JP6193352B2 - Tissue thickness compensator with elastic material - Google Patents

Description

(Cross-reference of related applications)
This non-provisional application is filed under US Patent Application No. 13 / 097,891, “Tissue Thickness Compensator For A Surgical Stapler Completing An Adjustable Anvil”, filed on September 29, 2011. This is a continuation-in-part application of US patent application Ser. No. 12 / 894,377 “Selective Orientable Implantable Fastener Cartridge” (filed on Sep. 30, 2010) based on US Patent Law Section 120. And the entire disclosures of which are incorporated herein by reference.

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

The following is a non-exhaustive list of embodiments of the invention that are claimed or may be claimed.
1. A surgical instrument fastener cartridge assembly comprising:
A cartridge body defining a longitudinal axis, the cartridge body including a fastener cavity;
A woven lattice that includes a woven lattice extending across the longitudinal axis of the cartridge body, wherein the woven lattice includes a resilient material;
A fastener movable between an initial position and a fired position, wherein the fastener is at least partially disposed within the fastener cavity when the fastener is in the initial position; Wherein the fastener is configured to compress the at least one woven lattice as the fastener moves to its fired position;
A fastener cartridge assembly comprising:
2. The fastener cartridge assembly of embodiment 1, wherein the fastener cavities are arranged in rows of fastener cavities, wherein the rows of fastener cavities are substantially parallel to the longitudinal axis.
3. 3. The fastener cartridge assembly of embodiment 1 or 2, wherein each woven lattice is oriented at approximately 45 degrees with respect to the longitudinal axis of the cartridge body.
4). At least one woven grid traverses the row of fastener cavities so that when the fastener is in an initial position, the at least one woven grid is in contact with the first leg of the fastener. The fastener cartridge assembly of embodiment 2, wherein the fastener cartridge assembly is disposed between the second leg.
5. Embodiment 5. A fastener cartridge assembly according to any one of embodiments 1-4, further comprising a sheet material, wherein the sheet material retains the woven lattice within the fastener cartridge.
6). The fastener cartridge of embodiment 1, wherein the woven lattice is at least partially filled with a material selected from the group consisting of hemostatic agents, antibacterial agents, anti-inflammatory agents, anticoagulants, and antibiotics. assembly.
7). An end effector assembly for a surgical instrument, comprising: the fastener cartridge assembly according to any one of embodiments 1-6; and an anvil.
8). A fastener cartridge assembly for a surgical instrument, the fastener cartridge assembly comprising:
The deck surface,
A fastener cavity in the deck surface;
A cartridge body including
A plurality of woven grids, wherein the woven grids include an elastic material, and wherein each woven grid includes an axis that intersects the deck surface;
A fastener movable between an initial position and a fired position, wherein the fastener is at least partially disposed within the fastener cavity when the fastener is in the initial position; Wherein the fastener is configured to compress the at least one woven lattice as the fastener moves to its fired position;
A fastener cartridge assembly comprising:
9. 9. The fastener cartridge assembly of embodiment 8, wherein the axis of each woven lattice is substantially perpendicular to the deck surface.
10. A first axis of the first woven grid extends through the first opening, wherein a second axis of the second woven grid extends through the second opening, and wherein the fastener But,
The base,
A first leg extending from the base, wherein the first opening is configured to receive the first leg;
A second leg extending from the base, wherein the second opening is configured to receive the second leg; and
Embodiment 10. A fastener cartridge assembly according to embodiment 8 or 9, comprising:
11. The fastener cartridge assembly according to any one of embodiments 8-10, further comprising a sheet material, wherein the woven lattice is disposed between the deck surface of the cartridge body and the sheet material. .
12 Embodiment 8. Any of Embodiments 8-11, wherein the woven lattice is at least partially filled with a material selected from the group consisting of hemostatic agents, antibacterial agents, anti-inflammatory agents, anticoagulants, and antibiotics. The fastener cartridge assembly according to claim.
13. Embodiment 14. A fastener cartridge assembly according to any of embodiments 8-12, wherein each said woven grid is secured to an adjacent woven grid.
14 14. An end effector assembly for a surgical instrument, comprising the fastener cartridge assembly according to any one of embodiments 8-13 and an anvil.
15. A fastener cartridge assembly for a surgical instrument, the fastener cartridge assembly comprising:
A cartridge body including a first longitudinal side and a second longitudinal side;
A tissue thickness compensator comprising a severable lattice, wherein the severable lattice is disposed laterally between the first longitudinal side and the second longitudinal side; ,
A fastener movable between an initial position and a fired position, wherein the fastener moves when the at least one fastener moves between its initial position and its fired position. A fastener cartridge assembly configured to engage a portion of the tissue thickness compensator.
16. Embodiment 16. The fastener cartridge assembly of embodiment 15 wherein at least one of the severable grids comprises a hydrophilic material, wherein the hydrophilic material expands after the severable grid is cut.
17. Embodiment 17 A fastener cartridge assembly according to embodiment 15 or 16, wherein the fastener is configured to pierce at least one of the severable grids as the fastener moves to its fired position.
18. Embodiment 15. Any of Embodiments 15-17, wherein the severable lattice is at least partially filled with a material selected from the group consisting of hemostatic agents, antimicrobial agents, anti-inflammatory agents, anticoagulants, and antibiotics. The fastener cartridge assembly according to claim.
19. An end effector assembly for a surgical instrument, the end effector assembly comprising:
The fastener cartridge assembly according to any one of embodiments 15-18,
With anvil,
A cutting element configured to translate along a longitudinal path between the first longitudinal side and the second longitudinal side of the cartridge body, wherein the cutting element is the longitudinal path A cutting element, wherein the cutting element is configured to cut at least one severable grid of the severable grid when translated along
An end effector assembly.
20. The firing member is configured to fire the fastener from the fastener cavity, wherein the anvil is configured to deform the fired fastener, whereby a portion of the tissue thickness compensator Embodiment 20. The end effector assembly of embodiment 19, wherein the end effector assembly is captured within the deformed fastener.

The features and advantages of the present invention, as well as the manner in which they are realized, will become more apparent from the following description of embodiments of the invention in conjunction with the accompanying drawings and provide a better understanding of the invention itself Will.
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 illustrates a portion of an end effector that clamps and staples tissue with an implantable staple cartridge. FIG. 6 illustrates a portion of an end effector that clamps and staples tissue with an implantable staple cartridge. FIG. 6 illustrates a portion of an end effector that clamps and staples tissue with an implantable staple cartridge. FIG. 6 illustrates a portion of an end effector that clamps and staples tissue with an implantable staple cartridge. FIG. 10 is a partial 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 thereof in an open position. FIG. 3 is another partial cross-sectional view of the end effector of FIG. 2 in a closed position. FIG. 4 is another partial cross-sectional 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. 5 illustrates a deformation of a surgical staple positioned within a foldable staple cartridge body in accordance with at least one embodiment. FIG. 5 illustrates a deformation of a surgical staple positioned within a foldable staple cartridge body in accordance with at least one embodiment. FIG. 5 illustrates a deformation of a surgical staple positioned within a foldable staple cartridge body in accordance with at least one embodiment. FIG. 5 illustrates a deformation of a surgical staple positioned within a foldable staple cartridge body in accordance with at least one embodiment. FIG. 3 illustrates staples positioned within a crushable staple cartridge body. 7B illustrates the collapsible staple cartridge body of FIG. 7A being crushed by an anvil. FIG. FIG. 7B illustrates the collapsible 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 collapsible staple cartridge of FIG. 7A in a fully collapsed state. FIG. 3 is a plan view of a staple cartridge according to at least one embodiment including staples embedded within a foldable staple cartridge body. FIG. 9 is an elevational view of the staple cartridge of FIG. 8. FIG. 6 is an exploded perspective view of an alternative embodiment of a compressible staple cartridge containing 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. FIG. 6 is a perspective view of a staple cartridge including 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. 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 over the tissue thickness compensator. It is a perspective view of the cartridge main body (or support part) of the staple cartridge of FIG. 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 including a rigid support portion and a compressible tissue thickness compensator showing the staples moving from an unfired 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 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. The longitudinal direction of the staple cartridge including the anvil in the closed position and the rigid support portion and the compressible tissue thickness compensator showing the staple moved from the unfired position to the fired position during the first sequence. FIG. 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 staple in an unfired 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 an unfired position. FIG. 35 is a detailed view of the staple cartridge of FIG. 34. 1 is an elevational view of a staple cartridge including an anvil in an open position, a rigid support portion and a compressible tissue thickness compensator showing the staple in an unfired position. FIG. A staple comprising a staple in an unfired position and an anvil in a closed position showing the tissue captured between the anvil and the tissue thickness compensator, a rigid support portion and a compressible tissue thickness compensator It is an elevation view of the cartridge. FIG. 38 is a detailed view of the anvil and staple cartridge of FIG. 37. A staple cartridge comprising a staple in an unfired position, an anvil in a closed position showing a thicker tissue captured between the anvil and the staple cartridge, 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. 41 shown in FIG. 39. FIG. 5 shows a tissue thickness compensator that compensates 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. FIG. 6 shows a tissue thickness compensator that can compensate for poorly formed staples. FIG. 5 shows a tissue thickness compensator disposed in a tissue region where a plurality of staple lines intersect. FIG. 3 shows tissue captured within a staple. FIG. 6 shows tissue and tissue thickness compensator captured within a staple. FIG. 3 shows tissue captured within a staple. FIG. 5 shows a thick tissue and tissue thickness compensator captured within a staple. FIG. 5 shows a thin tissue and tissue thickness compensator captured within a staple. FIG. 5 shows a tissue having an intermediate thickness captured within a staple and a tissue thickness compensator. FIG. 10 illustrates a tissue having another intermediate thickness captured within a staple and a tissue thickness compensator. FIG. 5 shows a thick tissue and tissue thickness compensator captured within a staple. FIG. 6 is a partial cross-sectional view of an end effector of a surgical stapling instrument showing a firing bar and staple firing thread in a retracted unfired 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 in a fully advanced (fired) position. FIG. 57 is a cross-sectional view of the end effector of FIG. 56 showing the firing bar in the 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. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 62 is a detailed view of the nonwoven material of the tissue thickness compensator of FIG. 61. FIG. 62 is an elevational view showing the tissue thickness compensator of FIG. 61 implanted against end effector tissue and released from the implant. 2 is a detailed view of a nonwoven material of a tissue thickness compensator according to at least one embodiment. FIG. FIG. 4 illustrates a cluster of randomly oriented crimped fibers according to at least one embodiment. FIG. 4 illustrates a cluster of randomly oriented crimped fibers according to at least one embodiment. FIG. 3 shows an array of crimped fibers according to at least one embodiment. FIG. 3 shows an array of crimped fibers according to at least one embodiment. FIG. 3 shows an array of crimped fibers according to at least one embodiment. FIG. 3 is a cross-sectional plan view of coiled fibers in a tissue thickness compensator, according to at least one embodiment. FIG. 71 is a plan sectional view of the coiled fiber of FIG. 70. FIG. 71 is a detailed cross-sectional view of the tissue thickness compensator of FIG. 70. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 72 is a diagram showing a deformation of the tissue thickness compensator of FIG. 71. FIG. 6 is a view of a fabric suture for a tissue thickness compensator showing the fabric suture in a loaded configuration, according to at least one embodiment. FIG. 74 is a view of the fabric suture of FIG. 73 showing the fabric suture in a released configuration. FIG. 74 is a plan view of a tissue thickness compensator with the woven suture of FIG. 73 in an end effector of a surgical instrument. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 77 is a partial plan view of the tissue thickness compensator of FIG. 76. FIG. 62 is an exploded view of the end effector and tissue thickness compensator fastener cartridge assembly of FIG. 61; FIG. 79 is a partial cross-sectional view of the fastener cartridge assembly of FIG. 78, showing unfired, partially fired, and fired fasteners. FIG. 79 is an elevational view of the fastener cartridge assembly of FIG. 78 showing a driver firing a fastener from a staple cavity of the fastener cartridge assembly into a tissue thickness compensator. FIG. 81 is a detailed view of the fastener cartridge assembly of FIG. 80. FIG. 62 is an elevational view of the tissue thickness compensator of FIG. 61 and the tissue captured in the fired fastener. FIG. 62 is an elevational view of the tissue thickness compensator of FIG. 61 and the tissue captured in the fired fastener. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 85 is a diagram showing a deformation of the deformable tube of the tissue thickness compensator of FIG. 84. FIG. 85 is a detailed view of the deformable tube of the tissue thickness compensator of FIG. 84. FIG. 6 illustrates deformation of a deformable tube of a tissue thickness compensator according to at least one embodiment. FIG. 3 is an elevational view of a tissue thickness compensator that includes a tube element embedded in tissue according to at least one embodiment. FIG. 3 is an elevational view of a tissue thickness compensator that includes a tube element embedded in tissue according to at least one embodiment. 2 is a partial perspective view of a deformable tube including a tube grid according to at least one embodiment. FIG. FIG. 93 is an elevational view of the tube strand of the deformable tube of FIG. 90. FIG. 91 is an elevational view of the deformable tube of FIG. 90. FIG. 93 is an elevation view of a plurality of tube strands of the deformable tube of FIG. 90 according to various embodiments. FIG. 93 is an elevational view of the tube grid of FIG. 90 implanted against tissue. FIG. 6 is a partial perspective view of a deformable tube according to at least one embodiment. FIG. 6 is a partial perspective view of a deformable tube according to at least one embodiment. FIG. 6 is a partial perspective view of a deformable tube according to at least one embodiment. FIG. 98 is an elevational view of the deformable tube of FIG. 97. FIG. 6 is a partial perspective view of a deformable tube according to at least one embodiment. FIG. 6 is a partial perspective view of a deformable tube according to at least one embodiment. FIG. 6 is a partial perspective view of a deformable tube according to at least one embodiment. FIG. 6 is a perspective view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 103 is an elevational view of the tube element of the tissue thickness compensator of FIG. 102. 102 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 102 showing the unclamped arrangement of the end effector. FIG. 102 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 102 showing the end effector clamped and fired configuration. FIG. FIG. 6 is an elevational cross-sectional view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. 106 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 106 showing the end effector clamped and fired configuration. FIG. FIG. 3 is an elevational cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is an elevational cross-sectional view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. 109 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 109 showing the end effector clamped and fired configuration. FIG. FIG. 6 is a perspective view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is an elevational cross-sectional view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is an elevational cross-sectional view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is an elevational cross-sectional view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is an elevational cross-sectional view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is a partial plan view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is a partial plan view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. 116 is a partial elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 116, showing the unclamped arrangement of the end effector. FIG. 116 is a partial elevational sectional view of the tissue thickness compensator and end effector of FIG. 116, showing the arrangement in which the end effector is clamped. FIG. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 121 is an elevational view of the tissue thickness compensator and end effector of FIG. 120. 120 is a perspective view of the tissue thickness compensator and end effector of FIG. 120, showing the end effector anvil moving toward the clamped configuration. FIG. 120 is an elevational view of the tissue thickness compensator and end effector of FIG. 120 showing the clamped arrangement of the end effector. FIG. FIG. 121 is an elevational cross-sectional view of the tube element of the tissue thickness compensator of FIG. 120 in an undeformed shape. FIG. 121 is an elevational cross-sectional view of the tube element of the tissue thickness compensator of FIG. 120 in a deformed shape. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. 126 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 126, showing the clamped arrangement of the end effector. FIG. 126 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 126 showing the end effector being fired and partially unclamped. FIG. FIG. 6 is a perspective view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. 6 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument, according to at least one embodiment. FIG. 130 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 130 showing the clamped arrangement of the end effector. FIG. 130 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 130, showing the arrangement in which the end effector is fired and not partially clamped. FIG. FIG. 132 is a detailed view of the tissue thickness compensator and end effector of FIG. 132. FIG. 5 is an elevational cross-sectional view of a tissue thickness compensator clamped within an end effector of a surgical instrument, according to at least one embodiment, illustrating the deployment of staples with staple firing threads. 134 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 134 showing the clamped configuration of the end effector. FIG. FIG. 135 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 134, showing the arrangement in which the end effector has been fired. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 137 is a perspective view of the tube element of the tissue thickness compensator of FIG. 137; 139 is a perspective view of the tube element of FIG. 138 cut between a first end and a second end; FIG. 137 is a perspective view of the tissue thickness compensator of FIG. 137 showing a cutting element that cuts the tissue thickness compensator and staples that engage the tissue thickness compensator. FIG. FIG. 138 is a perspective view of a frame configured to make the tissue thickness compensator of FIG. 137 according to at least one embodiment. 141 is an elevational cross-sectional view of the frame of FIG. 141 showing the tissue thickness compensator of FIG. 137 being hardened within the frame. FIG. FIG. 143 is an elevational cross-sectional view of a tissue thickness compensator removed from the frame of FIG. 142 and prepared for trimming with at least one cutting instrument; FIG. 145 is an elevational cross-sectional view of the tissue thickness compensator of FIG. 143 after trimming the tissue thickness compensator with at least one cutting instrument; FIG. 143 is an elevational cross-sectional view of a tissue thickness compensator formed within the frame of FIG. 142 showing a severable tube having various cross-sectional shapes. FIG. 10 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. 146 is a detailed view of the tissue thickness compensator of FIG. 146, according to at least one embodiment. FIG. FIG. 3 is a partial perspective view of a tissue thickness compensator according to at least one embodiment. FIG. 3 is a partial perspective view of a tissue thickness compensator according to at least one embodiment. FIG. 146 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 146 showing the unclamped arrangement of the end effector. 146 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 146 showing the clamped end effector. 146 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 146 showing the end effector clamped and fired configuration. 146 illustrates an elevational cross-sectional view of the tissue thickness compensator of FIG. 146 captured on fired staples. FIG. 146 shows an elevational cross-sectional view of the tissue thickness compensator of FIG. 146 captured on fired staples showing further expansion of the tissue thickness compensator. FIG. 3 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. FIG. 158 shows a partial elevation view of the tissue thickness compensator of FIG. 151 captured on fired staples. FIG. 153 is an elevational view of the deformable tube of the tissue thickness compensator of FIG. 151; FIG. 3 is an elevational view of a deformable tube according to at least one embodiment. FIG. 153 is a perspective cross-sectional view of the tissue thickness compensator of FIG. 151. 3 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument, according to at least one embodiment. FIG. 1 is a perspective view of a tissue thickness compensator according to at least one embodiment. FIG. 157 is a partial elevational cross-sectional view of the tissue thickness compensator of FIG. 157 showing the fastener engaged with the tissue and tissue thickness compensator. 2 is a perspective cross-sectional view of a tissue thickness compensator according to at least one embodiment. FIG. 1 is an elevational view of a tissue thickness compensator according to at least one embodiment. FIG. 1 is an elevational view of a tissue thickness compensator according to at least one embodiment. FIG. FIG. 6 is an elevational view of a tissue thickness compensator disposed on a circular end effector of a surgical instrument, according to at least one embodiment. 1 is an elevational view of a tissue thickness compensator according to at least one embodiment. FIG. 1 is an elevational view of a tissue thickness compensator according to at least one embodiment. FIG. 1 is an elevational view of a tissue thickness compensator according to at least one embodiment. FIG. 1 is an elevational view of a tissue thickness compensator according to at least one embodiment. FIG. 1 is an elevational view of a tissue thickness compensator according to at least one embodiment. FIG. FIG. 3 is a partial perspective view of a tissue thickness compensator according to at least one embodiment. FIG. 5 is a partial perspective view of a tissue thickness compensator disposed on an end effector of a surgical instrument, according to at least one embodiment. FIG. 6 is a partial perspective view of a tissue thickness compensator with fasteners disposed within its own opening, according to at least one embodiment. 169 is a partial perspective view of the tissue thickness compensator of FIG. 169 showing an undeformed shape of the tissue thickness compensator; 169 is a partial perspective view of the tissue thickness compensator of FIG. 169 showing the tissue thickness compensator with a partially deformed shape; FIG. 169 is a partial perspective view of the tissue thickness compensator of FIG. 169 showing a deformed tissue thickness compensator; FIG. 1 is a perspective view of a tissue thickness compensator according to at least one embodiment. FIG. FIG. 6 is a perspective view of an end effector of a stapling instrument including an anvil and a staple cartridge, according to at least one embodiment. 175 is a cross-sectional view of the end effector of FIG. 175 showing a staple in the staple cartridge in an unfired state and a tissue thickness compensator including an unpunctured sealed container, the container being illustrated in FIG. It is shown in a partially removed portion for the purpose. 175 is a cross-sectional view of the end effector of FIG. 175, showing the staple of FIG. 176 at least partially fired and the container at least partially punctured. FIG. 6 is a perspective view of an end effector of a stapling instrument including an anvil and a staple cartridge, according to at least one embodiment. 178 is a cross-sectional view of the end effector of FIG. 178 showing the staples in the staple cartridge in an unfired state and a sealed container disposed in the tissue thickness compensator of the staple cartridge in an unpunctured state. This container is shown with a portion removed for purposes of illustration. 178 is a cross-sectional view of the end effector of FIG. 178, wherein the staple of FIG. 179 is at least partially fired and the container is at least partially punctured and within the cartridge. FIG. 4 is a perspective view of an end effector of a stapling instrument including an anvil and a sealed container attached to the anvil according to at least one alternative embodiment, the container being partially removed for purposes of illustration. It is shown in the figure. 181 is a cross-sectional view of the end effector of FIG. 181, with the staples being at least partially fired from the staple cartridge and the container being attached to the anvil with at least partial puncture. FIG. 184 is a cross-sectional view of the container attached to the anvil of FIG. 181 in an expanded state. FIG. 184 is a detail view of the container attached to the anvil of FIG. 183 in an inflated state. Fig. 6 shows a container that expands transversely to a row of staples. Fig. 5 shows a plurality of containers that expand in a transverse direction relative to a staple row. 2 is a cross-sectional view of a staple cartridge according to various embodiments. FIG. FIG. 187 is a partial cross-sectional view of FIG. 187 in an embedded state. It is a fragmentary perspective view of the tissue thickness compensator before expansion. FIG. 189B is a partial perspective view of the tissue thickness compensator of FIG. 189A during expansion. 1 is a partial perspective view of a tissue thickness compensator comprising a fluid swellable composition according to various embodiments. FIG. FIG. 4 is a cross-sectional view of tissue disposed adjacent to a tissue thickness compensator according to various embodiments. 191 is a partial cross-sectional view of FIG. 191 after the staple cartridge has been fired. FIG. 191 shows the tissue thickness compensator of FIG. 191 implanted adjacent to the tissue. FIG. 6 is a partial perspective view of a tissue thickness compensator according to various embodiments. 196 is a perspective view of a jaw configured to receive the tissue thickness compensator of FIG. 194. FIG. FIG. 3 is a partial cross-sectional view of a staple cartridge showing staples deployed from the staple cartridge. FIG. 6 is a perspective view of an upper tissue thickness compensator and a lower tissue thickness compensator disposed within the effector of the disposable loading unit. 196 is a cross-sectional view of the lower tissue thickness compensator of FIG. 197 being manufactured in a mold, according to various embodiments. FIG. 6 is a cross-sectional view of a three layer tissue thickness compensator being manufactured in a mold, according to various embodiments. 1 is a cross-sectional view of an anvil including a tissue thickness compensator that includes a reinforcing material, according to various embodiments. FIG. FIG. 4 is a cross-sectional view of tissue disposed intermediate an upper tissue thickness compensator and a lower tissue thickness compensator, according to various embodiments. FIG. 200 is a cross-sectional view of FIG. 200 showing staples deployed from a staple cartridge. FIG. 200 is a cross-sectional view of FIG. 200 after the staple cartridge has been fired. FIG. 6 illustrates a needle configured to deliver fluid to a tissue thickness compensator attached to a staple cartridge, according to various embodiments. FIG. 203B is a cross-sectional view of a staple cartridge including a tissue thickness compensator configured to receive the needle of FIG. 203A. 6 illustrates a method of manufacturing a tissue thickness compensator according to various embodiments. FIG. 2 is a diagram and method of forming an inflatable thickness compensator according to various embodiments. Figure 3 shows micelles containing hydrogel precursors. 1 is a view of a surgical instrument that includes a tissue thickness compensator and a fluid that can be delivered to the tissue thickness compensator, according to various embodiments. FIG. FIG. 6 is a partial perspective view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument, according to at least one embodiment. FIG. 211 is a perspective view of the tube element of the tissue thickness compensator of FIG. 208. FIG. 209 is a perspective view of the tube element of FIG. 209 cut in half showing the fluid in contact with the hydrophilic material in each half. FIG. 220 is a perspective view of half of the cut tube element of FIG. 210 illustrating the expansion of the cut tube element.

  Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations described herein illustrate specific embodiments of the invention according to one aspect and such illustrations are not to be construed as limiting the scope of the invention in any way.

The applicant of this application also owns the following US patent applications, the entire contents of each of which are incorporated herein by reference:
US patent application Ser. No. 12 / 894,311 “SURGICAL INSTRUMENTS WITH RECONFIGURE SHAFFT SEGMENTS” (Attorney Docket No. END 6734 USNP / 100058);
US Patent Application No. 12 / 894,340 "SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STALPING INSTRUMENTS WITH COMM NSTA
US patent application Ser. No. 12 / 894,327 “JAW CLOSER ARRANGEMENTS FOR SURGICAL INSTRUMENTS” (Attorney Docket No. END6736USNP / 100060);
US patent application Ser. No. 12 / 894,351 “SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS”
US patent application Ser. No. 12 / 894,338, “IMPLANTABLE FASTNER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT” (Attorney Docket No. END6840USNP / 100525);
US patent application Ser. No. 12 / 894,369 “IMPLANTABLE FASTNER CARTRIDGE COMPRISING A SUPPORT RETAINER” (Attorney Docket No. END6841USNP / 100526);
US patent application Ser. No. 12 / 894,312 “IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS” (Attorney Docket No. END6842USNP / 100527);
US patent application Ser. No. 12 / 894,377 “SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE” (Attorney Docket No. END6843USNP / 100528);
US patent application Ser. No. 12 / 894,339 “SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL ARRANGEMENT” (Attorney Docket No. END6847USNP / 100532);
US patent application Ser. No. 12 / 894,360 “SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM” (Attorney Docket No. END6848USNP / 100533);
US patent application Ser. No. 12 / 894,322 “SURGICAL STAPLING INSTRUMENT WITH INTERCHANGABLE STAPLE CARTRIDGE ARRANGEMENTS” (Attorney Docket No. END6849USNP / 100534);
U.S. Patent Application No. 12 / 894,350 "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, “IMPLANTABLE FASTNER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS” (Attorney Docket No. END6856USNP / 100541);
US patent application Ser. No. 12 / 894,389 “COMPRESSABLE FASTENER CARTRIDGE” (Attorney Docket No. END6857 USNP / 100542);
US patent application Ser. No. 12 / 894,345 “FASTENERS SUPPORTED BY A FASTNER CARTRIDGE SUPPORT” (Attorney Docket No. END6858USNP / 100543);
US patent application Ser. No. 12 / 894,306 “COLLAPSIBLE FASTENER CARTRIDGE” (Attorney Docket No. END6859 USNP / 100544);
US patent application Ser. No. 12 / 894,318 “FASTENER SYSTEM COMPRISING A PLULARITY OF CONNECTED RETENTION MATRIX ELEMENTS” (Attorney Docket No. END6860USNP / 100546);
US patent application Ser. No. 12 / 894,330 “FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX” (Attorney Docket No. END6861USNP / 100547);
US patent application Ser. No. 12 / 894,361 “FASTENER SYSTEM COMPRISING A RETENTION MATRIX” (Attorney Docket No. END 6862 USNP / 100548);
US patent application Ser. No. 12 / 894,367 “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, “FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER” (Attorney Docket No. END 6864 USNP / 100550);
US patent application Ser. No. 12 / 894,376 “FASTENER SYSTEM COMPRISING A PLULARITY OF FASTENER CARTRIDGES” (Attorney Docket No. END6865USNP / 100551);
U.S. Patent Application No. 13 / 097,865 "SURGICAL STAPLLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS" (Attorney Docket No. END6735 USCIP1 / 100059CIP1);
U.S. Patent Application No. 13 / 097,936 "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLE" (Attorney Docket No. END6736USCIP1 / 100060CIP1);
U.S. Patent Application No. 13 / 097,954 "STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESIBLE POTION" (Attorney Docket Number END6840USCIP1 / 100525CIP1);
U.S. Patent Application No. 13 / 097,856 "STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITH A COMPRESIBLE PORTION THEREOF" (Attorney Docket No. END6841USCIP1 / 100526CIP1);
US Patent Application No. 13 / 097,928 “TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORATIONS” (Attorney Docket No. END6842USCIP1 / 100527CIP1);
US Patent Application No. 13 / 097,891 “TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLERS COMPRISING AN ADJUSTABLE ANVIL” (Attorney Docket No. END6843USCIP1 / 100528CIP1);
U.S. Patent Application No. 13 / 097,948 "STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISPORTION" (Attorney Docket No. END6847USCIP1 / 10032CIP1);
US Patent Application No. 13 / 097,907 “COMPRESSABLE STAPLE CARTRIDGE ASSEMBLY” (Attorney Docket No. END6848 USCIP1 / 1003353CIP1);
U.S. Patent Application No. 13 / 097,861 "TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERITES" (Attorney Docket No. END6849USCIP1 / 10004CIP1);
US patent application Ser. No. 13 / 097,869 “STAPLE CARTRIDGE LOADING ASSEMBLY” (Attorney Docket No. END6855 USCIP1 / 100540CIP1);
U.S. Patent Application No. 13 / 097,917 “COMPRESSABLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS” (Attorney Docket No. END6856 USCIP1 / 1001541CIP1);
US Patent Application No. 13 / 097,873 “STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTITION” (Attorney Docket No. END6857USCIP1 / 10000542CIP1);
U.S. Patent Application No. 13 / 097,938 “STAPLE CARTRIDGE COMPRISING COMPRESIBLE DISTORTION RESISTANT COMPONENTS” (Attorney Docket No. END6858 USCIP1 / 1003143CIP1);
U.S. Patent Application No. 13 / 097,924 "STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6859USCIP1 / 100544CIP1);
US patent application Ser. No. 13 / 242,029 “SURGICAL STAPLER WITH FLOATING ANVIL” (Attorney Docket No. END6841 USCIP2 / 100526CIP2);
US patent application Ser. No. 13 / 242,066 “CURVED END EFFECTOR FOR A STAPLING INSTRUMENT” (Attorney Docket No. END6841USCIP3 / 100526CIP3);
U.S. Patent Application No. 13 / 242,086 “STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK” (Attorney Docket No. END7020USNP / 110374);
U.S. Patent Application No. 13 / 241,912 "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT" (Attorney Docket No. END7019 USNP / 110375);
U.S. Patent Application No. 13 / 241,922 "SURGICAL STAPLIER WITH STATIONARY STAY DRIVER" (Attorney Docket No. END 7013 USNP / 110377);
US Patent Application No. 13 / 241,637 “SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATION MULTIPLE ACTUATION MOTIONS” (Attorney Docket No. END6888USNP3 / 110329); U.S. Patent No. "ARTICULABLE END EFFECTOR" (Attorney Docket No. END6888USNP2 / 110379).

The applicant of this application also owns the following US patent applications filed on the same day as this specification, the entire contents of which are each incorporated herein by reference.
U.S. Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES" (Attorney Docket No. END 6864 USCIP1 / 100550CIP1);
U.S. Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS" (Attorney Docket No. END 6864 USCIP2 / 100550CIP2);
US Patent Application No. ____________ "EXPANDABLE TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6843USCIP2 / 100528CIP2);
US Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR" (Attorney Docket No. END6843USCIP3 / 100528CIP3);
U.S. Patent Application No. ___________ "RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6843USCIP4 / 100528CIP4);
US Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR COMPRISING AT Least ONE MEDICAMENT" (Attorney Docket No. END6843USCIP5 / 100528CIP5);
US Patent Application No. ______________ "TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION" (Attorney Docket No. END6843USCIP6 / 100528CIP6);
US Patent Application No. ______________ "TISSUE THICKNESS COMPENSOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD" (Attorney Docket No. END6843USCIP7 / 100528CIP7);
US Patent Application No. ______________ "TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD" (Attorney Docket No. END6843USCIP8 / 100528CIP8)
US Patent Application No. ______________ "METHODS FOR FORMING TISSUE TICHKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS" (Attorney Docket No. END6843USCIP10 / 100528CP)
U.S. Patent Application No. ____________ "TISSUE THICKNESS COMPENSATORS" (Attorney Docket No. END6843USCIP11 / 100528CP11);
US Patent Application No. ___________ "LAYERED TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6843USCIP12 / 100528CP12);
US Patent Application No. ___________ "TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS" (Attorney Docket No. END6843USCIP13 / 100528CP13);
US Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFING A LOW PRESSURE ENVIRONMENT" (Attorney Docket No. END7100USNP / 110601);
U.S. Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS" (Attorney Docket No. END7101USNP / 110602);
US Patent Application No. ___________ "MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END7107USNP / 110603);
U.S. Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS" (Attorney Docket Number END7102USNP / 110604);
US Patent Application No. ___________ "TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME" (Attorney Docket No. END7103 USNP / 110605);
U.S. Patent Application No. ____________ "TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS" (Attorney Docket No. END7104USNP / 110606);
U.S. Patent Application No. ____________ "TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES" (Attorney Docket No. END7105USNP / 110607); and U.S. Patent Application No. ____________ "DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS" ( Agent reference number END7106 USNP / 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 illustrated in the accompanying drawings are non-limiting exemplary embodiments. Features illustrated or described in the context of one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are included in the scope of the present invention.

  Any of the methods disclosed or claimed herein for the manufacture, formation or other production of an article or product shall be employed to produce, form or otherwise produce the entire article or production of interest. And when such a method is employed to produce, form or otherwise make a part of the subject article or product, the remaining parts of the article or product produce, form or form the article or product. Other parts can be made in any manner, including employing any of the other methods disclosed and claimed herein for making, and the various parts so made are Can be combined in any manner. Similarly, an article or product disclosed or claimed herein may be used alone or in combination with any other article or product disclosed as being compatible therewith or in whole. As part. Thus, the specific features, structures or characteristics illustrated or described in connection with an article, product or method are, without limitation, the characteristics of one or more other compatible articles, products or methods. Can be combined, in whole or in part, with structures, or properties. Such modifications and variations are included in the scope of the present invention.

  It is disclosed herein that a particular embodiment of the invention or a particular article, product, or method, whether or not referring to a particular figure or otherwise, may include a particular structure, property, or characteristic. The reader will understand that the structure, property, or characteristic means that it can be embodied in the subject article, product or method in any compatible combination. In particular, such disclosures of any number of structures, properties or features are 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. Should be understood. Where such structures, characteristics or features are disclosed as alternatives to each other, they should be understood as disclosing alternatives that are substituted for each other.

  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 that is remote from the clinician. For convenience and clarity, it is further understood that spatial terms such as “vertical”, “horizontal”, “top”, “bottom” may be used herein in connection with the drawings. Like. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.

  Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily appreciate that the various methods and devices disclosed herein can be used in a number of surgical procedures and applications, including, for example, open surgical procedures. In reading the present Detailed Description, the reader will further recognize that the various devices disclosed herein may be formed in any manner (eg, through natural openings or in tissue). It will be understood that it can be inserted into the body through a made incision or puncture hole, etc.). The working portion or end effector of the instrument can be inserted directly into the patient's body or can be inserted through an access device having a working channel and advanced through the surgical instrument end effector and elongated shaft. Can be made.

  Returning to the drawings, like reference numerals indicate like elements 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 shapes and sizes operably attached thereto. In FIGS. 1-1E, 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 an “implantable” staple cartridge 30 and operably supports the anvil 20 that functions as the upper jaw 15 of the end effector 12.

  The elongate channel 14 may be made from 300 & 400 series, 17-4 & 17-7 stainless steel, titanium, etc., or may be formed by spaced sidewalls 16. Anvil 20 may be made of, for example, 300 & 400 series, 17-4 & 17-7 stainless steel, titanium, etc., having a plurality of staple forming pockets 23 formed therein, generally as 22 It may have a staple forming lower surface that is labeled. See Figures 1B-1E. In addition, the anvil 20 has a bifurcated ramp assembly 24 projecting proximally therefrom. An anvil pin 26 projects from each side wall of the tilt assembly 24 received in a corresponding slot or opening 18 in the side wall 16 of the elongate channel 14 to facilitate movably or pivotally attach thereto.

  Various forms of implantable staple cartridges may 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. Staple cartridge 30 has a body portion 31 of a compressible hemostatic material, such as, for example, oxidized regenerated cellulose (“ORC”) or bioabsorbable foam, in which are disposed metal staples 32 that are not formed therein. The entire cartridge is biodegradable film 38, such as the polydioxanone film sold under the trade name PDS®, to prevent the staples from being affected and the hemostatic material from being activated during the introduction and placement process. Or polyglycerol sebacate (PGS) film, or PGA (polyglycerol acid sold under the trade name Vicryl), PCL (polycaprolactone), PLA, or PLLA (polylactic acid), PHA (polyhydroxyalkanoate) , PGCL (Polygrecapron 25 sold under the trade name Monocryl), or other biodegradable film formed from a composite of PGA, PCL, PLA, PDS (impervious until rupture), It can be coated or coated. The body 31 of the staple cartridge 30 is sized to be removably supported within the elongate channel 14, as shown, so that when the anvil 20 contacts the staple cartridge 30, the interior of each Staples 32 are aligned with corresponding staple forming pockets 23 in the anvil.

  In use, once the end effector 12 is positioned adjacent the target tissue, the end effector 12 captures or clamps the target tissue between the top surface 36 of the staple cartridge 30 and the staple forming surface 22 of the anvil 20. To be operated. Staples 32 move anvil 20 in a path substantially parallel to elongate channel 14 to substantially move staple forming surface 22, and more particularly internal staple forming pocket 23, with upper surface 36 of staple cartridge 30. Formed by being simultaneously contacted with each other. As the anvil 20 continues to move into the staple cartridge 30, the legs 34 of the staples 32 contact the corresponding staple forming pockets 23 in the anvil 20 to bend the staple legs 34 and make the staples 32 “B-shaped”. Functions to form. Movement of the anvil 20 to the elongate channel 14 further compresses the staple 32 to the desired final formed height “FF”.

  The above staple forming process is shown generally in FIGS. For example, FIG. 1B illustrates the end effector 12 having a target tissue “T” between the anvil 20 and the top surface 36 of the implantable staple cartridge 30. FIG. 1C illustrates the initial clamping position of the anvil 20, where the anvil 20 is closed over the target tissue “T” to clamp the target tissue “T” between the anvil 20 and the top surface 36 of the staple cartridge 30. To do. FIG. 1D illustrates initial staple formation, where the anvil 20 begins to compress the staple cartridge 30 so that the legs 34 of the staples 32 begin to be formed by the staple forming pockets 23 in the anvil 20. FIG. 1E illustrates 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 fastened to the target tissue “T”, the surgeon moves the anvil 20 to the open position so that the cartridge body 31 and the staple 32 are attached to the target tissue while the end effector 12 is withdrawn from the patient. Allows to remain fixed. The end effector 12 forms all staples simultaneously when the two jaws 13, 15 are clamped together. The remaining “foldable” body material 31 functions as both a hemostatic agent (ORC) and a staple line reinforcement (PGA, PDS or any other film composition 38 described above). Further, since the staple 32 does not leave the cartridge body 31 during the formation, the possibility that the staple 32 is improperly formed during the formation is minimized. As used herein, the term “implantable” means that in addition to staples, the material of the cartridge body that supports 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 within the end effector after firing.

  In various implementations, the end effector 12 is configured to be coupled with an elongate shaft assembly 40 that protrudes from the handle assembly 100. End effector 12 (when closed) and elongate shaft assembly 40 may have similar cross-sectional shapes and are sized to operably pass through a working channel in a trocar tube or other shaped access device. obtain. 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 a surgical staple. It means that it can be manipulated internally as needed to complete the ring procedure. When in the closed position, the jaws 13 and 15 of the end effector 12 may provide the end effector with a generally circular cross-sectional shape that facilitates passage through the circular passage / opening. However, the end effector and elongate shaft assembly of the present invention can be provided with other cross-sectional shapes that can pass through access passages and openings having non-circular cross-sectional shapes, as far as possible. Thus, the overall size of the cross-section of the closed end effector is 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, for example, a “5 mm” end effector, meaning that the end effector can operatively pass through an opening that is at least about 5 mm in diameter.

  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 with an elongate shaft assembly 40 having a cross-sectional diameter of 5 mm. However, upon reading the detailed description of the present invention, it will become apparent that the present invention can be effectively used in connection with different sized end effectors. For example, a 10 mm end effector may be coupled to an elongate shaft having a 5 mm cross-sectional diameter. Conversely, in those applications where an access opening or path of 10 mm or more is provided, the elongate shaft assembly 40 may have a cross-sectional diameter of 10 mm (or more), but also a 5 mm or 10 mm end effector. Can also be activated. Accordingly, the outer shaft 40 may 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 distally from the handle assembly 100 in a generally straight line and defines 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 of other lengths and can have a joint on its inside, as described in detail below, with an end relative to the shaft or other portion of the handle assembly. The effector 12 may be configured to facilitate articulation. 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 has a pair of retaining trunnions 17 projecting therefrom, which are provided in the distal ends of the spine members 50, corresponding trunnion openings or cradle 52. The end effector 12 can be removably coupled to the elongate shaft assembly 40. The spine member 50 may be made of, for example, 6061 or 7075 aluminum, stainless steel, titanium, or the like.

  The handle assembly 100 includes a pistol grip type housing that can be made of two or more parts for assembly purposes. For example, the illustrated handle assembly 100 includes a right hand case member 102 and a left hand case member (not shown), which are made from a polymer or plastic member and designed to mate with each other. In such a case, the members can be bonded together by a snap function, a peg, and a socket molded or formed therein, and / or by an adhesive, a screw, or the like. The spinal member 50 has a proximal end 54 with a flange 56 formed thereon. The flange 56 is configured to be rotatably supported in a groove 106 formed by meshing ribs 108 projecting inward from the case members 102 and 104. Such a configuration facilitates attachment of the spine member 50 to the handle assembly 100, while the spine member 50 rotates relative to the handle assembly 100 with a 360 ° actuation about the longitudinal axis AA. to enable.

  As further seen in FIG. 1, the spine member 50 passes through and is supported by an attachment 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 rotatable 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, the 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), or the like, and is similarly attached 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. Thus, 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) about the longitudinal axis AA. It may be rotated by a 360 ° 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, which includes 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 can rotate relative to the longitudinal axis AA. To. 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 is axially on the spine member 50. Promote 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. Moving the firing tube 110 distally, axially and interacting with the anvil 20 for firing is referred to herein as “firing 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, firing trigger 130 has an upper portion 134 movably attached (pinned) to firing link 136 movably attached (pinned) to 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 may be 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. . 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 another alternative, the elongate shaft assembly 40 can be configured to be attached to an end effector of at least 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. The surgeon then 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 in 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 retention pin 162 that is movably supported within the upper portion 134 of the firing trigger 130. As described above, the firing tube 110 is first advanced distally into 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 urged 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 “fixed” 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 so that the end effector 12 is 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 with 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 over the spine member 50, eventually 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 toward 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 selects from a non-actuated position adjacent the proximal end of the end effector 12 to an actuated position by actuating the knife advance trigger 200. Can move forward. 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 greater than 38 HRC (Rockwell hardness C scale) and has a tissue cutting edge 176 formed on its distal end 174. , Slidably extending through a slot in the anvil 20 and a slot 33 located in the center of the staple cartridge 30 to cut through 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 actuation 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 that 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, where the retaining hook 214 is maintained engaged with the latch rod 216, thereby causing the firing trigger 130. Prevents the knife advance trigger 200 from being actuated except when is completely in the firing 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 severing the tissue or, if desired, after the staples have been fired. Facilitates the use of small implantable staple cartridges that provide the option of cutting tissue.

  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 is 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 another aspect of the invention, the surgical stapling arrangement can employ a staple driving element that can lift the staples toward the anvil. Details of these will be described later.

  Optionally, for 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 above-described staple formation height. 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.

  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'. Is coupled to or protrudes from the knife rod 180 and is otherwise manipulated in the manner described above with respect to the knife bar 172. However, in this embodiment, the knife bar 172 'is the end effector 12 " A separate distal knife member is not utilized in the end effector 12 ". The knife bar 172 'is formed thereon with an upper transverse member 173', and a lower It has a transverse member 175 '. The upper transverse member 173' is a corresponding elongated slot 25 in the anvil 20 ". The oriented to traverse slidably, lower transverse member 175 'is oriented so as to cross the elongated slot 252 of the "elongated channel 14 for" end effector 12. 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. , The anvil 20 "moves to the open position and disengages from the stapling and cut tissue. The anvil 20" may otherwise be identical to the anvil 20 described above, and the elongated channel 14 " May otherwise be identical to the elongate channel 14 described above.

  In these embodiments, the anvil 20 "is biased to the fully open position (Figure 2) by a spring or other opening configuration (not shown). The anvil 20" is fired in the manner described above. The axial movement of the adapter 150 moves between the open position and the fully clamped position. Once the firing adapter 150 is advanced to the fully clamped position (FIG. 3), the surgeon may then advance the knife bar 172 ″ distally in the manner described above. The surgeon manipulates the end effector with tissue. When used as a gripping device, 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 an 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 ″ becomes the end effector 12 ″. As the needle is advanced distally therethrough, 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 another alternative, the line of one or more staples may have a non-linear nature. 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 lines on each side of the elongated slot may have a zigzag shape.

  In accordance with the present invention, a staple cartridge can include a cartridge body and a plurality of staples housed within the cartridge body. In use, the staple cartridge can be incorporated at the surgical site and on the side of the tissue to be 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 with respect 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 fired from the staple cartridge, and in other cases, the staples may be fired 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 be moved from the open position into contact with the tissue T and positioned to position the cartridge T relative to the cartridge body 1010, as seen in FIG. 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. is there. 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. If desired, each deformable leg 1021 may include a tip, eg, a sharp tip 1023, which is positioned within 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.

  If desired, the first layer 1011 may be composed of a buttress material and / or a plastic material, such as polydioxanone (PDS) and / or polyglycolic acid (PGA), as described in more detail below. The bilayer 1012 may be composed of a bioabsorbable foam material and / or a compressible hemostatic material, such as oxidized regenerated cellulose (ORC). If desired, one or more of the first layer 1011, the second layer 1012, the third layer 1013, and the fourth layer 1014 may hold the staples 1020 within the staple cartridge body 1010, in addition, Staples 1020 may be maintained 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 a mixture of PGA, PLA, PDS, PHA, PGCL and / or PCL sold under the trade name Monocryl, Each of the second layer 1012 and the fourth layer 1014 may 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 the cartridge body, or the cartridge body layer, can be expressed in terms of compressibility (ie, the distance at which the 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 when 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, the compression of the cartridge body 1010 and the downward movement of the tissue contacting surface 1019 causes the tip 1023 of the staple leg 1021 to penetrate the first layer 1011 of the cartridge body 1010, penetrate the tissue T, and It may enter the forming pocket 1042. 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 being, for example, as illustrated 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. If desired, the staple cartridge support 1030 may include, for example, a plurality of support features, such as staple support grooves, slots or troughs 1032, which are deformed by the staple 1020, as described in more detail below. As being done, the staples 1020 may be configured to support the staples 1020 or at least the base 1022. 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 the cavity 1015, the staple cartridge body 1010 may further include one or more voids, eg, void 1016, which may or may not include a portion of staples positioned therein. It can also be configured to allow the cartridge body 1010 to be folded. The cavity 1015 and / or cavity 1016 is a cartridge body 1010 in which the wall defining the cavity and / or wall is bent downwardly to contact the cartridge support surface 1031 and / or be positioned below the cavity and / or cavity. It is configured to collapse in contact with the 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 appreciated 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, when comparing FIG. 6C and FIG. 6D, it can be noted that the first layer 1011 and the third layer 1013 were further compressed. 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 is moved away from and / or separated from the staple cartridge 1000. Sometimes. As shown in FIG. 6D, as a result of the above, the cartridge body 1010 can be embedded with staples 1020. In various situations, the implanted cartridge body 1010 can 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 composed of, for example, ORC (oxidized regenerated cellulose), extracellular protein (eg, collagen), polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (sold under the trade name Vircyl). PDS), polyhydroxyalkanoate (PHA), polygrecapron 25 (PGCL), polycaprolactone (PCL) sold under the trade name Monocryl, and / or a mixture of PGA, PLA, PDS, PHA, PGCL and / or PCL. Or the like. 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 adhered to the first layer 1011 and the third layer 1013 adhered 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 may include one or more rivets that may extend through one or more layers of the cartridge body 1010, for example. For example, each rivet is a first end or head positioned adjacent to the first layer 1011 and a second head, which can be assembled or formed by the second end of the rivet. A second head positioned adjacent to layer 1014 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 a bioabsorbable material such as a mixture of PGA, PLA, PDS, PHA, PGCL and / or PCL. 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 are captured within the staples 1020. obtain. 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. If desired, the staple cartridge 1000 may include one or more retention mechanisms, which may be configured to engage the staple cartridge support 1030, as described in more detail below. As a result, 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 opening or cannula of about 5 mm 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, the anvil 1040 may not apply a compressive force to the staple cartridge body 1010 when the second jaw is in its partially closed intermediate position, and in some other embodiments, the second jaw is partially The anvil 1040 may compress the staple cartridge body 1010 when in the closed intermediate position. 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 positioned relative to the target tissue as described above. Sometimes.

  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 staple cartridge support 1130. Contact surface 1141 may be included, staple cartridge 1100 may include tissue contact surface 1119, and staple cartridge support 1130 may include support surface 1131, which is configured to support staple cartridge 1100. Has been. 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 back to FIG. 7B, when the layers 1111 and 1112 are compressed, the second layer 1112 can collapse and the legs 1121 of the staple 1120 can pass through the first layer 1111 and into the tissue T. Staples 1120 can be positioned at least partially within the staple cavities or voids 1115 of the second layer 1112, and when the second layer 1112 is compressed, the staple cavities 1115 are folded, resulting in the second layer 1112 being in the staple 1120. Folds 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 crushed 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. If desired, 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. If desired, such weakened portions may include, for example, scribed lines, perforations, and / or thin cross-sections, which may be aligned 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 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, equal to, or less than the original undeformed cartridge height 1102a. Sometimes. Referring now to FIG. 7D, the anvil 1140 may be moved to a final firing position where the staple 1120 is 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 in various positions (ie, for example, an intermediate position 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 midway between adjacent staples 1120 may apply pressure or compressive force to the tissue T, which may provide various therapeutic effects. .

  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 within 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 again 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 comprise a support mechanism extending therethrough and / or defined therein, for example, the base 1122 of the staple 1120 will be described in more detail below. , And may be positioned within or supported by one or more support grooves, slots, or troughs 1132 in the stem cartridge support 1130.

  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. If desired, 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. 8 and 9, the inner layer 1212 does not include a staple cavity configured to receive a portion of the staple 1220, or the inner layer 1212 can 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 applied thereto. It can be configured to allow it to be folded when The inner layer 1212 may be composed of a lyophilized foam containing, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA). The ORC is commercially available under the trade name Surgicel and may comprise loosely knitted fabrics (such as surgical sponges), loose fibers (such as cotton balls), and / or foam. 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 Or it may 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 constructed from a water impermeable, or at least substantially water impermeable material, thereby compressing the cartridge body 1210 so that the staple legs 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 now to FIGS. 10-13, staples of a staple cartridge, such as, for example, staple cartridge 4100, are staples that move by the anvil as the anvil moves to the 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 can include a driver holder 4160, a plurality of staple drivers 4162 positioned within the driver holder 4160, and a staple cartridge pan 4180 that can be configured to hold the staple drivers 4162 within 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 assist in guiding the staple driver 4162 upward toward the anvil. obtain. Staple 4120 may be supported within slot 4163 by staple driver 4162, and staple 4120 may be fully positioned within slot 4163 when staple 4120 and staple driver 4162 are in their unfired positions. is there. 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 primarily to FIG. 11, the base of the staple 4120 may be positioned within the driver holder 4160, and the distal end of the staple 4120 may be embedded within the compressible cartridge body 4110. About 1/3 of the height of the staple 4120 may be positioned in the driver holder 4160, and about 2/3 of the staple 4120 may be positioned in the cartridge body 4110. Referring to FIG. 10A, the staple cartridge 4100 may further comprise a water permeable wrap or membrane 4111 that surrounds the cartridge body 4110 and the 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 that may be advanced longitudinally within the staple cartridge 4100 such that the sled 4170 Continuously engaging the staple driver 4162, the staple driver 4162 and the 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, each of the sleds 4170 can include at least one angled or inclined surface 4711 that slides under the staple driver 4162 as illustrated in FIG. The staple driver 4162 can be configured to lift.

  Further to the above, the staple 4120 can 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 embedded cartridge body 4110. It can be removed from the cartridge body 4110. 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 is connected within the cartridge pan 4180 such that the driver holder 4160, driver 4162, and / or sled 4170 can remain within the cartridge pan 4180 when the cartridge pan 4180 is removed from the surgical site. obtain. The driver 4162 can be ejected from the driver 4160 and left at the surgical site. For example, the driver 4162 includes polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA) sold under the trade name Vircyl, and polygregal sold under the trade name Monocryl. It may be composed of a bioabsorbable material such as capron 25 (PGCL), polycaprolactone (PCL), and / or a mixture of PGA, PLA, PDS, PHA, PGCL and / or PCL. Driver 4162 can 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, the driver holder 4160 and / or sled 4170 can be ejected from the 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. In addition, the thread 4170 can move the driver holder 4160 upward to the outside of the cartridge pan 4180 as well. For example, the driver holder 4160 and / or sled 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 include bioabsorbable materials such as polygrecapron 25 (PGCL), polycaprolactone (PCL), and / or a mixture of PGA, PLA, PDS, PHA, PGCL and / or PCL sold on the market. The sled 4170 may be integrally formed and / or attached to a drive bar or cutting member that 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, It 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 such as, for example, staples having about 0.46 cm (0.18 ") may be used, and about 0.30 cm ( A staple height of 0.12 ") may be positioned within the compressible layer 4110, and the compressible layer 4110 has an uncompressed height of, for example, about 0.14" obtain.

  As described herein, a staple cartridge can have a plurality of staples therein. If desired, such staples may be comprised of a metal wire that is deformed into a substantially U-shaped configuration having two staple legs. Alternatives are envisaged where the staple may comprise a different configuration such as two or more wires joined together having three or more staple legs. The wire used to form the staples may be round or at least include a 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 in place of staples. For example, such fasteners may comprise a pivotable arm that can be folded when engaged with an anvil. A two-part fastener can 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 sled 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 are the first of the cutting member or knife slot. May be positioned on two sides. 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, the outer 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 include six rows of staples. For example, the staple cartridge may include 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 may include an odd number of staple rows. For example, the staple cartridge may include 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 can include the same or at least substantially the same unformed staple height. Alternatively, one or more staple rows may include staples having a non-formed staple height that is different from 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.

  If desired, as described above, the staple cartridge may comprise a cartridge body having a plurality of staple cavities defined therein. The cartridge body can include 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 an unfired position that does not protrude from the cartridge body and a fired position that emerges from the cartridge body and can contact an anvil that is positioned 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 a surgical stapling and cutting instrument is a co-pending and co-pending US patent application “SURGICAL STAPLING INSTRUMENTING A MULTISTROKING FIRING, the entire disclosure of which is incorporated herein by reference. “POSITION INDICATOR AND RETRACTION MECHANISM”, Ser. Details are described in 10 / 374,026. 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, the entire disclosure of which is incorporated herein by reference. HAVING SEPARATE DISTINCT CLOSEING AND FIRING SYSTEMS ”.

  As described herein, the staple cartridge may comprise means for compensating 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) comprises a rigid first portion (eg, support portion 10010) and a compressible second portion (eg, tissue thickness compensator 10020). obtain. 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 base 10031 of the staple 10030 can be supported by a staple driver disposed within the support portion 10010, as will also be described in detail below, while at the same time the staple 10030. The legs 10032 can be at least partially housed 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 staple base 10031 to form a staple capture region 10039, which is captured by the tissue T and tissue thickness compensator 10020. Can be done. In various circumstances, the staple capture region 1000039 can be defined between the inner surface of the deformed leg 10032 and the inner surface of the base 10031. The size of the staple capture area may depend on several factors such as, for example, leg length, leg diameter, base width, and / or degree of leg deformation.

  Traditionally, surgeons often have to select appropriate staples having the appropriate staple height for the tissue to which they are 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 compensate for 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) is the thickness and / or type of tissue captured within the staple capture region 10039. Accordingly, a larger portion and / or a smaller portion of the staple capture region 10030 of each staple 10030 can be occupied. For example, if thinner tissue T is captured in the staple 10030, the tissue thickness compensator 10020 captures a larger portion of the staple capture region 10039 than if the thicker tissue T is captured in the staple 10030. Can occupy. Correspondingly, when a thicker tissue T is captured in the staple 10030, the tissue thickness compensator 10020 is more in the staple capture region 10030 than when a thinner tissue T is captured in the staple 10030. It can occupy a smaller part. In this way, the tissue thickness compensator can compensate for thinner and / or thicker tissue and compresses independently or at least substantially independent of the tissue thickness captured in the staples. Pressure can be applied to the tissue. In addition to the above, the tissue thickness compensator 10020 can compensate for various types or compressibility of the 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 the flow, the desired compression pressure can be applied to the surrounding tissue T. In various situations, in addition to the above, the tissue thickness compensator 10020 can also compensate for 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 may capture staples defined within such a malformed staple 10030. Even when region 10039 is increasing, sufficient compression pressure can still be applied to 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 compensate 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 staples can be used regardless of the thickness of tissue captured within the staples. 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 region 10039. With reference to FIG. 57, a portion of the tissue thickness compensator 10020 is captured within the staple 10030 to compress the tissue T and occupy 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 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 0.246 cm (0.097 ″). The height H is also dependent 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, if desired, the staple cartridge 10000 can further include a staple driver, as will be described in detail below, which is staple 10030. Can be lifted toward the anvil, and in at least one embodiment, 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 0.071 "(0.028"), thereby forming the staple 10030, for example, to a height of about 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. The staple 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 capturing area of the staple can be determined by the formation height of the staple and the width (or diameter) of the wire constituting the staple. The height of the staple capture region 10030 of the staple 10030 can be the staple formation height H minus twice the diameter width of the wire. The staple wire can have a diameter of, for example, about 0.0226 cm (0.0089 ″). The staple wire can be, for example, from about 0.0069 ″ to about 0.0119 cm (about 0.0175 cm to about 0.0302 cm). For example, the forming height H of the staple 10030 may be about 0.480 cm (0.189 ") and the staple wire diameter is about 0.0226 cm (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 may comprise, for example, an uncompressed height of about 0.318 cm (0.125 ″). The tissue thickness compensator may be, for example, about 0.003 ″ or greater. Of uncompressed height. The tissue thickness compensator can 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 60 than the unfired staple height. %, 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 unfired staple height. The uncompressed (or pre-deployment) height of the tissue thickness compensator may be, for example, 100% or more higher than the unfired staple height. The tissue thickness compensator may comprise an uncompressed height equal to the unfired height of the staple. The tissue thickness compensator may comprise an uncompressed height that is less than the unfired height of the staple. 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. This compressible second portion may have an uncompressed height that is higher than the uncompressed height of the tissue T to be stapled. This tissue thickness compensator may have an uncompressed height equal to the uncompressed height of the tissue T to be stapled. This tissue thickness compensator may have an uncompressed height that is shorter 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 can be deformed such that the staple capture area of each staple includes a height of, for example, about 2.0 mm, and the tissue T and tissue thickness compensator are at this height. Can be compressed within. In certain circumstances, for example, tissue T may include a compressed height of about 1.75 mm in the staple capture area, while a tissue thickness compensator may have a compressed height of about 0.25 mm in the staple capture area. This results in a staple capture area height of about 2.0 mm in total. In certain circumstances, for example, tissue T may include a compressed height of about 1.50 mm in the staple capture region, while a tissue thickness compensator has a compressed height of about 0.50 mm in the staple capture region. This can result in a staple capture area height of about 2.0 mm in total. In certain circumstances, for example, tissue T may include a compressed height of about 1.25 mm in the staple capture region, while a tissue thickness compensator has a compressed height of about 0.75 mm in the staple capture region. This can result in a staple capture area height of about 2.0 mm in total. In certain circumstances, for example, tissue T may include a compressed height of about 1.0 mm in the staple capture region, while a tissue thickness compensator has a compressed height of about 1.0 mm in the staple capture region. This can result in a staple capture area height of about 2.0 mm in total. In certain circumstances, for example, tissue T may include a compressed height of about 0.75 mm in the staple capture region, while a tissue thickness compensator has a compressed height of about 1.25 mm in the staple capture region. This can result in a staple capture area height of about 2.0 mm in total. In certain circumstances, for example, tissue T may include a compressed height of about 1.50 mm in the staple capture region, while a tissue thickness compensator has a compressed height of about 0.50 mm in the staple capture region. This can result in a staple capture area height of about 2.0 mm in total. In certain circumstances, for example, tissue T may include a compressed height of about 0.25 mm in the staple capture region, while a tissue thickness compensator has a compressed height of about 1.75 mm in the staple capture region. This can result in a staple capture area height of about 2.0 mm in total.

  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 fired height of the staple. The tissue thickness compensator may comprise an uncompressed height that is higher than the fired height of the staple. For example, the uncompressed height of the tissue thickness compensator is, for example, about 110% of the formed staple height, about 120% of the formed staple height, about 130% of the formed staple height, About 140% of the height, about 150% of the formed staple height, about 160% of the formed staple height, about 170% of the formed staple height, about 180% of the formed staple height, formed staple It may comprise a thickness of about 190% of the height and / or about 200% of the formed staple height. The tissue thickness compensator can have an uncompressed height that is more than twice as high as the fired height of the staple. The tissue thickness compensator can include, for example, a compressed height of about 85% to about 150% of the formed staple height. If desired, 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 about 40% of the uncompressed thickness. 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 about 90% of the uncompressed thickness. obtain. 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 thicker 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 may elastically expand between the tissue T and the staple base 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 region.

  This tissue thickness compensator is, for example, biocompatible, bioabsorbable, bioresorbable, biodurable, biodegradable, compressible, fluid absorbable, swellable, self-expandable, bioactive, drug, Material characterized by one or more of the following properties: pharmaceutical activity, antiadhesive, hemostatic, antibiotic, antibacterial, antiviral, nutritional, adhesive, penetrating, hydrophilic and / or hydrophobic Can be included. In accordance with the present invention, a surgical instrument comprising an anvil and a staple cartridge includes at least one or more hemostatic agents (eg, fibrin and thrombin), antibiotics (eg, doxycycline, and drugs (eg, matrix metalloprotease (MMP)). A tissue thickness compensator associated with the anvil and / or staple cartridge.

  The tissue thickness compensator can include synthetic and / or non-synthetic materials. The tissue thickness compensator can include a polymer composition that includes 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 can include, for example, a biocompatible foam. The biocompatible foam can include, for example, a porous open cell foam and / or a porous closed cell foam. The biocompatible foam may have a uniform pore morphology or a gradient pore morphology (ie, gradually increasing from small to large pores in one direction across the thickness of the foam). You may do it. The polymer composition comprises a porous scaffold, a porous matrix, a gel matrix, a hydrogel solution, 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, the tissue thickness compensator may include a foam reinforced with a fibrous matrix and also includes a foam having an additional hydrogel layer that expands in the presence of body fluid to provide further compression to the tissue. But you can. In accordance with the present invention, the tissue thickness compensator may further comprise a coating on the material and / or a second or third layer that expands in the presence of body fluid to provide further pressure on the tissue. May be included. 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 can comprise a microgel or a nanogel. The hydrogel may include carbohydrate-derived microgels and / or nanogels. The tissue thickness compensator can be reinforced with, for example, a fibrous nonwoven material or a fibrous mesh type component that can provide additional flexibility, synthesis, and / or strength. According to the present invention, the tissue thickness compensator has a porous form, which exhibits, for example, a gradient structure with small pores on one surface and larger pores on the other surface. Such a form may be more optimal for growing tissue or hemostasis treatment. Furthermore, this gradient can be configured with various bioabsorbable profiles. A short-term absorption profile may be preferable for hemostasis management, while a long-term absorption profile may 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, hydroxyethyl cellulose, cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC) , Hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitan, chitosan, casein, alginate, and combinations thereof, but are not limited thereto.

  Examples of synthetic absorbent 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 (PGCL), copolymer of 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 polyiminoca Bonate, tyrosine-based polycarbonate, poly (D, L-lactide-urethane), poly (hydroxybutyrate), poly (B-hydroxybutyrate), poly (E-caprolactone), polyethylene glycol (PEG), poly [bis ( Carboxylatophenoxy) phosphazene] poly (amino acid), pseudopoly (amino acid), absorbent polyurethane, poly (phosphazine), polyphosphazene, polyalkylene oxide, polyacrylamide, polyhydroxyethyl methyl acrylate, polyvinyl pyrrolidone, polyvinyl alcohol, poly ( Caprolactone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerol, copoly (ether-ester), polyalkylene oxalate, polyamide, poly (imino Carbonate), polyalkylene oxalate, and combinations thereof, but are not limited thereto. The polyester may be selected from the group consisting of polylactide, polyglycolide, trimethylene carbonate, polydioxanone, polycaprolactone, polybutester, and combinations thereof.

  Synthetic absorbent polymers are, for example, 90/10 poly (glycolide-L-lactide) copolymer (commercially available from Ethicon, Inc. under the tradename VICRYL (polyglactic 910)), polyglycolide (trade name from American Cyanamid Co.). Commercially available as DEXON), polydioxanone (commercially available under the trade name PDS from Ethicon, Inc.), poly (glycolide-trimethylene carbonate) random block copolymer (commercially available from American Cyanamid Co. as trade name MAXON), 75/25 poly (glycolide- One or more of ε-caprolactone-polygrecaprolactone 25) copolymer (commercially available from Ethicon under the trade name MONOCRYL) may be included.

  Examples of synthetic non-absorbable materials include polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate, polyamide (eg, nylon), polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), polystyrene (PS), Polyester, polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCCE), polyvinyl fluoride (PVF), fluorinated ethylene propylene (FEP), polyacetal, polysulfone, silicone (silicons) , And combinations thereof, but are 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 include expanded polytetrafluoroethylene (ePTFE) (commercially available from WL Gore & Associates, Inc. under the trade name GORE-TEX soft tissue patch) and co-polyether ester urethane foam (under the trade name NASOPORE from Polyganics). Commercially available).

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

  The synthetic absorbable polymer may include a bioabsorbable and biocompatible elastomer copolymer. Suitable bioabsorbable, biocompatible elastomeric copolymers are copolymers of ε-caprolactone and glycolide (preferably having a molar ratio of ε-caprolactone to glycolide of about 30:70 to about 70:30, preferably 35: 65 to about 65:35, most preferably 45:55 to 35:65); elastomeric copolymers of ε-caprolactone and lactide (including L-lactide, D-lactide, blends thereof, or lactic acid copolymers) (preferably Has a molar ratio of ε-caprolactone to lactide of about 35:65 to about 65:35, more preferably 45:55 to 30:70); p-dioxanone (1,4-dioxane-2-one) and lactide Elastomer copolymer (preferably p-dioxanone, including L-lactide, D-lactide, and lactic acid) A molar ratio of lactide of about 40:60 to about 60:40); an elastomeric copolymer of ε-caprolactone and p-dioxanone (preferably a molar ratio of ε-caprolactone to p-dioxanone of about 30:70 to about 70:30); elastomeric copolymer of p-dioxanone and trimethylene carbonate (preferably the molar ratio of p-dioxanone to trimethylene carbonate is from about 30:70 to about 70:30); elastomeric copolymer of trimethylene carbonate and glycolide ( Preferably, the molar ratio of trimethylene carbonate to glycolide is about 30:70 to about 70:30); an elastomer of trimethylene carbonate and lactide (including L-lactide, D-lactide, blends thereof, or lactic acid copolymers) Copolymer (preferably the molar ratio of trimethylene carbonate to lactide is 30: including 70 to about 70:30) and blends thereof, and the like. The elastomeric copolymer may comprise a copolymer of glycolide and ε-caprolactone. Alternatively, the elastomeric copolymer may comprise 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 can include an emulsifier. Examples of emulsifiers include water-soluble polymers such as, for example, polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyethylene glycol (PEG), polypropylene glycol (PPG), PLURONICS, TWEENS, polysaccharides, and combinations thereof. Can be, but is not limited to.

  The tissue thickness compensator can include a surfactant.

  Examples of surfactants include polyacrylic acid, metalose, methyl cellulose, ethyl cellulose, propyl cellulose, hydroxyethyl cellulose, carboxy group methyl cellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octyl Phenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether, polyoxyethylene nonyl phenyl ether, dialkylphenoxy poly (ethyleneoxy) ethanol, and polyoxamers may be included, but are not limited to these Not.

  The polymer composition can include a pharmaceutically active agent. The polymer composition can release a therapeutically effective amount of the pharmaceutically active agent. The pharmaceutically active agent can be released as the polymer composition is desorbed / adsorbed. The pharmaceutically active agent can be released into a liquid (eg, blood) that passes over or through the polymer composition. Examples of this pharmaceutically active agent include hemostatic agents and agents (eg, fibrin, thrombin, and oxidized regenerated cellulose (ORC)), anti-inflammatory agents (eg, diclofenac, aspirin, naproxen, sulindac, and hydrocortisone), antibiotics And antimicrobial agents or agents (eg, triclosan, silver ions, ampicillin, gentamicin, polymyxin B, chloramphenicol), and anti-cancer agents (eg, cisplatin, mitomycin, adriamycin).

  The polymer composition can include a hemostatic material. This tissue thickness compensator is made of poly (lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (caprolactone), poly (dioxanone), polywalken oxide, copoly (ether-ester), collagen, gelatin , Thrombin, fibrin, fibrinogen, fibronectin, elastin, albumin, hemoglobin, ovalbumin, polysaccharide, hyaluronic acid, chondroitin sulfate, hydroxyethyl starch, hydroxyethylcellulose, cellulose, oxidized cellulose, hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitan , Chitosan, agarose, maltose, maltodextrin, alginate, coagulation factor, methacrylate resin, polyurethane, cyano Chryrate, antiplatelet drug, vasoconstrictor, alum, calcium, RGD peptide, protein, protamine sulfate, ε-aminocaproic acid, ferric sulfate, basic ferric sulfate, ferric chloride, zinc, zinc chloride, chloride Hemostatic materials including aluminum, aluminum sulfate, aluminum acetate, permanganate, tannin, bone wax, polyethylene glycol, fucan, and combinations thereof may be included. This tissue thickness compensator can be characterized by hemostatic properties.

  The polymer composition of the tissue thickness compensator can be characterized, for example, by percent porosity, pore size, and / or hardness. The polymer composition can have, for example, a percent porosity of about 30% to about 99% by volume. The polymer composition can have a percent porosity of, for example, about 60% to about 98% by volume. The polymer composition can have a percent porosity of, for example, from about 85% to about 97% by volume. The polymer composition can include, for example, about 70% by weight PLLA and about 30% by weight PCL, for example, can have a porosity of about 90% by volume. For example, as a result, the polymer composition may comprise about 10% by volume of copolymer. The polymer composition can include, for example, about 65% by weight PGA and about 35% by weight PCL, and can have, for example, a porosity of about 93% to about 95% by volume. The polymer composition can have a porosity greater than 85%. The polymer composition can have a pore size of, for example, from about 5 micrometers to about 2000 micrometers. The polymer composition can have a pore size of, for example, from about 10 micrometers to about 100 micrometers. The polymer composition can include, for example, a copolymer of PGA and PCl. The polymer composition can have, for example, a pore size of about 100 micrometers to about 1000 micrometers. 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 may be measured according to any suitable scale, for example type A and / or type OO, according to ASTM D2240-00. The polymer composition of the tissue thickness compensator can have, for example, 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 can have a Shore A hardness value of less than 15A. The polymer composition of the tissue thickness compensator can have a Shore A hardness value of less than 10A. The polymer composition of the tissue thickness compensator can have a Shore A hardness value of less than 5A. The polymer composition can have a Shore OO composition value of, for example, from about 35 OO to about 75 OO.

  The polymer composition can have at least two of the properties described above. The polymer composition can 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 have. The polymer composition includes, for example, 70% by weight PLLA polymer composition and 30% by weight PCL polymer composition, 90% by volume porosity, 100 micrometer to 1000 micrometer pore size, and 4A to It may have a Shore A hardness of 16A and a Shore OO hardness value of 45 OO to 65 OO. This polymer composition comprises, for example, 65% by weight PGA polymer composition and 35% by weight PCL polymer composition, with a porosity of 93% to 95% by volume and a pore size of 10 to 100 micrometers. And a Shore A hardness of 4A-16A, and a Shore OO hardness value of 45OO-65OO.

  The tissue thickness compensator can include an expanding material. As described above, the tissue thickness compensator can include a compressed material that expands when uncompressed or deployed, for example. The tissue thickness compensator can include a self-expanding material formed in situ. The tissue thickness compensator can include at least one precursor selected to spontaneously crosslink when contacted with other precursors, water, and / or body fluids. Referring to FIG. 205a, the first precursor may be contacted with one or more other precursors to form an expandable and / or swellable tissue thickness compensator. The tissue thickness compensator can include a fluid swellable composition, such as, for example, a water swellable composition. The tissue thickness compensator can include a water-containing gel.

  Referring to FIGS. 189A and B, for example, to expand the tissue thickness compensator 70000, the tissue thickness compensator 70000 is selected to form a hydrogel in situ and / or in vivo. A body 70010 may be included. FIG. 189A shows a tissue thickness compensator 70000 that includes a capsule that includes a first hydrogel 70010A and a second hydrogel precursor 70010B prior to expansion. As shown in FIG. 189A, the first hydrogel precursor 70010A and the second hydrogel precursor 70010B can be physically separated from each other in the same capsule. The first capsule can include a first hydrogel precursor 70010A and the second capsule can include a second hydrogel precursor 70010B. FIG. 189B shows the expansion of the tissue thickness compensator 70000 when the hydrogel is formed in situ and / or in vivo. As shown in FIG. 189B, the capsule can be ruptured such that the first hydrogel precursor 70010A can contact the second hydrogel precursor 70010B to form a hydrogel 70020. The hydrogel can include an expandable material. The hydrogel can swell for up to 72 hours, for example.

  The tissue thickness compensator can include a biodegradable foam having capsules containing dry hydrogel particles or granules embedded therein. Without being bound to a particular theory, capsules within a foam can be formed by contacting an aqueous solution of a hydrogel precursor with an organic solution of a biocompatible material to form the foam. As shown in FIG. 206, the aqueous solution and the organic solution can form micelles. The aqueous and organic solutions can be dried to encapsulate the dried hydrogel particles or granules within the foam. For example, a hydrogel precursor (eg, a hydrophilic polymer) can be dissolved in water to form a micelle dispersion. This aqueous solution can be contacted with an organic solution of dioxane containing poly (glycolic acid) and polycaprolactone. The aqueous and organic solutions can be lyophilized to form a biodegradable foam having dispersed dry hydrogel particles or granules. Without being bound to a particular theory, it is believed that the micelles can form capsules with dry hydrogel particles or granules dispersed within the foam structure. The capsule can be ruptured to allow the dried hydrogel particles or granules to expand in contact with a fluid (eg, body fluid).

The tissue thickness compensator can expand upon contact with an activator such as, for example, a fluid. Referring to FIG. 190, for example, the tissue thickness compensator 70050 can include a swellable material (eg, hydrogel), which can be a fluid 70055 (eg, body fluid, saline, water, and / or activator, etc.). It expands when touching. Examples of body fluids can include blood, plasma, ascites, cerebrospinal fluid, urine, lymph, synovial fluid, vitreous humor, saliva, gastrointestinal lumen contents, bile, and / or gas (eg, CO ₂ ). However, it is not limited to these. The tissue thickness compensator 70050 can expand when the tissue thickness compensator 70050 absorbs bodily fluids. In another example, the tissue thickness compensator 70050 can include a non-crosslinked hydrogel that forms a crosslinked hydrogel and expands upon contact with an activator 70055 that includes a crosslinker. This tissue thickness compensator can expand upon contact with an activator. This tissue thickness compensator will expand or swell upon contact for up to 72 hours, for example, 24-72 hours, up to 24 hours, up to 48 hours, and up to 72 hours, and continuously increase pressure against the tissue. And / or may provide compression. As shown in FIG. 190, the initial thickness of the tissue thickness compensator 70050 may be less than the expanded thickness after the fluid 70055 contacts the tissue thickness compensator 70050.

  Referring to FIGS. 187 and 188a, a staple cartridge 70100 can include a tissue thickness compensator 70105 and a plurality of staples 70110, each including a staple leg 70112. As shown in FIG. 187, the tissue thickness compensator 70105 can have an initial thickness or a compressed height that is less than the fired height of the staple 70110. The tissue thickness compensator 70100 expands in situ and / or in vivo upon contact with fluid 70102 (eg, body fluid, saline, and / or activator, etc.) relative to the legs 70112 of the staple 70110. The tissue T can be pressed. As shown in FIG. 188, the tissue thickness compensator 70100 can expand and / or swell upon contact with the fluid 70102. The tissue thickness compensator 70105 may compensate for the thickness of the tissue T captured within each staple 70110. As shown in FIG. 188, the tissue thickness compensator 70105 can have an expanded thickness or an uncompressed height that is less than the fired height of the staple 70110.

  If desired, as described above, the tissue thickness compensator can include 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, and 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, It may be about 70% of the expanded thickness, about 80% of the expanded thickness, and / or about 90% of the expanded thickness. The expanded thickness of the tissue thickness compensator is, 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, It can be about 500 times, about 600 times, about 700 times, about 800 times, about 900 times, and / or about 1000 times thicker. The initial thickness of the tissue thickness compensator can be up to 1%, up to 5%, up to 10%, and up to 50% of the expanded thickness. The expanded thickness of the tissue thickness compensator may be 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. 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 region.

  As described above, the tissue thickness compensator can include a hydrogel. The hydrogel can include homopolymer hydrogels, copolymer hydrogels, multipolymer hydrogels, interpenetrating polymer hydrogels, and combinations thereof. The hydrogel can include microgels, nanogels, and combinations thereof. The hydrogel may include a hydrophilic polymer network that can absorb and / or retain fluid. The hydrogel can include non-crosslinked hydrogels, crosslinked hydrogels, and combinations thereof. The hydrogel may include chemical crosslinks, physical crosslinks, hydrophobic portions, and / or water insoluble portions. The hydrogel can be chemically crosslinked by polymerization, small molecule crosslinking, and / or polymer-polymer crosslinking. The hydrogel can be physically cross-linked by ionic interactions, hydrophobic interactions, hydrogen bonding interactions, steric complexation, and / or supramolecular chemistry. The hydrogel may be substantially insoluble due to cross-linking, hydrophobic portions, and / or insoluble portions, but may be expandable and / or swellable due to fluid absorption and / or retention. This precursor may crosslink with endogenous material and / or tissue.

  The hydrogel can include an environmentally sensitive hydrogel (ESH). The ESH can include materials having fluid swelling properties that are related 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 can swell or shrink in response to, for example, temperature, pH, electric field, ionic strength, enzymatic and / or chemical reactions, electrical and / or magnetic stimuli, and other physiological and environmental variables. . The ESH can include multifunctional acrylates, hydroxyethyl methacrylate (HEMA), elastomeric acrylates, and related monomers.

  The tissue thickness compensator comprising the 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 can include multiple layers. The plurality of layers can include a porous layer and / or a non-porous layer. For example, the tissue thickness compensator can include a non-porous layer and a porous layer. In another example, the tissue thickness compensator can include a porous layer between the first non-porous layer and the second non-porous layer. In another example, the tissue thickness compensator can include a non-porous layer between the first porous layer and the second porous layer. The non-porous layer and the porous layer can be disposed in any order relative to the surface of the staple cartridge and / or anvil.

  Examples of this non-synthetic material include albumin, alginate, carbohydrates, 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 can include hydroxyethyl cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, and combinations thereof. The collagen can include bovine pericardium. The carbohydrate can include a polysaccharide (eg, a lyophilized polysaccharide). The protein can include glycoproteins, proteoglycans, and combinations thereof.

  Examples of this synthetic material include poly (lactic acid), polyglycolic acid, poly (hydroxybutyrate), poly (phosphadine), 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 (dioxane), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerol, poly (amino acid) ), Copoly (ether ester), polyalkylene oxalate, polyamide, poly (imino carbonate), polyoxa ester, polyorthoester, poly Sufazen, and combinations thereof may include, but are not limited to. The non-synthetic material can be prepared synthetically, eg, synthetic hyaluronic acid, using conventional methods.

The hydrogel can be made from one or more hydrogel precursors. This precursor may comprise monomers and / or macromers. The hydrogel precursor may include electrophilic functional groups and / or nucleophilic electrophilic functional groups. In general, electrophilic species can react with nucleophilic species to form bonds. As used herein, the term “functional group” refers to an electrophilic or nucleophilic group that can react 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, succinimid Esters (eg, succinimidyl succinate and / or succinimidyl propionate), isocyanates, thiocyanates, carbodiimides, benzotriazoles, carbonates, epoxides, aldehydes, maleimides, imide esters, combinations thereof, and the like Can be mentioned, but is not limited to these. Electrophilic functional groups can include succinimidyl esters. Examples of nucleophilic functional _{groups, -NH 2, -SH, -OH,} -PH 2, and -CO-NH-NH ₂ but may include, but are not limited to.

  The hydrogel can be formed from a single precursor or multiple precursors. The hydrogel can 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. The hydrogel precursor can generally refer to a polymer, functional group, macromolecule, small molecule, and / or crosslinker that can be oxidized to the reaction that forms the hydrogel. The precursor may include a homogeneous solution, a heterogeneous solution, or a phase separation solution in a suitable solvent (eg, water or buffer). The buffer may have a pH of about 8 to about 12, for example, about 8.2 to about 9. Examples of buffers may include, but are not limited to, borate buffer. The precursor can be an emulsion. In accordance with the present invention, the first precursor can react with the second precursor to form a hydrogel. The first precursor can spontaneously crosslink when contacted with the second precursor. In accordance with the present invention, the first group of electrophilic functional groups of the first precursor may react with the second group of nucleophilic functional groups of the second precursor. When the precursor is mixed with 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. When at least a portion of this precursor reacts with a plurality of other precursors, the precursor can be crosslinked.

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

The tissue thickness compensator can include a cross-linking agent. The crosslinking agent is a low molecular weight divinyl or polyvinyl crosslinking agent (e.g., ethylene glycol diacrylate or dimethacrylate, di- -, tri -, or tetraethylene glycol diacrylate or dimethacrylate, allyl (meth) acrylate, C ₂ -C ₈ -Alkylene diacrylate or dimethacrylate, divinyl ether, divinyl sulfone, di- and trivinylbenzene, trimethylolpropane triacrylate or trimethacrylate, pentaerythritol tetraacrylate or tetramethacrylate, bisphenol A diacrylate or dimethacrylate, methylene bisacrylamide or Bismethacrylamide, ethylenebisacrylamide or ethylenebismethacrylamide, triallyl phthalate or diallyl The cross-linking agent can include N, N′-methylenebisacrylamide (“MBAA”).

  This tissue thickness compensator includes acrylate and / or methacrylate functional hydrogels, biocompatible photoinitiators, alkyl-cyanoacrylates, isocyanate functional macromers (optionally including amine functional macromers), succinimidyl ester functional groups Macromers (optionally containing amine and / or sulfhydryl functional macromers), epoxy functional macromers (optionally containing amine functional macromers) Protein and / or polypeptide and aldehyde crosslinkers, genipin, and water soluble carbodiimides , An anionic polysaccharide, and a polyvalent cation.

  The tissue thickness compensator can include unsaturated organic acid monomers, acrylic substituted alcohols, and / or acrylamide. This tissue thickness compensator includes methacrylic acid, acrylic acid, glycerol acrylate, glycerol methacrylate, 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, 2- (dimethylaminoethyl) methacrylate, N-vinylpyrrolidone, methacrylamide, and And / or N, N-dimethylacrylamide poly (methacrylic acid).

  The tissue thickness compensator can include a reinforcing material. The reinforcing material may include at least one of the non-synthetic materials and synthetic materials described above. This reinforcing material is collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethylcellulose, cellulose, oxidized cellulose, hydroxypropylcellulose, carboxyethylcellulose, carboxymethylcellulose, chitan, chitosan, alginate, poly (lactic acid), poly (lactic acid) Glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, polyhydroxyethylmethyl acrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly (caprolactone), poly (dioxanone), Polyacrylic acid, polyacetate, polycaprolactone, polypropylene, aliphatic polyester, grease Roll, poly (amino acids), copoly (ether - ester), polyalkylene oxalates, polyamides, poly (imino carbonates), polyalkylene oxalates, polyoxaesters, polyorthoesters, may include polyphosphazene, and combinations thereof.

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

  The reinforcing material can include mesh, single filament, multifilament braid, fiber, mat, felt, particles, and / or powder. This reinforcing material can be incorporated into a layer of tissue thickness compensator. This reinforcing material can 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 bobbin lace knitting. The present invention allows multiple reinforcement materials to be oriented in an irregular direction and / or a common direction. The common direction can be, for example, a direction parallel to the staple line and a direction perpendicular to the staple line. For example, single filament and / or multifilament braids may be oriented in irregular directions and / or common directions. This single filament and / or multifilament braid may be associated with a non-porous layer and / or a porous layer. The tissue thickness compensator can include a plurality of reinforcing fibers oriented in an irregular direction within the non-porous layer. The tissue thickness compensator can include a plurality of reinforcing fibers oriented in a common direction within the non-porous layer.

  Referring to FIG. 199, the anvil 70300 can include a tissue thickness compensator 70305 that includes a first non-porous layer 70307 and a second non-porous layer 70309 hermetically confining the reinforcing layer 70310. The reinforcing layer 70310 can comprise a hydrogel comprising ORC particles or fibers embedded therein, and the non-porous layer can comprise ORC. As shown in FIG. 199, the tissue thickness compensator 70305 can be configured to closely follow the contour of the anvil 70300. The inner layer of the tissue thickness compensator 70305 is closely aligned with the inner layer of the anvil 70300, which may include a forming pocket 70301.

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

  This tissue thickness compensator can be formed in situ. The hydrogel can be formed in situ. This tissue thickness compensator can be formed in situ by covalent, ionic, and / or hydrophobic bonds. Physical (non-covalent) crosslinking can occur by complexation, hydrogen bonding, desolvation, van der Waals interactions, ionic bonding, and combinations thereof. Chemical (covalent) crosslinking is achieved by any of a number of mechanisms, including free radical polymerization, condensation polymerization, anionic or cationic polymerization, step growth polymerization, electrophilic-nucleophilic reaction, and combinations thereof. be able to.

  Optionally, in situ formation of the tissue thickness compensator includes reacting two or more precursors that are physically separated until in situ contact and / or is responsive to environmental conditions. Can react with each other to form a hydrogel. In situ polymerization can be prepared from precursors that can react at the surgical site to form a polymer. This tissue thickness compensator can be formed by an in situ crosslinking reaction of the precursor. The precursor may include an initiator that can initiate a polymerization reaction for the formation of a tissue thickness compensator in situ. The tissue thickness compensator can include a precursor that can be activated at the time of application to produce a crosslinked hydrogel. In situ formation of the tissue thickness compensator can include activating at least one precursor to produce a bond that forms the tissue thickness compensator. If desired, activation can be achieved by changes in physical, biological, and / or chemical conditions at the surgical site, including temperature, pH, electric field, ionic strength, enzyme and Examples include, but are not limited to, chemical reactions, electrical and / or magnetic stimuli, and other physiological and environmental variables. This precursor can be introduced into the surgical site after contact outside the body.

  The tissue thickness compensator can include one or more capsules or cells, which can be configured to store at least one component therein. The capsule can be configured to store the hydrogel precursor therein. The capsule can be configured, for example, to store two components therein. The capsule can be configured to store therein a first hydrogel precursor and a second hydrogel precursor. The first capsule may be configured to store a first hydrogel precursor therein and the second capsule may be configured to store a second hydrogel precursor therein. As described above, the capsule can be aligned with, or at least substantially aligned with, the staple leg, thereby puncturing and / or otherwise capsulating the capsule when the staple leg contacts the capsule. It can be ruptured by the method. The capsule can be compressed, crushed, crushed, and / or otherwise ruptured when the staples are deployed. After the capsule ruptures, the ingredients stored in it can flow out of the capsule. The components stored therein may contact other components, the layer of tissue thickness compensator, and / or the tissue. Other ingredients may flow out of the same or another capsule provided within the layer of tissue thickness compensator and / or be delivered to the surgical site by the clinician. As a result of the above, the ingredients stored in the capsule can provide for the expansion and / or swelling of the tissue thickness compensator.

  The tissue thickness compensator can include a layer that includes the capsule. The capsule may include voids, pockets, domes, tubes, or combinations thereof associated with the layer. The capsule can include voids in the layer. This layer can include two layers that can be attached to each other and the capsule can be defined between the two layers. The capsule may include a dome over the surface of the layer. For example, at least a portion of the capsule can be placed in a dome that extends upward from the layer. The capsule can include pockets formed in the layer. The first portion of the capsule can include a dome and the second portion of the capsule can include a pocket. The capsule can include a tube embedded in the layer. The tube may include non-synthetic material and / or synthetic material (eg, PLA) as described herein. The tissue thickness compensator can include a bioabsorbable foam (eg, ORC) that includes a PLA tube embedded therein, which can encapsulate, for example, a hydrogel. The capsule may contain separate cells that are not connected to each other. One or more capsules may be in fluid communication with each other, eg, through one or more paths, conduits and / or channels that extend through the layers.

  The release rate of the component from the capsule can be, for example, the thickness of the tissue thickness compensator, the composition of the tissue thickness compensator, the size of the component, the hydrophilicity of the component, and / or the component, tissue thickness of the compensator. It can be controlled by physical and / or chemical interaction between the composition and / or surgical instrument. This layer may include one or more thin sections or weakened portions, eg, partial perforations, which can facilitate incision of the layer and rupture of the capsule by the legs. Partial perforations may not penetrate completely through the layer, and in some cases may penetrate completely through the layer.

  Referring to FIGS. 194 and 195a, the tissue thickness compensator 70150 can include an outer layer 70152A and an inner layer 70152B that include capsules 70154. The capsule can include a first encapsulated component and a second encapsulated component. The capsule can independently include one of a first encapsulated component and a second encapsulated component. The first encapsulated component can be separated from the second encapsulated component. This outer layer 70152A can include a tissue contacting surface. This inner layer 70152B can include an instrument contacting surface. Instrument contact surface 70152B can be releasably attached to anvil 70156. Outer layer 70152A may be attached to inner layer 70152B and may define a gap between outer layer 70152A and inner layer 70152B. As shown in FIG. 194, each capsule 70154 may include a dome on the instrument contacting surface of the inner layer 70152B. The dome may include partial perforations to facilitate layer piercing and capsule rupture by the staple legs. As shown in FIG. 195, the anvil 70156 can include a plurality of forming pocket rows 70158, and the dome of the capsule 70154 can be aligned with the forming pocket 70158. The tissue contacting surface may include a flat surface without a dome. The tissue contacting surface may include one or more capsules, such as capsule 70154 extending from the surface, for example.

  If desired, the anvil can include a tissue thickness compensator that includes an encapsulating component that includes at least one spherical particle. The tissue thickness compensator can include a capsule that includes a first encapsulating component and a second encapsulating component. The tissue thickness compensator can include a capsule comprising first microsphere particles and second microsphere particles.

  Referring to FIG. 196, the stapling apparatus can include an anvil 70180 and a staple cartridge (shown in another figure). The staple 70190 of the staple cartridge can be deformed by the anvil 70180 when the anvil 70180 is closed and / or by the staple driver system 70192 that moves the staple 70190 toward the closed anvil 70180. Staple legs 70194 contact anvil 70180, which causes staple 70190 to be at least partially deformed. Anvil 70180 can include a tissue thickness compensator 70182 that includes an outer layer 70183A and an inner layer 70183B. The tissue thickness compensator 70182 can include a first encapsulation component and a second encapsulation component. Capsule 210185 is positioned so that when staple legs 70194 are pushed through tissue T and outer layer 70183A, staple legs 70194 can puncture and / or otherwise rupture capsule 70185. Can be aligned or at least substantially aligned. As shown in FIG. 196, staple 70190C is in a fully fired position, staple 70190B is in the process of being fired, and staple 70190A is in an unfired position. The legs of staples 70190C and 70190B travel through tissue T, outer layer 70183A of tissue thickness compensator 70182, and inner layer 70183B and contact anvil 70180 disposed on the opposite side of the staple cartridge. When the capsule 70185 ruptures, the encapsulated components flow out and can come into contact with each other, for example, body fluid and / or tissue T. The encapsulating component can react to form a reaction product, such as, for example, a hydrogel, causing the tissue T to expand between the staple base and press the tissue T against the staple legs. it can. In various situations, as a result of the above, the tissue thickness compensator can be configured to fill any gaps in the staple capture region.

  This tissue thickness compensator may be suitable for use with surgical instruments. As described 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 to fit a staple cartridge and / or anvil. As described above, the tissue thickness compensator can be releasably attached to a staple cartridge and / or an anvil. The tissue thickness compensator can be in any mechanical and / or chemical aspect such that contact between the tissue thickness compensator and the staple cartridge and / or anvil can be maintained before and during the staple process. It can be attached to a staple cartridge and / or an anvil. The tissue thickness compensator can be removed or released from the staple cartridge and / or anvil after the staple has been punctured into 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 leaves the tissue thickness compensator.

  Referring to FIGS. 191-193, the stapling device 70118 can include an anvil 70120 and a 70130 staple cartridge 70122 that includes a firing member 70124, a plurality of staples 70128, a knife edge 70129, and a tissue thickness compensator. The tissue thickness compensator 70130 can include at least one encapsulating component. This encapsulated component may rupture when the tissue thickness compensator is compressed, stapled, and / or cut. Referring to FIG. 192, for example, the staple 70128 has legs that move through the tissue thickness compensator 70130, penetrates the lower and upper surfaces of the tissue thickness compensator 70130, enters the tissue T, and staples. It can be deployed between an unfired position and a fired position so as to contact an anvil 70120 disposed relative to cartridge 70118. The encapsulating components may react with each other and / or hydrophilic powders embedded or dispersed within the tissue thickness compensator and / or with body fluids to expand or swell the tissue thickness compensator 70130. As the legs are deformed against the anvil, each staple leg captures a portion of tissue thickness compensator 70130 and a portion of tissue T within each staple 70128 and applies a compressive force to the tissue T. You can hang it. As shown in FIGS. 192 and 193, the tissue thickness compensator 70130 can compensate for the thickness of the tissue T captured within each staple 70128.

  Referring to FIG. 197, a surgical instrument 70200 can include an anvil 70205 that includes an upper tissue thickness compensator 70210 and a staple cartridge 70215 that includes a lower tissue thickness compensator that includes an outer layer 70220 and an inner layer 70225. . The upper tissue thickness compensator 70210 can be placed on the first side of the target tissue and the lower tissue thickness compensator can be placed on the second side of the tissue. For example, the upper tissue thickness compensator 70210 can include an ORC, the outer layer of the lower tissue thickness compensator can include a hydrogel having ORC particles embedded therein, and the inner layer of the tissue thickness compensator May include an ORC.

  Referring to FIGS. 200-202a, a surgical instrument 70400 may include a staple cartridge 70405 and an anvil 70410. The staple cartridge 70405 can include a tissue thickness compensator 70415 that includes a bioabsorbable foam. The bioabsorbable foam can include a capsule that includes an encapsulating component 70420. The bioabsorbable foam can include an ORC and the encapsulated component can include, for example, a drug. The tissue thickness compensator 70415 of the anvil 70410 can include an inner layer 70425 and an outer layer 70430. For example, the inner layer 70425 can include a bioabsorbable foam and the outer layer 70430 can include a hydrogel (optionally including a reinforcing material). Referring primarily to FIG. 201 during a typical firing sequence, the sled 70435 may first contact the staple 70440A and begin to lift the staples up. As the sled 70435 is advanced further in the distal direction, the sled 70435 may in turn begin to lift the staples 70440B-D and other subsequent staples. The sled 70435 can move the staple 70440 upward, causing the staple legs to contact the opposing anvil 70410 and deform into the desired shape. With respect to the firing sequence shown in FIG. 201, staples 70440A-C have moved to a fully fired position, staple 70440D is in the firing process, and staple 70420E is still in an unfired position. The encapsulating component 70470 can be ruptured by the staple legs during a typical firing sequence. The encapsulating component 70420 can flow out of the capsule around the staple legs and contact the tissue T. In various circumstances, additional compression of the tissue thickness compensator can squeeze additional drug from the capsule. This agent can quickly treat tissue and reduce bleeding from the tissue.

  In various situations, a surgeon, or other clinician, delivers a fluid to the tissue thickness compensator to form a tissue thickness compensator that includes at least one agent stored and / or absorbed therein. can do. In accordance with the present invention, a staple cartridge and / or anvil can include a port configured to provide access to a tissue thickness compensator. Referring to FIG. 203B, the staple cartridge 70500 can include, for example, a port 70505 at its distal end. Port 70505 may be configured to receive a needle 70510, such as, for example, a fenestrated needle shown in FIG. 203A. The clinician can insert needle 70510 through port 70505 and into tissue thickness compensator 70515 to deliver fluid to tissue thickness compensator 70515. This fluid may include, for example, a drug and a hydrogel precursor. As described above, when the tissue thickness compensator is ruptured and / or compressed, this fluid may be released from the tissue thickness compensator into the tissue. For example, the drug can be released from the tissue thickness compensator 70515 as the tissue thickness compensator 70515 is biodegraded.

  Referring now to FIG. 14, a staple cartridge (eg, staple cartridge 10000) may include a support portion 10010 and a compressible tissue thickness compensator 10020. With reference now to FIGS. 16-18, the support portion 10010 can include a deck surface 10011 and a plurality of staple cavities 10012 defined within the support portion 10010. Each staple cavity 10012 may be configured, for example, to dimensionally store a staple (eg, staple 10030) therein. Staple cartridge 10000 may further include a plurality of staple drivers 10040 that each support one or more staples 10030 within staple cavity 10012 when staples 10030 and staple drivers 10040 are in an unfired position. Can be configured. 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 staples and staples 10030 and staple drivers 10040. Can be configured to limit relative movement between the two. Referring again to FIG. 16, the staple cartridge 10000 may further include a staple firing sled 10050, which positions the staple driver 10040 and the staple 10030 relative to the staple cartridge 10000 from their unfired positions. The staple cartridge can be moved from the proximal end 10001 to the distal end 10002 for continuous lifting toward the anvil. Referring primarily to FIGS. 16 and 18, each staple 10030 includes a base 10031 and one or more legs 10032 extending from the base 10031, each staple being substantially U-shaped, for example. And may be at least one of substantially V-shaped. The staple 10030 can be configured such that the tips of the staple legs 10032 are retracted against the deck surface 10011 of the support portion 10010 when the staple 10030 is in the unfired position. The staple 10030 can be configured such that the tips of the staple legs 10032 are flat with respect to the deck surface 10011 of the support portion 10010 when the staple 10030 is in the unfired position. Staple 10030 is configured such that the tips of staple legs 10032 or at least a portion of staple legs 10032 extend above deck surface 10011 of support portion 10010 when staples 10030 are in the unfired position. be able to. In such cases, the staple legs 10032 can extend into and be embedded within the tissue thickness compensator 10020 when the staple 10030 is in the unfired position. For example, the staple legs 10032 may extend about 0.075 ″ above the deck surface 10011. In various embodiments, the staple legs 10032 may be about 0 above the deck surface 10011, for example. The tissue thickness compensator 10020 may further include, for example, about 0.20 cm to about 0. 0, about 0.025 ″ to about 0.125 ″. An uncompressed thickness of about 318 cm (about 0.08 "to about 0.125") may be provided.

  In use, and with reference primarily to FIG. 31 above, an anvil (eg, anvil 10060) can be moved to a closed position relative to staple cartridge 10000. As will be described in more detail below, the anvil 10060 can place tissue as opposed to the tissue thickness compensator 10020, and for example, the tissue thickness compensator 10020 can be placed against the deck surface 10011 of the support portion 10010. Can be compressed. Once the anvil 10060 is properly positioned, staples 10030 can be deployed, as also shown in FIG. If desired, as described above, the staple firing sled 10050 can move 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 contacts the staple driver 10040 and lifts the staple driver 10040 upward within the staple cavity 10012. Each of the sled 10050 and the staple driver 10040 can include one or more inclined surfaces (oblique surfaces), which 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 include at least one inclined surface 10042, and the thread 10050 can include at least one or more inclined surfaces 10052, where the thread 10050 staples. The inclined surface 10052 may be configured to slide under the inclined surface 10042 when advanced distally within the cartridge. As the staple driver 10040 is lifted upward within the respective staple cavity 10012, the staple driver 10040 lifts the staple 10030 upward so that the staple 10030 emerges from the staple cavity 10012 through the opening in the staple deck 10011. Can do. Referring primarily to FIGS. 25-27 during a typical firing sequence, the sled 10050 may first contact the staple 10030a and begin to lift the staple 10030a up. As the sled 10050 is advanced further in the distal direction, the sled 10050 may in turn begin to further lift the staples 10030b, 10030c, 10030d, 10030e, and 10030f, and other subsequent staples. As shown in FIG. 27, the thread 10050 can drive the staple 10030 upward so that the staple leg 10032 contacts the opposing anvil, is deformed to the desired shape, and is fired from the support portion 10010. In various situations, the sled 10030 can move several staples upward simultaneously as part of the firing sequence. With respect to 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 supported by firing. Housed in 10010, staples 10030e and 10030f are still in the unfired position.

  As described above, referring to FIG. 33, the staple legs 10032 of the staple 10030 can extend over the deck surface 10011 of the support portion 10010 when the staple 10030 is in the unfired position. Further, with respect to this firing sequence shown in FIG. 27, staples 10030e and 10030f are shown in an unfired position, and their staple legs 10032 exit above deck surface 10011 and into tissue thickness compensator 10020. It is extended. When the staple 10030 is in the unfired position, the tip of the staple leg 10032 or any portion of the staple leg 10032 cannot protrude through the tissue contacting upper surface 10021 of the tissue thickness compensator 10020. As the staple 10030 moves from the unfired position to the fired position, the tips of the staple legs may protrude through the tissue contacting surface 10032 as shown in FIG. The tip of the staple leg 10032 can include a sharp tip that can incise and penetrate the tissue thickness compensator 10020. The tissue thickness compensator 10020 may include a plurality of openings that receive the staple legs 10032 so that the staple legs 10032 can slide relative to the tissue thickness compensator 10020. Can be configured. 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. In accordance with the present invention, a first guide 10013 can be placed at the first end of each staple cavity opening and a second guide 10013 can be placed at the second end of each staple cavity opening, thereby Each first guide 10013 can support a first staple leg 10032 of the staple 10030 and each second guide 10013 can support a 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. If desired, 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 comprise a single continuous sheet 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. The sheet material can cover the staple cavity opening of the support portion 10010, or alternatively, the sheet material can include an opening, which can be aligned or at least partially aligned with the staple cavity opening. In accordance with the present invention, the tissue thickness compensator can be constructed from 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 can include one or more openings and / or slots defined in the wrap 10022. (E.g., 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, etc., thereby increasing the ends of the protrusions 10014 and consequently limiting the relative movement between the wrap 10022 and the support portion 10010. . As shown in FIG. 15, the wrap 10022 includes one or more perforations 10025 that can facilitate peeling the wrap 10022 from the support portion 10010. Referring now to FIG. 24, the tissue thickness compensator can comprise a wrap 10222 comprising a plurality of openings 10223 that are aligned or at least partially aligned with the staple cavity openings of 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.

  If desired, as described above, the tissue thickness compensator can include a wrap that releasably holds the compressible core against the support portion 10010. For example, referring to FIG. 16, the staple cartridge can 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. If desired, each retaining clip 10026 can include an opening 1000028 that 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 dish-like portion 10027 that extends below the support portion 10010 and can 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 unfired 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. If desired, 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 in the support portion 10010 when the staple 10030 is fired. In accordance with the present invention, a corresponding knife slot can extend through the anvil disposed relative to the staple cartridge 10000 such that the cutting edge 10053 extends between the anvil and the support portion 10010. The 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. While the sled 10050 can be retracted proximally with the firing member 10052, in various embodiments, referring now to FIG. 59, the sled 10050 can be of the staple cartridge 10000 when the firing member 10052 is retracted. It can be left on the distal end 10002 side. 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 non-implant portion (including the support portion 10010) of the consumed staple cartridge 10000 is replaced by the staple cartridge. It can be removed from 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, staple cartridge channel 10070, firing member 10052, and / or staple cartridge 10000 can constitute a cooperating function, which is new (or unfired) disposed within 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 unfired 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 is removed. Can fall downward from its 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 firing member 10052 is fully retracted, firing member 10052 cannot be advanced distally again 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 is configured to move the staple driver 10040 between a first unfired position and a second fired position in order to fire the staple 10030 from the support portion 10010. Can do. After the staple 10030 is fired from the support portion 10010, the staple driver 10040 can be received within the staple cavity 10012. The support portion 10010 can constitute one or more retention mechanisms, which can be configured to prevent the staple driver 10040 from being fired or dropped from the 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 formed on and / or around the base of each staple 10030 such that the driver is integrally formed with the staple. US Patent Application No. 11 / 541,123 "SURGICAL STAPLES HAVING COMPRESIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEHERE AND STAPLING INSTRUMENTS FOR DEPELOYING 9 Incorporated.

  As described above, a surgical stapling instrument receives a staple cartridge, an anvil rotatably coupled to the staple cartridge channel, and a firing member that includes a knife edge movable relative to the anvil and the staple cartridge channel. A staple cartridge channel configured as described above. 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 used 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, replacing a disposable loading unit assembly. As part of this, it can be exchanged 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 on Feb. 15, 2008). Which is incorporated herein by reference.

  The tissue thickness compensator can include 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. This tissue thickness compensator is a conventional method such as, for example, mixing, blending, blending, spraying, siphoning, solvent evaporation, immersion, brushing, vapor deposition, extrusion, calendering, cast molding, mold molding, and the like. Can be obtained using In extrusion molding, the opening may be in the form of a die that includes at least one opening that imparts shape to the resulting 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, spin processing, solvent welding, coating methods (eg dip coating and spin coating). , Solution casting and film casting, plastisol processing (including knife coating, roller coating and cast molding), and combinations thereof, but are not limited to these. In injection molding, the openings can include nozzles and / or channels / runners and / or mold cavities and shapes. In compression molding, the composition can be molded by placing it in a mold cavity, heating it to a suitable temperature and subjecting it to compression at a relatively high pressure. In cast molding, the composition may include liquids or slurries that are poured into or on and / or around the mold or an article that replicates the shape of the mold or article. Can be provided in a method. After cast molding, the composition can be dried, cooled, and / or cured to form a solid.

  In accordance with the present invention, a method for producing a tissue thickness compensator generally provides a tissue thickness compensator composition, liquefying and fluidizing the composition, and its molten, semi-molten, or Forming the composition in the plastic state into layers and / or films having a desired thickness. Referring to FIG. 198A, a tissue thickness compensator is formed by dissolving a hydrogel precursor in an aqueous solution, dispersing biocompatible particles and / or fibers therein, and having biocompatible particles therein. Providing a mold, supplying the solution to the mold, contacting the activator with the solution, curing the solution to include an outer layer containing biocompatible particles, and It can be manufactured by forming a tissue thickness compensator that includes an inner layer containing embedded biocompatible particles. As shown in FIG. 198A, a biocompatible layer 70250 is provided at the bottom of the mold 70260 to supply an aqueous solution of hydrogel precursor 70255 having biocompatible particles 70257 deposited therein to the mold 70260. A second layer comprising a hydrogel having an ecological synthetic fiber (eg ORC) disposed therein and a first layer comprising an ecological synthetic material (eg ORC); A tissue thickness compensator can be formed. The tissue thickness compensator can include a foam that includes an outer layer that includes biocompatible particles and an inner layer that includes biocompatible particles embedded therein. The tissue thickness compensator dissolves sodium alginate in water, disperses the ORC particles therein, provides a mold having ORC particles therein, and pours the solution into the mold. Initiating the crosslinking of sodium alginate by spraying or blowing calcium chloride into contact with the solution, and lyophilizing the hydrogel to form an outer layer comprising ORC, the hydrogel and the ORC particles embedded therein. It can be manufactured by forming a tissue thickness compensator that includes an inner layer.

  Referring to FIG. 198B, one method of making a three-layer tissue thickness compensator involves dissolving a first hydrogel precursor in a first aqueous solution and dispersing biocompatible particles and / or fibers in the first aqueous solution. Providing a mold 70260 having a first layer 70250 of biocompatible particles therein, supplying a first aqueous solution to the mold, contacting the activator and the first aqueous solution, Curing the first solution to form the second layer 70255; dissolving the second hydrogel precursor in the second aqueous solution; supplying the second aqueous solution to the mold; and curing the second aqueous solution to form the second layer 70255. Forming three layers 70265. A three-layer tissue thickness compensator comprises a molding die having sodium alginate dissolved in water to form a first aqueous solution, ORC particles dispersed in the first aqueous solution, and a first layer of ORC particles therein. Providing, pouring the first aqueous solution into a mold, initiating cross-linking of sodium alginate by spraying or blowing calcium chloride into contact with the solution, freeze-drying the first aqueous solution, and Forming a second layer comprising a hydrogel having embedded ORC particles; dissolving sodium alginate in water to form a second aqueous solution; pouring the second aqueous solution into a mold; and spraying calcium chloride Or initiating crosslinking of sodium alginate by blowing into contact with the solution and lyophilizing the second aqueous solution, By forming a third layer containing Dorogeru may be prepared.

  In accordance with the present invention, a method of manufacturing a tissue thickness compensator comprising at least one agent stored and / or absorbed therein generally provides a tissue thickness compensator and the tissue thickness compensator as a drug. And allowing the drug to be retained within the tissue thickness compensator. A method of making a tissue thickness compensator comprising an antimicrobial material includes providing a hydrogel, drying the hydrogel, swelling the hydrogel in an aqueous silver nitrate solution, and contacting the hydrogel with a sodium chloride solution. Forming a tissue thickness compensator having antibacterial properties. The tissue thickness compensator can include silver dispersed therein.

  Referring to FIG. 204, one method for manufacturing a tissue thickness compensator can include coextrusion and / or adhesion. The tissue thickness compensator 70550 can include, for example, a laminate that includes a first layer 70555 and a second layer 70560 that hermetically enclose an inner layer 70565 that includes a hydrogel. The hydrogel can include, for example, dry films, dry foams, powders, and / or granules. The hydrogel can include superabsorbent materials such as polyvinylpyrrolidone, carboxymethylcellulose, polysulfurpropyl acrylate, and the like. The first layer and / or the second layer are produced in-line by feeding the raw material of the first layer and the second layer, respectively, from the hopper to the extruder, thereby feeding the first layer and the second layer. can do. The raw material of the inner layer 70565 can be added to the hopper of the extruder. Raw materials can be mixed and blended dispersively at the high temperatures of the extruder. An inner layer 70565 can be deposited on the surface of the first layer 70555 as the raw material exits the die 70570 at the opening. The tissue thickness compensator can include foam, film, powder, and / or granules. The first and second layers 70555 and 70560 may be disposed in an opposing positional relationship. The second layer 70560 can be aligned with the first layer 70555 in an opposed positional relationship by a roller 70575. The first layer 70555 can be adhered to the second layer 70560, and the first and second layers 70555, 70560 can physically confine the inner layer 70565. The layers can be bonded together to form a tissue thickness compensator 70550, for example, through light pressure, a conventional calender bonding process, and / or the use of an adhesive. As shown in FIG. 78, the first and second layers 70555 and 70560 can be joined together, for example, by a roll process utilizing grooved rollers 70580. Optionally, as a result of the above, the inner layer 70565 can be encapsulated and / or sealed by first and second layers 70555 and 70560 that can collectively form an outer layer or barrier. The outer layer may prevent or reduce moisture from contacting the inner layer 70565 until the outer layer ruptures.

  Referring to FIG. 61, the end effector 12 (FIG. 1) of the surgical instrument 10 can be configured to receive a fastener cartridge assembly, such as, for example, a staple cartridge 20000. As shown in FIG. 61, staple cartridge 20000 can be configured to fit within cartridge channel 20072 of jaw 20070 of end effector 12. Alternatively, the staple cartridge 20000 may be integrated with the end effector 12, so that the staple cartridge 20000 and the end effector 12 may form a single unit structure. Staple cartridge 20000 can include a first body portion, such as, for example, a rigid indicating portion 20010. Staple cartridge 20000 can further include a second body portion, such as a compressible portion or tissue thickness compensator 20020, for example. Alternatively, the tissue thickness compensator 20020 does not constitute an integral part of the staple cartridge 20000 but can be arranged in a different manner relative to the end effector 12. For example, the tissue thickness compensator 20020 can be secured to the anvil 20060 of the end effector 12 or can be retained in the end effector 12 in other manners. Referring to FIG. 78, the staple cartridge can further include a retention clip 20106, which can be configured to prevent the tissue thickness compensator 20020 from prematurely disengaging from the support portion 20010. The reader will understand that the tissue thickness compensators described herein can be installed or otherwise engaged in various end effectors and are within the scope of this disclosure. Like.

  Referring now to FIG. 78, similar to the tissue thickness compensator described herein, the tissue thickness compensator 20020 can be released or released from the surgical end effector 12. For example, the rigid support portion 20010 of the staple cartridge 20000 can release the tissue thickness compensator 20020 from the rigid support portion 20010 while still engaging the fastener cartridge channel 20072 of the end effector jaw 20070. The tissue thickness compensator 20020 can be released from the end effector 12 after the staple 20030 (FIGS. 78-83) is deployed from the staple cavity 20012 in the rigid support portion 2010. Staples 20030 are fired from staple cavity 20012, which allows staples 20030 to engage tissue thickness compensator 20020. Referring also generally to FIGS. 63, 82 and 83, the staple 20030 can capture a portion of the tissue thickness compensator 20020 along with the staple-engaged tissue T. The tissue thickness compensator 20020 may be deformable and the tissue thickness compensator 20020 captured in the fired staple 20030 may be compressed. Similar to the tissue thickness compensator described herein, the tissue thickness compensator 20020 compensates for the various thicknesses, compressibility, and / or density of the tissue T captured within each staple 20030. be able to. Further, as also described herein, the tissue thickness compensator 20020 can compensate for gaps caused by poorly formed staples 20030.

  The tissue thickness compensator 20020 is compressible between an uncompressed height and a compressed height. Referring to FIG. 78, the tissue thickness compensator 20020 can have an upper surface 20001 and a lower surface 22022. The height of the tissue thickness compensator can be the distance between the upper surface 20001 and the lower surface 200222. The uncompressed height of the tissue thickness compensator 20020 is the top surface when the force applied to the tissue thickness compensator 20020 is minimal or no force, i.e., when the tissue thickness compensator 20020 is not compressed. It may be the distance between 20001 and the lower surface 20022. The compressed height of the tissue thickness compensator 20020 is such that when a force is applied to the tissue thickness compensator 20020, for example, when the fired staple 20030 is capturing a portion of the tissue thickness compensator 20020. , The distance between the upper surface 20001 and the lower surface 22022. The tissue thickness compensator 20020 can have a distal end 20025 and a proximal end 20026. As shown in FIG. 78, the uncompressed height of the tissue thickness compensator 20020 can be uniform between the distal end 20025 and the proximal end 20026 of the tissue thickness compensator 20020. Alternatively, the uncompressed height may vary between the distal end 20025 and the proximal end 20026. For example, the upper surface 20001 and / or the lower surface 20022 of the tissue thickness compensator 20020 may be inclined and / or stepped with respect to the other so that the uncompressed height is proximal and distal It can vary between the ends 20025. The uncompressed height of the tissue thickness compensator 20020 can be, for example, about 0.20 centimeters (0.08 inches). Alternatively, the uncompressed height of the tissue thickness compensator 20020 can be, for example, from about 0.064 centimeters to about 0.25 centimeters (about 0.025 inches to about 0.10 inches).

  As detailed herein, the tissue thickness compensator 20020 can be compressed to different compression heights between its proximal and distal ends 20026 and 20025. Alternatively, the tissue thickness compensator 20020 can be compressed uniformly throughout its length. The compression height of the tissue thickness compensator 20020 can depend on, for example, the shape of the end effector 12, the tissue thickness compensator 20020, the engaged tissue T and / or the properties of the staples 20030. The compressed height of the tissue thickness compensator 20020 can be related to the tissue gap of the end effector 12. If desired, when the anvil 20060 is clamped toward the staple cartridge 20000, the tissue gap can be, for example, between the deck surface 20011 (FIG. 78) of the staple cartridge 20000 and the tissue contacting surface 20061 (FIG. 61) of the anvil 20060. Can be defined. The tissue gap may be, for example, about 0.064 centimeters or about 0.254 centimeters (about 0.025 inches or about 0.100 inches). The tissue gap can be, for example, about 0.750 millimeters or about 3.500 millimeters. The compressed height of the tissue thickness compensator 20020 may be, for example, equal to or substantially equal to the tissue gap. If the tissue T is placed in the tissue gap of the end effector 12, the compressed height of the tissue thickness compensator can be a smaller value to fit the tissue T. For example, if the tissue gap is about 0.750 millimeters, the compression height of the tissue thickness compensator can be about 0.500 millimeters. If the tissue gap is about 3.500 millimeters, the compressed thickness 20020 of the tissue thickness compensator can be, for example, about 2.5 mm. Further, the tissue thickness compensator 20020 can include a minimum compressed height. For example, the minimum compressed height 20020 of the tissue thickness compensator can be about 0.250 millimeters. The tissue gap defined between the staple cartridge deck surface and the anvil tissue contacting surface may be, for example, equal to or at least substantially equal to the uncompressed height of the tissue thickness compensator.

  Referring to FIG. 62, a tissue thickness compensator 20020 can include a fibrous nonwoven material 20080 that includes fibers 20008. The tissue thickness compensator 20020 can include a felt or felt-like material. The fibers 20008 in the nonwoven material 20080 can be bonded together by any method known in the art including, for example, needle punching, thermal bonding, hydroentanglement, ultrasonic pattern bonding, chemical bonding, and Examples include, but are not limited to, meltblown adhesion. Further, the layers of nonwoven material 20080 can be mechanically, thermally, or chemically combined to form a tissue thickness compensator 20020. As detailed herein, fibrous nonwoven material 20080 may be compressible, which may allow compression of tissue thickness compensator 20020. The tissue thickness compensator 20020 can also include an incompressible portion. For example, the tissue thickness compensator 20020 can include a compressible nonwoven material 20080 and an incompressible portion.

  Still referring primarily to FIG. 62, the nonwoven material 20080 can include a plurality of fibers 20008. At least some of the fibers 20008 in the nonwoven material 20080 can be crimped fibers 20008. The crimped fiber 20008 may be crimped, twisted, coiled, bent, restoring force, spiral, curled, and / or bent, for example, within the nonwoven material 20080. As detailed herein, the crimped fibers 20086 can be formed in any shape such that deformation of the crimped fibers 20086 creates a spring load or restoring force. The crimped fibers 20008 can form a coil shape or a substantially coil-like shape by thermoforming. The crimped fibers 20008 can be formed from non-crimped fibers 20009. For example, the non-crimped fibers 20009 can be wrapped around a heated mandrel to form a substantially coil-like shape.

  The tissue thickness compensator 20020 can include a homogeneous absorbent polymer matrix. A homogeneous absorbent polymer matrix can include, for example, foams, gels, and / or films. Further, a plurality of fibers 20008 can be dispersed throughout the homogeneous absorbent polymer matrix. At least a portion of the fibers 20008 within the homogeneous absorbent polymer matrix can be, for example, crimped fibers 20008. As detailed herein, the homogeneous absorbent polymer matrix of the tissue thickness compensator 2002 can be compressible.

  Referring to FIGS. 65 and 66, the crimped fibers 20086 can be randomly distributed over at least a portion of the nonwoven material 20080. For example, the crimped fibers 20086 are randomly distributed throughout the nonwoven material 20080 so that some of the nonwoven material 20080 may contain more crimped fibers 20086 than other parts of the nonwoven material 20080. Further, the crimped fibers 20086 can agglomerate in, for example, fiber clusters 20085a, 20085b, 20085c, 20085d and 20085e in the nonwoven material 20080. The shape of the crimped fibers 20086 can cause entanglement of the fibers 20086 during the manufacture of the nonwoven material 20080. The entanglement of the crimped fibers 20086 can result in the formation of fiber clusters 20085a, 20085b, 20085c, 20085d and 20085e. Additionally or alternatively, the crimped fibers 20086 are randomly oriented throughout the nonwoven material 20080. For example, referring to FIG. 62, the first crimped fiber 20086a faces the first direction, the second crimped fiber 20086b faces the second direction, and the third crimped fiber 20086c faces the third direction.

  The crimped fibers 20008 can be systematically distributed and / or arranged over at least a portion of the nonwoven material 20080. For example, here, FIG. 67, the crimped fibers 20186 can be arranged in an array 20185, a plurality of crimped fibers 20186a are arranged in a first direction, and a plurality of other crimped fibers 20186b are arranged in a second direction. The The crimped fibers 20186 can overlap so as to be entangled or interconnected. The crimped fibers 20186 can be systematically arranged so that the crimped fibers 20186a are substantially parallel to another crimped fiber 20186a. Yet another crimped fiber 20186b can substantially cross several crimped fibers 20186a. If desired, the crimped fibers 20186a may be substantially aligned with the first axis Y, and the crimped fibers 20186b may be substantially aligned with the second axis X. The first axis Y can be, for example, perpendicular or substantially perpendicular to the second axis X.

  Referring primarily to FIG. 68, the crimped fibers 20286 can be arranged in an array 20285. Each crimped fiber 20286 can include a longitudinal axis defined between a first end 20287 and a second end 20289 of the crimped fiber 20286. The crimped fibers 20286 can be systematically distributed within the nonwoven material 20080 such that the first end 20287 of one crimped fiber 20286 is adjacent to the second end 20289 of another crimped fiber 20286. Can be placed. Alternatively, referring now to FIG. 69, the fiber array 20385 has a first crimped fiber 20386a oriented in the first direction, a second crimped fiber 20386b oriented in the second direction, and a third oriented in the third direction. Crimp fibers 20386c may be included. In accordance with the present invention, a single pattern or arrangement of crimped fibers 20286 can be repeated throughout the nonwoven material 20080. The crimped fibers can be arranged in different patterns throughout the nonwoven material 20080. As another alternative, the nonwoven material 20080 includes at least one pattern of crimped fibers and may include a plurality of crimped fibers that are irregularly oriented and / or randomly distributed.

  Referring again to FIG. 62, the plurality of fibers 20008 in the nonwoven material 20080 can include at least some non-crimped fibers 20009. Non-crimped fibers 20009 and crimped fibers 200008 in nonwoven material 20080 can be entangled or interconnected. The ratio of crimped fibers 20008 and non-crimped fibers 20009 can be, for example, about 25: 1. Alternatively, the ratio of crimped fibers 20008 to non-crimped fibers 20009 can be, for example, about 1:25. Alternatively, the ratio of crimped fibers 20008 to non-crimped fibers 20009 can be, for example, about 1: 1. As detailed herein, the number of crimped fibers 20086 per unit volume of nonwoven material 20080 can affect the restoring force produced by nonwoven material 20080 when nonwoven material 20080 is deformed. . Also, as detailed herein, the restoring force produced by this nonwoven material 20080 can further include, for example, the material, shape, dimensions, and crimped fibers and non-crimped fibers 200008, 20084 in nonwoven material 20080. It may depend on position and / or orientation.

  The fibers 20008 of the nonwoven material 20080 can comprise a polymer composition. The polymer composition of the fiber 20002 can include a non-absorbable polymer, an absorbent polymer, or a combination thereof. The absorbable polymer can include a bioabsorbable, biocompatible elastomeric polymer. Further, the composition of the fibers 20008 can include synthetic polymers, non-synthetic polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. For example, the fiber 20008 can include a 90/10 poly (glycolide-L-lactide) copolymer, such as Ethicon, Inc. under the trade name “VICRYL (polygraphic 910)”. Copolymers commercially available from can be included. Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and oxidized regenerated cellulose. Optionally, similar to the polymer composition of the tissue thickness compensator described herein, the polymer composition of fiber 20008 can include, for example, an absorbent polymer, a non-absorbable polymer, a synthetic polymer, and / or a non-polymer. Synthetic polymers can be included in various weight percent amounts.

  The crimped fibers 20086 of the nonwoven material 20080 can include a first polymer composition, and the non-crimped fibers 20084 of the nonwoven material 20080 can include a different polymer composition. For example, crimped fiber 20008 can include a synthetic polymer such as, for example, 90/10 poly (glycolide-L-lactide), while non-crimped fiber 20008 can include a non-synthetic polymer such as, for example, oxidized regenerated cellulose. . Alternatively, crimped fiber 20008 and non-crimped fiber 20009 can comprise the same polymer composition.

  As described above, crimped fibers 20008 and non-crimped fibers 20009 can be bonded together by, for example, needle punching, thermal bonding, hydroentanglement, ultrasonic pattern bonding, chemical bonding, and meltblown bonding. For example, the crimped fiber 20008 containing a synthetic polymer such as “VICRYL (polygraphic 910)” and the non-crimped fiber 20009 containing oxidized regenerated cellulose can be needle punched together to form the nonwoven material 20080. Non-woven material 20080 includes, for example, about 5% to 50% by weight crimped “VICRYL (polygraphic 910)” fiber 20008 and about 5% to 50% by weight non-crimped oxidized regenerated cellulose (ORC) fiber 20004 Can be included. When the nonwoven material 20080 contacts the tissue T, the non-crimped ORC fibers 20009 can react rapidly with, for example, plasma in the tissue to form a gelatinous mass. Formation of a gelatinous ORC mass can occur immediately or almost immediately upon tissue contact. Further, after the gelatinous ORC mass is formed, the crimped “VICRYL (polygraphic 910)” fiber 20008 can remain dispersed throughout the nonwoven material 20080. For example, the crimped fibers 20086 may be suspended in a gelatinous ORC mass. As detailed herein, when the gelatinous ORC mass is bioabsorbed, the crimped “VICRYL (polygraphic 910)” fiber 20008 can apply a spring return force to adjacent tissue. . Further, as detailed herein, the tissue can begin to heal around the “VICRYL (polygraphic 910)” fibers and / or formed staples 30030.

  Referring primarily to FIGS. 78-81, the support portion 20010 of the staple cartridge 20000 can include a cartridge body 20017, an upper deck surface 20011, and a plurality of staple cavities 20012. Each staple cavity 20012 may define an opening in the deck surface 20011. Staples 20030 can be removably disposed within staple cavities 20012. In accordance with the present invention, one staple 20030 is disposed within each staple cavity 20012. Referring primarily to FIGS. 82 and 83, similar to the staples described herein, each staple 20030 can include a base 20031 having a first end 20035 and a second end 20036. The staple leg 20032 may extend from the first end 20035 of the base 20031, and the other staple leg 20032 may extend from the second end 20036 of the base 20031. Referring again to FIGS. 78-81, prior to deploying the staples 20030, the base 20031 of each staple 20030 can be supported by a staple driver 20040 disposed within the rigid support portion 20010 of the staple cartridge 20000. Also, the leg 20032 of each staple 20030 may be at least partially housed within the staple cavity 20012, prior to deployment of the staple 20030.

  The staple 20030 can be deployed between an initial position and a fired position. For example, referring primarily to FIG. 81, staples 20030 can be in an initial position (staples 20030e, 20030f), partially fired or intermediate positions (staples 20030c, 20030d), or fired positions (staples 20030a, 20030b). . The driver 20040 can move the staples between the initial position and the fired position. For example, the base 20031 of each staple 20030 can be supported by a driver 20040. Legs 20032 of staples (eg, staples 20030e, 20030f in FIG. 80) may be disposed within staple cavities 20012. As the firing member or staple firing sled 20050 translates from the proximal end 20001 to the distal end 20002 of the staple cartridge 20000, the sloping surface 20000051 on the sled 20050 contacts the sloping surface 20042 on the driver 20040 and contacts Staples 20030 disposed on the driver 20040 that is being operated can be deployed. The staple 20030 can be deployed between an initial position and a fired position so that the legs 20032 move through the nonwoven material 20080 of the tissue thickness compensator 20020 and the upper side of the tissue thickness compensator 20020. Penetrates the surface 20021, enters the tissue T, and contacts an anvil 20060 (FIG. 61) disposed relative to the staple cartridge 20000 of the end effector 12. The staple legs 20032 are deformed against the anvil 20060 and the legs 20032 of each staple 20030 can capture a portion of the nonwoven material 20080 and a portion of the tissue T.

  In the firing configuration (FIGS. 82 and 83), each staple 20030 can apply a compressive force against the tissue T and tissue thickness compensator 20020 captured within the staple 20030. Referring primarily to FIGS. 80 and 81, the leg 20032 of each staple 20030 can be deformed downward toward the base 20031 of the staple 20030 to form a staple capture region 200039. The staple capture area 20009 can be an area where the tissue T and tissue thickness compensator 20020 can be captured by the fired staple 20030. In various situations, the staple capture region 20009 can be defined between the deformed leg 20032 and the inner surface of the base 20003 of the staple 20030. The size of the capture area 200039 of the staple 20030 may depend on several factors such as, for example, leg length, leg diameter, base width, and / or degree of leg deformation.

  If desired, when the nonwoven material 20080 is captured in the staple capture region 200039, the captured portion of the nonwoven material 20080 can be compressed. The compressed height of the nonwoven material 20080 captured in the staple capture area 20009 can vary within the staple cartridge 20000 depending on the tissue T within the same staple capture area 20009. For example, if the tissue T is relatively thin, the staple capture region 20009 may have more room for the nonwoven material 20080 so that the nonwoven material 20080 is not compressed as much as the tissue T is thicker. If the tissue T is relatively thick, the nonwoven material 20080 can be more compressed to accommodate the thicker tissue T, for example. For example, referring to FIG. 82, the nonwoven material 20080 is compressed to a first height, for example, in a first staple capture area 20009a, compressed to a second height in a second staple capture area 20009b, and a third staple capture area Compressed to a third height at 20039c, compressed to a first height at a fourth staple capture region 20039d, and compressed to a fifth height at a fifth staple capture region 20039e. Similarly, as shown in FIG. 83, the nonwoven material 20080 is compressed to a first height in the first staple capture area 20009a, compressed to a second height in the second staple capture area 20009b, and the third staple capture area It can be compressed to a third height at 20039c and compressed to a first height at a fourth staple capture area 20039d. Alternatively, the compressed height of the nonwoven material 20080 can be uniform throughout the staple cartridge 20010.

  If desired, the applied force can cause the nonwoven material 20080 to move from an uncompressed initial shape to a compressed shape. Further, the nonwoven material 20080 may be elastic, so that when compressed, the nonwoven material 20080 can generate a spring return or restoring force. When deformed, the nonwoven material 20080 may attempt to recover from a compressed or deformed shape. As the nonwoven material 20080 attempts to recover, a spring return force or restoring force can be applied to the tissue captured together in the staple capture region 30039, as detailed herein. Next, when this applied force is removed, the nonwoven material can be restored from the compressed shape by the restoring force. Nonwoven material 20080 can return to its initial uncompressed shape, or it can return to a shape that is substantially similar to the initial uncompressed shape. The deformation of the nonwoven material 20080 can be elastic. The deformation of the nonwoven material can be partly elastic and partly plastic.

  When a portion of the nonwoven material 20080 is compressed in the staple capture region 20009, the crimped fibers 20008 in that portion of the nonwoven compensator 200030 can also be compressed or otherwise deformed. The amount of deformation of the crimped fiber 20008 can correspond to the amount of captured portion of the nonwoven material 20080 that is being compressed. For example, referring to FIG. 63, the nonwoven material 20080 can be captured by deployed staples 20030. As the nonwoven material 20080 is more compressed by the deployed staples 20030, the average deformation of the crimped fibers 20008 can increase. Furthermore, as the nonwoven material 20080 is less compressed by the deployed staples, the average deformation of the crimped fibers 20086 can be reduced. Similarly, with reference to FIGS. 82 and 83, in the staple capture region 20039d where the nonwoven material 20080 is more compressed, the crimped fibers 20086 in the staple capture region 20039d may be more deformed on average. Further, in the staple capture region 20009a where the nonwoven material 20080 has a low degree of compression, the crimped fibers 20086 in the staple capture region 20039a may be less deformed on average.

  The ability of nonwoven material 20080 to recover from a deformed shape, i.e., the elasticity of nonwoven material 20080, may be a function of the elasticity of crimped fibers 20086 in nonwoven material 20080. The crimped fiber 20086 can be elastically deformed. The deformation of the crimped fiber 20008 can be partly elastic and partly plastic. If desired, compression of each crimped fiber 20086 can cause the compressed crimped fiber 20086 to generate a spring return or restoring force. For example, the compressed crimped fiber 20086 can generate a restoring force as the fiber 20086 attempts to return from its compressed shape. The fiber 20086 may attempt to return to an initial uncompressed shape or a shape substantially similar thereto. The crimped fibers 20086 may attempt to return partially to the initial shape. If desired, the crimped fibers 20086 in the nonwoven material 20080 can be elastic. When the crimped fiber 20086 is made of a linear elastic material, the restoring force of the compressed crimped fiber 20086 can be a function of, for example, the amount of compression of the crimped fiber 20086 and the spring constant of the crimped fiber 20086. The spring constant of the crimped fiber 20086 can depend, for example, at least on the orientation, material, shape, and / or dimensions of the crimped fiber 20086.

  The crimped fibers 20086 in the nonwoven material 20080 can include a uniform spring constant. Alternatively, the spring constants of the crimped fibers 20086 of the nonwoven material 20080 may be different. When a crimped fiber 20086 having a large spring constant is significantly compressed, the crimped fiber 20086 can generate a large restoring force. If the degree of compression of the crimped fiber 20086 that also has a large spring constant is small, the crimped fiber 20086 can produce a smaller restoring force. The collection of restoring forces generated by the compressed crimped fibers 20086 in the nonwoven material 20080 can generate a total restoring force for the entire nonwoven material 20080 of the tissue thickness compensator 20020. The nonwoven material 20080 can apply this total restoring force to the tissue T captured within the fired staples 20030 of the compressed nonwoven material 20080.

  Further, the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 can affect the spring constant of the nonwoven material 20080. For example, the elasticity of the nonwoven material 20080 can be low, for example, if the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 is small. The elasticity of the nonwoven material 20080 can be increased, for example, when the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 is large. The elasticity of the nonwoven material 20080 can be even higher, for example, when the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 is further increased. When the elasticity of the nonwoven material 20080 is low, for example, when the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 is small, the total restoration applied by the tissue thickness compensator 20020 to the captured tissue T The force can also be reduced. When the elasticity of the nonwoven material 20080 is high, for example, when the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 is large, collective restoration applied to the captured tissue T by the tissue thickness compensator 20020 Power can also increase.

  Referring primarily to FIG. 64, the nonwoven material 20080 'of tissue thickness compensator 20020' can include a therapeutic agent 20088, eg, a drug and / or a pharmaceutically active agent. Nonwoven material 20080 'may release a therapeutically effective amount of therapeutic agent 20088. For example, therapeutic agent 20088 can be released as nonwoven material 20080 'is absorbed. The therapeutic agent 20088 can be released into a fluid (eg, blood), for example, through or through the nonwoven material 20080 '. Examples of this pharmaceutically active agent 20008 include hemostatic agents and agents (eg, fibrin, thrombin, and / or oxidized regenerated cellulose (ORC)), anti-inflammatory agents (eg, diclofenac, aspirin, naproxen, sulindac, and / or Hydrocortisone), antibiotics and antibacterial agents or drugs (eg, triclosan, silver ions, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol), and anticancer agents (eg, cisplatin, mitomycin, and / or adriamycin) Can be, but is not limited to. The therapeutic agent 20088 can include, for example, a biologic such as a stem cell. The fibers 20008 of the nonwoven material 20080 'can include a therapeutic agent 20088. Alternatively, therapeutic agent 20088 may be added to nonwoven material 20080 'or may be otherwise incorporated into tissue thickness compensator 20020'.

  Referring primarily to FIGS. 70-70B, the tissue thickness compensator 20520 for the end effector 12 (FIG. 61) may include a plurality of springs or coil fibers 20586. Similar to the crimped fiber 200086 described herein, the coiled fiber 20586 can be crimped, twisted, coiled, bent, twisted, spiraled, curled, and / or bent, for example, within the tissue thickness compensator 20520. It may be. Coil fiber 20586 can be wound around a mandrel to form a coiled or substantially coiled shape. The coil fibers 20586 may be irregularly oriented and / or distributed irregularly throughout the tissue thickness compensator 20520. Alternatively, the coil fibers 20586 may be systematically arranged and / or distributed uniformly throughout the tissue thickness compensator 20520. For example, referring to FIG. 70, the coil fiber 20586 can include a longitudinal axis between the first end 20588 and the second end 20589 of the coil fiber 20586. The longitudinal axes of the coil fibers 20520 in the tissue thickness compensator 20520 can be parallel or substantially parallel. The first end 20588 of each coil fiber 20520 is disposed along the first longitudinal side 20523 of the tissue thickness compensator 20520 and the second end 20589 of each coil fiber 20586 is the second of the tissue thickness compensator 20520. Can be disposed along the longitudinal side 20524. In such an arrangement, the coil fibers 20586 can traverse the tissue thickness compensator laterally. Alternatively, the coil fibers 20586 may traverse the tissue thickness compensator 20520 in a longitudinal direction or diagonally.

  If desired, the coil fiber 20586 may include a polymer composition, similar to the crimped fiber 20008 described herein. The crimped fiber 20586 may be at least partially elastic, which may generate a recovery force by deformation of the crimped fiber 20586. The polymer composition of coil fiber 20586 can include, for example, polycaprolactone (PCL), which renders coil fiber 20586 insoluble in chlorophyll solvent. Referring to FIG. 70A, a spring or coil fiber 20520 can be retained within the compensation material 20580. Compensation material 20580 can hold coil fiber 20586 in a loaded position so that coil fiber 20586 can apply a spring load to or in compensation material 20580. The compensation material 20580 can hold the coil fiber 20586 in a neutral position so that the coil fiber 20586 does not apply a spring load to or within the compensation material 20580. Compensation material 20580 may be bioabsorbable and may optionally include a foam, such as, for example, a polyglycolic acid (PGA) foam. Further, the compensation material 20580 can be soluble in, for example, a chlorophyll solvent. The tissue thickness compensator can include coil fiber 20586 that includes polycaprolactone (PCL) and compensation material 20580 that includes polyglycolic acid (PGA) foam so that the coil fiber 20520 is not soluble in the chlorophyll solvent, Compensation material 20580 can be soluble in a chlorophyll solvent. Compensation material 20580 can be at least partially elastic so that compression of compensation material 20580 can generate a restoring force. Further, referring to FIG. 70B, the compensation material 20580 of the tissue thickness compensator 20520 can include a therapeutic agent 20588 such as, for example, stem cells. Compensation material 20580 may release a therapeutically effective amount of therapeutic agent 20588 when compensation material 20580 is absorbed.

  Similar to the tissue thickness compensator 20020 described herein, the tissue thickness compensator 20520 can be compressible. For example, when the staple 20030 (FIGS. 78-81) is deployed from the initial position to the fired position, the staple 20030 may engage a portion of the tissue thickness compensator 20520. In accordance with the present invention, the staple 20030 can capture a portion of the tissue thickness compensator 20520 and the adjacent tissue T. The staple 20030 can apply a compressive force to the tissue thickness compensator 20520 and the captured portion of the tissue T, thereby compressing the tissue thickness compensator 20520 from an uncompressed height to a compressed height. obtain. Compression of the tissue thickness compensator 20520 can cause a corresponding deformation in the coil fiber 20586 therein. As detailed herein, the deformation of each coil fiber 20586 can generate a restoring force, which is the elasticity of the coil fiber, eg, the amount of deformation of the coil fiber 20586, and / or the coil fiber. May depend on the spring constant of 20586. The spring constant of the coil fiber 20586 may depend, for example, at least on the orientation, material, shape, and / or dimensions of the coil fiber 20586. Deformation of the coil fibers 20586 within the tissue thickness compensator 20520 can generate a restoring force throughout the tissue thickness compensator 20520. The tissue thickness compensator 20520 can apply the collective restoring force generated by the deformed coil fiber 20586 and / or the elastic compensation material 20586 to the tissue T captured in the fired staple 20030. .

  Referring primarily to FIGS. 71 and 72, the tissue thickness compensator 20620 for the end effector 12 may include a plurality of spring coils 20686. Similar to the crimped fiber 200086 and coiled fiber 20586 described herein, the spring coil 20686 can be crimped, twisted, coiled, bent, twisted, spiraled, curled, for example, within a tissue thickness compensator 20620. And / or may be bent. If desired, similar to the fibers and coils described herein, the spring coil 20686 can include a polymer composition. Further, the spring coil 20686 is at least partially elastic, which can cause a restoring force due to deformation of the spring coil 20686. Spring coil 20686 may include a first end 20687, a second end 20687, and a longitudinal axis therebetween. Referring to FIG. 71, for example, the first end 20686 of the spring coil 20686 may be at or near the proximal end 20626 of the tissue thickness compensator, and the second end 20687 of the spring coil 20686 is the tissue thickness. It may be at or near the distal end 20625 of the thickness compensator 20620 so that the spring coil 20686 can traverse the tissue thickness compensator 20620 longitudinally. Alternatively, the coil fibers 20686 may traverse the tissue thickness compensator 20620 laterally or diagonally.

  The tissue thickness compensator 20620 can include an outer film 20680 that at least partially encloses at least one spring coil 20686. Referring to FIG. 71, the outer film 20680 can extend around the outer periphery of a plurality of spring coils 20686 within the tissue thickness compensator 20620. Alternatively, the outer film 20680 can completely encapsulate the spring coil 20686 or at least one spring coil 20686 of the tissue thickness compensator 20620. The outer film 20680 can hold the spring coil 20686 in the end effector 12. The outer film 20680 can hold the spring coil 20686 in a loaded position so that the spring coil 20686 can generate a spring load and apply a spring return force to the outer film 20680. Alternatively, the outer film 20680 can hold the spring coil 20686 in the neutral position. The tissue thickness compensator 20620 can further include a filler material 20624. Filler material 20624 may be retained within and / or around spring coil 20686 by outer film 20680. Filler material 20624 can include a therapeutic agent 20688, similar to the therapeutic agents described herein. Further, the filler material 20624 can support the spring coil 20686 within the tissue thickness compensator 20620. The filling material 20624 may be compressible and may be at least partially elastic so that the filling material 20624 is produced by the tissue thickness compensator 20620 as detailed herein. This can contribute to the spring return force or restoring force.

  Similar to the tissue thickness compensator described herein, the tissue thickness compensator 20620 can be compressible. As staple 20030 (FIGS. 78-81) is deployed from the initial position to the fired position, staple 20030 may engage a portion of tissue thickness compensator 20620. If desired, each staple 20030 can capture a portion of the tissue thickness compensator 20620 along with the adjacent tissue T. The staple 20030 can apply a compressive force to the tissue thickness compensator 20620 and the captured tissue T so that the tissue thickness compensator 20620 can be compressed between an uncompressed height and a compressed height. Compression of the tissue thickness compensator 20620 can cause a corresponding deformation in the spring coil 20686 held therein (FIG. 72). As detailed herein, the deformation of each spring coil 20686 can generate a restoring force, which is the elasticity of the spring coil 20686, eg, the amount of deformation of the spring coil 20686, and / or the spring. It can depend on the spring constant of the coil 20686. The spring constant of the spring coil 20686 may depend, for example, at least on the material, shape, and / or dimensions of the spring coil 20686. Further, depending on the elasticity of the filler material 20624 and outer film 20680, compression of the filler material 20624 and / or outer film 20680 can also produce a restoring force. At least the set of restoring forces generated by the deformed spring coil 20686, the filling material 20624 and / or the outer film 20680 in the tissue thickness compensator 20620 can generate a restoring force throughout the tissue thickness compensator 20620. . The tissue thickness compensator 20620 can apply the collective restoring force generated by the deformed spring coil 20686 to the tissue T captured within the fired staple 20030.

  If desired, and referring primarily to FIGS. 73-75, the tissue thickness compensator 20720 for the end effector 12 may include a plurality of spring coils 20786. Similar to the coil fibers and springs described herein, the spring coil 20786 can be crimped, twisted, coiled, bent, twisted, spiraled, curled, and / or bent, for example, within a tissue thickness compensator 20720. It may be. The spring coil 20786 is at least partially elastic so that a restoring force can be generated by deformation of the spring coil 20786. Further, the spring coil 20786 may include a first end 20787, a second end 20789, and a longitudinal axis therebetween. Referring primarily to FIG. 75, the first end 20787 of the spring coil 20786 may be at or near the proximal end 20726 of the tissue thickness compensator 20720 and the second end 20789 of the spring coil 20786 is the tissue thickness. It may be at or near the distal end 20725 of the thickness compensator 20720 so that the spring coil 20786 can traverse the tissue thickness compensator 20720 longitudinally. Spring coil 20786 may extend longitudinally in two parallel rows within tissue thickness compensator 20720. A tissue thickness compensator 20720 is disposed within the end effector 12 so that the threads 20050 (FIG. 61) or cutting elements 20052 can translate along slots 20015 between parallel rows of spring coils 20786. Alternatively, the spring coil 20786 may traverse the tissue thickness compensator 20720 laterally or diagonally.

  Referring again to FIG. 75, the spring coil 20786 may be retained or embedded within the compensation material 20780. Compensation material 20780 may be bioabsorbable and may optionally include a foam, such as, for example, a polyglycolic acid (PGA) foam. The compensation material 20780 may be elastic, so that deformation of the compensation material 20780 can produce a spring return force. The compensation material 20780 can be soluble in, for example, a chlorophyll solvent. For example, a tissue thickness compensator can include a spring coil 20786 that includes polycaprolactone (PCL) and a compensation material 20780 that includes polyglycolic acid (PGA) foam so that the spring coil 20786 is insoluble in chlorophyll solvent. However, the compensation material 20780 can be soluble in the chlorophyll solvent. The compensation material 20780 may be at least partially elastic so that deformation of the compensation material 20780 can produce a spring load or a restoring force.

  The tissue thickness compensator 20720 may include a woven yarn 20790, which may extend between parallel rows of spring coils 20786. For example, referring to FIG. 75, the first mating yarn 20790 may obliquely traverse two parallel rows of spring coils 20786, and the second mating yarn 20790 may also be two parallel rows of spring coils 20786. May be crossed diagonally. The first and second combined weave yarns 20790 may intersect in a cross shape. The combined weaving yarn 20790 may cross the cross multiple times along the length of the tissue thickness compensator 20720. The combined weave thread 20790 can hold the spring coil 20786 in a loaded configuration so that the spring coil 20786 can be held in a substantially flat position within the tissue thickness compensator 20720. The mating yarn 20790 across the tissue thickness compensator 20720 can be attached directly to the spring coil 20786. Alternatively, the mating yarn 20790 can be coupled to the spring coil 20786 via a support 20792 extending through each spring coil 20786 along its longitudinal axis.

  As detailed herein, the staple cartridge 20000 can include a slot 20015 configured to receive a translational thread 20050 that includes a cutting element 20052 (FIG. 61). As the sled 20050 translates along the slot 20015, the sled 20050 can fire the staple 20030 from the fastener cavity 20012 in the staple cartridge 20000 and the cutting element 20052 can cut the tissue T simultaneously or nearly simultaneously. . Referring back to FIG. 75, as the cutting element 20052 translates, the cross-woven yarn 20790 that crosses between the parallel rows of spring coils 20786 in the tissue thickness compensator 20720 may also be cut. When the woven yarn 20790 is cut, each spring coil 20786 is released from its load configuration and each spring coil 20786 is moved from a substantially flat position to a stretched position within the tissue thickness compensator 20720. Get back. If desired, when the spring coil 20786 is stretched, the compensation material 20780 surrounding the spring coil 20786 may also be stretched.

  Optionally, when the staple 20030 (FIGS. 78-81) is deployed from the initial position to the fired position, the staple 20030 engages a portion of the tissue thickness compensator 20720 and the tissue thickness compensator 20720 is in the staple 20030. A compressive force can be applied to the tissue T while expanding or attempting to expand therein. If desired, at least one staple 20030 can capture a portion of tissue thickness compensator 20720 along with adjacent tissue T. The staple 20030 can apply a compressive force to the tissue thickness compensator 20720 and the captured tissue T so that the tissue thickness, compensator 20720 can be compressed between an uncompressed height and a compressed height. . The compression of the tissue thickness compensator 20720 can cause a corresponding deformation in the spring coil 20786 and the compensation material 20780 held therein. As detailed herein, the deformation of each spring coil 20786 can generate a restoring force, which is the elasticity of the spring coil, eg, the amount of deformation of the spring coil 20786, and / or the spring coil. May depend on the spring constant of 20786. The spring constant of the spring coil 20786 may depend, for example, at least on the orientation, material, shape, and / or dimensions of the spring coil 20786. At least the set of restoring forces generated by the deformed spring coil 20786 in the tissue thickness compensator 20720 and / or the compensation material 30380 can generate a restoring force throughout the tissue thickness compensator 20720. The tissue thickness compensator 20720 can apply the collective restoring force generated by the deformed spring coil 20786 in the tissue thickness compensator 20720 to the captured tissue T and fired staple 20030.

  If desired, and primarily referring to FIGS. 76 and 77, the tissue thickness compensator 20820 for the surgical end effector 12 can include a spring coil 20886. Similar to the fibers and coils described herein, the spring coil 20886 is, for example, crimped, twisted, coiled, folded, twisted, spiraled, curled, and / or bent within the tissue thickness compensator 20820. May be. The spring coil 20886 can include a polymer composition and can be at least partially elastic so that deformation of the spring coil 20886 can generate a spring return force. Further, the spring coil 20886 can include a first end 20887 and a second end 20889. Referring to FIG. 76, the first end 20877 may be at or near the proximal end 20826 of the tissue thickness compensator 20820 and the second end 20889 is the distal end 20825 of the tissue thickness compensator 20820 or It may be nearby. The spring coil 20886 can meander or bend from the proximal end 20825 to the distal end 20826 of the tissue thickness compensator 20820.

  Referring again to FIG. 76, the spring coil 20886 may be retained or embedded within the compensation material 20880. Compensation material 20880 may be bioabsorbable and may optionally include a foam, such as a polyglycolic acid (PGA) foam. Compensation material 20880 can be soluble in, for example, a chlorophyll solvent. The tissue thickness compensator can include a spring coil 20886 that includes polycaprolactone (PCL) and a compensation material 20880 that includes polyglycolic acid (PGA) foam so that the spring coil 20886 is insoluble in chlorophyll solvent, Compensation material 20880 can be soluble in a chlorophyll solvent. The compensation material 20880 may be at least partially elastic so that deformation of the compensation material 20880 can produce a spring load or a restoring force.

  Similar to the tissue thickness compensator described herein, for example, the tissue thickness compensator 20820 can be compressible. Compression of the tissue thickness compensator 20820 can cause deformation of at least a portion of the spring coil 20886 held or embedded within the compensation material 20880 of the tissue thickness compensator 20820. As described in detail herein, deformation of the spring coil 20886 can generate a restoring force, which is the elasticity of the spring coil 20886, eg, the amount of deformation of the spring coil 20886, and / or the spring coil. May depend on 20886 spring constant. At least the set of restoring forces generated by the deformed spring coil 20886 and / or the deformed compensation material 20880 can generate a restoring force throughout the tissue thickness compensator 20820. The tissue thickness compensator 20820 may apply a collective restoring force to the tissue T captured within the fired staple 20030.

  Referring now to FIG. 84, the surgical end effector 12 can include a tissue thickness compensator 30020 having at least one tubular element 30080. The tissue thickness compensator 30020 can be retained within the surgical end effector 12. As detailed herein, the fasteners in the end effector 12 are moved so that the fasteners move to the fired position and deform at least a portion of the tubular element 30080 in the tissue thickness compensator 30020. Can be deployed. A tissue thickness compensator comprising at least one tubular element as described herein can be attached or otherwise engaged to various surgical end effectors, and these are disclosed herein. The reader will understand that it is within range.

  If desired, with continued reference to FIG. 84, the tissue thickness compensator 30020 can be positioned relative to the anvil 30060 of the end effector 12. Alternatively, the tissue thickness compensator 30020 can be positioned relative to the fastener cartridge assembly (eg, staple cartridge 30000) of the end effector 12. Staple cartridge 30000 can be configured to fit within cartridge channel 30072 of jaw 30070 of end effector 12. For example, the tissue thickness compensator 30020 can be releasably secured to the staple cartridge 30000. The tubular element 30080 of the tissue thickness compensator 30020 can be positioned adjacent to the upper deck surface 30011 of the rigid support portion 30010 of the staple cartridge 30000. Tubular element 30080 may be secured to upper deck surface 30011 by an adhesive or wrap (a wrap similar to at least one of the wraps described herein) (eg, FIG. 16). The tissue thickness compensator 30020 can be integrated into an assembly that includes the staple cartridge 30000 so that the staple cartridge 30000 and the tissue thickness compensator 30020 can be formed as a single unit structure. For example, the staple cartridge 30000 can include a first body portion (eg, rigid support portion 30010) and a second body portion (eg, tissue thickness compensator 30020).

  84-86, the tubular element 30080 within the tissue thickness compensator 30020 can include an elongate portion 30082 having at least one lumen 30084 extending at least partially therethrough. Referring primarily to FIG. 86, the elongated portion 30082 of the tubular element 3080 can include woven or braided strands 30090, as detailed herein. Alternatively, the elongated portion 30082 may comprise a solid structure, such as a polymer extrudate, for example, rather than a woven strand 30090. The elongated portion 30082 of the tubular element 30080 can include a thickness. The thickness of the elongate portion 30082 can be substantially uniform around its length and diameter. In other cases, this thickness may be different. The elongated portion 30082 may be elongated, for example, such that the length of the elongated portion 30082 is greater than the diameter of the elongated portion 30082. The elongated portion may have a length of, for example, about 3.05 centimeters to about 6.60 centimeters (about 1.20 inches to about 2.60 inches) and about 0.25 centimeters to about 0.38 centimeters ( From about 0.10 inch to about 0.15 inch). For example, the length of the tubular element 20080 may be about 3.56 centimeters (1.40 inches), for example, the diameter of the tubular element 20080 may be about 0.318 centimeters (0.125 inches). ). Further, the elongated portion 30082 may define a substantially circular or elliptical cross-sectional shape, for example. Alternatively, the cross-sectional shape can include, for example, a triangular, hexagonal, and / or octagonal polygonal shape. Referring again to FIG. 84, the tubular element 3080 can include a first distal end 30083 and a second proximal end 30085. The cross-sectional shape of the elongate portion 30082 may be narrow at the first and / or second ends 30083, 30085, and at least one end 30083, 30085 of the tubular element 30080 may be sealed or sealed. Alternatively, the lumen 30084 may continue through the distal ends 30083, 30085 of the tubular element 30080, whereby the ends 30083, 30085 may be open.

  Tubular element 30080 can include a single central lumen 30084 that extends at least partially through elongate portion 30084. Lumen 30084 can extend the entire length of elongate portion 30084. As another alternative, the tubular element 3080 can include a plurality of lumens 30084 extending therethrough. Lumen 30084 extending through tubular element 30080 can be circular, quasi-circular, wedge-shaped, and / or combinations thereof. In accordance with the present invention, tubular element 3080 may further include a support web that may form, for example, a modified “T” shape or “X” shape within lumen 30084. The dimensions, lumens, and / or support web of the tubular element 30080 can define the cross-sectional shape of the tubular element 30080. The cross-sectional shape of the tubular element 30080 may be consistent throughout its length, or may vary along the cross-sectional shape teeth of the tubular element 30080 and its length. As detailed herein, the cross-sectional shape of the tubular element 30080 can affect the compressibility and elasticity of the tubular element 30080.

  Tubular element 30080 can include a vertical diameter and a horizontal diameter. This dimension should be selected depending on the arrangement of the tubular elements 3080 within the end effector 12, the dimensions of the end effector 12 (including the tissue gap of the end effector 12), and the expected shape of the staple capture region 30039. Can do. For example, the vertical diameter of the tubular element 3080 may be related to the expected height of the formed staple. In such cases, the vertical diameter of the tubular element 30080 is such that when the tubular element 30080 is captured within the formed staple 30030, the vertical diameter can be reduced from about 5% to about 20%. Can be selected. For example, a tubular element 30080 having a vertical diameter of about 0.254 centimeters (0.100 inches) is about 0.203 centimeters to about 0.241 centimeters (about 0.080 inches to about 0.095 inches). Can be used for staples having a predicted formed height. As a result, the vertical diameter of the tubular element 30080 can be reduced to about 5% to about 20% when the tissue T is captured within the formed staple 30030, even when it is not captured therein. When the tissue T is captured in the formed staple 30030, the degree of compression of the tubular element 30080 can be even greater. The vertical diameter may be uniform throughout the length of the tubular element 30080, or the vertical diameter may vary along its length.

  The horizontal diameter of the tubular element 30080 may be greater than, equal to, or smaller than the vertical diameter of the tubular element 30080 when the tubular element 30080 is in an undeformed or restored shape. For example, referring to FIG. 85, the horizontal diameter can be, for example, about three times the vertical diameter. For example, the horizontal diameter can be about 1.016 centimeters (0.400 inches) and the vertical diameter can be about 0.318 centimeters (0.125 inches). Alternatively, referring now to FIG. 87, the horizontal diameter of the tubular element 31080 is equal to or substantially equal to the vertical diameter of the tubular element 31080 when the tubular element 31080 is in an undeformed or restored shape. Also good. For example, the horizontal diameter can be about 0.318 centimeters (0.125 inches) and the vertical diameter can also be about 0.318 centimeters (0.125 inches). Tubular element 30080 has a vertical diameter of about 0.318 centimeters (0.125 inches), a horizontal diameter of about 1.016 centimeters (0.400 inches), and about 3.556 centimeters (1.400 inches). ). As detailed herein, when a force A is applied to the tubular elements 30080 and / or 31080, the tubular elements deform so that the cross-sectional shape (including horizontal and vertical diameters) can change. can do.

  Referring again to FIGS. 84-86, the tubular element 30080 of the tissue thickness compensator 30020 can be deformable. The entire tubular element 30080 can be deformable. For example, the tubular element 30080 can be deformable from the proximal end 30083 to the distal end 30085 of the elongate portion 30082 and over its entire circumference. Alternatively, only a portion of the tubular element 3080 may be deformable. For example, only the intermediate length of the elongated portion 30082 and / or only a portion of the circumference of the tubular element 30080 may be deformable.

  When a compressive force is applied to one contact point on the elongated portion 30082 of the tubular element 30080, the contact point can move to change the cross-sectional shape of the tubular element 30080. For example, referring again to FIG. 85, the tubular element 30080 can include an upper vertex 30086 and a lower vertex 30088 of the elongated portion 30082. In the initial undeformed shape, the tubular element 30080 may include an undeformed cross-sectional dimension, including an undeformed vertical diameter between the upper vertex 30086 and the lower vertex 30088. When the compressive force A is applied to the upper vertex 30086, the tubular element 30080 can shift to a deformed shape. In the deformed shape, the cross-sectional dimensions of the tube 30080 can vary. For example, the tube 30086 can include a deformed vertical diameter between the upper vertex 30086 and the lower vertex 30088, which can be smaller than the undeformed vertical diameter. Referring to FIG. 87, for example, when the tubular element 30080 transitions from an undeformed shape to a deformed shape, the horizontal diameter of the deformable tube 30080 can be increased. The deformed cross-sectional dimension of the deformable tube 30080 can depend at least on the position, angular orientation, and / or magnitude of the applied force A. As detailed herein, deformation of the tubular element 30080 can generate a spring return or restoring force that can depend on the elasticity of the tubular element 30080.

  With continued reference to FIG. 85, the tubular element 30080 may generate a spring return or restoring force when compressed. In such a case, as described above, when a force A is applied to a contact point on the elongated portion 30082 of the tubular element 30080, the tubular element 30080 changes from an initial undeformed shape to a deformed shape. Can migrate. When the applied force A is removed, the deformed tube 30080 can recover from the deformed shape. The deformed tube 30080 can return to the initial non-deformed shape, or can return to a shape that is substantially similar to the initial non-deformed shape. The ability of the tubular element 30080 to recover from the deformed shape is related to the elasticity of the tubular element 30080.

  Referring again to FIG. 85, the tubular element 30080 can apply a spring return force or a restoring force. The restoring force is generated by the tubular element 30080 when force A is applied to the tubular element 30080 (FIGS. 88 and 89), for example, by staples 30030, as detailed herein. obtain. The applied force A can change the cross-sectional shape of the tubular element 30080. Further, in a linear elastic material, the restoring force of each deformed portion of the tubular element 30080 can be a function of the deformation dimension of the tubular element 30080 and the spring constant of that portion of the tubular element 30080. The spring constant of the tubular element 30080 can depend, for example, at least on the orientation, material, cross-sectional shape, and / or dimensions of the tubular element 30080. The tubular element 30080 of the tissue thickness compensator 30020 can include a uniform spring constant. Alternatively, the spring constant may vary along the length and / or circumference of the tubular element 30080. When a portion of the tubular element 30080 having the first spring constant is significantly compressed, the tubular element 30080 can generate a large restoring force. If a portion of the tubular element 30080 having the same first spring constant is compressed less than that, the tubular element 30080 may produce a smaller restoring force.

  Referring again to FIG. 84, the tubular element 30080 of the tissue thickness compensator 30020 can comprise a polymer composition. The elongated portion 30082 of the tubular element 3080 can comprise a polymer composition. Furthermore, the polymer composition may at least partially comprise an elastic material, whereby deformation of the tubular element 30080 can generate a restoring force. The polymer composition can include, for example, a non-absorbable polymer, an absorbent polymer, or a combination thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. The absorbent polymer can include, for example, a bioabsorbable biocompatible elastomeric polymer. Further, the polymer composition of the tubular element 3080 can include, for example, a synthetic polymer, a non-synthetic polymer, or a combination thereof. If desired, the polymer composition of the tubular element 30080 can be, for example, an absorptive polymer, a non-absorbable polymer, a synthetic material, as well as the polymer composition of the tissue thickness compensator described elsewhere herein. Polymers and / or non-synthetic polymers can be included in various weight percent amounts.

  Referring to FIGS. 84 and 85, the tubular element 30080 can include a therapeutic agent 30098, eg, a pharmaceutically active agent and / or agent. The therapeutic agent 30098 can be retained within the lumen 30084 of the tubular element 3080. The elongated portion 30082 can encapsulate or partially encapsulate the therapeutic agent 30098. Additionally or alternatively, the polymer composition of the elongate portion 30082 can include a therapeutic agent 30098. Tubular element 30080 may release a therapeutically effective amount of therapeutic agent 30098. The therapeutic agent 30098 can be released as the tubular element 3080 is absorbed. For example, therapeutic agent 30098 can be released into a fluid (eg, blood) through or through tubular element 3080. As an additional alternative, the therapeutic agent 30098 may include a staple 30030 (FIGS. 88 and 89) piercing the tubular element 30080 and / or a cutting element 30052 on the staple firing thread 30050 (FIG. 84). Can be released when a portion of is cut. Examples of this pharmaceutically active agent 30098 include hemostatic agents and agents (eg, fibrin, thrombin, and / or oxidized regenerated cellulose (ORC)), anti-inflammatory agents (eg, diclofenac, aspirin, naproxen, sulindac, and / or Hydrocortisone), antibiotics and antibacterial agents or drugs (eg, triclosan, silver ion, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol), anticancer agents (eg, cisplatin, mitomycin, and / or adriamycin), and / or Or it may include, but is not limited to, biologics (eg, stem cells).

  Referring again to FIGS. 84, 88 and 89, a fastener, such as staple 30030, is deployed from, for example, staple cartridge 30000, whereby staple 30030 engages tissue thickness compensator 30020, and the tubular element therein A force A may be applied to 32080. As described above, when the force A is applied to the tubular element 30080, the tubular element 30080 is deformed. Similar to the end effector 12 described herein, the rigid support portion 30010 of the staple cartridge 30000 can include a cartridge body 30017, a deck surface 30011, and a plurality of staple cavities 30012 therein. Each staple cavity 30012 can define an opening in the deck surface 30011, and the staple 30030 can be removably disposed within the staple cavity 30012 (FIG. 104). Referring primarily to FIGS. 88 and 89, each staple 30030 can include a base 30031 and two staple legs 30032 extending from the base 30031. Prior to deploying the staples 30030, the base 30031 of each staple 30030 may be supported by a staple driver 30040 (FIG. 104) disposed within the rigid support portion 30010 of the staple cartridge 30000. Also, the leg 30032 of each staple 30030 can be at least partially received within the staple cavity 30012 prior to deployment of the staple 30030 (FIG. 104).

  If desired, the staples 30030 can be deployed between an initial position and a fired position as detailed herein. For example, staple firing sled 30050 can engage a driver 30040 (FIG. 104) to move at least one staple 30030 between an initial position and a fired position. Referring primarily to FIG. 88, the staple 30030 can be moved to the fired position and the legs 30032 of the staple 30030 engage the tubular element 3080 of the tissue thickness compensator 32020 and enter the tissue T, The anvil 30060 (FIG. 104) disposed relative to the staple cartridge 30000 of the surgical end effector 12 may be contacted. Staple forming pockets 30062 in anvil 30060 can fold staple legs 30032 so that fired staple 30030 can capture a portion of tubular element 3080 and a portion of tissue T within staple capture region 30039. As described in detail herein, as the staple 30030 moves between the initial position and the fired position, at least one staple leg 30032 is the tubular element 3280 of the tissue thickness compensator 32020. Can be punctured. Alternatively, the staple legs 30032 may move along the outer periphery of the tubular element 3080, thereby avoiding the staple legs 30032 from piercing the tubular element 3080. Similar to the fasteners described herein, the legs 30032 of each staple 30030 can be deformed downward toward the base 30031 of the staple 30030 to form a staple capture region 30039 therebetween. Staple capture region 30039 can be a region where a portion of tissue T and tissue thickness compensator 32020 can be captured by fired staple 30030. In the fired position, each staple 30030 can apply a compressive force against the tissue T and tissue thickness compensator 32020 captured in the staple capture region 30039 of the staple 30030.

  With continued reference to FIG. 88, once the tubular element 3080 is captured within the staple capture region 30039, the captured portion of the tubular element 3080 can be deformed as described herein. Furthermore, the tubular element 32080 is deformed into different deformed shapes in different staple capture regions 30039 depending on, for example, the thickness, compressibility, and / or density of the tissue T captured in the same staple capture region 30039. obtain. The tubular element 3080 of the tissue thickness compensator 3080 can extend longitudinally through the continuous staple capture region 30039. In such an arrangement, the tubular elements 3080 can be deformed into different deformed shapes at each staple capture region 30039 along a row of fired staples 30030. Referring now to FIG. 89, the tubular elements 33080 of the tissue thickness compensator 33020 can be arranged laterally in the staple capture region 30039 along the row of fired staples 30030. Tubular element 33080 can be held by flexible shell 33210. In such an arrangement, the tubular element 33080 and the flexible shell 33210 can be deformed to different deformed shapes in each staple capture region 30039. For example, if the tissue T is thinner, the degree of compression of the tubular element 33080 can be reduced, and if the tissue T is thicker, the degree of compression of the tubular element 33080 can be increased to accommodate the thicker tissue T. Alternatively, the deformation dimension of the tubular element 33080 can be uniform throughout the length and / or width of the tissue thickness compensator 33020.

  With reference to FIGS. 90-92, the tubular element 34080 within the tissue thickness compensator 34020 can include a plurality of strands 34090. Referring primarily to FIG. 90, the strands 34090 can be woven or knitted into a tubular lattice 34092 to form a tubular element 34080. The tubular lattice 34092 formed by the strands 34090 can be substantially hollow. The strands 34090 of the tubular element 34080 can be solid strands, tubular strands, and / or other suitable shapes. For example, referring to FIG. 91, the single strand 34090 of the tubular lattice 34092 can be a tube. With reference to FIG. 93, the strand 34090 can include at least one lumen 34994 extending therethrough. The number, shape, and / or dimensions of lumens 34904 can determine the cross-sectional shape of strands 34090. For example, the strand 34090 can include a circular lumen, a semicircular lumen, a wedge-shaped lumen, and / or combinations thereof. In accordance with the present invention, the strand 34090 may further include a support web 34096 that may form, for example, a modified “T” or “X” shape. At least the diameter of the strand 34090, the lumen extending therethrough, and the support web can characterize the cross-sectional shape of the strand 34090. The cross-sectional shape of each strand 34090 is the spring return force or restoring force generated by the strand 34090 and the corresponding spring return force or restoring force generated by the tubular element 34080, as detailed herein. Can affect.

  Referring to FIG. 94, the tubular grid 34092 of the strands 34090 can be deformable. Tubular lattice 34092 may create or contribute to the deformability and / or elasticity of tubular element 34080. For example, the strands 34090 of the tubular lattice 34092 can be woven together so that the strands 34090 slide and / or bend relative to each other. When a force is applied to the elongated portion 34082 of the tubular element 34080, the strands 34090 present therein can slide and / or bend and the tubular lattice 34092 can transition to a deformed shape. For example, referring still to FIG. 94, the staple 30030 compresses the tubular lattice 34092 and tissue T captured in the staple capture region 34039, which causes the strands 34090 of the tubular lattice 34092 to slide and move relative to each other. It can be bent. When the tubular lattice 34092 is compressed into a deformed shape to accommodate the captured tissue T in the staple capture region 30039, the upper vertex 34086 of the tubular lattice 34092 is at the lower vertex 34088 of the tubular lattice 34092. Can move toward. In various situations, the tubular grid 34092 captured in the fired staple 30030 may attempt to return to an undeformed shape and apply a restoring force to the captured tissue T. Further, the portion of the tubular grid 34092 that is between the staple capture regions 30039 (ie, the portion that is not captured within the fired staple 30030) is also caused by deformation of the adjacent portion of the tubular lattice 34092 that is within the staple capture region 30039. Can be deformed. If the tubular grid 34092 is deformed, the tubular grid 34092 may attempt to recover or partially recover from the deformed shape. If desired, portions of the tubular lattice 34092 can return to the initial shape, and other portions of the tubular lattice 34092 can only be partially restored and / or remain fully compressed.

  As with the description of the tubular element herein, each strand 34090 may be deformable. Furthermore, the deformation of the strands 34090 can generate a restoring force that depends on the elasticity of each strand 34090. Referring primarily to FIGS. 91 and 92, each strand 34090 of the tubular lattice 34092 can be tubular. Alternatively, each strand 34090 of the tubular lattice 34092 can be solid. As another alternative, the tubular lattice 30092 may include at least one tubular strand 34090, at least one solid strand 34090, at least one “X” or “T” shaped strand 34090, and / or combinations thereof. Can be included.

  The strand 34090 of the tubular element 34080 may comprise a polymer composition. The polymer composition of strands 34090 can include non-absorbable polymers, absorbent polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. The absorbent polymer can include, for example, a bioabsorbable biocompatible elastomeric polymer. Further, the composition of strands 34090 can include synthetic polymers, non-synthetic polymers, and / or combinations thereof. If desired, similar to the polymer composition of the tissue thickness compensator described elsewhere herein, the polymer composition of strand 34090 can include, for example, an absorbent polymer, a non-absorbable polymer, a synthetic polymer, And / or non-synthetic polymers may be included in various weight percent amounts.

  The strand 34090 of the tubular element 34080 can further include a therapeutic agent 34098 (FIG. 91), eg, a pharmaceutically active agent and / or agent. Strand 34090 may release a therapeutically effective amount of therapeutic agent 34098. The therapeutic agent 34098 can be released as the tubular strand 34090 is absorbed. For example, therapeutic agent 30098 can be released into or through a fluid (eg, blood) through or through strand 34090. As another alternative, the therapeutic agent 34098 is used when the staple 30030 punctures the strand 34090 and / or the cutting element 30052 on the staple firing thread 30050 (FIG. 84) cuts a portion of the tubular lattice 34092. Can be released. Examples of this pharmaceutically active agent 34098 include hemostatic agents and agents (eg, fibrin, thrombin, and / or oxidized regenerated cellulose (ORC)), anti-inflammatory agents (eg, diclofenac, aspirin, naproxen, sulindac, and / or Hydrocortisone), antibiotics and antibacterial agents or drugs (eg, triclosan, silver ion, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol), anticancer agents (eg, cisplatin, mitomycin, and / or adriamycin), and / or Or it may include, but is not limited to, biologics (eg, stem cells).

  With reference to FIGS. 95 and 96, the tubular element 35080 can include multiple layers 35100 of strands 35090. Tubular element 35080 may include a multi-layer 35100 tubular grid 35092. Referring to FIG. 95, tubular element 35080 can include, for example, strands 35090 of first layer 35100a and second layer 35100b. Referring now to FIG. 96, the tubular element 35180 of the tissue thickness compensator 35120 can include, for example, a strand 35090 of the third layer 35100c. Further, the different layers 35100 in the tubular element 35180 can comprise different materials. Each layer 35100a, 35100b, 35100c can be bioabsorbable and each layer 35100a, 35100b, 35100c can comprise a different polymer composition. For example, the first layer 35100a can include a first polymer composition. The second layer 35100b can include a second polymer composition. The third layer 35100c can include a third polymer composition. In such cases, the layers 35100a, 35100b, 35100c of the tubular element 35180 can be bioabsorbed at different rates. For example, the first layer 35100a may be absorbed rapidly, the second layer 35100b may be absorbed more slowly than the first layer 35100a, and the third layer 35100c may be absorbed more than the first layer 35100a and / or the second layer 35100b. Can be absorbed slowly. Alternatively, the first layer 35100a may be absorbed slowly, the second layer 35100b may be absorbed faster than the first layer 35100a, and the third layer 35100c may be absorbed faster than the first layer 35100a and / or the second layer 35100b. Can be absorbed.

  Similar to strand 34090 described herein, strand 35090 in tubular element 35180 may include drug 35098. Referring again to FIG. 95, to control the elution or release of drug 35098, the strand 35090 of the first layer 35100a containing the drug 35098a can be bioabsorbed at a first rate and the strand 35090 of the second layer 35100b containing the drug 30098b. Can be bioabsorbed at a second rate. For example, the first layer 35100a can be rapidly absorbed to allow a rapid initial release of drug 35098a and the second layer 35100b can be absorbed more slowly to allow controlled release of the drug 30098. The drug 35098a in the strand 35090 of the first layer 30100a may be different from the drug 35098b in the strand 35090 of the second layer 35100b. For example, the strand 35090 of the first layer 35100a can include oxidized regenerated cellulose (ORC), and the strand 35090 of the second layer 35100b can include a solution including hyaluronic acid. In such a case, oxidized regenerated cellulose is released by the initial absorption of the first layer 35100a to help control bleeding, and then the second layer 35100b is absorbed, thereby releasing a solution containing hyaluronic acid to form tissue. Can help prevent adhesion. Alternatively, layers 35100a, 35100b can include the same agent 35098a, 35098b. For example, referring again to FIG. 96, the strands 35090 of layers 35100a, 35100b, and 35100c can include an anti-cancer agent (eg, cisplatin). Further, the first layer 35100a is rapidly absorbed, allowing a rapid initial release of cisplatin, the second layer 35100b is absorbed more slowly, allowing controlled release of cisplatin, and the third layer 35100c is the slowest. It can be absorbed to allow longer term controlled release of cisplatin.

  With reference to FIGS. 97 and 98, the tissue thickness compensator 36020 can include a coating material 36024. The coating material 36024 can be formed on the outside of the tubular element 36080, on the inside of the tubular element 36080, or on both the outside and inside of the tubular element 36080. Referring to FIG. 97, the coating material 36024 can be co-injected both inside and outside the tubular element 36080, and the tubular element 36080 can include a tubular grid 36092 of strands 36090. Similar to the polymer compositions described herein, the coating material 36024 can be, for example, polyglycolic acid (PGA), poly (lactic acid) (PLA), and / or any other suitable bioabsorbable and biocompatible. May include an elastomeric polymer. Further, the coating material 36024 can be non-porous, thereby allowing the coating material 36024 to form a fluid impermeable layer within the tubular element 36080. The coating material 36024 may define a lumen 36084 therethrough.

  Further to the above description, the tubular elements 36080 and / or the strands 36090 within the tubular grid 36092 may include a therapeutic agent 36098. With continued reference to FIGS. 97 and 98, the non-porous coating material 36024 can include a drug 36098 within the inner lumen 36084a. Alternatively or in addition, the non-porous coating material 36024 can include a drug 36098 within the intermediate lumen 36084 (eg, an intermediate lumen comprising a tubular lattice 36092 of drug-containing strands 36090) 36084b). Similar to the above, the tubular element 36080 can be positioned relative to the staple cavity 30012 and the cutting element 30052 in the staple cartridge 30000 (FIG. 84). Deployment of the staple 30030 and / or translation of the cutting element 30052 can be configured to puncture or rupture the non-porous coating material 36024, thereby providing at least one lumen 36084 of the tubular element 30080. The drug 36098 contained within may be released from lumen 30084. Referring to FIG. 99, the tubular element 37080 can include a non-porous film 37110. The non-porous film 37110 can at least partially surround the tubular lattice 37092 or the first layer 37100a and the second layer 37100b of the tubular lattice 30092, thereby providing a coating material 36024 as described herein. As well as a fluid-impermeable coating.

  As described above, the tubular element comprises at least one of a bioabsorbable material, a therapeutic agent, a plurality of strands, a tubular lattice, a layer of tubular lattice, a coating material, a non-porous film, or a combination thereof. May be included. For example, referring to FIG. 100, the tubular element 38080 can include a coating material 38024 and a plurality of strands 38090 disposed through the central lumen 38084 of the tubular element 38080. The strand 38090 can include a therapeutic agent 38098. Alternatively, for example, referring to FIG. 101, the tubular element 39080 can include a coating material 39024 and a therapeutic agent 39998, for example, disposed within the central lumen 39084 of the tubular element 39080. If desired, at least one of the tubular element 39080 and the coating material 39024 can include a fluid therapeutic agent 39998.

  Referring again primarily to FIG. 84, the tubular element 3080 can be positioned relative to the rigid support portion 30010 of the staple cartridge 30000. Tubular element 30080 may be longitudinally disposed adjacent to rigid support portion 30010. Tubular element 30080 may be substantially parallel to or along a longitudinal slot or cavity 30015 in rigid support portion 30010. Tubular element 30080 may be along longitudinal slot 30015 such that a portion of tubular element 30080 may overlap a portion of longitudinal slot 30015. In such a case, the cutting element 30052 on the staple firing thread 30050 can cut a portion of the tubular element 30080 as the cutting edge 30052 translates along the longitudinal slot 30015. Alternatively, the tubular element 30080 can be longitudinally disposed on the first or second side of the longitudinal slot 30015. As another alternative, the tubular element 30080 is positioned relative to the rigid support portion 30010 of the staple cartridge 30000 so that the tubular element 30080 traverses at least a portion of the rigid support portion 30010 laterally or diagonally. obtain.

  Referring to FIG. 102, for example, the tissue thickness compensator 40020 can include a plurality of tubular elements 40080. Tubular element 40080 can include, for example, different lengths, cross-sectional shapes, and / or materials. Further, the tubular element 40080 is disposed relative to the rigid support portion 40010 of the staple cartridge 30000 so that the tube axes of the tubular element 40080 can be parallel to each other. The tube axis of the tubular element 40080 may be aligned in the longitudinal direction so that the first tubular element 40080 can be disposed within the other tubular element 40080. Alternatively, parallel tubular elements 40080 can traverse the staple cartridge 30000 longitudinally, for example. As another alternative, parallel tubular elements 40080 can traverse staple cartridge 30000 laterally or diagonally. Alternatively, the non-parallel tubular elements 40080 may be oriented at an angle with respect to each other so that their tube axes intersect and / or be non-parallel to each other.

  Referring to FIGS. 102-105, the tissue thickness compensator 40020 can have two tubular elements 40080. The first tubular element 40080a is disposed longitudinally on the first side of the longitudinal slot 30015 within the rigid support portion 30010, and the second tubular element 40080b is disposed longitudinally on the third side of the longitudinal slot 30015. Can be done. Each tubular element 40080 may include a tubular lattice 40092 of strands 40090. The staple cartridge 30000 can include, for example, a total of six rows of staple cavities 30012, and three rows of staple cavities 30012 can be disposed on each side of the longitudinal slot 30015. In such cases, the cutting edge 30052 on the translating staple firing thread 30050 may not be necessary to cut a portion of the tubular element 40080.

  Similarly, referring now to FIGS. 106-107, the tissue thickness compensator 41020 can include two tubular elements 41080a, 41080b disposed longitudinally within the staple cartridge 30000. Similar to the above, three rows of staples 30030 in staple cavities 30012 engage one tubular element 41080a and another three rows of staples 30030 in staple cavities 30012 engage another tubular element 41080b. Can do. With continued reference to FIGS. 106-107, the deployed staple 30030 can engage the tubular element 40080 at various locations across the cross-section of the tubular element 40080. As described herein, the spring return elasticity and corresponding restoring force applied by the tubular element 41080 may depend, inter alia, on the cross-sectional shape of the tubular element 41080. Staples 30030 located in the staple catching region 30039 near or near the arc portion of the tubular element 41080 have a greater restoring force than the staples 30030 located in the staple catching region 30039 located near the non-arc portion. Can receive. Similarly, the staple 30030 disposed within the staple capture region 30039 in the non-arc portion of the tubular element 41080 is more than the restoring force experienced by the staple 30030 disposed at or near the arc portion of the tubular element 30080. Can receive a small resilience. In other words, the arc portion of the tubular element 41080 may have a greater spring constant than the non-arc portion of the tubular element 41080. This is due to the possibility that a greater amount of elastic material can be captured by staples 30030 along such portions. Optionally, as a result, primarily referring to FIG. 107, the restoring force generated by the tissue thickness compensator 41020 is greater near the staples 30030 and 30030c and near the staples 30030b within the tubular element 30080a. Can be smaller. Correspondingly, the restoring force generated by the tissue thickness compensator 41020 can be greater near the staples 30030d and 30030f in the tubular element 30080b than near the staples 30030e.

  Referring again to FIGS. 102-105, the cross-sectional shape of the strands 40090 comprising the tubular lattice 40092 can be selected to provide the desired spring return elasticity and corresponding restoring force applied by the tubular lattice 40092. . For example, referring again to FIG. 103, the strand 40090a disposed in the arc portion of the tubular element 40080 may include an X-shaped cross section, while the strand 40090b disposed in the non-arc portion of the tubular element 40080 is A tubular cross section may be included. Strands 40090a and 40090b comprising different cross-sectional shapes can be interwoven to form a tubular lattice 40092. Alternatively, the strands 40090a and 40090b can be bonded together, for example, with an adhesive. Referring to FIGS. 104 and 105, the various cross-sectional strands 40090 of the tubular element 40080 can optimize the restoring force experienced by the staple capture region 30039 across the staple cartridge 30000. A particular cross-sectional shape can be selected such that the spring return constant in the staple capture region 30039 is substantially balanced or equal across the staple cartridge.

  Referring to FIG. 108, the tubular elements 41080a, 41080b of the tissue thickness compensator 41120 can be joined together by adjacent portions 41126. Although the translating cutting element 30052 may be configured to pass between the tubular elements 41080a and 41080b, the cutting element 30052 may need to cut at least a portion of the adjacent portion 41126. Adjacent portion 41126 can include a soft material (eg, foam or gel) that can be easily cut by a translating cutting element 30052. The adjacent portion 41026 can releasably secure the tissue thickness compensator 41120 to the surgical end effector 12. The adjacent portion 41126 can be secured to the upper deck surface 30011 of the rigid support portion 30010 such that the adjacent portion 41126 is within the surgical end effector 12 after the tubular elements 41080a, 41080b are released therefrom. It can remain held.

  109-110, the tissue thickness compensator 42020 can include a plurality of tubular elements 42080 such that, for example, the number of tubular elements 42080 is equal to the number of rows of staple cavities 30012 within the staple cartridge 30000. Can be the same. Staple cartridge 30000 can include six rows of staple cavities 30012 and tissue thickness compensator 42020 can include six tubular elements 42080. Each tubular element 42080 can be substantially aligned with a row of staple cavities 30012. When staples 30030 are fired from a row of staple cavities 30012, each staple 30030 from that row can pierce the same tubular element 42080 (FIG. 110). Deformation of one tube 42080 can have little or no effect on the deformation of adjacent tubes 42080. Accordingly, the tubular element 42080 can apply a substantially individual and customized spring return force within the staple capture region 30039 across the width of the staple cartridge 30030. If staples 30030 fired from multiple rows of staple cavities 30012 engage the same tubular element 35080 (FIG. 107), the deformation of the tubular element 35080 may be less customizable. For example, deformation of the tubular element 35080 in the first row of staple capture regions 30039 may affect the deformation of that tubular element 35080 in another row of staple capture regions 30039. The translating cutting edge 30052 may avoid cutting the tubular element 42080. Alternatively, referring to FIG. 111, the tissue thickness compensator 43020 can include more than six tubular elements 43080 (eg, seven tubular elements 44080). Further, the tubular elements 43080 can be arranged symmetrically or asymmetrically within the end effector 12. When the odd number of tubular elements 43080 are arranged longitudinally and symmetrically within the end effector 12, the translating cutting element 30052 is configured to cut the central tubular element overlying the longitudinal channel 30015. obtain.

  Referring to FIG. 112, the tissue thickness compensator 44020 can include a central tubular element 44080b that is at least partially aligned with the longitudinal slot 30015 in the rigid support portion 33010 of the staple cartridge 30000. The tissue thickness compensator 44020 can further include at least one peripheral tubular element 44080a, 44080c on the side of the longitudinal slot 30015. For example, the tissue thickness compensator 44020 can include three tubular elements 44080. The first peripheral tubular element 44080a may be longitudinally disposed on the first side of the longitudinal slot 30015 of the staple cartridge 30000, and the central tubular element 44080b is substantially above and / or aligned with the longitudinal slot 30015. The second outer tubular element 44080c may be disposed longitudinally on the second side of the longitudinal slot 30015. The central tubular element 44080b may include a horizontal diameter that is substantially longer than the vertical diameter. The central tubular element 44080b, and / or any other tubular element, may overlap multiple rows of staple cavities 30012. With continued reference to FIG. 112, the central tubular element 44080 b can overlap, for example, four staple rows of staple cavities 30012, and each peripheral tubular element 44080 a, 44080 c can overlap a single row of staple cavities 30012. Alternatively, the central tubular element 44080b can overlap with less than four rows of staple cavities 30012, eg, two rows of staple cavities 30012. Further, the peripheral tubular elements 44080a, 44080c may overlap more than one row of staple cavities 30012, eg, two rows of staple cavities 30012. Referring now to FIG. 113, the central tubular element 44180b of the tissue thickness compensator 44120 can include a therapeutic agent 44198 within the lumen 44184 of the central tubular element 44180b. If desired, the central tubular element 44180b and / or the at least one peripheral tubular element 44080a, 44080c may include a therapeutic agent 44198 and / or any other suitable therapeutic agent.

  Referring to FIG. 114, the tissue thickness compensator 44220 includes a shell 44224, which can be similar to the dressing material 32024 described herein. The shell 44224 maintains the position of the plurality of tubular elements 44080 within the end effector 12. The shell 44224 can be co-extruded with the tubular element 44080. Tubular element 44080 can include a tubular grid 44409 of strands 44090. Similar to the polymer compositions described elsewhere herein, the shell 44224 can be, for example, polyglycolic acid (PGA), poly (lactic acid) (PLA), and / or any other suitable bioabsorbable. And may include a biocompatible elastomeric polymer. Further, the shell 44224 may be non-porous, so that the shell 44224 may form a fluid impermeable layer within the tissue thickness compensator 44220, for example. Further to the description herein, the tubular elements 44080 and / or the strands 44090 within the tubular lattice 44092 may include a therapeutic agent 44998. Non-porous shell 44224 may include a therapeutic agent 44098 within a tissue thickness compensator. As described above, the tubular element 44080 can be positioned relative to the staple cavity 30012 and the cutting element 30052 in the staple cartridge 30000. The deployment of the staple 30030 and / or translation of the cutting element 30052 can be configured to puncture or rupture the non-porous shell 44224 so that the therapeutic agent 44198 included therein is tissue thickness. It can be released from the compensator 44020.

  Referring to FIG. 115, the tissue thickness compensator 44320 can include a central tubular element 44380b that includes a tubular lattice 44392. The tubular lattice 44392 may have a nonwoven portion or gap 44381 that may be substantially aligned with the longitudinal slot 30015 of the rigid support portion 30010. In such a case, the woven portion of the tubular grid 44092 of the tubular element 44380b does not overlap the longitudinal slot 30015. Accordingly, the cutting element 30052 on the translating staple firing thread 30052 can translate along the longitudinal slot 30015 without cutting the overlap of the woven portion of the tubular grid 44392. Staples 30030c and 30030d disposed adjacent to gap 44381 in tubular element 44380b may receive less support from the tubular grid 44392 structure, but provide additional support to these staples 30030 with additional functionality. And / or additional resiliency can be provided within the staple capture region 30039 therein. For example, as detailed herein, for example, additional tubular elements, support webs, springs, and / or buttress material may be disposed on at least one of the inside and outside of the tubular element 44380b near the gap 44381. can do.

  Referring now to FIGS. 116-119a, the tissue thickness compensator 45020 can include a plurality of tubular elements 45080 that transversely traverse the staple cartridge 30000. The tubular elements 45080 may be disposed perpendicular to the rows of staple cavities 30012 and / or to the longitudinal axis of the rigid support portion 30010 of the staple cartridge 30000. Referring to FIG. 116, the tubular element 45080 can traverse the longitudinal slot 30015 of the staple cartridge 30000 such that the cutting element 30052 on the staple firing thread 30050 causes the staple firing thread 30050 to be in the longitudinal slot 30015. Can be configured to cut the tubular element 45080 as it translates along. Alternatively, referring now to FIG. 117, the tissue thickness compensator 46020 can include two sets of tubular elements 46080 transversely. A first set of transversely traversing tubular elements 46080a can be disposed on the first side of the longitudinal slot 30015, and a second set of transversely traversing tubular elements 46080b is disposed on the longitudinal slot 30015. It can be arranged on the second side. In such an arrangement, the cutting element 30052 can be configured to pass between two sets of tubular elements 46080 without cutting a portion of the tubular elements 46080. Alternatively, the cutting element 30052 can cut at least one tubular element 46080 that traverses the longitudinal slot 30015, where at least one other tubular element 46080 can traverse the longitudinal slot 30015. Therefore, it is not cut by the cutting element 30052.

  As the tubular element 45080 traverses the staple cartridge 30000 laterally, referring to FIGS. 118 and 119, the staple 30030 may engage at least one tubular element 45080 within each staple capture region 30039. In such an arrangement, each tubular element 45080 may provide a separate restoring force over the length of the staple cartridge 30000. For example, referring primarily to FIG. 119, the tubular element 45080 disposed near the proximal end of the tissue thickness compensator 45020 (where the tissue is thicker) is near the distal end of the tissue thickness compensator 45020 ( The degree of compression can be greater than the tubular element 45080 located where the tissue is thinner). As a result, the tubular element 45080 disposed near the proximal end of the tissue thickness compensator 45020 is less than the restoring force that can be generated by the tubular element 46080 disposed near the distal end of the tissue thickness compensator 45020. Can also provide great resilience. Still referring to FIG. 119, deformation of one tube 45080 can have little or no effect on deformation of adjacent tubes 45080. Accordingly, the tubular element 45080 can apply a substantially individual and customized spring return force within the staple capture region 30039 over the length of the staple cartridge 30030. If multiple staples 30030 fired from a single row of staple cavities 30012 engage the same tubular element 35080, the deformation of the tubular element 35080 may be less customizable. For example, deformation of tubular element 35080 in staple capture region 30039 can affect deformation of that tubular element 35080 in another staple capture region 30039.

  As another alternative, referring to FIGS. 120-125, the tubular element 47080 of the tissue thickness compensator 47020 can traverse the staple cartridge 30000 diagonally. The tubular element 47080 can traverse the longitudinal slot 30015 of the staple cartridge 30000 so that the cutting element 30052 on the staple firing thread 30050 is translated as the staple firing thread 30052 translates along the longitudinal slot 30015. And can be configured to cut an obliquely traversing tubular element 47080. Alternatively, the tissue thickness compensator 47020 can include two sets of diagonally traversing tubular elements 47080. The first set of diagonally traversing tubular elements 47080 can be disposed on the first side of the longitudinal slot 30015 and the second set of diagonally traversing tubular elements 47080 is the second of the longitudinal slots 30015. Can be placed on the side. In such an arrangement, the cutting element 30052 can pass between the two sets of tubular elements 47080 and does not cut the tubular elements 47080.

  With continued reference to FIGS. 120-123, diagonally traversing tubular elements 47080 can be positioned within staple cartridge 30000 such that a gap is defined between tubular elements 47080. Adjacent tubular element 47080 provides space for horizontal expansion of tubular element 47080 when, for example, compressive force is applied by tissue T captured within staple capture region 30039 of formed staple 30030. Can be provided. Tubular elements 47080 can be connected across the gap by a film or sheet material 47024. The sheet material can be disposed on at least one of the deck surface 30011 of the rigid support portion 30010 and / or the tissue contacting surface of the tubular element 47080.

  124 and 125, at least one obliquely traversing tubular element 47080 is positioned relative to the staple cavity 30012 in the staple cartridge 30000, whereby the tubular element 47080 is a plurality of staple cavities 30012. Can be disposed between legs 30032 of staples 30030 deployed from a plurality of rows. As the staple 30030 moves from the initial position to the fired position, the staple legs 30032 may remain disposed about the tubular element 47080, as detailed herein. Further, the staple can be deformed, for example, such that the staple legs 30032 wrap around the tubular element 47080. In such an arrangement, the staple 30030 can be configured to move to a fired or formed position without piercing the tubular element 47080. Movement of the staple legs 30032 about the tubular element 47080 may prevent accidental release of the therapeutic agent 47098 held therein. The selected angular orientation of each tubular element 47080 relative to the longitudinal slot 30015 of the staple cartridge 30000 may depend on the position of the staple cavity 30012 of the staple cartridge 30000. For example, the tubular element 47080 can be disposed at an angle of about 45 degrees with respect to the longitudinal slot 30015 of the staple cartridge 30000. Alternatively, the tubular element 47080 can be disposed at an angle of 15 to 75 degrees with respect to the longitudinal slot 30015 of the staple cartridge 30000, for example.

  As with the overall description of the present disclosure, the plurality of tubular elements in the tissue thickness compensator can be, for example, a binder, wrap, web, coating, compensation material, and / or any other suitable bonding adhesive or Can be connected by structure. Referring to FIGS. 126-128, the flexible shell 48024 may surround or enclose the tubular element 48080 within the tissue thickness compensator 48020. The flexible shell 48024 can restrain the tubular elements 48080 in the end effector 12 and hold each tubular element 48080 in place (eg, in a longitudinal direction aligned with a row of staple cavities 30012). The tissue thickness compensator 48020 can include, for example, six tubular elements 48080. The flexible shell 48024 may be sufficiently deformable and resilient to allow the tubular element 48020 contained therein to be constrained while allowing the tubular element 48080 to be deformed and restored. Further, the flexible shell 48024 can securely enclose the tubular element 48080 and can remain securely engaged to the tubular element 48080 as it deforms and / or restores.

  Referring to FIG. 127, before deploying staple 30030, anvil 30060 may pivot or rotate downward to compress tissue thickness compensator 48020 and tissue T between anvil 30060 and staple cartridge 30000. . The compression of the tissue thickness compensator 48020 can include a corresponding compression of the flexible shell 48024 and the tubular element 48020 therein. When the tubular element 48020 is deformed, the flexible shell 48024 can be similarly deformed. Tubular element 48020 is uniformly compressed across the width of staple cartridge 30000, and flexible shell 48024 can be similarly uniformly compressed across tubular element 48080. Referring to FIG. 128, when the anvil 30060 is opened after the staple 30030 is deployed from the staple cartridge 30000, the tubular element 48080 can be restored or partially restored from the compressed shape (FIG. 127). According to the present invention, the tubular element 48080 can be restored so that the tubular element 48080 returns to its initial undeformed shape. Tubular element 48080 can be partially restored such that tubular element 48080 partially returns to its initial undeformed shape. For example, the deformation of the tubular element 48080 can be partly elastic and partly plastic. When the tubular elements 48080 are restored, the flexible shell 48024 may remain securely engaged with each tubular element 48080. Tubular element 48080 and flexible shell 48024 allow tubular element 48080 and tissue T to fill staple capture region 30039 while tubular element 48080 applies an appropriate restoring force to tissue T therein. To some extent it can be restored. Referring to FIG. 129, in other cases, a tissue thickness compensator 48120 that includes, for example, six tubular elements 48180 held within a flexible shell 48124 is disposed on the anvil 30060 of the end effector 12. obtain.

  130-133, the tissue thickness compensator 49020 can include a tubular element 49080 disposed longitudinally along the longitudinal axis of the anvil 30060. The tissue thickness compensator 49020 can be secured to the anvil 30060 of the end effector 12 by a compressible compensation material 49024. Further, compressible compensation material 49024 can surround or enclose tubular element 49080. Similar to the description herein, the tubular element 49080 may include at least one therapeutic agent 49098 that absorbs various components of the tissue thickness compensator 49020, staples 30030 fired from the staple cartridge 30000. Can be released by puncturing the tubular element 49080 and / or the cutting element 30052.

  Referring to FIG. 131, the staple cartridge 30000 can include staples 30030 disposed within the staple cavity 30012, and prior to deployment of the staples 30030, the anvil 30060 and the tissue thickness compensator 49020 attached thereto are stapled. The tissue T that pivots toward the cartridge 30000 and is trapped in between may be compressed. The tubular element 49080 of the tissue thickness compensator 49020 can be uniformly deformed along the length of the staple cartridge 30000 by pivoting the anvil 30060 (FIG. 131). 132 and 133, staple firing sled 30050 translates along longitudinal slot 30015 in staple cartridge 30000 and engages each driver 30040 disposed under staple 30030 in staple cavity 30010; Each engaged driver 30040 can fire or fire the staple 30030 from the staple cavity 30012. When the anvil 30060 releases the pressure on the tissue T and the tissue thickness compensator 49020, the tissue thickness compensator 49020 (including the tubular element 49080 and the compressible compensation material 49024) is restored from the compressed shape (FIG. 131). (FIGS. 132 and 133) may be restored or partially restored. Tubular element 49080 and compressible compensation material 49024 allow tissue thickness compensator 49020 to apply a restoring force to captured tissue T, while tissue thickness compensator 49020 and tissue T fill staple capture region 30039. It can be restored to such an extent that

  With reference to FIGS. 124-126, two tissue thickness compensators 50020a, 50020b may be disposed within the end effector 12 of the surgical instrument. For example, the first tissue thickness compensator 50020a can be attached to the staple cartridge 30000 in the lower jaw 30070 and the second tissue thickness compensator 50020b can be attached to the anvil 30060. The first tissue thickness compensator 50020a can include a plurality of tubular elements 50080 disposed longitudinally and retained within the first compensation material 50024a. At least one tubular element 50080 can include a therapeutic agent 50098, similar to the therapeutic agents described herein. The first compensation material 50024a can be deformable or substantially rigid. Further, the first compensation material 50024a can hold the tubular element 50080 in a position relative to the staple channel 30000. For example, the first compensation material 50024a can hold each tubular element 50080 longitudinally along a row of staple cavities 30012. The second tissue thickness compensator 50020b may include a first compensation material 50024a, a second compensation material 50024b, and / or a third compensation material 50024c. The second and third compensation materials 50024b, 50024c may be deformable or substantially rigid.

  The anvil 30060 can pivot to apply a compressive force against the tissue thickness compensators 50020a, 50020b and the tissue T between the anvil 30060 and the staple cartridge 30000. In some cases, neither the first tissue thickness compensator 50020a nor the second tissue thickness compensator 50020b may be compressible. Alternatively, at least one of the first tissue thickness compensator 50020a and / or the second tissue thickness compensator 50020b may be compressible. When staples 30030 are fired from staple cartridge 30000, referring now to FIGS. 135 and 136, each staple 30030 may puncture a tubular element 50080 held within a first tissue thickness compensator 50020a. As shown in FIG. 135, the therapeutic agent 50098 held within the tubular element 50080 can be released when the staple 30030 punctures the tubular element 50080. Once released, the therapeutic agent 50098 may coat the staple legs 30032 and the tissue T around the fired staple 30030. Staple 30030 can also puncture second tissue thickness compensator 50020b when staple 30030 is fired from staple cartridge 30000.

  Referring to FIGS. 137-140, the tissue thickness compensator 51020 can include at least one tubular element 51080 that transversely intersects the tissue thickness compensator 51020. For example, referring to FIG. 137, the tissue thickness compensator 51020 is positioned relative to the staple cartridge 30000 such that the first end 51083 of the transversely traversing tubular element 51080 is the first of the staple cartridge 30000. A second end 51085 of the tubular element 51080 disposed near the longitudinal side and transversely transverse may be disposed near the second longitudinal side of the staple cartridge 30000. Tubular element 51080 may include, for example, a capsule-like shape. As shown in FIG. 138, the tubular element 51080 may have a perforation between a first end 51083 and a second end 51085, and in some cases, the tubular element 51080 may have a central position 51087 of the tubular element 51080 or It may have a perforation nearby. Tubular element 51080 may comprise a polymer composition, for example, a bioabsorbable biocompatible elastomeric polymer. Further, referring again to FIG. 137, the tissue thickness compensator 51020 can include a plurality of laterally traversing tubular elements 51080. For example, 13 tubular elements 51080 can be disposed laterally within the tissue thickness compensator 51020.

  Referring again to FIG. 137, the tissue thickness compensator 51020 can further include a compensation material 51024 that at least partially surrounds the tubular element 51080. Compensation material 51024 can include a bioabsorbable polymer, such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and / or oxidized regenerated cellulose (ORC). Compensation material 51024 can hold tubular element 51080 in position within tissue thickness compensator 51020. Further, the compensation material 51024 can be secured to the upper deck surface 30011 of the rigid support portion 30010 of the staple cartridge 30000 so that the compensation material 51020 can be securely disposed within the end effector 12. Compensation material 51024 can include at least one agent 51098.

  With continued reference to FIG. 137, the laterally disposed tubular element 51080 can be disposed relative to the translational cutting element 30052, whereby the cutting element 30052 can be configured to cut the tubular element 51080. Cutting element 30052 may cut tubular element 51080 at or near the perforation. When tubular element 51080 is cut in half, the cut portion of tubular element 51080 can be configured to swell or expand as shown in FIG. For example, the tubular element 51080 can include a hydrophilic material 51099, which can be released and / or exposed when the tubular element 51080 is cut. Furthermore, when the hydrophilic material 51099 comes into contact with body fluid in the tissue T, the hydrophilic material 51099 can attract the fluid, thereby causing the tubular element 51080 to swell or expand. As tubular element 51080 expands, compensation material 51024 surrounding tubular element 51080 can be moved or adjusted to accommodate swollen tubular element 51080. For example, if the compensation material 51024 includes gelatin, the gelatin can migrate to accommodate the swollen tubular element 51080. Referring now to FIG. 140, the expansion of the tubular element 51080 and the movement of the compensation material 51024 can cause a corresponding expansion of the tissue thickness compensator 51020.

  As with other tissue thickness compensators described throughout this disclosure, the tissue thickness compensator 51020 can be deformed or compressed by an applied force. In addition, the tissue thickness compensator 51020 can be sufficiently resilient to generate a spring return force when deformed by an applied force and then be restored or partially restored when the applied force is subsequently removed. . If desired, the staple 30030 can deform the tissue thickness compensator 51020 when the tissue thickness compensator 51020 is captured within the staple capture region 30039. For example, the staple 30030 can deform the tubular element 51080 and / or compensation material 51024 of the tissue thickness compensator 51020 captured within the fired staple 30030. If desired, the non-captured portion of the tissue thickness compensator 51020 can also be deformed by deformation of the staple capture region 30039. Once deformed, the tissue thickness compensator 51020 may attempt to recover from the deformed shape. If desired, such restoration can occur prior to the hydrophilic expansion of the tubular element 51080, simultaneously with the hydrophilic expansion of the tubular element 51080, and / or after the hydrophilic expansion of the tubular element 51080. As the tissue thickness compensator 51020 attempts to restore, a restoring force can be applied to the tissue captured together in the staple capture region 30039, as detailed herein.

  If desired, at least one tubular element 51080 and / or compensation material 51024 in the tissue thickness compensator 51020 can include a therapeutic agent 51098. When the tubular element 51080 containing the therapeutic agent 51098 is cut, the therapeutic agent 51098 contained within the tubular element 51080 can be released. Further, if the compensation material 51024 includes a therapeutic agent 51098, the therapeutic agent 51098 can be released as the bioabsorbable compensation material 51024 is absorbed. Tissue thickness compensator 51020 may provide a rapid initial release of therapeutic agent 51098 followed by a controlled release of therapeutic agent 51098. For example, the tissue thickness compensator 51020 may provide a rapid initial release of the therapeutic agent 51098 from the tubular element 51080 to the tissue T when the tubular element 51080 containing the therapeutic agent 51098 is cut. Further, the tissue thickness compensator 51020 can provide long-term controlled release of the therapeutic agent 51098 when the bioabsorbable compensation material 51024 containing the therapeutic agent 51098 is absorbed. At least a portion of the therapeutic agent 51098 may remain in the tubular element 51080 for a short period of time before the therapeutic agent 51098 flows into the compensation material 51024. Alternatively, at least a portion of the therapeutic agent 51098 may remain in the tubular element 51080 until the tubular element 51080 is absorbed. The therapeutic agent 51098 released from the tubular element 51080 and the compensation material 51024 can be the same. Alternatively, tubular element 51080 and compensation material 51024 can include, for example, different therapeutic agents, or a combination of different therapeutic agents.

  With continued reference to FIG. 140, the end effector 12 can cut the tissue T and fire staples 30030 on the cut tissue T substantially simultaneously or immediately thereafter. In such a case, the staple 30030 can be deployed in the tissue T immediately after the cutting element 30052 cuts the tubular element 51080 adjacent to the tissue T. In other words, the staple 30030 can engage the tissue thickness compensator 51020 immediately after or simultaneously with the swelling of the tubular element 51080 and the expansion of the tissue thickness compensator 51020. The tissue thickness compensator 51020 can continue to grow or expand after the staples 30030 are fired into the tissue T. Staple 30030 can be configured to puncture tubular element 51080 when staple 30030 is deployed. In such a case, the therapeutic agent 51098 still remaining on the cut tubular element 51080 can be released from the tubular element 51080 and in some cases can cover the legs 30031 of the fired staple 30030.

  Referring to FIG. 141, the tissue thickness compensator 51020 can be manufactured, for example, by a mold technique. According to the present invention, the frame (mold) 51120 may include a first longitudinal side 51122 and a second longitudinal side 51124. Each longitudinal side 51124 may include one or more notches 51130 that may be configured to receive first or second ends 50183, 50185 of tubular element 51080, respectively. The first end 50183 of the tubular element 51080 can be disposed within the first notch 51130a of the first longitudinal side surface 51122, and the second end 50183 of the tubular element 51080 is the first end of the second longitudinal side surface 51124. Two cutouts 51130b can be placed so that the tubular element 51080 traverses the frame 51120 laterally. The notch 51180 includes a semi-circular groove that can securely hold the first or second end 50183, 50185 of the tubular element 51080 therein. The first notch 51130a can be positioned directly opposite the second notch 51130b and the tubular element 51080 is positioned perpendicular to, or at least substantially perpendicular to, the longitudinal axis 51120 of the frame. Can do. Alternatively, the first cutout 51130a may be in a position offset from the second cutout 51130b, so that the tubular element 51080 can be positioned at an angle with respect to the longitudinal axis 51120 of the frame. As another alternative, at least one tubular element 51080 is disposed longitudinally within the frame 51120 such that the tubular element can extend between the lateral sides 51126, 51128 of the frame 51120. . Further, for example, at least one tubular element may be inserted between two cutouts in the lateral sides 51126, 51128 of the frame, or between a cutout on the lateral side 51126 and a cutout on the longitudinal side 51124. Can be arranged diagonally in the frame. The frame 51120 can include a support shelf 51136, which can support a tubular element 51080 disposed within the frame 51120.

  The frame 51120 can include a notch 51130 for receiving, for example, twelve tubular elements 51080. The frame cutout 51130 may be occupied by the tubular element 51080, or not all of the cutout 51130 may be occupied. If desired, at least one tubular element 51080 can be disposed within the frame 51120. At least half of the cutouts 51130 can receive the tubular element 51080. Once the tubular element 51080 is placed in the frame 51120, compensation material 51024 can be added to the frame 51120. Compensation material 51024 can be a fluid when applied to frame 51120. For example, compensation material 51024 can be poured into frame 51120 and can flow around tubular element 51080 disposed therein. Referring to FIG. 142, fluid compensation material 51024 can flow around tubular element 51080 supported by notch 51130 in frame 51120. After the compensation material 51024 has cured, or at least fully cured, referring now to FIG. 143, the tissue thickness compensator 51020 comprising the compensation material 51024 and the tubular element 51080 can be removed from the frame 51120. The tissue thickness compensator 51020 can be trimmed. For example, excess compensation material 51024 can be removed from the tissue thickness compensator 51020 to substantially flatten the longitudinal sides of the compensation material. Still referring to FIG. 144, the first end and the second end 50183, 50185 of the tubular element 51080 can be pressed or closed together to seal the tubular element 51080. This end can be closed before the tubular element 51080 is placed on the frame 51120. Alternatively, the ends 51083, 51085 can be cut in a trimming process, and then a thermal stacking process can be used to seal and / or close the ends 51083, 51085 of the tubular element 51080.

  Referring again to FIG. 141, a reinforcing pin 51127 can be disposed within each tubular element 51080. For example, the reinforcing pin 51127 can extend through the longitudinal lumen of the tubular element 51080. The reinforcing pins 51127 may extend beyond each tubular element 51080 so that the reinforcing pins 51127 can be placed in the notches 51130 in the frame 51120. In embodiments having a reinforcing pin 51127, the reinforcing pin 51127 supports the tubular element 51080, for example, when the compensation material 51204 is poured into the frame 51120 and the fluid compensation material 51024 flows around the tubular element 51080. be able to. Once the compensation material 51024 has cured, solidified, and / or lyophilized, or sufficiently cured, solidified, and / or lyophilized, the tissue thickness compensator 51020 is removed from the frame 51120 and reinforced. Pin 51127 can be removed from the longitudinal lumen of tubular element 51080. Tubular element 51080 can then be filled, for example, with a drug. After filling the tubular element 51080 with the drug, the tissue thickness compensator 51020 (including the ends 51083, 51085 of the tubular element 51080) can be trimmed. The tissue thickness compensator 51020 can, for example, be die cut and / or sealed with heat and / or pressure.

  As described herein, the tissue thickness compensator 52020 can include a plurality of tubular elements 51080. Referring now to FIG. 145, tubular element 51080 can include various material properties, dimensions and shapes. For example, the first tubular element 51080a can include a first thickness and a first material, and the second tubular element 51080b can include a second thickness and a second material. If desired, at least two tubular elements 51080 within the tissue thickness compensator 52020 can comprise the same material. Alternatively, each tubular element 51080 within the tissue thickness compensator 52020 can comprise a different material. Similarly, at least two tubular elements 51080 within the tissue thickness compensator 52020 can include the same shape. Alternatively, each tubular element 51080 within the tissue thickness compensator 52020 can include a different shape.

  Referring now to FIGS. 208-211, the tissue thickness compensator 51220 can include at least one tubular element 51280 that transversely traverses the tissue thickness compensator 51220. Referring to FIG. 208, the tissue thickness compensator 51220 can be positioned relative to the anvil 30060 of the end effector 12. The tissue thickness compensator 51220 can be secured, for example, to the securing surface 30061 of the anvil 30060 of the end effector 12. Referring primarily to FIG. 209, the tubular element 51280 can include, for example, a capsule-like shape. Tubular element 51280 can comprise a polymer composition, for example, a bioabsorbable biocompatible elastomeric polymer.

  Referring again to FIG. 208, the tissue thickness compensator 51220 can further include a compensation material 51224 that at least partially surrounds the tubular element 51280. Compensation material 51224 can include a bioabsorbable polymer, such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and / or oxidized regenerated cellulose (ORC). Similar to the above, the compensation material 51024 can hold the tubular element 51280 in position within the tissue thickness compensator 51220. Further, the compensation material 51224 can be secured to the securing surface 30061 of the anvil 30060 so that the compensation material 51220 can be securely positioned within the end effector 12. Compensation material 51224 can include at least one agent.

  With continued reference to FIG. 208, the laterally disposed tubular element 51280 is disposed relative to the cutting element 30252 on the translational thread 30250 such that the translational cutting element 30252 cuts the tubular element 51280. Can be configured. The cutting element 30252 can cut the tubular element 51280 at or near the center of each tubular element 51280, for example. When tubular element 51280 is cut in half, the cut portion of tubular element 51280 may be configured to swell or expand as shown in FIG. Referring primarily to FIG. 210, the tubular element 51280 can include a hydrophilic material 51099 that can be released and / or exposed once the tubular element 51280 is cut. Further, referring now to FIG. 211, when the hydrophilic material 51099 contacts body fluid in the tissue T, the hydrophilic material 51099 can attract fluid thereby causing the tubular element 51280 to swell or expand. As the tubular element 51280 expands, the compensation material 51224 surrounding the tubular element 51280 can be moved or adjusted to accommodate the swollen tubular element 51280. For example, if the compensation material 51224 includes gelatin, the gelatin can migrate to accommodate the swollen tubular element 51280. Referring again to FIG. 208, the expansion of the tubular element 51280 and the movement of the compensation material 51224 can cause a corresponding expansion of the tissue thickness compensator 51220.

  Like other tissue thickness compensators described throughout this disclosure, the tissue thickness compensator 51220 can be deformed or compressed by an applied force. In addition, the tissue thickness compensator 51220 can be sufficiently resilient to generate a spring return force when deformed by an applied force and then be restored or partially restored when the applied force is subsequently removed. . If desired, the staple 30030 can deform the tissue thickness compensator 51220 when the tissue thickness compensator 51220 is captured within the staple capture region 30039 (FIG. 88). For example, the staple 30030 can deform the tubular element 51280 and / or compensation material 51224 of the tissue thickness compensator 51220 captured within the fired staple 30030. If desired, the non-captured portion of the tissue thickness compensator 51220 can also be deformed by deformation of the staple capture region 30039. Once deformed, the tissue thickness compensator 51220 may attempt to recover from the deformed shape. If desired, such restoration can occur prior to the hydrophilic expansion of the tubular element 51280, simultaneously with the hydrophilic expansion of the tubular element 51280, and / or after the hydrophilic expansion of the tubular element 51280. As the tissue thickness compensator 51220 attempts to restore, a restoring force can be applied to the tissue captured together in the staple capture region 30039, as detailed herein.

  With reference to FIGS. 146-149, the tissue thickness compensator 52020 is one that transversely traverses the tissue thickness compensator 52020, similar to at least one of the tissue thickness compensators described herein. The above tubular element 52080 may be included. The tissue thickness compensator 52020 can include a plurality of laterally transverse tubular elements 52080. The tissue thickness compensator 52020 can further include one or more sheet materials 52024 that retain or retain at least one tubular element 52080 within the tissue thickness compensator 52020. One or more sheet materials 52024 can be placed above and / or below the tubular element 52080 to securely hold each tubular element 52080 within the tissue thickness compensator 52020. Referring primarily to FIG. 146, the tissue thickness compensator can include a first sheet material 52024a and a second sheet material 52024b. Tubular element 52080 may be disposed between first and second sheet materials 52024a, 52024b. Still referring to FIG. 146, the sheet material 52024 b can be secured to the upper deck surface 30011 of the rigid support portion of the staple cartridge 30000 so that the tissue thickness compensator 52020 is securely positioned within the end effector 12. obtain. Alternatively, one or more sheet materials 52024 can be secured to the anvil 30060 or otherwise retained within the end effector 12.

  Referring primarily to FIG. 147, the tissue thickness compensator 52020 can be porous and / or permeable. For example, the sheet material 52024 can include a plurality of openings 52026. The opening 52026 can be substantially circular. The opening 52016 can be visible in the sheet material 52024. Alternatively, the opening 52036 can be fine. With continued reference to FIG. 147, the tubular element 52080 can also include a plurality of openings 52026. With reference to FIG. 148, the tissue thickness compensator 52120 can include a sheet material 52124 that includes a plurality of non-circular openings 52126. For example, the opening 52126 may include a diamond shape and / or a slot shape. Alternatively, referring to FIG. 149, the tissue thickness compensator 52220 can include a tubular element 52280 that includes a permeable tubular lattice 52292. Sheet material 52224 may comprise a bioabsorbable biocompatible elastomeric polymer and may comprise, for example, a drug.

  At least one tubular element 52080 may be configured to swell or expand as shown in FIGS. For example, referring to FIG. 150A, a tubular element 52080 can be disposed in the tissue thickness compensator 52020 between the first and second sheet materials 52024a, 52024b. When the tissue thickness compensator 52020 contacts the tissue T, the tissue thickness compensator 52020 can expand, as shown in FIG. 150B. For example, the tubular element 52080 may include a hydrophilic material 52099 that expands upon exposure to fluid in or on the tissue T. Further, as described above, the sheet material 52024 and the tubular element 52080 may be permeable so that fluid from the tissue T penetrates the tissue thickness compensator 52020, which fluid is the tubular element. May contact hydrophilic material 52099 in 52080. As the tubular element 52080 expands, the sheet material 52024 surrounding the tubular element 52080 can be moved or adjusted to accommodate the swollen tubular element 52080. As with the various tissue thickness compensators described throughout this disclosure, the expanded tissue thickness compensator 52020 is applied by an applied force (eg, fired staples as shown in FIG. 150C). It can be deformed or compressed by the compression force). In addition, the tissue thickness compensator 52020 can be sufficiently resilient to generate a spring return force when deformed by an applied force and then be restored when the applied force is removed. Referring now to FIGS. 150D and 150E, the tissue thickness compensator 52020 can be restored to a different shape in different staple capture regions 30039 in order to properly accommodate the captured tissue T.

  Referring to FIGS. 151-156, the tissue thickness compensator 53020 can include a plurality of tubular elements 53080 arranged vertically. If desired, each tubular element 53080 may include a tube axis that is substantially perpendicular to the upper deck surface 30011 of the rigid support portion 30010 of the staple cartridge 30000. Further, the first end of each tubular element 53080 may be disposed adjacent to the upper deck surface 30011, for example. Tubular element 53080 can be deformable and can include, for example, an elastomeric polymer. If desired, as shown in FIG. 152, tubular element 53080 can be compressed when captured within staple capture region 30039 with staple-engaged tissue T. Tubular element 53080 can include an elastic material, so that deformation of tubular element 53080 can generate a restoring force when tubular element 53080 attempts to recover from a deformed shape. The deformation of the tubular element 53080 can be at least partly elastic and at least partly plastic. The tubular element 53080 can be configured to act as a spring under an applied force and can be configured not to bend. Referring to FIG. 153, the tubular element 53080 can be substantially cylindrical. Referring to FIG. 154, tubular element 53180 can include a bent region 53112. Tubular element 53180 may be configured to bend or deform at bend region 53112 when a compressive force is applied. The tubular element 53180 can be elastically and / or plastically deformed and then designed to bend suddenly at the bending region 53112 under a predetermined bending force.

  Referring primarily to FIG. 155, the first tubular element 53080 can be disposed at the first end of the staple cavity 30012 and the other tubular element 53080 can be disposed at the second end of the staple cavity 30012. As shown in FIG. 153, the tubular element 53080 may include a lumen 53084 extending therethrough. Referring again to FIG. 152, as the staple 30030 moves from the initial position to the fired position, each staple leg 30032 may be configured to pass through the lumen 53084 of each tubular element 53080. Alternatively, referring primarily to FIG. 156, vertically arranged tubular elements 54080 can be arranged within the tissue thickness compensator 54020 such that the tubular elements 54080 are along or in contact with each other. In other words, the tubular elements 54080 can be clustered or assembled together. Tubular elements 54080 can be systematically arranged within tissue thickness compensator 54020. However, in some cases, the tubular elements 54080 can be arranged irregularly.

  Referring again to FIGS. 151, 155, and 156, the tissue thickness compensator 53020 can further include a sheet material 53024 that holds or retains the tubular element 53080 within the tissue thickness compensator 53020. Sheet material 53024 can be placed above and / or below the tubular elements 53080 and can securely hold each tubular element 53080 within the tissue thickness compensator 53020. The tissue thickness compensator 53020 can include first and second sheet materials 53024. Tubular element 53080 can be disposed between first and second sheet materials 53024. Further, the sheet material 53024 can be secured to the upper deck surface 30011 of the rigid support portion of the staple cartridge 30000 so that the tissue thickness compensator 53020 can be securely positioned within the end effector 12. Alternatively, the sheet material 53024 can be secured to the anvil 30060 or otherwise retained within the end effector 12. The sheet material 53024 can be sufficiently deformable such that when the spring 55080 in the tissue thickness compensator is deformed, the sheet material 53024 is deformed.

  Referring to FIGS. 157 and 158, the tissue thickness compensator 55020 can include at least one spring 55080 that is sufficiently resilient so that it can generate a spring return force when deformed. Referring primarily to FIG. 157, the tissue thickness compensator 55020 can include a plurality of springs 55080, for example, can include three rows of springs 55080. The springs 55080 can be systematically and / or irregularly arranged within the tissue thickness compensator 55020. Spring 55080 can include, for example, an elastomeric polymer. The shape of the spring 55080 may allow its deformation. The spring 55080 can be deformed from an initial shape to a deformed shape. For example, if a portion of the tissue thickness compensator 55020 is captured in the staple capture region 30039, the spring 55080 in and / or around the staple capture region 30039 may be deformed. The spring 55080 can be bent or collapsed under the compressive force applied by the fired staple 30030, and the spring 55080 can generate a restoring force, which is the spring constant of the deformed spring 55080, and / or Or a function of the deformed amount of the spring 55080. Spring 55080 can function as a sponge under the compressive force applied by fired staple 30030. Further, as detailed throughout the present disclosure, the spring 55080 may include a compensation material.

  The tissue thickness compensator 55020 can further include one or more sheet materials 55024 that retain or retain at least one spring 55080 within the tissue thickness compensator 55020. The sheet material 55024 may be placed over and / or under the spring 55080 and may be securely held by the spring 55080 in the tissue thickness compensator 55020. The tissue thickness compensator 55020 can include a first sheet material 55024a and a second sheet material 55024b. Tubular element 52080 may be disposed between first and second sheet materials 55024a, 55024b. Referring primarily to FIG. 158, the tissue thickness compensator 55020 can further include a third sheet material 55024c disposed adjacent to either the first or second sheet material 55024a, 55024b. If desired, at least one sheet material 55024 can be secured to the upper deck surface 30011 of the rigid support portion of the staple cartridge 30000 so that the tissue thickness compensator 55020 can be securely positioned within the end effector 12. . Alternatively, at least one sheet material 55024 can be secured to the anvil 30060 or otherwise retained within the end effector 12.

  Referring now to FIG. 158, when the staple 30030 is fired from the staple cartridge 30000 (FIG. 156), the staple 30030 may engage the tissue thickness compensator 55020. Fired staple 30030 may capture a portion of tissue T and tissue thickness compensator 55020 within staple capture region 30039. The spring 55080 can be deformable so that the tissue thickness compensator 55020 can compress when captured by the fired staple 30030. The springs 55080 may be disposed between fired staples 30030 in the tissue thickness compensator 55020. Alternatively, at least one spring 55080 can be captured within the staple capture region 30039.

  Referring to FIG. 159, the tissue thickness compensator 60020 can include at least two compensation layers 60022. The tissue thickness compensator 60020 can include a plurality of compensation layers 60022, which can overlap one above the other, be placed next to each other, or a combination thereof. As detailed herein, the compensation layer 60022 of the tissue thickness compensator 60020 can include, for example, different shapes and / or material properties. Furthermore, as detailed herein, pockets and / or channels may exist between adjacently superimposed compensation layers 60022. For example, the tissue thickness compensator 62020 can include six compensation layers 62022a, 62022b, 62022c, 62022d, 62022e, and 62022f, which can be stacked one above the other (FIG. 174).

  Referring to FIGS. 160, 161, and 163-168, the tissue thickness compensator can include a first compensation layer 60122a and a second compensation layer 60122b. The first compensation layer 60122a can be overlaid adjacent to the second compensation layer 60122b. Adjacent superposed compensation layers 60122 are separated by separation gaps or pockets 60132. Referring primarily to FIG. 160, the tissue thickness compensator 60120 can include at least one cantilever beam or support 60124 disposed between the first and second compensation layers 60122a, 60122b. The support 60124 can be configured to dispose the first compensation layer 60122a relative to the second compensation layer 60122b, whereby the compensation layer 60122 can be separated by the separation gap 60132. As detailed herein, deformation of support 60124 and / or compensation layers 60122a, 60122b may, for example, reduce separation gap 60132.

  The support beam of the tissue thickness compensator can include a variety of shapes and dimensions. For example, the support beam may be a simple I beam, a center single bend support beam 60124 (FIG. 160), a single bend support beam 60224 (FIG. 161) offset from the center, an elliptical support beam 60324 (FIG. 163), a multi-bend support beam 60424 (FIG. 164), and / or a symmetrical double cantilever support beam 60524 (FIG. 165). Further, referring now to FIGS. 160, 166, and 167, for example, the support beam 60624 may be thinner than the at least one compensation layer 60122 (FIG. 166), and the support beam 60724 may be at least one compensation layer 60122. (FIG. 167) and / or the support beam 60124 may be substantially the same thickness as the at least one compensation layer 60122 (FIG. 160). The material, shape and / or dimensions of the support beam 60124 can affect, for example, the deformation and spring return elasticity of the tissue thickness compensator 60120.

  With continued reference to FIG. 160, the compensation layer 60122 and support beam 60124 of the tissue thickness compensator 60120 can comprise different materials, for example with respect to structural materials, biomaterials, and / or electrical materials. For example, at least one compensation layer 60122 can comprise a polymer composition. The polymer composition can include an elastic material at least in part so that deformation of the compensation layer 60122 and / or the support beam 60124 can generate a spring return force. The polymer composition of the compensation layer 60122 can include a non-absorbing polymer, an absorbing polymer, or a combination thereof. The absorbent polymer can include, for example, a bioabsorbable biocompatible elastomeric polymer. Further, the composition of the compensation layer 60122 can include synthetic polymers, non-synthetic polymers, and / or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly (lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. Examples of non-synthetic polymers include, but are not limited to, polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and oxidized regenerated cellulose. If desired, as well as the polymer composition of the tissue thickness compensator described elsewhere herein, the polymer composition of the compensation layer 60122 can include, for example, an absorbent polymer, a non-absorbable polymer, a synthetic polymer. And / or non-synthetic polymers may be included in various weight percent amounts. If desired, each compensation layer 60022 in the tissue thickness compensator 60120 can comprise a different polymer composition, or at least two compensation layers 60122 can comprise the same polymer composition.

  Referring again to FIG. 159, at least one compensation layer 60022 can include a therapeutic agent 60098, such as a drug or pharmaceutically active agent, for example. Compensation layer 60022 may release a therapeutically effective amount of therapeutic agent 60098. The therapeutic agent 60098 can be released as the compensation layer 60022 is absorbed. Examples of this pharmaceutically active agent 60098 include hemostatic agents and agents (eg, fibrin, thrombin, and / or oxidized regenerated cellulose (ORC)), anti-inflammatory agents (eg, diclofenac, aspirin, naproxen, sulindac, and / or Hydrocortisone), antibiotics and antibacterial agents or drugs (eg, triclosan, silver ions, ampicillin, gentamicin, polymyxin B, and / or chloramphenicol), and anticancer agents (eg, cisplatin, mitomycin, and / or adriamycin) Can be, but is not limited to. The therapeutic agent 60098 can include, for example, a biologic such as a stem cell. If desired, each compensation layer 60022 in the tissue thickness compensator 60020 can contain a different therapeutic agent 60098, or at least two compensation layers 60022 can contain the same therapeutic agent 60098. A compensation layer 60022 containing a therapeutic agent 60098 (eg, a biologic, etc.) can be encapsulated between two structural compensation layers 60022 containing a polymer composition (eg, a polyglycolic acid (PGA) foam, etc.). In accordance with the present invention, the compensation layer 60022 may further include a conductive material (eg, copper, etc.).

  Referring again to FIG. 174, the compensation layer 62022 in the tissue thickness compensator 62020 can have different shapes. Compensation layer 62022 may form at least one three-dimensional conduit 62032 between layers 62022 when layer 62022 is disposed adjacent to tissue thickness compensator 62020. For example, when the second compensation layer 62022b including a channel is disposed on the substantially flat third compensation layer 62022c, the channel and the flat surface of the third compensation layer 62022c are in between three-dimensional. A conduit 62032a may be defined. Similarly, for example, if the fifth compensation layer 62022e including a channel is disposed under the fourth compensation layer 62022d including the corresponding channel, the channels are compensated for adjacently superimposed compensation layers 62022d and 62022e. Can form a three-dimensional conduit 62032b defined by the channels within. Conduit 62032 can guide fluid and / or body fluid as it flows through tissue thickness compensator 62020.

  Referring to FIG. 170, tissue thickness compensator 61020 can include a compensation layer 61022 (eg, layers 60122a and 21022b) configured to receive staples 30030 deployed from staple cartridge 20000 (FIG. 169). . As the staple 30030 moves from the initial position to the fired position, at least one compensation layer 61022 may guide the staple legs 30032 to the fired position. If desired, the at least one compensation layer 61022 may include an opening 61030 extending therethrough, the opening 61030 from which the staple 30030 is removed from the staple cartridge 20000 (FIG. 169). When fired, they can be arranged to receive the staple legs 30032 of the deployed staple 30030. Alternatively, referring again to FIG. 174, the staple legs 30032 can pierce at least one compensation layer (eg, compensation layer 62022f, etc.), which can include, for example, at least one compensation layer (eg, compensation layer). 6202a), etc.) through the opening 62030.

  Referring primarily to FIG. 170, the tissue thickness compensator 60120 can include at least one support tab 61026 on one of the compensation layers 61022a, 61022b. The support tab 61026 can project into a separation gap 61032 defined between adjacent compensation layers, such as, for example, the gap 61032 between the first compensation layer 61020a and the second compensation layer 61020b. The support tab 61026 can extend from the longitudinal side of the first compensation layer 61022a. Further, the support tabs 61026 may extend along the length of the longitudinal side or may be along only a portion thereof. If desired, at least one support tab 61026 can extend from the two longitudinal sides of the compensation layers 61022a, 61022b. Further, adjacently disposed compensation layers 61022a, 61022b include corresponding support tabs 60126 such that the support tabs 60126 extending from the first compensation layer 60122a are at least partially in the second compensation layer 60122b. Can be aligned with support tabs 60126 extending from. Referring again to FIG. 168, the tissue thickness compensator 60820 can include a limiter plate 60828 between adjacent compensation layers 60122a, 60122b. The limiter plate 60828 may be disposed in the gap 60132 defined between the first compensation layer 60122a and the second compensation layer 60122b, for example. As described in detail herein, support tab 61026 and / or limiter plate 60828 can control deformation and / or bending of support 60124 and / or compensation layers 60122a, 60122b.

  As described above, the compensation layer 60022 of the tissue thickness compensator 60020 can include different materials, shapes, and / or dimensions. Such a tissue thickness compensator 60020 can be manufactured by various manufacturing techniques. Referring primarily to FIG. 159, the tissue thickness compensator 60022 can be manufactured by lithography, stereolithography (SLA), or a silk screen process. For example, the stereolithographic manufacturing process can form a tissue thickness compensator 60020 in which each compensation layer 60022 includes a different material and / or geometry. For example, the ultraviolet light of the stereolithography apparatus can describe the shape of the first compensation layer 60022, whereby the first compensation layer 60022 including the first material, shape and / or dimensions can be cured by the ultraviolet light. The ultraviolet light then describes the shape of the second compensation layer 60022, whereby the second compensation layer 60022 including the second material, shape and / or dimensions can be cured by the ultraviolet light. In accordance with the present invention, a stereolithography apparatus can draw a compensation layer 60022 that is superimposed on top of each other, side by side, or a combination thereof. Further, the compensation layer 60022 can be drawn such that there is a pocket 60132 between adjacent compensation layers 60022. Because the stereolithography apparatus can produce very thin layers with unique shapes, the tissue thickness compensator 60020 produced by the stereolithography process can include very complex three-dimensional shapes.

  Referring to FIG. 169, a tissue thickness compensator 60920 can be placed in the end effector 12 of the surgical instrument 10 (FIG. 1). The tissue thickness compensator 60920 can be positioned relative to the staple cartridge 20000 of the end effector 12. For example, the tissue thickness compensator 60920 can be releasably secured to the staple cartridge 20000. At least one compensation layer 60922 of the tissue thickness compensator 60920 can be disposed adjacent to the upper deck surface 20011 (FIG. 79) of the staple cartridge 20000. For example, the second compensation layer 60922b can be secured to the upper deck surface 20011 by an adhesive or a wrap similar to at least one of the wraps described herein (FIG. 16). The tissue thickness compensator 60920 may be integrated into the staple cartridge 20000 so that the staple cartridge 20000 and the tissue thickness compensator 60920 can be formed as a single unit structure. For example, the staple cartridge 20000 can include a first body portion (eg, rigid support portion 20010 (FIG. 79)) and a second body portion (eg, tissue thickness compensator 60920).

  With continued reference to FIG. 169, the tissue thickness compensator 60920 can include a first compensator portion 60920a and a second compensator portion 60920b. The first compensator portion 60920a can be disposed on the first longitudinal side of the staple cartridge 20000, and the second compensator portion 60920b can be disposed on the second longitudinal side of the staple cartridge 20000. If desired, when the tissue thickness compensator 60920 is positioned relative to the staple cartridge 20000, the longitudinal slot 20015 (FIG. 78) in the rigid support portion 20010 (FIG. 78) includes a first compensator portion 60920a and a second compensator portion 60920a. It may extend between compensator portions 60920b. As the cutting element 20052 on the staple firing thread 20050 (FIG. 78) translates through the end effector 12, the cutting element 20052 may, for example, cut the first compensator without cutting a portion of the tissue thickness compensator 60920. A longitudinal slot 20015 can be passed between the portion 60920a and the second compensator portion 60920b. Alternatively, the cutting element 20052 can be configured to cut a portion of the tissue thickness compensator 60920.

  Referring now to FIG. 162, the tissue thickness compensator 63020 can be configured to fit the end effector 12 'of a circular surgical instrument. The tissue thickness compensator 62030 can include a circular first compensation layer 63002a and a circular second compensation layer 63002b. The second compensation layer 63022b can be disposed on the circular upper deck surface 20011 'of the circular staple cartridge 20000', and the second compensation layer 63022b can include a shape corresponding to the shape of the deck surface 20011 '. For example, the deck surface 20011 'can include a stepped portion, and the second compensation layer 63022b can include a corresponding stepped portion. The tissue thickness compensator can further include, for example, at least one support 63024 and / or support tab 63026 that extends around the tissue thickness compensator 63020.

  Referring again to FIG. 170, the fired staple 30030 can be configured to engage the tissue thickness compensator 60920. As described throughout this disclosure, fired staple 30030 can capture tissue thickness compensator 60920 and tissue T and apply a compressive force against tissue thickness compensator 60920. Further, referring primarily to FIGS. 171-173, the tissue thickness compensator 60920 can be deformable. If desired, as described above, the first compensation layer 60920a may be separated from the second compensation layer 60920b by the separation gap 60932. Referring to FIG. 171, before compressing the tissue thickness compensator 60920, the gap 60932 can include a first distance. Support 60924 can be configured to deform when compressive force A is applied to tissue thickness compensator 60920 and tissue T (eg, by fired staples 30030 (FIG. 170)). Referring now to FIG. 172, the uniflex support beam 60924 bends under compressive force A, thereby causing the separation gap 60932 between the first compensation layer 60920a and the second compensation layer 60920b to be a second distance. Decrease. Referring mainly to FIG. 173, the first and second compensation layers 60922a and 60922b may also be deformed under the compressive force A. Support tab 60926 can limit deformation of compensation layer 60920. For example, the support tabs 60926 can prevent excessive bending of the compensation layer 60920 by supporting the longitudinal sides of the compensation layer 60920 when in contact with each other. Support tab 60926 may be further configured to bend or fold under compressive force A. In addition, or alternatively, the limiter plate 60128 (FIG. 168) detailed herein may be used to deform the compensation layer 60920 when the compensation layer 60920 and / or the support tab 60926 contact the limiter plate 60128. Can be limited.

  Further, like the various tissue thickness compensators described herein, the tissue thickness compensator 60920 can generate a spring return force or a restoring force when deformed. The restoring force generated by the deformed tissue thickness compensator is at least the orientation, size, material, and / or shape of the tissue thickness compensator 60920 and the amount of deformation of the tissue thickness compensator 60920 due to the applied force. And can depend on. Further, at least a portion of the tissue thickness compensator 60920 is resilient, which may cause the tissue thickness compensator 60920 to generate a spring load or restoring force when deformed by the fired staple 30030. The support 60924 can include an elastic material and / or the at least one compensation layer 60922 can include an elastic material such that the tissue thickness compensator 60920 can be resilient.

  Referring now to FIG. 175, the end effector of the surgical stapling instrument can include a first jaw and a second jaw, wherein at least one of the first jaw and the second jaw is configured to move relative to the other. obtain. The end effector may include a first jaw that includes a staple cartridge channel 19070 and a second jaw that includes an anvil 19060, and the anvil 19060 may pivot, for example, toward and / or away from the staple cartridge channel 19070. . Staple cartridge channel 19070 can be configured to receive staple cartridge 19000, for example, it can be removably retained within staple cartridge channel 19070. The staple cartridge 19000 can include a cartridge body 19010 and a tissue thickness compensator 19020, which can be removably attached to the cartridge body 19010. Referring now to FIG. 176, the cartridge body 19010 can include a plurality of staple cavities 19012 and staples 19030 disposed within each staple cavity 19012. Staple 19030 may also be supported by a staple driver 19040 disposed within cartridge body 19010, for example, a thread and / or firing member may be advanced through staple cartridge 19000, as shown in FIG. The staple driver 19040 can be lifted up within the staple cavity 19012 and the staple 19030 can be fired from the staple cavity 19012.

  Referring primarily to FIGS. 175 and 176, the tissue thickness compensator 19020 can include a resilient member 19022 and a container 19024 that encloses the resilient member 19022. Container 19024 may be sealed and may define a cavity containing an internal pressure having a pressure that is different from the ambient atmospheric pressure. The internal pressure may be higher than the ambient atmospheric pressure, while alternatively, the internal pressure may be lower than the ambient atmospheric pressure. In embodiments where the container 19024 includes a pressure that is less than the ambient atmospheric pressure, the sidewalls of the container 19024 can seal the vacuum. In such a case, the vacuum can cause the container 19024 to be distorted, crushed, and / or flat, and the resilient member 19022 disposed within the container 19024 can be resiliently compressed within the container 19024. When a vacuum is generated in the container 19024, the resilient member 19022 can be bent or deformed downward and held in place by the sidewalls of the container 19024 in a compressed (or vacuum packed) state.

  The elastic member 19022 and the container 19024 are made of a biocompatible material. If desired, the resilient member 19022 and / or the container 19024 may be made of a bioabsorbable material, such as, for example, PLLA, PGA, and / or PCL. The elastic member 19022 may be made of an elastic material. The resilient member 19022 may also include structural resiliency. For example, the resilient member 19022 can be in the shape of a hollow tube.

  Further to the above, the tissue thickness compensator 19020 can be disposed opposite or adjacent to the deck surface 19011 of the cartridge body 19010. When the staple 19030 is fired at least partially, referring now to FIG. 177, the legs of the staple 19030 can puncture or rupture the container 19024. The container 19024 can include a central portion 19026 that can be disposed over the cutting slot 19016 of the cartridge body 19010 such that the cutting member 19080 has been advanced to place tissue T between the staple cartridge 19000 and the anvil 19060. The cutting member 19080 can also cut the central portion 19026 of the container 19024 so that the container 19024 can be punctured or ruptured. In any case, once the container 19024 ruptures, the internal pressure of the container 19024 equals the pressure surrounding the tissue thickness compensator 19020, and the resilient member 19022 is elastically expanded, undistorted and / or flat. It is restored to a shape that is not, or at least partially restored. In such a case, the resilient member 19022 can apply a biasing force against the tissue T captured within the deformed staple 19020. More specifically, the legs of staples 19030 capture tissue T and at least a portion of resilient member 19022 within staples 19030 after being deformed by the forming surface of pockets 19062 defined within anvil 19060. This allows the tissue thickness compensator 19020 to compensate for the thickness of the tissue T captured within the staple 19030 when the container 19024 ruptures. For example, if the tissue T captured in the staple 19030 is relatively thin, the resilient member 19022 captured in the staple 19030 expands to fill the gap in the staple 19030 and compress sufficiently against the tissue T. A force can be applied. Correspondingly, if the tissue T captured within the staple 19030 is relatively thick, the resilient member 19022 captured within the staple 19030 is compressed to create room for the thicker tissue within the staple 19030. As well, and a sufficient compressive force can be applied to the tissue T as well.

  Once the container 19024 is punctured, the resilient member 19022 may expand and attempt to resiliently return to its original shape, as outlined above. In certain situations, a portion of the resilient member 19022 captured within the staple 19030 may not return to its original undistorted shape. In such a situation, the resilient member 19022 can include a spring that can apply a compressive force to the tissue T captured within the staple 19030. In accordance with the present invention, the resilient member 19022 is comparable to a linear spring, and the compressive force applied by the resilient member 19022 is proportional to the amount or distance that the resilient member 19022 remains bent within the staple 19030. Can do. Alternatively, in accordance with the present invention, the resilient member 19022 is comparable to a non-linear spring and the compressive force applied by the resilient member 19022 is an amount or distance that the resilient member 19022 remains bent within the staple 19030. It is not proportional to it.

  Referring primarily to FIGS. 178 and 179, the staple cartridge 19200 can include a tissue thickness compensator 19220, which can include one or more sealed containers 19222 therein. Each container 19222 may be sealed and may contain internal pressure. The internal pressure in the sealed container 19222 may exceed atmospheric pressure, while the internal pressure in the sealed container 19222 may be lower than atmospheric pressure. If the internal pressure in the container 19222 is lower than atmospheric pressure, the container 19222 can be described as including a vacuum. If desired, one or more containers 19222 may be wrapped or contained in, for example, an outer shroud, container, wrap, and / or film 19224, and the tissue thickness compensator 19220 may be attached to the cartridge body 19010. It can be placed on the deck surface 19011. Each container 19222 has a circular (or at least substantially circular) cross section and can be manufactured from a tube having a closed end and an open end. The vacuum is evacuated from the open end side of the tube, and when sufficient vacuum is reached in the tube, the open end can be closed and sealed. For example, the tube may include a polymeric material, for example, the open end of the tube may be heat squeezed to close and seal it. In any case, the vacuum within each container 19222 can pull the tube sidewalls inwardly to elastically distort and / or flatten the tube. Container 19222 is illustrated in FIG. 179 at least partially flattened.

  When the staple 19030 is in the unfired position, the tip of the staple 19030 can be positioned below the tissue thickness compensator 19220, as shown in FIG. For example, the staples 19030 may be disposed within the respective staple cavities 19012 such that the staples 19030 contact the container 19222 until moved from an unfired position (FIG. 179) to a fired position (FIG. 180). You can avoid it. The wrap 19224 of the tissue thickness compensator 19220 can prevent the container 19220 from being prematurely punctured by the staple 19030. When the staple 19030 is fired at least partially, referring now to FIG. 180, the legs of the staple 19030 can puncture or rupture the container 19222. In such a situation, the internal pressure in the container 19222 is equal to the pressure surrounding the container 19222 and is elastically expanded and restored to an undistorted and / or unflattened shape, or at least partially Restored. In such a situation, the punctured container 19222 may apply a biasing force against the tissue captured within the deformed staple 19030. More specifically, the legs of the staple 19030 capture the tissue T in the staple 19030 and at least a portion of the container 19222 after being deformed by the forming surface of the pocket 19062 defined in the anvil 19060. This allows the container 19222 to compensate for the thickness of the tissue T captured within the staple 19030 when the container 19222 ruptures. For example, if the tissue T captured within the staple 19030 is relatively thin, the container 19222 captured within the staple 19030 expands to fill the gap within the staple 19030 and at the same time sufficiently compress against the tissue T. A force can be applied. Correspondingly, if the tissue T captured within the staple 19030 is relatively thick, the container 19222 captured within the staple 19030 remains compressed to make room for the thicker tissue within the staple 19030. At the same time, a sufficient compressive force can be applied to the tissue T.

  When container 19222 is punctured, container 19222 may expand and attempt to elastically return to its original shape, as outlined above. A portion of the container 19222 captured within the staple 19030 may not return to its original undistorted shape. In such a situation, the container 19222 can include a spring that can apply a compressive force to the tissue T captured within the staple 19030. In accordance with the present invention, the container 19222 is comparable to a linear spring and the compressive force applied by the container 19222 may be proportional to the amount or distance that the container 19222 remains bent within the staple 19030. Alternatively, the container 19222 is comparable to a non-linear spring and the compressive force applied by the container 19222 is not proportional to the amount or distance that the container 19222 remains bent within the staple 19030. Container 19222 can be hollow, and can be empty when in a sealed configuration. Alternatively, each container 19222 may define a cavity and may further include at least one agent contained therein. Container 19222 may contain at least one drug, which may be released and / or bioabsorbed, for example.

  The containers 19222 of the tissue thickness compensator 19220 can be arranged in any suitable manner. As shown in FIG. 178, staple cavities 19012 defined within the cartridge body 19010 and staples 19030 disposed within the staple cavities 19012 can be arranged in rows. As shown, the staple cavities 19012 can be arranged in, for example, six rows of longitudinal straight lines. However, any suitable arrangement can be utilized for the staple cavity 19012. As further shown in FIG. 178, the tissue thickness compensator 19220 can include six containers 19222, each of which can be aligned with or disposed over a row of staple cavities 19012. Each staple 19030 in a row with staple cavities 19012 can be configured to pierce the same container 19222. In certain circumstances, the legs of some staple staples 19030 may not pierce the container 19222 disposed thereon. However, if the container 19222 defines a continuous internal cavity, for example, this cavity is sufficiently punctured by at least one staple 19030 so that the pressure of the internal cavity is equal to the atmospheric pressure around the container 19222. Can be equal. Referring now to FIG. 185, the tissue thickness compensator includes a container (eg, container 19222 ′) that can extend in a direction across the line of staples 19030. For example, the container 19222 'can extend across multiple staple rows. Referring now to FIG. 186, the tissue thickness compensator 19220 ″ can include a plurality of containers 19222 ″ that extend in a direction perpendicular to, or at least substantially perpendicular to, the line of staples 19030. obtain. For example, some containers 19222 "may be punctured by staples 19030, while other containers may not be punctured by staples 19030. Containers 19222" traverse or pass through the cutting path. In this cutting path, for example, the cutting member can cut and rupture the container 19222 ".

  If desired, as described above, a tissue thickness compensator (eg, tissue thickness compensator 19220) can include, for example, a plurality of sealed containers (eg, containers 19222, etc.). As described above, each sealed container 19222 can include a separate internal pressure. The containers 19222 can have different internal pressures. For example, the first container 19222 can include an inner vacuum having a first pressure, and the second container 19222 can include an inner vacuum having a second different pressure. For example, the degree of strain or flattening of the container 19222 can be a function of the vacuum pressure contained therein. For example, a container 19222 having a larger vacuum can be more distorted or flattened than a container 19222 having a smaller vacuum. The container cavity may be divided into two or more separate sealed cavities, each of which may include a separate internal pressure. For example, some staples in a staple row may be configured and arranged to pierce a first cavity defined in the container, while other staples in the staple row are in the container. It may be configured and arranged to pierce the defined second cavity. In such a case, especially in embodiments where the staples in the staple row are fired sequentially from one end of the staple row to the other, as described above, the cavities also burst when the other cavities burst. One of the two can remain intact and maintain the internal pressure. The first cavity may have an internal pressure having a first vacuum pressure and the second cavity may have an internal pressure having a second different vacuum pressure. In accordance with the present invention, an intact cavity can maintain an internal pressure until the container is bioabsorbed, thereby creating a timed pressure release.

  Referring now to FIGS. 181 and 182, a tissue thickness compensator (eg, tissue thickness compensator 19120) can be attached to the anvil 19160. Similar to the above, the tissue thickness compensator 19120 can include a container 19124 and a plurality of resilient members 19122 disposed therein. Also as described above, the container 19124 may define a cavity containing an internal pressure having a pressure below or above atmospheric pressure around the tissue thickness compensator 19120. When the internal pressure in the container 19124 includes a vacuum, the container 19124 and the elastic member 19122 disposed therein are distorted by a pressure difference between the vacuum in the container 19124 and the atmospheric pressure outside the container 19124. It can collapse and / or become flat. In use, the anvil 19160 moves to the closed position, where the anvil 19160 is disposed on the opposite side of the staple cartridge 19100 and the tissue engaging surface 19121 of the container 19124 is between the tissue thickness compensator 19120 and the staple cartridge 19100. Engage tissue T disposed therebetween. In use, firing member 19080 can be advanced distally to fire staples 19030 and simultaneously cut tissue T as described above. The tissue thickness compensator 19120 may further include an intermediate portion 19126 that may be aligned with a cutting slot defined in the anvil 19160 such that the firing member 19080 passes distally through the tissue thickness compensator 19120. When advanced, the firing member 19080 can puncture or rupture the container 19124. Further, similar to the above, the firing member 19080 can raise the staple driver 19040 upward to fire the staple 19030, thereby causing the staple 19030 to contact the anvil 19160, as shown in FIG. Can be transformed into When staple 19030 is fired, staple 19030 can puncture tissue T and then puncture or rupture container 19124, thereby being disposed within container 19124, as outlined above. The resilient member 19122 can be at least partially inflated.

  Further to the above, the tissue thickness compensator can comprise a biocompatible material. Biocompatible materials (e.g., foams) are used to provide desirable properties to the material, such as tackifiers, surfactants, fillers, crosslinkers, pigments, dyes, antioxidants, and other stabilizers. And / or combinations thereof. The biocompatible foam can include a surfactant. Surfactants can be applied to the surface of the material and / or dispersed within the material. Without being bound to a particular theory, a surfactant applied to a biocompatible material can reduce the surface tension of the fluid in contact with the material. For example, a surfactant can reduce the surface tension of water in contact with the material because it promotes water penetration into the material. Water can act as a catalyst. Surfactants can increase the hydrophilicity of the material.

  Surfactants can include anionic surfactants, cationic surfactants, and / or nonionic surfactants. Examples of surfactants include polyacrylic acid, metalose, methyl cellulose, ethyl cellulose, propyl cellulose, hydroxyethyl cellulose, carboxy group methyl cellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octyl Examples include phenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether, polyoxyethylene nonylphenyl ether, dialkylphenoxy poly (ethyleneoxy) ethanol, and polyoxamers, and combinations thereof. However, it is not limited to these. The surfactant may comprise a copolymer of polyethylene glycol and polypropylene glycol. The surfactant can include a phospholipid surfactant. Phospholipid surfactants can provide antimicrobial stabilizing properties and / or can disperse other materials within the biocompatible material. The tissue thickness compensator can include at least one agent. The tissue thickness compensator can include one or more natural materials, non-synthetic materials, and / or synthetic materials described herein. The tissue thickness compensator can include gelatin, collagen, hyaluronic acid, oxidized regenerated cellulose, polyglycolic acid, polycaprolactone, polylactic acid, polydioxanone, polyhydroxyalkanoate, polygrecaprone, and combinations thereof. The tissue thickness compensator can include a film containing at least one drug. The tissue thickness compensator can include a biodegradable film that includes at least one agent. The drug can be a liquid, a gel, and / or a powder. The agent can include an anticancer agent (eg, cisplatin, mitomycin, and / or adriamycin).

  The tissue thickness compensator can include a biodegradable material to provide controlled elution of at least one drug as the biodegradable material degrades. A biodegradable material can degrade, disassemble, or lose structural integrity when the biodegradable material contacts an activator (eg, an activator fluid). The activator fluid may include, for example, saline or any other electrolyte solution. The biodegradable material may contact the activator fluid by conventional techniques including, but not limited to, sprays, dip, and / or brushes. In use, for example, a surgeon may replace an end effector and / or staple cartridge including a tissue thickness compensator containing at least one agent with an activator fluid (salt solution such as sodium chloride, calcium chloride, and / or potassium chloride). Can be soaked). The tissue thickness compensator can release the drug as the tissue thickness compensator degrades. Drug dissolution from the tissue thickness compensator can be characterized by a rapid initial dissolution rate and a slow retained dissolution rate.

  In accordance with the present invention, the tissue thickness compensator can include a biocompatible material that can include, for example, an oxidizing agent. The oxidizing agent can 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 a peroxygen oxidant and a hypohalite oxidant, such as hydrogen peroxide, hypochlorite, hypochlorite, hypoiodite, and percarbonate. And so on. Oxidizing agents can include alkali metal chlorites, hypochlorites, and perborates, such as sodium chlorite, sodium hypochlorite, and sodium perborate. The oxidizing agent can include vanadate. The oxidizing agent can include ascorbic acid. The oxidizing agent can be an active oxygen generator. In accordance with the present invention, the tissue scaffold can include a biocompatible material that includes an oxidizing agent.

  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 can be ground into microparticles and / or nanoparticles. The oxidizing agent can be incorporated into the biocompatible material by suspending the oxidizing agent in the polymer solution. The oxidizing agent can be incorporated into the biocompatible material during the lyophilization process. After lyophilization, an oxidizing agent can be attached to the cell wall of the biocompatible material and interact with the tissue upon contact. The oxidizing agent may not be chemically bonded to the biocompatible material. Percarbonate dry powder can be embedded in biocompatible foam to provide long-term biological effects due to sustained release of oxygen. Percarbonate dry powder can be embedded in non-woven polymer fibers to provide long-term biological effects due to sustained release of oxygen. The biocompatible material can include an oxidizing agent and drugs such as doxycycline and ascorbic acid.

  The biocompatible material may include a rapid release oxidant and / or a sustained release oxidant. The elution of the oxidant from the biocompatible material can be characterized by a rapid initial dissolution rate and a slow sustained dissolution rate. Oxidizing agents can generate oxygen when in contact with body fluids (eg, water, etc.). Examples of body fluids can include, but are not limited to, blood, plasma, ascites, cerebrospinal fluid, urine, lymph, synovial fluid, vitreous humor, saliva, gastrointestinal lumen contents, and / or bile. Without being bound by any particular theory, oxidizing agents reduce mechanical death, enhance cellular viability, and / or mechanical strength between tissues that may have been damaged by cutting and / or stapling. Can be maintained. The biocompatible material can include at least one microparticle and / or nanoparticle. The biocompatible material can include one or more 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 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 can provide controlled release of the drug. The microparticles and / or nanoparticles can include at least one drug. The microparticles and / or nanoparticles can include, for example, hemostatic agents, antibacterial agents, and / or oxidizing agents. The tissue thickness compensator can comprise a biocompatible foam comprising a hemostatic agent comprising oxidized regenerated cellulose. Antibacterial agents including doxycycline and / or gentamicin and / or oxidizing agents including percarbant may be included. The microparticles and / or nanoparticles can provide controlled release of the drug, for example, for up to 3 days.

  Microparticles and / or nanoparticles can be embedded within the biocompatible material during the manufacturing process. For example, a biocompatible polymer such as PGA / PCL can be contacted with a solvent (eg, dioxane) to form a mixture. The biocompatible polymer can be pulverized to form particles. Dry particles (with or without ORC) can contact the mixture to form a suspension. This suspension can be lyophilized to form a biocompatible foam comprising PGA / PCL with dry and / or ORC particles embedded therein.

  The tissue thickness compensator or layer disclosed herein can include, 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, polyanhydride, polyester Amides and / or polyoxaesters may be included. According to the present invention, the tissue thickness compensator can comprise, for example, PGA / PLA (poly (glycolic acid-co-lactic acid)) and / or PDS / PLA (poly (p-dioxanone-co-lactic acid)). In accordance with the present invention, the tissue thickness compensator can include, for example, an organic material. The tissue thickness compensator can include, for example, carboxymethylcellulose, sodium alginate, crosslinked hyaluronic acid, and / or oxidized regenerated cellulose. In accordance with the present invention, the tissue thickness compensator may include, for example, a durometer of 3-7 Shore A (30-50 Shore OO) range, with a maximum hardness of 15 Shore A (65 Shore OO). The tissue thickness compensator is, for example, 40% compressed at a load of 0.03N (3 lbf), 60% compressed at a load of 0.06N (6 lbf), and / or 80% compressed at a load of 0.20 N (20 lbf). Can do. One or more gases (eg, air, nitrogen, carbon dioxide, and / or oxygen, etc.) can be aerated and / or included in the tissue thickness compensator. The tissue thickness compensator may include beads therein, which may include from about 50% to about 75% of the material stiffness including the tissue thickness compensator.

  In accordance with the present invention, tissue thickness compensators can include, for example, hyaluronic acid, nutrients, fibrin, thrombin, platelet-rich plasma, sulfasalazine (Azulfidine®-5ASA + sulfapyridinediazo linkage))-prodrug-colon bacteria ( Azo reductase), mesalamine (5ASA, with various prodrug configurations for delayed release), asacol® (5ASA + Eudragit-S coating-pH> 7 (coating dissolution)), Pentasa® ( 5ASA + ethylcellulose coating—time / pH dependent delayed release), Messaal® (5ASA + Eudragit-L coating—pH> 6), olsalazine (5ASA + 5ASA-colon bacteria (azoreductase)), balsalazine 5ASA + 4 aminobenzoyl-B-alanine) -colon bacteria (azo reductase)), granule mesalamine, rialda (mesalamine delayed and SR preparation), HMPL-004 (TNF-α, interleukin-1β, and nuclear factor kappa B , CCX282-B (oral chemokine receptor antagonist, inhibits T lymphocyte trafficking to the intestinal mucosa), rifaximin (non-absorbable broad-spectrum antibiotic), infliximab, mouse chimera ( Monoclonal antibody targeting TNF-α for symptom / symptom reduction and clinical remission in adult / pediatric patients with moderate / severe luminal and clonal Crohn's disease who have had poor response to conventional therapy Approved), adalimumab, all human IgG1 (anti-TNF-α monoclonal antibody-Crohn's disease) Approved for the induction and maintenance of clinical remission in adults with moderate / severe active Crohn's disease / symptom relief and poor response to conventional therapy or intolerance to infliximab ), Sertolizumab pegol, humanized anti-TNF FAB '(monoclonal antibody fragment conjugated to polyethylene glycol-in adult patients with moderate / severe Crohn's disease who have reduced symptoms / symptoms of Crohn's disease and poor response to conventional therapy Approved for induction and maintenance of response), natalizumab, first non-TNF-α inhibitor (a biologic approved for Crohn's disease), humanized monoclonal IgG4 antibody (targeting α-4-integrin) -Inflammatory shrimp with insufficient or intolerant response to conventional Crohn's disease treatment and TNF-α inhibitors FDA approved), a combined immunomodulator that can be administered with infliximab, azathioprine 6-mercaptopurine (purine synthesis inhibitor) for the induction and maintenance of clinical response and remission in patients with moderate / severe Crohn's disease -Prodrugs), methotrexate (binds to dihydrofolate reductase (DHFR) involved in tetrahydrofolate synthesis and inhibits all purine synthesis), allopurinol and thiopurine treatments, PPI, acid repression protecting the healing line H2, C-Diff-Frazil, vancomycin (fecal metastasis treatment; probiotics; normal gut flora regulation), and / or rifaximin (bacterial overgrowth treatment (especially hepatic encephalopathy)); It is not absorbed even in the digestive tract with the action of

  As described above, the tissue thickness compensator may compensate for changes in tissue thickness captured, for example, in staples fired from a staple cartridge and / or contained within a staple line. In other words, a particular staple in a staple line can capture a thick tissue portion, and another staple in that staple line can capture a thin tissue portion. In such a situation, the tissue thickness compensator corresponds to different heights or thicknesses in the staple and compresses the tissue captured in the staple regardless of whether the captured tissue is thick or thin. Apply. In accordance with the present invention, the tissue thickness compensator can compensate for changes in tissue hardness. For example, a particular staple in a staple line can capture a highly compressible tissue portion and another staple in that staple line can capture a less compressible tissue portion. In such situations, tissue thickness compensators correspond to lower heights in staples that have captured tissue with lower compressibility or higher hardness, as well as higher compressibility or higher. It can be configured to accommodate higher heights in staples that have captured tissue having a low hardness. In any case, regardless of whether the tissue thickness compensator captures, for example, a change in tissue thickness and / or a change in tissue hardness, for example, a “tissue compensator” and / or “compensation” It may be referred to as a “sweater”.

  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 developments from the present disclosure as known in the art to which this invention pertains or which are included in conventional practice.

Embodiment
(1) a surgical instrument fastener cartridge assembly comprising:
A cartridge body defining a longitudinal axis, wherein the cartridge body includes a fastener cavity;
A woven grid extending across the longitudinal axis of the cartridge body, the woven grid comprising a resilient material;
A fastener movable between an initial position and a fired position, wherein the fastener is at least partially disposed within the fastener cavity when the fastener is in the initial position; and A fastener cartridge assembly, wherein the fastener is configured to compress the at least one woven lattice as the tool moves to its fired position.
2. The fastener cartridge assembly of embodiment 1, wherein the fastener cavities are arranged in rows of fastener cavities, and the rows of fastener cavities are substantially parallel to the longitudinal axis. .
3. The fastener cartridge assembly according to embodiment 1 or 2, wherein each woven lattice is oriented at approximately 45 degrees with respect to the longitudinal axis of the cartridge body.
(4) At least one of the woven grids traverses the row of fastener cavities so that the at least one woven grid is the first of the fasteners when the fastener is in an initial position. The fastener cartridge assembly of embodiment 2, wherein the fastener cartridge assembly is disposed between the leg and the second leg.
5. The fastener cartridge assembly according to any of embodiments 1-4, further comprising a material sheet, wherein the material sheet holds the woven lattice in the fastener cartridge.

(6) The embodiment of embodiment 1, wherein the woven lattice is at least partially filled with a material selected from the group comprising hemostatic agents, antibacterial agents, anti-inflammatory agents, anticoagulants, and antibiotics. Fastener cartridge assembly.
(7) An end effector assembly for a surgical instrument, comprising: the fastener cartridge assembly according to any of embodiments 1-6; and an anvil.
(8) A surgical instrument fastener cartridge assembly, wherein the fastener cartridge assembly comprises:
A cartridge body,
The deck surface,
A fastener cavity in the deck surface;
Including the cartridge body,
A plurality of woven grids, wherein the woven grids include a resilient material and each woven grid includes an axis that intersects the deck surface;
A fastener movable between an initial position and a fired position, wherein the fastener is at least partially disposed within the fastener cavity when the fastener is in the initial position; and A fastener configured to compress the at least one woven lattice as the tool moves to its fired position;
A fastener cartridge assembly comprising:
9. The fastener cartridge assembly according to embodiment 8, wherein the axis of each woven lattice is substantially perpendicular to the deck surface.
(10) The first axis of the first woven grid extends through the first opening, the second axis of the second woven grid extends through the second opening, and the fastener is ,
The base,
A first leg extending from the base, wherein the first opening is configured to receive the first leg;
Embodiment 8 or 9, comprising: a second leg extending from the base, wherein the second opening is configured to receive the second leg. A fastener cartridge assembly as described.

(11) The fastener cartridge assembly according to any of embodiments 8-10, further comprising a material sheet, wherein the woven lattice is disposed intermediate the deck surface of the cartridge body and the material sheet.
(12) Embodiments 8-11 wherein the woven lattice is at least partially filled with a material selected from the group comprising hemostatic agents, antibacterial agents, anti-inflammatory agents, anticoagulants, and antibiotics. A fastener cartridge assembly according to any one of the preceding claims.
(13) The fastener cartridge assembly according to any of embodiments 8-12, wherein each woven grid is secured to an adjacent woven grid.
(14) An end effector assembly for a surgical instrument, comprising: the fastener cartridge assembly according to any one of embodiments 8-13; and an anvil.
(15) A fastener cartridge assembly for a surgical instrument, wherein the fastener cartridge assembly comprises:
A cartridge body including a first longitudinal side and a second longitudinal side;
A tissue thickness compensator comprising a severable grid, wherein the severable grid is disposed laterally intermediate the first longitudinal side and the second longitudinal side; ,
A fastener that is movable between an initial position and a fired position, wherein the fastener moves when the at least one fastener moves between its initial position and its fired position. A fastener cartridge assembly configured to engage a portion of a tissue thickness compensator.

16. The fastener cartridge assembly according to embodiment 15, wherein at least one of the severable grids comprises a hydrophilic material and the hydrophilic material expands after the severable grid is cut.
17. The fastener of embodiment 15 or 16, wherein the fastener is configured to puncture at least one of the severable grids as the fastener moves to its fired position. Cartridge assembly.
(18) The embodiment of any one of embodiments 15-17, wherein the severable lattice is at least partially filled with a material selected from the group comprising hemostatic agents, antibacterial agents, anti-inflammatory agents, anticoagulants, and antibiotics. A fastener cartridge assembly according to any one of the preceding claims.
(19) A surgical instrument end effector assembly comprising:
A fastener cartridge assembly according to any of embodiments 15-18;
With anvil,
A cutting element configured to translate along a longitudinal path intermediate the first longitudinal side and the second longitudinal side of the cartridge body, the cutting element being along the longitudinal path An end effector assembly, wherein the cutting element is configured to cut at least one of the severable grids when translating.
(20) A firing member is configured to fire the fastener from the fastener cavity, and the anvil is configured to deform the fired fastener, whereby the tissue thickness compensator Embodiment 21. The end effector assembly of embodiment 19, wherein a portion is captured within the deformed fastener.

Claims (14)

A surgical instrument fastener cartridge assembly comprising:
A cartridge body defining a longitudinal axis, wherein the cartridge body includes a fastener cavity;
A woven grid extending across the longitudinal axis of the cartridge body, the woven grid comprising a resilient material;
A fastener movable between an initial position and a fired position, wherein the fastener is at least partially disposed within the fastener cavity when the fastener is in the initial position; and A fastener cartridge assembly, wherein the fastener is configured to compress the at least one woven lattice as the tool moves to its fired position.   The fastener cartridge assembly of claim 1, wherein the fastener cavities are arranged in rows of fastener cavities, the rows of fastener cavities being substantially parallel to the longitudinal axis.   The fastener cartridge assembly of claim 1 or 2, wherein each woven lattice is oriented at approximately 45 degrees relative to the longitudinal axis of the cartridge body.   At least one woven grid crosses the row of fastener cavities so that when the fastener is in an initial position, the at least one woven grid is in contact with the first leg of the fastener. The fastener cartridge assembly of claim 2, disposed between the second leg.   The fastener cartridge assembly according to any one of claims 1 to 4, further comprising a sheet of material, wherein the sheet of material retains the woven lattice within the fastener cartridge.   The fastener cartridge of claim 1, wherein the woven lattice is at least partially filled with a material selected from the group comprising hemostatic agents, antibacterial agents, anti-inflammatory agents, anticoagulants, and antibiotics. assembly.   An end effector assembly for a surgical instrument, comprising: the fastener cartridge assembly according to any one of claims 1 to 6; and an anvil. A fastener cartridge assembly for a surgical instrument, the fastener cartridge assembly comprising:
A cartridge body,
The deck surface,
A fastener cavity in the deck surface;
Including the cartridge body,
A plurality of woven grids, wherein the woven grids include a resilient material and each woven grid includes an axis that intersects the deck surface;
A fastener movable between an initial position and a fired position, wherein the fastener is at least partially disposed within the fastener cavity when the fastener is in the initial position; and A fastener configured to compress the at least one woven lattice as the tool moves to its fired position;
A fastener cartridge assembly comprising:   The fastener cartridge assembly of claim 8, wherein the axis of each woven lattice is substantially perpendicular to the deck surface. The first axis of the first woven grid extends through the first opening, the second axis of the second woven grid extends through the second opening, and the fastener comprises:
The base,
A first leg extending from the base, wherein the first opening is configured to receive the first leg;
A second leg extending from the base, wherein the second opening is configured to receive the second leg, according to claim 8 or 9, A fastener cartridge assembly as described.   11. A fastener cartridge assembly according to any one of claims 8 to 10, further comprising a material sheet, wherein the woven lattice is disposed intermediate the deck surface of the cartridge body and the material sheet.   12. The fabric according to any one of claims 8 to 11, wherein the woven lattice is at least partially filled with a material selected from the group comprising hemostatic agents, antibacterial agents, anti-inflammatory agents, anticoagulants, and antibiotics. The fastener cartridge assembly according to claim.   The fastener cartridge assembly according to any one of claims 8 to 12, wherein each woven grid is secured to an adjacent woven grid.   An end effector assembly for a surgical instrument, comprising: the fastener cartridge assembly according to any one of claims 8 to 13; and an anvil.

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