RU2635007C2 - Tissue thickness compensator containing structure for elastic load application - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: cassette assembly with fastening elements for a surgical instrument end effector contains a cassette housing, a deformable tube and a fastening element. The fastening element is movable between the initial position and the activated position. The deformable tube is located longitudinally along the length of the housing. When the fastening element is moved to the activated position, it compresses part of the deformable tube. The deformable tube contains an elastic material which creates a restoring force. The deformable tube may comprise a grid of strands interwoven together to form a tube wall. Additionally, the deformable tube may be bioresorbable and may contain a therapeutic agent. The cassette assembly with fastening elements may comprise a plurality of substantially parallel deformable tubes disposed side by side and/or one inside the other.

EFFECT: method improvement.

20 cl, 211 dwg

Description

Cross References to Related Applications

This unconditional patent application is a partial continuation of the application pursuant to §120 of section 35 of the US Patent Code No. 13 / 097,891, entitled “Tissue Thickness Compensator for Surgical Stapling Instrument Containing Adjustable Stop”, filed April 29, 2011, which represents This is a partial continuation of the application pursuant to Section 120 of Section 35 of the US Patent Code No. 12 / 894,377 entitled "Implantable cassette with fasteners with selective orientation" filed September 30, 2010 ., The disclosures of which are incorporated herein by reference.

BACKGROUND

The present invention relates to surgical instruments and, in various embodiments, to surgical cutting and stapling instruments and cassettes with staples used in them, which are capable of cutting and stapling tissue with staples.

SUMMARY OF THE INVENTION

The following is a non-exhaustive list of embodiments of the present invention that are claimed or may be claimed.

1. A cartridge assembly with fasteners for a surgical instrument, comprising:

cassette case;

a deformable tube located relative to the cassette body, and the deformable tube contains an elastic material; and

a fastener configured to move between the initial position and the activated position, the fastener being configured to engage a portion of the deformable tube when moving the fastener to its activated position.

2. A cartridge assembly with fasteners according to embodiment 1, comprising:

a platform; and

at least one row of sockets for fasteners in the platform, and a deformable tube covers at least one row of sockets for fasteners.

3. The cartridge assembly with fasteners according to embodiment 2, wherein the deformable tube is adjacent to the platform of the cartridge housing.

4. A cassette assembly with fasteners according to embodiment 2 or embodiment 3, wherein at least one row of sockets for fasteners comprises substantially parallel rows of sockets for brackets, and wherein the cassette body comprises:

a groove extending between two essentially parallel rows of nests for staples; and

a cutting element configured to progressively move within the groove, wherein at least a portion of the deformable tube covers the groove so that the cutting element is configured to cut at least a portion of the deformable tube.

5. The cartridge assembly with fasteners according to any one of embodiments 2-4, wherein the deformable tube is a first deformable tube, wherein the cartridge assembly with fasteners further comprises a second deformable tube, the second deformable tube being substantially parallel to the first deformable tube.

6. The cartridge assembly with fasteners according to embodiment 5, wherein the second deformable tube is located inside the first deformable tube.

7. The cartridge assembly with fasteners of embodiment 6, further comprising a third deformable tube, the third deformable tube being located inside the second deformable tube.

8. Cassette assembly with fasteners according to embodiment 5 or embodiment 6, further comprising a third deformable tube, the first deformable tube aligned with a longitudinal axis formed by the cassette body, the second deformable tube located on the first side of the first deformable tube, and the third a deformable tube is located on the second side of the first deformable tube.

9. The cartridge assembly with fasteners according to any one of embodiments 5-8, wherein the first deformable tube and the second deformable tube are coextruded with the adjacent part to form a single part.

10. The cartridge assembly with fasteners according to any preceding embodiment, in which the deformable tube comprises a lattice of strands intertwined together to form a tube wall.

11. The cartridge assembly with fasteners according to embodiment 10, wherein the strand grating comprises tubular strands.

12. The cartridge assembly with fasteners of Embodiment 10 or Embodiment 11 wherein the strand grating comprises bioabsorbable strands.

13. The cartridge assembly with fasteners according to any one of embodiments 10-12, wherein the deformable tube further comprises a non-porous tube located outside or inside the strand grate, and wherein the non-porous tube is coextruded with the strand grate.

14. A cartridge assembly with fasteners according to embodiment 13, wherein the strand grating is at least partially filled with a therapeutic agent for treating tissue.

15. A cassette with fasteners for a surgical instrument, comprising:

cassette body forming a longitudinal axis;

a first plurality of strands intertwined into an elastic lattice, the elastic lattice being substantially parallel to the longitudinal axis; and

fasteners arranged to move between the initial position and the activated position, and at least one such fastener is configured to compress a portion of the elastic lattice when moving at least one fastener to its activated position.

16. A cassette with fasteners according to embodiment 15, wherein the elastic lattice is a first elastic lattice, wherein the cassette with fasteners further comprises a second plurality of strands interwoven into a second elastic lattice, the second elastic lattice being substantially parallel to said longitudinal axis, and wherein at least one of the first plurality of strands and the second plurality of strands comprises tubular strands.

17. An end effector assembly for a surgical instrument, comprising:

emphasis;

cassette with fasteners containing:

at least one row of sockets for fasteners; and

fasteners made to move between the initial position and the activated position, each fastener in its initial position is located inside the socket for the fastener; and

a tube, the tube containing elastic material, and wherein the tube is substantially parallel to at least one row of sockets for fasteners;

moreover, at least one fastening element is configured to deform a portion of the tube when it is moved to the activated position.

18. The end effector assembly of embodiment 17, wherein the tube comprises a therapeutic agent for treating tissue.

19. The end effector assembly of embodiment 18, wherein the tube is bioabsorbable so that the tube releases a therapeutic agent upon bioabsorption.

20. The end effector assembly of embodiment 18 or embodiment 19, further comprising a cutting element configured to progressively move along at least a portion of the groove in the cassette with the fasteners, wherein at least one of the cutting element and the plurality of fasteners is made with the ability to penetrate the tube so that the therapeutic agent is released from the tube.

BRIEF DESCRIPTION OF THE FIGURES

Features and advantages of the present invention, as well as a method of achieving them, will become more apparent, and the invention itself will become more apparent after reading the following description of embodiments of the present invention in conjunction with the accompanying figures.

In FIG. 1 is a cross-sectional view of an embodiment of a surgical instrument.

In FIG. 1A is a perspective view of one embodiment of an implantable cassette with brackets.

In FIG. 1B-1E show portions of an end effector clamping and stitching tissue with an implantable cassette with staples.

In FIG. 2 is a partial cross-sectional side view of another end effector connected to a part of a surgical instrument, the end effector supporting a surgical cassette with brackets and its stop in the open position.

In FIG. 3 is another partial side cross-sectional view of the end effector shown in FIG. 2, in the closed position.

In FIG. 4 is another partial side cross-sectional view of the end effector shown in FIG. 2 and 3, on which the scalpel holder begins to advance through the end effector.

In FIG. 5 is another partial side cross-sectional view of the end effector shown in FIG. 2-4, on which the scalpel holder is partially advanced through it.

In FIG. 6A-6D are a diagram of a deformation of a surgical staple located inside a body of a crushable cassette with brackets in accordance with at least one embodiment.

In FIG. 7A is a diagram illustrating a bracket located in a housing of a crushable cassette with brackets.

In FIG. 7B is a diagram illustrating a process of crushing the body of a crushable cassette with brackets shown in FIG. 7A, using the stop.

In FIG. 7C is a diagram illustrating a process of further crushing the casing of a crushable cassette with brackets shown in FIG. 7A, using the stop.

In FIG. 7D is a diagram illustrating a bracket shown in FIG. 7A, in a fully formed configuration and a crushable cassette with brackets, shown in FIG. 7A, in a completely crushed state.

In FIG. 8 is a plan view of a staple cassette in accordance with at least one embodiment comprising brackets placed in a casing of a crushable cassette with staples.

In FIG. 9 is a perspective view of a cassette with brackets shown in FIG. 8.

In FIG. 10 shows a perspective view with a spatial separation of the components of an alternative embodiment of a compressible cassette with brackets containing brackets and a system for moving the brackets close to the stop.

In FIG. 10A is a partial partial cross-sectional view of an alternative embodiment of a cassette with brackets shown in FIG. 10.

In FIG. 11 is a cross-sectional view of a cassette with brackets shown in FIG. 10.

In FIG. 12 is a perspective view of a slide arranged to pass through a cassette with brackets shown in FIG. 10, and moving the brackets to the stop.

In FIG. 13 shows a diagram of the ejector brackets, which can be lifted against the stop by the slide shown in FIG. 12.

In FIG. 14 is a perspective view of a staple cartridge comprising a rigid support portion and a compressible tissue thickness compensator for use with a surgical stapling instrument in accordance with at least one embodiment of the present invention.

In FIG. 15 is a partially exploded view of the components of the bracket cassette shown in FIG. fourteen.

In FIG. 16 is a view with a complete spatial separation of the components of the cassette with brackets shown in FIG. fourteen.

In FIG. 17 is another view of the spatial separation of the components of the cassette with brackets, presented in FIG. 14, without a sheath covering the tissue thickness compensator.

In FIG. 18 is a perspective view of a housing, or support portion, of a cassette with brackets shown in FIG. fourteen.

In FIG. 19 is a top perspective view of a slide arranged to move within a cassette with brackets shown in FIG. 14 to accommodate the staples from the staple cartridge.

In FIG. 20 is a bottom perspective view of the slide shown in FIG. 19.

In FIG. 21 is a perspective view of the slide shown in FIG. 19.

In FIG. 22 is a perspective view from above of an ejector configured to support one or more staples and to be lifted upward using the slide shown in FIG. 19 to eject the staples from the staple cartridge.

In FIG. 23 is a perspective view from below of the ejector shown in FIG. 22.

In FIG. 24 shows a shell configured to at least partially surround a compressible tissue thickness compensator of a cassette with brackets.

In FIG. 25 is a partial partial cross-sectional view of a cassette with brackets comprising a rigid support portion and a compressible tissue thickness compensator, illustrating staples moving during the first sequence from an inactive position to an activated position.

In FIG. 26 is a perspective view of a cassette with brackets shown in FIG. 25.

In FIG. 27 is a detailed perspective view of a cassette with brackets shown in FIG. 25.

In FIG. 28 is an end view in cross section of a cassette with brackets shown in FIG. 25.

In FIG. 29 is a bottom view of the cassette with brackets shown in FIG. 25.

In FIG. 30 is a detailed bottom view of the cassette with brackets shown in FIG. 25.

In FIG. 31 is a longitudinal sectional view of an abutment in a closed position and a cassette with brackets comprising a rigid support portion and a compressible tissue thickness compensator, illustrating staples moved during the first sequence from an inactive position to an activated position.

In FIG. 32 is another cross-sectional view of a stop and a cassette with brackets shown in FIG. 31 illustrating an emphasis in an open position after completion of a starting sequence.

In FIG. 33 is a partial detailed view of a cassette with brackets shown in FIG. 31 illustrating staples in an inactive position.

In FIG. 34 is a cross-sectional elevational view of a staple cartridge containing a rigid support portion and a compressible tissue thickness compensator illustrating staples in an inactive position.

In FIG. 35 is a detailed view of the cassette with brackets shown in FIG. 34.

In FIG. 36 is a perspective view of an abutment in an open position and a cassette with brackets comprising a rigid support portion and a compressible tissue thickness compensator illustrating staples in an inactive position.

In FIG. 37 is a perspective view of a stop in a closed position and a cassette with brackets comprising a rigid support portion and a compressible tissue thickness compensator illustrating staples in an inactive position and tissue sandwiched between a stop and a tissue thickness compensator.

In FIG. 38 is a detailed view of a stop and a cassette with brackets shown in FIG. 37.

In FIG. 39 is a perspective view of an abutment in the closed position and a cassette with brackets comprising a rigid support portion and a compressible tissue thickness compensator illustrating staples in an inactive position and a thicker fabric located between the abutment and the cassette with brackets.

In FIG. 40 is a detailed view of a stop and a cassette with brackets shown in FIG. 39.

In FIG. 41 is a perspective view of a stop and a cassette with brackets shown in FIG. 39 illustrating a fabric of different thickness located between the stop and the cassette with brackets.

In FIG. 42 is a detailed view of the stop and the cassette with brackets shown in FIG. 39, as presented in FIG. 41.

In FIG. 43 is a diagram illustrating a tissue thickness compensator that compensates for different tissue thicknesses sandwiched inside different staples.

In FIG. 44 is a diagram illustrating a tissue thickness compensator applying compressive pressure to one or more vessels dissected by a staple line.

In FIG. 45 is a diagram illustrating a situation in which one or more staples are not formed correctly.

In FIG. 46 is a diagram illustrating a tissue thickness compensator capable of compensating for improperly formed staples.

In FIG. 47 is a diagram illustrating a tissue thickness compensator located in a tissue region where a plurality of staple lines intersect.

In FIG. 48 is a diagram illustrating tissue trapped inside a staple.

In FIG. 49 is a diagram illustrating tissue and a tissue thickness compensator trapped inside the bracket.

In FIG. 50 is a diagram illustrating tissue trapped inside a staple.

In FIG. 51 is a diagram illustrating thick tissue and a tissue thickness compensator trapped inside the bracket.

In FIG. 52 is a diagram illustrating thin tissue and a tissue thickness compensator trapped inside the bracket.

In FIG. 53 is a diagram illustrating an intermediate thickness fabric and a tissue thickness compensator trapped inside the bracket.

In FIG. 54 is a diagram illustrating a fabric of a different intermediate thickness and a tissue thickness compensator trapped inside the staple.

In FIG. 55 is a diagram illustrating thick tissue and a tissue thickness compensator trapped inside the bracket.

In FIG. 56 is a partial cross-sectional view of an end effector of a surgical suturing instrument, illustrating a trigger bar and a slide for activating staples in a drawn, inactive position.

In FIG. 57 shows another partial cross-sectional view of the end effector shown in FIG. 56, illustrating a launch rod and a slide for activating staples in a partially advanced position.

In FIG. 58 is a cross-sectional view of an end effector shown in FIG. 56 illustrating a launch rod in a fully advanced, or activated, position.

In FIG. 59 is a cross-sectional view of an end effector shown in FIG. 56, illustrating the launch rod in the position drawn after activation and the slide for activating the staples remaining in their fully activated position.

In FIG. 60 is a detailed view of the launch rod in the drawn position shown in FIG. 59.

In FIG. 61 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 62 is a detailed view of the nonwoven fabric thickness compensator depicted in FIG. 61.

In FIG. 63 is a perspective view showing a tissue thickness compensator shown in FIG. 61, implanted close to the tissue and released from the end effector.

In FIG. 64 is a detailed view of the nonwoven fabric thickness compensator in accordance with at least one embodiment.

In FIG. 65 is a schematic view showing clusters of randomly oriented compressed fibers in accordance with at least one embodiment.

In FIG. 66 is a schematic view showing a cluster of randomly oriented compressed fibers in accordance with at least one embodiment.

In FIG. 67 is a schematic view showing a configuration of compressed fibers in accordance with at least one embodiment.

In FIG. 68 is a schematic view showing a configuration of compressed fibers in accordance with at least one embodiment.

In FIG. 69 is a schematic view showing a configuration of compressed fibers in accordance with at least one embodiment.

In FIG. 70 is a horizontal cross-sectional view of twisted fibers in a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 70A is a horizontal cross-sectional view of the twisted fibers shown in FIG. 70.

In FIG. 70B is a detailed cross-sectional view of the tissue thickness compensator shown in FIG. 70.

In FIG. 71 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 72 is a diagram showing the deformation of the tissue thickness compensator shown in FIG. 71.

In FIG. 73 is a diagram of a braided yarn for compensating the thickness of a fabric on which a braided yarn is shown in a loaded configuration in accordance with at least one embodiment.

In FIG. 74 is a schematic representation of the woven yarn depicted in FIG. 73, on which the braided thread is in the released configuration.

In FIG. 75 is a perspective view of a tissue thickness compensator having a woven thread depicted in FIG. 73, in the end effector of a surgical stapling instrument.

In FIG. 76 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 77 is a partial horizontal view of the tissue thickness compensator shown in FIG. 76.

In FIG. 78 is an exploded view of the components of a cartridge assembly with fasteners for an end effector and tissue thickness compensator shown in FIG. 61.

In FIG. 79 is a partial cross-sectional view of a cartridge assembly with fasteners shown in FIG. 78, in which the fasteners are shown inactive, partially activated, and fully activated.

In FIG. 80 is a perspective view of a cartridge assembly with fasteners shown in FIG. 78, which shows an ejector that activates fasteners from the slots for the brackets of the staple cartridge assembly to the tissue thickness compensator.

In FIG. 81 is a detailed view of a cartridge assembly with fasteners shown in FIG. 80.

In FIG. 82 is a perspective view of the tissue thickness compensator shown in FIG. 61, as well as tissue trapped inside activated fasteners.

In FIG. 83 is a perspective view of the tissue thickness compensator shown in FIG. 61, and tissue trapped within the activated fasteners.

In FIG. 84 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 85 is a diagram showing the deformation of a deformable tube of a tissue thickness compensator shown in FIG. 84.

In FIG. 86 is a detailed view of a deformable tube of a tissue thickness compensator shown in FIG. 84.

In FIG. 87 is a diagram showing the deformation of a deformable tube of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 88 is a perspective view of a tissue thickness compensator comprising a tubular member implanted close to the tissue in accordance with at least one embodiment.

In FIG. 89 is a perspective view of a tissue thickness compensator comprising tubular elements implanted close to the tissue in accordance with at least one embodiment.

In FIG. 90 is a partial perspective view of a deformable tube comprising a tube sheet in accordance with at least one embodiment.

In FIG. 91 is a perspective view of a tubular lock of a deformable tube shown in FIG. 90.

In FIG. 92 is a perspective view of a deformable tube shown in FIG. 90.

In FIG. 93 is a perspective view of a plurality of tubular strands for a deformable tube shown in FIG. 90, in accordance with various embodiments.

In FIG. 94 is a perspective view of the tubular lattice shown in FIG. 90 implanted close to the tissue.

In FIG. 95 is a partial perspective view of a deformable tube in accordance with at least one embodiment.

In FIG. 96 is a partial perspective view of a deformable tube in accordance with at least one embodiment.

In FIG. 97 is a partial perspective view of a deformable tube in accordance with at least one embodiment.

In FIG. 98 is a perspective view of a deformable tube shown in FIG. 97.

In FIG. 99 is a partial perspective view of a deformable tube in accordance with at least one embodiment.

In FIG. 100 is a partial perspective view of a deformable tube in accordance with at least one embodiment.

In FIG. 101 is a partial perspective view of a deformable tube in accordance with at least one embodiment.

In FIG. 102 is a perspective view of a tissue thickness compensator located in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 103 is a perspective view of the tubular member of the tissue thickness compensator shown in FIG. 102.

In FIG. 104 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 102, in which the end effector is shown in an unclamped configuration.

In FIG. 105 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 102, in which the end effector is shown in a clamped and activated configuration.

In FIG. 106 is a vertical cross-sectional view of a tissue thickness compensator located in an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 107 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 106, in which the end effector is shown in a clamped and activated configuration.

In FIG. 108 is a vertical cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 109 is a vertical cross-sectional view of a tissue thickness compensator located in an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 110 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 109, in which the end effector is shown in a clamped and activated configuration.

In FIG. 111 is a perspective view of a tissue thickness compensator located in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 112 is a vertical cross-sectional view of a tissue thickness compensator located in an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 113 is a vertical cross-sectional view of a tissue thickness compensator located in an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 114 is a vertical cross-sectional view of a tissue thickness compensator located in an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 115 is a vertical cross-sectional view of a tissue thickness compensator located in an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 116 is a partial perspective view of a tissue thickness compensator located in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 117 is a partial horizontal view of a tissue thickness compensator located in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 118 is a partial vertical cross-sectional view of a tissue thickness compensator and an end effector of FIG. 116, in which the end effector is shown in an unclamped configuration.

In FIG. 119 is a partial elevational view in cross-section of a tissue thickness compensator and an end effector shown in FIG. 116, in which the end effector is shown in an unclamped configuration.

In FIG. 120 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 121 is a perspective view of a tissue thickness compensator and an end effector shown in FIG. 120.

In FIG. 122 is a perspective view of a tissue thickness compensator and an end effector shown in FIG. 120, in which the stop of the end effector is shown moving towards the clamped configuration.

In FIG. 123 is a perspective view of a tissue thickness compensator and an end effector shown in FIG. 120, in which the end effector is shown in a clamped configuration.

In FIG. 124 is a vertical cross-sectional view of the tubular elements of the tissue thickness compensator shown in FIG. 120, in an undeformed configuration.

In FIG. 125 is a vertical cross-sectional view of the tubular elements of the tissue thickness compensator shown in FIG. 120, in a deformed configuration.

In FIG. 126 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 127 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 126, in which the end effector is shown in a clamped configuration.

In FIG. 128 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 126, in which the end effector is shown in an activated and partially unclamped configuration.

In FIG. 129 is a perspective view of a tissue thickness compensator located in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 130 is a vertical cross-sectional view of a tissue thickness compensator mounted on a stop of an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 131 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 130, in which the end effector is shown in a clamped configuration.

In FIG. 132 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 130, in which the end effector is shown in an activated and partially unclamped configuration.

In FIG. 133 is a detailed view of the tissue thickness compensator and the end effector shown in FIG. 132.

In FIG. 134 is a vertical cross-sectional view of a tissue thickness compensator sandwiched in an end effector of a surgical instrument, showing placement of staples using a slide to activate staples, in accordance with at least one embodiment.

In FIG. 135 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 134, in which the end effector is shown in a clamped configuration.

In FIG. 136 is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 134, in which the end effector is shown in an activated configuration.

In FIG. 137 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 138 is a perspective view of a tubular member of a tissue thickness compensator shown in FIG. 137.

In FIG. 139 is a perspective view of the tubular member shown in FIG. 138, cut between the first and second end.

In FIG. 140 is a perspective view of a tissue thickness compensator shown in FIG. 137, which shows a cutting element dissecting the tissue thickness compensator and staples engaging the tissue thickness compensator.

In FIG. 141 is a perspective view of a frame configured to obtain a fabric thickness compensator depicted in FIG. 137, in accordance with at least one embodiment.

In FIG. 142 is a vertical cross-sectional view of the frame shown in FIG. 141, which shows a tissue thickness compensator shown in FIG. 137, polymerizable in a frame.

In FIG. 143 is a vertical cross-sectional view of a tissue thickness compensator extracted from the frame shown in FIG. 142, and prepared for cutting with at least one cutting tool.

In FIG. 144 is a vertical cross-sectional view of a tissue thickness compensator shown in FIG. 143, after at least one cutting tool has cut the tissue thickness compensator.

In FIG. 145 is a vertical cross-sectional view of a tissue thickness compensator formed in the frame shown in FIG. 142, which shows dissected tubes having various geometric cross-sectional shapes.

In FIG. 146 is a perspective view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 147 is a detailed view of the fabric thickness compensator shown in FIG. 146, in accordance with at least one embodiment.

In FIG. 148 is a partial perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 149 is a partial perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 150A is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 146, in which the end effector is shown in an unclamped configuration.

In FIG. 150B is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 146, in which the end effector is shown in a clamped configuration.

In FIG. 150C is a vertical cross-sectional view of a tissue thickness compensator and an end effector shown in FIG. 146, in which the end effector is shown in a clamped and activated configuration.

In FIG. 150D is a vertical cross-sectional view of the fabric thickness compensator shown in FIG. 146 trapped in activated braces.

In FIG. 150E is a vertical cross-sectional view of the tissue thickness compensator shown in FIG. 146, trapped in activated staples, showing additional expansion of the tissue thickness compensator.

In FIG. 151 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 152 is a partial elevational view of the tissue thickness compensator depicted in FIG. 151 trapped in the activated bracket.

In FIG. 153 is a perspective view of a deformable tube of a tissue thickness compensator shown in FIG. 151.

In FIG. 154 is a perspective view of a deformable tube in accordance with at least one embodiment.

In FIG. 155 is a perspective view in cross section of a tissue thickness compensator shown in FIG. 151.

In FIG. 156 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 157 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 158 is a partial cross-sectional elevational view of the tissue thickness compensator shown in FIG. 157, which shows a fastener engaged with fabric and with a tissue thickness compensator.

In FIG. 159 is a perspective cross-sectional view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 160 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 161 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 162 is a perspective view of a tissue thickness compensator located in a circular end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 163 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 164 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 165 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 166 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 167 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 168 is a partial perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 169 is a partial perspective view of a tissue thickness compensator located in an end effector of a surgical stapling instrument in accordance with at least one embodiment.

In FIG. 170 is a partial perspective view of a tissue thickness compensator with a fastener located in its openings in accordance with at least one embodiment.

In FIG. 171 is a partial perspective view of a tissue thickness compensator shown in FIG. 169, which shows a tissue thickness compensator in an undeformed configuration.

In FIG. 172 is a partial perspective view of a tissue thickness compensator depicted in FIG. 169, which shows a tissue thickness compensator in a partially deformed configuration.

In FIG. 173 is a partial perspective view of a tissue thickness compensator depicted in FIG. 169, which shows a tissue thickness compensator in a deformed configuration.

In FIG. 174 is a perspective view of a tissue thickness compensator in accordance with at least one embodiment.

In FIG. 175 is a perspective view of an end effector of a stapling tool comprising an emphasis and a cassette with brackets, in accordance with at least one embodiment.

In FIG. 176 is a cross-sectional view of an end effector shown in FIG. 175, which shows the brackets located inside the cassette with brackets in an inactive state, and a tissue thickness compensator containing a sealed vessel in an unbreakable state, the vessel shown with its parts removed for illustration purposes.

In FIG. 177 is a cross-sectional view of an end effector shown in FIG. 175, on which the brackets shown in FIG. 176 are shown in an at least partially activated state, and the vessel is shown in an at least partially punctured state.

In FIG. 178 is a perspective view of an end effector of a surgical stapling instrument comprising an emphasis and a cassette with brackets, in accordance with at least one embodiment.

In FIG. 179 is a cross-sectional view of an end effector shown in FIG. 178, wherein the brackets located inside the cassette with brackets are shown in an inactive state, and the sealed vessels located inside the tissue thickness compensator of the cassette with brackets are shown in an unbreakable state, the vessels being shown with their parts removed for illustration purposes.

In FIG. 180 is a cross-sectional view of an end effector shown in FIG. 178, on which the staples shown in FIG. 179 are in an at least partially activated state, and the vessels in the cassette with brackets are in an at least partially punctured state.

In FIG. 181 is a perspective view of an end effector of a stapling instrument comprising an abutment and a sealed vessel attached to an abutment in accordance with at least one alternative embodiment, the vessel being shown with its parts removed for illustrative purposes.

In FIG. 182 is a cross-sectional view of an end effector shown in FIG. 181, in which the brackets are shown at least partially activated from the cassette with the brackets, and the vessels attached to the stop are shown at least partially punctured.

In FIG. 183 is a cross-sectional view of a vessel attached to the abutment shown in FIG. 181, which is shown in an expanded state.

In FIG. 184 is a detailed view of the vessel attached to the abutment shown in FIG. 183, which is shown in an expanded state.

In FIG. 185 shows a vessel extending in a direction transverse to the line of staples.

In FIG. 186, a plurality of vessels are shown extending in directions transverse to the line of staples.

In FIG. 187 is a cross-sectional view of a staple cartridge in accordance with various embodiments.

In FIG. 188 is a partial cross-sectional view shown in FIG. 187, in the implanted state.

In FIG. 189A is a partial perspective view of a tissue thickness compensator prior to expansion.

In FIG. 189B is a partial perspective view of a tissue thickness compensator depicted in FIG. 189, during expansion.

In FIG. 190 is a partial perspective view of a tissue thickness compensator comprising a fluid swellable composition in accordance with various embodiments.

In FIG. 191 is a cross-sectional view of a fabric adjacent to a tissue thickness compensator, in accordance with various embodiments.

In FIG. 192 is a partial cross-sectional view shown in FIG. 191, after activating the cassette with brackets.

In FIG. 193 is a diagram showing a tissue thickness compensator shown in FIG. 191 implanted adjacent to tissue.

In FIG. 194 is a partial perspective view of a tissue thickness compensator in accordance with various embodiments.

In FIG. 195 is a perspective view of a jaw configured to receive a tissue thickness compensator depicted in FIG. 194.

In FIG. 196 is a partial cross-sectional view of a staple cassette showing brackets after being placed from the staple cassette.

In FIG. 197 is a perspective view of an upper tissue thickness compensator and a lower tissue thickness compensator located inside an effector of a disposable loading module.

In FIG. 198A is a cross-sectional view of the lower fabric thickness compensator shown in FIG. 197, which is made in the mold for molding in accordance with various options for implementation.

In FIG. 198B is a cross-sectional view of a three-layer fabric thickness compensator that is made into a mold in accordance with various embodiments.

In FIG. 199 is a cross-sectional view of an abutment comprising a tissue thickness compensator comprising a reinforcing material in accordance with various embodiments.

In FIG. 200 is a cross-sectional view of a fabric disposed between an upper tissue thickness compensator and a lower tissue thickness compensator, in accordance with various embodiments.

In FIG. 201 is a cross-sectional view shown in FIG. 200, which shows the staples after placement from the cassette with brackets.

In FIG. 202 is a cross-sectional view shown in FIG. 200, after activating the cassette with brackets.

In FIG. 203A illustrates a needle configured to deliver fluid to a tissue thickness compensator attached to a staple cartridge in accordance with various embodiments.

In FIG. 203B is a cross-sectional view of a staple cartridge containing a tissue thickness compensator configured to receive the needle of FIG. 203A.

In FIG. 204 shows a method of manufacturing a tissue thickness compensator in accordance with various embodiments.

In FIG. 205 shows a diagram and a method of forming an expanding tissue thickness compensator in accordance with various embodiments.

In FIG. 206 shows a micelle containing the hydrogel starting material; and

In FIG. 207 is a diagram of a surgical instrument comprising a tissue thickness compensator and fluids that can be delivered to a tissue thickness compensator in accordance with various embodiments.

In FIG. 208 is a partial perspective view of a tissue thickness compensator mounted on a stop of an end effector of a surgical instrument in accordance with at least one embodiment.

In FIG. 209 is a perspective view of a tubular member of a tissue thickness compensator shown in FIG. 208.

In FIG. 210 is a perspective view of the tubular member shown in FIG. 209, which shows a tubular element dissected into two halves, and a fluid in contact with a hydrophilic substance within each half.

In FIG. 211 is a perspective view of half of a dissected tubular member shown in FIG. 210, which shows the expansion of the dissected tubular element.

Corresponding elements in different views are indicated by the corresponding symbols. The illustrative examples presented herein in one form are intended to illustrate certain embodiments of the present invention, and such illustrative examples should not be construed as in any way limiting the scope of the present invention.

DETAILED DESCRIPTION

The applicant for this application is also the owner of the applications for US patents listed below, each of which is fully incorporated herein by reference:

US Patent Application No. 12 / 894,311, entitled “SURGICAL INSTRUMENTS CONTAINING SEGMENT ROD WITH CONFIGURABLE CONFIGURATION”, Patent Attorney File No. END6734USNP / 100058;

US Patent Application No. 12 / 894,340, entitled “CARTRIDGE WITH SURGICAL BRACKETS SUPPORTING NONLINEAR LOCATED BRACKETS AND SURGICAL STAPLING INSTRUMENTS WITH GENERALLY DEPTH GRINDED UNDERGROUNDED UNDERGROUNDED USE

US Patent Application No. 12 / 894,327, entitled “CONFIGURATIONS FOR CLOSING BRANCH SURGICAL INSTRUMENTS”, Patent Attorney File No. END6736USNP / 100060;

US Patent Application No. 12 / 894,351, entitled “SURGICAL CUTTING AND STITCHING TOOLS WITH SEPARATE AND SEPARATE PLACEMENT SYSTEMS FOR FASTENING ELEMENTS AND CUTTING OF FABRIC”, US Pat.

US Patent Application No. 12 / 894,338 entitled “IMPLANTABLE FASTENING CASSETTE HAVING A NON-STANDARD CONFIGURATION”, Patent Attorney File No. END6840USNP / 100525;

US Patent Application No. 12 / 894,369, entitled “IMPLANTABLE FASTENING CARTRIDGE CONTAINING A SUPPORT LATCH”, Patent Attorney File No. END6841USNP / 100526;

US Patent Application No. 12 / 894,312, entitled “IMPLANTED FASTENING ELEMENT CARTRIDGE CONTAINING MANY LAYERS”, Patent Attorney File No. END6842USNP / 100527;

US Patent Application No. 12 / 894,377 entitled “SELECTIVELY ORIENTED IMPLANTED FASTENING ELEMENT CASSETTE”, Patent Attorney Dossier No. END6843USNP / 100528;

US Patent Application No. 12 / 894,339, entitled “SURGICAL SEWING TOOL WITH COMPACT HINGE CONTROL DEVICE CONFIGURATION”, Patent Attorney File No. END6847USNP / 100532;

US Patent Application No. 12 / 894,360 entitled “SURGICAL STAPLING TOOL WITH REGULATED BRACKET FORMING SYSTEM”, Patent Attorney File No. END6848USNP / 100533;

US Patent Application No. 12 / 894,322, entitled “SURGICAL STAPLING TOOL WITH INTERCHANGEABLE CARTRIDGE CARTRIDGED CONFIGURATIONS”, file of Patent Attorney No. END6849USNP / 100534;

US Patent Application No. 12 / 894,350 entitled “SURGICAL CARTRIDGES WITH STAPLES WITH SEPARABLE SUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTION OF LONG-TERM RELATED ARTICLES 55”

US Patent Application No. 12 / 894,383, entitled “IMPLANTABLE CARTRIDGES WITH FASTENING ELEMENTS CONTAINING BIO-RESORBABLE LAYERS”, Patent Attorney File No. END6856USNP / 100541;

US Patent Application No. 12 / 894,389, entitled “COMPRESSIBLE CASSETTE WITH FASTENING ELEMENTS”, Patent Attorney File No. END6857USNP / 100542;

US Patent Application No. 12 / 894,345, entitled “FIXING ELEMENTS SUPPORTED BY THE SUPPORT ELEMENT OF THE CARTRIDGE WITH FASTENING ELEMENTS”, Patent Attorney File No. END6858USNP / 100543;

US Patent Application No. 12 / 894,306, entitled “MEDIUM CARTRIDGE WITH FASTENING ELEMENTS”, dossier of patent attorney No. END6859USNP / 100544;

US Patent Application No. 12 / 894,318, entitled “A SEWING SYSTEM CONTAINING MULTIPLE RELATED MATERIALS CONTAINING MATRIX”, Patent Attorney File No. END6860USNP / 100546;

US Patent Application No. 12 / 894,330, entitled “SEWING SYSTEM CONTAINING A HOLDING MATRIX AND A LEVELING MATRIX”, Patent Attorney File No. END6861USNP / 100547;

US Patent Application No. 12 / 894,361, entitled “SEWING SYSTEM CONTAINING A HOLDING MATRIX”, Patent Attorney File No. END6862USNP / 100548;

US Patent Application No. 12 / 894,367, entitled “SEWING TOOL FOR OPERATING A SEWING SYSTEM CONTAINING A RETAINING MATRIX”, Patent Attorney File No. END6863USNP / 100549;

US Patent Application No. 12 / 894,388, entitled “SEWING SYSTEM CONTAINING A RETAINING MATRIX AND COVER”, Patent Attorney File No. END6864USNP / 100550;

US Patent Application No. 12 / 894,376, entitled “A SEWING SYSTEM CONTAINING MANY CARTRIDGES WITH FASTENING ELEMENTS,” Patent Attorney Dossier No. END6865USNP / 100551;

US Patent Application No. 13 / 097,865, entitled “SUPPORT FOR A SURGICAL STITCHING TOOL CONTAINING MANY FORMING DEPTHS”, Patent Attorney File No. END6735USCIP1 / 100059CIP1;

US Patent Application No. 13 / 097,936, entitled “FABRIC THICKNESS COMPENSATOR FOR SURGICAL BINDING INSTRUMENT”, Patent Attorney File No. END6736USCIP1 / 100060CIP1;

US Patent Application No. 13 / 097,954 entitled "BRACKET CARTRIDGE CONTAINING A COMPRESSIBLE PART OF VARIABLE THICKNESS", dossier of patent attorney No. END6840USCIP1 / 100525CIP1;

US Patent Application No. 13 / 097,856, entitled “BRACKET CARTRIDGE CONTAINING BRACKETS LOCATED INSIDE ITS COMPRESSIBLE PART”, Patent Attorney File No. END6841USCIP1 / 100526CIP1;

US Patent Application No. 13 / 097,928 entitled “FABRIC THICKNESS COMPENSATOR CONTAINING REMOVABLE PARTS”, Patent Attorney File No. END6842USCIP1 / 100527CIP1;

US Patent Application No. 13 / 097,891, entitled “FABRIC THICKNESS COMPENSATOR FOR A SURGICAL STAPLING TOOL CONTAINING AN ADJUSTABLE STOP,” Patent Attorney Dossier No. END6843USCIP1 / 100528CIP1;

US Patent Application No. 13 / 097,948, entitled “STAFF CARTRIDGE CONTAINING A REGULATED DISTAL PART”, Patent Attorney File No. END6847USCIP1 / 100532CIP1;

US Patent Application No. 13 / 097,907, entitled “COMPRESSIBLE CARTRIDGE WITH STAPLES” ASSEMBLY, Patent Attorney File No. END6848USCIP1 / 100533CIP1;

US Patent Application No. 13 / 097,861, entitled “FABRIC THICKNESS COMPENSATOR CONTAINING PARTS HAVING VARIOUS PROPERTIES”, Patent Attorney File No. END6849USCIP1 / 100534CIP1;

US Patent Application No. 13 / 097,869, entitled “LOADING CARTRIDGE WITH BRACKETS”, Patent Attorney File No. END6855USCIP1 / 100540CIP1;

US Patent Application No. 13 / 097,917 entitled “COMPRESSIBLE CARTRIDGE WITH BRACKETS CONTAINING LEVELING ELEMENTS”, dossier of patent attorney No. END6856USCIP1 / 100541CIP1;

US Patent Application No. 13 / 097,873, entitled “BRACKET CARTRIDGE CONTAINING A PART EXECUTED WITH RELEASE OPPORTUNITY”, Patent Attorney File No. END6857USCIP1 / 100542CIP1;

US Patent Application No. 13 / 097,938, entitled “STAPLE CARTRIDGE CONTAINING COMPRESSIBLE COMPONENTS RESISTANT TO CRANKS”, Patent Attorney File No. END6858USCIP1 / 100543CIP1;

US Patent Application No. 13 / 097,924, entitled “STAPLE CARTRIDGE CONTAINING A FABRIC THICKNESS COMPENSATOR”, Patent Attorney File No. END6859USCIP1 / 100544CIP1;

US Patent Application No. 13 / 242,029, entitled “SURGICAL STAPLING INSTRUMENT WITH A MOBILE KEEPER”, Patent Attorney File No. END6841USCIP2 / 100526CIP2;

US Patent Application No. 13 / 242,066, entitled “CURVED END EFFECTOR FOR BINDING TOOL”, Patent Attorney Dossier No. END6841USCIP3 / 100526CIP3;

US Patent Application No. 13 / 242,086, entitled “Bracket Cassette Including Media Recognition Platform”, Patent Attorney File No. END7020USNP / 110374;

US Patent Application No. 13 / 241,912, entitled “CARTRIDGE TAPE CARTRIDGE INCLUDING A MOBILE PLATFORM CONFIGURATION”, Patent Attorney File No. END7019USNP / 110375;

US Patent Application No. 13 / 241,922, entitled “SURGICAL STAPLING TOOL WITH MOBILE STAPLE ESCAPERS”, Patent Attorney File No. END7013USNP / 110377;

US Patent Application No. 13 / 241,637, entitled “SURGICAL STAPLING TOOL WITH THE RELAY ASSEMBLY FOR GENERATING A LOT OF START-UP MOVEMENTS”, Patent Attorney File No. END6888USNP3 / 110378; and

US Patent Application No. 13 / 241,629, entitled “SURGICAL INSTRUMENT WITH A SELECTIVELY TURNABLE END EFFECTOR”, Patent Attorney File No. END6888USNP2 / 110379.

The applicant of this application also owns the following US patent applications filed on the same day as this application, and each of them is fully incorporated into this document by reference:

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATOR CONTAINING MULTIPLE CAPSULES,” Patent Attorney Dossier No. END6864USCIP1 / 100550CIP1;

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATOR CONTAINING MULTIPLE LAYERS”, Patent Attorney File No. END6864USCIP2 / 100550CIP2;

US Patent Application No. _______________ entitled “EXTENDABLE FABRIC THICKNESS COMPENSATOR”, Patent Attorney Dossier END6843USCIP2 / 100528CIP2;

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATOR CONTAINING A RESERVOIR”, Patent Attorney File No. END6843USCIP3 / 100528CIP3;

US Patent Application No. _______________ entitled “LIMITER ASSEMBLY INCLUDING FABRIC THICKNESS COMPENSATOR”, Patent Attorney File No. END6843USCIP4 / 100528CIP4;

US Patent Application No. _______________, entitled “FABRIC THICKNESS COMPENSATOR CONTAINING AT LEAST ONE MEDICINE”, Patent Attorney File No. END6843USCIP5 / 100528CIP5;

US Patent Application No. _______________, entitled “FABRIC THICKNESS COMPENSATOR WITH CONTROLLED RELEASE AND EXTENSION”, Patent Attorney File No. END6843USCIP6 / 100528CIP6;

US Patent Application No. _______________, entitled “FABRIC THICKNESS COMPENSATOR CONTAINING FIBERS FOR ELASTIC FORCE”, dossier of patent attorney No. END6843USCIP7 / 100528CIP7;

US Patent Application No. _______________, entitled “FABRIC THICKNESS COMPENSATOR CONTAINING ELASTIC ELEMENTS”, Patent Attorney File No. END6843USCIP9 / 100528CIP9;

US Patent Application No. _______________ entitled “METHODS FOR FORMING FABRIC THICKNESS COMPENSATORS CONFIGURATIONS FOR SURGICAL BINDING INSTRUMENTS”, Patent Attorney File No. END6843USCIP10 / 100528CP10;

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATORS”, Patent Attorney File No. END6843USCIP11 / 100528CP11;

US Patent Application No. _______________ entitled “LAYERED FABRIC THICKNESS COMPENSATOR”, Patent Attorney File No. END6843USCIP12 / 100528CP12;

US Patent Application No. _______________, entitled “FABRIC THICKNESS COMPENSATOR FOR CIRCULAR SURGICAL SEWING INSTRUMENTS”, Patent Attorney File No. END6843USCIP13 / 100528CP13;

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATOR CONTAINING LOW PRESSURE CAPSULES”, Patent Attorney File No. END7100USNP / 110601;

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATOR FORMED FROM A LOT OF MATERIALS”, dossier of patent attorney No. END7101USNP / 110602;

US Patent Application No. _______________, entitled “ITEM COMPLETED WITH THE POSSIBILITY OF MOVING, FOR USE WITH A FABRIC THICKNESS COMPENSATOR”, dossier of the patent attorney No. END7107USNP / 110603;

US Patent Application No. _______________, entitled “FABRIC THICKNESS COMPENSATOR CONTAINING MANY MEDICINES,” Patent Attorney File No. END7102USNP / 110604;

US Patent Application No. _______________, entitled “FABRIC THICKNESS COMPENSATOR AND METHOD FOR PRODUCING IT,” Patent Attorney Dossier No. END7103USNP / 110605;

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATOR CONTAINING CHANNELS”, Patent Attorney File No. END7104USNP / 110606;

US Patent Application No. _______________ entitled “FABRIC THICKNESS COMPENSATOR CONTAINING FABRIC ELEMENTS”, Patent Attorney File No. END7105USNP / 110607; and

US Patent Application No. _______________ entitled “DEVICES AND METHODS FOR ATTACHING MATERIALS COMPENSATING THICKNESS OF FABRIC TO SURGICAL STAPLING INSTRUMENTS”, Patent Attorney File No. END7108US.

For a more complete understanding of the design, principles of operation, production and application of the devices and methods described herein, a description of certain examples of implementation. One or more examples of these embodiments are shown in the accompanying figures. Specialists in this field it is clear that the devices and methods described in detail in this document and presented in the accompanying figures are examples of embodiments that are not restrictive. Features shown or described with reference to one embodiment may be combined with features of other embodiments. The scope of the present invention covers all such modifications and variations.

Any of the methods described or claimed in this document for the manufacture, formation or otherwise preparation of an article or product can be used to manufacture, form or otherwise obtain a portion or all of the article or product in question, which method can be used to manufacture, form or otherwise obtaining the part or product or product in question, since the rest of the product or product can be obtained in any way, including the use of any other sobov which have been described or claimed herein for the manufacture, formation or otherwise obtain products or product, as well as the various parts which can be combined in any manner after forming. Similarly, any product or product described or claimed in this document may exist separately or in combination, as well as an integral part of any other described product or product with which it is compatible. Thus, the specific features, structures, or characteristics shown or described in connection with a single product, product, or method can be unboundedly, in whole or in part, combined with the features, structures, or characteristics of one or more compatible products, products, or methods. The scope of the present invention covers all such modifications and variations.

If a description is made or a reference is made to a specific figure, or the like, where a particular embodiment of the present invention or a particular product, product or method may contain certain structures, characteristics or features, it should be understood that this means that these structures, characteristics or features may be embodied in the product, product or method in question in any possible combination. In particular, from such a description of the multitude of optional structures, characteristics or features, it should be understood that all of these structures, characteristics or features can also be described in combination with each other, except in cases of structures, characteristics or features that are described as alternatives to each other. If such structures, characteristics or features are described as alternatives to each other, it should be understood from the description of such alternatives that they can serve as a substitute for each other.

As used herein, the terms “proximal” and “distal” are used with reference to a physician manipulating the handle of a surgical instrument. The term "proximal" refers to the part located closest to the doctor, and the term "distal" refers to the part located away from the doctor. It should also be understood that for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “top” and “bottom” may be used with respect to the figures in this document. However, surgical instruments are used in many orientations and positions, and these terms are not limiting and / or absolute.

Various examples of devices and methods for carrying out laparoscopic and minimally invasive surgical interventions are proposed. However, it is very valuable that the various methods and devices described herein can be used for a wide variety of surgical interventions and applications associated with open surgical interventions. In the course of this detailed description, it can be further appreciated that the various tools described herein can be inserted into the body in any way, such as through a natural hole, through an incision or puncture formed in the tissue, and the like. The working parts or parts of the end effectors of the instruments can be inserted directly into the patient’s body or through an access device that has a working channel through which the end effector and the extended shaft of the surgical instrument can be advanced.

In the figures, similar numerical designations are used to indicate similar elements in different images. In FIG. 1 shows a surgical instrument 10 in which a number of unique advantages are realized. Surgical stapling instrument 10 is configured to adjust and / or activate end effectors 12 of various shapes and sizes that are functionally attached to it. For example, in FIG. 1-1E, the end effector 12 includes an elongated channel 14 forming the lower jaw 13 of the end effector 12. The elongated channel 14 is configured to support the implantable cassette with brackets 30, and also to support the stop 20, which acts as the upper jaw 15 of the end effector 12 .

The elongated channel 14 can be produced, for example, from stainless steel of the 300 and 400 series, 17-4 and 17-7, titanium, and the like, and can also be formed from side walls 16 that are located at a distance from each other. The stop 20 can be produced, for example, from stainless steel of the 300 and 400 series, 17-4 and 17-7, titanium, and the like. and have a bottom surface for forming the brackets, generally referred to as 22, which has a plurality of recesses formed therein to form the brackets 23. See FIG. 1B-1E. In addition, the stop 20 has a node forked inclined surface 24, protruding from it proximally. On each side of the assembly of the inclined surface 24, a stop pin 26 protrudes into the corresponding groove or hole 18 in the side walls 16 of the elongated channel 14 to facilitate its attachment to the channel with the possibility of movement or rotation.

Various forms of implantable staple cassettes can be used with various surgical instruments described herein. Specific configurations and designs of cassettes with brackets are described in detail below. However, in FIG. 1A, an implantable cassette with brackets 30 is shown. The cassette with brackets 30 has a body part 31 consisting of a compressible hemostatic material, for example, oxidized regenerated cellulose (ORC) or bioabsorbable foam, in which rows of uniform metal brackets 32 are supported. To prevent exposure to the staples and activation of the hemostatic material during insertion and placement of the cartridge; the entire cartridge may be coated or wrapped in a film of biodegradable material 38, such as a polydio film xanone commercially available under the PDS® trademark, or polyglycerin sebacinate (PGS) film or other biodegradable films formed from PGA (polyglycolic acid available on the market under the Vicryl trademark), PCL (polycaprolactone), PLA or PLLA (polylactic acid) ), PHA (polyhydroxyalkanoate), PGCL (polyglexaprone 25, commercially available under the trademark Monocryl) or a mixture of PGA, PCL, PLA, PDS, impervious to tearing. The housing 31 of the cassette with brackets 30 has dimensions that can be removably supported inside the elongated channel 14, as shown in the figures, so that each bracket 32 located therein is aligned with the corresponding recesses to form the brackets 23 in the stop when the stop 20 is brought into forming contact with cassette with staples 30.

In the process of application, after the location of the end effector 12 adjacent to the target tissue, the end effector 12 is manipulated to grasp or clamp the target tissue between the upper side 36 of the cassette with the brackets 30 and the surface for forming the brackets 22 of the stop 20. The brackets 32 are formed by moving the stop 20 along a path that essentially parallel to the elongated channel 14, to bring the surface to form the brackets 22 and, more specifically, the recesses on it to form the brackets 23 in substantially simultaneous contact with the upper side th 36 cassettes with brackets 30. While continuing to move the stop 20 into the cassette with brackets 30, the legs 34 of the brackets 32 are in contact with the corresponding recess to form the brackets 23 in the stop 20, which serves to bend the legs of the 34 brackets to give the brackets 32 a letter B. Additional movement stop 20 to the elongated channel 14 leads to additional compression and the formation of brackets 32 to the desired final height FF in the formed state.

The above-described staple forming process is essentially depicted in FIG. 1B-1E. For example, in FIG. 1B shows an end effector 12 with a target tissue T between the abutment 20 and the upper side 36 of the implantable cassette with brackets 30. FIG. 1C shows the initial locking position of the stop 20, in which the stop 20 is closed on the target fabric T to lock the target fabric T between the stop 20 and the upper side 36 of the cassette with brackets 30. FIG. 1D, the first step of forming the bracket is shown, in which the stop 20 began to compress the cassette with the brackets 30 so that the formation of legs 34 of the brackets 32 with recesses begins to form the brackets 23 of the stop 20. In FIG. 1E, a bracket 32 is shown in its final formed state passing through the target tissue T, with the stop 20 being removed for clarity. After the brackets 32 are formed and attached to the target tissue T, the surgeon moves the stop 20 to the open position to allow the cassette body 31 and the brackets 32 to remain in the target tissue T when the end effector 12 is removed from the patient’s body. The end effector 12 forms all the brackets simultaneously when two jaws 13 and 15 are compressed together. The remaining materials of the “crumpled” case of the cartridge 31 serve as hemostatic means (ORC), as well as reinforcing a number of superimposed braces (PGA, PDS or a film of any other composition from these above 38). In addition, since the brackets 32 do not need to leave the cassette 31 during formation, the likelihood of incorrect formation of the brackets 32 during the formation is minimized. As used herein, the term “implantable” means that, in addition to the staples, the cassette case materials that support the staples also remain in the patient’s body and can ultimately resorb in it. Such implantable cassettes with brackets differ from prior art cassette configurations, which remain located entirely inside the end effector after activation.

In various embodiments, the end effector 12 is configured to connect to an elongated shaft assembly 40 that protrudes from the handle assembly 100. The end effector 12 (in the closed state) and the elongated shaft assembly 40 may have similar cross-sectional shapes and sizes that allow functional passage through a trocar tube or a working channel of an access instrument of another shape. As used herein, the term “functionally pass” means that the end effector and at least a portion of the elongated shaft assembly can be inserted through the channel or opening of the tube and can be manipulated within them in a manner that is necessary to conduct a surgical tissue stitching procedure . When the jaws 13 and 15 of the end effector 12 are closed, its cross section is approximately circular, which facilitates its passage through holes and passages of circular cross section. However, the end effectors of the present invention, as well as the nodes of the elongated shaft, may have other cross-sectional shapes that can be differently passed through access channels and openings having a non-circular cross-sectional shape. Thus, the total cross-sectional dimension of the end effector in the closed position is related to the size of the channel or hole through which it is supposed to pass. Thus, for example, an end effector can be referred to as an end effector of “5 mm size”, which means that it can be functionally passed through an opening that has a diameter of at least about 5 mm.

The elongated shaft assembly 40 may have substantially the same external diameter as the external diameter of the end effector 12 in the closed position. For example, a 5 mm end effector can be connected to an elongated shaft 40 assembly with a cross-sectional diameter of 5 mm. However, as the present detailed description is presented, it will become clear that, in the framework of the present invention, end effectors of different sizes can be effectively used. For example, a 10 mm end effector can be attached to an elongated shaft with a cross-sectional diameter of 5 mm. Conversely, for applications in which there is a channel or access hole of 10 mm or more in size, the elongated shaft assembly 40 may have a cross-sectional diameter of 10 mm (or more), but can also activate an end effector of 5 mm or 10 mm in size. Accordingly, the outer rod 40 may have an outer diameter equal to or different from the outer diameter of the end effector 12 attached to it in the closed position.

As shown in the figures, the elongated shaft assembly 40 extends distally from the handle assembly 100 in a substantially straight line and forms a longitudinal axis A-A. For example, the elongated shaft assembly 40 may have a length of approximately 229-406 mm (9-16 inches). However, the elongated shaft assembly 40 may have a different length, or may have connecting elements therein, or otherwise be configured to facilitate pivoting of the end effector 12 relative to other parts of the shaft assembly or handle, as described in more detail below. The elongated rod assembly 40 has a trunnion element 50, which 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 supports 17 protruding from it, having a size that allows them to be received inside the corresponding support holes, or pockets , 52 located at the distal end of the trunnion element 50, which allows the end effector 12 to be removably connected to the elongated shaft assembly 40. The trunnion element 50 can be produced, for example, from an aluminum alloy of grade 6061 and and 7075, stainless steel, titanium, etc.

The handle assembly 100 comprises a pistol grip type housing that can be made from two or more fragments to facilitate assembly. For example, the handle assembly 100 shown in the figures comprises a right housing element 102 and a left housing element (not shown) cast or otherwise made from a polymer or plastic material and configured to be mated. Such housing elements can be attached to each other using latches, pins and slots, molded or otherwise formed in them, and / or adhesive, screws, etc. The trunnion element 50 has a proximal end 54 on which a flange 56 is formed. The flange 56 is rotatably supported inside a groove 106 formed by mating ribs 108 that protrude inwardly with each of the elements of the housing 102 and 104. This configuration facilitates the attachment of the trunnion element. 50 to the handle assembly 100, allowing the trunnion member 50 to rotate 360 ° about the handle assembly 100 around the longitudinal axis AA.

As further presented in FIG. 1, an axle member 50 extends through a mounting sleeve 60 that is rotatably mounted on and supported by a handle assembly 100. The mounting sleeve 60 has a proximal flange 62 and a distal flange 64, which form a groove for rotation 65, configured to receive the nose 101 of the handle assembly 100 for rotation. This configuration allows the mounting sleeve 60 to rotate around the longitudinal axis AA relative to the handle assembly 100. The trunnion element 50 is fixedly mounted on the mounting sleeve 60 with a pin 66. In addition, a rotary handle 70 is attached to the mounting sleeve 60. For example, the rotary handle 70 has a hollow part of the mounting flange 72, which has a size that allows you to take part of the holding sleeve 60. The rotary handle 70 can be made, for example, of glass-filled or carbon-filled nylon, polycarbonate, Ultem®, etc., and, cr Moreover, it is attached to the holding sleeve 60 with a pin of the pin 66. In addition, a retaining flange 74 protruding inwardly is formed on a part of the mounting flange 72, which is adapted to extend into a radial groove 68 formed on the mounting sleeve 60. Thus, the surgeon can rotate trunnion element 50 (and end effector 12 attached thereto) around the longitudinal axis AA by 360 ° by gripping the rotary handle 70 and rotating it relative to the handle assembly 100.

The stop 20 is held open by the spring of the stop 21 and / or another biasing configuration. The stop 20 is arranged to selectively move from an open position to various closed or locking and starting positions by a trigger system, essentially referred to as element 109. The trigger system 109 includes a “trigger element” 110 that includes a hollow trigger tube 110. The hollow trigger tube 110 is made with the possibility of axial movement along the element of the journal 50 and, thus, forms the outer part of the node of the elongated rod 40. The launch tube 110 may be made of polymer or other suitable material and may have a proximal end attached to the trigger beam 114 of the trigger system 109. For example, the trigger beam 114 may be cast at the proximal end of the trigger tube 110. However, other configurations of the fastener may be used.

As represented in FIG. 1, the launching beam 114 can be rotatably supported inside the support sleeve 120, configured to axially move inside the handle assembly 100. The support sleeve 120 has a pair of laterally extending ribs having a size that allows them to be received so that they can slide into the grooves formed under the ribs right and left body elements. Thus, the support sleeve 120 can axially slide inside the handle housing 100, allowing the launch traverse 114 and the launch tube 110 to rotate about it about the longitudinal axis A-A. According to the present invention, there is a longitudinal groove in the launch tube 110, allowing the pin of the pin 66 to pass through it into the element of the pin 50, facilitating the axial movement of the launch tube 110 along the element of the pin 50.

The starter system 109 further comprises a trigger 130, which controls the axial movement of the starter tube 110 along the spigot element 50. See FIG. 1. Such an axial movement of the trigger tube 110 in the distal direction to the trigger interaction with the stop 20 is referred to herein as the “trigger motion”. As shown in FIG. 1, the trigger 130 is connected by a pivot pin 132 to the handle assembly 100 for displacement or pivoting. A torsion spring 135 is used to displace the trigger 130 from a portion of the pistol grip 107 of the handle assembly 100 to an inactive “open”, or initial, position. As shown in FIG. 1, the trigger 130 has an upper portion 134 that is movably attached (with pins) to the trigger rods 136, which are pivotally attached (with pins) to the support sleeve 120. Thus, the trigger 130 is moved from its initial position (FIG. 1) to an end position adjacent to a portion of the pistol grip 107 of the handle assembly 100 will cause the trigger beam 114 and trigger tube 110 to move in the distal direction DD. Moving the trigger 130 from the pistol grip part 107 of the handle assembly 100 (under the influence of torsion spring displacement 135) will cause the trigger traverse 114 and trigger tube 110 to move in the proximal direction PD along the axle member 50.

The present invention can be used with implantable cassettes with brackets of various sizes and configurations. For example, the surgical instrument 10, when used in combination with the first trigger adapter 140, can be used with an end effector 12 of size 5 mm and a length of approximately 20 mm (or another length) that supports an implantable cassette with brackets 30. This size of the end effector may be particularly suitable , for example, to perform relatively thin dissecting and vascular operations. However, as described in more detail below, the surgical instrument 10 can also be used, for example, in combination with end effectors and cassettes with brackets of other sizes when replacing the first trigger adapter 140 with a second trigger adapter. In a further alternative embodiment, the elongated shaft assembly 40 may be configured to attach only one shape or size to the end effector.

The method for removably connecting the end effector 12 to the trunnion element 50 is described below. The connection process begins by inserting the retaining supports 17 on the elongated channel 14 into the receiving pockets 52 in the trunnion element 50. The surgeon then moves the trigger 130 to the pistol grip 107 of the housing assembly 100 to advance the trigger the tube 110 and the first trigger adapter 140 distally along the proximal end portion 47 of the elongated channel 14 so as to fix the supports 17 in the respective pockets 52. This is the position of the first trigger adapter 14 0 over supports 17 is referred to herein as “connected position”. The present invention can also use the end effector lock assembly to lock the trigger 130 in position after attaching the end effector 12 to the pin member 50.

More specifically, one embodiment of the end effector blocking assembly 160 includes a holding pin 162 that can be supported to move in the upper portion 134 of the trigger 130. As described above, the trigger tube 110 must first be distally advanced to a connected position in which the first trigger adapter 140 holds the retaining supports 17 of the end effector 12 in the receiving pockets 52 in the trunnion element 50. The surgeon pushes the trigger adapter 140 distally to the connected position by pulling the trigger hook and 130 from the initial position to the pistol grip 107. With the initial activation of the trigger 130, the holding pin 162 moves distally until the trigger tube 110 moves the first trigger adapter 140 to the connected position, in which the holding pin 162 is moved to the blocking cavity 164, formed in the housing element. When the holding pin 162 enters the blocking cavity 164, the pin 162 does not necessarily produce an audible “click” or other sound, in addition, the surgeon senses, by touch, that the end effector 12 is “latched” on the trunnion element 50. In addition, the surgeon cannot inadvertently continue activating the trigger 130 to start forming the brackets 32 in the end effector 12 without deliberately displacing the holding pin 162 from the blocking cavity 164. Similarly, if the surgeon releases the trigger 130 in the connected position ii, it is retained in such position the retaining pin 162, not allowing the trigger 130 to return to its original state, thereby disconnecting the end effector 12 of the trunnion member 50.

The present invention may further include a trigger lock button 137, which is pivotally attached to the handle assembly 100. In one form, the lock button of the trigger system 137 has a latch 138 formed at the distal end that is oriented to engage the trigger beam 114 when the trigger release button is in the first lock position. As represented in FIG. 1, a locking spring 139 is used to shift the lock button of the trigger system 137 to a first locking position. In various situations, the latch 138 is used to engage the launch yoke 114 at a point at which the position of the launch yoke 114 on the trunnion element 50 corresponds to the point at which the first launch adapter 140 is ready to start moving distally upward along the inclined surface of the latch 28 on the abutment 20. It should be understood that when the first start adapter 140 moves axially up the inclined surface of the fixation 28, the stop 20 moves along such a path that its part of the surface for forming the staples 22 remains essentially parallel noy upper side 36 of the staple cartridge 30.

After connecting the end effector 12 to the trunnion element 50, the process of forming the brackets begins, the first stage of which is pressing the lock button of the trigger system 137 to provide additional movement of the trigger beam 114 distally along the trunnion element 50 and ultimately pressing the stop 20 into the cassette with brackets 30. After pressing the lock button of the trigger system 137, the surgeon continues to activate the trigger 130 to the pistol grip 107, thereby feeding the first trigger adapter 140 upwardly hydrochloric surface for forming staples 29 for actuating the stop 20 in the contact forming staples 32 in the staple cartridge 30. The trigger lock button 137 protects the system from inadvertent formation of staples 32 until the surgeon is ready to begin the process. In this embodiment, the surgeon must press the lock button of the trigger system 137 to be able to further activate the trigger 130 to start the stapling process.

If desired, the surgical instrument 10 can be used solely as a tissue stitching device. However, the present invention may also include a tissue dissection system, substantially numbered 170. In at least one form, the tissue dissection system 170 comprises a scalpel element 172 that can be selectively advanced from an inactive position adjacent to the proximal end of the end effector 12 to the activated position by activating the trigger mechanism for advancing the scalpel 200. The element of the scalpel 172 is supported to move within the element of the journal 50 and is attached to the stem of the scalpel 180 and whether otherwise comes out of it. The scalpel element 172 can be produced, for example, from stainless steel grade 420 or 440 with a hardness of more than 38 HRC (Rockwell hardness, scale C) and can have an edge for dissecting tissue 176 formed at its distal end 174, and can also be made with the possibility of sliding passage through a groove in an abutment 20 and a centrally located groove 33 in a cassette with staples 30 for dissecting tissue clamped in the end effector 12. The scalpel 180 passes through the element of the axle 50 and has a proximal end part made with the possibility of transmission forces on the gear drive of the scalpel, functionally attached to the trigger for moving the scalpel 200. The trigger for moving the scalpel 200 is attached to the pivot pin 132 so that it can rotate or otherwise be activated without actuating the trigger 130. In accordance with the present invention the hinge pin 132 is also attached to the first gear of the scalpel drive 192, so that the activation of the trigger mechanism for advancing the scalpel 200 also leads to the rotation of the first pole audio scalpel actuator 192. Between the first drive gear scalpel handle 192 and housing 100 is attached a return spring of the trigger mechanism 202, biasing the trigger promotion scalpel 200 in the initial or non-activated, position.

The scalpel drive gear also includes a second scalpel drive gear 194, which is rotatably supported on the second gear spindle and is meshed with the first scalpel drive gear 192. The second scalpel drive gear 194 is engaged with the third scalpel drive gear 196, which is supported on third gear spindle. The fourth gear pinion of the scalpel 198 is also supported on the spindle of the third gear 195. The fourth pinion gear of the scalpel 198 is adapted to engage with the transmission of a drive force to a series of ring teeth or pinion rings at the proximal end of the scalpel shaft 180. Thus, this configuration allows the fourth pinion gear of the scalpel 198 axially push the scalpel stem 180 in the distal direction DD or proximal direction PD, allowing the trigger rod 180 to rotate around the longitudinal axis AA flax the fourth gear drive of the scalpel 198. Accordingly, the surgeon can axially advance the trigger rod 180 and ultimately the element of the scalpel 172 distally by pulling the trigger for moving the scalpel 200 to the pistol grip 107 of the handle assembly 100.

The present invention further includes a scalpel blocking system 210, preventing the scalpel element 172 from advancing until the trigger 130 is fully engaged. Thus, such an element prevents operation of the scalpel advancement system 170 until the braces are first applied or formed in the tissue. As shown in FIG. 1, various embodiments of a scalpel 210 lock system comprise a scalpel retainer 211 that is pivotally supported within a portion of the pistol grip 107 of the handle assembly 100. The scalpel retainer 211 has an activating end 212 that is engageable with a trigger 130 when the trigger 130 is in the fully activated position. In addition, at the other end, the scalpel retainer 211 has a holding hook 214 adapted to engage the retainer rod 216 on the first gear of the scalpel 192. The scalpel lock spring 218 is designed to bias the scalpel 211 into a locked position in which the holding hook 214 is engaged with the stem of the latch 216 and prevents activation of the trigger for advancing the scalpel 200 until the trigger 130 is moved to the fully activated position.

After stapling (forming) staples in the target tissue, the surgeon can press the release button of the trigger 167 to allow the trigger 130 to return to its original position under the biasing action of the torsion spring 135, which allows the stop 20 to move to the open position under the influence of the spring 21. When the tool is in the open position, the surgeon can remove the end effector 12 from the patient’s body, leaving an implantable cassette with brackets 30 and brackets 32 in it. In those applications in which the end effector was inserted into the patient’s body through the hole, the working channel, etc., the surgeon puts the emphasis 20 back into the closed position by activating the trigger 130 to allow the end effector 12 to be brought out through the hole or working channel. However, if the surgeon wants to dissect the target tissue after stapling, he activates the trigger to advance the scalpel 200 as described above to push the scalpel holder 172 through the target tissue to the end of the end effector. Then, the surgeon can release the trigger mechanism for advancing the scalpel 200, which allows the return spring of the trigger mechanism 202 through the trigger gear to return the scalpel holder 172 to its initial (inactive) position. After the scalpel holder 172 has returned to its initial position, the surgeon can open the jaws of the end effector 13 and 15 to release the implantable cassette 30 in the patient’s body and then remove the end effector 12 from the patient. Thus, such surgical instruments facilitate the use of small implantable cassettes with brackets that can be inserted through the working channels and openings of a relatively small size, while providing the surgeon with the possibility of applying staples without cutting tissue or, if necessary, also cutting tissue after stapling.

In various unique and innovative embodiments of the present invention, a compressible cassette with brackets is used that supports the brackets in a substantially stationary position to form contact with the stop. The emphasis is pushed into undeformed brackets, where, for example, the degree of staple formation achieved depends on how far the emphasis has been extended into the brackets. This configuration allows the surgeon to adjust the forming or starting force applied to the brackets and thereby change the final height of the brackets in the formed state. In other embodiments of the present invention, surgical stapling configurations may use staple ejector elements that can raise the staples to the stop. Such embodiments are described in more detail below.

Taking into account the embodiments described above, the magnitude of the trigger movement applied to the stop, made with the possibility of movement, does not necessarily depend on the degree of activation of the trigger. For example, if the surgeon wants to receive only partially formed staples, the trigger is only partially fed inward to the pistol grip 107. To achieve the formation of staples to a greater extent, the surgeon simply additionally presses the trigger, which leads to further advancement of the stop into forming contact with the brackets. As used herein, the term “forming contact” means that the surface for forming the staples or the recess for forming the staples is in contact with the ends of the legs of the staples and the legs are formed or bent to bring them into the formed position. The term “degree of staple formation” means to what extent the legs of the staples are bent, and ultimately refers to the height of the staple formation, as described above. Specialists in this field will also be clear that, since the emphasis 20 moves essentially parallel to the cassette with the brackets when starting movements are applied to it, the brackets are formed essentially simultaneously with obtaining essentially the same heights in the formed state.

In FIG. 2 and 3, an alternative end effector 12 ″ is shown, similar to the end effector 12 ′ described above, except for the following differences, which are made with the possibility of using the scalpel holder 172 ′. The scalpel holder 172 'is connected to or protrudes from the stem of the scalpel 180 and otherwise functions in the manner described above with respect to the scalpel holder 172. However, in this embodiment, the scalpel holder 172' has a length sufficient to extend through the entire length of the end effector 12 '' therefore, a separate distal scalpel element in the end effector 12 ″ is not used. The scalpel holder 172 'has an upper transverse element 173' and a lower transverse element 175 'formed on it. The upper transverse element 173 'is oriented so as to intersect with sliding the corresponding elongated groove 250 at the stop 20' ', and the lower transverse element 175' is oriented with the possibility of passing through the elongated groove 252 in the elongated channel 14 '' of the end effector 12 ''. An abutment groove (not shown) is also provided in the abutment 20 ″ so that when the scalpel holder 172 ’is brought to its final position with a thin end effector 12 ″, the upper transverse element 173’ falls out through the corresponding groove, allowing the abutment 20 'to move in the open position for uncoupling stitched and dissected tissue. Otherwise, the stop 20 ″ may be identical to the abutment 20 described above, and the elongated channel 14 ″ may otherwise be identical to the elongated channel 14 described above.

In these embodiments, the stop 20 ″ is biased toward the fully open position (FIG. 2) by a spring or other opening configuration (not shown). The stop 20 ″ is moved between the open position and the fully locked position by axially moving the trigger adapter 150 in the manner described above. After moving the trigger adapter 150 to the fully locked position (FIG. 3), the surgeon can advance the scalpel holder 172 ″ distally in the manner described above. If the surgeon needs to use the end effector as a gripping device for working with tissue, he can move the trigger adapter proximally to ensure that the stop 20 '' moves from the elongated channel 14 '', as shown by the dotted line in FIG. 4. In this embodiment, when moving the scalpel holder 172 ″ distally, the upper transverse element 173 ′ and the lower transverse element 175 ′ bring the stop 20 ″ and the elongated channel 14 ″ together to achieve the desired staple formation as the scalpel holder 172 ″ moves. distally through a 12 '' end effector. See FIG. 5. Thus, in this embodiment, the formation of staples is carried out simultaneously with the dissection of the tissue, but the staples themselves can be formed sequentially as the scalpel holder 172 ″ is pushed distally.

Unique and new features of various surgical cassettes with brackets and surgical instruments of the present invention allow staples in these cassettes to be placed in one or more linear or non-linear rows. Many of these staple lines can be made on each side of the elongated groove, which runs centrally inside the cassette with staples for receiving the cutting element into it. In one embodiment, for example, the brackets in one line can be substantially parallel to the staples in the adjacent staple line (s), but offset from them. In a further alternative embodiment, one or more staple lines may be non-linear. This means that the base of at least one bracket in the staple line can extend along an axis that substantially intersects the bases of other staples located in the same staple line. For example, the staple lines on each side of the elongated groove may have a zigzag appearance.

In accordance with the present invention, the cassette with brackets may comprise a cassette body and a plurality of brackets located inside the cassette body. During use, the cassette with brackets can be placed in the surgical field and placed on one side of the treated tissue. In addition, on the opposite side of the fabric, a staple-forming stop can be arranged. The emphasis can be located in the first jaw, and the cassette with brackets in the other jaw, while the first jaw and / or second jaw can be moved to each other. After positioning the cassette with brackets and stop relative to the fabric, the staples can be pushed out of the cassette body with staples so that the staples can pierce the fabric and come into contact with the staple-forming stop. After placing the brackets from the cassette case with brackets, it can be removed from the surgical field. The cassette with brackets or at least part of the cassette with brackets can be implanted together with brackets. For example, as described in more detail below, a cassette with brackets may comprise a cassette body that can be compressed, squeezed and / or deformed by a stop when the stop moves from an open position to a closed position. When squeezing, breaking and / or creasing the cartridge case, the emphasis may deform the brackets located inside the cartridge case. In an alternative embodiment, the jaw supporting the cassette with brackets can be moved to the stop in the closed position. In another case, the staples may be deformed while they are at least partially located inside the cassette body. In some cases, the brackets can not be pushed out of the cassette with brackets, while in other cases, the brackets can be pushed out of the cassette with brackets along with part of the cassette case.

As represented in FIG. 6A-6D, a compressible cassette with brackets, such as, for example, a cassette with brackets 1000, may include a compressible implantable cassette 1010 and, in addition, a plurality of staples 1020 located in a compressible cassette 1010, although in FIG. 6A-6D, only one bracket 1020 is provided. FIG. 6A shows a cassette with brackets 1000 supported by a support element of a cassette with brackets or a channel for a cassette with brackets 1030, the cassette with brackets 1000 being shown in an uncompressed state. In such an uncompressed position, the abutment 1040 may be in contact with tissue T or not in contact with it. During use, the emphasis 1040 can be moved from the open position into contact with the fabric T, as shown in FIG. 6B, thereby bringing the fabric T to a certain position relative to the cassette 1010 body. Although the emphasis 1040 can ensure that the fabric T is in close proximity to the fabric contacting surface 1019 of the cassette body with brackets 1010, as shown in FIG. 6B, the cassette case with brackets 1010 in this position may experience a slight compressive force or pressure (if applicable), and the brackets 1020 may remain in an unformed or inactive state. As represented in FIG. 6A and 6B, a cassette case with brackets 1010 may comprise one or more layers, and legs 1021 of brackets 1020 may extend upward through these layers. The cartridge case 1010 may comprise a first layer 1011, a second layer 1012, a third layer 1013, the second layer 1012 being located between the first layer 1011, the third layer 1013 and the fourth layer 1014, the third layer 1013 being located between the second layer 1012 and the fourth layer 1014 The bases 1022 of the brackets 1020 may be located inside the cavities 1015 in the fourth layer 1014, and the legs 1021 of the brackets may vertically extend from the bases 1022 and pass, for example, through the fourth layer 1014, the third layer 1013 and the second layer 1012. Each deformable leg 1021 may optionally containa tip, such as, for example, a sharp tip 1023, which, for example, can be located in the second layer 1012 when the cassette with brackets 1000 is in an uncompressed state. For example, the tips 1023 may not protrude and / or penetrate the first layer 1011, while the tips 1023 may not protrude through the tissue-contacting surface 1019 until the cassette with brackets 1000 is in an uncompressed state. The sharp tips 1023 may be located in the third layer 1013 and / or any other suitable layer when the cassette with brackets is in an uncompressed state. Alternatively, the bracket cassette body may have any suitable number of layers, such as, for example, less than four layers or more than four layers.

As described in more detail below, the first layer 1011 can optionally be formed from a reinforcing material and / or plastic material, such as, for example, polydioxanone (PDS) and / or polyglycolic acid (PGA), and the second layer 1012 can be formed from bioabsorbable foam and / or compressible hemostatic material, such as, for example, oxidized regenerated cellulose (ORC). One or more of the first layer 1011, the second layer 1012, the third layer 1013, and the fourth layer 1014 can optionally hold the brackets 1020 inside the cassette body with brackets 1010 and, in addition, provide the brackets 1020 in alignment with each other. The third layer 1013 may be formed of a reinforcing material or a completely crumple-free or inelastic material, which may be configured to hold the legs 1021 of the brackets 1020 in a certain position relative to each other. Moreover, the second layer 1012 and the fourth layer 1014, which are located on opposite sides of the third layer 1013, can stabilize or reduce the movement of the staples 1020, even if the second layer 1012 and the fourth layer 1014 can be formed from compressible foam or elastic material. The ends 1023 of the legs 1021 of the brackets can be at least partially immersed in the first layer 1011. For example, the first layer 1011 and the third layer 1013 can be made to jointly and firmly hold the legs 1021 of the brackets in a certain position. Each of the first layer 1011 and the third layer 1013 may be formed from bioabsorbable plastic sheets, such as, for example, polyglycolic acid (PGA), commercially available under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglexaprone 25 (PGCL), commercially available under the trade name Monocryl, polycaprolactone (PCL) and / or a mixture of PGA, PLA, PDS, PHA, PGCL and / or PCL, and each of the second layer 1012 and the fourth layer 1014 may be formed from at least one hemostatic material or agent.

Although the first layer 1011 may be compressible, the second layer 1012 may be substantially more compressible than the first layer 1011. For example, the second layer 1012 may be, for example, approximately two times more compressible, approximately three times more compressible, approximately four times more compressible, about five times more compressible and / or about ten times more compressible than the first layer 1011. In other words, for a given force, the second layer 1012 can be compressed about two times, about three times, about four A few times, about five times and / or about ten times stronger than the first layer 1011. The second layer 1012 can be, for example, about two to ten times more compressible than the first layer 1011. The second layer 1012 can contain many formed there are air voids, and the number and / or size of air voids in the second layer 1012 can be controlled to provide the necessary compressibility of the second layer 1012. Similar to the above, although the third layer 1013 can be compressible, the fourth layer 1014 can be essentially more wettable than the third layer 1013. For example, the fourth layer 1014 can be, for example, about two times more compressible, about three times more compressible, about four times more compressible, about five times more compressible and / or about ten times more compressible than the third layer 1013. In other words, for a given force, the fourth layer 1014 can be compressed approximately two times, approximately three times, approximately four times, approximately five times and / or approximately ten times stronger, h m is the third layer 1013. The fourth layer 1014 may be between layers whose compressibility is approximately two to ten times greater than, for example, the compressibility of the third layer 1013. The fourth layer 1014 may contain many air voids formed therein, the number and / or dimensions air voids in the fourth layer 1014 can be controlled to provide the necessary compressibility of the fourth layer 1014. In various situations, the compressibility of the cassette body, or the layer of the cassette body, can be described as a compression ratio, i.e. the distance that the layer compresses when a given force is applied. For example, a layer with a higher compression ratio will compress over a greater distance when a predetermined compressive force is applied to it, compared to a layer with a lower compression ratio. This means that the second layer 1012 can have a higher compression ratio than the first layer 1011, and the fourth layer 1014 can likewise have a higher compression ratio than the third layer 1013. The second layer 1012 and the fourth layer 1014 can be formed from one and the same material and have the same compression ratio. The second layer 1012 and the fourth layer 1014 may be formed from materials having different compression ratios. The first layer 1011 and the third layer 1013 can likewise be formed from the same material and can have the same compression ratio. The first layer 1011 and the third layer 1013 may be formed from materials having different compression ratios.

When the abutment 1040 moves to the closed position, the abutment 1040 can contact the fabric T and apply a compressive force to the fabric T and the cassette with staples 1000, as shown in FIG. 6C. In such circumstances, the stop 1040 may push the upper surface, or the fabric contacting surface 1019, of the cassette 1010 down to the support element of the cassette with brackets 1030. The support element of the cassette with brackets 1030 may include a support surface for the cartridge 1031, which can be configured to support cassettes with brackets 1000 so that the cassette with brackets 1000 is compressed between the supporting surface for the cassette 1031 and the contact surface 1041 of the stop 1040. Due to the pressure applied by the stop 1040, the housing the cassettes 1010 can be compressed, and the abutment 1040 can come into contact with the brackets 1020. More specifically, squeezing the cassette 1010 and moving the tissue contact surface 1019 down can cause the tips 1023 of the staples 10 to pierce the first layer 1011 of the cassette 1010, to pierce the fabric T and enter the forming recesses 1042 in the abutment 1040. When the cassette 1010 is further compressed under the influence of the abutment 1040, the tips 1023 can contact the walls forming the forming recesses 1042, and thus, the legs 1021 can, for example, deform bend or bend inward as shown in FIG. 6C. After deformation of the legs 1021 staples, as shown in FIG. 6C, the bases 1022 of the brackets 1020 may be in contact with or supported by the cartridge support member with brackets 1030. As described in more detail below, the support element of the cassette with brackets 1030 may optionally contain many support elements, such as, for example, support grooves, grooves or grooves 1032, which can be configured to support the brackets 1020 or at least the base 1022 of the brackets 1020 in the process of deformation of the brackets 1020. As shown in FIG. 6C, the cavities 1015 in the fourth layer 1014 may collapse when a compressive force is applied to the cassette body with brackets 1010. In addition to the cavities 1015, the cassette body with brackets 1010 may additionally contain one or more voids, such as, for example, voids 1016, which may or may not contain a part of the bracket located in them and which can be configured to crush the cassette 1010. Cavities 1015 and / or voids 1016 can be crushed so that the walls forming the cavities deflect downward and contact contacted with the supporting surface for the cartridge 1031 and / or in contact with the layer of the cartridge body 1010 located under the cavities and / or voids.

From a comparison of FIG. 6B and FIG. 6C, it is apparent that the second layer 1012 and the fourth layer 1014 were essentially compressed by applying a compressive pressure with an abutment 1040. It can also be noted that the first layer 1011 and the third layer 1013 were also compressed. When the emphasis 1040 is moved to the closed position, the emphasis 1040 can continue to compress the cassette 1010, pushing the fabric contacting surface 1019 down to the cassette support element 1030. When the cassette 101 101 is further compressed, the emphasis 1040 can deform the brackets 1020 to their final shape, as presented in FIG. 6D. As represented in FIG. 6D, the legs 1021 of each bracket 1020 can be deformed downward to the base 1022 of each bracket 1020 to grip at least a portion of fabric T, the first layer 1011, the second layer 1012, the third layer 1013 and the fourth layer 1014 between the deformable legs 1021 and the base 1022. Of comparison FIG. 6C and 6D, it is also apparent that the second layer 1012 and the fourth layer 1014 were substantially further compressed by applying compressive pressure by the abutment 1040. When comparing FIG. 6C and 6D, it can also be noted that the first layer 1011 and the third layer 1013 were also further compressed. After the staples 1020 are completely or at least sufficiently formed, the abutment 1040 can be lifted from the fabric T, and the cassette support element with staples 1030 can be moved and / or detached from the cassette with staples 1000. As shown in FIG. 6D, as a result of the above, the cassette 1010 can be implanted with brackets 1020. In various situations, the implanted cassette 1010 can support tissue along the line of staples. In some situations, a hemostatic agent and / or any other suitable therapeutic drug contained within the implanted cassette 1010 may affect the tissue for some time. A hemostatic agent, as described above, can reduce bleeding of stitched and / or dissected tissue, while a binding agent or tissue adhesive can provide tissue strength for some time. The implanted cassette 1010 body may be formed from materials such as, for example, ORC (oxidized regenerated cellulose), an extracellular protein matrix such as collagen, polyglycolic acid (PGA), commercially available under the trade name Vicryl, polylactic acid (PLA or PLLA ), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglexaprone 25 (PGCL), commercially available under the trade name Monocryl, polycaprolactone (PCL) and / or a mixture of PGA, PLA, PDS, PHA, PGCL and / or PCL. In certain situations, the cartridge case 1010 may contain an antibiotic and / or antimicrobial material, such as, for example, colloidal silver and / or triclosan, which can reduce the risk of infection in the surgical field.

The layers of the cassette 1010 can be connected to each other. The second layer 1012 can be adhesively bonded to the first layer 1011, the third layer 1013 can be adhesively bonded to the second layer 1012, and the fourth layer 1014 can be adhesively bonded to the third layer 1013 using at least one adhesive, such as, for example, fibrin and / or protein hydrogel. The layers of the cassette 1010 can be connected to each other due to interlocking mechanical elements. For example, each of the first layer 1011 and the second layer 1012 may contain corresponding interlocking elements, such as, for example, a groove attachment and / or a dovetail joint. Each of the second layer 1012 and the third layer 1013 may similarly contain corresponding interconnected elements, while each of the third layer 1013 and the fourth layer 1014 may contain corresponding interconnected elements. Although not shown, the cassette with brackets 1000 may contain one or more rivets that can pass, for example, through one or more layers of the cassette 1010. For example, each rivet may contain a first end, or a head adjacent to the first layer 1011, and a second head located adjacent to the fourth layer 1014, which can either be connected or formed at the second end of the rivet. Due to the compressibility of the cartridge case 1010, rivets can compress the cartridge case 1010 in such a way that, for example, the rivet heads are lowered relative to the fabric contacting surface 1019 and / or the bottom surface 1018 of the cartridge case 1010. For example, rivets can be formed from bioabsorbable material such as for example, polyglycolic acid sold under the trade name Vicryl (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglexaprone 25 (PGCL) sold under the trademark Monocr yl, polycaprolactone (PCL), and / or a composite material consisting, for example, of PGA, PLA, PDS, PHA, PGCL and / or PCL. The layers of the cassette 1010 can only be connected to each other by means of the brackets 1020 contained therein. For example, friction contact between the legs of the staples 1021 and the cassette 1010, for example, can hold the layers of the cassette 1010 together and after the brackets are formed , the layers are inside the brackets 1020. At least part of the legs 1021 brackets may contain a rough surface or a rough coating, which increases the friction force between the brackets 1020 and the cassette 1010.

As described above, the surgical instrument may comprise a first jaw including a cassette support member with brackets 1030 and a second jaw including a stop 1040. As described in more detail below, a cassette with brackets 1000 may optionally contain one or more holding elements that can be formed with the possibility of engagement with the supporting element of the cartridge with brackets 1030 and, thus, can provide a holding detachable connection of the cartridge with brackets 1000 with the supporting element of the cartridge with brackets 1030. A cartridge with brackets 1000 can but adhesive to attach to the support element of the cassette with brackets 1030 using at least one adhesive, such as, for example, fibrin and / or protein hydrogel. During application in at least one situation, especially in laparoscopic and / or endoscopic surgery, the second jaw can be moved to the closed position opposite the first jaw, for example, so that the first and second jaws can be inserted through the trocar into the surgical field. For example, the trocar may form an internal opening or cannula with a diameter of approximately 5 mm, through which the first and second branches can be inserted. The second jaw can be moved to a partially closed position, which is intermediate between the open position and the closed position, which allows the first and second jaws to be inserted through the trocar without deforming the brackets 1020 contained in the cassette body with brackets 1010. For example, the stop 1040 may not exert compressive force to the cassette case with brackets 1010 when the second jaw is in its partially closed intermediate position, while the stop 1040 can compress the cassette case with brackets 1010 when the second jaw is in its h Stična closed intermediate position. Even if the emphasis 1040 can compress the cartridge case with brackets 1010 when it is in such an intermediate position, the emphasis 1040 may not sufficiently compress the cartridge case with brackets 1010 so that the emphasis 1040 can come into contact with the brackets 1020, and / or in such a way so that the brackets 1020 deform under the influence of the stop 1040. After the first and second branches are inserted through the trocar into the surgical field, the second branch can be opened again, and the stop 1040 and the cassette with brackets 1000 can be positioned in the necessary position relative to the fabric, as described above.

As represented in FIG. 7A-7D, the end effector of a surgical stapling instrument may include an implantable cassette with brackets 1100 located between the abutment 1140 and the supporting element of the cassette with brackets 1130. Like the abutment 1140, the abutment 1140 may include tissue contacting surface 1141, and the cassette with brackets 1100 may include contact with fabric surface 1119, and the supporting element of the cassette with brackets 1130 may contain a supporting surface 1131, which can be configured to support the cassette with brackets 1100. As shown in FIG . 7A, the abutment 1140 can be used to position the fabric T adjacent to the fabric contact surface 1119 of the cassette with brackets 1100 without deforming the cassette with the brackets 1100, and when the abutment 1140 is in this position, the fabric contacting surface 1141 can be spaced 1101a from the support the surface for the cassette with brackets 1131, and the contact surface with the fabric 1119 may be located at a distance 1102a from the supporting surface for the cassette with brackets 1131. After that, when the emphasis 1140 is moved to the supporting element of the cassette with brackets 1130, as presented in FIG. 7B, the abutment 1140 may push the upper surface, or the fabric contacting surface 1119, the cassettes with the brackets 1100 down, and squeeze the first layer 1111 and the second layer 1112 of the cassette 1110. When the layers 1111 and 1112 are compressed, as shown in FIG. 7B, the second layer 1112 may be destroyed, and the legs 1121 of the brackets 1120 may pierce the first layer 1111 and enter tissue T. For example, the brackets 1120 may be at least partially located inside the brackets, or voids, 1115 in the second layer 1112, and when the second layer 1112 is compressed, the slots for the brackets 1115 are compressed and, as a result, allow the second layer 1112 to wrinkle around the brackets 1120. The second layer 1112 may contain parts of the cover 1116 that can be distributed over the slots for the brackets 1115 and cover at least partially cover the slots for brackets 1115. In FIG. 7B shows parts of the coating 1116 that, when broken, fall down into the slots for the brackets 1115. The second layer 1112 may contain one or more weakened parts that can facilitate the crushing of the second layer 1112. Such weakened parts may optionally contain, for example, notches, perforations and / or thin in cross section parts that can provide controlled creasing of the cassette 1110. The first layer 1111 may contain one or more weakened parts that facilitate the passage of the legs 1121 staples through the first layer 1111. That ix weakened portion may optionally contain, for example, notches, perforations and / or thinner cross-sectional parts which can be aligned, or at least substantially aligned with the legs 1121 of staples.

When the abutment 1140 is in a partially closed, inactive position, as shown in FIG. 7A, the abutment 1140 may be located at a distance 1101a from the bearing surface for the cartridge 1131 so that a gap is formed between them. This gap can be filled with a cassette with brackets 1100 with a height of 1102a and body tissues T. As the stop 1140 moves down to compress the cassette 1100, as shown in FIG. 7B, the distance between the tissue-contacting surface 1141 and the supporting surface for the cartridge 1131 may be formed by a distance 1101b that is shorter than the distance 1101a. In various situations, the gap between the fabric contacting surface 1141 of the abutment 1140 and the supporting surface for the cartridge 1131 formed by the distance 1101b may be greater than the initial height of the undeformed cartridge with brackets 1102a. When the stop 1140 is moved closer to the supporting surface for the cassette 1131, as shown in FIG. 7C, the second layer 1112 may continue to wrinkle, and the distance between the bracket legs 1121 and the forming recesses 1142 may decrease. Similarly, the distance between the tissue-contacting surface 1141 and the supporting surface for the cassette 1131 can be reduced to a distance 1101c that can be greater, less than, or equal to the original height of the undeformed cassette 1102a. As represented in FIG. 7D, the abutment 1140 can be moved to a final, activated position in which the brackets 1120 are fully formed or at least formed to the desired height. In this position, the fabric contacting surface 1141 of the abutment 1140 may be at a distance 1101d from the supporting surface for the cartridge 1131, the distance 1101d being less than the original height of the undeformed cartridge 1102a. As represented in FIG. 7D, the bracket slots 1115 may be completely or at least substantially wrinkled, and the brackets 1120 may be completely or at least substantially surrounded by a crumpled second layer 1112. In various situations, thereafter, the emphasis 1140 may be moved away from the cassette with the brackets 1100. After the stop 1140 is detached from the cassette with brackets 1100, the cassette 1110 can at least partially experience reverse expansion in different sections, that is, for example, in the sections between adjacent brackets 1120. The compressed cassette 1110 may not regain its shape due to the elastic guests. The formed brackets 1120, as well as the cassette body 1110 located between adjacent brackets 1120, can exert pressure or exert a compressive force on tissue T, which can provide various therapeutic effects.

As described above with reference to FIG. 7A, each bracket 1120 may comprise staple legs 1121 protruding from it. Although the staples 1120 shown in the figures contain two staple legs 1121, various staples can be used that can contain one staple leg or, in an alternative embodiment, more than two staple legs, such as three staple legs or four staple legs. As represented in FIG. 7A, each bracket leg 1121 can be placed in the second layer 1112 of the cartridge case 1110 so as to secure the brackets 1120 inside the second layer 1112. The brackets 1120 can be inserted into the bracket slots 1115 in the cartridge case 1110 so that the ends 1123 of the bracket legs 1121 enter the slots 1115 earlier than the bases 1122. After inserting the tips 1123 into the slots 1115, the tips 1123 can be pressed into parts of the cover 1116 and the second layer 1112 can be cut. The brackets 1120 can be placed to a substantial depth inside the second layer 1112 so that the brackets 1120 do not move or along at least essentially WUs did not move relative to the second layer 1112. The brackets 1120 can be immersed inside the second layer 1112 to a sufficient depth so that the bases 1122 are located inside the nests for the brackets 1115 or immersed inside these nests. Alternatively, the bases 1122 may not be located inside the second layer 1112 or may not be immersed inside it. In accordance with FIG. 7A, the bases 1122 may extend beneath the lower surface 1118 of the cartridge case 1110. The bases 1122 may lie on the supporting surface for the cartridge 1130 or may be located directly opposite it. The supporting surface for the cartridge 1130 may contain supporting elements protruding from it and / or formed therein, for example, the bases 1122 of the brackets 1120 can be located inside and supported by one or more supporting grooves, grooves or grooves 1132, for example, on the supporting surface of the cartridge 1130 as described in more detail below.

As represented in FIG. 8 and 9, a cassette with brackets, such as, for example, a cassette with brackets 1200, may comprise a compressible implantable cassette 1210 containing an outer layer 1211 and an inner layer 1212. Similar to the above, the cassette with brackets 1200 may contain a plurality of brackets 1220 located inside cassettes 1210. Each bracket 1220 may optionally include a base 1222 and one or more protruding legs 1221 of brackets. For example, the legs 1221 of the bracket can be inserted into the inner layer 1212 and immersed in it to such a depth that the bases 1222 of the brackets 1220, for example, abut and / or are adjacent to the lower surface 1218 of the inner layer 1212. As shown in FIG. 8 and 9, the inner layer 1212 does not contain any bracket slots adapted to receive part of the brackets 1220, while alternatively the inner layer 1212 may include such bracket slots. In addition to the above, the inner layer 1212 can be formed from a compressible material, such as bioabsorbable foam and / or oxidized regenerated cellulose (ORC), and it can be configured to crush the cassette 1210 when subjected to a compressive load. The inner layer 1212 may be formed from lyophilized foam containing, for example, polylactic acid (PLA) and / or polyglycolic acid (PGA). ORC is commercially available under the Surgicel brand name and may contain rare weave fabrics (such as surgical tampons), individual fibers (like cotton balls) and / or foam. The inner layer 1212 may be formed from a material including drugs, such as, for example, lyophilized thrombin and / or fibrin, which are inside the layer and / or applied as a coating and can, for example, be activated by the action of water and / or biological fluids in the patient’s body. For example, lyophilized thrombin and / or fibrin can be applied, for example, to a matrix of Vicryl (PGA) material. However, in certain situations, activated drugs may be inadvertently activated, for example, by inserting a cassette with brackets 1200 into the surgical field in a patient. As represented in FIG. 8 and 9, the outer layer 1211 may be formed of a waterproof or at least substantially waterproof material such that liquids cannot come into contact or at least substantially cannot come into contact with the inner layer 1212 until the cassette body is compressed 1210 and penetration of the legs of the staples through the outer layer 1211 and / or until the dissection of the outer layer 1211 in one way or another. The outer layer 1211 may be formed from a reinforcing material and / or plastic material, such as, for example, polydioxanone (PDS) and / or polyglycolic acid (PGA). The outer layer 1211 may comprise a shell surrounding the inner layer 1212 and the brackets 1220. In particular, the brackets 1220 can be inserted into the inner layer 1212, and the outer layer 1211 can be wrapped around a subunit containing the inner layer 1212 and brackets 1220, and then sealed.

As described herein, staples from the cassette with brackets are completely formed by the stop when it is moved to the closed position. Alternatively, as presented in FIG. 10-13, the brackets of the cassette with brackets, such as, for example, the cassette with brackets 4100, can be deformed by the stop when moving the stop to the closed position, and in addition, the bracket ejector system, which moves the brackets to the closed stop. The cassette with brackets 4100 may include a compressible cassette 4110, which can be formed, for example, of foam, as well as a plurality of brackets 4120 at least partially located inside the compressible cassette 4110. The bracket ejector system may include a holder 4160, a plurality of ejectors 4162 located inside the holder of the ejectors 4160, and a tray for the cartridge with brackets 4180, which can be configured to hold the ejectors of the brackets 4162 in the holder of the ejectors 4160. For example, you alkivateli staples 4162 may be located within one or more slots 4163 in holder 4160 ejectors, wherein the side walls of the grooves 4163 can contribute toward staple pushers 4162 upwardly toward the anvil. The brackets 4120 can be supported inside the grooves 4163 by means of the ejector brackets 4162, the brackets 4120 can be completely located inside the grooves 4163 when the brackets 4120 and the ejector brackets 4162 are in their inactive positions. Alternatively, at least a portion of the brackets 4120 may protrude upward through the open ends 4161 of the grooves 4163 when the brackets 4120 and the ejectors of the brackets 4162 are in their inactive positions. For example, as predominantly represented in FIG. 11, the bases of the brackets 4120 can be located inside the holder of the ejectors 4160, and the ends of the brackets 4120 can be placed inside the compressible housing of the cartridge 4110. About one third of the length of the brackets 4120 can be located inside the holder of the ejectors 4160, and approximately two-thirds of the length of the brackets 4120 can be located inside the cartridge case 4110. As represented in FIG. 10A, the cassette with brackets 4100 may further comprise a waterproof casing or membrane 4111 that surrounds, for example, the cassette 4110 and the ejector holder 4160.

During use, the cassette with brackets 4100 can be located, for example, inside the channel for the cassette with brackets, and the emphasis can be moved to the cassette with brackets 4100 in the closed position. The emphasis may be in contact with the compressible housing of the cassette 4110 and compress it when the emphasis is moved to its closed position. The emphasis may not come into contact with the brackets 4120 when the emphasis is in its closed position. The stop can contact the legs of the staples 4120 and at least partially deform the brackets 4120 when the stop is moved to its closed position. In any case, the cassette with brackets 4100 may additionally contain one or more slides 4170, which can be advanced longitudinally inside the cassette with brackets 4100 so that the slide 4170 can sequentially engage the ejectors of the brackets 4162 and move the ejectors of the brackets 4162 and staples 4120 to the stop. The slide 4170 can slide between the cassette tray with brackets 4180 and the ejectors of the brackets 4162. If closing the stop starts the process of forming brackets 4120, moving the brackets 4120 up to the stop can complete the process of forming and deform the brackets 4120 to their fully formed state or at least to the necessary heights. If closing the stop does not deform the brackets 4120, moving the brackets 4120 up to the stop can start and complete the formation process and deform the brackets 4120 to their fully formed state or at least to the required height. The slide 4170 can be advanced from the proximal end of the cassette with brackets 4100 to the distal end of the cassette with brackets 4100 so that the brackets 4120 located at the proximal end of the cassette with brackets 4100 are fully formed until the brackets 4120 located at the distal end of the cassette with brackets 4100 are fully formed As presented in FIG. 12, the slide 4170 may have at least one angled or inclined surface 4711 that can slide under the ejectors of the brackets 4162 and raise the ejectors of the brackets 4162, as shown in FIG. 13.

In addition to the above, staples 4120 can be formed to grip at least a portion of tissue T and at least a portion of the compressible cassette body 4110 with staples 4100. After staples 4120 are formed, the emphasis and channel for the cassette with staples 4130 of the surgical stapler can be moved away from the implanted cassettes with brackets 4100. In various situations, the cassette tray 4180 can be fixedly engaged with the cassette channel with brackets 4130, and thus, the cassette tray 4180 can be separated from the compressible housing to ssety channel 4110 when pulling the cassette 4130 by the staple cartridge housing implanted 4110. As also shown in FIG. 10, the cassette tray 4180 may include opposing side walls 4181 between which the cassette body 4110 is removably disposed. For example, the compressible cassette body 4110 can be compressed between the side walls 4181 so that the cassette body 4110 can be removably held between them and releasably detached from cassette tray 4180 while pushing cassette tray 4180. For example, ejector holder 4160 can be connected to cassette tray 4180 so that ejector holder 4160, ejector 4162 and / or slide 4170 can Stavan in the pan cassette 4180 when removing the tray cassette 4180 of the surgical field. Ejector 4162 can be pushed out of ejector holder 4160 and left inside the operative field. For example, 4162 ejectors can be formed from a bioabsorbable material such as polyglycolic acid (PGA) sold under the trademark Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polyglexaprone 25 (PGCL) sold under the brand name Monocryl, polycaprolactone (PCL) and / or a composite material consisting, for example, of PGA, PLA, PDS, PHA, PGCL and / or PCL. The ejector brackets 4162 can be attached to the brackets 4120 so that the ejector 4162 are placed with the brackets 4120. For example, each ejector 4162 may include a groove configured to receive, for example, the bases of the brackets 4120, and the grooves can be made to receive the bases of the brackets with interference and / or snap fit.

In addition to the above, the ejector holder 4160 and / or the slide 4170 can be ejected from the tray for the cartridge 4180. For example, the slide 4170 can slide between the cartridge tray 4180 and the ejector holder 4160 so that the slide 4170 can move the ejector holder 4160 up out tray tray 4180, when the slide 4170 is advanced to push the ejectors staples 4162 and staples 4120 up. For example, the ejector holder 4160 and / or the slide 4170 can be formed from a bioabsorbable material such as, for example, polyglycolic acid (PGA) sold under the trademark Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA) ), polyglecaprone 25 (PGCL) sold under the brand name Monocryl, polycaprolactone (PCL) and / or a mixture consisting of, for example, PGA, PLA, PDS, PHA, PGCL and / or PCL. The slide 4170 may be integral and / or attached to a push rod or cutting element that pushes the slide 4170 through the cassette 4100. In such cases, the slide 4170 may not be ejected from the tray 4180 and may be left in the surgical stapling instrument, whereas in other cases, in which the slide 4170 is not attached to the push rod, the slide 4170 can be left in the surgical field. In any case, in addition to the above, the compressibility of the cassette 4110 allows the use of wider cassettes with brackets inside the end effector of the surgical stapling instrument, since the cassette 4110 can compress when the stop of the stapling instrument is closed. As a result of at least partial deformation of the staples, when closing the stop, longer staples can be used, such as, for example, staples approximately 4.6 mm (0.18 in) high, with approximately 3.0 mm (0.12 in) high the brackets may be located within the compressible layer 4110, the compressible layer 4110 in the uncompressed state may have a height of, for example, approximately 3.6 mm (0.14 inches).

As described herein, a cassette with brackets may contain many brackets. Optionally, such brackets may be formed from a metal wire deformed into a substantially U-shape configuration with two legs of the bracket. Alternatives are possible in which the brackets may have different configurations, such as two or more wires connected together containing three or more legs of the bracket. The wire or wires used to form the brackets may have a circular or at least substantially circular cross section. The staple wire may have any other suitable cross section, such as, for example, square and / or rectangular cross sections. Staples can be formed from plastic wire. Staples can be formed from metal wire coated with plastic. In accordance with the present invention, the cartridge may comprise a fastener of any suitable type in addition to or instead of staples. For example, such a fastener may comprise pivoting links that can be folded upon engagement with a stop. Two-part fasteners may be used. For example, the cassette with brackets may comprise a plurality of first parts of the fastener, and the stop may comprise a plurality of second parts of the fastener that connect to the first parts of the fastener when the stop is pressed against the cassette with brackets. As described above, the slide or ejector can advance inside the cassette with brackets to complete the process of forming the brackets. The slide or ejector can move inside the stop to move one or more forming elements down to engage with the opposite cassette with brackets or fasteners located therein.

As described herein, a cassette with brackets may contain four rows of brackets located therein. Four rows of staples can be located in two inner rows of staples and two outer rows of staples. For example, the inner row of brackets and the outer row of brackets can be located on the first side of the groove for the cutting element, or the scalpel, inside the cassette with brackets, and similarly, the inner row of brackets and the outer row of brackets can be located on the second side of the groove for the cutting element, or scalpel. The cassette with brackets may not contain a groove for the cutting element; however, instead of the groove for the cassette with brackets, such a cassette with brackets may contain a special part made with the possibility of dissection by the cutting element. The inner row of staples can be located inside the cassette with staples so that they are located at an equal or at least substantially equal distance from the groove for the cutting element. Similarly, the outer rows of staples can be located inside the cassette with staples so that they are located at an equal or at least substantially equal distance from the groove for the cutting element. In accordance with the present invention, the cassette with brackets may contain more or less than four rows of brackets located inside it. A cassette with brackets can contain six rows of brackets. For example, a cassette with brackets may contain three rows of brackets on the first side of the groove for the cutting element and three rows of brackets on the second side of the groove for the cutting element. A staple cartridge may contain an odd number of rows of staples. For example, a cassette with brackets may contain two rows of brackets on the first side of the groove for the cutting element and three rows of brackets on the second side of the groove for the cutting element. Rows of staples may contain staples of the same or at least substantially the same height in an unformed state. Alternatively, one or more rows of staples may comprise staples with a height in an unformed state other than the height of the other staples. For example, the brackets on the first side of the groove for the cutting element may have a first height in the unformed state, and the brackets on the second side of the groove for the cutting element may have a second height in the unformed state, which, for example, differs from the first height.

Optionally, as described above, the cassette with the brackets may comprise a cassette housing containing a plurality of bracket sockets formed therein. The cassette body may comprise a platform and an upper surface of the platform, wherein each bracket socket may form an opening in the surface of the platform. As described above, the staples can also be located inside each staple slot so that the staples are stored inside the cassette body until they are pushed out. Before being pushed out of the cartridge case, the brackets may be contained within the cartridge case so that the brackets do not protrude above the platform surface. Since in such cases, the staples are located below the surface of the platform, the possibility of damage and / or premature contact with the target tissue can be reduced. In various circumstances, the brackets can be moved between an inactive position in which they do not protrude from the cassette body and an activated position in which they protrude from the cassette body and can come in contact with a stop located opposite the cassette with brackets. The emphasis and / or forming recesses formed inside the emphasis can be located at a predetermined distance from the platform surface so that when the brackets are fed from the cassette body, the brackets deform, acquiring a predetermined height in the formed state. In some situations, the thickness of the fabric trapped between the stop and the cassette with the brackets can be changed, and therefore, thicker fabric can be grasped inside certain brackets, and thinner fabric can be grasped inside certain other brackets. In any case, the pressure or clamping force applied to the fabric by the brackets may, for example, differ for different brackets or may vary between brackets at one end of a row of brackets and at the other end of a row of brackets. In certain situations, the gap between the stop and the platform of the cassette with brackets can be controlled so that the brackets overlap with the creation of a certain minimum clamping force inside each bracket. However, in some such situations, there may still be significant variability in the clamping force within different staples. Surgical stapling instruments are described in US Pat. No. 7,380,696, issued June 3, 2008, the entire contents of which are incorporated herein by reference. An illustrative multi-stroke handle for a surgical stapling and dissecting instrument is described in more detail in the simultaneously filed and patent application of the United States, entitled “SURGICAL STAPLING INSTRUMENT WITH THE MULTI-START POSITION INDICATOR AND THE MECHANISM 37.0, which contains 37 V this document by reference. Other applications of the present invention may include a single-cycle start, as described in the simultaneously filed and owned by the same authors US patent application entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE INDEPENDENT CLOSING AND STARTING SYSTEMS", No. 32 of which 10/44 fully incorporated herein by reference.

As described herein, a staple cartridge may include means for compensating for the thickness of the tissue trapped inside the staples installed from the staple cartridge. As represented in FIG. 14, a cassette with brackets, for example, such as a cassette with brackets 10000, may comprise a rigid first part, for example a support part 10010, and a compressible second part, for example, a fabric thickness compensator 10020. As is mainly shown in FIG. 16, the support portion 10010 may comprise a cassette body, an upper surface of the platform 10011 and a plurality of bracket sockets 10012, wherein, as described above, each socket for the bracket 10012 may form an opening in the surface of the platform 10011. The bracket 10030, for example, can be removably located in each socket for the bracket 10012. For example, each bracket 10030 may include a base 10031 and one or more legs 10032 extending from the base 10031. Before placing the brackets 10030, which is also described in more detail below, the bases 10031 of the brackets 10030 may be supported by staple loops located inside the supporting part 10010, and at the same time the legs 10032 of the staples 10030 can be at least partially contained inside the staple sockets 10012. The staples 10030 can be moved between the inactive position and the activated position, as a result of which the legs 10032 are moved through the fabric thickness compensator 10020, penetrate through the upper surface of the fabric thickness compensator 10020, penetrate fabric T and come into contact with an emphasis opposite the cartridge with brackets 10000. When legs 10032 are deformed against the emphasis, these knife 10032 and 10030 may each capture bracket portion compensator tissue thickness and 10020 part fabric T inside each bracket 10030 and attach to tissue compression force. In addition to the above, the legs 10032 of each bracket 10030 can be deformed downward to the base of the bracket 10031 to form a grip area of the bracket 10039 into which fabric T and tissue thickness compensator 10020 can be gripped. In various situations, the grip area of the bracket 10039 can be formed between the inner surfaces of the deformed legs 10032 and the inner surface of the base 10031. The size of the grip area of the bracket may depend on several factors, for example, on the length of the legs, the diameter of the legs, the width of the base and / or the degree of deformation ation legs.

Previously, the surgeon often needed to choose staples that fit the height of the stitched fabric. For example, the surgeon could choose long staples for use on thick tissue and short staples for use on thin tissue. However, in some situations, the thickness of the stitched fabric was uneven, and therefore, some staples might not achieve the desired activated configuration. For example, in FIG. 48 shows the long staple used when working with a thin cloth. As shown in FIG. 49, when a tissue thickness compensator, such as a tissue thickness compensator 10020, is used when operating, for example with thin tissue, for example, a desired activated configuration can be imparted to the large bracket.

Due to its compressibility, a tissue thickness compensator can compensate for the thickness of the tissue trapped inside each staple. More specifically, as shown in FIG. 43 and 44, a tissue thickness compensator, for example a fabric thickness compensator 10020, may use a larger and / or smaller portion of the grip area 10039 of each bracket 10030 depending on the thickness and / or type of fabric located within the grip region of the bracket 10039. For example, if the inside of the bracket 10030, a thinner fabric T is captured, a tissue thickness compensator 10020 can occupy a larger part of the grip area of the bracket 10039 than in a situation where a thicker fabric T is caught inside the bracket 10030. Accordingly, if a thicker fabric T is caught inside the bracket 10030, the tissue thickness compensator 10020 may occupy a smaller portion of the grip area of the staple 10039 than in a situation where a thinner fabric T is trapped inside the staple 10030. Thus, the tissue thickness compensator can compensate for thinner and / or thicker fabric and allow compressive pressure to be applied to the fabric independently or at least substantially independently of the thickness of the tissue trapped inside the staples. In addition to the above, a tissue thickness compensator 10020 can compensate for the difference in types or compression ratios of tissues trapped inside various staples 10030. As shown in FIG. 44, tissue thickness compensator 10020 may apply compressive force to vascular tissue T, which may include vessels V, and, as a result, limit bleeding through more compressible vessels V, while still applying the desired compressive pressure to surrounding tissue T. In various situations , in addition to the above, a tissue thickness compensator 10020 can also compensate for conditions arising from improperly formed staples. As shown in FIG. 45, improper formation of various staples 10030 can lead to the formation of more extensive grip areas of the staple 10039 within such staples. Due to the elasticity of the fabric thickness compensator 10020, as shown in FIG. 46, a tissue thickness compensator 10020 located within improperly formed staples 10030 can still exert sufficient compressive pressure on fabric T, despite the gripping areas of the bracket 10039 formed within such improperly formed staples 10030 can be increased. In various situations, a tissue thickness compensator 10020 placed between adjacent brackets 10030 can be displaced relative to fabric T by correctly formed brackets 10030 surrounding the malformed bracket 10030, and as a result, apply compressive pressure to the fabric surrounding and / or trapped inside the malformed bracket 10030. In various situations, a tissue thickness compensator can compensate for a difference in tissue density, which may be due, for example, calcification, fibrous zones and / or tissue, previously stitched or processed.

In accordance with the present invention, a fixed or unchanged tissue gap can be formed between the support portion and the abutment, as a result of which the staples can be deformed to a predetermined height regardless of the thickness of the fabric trapped inside the staples. When using a tissue thickness compensator in such cases, the tissue thickness compensator can adapt to the tissue trapped between the stop and the supporting portion of the cassette with brackets, and, due to its elasticity, the tissue thickness compensator can apply additional compressive pressure to the fabric. As shown in FIG. 50-55, the bracket 10030 is formed to a predetermined height H. As shown in FIG. 50, a tissue thickness compensator was not used, and fabric T occupies the entire grip area of the bracket 10039. In FIG. 57, a portion of the tissue thickness compensator 10020 is captured inside the bracket 10030, fabric T is compressed, and at least a portion of the capture region of the bracket 10039 is occupied. In FIG. 52, a thin tissue T is trapped inside the bracket 10030. In this embodiment, the compressed tissue T has a height of approximately 2/9 H, and the compressed tissue thickness compensator 10020 has a height of, for example, approximately 7/9 H. As shown in FIG. 53, a fabric T having an intermediate thickness is trapped inside the bracket 10030. In this embodiment, the compressed fabric T has a height of approximately 4/9 H, and the compressed tissue thickness compensator 10020 has a height of, for example, approximately 5/9 H. As shown in FIG. . 54, a fabric T having an intermediate thickness is trapped inside the bracket 10030. In this embodiment, the compressed fabric T has a height of approximately 2/3 H, and the compressed tissue thickness compensator 10020 has a height of, for example, approximately 1/3 H. In FIG. 53, thick tissue T is trapped inside the staple 10030. In this embodiment, the compressed tissue T has a height of approximately 8/9 H, and the compressed tissue thickness compensator 10020 has a height of, for example, approximately 1/9 H. In various situations, the tissue thickness compensator may have a height in a compressed state, comprising, for example, about 10% of the grip height of the bracket, about 20% of the grip height of the bracket, about 30% of the grip height of the bracket, about 40% of the grip height of the bracket, about 50% of the grip height of the bracket, about 60% of the grip height cotton wool staples, about 70% of the grip height of the staple, about 80% of the grip height of the staple and / or about 90% of the grip height of the staple.

The brackets 10030 in an unformed state may have any suitable height. The brackets 10030 in an unformed state may have a height of from about 2 mm to about 4.8 mm. For example, staples 10030 may have an unformed height of approximately 2.0 mm, approximately 2.5 mm, approximately 3.0 mm, approximately 3.4 mm, approximately 3.5 mm, approximately 3.8 mm, approximately 4.0 mm, approximately 4.1 mm and / or approximately 4.8 mm. The height H, which the brackets may acquire after deformation, may be due to the distance between the surface of the platform 10011 of the support part 10010 and the opposite stop. The distance between the surface of the platform 10011 and the abutment contact surface may be approximately 2.5 mm (0.097 in). The height H may also be due to the depth of the forming recesses formed inside the stop. The depth of the forming recesses can be measured, for example, from the surface in contact with the tissue. Optionally, as described in more detail below, the cassette with brackets 10000 may further comprise brackets that can lift the brackets 10030 to the stop and lift, or “squeeze”, the brackets above the surface of the platform 10011. In such cases, the height H that the brackets 10030 acquire when forming , can also be determined by the distance by which the brackets 10030 are removed relative to the surface of the platform. For example, staples 10030 can be pulled out, for example, by about 0.71 mm (0.028 in.), Which will result in staples 10030, for example, being formed with a height of 4.80 mm (0.189 in.). The height of the staples 10030 after formation may be approximately 0.8 mm, approximately 1.0 mm, approximately 1.5 mm, approximately 1.8 mm, approximately 2.0 mm and / or approximately 2.25 mm. The height of the staples after formation may be, for example, from about 2.25 mm to about 3.0 mm. In addition to the above, the height of the grip area of the bracket can be determined by the height of the bracket in the formed state and the thickness or diameter of the wire from which the bracket is formed. The height of the grip region 10039 of the bracket 10030 can be defined as the height of the bracket in the formed state H minus two wire diameters. The diameter of the staple wire may be, for example, approximately 0.23 mm (0.0089 in). The diameter of the staple wire may be, for example, from about 0.18 mm (0.0069 in) to about 0.30 mm (0.0119 in). For example, the height H of the bracket 10030 in the formed state may be approximately 4.80 mm (0.189 inches) and the diameter of the wire for the bracket may be approximately 0.23 mm (0.0089 inches), resulting in a height of the grip area of the bracket of, for example , approximately 4.34 mm (0.171 in.).

In addition to the above, the tissue thickness compensator may have a height in an uncompressed or unstated condition and may be configured to deform to one of a plurality of heights in a compressed state. The height of the fabric thickness compensator when uncompressed may be, for example, about 3.18 mm (0.125 in). The height of the tissue thickness compensator when uncompressed may be, for example, approximately 2.0 mm (0.080 inches). The height of the tissue thickness compensator in an uncompressed or unstated condition may exceed the height of the staples in an inactive state. The height of the uncompressed, or undetermined, tissue thickness compensator can be, for example, about 10% more, about 20% more, about 30% more, about 40% more, about 50% more, about 60% more, about 70% more, about 80% more, about 90% more and / or about 100% more than the height of the staples in the inactive state. The height of the uncompressed, or unstated, tissue thickness compensator may, for example, be no more than about 100% greater than the height of the staples in an inactive state. The height of the uncompressed, or unstated, tissue thickness compensator may be, for example, more than 100% greater than the height of the staples in an inactive state. The tissue thickness compensator may have an uncompressed height equal to the height of the staples in an inactive state. The tissue thickness compensator may have a height in an uncompressed state that is less than the height of the staples in an inactive state. The height of the uncompressed, or undetermined, tissue thickness compensator can be about 10% less, about 20% less, about 30% less, about 40% less, about 50% less, about 60% less, about 70 % less, about 80% less and / or about 90% less than the height of the staples in an inactive state. The compressible second part may have a height in an uncompressed state that exceeds the height of the stitched fabric T in an uncompressed state. The tissue thickness compensator may have a height in the uncompressed state, which is equal to the height of the stitched fabric T in the uncompressed state. The tissue thickness compensator may have an uncompressed height that is less than the height of the stitched fabric T in the uncompressed state.

As described above, a tissue thickness compensator can be clamped inside a plurality of formed staples, regardless of whether a thin or thick fabric is gripped inside the staples. For example, the staples within one line or row of staples can be deformed so that the height of the grip area of each staple will be, for example, approximately 2.0 mm, the fabric T and the tissue thickness compensator can be compressed within a given height. For example, in certain situations, the height of the compressed tissue T can be approximately 1.75 mm inside the grip area of the bracket, while the height of the compressed tissue thickness compensator can be approximately 0.25 mm inside the grip area of the bracket, thereby the overall height of the grip area the staples will be approximately 2.0 mm. For example, in certain situations, the height of the fabric T in a compressed state can be approximately 1.50 mm inside the grip area of the staple, while the height of the compensator for the thickness of the fabric in a compressed state can be approximately 0.50 mm inside the grip area of the staple, thereby the total height of the grip area the staples will be approximately 2.0 mm. For example, in certain situations, the height of the fabric T in a compressed state can be approximately 1.25 mm inside the grip area of the staple, while the height of the fabric thickness compensator in the compressed state can be approximately 0.75 mm inside the grip area of the staple, thereby the overall height of the grip area the staples will be approximately 2.0 mm. For example, in certain situations, the height of the fabric T in a compressed state can be approximately 1.0 mm inside the grip area of the staple, while the height of the compensator for the thickness of the fabric in a compressed state can be approximately 1.0 mm inside the grip area of the staple, thereby the total height of the grip area the staples will be approximately 2.0 mm. For example, in certain situations, the height of the fabric T in a compressed state can be approximately 0.75 mm inside the grip area of the staple, while the height of the fabric thickness compensator in the compressed state can be approximately 1.25 mm inside the grip area of the staple, thereby the overall height of the grip area the staples will be approximately 2.0 mm. For example, in certain situations, the height of the fabric T in a compressed state can be approximately 1.50 mm inside the grip area of the staple, while the height of the compensator for the thickness of the fabric in a compressed state can be approximately 0.50 mm inside the grip area of the staple, thereby the total height of the grip area the staples will be approximately 2.0 mm. For example, in certain situations, the height of the fabric T in a compressed state can be approximately 0.25 mm inside the grip area of the staple, while the height of the compensator for the thickness of the fabric in the compressed state can be approximately 1.75 mm inside the grip area of the staple, thereby the total height of the grip area the staples will be approximately 2.0 mm.

In addition to the above, the height of the tissue thickness compensator in an uncompressed state may be less than the height of the staples in the activated state. The height of the tissue thickness compensator in an uncompressed state may be equal to the height of the staples in the activated state. The height of the tissue thickness compensator in an uncompressed state may be greater than the height of the staples in the activated state. For example, the height of the fabric thickness compensator in an uncompressed state may be, for example, about 110% of the height of the formed bracket, about 120% of the height of the formed bracket, about 130% of the height of the formed bracket, about 140% of the height of the formed bracket, about 150% of the height of the formed bracket, approximately 160% of the height of the formed bracket, approximately 170% of the height of the formed bracket, approximately 180% of the height of the formed bracket, approximately 190% of the height of the formed bracket, and / or approximately 200% of the height formed staples. The height of the tissue thickness compensator in an uncompressed state can more than double the height of the staples in the activated state. The height of the tissue thickness compensator in a compressed state may be, for example, from about 85% to about 150% of the height of the formed staple. Optionally, as described above, the height of the tissue thickness compensator may vary from a thickness in an uncompressed state to a thickness in a compressed state. The thickness of the fabric thickness compensator in a compressed state can be, for example, approximately 10% of its thickness in an uncompressed state, approximately 20% of its thickness in an uncompressed state, approximately 30% of its thickness in an uncompressed state, approximately 40% of its thickness in an uncompressed state, approximately 50 % of its thickness in an uncompressed state, approximately 60% of its thickness in an uncompressed state, approximately 70% of its thickness in an uncompressed state, approximately 80% of its thickness in an uncompressed state and / or approximately 90% of its thickness in an uncompressed state standing. The thickness of the tissue thickness compensator in an uncompressed state can, for example, be approximately doubled, approximately ten times, approximately fifty times and / or approximately one hundred times greater than its thickness in a compressed state. The thickness of the tissue thickness compensator in a compressed state can be, for example, from about 60% to about 99% of its thickness in an uncompressed state. The thickness of the fabric thickness compensator in an uncompressed state may be at least 50% greater than its thickness in a compressed state. The thickness of the fabric thickness compensator in an uncompressed state can be one hundred times greater than its thickness in a compressed state. The compressible second part may be elastic or at least partially elastic and may bias the fabric T against the deformed legs of the staples. For example, the compressible second part can elastically expand between the fabric T and the base of the staple, pushing the fabric T close to the legs of the staple. As described in more detail below, a tissue thickness compensator may be located between the T fabric 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 within the grip area of the bracket.

The tissue thickness compensator may contain materials characterized by one or more of the following properties: for example, biocompatibility, bioabsorbability, bioresorption, biostability, biodegradability, compressibility, absorbability in a fluid, swelling, self-expansion, bioactivity, availability of a drug, pharmaceutical activity, anti-adhesive properties hemostatic properties, antibiotic properties, antimicrobial properties, antiviral properties, nutritional properties, adhesiveness, permeability, hydrophilicity and / or hydrophobicity. In accordance with the present invention, a surgical instrument comprising an abutment and a cassette with staples may include a tissue thickness compensator and / or a cassette with staples containing at least one hemostatic agent such as fibrin or thrombin, an antibiotic such as doxycycline and a drug, such as, for example, matrix metalloproteinases (MMP).

The tissue thickness compensator may contain synthetic and / or non-synthetic materials. The tissue thickness compensator may comprise a polymer composition comprising one or more synthetic polymers and / or one or more non-synthetic polymers. The synthetic polymer may comprise a synthetic absorbable polymer and / or a synthetic non-absorbable polymer. The polymer composition may contain, for example, a biocompatible foam. The biocompatible foam may comprise, for example, porous foam with open cells and / or closed cells. The biocompatible foam may have a uniform pore morphology or gradient pore morphology (i.e., small pores gradually increase in size to large pores in one direction across the thickness of the material). The polymer composition may contain one or more of a porous framework, a porous matrix, a gel matrix, a hydrogel matrix, a solution matrix, a fibrous matrix, a tubular matrix, a composite matrix, a membrane matrix, a biostable polymer, a biodegradable polymer, and combinations thereof. For example, a tissue thickness compensator may comprise foam reinforced with a fiber matrix, or may comprise foam having an additional hydrogel layer that expands in the presence of body fluids to further compress tissue. In accordance with the present invention, the tissue thickness compensator may also comprise a coating on the material and / or a second or third layer expanding in the presence of body fluids to further provide tissue compression. Such a layer may be a hydrogel, for example, of synthetic and / or natural origin, which may be biologically stable and / or biodegradable. The tissue thickness compensator may comprise a microgel or a nanogel. The hydrogel may contain microgels and / or nanogels of carbohydrate origin. The tissue thickness compensator can be reinforced, for example, with fibrous nonwoven fabric or mesh-type fibrous elements, which can provide additional flexibility, rigidity and / or strength. In accordance with the present invention, the tissue thickness compensator has a porous morphology showing a gradient structure, for example, small pores on one surface and larger pores on another surface. Such morphology may be more optimal for tissue ingrowth or hemostatic properties. Additionally, the gradient can also be combined with a variable bioabsorption profile. A short-term resorption profile may be preferable to stop bleeding, while a long-term resorption profile can provide better healing of the tissue without separation of fluids.

Examples of non-synthetic materials include, but are not limited to, lyophilized polysaccharide, glycoprotein, bovine pericardium, collagen, gelatin, fibrin, fibrinogen, elastin, proteoglycan, keratin, albumin, hydroxyethyl cellulose, cellulose, oxidized cellulose, oxidized cellulose cellulose cellulose cellulose cellulose cellulose cellulose cellulose cellulose cellulose cellulose rehydrogen carboxymethyl cellulose, chitin, chitosan, casein, alginate, and combinations thereof.

Examples of synthetic absorbable materials include, but are not limited to, polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyglycolic acid (PGA), polytrimethylene carbonate (TMC), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA) , copolymer of glycolide and ε-caprolactone (PGCL), copolymer of glycolide and trimethylene carbonate, polyglycerol sebacinate (PGS), polydioxanone (PDS), polyesters, polyorthoesters, polyoxyesters, polyesters, polyesters, polyesters, polyamides reds, polyetheramides, tyrosine polyarylates, polyamines, tyrosine polyiminocarbonates, tyrosine polycarbonates, poly-D, L-lactide-urethane, polyhydroxybutyrate, poly-B-hydroxybutyrate, poly-E-caprolactone, polyethylene glycol (PEG), poly [bis] -phosphazene] -polyamino acids, pseudo-polyamino acids, absorbable polyurethanes, polyphosphazine, polyphosphazenes, polyalkylene oxides, polyacrylamides, polyhydroxyethyl methyl acrylate, polyvinyl pyrrolidone, polyvinyl alcohols, polycaprolactone, polyacrylic acid, polyacrylic acid flax, aliphatic polyesters, glycerols, copolymers of esters and ethers, polialkilenoksalaty, polyamides, poliiminokarbonaty, polialkilenoksalaty and combinations thereof. The polyester can be selected from the group consisting of polylactides, polyglycolides, trimethylene carbonates, polydioxanones, polycaprolactones, polybutethers and combinations thereof.

A synthetic resorbable polymer may contain, for example, one or more of a 90/10 glycolide-L-lactide copolymer marketed by Ethicon, Inc. under the trade name VICRYL (polyglactic 910), a polyglycolide commercially available from American Cyanamid Co. under the trade name DEXON, a polydioxanone commercially available from Ethicon, Inc. under the trade name PDS, a statistical block copolymer of glycolide and trimethylene carbonate marketed by American Cyanamid Co. under the trade name MAXON, a copolymer of 75/25 glycolide and ε-caprolactone (polyglecaprolactone 25), marketed by Ethicon under the trade name MONOCRYL.

Examples of synthetic non-absorbable materials include, but are not limited to, polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate, polyamides such as nylon, polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), polystyrene (PS), polyester, polyetheretherketone (PEEK) polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCE), polyvinyl fluoride (PVF), fluorinated ethylene propylene (FEP), polyacetal, polysulfone, silicones and combinations thereof. Synthetic non-absorbable polymers may include, without limitation, foam elastomers and porous elastomers, for example silicone, polyisoprene and rubber. Synthetic polymers may contain porous polytetrafluoroethylene (ePTFE) marketed by W. L. Gore & Associates, Inc. under the trade name GORE-TEX Soft Tissue Patch; and urethane ester polyester foam copolymer marketed by Polyganics under the trade name NASOPORE.

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

A synthetic resorbable polymer may contain a bioresorbable biocompatible elastomeric copolymer. Suitable bioresorbable biocompatible elastomeric copolymers include, but are not limited to, ε-caprolactone-glycolide copolymers (preferably with a molar ratio of ε-caprolactone and glycolide from about 30:70 to about 70:30, preferably from 35:65 to about 65:35, more preferably - from 45:55 to 35:65); elastomeric copolymers of ε-caprolactone and lactide, including L-lactide, D-lactide or mixtures thereof, or copolymers of lactic acid (preferably with a molar ratio of ε-caprolactone and lactide from about 35:65 to about 65:35, more preferably from 45: 55 to 30:70), elastomeric copolymers of p-dioxanone (1,4-dioxan-2-one) and lactide, including L-lactide, D-lactide and lactic acid (preferably with a molar ratio of p-dioxanone to lactide from about 40 : 60 to about 60:40); elastomeric copolymers of ε-caprolactone and p-dioxanone (preferably with a molar ratio of ε-caprolactone and p-dioxanone of from about 30:70 to about 70:30); elastomeric copolymers of p-dioxanone and trimethylene carbonate (preferably with a molar ratio of p-dioxanone and trimethylene carbonate from about 30:70 to about 70:30); elastomeric copolymers of trimethylene carbonate and glycolide (preferably with a molar ratio of trimethylene carbonate and glycolide from about 30:70 to about 70:30); an elastomeric copolymer of trimethylene carbonate and lactide, including L-lactide, D-lactide, mixtures thereof or lactic acid copolymers (preferably with a molar ratio of trimethylene carbonate and lactide from about 30:70 to about 70:30) and mixtures thereof. The elastomeric copolymer may be a copolymer of glycolide and ε-caprolactone. In an alternative embodiment, the elastomeric copolymer is a copolymer of lactide and ε-caprolactone.

The descriptions given in US Patent No. 5,468,253, entitled "ELASTOMERIC MEDICAL DEVICE", issued November 21, 1995, and US Patent No. 6,325,810, entitled "POROUS STRENGTHENING ELEMENT FOR SEWING DEVICE, issued in December 4, issued on December 4 this document by reference.

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

The tissue thickness compensator may contain a surfactant.

Examples of surfactants may include, but are not limited to, polyacrylic acid, metallose, methyl cellulose, ethyl cellulose, propyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene ethylene ether, polyethylene ethylene ether, polyethylene ethylene ether, ethyl ethylene ether polyoxyethylene ether, polyoxyethylene nonylphenyl ether, dialkylphenoxypolyethyleneoxyethanol and polyoxamers.

The polymer composition may contain a pharmaceutically active agent. The polymer composition may release a therapeutically effective amount of a pharmaceutically active agent. The pharmaceutically active agent may be released as the polymer composition is dissolved / resorbed. The pharmaceutically active agent may be released into the fluid, for example into the blood, passing through or on top of the polymer composition. Examples of pharmaceutically active agents may include, without limitation, hemostatic agents and drugs, such as, for example, fibrin, thrombin and oxidized regenerated cellulose (ORC); anti-inflammatory drugs, such as, for example, diclofenac, aspirin, naproxen, sulindac and hydrocortisone; antibiotics and antimicrobial drugs or agents, such as, for example, triclosan, silver ions, ampicillin, gentamicin, polymyxin B, chloramphenicol; and anti-cancer agents, such as, for example, cisplatin, mitomycin, adriamycin.

The polymer composition may contain hemostatic material. The tissue thickness compensator may contain hemostatic materials containing polylactic acid, polyglycolic acid, polyhydroxybutyrate, polycaprolactone, polydioxanone, polyalkylene oxides, copolymers of ethers and esters, collagen, gelatin, thrombin, fibrin, fibrinogen, fibrinectin, heminbis, albumin, albumin, albumin, albumin hyaluronic acid, chondroitin sulfate, hydroxyethyl starch, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, agarose, maltose, maltodextrin, alginate, blood coagulation factors, methacrylate, polyurethanes, cyanoacrylates, platelet agonists, vasoconstrictors, aluminum alum, calcium, RGD peptides, proteins, protamine sulfate, ferric acid, aminocapate, acid basic ferrous sulfates, ferric chloride, zinc, zinc chloride, aluminum chloride, aluminum sulfates, aluminum acetates, permanganates, tannins, bone wax, polyethylene glycols, fucans and combinations thereof. The tissue thickness compensator may have hemostatic properties.

The polymer composition of the tissue thickness compensator may be characterized, for example, by a coefficient of porosity, pore size and / or hardness. The porosity coefficient of the polymer composition may be from about 30% vol. up to about 99% vol. The porosity coefficient of the polymer composition may be from about 60% vol. up to about 98% vol. The porosity coefficient of the polymer composition may be from about 85% vol. up to approximately 97% vol. The polymer composition may contain, for example, approximately 70% by weight. PLLA and approximately 30% weight. PCL, and its porosity coefficient may be approximately 90% vol. For example, because of this, the polymer composition will contain about 10% vol. copolymer. The polymer composition may contain, for example, approximately 65% by weight. PGA and approximately 35% weight. PCL, and its porosity coefficient may be from about 93% vol. up to about 95% vol. The porosity coefficient of the polymer composition may be more than 85% vol. The pore size of the polymer composition can be, for example, from about 5 micrometers to about 2000 micrometers. The pore size of the polymer composition may, for example, be from about 10 micrometers to about 100 micrometers. For example, the polymer composition may comprise a copolymer of PGA and PCL. The pore size of the polymer composition may, for example, be from about 100 micrometers to about 1000 micrometers. For example, the polymer composition may comprise a copolymer of PLLA and PCL.

In accordance with certain aspects, the hardness of the polymer composition can be expressed as Shore hardness, which is defined as the resistance to prolonged indentation of a material and is measured by a durometer, for example, a Shore durometer. In order to measure the value of the durometer for a given material, pressure is applied to it using the pressing tip of the durometer in accordance with ASTM D2240-00, entitled "Standard Method for Analyzing the Hardness of Rubber on a Durometer", which is incorporated herein by reference in its entirety. The pressing tip of the durometer can act on the material for a sufficient time, for example, 15 seconds, after which readings are taken from the corresponding scale. Depending on the type of scale used, a value of 0 can be obtained if the pressing tip has completely penetrated into the material, and a value of 100 can be obtained if the penetration of the tip into the material is not observed. This value is dimensionless. The value of the durometer can be determined on any suitable scale, for example, on scales of type A and / or type OO in accordance with ASTM D2240-00. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of, for example, from about 4 A to about 16 A, which corresponds to values from about 45 OO to about 65 OO on a Shore OO scale. For example, the polymer composition may comprise a PLLA / PCL copolymer or a PGA / PCL copolymer. The polymer composition of the fabric thickness compensator can have a Shore A hardness of less than 15 A. The polymer composition of the fabric thickness compensator can have a Shore A hardness of less than 10 A. The polymer composition of the fabric thickness compensator can have a Shore A hardness of less than 5 A. Polymer material the composition may have a Shore OO scale of, for example, from about 35 OO to about 75 OO.

The polymer composition may have at least two of the above properties. The polymer composition may have at least three of the above properties. The polymer composition may have porosity, for example, from 85% to 97% vol., Pore size from 5 micrometers to 2000 micrometers, shore hardness A from 4 A to 16 A, shore hardness OO from 45 OO to 65 OO. The polymer composition may contain, for example, 70% by weight. the polymer composition PLLA and 30% weight. PCL polymer composition, have a porosity of 90% by volume, pore size from 100 micrometers to 1000 micrometers, shore hardness A from 4 A to 16 A and shore hardness OO from 45 OO to 65 OO. The polymer composition may contain, for example, 65% by weight. PGA polymer composition and 35% weight. PCL polymer composition, having a porosity of 93% to 95% by volume, pore size of 10 micrometers to 100 micrometers, Shore A hardness of 4 A to 16 A and Shore OO hardness of 45 OO to 65 OO.

The tissue thickness compensator may comprise expandable material. As described above, the tissue thickness compensator may comprise compressed material that expands, for example, upon removal of load or installation. The tissue thickness compensator may comprise a self-expanding material formed in situ. The tissue thickness compensator may contain at least one starting material selected with the possibility of spontaneous crosslinking upon contact with at least one of the other (s) starting material (s), water and / or biological fluids. As shown in FIG. 205, the first starting material may be contacted with one or more other starting materials to form an expanding and / or swelling tissue thickness compensator. The tissue thickness compensator may comprise a fluid swellable composition, such as, for example, a water swellable composition. The tissue thickness compensator may comprise an aqueous gel.

As shown in FIG. 189A and B, for example, a tissue thickness compensator 70,000 may comprise at least one hydrogel starting material 70010 selected to form a hydrogel in situ and / or in vivo to expand the tissue thickness compensator 70,000. In FIG. 189A shows a tissue thickness compensator 70,000 containing a capsule that, prior to expansion, contains a first hydrogel starting material 70010A and a second hydrogel starting material 70010B. As shown in FIG. 189A, the first hydrogel starting material 70010A and the second hydrogel starting material 70010B can be physically separated from each other in one capsule. The first capsule may contain a first hydrogel starting material 70010A, and the second capsule may contain a second hydrogel starting materials 70010B. In FIG. 189B shows the expansion of a tissue thickness compensator of 70,000 upon the formation of a hydrogel in situ and / or in vivo. As shown in FIG. 189B, the capsule may be broken and the first hydrogel starting material 70010A may come into contact with the second hydrogel starting material 70010B to form hydrogel 70020. The hydrogel may contain expandable material. Hydrogel expansion may take, for example, a maximum of 72 hours.

The tissue thickness compensator may comprise a biodegradable foam having capsules containing dry hydrogel particles or granules inside. Without striving to be limited by any theory, capsules in the foam can form upon contact of an aqueous solution of the hydrogel starting material and an organic solution of biocompatible materials to form a foam. As shown in FIG. 206, an aqueous solution and an organic solution can form micelles. The aqueous solution and the organic solution can be dried to seal dry hydrogel particles or granules inside the foam. For example, a hydrogel starting material, such as a hydrophilic polymer, can be dissolved in water to form a micelle dispersion. The aqueous solution may be contacted with an organic dioxane solution containing polyglycolic acid and polycaprolactone. The aqueous and organic solutions can be lyophilized to form a biodegradable foam having dispersed dry hydrogel particles or granules. Without striving to be limited by any theory, it is believed that micelles form capsules in which dry hydrogel particles or granules are dispersed within the foam structure. Capsules can be broken, and dry hydrogel particles or granules can come into contact with a fluid, such as a biological fluid, and expand.

The tissue thickness compensator may expand upon contact with an activator, such as, for example, a fluid. As shown, for example, in FIG. 190, a tissue thickness compensator 70050 may comprise a swellable material, such as a hydrogel, that expands upon contact with a fluid 70055, such as, for example, biological fluids, saline, water, and / or an activator. Examples of biological fluids may include, without limitation, blood, plasma, peritoneal fluid, cerebrospinal fluid, urine, lymphatic fluid, synovial fluid, vitreous fluid, saliva, gastrointestinal contents, bile and / or gas (e.g., CO ₂ ) The fabric thickness compensator 70050 can expand when the fabric thickness compensator 70050 absorbs fluid. In another example, the tissue thickness compensator 70050 may comprise a transversely crosslinked hydrogel, which, upon contact with an activator 70055 containing a crosslinking agent, forms a crosslinked hydrogel. The tissue thickness compensator can expand upon contact with the activator. The tissue thickness compensator can expand or swell as a result of contact, for example, for a maximum of 72 hours, for example 24-72 hours, maximum 24 hours, maximum 48 hours and maximum 72 hours, to provide continuously increasing pressure and / or compression of the tissue. As shown in FIG. 190, the initial thickness of the fabric thickness compensator 70050 may be less than the expanded thickness after the fluid 70055 contacts the fabric thickness compensator 70050.

As shown in FIG. 187 and 188a, the cassette with brackets 70100 may comprise a fabric thickness compensator 70105 and a plurality of brackets 70110, each containing legs of the bracket 70112. As shown in FIG. 187, the tissue thickness compensator 70105 may have an initial thickness or height in a compressed state that is less than the height of the brackets 70110 in the activated state. The tissue thickness compensator 70100 can be configured to expand in situ and / or in vivo by contact with a fluid 70102, such as biological fluids, saline and / or activator, for example, to push tissue T against the legs 70112 of the bracket 70110. 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 can compensate for the thickness of the tissue T trapped inside each staple 70110. As shown in FIG. 188, the tissue thickness compensator 70105 may have an expanded thickness or height in an uncompressed state that is less than the height of the brackets 70110 in the activated state.

Optionally, as described above, the tissue thickness compensator may have an original thickness and a thickness after expansion. The initial thickness of the tissue thickness compensator may be, for example, approximately 0.001% of the thickness after expansion, approximately 0.01% of the thickness after expansion, approximately 0.1% of the thickness after expansion, approximately 1% of the thickness after expansion, approximately 10% of thickness after expansion, approximately 20% of the thickness after expansion, approximately 30% of the thickness after expansion, approximately 40% of the thickness after expansion, approximately 50% of the thickness after expansion, approximately 60% of the thickness after expansion, riblizitelno 70% of the thickness after expansion, approximately 80% of the thickness after the extension and / or approximately 90% of the thickness after expansion. The thickness of the tissue thickness compensator after expansion can be, for example, approximately two times, approximately five times, approximately ten times, approximately fifty times, approximately one hundred times, approximately two hundred times, approximately three hundred times, approximately four hundred times about five hundred times, about six hundred times, about seven hundred times, about eight hundred times, about nine hundred times and / or about a thousand times more than its original thickness. The initial thickness of the tissue thickness compensator can be up to 1% of its thickness after expansion, up to 5% of its thickness after expansion, up to 10% of its thickness after expansion, and up to 50% of its thickness after expansion. The thickness of the tissue thickness compensator after expansion can be at least 50% more than its original thickness, at least 100% more than its original thickness, at least 300% more than its original thickness, and at least 500% more than its original thickness. As described above, as a result of the above, in various situations, the tissue thickness compensator can be configured to fill any intervals within the grip area of the bracket.

As described above, the tissue thickness compensator may comprise a hydrogel. The hydrogel may contain homopolymer hydrogels, copolymer hydrogels, multipolymer hydrogels, hydrogels from interpenetrating polymers, and combinations thereof. The hydrogel may contain microgels, nano-gels, and combinations thereof. The hydrogel may essentially be a hydrophilic polymer network capable of absorbing and / or retaining fluids. The hydrogel may be a non-crosslinked hydrogel, a crosslinked hydrogel, and combinations thereof. The hydrogel may contain chemical crosslinking, physical crosslinking, hydrophobic segments and / or water-insoluble segments. Chemical crosslinking in a hydrogel can be obtained by polymerization, low molecular weight crosslinking and / or polymer-polymer crosslinking. Physical crosslinking in a hydrogel can be obtained by ionic interactions, hydrophobic interactions, using hydrogen bonds, the formation of stereo complexes and / or supramolecular chemical interactions. The hydrogel may be substantially water insoluble due to crosslinking, hydrophobic segments and / or water insoluble segments, but may be able to expand and / or swell due to absorption and / or retention of fluids. The starting material may crosslink endogenous materials and / or tissues.

The hydrogel may be an environmental sensitive hydrogel (ESH). An ESH gel may contain materials that exhibit fluid swelling properties depending on environmental conditions. Environmental conditions may include, without limitation, physical conditions, biological conditions and / or chemical conditions in the surgical field. A hydrogel may swell or contract, for example, depending on temperature, pH, electric fields, ionic strength, enzymatic and / or chemical reactions, electrical and / or magnetic stimuli, and other physiological and environmental variables. ESH gels may contain multifunctional acrylates, hydroxyethyl methacrylate (HEMA), elastomeric acrylates and the corresponding monomers.

A tissue thickness compensator formed from a hydrogel may comprise at least one of the non-synthetic materials and / or synthetic materials described above. The hydrogel may be a synthetic hydrogel and / or non-synthetic hydrogel. The tissue thickness compensator may comprise multiple layers. Many layers may contain porous layers and / or non-porous layers. For example, a tissue thickness compensator may include a non-porous layer and a porous layer. In another example, the tissue thickness compensator may comprise a porous layer located between the first non-porous layer and the second non-porous layer. In another example, the tissue thickness compensator may comprise a non-porous layer located between the first porous layer and the second porous layer. Non-porous layers and porous layers can be arranged in any order relative to the surfaces of the cassette with brackets and / or emphasis.

Examples of non-synthetic materials may include, without limitation, albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, serum and starch. Cellulose may be hydroxyethyl cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, and combinations thereof. Collagen may be bovine pericardium. The carbohydrate may be a polysaccharide, such as a lyophilized polysaccharide. The protein may be a glycoprotein, proteoglycan, and combinations thereof.

Examples of synthetic materials may include, but are not limited to, polylactic acid, polyglycolic acid, polyhydroxybutyrate, polyphosphazine, polyesters, polyethylene glycols, polyethylene oxide, copolymer of polyethylene oxide and polypropylene oxide, copolyethylene oxide, polyalkylene oxides, polyacrylamide, polyhydroxypropyl polyvinylidene, polyhydroxy-polyvinylpyrrolidinone, polyacetate, polypropylene, aliphatic polyesters, glycerins, polyamino acids, copolymers of simple and complex x esters, polyalkylene oxalates, polyamides, polyiminocarbonates, polyoxy esters, polyorthoesters, polyphosphazenes and combinations thereof. The above non-synthetic materials can be obtained synthetically using conventional methods, for example, synthetic hyaluronic acid.

The hydrogel can be obtained from one or more of the hydrogel starting materials. The starting material may be a monomer and / or macromer. The starting material of the hydrogel may contain an electrophilic functional group and / or a nucleophilic-electrophilic functional group. In general, electrophilic groups can interact with nucleophilic groups to form a bond. The term “functional group” as used herein means electrophilic or nucleophilic groups capable of interacting with each other to form a bond. Examples of electrophilic functional groups include, but are not limited to, N-hydroxysuccinimides (NHS), sulfosuccinimides, carbonyldiimidazole, sulfonyl chloride, aryl halides, sulfosuccinimidyl ethers, N-hydroxysuccinimidyl ethers, such as succinimidium, succinimidium and succinimides , epoxides, aldehydes, maleimides, imido esters, combinations thereof, and the like. The electrophilic functional group may be a succinimidyl ether. Examples of nucleophilic functional groups include, but are not limited to, —NH ₂ , —SH, —OH, —PH _2, and —CO — NH — NH ₂ .

A hydrogel may be formed from a single starting material or a plurality of starting materials. A hydrogel may be formed from a first starting material and a second starting material. The first hydrogel starting material and the second hydrogel starting material may, in contact, form the hydrogel in situ and / or in vivo. Essentially, the hydrogel starting material may relate to a polymer, a functional group, a macromolecule, a small molecule, and / or a crosslinking agent involved in the reaction to form a hydrogel. The starting material may be a homogeneous solution, a heterogeneous or phase separated solution in a suitable solvent, such as, for example, water or a buffer solution. The buffer may have a pH from about 8 to about 12, such as from about 8.2 to about 9. Examples of buffer solutions may include, but are not limited to, borate buffer solutions. The initial substance (s) may be in the form of an emulsion. According to the present invention, the first starting material can react with the second starting material to form a hydrogel. The first starting material can spontaneously form bonds upon contact with the second starting material. In accordance with the present invention, a first set of electrophilic functional groups on a first starting material can interact with a second set of nucleophilic functional groups on a second starting material. When starting materials are mixed under conditions conducive to the reaction (for example, pH, temperature and / or solvent), functional groups can interact with each other to form covalent bonds. Starting materials may become crosslinked if at least some of the starting materials interact with more than one other starting material.

The tissue thickness compensator may contain at least one monomer selected from the group consisting of 3-sulfopropyl acrylate (KSPA) potassium salt, sodium acrylate (NaA), N- (tris (hydroxymethyl) methyl) acrylamide (“tris acrylic”), and 2-acrylamido-2-methyl-1-propanesulfonic acid (AMPS). The tissue thickness compensator may be a copolymer containing two or more monomers selected from the group consisting of KSPA, NaA, Tris Acrylic, AMPS. The tissue thickness compensator may contain homopolymers derived from KSPA, NaA, Tris acrylic and AMPS. The tissue thickness compensator may contain hydrophilicity modifying monomers copolymerizable with it. Hydrophilicity modifier monomers may contain methyl methacrylate, butyl acrylate, cyclohexyl acrylate, styrene, styrene sulfonic acid.

The tissue thickness compensator may contain a crosslinking agent. The crosslinking agent may be a low molecular weight di- or polyvinyl crosslinking agent, such as ethylene glycol diacrylate or dimethacrylate, di-, tri- or tetraethylene glycol diacrylate or dimethacrylate, allyl (meth) acrylate, C ₂ -C ₈ -alkylene diacrylate or divimethyl , divinyl sulfone, di- and trivinyl benzene, trimethylol propane triacrylate or trimethacrylate, pentaerythritol tetraacrylate or tetramethacrylate, diacrylate or dimethacrylate of bisphenol A, methylene-bisacrylamide or bisomethacrylamide, ethylene bisacrylamide or acrylamide, triallilftalat or diallyl phthalate. The crosslinking agent may be N, N'-methylenebisacrylamide (MBAA).

The tissue thickness compensator may comprise at least one of hydrogels with functional groups of acrylate and / or methacrylate, a biocompatible photoinitiator, alkyl cyanoacrylates, isocyanate functional macromers, optionally containing amine functional macromers, functional macromers of succinimidyl ether, optionally containing amine and / or sulfide epoxy functional macromers, optionally containing amine functional macromers, protein mixtures and / and and polypeptides and aldehyde crosslinking agents, genipin and water-soluble carbodiimides, anionic polysaccharides and polyvalent cations.

The tissue thickness compensator may contain unsaturated organic acid monomers, acrylic substituted alcohols and / or acrylamides. The tissue thickness compensator may comprise methacrylic acids, acrylic acids, glycerol acrylate, glycerol methacrylate, 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, 2- (dimethylaminoethyl) methacrylate, N-vinylpyrrolidone, methacrylamide and / or N, N-dimethylmethyl acrylamide.

The tissue thickness compensator may include reinforcing material. The reinforcing material may contain at least one of the synthetic and non-synthetic materials described above. The reinforcing material may contain collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, polyethylene glycol polyglycol, polyglycol polyglycol, polyglycol polyglycol , polyalkylene oxides, polyacrylamides, polyhydroxyethyl methyl acrylate, polyvinyl pyrrolidone, polyvinyl alcohols, polycaprolactone, polydioxanone, polyacrylic acid, gender acetate, polycaprolactone, polypropylene, aliphatic polyesters, glycerols, polyamino acids, copolymers of esters and ethers, polialkilenoksalaty, polyamides, poliiminokarbonaty, polialkilenoksalaty, polioksaefiry, polyorthoesters, polyphosphazenes and combinations thereof.

The tissue thickness compensator may comprise a layer containing a reinforcing material. The porous layer and / or non-porous layer of a tissue thickness compensator may comprise a reinforcing material. For example, the porous layer may contain a reinforcing material, and the non-porous layer may not contain a reinforcing material. The reinforcing layer may be an inner layer located between the first non-porous layer and the second non-porous layer. The reinforcing layer may be an outer layer of a tissue thickness compensator. The reinforcing layer may be the outer surface of the tissue thickness compensator.

The reinforcing material may contain cells, monofilaments, multifilament bundles, fibers, litter, felt, particles and / or powders. Reinforcing material may be embedded in the layer of tissue thickness compensator. The reinforcing material may be embedded in at least one of the non-porous layer and / or porous layer. A mesh of reinforcing material can be formed using traditional methods, such as, for example, knitting, weaving, weaving and / or lace.

According to the present invention, a plurality of reinforcing materials can be oriented randomly and / or in a general direction. The general direction may, for example, be parallel to the staple line and perpendicular to the staple line. For example, monofilaments and / or multifilament bundles can be oriented in a random direction and / or in a general direction. Monofilaments and / or multifilament bundles can be associated with a non-porous layer and / or with a porous layer. The tissue thickness compensator may comprise a plurality of reinforcing fibers oriented in a random direction within the non-porous layer. The tissue thickness compensator may comprise a plurality of reinforcing fibers oriented in a general direction within the non-porous layer.

As shown in FIG. 199, the abutment 70300 may comprise a fabric thickness compensator 70305 comprising a first non-porous layer 70307 and a second non-porous layer 70309 sealed around the reinforcing layer 70310. The reinforcing layer 70310 may contain a hydrogel containing ORC particles or fibers embedded therein, and the non-porous layers may contain ORC. As shown in FIG. 199, the tissue thickness compensator 70305 may be configured to conform to the contour of the stop 70300. The inner layer of the tissue thickness compensator 70305 may correspond to the inner surface of the stop 70300, which includes recesses for forming 70301.

The fibers can form a non-woven material, such as, for example, litter and felt. The fibers can have any suitable length, for example, from 0.1 mm to 100 mm and from 0.4 mm to 50 mm. The reinforcing material can be ground into powder. The powder may have a particle size of, for example, from 10 μm to 1 cm. The powder may be included in the tissue thickness compensator.

The tissue thickness compensator may be formed in situ. The hydrogel can be formed in situ. The tissue thickness compensator can be formed in situ using covalent, ionic and / or hydrophobic bonds. Physical (non-covalent) crosslinking may be due to complexation, hydrogen bonds, desolvation, van der Waals interactions, ionic bonds, and combinations thereof. Chemical (covalent) crosslinking can be due to any number of mechanisms, including: free radical polymerization, condensation polymerization, anionic or cationic polymerization, stepwise polymerization, electrophilic nucleophilic reactions, and combinations thereof.

Optionally, in situ formation of a tissue thickness compensator may comprise the interaction of two or more starting materials that are physically separated prior to their in situ contact and / or interacting under certain environmental conditions with the formation of a hydrogel. In situ polymerizable polymers can be obtained from the starting material (s), which, when reacted, form a polymer in the operative field. The tissue thickness compensator can be formed as a result of crosslinking reactions of the initial substance (s) in situ. The starting material may comprise an initiator capable of initiating a polymerization reaction to form an in situ tissue thickness compensator. The tissue thickness compensator may contain a starting material that can be activated at the time of use to form a crosslinked hydrogel. The formation of a tissue thickness compensator in situ may comprise activating at least one starting material to form bonds and form a tissue thickness compensator. Optionally, activation can be achieved by changing physical conditions, biological conditions and / or chemical conditions in the surgical field, including, without limitation, temperature, pH, electric fields, ionic strength, enzymatic and / or chemical reactions, electrical and / or magnetic stimuli, and also other physiological and environmental variables. The starting materials can be contacted outside the body and placed in the surgical field.

The tissue thickness compensator may comprise one or more capsules, or cells, configured to store at least one component. The capsule may be configured to store the hydrogel starting material. The capsule may be configured to store, for example, two components. The capsule may be configured to store the first hydrogel starting material and the second hydrogel starting material. The first capsule may be configured to store the first hydrogel starting material, and the second capsule may be configured to store the second hydrogel starting material. As described above, the capsules can be aligned or at least substantially aligned with the legs of the brackets for piercing and / or breaking the capsules otherwise by contacting the legs of the brackets with the capsule. Capsules may be compressed, crushed, crushed and / or otherwise torn when brackets are installed. After capsule disruption, the component (s) stored in them may leak out of the capsule. The component stored inside the capsule may come into contact with other components, layers of tissue thickness compensator and / or tissue. Other components may leak from similar or other capsules located in the layers of the tissue thickness compensator and / or introduced into the surgical field by a doctor. As a result of the above, the component (s) stored inside the capsules can provide expansion and / or swelling of the tissue thickness compensator.

The tissue thickness compensator may comprise a layer containing capsules. The capsule may be a void, a recess, a dome, a tube, and combinations thereof associated with the layer. Capsules may be voids in a layer. The layer may contain two layers that can be attached to each other, and capsules can be formed between two layers. Capsules may be domes on the surface of the layer. For example, at least a portion of the capsules may be located inside domes extending upward from the layer. Capsules may represent recesses formed within the layer. The first part of the capsules may be a dome, and the second part of the capsules may be a recess. Capsules may be a tube embedded inside the layer. The tube may be formed from non-synthetic and / or synthetic materials described herein, such as PLA. The tissue thickness compensator can be a bioabsorbable foam, such as ORC, containing embedded PLA tubes, and, for example, a hydrogel can be sealed inside the tubes. Capsules may contain separate cells that are not connected to each other. One or more capsules may be in fluid communication, for example, through one or more channels, passages and / or ducts passing through the layer.

The release rate of the component from the capsule can be controlled, for example, by 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 physical and / or chemical interactions between the components, the composition of the tissue thickness compensator and / or surgical instrument. The layer may contain one or more thin sections or weakened parts, such as, for example, partial perforations, which can facilitate incision of the layer and rupture of the capsules. Partial perforations may not completely pass through the layer, while in some cases, perforations may completely pass through the layer.

As shown in FIG. 194 and 195a, the fabric thickness compensator 70150 may comprise an outer layer 70152A and an inner layer 70152B containing capsules 70154. The capsule may comprise a first sealed component and a second sealed component. Capsules may independently contain one of the first sealed component and the second sealed component. The first sealed component may be separated from the second sealed component. Outer layer 70152A may include a tissue contact surface. The inner layer 70152B may comprise a tool-contacting surface. The tool-contacting surface 70152B may be detachably attached to the abutment 70156. The outer layer 70152A may be attached to the inner layer 70152B to form a void between the outer layer 70152A and the inner layer 70152B. As shown in FIG. 194, each capsule 70154 may comprise a dome on a tool-contacting surface of the inner layer 70152B. The dome may contain partial perforations that facilitate the dissection of the layer by the legs of the bracket and rupture of the capsule. As shown in FIG. 195, the abutment 70156 may comprise a plurality of rows of recesses for forming 70158, wherein the domes of capsules 70154 may be aligned with recesses for forming 70158. The fabric contact surface may comprise a flat surface without domes. The tissue contacting surface may comprise, for example, one or more capsules, such as capsules 70154, extending from it.

Optionally, the stop may comprise a tissue thickness compensator comprising a sealed component comprising at least one microspherical particle. The tissue thickness compensator may comprise a capsule comprising a first sealed component and a second sealed component. The tissue thickness compensator may comprise a capsule containing a first microspherical particle and a second microspherical particle.

As shown in FIG. 196, the stapler may include a stop 70180 and a cassette with staples (shown in other figures). The cassette brackets 70190 with brackets can be deformed using the stop 70180 when moving the stop 70180 to the closed position and / or using the staple ejector system 70192, which moves the staples 70190 to the closed stop 70180. The staple legs 70194 can contact the stop 70180 so that the staples 70190 is at least partially deformed. The emphasis 70180 may comprise a tissue thickness compensator 70182 comprising an outer layer 70183A and an inner layer 70183B. The fabric thickness compensator 70182 may comprise a first sealed component and a second sealed component. Capsules 210185 can be aligned or at least substantially aligned such that when the legs of the staples 70194 are pushed through the fabric T and the outer layer 70183A, the legs of the staples 70194 can pierce and / or otherwise tear the capsules 70185. In FIG. 196, bracket 70190C is in its fully activated position, bracket 70190B is in the activation process, and bracket 70190A is in its inactive position. The legs of the brackets 70190C and 70190B moved through the fabric T, the outer layer 70183A and the inner layer 70183B of the fabric thickness compensator 70182 and came into contact with the stop 70180 opposite the cassette with brackets. After capsule 70185 ruptures, the sealed components may leak out and, for example, come into contact with each other, biological fluids and / or tissue T. The sealed components can interact to form a reaction product, such as a hydrogel, which expands between the tissue T and the base of the bracket, pushing fabric T against the legs of the staple. In various situations, as a result of the above, the tissue thickness compensator can be configured to fill any gaps within the grip area of the bracket.

A tissue thickness compensator may be suitable for use with a surgical instrument. As described above, the tissue thickness compensator may be connected to the cassette with brackets and / or with a stop. The tissue thickness compensator can be made in any shape, size and / or length, suitable for installation on a cassette with brackets and / or on the stop. As described herein, a tissue thickness compensator can be detachably attached to a cassette with brackets and / or to a stop. The tissue thickness compensator can be attached to the cassette with brackets and / or to the stop by any mechanical and / or chemical method capable of holding the fabric thickness compensator in contact with the cassette with brackets and / or stop before and during stitching. The tissue thickness compensator can be removed or removed from the cassette with staples and / or stop after the staples penetrate the tissue thickness compensator. The tissue thickness compensator can be removed or released from the cassette with brackets and / or the stop when moving the cassette with brackets and / or the stop from the tissue thickness compensator.

As shown in FIG. 191-193, the stapler 70118 may include a stop 70120 and a cassette with brackets 70122, containing a trigger 70124, a plurality of brackets 70128, a cutting edge 70129 and a fabric thickness compensator 70130. The fabric thickness compensator 70130 may include at least one sealed component. The sealed component may be torn by compression, stitching and / or cutting of the tissue thickness compensator. As shown in FIG. 192, for example, the placement of staples 70128 between the non-activated position and the activated position can be carried out so that the legs of the staples move through the fabric thickness compensator 70130, penetrate the lower surface and the upper surface of the fabric thickness compensator 70130, penetrate the fabric T and come into contact with the stop 70120 located opposite the cassette with brackets 70118. The sealed components can interact with each other, hydrophilic powder, embedded or dispersed in the tissue thickness compensator, and / or biologically fluids, expanding or swelling the tissue thickness compensator 70130. When the legs are deformed against the stop, the legs of each bracket can grab part of the tissue thickness compensator 70130 and part of the fabric T inside each bracket 70128 and apply a compressive force to the fabric T. As shown in FIG. 192 and 193, the fabric thickness compensator 70130 can compensate for the thickness of the tissue T trapped inside each bracket 70128.

As shown in FIG. 197, the surgical instrument 70200 may include an abutment 70205 containing an upper tissue thickness compensator 70210 and a cassette with brackets 70215 containing a lower tissue thickness compensator that includes an outer layer 70220 and an inner layer 70225. An upper tissue thickness compensator 70210 may be located on the first side target tissue, and a lower tissue thickness compensator may be located on the second side of the fabric. The upper tissue thickness compensator 70210 may comprise ORC, the outer layer of the lower tissue thickness compensator may comprise a hydrogel having ORC particles embedded therein, and the inner layer of the lower tissue thickness compensator may comprise, for example, ORC.

As shown in FIG. 200-202, a surgical instrument 70400 may comprise a cassette with brackets 70405 and an abutment 70410. A cassette with brackets 70405 may include a tissue thickness compensator 70415, including bioabsorbable foam. The bioabsorbable foam may contain a capsule that contains a sealed component 70420. The bioabsorbable foam may contain ORC, and the sealed component may contain, for example, a drug. The fabric thickness compensator 70415 of the stop 70410 may comprise an inner layer 70425 and an outer layer 70430. The inner layer 70425 may contain bioabsorbable foam, and the outer layer 70430 may contain a hydrogel, optionally containing, for example, reinforcing materials. In one example of a start sequence, as shown primarily in FIG. 201, the slide 70435 may first contact the bracket 70440A and begin to lift the bracket up. With further distal advancement of the slide 70435, the slide 70435 can begin to lift the staples 70440B-D and any other subsequent staples in turn. The slide 70435 can push the brackets 70440 up so that the legs of the staples are in contact with the opposite stop 70410 and are deformed into the desired shape. With respect to the starting sequence shown in FIG. 201, the brackets 70440A-C were moved to their fully activated positions, the bracket 70440D is in the activation process, and the bracket 70420E is still in its inactive position. Sealed component 70470 may be torn apart by staple legs during an example start sequence. Sealed component 70420 may leak out of the capsule around the legs of the staples to contact tissue T. In various circumstances, additional compression of the tissue thickness compensator may squeeze additional drug from the capsule. The drug can directly treat the tissue and can reduce bleeding from the tissue.

In various circumstances, the surgeon or other physician may supply fluid to the tissue thickness compensator to obtain a tissue thickness compensator containing at least one drug that is stored and / or absorbed therein. In accordance with the present invention, the cassette with brackets and / or emphasis may include a port configured to provide access to the tissue thickness compensator. As shown in FIG. 203B, the cassette with brackets 70500 may comprise, for example, port 70505 at its distal end. Port 70505 may be configured to receive a needle 70510, such as a needle with holes, shown in FIG. 203A. A doctor may insert a needle 70510 through port 70505 into a tissue thickness compensator 70515 to deliver fluid to a tissue thickness compensator 70515. The fluid may contain, for example, a drug and a hydrogel starting material. As described above, a fluid may be released from the tissue thickness compensator into the tissue upon rupture and / or compression of the tissue thickness compensator. For example, a drug may be released from the tissue thickness compensator 70515 as the tissue thickness compensator 70515 is bioabsorbed.

As represented in FIG. 14, a cassette with brackets, such as, for example, a cassette with brackets 10000, may comprise a support portion 10010 and a compressible tissue thickness compensator 10020. As shown in FIG. 16-18, the support portion 10010 may comprise a surface of the platform 10011 and a plurality of sockets for brackets 10012 formed within the support portion 10010. Each bracket slot 10012 may be shaped and sized to allow removable storage of a bracket, such as a bracket 10030. A cassette with the brackets 10000 may further comprise a plurality of ejector brackets 10040, each of which may be configured to support one or more brackets 10030 inside the brackets 10012 when the brackets 10030 and the ejector brackets 10040 are in an inactive position. For example, as predominantly shown in FIG. 22 and 23, each bracket ejector 10040 may comprise, for example, one or more pockets or grooves 10041, for example, which may be configured to support brackets and restrict relative movement between the brackets 10030 and the bracket ejectors 10040. As also shown in FIG. . 16, the cassette with brackets 10000 may further comprise a slide for activating the brackets 10050, which can be moved from the proximal end 10001 to the distal end 10002 of the cassette with brackets for sequentially lifting the ejectors brackets 10040 and brackets 10030 from their inactive position to the stop located opposite the cassette with brackets 10000. As predominantly shown in FIG. 16 and 18, each bracket 10030 may comprise a base 10031 and one or more legs 10032 extending from the base 10031, each bracket may have, for example, at least one of a substantially U-shaped and substantially V-shaped. The brackets 10030 can be designed so that the ends of the staple legs 10032 are recessed relative to the surface of the platform 10011 of the support portion 10010 when the brackets 10030 are in an inactive position. The brackets 10030 may be configured so that the ends of the legs 10032 of the brackets are flush with the surface of the platform 10011 of the support portion 10010 when the brackets 10030 are in an inactive position. The brackets 10030 may be configured such that the ends of the bracket legs 10032 or at least some of the bracket legs 10032 protrude above the surface of the platform 10011 of the support portion 10010 when the brackets 10030 are in an inactive position. In such cases, the legs 10032 of the staples can pass through the fabric thickness compensator 10020 and can be placed inside it when the staples 10030 are in an inactive position. For example, legs 10032 staples may protrude above the surface of the platform 10011, for example, approximately 1.9 mm (0.075 inches). The legs 10032 staples can protrude above the surface of the platform 10011 at a distance of, for example, from about 0.64 mm (0.025 in.) To about 3.18 mm (0.125 in.). In addition to the above, fabric thickness compensator 10020 may, in an uncompressed state, have a thickness of from about 2.0 mm (0.08 inches) to about 3.18 mm (0.125 inches).

In the process of application, in addition to the above and as shown mainly in FIG. 31, the emphasis, for example, emphasis 10060, can be moved to the closed position opposite the cassette with brackets 10000. As described in more detail below, emphasis 10060 can position the fabric, for example, close to the fabric thickness compensator 10020 and press the fabric thickness compensator 10020 close to the surface the platform 10011 of the support part 10010. After the emphasis 10060 has taken a suitable position, it is possible to place the brackets 10030, as shown in FIG. 31. Optionally, as indicated above, the slide for activating the staples 10050 can be moved from the proximal end 10001 of the cassette with staples 10000 to the distal end 10002, as shown in FIG. 32. When advancing the slide 10050, the slide 10050 can contact the staple ejectors 10040 and lift the staple ejectors 10040 up inside the staple sockets 10012. Each of the 10050 sleds and staple ejectors 10040 can contain one or more inclined surfaces that can move the staple ejectors 10040 together up from their inactive position. For example, as shown in FIG. 19-23, each bracket ejector 10040 may include at least one inclined surface 10042, and the slide 10050 may contain one or more inclined surfaces 10052, which may be configured so that the inclined surfaces 10052 can slide under the inclined surface 10042 while distally moving sled 10050 inside the cassette with brackets. When the bracket pushers 10040 rise up inside the corresponding bracket pockets 10012, the bracket pushers 10040 can lift the brackets 10030 up so that the brackets 10030 can exit the bracket pockets 10012 through the holes in the bracket platform 10011. In one example of a starting sequence, as shown mainly in FIG. 25-27, the slide 10050 may first contact the bracket 10030a and begin to lift the bracket 10030a up. With further distal advancement of the slide 10050, the slide 10050 can begin to lift the brackets 10030b, 10030c, 10030d, 10030e and 10030f and all other subsequent brackets in turn. As shown in FIG. 27, the slide 10050 can push the brackets 10030 upward so that the legs of the brackets 10032 contact the opposite stop, deform to become the desired shape, and are pushed out of the support part 10010. In various situations, the slide 10030 during the start-up sequence can move several brackets simultaneously up . If we consider the starting sequence shown in FIG. 27, the brackets 10030a and 10030b are moved to the fully activated position and pushed out of the support part 10010, the brackets 10030c and 10030d are in the activation process and at least partially placed inside the support part 10010, and the brackets 10030e and 10030f are still in the inactive position.

As described above and as shown in FIG. 33, the legs 10032 of the brackets 10030 may extend above the surface of the platform 10011 of the support portion 10010 when the brackets 10030 are in an inactive position. If we additionally consider the starting sequence shown in FIG. 27, the brackets 10030e and 10030f are depicted in an inactive position, and their staple legs 10032 protrude above the surface of the platform 10011 and enter the fabric thickness compensator 10020. The ends of the staple legs 10032 or some other part of the staple legs 10032 may not pass through the upper tissue contact tissue thickness compensator surface 10021 10020 when the brackets 10030 are in an inactive position. As the brackets 10030 move from the non-activated position to the activated position, as shown in FIG. 27, the ends of the staple legs can pass through the surface 10032 in contact with the fabric. The ends of the staple legs 10032 can have sharp ends that can cut and puncture the tissue thickness compensator 10020. The fabric thickness compensator 10020 can contain many holes that can be configured to receive legs 10032 staples and ensuring the sliding of the legs 10032 staples relative to the compensator for the thickness of the fabric 10020. The supporting part 10010 may further comprise a plurality of guides 10013 extending from the surface of the platform 10011. Will direct Whether 10013 may be located adjacent the openings of jacks for staples in the platform surface of the 10011 so that the guides for the legs of staples 10032 10013. The guide may at least partially supported by 10013 can be disposed at the proximal end and / or distal end of the hole socket for staples. In accordance with the present invention, the first guide 10013 may be located on the first end of each hole of the bracket socket, and the second guide 10013 may be located on the second end of each hole of the bracket socket so that each first guide 10013 can support the first leg 10032 of the bracket 10030, and every second guide 10013 could support a second bracket leg 10032. As represented in FIG. 33, each guide 10013 may include a groove or groove, such as, for example, a groove 10016, into which the bracket leg 10032 can be slidably received. Optionally, each guide 10013 may include a hook, protrusion, and / or spike that can protrude from the surface of the platform 10011 and extend into the tissue thickness compensator 10020. As described in more detail below, hooks, protrusions, and / or spikes can reduce the relative movement between the tissue thickness compensator. 10020 and the supporting part 10010. The ends of the legs 10032 of the staples may be located inside the guides 10013 and may not protrude above the upper surface of the guides 10013 when the brackets 10030 are in the inactive position. For example, the guides 10013 may form the height of the guides, and the brackets 10030 may not protrude above a given height of the guides when the brackets are in an inactive position.

In accordance with the present invention, a tissue thickness compensator, for example, a tissue thickness compensator 10020, may be formed from a single sheet of material. The fabric thickness compensator may comprise a continuous sheet of material capable of covering the entire upper surface of the platform 10011 of the support portion 10010, or, in an alternative embodiment, not covering the entire surface of the platform 10011. The material sheet may cover the holes of the slots for the brackets in the support portion 10010, while alternatively the sheet The material may comprise holes that can be aligned or at least partially aligned with the holes of the bracket sockets. In accordance with the present invention, a tissue thickness compensator can be formed from multiple layers of material. As represented in FIG. 15, the tissue thickness compensator may comprise a compressible core and a sheath surrounding the compressible core. The shell 10022 may be configured to releasably hold the compressible core on the support portion 10010. For example, the support portion 10010 may comprise one or more protrusions extending therefrom, for example protrusions 10014 (FIG. 18), which may be received inside one or more holes and / or grooves, for example, holes 10024 formed in the shell 10022. The protrusions 10014 and the holes 10024 can be made so that the protrusions 10014 can hold the shell 10022 on the supporting part 10010. The ends of the protrusions 10014 can be deformed, for example, with thermal stretching power to increase the ends of the protrusions 10014 and, as a result, limit the relative movement between the shell 10022 and the supporting part 10010. The shell 10022 may contain one or more holes 10025, which can facilitate the release of the shell 10022 from the supporting part 10010, as shown in FIG. . 15. As shown in FIG. 24, the tissue thickness compensator may comprise a sheath 10222 including a plurality of holes 10223, wherein the holes 10223 can be aligned or at least partially aligned with the holes of the bracket slots in the support portion 10010. The core of the tissue thickness compensator may also include holes that are aligned or at least partially aligned with the holes 10223 in the sheath 10222. Alternatively, the core of the tissue thickness compensator may have a continuous body and extend under the holes 10223 so that the continuous body covers hole holes for brackets in the surface of the platform 10011.

Optionally, as described above, the tissue thickness compensator may include a sheath for releasably holding the compressible core on the support portion 10010. For example, as shown in FIG. 16, the cassette with brackets may further comprise holding clips 10026, which may be configured to prevent premature separation of the casing and compressible core from the support portion 10010. Optionally, each holding clip 10026 may comprise holes 10028 that may be configured to receive protrusions 10014, extending from the supporting part 10010 so that the holding clips 10026 can be supported on the supporting part 10010. Each holding clip 10026 may contain at least one part of the sub it is 10027, which can extend under the support part 10010 and support and hold the ejectors of the brackets 10040 inside the support part 10010. As described above, the tissue thickness compensator can be removably attached to the support part 10010 using brackets 10030. More specifically, which is also described above, the legs of the brackets 10030 can pass into the fabric thickness compensator 10020 when the brackets 10030 are in the inactive position, as a result, releasably holding the fabric thickness compensator 10020 on the supporting part 10010. The legs of the brackets 10030 can contact the side walls of the joint corresponding slots for brackets 10012, and due to friction between the legs 10032 of the brackets and the side walls, the brackets 10030 and the fabric thickness compensator 10020 can be held in position until the brackets 10030 are placed from the cassette with brackets 10000. When the brackets 10030 are brought into the working position, the fabric thickness compensator 10020 can be gripped inside the staples 10030 and held close to the stitched fabric T. After moving the emphasis to the open position to release the fabric T, the supporting part 10010 can be moved from the fabric thickness compensator 10020, which remains sewn to t cani. An adhesive may be used to removably attach the tissue thickness compensator 10020 to the support portion 10010. A two-component adhesive can be used, whereby the first adhesive component can be applied to the surface of the platform 10011, and the second adhesive component can be applied to the fabric thickness compensator 10020 so that when the fabric thickness compensator 10020 is placed close to the surface of the platform 10011, the first component can contact the second component as a result of which the adhesive is activated with the formation of a detachable connection between the tissue thickness compensator 10020 and the supporting part 10010. Optionally, any other suitable means of creating a detachable retaining connection between the tissue thickness compensator and the supporting portion of the bracket cassette.

In addition to the above, the slide 10050 can move from the proximal end 10001 to the distal end 10002, fully accommodating all the brackets 10030 contained within the cassette with brackets 10000. As shown in FIG. 56-60, the slide 10050 can move distally inside the longitudinal cavity 10016 inside the supporting part 10010 by means of a trigger element or scalpel holder, 10052 surgical stapling instrument. During use, a cassette with brackets 10000 can be inserted into the channel for the cassette with staples in the jaw of the surgical stapling instrument, for example, in the channel for the cassette with brackets 10070, and push the trigger 10052 until it contacts the slide 10050, as shown in FIG. 56. When the slide 10050 is distally advanced by the trigger 10052, the slide 10050 can contact the most proximal ejector or ejectors of the staples 10040 and activate or push the staples 10030 out of the cassette body with the staples 10010 as described above. As shown in FIG. 56, the trigger element 10052 may further comprise a cutting edge 10053, which can move distally along the groove for the scalpel, made in the supporting part 10010, as the brackets 10030 are activated. In accordance with the present invention, the corresponding groove for the scalpel can pass through a stop located opposite the cartridge with brackets 10000, so that the cutting edge 10053 can extend between the abutment and the supporting part 10010 and cut through the fabric located between them and the fabric thickness compensator. In various situations, the trigger element 10052 can advance the slide 10050 distally until the slide 10050 reaches the distal end 10002 of the cassette with brackets 10000, as shown in FIG. 58. At such a moment, the trigger element 10052 can be retracted proximally. The trigger 10052 can retract the slide 10050 proximally, however, as shown in FIG. 59, when the trigger element 10052 is retracted, the slide 10050 may remain at the distal end 10002 of the cartridge with brackets 10000. After the trigger element 10052 is sufficiently retracted, the emphasis can be opened again, the tissue thickness compensator 10020 can be separated from the support portion 10010, and the remaining unimplanted portion of the used cassettes with brackets 10000, including the supporting part 10010, can be removed from the channel for the cassette with brackets 10070.

After removing the used cassette with brackets 10000 from the channel for the cassette with brackets, in addition to the above, in the channel for the cassette with brackets 10070 you can insert a new cassette with brackets 10000 or any other suitable cassette with brackets. In addition to the above, the channel for the cartridge with the brackets 10070, the trigger element 10052 and / or the cartridge with the brackets 10000 may contain auxiliary elements that can prevent the distal advancement of the trigger element 10052 for the second, subsequent time, without installing a new inactive cartridge with the brackets 10000 in the channel for a cassette with brackets 10070. More specifically, as shown in FIG. 56, when the trigger element 10052 is advanced to contact with the slide 10050, and also when the slide 10050 is in its proximal inactive position, the support nose 10055 of the trigger element 10052 may be located on and / or over the support collar 10056 on the slide 10050 so that the trigger the element 10052 was held high enough so that the fuse, or crossbar, 10054, passing from the starting element 10052, did not fall into the recess for the fuse formed inside the channel for the cartridge with brackets. Since the fuse 10054 does not fall into the fuse hole, in such circumstances, the fuse 10054 will not be able to abut against the distal side wall 10057 of the fuse hole while advancing the trigger element 10052. As the trigger element 10052 distally pushes the slide 10050, the trigger element 10052 can be supported in its upper starting position due to the fact that the supporting nose part 10055 lies on the supporting collar 10056. When the starting element 10052 is retracted relative to the slide 10050, as described above and shown in f IG. 59, the trigger element 10052 may move out of an elevated position and fall down because the nose nose 10055 no longer lies on the support shoulder 10056 of the slide 10050. For example, the surgical brace may include a spring 10058 and / or any other suitable biasing element that can be made with the possibility of shifting the trigger element 10052 in the lower position. After fully retracting the trigger element 10052, as shown in FIG. 60, the trigger element 10052 cannot again be distally advanced through the used cassette with brackets 10000. More specifically, the trigger element 10052 cannot be held in its upper position by the sled 10050, since the sled 10050 remains at the distal end of the 10002 cassette with the staples 10000 Therefore, as indicated above, if the trigger 10052 is again advanced forward without replacing the cassette with brackets, the fuse bar 10054 will come into contact with the side wall 10057 of the recess for the holder, which will not allow once again to distally advance the trigger element 10052 into the cartridge with brackets 10000. In other words, after replacing the used cartridge with brackets 10000 with a new one in a new cartridge with bracket brackets, the rails 10050 will be located proximally, they will be able to hold the trigger 10052 in its upper position and provide the ability to again distally advance the trigger element 10052.

As described above, the slide 10050 can be configured to move the ejector brackets 10040 between the first non-activated position and the second activated position to eject the brackets 10030 from the support part 10010. The ejector brackets 10040 after ejecting the brackets 10030 from the support part 10010 may be inside the bracket slots 10012. The support portion 10010 may comprise one or more retaining elements, which may be configured to prevent the ejectors or ejectors of the brackets 10040 from being ejected from the slots b 10012. Alternatively sled 10050 may be configured to eject staples from the ejectors 10040 10010 support part together with braces 10030. For example, 10040 ejectors staples may be formed from such a bioabsorbable and / or biocompatible material such as, for example, Ultem. The bracket ejector can be attached to the brackets 10030. For example, the bracket ejector can be molded on top of and around each bracket 10030 and so that the ejector is integral with the bracket. US Patent Application No. 11 / 541,123, entitled “SURGICAL SCRAPLES HAVING COMPRESSIBLE OR CRUSHING ELEMENTS FOR FIXING IN THEM FABRIC, AND SEWING TOOLS FOR PLACING”, hereby incorporated by reference in their entirety herewith on September 29, 2006.

As described above, the surgical stapling instrument may include a cassette holder with brackets adapted to receive a cassette with brackets, an abutment pivotally coupled to a channel for a cassette with brackets, and a trigger element containing a scalpel blade that is movable relative to emphasis and the channel for the cartridge with brackets. During use, the cassette with brackets can be located inside the channel for the cassette with brackets, and after at least partially spending the cassette with brackets, the cassette with brackets can be removed from the channel for the cassette with brackets and replaced with a new cassette with brackets. For example, a channel for a cassette with brackets, an emphasis and / or a trigger element of a surgical stapling instrument can be reused with a removable cassette with brackets. In alternative embodiments, the cassette with brackets may comprise a portion of the disposable assembly of the loading module, which may include, for example, a channel for the cassette with brackets, a stop and / or trigger, which can be replaced with the cassette with the brackets as part of the replacement of the disposable assembly of the loading module. Certain variations of the disposable loading module assembly are described in US Patent Application No. 12 / 031,817, entitled “CONFIGURATIONS FOR CONNECTING AN END SECTOR FOR A SURGICAL CUTTING AND BINDING INSTRUMENT”, filed February 15, 2008, the full description of which is incorporated herein by reference.

The tissue thickness compensator may comprise a composition suitable for extrusion, molding and / or molding, comprising at least one of the synthetic and / or non-synthetic materials described herein. The tissue thickness compensator may comprise a film or sheet containing one or more layers. The fabric thickness compensator can be obtained using traditional methods, such as, for example, mixing, blending, compounding, spraying, capillary flowing, evaporation of the solvent, immersion, brushing, vapor deposition, extrusion, calendering, molding, molding, etc. . During extrusion, the hole may be in the form of a die containing at least one hole shaping the outgoing extrudate. When calendering, the hole may be a gap between two rolls. Conventional molding methods may include, without limitation, blow molding, injection molding, foam injection, injection molding, thermoforming, extrusion, foam extrusion, film blowing, calendering, extrusion, solvent welding, coating methods such as dipping coatings and centrifugal coating, solution casting and film casting, plastisol treatment (including coating with a knife device, rollers, and casting), and combinations thereof. In injection molding, the hole may comprise a nozzle and / or channels / rollers and / or cavities and mold elements. In compression molding, the composition can be placed in the cavity of the injection mold, heated to a suitable temperature and molded by compression with a relatively high pressure. When casting, the composition may be a liquid or suspension that can be poured or otherwise placed in / on / around the mold or object to reproduce the elements of the mold or object. After casting, the composition can be dried, cooled and / or polymerized to give a solid.

In accordance with the present invention, a method of manufacturing a tissue thickness compensator may essentially comprise preparing a composition for a tissue thickness compensator, liquefying the composition to fluidize it, and forming the composition in a molten, semi-molten or plastic state to produce a layer and / or film having a desired thickness. As shown in FIG. 198A, a tissue thickness compensator can be made by dissolving the hydrogel starting material in an aqueous solution, dispersing biocompatible particles and / or fibers therein, preparing a molding mold having biocompatible particles, feeding the solution into a molding mold, bringing the activator into contact and solution and polymerization of the solution with the formation of a tissue thickness compensator containing an outer layer that contains biocompatible particles, and an inner layer that contains biocompatible particles embedded in it. As shown in FIG. 198A, a biocompatible layer 70250 may be provided at the bottom of the casting mold 70260, and an aqueous solution of the hydrogel starting material 70255 having biocompatible particles 70257 disposed therein can be provided in the casting mold 70260, and polymerization can be performed to form a fabric thickness compensator having a first layer containing a biocompatible material, for example, such as ORC, and a second layer containing a hydrogel, having biocompatible fibers, for example, such as ORC fibers placed therein. The tissue thickness compensator may comprise a foam that contains an outer layer containing biocompatible particles and an inner layer containing biocompatible particles embedded therein. A tissue thickness compensator can be made by dissolving sodium alginate in water, dispersing the ORC particles in it, preparing a casting mold having ORC particles in it, pouring the solution into the casting mold, spraying or infusing calcium chloride to contact the solution to initiate cross-linking of the alginate sodium, lyophilization of the hydrogel with the formation of a compensator for the thickness of the tissue containing the outer layer that contains ORC, and the inner layer that contains the hydrogel and ORC particles embedded in it.

As shown in FIG. 198B, a method of manufacturing a three-layer tissue thickness compensator may essentially include dissolving the first hydrogel starting material in a first aqueous solution, dispersing biocompatible particles and / or fibers in a first aqueous solution, preparing an injection mold 70260 having a first layer 70250 of biocompatible particles therein, feeding the first aqueous solution into a casting mold, bringing the activator and the first aqueous solution into contact, polymerizing the first aqueous solution to form a second layer 70255, dissolving the second initial hydrogel substances in a second aqueous solution, feeding a second aqueous solution into a casting mold, polymerizing a second aqueous solution to form a third layer 70265. A three-layer tissue thickness compensator can be made by dissolving sodium alginate in water to form a first aqueous solution, dispersing ORC particles in the first aqueous a solution, preparing a casting mold having a first layer of ORC particles in it, pouring a first aqueous solution into a casting, spraying or infusion mold of calcium chloride to contact the first aqueous m solution to initiate cross-linking of sodium alginate, lyophilization of the first aqueous solution to form a second layer containing a hydrogel having ORC particles embedded in it, dissolving sodium alginate in water to form a second aqueous solution, pouring the second aqueous solution into a casting mold, spraying or infusion of calcium chloride to contact a second aqueous solution to initiate crosslinking of sodium alginate, lyophilization of the second aqueous solution to form a third layer containing hydrogel b.

According to the present invention, a method of manufacturing a tissue thickness compensator comprising at least one drug incorporated or absorbed therein may essentially comprise preparing a tissue thickness compensator and bringing the tissue thickness compensator into contact with the drug to hold the drug inside the thickness compensator tissue. A method of manufacturing a tissue thickness compensator containing an antibacterial material may include preparing a hydrogel, drying the hydrogel, swelling the hydrogel in an aqueous solution of silver nitrate, and bringing the hydrogel into contact with a sodium chloride solution to form a tissue thickness compensator having antibacterial properties. The tissue thickness compensator may contain silver dispersed therein.

As shown in FIG. 204, a method of manufacturing a tissue thickness compensator may include co-extrusion and / or bonding. The tissue thickness compensator 70550 may comprise a multilayer material that comprises a first layer 70555 and a second layer 70560, hermetically covering the inner layer 70565, which contains, for example, a hydrogel. The hydrogel may contain, for example, a dry film, dry foam, powder and / or granules. The hydrogel may contain superabsorbent materials, for example, such as polyvinylpyrrolidone, carboxymethyl cellulose, polysulfopropyl acrylate. The first and / or second layers can be obtained on the production line by supplying raw materials for the first and second layers, respectively, to the extruder from the funnel and subsequent feeding of the first and second layers. The raw materials of the inner layer 70565 can be added to the extruder funnel. The raw materials can be dispersed mixed, and from them can be prepared at elevated temperatures inside the extruder. As raw materials exit the die opening 70570, the inner layer 70565 can be deposited on the surface of the first layer 70555. The tissue thickness compensator may comprise foam, film, powder and / or granule. The first and second layers 70555 and 70560 can be arranged so as to create a relationship in which they face each other. The second layer 70560 can be aligned with the first layer 70555 so as to create a relationship in which they are facing each other using a roll 70575. The first layer 70555 can be adhesively attached to the second layer 70560, and the first and second layers 70555, 70560 can physically capture inner layer 70565. The layers can be joined together at low pressure using traditional bonding processes by calendering and / or using adhesives, for example, with the formation of a fabric thickness compensator 70550. As shown in FIG. 78, the first and second layers 70555 and 70560 can, for example, be joined together by a rolling process using a grooved roller 70580. As a result of the above, optionally the inner layer 70565 may be contained and / or sealed by the first and second layers 70555 and 70560, which together form the outer layer, or barrier. The outer layer can prevent or reduce the contact of moisture with the inner layer 70565 until the outer layer is torn.

As shown in FIG. 61, the end effector 12 for the surgical instrument 10 (FIG. 1) may be configured to receive a cartridge assembly with fasteners, such as, for example, a cartridge with clips 20,000. As shown in FIG. 61, the cassette with brackets 20,000 can be configured to insert end effector 12 into branch channel 20072 of the cassette 20072. Alternatively, the cassette with brackets 20,000 can be integrally formed with end effector 12 such that the cassette with brackets 20,000 and end effector 12 are formed into type of construction with a single module. A cassette with brackets 20000 may comprise a first casing part, for example, such as a rigid support part 20010. A cassette with brackets 20000 may also comprise a second casing part, such as a compressible part or fabric thickness compensator 20020. Alternatively, a fabric thickness compensator 20020 may not contain the integral part of the cassette with brackets 20,000, but can be located differently relative to the end effector 12. For example, the tissue thickness compensator 20020 can be fixed to the stop 20060 of the end effector 12 or can otherwise be held tsya in the end effector 12. As shown in FIG. 78, the cassette with brackets may further comprise holding clips 20126, which may be configured to impede premature disconnection of the tissue thickness compensator 20020 from the support portion 20010. It will be apparent to the reader that the tissue thickness compensators described herein can be installed or otherwise engaged with different end effectors, and also that they are within the scope of the present invention.

Similar to tissue thickness compensators described herein, as shown in FIG. 78, the tissue thickness compensator 20020 can be released or uncoupled from the surgical end effector 12. For example, the rigid support portion 20010 of the cassette with brackets 20,000 can remain engaged with the cassette channel with fasteners 20072 of the end effector branch 20070 when the tissue thickness compensator 20020 is detached from the rigid the supporting part 20010. The fabric thickness compensator 20020 can be released from the end effector 12 after placing the staples 20030 (FIG. 78-83) from the slots for staples 20012 in the rigid supporting part 2010. The staples 20030 can be activated from the slots for I have brackets 20012 in such a way that the brackets 20030 engage with the fabric thickness compensator 20020. Also, as shown essentially in FIG. 63, 82, and 83, the bracket 20030 can grab a portion of the tissue thickness compensator 20020 with the stapled fabric T. The tissue thickness compensator 20020 can be deformable, and the portion of the tissue thickness compensator 20020 trapped inside the activated bracket 20030 can be compressed. Similar to fabric thickness compensators described herein, fabric thickness compensator 20020 can compensate for different thicknesses, compressibility and / or density of fabric T trapped inside each staple 20030. Additionally, as also described herein, fabric thickness compensator 20020 can compensate for gaps created by improperly formed brackets 20030.

The fabric thickness compensator 20020 may be compressible with a transition between the height (s) in the uncompressed state and the height (s) in the compressed state. As shown in FIG. 78, the fabric thickness compensator 20020 may have an upper surface 20021 and a lower surface 20022. The height of the fabric thickness compensator may be the distance between the upper surface 20021 and the lower surface 20022. The uncompressed height of the fabric thickness compensator 20020 may be the distance between the upper surface 20021 and the lower surface 20022 in the absence of the application of force or with the application of minimal force to the compensator tissue thickness 20020, i.e. when the fabric thickness compensator 20020 is not compressed. The compressed height of the fabric thickness compensator 20020 may be the distance between the upper surface 20021 and the lower surface 20022 when a force is applied to the fabric thickness compensator 20020, for example, when the activated bracket 20030 grips a portion of the fabric thickness compensator 20020. The fabric thickness compensator 20020 may have a distal end 20025 and proximal end 20026. As shown in FIG. 78, the height in the uncompressed state of the tissue thickness compensator 20020 between the distal end 20025 and the proximal end 20026 of the tissue thickness compensator 20020 may be uniform. Alternatively, the uncompressed height between the distal end 20025 and the proximal end 20026 may vary. For example, the upper surface 20021 and / or the lower surface 20022 of the tissue thickness compensator 20020 may be tilted and / or stepwise relative to another, so that the height in the uncompressed state between the proximal end 20026 and the distal end 20025 changes. The uncompressed height of the fabric thickness compensator 20020 may be, for example, approximately 2.0 mm (0.08 inches). In an alternative embodiment, the height in the uncompressed state of the fabric thickness compensator 20020 may vary, for example, from about 0.64 mm (0.025 in) to about 2.5 mm (0.10 in).

As described in more detail herein, a tissue thickness compensator 20020 between its proximal end 20026 and the distal end 20025 can be compressed to different heights in a compressed state. Alternatively, the fabric thickness compensator 20020 may be uniformly compressed along its length. The height (s) in the compressed state of the fabric thickness compensator 20020 may (may) depend, for example, on the geometrical shape of the end effector 12, the characteristics of the fabric thickness compensator 20020, the mesh T and / or staples 20030. The compressed height of the fabric thickness compensator 20020 may be associated with a tissue gap in the end effector 12. Optionally, when the stop 20060 is pressed against the cassette with brackets 20000, between the upper surface of the platform 20011 (FIG. 78) of the cassette with brackets 20000 and the contact surface 2001 (FIG. 61) of the stop 20060 might s formed tissue gap. The fabric clearance may be, for example, approximately 0.64 mm (0.025 inches) or approximately 2.5 mm (0.100 inches). The tissue gap may be, for example, approximately 0.750 millimeters or approximately 3,500 millimeters. The compressed height of the tissue thickness compensator 20020 may, for example, be equal to or substantially equal to the tissue gap. When the tissue T is located within the tissue gap of the end effector 12, the compressed height of the tissue thickness compensator may be less to accommodate the tissue T. For example, if the tissue gap is approximately 0.750 millimeters, then the compressed height of the tissue thickness compensator may be approximately 0.500 millimeters. For example, if the tissue gap is approximately 3,500 millimeters, then the compressed height of the tissue thickness compensator 20020 may be approximately 2.5 mm. In addition, the fabric thickness compensator 20020 may include a minimum height in a compressed state. For example, the minimum height in the compressed state of the tissue thickness compensator 20020 may be approximately 0.250 ml. The tissue gap formed between the surface of the cassette platform with the brackets and the abutment surface in contact with the fabric may, for example, be equal to or at least substantially equal to the height in the uncompressed state of the tissue thickness compensator.

As shown primarily in FIG. 62, fabric thickness compensator 20020 may comprise a fibrous nonwoven fabric 20080 including fibers 20082. Fabric thickness compensator 20020 may comprise felt or felt-like material. Fibers 20082 in non-woven fabric 20080 can be bonded together by any means known in the art, including, without limitation, the needle-punched method, temperature bonding, hydro-bonding, ultrasonic bonding, chemical bonding and aerodynamic bonding. Additionally, layers of nonwoven fabric 20080 can be bonded together mechanically, thermally or chemically to form a fabric thickness compensator 20020. As described in more detail herein, fiber nonwoven fabric 20080 can be compressible, which can compress fabric thickness compensator 20020. Fabric thickness compensator 20020 also may contain an incompressible part. For example, a fabric thickness compensator 20020 may comprise a compressible nonwoven fabric 20080 and an incompressible portion.

As shown primarily in FIG. 62, non-woven fabric 20080 may comprise a plurality of fibers 20082. At least some of the fibers 20082 in the non-woven fabric 20080 may be compressed fibers 20086. Compressed fibers 20086 may be, for example, compressed, spun, twisted, curved, deformed, curled, curled and / or bent fibers within non-woven fabric 20080. As described in more detail herein, compressed fibers 20086 may be given any suitable shape so that the deformation of compressed fibers 20086 creates a spring load or restoring force. Compressed fibers 20086 by thermoforming can be twisted or substantially helical in shape. Compressed fibers 20086 can be formed from uncompressed fibers 20084. For example, uncompressed fibers 20084 can be wrapped around a heated mandrel to form a substantially spiral shape.

The tissue thickness compensator 20020 may comprise a uniform absorbable polymer matrix. The uniform absorbable polymer matrix may comprise, for example, foam, gel and / or film. Additionally, a plurality of 20082 fibers may be dispersed in a uniform absorbable polymer matrix. At least some of the 20082 fibers in a uniform absorbable polymer matrix may be, for example, compressed 20086. As described in more detail herein, a uniform absorbent polymer matrix of a tissue thickness compensator 2002 may be compressible.

As shown in FIG. 65 and 66, the compressed fibers 20086 can be randomly dispersed in at least a portion of the nonwoven fabric 20080. For example, the compressed fibers 20086 can be randomly dispersed in the nonwoven fabric 20080 such that a portion of the nonwoven fabric 20080 contains more compressed fibers 20086 than others parts of nonwoven fabric 20080. Additionally, compressed fibers 20086 can be assembled into fiber clusters in nonwoven fabric 20080, for example, nonwoven fabric 20085a, 20085b, 20085c, 20085d and 20085e. The shape of the compressed fibers 20086 may be such that it causes entanglement of the fibers 20086 in the manufacturing process of nonwoven material 20080; entanglement of compressed fibers 20086, in turn, can lead to the formation of clusters of fibers 20085a, 20085b, 20085c, 20085d and 20085e. Additionally or alternatively, the compressed fibers 20086 may be randomly oriented on the nonwoven fabric 20080. For example, as shown in FIG. 62, the first compressed fiber 20086a may be oriented in the first direction, the second compressed fiber 20086b may be oriented in the second direction, and the third compressed fiber 20086c may be oriented in the third direction.

Compressed fibers 20086 can be systematically distributed and / or located at least in part of the nonwoven fabric 20080. For example, as shown in FIG. 67, compressed fibers 20186 may be located in a configuration 20185 in which a plurality of compressed fibers 20186a are located in a first direction and another plurality of compressed fibers 20186b are located in a second direction. Compressed fibers 20186 can overlap in such a way that they become tangled or interconnected with each other. Compressed fibers 20186 can be systematically arranged such that compressed fibers 20186a are substantially parallel to another compressed fiber 20186a. Another compressed fiber 20186b may be substantially transverse to some compressed fibers 20186a. Optionally, the compressed fibers 20186a may be substantially aligned along the first Y axis, and the compressed fibers 20186b may be substantially aligned along the second X axis. The first Y axis may, for example, be perpendicular or substantially perpendicular to the second X axis.

As shown primarily in FIG. 68, the crimped fibers 20286 can be arranged in a configuration 20285. Each crimped fiber 20286 may comprise a longitudinal axis formed between the first end 20287 and the second end 20289 of the compressed fiber 20286. The compressed fibers 20286 can be systematically distributed in the nonwoven fabric 20080 so that the first the end 20287 of one compressed fiber 20286 was adjacent to the second end 20289 of the other compressed fiber 20286. Alternatively, as shown in FIG. 69, the fiber configuration 20385 may, for example, comprise a first compressed fiber 20386a oriented in a first direction, a second compressed fiber 20386b oriented in a second direction, and a third compressed fiber 20386c oriented in a third direction. In accordance with the present invention, a single pattern or configuration of crimped fibers 20286 may be repeated over nonwoven fabric 20080. Compressed fibers may be arranged over nonwoven fabric 20080 in accordance with different patterns. As a further alternative, the nonwoven fabric 20080 may comprise at least one pattern of compressed fibers, as well as a plurality of randomly oriented and / or randomly distributed compressed fibers.

As shown in FIG. 62, a plurality of fibers 20082 in nonwoven fabric 20080 may comprise at least some uncompressed fibers 20084. The uncompressed fibers 20084 and compressed fibers 20086 in nonwoven fabric 20080 may be entangled or interconnected. The ratio of compressed fibers 20086 and uncompressed fibers 20084 may be, for example, approximately 25: 1. Alternatively, the ratio of compressed fibers 20086 to uncompressed fibers 20084 may be, for example, approximately 1:25. Alternatively, the ratio of compressed fibers 20086 to uncompressed fibers 20084 may be, for example, approximately 1: 1. As described in more detail herein, the number of compressed fibers 20086 per unit volume of nonwoven fabric 20,080 may affect the recovery force created by the nonwoven fabric 20080 upon deformation of the nonwoven fabric 20,080. As also described in more detail herein, the recovery force created by the nonwoven fabric 20,080 may also depend, for example, on the material, shape, size, position and / or orientation of the compressed and uncompressed fibers 20086, 20084 in the nonwoven material 20080.

Fibers 20082 non-woven material 20080 may contain a polymer composition. The polymer composition of fibers 20082 may contain non-absorbable polymers, absorbable polymers, or combinations thereof. Absorbable polymers may include bioresorbable biocompatible elastomeric polymers. In addition, the polymer composition of the fibers 20082 may contain synthetic polymers, non-synthetic polymers, or combinations thereof. Examples of synthetic polymers include, without limitation, polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. For example, 20082 fibers may contain a copolymer of 90/10 glycolide and L-lactide, such as, for example, a copolymer commercially available from Ethicon Inc. under the trade name VICRYL (polyglactic 910). Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharide, glycoprotein, elastin, proteoglycan, gelatin, collagen, and oxidized regenerated cellulose (ORC). Optionally, similarly to the polymer compositions in tissue thickness compensators described herein, the polymer composition of fibers 20082 may include different weight ratios of the amount of absorbable polymers, non-absorbable polymers, synthetic polymers and / or non-synthetic polymers.

Compressed fibers 20086 of nonwoven fabric 20080 may comprise a first polymer composition, and uncompressed fibers 20084 of nonwoven fabric 20080 may comprise another polymer composition. For example, compressed fibers 20086 may contain synthetic polymer (s), such as, for example, a copolymer of 90/10 glycolide and L-lactide, while uncompressed fibers 20084 may contain non-synthetic polymer (- s), such as, for example, oxidized regenerated cellulose. Alternative compressed fibers 20086 and uncompressed fibers 20084 may contain the same polymer composition.

As described herein, compressed fibers 20086 and uncompressed fibers 20084 can be bonded together, for example, by needle punching, heat bonding, hydrolinking, ultrasonic pattern bonding, chemical bonding and aerodynamic spray bonding. Compressed fibers 20086 containing synthetic polymers, such as, for example, VICRYL (polyglactic 910), and uncompressed fibers 20084 containing oxidized regenerated cellulose can be joined together by needle-punching to form nonwoven fabric 20080. Nonwoven fabric 20080 may contain, for example, from about 5% to 50% by weight of compressed fibers from VICRYL (polyglactic 910) 20086 and approximately 5% to 50% by weight of unpressed fibers of oxidized regenerated cellulose (ORC) 20084. When non-woven fabric 2000 comes in contact with T fabric, ORC 20084 non-compressed fibers m For example, quickly interact with plasma in tissue to form a gelatinous mass. The formation of gelatinous mass ORC can occur instantly or almost instantly in contact with tissue. Additionally, after the formation of a gelatinous mass of ORC, compressed fibers from VICRYL (polyglactic 910) 20086 can remain dispersed over non-woven fabric 20080. For example, compressed fibers 20086 can be suspended in a gelatinous mass of ORC. As the ORC gelatinous mass bioabsorbs, compressed fibers from VICRYL (polyglactic 910) 20086 can exert a spring force on adjacent tissue, as described in more detail herein. Additionally, tissue healing may begin around the fibers of VICRYL (polyglactic 910) and / or the formed staples 30030, as also described in more detail herein.

As shown primarily in FIG. 78-81, the support portion 20010 of the cartridge with brackets 20000 may comprise a cartridge case 20017, an upper surface of the platform 20011 and a plurality of slots for brackets 20012. Each bracket slot 20012 may form an opening in the surface of the platform 20011. The bracket 20030 may be removably located in the slot for staples 20012. In accordance with the present invention, in each slot for brackets 20012 there is one bracket 20030. As shown primarily in FIG. 82 and 83, and similarly to the brackets described herein, each bracket 20030 may comprise a base 20031 having a first end 20035 and a second end 20036. The leg of the bracket 20032 may extend from the first end 20035 of the base 20031, and the other leg 20032 may extend from the second end 20036 founding 20031. As shown in FIG. 78-81, prior to placement of the brackets 20030, the base 20031 of each bracket 20030 may be supported by a bracket ejector 20040 located within the rigid support portion 20010 of the cartridge with brackets 20000. Also, prior to placement of the brackets 20030, the legs 20032 of each bracket 20030 may at least partially be contained within the bracket slot 20012.

Feet 20030 can be placed between the starting position and the activated position. For example, as shown primarily in FIG. 81, the brackets 20030 may be in the starting position (brackets 20030e, 20030f), partially activated or intermediate position (brackets 20030c, 20030d) or activated position (brackets 20030a, 20030b). The ejector 20040 can push the staples between the starting position and the activated position. For example, the base 20031 of each bracket 20030 may be supported by the ejector 20040. The legs 20032 of the bracket (for example, the brackets 20030e, 20030f of FIG. 80) may be located inside the slot for the brackets 20012. As the trigger or slide to activate the brackets 20050 translates from the proximal end 20001 to the distal end 20002 of the cassette with brackets 20000, the inclined surface 20051 on the rails 20050 can contact the inclined surface 20042 on the ejector 20040 to accommodate the bracket 20030 located above the contacted ejector 20040. The staples 20030 can be placed between the initial position and the activated position so that the legs 20032 move through the nonwoven fabric 20080 of the fabric thickness compensator 20020, penetrate the upper surface 20021 of the fabric thickness compensator 20020, penetrate the fabric T and contact the stop 20060 (FIG. 61), located opposite the cartridge with brackets 20000 in the end effector 12. The legs of the brackets 20032 can be deformed close to the stop 20060 and the legs 20032 of each bracket 20030 can capture part of the non-woven material 20080 and part of the fabric T.

In the activated configuration (FIGS. 82 and 83), each bracket 20030 can exert a compressive force on the fabric T and tissue thickness compensator 20020 trapped inside the bracket 20030. As shown primarily in FIG. 80 and 81, legs 20032 of each staple 20030 can be deformed downward to the base 20031 of the staple 20030 to form a grip area of the staple 20039. The grip area of the staple 20039 can be an area in which the activated bracket 20030 can grip tissue T and tissue thickness compensator 20020. B In different circumstances, the grip area of the bracket 20039 may be formed between the inner surfaces of the deformed legs 20032 and the inner surface of the base 20031 of the bracket 20030. The size of the grip area 20039 of the bracket 20030 may depend on several factors, for example Example, from the length of the legs, the diameter of the legs, the width of the base and / or the degree of deformation of the legs.

Optionally, when gripping the nonwoven fabric 20080 into the grip area of the bracket 20039, the captured portion of the nonwoven fabric 20080 may be compressed. The compressed height of the nonwoven fabric 20 080 captured in the grip area of the bracket 20039 may vary within the cassette with the brackets 20000 depending on the fabric T in the same grip area of the bracket 20039. For example, in the case of a thinner fabric T in the grip area of the bracket 20039 there is more room for non-woven fabric 20080, and as a result, the non-woven fabric 20080 may not be compressed as if the fabric T were thicker. In the case of a thicker fabric T, the nonwoven fabric 20080 may be compressed more, for example, to accommodate the thicker fabric T. For example, as shown in FIG. 82, non-woven fabric 20080, for example, can be compressed to a first height in the first grip area of the bracket 20039a, to a second height in the second grip area of the bracket 20039b, to a third height in the third grip area of the bracket 20039c, to a fourth height in the fourth grip area of the bracket 20039d and to the fifth height in the fifth capture area of the bracket 20039e. Similarly, as shown in FIG. 83, the nonwoven fabric 20080 can be compressed to a first height in the first grip area of the bracket 20039a, to a second height in the second grip area of the bracket 20039b, to a third height in the third grip area of the bracket 20039c and to a fourth height in the fourth grip area of the bracket 20039d. Alternatively, the compressed height of the nonwoven fabric 20080 may be uniform across the cassette with brackets 20010.

Optionally, an applied force may transfer the nonwoven fabric 20080 from the original uncompressed configuration to the compressed configuration. Additionally, the nonwoven fabric 20080 can be resilient, so that when compressed, the nonwoven fabric 20080 can create a spring-loaded or restoring force. The deformed nonwoven material 20080 may seek to recover from a compressed or deformed configuration. When the nonwoven fabric 20080 seeks to regain shape, it can exert a spring-loaded or restoring force on the tissue also trapped in the grip region of the staple 30039, as described in more detail herein. In the subsequent elimination of the applied force, the restoring force may cause the nonwoven material to recover from the compressed configuration. Non-woven fabric 20080 may restore shape to the original uncompressed configuration, or may restore shape to a configuration substantially similar to the original uncompressed configuration. The deformation of the nonwoven material 20080 may be elastic. The deformation of the nonwoven material may be partially elastic and partially plastic.

When a portion of the nonwoven fabric 20080 is compressed in the grip area of the bracket 20039, the compressed fibers 20086 in this portion of the nonwoven compensator 20039 can also be compressed or otherwise deformed. The degree of deformation of the compressed fiber 20086 may correspond to the degree of compression of the captured portion of the nonwoven material 20080. For example, as shown in FIG. 63, the nonwoven fabric 20080 can be gripped by placing the brackets 20030. In cases where the nonwoven fabric 20080 is more compressed by the placed bracket 20030, the average deformation of the compressed fibers 20086 may be greater. Additionally, in cases where the non-woven material 20080 is less compressed by the placed bracket, the average deformation of the compressed fibers 20086 may be less. Similarly, as shown in FIG. 82 and 83, in the grip region 20039d, in which the nonwoven fabric 20080 is compressed to a greater degree, the compressed fibers 20086 in this grip region 20039d are, on average, more deformed. Additionally, in the grip region 20039a in which the nonwoven fabric 20080 is less compressed, the compressed fibers 20086 in this grip region 20039a are less deformed on average.

The ability of non-woven fabric 20080 to restore shape from a deformed configuration, i.e. the elasticity of the nonwoven fabric 20080 may depend on the elasticity of the compressed fibers 20086 in the nonwoven fabric 20080. Compressed fibers 20086 may undergo elastic deformation. Deformation of compressed fibers 20086 may be partially elastic and partially plastic. Optionally, the compression of each compressed fiber 20086 may result in the compressed fibers 20086 creating a spring or restoring force. For example, compressed compressed fibers 20086 can create a restoring force as 20086 fibers tend to restore shape from their compressed configuration. Fibers 20086 may seek to return to their original uncompressed configuration or to a configuration substantially similar to it. Compressed fibers 20086 may seek to partially return to their original configuration. Optionally, only a portion of the compressed fibers 20086 in the nonwoven fabric 20080 may be resilient. When the compressed fiber 20086 is formed from a linearly elastic material, the recovery force of the compressed compressed fiber 20086 may depend, for example, on the compression ratio of the compressed fiber 20086 and the elasticity coefficient of the compressed fiber 20086. The elasticity coefficient of the compressed fiber 20086 may depend, for example, at least on orientation, material, shape and / or size of compressed fiber 20086.

Compressed fibers 20086 in non-woven fabric 20080 may contain a uniform coefficient of elasticity. Alternatively, the coefficient of elasticity of compressed fibers 20086 in nonwoven fabric 20080 may vary. With strong compression of the compressed fiber 20086 having a high coefficient of elasticity, the compressed fiber 20086 can create a large restoring force. With less compression of the compressed fiber 20086 having the same high coefficient of elasticity, the compressed fiber 20086 can produce less restoring force. The cumulative amount of restoring forces created by compressed squeezed fibers 20086 in non-woven fabric 20080 can create a total restoring force on the non-woven material 20080 of the fabric thickness compensator 20020. Non-woven material 20080 can exert a total restoring force on the fabric T trapped inside the activated bracket 20030, with the compressed non-woven material 20080.

Moreover, the elasticity coefficient of a nonwoven material 20080 may be affected by the number of compressed fibers 20086 per unit volume of nonwoven material 20,080. For example, the elasticity of the nonwoven material 20080 may be low, for example, if the number of compressed fibers 20086 per unit volume of nonwoven material 20,080 is low; for example, the elasticity of the nonwoven material 20080 may be higher with a larger number of compressed fibers 20086 per unit volume of nonwoven material 20080; and, for example, the elasticity of the nonwoven fabric 20080 can be even higher with an even greater number of compressed fibers 20086 per unit volume of nonwoven fabric 20080. If the elasticity of the nonwoven fabric 20080 is low, for example, when the number of compressed fibers 20086 per unit volume of nonwoven fabric 20080 is low, the overall recovery the force exerted by the tissue thickness compensator 20020 to the captured tissue T may also be low. If the elasticity of the nonwoven fabric 20080 is higher, for example, when the number of compressed fibers 20086 per unit volume of the nonwoven fabric 20,080 is greater, the combined restoring force exerted by the compensator for the thickness of the fabric 20020 to the captured fabric T can also be higher.

As shown primarily in FIG. 64, the non-woven fabric 20080 'of a tissue thickness compensator 20020' may comprise a therapeutic agent 20088, for example, such as a drug and / or pharmaceutically active agent. Non-woven fabric 20080 ′ can release a therapeutically effective amount of therapeutic agent 20088. For example, therapeutic agent 20088 can be released as the non-woven fabric 20080 ′ is absorbed. The therapeutic agent 20088 can be released into a fluid, for example, such as blood, passing over or through the non-woven fabric 20080 ′. Examples of therapeutic agents 20088 may include, without limitation, hemostatic agents and drugs, for example, such as fibrin, thrombin and / or oxidized regenerated cellulose (ORC); anti-inflammatory drugs, such as, for example, diclofenac, aspirin, naproxen, sulindac and / or hydrocortisone; antibiotics and antimicrobial drugs or agents, such as, for example, triclosan, silver ions, ampicillin, gentamicin, polymyxin B and / or chloramphenicol; and anti-cancer agents, such as, for example, cisplatin, mitomycin and / or adriamycin. The therapeutic agent 20088 may contain a biological product, for example, such as a stem cell. Fibers 20082 of nonwoven fabric 20080 ′ may comprise therapeutic agent 20088. Alternatively, therapeutic agent 20088 may be added to nonwoven fabric 20080 ′ or otherwise integrated into a fabric thickness compensator 20020 ′.

As shown primarily in FIG. 70-70B, tissue thickness compensator 20520 for end effector 12 (FIG. 61) may comprise a plurality of springs or twisted fibers 20586. Similarly to crimped fibers 20086 described herein, twisted fibers 20586 inside tissue thickness compensator 20520 can be, for example, crimped twisted, curved, deformed, spiral, twisted and / or curved. Twisted fibers 20586 can be wrapped around the mandrel to form a twisted or substantially helical shape. The twisted fibers 20586 can be randomly oriented and / or randomly distributed over the tissue thickness compensator 20520. Alternatively, the twisted fibers 20586 can be arranged systematically and / or evenly distributed over the tissue thickness compensator 20520. For example, as shown in FIG. 70, the twisted fibers 20586 may comprise a longitudinal axis between the first end 20587 and the second end 20589 of the twisted fiber 20586. The longitudinal axis of the twisted fibers 20520 in the tissue thickness compensator 20520 may be parallel or substantially parallel. The first end 20587 of each twisted fiber 20520 can be located along the first longitudinal side 20523 of the fabric thickness compensator 20520, and the second end 20589 of each twisted fiber 20586 can be located along the second longitudinal side 20524 of the fabric thickness compensator 20520. In this configuration, the twisted fibers 20586 can pass laterally through the fabric thickness compensator. Alternatively, twisted fibers 20586 may extend longitudinally or diagonally through the fabric thickness compensator 20520.

Optionally, similarly to the compressed fibers 20086 described herein, twisted fibers 20586 may comprise a polymer composition. Compressed fibers 20586 can be at least partially elastic, so that the deformation of compressed fibers 20586 creates a restoring force. The polymer composition of twisted fibers 20586 may contain, for example, polycaprolactone (PCL), so that spiral fibers 20586 are insoluble in a chlorophyll solvent. As shown in FIG. 70A, springs or twisted fibers 20520 can be held in compensating material 20580. Compensating material 20580 can hold twisted fibers 20586 in a loaded position, so that twisted fibers 20586 apply a spring load to or inside the compensating material 20580. Compensating material 20580 can hold twisted fibers 20586 in neutral position so that the twisted fibers 20586 do not exert a spring load on or inside the compensating material 20580. The compensating material 20580 may be bioabsorbable, and in some cases, may contain foam, such as, for example, polyglycolic acid (PGA) foam. Moreover, the compensating material 20580 may be soluble, for example, in a chlorophyll solvent. The tissue thickness compensator may contain twisted fibers 20586, which contain, for example, polycaprolactone (PCL), and a compensating material 20580, which contains polyglycolic acid foam (PGA), so that the twisted fibers 20520 are insoluble in a chlorophyll solvent, while the compensating material 20580 is soluble in a chlorophyll solvent. The compensating material 20580 can be at least partially elastic, so that when the compensating material 20580 is compressed, a restoring force is created. Additionally, as shown in FIG. 70B, tissue thickness expansion material 20580 compensating material 20520 may comprise a therapeutic agent 20588, for example, such as stem cells. Compensating material 20580 can release a therapeutically effective amount of therapeutic agent 20588 as absorbent material 20580 is absorbed.

Similar to tissue thickness compensator 20020 described herein, fabric thickness compensator 20520 can be compressible. For example, when placing the staples 20030 (FIG. 78-81) from the initial position to the activated position, the staples 20030 can engage a portion of the fabric thickness compensator 20520. According to the present invention, the bracket 20030 can capture the fabric thickness compensator 20520 and adjacent fabric T. The bracket 20030 can apply compressive force to the gripped portion of the tissue thickness compensator 20520 and fabric T, so that the tissue thickness compensator 20520 is compressed from a height in an uncompressed state to a height in a compressed state. Compression of the tissue thickness compensator 20520 may result in corresponding deformation of the twisted fibers 20586 therein. As described in more detail herein, the deformation of each twisted fiber 20586 can create a restoring force, which can depend, for example, on the elasticity of the twisted fiber, the degree of deformation of the twisted fiber 20586 and / or the coefficient of elasticity of the twisted fiber 20586. The coefficient of elasticity of the twisted fiber 20586 can at least depend, for example, on the orientation, material, shape and / or size of the twisted fiber 20586. The deformation of the twisted fibers 20586 in the tissue thickness compensator 20520 can create restoring forces on the fabric thickness compensator 20520. The fabric thickness compensator 20520 may apply the combined restoring force created by the deformed twisted fibers 20586 and / or the elastic compensating material 20586 to the tissue T trapped in the activated brackets 20030.

As shown primarily in FIG. 71 and 72, tissue thickness compensator 20620 for end effector 12 may comprise a plurality of spring coils 20686. Like crimped fibers 20086 and twisted fibers 20586 described herein, spring coils 20686 inside tissue thickness compensator 20620 may, for example, be crimped, twisted, curved, deformed, spiral, twisted and / or curved. Optionally, like the fibers and coils described herein, spring coils 20686 may comprise a polymer composition. Additionally, the spring coils 20686 can be at least partially elastic, so that the deformation of the spring coils 20686 creates a restoring force. Spring coils 20686 may comprise a first end 20687, a second end 20689, and a longitudinal axis between them. As shown in FIG. 71, the first end 20686 of the spring coil 20686 can be located at or near the proximal end 20626 of the tissue thickness compensator, and the second end 20689 of the same spring coil 20686 can be located at or near the distal end 20625 of the tissue thickness compensator 20620, resulting in, for example, a spring coil 20686 extends longitudinally through a tissue thickness compensator 20620. Alternatively, twisted fibers 20686 may laterally or diagonally pass through a tissue thickness compensator 20620.

The tissue thickness compensator 20620 may comprise an outer film 20680 that at least partially surrounds at least one spring coil 20686. As shown in FIG. 71, an outer film 20680 can extend around the perimeter of a plurality of spring coils 20686 in a tissue thickness compensator 20620. Alternatively, an outer film 20680 can completely seal the spring coils 20686 or at least one spring coil 20686 in a tissue thickness compensator 20620. An outer film 20680 can hold the spring coils 20686 in the end effector 12. The outer film 20680 can hold the spring coils 20686 in the loaded position, so that the spring coils 20686 create a spring load and apply a spring force e to the outer film 20680. Alternatively, the outer film 20680 can hold the spiral spring 20686 in the neutral position. The tissue thickness compensator 20620 may also contain filling material 20624. The filling material 20624 can be held inside and around the spring coils 20686 using an outer film 20680. The filling material 20624 may contain a therapeutic agent 20688 similar to the therapeutic agents described herein. Additionally, the filling material 20624 can support spring coils 20686 inside the tissue thickness compensator 20620. The filling material 20624 can be compressible and at least partially resilient, so that the filling material 20624 also contributes to the creation of spring-loaded or restoring force by the thickness compensator of the fabric 20620, as described in more detail in this document.

Similar to tissue thickness compensators described herein, fabric thickness compensator 20620 can be compressible. When the brackets 20030 (FIG. 78-81) are placed from the initial position to the activated position, the brackets 20030 can engage a part of the tissue thickness compensator 20620. Optionally, each bracket 20030 can grab a part of the tissue thickness compensator 20620 with adjacent fabric T. The bracket 20030 can exert a compressive force on the captured portion of the tissue thickness compensator 20620 and the captured tissue T, so that the tissue thickness compensator 20620 is compressed, moving from a height in an uncompressed state to a height in a compressed state. Compression of the tissue thickness compensator 20620 may result in corresponding deformation of the spring coils 20686 held therein (FIG. 72). As described in more detail herein, the deformation of each spring coil 20686 can create a restoring force, which depends, for example, on the elasticity of the spring coil 20686, the degree of deformation of the spring coil 20686 and / or the coefficient of elasticity of the spring coil 20686. The coefficient of elasticity of the spring coil 20686 may depend , for example, at least the material, shape and / or dimensions of the spring coil 20686. Moreover, depending on the elasticity of the filling material 20624 and the outer film 20680, compression of the filling material Ala 20624 and / or outer film 20680 can also create restorative forces. The combination of restoring forces created by at least deformed spring coils 20686, filling material 20624 and / or an outer film 20680 in the tissue thickness compensator 20620 can create restoring forces on the tissue thickness compensator 20620. The tissue thickness compensator 20620 can exert the combined restoring force created by the deformed spring spirals 20686, to tissue T captured in activated bracket 20030.

Optional, as shown primarily in FIG. 73-75, tissue thickness compensator 20720 for end effector 12 may comprise a plurality of spring coils 20786. Like the spun fibers and springs described herein, spring coils 20786 inside tissue thickness compensator 20720 may be, for example, crimped, twisted, curved, deformed spiral, twisted and / or curved. The spring coils 20786 can be at least partially elastic, so that the deformation of the spring coils 20786 creates a restoring force. Additionally, the spring coils 20786 may comprise a first end 20787, a second end 20789 and a longitudinal axis between them. As shown primarily in FIG. 75, the first end 20787 of the spring coil 20786 can be located at or near the proximal end 20726 of the tissue thickness compensator 20720, and the second end 20789 of this spring coil 20786 can be located at or near the distal end 20725 of the tissue thickness compensator 20720, so that the spring coil 20786 longitudinally passes through the tissue thickness compensator 20720. A spring coil 20786 in the tissue thickness compensator 20720 may extend longitudinally in two parallel rows. The tissue thickness compensator 20720 can be located in the end effector 12 so that the slide 20050 (FIG. 61) or the cutting element 20052 can translate along the groove 20015 between the parallel rows of spring coils 20786. Alternatively, the spring coils 20786 can laterally or diagonally pass through the thickness compensator fabric 20720.

As also shown in FIG. 75, spring coils 20786 can be held or incorporated into compensating material 20780. Compensating material 20780 may be bioabsorbable, and in some cases may contain foam, such as, for example, polyglycolic acid (PGA) foam. The compensating material 20780 may be resilient, so that deformation of the compensating material 20780 creates a spring force. Compensating material 20780 may be soluble, for example, in a chlorophyll solvent. For example, a tissue thickness compensator may include spring coils 20786, containing, for example, polycaprolactone (PCL), and compensating material 20780 containing polyglycolic acid foam (PGA), so that spring coils 20786 are insoluble in chlorophyll solvent, and the compensating material 20780 is soluble in chlorophyll solvent. The compensating material 20780 may be at least partially elastic, so that the deformation of the compensating material 20780 creates a spring load or a restoring force.

The fabric thickness compensator 20720 may comprise interwoven yarns 20790 that can extend between parallel rows of spring coils 20786. For example, as shown in FIG. 75, the first interwoven yarn 20790 can diagonally pass through two parallel rows of spring coils 20786, and the second interwoven yarn 20790 can also diagonally pass through two parallel rows of spring coils 20786. The first and second interwoven yarn 20790 can be arranged crosswise. The interwoven yarns 20790 can intersect crosswise many times along the length of the fabric thickness compensator 20720. The interwoven yarns 20790 can hold the spring coils 20786 in a loaded configuration such that the spring coils 20786 are held essentially flat in the fabric thickness compensator 20720. The interwoven yarns 20790 passing through the fabric thickness compensator 20720 can be attached directly to the spring coils 20786. Alternatively, the interwoven yarns 20790 can be connected to the spring coils 20786 through a support 20792 passing through each spring coil 20786 along its longitudinal axis.

As described in more detail herein, a cassette with brackets 20000 may include a groove 20015 configured to receive translationally moving sled 20050 containing a cutting element 20052 (FIG. 61). When translating the slide 2050 along the groove 20015, the slide 20050 can push the brackets 20030 out of the fastener seats 20012 in the cassette with the brackets 20000, and the cutting element 20052 can cut the fabric T simultaneously or almost simultaneously. As also shown in FIG. 75, as the cutting element 20052 is moved forward, it can also cut through the interwoven yarns 20790, which intersect crosswise between the parallel rows of spring coils 20786 in the fabric thickness compensator 20720. When dissecting the interwoven yarns 20790, each coil spring 20786 can be released from its loaded configuration so that each spring coil 20786 returns from a loaded substantially flat position in the tissue thickness compensator 20720 to an expanded position. Optionally, as the spring coil 20786 expands, the compensating material 20780 surrounding the spring coil 20786 can also expand.

Optionally, as the brackets 20030 (FIG. 78-81) are placed from the initial position to the activated position, the brackets 20030 may engage a portion of the tissue thickness compensator 20720, and the tissue thickness compensator 20720 may expand or attempt to expand inside the brackets 20030 and apply compressive force to the tissue T. Optionally, at least one bracket 20030 can capture a portion of the tissue thickness compensator 20720 with adjacent tissue T. The bracket 20030 can compressively capture the captured portion of the tissue thickness compensator 20720 and the captured tissue T, as a result of ltate that tissue thickness compensator 20720 is compressed, changing the height of the uncompressed height to a compressed state. Compression of the tissue thickness compensator 20720 may result in corresponding deformation of the spring coils 20786 held therein and the compensating material 20780. As described in more detail herein, deformation of each coil spring 20786 can create a restoring force, which can depend, for example, on the elasticity of the spring coil, the degree of deformation of the spring coil 20786 and / or the coefficient of elasticity of the spring coil 20786. The coefficient of elasticity of the spring spiral 20786 can at least depend, for example, on the orientation nth, material, shape and / or size of the spring spiral 20786. The combination of restoring forces created by at least deformed spring spirals 20786 and / or compensating material 30380 in the tissue thickness compensator 20720 can create a restoring force on the tissue thickness compensator 20720. Fabric thickness compensator 20720 may apply the combined restoring force exerted by the deformed spring coils 20786 in the tissue thickness compensator 20720 to the tissue T captured by the activated brackets 20030.

Optional, as shown primarily in FIG. 76 and 77, the tissue thickness compensator 20820 for the surgical end effector 12 may comprise a spring coil 20886. Like the fibers and springs described herein, spring spirals 20886 inside the tissue thickness compensator 20820 may, for example, be crimped, twisted, curved, deformed, spiral, twisted and / or curved. The spring coil 20886 may comprise a polymer composition and may be at least partially elastic, so that deformation of the spring coil 20886 creates a spring force. Additionally, the spring coil 20886 may comprise a first end 20887 and a second end 20889. As shown in FIG. 76, the first end 20887 can be located at or near the proximal end 20826 of the tissue thickness compensator 20820, and the second end 20889 can be located at or near the distal end 20825 of the tissue thickness compensator 20820. The spring coil 20886 can wriggle or bend from the proximal end of 20825 to a distal end 20826 of a tissue thickness compensator 20820.

As also shown in FIG. 76, the spring coil 20886 can be held or embedded in the compensating material 20880. The compensating material 20880 may be bioabsorbable, and in some cases may contain foam, such as, for example, polyglycolic acid (PGA) foam. Compensating material 20880 may be soluble, for example, in a chlorophyll solvent. The tissue thickness compensator may comprise spring coils 20886 containing, for example, polycaprolactone (PCL), and compensating material 20880 comprising polyglycolic acid foam (PGA), so that spring coils 20886 are insoluble in a chlorophyll solvent, and the compensating material 20880 is soluble in a chlorophyll solvent . The compensating material 20880 may be at least partially elastic, so that deformation of the compensating material 20880 creates a spring load or a restoring force.

Similar to tissue thickness compensators described herein, fabric thickness compensator 20820 may be compressible. Compression of the tissue thickness compensator 20820 may result in deformation of at least a portion of the spring coil 20886 held or integrated in the tissue thickness compensator 20880 compensating material 20820. As described in more detail herein, deformation of the spring coil 20886 can create restoring forces that may depend. for example, from the elasticity of the spring spiral 20886, the degree of deformation of the spring spiral 20886 and / or the coefficient of elasticity of the spring spiral 20886. The set of restoring forces created by of at least a deformed spring coil 20886 and / or a deformed compensating material 20880, can create restoring forces on the tissue thickness compensator 20820. The tissue thickness compensator 20820 can exert a combined restoring force on the tissue T trapped in the activated braces 20030.

As shown in FIG. 84, the surgical end effector 12 may comprise a tissue thickness compensator 30020 having at least one tubular member 30080. The tissue thickness compensator 30020 may be held in the surgical end effector 12. As described in more detail herein, the fastener in the end effector 12 may be arranged so that the fastener moves to the activated position and deforms at least a portion of the tubular element 30080 in the tissue thickness compensator 30020. It will be apparent to the reader that the thickness compensators S fabrics containing at least one tubular element, as described herein, may be installed or otherwise engaged with various surgical end effectors, and also that they are within the scope of the present invention.

Optional, as shown in FIG. 84, the tissue thickness compensator 30020 may be positioned relative to the stop 30060 of the end effector 12. Alternatively, the tissue thickness compensator 30020 may be positioned relative to the cartridge assembly with fasteners, such as the cartridge with brackets 30000 of the end effector 12. The cartridge with brackets 30000 may be configured installation in the channel for the cartridge 30072 jaws 30070 end effector 12. For example, the compensator for the thickness of the fabric 30020 can be detachably mounted on the cartridge with brackets 30000. The tubular element 30080 compensator tissue thickness 30020 may be adjacent to the upper surface of the platform 30011 of the rigid support portion 30010 of the cassette with brackets 30000. The tubular member 30080 may be secured to the upper surface of the platform 30011 using an adhesive or sheath similar to at least one of the sheaths described herein (e.g., FIG. 16). The fabric thickness compensator 30020 can be made integrally with the assembly containing the cassette with brackets 30000, so that the cassette with brackets 30000 and the fabric thickness compensator 30020 are formed as a structure with a single module. For example, a cassette with brackets 30000 may comprise a first housing part, such as, for example, a rigid support part 30010, and a second housing part, for example, such as a fabric thickness compensator 30020.

As shown in FIG. 84-86, the tubular member 30080 in the tissue thickness compensator 30020 may comprise an elongated portion 30082 having at least one clearance 30084 that extends at least partially through it. As shown primarily in FIG. 86, an elongated portion 30082 of the tubular member 30080 may comprise woven or braided strands 30090, as described in more detail herein. Alternatively, the elongated portion 30082 may comprise a continuous structure such as polymer extrusion rather than woven strands 30090. The elongated portion 30082 of the tubular member 30080 may comprise a thickness. The thickness of the elongated portion 30082 may be substantially uniform along its length and around the diameter; in other cases, the thickness may vary. 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, for example, have a length of from about 30.5 mm (1.20 inches) to about 66.0 mm (2 , 60 inches) and a diameter of from about 2.5 mm (0.10 inches) to about 3.81 mm (0.15 inches). The length of the tubular member 20080 may be, for example, approximately 35.6 mm (1.40 inches), and the diameter of the tubular member 20080 may be, for example, approximately 3.18 mm (0.125 inches). Moreover, the elongated portion 30082 may, for example, form a substantially circular or elliptical cross-sectional shape. Alternatively, the cross-sectional shape may comprise a polygonal shape, such as, for example, a triangle, a hexagon and / or an octagon. As also shown in FIG. 84, the tubular member 30080 may comprise a first distal end 30083 and a second proximal end 30085. The cross-sectional shape of the elongated portion 30082 may narrow at the first and / or second end 30083, 30085, with at least one end 30083, 30085 of the tubular member 30080 closed and / or sealed. Alternatively, the lumen 30084 can extend through the distal ends 30083, 30085 of the tubular member 30080, so that the ends 30083, 30085 are open.

The tubular member 30080 may comprise one central lumen 30084 extending at least partially through the elongated portion 30084. The clearance 30084 may extend through the full length of the elongated portion 30084. In a further alternative embodiment, the tubular member 30080 may comprise a plurality of gaps 30084 passing through it. Gaps 30084 passing through the tubular element 30080 may have a round, semicircular, beveled shape and / or combinations thereof. In accordance with the present invention, the tubular member 30080 may also comprise support meshes that may form a modified T or X shape within the lumen 30084. Dimensions, clearance (s) and / or support (s) inside the tubular member 30080 may form a cross-sectional shape of the tubular member 30080. The cross-sectional shape of the tubular member 30080 may be the same in length or alternatively the cross-sectional shape of the tubular member 30080 may vary along its length. As described in more detail herein, the cross-sectional shape of the tubular member 30080 may affect the compressibility and elasticity of the tubular member 30080.

The tubular element 30080 may comprise a vertical diameter and a horizontal diameter; its dimensions can be selected depending on the configuration of the tubular element 30080 in the end effector 12, the dimensions of the end effector 12, including the tissue gap of the end effector 12, and also on the expected geometric shape of the gripping areas of the staples 30039. For example, the vertical diameter of the tubular element 30080 may depend on the expected height of the formed bracket. In such cases, the vertical diameter of the tubular element 30080 can be selected so that the vertical diameter can be reduced from about 5% to about 20% when gripping the tubular element 30080 inside the formed bracket 30030. For example, a tubular element 30080 with a vertical diameter of approximately 2.5 mm ( 0.100 inches) can be used with brackets having an expected formed height of from about 2.0 mm (0.080 inches) to about 2.4 mm (0.095 inches). As a result, the vertical diameter of the tubular member 30080 can be reduced by about 5% to about 20% when the formed staple 30030 is caught inside even if there is no tissue T trapped therein. If tissue T is trapped inside the formed staple 30030, then the compression of the tubular member 30080 can to be even stronger. The vertical diameter may be uniform along the length of the tubular member 30080, or alternatively, the vertical diameter may vary along its length.

The horizontal diameter of the tubular element 30080 in the undeformed or restored configuration of the tubular element 30080 may be equal to, greater than or less than the vertical diameter of the tubular element 30080. For example, as shown in FIG. 85, the horizontal diameter, for example, may be approximately three times the vertical diameter. For example, the horizontal diameter may be approximately 10 mm (0.400 inches), and the vertical diameter may be approximately 3.18 mm (0.125 inches). Alternatively, as shown in FIG. 87, the horizontal diameter of the tubular member 31080 may be equal to or substantially equal to the vertical diameter of the tubular member 31080 when the tubular member 31080 is in an undeformed or restored configuration. For example, the horizontal diameter may be approximately 3.18 mm (0.125 inches), and the vertical diameter may also be approximately 3.18 mm (0.125 inches). The tubular member 30080 may have a vertical diameter of approximately 3.18 mm (0.125 inches), a horizontal diameter of approximately 10 mm (0.400 inches), and a length of approximately 36 mm (1.400 inches). As described in more detail herein, by applying a force A to the tubular member 30080 and / or 31080, the tubular member can be deformed such that the geometric shape of the cross section, including horizontal and vertical diameters, can vary.

As also shown in FIG. 84-86, the tubular member 30080 in the tissue thickness compensator 30020 may be deformable. The entire tubular element 30080 may be deformable. For example, the tubular element 30080 may be deformable from the proximal end 30083 to the distal end 30085 of the elongated portion 30082 and around its entire circumference. Alternatively, only part of the tubular member 30080 can be deformable. For example, only an intermediate length of the elongated portion 30082 and / or only part of the circumference of the tubular member 30080 can be deformable.

When a compressive force is applied to the contact point on the elongated portion 30082 of the tubular member 30080, the contact point may be displaced, as a result of which the cross-sectional dimensions of the tubular member 30080 may change. For example, as also shown in FIG. 85, the tubular member 30080 may comprise an upper peak 30086 and a lower peak 30088 on an elongated portion 30082. In the original undeformed configuration, the tubular member 30080 may comprise undeformed cross-sectional dimensions, including an undeformed vertical diameter between the upper peak 30086 and the lower peak 30088. With compressive force And toward the top apex 30086, the tubular member 30080 can move into a deformed configuration. In a deformed configuration, the cross-sectional dimensions of the tube 30080 can be changed. For example, the tube 30086 may contain a deformed vertical diameter between the upper peak 30086 and the lower peak 30088, which may be smaller than the undeformed vertical diameter. As shown in FIG. 87, the horizontal diameter of the deformed tube 30080 can be lengthened, for example, by moving the tubular member 30080 from an undeformed configuration to a deformed configuration. The deformed cross-sectional dimensions of the deformed tube 30080 may at least depend on the position, angular orientation, and / or magnitude of the applied force A. As described in more detail herein, deformation of the tubular member 30080 may create a spring-loaded or restoring force, which may depend on the elasticity of the tubular element 30080.

As shown in FIG. 85, the tubular member 30080 in compression may create a spring or restoring force. In such cases, as described herein, the tubular member 30080 can move from the original undeformed configuration to the deformed configuration by applying a force A to the contact point on the elongated portion 30082 of the tubular member 30080. When the applied force A is removed, the deformed tube 30080 can reconstruct from the deformed configurations. The deformed tube 30080 may restore the original undeformed configuration, or may restore a configuration substantially similar to the original undeformed configuration. The ability of the tubular member 30080 to restore shape from a deformed configuration is related to the elasticity of the tubular member 30080.

As also shown in FIG. 85, tubular member 30080 may exert a springing or restoring force. A restoring force can be created by the tubular member 30080 by applying a force A to the tubular member 30080, for example, using a bracket 30030 (FIGS. 88 and 89), as described in more detail herein. The applied force A can vary the cross-sectional dimensions of the tubular element 30080. Moreover, in linearly elastic materials, the restoring force of each deformed part of the tubular element 30080 may depend on the dimensions of the tubular element 30080 in the deformed state, as well as on the coefficient of elasticity of this part of the tubular element 30080. The coefficient of elasticity of the tubular element 30080 may, for example, depend at least on the orientation, material, geometrical shape of the cross section and / or on the dimensions of the tube th element 30080. The tubular member 30080 in tissue thickness compensator 30020 can comprise a uniform elastic coefficient. Alternatively, the coefficient of elasticity can vary along the length and / or around the diameter of the tubular member 30080. When the portion of the tubular member 30080 having the first coefficient of elasticity is strongly compressed, the tubular member 30080 can generate a large restoring force. With less compression of the tubular member 30080 having the same first coefficient of elasticity, the tubular member 30080 can produce less restoring force.

As also shown in FIG. 84, the tubular member 30080 in the tissue thickness compensator 30020 may comprise a polymer composition. The elongated portion 30082 of the tubular member 30080 may comprise a polymer composition. Additionally, the polymer composition may contain at least partially elastic material, so that the deformation of the tubular element 30080 creates a restoring force. The polymer composition may contain, for example, non-absorbable polymers, absorbable polymers, or combinations thereof. Examples of synthetic polymers include, without limitation, polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. Absorbable polymers may include, for example, bioresorbable biocompatible elastomeric polymers. Moreover, the polymer composition of the tubular element 30080 may contain, for example, synthetic polymers, non-synthetic polymers, or combinations thereof. Optionally, similarly to the polymer compositions described in other sections of this document, the polymer composition of the tubular element 30080 may include different weight ratios of the amount of absorbable polymers, non-absorbable polymers, synthetic polymers and / or non-synthetic polymers.

As shown in FIG. 84 and 85, the tubular member 30080 may comprise a therapeutic agent 30098, for example, such as a pharmaceutically active agent or drug. The therapeutic agent 30098 may be held in the lumen 30084 of the tubular member 30080. The elongated portion 30082 may seal or partially seal the therapeutic agent 30098. Additionally or alternatively, the therapeutic agent 30098 may form part of the polymer composition of the elongated portion 30082. The tubular member 30080 may release a therapeutically effective amount of therapeutic agent 30098 The therapeutic agent 30098 may be released as the tubular member 30080 is absorbed. For example, therapeutic agent 30098 may t released into the fluid (for example, into the blood), passing above the tubular element 30080 or through it. As an additional alternative, therapeutic agent 30098 can be released, for example, by piercing with a bracket 30030 (FIGS. 88 and 89) a tubular element 30080 and / or by cutting a portion of the tubular element 30080 with a cutting element 30052 on a slide to activate the brackets 30050 (FIG. 84) . Examples of therapeutic agents 30098 may include, without limitation, hemostatic agents and drugs, such as, for example, fibrin, thrombin and / or oxidized regenerated cellulose (ORC), anti-inflammatory drugs, such as, for example, diclofenac, aspirin, naproxen, sulindac and / or hydrocortisone, antibiotics, and antimicrobials or agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B and / or chloramphenicol, anti-cancer agents such as cisplatin, mit icin and / or adriamycin, and / or biological products, for example, stem cells.

As also shown in FIG. 84, 88 and 89, fasteners, for example, such as staples 30030, can be placed from the cassette with brackets 30000 so that the staples 30030 engage the tissue thickness compensator 30020 and apply a force A to the tubular member 32080 therein. As described herein, the application of force A to the tubular member 30080 may cause the tubular member 30080 to deform. Like the end effectors 12 described herein, the rigid cassette supporting portion 30010 with brackets 30000 may comprise a cassette body 30017, a platform surface 30011 and a plurality of slots for brackets 30012. Each bracket slot 30012 may form an opening in the surface of the platform 30011, and the bracket 30030 may be removably located in the bracket slot 30012 (FIG. 104). As shown primarily in FIG. 88 and 89, each bracket 30030 may comprise a base 30031 and two bracket legs 30032 extending from the base 30031. Prior to placement of the brackets 30030, the base 30031 of each bracket 30030 may be supported by a bracket ejector 30040 (FIG. 104) located within the rigid support portion 30010 of the cassette with staples 30000. Also, until staples 30030 are placed, the legs 30032 of each staple 30030 may be at least partially contained within the staple socket 30012 (FIG. 104).

Optionally, as described in more detail herein, the brackets 30030 may be placed from a starting position into an activated position. For example, the slide for activating the staples 30050 may engage the ejector 30040 (FIG. 104) to move at least one bracket 30030 between the initial position and the activated position. As shown primarily in FIG. 88, the bracket 30030 can be moved to the activated position, the legs 30032 of the bracket 30030 engage the tubular element 32080 of the tissue thickness compensator 32020, penetrate into the tissue T and come into contact with the stop 30060 (FIG. 104) located in the surgical end effector 12 opposite the cassette with brackets 30000 The recesses for forming the staples 30062 in the abutment 30060 can bend the legs of the staples 30032 so that the activated staple 30030 grips part of the tubular member 32080 and part of the fabric T in the grip area of the staple 30039. As described in more detail herein, enshey least one leg of staples 30032 may puncture the tubular member 32080 compensator tissue thickness when moving 32020 30030 bracket between a rest position and an activated position. Alternatively, the legs of the brackets 30032 can move around the perimeter of the tubular element 32080 so that the legs of the brackets 30032 do not pierce the tubular element 32080. Like the fasteners described herein, the legs 30032 of each bracket 30030 can be deformed down to the base 30031 of the bracket 30030 to form an area between them the grip of the bracket 30039. The grip area of the bracket 30039 may be an area in which the activated bracket 32020 grips the tissue T and part of the tissue thickness compensator 30030. In the activated position, each bracket 30030 can There is a compressive force applied to the fabric T and the tissue thickness compensator 32020 trapped inside the grip area 30039 of the staple 30030.

As shown in FIG. 88, when gripping the tubular member 32080 in the gripping area of the bracket 30039, the gripped portion of the tubular member 32080 may be deformed as described herein. Moreover, the tubular element 32080 can be deformed into different deformed configurations in different gripping areas of the staples 30039 depending on, for example, the thickness, compressibility and / or density of the fabric T trapped in the same gripping area of the staple 30039. The tubular element 32080 in the tissue thickness compensator 32080 may extend longitudinally through successive gripping areas of the brackets 30039. In this configuration, the tubular member 32080 may be deformed into different deformed configurations in each gripping area of the bracket 30039 along a row activated s staples 30030. As shown in FIG. 89, the tubular members 33080 in the tissue thickness compensator 33020 can be laterally positioned in the gripping areas of the staples 30039 along a series of activated staples 30030. The tubular members 33080 can be held by the flexible sheath 33210. In such configurations, the tubular elements 33080 and the flexible sheath 33210 can be given different deformed configurations in each grip area of the bracket 30039. For example, where the fabric T is thinner, the tubular elements 33080 can be compressed less, and where the fabric T is thicker, the tubular elements 33080 can be compressed stronger, accommodating a thicker fabric T. Alternatively, the dimensions of the tubular elements 33080 in a deformed state can be uniform along the entire length and / or width of the fabric thickness compensator 33020.

As shown in FIG. 90-92, the tubular member 34080 in the tissue thickness compensator 34020 may comprise a plurality of strands 34090. As shown primarily in FIG. 90, the strands 34090 may be woven or woven into a tubular grid 34092 forming a tubular element 34080. The tubular grid 34092 formed by the strands 34090 may be substantially hollow. The strands 34090 of the tubular member 34080 may be solid strands, tubular strands and / or strands of any other suitable shape. For example, as shown in FIG. 91, one strand 34090 of the tube sheet 34092 may be a tube. As shown in FIG. 93, a strand 34090 may contain at least one clearance 34094 passing through it. The number, geometrical shape and / or size (s) of the grooves 34094 may determine the cross-sectional shape of the strand 34090. For example, the strand 34090 may contain round clearance (s), semicircular (s) clearance (s), beveled (s) clearance (s) and / or combinations thereof. In accordance with the present invention, the strand 34090 may also contain support nets 34096, which can form a modified T or X-shape. The cross-sectional shape of the strand 34090 can be determined by at least the diameter of the strand 34090, the passage (s) passing through it by the lumen (s) and the support (s) of the mesh (s). The cross-sectional shape of each strand 34090, as described in more detail herein, can affect the springing or restoring force exerted by the strand 34090 and the corresponding springing or restoring force exerted by the tubular member 34080.

As shown in FIG. 94, the tubular lattice 34092 of the strands 34090 may be deformable. The tubular grating 34092 can determine or contribute to the deformability and / or elasticity of the tubular element 34080. For example, the strands 34090 of the tubular grating 34092 can be twisted together so that the strands 34090 are slidable and / or bent relative to each other. When a force is applied to the elongated portion 34082 of the tubular member 34080, the strands 34090 therein may slide and / or bend so that the tubular grating 34092 moves into a deformed configuration. For example, as shown in FIG. 94, the bracket 30030 can compress the tube sheet 34092 and the fabric T caught in the grip area of the bracket 34039, which can cause the strands 34090 of the tube sheet 34092 to slide and / or bend relative to each other. When the tubular grating 34092 is compressed into a deformable configuration, the upper vertex 34086 of the tubular grating 34092 can move to the lower apex 34088 of the tubular grating 34092, accommodating the tissue T captured in the grip region of the bracket 30039. In various circumstances, the tubular grating 34092 captured in the activated bracket 30030 will tend return to its undeformed configuration, and can apply a restoring force to the captured tissue T. Additionally, parts of the tubular lattice 34092 located between the gripping regions of the staples 30039, i.e. those that are not trapped inside the activated bracket 30030 can also be deformed due to the deformation of adjacent parts of the tubular lattice 34092, which are inside the gripping areas of the brackets 30039. Where the tubular lattice 34092 is deformed, the lattice 34092 may tend to restore shape or partially restore shape from a deformed configuration. Optionally, portions of the tubular grating 34092 can restore shape to their original configurations, and other parts of the tubular grating 34092 can only restore shape partially and / or remain fully compressed.

Similar to the description of the tubular elements presented in the present description, each strand 34090 can also be deformable. Additionally, deformation of the strand 34090 can create a restoring force, which depends on the elasticity of each strand 34090. As shown mainly in FIG. 91 and 92, each strand 34090 of the tubular grating 34092 may be tubular. Alternatively, each strand 34090 of the tube sheet 34092 may be continuous. In a further alternative embodiment, the tubular grating 30092 may comprise at least one tubular strand 34090, at least one continuous strand 34090, at least one X- or T-shaped strand 34090 and / or a combination thereof.

The strands 34090 in the tubular element 34080 may contain a polymer composition. The polymer composition of the strand 34090 may contain non-absorbable polymers, absorbable polymers, or combinations thereof. Examples of synthetic polymers include, without limitation, polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. Absorbable polymers may include, for example, bioresorbable biocompatible elastomeric polymers. Moreover, the polymer composition of the strand 34090 may contain synthetic polymers, non-synthetic polymers and / or combinations thereof. Optionally, similarly to the polymer compositions described in other sections of this document, the polymer composition of strand 34090 may contain different weight ratios of the amount of absorbable polymers, non-absorbable polymers, synthetic polymers and / or non-synthetic polymers.

The strands 34090 in the tubular member 34080 may further comprise a therapeutic agent 34098 (FIG. 91), for example, such as a pharmaceutically active agent or a drug. A strand 34090 can release a therapeutically effective amount of a therapeutic agent 34098. A therapeutic agent 34098 can be released as the tubular strand 34090 is absorbed. For example, a therapeutic agent 30098 can be released into a fluid, such as blood, passing over or through a 34090 strand. In a further alternative embodiment, therapeutic agent 34098 may be released, for example, by piercing a strand 30030 with a strand 34090 and / or by cutting a portion of the tube sheet 34092 with a cutting member 30052 on a slide to activate the brackets 30050 (FIG. 84). Examples of therapeutic agents 34098 may include, without limitation, hemostatic agents and drugs, for example, such as fibrin, thrombin and / or oxidized regenerated cellulose (ORC), anti-inflammatory drugs, for example, such as diclofenac, aspirin, naproxen, sulindac and / or hydrocortisone, antibiotics and antimicrobial drugs or agents, for example, such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B and / or chloramphenicol, anticancer agents, for example, such as c isplatin, mitomycin and / or adriamycin; and / or biological products, for example, such as stem cells.

As shown in FIG. 95 and 96, the tubular member 35080 may comprise a plurality of layers 35100 strands 35090. The tubular member 35080 may comprise a plurality of layers 35100 tubular grids 35092. As shown in FIG. 95, the tubular member 35080 may, for example, comprise a first layer 35100a and a second layer 35100b of strands 35090. As shown in FIG. 96, the tissue thickness compensator tubular member 35180 of the fabric thickness 35120 may comprise, for example, a third strand layer 35100c of strands 35090. Moreover, the different layers 35100 in the tubular member 35180 may contain different materials. Each layer 35100a, 35100b, 35100c may be bioabsorbable, each layer 35100a, 35100b, 35100c may contain different polymer compositions. For example, the first layer 35100a may comprise a first polymer composition; the second layer 35100b may comprise a second polymer composition; and the third layer 35100c may comprise a third polymer composition. In such cases, the layers 35100a, 35100b, 35100c of the tubular member 35180 may undergo bioabsorption at different rates. For example, the first layer 35100a can be absorbed quickly, the second layer 35100b can be absorbed slower than the first layer 35100a, and the third layer 35100c can be absorbed slower than the first layer 35100a and / or second layer 35100b. 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.

Similarly to the strands 34090 described herein, the strands 35090 in the tubular member 35180 may contain the drug 35098. As shown in FIG. 95, to control the elution or release of drug (s) 35098, the first layer 35100a of strands 35090a containing drug 35098a may undergo bioabsorption at a first rate, and the second layer 35100b of strands 35090 containing drug 30098b may be bioabsorption at a second rate. For example, the first layer 35100a can be absorbed quickly to provide a quick initial release of the drug 35098a, and the second layer 35100b can be absorbed more slowly to provide a controlled release of the drug 30098b. The drug 35098a in the strands 35090 of the first layer 30100a may be different from the drug 35098b in the strands 35090 of the second layer 35100b. For example, strands 35090 in the first layer 35100a may contain oxidized regenerated cellulose (ORC), and strands 35090 in the second layer 35100b may contain a solution that contains hyaluronic acid. In such cases, the initial absorption of the first layer 35100a can release oxidized regenerated cellulose to control bleeding, and the subsequent absorption of the second layer 35100b can release a solution containing hyaluronic acid to prevent the formation of adhesions in the tissue. Alternatively, layers 35100a, 35100b may contain the same drug 35098a, 35098b. For example, as also shown in FIG. 96, strands 35090 in layers 35100a, 35100b and 35100c may contain an anti-cancer agent, for example, such as cisplatin. Moreover, the first layer 35100a can be absorbed quickly to provide a fast initial release of cisplatin, the second layer 35100b can be absorbed more slowly to provide a controlled release of cisplatin, and the third layer 35100c can be absorbed more slowly to provide a longer, controlled release of cisplatin.

As shown in FIG. 97 and 98, fabric thickness compensator 36020 may comprise molded material 36024. Molded material 36024 may be formed outside of tubular member 36080, inside tubular member 36080, or both inside and outside of tubular member 36080. As shown in FIG. 97, the molded material 36024 may be coextruded both inside and outside the tubular member 36080, and the tubular member 36080 may comprise a tubular grid 36092 of 36090 strands. Similarly to the polymer composition described herein, the molded material 36024 may comprise, for example, polyglycol acid (PGA), polylactic acid (PLA) and / or any other suitable bioabsorbable and biocompatible elastomeric polymers. Additionally, the molded material 36024 may be non-porous, so that the molded material 36024 forms a fluid-tight layer in the tubular member 36080. A lumen 36084 can be formed through the molded material 36024.

In addition to the above, the tubular member 36080 and / or the strands 36090 in the tubular grid 36092 may contain a therapeutic agent 36098. As shown in FIG. 97 and 98, the non-porous molded material 36024 may contain the drug 36098 inside the inner lumen 36084a. Alternatively or additionally, the non-porous molded material 36024 may contain the drug 36098 inside the intermediate lumen 36084b, for example, such as the intermediate lumen 36084b, which contains the tubular grid 36092 of the drug-containing strands 36090. Similar to the above, the tubular element 36080 can be located relative to the nests for staples 30012 and a cutting element 30052 in the cassette with staples 30000 (FIG. 84). The placement of the staples 30030 and / or the translational movement of the cutting element 30052 may be capable of puncturing or tearing the non-porous molded material 36024, so that the drug 36098 contained in at least one lumen 36084 of the tubular element 30080 can be released from the lumen 30084. As shown in FIG. 99, the tubular member 37080 may comprise a non-porous film 37110. The non-porous film 37110 may at least partially surround the tubular 37092 or the first layer 37100a and the second layer 37100b of the tubular grids 30092 to provide a fluid-tight coating similar to the molding 36024 described herein document.

As described herein, the tubular element may comprise at least one of a bioabsorbable material, a therapeutic agent, a plurality of strands, a tubular grating, layers of tubular gratings, a molded material, a non-porous film, or combinations thereof. For example, as shown in FIG. 100, the tubular member 38080 may comprise a molded material 38024 and a plurality of strands 38090 located through a central lumen 38084 of the tubular member 38080. The strands 38090 may comprise a therapeutic agent 38098. Alternatively, for example, as shown in FIG. 101, the tubular member 39080 may comprise a molded material 39024 and a therapeutic agent 39098 located in a central lumen 39084 of the tubular member 39080. Optionally, at least one of the tubular member 39080 and the molded material 39024 may comprise a flowable therapeutic agent 39098.

As also shown primarily in FIG. 84, the tubular member 30080 may be located relative to the rigid support portion 30010 of the cassette with brackets 30000. The tubular member 30080 may be longitudinally adjacent to the rigid support portion 30010. The tubular member 30080 may be substantially parallel to or aligned with the longitudinal groove or cavity 30015 in the rigid the supporting part 30010. The tubular element 30080 can be aligned with the longitudinal groove 30015 so that part of the tubular element 30080 overlaps part of the longitudinal groove 30015. In such cases, the cutting element 30052 on the slide to activate the staples 30050 m can dissect a portion of the tubular member 30080 as the cutting edge 30052 progressively moves along the longitudinal groove 30015. Alternatively, the tubular member 30080 may be longitudinally located on the first or second side of the longitudinal groove 30015. In a further alternative embodiment, the tubular member 30080 may be located relative to the rigid support portion 30010 cassettes with brackets 30000 so that the tubular element 30080 laterally or diagonally pass through at least a portion of the rigid support portion 30010.

As shown, for example, in FIG. 102, the tissue thickness compensator 40020 may comprise a plurality of tubular elements 40080. For example, the tubular elements 40080 may comprise different lengths, cross-sectional shapes and / or materials. Additionally, the tubular elements 40080 may be located relative to the rigid support portion 40010 of the cassette with brackets 30000 so that the tubular axis of the tubular elements 40080 are parallel to each other. The tubular axes of the tubular members 40080 may be longitudinally aligned so that the first tubular member 40080 is located inside another tubular member 40080. Alternatively, the parallel tubular members 40080, for example, may longitudinally pass through a cassette with brackets 30000. In a further alternative, the parallel tubular members 40080 may be laterally or diagonally pass through a cassette with brackets 30000. Alternatively, non-parallel tubular elements 40080 can be oriented at an angle relative to each other so that their tubular axes intersect and / or are not parallel to each other.

As shown in FIG. 102-105, a fabric thickness compensator 40020 may have two tubular members 40080; the first tubular element 40080a may be longitudinally located on the first side of the longitudinal groove 30015 in the rigid support portion 30010, and the second tubular element 40080b may be longitudinally located on the second side of the longitudinal groove 30015. Each tubular element 40080 may comprise a tubular grating 40092 of strands 40090. Cassette with brackets 30000 may contain a total of six rows of slots for brackets 30012, and, for example, three rows of slots for brackets 30012 are located on each side of the longitudinal groove 30015. In such cases, the cutting edge 30052 is translationally moving In order to activate the staples 30050, the slide may not be required to cut part of the tubular element 40080.

Similarly, as shown in FIG. 106-107, the fabric thickness compensator 41020 may comprise two tubular members 41080a, 41080b longitudinally disposed in a cassette with brackets 30000. Similar to the above, the brackets 30030 of three rows of slots for brackets 30012 can engage one tubular element 41080a, and the brackets 30030 of three other rows of sockets for brackets 30012 may engage another tubular element 41080b. As shown in FIG. 106-107, the placed brackets 30030 may engage the tubular member 40080 in different places through the cross section of the tubular member 40080. As described herein, the spring loaded elasticity and the corresponding restoring force exerted by the tubular member 41080 may depend, inter alia, on the cross-sectional shape the tubular element 41080. The bracket 30030, located in the grip area of the bracket 30039, located in the arcuate part of the tubular element 41080 or near it, may experience more restoring force, it bracket 30030 30039 staples in capture situated nearby nedugoobraznoy portion. Similarly, the bracket 30030 located in the grip region of the bracket 30039 in the arched portion of the tubular member 41080 may experience less restoring force than the restoring force experienced by the bracket 30030 located in or near the curved portion of the tubular member 30080. In other words, the arcuate parts of the tubular element 41080 can have a greater coefficient of elasticity than the arcuate part of the tubular element 41080, due to the possibility of gripping more elastic material with brackets 30030 along such parts. As a result, this is optional, as shown in FIG. 107, the restoring force exerted by the tissue thickness compensator 41020 may be greater in the vicinity of the staples 30030a and 30030c and less in the vicinity of the bracket 30030b in the tubular member 30080a. Accordingly, the restoring force generated by the tissue thickness compensator 41020 may be greater in the vicinity of the staples 30030d and 30030 than in the vicinity of the bracket 30030e in the tubular member 30080b.

As shown in FIG. 102-105, geometric cross-sectional shapes of the strands 40090 forming the tubular grating 40092 can be selected to provide the desired spring-loaded elasticity and the corresponding restoring force exerted by the tubular grating 40092. For example, as also shown in FIG. 103, strands 40090a located in the arcuate portions of the tubular element 40080 may contain X-shaped cross sections, while strands 40090b located in the arcuate portions of the tubular element 40080 may contain tubular cross sections. Strands 40090a and 40090b, containing different geometric cross-sectional shapes, can be twisted together to form a tubular lattice 40092. Alternatively, strands 40090a and 40090b can be attached to each other, for example, using adhesive. As shown in FIG. 104 and 105, different geometric cross-sectional shapes of the strands 40090 in the tubular element 40080 allow optimizing the restoring force that is tested in the gripping areas of the staples 30039 in the cassette with brackets 30000. Specific geometric cross-sectional shapes can be chosen so that the constant elasticity in the gripping areas of the staples 30039 in the cassette with brackets is essentially balanced or the same.

As shown in FIG. 108, the tubular thickness compensator tubular members 41080a, 41080b of the fabric 41120 can be fastened together by an adjacent portion 41126. Although the translationally moving cutting member 30052 can be configured to extend between the tubular members 41080a and 41080b, it may be necessary for the cutting member 30052 to cut through at least a portion of an adjacent portion 41126. The connecting portion 41126 may comprise a soft material, such as, for example, foam or gel, easily dissected by a translationally cutting cutting element 30052. Adjacent portion 41026 may detachably fasten the tissue thickness compensator 41120 to the surgical end effector 12. The adjacent part 41126 can be fixed on the upper surface of the platform 30011 of the rigid support part 30010 so that the adjacent part 41126 remains held in the surgical end effector 12 after releasing the tubular elements 41080a, 41080b from it.

As shown in FIG. 109-110, the fabric thickness compensator 42020 may comprise a plurality of tubular elements 42080, such that the number of tubular elements 42080, for example, matches the number of rows of slots for brackets 30012 in a cassette with brackets 30000. A cassette with brackets 30000 may contain six rows of slots for brackets 30012 and the fabric thickness compensator 42020 may comprise six tubular members 42080. Each tubular member 42080 can be substantially aligned with a row of bracket slots 30012. When pushing the brackets 30030 from a row of bracket slots 30012, each bracket 30030 from this row can pierce the same tr sponge element 42080 (FIG. 110). The deformation of one tube 42080 may have little or no effect on the deformation of the adjacent tube 42080. Accordingly, the tubular elements 42080 can exert a substantially discrete and individual spring-loaded force in the gripping areas of the brackets 30039 across the width of the cassette with brackets 30030. When the brackets 30030 activated from the plurality of rows of slots for brackets 30012, the same tubular element 35080 (FIG. 107) is engaged, the deformation of the tubular element 35080 may be less individual. For example, deformation of the tubular member 35080 in the grip region of the bracket 30039 in the first row may affect the deformation of this tubular element 35080 in the grip region of the bracket 30039 in another row. The translational movement of the cutting edge 30052 can prevent the dissection of the tubular elements 42080. Alternatively, as shown in FIG. 111, the tissue thickness compensator 43020 may comprise more than six tubular elements 43080, for example, such as seven tubular elements 44080. Additionally, the tubular elements 43080 may be located symmetrically or asymmetrically in the end effector 12. If an odd number of tubular elements 43080 are located in the end effector 12 longitudinally and symmetrically, the translationally moving cutting element 30052 can be configured to dissect the middle tubular element that covers the longitudinal channel 30015.

As shown in FIG. 112, the tissue thickness compensator 44020 may comprise a central tubular member 44080b at least partially aligned with a longitudinal groove 30015 in the rigid support portion 33010 of the cassette with brackets 30000. The tissue thickness compensator 44020 may further comprise at least one peripheral tubular member 44080a, 44080c, located on the side of the longitudinal groove 30015. For example, the tissue thickness compensator 44020 may comprise three tubular elements 44080: the first peripheral tubular element 44080a may be located longitudinally on the first side p a single groove of the cassette 30015 with brackets 30000, the central tubular element 44080b may be substantially above and / or aligned with the longitudinal groove 30015, and the second peripheral element 44080c may be longitudinally located on the second side of the longitudinal groove 30015. The central tubular element 44080b may comprise a horizontal a diameter substantially elongated with respect to the vertical diameter. The central tubular element 44080b and / or any other tubular element may overlap a plurality of rows of slots for brackets 30012. As shown in FIG. 112, for example, the central tubular member 44080b may overlap, for example, four rows of bracket slots 30012, and each peripheral tubular member 44080a, 44080c may overlap one row of bracket slots 30012. Alternatively, the central tubular member 44080b may overlap, for example, less than four rows slots for brackets 30012, for example, such as two rows of slots for brackets 30012. Additionally, peripheral tubular elements 44080a, 44080c can overlap more than one row of slots for brackets 30012, for example, such as two rows of slots for brackets 30012. As shown in FIG. 113, the central tubular member 44120b of the tissue thickness compensator 44120 may comprise a therapeutic agent 44198 in the lumen 44184 of the central tubular member 44180b. Optionally, the central tubular member 44180b and / or at least one peripheral tubular member 44080a, 44080c may comprise a therapeutic agent 44198 and / or any other suitable therapeutic agent.

As shown in FIG. 114, the fabric thickness compensator 44220 may comprise a sheath 44224, which may be similar to the molded material 32024 described herein. Shell 44224 holds a plurality of tubular members 44080 in position at end effector 12. Shell 44224 may be coextruded with tubular members 44080. Tubular members 44080 may comprise a tubular grating 44092 from strands 44090. Like the polymer compositions described in other sections of this document, sheath 44224 may contain, for example, polyglycolic acid (PGA), polylactic acid (PLA) and / or any other suitable bioresorbable biocompatible elastomeric polymers. Additionally, sheath 44224 may be, for example, non-porous, so that sheath 44224 forms a fluid-tight layer in the fabric thickness expansion joint 44220. In addition to described herein, tubular member 44080 and / or strands 44090 in tubular lattice 44092 may contain therapeutic agent 44098 Non-porous membrane 44224 may contain therapeutic agent 44098 inside the tissue thickness compensator. As described herein, the tubular member 44080 may be positioned relative to the slots for the brackets 30012 and the cutting element 30052 in the cassette with the brackets 30000. The placement of the brackets 30030 and / or the translational movement of the cutting element 30052 can be performed to pierce or tear the non-porous shell 44224 so to release from the tissue thickness compensator 44020 therapeutic agent 44198 contained therein.

As shown in FIG. 115, the fabric thickness compensator 44320 may comprise a central tubular member 44380b that includes the tubular mesh 44392. The tubular mesh 44392 may have a non-woven portion or gap 44381 substantially aligned with the longitudinal groove 30015 of the rigid support portion 30010. In such cases, the braided portion of the tubular mesh 44092 the tubular element 44380b does not overlap the longitudinal groove 30015. Accordingly, the cutting element 30052 on the translationally moving slide to activate the staples 30052 can progressively move along the longitudinal groove 30015 without cutting the overlapping braided portion of the tube sheet 44392. Although the brackets 30030c and 30030d adjacent to the gap 44381 in the tube element 44380b can receive less support from the structure of the tube sheet 44392, additional elements can provide support for these brackets 30030 and / or additional restoring force to them the gripping areas of the brackets 30039. For example, as described in more detail herein, additional tubular elements, support nets, springs and / or reinforcing materials may, for example, be located at least in accordance Corollary to one embodiment of the inside and outside of the tubular member adjacent the gap 44380b 44381.

As shown in FIG. 116-119, the fabric thickness compensator 45020 may comprise a plurality of tubular elements 45080 laterally extending through the cassette with brackets 30000. The tubular elements 45080 may be perpendicular to the rows of slots for brackets 30012 and / or the longitudinal axis of the rigid support portion 30010 of the cassette with brackets 30000. As shown in FIG. 116, tubular elements 45080 can extend through a longitudinal groove 30015 in a cassette with brackets 30000 so that the cutting element 30052 on the slide for activating the brackets 30050 is configured to cut the tubular elements 45080 as the slide moves to activate the brackets 30050 along the longitudinal groove 30015. Alternative as shown in FIG. 117, the fabric thickness compensator 46020 may comprise two sets of laterally extending tubular members 46080. A first set of laterally extending tubular members 46080a may be located on the first side of the longitudinal groove 30015, and a second set of laterally extending tubular elements 46080b may be located on the second side of the longitudinal groove 30015 In this configuration, the cutting element 30052 can be configured to pass between two sets of tubular elements 46080 without cutting part of the tubular elements 46080. Alternative but the cutting element 30052 can cut through at least one tubular element 46080 passing through the longitudinal groove 30015, while at least one other tubular element 46080 does not pass through the longitudinal groove 30015 and is not cut by the cutting element 30052.

As the tubular elements 45080 laterally pass through the cassette with brackets 30000, as shown in FIG. 118 and 119, the bracket 30030 can engage at least one tubular member 45080 in each gripping area of the bracket 30039. In this configuration, each tubular member 45080 can provide a discrete restoring force along the length of the cassette with brackets 30000. For example, as shown primarily in FIG. 119, tubular elements 45080 located near the proximal end of the tissue thickness compensator 45020, where the tissue is thicker, can be strongly compressed in comparison with tubular elements 45080 located near the distal end of the tissue thickness compensator 45020, where the fabric is thinner. As a result of this, tubular elements 45080 located closer to the proximal end of the tissue thickness compensator 45020 can provide more restoring force than the restoring force that can be created by tubular elements 46080 located closer to the distal end of the tissue thickness compensator 45020. Additionally, as shown in FIG. 119, the deformation of one tube 45080 may have little or no effect on the deformation of the adjacent tube 45080. Accordingly, the tubular members 45080 can exert a substantially discrete and individual spring-loaded force in the gripping areas of the brackets 30039 along the length of the cassette 30030. When the plurality of brackets 30030 activated from one row of sockets for brackets 30012, the same tubular element 35080 is engaged, the deformation of the tubular element 35080 may be less individual. For example, deformation of the tubular member 35080 in one gripping area of the bracket 30039 may affect the deformation of this tubular member 35080 in another gripping area of the bracket 30039.

In a further alternative embodiment, as shown in FIG. 120-125, the tubular elements 47080 of the fabric thickness compensator 47020 can diagonally pass through a cassette with brackets 30000. The tubular elements 47080 can pass through a longitudinal groove 30015 of a cassette with brackets 30000 so that the cutting element 30052 on the rails for activating staples 30050 is configured to be cut diagonally passing tubular elements 47080 as the slide moves progressively to activate 30052 along the longitudinal groove 30015. Alternatively, the tissue thickness compensator 47020 may comprise two sets of diagonally extending tubular elements 47080. A first set of diagonally extending tubular elements 47080 may be located on the first side of the longitudinal groove 30015, and a second set of diagonally extending tubular elements 47080 may be located on the second side of the longitudinal groove 30015. In this configuration, the cutting element 30052 may extend between two sets of tubular elements 47080, without dissecting a single tubular element 47080.

As shown in FIG. 120-123, diagonally extending tubular elements 47080 can be arranged in a cassette with brackets 30000 so that a gap is formed between the tubular elements 47080. The gap between adjacent tubular elements 47080 can provide space for horizontal expansion of the tubular elements 47080 when a compressive force is applied to them, such as, for example, with a tissue T trapped inside the grip region 30039 of the formed bracket 30030. The tubular elements 47080 can be connected through the gap using film or sheet of material 47024. The sheet of material may be located on at least one of the surface of the platform 30011 of the rigid support portion 30010 and / or the side of the tubular els in contact with the fabric 47080 cops.

As shown in FIG. 124 and 125, at least one diagonally extending tubular member 47080 may be positioned relative to the bracket sockets 30012 in the cassette with the brackets 30000 so that the tubular member 47080 is located between the legs 30032 of the brackets 30030 located from a plurality of rows of bracket sockets 30012. By as the brackets 30030 move from their initial position to the activated position, as described in more detail herein, the legs of the brackets 30032 can remain located around the tubular element 47080. Additionally, the brackets can be deformed, for example, Thus, the legs of the brackets 30032 are wrapped around the perimeter of the tubular element 47080. In this configuration, the brackets 30030 can be moved to an activated or formed position without puncture of the tubular element 47080. Moving the legs of the brackets 30032 around the tubular element 47080 prevents unintentional release of therapeutic agent 47098. The selected angular orientation of each tubular element 47080 relative to the longitudinal groove 30015 of the cassette with brackets 30000 may depend from the position of the slots for the brackets 30012 in the cassette with the brackets 30000. For example, the tubular elements 47080 can be located at an angle of approximately 45 (forty-five) degrees relative to the longitudinal groove 30015 of the cassette with the brackets 30000. Alternatively, the tubular elements 47080 can be located, for example, under angle from 15 (fifteen) to 75 (seventy five) degrees relative to the longitudinal groove of 30015 cassettes with brackets 30000.

Similar to the descriptions presented herein, a plurality of tubular elements in a tissue thickness compensator can be joined, for example, by a bonding agent, sheath, mesh, molding, compensating material and / or any other suitable bonding adhesive or structure. As shown in FIG. 126-128, flexible jacket 48024 can surround or seal the tubular members 48080 in a fabric thickness compensator 48020. Flexible jacket 48024 can hold the tubular members 48080 in the end effector 12 and can hold each tubular member 48080 in a position, such as for example, longitudinal alignment with a row nests for brackets 30012. The fabric thickness compensator 48020 may contain, for example, six tubular elements 48080. The flexible shell 48024 can be sufficiently deformable and resilient to hold the tubular elements 48020 contained therein with ensuring the deformation and restoration of the shape of the tubular elements 48080. Additionally, the flexible shell 48024 can tightly surround the tubular elements 48080 and can maintain tight engagement with the tubular elements 48080 as they deform and / or restore shape.

As shown in FIG. 127, before placing the staples 30030, the emphasis 30060 can be rotated or rotated downward, compressing the tissue thickness compensator 48020 and the fabric T between the emphasis 30060 and the cassette with brackets 30000. Compressing the tissue thickness compensator 48020 may include corresponding compression of the flexible shell 48024 and tubular elements 48020 therein. As the tubular members 48020 deform, the flexible sheath 48024 may deform in a similar manner. The tubular members 48020 can be uniformly compressed across the width of the cassette with brackets 30000, and the flexible sheath 48024 can experience similarly uniform compression over the tubular members 48080. As shown in FIG. 128, when the stop 30060 opens after placing the staples 30030 from the cassette with the staples 30000, the tubular elements 48080 can restore shape or partially restore shape from the compressed configurations (FIG. 127). In accordance with the present invention, the tubular member 48080 can restore shape so that the tubular member 48080 returns to its original undeformed configuration. The tubular element 48080 can partially restore its shape so that the tubular element 48080 partially returns to its original undeformed configuration. For example, the deformation of the tubular element 48080 may be partially elastic and partially plastic. As the shape of the tubular members 48080 is restored, the flexible sheath 48024 may remain in tight engagement with each tubular member 48080. The tubular members 48080 and the flexible sheath 48024 can restore shape to such an extent that the tubular members 48080 and fabric T fill the gripping areas of the staples 30039 when the tubular elements 48080 apply a corresponding restoring force to tissue T in it. As shown in FIG. 129, in other cases, a tissue thickness compensator 48120 containing six tubular elements 48180 held in a flexible sheath 48124 may be located, for example, on the stop 30060 of the end effector 12.

As shown in FIG. 130-133, the fabric thickness compensator 49020 may comprise a tubular member 49080 located longitudinally along the longitudinal axis of the abutment 30060. The fabric thickness compensator 49020 may be secured to the abutment 30060 of the end effector 12 using compressible compensating material 49024. Additionally, the compressible compensating material 49024 may surround or seal the tubular element 49080. Similar to the descriptions presented herein, the tubular element 49080 may contain at least one therapeutic agent 49098, which may be released by absorbing various components of the tissue thickness compensator 49020, piercing the tubular element 49080 with brackets 30030 activated from the cassette with brackets 30000, and / or using a cutting element 30052.

As shown in FIG. 131, the cassette with staples 30000 may comprise staples 30030 located in the slots for staples 30012, and before placing the staples 30030, the emphasis 30060 and the fabric thickness compensator 49020 attached to it can be turned to the cassette with staples 30000 and squeeze the fabric T caught between them. The tubular element 49080 of the fabric thickness compensator 49020 can be deformed evenly along the length of the cassette with brackets 30000 using a rotating stop 30060 (FIG. 131). As shown in FIG. 132 and 133, the slide for activating the brackets 30050 can translationally move along the longitudinal groove 30015 in the cassette with brackets 30000 and engage each ejector 30040 located under the bracket 30030 in the slot for brackets 30010, and each engaged ejector 30040 can activate or push the bracket 30030 from the slot for the bracket 30012. When the stop 30060 ceases to exert pressure on the fabric T and the fabric thickness compensator 49020, the fabric thickness compensator 49020, including the tubular element 49080 and compressible compensating material 49024, can restore shape or it is astatic to restore the shape from the compressed configurations (FIG. 131) to the restored configuration (FIGS. 132 and 133). Tubular member 49080 and compressible compensating material 49024 can restore shape to the extent that fabric thickness compensator 49020 and fabric T fill the gripping areas of staples 30039, while fabric thickness compensator 49020 exerts a restoring force on the captured fabric T.

As shown in FIG. 124-126, two tissue thickness compensators 50020a, 50020b may be located in the end effector 12 of the surgical instrument. For example, a first tissue thickness compensator 50020a may be attached to a cassette with brackets 30000 in the lower jaw 30070, and a second tissue thickness compensator 50020b may be attached to a stop 30060. The first tissue thickness compensator 50020a may comprise a plurality of tubular elements 50080 located longitudinally and held in the first compensating material 50024a. At least one tubular element 50080 may comprise a therapeutic agent 50098 similar to the therapeutic agents described herein. The first compensating material 50024a may be deformable or substantially rigid. Additionally, the first compensating material 50024a can hold the tubular elements 50080 in position relative to the channel for brackets 30000. For example, the first compensating material 50024a can hold each tubular element 50080 in longitudinal alignment with a number of slots for brackets 30012. The second fabric thickness compensator 50020b may contain a first compensating material 50024a, a second compensating material 50024b and / or a third compensating material 50024c. The second and third compensating materials 50024b, 50024c may be deformable or substantially rigid.

The abutment 30060 can rotate and apply compressive force to the fabric thickness expansion joints 50020a, 50020b and fabric T between the abutment 30060 and the cassette with staples 30000. In some cases, neither the first fabric thickness compensators 50020a nor the second fabric thickness compensators 50020b are compressible. Alternatively, at least one component of the first tissue thickness compensators 50020a and / or the second tissue thickness compensators 50020b may be compressible. When activating the staples 30030 from the cassette with staples 30000, as shown in FIG. 135 and 136, each bracket 30030 may pierce the tubular member 50080 held in the first tissue thickness compensator 50020a. As shown in FIG. 135, the therapeutic agent 50098 held in the tubular member 50080 can be released by piercing the tubular member 50080 with a bracket 30030. When released, the therapeutic agent 50098 can cover the legs of the staples 30032 and the fabric T surrounding the activated bracket 30030. The staples 30030 can also puncture a second thickness compensator tissue 50020b when activating staples 30030 from a cassette with staples 30000.

As shown in FIG. 137-140, tissue thickness compensator 51020 may comprise at least one tubular element 51080 laterally extending through tissue thickness compensator 51020. For example, as shown in FIG. 137, the tissue thickness compensator 51020 can be positioned relative to the cassette with brackets 30000 so that the first end 51083 of the laterally extending tubular element 51080 can be located near the first longitudinal side of the cassette with brackets 30000, and the second end 51085 of the laterally extending tubular element 51080 can be located near the second longitudinal side of the cassette with brackets 30000. For example, the tubular element 51080 may contain a capsule-like shape. As shown in FIG. 138, the tubular member 51080 may be perforated between the first end 51083 and the second end 51085, and in some cases, the tubular member 51080 may be perforated at or near the center 51087 of the tubular member 51080. The tubular element 51080 may comprise a polymer composition, such as, for example, a bioresorbable biocompatible elastomeric polymer. Additionally, as shown in FIG. 137, the tissue thickness compensator 51020 may comprise a plurality of laterally extending tubular members 51080. For example, thirteen tubular elements 51080 may be laterally disposed in the tissue thickness compensator 51020.

As shown in FIG. 137, the tissue thickness compensator 51020 may further comprise a compensating material 51024 at least partially surrounding the tubular elements 51080. The compensating material 51024 may comprise a bioabsorbable polymer, such as a lyophilized polysaccharide, glycoprotein, elastin, proteoglycan, gelatin, collagen and / or oxidized regenerated cellulose (ORC). The compensating material 51024 can hold the tubular elements 51080 in position in the fabric thickness compensator 51020. Additionally, the compensating material 51024 can be fixed to the upper surface of the platform 30011 of the rigid support portion 30010 of the cassette with brackets 30000 so that the compensating material 51020 is securely located in the end effector 12. Compensating material 51024 may contain at least one drug 51098.

As shown in FIG. 137, laterally spaced tubular members 51080 may be positioned relative to the progressively moving cutting member 30052 so that the cutting member 30052 is capable of dissecting the tubular members 51080. The cutting member 30052 may cut through the tubular members 51080 near or in the perforations. When dissecting the tubular elements 51080 into two halves, the dissected parts of the tubular elements 51080 can be made to swell or expand, as shown in FIG. 139. For example, the tubular element 51080 may contain a hydrophilic substance 51099, which can be released and / or open when the tubular element 51080 is cut. Moreover, when the hydrophilic substance 51099 contacts biological fluids in tissue T, the hydrophilic substance 51099 may attract a fluid, which can lead to swelling or expansion of the tubular element 51080. As the tubular element 51080 expands, the compensating material 51024 surrounding the tubular element 51080 can be displaced or adjusted so that tit swollen tubular member 51080. For example, if 51024 compensating material comprises gelatin, gelatin can be shifted to accommodate the swollen tubular elements 51080. As shown in FIG. 140, the expansion of the tubular elements 51080 and the offset of the compensating material 51024 may result in a corresponding expansion of the tissue thickness compensator 51020.

Similar to other tissue thickness compensators described herein, fabric thickness compensator 51020 may deform or contract when applied. Additionally, the fabric thickness compensator 51020 can be sufficiently elastic, so that during deformation with the help of the applied force it creates a spring-loaded force, and also can subsequently restore the shape or partially restore the shape upon termination of the application of force. Optionally, when the tissue thickness compensator 51020 is gripped in the grip region of the bracket 30039, the bracket 30030 may deform the tissue thickness compensator 51020. For example, the bracket 30030 may deform the tubular members 51080 and / or the tissue thickness compensator compensating material 51024 51020 trapped inside the activated bracket 30030. Optional the uncaught portions of the tissue thickness compensator 51020 may also be deformed due to deformation in the gripping areas of the staples 30039. During deformation, the tissue thickness compensator 51020 may tend to recover s shape from a deformed configuration. Optionally, such shape recovery can occur before 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 fabric thickness compensator 51020 tends to restore shape, it can exert a restoring force on the fabric. also captured in the capture area of the bracket 30039, as described in more detail herein.

Optionally, at least one of the tubular elements 51080 and / or the compensating material 51024 in the tissue thickness compensator 51020 may comprise a therapeutic agent 51098. When a tubular element 51080 containing a therapeutic agent 51098 is dissected, therapeutic agent 51098 contained within the tubular elements 51080 may be released. Moreover, when the compensating material 51024 contains the therapeutic agent 51098, the therapeutic agent 51098 can be released as the bioabsorbable compensating material 51024 is absorbed. The tissue thickness compensator 51020 can provide a quick initial release of the therapeutic agent 51098 followed by the controlled release of the therapeutic agent 51098. For example, the tissue thickness compensator 51020 may provide rapid initial release of therapeutic agent 51098 from tubular elements 51080 into tissue T along incision lines when dissecting tubular elements 51080 containing therapeutic agent 51098. Additionally, as the bioabsorbable compensating material 51024 containing therapeutic agent 51098 is absorbed, tissue thickness compensator 51020 may provide sustained controlled release of therapeutic agent 51098. At least a portion of therapeutic agent 51098 may remain in the tubular element 51080 for a short period of time before therapeutic agent 51098 flows into the compensating material 51024. Alternatively, at least a portion of the therapeutic agent 51098 may remain in the tubular member to 51080 until the tubular member 51080 is not absorbed. The therapeutic agent 51098 released from the tubular member 51080 and the compensating material 51024 may be the same. Alternatively, the tubular member 51080 and the compensating material 51024 may contain, for example, different therapeutic agents or different combinations of therapeutic agents.

As shown in FIG. 140, end effector 12 can cut tissue T and activate staples 30030 into dissected tissue T almost simultaneously or in quick succession. In such cases, the clip 30030 can be placed in the fabric T immediately after the cutting element 30052 has cut through the tubular element 51080 adjacent to the fabric T. In other words, the clip 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 fabric thickness compensator 51020. The fabric thickness compensator 51020 can continue to grow or expand after activating the staples 30030 into the fabric T. The staples 30030 can be configured to puncture the tubular elements 51080 when placing the staples 30030. In such In some cases, therapeutic agents 51098 still held in dissected tubular elements 51080 may be released from the tubular elements 51080, and in some cases may cover the legs 30031 of the activated brackets 30030.

As shown in FIG. 141, a fabric thickness compensator 51020 may be fabricated, for example, using injection molding techniques. In accordance with the present invention, the frame, or mold, 51120 may include a first longitudinal side 51122 and a second longitudinal side 51124. Each longitudinal side 51124 may contain one or more slots 51130, each of which is configured to receive the first or second end 50183, 50185 of the tubular element 51080. The first end 50183 of the tubular element 51080 can be located in the first slot 51130a on the first longitudinal side 51122, and the second end 50183 of the tubular element 51080 can be located in the second slot 51130b on the second one side 51124 so that the tubular member 51080 laterally extends through the frame 51120. The slot 51180 may comprise a semicircular groove that can securely fasten therein the first or second end 50183, 50185 of the tubular member 51080. The first slot 51130a can be located directly across the second slot 51130b and the tubular member 51080 may be located perpendicular or at least substantially perpendicular to the longitudinal axis of the frame 51120. Alternatively, the first slot 51130a may be offset from the second slot 51130b so that the tubulars the element 51080 is positioned at an angle relative to the longitudinal axis of the frame 51120. In a further alternative, at least one tubular element 51080 may be longitudinally located inside the frame 51120 so that the tubular element extends between the sides 51126, 51128 of the frame 51120. Additionally, at least one tubular the element can be positioned in the frame at an angle, for example, between two slots on the sides 51126, 51128 of the frame and / or between the slot on the side 51126 and the slot on the longitudinal side 51124. The frame 51120 may contain about a pork shoulder 51136, which can support the tubular elements 51080 located inside the frame 51120.

The frame 51120 may include slots 51130 to accommodate, for example, twelve tubular elements 51080. The slots of the frame 51130 may be filled with tubular elements 51080, while alternatively not all of the slots 51130 may be filled. Optionally, at least one slot may be located in the frame 51120 tubular element 51080. The tubular elements 51080 can be received in at least half of the slots 51130. After the tubular elements 51080 are located in the frame 51120, compensating material 51024 can be added to the frame 51120. Compensating material 51024 by adding leniya in the frame 51120 may be fluid. For example, compensating material 51024 may be poured into the frame 51120 and may leak around the tubular elements 51080 located therein. As shown in FIG. 142, fluid compensating material 51024 may flow around the tubular member 51080 supported by slots 51130 in the frame 51120. After polymerization or at least sufficient polymerization of the compensating material 51024, as shown in FIG. 143, tissue thickness compensator 51020, comprising compensating material 51024 and tubular elements 51080, can be removed from frame 51120. Fabric thickness compensator 51020 can be trimmed. For example, excess compensation material 51024 can be removed from the fabric thickness compensator 51020 so that the longitudinal sides of the compensation material are substantially flat. Moreover, as shown in FIG. 144, the first and second ends 50183, 50185 of the tubular elements 51080 can be pressed together or closed to seal the tubular element 51080. The ends can be closed before the tubular elements 51080 are placed in the frame 51120. Alternatively, the ends 51083, 51085 can be intersected during cutting and using the thermal bonding process, sealing and / or closing of the ends 51083, 51085 of the tubular elements 51080 is performed.

As also shown in FIG. 141, a stiffening pin 51127 may be positioned within each tubular member 51080. For example, the stiffening pin 51127 may extend through the longitudinal clearance of the tubular member 51080. The stiffening pin 51127 may extend beyond each tubular member 51080 so that the stiffening pin 51127 can be positioned in slots 51130 in the frame 51120. In embodiments using stiffening pins 51127, stiffening pins 51127 can support tubular elements 51080, for example, when filling compensating material 51204 into frame 51120, as well as when fluid compensating The material 51024 flows around the tubular elements 51080. After the compensating material 51024 is polymerized, hardened and / or lyophilized, polymerized, solidified and / or lyophilized, the fabric thickness compensator 51020 can be removed from the frame 51020 and the stiffening pins 51127 can be removed from longitudinal gaps of the tubular elements 51080. Then, the tubular elements 51080 can be filled, for example, with drugs. After filling the tubular elements 51080 with drugs, the tissue thickness compensator 51020, including the ends 51083, 51085 of the tubular elements 51080, can, for example, be cut off. The fabric thickness compensator 51020 can be cut, for example, with a stamp and / or sealed by heating and / or under pressure.

As described herein, a tissue thickness compensator 52020 may comprise a plurality of tubular elements 51080. As shown in FIG. 145, tubular elements 51080 may contain different material properties, dimensions, and geometric shapes. For example, the first tubular element 51080a may comprise a first thickness and a first material, and the second tubular element 51080b may comprise a second thickness and a second material. Optionally, at least two tubular elements 51080 in the tissue thickness compensator 52020 may contain the same material. Alternatively, each tubular element 51080 in the tissue thickness compensator 5202 may contain different materials. Similarly, at least two tubular elements 51080 in the tissue thickness compensator 52020 may contain the same geometric shape. Alternatively, each tubular element 51080 in the tissue thickness compensator 52020 may comprise different geometric shapes.

As shown in FIG. 208-211, tissue thickness compensator 51220 may include at least one tubular member 51280 laterally extending through tissue thickness compensator 51220. As shown in FIG. 208, tissue thickness compensator 51220 can be positioned relative to stop 30060 of end effector 12. Fabric thickness compensator 51220 can be mounted, for example, on the fixing surface 30061 of stop 30060 of end effector 12. As shown primarily in FIG. 209, the tubular member 51280 may comprise, for example, a capsule shape. The tubular member 51280 may comprise a polymer composition, for example, a bioresorbable biocompatible elastomeric polymer.

As shown in FIG. 208, tissue thickness compensator 51220 may further comprise compensating material 51224 at least partially surrounding tubular elements 51280. Compensating material 51224 may comprise a bioabsorbable polymer, such as, for example, lyophilized polysaccharide, glycoprotein, elastin, proteoglycan, gelatin, collagen and / or oxidized regenerated cellulose (ORC). Similar to the above, the compensating material 51024 can hold the tubular elements 51280 in position in the fabric thickness compensator 51220. Additionally, the compensating material 51224 can be fixed to the fixing surface 30061 of the stop 30060 so that the compensating material 51220 is securely located in the end effector 12. The compensating material 51224 can contain at least one drug.

As also shown in FIG. 208, laterally positioned tubular members 51280 may be positioned relative to the cutting member 30252 on the translationally moving slide 30250 so that the progressively movable cutting member 30252 is configured to cut the tubular members 51280. The cutting member 30252 may cut through the tubular members 51280, for example, in the center of each tubular element 51280 or close to it. When dissecting the tubular elements 51280 into two halves, the dissected parts of the tubular elements 51280 can be made to swell or expand, as shown in FIG. 208. As shown primarily in FIG. 210, the tubular member 51280 may comprise a hydrophilic substance 51099, which may be released and / or opened by dissecting the tubular member 51280. Moreover, as shown in FIG. 211, upon contact of the hydrophilic substance 51099 with biological fluids in the tissue T, the hydrophilic substance 51099 may attract fluid, which may cause swelling or expansion of the tubular member 51280. As the tubular member 51280 expands, the compensating material 51224 surrounding the tubular member 51280 may shift or adjusted so that it accommodates the swollen tubular element 51280. For example, if the compensating material 51224 contains gelatin, the gelatin can be displaced to accommodate the swollen tubular element 51280. K Also shown in FIG. 208, the expansion of the tubular members 51280 and the offset of the compensating material 51224 may result in a corresponding expansion of the fabric thickness compensator 51220.

Similar to other tissue thickness compensators described herein, fabric thickness compensator 51220 may deform or contract when applied. Additionally, the fabric thickness compensator 51220 can be quite elastic, so that when deformed with the help of the applied force, it creates a spring-loaded force, and subsequently could restore the shape or partially restore the shape upon termination of the application of force. Optionally, when the tissue thickness compensator 51220 is gripped in the grip region of the staple 30039 (FIG. 88), the bracket 30030 can deform the fabric thickness compensator 51220. For example, the bracket 30030 can deform the tubular members 51280 and / or the fabric thickness compensator compensating material 51224 51220 trapped inside activated bracket 30030. Optionally, non-trapped portions of tissue thickness compensator 51220 may also deform due to deformation in gripping areas of staples 30039. During deformation, tissue thickness compensator 51220 may tend to recover ovit shape from a deformed configuration. Optionally, such shape recovery may occur before the hydrophilic expansion of the tubular member 51280, simultaneously with the hydrophilic expansion of the tubular member 51280 and / or after the hydrophilic expansion of the tubular member 51280. As the tissue thickness compensator 51220 seeks to restore shape, it may exert a restoring force on the fabric. also captured in the capture area of the bracket 30039, as described in more detail herein.

As shown in FIG. 146-149, tissue thickness compensator 52020 may comprise one or more tubular elements 52080 laterally extending through tissue thickness compensator 52020, similar to at least one tissue thickness compensator described herein. The fabric thickness compensator 52020 may comprise a plurality of laterally extending tubular elements 52080. The fabric thickness compensator 52020 may further comprise one or more sheets of material 52024 holding or fixing at least one tubular element 52080 in the fabric thickness compensator 52020. One or more sheets of material 52024 may be located above and / or below the tubular elements 52080 and can reliably hold each tubular element 52080 in the tissue thickness compensator 52020. As shown mainly in FIG. 146, the tissue thickness compensator may comprise a first sheet of material 52024a and a second sheet of material 52024b. Tubular elements 52080 may be located between the first and second sheets of material 52024a, 52024b. Additionally, as also shown in FIG. 146, a sheet of material 52024b may be secured to the upper surface of the cassette rigid support platform 30011 with brackets 30000 so that the tissue thickness compensator 52020 is securely located in the end effector 12. Alternatively, one or more sheets of material 52024 may be secured to a stop 30060 or otherwise held in the end effector 12.

As shown primarily in FIG. 147, tissue thickness compensator 52020 may be porous and / or permeable. For example, a sheet of material 52024 may comprise a plurality of holes 52026. Holes 52026 may be substantially circular. Holes 52036 in the sheet of material 52024 may be visible. Alternatively, openings 52036 may be microscopic. As shown in FIG. 147, tubular elements 52080 may also include a plurality of holes 52026. As shown in FIG. 148, the fabric thickness compensator 52120 may comprise a sheet of material 52124 that contains a plurality of non-circular holes 52126. For example, holes 52126 may be in the form of a rhombus and / or groove. Alternatively, as shown in FIG. 149, tissue thickness compensator 52220 may comprise a tubular element 52280, which comprises a permeable tubular lattice 52292. Material sheet 52224 may contain a bioresorbable biocompatible elastomeric polymer and may contain, for example, a drug.

At least one tubular element 52080 may be configured to swell or expand, as shown in FIG. 150A-150D. For example, as shown in FIG. 150A, tubular members 52080 may be disposed between the first and second sheets of material 52024a, 52024b in the fabric thickness compensator 52020. When the fabric thickness compensator 52020 is in contact with fabric T, as shown in FIG. 150B, fabric thickness compensator 52020 may expand. For example, tubular elements 52080 may contain a hydrophilic substance 52099, which expands under the influence of a fluid in tissue T and / or on it. Additionally, the sheet of material 52024 and tubular elements 52080 can be permeable, as described herein, so that fluid from fabric T can penetrate the tissue thickness compensator 52020, thereby allowing fluid to come into contact with hydrophilic substance 52099 inside the tubular elements 52080. As the tubular elements 52080 expand, the sheet of material 52024 surrounding the tubular elements 52080 can be displaced or adjusted to accommodate the swollen tubular elements 52080. Similar to various thickness expansion joints, t The cans described in other sections of this document, the expanded tissue thickness compensator 52020 can be deformed or compressed using an applied force, such as, for example, a compressive force applied by activated brackets, as shown in FIG. 150C. Additionally, the fabric thickness compensator 52020 can be sufficiently elastic, so that during deformation by the applied force it creates a spring-loaded force, and also subsequently could restore shape when the applied force is removed. As shown in FIG. 150D and 150E, tissue thickness compensator 52020 can reconstruct to different configurations in different gripping areas of staples 30039, appropriately accommodating captured tissue T.

As shown in FIG. 151-156, the fabric thickness compensator 53020 may comprise a plurality of vertically arranged tubular elements 53080. Optionally, the tubular axis of each tubular element 53080 may be substantially perpendicular to the upper surface of the platform 30011 of the rigid cassette support portion 30010 with brackets 30000. Additionally, the first end of each tubular element 53080 may be located, for example, adjacent to the upper surface of the platform 30011. The tubular elements 53080 may be deformable and may contain, for example, an elastomeric polymer. Optional, as shown in FIG. 152, the tubular members 53080 can be compressed when gripping the staple bracket 30039 with the stapled fabric T. The tubular member 53080 may comprise elastic material so that deformation of the tubular member 53080 creates a restoring force as the tubular member 53080 tends to recover from deformed configuration. The deformation of the tubular element 53080 may be at least partially elastic and at least partially plastic. The tubular element 53080 may be configured to act like a spring with an applied force and may not be designed to bend. As shown in FIG. 153, tubular elements 53080 may be substantially cylindrical. As shown in FIG. 154, the tubular member 53180 may comprise a bending region 53112. The tubular member 53180 may be configured to bend or deform in the bending region 53112 by applying a compressive force thereto. The tubular element 53180 can deform elastically and / or plastically, and can also be designed to abruptly bend the bending region 53112 with a pre-selected bending force.

As shown primarily in FIG. 155, the first tubular member 53080 may be located at the first end of the bracket holder 30012, and the other tubular element 53080 may be located at the second end of the bracket holder 30012. As shown in FIG. 153, the tubular member 53080 may comprise a lumen 53084 passing through it. As also shown in FIG. 152, by moving the bracket 30030 from its initial position to the activated position, each leg of the bracket 30032 can be configured to pass through the lumen 53084 of each tubular member 53080. Alternatively, as shown in FIG. 156, vertically arranged tubular elements 54080 may be located in the tissue thickness compensator 54020 so that the tubular elements 54080 abut against each other or contact each other. In other words, the tubular elements 54080 can be grouped in clusters or assembled together. The tubular elements 54080 can be located systemically in the tissue thickness compensator 54020; however, in other cases, the tubular elements 54080 may be randomly positioned.

As shown in FIG. 151, 155 and 156, the fabric thickness compensator 53020 may also include a sheet of material 53024 that holds or fixes the tubular elements 53080 in the fabric thickness compensator 53020. The material sheet 53024 can be located above and / or below the tubular elements 53080 and can hold each one securely the tubular element 53080 in the fabric thickness compensator 53020. The fabric thickness compensator 53020 may comprise first and second sheets of material 53024. The tubular elements 53080 may be located between the first and second sheets of material 53024. Additionally, the material sheet La 53024 can be mounted on the upper surface of the platform 30011 of the rigid support part of the cassette with brackets 30000 so that the tissue thickness compensator 53020 is securely located in the end effector 12. Alternatively, the sheet of material 53024 can be fixed on the stop 30060 or can otherwise be held in the end effector 12 The sheet of material 53024 can be sufficiently deformable, so that the sheet of material 53024 deforms as the springs 55080 deform inside the tissue thickness compensator.

As shown in FIG. 157 and 158, the fabric thickness compensator 55020 may comprise at least one spring 55080, sufficiently elastic so that it can create a spring-loaded force upon deformation. As shown primarily in FIG. 157, the fabric thickness compensator 55020 may comprise a plurality of springs 55080, such as, for example, three rows of springs 55080. The springs 55080 can be arranged in the fabric thickness compensator 55020 systematically and / or randomly. Springs 55080 may contain, for example, an elastomeric polymer. The shape of the springs 55080 can allow their deformation. Springs 55080 can be deformed from the original configuration to a deformed configuration. For example, when gripping a portion of the tissue thickness compensator 55020 in the grip area of the staple 30039, springs 55080 in the grip area of the staple 30039 and / or around it can be deformed. Springs 55080 can bend or compress under the action of a compressive force applied to the activated bracket 30030, and springs 55080 can create a restoring force, which depends, for example, on the coefficient of elasticity of the deformed spring 55080 and / or on the deformation value of the spring 55080. Spring 55080 under the influence of compressive The force exerted by the activated bracket 30030 can act like a sponge. Additionally, spring 55080 may comprise compensating material, as described in more detail herein.

The fabric thickness compensator 55020 may further comprise one or more sheets of material 55024 holding or fixing at least one spring 55080 in the fabric thickness compensator 55020. The sheets of material 55024 can be located above and / or below the springs 55080 and can reliably hold the springs 55080 in the compensator fabric thickness 55020. The fabric thickness compensator 55020 may comprise a first sheet of material 55024a and a second sheet of material 55024b. Tubular elements 52080 may be located between the first and second sheets of material 55024a, 55024b. As shown primarily in FIG. 158, the fabric thickness compensator 55020 may further comprise a third sheet of material 55024c located adjacent to either the first or second sheet of material 55024a, 55024b. Optionally, at least one sheet of material 55024 can be fixed to the upper surface of the platform 30011 of the rigid support portion of the cassette with brackets 30000 so that the fabric thickness compensator 55020 is securely located in the end effector 12. Alternatively, at least one sheet of material 55024 can be fixed on the stop 30060 or may otherwise be held in end effector 12.

As shown in FIG. 158, when activating the bracket 30030 from the cassette with the brackets 30000 (FIG. 156), the bracket 30030 can engage the tissue thickness compensator 55020. The activated bracket 30030 can capture tissue T and part of the tissue thickness compensator 55020 in the grip region of the bracket 30039. The springs 55080 can be deformable, so that the tissue thickness compensator 55020 is compressed upon gripping by the activated bracket 30030. Springs 55080 may be located in the tissue thickness compensator 55020 between the activated brackets 30030. Alternatively, at least one spring 55080 may be gripped within the region of grip bracket 30039.

As shown in FIG. 159, a tissue thickness compensator 60020 may comprise at least two compensating layers 60022. A tissue thickness compensator 60020 may comprise a plurality of compensating layers 60022 that may be stacked on top of each other, located side by side, or in combination thereof. As described in more detail herein, the compensating layers 60022 of the thickness compensator fabric 60020 may contain, for example, different geometric and / or material properties. Moreover, as described in more detail herein, recesses and / or channels may exist between adjacent stacked compensating layers 60022. For example, the fabric thickness compensator 62020 may comprise six compensation layers 62022a, 62022b, 62022c, 62022d, 62022e, 62022f, which can be adjacent to one another (FIG. 174).

As shown in FIG. 160, 161 and 163-168, the tissue thickness compensator may comprise a first compensating layer 60122a and a second compensating layer 60122b. The first compensating layer 60122a may be adjacent to be laid over the second compensating layer 60122b. Adjacently laid compensating layers 60122 may be separated by a separating gap or recess 60132. As shown primarily in FIG. 160, the fabric thickness compensator 60120 may also include at least one cantilever beam or support 60124 located between the first and second compensation layers 60122a, 60122b. The support 60124 may be arranged to position the first compensation layer 60122a relative to the second compensation layer 60122b so that the compensation layers 60122 are separated by a separating gap 60132. As described in more detail herein, deformation of the support 60124 and / or the compensation layers 60122a, 60122b, for example, may lead to a decrease in the separation gap 60132.

The support bar of the tissue thickness compensator may contain various geometric shapes and sizes. For example, the support bar may be a simple I-beam, a centered support beam with one bend 60124 (FIG. 160), off-center support beam with one bend 60224 (FIG. 161), an elliptical support beam 60324 (FIG. 163), support a crossbar with many bends 60424 (FIG. 164) and / or a symmetrical cantilever supporting crossbar 60524 (FIG. 165). Moreover, as shown in FIG. 160, 166 and 167, the support bar 60624, for example, may be thinner than at least one compensating layer 60122 (FIG. 166), the support bar 60724 may be thicker than at least one compensating layer 60122 (FIG. 167) and / or the support the bar 60124 may have substantially the same thickness as the at least one compensating layer 60122 (FIG. 160). The material, geometric shape and / or dimensions of the support beam 60124, for example, can affect the deformability and spring-loaded elasticity of the fabric thickness compensator 60120.

As also shown in FIG. 160, the compensation layers 60122 and the support bar 60124 of the tissue thickness compensator 60120 may contain different materials, for example, such as structural material, biological material and / or electrical material. For example, at least one compensating layer 60122 may comprise a polymer composition. The polymer composition may contain at least partially elastic material, so that the deformation of the compensating layer 60122 and / or the supporting beam 60124 can create a spring-loaded force. The polymer composition of the compensating layer 60122 may contain non-absorbable polymers, absorbable polymers, or combinations thereof. Absorbable polymers may include, for example, bioresorbable biocompatible elastomeric polymers. Moreover, the polymer composition of the compensating layer 60122 may contain synthetic polymers, non-synthetic polymers and / or combinations thereof. Examples of synthetic polymers include, without limitation, polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. Examples of non-synthetic polymers include, without limitation, polysaccharides, glycoprotein, elastin, proteoglycan, gelatin, collagen and oxidized regenerated cellulose (ORC). Optionally, similar to the polymer compositions described in other sections of this document, the polymer composition of the compensating layers 60122 may include different weight ratios of the amount of absorbable polymers, non-absorbable polymers, synthetic polymers and non-synthetic polymers. Optionally, each compensating layer 60022 in the fabric thickness compensator 60120 may contain different polymer compositions, or alternatively at least two compensating layers 60122 may contain the same polymer composition.

As also shown in FIG. 159, at least one compensating layer 60022 may comprise a therapeutic agent 60098, for example, such as a drug or pharmaceutically active agent. The compensating layer 60022 may release a therapeutically effective amount of therapeutic agent 60098. The therapeutic agent 60022 may be released as the compensating layer 60098 is absorbed. Examples of therapeutic agents 60098 may include, without limitation, hemostatic agents and drugs, such as, for example, fibrin, thrombin and / or oxidized regenerated cellulose (ORC), anti-inflammatory drugs, such as, for example, diclofenac, aspirin, naproxen, sulindac and / or hydrocortisone, antibi tics and medicaments or antimicrobial agents such as, for example, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B and / or chloramphenicol, anticancer agents such as cisplatin, mitomycin and / or adriamycin. The therapeutic agent 60098 may contain a biological product, for example, such as a stem cell. Optionally, each compensating layer 60022 in the tissue thickness compensator 60020 may contain different therapeutic agents 60098, or alternatively at least two compensating layers 60022 may contain the same therapeutic agent 60098. The compensating layer 60022 containing therapeutic agent 60098, for example, such as a biological product, may be sandwiched between two structural compensation layers 60022 containing a polymer composition, such as, for example, polyglycolic acid foam (PGA). In accordance with the present invention, the compensation layer 60022 may also comprise an electrically conductive material, such as, for example, copper.

As also shown in FIG. 174, the compensating layers 62022 in the tissue thickness compensator 62020 may have different geometric shapes. When the layers 62022 are arranged adjacent to the tissue thickness compensator 62020, the compensation layers 62022 can form at least one three-dimensional passage 62032 between the layers 62022. For example, when the second compensation layer 62022b containing the channel is located above the substantially flat third compensation layer 62022c, the channel and the plane the surface of the third compensating layer 62022c can form between them a three-dimensional passage 62032a. Similarly, for example, if the fifth compensating layer 62022e containing the channel is located under the fourth compensating layer 62022d containing the corresponding channel, the channels can form a three-dimensional passage 62032b formed by the channels in adjacent adjacent compensating layers 62022d, 62022e. Aisles 62032 can guide therapeutic agents and / or biological fluids when flowing through tissue thickness compensator 62020.

As shown in FIG. 170, the tissue thickness compensator 61020 may comprise compensating layers 61022, for example, such as layers 60122a and 21022b configured to receive staples 30030 placed from a cassette with staples 20,000 (FIG. 169). As the bracket 30030 moves from its initial position to the activated position, the geometric shape of at least one compensating layer 61022 can guide the legs of the staples 30032 to the activated position. Optionally, at least one compensating layer 61022 may include holes 61030 passing through it, and holes 61030 can be arranged to receive the legs of the staples 30032 of the placed staples 30030 when the staples 30030 are activated from the cassette with staples 20000 (FIG. 169), as described in more detail in this document. Alternatively, as also shown in FIG. 174, the legs of the staples 30032 can pierce at least one compensating layer, for example, such as a compensating layer 62022f, and can be received through holes 62030 in at least one compensating layer, for example, such as a compensating layer 62022a.

As shown primarily in FIG. 170, the fabric thickness compensator 60120 may include at least one supporting tongue 61026 on one of the compensating layers 61022a, 61022b. The support tongue 61026 may protrude into a separating gap 61032 formed between adjacent compensation layers, such as a gap 61032 between the first compensation layer 61020a and the second compensation layer 61020b. The supporting tongue 61026 may protrude from the longitudinal side of the first compensating layer 61022a. Additionally, the supporting tongue 61026 can extend along the length of the longitudinal side or only along its part. Optionally, at least one support tongue 61026 may protrude from two longitudinal sides of the compensating layer 61022a, 61022b. Additionally adjacent compensation layers 61022a, 61022b may comprise respective support tabs 60126 so that the reference tab 60126 extending from the first compensation layer 60122a can be at least partially aligned with the reference tab 60126 extending from the second compensation layer 60122b. As also shown in FIG. 168, tissue thickness compensator 60820 may comprise a limiter plate 60828 between adjacent compensation layers 60122a, 60122b. The restrictor plate 60828 may be located, for example, in a gap 60132 formed between the first compensating layer 60122a and the second compensating layer 60122b. As described in more detail herein, the support tab (s) 61026 and / or the plate (s) of the stopper 60828 can control the deformation and / or deflection of the support 60124 and / or the compensation layers 60122a, 60122b.

As described herein, the compensating layers 60022 of the thickness compensator fabric 60020 may contain different materials, geometric shapes and / or sizes. Such fabric thickness compensators 60020 can be assembled using various manufacturing methods. As shown primarily in FIG. 159, fabric thickness compensator 60022 can be fabricated using lithographic, stereolithographic (SLA) processes, or silk screen printing. For example, using a stereolithographic production process, it is possible to create a fabric thickness compensator 60020 in which each compensating layer 60022 contains different materials and / or geometric elements. For example, using ultraviolet radiation in a stereolithographic machine, it is possible to draw the geometric shape of the first compensation layer 60022, so that the first compensation layer 60022, containing the first material, geometric shape and / or dimensions, is polymerized by ultraviolet radiation. Using ultraviolet radiation, the geometric shape of the second compensating layer 60022 can be drawn so that the second compensating layer 60022, containing the second material, geometric shape and / or dimensions, is polymerized by ultraviolet radiation. In accordance with the present invention, a stereolithographic machine can draw compensating layers 60022 on top of each other, side by side, or in the form of a combination thereof. Additionally, the compensation layers 60022 can be drawn in such a way that recesses 60132 exist between the compensation layers 60022. Since the stereolithographic machine can create very thin layers having unique geometric shapes, the fabric thickness compensator 60020 produced using the stereolithographic process can contain a very complex three-dimensional geometric form.

As shown in FIG. 169, tissue thickness compensator 60920 may be located in end effector 12 of surgical instrument 10 (FIG. 1). The fabric thickness compensator 60920 can be positioned relative to the cartridge with brackets 20,000 of the end effector 12. For example, the fabric thickness compensator 60920 can be detachably fixed to the cartridge with the brackets 20000. At least one compensating layer 60922 of the fabric thickness compensator 60920 can be adjacent to the upper surface of the platform 20011 (FIG. 79) cassettes with brackets 20000. For example, the second compensating layer 60922b can be fixed on the upper surface of the platform 20011 using adhesive or sheath similar to at least one of membranes described herein (FIG. 16). The fabric thickness compensator 60920 can be made integrally with the cassette with brackets 20000, so that the cassette with brackets 20000 and the fabric thickness compensator 60920 are formed as a structure with a single module. For example, a cassette with brackets 20000 may comprise a first housing part, such as a rigid support part 20010 (FIG. 79), and a second housing part, such as a fabric thickness compensator 60920.

As shown in FIG. 169, the tissue thickness compensator 60920 may comprise a first part of the compensator 60920a and a second part of the compensator 60920b. The first part of the compensator 60920a can be located on the first longitudinal side of the cartridge with brackets 20,000, and the second part of the compensator 60920b can be located on the second longitudinal side of the cartridge with brackets 20,000. Optionally, if the fabric thickness compensator 60920 is located relative to the cartridge with brackets 20,000, between the first part the compensator 60920a and the second part of the compensator 60920b may extend a longitudinal groove 20015 (FIG. 78) in the rigid support portion 20010 (FIG. 78). When translating the cutting element 20052 on the slide to activate the brackets 20050 (FIG. 78), along the end effector 12, the cutting element 20052 can pass, for example, through a longitudinal groove 20015 between the first part of the compensator 60920a and the second part of the compensator 60920b without cutting the part of the fabric thickness compensator 60920. Alternatively, the cutting element 20052 may be configured to cut a portion of the tissue thickness compensator 60920.

As shown in FIG. 162, tissue thickness compensator 63020 may be configured to insert a circular surgical instrument into end effector 12 '. The tissue thickness compensator 62030 may comprise a first circular compensation layer 63022a and a second circular compensation layer 63022b. The second compensating layer 63022b may be located on the circular upper surface of the circular cassette platform 20011 'with brackets 20000', the second compensating layer 63022b may contain a geometric shape corresponding to the geometric shape of the surface of the platform 20011 '. For example, the surface of the platform 20011 ′ may comprise a stepped portion, and the second compensation layer 63022b may comprise a corresponding stepped portion. The tissue thickness compensator may further comprise at least one support 63024 and / or support tabs 63026, for example, extending around the tissue thickness compensator 63020.

As also shown in FIG. 170, activated staples 30030 can be adapted to engage tissue thickness compensator 60920. As described herein, activated bracket 30030 can grip part of tissue thickness compensator 60920 and tissue part T and apply compressive force to tissue thickness compensator 60920. Additionally, as shown mainly in FIG. 171-173, tissue thickness compensator 60920 may be deformable. Optionally, as described herein, the first compensating layer 60920a may be separated from the second compensating layer 60920b by a separating gap 60932. As shown in FIG. 171, prior to compression of the tissue thickness compensator 60920, the gap 60932 may comprise a first distance. When a compressive force A is applied to the thickness compensator of the fabric 60920 and fabric T, for example, using the activated bracket 30030 (FIG. 170), the support 60924 can be deformed. As shown in FIG. 172, the single-fold support bar 60924 can be bent by the compressive force A so that the separation gap 60932 between the first compensating layer 60920a and the second compensating layer 60920b is reduced to a second distance. As shown primarily in FIG. 173, the first and second compensation layers 60922a, 60922b can also be deformed by the compressive force A. The support tabs 60926 can control the deformation of the compensation layers 60920. For example, the support tabs 60926 can prevent excessive folding of the compensation layers 60920 by supporting the longitudinal sides of the compensation layer 60920 when they come in contact with each other. The support tabs 60926 can also be bent or deformed by the compressive force A. Additionally or alternatively, the stopper plate 60128 (FIG. 168), described in more detail herein, can limit the deformation of the compensation layers 60920 when the compensation layers 60920 and / or support tongues 60926 with stop plate 60128.

Moreover, similarly to the various tissue thickness compensators described herein, the tissue thickness compensator 60920 during deformation can create a spring-loaded or restoring force. The restoring force generated by the deformed tissue thickness compensator may at least depend on the orientation, size, material and / or geometric shape of the tissue thickness compensator 60920, as well as on the amount of deformation of the tissue thickness compensator 60920 using the applied force. Moreover, at least a portion of the tissue thickness compensator 60920 may be resilient, so that the tissue thickness compensator 60920 creates a spring load or a restoring force upon deformation by the activated bracket 30030. Support 60924 may comprise an elastic material and / or at least one compensating layer 60922 may contain elastic material, so that the compensator for the thickness of the fabric 60920 is elastic.

As shown in FIG. 175, the end effector of a surgical stapling instrument may comprise a first jaw and a second jaw, wherein at least one of the first jaw and the second jaw may be movable relative to the other. The end effector may include a first jaw including a channel for a cassette with brackets 19070, and a second jaw including a stop 19060, and the emphasis 19060 can rotate, for example, to the channel for the cassette with brackets 19070 and / or from it. The channel for the cassette with brackets 19070 can, for example, be adapted to receive a cassette with brackets 19000, which, for example, can be removably held inside the channel for the cassette with brackets 19070. The cassette with brackets 19000 can comprise a cassette body 19010 and a fabric thickness compensator 19020, moreover, the tissue thickness compensator 19020 can be removably attached to the cassette body 19010. As shown in FIG. 176, the cassette body 19010 may comprise a plurality of slots for staples 19012 and staples 19030 located inside each nest for staples 19012. Also, the staples 19030 can be supported by ejectors staples 19040 located inside the cassette 19010, and the slides can be moved through the cassette with staples 19000 and / or a trigger element by lifting the pushers of the brackets 19040 up inside the slots for the brackets 19012, as shown in FIG. 177, and pushing the brackets 19030 out of the socket for brackets 19012.

As shown primarily in FIG. 175 and 176, the tissue thickness compensator 19020 may comprise elastic elements 19022 and a vessel 19024 sealing the elastic elements 19022. Vessel 19024 may be airtight and may form a cavity containing an internal atmosphere having a pressure different from ambient atmospheric pressure. The pressure of the internal atmosphere may be greater than the pressure of the surrounding atmosphere, while alternatively the pressure of the internal atmosphere may be less than the pressure of the surrounding atmosphere. In embodiments where the vessel 19024 contains a pressure that is less than the pressure of the surrounding atmosphere, the side wall of the vessel 19024 may span a vacuum. In such cases, the vacuum can cause the vessel 19024 to deform, compress and / or flatten, and the elastic elements 19022 located inside the vessel 19024 can elastically compress inside the vessel 19024. When creating a vacuum in the vessel 19024, the elastic elements 19022 can deviate or deform downward and can be held in position by the side walls of vessel 19024 in a compressed, or evacuated, state.

The elastic element 19022 and the vessel 19024 are formed from biocompatible materials. Optionally, elastic member 19022 and / or vessel 19024 may be formed from bioabsorbable materials, such as, for example, PLLA, PGA and / or PCL. The elastic member 19022 may be formed of an elastic material. The elastic element 19022 may also contain structural elasticity. For example, resilient member 19022 may be in the form of a hollow tube.

In addition to the above, the tissue thickness compensator 19020 can be located adjacent to or adjacent to the surface of the platform 19011 of the cassette 19010. When the brackets 19030 are at least partially activated, as shown in FIG. 177, the legs of the staples 19030 can pierce or tear the vessel 19024. The vessel 19024 can contain a central part 19026, which can be located above the cutting groove 19016 of the cassette 19010 so that while moving the cutting element 19080 and cutting tissue T located between the cassette with brackets 19000 and with a stop 19060, the cutting element 19080 can also cut through the central part 19026 of the vessel 19024, thereby piercing or breaking the vessel 19024. In any case, after the breaking of the vessel 19024, the internal atmosphere inside the vessel 19024 can be aligned with the atmosphere surrounding a compensating fabric thickness compensator 19020, which allows the elastic elements 19022 to elastically expand and accept or at least partially accept their undeformed and / or non-flattened configuration. In such circumstances, the elastic elements 19022 can exert a biasing force on the fabric T trapped inside the deformed brackets 19020. More specifically, after deformation by the forming surfaces of the recesses 19062 formed in the abutment 19060, the legs of the brackets 19030 can trap the fabric T and at least a portion of the elastic element 19022 inside the brackets 19030 so that when the vessel 19024 ruptures, the tissue thickness compensator 19020 can compensate for the thickness of the tissue T trapped inside the brackets 19030. For example, if the tissue T trapped inside the bracket 19030 is thinner, then elastic the element 19022 trapped inside this bracket 19030 can expand and fill the gaps inside the bracket 19030, and also apply sufficient compressive force to the fabric T. Accordingly, if the fabric T trapped inside the bracket 19030 is thicker, then the elastic element 19022 trapped inside this the staples 19030 can remain compressed, leaving room for a thicker fabric inside the staples 19030 and, likewise, applying sufficient compressive force to the tissue T.

When punctured the vessel 19024, as briefly described above, the elastic elements 19022 can expand in an attempt to resiliently return to their original configuration. In some circumstances, part of the elastic elements 19022 trapped inside the brackets 19030 may not be able to return to their original undeformed configuration. In such circumstances, the elastic elements 19022 can comprise a spring that can exert a compressive force on the tissue T trapped inside the staples 19030. According to the present invention, the elastic element 19022 can simulate a linear spring, the compressive force exerted by the elastic element 19022 being linearly proportional to or the distance the elastic element 19022 remains deflected inside the bracket 19030. Alternatively, the elastic element 19022 can simulate a non-linear spring, and the compressive force applied by elastic The element 19022 is not linearly proportional to the magnitude or distance by which the elastic element 19022 remains deflected within the bracket 19030.

As shown primarily in FIG. 178 and 179, the cassette with brackets 19200 may comprise a tissue thickness compensator 19220, which may contain one or more sealed vessels 19222. Each of the vessels 19222 may be sealed and may contain an internal atmosphere. The pressure of the internal atmosphere inside the sealed vessel 19222 may exceed atmospheric pressure, while the pressure of the internal atmosphere inside the sealed vessel 19222 may be lower than atmospheric pressure. If the pressure of the internal atmosphere inside the vessel 19222 is lower than atmospheric pressure, then the vessel 19222 can be described as containing a vacuum. Optionally, one or more vessels 19222 can be wrapped or contained, for example, in an outer cap, container, shell, and / or film 19224, the fabric thickness compensator 19220 can be located above the surface of platform 19011 of the cassette body 19010. Each vessel 19222 can be made of a tube having a round or at least substantially circular cross section and, for example, having a closed end and an open end. You can create a vacuum in the tube from the open end, and when sufficient vacuum is reached inside the tube, the open end can be closed and sealed. For example, the tube may be formed of a polymeric material, the open end of the tube can be closed and sealed. In any case, the vacuum inside each vessel 19222 can lead to the elongation of the side walls of the tube inward and to elastic deformation and / or flattening of the tube. In FIG. 179 vessels 19222 are shown in at least partially flattened state.

When the brackets 19030 are in their inactive position, as shown in FIG. 179, the ends of the staples 19030 can be located under the fabric thickness compensator 19220. For example, the staples 19030 can be located inside their respective staple sockets 19012 so that the staples 19030 do not come into contact with the vessels 19222 until the staples 19030 move out of the inactive the provisions shown in FIG. 179, in their activated positions shown in FIG. 180. Sheath 19224 of tissue thickness compensator 19220 can protect vessels 19220 from premature puncture with brackets 19030. When the brackets 19030 are at least partially activated, as shown in FIG. 180, the legs of the brackets 19030 can puncture or tear apart the vessels 19222. In such circumstances, the internal atmospheres inside the vessels 19222 can align with the atmosphere surrounding the vessels 19222 and expand elastically, assuming or at least partially assuming their undeformed and / or un-flattened configuration. In such circumstances, the punctured vessels 19222 can exert a biasing force on the tissue trapped inside the deformed staples 19030. More specifically, after deformation by the forming surfaces of the recesses 19062 formed in the abutment 19060, the legs of the staples 19030 can trap the fabric T and at least part of the vessel 19222 inside the staples 19030 so that when the vessel 19222 ruptures, the vessels 19222 can compensate for the thickness of the tissue T trapped inside the staples 19030. For example, if the tissue T trapped inside the bracket 19030 is thinner, then the vessel 19222 trapped inside this bracket 19 030, can expand, filling the gaps inside the bracket 19030, and at the same time applying sufficient compressive force to the tissue T. Accordingly, if the tissue T trapped inside the bracket 19030 is thicker, then the vessel 19222 trapped inside this bracket 19030 can remain compressed. leaving room for a thicker fabric inside the bracket 19030 and at the same time applying sufficient compressive force to the T fabric.

When punctured vessels 19222, as briefly described above, vessels 19222 can expand in an attempt to resiliently return to their original configuration. A part of the vessels 19222 trapped inside the brackets 19030 may not have the ability to return to their original undeformed shape. In such circumstances, the vessel 19222 may comprise a spring that can exert a compressive force on the tissue T trapped inside the brackets 19030. In accordance with the present invention, the vessel 19222 can simulate a linear spring, and the compressive force exerted by the vessel 19222 is linearly proportional to the size or distance by which vessel 19222 inside the bracket 19030 remains rejected. Alternatively, the vessel 19222 can simulate a non-linear spring, and the compressive force exerted by the vessel 19222 is not linearly proportional to the size or distance by which the vessel 19222 inside the bracket 19030 remains deflected. Vessels 19222 may be hollow and empty when they are in their sealed configuration. Alternatively, each of the vessels 19222 may form a cavity and may further include at least one drug contained therein. Vessels 19222 may be formed from at least one drug, which may, for example, be released and / or bioabsorbed.

Vessels 19222 compensator tissue thickness 19220 can be located in any suitable way. As shown in FIG. 178, the bracket slots 19012 formed in the cartridge case 19010 and the brackets 19030 located in the bracket slots 19012 may be arranged in rows. As shown, the slots for brackets 19012 can be arranged, for example, in six longitudinal linear rows, however, any suitable configuration of the slots for brackets 19012 can be used. As also shown in FIG. 178, the tissue thickness compensator 19220 may contain six vessels 19222, each vessel 19222 may be aligned or located above a row of slots for brackets 19012. Each of the brackets 19030 inside a series of slots for brackets 19012 can be punctured with the same vessel 19222. In some situations, some of the legs of the brackets 19030 may not pierce the vessel 19222 located above them, however, if the vessel 19222 forms, for example, a continuous internal cavity, the cavity may be sufficiently pierced by at least one of the brackets 19030 to The atmospheric pressure of the inner cavity was leveled with the atmospheric pressure surrounding the vessel 19222. As shown in FIG. 185, the tissue thickness compensator may comprise a vessel, such as, for example, vessel 19222 ′, which can extend in a direction transverse to the line of staples 19030. For example, vessel 19222 ′ can pass through a plurality of rows of staples. As shown in FIG. 186, the tissue thickness compensator 19220 ″ may contain a plurality of vessels 19222 ″ extending in a direction that is perpendicular or at least substantially perpendicular to the line of staples 19030. For example, some of the vessels 19222 ″ may be punctured with staples 19030, while how others may not be pierced with brackets 19030. Vessels 19222 ″ may pass through a cutting path on which the cutting element can, for example, cross and rupture vessels 19222 ″, or along it.

Optionally, as described above, a tissue thickness compensator, for example, such as a fabric thickness compensator 19220, may contain a plurality of pressurized tanks, such as vessels 19222. As also described above, each of the sealed vessels 19222 may contain a separate internal atmosphere. Vessels 19222 may have different internal pressures. For example, the first vessel 19222 may contain an internal vacuum having a first pressure, and the second vessel 19222 may contain an internal vacuum having a second, different pressure. For example, the magnitude of the deformation or flattening of the vessel 19222 may depend on the magnitude of the vacuum pressure of the internal atmosphere contained therein. For example, a vessel 19222 having a large vacuum value can be deformed or flattened to a greater extent compared to a vessel 19222 having a lower vacuum value. The cavity of the vessel can be segmented into two or more separate sealed cavities, each individual sealed cavity may contain a separate internal atmosphere. For example, some of the staples within a series of staples can be configured and positioned to puncture a first cavity formed in a vessel, while other staples within a series of staples can be configured and positioned to puncture, for example, a second cavity formed in a vessel. In such cases, especially in those embodiments in which the brackets in the row of staples are sequentially activated from one end of the row of staples to the other, as described above, one of the cavities can remain intact and can maintain its internal atmosphere when the other cavity is torn. The first cavity may have an internal atmosphere having a first vacuum pressure, and the second cavity may have an internal atmosphere having, for example, a second, different vacuum pressure. In accordance with the present invention, a cavity that remains intact can maintain its internal pressure until the vessel is bioabsorbed, thereby creating a delayed release of pressure.

As shown in FIG. 181 and 182, a tissue thickness compensator, such as, for example, a tissue thickness compensator 19120, may be attached to a stop 19160. Similar to the above, the tissue thickness compensator 19120 may comprise a vessel 19124 and a plurality of resilient elements 19122 located within it. Also, similar to that indicated above, a cavity may be formed in the vessel 19124 containing an internal atmosphere having a pressure that is less than or greater than the pressure of the atmosphere surrounding the tissue thickness compensator 19120. If the internal atmosphere inside the vessel 19124 contains a vacuum, then the vessel 19124 and the resilient elements 19122 located therein may be deformed, compressed and / or flattened due to the pressure difference between the vacuum in the vessel 19124 and atmospheric pressure outside the vessel 19124. During use, the stop 19160 can be moved to the closed position in which it is located opposite the cartridge with brackets 19100, and also in which the fabric-engaging surface 19121 on the vessel 19124 can engage fabric T located between the tissue thickness compensator 19120 and the cassette with brackets 19100. During use, the trigger element 19080 can be advanced distally by activating the brackets 19030, as described above, and at the same time dissecting the fabric T. The tissue thickness compensator 19120 may further comprise an intermediate part 19126 that can be aligned with the cutting groove formed in the stop 19160, and distally moving the trigger 1909080 through the tissue thickness compensator 19120, the trigger element 19080 can puncture or rupture the vessel 19124. Also, similarly to the above, the trigger element 19080 can lift the pushers 19040 up and activate the brackets 19030 so that 19030 of staples can contact the abutment 19160 and deform in their deformed configuration, as shown in FIG. 183. When the brackets 19030 are activated, the brackets 19030 can puncture the tissue T and then pierce or tear the vessel 19124, so that the elastic elements 19122 located inside the vessel 19124 can at least partially expand, as briefly described above.

In addition to the above, a tissue thickness compensator can be formed from a biocompatible material. A biocompatible material, such as foam, may contain tackifying agents, surfactants, fillers, cross-linking agents, pigments, colorants, antioxidants and other stabilizers and / or combinations thereof to provide the desired material properties. The biocompatible foam may contain a surfactant. The surfactant can be applied to the surface of the material and / or dispersed within the material. Without striving to be limited to a specific theory, a surfactant deposited on a biocompatible material can reduce the surface tension of fluids in contact with the material. For example, a surfactant can reduce the surface tension of water in contact with the material in order to accelerate the penetration of water into the material. Water can act as a catalyst. A surfactant can increase the hydrophilicity of the material.

The surfactant may be an anionic surfactant, a cationic surfactant and / or a nonionic surfactant. Examples of surfactants include, without limitation, polyacrylic acid, metalozu, methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polioksietilenoktilovy ether, polyoxyethylene octylphenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether, polyoxyethylene nonylphenyl ether, dialkilfenoksipolietilenoksietanol and polyoxamers and combinations thereof. The surfactant may contain a copolymer of polyethylene glycol and polypropylene glycol. The surfactant may be a phospholipid surfactant. The phospholipid surfactant may confer antibacterial stabilizing properties and / or disperse other materials into a biocompatible material. The tissue thickness compensator may contain at least one drug. The tissue thickness compensator may comprise one or more natural materials, non-synthetic materials and / or synthetic materials, as described herein. The tissue thickness compensator may contain a biocompatible material containing gelatin, collagen, hyaluronic acid, oxidized regenerated cellulose, polyglycolic acid, polycaprolactone, polylactic acid, polydioxanone, polyhydroxyalkanoate, polyglexaprone, and combinations thereof. The tissue thickness compensator may comprise a film containing at least one drug. The tissue thickness compensator may comprise a biodegradable film containing at least one drug. The drug may contain a liquid, gel and / or powder. Medicines may contain anti-cancer agents, such as, for example, cisplatin, mitomycin and / or adriamycin.

The tissue thickness compensator may contain biodegradable material to allow for controlled release of at least one drug as the biodegradable material decomposes. The biodegradable material can decompose, decompose into components, or lose structural integrity when the biodegradable material contacts an activator, such as, for example, an activating fluid. The activating fluid may contain, for example, physiological saline or any other electrolyte solution. The biodegradable material may be contacted with an activating fluid by conventional methods, including, but not limited to, spraying, dipping and / or brushing methods. During use, for example, the surgeon can dip the end effector and / or cassette with brackets containing a tissue thickness compensator containing at least one drug into an activating fluid containing saline, such as a solution of sodium chloride, calcium chloride and / or potassium chloride. The tissue thickness compensator can release the drug as the tissue thickness compensator decomposes. Isolation of the drug from the tissue thickness compensator can be characterized by a fast initial release and a slower, slower release.

In accordance with the present invention, a tissue thickness compensator, for example, may be formed from a biocompatible material that may contain an oxidizing agent. The oxidizing agent may be an organic peroxide and / or inorganic peroxide. Examples of oxidizing agents may include, without limitation, hydrogen peroxide, urea peroxide, calcium peroxide and magnesium peroxide, as well as sodium percarbonate. The oxidizing agent may contain peroxigen-based oxidants and hypohalogenite-based oxidizing agents, such as, for example, hydrogen peroxide, hypochlorous acid, hypochlorites, hypocodites and percarbonates. The oxidizing agent may contain alkali metal chlorites, perborates and hypochlorites, such as, for example, sodium chlorite, sodium hypochlorite and sodium perborate. The oxidizing agent may contain vanadate. The oxidizing agent may contain ascorbic acid. The oxidizing agent may comprise an active oxygen generator. In accordance with the present invention, the tissue scaffold may comprise a biocompatible material containing an oxidizing agent.

The biocompatible material may contain a liquid, gel and / or powder. The oxidizing agent may contain, for example, microparticles and / or nanoparticles. For example, the oxidizing agent can be milled into microparticles and / or nanoparticles. The oxidizing agent may be incorporated into the biocompatible material by suspending the oxidizing agent in a polymer solution. The oxidizing agent may be incorporated into the biocompatible material during lyophilization. After lyophilization, the oxidizing agent can be attached to the cell walls of the biocompatible material in order to contact with the tissue. The oxidizing agent may not be chemically bound to the biocompatible material. The dry percarbonate powder can be incorporated into the biocompatible foam to provide a long lasting biological effect by slow release of oxygen. The dry percarbonate powder can be embedded inside the polymer fiber in a non-woven structure to provide a long lasting biological effect by slow release of oxygen. The biocompatible material may contain an oxidizing agent and a drug, such as, for example, doxycycline and ascorbic acid.

The biocompatible material may contain a quick release oxidizing agent and / or an oxidizing agent with a slower, slower release. The release of the oxidizing agent from the biocompatible material may be characterized by a fast initial release and a slower, slower release. The oxidizing agent may generate oxygen when the oxidizing agent is in contact with a biological fluid, such as, for example, water. Examples of biological fluids may include, without limitation, blood, plasma, peritoneal fluid, cerebrospinal fluid, urine, lymphatic fluid, synovial fluid, vitreous fluids, saliva, gastrointestinal contents and / or bile. Without striving to be limited by a specific theory, the oxidizing agent can reduce cell death, increase tissue viability and / or maintain the mechanical strength of tissues that can be damaged during dissection and / or stapling.

The biocompatible material may contain at least one microparticle and / or nanoparticle. The biocompatible material may contain one or more natural materials, non-synthetic materials, and synthetic materials described herein. The biocompatible material may contain particles with an average diameter of from about 10 nm to about 100 nm and / or from about 10 microns to about 100 microns, for example, 45-50 nm and / or 45-50 microns. The biocompatible material may comprise a biocompatible foam containing at least one microparticle and / or nanoparticle embedded therein. The microparticle and / or nanoparticle may not be chemically bound to the biocompatible material. The microparticle and / or nanoparticle can provide controlled release of the drug. The microparticle and / or nanoparticle may contain at least one drug. The microparticle and / or nanoparticle may contain, for example, a hemostatic agent, an antimicrobial agent and / or an oxidizing agent. The tissue thickness compensator may comprise a biocompatible foam containing a hemostatic agent containing oxidized regenerated cellulose, an antimicrobial agent containing doxycycline and / or gentamicin, and / or an oxidizing agent containing percarbonate. The microparticle and / or nanoparticle can provide controlled release of the drug, for example, for a period of up to three days.

A microparticle and / or nanoparticle can be incorporated into a biocompatible material during the manufacturing process. For example, a biocompatible polymer, such as, for example, PGA / PCL, can be contacted with a solvent, such as, for example, dioxane, to form a mixture. The biocompatible polymer can be ground to form particles. Dry particles, with or without ORC particles, can be brought into contact with the mixture to form a suspension. The suspension may be subjected to a lyophilization process to form a biocompatible foam containing PGA / PCL having dry particles and / or ORC particles incorporated therein.

Fabric thickness compensators or layers described herein can be formed, for example, from an absorbable polymer. For example, a tissue thickness compensator can be formed from foam, film, fibrous woven and fibrous non-woven PGA, PGA / PCL (copolymer of glycolic acid and caprolactone), PLA / PCL (copolymer of lactic acid and caprolactone), PLLA / PCL, PGA / TMC ( copolymer of glycolic acid and trimethylene carbonate), PDS, PEPBO or another absorbable polyurethane, polyester, polycarbonate, polyorthoesters, polyanhydrides, polyetheramides and / or polyoxyesters. In accordance with the present invention, a tissue thickness compensator can be formed, for example, from PGA / PLA (a copolymer of glycolic acid and lactic acid) and / or PDS / PLA (a copolymer of p-dioxanone and lactic acid). In accordance with the present invention, a tissue thickness compensator can be formed, for example, from organic material. The tissue thickness compensator can be formed, for example, from carboxymethyl cellulose, sodium alginate, cross-linked hyaluronic acid and / or oxidized regenerated cellulose. In accordance with the present invention, the tissue thickness compensator may have a hardness, for example, in the range of 3-7 Shore A (30-50 Shore OO) with a maximum stiffness of 15 Shore A (65 Shore OO). For example, a tissue thickness compensator can be subjected to 40% compression at a load of 13 N (3 fs), 60% compression at a load of 27 N (6 fs) and / or 80% compression at a load of 89 N (20 fs). One or more gases, such as air, nitrogen, carbon dioxide and / or oxygen, for example, can be passed through a tissue thickness compensator and / or contained within it. The tissue thickness compensator may comprise vials located within it, which comprise from about 50% to about 75% stiffness of the material from which the tissue thickness compensator is formed.

In accordance with the present invention, the tissue thickness compensator may contain, for example, hyaluronic acid, nutrients, fibrin, thrombin, platelet-rich plasma, sulfasalazine (Azulfidin® - diazocompound 5ASA and sulfapyridine) - prodrug - intestinal bacteria (azoreductase), 5 mesamine various delayed-release prodrug configurations), Asacol® (5ASA + S-coated Eudragit - pH> 7 (dissolved coating), Pentasu® (5ASA + coated ethylene cellulose - slow release, depending on the ratio time / pH), Mesasal® (5ASA + L-coated eudragit - pH> 6), olsalazine (5ASA + 5ASA - intestinal bacteria (azo reductase)), balsalazide (5ASA + 4 aminobenzoyl-B-alanine) - intestinal bacteria (azo reductase )), granular mesalamine, lialdo (delay and SR composition of mesalamine), HMPL-004 (herbal mixtures that can inhibit TNF-alpha, interleukin-1 beta and nuclear-kappa B activation), CCX282-B (antagonist of chemokine receptors in the oral cavity that interferes with the traffic of T-lymphocytes in the intestinal mucosa), rifaximin (a non-absorbable broad-spectrum antibiotic), in fliximab, a murine chimeric antibody (a monoclonal antibody directed against TNF-alpha - approved to reduce signs / symptoms and maintain clinical remission in adults / pediatric patients with moderate / severe luminal and fistulizing Crohn's disease who have had an inadequate response to conventional therapy), adalimumab, total human IgG1 (against TNF-alpha monoclonal antibody - approved to reduce the signs / symptoms of Crohn's disease and to induce and maintain clinical remission in adult patients with moderate / severe active Crohn’s disease with an inadequate response to conventional methods of treatment, or with infliximab intolerance), certolizumab pegol, humanized against TNF FAB '(a fragment of a monoclonal antibody bound to polyethylene glycol - approved to reduce the signs / symptoms of Crohn's disease and to induce and maintain reactions in adult patients with moderate / severe illness with an inadequate response to conventional methods of treatment), natalizumab, the first non-TNF-alpha inhibitor (biological compound - approved for treatment I am Crohn's disease), a humanized monoclonal IgG4 antibody (designed to fight alpha-4 integrin - approved by the FDA to stimulate and maintain a clinical response and remission in patients with moderate / severe illness with signs of inflammation, as well as inadequate responses to conventional treatments Crohn’s disease or those who cannot tolerate conventional methods of treatment of Crohn’s disease and TNF-alpha inhibitors), concomitant immunomodulators potentially prescribed with infliximab, azathioprine 6-mercaptopurine (purine synthetic the inhibitor is a prodrug), methotrexate (binds dihydrofolate reductase (DHFR), an enzyme that participates in the synthesis of tetrahydrofolate, inhibits all purine synthesis), allopurinol and thioprine therapy, PPI, H2 for acid suppression to protect the healing line, CDiff-flagyl, vancomycin ( fecal translocation treatment; probiotics; repopulation of normal intraluminal flora) and / or rifaximin (treatment of bacterial growth (in particular, hepatic encephalopathy); does not resolve in the gastrointestinal tract with exposure to intraluminal bacteria).

As described herein, a tissue thickness compensator can compensate for changes in the thickness of the tissue trapped inside the staples, which, for example, are ejected from the cassette with staples and / or are contained within the line of staples. In other words, certain staples within the line of staples can capture thick parts of the fabric, while other staples within the line of staples can capture thin parts of the fabric. In such circumstances, the tissue thickness compensator can take different heights or thicknesses within the staples and apply a compressive force to the tissue trapped inside the staples, regardless of the thickness of the trapped tissue. In accordance with the present invention, a tissue thickness compensator can compensate for changes in tissue hardness. For example, certain staples within the staple line can grab well-compressible parts of the fabric, while other staples within the staple line can grab less compressible parts of the fabric. In such circumstances, the tissue thickness compensator, for example, may be configured to accept a lower height inside the staples gripping the fabric having a lower compressibility, or a higher hardness, and, accordingly, a greater height inside the staples gripping the fabric having a higher compressibility, or lower hardness. For example, in any case, the compensator for the thickness of the fabric, regardless of whether it compensates for changes in height and / or changes in the hardness of the fabric, for example, may be called a “tissue compensator” and / or “compensator”.

The devices described herein may be configured for single or multiple use. However, in each case, after at least one application, the device can be reused after appropriate restoration. Recovery may include any combination of the steps of disassembling the device, cleaning or replacing specific elements, followed by reassembly. In particular, it is possible to disassemble the device and selectively replace or remove in any combination any number of specific elements or parts. After cleaning and / or replacing specific parts, the device can be reassembled for subsequent use in repair centers or in the operating unit immediately before surgery. Those skilled in the art will appreciate that various methods of disassembling, cleaning / replacing, and reassembling can be used in rebuilding a device. The use of such methods and the resulting reconditioned device are included in the scope of this application.

Preferably, the present invention described herein undergoes treatment before use in a surgical operation. First of all, a new or used tool is received and always cleaned. Then it can be sterilized. According to one sterilization method, the instrument is placed in a closed and sealed container, such as a plastic bag or a Tyvek bag (TYVEK). The container and instrument are then placed in a field of exposure to radiation that can penetrate into the container, such as gamma radiation, X-rays or high energy electrons. Radiation kills bacteria on the surface of the instrument and in the container. The sterilized instrument can then be stored in a sterile container. A sealed container keeps the instrument in a sterile condition until it is opened in a medical facility.

Any patent, publication, or other description material that is fully or partially incorporated herein by reference is an integral part of this document to the extent that it does not contradict the existing definitions, statements or other description material presented in this description. Thus, the description, expressly presented in this document, to the extent that it is necessary, prevails over any information that contradicts the material included in this document by reference. Any material or part thereof, indicated as incorporated herein by reference, but contrary to existing definitions, statements or other description material presented in this document will be included in this document only to the extent that between the included material and the existing description material no contradictions arise.

Although examples of industrial designs are presented in the description of the present invention, the present invention can be further modified within the spirit and scope of the present description. Therefore, it is intended that the present application cover all possible variations, methods of use, or modifications of the present invention using its basic principles. It is further contemplated that the present application covers such deviations from the present description that are suitable for known or accepted practice in the field to which the present invention belongs.

Claims (38)

1. A cartridge assembly with fasteners for a surgical instrument, comprising: cassette case; a deformable tube located relative to the cassette body, wherein the deformable tube contains elastic material, while the cassette body and the deformable tube are integrally formed; and a fastener configured to move between the initial position and the activated position, the fastener being configured to engage a portion of the deformable tube when moving the fastener to its activated position. 2. The cartridge assembly with fasteners according to claim 1, wherein the cartridge housing comprises: a platform; and at least one row of sockets for fasteners in the platform, and a deformable tube covers at least one row of sockets for fasteners. 3. The cartridge assembly with fasteners according to claim 2, wherein the deformable tube is adjacent to the cartridge case platform. 4. The cartridge assembly with fasteners according to claim 2, wherein said at least one row of fastener slots comprises substantially parallel rows of bracket slots, and wherein the cassette body comprises: a groove extending between two essentially parallel rows of nests for staples; and a cutting element configured to progressively move within the groove, wherein at least a portion of the deformable tube covers the groove so that the cutting element is configured to cut at least a portion of the deformable tube. 5. The cartridge assembly with fasteners according to claim 2, wherein the deformable tube comprises a first deformable tube, wherein the cartridge assembly with fasteners further comprises a second deformable tube, wherein the second deformable tube is substantially parallel to the first deformable tube. 6. The cartridge assembly with fasteners according to claim 5, wherein the second deformable tube is located inside the first deformable tube. 7. The cartridge assembly with fasteners according to claim 6, further comprising a third deformable tube, the third deformable tube being located inside the second deformable tube. 8. The cartridge assembly with fasteners according to claim 5, further comprising a third deformable tube, the first deformable tube aligned with the longitudinal axis formed by the cassette body, the second deformable tube located on the first side of the first deformable tube, and the third deformable tube located on the second side of the first deformable tube. 9. The cartridge assembly with fasteners according to claim 5, wherein the first deformable tube and the second deformable tube are coextruded with the adjacent part to form a single part. 10. The cartridge assembly with fasteners according to claim 1, wherein the deformable tube comprises a lattice of strands intertwined together to form a tube wall. 11. The cartridge assembly with fasteners according to claim 10, in which the lattice of the strands contains tubular strands. 12. The cassette assembly with fasteners according to claim 10, wherein the lattice of the strands contains bioabsorbable strands. 13. The cartridge assembly with fasteners according to claim 10, wherein the deformable tube further comprises a non-porous tube located outside or inside the strand grating, and wherein the non-porous tube is coextruded with the strand grating. 14. The cartridge assembly with fasteners according to claim 13, wherein the strand grating is at least partially filled with a therapeutic agent for treating tissue. 15. Surgical cassette tool containing: cassette case defining a longitudinal axis; a first plurality of strands intertwined into an elastic lattice, the elastic lattice being substantially parallel to the longitudinal axis; and fasteners made to move between the initial position and the activated position, and at least one such fastener is configured to compress part of the elastic lattice when moving the specified at least one fastener to its activated position. 16. A cassette with fasteners according to claim 15, wherein the elastic lattice comprises a first elastic lattice, the cassette with fasteners further comprising a second plurality of strands interwoven into a second elastic lattice, the second elastic lattice being substantially parallel to said longitudinal axis, and wherein at least one of the first plurality of strands and the second plurality of strands comprises tubular strands. 17. An end effector assembly for a surgical instrument, comprising: emphasis; cassette with fasteners containing: at least one row of sockets for fasteners; and fasteners made to move between the initial position and the activated position, each fastener in its initial position is located inside the socket for the fastener; and a tube integral with the cassette with fasteners, the tube containing elastic material, and the tube being substantially parallel to said at least one row of sockets for fasteners; moreover, at least one fastening element is configured to deform a portion of the tube when it is moved to the activated position. 18. The node end effector according to claim 17, in which the tube contains a therapeutic agent for treating tissue. 19. The node end effector according to claim 18, in which the tube is bioabsorbable, so that the tube releases a therapeutic agent upon bioabsorption. 20. The end effector assembly of claim 18, further comprising a cutting element configured to progressively move along at least a portion of the groove in the cassette with fasteners, wherein at least one of the cutting element and the plurality of fasteners is configured to penetrate the tube so that the therapeutic agent is released from the tube.

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