact. The oxidizing agent may not be chemically bonded to the biocompatible material. Percarbonate drying power may be embedded in a biocompatible foam in order to biologically affect the long term due to the slow release of oxygen. Percarbonate drying power may be embedded in non-woven polymer fibers in order to biologically affect the long term due to the slow release of oxygen. The biocompatible material may include an oxidizing agent and a drug, such as doxycycline and ascorbic acid, for example.

  The biocompatible material may include an immediate release oxidant and / or a slow sustained release oxidant. Oxidant elution from the biocompatible material may be characterized by a rapid initial dissolution rate and a slow sustained dissolution rate. The oxidant may generate oxygen when the oxidant comes in contact with a body fluid such as water, for example. Examples of body fluids may include, but are not limited to, blood, plasma, ascites, cerebral spinal fluid, urine, lymph, synovial fluid, vitreous humor, saliva, gastrointestinal contents, and / or bile. While not wishing to be bound by any particular theory, an oxidizing agent reduces cell death, enhances tissue viability, and / or is damaged during cutting and / or stapling You can keep the mechanical strength between tissues.

  The biocompatible material may include at least one microparticle and / or nanoparticle. The biocompatible material may include one or more of the natural materials, non-synthetic materials, and synthetic materials described herein. The biocompatible material may include particles having an average particle size of about 10 nm to about 100 nm and / or about 10 μm to about 100 μm, such as, for example, 45-50 nm and / or 45-50 μm. The biocompatible material may include a biocompatible foam that includes at least one microparticle and / or nanoparticle embedded therein. The microparticles and / or nanoparticles may not be chemically bonded to the biocompatible material. Microparticles and / or nanoparticles may provide controlled release of the drug. The microparticles and / or nanoparticles may include at least one drug. The microparticles and / or nanoparticles may include, for example, hemostatic agents, antibacterial agents, and / or oxidizing agents. The tissue thickness compensator includes a biocompatible foam that includes a hemostatic agent including oxidized regenerated cellulose, an antimicrobial agent including doxycycline and / or gentamicin, and / or an oxidizing agent including percarbant. But you can. The microparticles and / or nanoparticles may provide, for example, controlled release of the drug for up to 3 days.

  The microparticles and / or nanoparticles may be embedded in the biocompatible material during the manufacturing process. For example, a biocompatible polymer such as PGA / PCL can be contacted with a solvent such as dioxane, for example, to form a mixture. A biocompatible polymer can be ground to form particles. Dry particles can be contacted with the mixture to form a suspension with or without ORC particles. The suspension can be lyophilized to form a biocompatible foam comprising PGA / PCL with dried particles and / or ORC particles embedded therein.

  The tissue thickness compensator or layer disclosed herein can be composed of, for example, an absorbent polymer. The tissue thickness compensator is, for example, foam, film, fibrous woven fabric, fibrous nonwoven fabric PGA, PGA / PCL (poly (glycolic acid-co-caprolactone)), PLA / PCL (poly (lactic acid-co-polycaprolactone). )), PLLA / PCL, PGA / TMC (poly (glycolic acid-co-trimethylene carbonate)), PDS, PEPBO, or other absorbent polyurethane, polyester, polycarbonate, polyorthoester, poly (anhydride), polyester It may be composed of amides and / or polyoxaesters. According to the present invention, the tissue thickness compensator is composed of, for example, PGA / PLA (poly (glycolic acid-co-lactic acid)) and / or PDS / PLA (poly (p-dioxanone-co-lactic acid)). Can be done. According to the present invention, the tissue thickness compensator can be comprised of, for example, an organic material. The tissue thickness compensator can be composed of, for example, carboxymethylcellulose, sodium alginate, crosslinked hyaluronic acid, and / or oxidized regenerated cellulose. According to the present invention, the tissue thickness compensator can be composed of, for example, a durometer in the range of Shore A3-7 (Shore OO 30-50) with a maximum hardness of Shore A15 (Shore OO65). The tissue thickness compensator is subjected to, for example, 40% compression at a load of 13 N (3 lbf), 60% compression at a load of 27 N (6 lbf), and / or 80% compression at a load of 89 N (20 lbf). Can do. For example, one or more gases, such as air, nitrogen, carbon dioxide, and / or oxygen, can be bubbled in and / or contained within the tissue thickness compensator. The tissue thickness compensator can include beads comprised therein of about 50% to about 75% of the material hardness that makes up the tissue thickness compensator.

  According to the present invention, the tissue thickness compensator is, for example, hyaluronic acid, nutrition, fibrin, thrombin, platelet rich plasma, sulfasalazine (Asulfidin-5ASA + sulfapyridine, azo bond) Prodrugs-E. coli (azoreductase), mesalamine (5ASA with different prodrug forms for delayed release), Asacol® (coated with 5ASA + Eudragit-S-pH> 7 (coating degradation)) Pentasa® (coated with 5ASA + ethylcellulose—slow release depending on time / pH), Mesasar® (coated with 5ASA + Yudragit-L—pH> 6), olsalazine (5ASA + 5ASA-E. Coli ( Azoreductase ), Balsalazide (5ASA + 4 aminobenzoyl-B-alanine) -E. Coli (azoreductase)), mesalamine granules, rialda (mesalamine delayed and SR formulation), HMPL-004 (TNF-alpha, interleukin-1 beta, and intranuclear) Mixed herbal medicine capable of inhibiting kappa B activity), CCX282-B (oral chemokine receptor antagonist that interferes with transport of T lymphocytes to the intestinal mucosa), rifaximin (non-absorbable broad-spectrum antibiotic), infliximab, murine chymieric (Monoclonal antibodies directed against TNF-alpha—reduces signs / symptoms of adult / pediatric patients with moderate / severe luminal and fistulous Crohn's disease who responded inappropriately to conventional therapy and Approved to maintain clinical remission), a Darimumab, all-human IgG1 (anti-TNF-alpha monoclonal antibody-moderate / severe to reduce signs / symptoms of Crohn's disease and to inappropriately respond to conventional therapy or intolerance to infliximab Approved to induce and maintain clinical remission in adult patients with active Crohn's disease), Sertolizumab Pegor, humanized anti-TNF FAB '(monoclonal antibody fragment linked to polyethylene glycol-indication of Crohn's disease / Approved to reduce symptoms and to induce and maintain the response of adult patients with moderate / severe illness who responded inappropriately to conventional treatment), natalizumab, the first non-TNF-alpha Inhibitors (biological compounds approved for Crohn's disease), humanized monoclonal IgG4 antibodies (alpha Moderate / severe that is directed against 4 integrins-has evidence of inflammation, reacts inappropriately to conventional Crohn's disease treatment and inhibitors of TNF-alpha, or cannot tolerate treatment and inhibitors EDA approved for inducing and maintaining clinical response and remission in patients with illness of the disease), a combined immunomodulator that may be given together with infliximab, azathioprine 6-mercaptopurine (purine synthesis inhibitor-prodrug), Methotrexate (which binds to the dihydrofolate reductase (DHFR) enzyme involved in tetrahydrofolate synthesis and inhibits all purine synthesis), allopurinol and Thioprine treatment, PPI, H2 for acid suppression to protect the fusion line, difficile bacteria ( C-Diff) -Frazil, vancomycin (E. coli Lance location treatment, probiotics, normal luminal flora regrowth), and / or rifaximin (treatment of bacterial overgrowth (especially hepatic encephalopathy), not absorbed into the digestive tract with action against luminal bacteria) Can be included.

  As described herein, a tissue thickness compensator can compensate for variations in the thickness of tissue ejected from, for example, a staple cartridge and / or captured in staples contained within a staple line. it can. In other words, certain staples in the staple line can capture a thick portion of tissue, and other staples in the staple line can capture a thin portion of tissue. In such a situation, the tissue thickness compensator can assume different heights or thicknesses within the staple and are captured in the staple regardless of whether the captured tissue is thick or thin. A compressive force can be applied to the tissue. According to the present invention, the tissue thickness compensator can compensate for variations in tissue hardness. For example, certain staples in the staple line can capture a highly compressible portion of tissue and other staples in the staple line can capture a less compressible portion of tissue. In such situations, the tissue thickness compensator, for example, has a low compressibility, i.e., a low height within the staple that has captured the tissue having a high hardness, correspondingly a high compressibility, i.e., a low hardness. It can be configured to assume a high height within the staple that captured the tissue. In any case, a tissue thickness compensator is, for example, “tissue compensator” and / or “compensator” regardless of whether it compensates for variations in tissue thickness and / or tissue hardness, for example. Can be referred to as

  The devices disclosed herein can be designed to be disposed of after a single use, or designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of equipment disassembly steps, subsequent cleaning steps or specific part replacement steps, and subsequent reassembly steps. In particular, the device can be disassembled, and any number of the particular parts or members of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular members, the device can be reassembled at a reconditioning facility or by a surgical team immediately prior to a surgical procedure and then used for subsequent use. One skilled in the art will recognize that various techniques for disassembly, cleaning / replacement, and reassembly can be used to recondition the device. The use of such techniques, and the resulting reconditioned device, are all within the scope of this application.

  Preferably, the invention described herein is processed before surgery. First, a new or used instrument is obtained and cleaned as necessary. The instrument can then be sterilized. In one sterilization method, the instrument is placed in a closed and sealed container such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high energy electron beams. This radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

  Any patent publication or other disclosure referred to herein, in whole or in part, is incorporated into the current definition, description, or other disclosure that is incorporated herein by reference. Incorporated in this specification only to the extent that they do not conflict with objects. As such, and to the extent necessary, the disclosure expressly set forth herein shall supersede any inconsistent content incorporated herein by reference. All content, or portions thereof, which is incorporated herein by reference but which contradicts existing definitions, views, or other disclosures contained herein, is incorporated herein by reference. It shall be incorporated only to the extent that no contradiction arises between the existing disclosure content.

  While the present invention has been described as having an exemplary configuration, the present invention can be further modified within the spirit and scope of the present disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Furthermore, this application is intended to cover any developments from the present disclosure that are known or conventional in the art to which this invention pertains.

Embodiment
(1) a compensator attachable to an anvil of a coupling device, wherein the anvil comprises a forming surface, the compensator comprising:
A first layer composed of a first fiber and a second fiber, wherein the first fiber is composed of a first material, and the second fiber is composed of a second material, A first layer, wherein the first material is different from the second material, wherein the first fiber and the second fiber are present in the first layer according to a first ratio;
A second layer composed of the first fibers and the second fibers, wherein the first fibers and the second fibers are present in the second layer according to a second ratio; A second layer, wherein the first ratio is different from the second ratio;
A compensator comprising an attachment portion configured to be attached to the anvil.
(2) The compensator according to embodiment 1, wherein the first material includes oxidized regenerated cellulose and the second material includes an absorbent polymer.
(3) The first ratio of the first fibers to the second fibers is about 4: 1 and the second ratio of the first fibers to the second fibers is about 1: 4. The compensator according to embodiment 1 or 2, wherein
(4) The compensator according to embodiment 1 or 3, wherein the first layer includes a tissue contact surface, and the second material includes oxidized regenerated cellulose.
(5) In the first layer, the second fibers are woven into the first fibers, and in the second layer, the first fibers are woven into the second fibers. The compensator according to any one of aspects 1 to 4.

(6) The compensator according to embodiment 1, further comprising a drug absorbed in the first fiber.
(7) a compensator attachable to an anvil of a coupling device, wherein the anvil comprises a forming surface, the compensator comprising:
An absorbent outer layer comprising a first drug adapted to be absorbed primarily during the first stage of the healing process;
An absorbent intermediate layer comprising a second agent adapted to be absorbed primarily during the second stage of the healing process;
A compensator comprising an inner layer comprising a third agent adapted to be absorbed primarily during the third stage of the healing process.
(8) The compensator according to embodiment 7, wherein the first drug includes a hemostatic material, the second drug includes an anti-inflammatory material, and the third drug includes a collagen material.
(9) The compensator according to embodiment 7 or 8, wherein the first drug includes a hemostatic material, the second drug includes an antibacterial material, and the third drug includes a collagen material.
(10) The compensator according to any of embodiments 7-9, wherein at least one of the intermediate layers includes an annular layer surrounding the inner layer, and the outer layer includes an annular layer surrounding the at least one intermediate layer.

(11) Any of the embodiments 7-10, wherein the first healing stage at least partially overlaps the second healing stage, and the second healing stage at least partially overlaps the third healing stage. Compensation sweater according to crab.
(12) The compensator according to embodiment 11, wherein the first healing stage partially overlaps the third healing stage.
(13) A method for producing a tissue thickness compensator,
Obtaining a fiber comprising a substrate and a drug;
Preparing a solution of a first liquid and a second liquid;
Mixing the fibers into the solution;
Injecting the solution into a mold;
Lyophilizing said solution.
14. The method of embodiment 13, wherein the fibers are obtained by coating the substrate with the agent.
15. The method of embodiment 13, wherein the fibers are obtained by extruding the substrate and drug simultaneously.

16. The method of embodiment 13, wherein the fiber is obtained by impregnating the substrate with the agent.
(17) Embodiments 13 to 13 wherein the solution is lyophilized by placing the mold in a vacuum chamber, reducing the atmospheric pressure in the vacuum chamber, and lowering the temperature in the vacuum chamber. The method according to any one of 16.
18. The method of any of embodiments 13-17, further comprising allowing the fibers to settle to the bottom of the mold prior to lyophilizing the solution.
(19) The method according to any of embodiments 13-18, wherein the lyophilization of the solution produces a material sheet and the method further comprises tearing the material sheet.

Claims (19)

A compensator attachable to an anvil of a coupling device, wherein the anvil comprises a forming surface, the compensator comprising:
A first layer composed of a first fiber and a second fiber, wherein the first fiber is composed of a first material, and the second fiber is composed of a second material, A first layer, wherein the first material is different from the second material, wherein the first fiber and the second fiber are present in the first layer according to a first ratio;
A second layer composed of the first fibers and the second fibers, wherein the first fibers and the second fibers are present in the second layer according to a second ratio; A second layer, wherein the first ratio is different from the second ratio;
A compensator comprising an attachment portion configured to be attached to the anvil.   The compensator of claim 1, wherein the first material comprises oxidized regenerated cellulose and the second material comprises an absorbent polymer.   The first ratio of the first fibers to the second fibers is about 4: 1, and the second ratio of the first fibers to the second fibers is about 1: 4; The compensator according to claim 1 or 2.   4. A compensator according to claim 1 or 3, wherein the first layer comprises a tissue contacting surface and the second material comprises oxidized regenerated cellulose.   In the first layer, the second fibers are woven into the first fibers, and in the second layer, the first fibers are woven into the second fibers. 5. A compensator according to any one of 4 above.   The compensator of claim 1, further comprising a drug absorbed into the first fiber. A compensator attachable to an anvil of a coupling device, wherein the anvil comprises a forming surface, the compensator comprising:
An absorbent outer layer comprising a first drug adapted to be absorbed primarily during the first stage of the healing process;
An absorbent intermediate layer comprising a second agent adapted to be absorbed primarily during the second stage of the healing process;
A compensator comprising an inner layer comprising a third agent adapted to be absorbed primarily during the third stage of the healing process.   The compensator according to claim 7, wherein the first agent comprises a hemostatic material, the second agent comprises an anti-inflammatory material, and the third agent comprises a collagen material.   The compensator according to claim 7 or 8, wherein the first agent comprises a hemostatic material, the second agent comprises an antimicrobial material, and the third agent comprises a collagen material.   The compensator according to any one of claims 7 to 9, wherein at least one of the intermediate layers includes an annular layer surrounding the inner layer and the outer layer includes an annular layer surrounding the at least one intermediate layer.   11. The method of claim 7, wherein the first healing stage at least partially overlaps the second healing stage, and the second healing stage at least partially overlaps the third healing stage. Compensation sweater as described in 1.   The compensator according to claim 11, wherein the first healing stage partially overlaps the third healing stage. A method of manufacturing a tissue thickness compensator comprising:
Obtaining a fiber comprising a substrate and a drug;
Preparing a solution of a first liquid and a second liquid;
Mixing the fibers into the solution;
Injecting the solution into a mold;
Lyophilizing said solution.   14. The method of claim 13, wherein the fibers are obtained by coating the substrate with the agent.   14. The method of claim 13, wherein the fibers are obtained by extruding the substrate and drug simultaneously.   14. The method of claim 13, wherein the fibers are obtained by impregnating the substrate with the agent.   17. The solution of any of claims 13 to 16, wherein the solution is lyophilized by placing the mold in a vacuum chamber, reducing the air pressure in the vacuum chamber, and lowering the temperature in the vacuum chamber. The method according to claim 1.   18. A method according to any one of claims 13 to 17, further comprising allowing the fibers to settle to the bottom of the mold prior to lyophilizing the solution.   19. The method of any one of claims 13-18, wherein the lyophilization of the solution produces a material sheet, and the method further comprises tearing the material sheet.

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