CN114585311A - Compressible non-fibrous adjunct - Google Patents

Abstract

The present invention provides a stapling assembly for use with a surgical stapler. In an exemplary embodiment, the stapling assembly includes a cartridge having a plurality of staples disposed therein and a non-fibrous adjunct formed of at least one molten bioabsorbable polymer and configured to be releasably retained on the cartridge. An adjunct system for use with a surgical stapler is also provided. Surgical end effectors for using the stapling assembly are also provided. Methods for making the stapling assembly and using the stapling assembly are also provided.

Description

Compressible non-fibrous adjunct

Cross Reference to Related Applications

This application claims priority from U.S. provisional patent application 62/900,708 entitled "bioavailable Resin for Additive Manufacturing" filed on 16.9.2019, U.S. provisional patent application 62/913,227 entitled "bioavailable Resin for Additive Manufacturing" filed on 10.10.2019, and U.S. provisional patent application 63/053,863 entitled "compatible 3D Printed screens" filed on 20.7.2020, the disclosures of which are incorporated herein by reference in their entireties.

Technical Field

Compressible non-fibrous appendages and methods of making and using the compressible non-fibrous appendages are provided.

Background

Surgical staplers are used in surgical procedures to close openings in tissues, vessels, ducts, shunts, or other objects or body parts involved in a particular procedure. These openings may be naturally occurring, such as blood vessels or passages in internal organs like the stomach, or they may be formed by the surgeon during surgery, such as by puncturing tissue or blood vessels to form bypasses or anastomoses or by cutting tissue during a stapling procedure.

Some surgical staplers require the surgeon to select the appropriate staple having the appropriate staple height for the tissue being stapled. For example, the surgeon may select long staples for thick tissue and short staples for thin tissue. However, in some cases, the stapled tissue does not have a consistent thickness, and thus the staples do not achieve the desired fired configuration at each staple site. Thus, the desired seal cannot be formed at or near all suture sites, allowing blood, air, gastrointestinal fluids, and other fluids to seep through the unsealed site.

In addition, staples that are recessed channels, like other objects and materials that may be implanted in conjunction with a surgical procedure similar to suturing, often lack some of the characteristics of the tissue in which they are implanted. For example, staples and other objects and materials may lack the natural flexibility of the tissue in which they are implanted and therefore cannot withstand the pressure differential within the tissue at the implantation site. This can lead to undesirable tearing of tissue at or near the suture site and thus to leakage.

Accordingly, there remains a need for improved instruments and methods for addressing the current problems of surgical staplers.

Disclosure of Invention

A stapling assembly for use with a surgical stapler is also provided. In one exemplary embodiment, a stapling assembly includes a non-fibrous adjunct and a cartridge having a plurality of staples disposed therein, the plurality of staples configured to be deployed into tissue, and the non-fibrous adjunct being formed from at least one molten bioabsorbable polymer and configured to be releasably retained on the cartridge such that the adjunct can be attached to tissue by the plurality of staples in the cartridge. The adjunct has a first end, a second end, and a longitudinal axis extending therebetween, wherein the adjunct comprises at least two distinct compression zones, each compression zone defined by a distinct lattice structure of repeating geometric units formed by interconnected struts. Each grid structure has a different compressive strength such that the adjunct has a variable compressive strength in the transverse direction relative to its longitudinal axis.

The compression zone can have a variety of configurations. For example, in some embodiments, the at least two distinct compression zones may include a first compression zone having a first compressive strength and a second compression zone having a second compressive strength less than the first compressive strength. In other embodiments, the at least two distinct compression zones may include a first compression zone having a first compressive strength and a second compression zone having a second compressive strength less than the first compressive strength. In certain embodiments, a cartridge can comprise a slot extending into and along at least a portion of the cartridge and can be configured to receive a cutting element, wherein the second compression zone can be configured to at least partially overlap the slot when an adjunct is attached to the cartridge. In some embodiments, at least a portion of the first compression zone can be positioned around a perimeter of the adjunct. In other embodiments, the at least two distinct compression zones may include a third compression zone having a third compressive strength that is less than the second compressive strength. In some embodiments, at least a portion of the third compression zone can be positioned around a perimeter of the adjunct. In certain embodiments, a cartridge can comprise a slot extending into and along at least a portion of the cartridge and can be configured to receive a cutting element, wherein the third compression zone can be configured to at least partially align with the slot when an adjunct is attached to the cartridge.

The adjunct can have a variety of configurations. For example, in some embodiments, an adjunct can have a tissue-contacting surface and a cartridge-contacting surface opposite the tissue-contacting surface, the cartridge-contacting surface having a plurality of attachment features extending outwardly therefrom and configured to extend to a recess defined within a cartridge. In other embodiments, the plurality of attachment features can be arranged in a repeating pattern across the cartridge contacting surface, which repeating pattern can be configured to substantially overlap with a repeating pattern of recesses defined within the cartridge.

In another exemplary embodiment, a stapling assembly for use with a surgical stapler includes a non-fibrous adjunct and a cartridge having a plurality of staples disposed therein, the plurality of staples configured to be deployed into tissue, and the non-fibrous adjunct being formed from at least one molten bioabsorbable polymer and configured to be releasably retained on the cartridge such that the adjunct can be attached to tissue by the plurality of staples in the cartridge. The adjunct includes a first compression zone having a first compressive strength defined by a first lattice structure formed of a plurality of first repeating cells and a second compression zone having a second compressive strength different from the first compressive strength defined by a second lattice structure formed of a plurality of second repeating cells different from the first repeating cells. The first and second compressed zones are positioned adjacent to each other relative to the longitudinal axis of the adjunct and are laterally offset from each other.

The repeating unit cell can have a variety of configurations. For example, in some embodiments, a first repeating unit cell may be a first triply periodic minimal surface structure, wherein a second plurality of repeating unit cells may be a second triply periodic minimal surface structure. In other embodiments, the first triply periodic minimum surface structure may vary in at least one of height and wall thickness as compared to the height and wall thickness of the second triply periodic minimum surface structure.

The adjunct can have a variety of configurations. For example, in some embodiments, the adjunct can include a third compression region having a third compressive strength that can be different from the first compressive strength and the second compressive strength, the third compression region defined by a third lattice structure formed from a plurality of third repeating cells, wherein the third compression region can be laterally offset from the first compression region and the second compression region. In other embodiments, the first repeating unit cell may be a first triply periodic minimal surface structure, the second plurality of repeating unit cells may be a second triply periodic minimal surface structure, and the third plurality of repeating unit cells may be a third triply periodic minimal surface structure. In some embodiments, the first, second, and third ternary periodic minimal surface structures may vary in at least one of height and wall thickness relative to one another. In certain embodiments, the first, second, and third tertiary periodic minimal surface structures may be Schwarz-P structures. In other embodiments, the first compression zone may be an innermost compression zone of the adjunct and the third compression zone may be an outermost compression zone of the adjunct. In other embodiments, the third compressive strength may be less than the first compressive strength and the second compressive strength. In certain embodiments, the cartridge can include a slot extending into and along at least a portion of the cartridge and can be configured to receive a cutting element, wherein the first compression zone can be a proximal-most compression zone relative to the slot.

Drawings

The present invention will be more fully understood from the detailed description given hereinbelow with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of an exemplary embodiment of a conventional surgical stapling and severing instrument;

FIG. 2A is a top view of a staple cartridge used with the surgical stapling and severing instrument of FIG. 1;

FIG. 2B is a side view of the staple cartridge of FIG. 2A;

FIG. 2C is a perspective view of a portion of the tissue contacting surface of the staple cartridge of FIG. 2A;

FIG. 3 is a side view of staples that can be disposed within a staple cartridge of the surgical cartridge assembly of FIG. 4 in an unfired (pre-deployed) configuration;

FIG. 4 is a perspective view of a knife and firing bar ("E-beam") of the surgical stapling and severing instrument of FIG. 1;

FIG. 5 is a perspective view of a wedge sled of a staple cartridge of the surgical stapling and severing instrument of FIG. 1;

FIG. 6A is a longitudinal cross-sectional view of an exemplary embodiment of a surgical cartridge assembly having a compressible non-fibrous adjunct attached to a top surface or deck surface of a staple cartridge;

FIG. 6B is a longitudinal cross-sectional view of a surgical end effector having an anvil pivotally coupled to the elongate staple channel and the surgical cartridge assembly of FIG. 6A disposed within and coupled to the elongate staple channel showing the anvil in a closed position without any tissue between the anvil and the adjunct;

FIG. 7 is a partially schematic illustration showing the adjunct of FIGS. 6A-6B in a tissue deployed condition;

FIG. 8A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 8B is a side view of the adjunct of FIG. 8A;

FIG. 8C is a top view of the appendage of FIG. 8A;

FIG. 8D is a cross-sectional view of the appendage of FIG. 8C taken at line 8D-8D;

FIG. 8E is a cross-sectional view of the appendage of FIG. 8C taken at line 8E-8E;

FIG. 8F is an enlarged view of a portion of the appendage of FIG. 8C taken at 8F;

FIG. 8G is a partial schematic view showing the adjunct of FIG. 8A in a tissue deployed state;

FIG. 9A is a side view of a single cell of the adjunct of FIG. 8A;

FIG. 9B is a perspective view of a single cell of FIG. 9A;

FIG. 10A is a schematic diagram of an exemplary cell in a pre-compressed state;

FIG. 10B is a schematic illustration of the cell of FIG. 10A in a first compressed state;

FIG. 10C is a schematic view of the cell of FIG. 10A in a second compressed state;

FIG. 10D is a schematic of the cell of FIG. 10A in a dense state;

FIG. 11 is a schematic illustration of the relationship between the states of the cells of FIGS. 10A-10D and the stress-strain curves of the resulting compressible non-fibrous adjunct;

FIG. 12A is a top view of an exemplary embodiment of a compressible, non-fibrous adjunct formed from repeating unit cells of an embodiment of a modified Schwarz-P structure;

FIG. 12B is a top view of an exemplary embodiment of a compressible, non-fibrous adjunct formed from repeating cells of another embodiment of a modified Schwarz-P structure;

FIG. 12C is a top view of an exemplary embodiment of a compressible non-fibrous adjunct formed from a repeating unit cell of another embodiment of a modified Schwarz-P structure;

FIG. 12D is a top view of an exemplary embodiment of a compressible non-fibrous adjunct formed from a repeating unit cell of another embodiment of a modified Schwarz-P structure;

FIG. 13A is a perspective view of another exemplary embodiment of a single cell;

FIG. 13B is a top view of an exemplary embodiment of a compressible non-fibrous adjunct formed from the repeating unit cell of FIG. 13A;

FIG. 14A is a perspective view of another exemplary embodiment of a single cell;

FIG. 14B is a top view of an exemplary embodiment of a compressible non-fibrous adjunct formed from the repeating unit cell of FIG. 14A;

FIG. 15A is a perspective view of another exemplary embodiment of a single cell;

FIG. 15B is a top view of an exemplary embodiment of a compressible non-fibrous adjunct formed from the repeating unit cells of FIG. 15A;

FIG. 16A is a perspective view of another exemplary embodiment of a single cell;

FIG. 16B is a top view of an exemplary embodiment of a compressible, non-fibrous adjunct formed from the repeating unit cell of FIG. 16A;

FIG. 17A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 17B is a cross-sectional view of the appendage of FIG. 17A taken at line 17B-17B;

FIG. 17C is a cross-sectional view of the adjunct of FIG. 17A, taken at line 17C-17C;

FIG. 18 is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct disposed on a staple cartridge;

FIG. 19A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct with a channel attachment;

FIG. 19B is a cross-sectional view of the appendage of FIG. 19A taken at line 19B-19B;

FIG. 20 is a partial perspective view of another exemplary embodiment of a compressible non-fibrous adjunct with a channel attachment;

FIG. 21 is a partial perspective view of another exemplary embodiment of a compressible non-fibrous adjunct with a channel attachment;

FIG. 22A is a partially exploded perspective view of an exemplary embodiment of a stapling assembly having compressible non-fibrous appendages releasably retained on a staple cartridge, each having a corresponding edge attachment feature;

FIG. 22B is an enlarged cross-sectional view of a portion of the suturing assembly taken at lines 22B-22B showing two edge attachment features prior to engagement;

FIG. 22C is a cross-sectional view of a portion of the suturing assembly of FIG. 22B, showing the two edge attachment features engaged;

FIG. 23A is a perspective view of another exemplary embodiment of a stapling assembly having compressible non-fibrous appendages releasably retained on a staple cartridge, each having a corresponding edge attachment feature, showing the edge attachment features engaged;

FIG. 23B is an enlarged view of a portion of the suturing assembly of FIG. 23B;

FIG. 24 is a perspective view of another exemplary embodiment of a staple cartridge having end attachment features;

FIG. 25 is a perspective view of another exemplary embodiment of a staple cartridge having end attachment features;

FIG. 26A is an exploded view of another exemplary embodiment of a stapling assembly having a staple cartridge and a compressible non-fibrous adjunct, wherein an attachment feature is releasably retained on the compressible non-fibrous adjunct;

FIG. 26B is a cross-sectional view of the suturing assembly of FIG. 26A taken at line 26B-26B;

FIG. 26C is a cross-sectional view of the suturing assembly of FIG. 26A taken at line 26C-26C;

FIG. 27 is a partial cross-sectional view of another exemplary embodiment of a stapling assembly having a compressible, non-fibrous adjunct releasably retained on a staple cartridge;

FIG. 28A is a partial cross-sectional view of another exemplary embodiment of a stapling assembly having a compressible, non-fibrous adjunct releasably retained on a staple cartridge;

FIG. 28B is a partial schematic view showing the adjunct of FIG. 28A in a tissue deployed condition;

FIG. 29 is a partial cross-sectional view of another exemplary embodiment of a stapling assembly having a compressible, non-fibrous adjunct releasably retained on a staple cartridge;

FIG. 30A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 30B is a front plan view of the appendage of FIG. 30A;

FIG. 31A is a perspective view of one embodiment of a compressible non-fibrous adjunct;

FIG. 31B is a perspective view of a single cell of the adjunct of FIG. 31A;

FIG. 31C is a side view of the cell of FIG. 31B;

FIG. 31D is an alternative side view of the cell of FIGS. 31B-31C;

FIG. 32A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 32B is a perspective view of a single cell of the adjunct of FIG. 32A;

FIG. 32C is a side view of the cell of FIG. 32B;

FIG. 32D is a cross-sectional top view of the cell of FIGS. 32B-32C taken along line 32D-32D of FIG. 32C;

FIG. 33A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 33B is a perspective view of a single cell of the adjunct of FIG. 33A;

FIG. 33C is a side view of the cell of FIG. 33B;

FIG. 33D is a cross-sectional top view of the cell of FIGS. 33B-33C taken along line 33D-33D of FIG. 33C;

FIG. 33E is an alternative side view of the cell of FIGS. 33B-33C;

FIG. 34A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 34B is a perspective view of a single cell of the adjunct of FIG. 34A;

FIG. 34C is a side view of the cell of FIG. 34B;

FIG. 34D is a top view of the cell of FIGS. 34B-34C;

FIG. 34E is an alternative side view of the cell of FIGS. 34B-34C;

FIG. 35 is a perspective view of another exemplary embodiment of a cell;

FIG. 36 is a perspective view of another exemplary embodiment of a cell;

FIG. 37A is a partially exploded perspective view of another exemplary embodiment of a stapling assembly having a staple cartridge and a compressible non-fibrous adjunct;

FIG. 37B is a cross-sectional view of a portion of the suturing assembly of FIG. 37A taken at line 37B-37B;

FIG. 38A is a schematic view of a portion of the stapling assembly of FIG. 37B, showing tissue disposed onto an adjunct;

FIG. 38B is a partial schematic view showing the adjunct of FIG. 37A in a tissue deployed condition;

FIG. 39A is an exploded view of an exemplary embodiment of a stapling assembly having a staple cartridge and an adjunct, wherein only a second outer layer of the adjunct is shown;

FIG. 39B is a front view of the suturing assembly of FIG. 39A;

FIG. 40 is a perspective view of another exemplary embodiment of a stapling assembly having a compressible non-fibrous adjunct releasably retained on a staple cartridge;

FIG. 41A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 41B is a cross-sectional view of a portion of the adjunct of FIG. 41A taken at line 41B-41B and releasably retained on a staple cartridge;

FIG. 41C is a cross-sectional view of a portion of the adjunct of FIG. 41A taken at line 41C-41C and releasably retained on the staple cartridge;

FIG. 42A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 42B is a partial schematic view showing the adjunct of FIG. 42A in a tissue deployed condition;

FIG. 43A is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 43B is a cross-sectional view of the adjunct of FIG. 43A taken at line 43B-43B;

FIG. 44A is a cross-sectional view of another exemplary embodiment of a compressible, non-fibrous adjunct, showing only a portion of the adjunct being releasably retained to a staple cartridge;

FIG. 44B is a partial schematic view showing tissue clamped between the anvil and a portion of the adjunct of FIG. 44A with staples partially deployed from the staple cartridge through the adjunct;

FIG. 44C is a partial schematic view showing the adjunct of FIG. 44A in a tissue deployed condition;

FIG. 45A is a partially exploded perspective view of another exemplary embodiment of a stapling assembly having a compressible non-fibrous adjunct releasably retained on a staple cartridge;

FIG. 45B is a top view of a portion of the suturing assembly of FIG. 45A;

FIG. 45C is a cross-sectional view of the suturing assembly of FIG. 45B taken at line 45C-45C;

FIG. 46A is a perspective view of another exemplary embodiment of a portion of a stapling assembly having a compressible non-fibrous adjunct releasably retained on a staple cartridge;

FIG. 46B is a top view of a portion of the suturing assembly of FIG. 46A;

FIG. 47A is a front cross-sectional view of an exemplary embodiment of a surgical end effector having an anvil and a stapling assembly with a compressible, non-fibrous adjunct releasably retained on a staple cartridge, showing the surgical end effector in a closed position with no tissue positioned between the anvil and the stapling assembly;

FIG. 47B is a cross-sectional front view of the surgical end effector of FIG. 47A showing tissue clamped between the anvil and stapling assembly and stapled to the compressible, non-fibrous adjunct;

FIG. 47C is a cross-sectional front view of only the suturing assembly of FIG. 47A;

FIG. 48A is a cross-sectional front view of another exemplary embodiment of a surgical end effector having an anvil and a stapling assembly with a compressible, non-fibrous adjunct releasably retained on a staple cartridge illustrating the surgical end effector in a closed position with no tissue positioned between the anvil and the stapling assembly;

FIG. 48B is a cross-sectional front view of the surgical end effector of FIG. 48A showing tissue clamped between the anvil and stapling assembly and stapled to the compressible, non-fibrous adjunct;

FIG. 48C is a cross-sectional front view of only the suturing assembly of FIG. 48A;

FIG. 49 is a perspective view of another exemplary embodiment of a compressible non-fibrous adjunct;

FIG. 50A is a side view of an exemplary embodiment of a surgical end effector having an anvil and a stapling assembly with a compressible, non-fibrous adjunct releasably retained on a staple cartridge, showing the surgical end effector in a closed position with no tissue positioned between the anvil and the stapling assembly;

FIG. 50B is a side view of the surgical end effector of FIG. 50A showing tissue clamped between the anvil and stapling assembly;

FIG. 50C is a side view of only the suturing assembly of FIG. 50A;

FIG. 51A is a cross-sectional front view of another exemplary embodiment of a surgical end effector having an anvil and a stapling assembly with a compressible, non-fibrous adjunct releasably retained on a staple cartridge illustrating the surgical end effector in a closed position with no tissue positioned between the anvil and the stapling assembly;

FIG. 51B is a cross-sectional front view of the compressible only non-fibrous adjunct of FIG. 51A;

FIG. 52A is a cross-sectional front view of another exemplary embodiment of a surgical end effector having an anvil and a stapling assembly with a compressible, non-fibrous adjunct releasably retained on a staple cartridge illustrating the surgical end effector in a closed position with no tissue positioned between the anvil and the stapling assembly;

FIG. 52B is an enlarged, cross-sectional, front view of only a portion of the stapling assembly of FIG. 52A;

FIG. 53 is a cross-sectional view of a portion of another exemplary embodiment of a compressible non-fibrous adjunct releasably retained on a staple cartridge;

FIG. 54 is a cross-sectional view of a portion of another exemplary embodiment of a compressible, non-fibrous adjunct releasably retained on a staple cartridge, showing only three staples from three staple rows of the staple cartridge;

FIG. 55 is a schematic illustration of a stress-strain curve of the adjunct of FIG. 54 at each of three staples;

FIG. 56 is a graph illustrating stress-strain curves for the exemplary compressible non-fibrous adjunct (adjunct 1) of examples 9 and 10;

FIG. 57 is a graph illustrating stress-strain curves for exemplary compressible non-fibrous appendages of examples 9 and 10 (appendages 2-5); and is

FIG. 58 is a graph showing stress-strain curves for six exemplary embodiments of the compressible non-fibrous adjunct of example 11.

Detailed Description

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the accessories, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the attachments, systems and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

Surgical stapling assemblies and methods of making and using the same are provided. In general, a surgical stapling assembly can include a staple cartridge having a compressible bioabsorbable non-fibrous adjunct configured to be releasably retained thereon and having staples disposed therein. In some embodiments, the non-fibrous adjunct can be formed from a matrix comprising at least one molten bioabsorbable polymer, and thus the non-fibrous adjunct can be three-dimensionally printed. In other embodiments, the non-fibrous adjunct can be partially or fully formed by any suitable non-additive manufacturing process, such as injection molding, foaming, and molding processes as understood by those skilled in the art. As discussed herein, various appendages can be configured to compensate for changes in tissue properties (such as changes in tissue thickness), and/or to promote tissue ingrowth when the appendage is sutured to tissue. For example, the adjunct can be configured such that the adjunct experiences a strain in a range of about 0.1 (10% deformation) to 0.9 (90% deformation) when subjected to an applied stress in a range of about 30kPa to 90 kPa. That is, the adjunct described herein can be configured to deform from about 10% to 90% when the adjunct is under a stress of between (and/or including) about 30kPa to 90kPa, for example, when the adjunct is in a tissue deployed state.

An exemplary stapling assembly can include various features to facilitate the application of surgical staples, as described herein and shown in the figures. However, those skilled in the art will appreciate that the stapling assembly may include only some of these features and/or it may include a plurality of other features known in the art. The seaming assemblies described herein are intended to represent only certain exemplary embodiments. Further, while the adjunct is described in connection with a surgical staple cartridge assembly, the adjunct can be used in connection with a staple recharger that is not staple cartridge based or any type of surgical instrument.

Fig. 1 illustrates an exemplary surgical stapling and severing device 100 suitable for use with an implantable adjunct. The illustrated surgical stapling and severing device 100 includes a staple applying assembly 106 or end effector having an anvil 102 pivotally coupled to an elongate staple channel 104. Thus, the staple applying assembly 106 is movable between an open position (as shown in FIG. 1) and a closed position wherein the anvil 102 is positioned adjacent the elongate staple channel 104 to engage tissue therebetween. The staple applying assembly 106 may be attached at its proximal end to an elongate shaft 108 that forms a tool portion 110. When the staple applying assembly 106 is closed, or at least substantially closed (e.g., the anvil 102 is moved toward the elongate staple channel from the open position in fig. 1), the tool portion 110 can assume a cross-section sufficiently small to accommodate insertion of the staple applying assembly 106 through a trocar. While the device 100 is configured to staple and sever tissue, surgical devices configured to staple but not sever tissue are also contemplated herein.

In various circumstances, the staple applying assembly 106 can be manipulated by a handle 112 that is connected to the elongate shaft 108. The handle 112 may comprise: user controls such as a rotation knob 114 that rotates the elongate shaft 108 and staple applying assembly 106 about the longitudinal axis of the elongate shaft 108; and a closure trigger 116 that is pivotable relative to a pistol grip 118 to close the staple applying assembly 106. For example, when the closure trigger 116 is clamped, the closure release button 120 may reside outwardly on the handle 112 such that the closure release button 120 may be depressed to release the closure trigger 116 and open the staple applying assembly 106.

A firing trigger 122, which is pivotable relative to the closure trigger 116, can cause the staple applying assembly 106 to simultaneously sever and staple tissue clamped therein. In various circumstances, multiple firing strokes may be employed using the firing trigger 122 to reduce the amount of force required to be applied by the surgeon's hand per stroke. In certain embodiments, the handle 112 may include one or more rotatable indicator wheels, such as rotatable indicator wheel 124 that may indicate the progress of firing. If desired, a manual firing release lever 126 may allow the firing system to retract before full firing travel is complete, and further, in the event of a stuck and/or failed firing system, the firing release lever 126 may allow a surgeon or other clinician to retract the firing system.

Additional details regarding the surgical stapling and severing device 100 and other surgical stapling and severing devices suitable for use with the present disclosure are described, for example, in U.S. patent No. 9,332,984 and U.S. patent publication No. 2009/0090763, the disclosures of which are incorporated herein by reference in their entirety. In addition, the surgical stapling and severing device need not include a handle, but rather may have a housing configured to be coupled to a surgical robot, for example, as described in U.S. patent application No. 2019/0059889, the disclosure of which is incorporated herein by reference in its entirety.

As further shown in FIG. 1, staple cartridge 200 may be used with instrument 100. In use, the staple cartridge 200 is placed within and coupled to the elongate staple channel 104. While the staple cartridge 200 can have various configurations, in this illustrated embodiment, the staple cartridge 200 shown in more detail in fig. 2A-2B has a proximal end 202A and a distal end 202B with a longitudinal axis (L)_C) Extending therebetween. Thus, when the staple cartridge 200 is inserted into the elongate staple channel 104 (FIG. 1), the longitudinal axis (L)_C) Longitudinal axis (L) of the elongated shaft 108_S) And (6) aligning. In addition, the staple cartridge 200 includes a longitudinal slot 210 defined by two opposing walls 210a, 210b and configured to receive at least a portion of a firing member of a firing assembly, such as the firing assembly 400 in fig. 4, as discussed further below. As shown, the longitudinal slot 202 extends from the proximal end 202a toward the distal end 202b of the staple cartridge 200. It is also contemplated herein that in other embodiments, the longitudinal slot 202 may be omitted.

The illustrated staple cartridge 200 includes staple cavities 212, 214 defined therein, wherein each staple cavity 212, 214 is configured to removably receive at least a portion of a staple (not shown). The number, shape, and location of the staple cavities can vary and can depend at least on the size and shape of the staples removably disposed therein. In the illustrated embodiment, the staple cavities are arranged in two sets of three longitudinal arrangements, with a first set of staple cavities 212 positioned on a first side of the longitudinal slot 210 and a second set of staple cavities 214 positioned on a second side of the longitudinal slot 210. On each side of longitudinal slot 210, and thus for each group of rows, a first longitudinal row of staple cavities 212a, 214a extends along longitudinal slot 210, a second row of staple cavities 212b, 214b extends along first row of staple cavities 212a, 214b, and a third row of staple cavities 212c, 214c extends along second row of staple cavities 212b, 214 b. For each set of rows, the first, second, and third rows of staple cavities 212a, 214b, 212b, 214c are parallel to each other and to longitudinal slot 210. Further, as shown, for each group of rows, the second row of staple cavities 212b, 214b is staggered relative to the first and third rows of staple cavities 212a, 212c, 214a, 214 c. In other embodiments, the rows of staple cavities 212, 214 in each set are not parallel to each other and/or the longitudinal slot 210.

Staples releasably stored in the staple cavities 212, 214 can have a variety of configurations. An exemplary staple 300 that can be releasably stored in each of the staple cavities 212, 214 is shown in fig. 3 in its unfired (pre-deployed, unformed) configuration. The illustrated staple 300 includes a crown (base) 302 and two legs 304 extending from each end of the crown 302. In this embodiment, the crown 302 extends in a linear direction and the legs 304 have the same unformed height, while in other embodiments the crown may be a stepped crown, such as similar to crowns 2804c, 2806c, 2808c in fig. 28A, and/or the legs may have different unformed heights (see fig. 29). Additionally, prior to deployment of staples 300, crown 302 can be supported by staple drivers positioned within staple cartridge 200, and at the same time, legs 304 can be at least partially received within staple cavities 212, 214. Additionally, when the staples 300 are in their unfired positions, the staple legs 304 can extend beyond a top surface of the staple cartridge 200, such as the top surface 206. In some cases, as shown in FIG. 3, the tips 306 of the staple legs 304 can be sharp and sharp, which can cut into and penetrate tissue.

In use, the staples 300 can be deformed from an unfired position to a fired position such that the staple legs 304 move through the staple cavities 212, 214, penetrate tissue positioned between the anvil 102 and the staple cartridge 200, and contact the anvil 102. As the staple legs 304 are deformed against the anvil 102, the legs 304 of each staple 300 can capture a portion of the tissue within each staple 300 and apply a compressive force to the tissue. In addition, the legs 304 of each staple 300 can be deformed downward toward the crowns 302 of the staple 300 to form staple entrapment areas in which tissue can be captured. In various instances, a staple entrapment area can be defined between an inner surface of the deformed leg and an inner surface of the crown of the staple. For example, the size of the staple entrapment area may depend on several factors, such as the length of the legs, the diameter of the legs, the width of the crown, and/or the degree of deformation of the legs.

In some embodiments, all of the staples disposed within the staple cartridge 200 can have the same unfired (pre-deployed, unformed) configuration. In other embodiments, the staples can comprise at least two groups of staples, each group of staples having a different unfired (pre-deployed, unformed) configuration relative to one another, e.g., varying in height and/or shape relative to one another, etc. For example, staple cartridge 200 can comprise a first group of staples having a first height disposed within first row of staple cavities 212a, 214a, a second group of staples having a second height disposed within second row of staple cavities 212b, 214b, and a third group of staples having a third height disposed within third row of staple cavities 212c, 214 c. In some embodiments, the first height, the second height, and the third height may be different, wherein the third height is greater than the first height and the second height. In other embodiments, the first height and the second height are the same, but the third height is different from and greater than the first height and the second height. Those skilled in the art will appreciate that other combinations of staples are contemplated herein.

Additionally, the staples may include one or more external coatings, for example, a sodium stearate lubricant and/or an antimicrobial agent. The antimicrobial agent may be applied to the nail as its own coating or incorporated into another coating, such as a lubricant. Non-limiting examples of suitable antimicrobial agents include 5-chloro-2- (2, 4-dichlorophenoxy) phenol, chlorhexidine, silver preparations (e.g., nanocrystalline silver), arginine ethyl Laurate (LAE), octenidine, polyhexamethylene biguanide (PHMB), taurolidine, lactic acid, citric acid, acetic acid, and salts thereof.

Referring back to fig. 2A-2B, staple cartridge 200 extends from a top or deck surface 206 to a bottom surface 208, wherein the top surface 206 is configured as a tissue-facing surface and the bottom surface 208 is configured as a channel-facing surface. Thus, when the staple cartridge 200 is inserted into the elongate staple channel 104, as shown in FIG. 1, the top surface 206 faces the anvil 102 and the bottom surface 208 (obscured) faces the elongate staple channel 104.

In some embodiments, the top surface 206 may include surface features defined therein. For example, the surface features may be recessed channels defined within the top surface 206. As shown in more detail in fig. 2C, a first recessed channel 216 surrounds each first staple cavity 212a, 214 a. Each first recessed channel 216 is defined by a substantially triangular wall 216a having a proximally directed apex, a distally directed apex, and a laterally outwardly directed apex. In addition, each first recessed channel 216 includes a first floor 206a at a first height from the top surface 206. A second recessed channel 218 surrounds each second staple cavity 212b, 214 b. Each second recessed channel 218 is defined by a substantially diamond-shaped wall 218a that includes a proximally-directed apex, a distally-directed apex, a laterally-inwardly-directed apex, and a laterally-outwardly-directed apex relative to the longitudinal axis. In addition, each second recessed channel 218 includes a second floor 206b at a second height from top surface 206. A third recessed channel 220 surrounds each third staple cavity 212c, 214 c. Each third recessed channel 220 is defined by a substantially triangular wall 220a that includes a proximally directed apex, a distally directed apex, and an apex that is directed laterally inward relative to the longitudinal axis. In addition, each third recessed channel 220 includes a third bottom plate 206c at a third height from top surface 206. In some embodiments, the first height of the first recessed channel 216, the second height of the second recessed channel 218, and the third height of the third recessed channel 220 may have the same height. In other cases, the first height, the second height, and/or the third height may be different. Additional details regarding surface features and other exemplary surface features may be found in U.S. patent No. 2016/0106427, which is incorporated herein by reference in its entirety. Additionally, as will be discussed in greater detail below, the recessed channels 216, 218, 220 can be used to interact with an adjunct, such as an adjunct 2600 in fig. 26A-26C, that can be releasably retained on a top surface of the cartridge prior to staple deployment.

Referring to fig. 4 and 5, a firing assembly, such as firing assembly 400, may be used with a surgical stapling and severing device, such as device 100 of fig. 1. The firing assembly 400 can be configured to advance a wedge sled 500 having a wedge 502 configured to deploy staples from the staple cartridge 200 into tissue captured between an anvil (e.g., anvil 102 in fig. 1) and a staple cartridge (e.g., staple cartridge 200 in fig. 1). In addition, an E-beam 402 at a distal portion of the firing assembly 400 can fire staples from the staple cartridge. During firing, the E-beam 402 may also pivot the anvil toward the staple cartridge and, thus, move the staple applying assembly from an open position to a closed position. The illustrated E-beam 402 includes a pair of top pins 404, a pair of middle pins 406 that may follow a portion 504 of the wedge sled 500, and a bottom pin or foot 408. The E-beam 402 may also include a sharp cutting edge 410 configured to sever captured tissue as the firing assembly 400 is advanced distally, and thus toward the distal end of the staple cartridge. In addition, integrally formed proximally projecting top guide 412 and middle guide 414, which cradle each vertical end of cutting edge 410, may further define a tissue staging area 416, thereby helping to guide tissue to sharp cutting edge 410 prior to severing the tissue. The intermediate guide 414 can also be used to engage and fire staples within the staple cartridge by abutting the stepped central member 506 of the wedge sled 500 that affects staple formation by the staple applying assembly 106.

In use, the anvil 102 of FIG. 1 may be moved into the closed position by depressing the closure trigger of FIG. 1 to advance the E-beam 402 of FIG. 4. The anvil can position tissue against at least a top surface 206 of the staple cartridge 200 as in fig. 2A-2C. Once the anvil has been properly positioned, the staples 300 disposed within the staple cartridge of fig. 3 can be deployed.

To deploy staples from the staple cartridge, as discussed above, the sled 500 in fig. 5 can be moved from the proximal end toward the distal end of the cartridge body, and thus toward the distal end of the staple cartridge. As the firing assembly 400 in FIG. 4 is advanced, the sled can upwardly contact and lift the staple drivers within the staple cartridge within the staple cavities 212, 214. In at least one example, the sled and staple drivers can each comprise one or more ramps or inclined surfaces that can cooperate to move the staple drivers upwardly from their unfired positions. When the staple drivers are lifted upward within their respective staple cavities, the staples are pushed upward such that the staples emerge from their staple cavities and penetrate into the tissue. In various instances, as part of the firing sequence, the sled can simultaneously move several staples upward.

As described above, the suturing device may be used in combination with a compressible adjunct. Those skilled in the art will appreciate that while an adjunct is shown and described below, the adjunct disclosed herein can be used with other surgical instruments and need not be coupled to a staple cartridge as described. Further, those skilled in the art will also appreciate that the staple cartridge need not be replaceable.

As discussed above, with some surgical staplers, a surgeon typically needs to select the appropriate staples having the appropriate staple heights for the tissue to be stapled. For example, a surgeon will utilize long staples for thick tissue and short staples for thin tissue. However, in some cases, the stapled tissue does not have a uniform thickness, and thus the staples do not achieve the desired fired configuration for each portion of the stapled tissue (e.g., thick and thin tissue portions). When staples having the same or substantially greater height are used, the inconsistent thickness of the tissue can also lead to undesirable leakage and/or tearing of the tissue at the staple site, particularly when the staple site is exposed to pressure within the tissue at the staple site and/or along the staple line.

Thus, various embodiments of non-fibrous adjunct are provided that can be configured to compensate for variations in thickness of tissue captured within fired (deployed) staples to avoid the need to account for staple height when stapling tissue during a surgical procedure. That is, the adjunct described herein can allow a set of staples having the same or similar height to be used to staple tissue having varying thicknesses (e.g., from thin to thick tissue), while also providing, in combination with the adjunct, sufficient tissue compression within and between the fired staples. Thus, the adjunct described herein can maintain proper compression of thin or thick tissue sutured to the adjunct, thereby minimizing leakage and/or tearing of tissue at the suture site.

Alternatively or additionally, the non-fibrous adjunct can be configured to promote tissue ingrowth. In various circumstances, it is desirable to promote tissue ingrowth in an implantable adjunct to promote healing of the treated tissue (e.g., stapled and/or incised tissue) and/or to accelerate recovery of the patient. More specifically, the in-growth of tissue in an implantable adjunct can reduce the incidence, extent, and/or duration of inflammation at a surgical site. The ingrowth of tissue in and/or around the implantable adjunct can control the spread of infection, for example, at the surgical site. The ingrowth of blood vessels, and particularly white blood cells, for example, in and/or around the implanted adjunct can counteract infection in and/or around the implanted adjunct and adjacent tissue. Tissue ingrowth can also promote the acceptance of foreign objects (e.g., implantable appendages and staples) by the patient's body and can reduce the likelihood that the patient's body will reject foreign objects. Rejection of the foreign body may result in infection and/or inflammation at the surgical site.

Unlike conventional appendages (e.g., non-three-dimensionally printed appendages such as foam appendages and woven/non-woven non-fibrous appendages), these non-fibrous appendages are three-dimensionally (3D) printed and thus may be formed with a consistent and reproducible microstructure (unit). That is, unlike other manufacturing methods, 3D printing significantly improves control over microstructure features such as placement and connection of components. Thus, the variability of both the microstructure and the attendant properties of the adjunct of the present invention is reduced as compared to conventional adjuncts. For example, the appendages of the present invention may be structured such that they compress a predetermined amount in a substantially uniform manner. Fine control over the microstructure may also allow tailoring of the porosity of the adjunct to enhance tissue ingrowth. The non-fibrous adjunct of the present invention can also be adapted for use with a variety of staples and tissue types.

Generally, the adjunct provided herein is designed and positioned on top of a staple cartridge (e.g., staple cartridge 200). As the staples are fired (deployed) from the cartridge, the staples penetrate the adjunct and enter the tissue. When the legs of the staples are deformed against an anvil positioned opposite the staple cartridge, the deformed legs capture a portion of the adjunct and a portion of the tissue within each staple. That is, when the staples are fired into the tissue, at least a portion of the adjunct becomes positioned between the tissue and the fired staples. While the adjunct described herein can be configured to attach to a staple cartridge, it is also contemplated herein that the adjunct can be configured to mate with other instrument components, such as an anvil of a surgical stapler. One of ordinary skill in the art will appreciate that the adjunct provided herein can be used with replaceable cartridge or non-cartridge based staple reloaders.

Method of suturing tissue

Fig. 6A-6B illustrate an exemplary embodiment of a stapling assembly 600 that includes a staple cartridge 602 and an adjunct 604. For simplicity, the adjunct 604 is generally illustrated in fig. 6A-6B, and various structural configurations of the adjunct are described in more detail below. Staple cartridge 602 may be similar to staple cartridge 200 (fig. 1-3) except for the differences described in detail below, and thus common features are not described in detail herein. As shown, adjunct 604 is positioned against staple cartridge 602. Although partially obscured in FIG. 6, staple cartridge 602 includes staples 606, which may be similar to staples 300 in FIG. 3, which are configured to be deployed into tissue. The staples 606 may have any suitable unformed (pre-deployed) height. For example, the staples 606 may have an unformed height of between about 2mm to 4.8 mm. The crown of the staple may be supported by a staple driver (not shown) prior to deployment.

In the illustrated embodiment, adjunct 604 can mate with at least a portion of a top surface or deck surface 608 of staple cartridge 602. In some embodiments, a top surface 608 of staple cartridge 602 can include one or more surface features, such as recessed channels 216, 218, 220 shown in fig. 2A and 2C. The one or more surface features may be configured to engage the adjunct 604 to avoid undesired movement of the adjunct 604 relative to the staple cartridge 602 and/or to prevent premature release of the adjunct 604 from the staple cartridge 602. Exemplary surface features are described in U.S. patent publication No. 2016/0106427, which is incorporated by reference herein in its entirety.

FIG. 6B illustrates stapling assembly 600 placed within and coupled to an elongate staple channel 610 of a surgical end effector 601 similar to surgical end effector 106 of FIG. 1. The anvil 612 is pivotally coupled to the elongate staple channel 610 and, thus, moves between an open position and a closed position relative to the elongate staple channel 610 (and, thus, relative to the staple cartridge 602). The anvil 612 is shown in the closed position of FIG. 6B and creating a tissue gap T between the staple cartridge 602 and the anvil 612 _G. More specifically, the tissue gap T_GDefined by the distance between the tissue-compressing surface 612a of the anvil 612 (e.g., the tissue-engaging surface between the staple-forming pockets in the anvil) and the tissue-contacting surface 604a of the adjunct 604. In the illustrated embodiment, the tissue-compressing surface 612a of the anvil 612 and the tissue-contacting surface 604a of the adjunct 604 are both planar or substantially planar (e.g., planar within manufacturing tolerances). Thus, when the anvil 612 is in the closed position, as shown in FIG. 6B, the tissue gap T is present when no tissue is disposed therein_GAre generally uniform (e.g., nominally the same within manufacturing tolerances). In other words, the tissue gap T_GThe cross-end effector 601 is generally constant (e.g., in the y-direction) (e.g., constant within manufacturing tolerances). In other embodiments, the tissue-compressing surface of the anvil can comprise a stepped surface having longitudinal steps between adjacent longitudinal portions and thus creating a stepped profile (e.g., in the y-direction). In such embodiments, the tissue gap T_GVariations may occur.

The adjunct 604 can be compressed to allow the adjunct to compress to different heights to compensate for different tissue thicknesses captured within the deployed staples. The adjunct 604 has an uncompressed (undeformed) or pre-deployed height and is configured to be deformable to one of a plurality of compressed (deformed) or deployed heights. For example, the adjunct 604 can have an uncompressed height that is greater than a fired height of the staples 606 disposed within the staple cartridge 602 (e.g., the height (H) of the fired staples 606a in fig. 7). That is, the adjunct 604 can have an undeformed state in which a maximum height of the adjunct 604 is greater than a maximum height of the firing staples (e.g., staples in the formed configuration). In one embodiment, the uncompressed height of the adjunct 604 can be about 10% higher, about 20% higher, about 30% higher, about 40% higher, about 50% higher, about 60% higher, about 70% higher, about 80% higher, about 90% higher, or about 100% higher than the fired height of the staples 606. In certain embodiments, for example, the uncompressed height of the adjunct 604 can be more than 100% higher than the fired height of the staples 606.

In use, once a surgical stapling and severing device (such as device 100 in fig. 1) is directed to a surgical site, tissue is positioned between the anvil 612 and the stapling assembly 600 such that the anvil 612 is positioned adjacent a first side of the tissue and the stapling assembly 600 is positioned adjacent a second side of the tissue (e.g., the tissue may be positioned against the tissue contacting surface 604a of the adjunct 604). Once tissue is positioned between the anvil 612 and the stapling assembly 600, the surgical stapler can be actuated, for example as discussed above, to clamp the tissue between the anvil 612 and the stapling assembly 600 (e.g., between the tissue-compressing surface 612a of the anvil 612 and the tissue-contacting surface 604a of the adjunct 604), and deploy staples from the cartridge through the adjunct and into the tissue to staple and attach the adjunct to the tissue.

As shown in fig. 7, when the staples 606 are fired, the tissue (T) and a portion of the adjunct 604 are captured by the fired (formed) staples 606 a. As discussed above, the firing staples 606a each define a trapped region therein for receiving the captured adjunct 604 and tissue (T). The entrapment area defined by the firing staples 606a is at least partially limited by the height (H) of the firing staples 606 a. For example, the height of the firing staples 606a may be about 0.160 inches or less. In some embodiments, the height of the firing staples 606a can be about 0.130 inches or less. In one embodiment, the height of the firing staples 606a may be about 0.020 to 0.130 inches. In another embodiment, the height of the firing staples 606a may be about 0.060 inches to 0.160 inches.

As described above, the adjunct 604 can be compressed within a plurality of fired staples regardless of whether the thickness of the tissue captured within the staples is the same or different within each fired staple. In at least one exemplary embodiment, the staples within a staple line or row can be deformed such that the fired height is, for example, about 2.75mm, wherein the tissue (T) and adjunct 604 can be compressed within this height. In some cases, the tissue (T) may have a compressed height of about 1.0mm, and the adjunct 604 may have a compressed height of about 1.75 mm. In some cases, the tissue (T) may have a compressed height of about 1.50mm, and the adjunct 604 may have a compressed height of about 1.25 mm. In some cases, the tissue (T) may have a compressed height of about 1.75mm, and the adjunct 604 may have a compressed height of about 1.00 mm. In some cases, the tissue (T) may have a compressed height of about 2.00mm, and the adjunct 604 may have a compressed height of about 0.75 mm. In some cases, the tissue (T) may have a compressed height of about 2.25mm, and the adjunct 604 may have a compressed height of about 0.50 mm. Thus, the sum of the compressed heights of the captured tissue (T) and the adjunct 604 can be equal to, or at least substantially equal to, the height (H) of the firing staples 606 a.

In addition, most structures typically behave in a manner in which the strain (deformation) of a material increases as the stress applied to the material increases. However, for surgical stapling, it is desirable that the strain of the appendages increase over a relatively narrow stress range, and thus, as discussed in more detail below, the appendages described herein may be structured in such a way that they may exhibit a flat or moderately sloped "stress plateau". In general, a stress plateau is a solution in compression in the stress-strain curve of a porous material, which corresponds to a progressive cell collapse by elastic buckling and depends on the nature of the solid from which the material is made. That is, as a given structure deforms under compression, strain may increase without significantly increasing stress, and thus leading to stress plateaus, advantageously delaying densification (e.g., solid height) of the structure. Thus, the adjunct described herein can be designed to undergo compression over an extended period of time over the entire range of stresses that are typically applied to the adjunct while it is in a tissue deployed state (e.g., when the adjunct is sutured into a tissue body).

Accordingly, the structure of the adjunct can be designed such that the adjunct can experience a strain in the range of 0.1 to 0.9 when under an applied stress in the range of 30kPa to 90kPa when the adjunct and tissue are captured within the firing staples. The applied stress is the stress applied by the stapled tissue against the adjunct when the adjunct is in a tissue deployed state. Those skilled in the art will appreciate that the stress applied by the tissue is dependent on various stapling conditions (e.g., tissue thickness, formed staple height, pressure within the tissue). For example, hypertension is generally considered to be 210mmHg, and thus it is desirable for the adjunct of the present invention to withstand an applied stress equal to or greater than 210mmHg for a predetermined period of time without achieving densification. In other embodiments, the strain may be in a range of about 0.1 to 0.8, about 0.1 to 0.7, about 0.1 to 0.6, about 0.2 to 0.8, about 0.2 to 0.7, about 0.3 to 0.8, about 0.3 to 0.9, about 0.4 to 0.8, about 0.4 to 0.7, about 0.5 to 0.8, or about 0.5 to 0.9. Thus, the appendages described herein may be configured to be deformable and thus not reach their solid height under a predetermined amount of applied stress.

To design an appendage configured to be able to experience a strain in the range of about 0.1 to 0.9 when under an applied stress in the range of about 30kPa to 90kPa, the principle of hooke's law (F ═ kD) may be used. For example, given the force (stress) to be applied to the tissue-deploying adjunct, the adjunct can be designed to have a predetermined stiffness (k). Stiffness may be adjusted by tuning the geometry of the appendage (e.g., shape, wall thickness, height, and/or interconnectivity of the cells, e.g., angles and spaces between cells and/or diameters of struts of the cells and/or struts of the cellsInterconnectivity, e.g., angles and spaces between struts). Additionally, the adjunct can be designed to have a maximum amount of compressive displacement for a minimum tissue thickness (e.g., 1mm), and thus the length of displacement D can be a combination of the minimum tissue thickness (e.g., 1mm) plus the thickness of the adjunct when stapled to tissue at a given maximum staple height (e.g., 2.75 mm). For example, in one embodiment, the adjunct can be structured to have a height greater than a maximum molded suture height of 2.75mm, and can be compressed to a height of 1.75mm when sutured to tissue having a minimum thickness of 1 mm. Thus, the adjunct can vary in compressibility to maintain a constant length of displacement D such that the stiffness (k) and total thickness (D) of the captured tissue and adjunct can apply 3gf/mm to the captured tissue ²Of the stress of (c). It should be noted that one skilled in the art will appreciate that the foregoing equations may be modified to account for temperature changes, for example, when bringing the adjunct from room temperature to body temperature after implantation. Additionally, the foregoing discussion of hooke's law represents an approximation. Thus, those skilled in the art will appreciate that the principles of large deformation mechanics (also known as finite elasticity) can be used to more accurately predict the relationship between stress and strain by using constitutive equations tailored for the material of interest.

Thus, the compressibility profile of the appendage can be controlled by at least the structural configuration of the cells and the interconnectivity therebetween. Accordingly, the structural configuration of the cells may be tailored to achieve an adjunct having desired mechanical properties for stapling tissue. Because there is a limited range of in-tissue pressure, tissue thickness, and formed staple height, an appropriate geometry of the adjunct, and thus a cell, can be determined that is effective to allow the adjunct to withstand a desired amount of strain at a substantially constant rate while applying a desired amount of stress. In other words, the structural configuration of the cells can be designed to create an adjunct that can apply a substantially continuous desired stress (e.g., at least 3 gf/mm) to the suture tissue under a range of suture conditions ²) For a given amount of time. That is, the invention is attached as described in more detail belowThe adjunct is formed of a compressible material and is geometrically configured to allow the adjunct to be compressed to different heights in a predetermined plane when sutured to tissue. Furthermore, the response of such changes by the adjunct may also allow the adjunct to maintain its application of a continuous desired stress to tissue when the adjunct is exposed to fluctuations in pressure within the tissue, which may occur when the adjunct is sutured to tissue (e.g., peaks in blood pressure).

Accessories

The adjunct can have a variety of configurations. The adjunct generally includes a tissue contacting surface and a cartridge contacting surface with an elongate body (e.g., an internal structure) positioned therebetween. In certain embodiments, the tissue contacting surface and/or the cartridge contacting surface can have a different structure than the elongate body, thereby forming a tissue contacting layer and a cartridge contacting layer. As described in greater detail below, the adjunct can have a strut-based configuration, a non-strut-based configuration, or a combination thereof.

In addition, each exemplary appendage is shown in partial form (e.g., not full length), and thus one skilled in the art will appreciate the length of the appendage (i.e., along its longitudinal axis (L) _A) Can be longer as identified in each embodiment. The length may vary based on the length of the staple cartridge or anvil. The width may also vary as desired. In addition, each exemplary adjunct is configured to be positioned on a cartridge or anvil surface such that a longitudinal axis L of each adjunct is aligned with a longitudinal axis (L) of the cartridge or anvil_A) Aligned with and extending along the longitudinal axis. These appendages are structured to compress when exposed to a compressive force (e.g., stress or load).

The appendages described herein may have various average lengths, widths, and thicknesses. For example, in some embodiments, the adjunct can have an average length in a range of about 20mm to 100mm or about 40mm to 100 mm. In other embodiments, the adjunct can have an average width in a range of about 5mm to 10 mm. In yet another embodiment, the adjunct can have an average thickness in a range of about 1mm to 6mm, about 1mm to 8mm, about 2mm to 6mm, or about 2mm to 8 mm. In one embodiment, exemplary appendages may have an average length in a range of about 20mm to 100mm, an average thickness in a range of 5mm to 10mm, and an average thickness in a range of about 1mm to 8 mm.

The elongate body may be formed from one or more grid structures each formed from interconnected cells. While the cells may have various configurations, in some embodiments, the cells may be stay-free based cells, while in other embodiments, the cells may be stay-based cells. The struts may be non-hollow rods or bars formed entirely or substantially of solid material. In certain embodiments, one or more grid structures may be formed of interconnected repeating unit cells. Additionally, in certain embodiments, the elongated body may include at least one lattice structure formed from strut-free based cells and at least one lattice structure formed from strut-based cells (see fig. 54).

Each grid structure extends from a first surface (e.g., a top surface) to a second surface (e.g., a bottom surface). At least a portion of the first surface of the at least one lattice structure can serve as a tissue contacting surface of the adjunct and at least a portion of the second surface of the at least one lattice structure can serve as a cartridge contacting surface of the adjunct, depending on the overall structural configuration of the adjunct. One skilled in the art will appreciate that each lattice structure can have additional tissue contacting surfaces (e.g., one or more lateral side surfaces relative to the top surface).

In certain embodiments, the adjunct can comprise a tissue contacting layer disposed on at least a portion of the first surface of the at least one lattice structure of the inner structure. The tissue contact layer has a thickness extending between a first surface (e.g., a top surface) and a second surface (e.g., a bottom surface). Thus, the first surface of the tissue contacting layer alone or in combination with at least a portion of the first surface of the at least one lattice structure can serve as a tissue contacting surface for the resulting adjunct. The tissue contacting layer can have a variety of configurations. For example, in some embodiments, the tissue contacting layer is in the form of a lattice structure formed of interconnected repeating lattices, which may be different from the lattice structure of the elongate body, while in other embodiments, the tissue contacting layer is in the form of a membrane.

Alternatively or additionally, the adjunct can comprise a cartridge contact layer disposed on at least a portion of the second surface of the at least one lattice structure. The cartridge contact layer can have a thickness that extends from a first surface (e.g., a top surface) to a second surface (e.g., a bottom surface). Thus, the second surface of the bin contact layer alone or in combination with at least a portion of the second surface of at least one grid structure may serve as a bin contact surface for the resulting appendage. The cartridge contact layer can have a variety of configurations. For example, in some embodiments, the cartridge contact layer is in the form of a grid structure formed of interconnected repeating cells, which may be different from the grid structure of the elongated body, while in other embodiments, the cartridge contact layer is in the form of a film. In some embodiments, the film may be a pressure sensitive adhesive, while in other embodiments, the film may include one or more attachment features that extend.

Stitchless-based appendages

As described above, the adjunct can include a lattice structure formed from strut-free based cells (e.g., repeating strut-free based cells). In other words, in contrast to strut-based cells characterized by the presence of sharp or pointed angles, strut-free cells may be characterized by curved surfaces. For example, the cells may be based on a Triple Periodic Minimum Surface (TPMS). TPMS is the smallest surface that repeats itself in three dimensions. The term "minimal surface" as used in this specification refers to the smallest surface as known in mathematics. Thus, in some embodiments, the cells can be a Schwarz structure (e.g., Schwarz-P, Schwarz Diamond), a modified Schwarz structure, a spiral (e.g., Schoen Gyroid) structure, a cosine structure, and a coke drum structure.

As discussed in more detail below, the stackless-based cell can have various structural configurations (e.g., height, width, wall thickness, shape). In some embodiments, the strut-based cells of the adjunct can be substantially uniform (e.g., nominally the same within manufacturing tolerances), while in other embodiments, at least a portion of the strut-free-based cells of the adjunct can vary in shape and/or size relative to the remainder of the strut-based cells.

For example, in some embodiments, each of the strut-free based cells may have a wall thickness of about 0.05mm to 0.6 mm. In certain embodiments, the wall thickness may be about 0.1mm to 0.3 mm. In one embodiment, the wall thickness may be about 0.2 mm. In certain embodiments, the wall thickness of all strut-free based cells of the adjunct can be substantially uniform (e.g., nominally the same within manufacturing tolerances). In other embodiments, for example, where the adjunct is formed from two or more sets of cells, each set of cells can have a different wall thickness. For example, in one embodiment, an adjunct can include first repeating cells each having a first wall thickness, second repeating cells each having a second wall thickness greater than the first wall thickness, and third repeating cells each having a third wall thickness greater than the second wall thickness. Alternatively or in addition, the first repeating cell may have a first height (e.g., a maximum height), a second height (e.g., a maximum height) greater than the first height, and a third height (e.g., a maximum height) greater than the second height.

In some embodiments, the surface to volume ratio of each unit cell may be about 5 to 30. In certain embodiments, the surface to volume ratio of each unit cell may be about 7 to 20.

Schwarz-P structure

Fig. 8A-8F are exemplary embodiments of an adjunct 800 having a tissue contacting surface 802 and a cartridge contacting surface 804. The adjunct 800 includes interconnected repeating studless cells 810, one of which is shown in more detail in fig. 9A-9B. Although the adjunct 800 is shown with four longitudinal rows (L) of 20 repeating cells 810 each₁、L₂、L₃、L₄) Those skilled in the art will appreciate thatIt is understood that the number and number of rows of cells of the adjunct can depend at least on the size and shape of the staple cartridge and/or anvil to which the adjunct is to be applied, and thus the adjunct is not limited to the number of longitudinal rows and cells shown in the figures. In addition, while only one type of repeating studless cell is shown, in other embodiments, an adjunct can be formed from a combination of a first repeating studless cell and a second repeating studless cell that is different from the first repeating studless cell, and so forth.

Whereas the adjunct 800 is formed from repeating cells 810 having substantially identical structural configurations (e.g., nominally identical within manufacturing tolerances), the following discussion pertains to one repeating cell 810. As shown in fig. 9A-9B, the repeating cell 810 has a top portion 812, a bottom structure 814, and a middle portion 816 extending therebetween.

In this illustrated embodiment, the repeating unit cell 810 is configured as a Schwarz-P structure, and thus, the surface profile of the unit cell 810 is defined by a minimum surface. That is, the exterior surface 820 and the interior surface 822 of the unit cell 810 are each defined by a minimum surface. Thus, in the illustrated embodiment, the exterior surface 820 and the interior surface 822 are generally concave, forming arcuate sides 821 of the cells 810. Additionally, the interior surface 822 defines an interior volume 824 of the cell 810. Thus, the cell 810 may be characterized as being hollow. The Schwarz-P minimum surface can be functionally represented as: cos (x) + cos (y) + cos (z) ═ 0.

The cell 810 also includes a connection interface 826 that may be used to interconnect the cell 810 to other cells 810, thereby forming the adjunct 800 shown in fig. 8A-8E. In the illustrated embodiment, the cell includes six connection interfaces 826 that form the six outermost surfaces of the cell 810, e.g., top and bottom outermost surfaces 827a, 827b, left and right outermost surfaces 829a, 829b, and front and back outermost surfaces 831a, 831 b. The top and bottom outermost surfaces 827a, 827b are generally planar with respect to each other (e.g., planar within manufacturing tolerances) and offset in the x-direction, the left and right outermost surfaces 829a, 829b are generally planar with respect to each other (e.g., planar within manufacturing tolerances) and offset in the y-direction, and the front and rear outermost surfaces 831a, 831b are generally planar with respect to each other (e.g., planar within manufacturing tolerances) and offset in the z-direction. Thus, the total exterior surfaces of the cell 810 include planar surfaces (e.g., outermost surfaces 827a, 827b, 829a, 829b, 831a, 831b) and non-planar surfaces (e.g., exterior surfaces 820 extending between connection interfaces 826). In addition, because the adjunct 800 is formed only from repeating cells 810, the top portion 812 including the topmost outer surface 812a forms the tissue-contacting surface 802 of the adjunct 800, and the bottommost outer surface 814a of the bottom structure 814 of the cells (e.g., in the x-direction) forms the cartridge-contacting surface 804 of the adjunct 800. Thus, the tissue contacting surface 802 is formed of a planar surface and a non-planar surface.

Additionally, based on the overall geometry of the repeating cells 810 and the interconnection at their corresponding connection interfaces 826 with one another, the overall outer surface of the resulting appendage 800 is formed from generally planar (e.g., planar within manufacturing tolerances) surfaces separated by non-planar surfaces. As shown, the top and bottom outermost surfaces 850a, 850b of the appendage 800 are furthest from a bisector extending in the YZ plane, the left and right outermost surfaces 852a, 852b of the appendage 800 are furthest from a bisector extending in the XZ plane, and the front and back outermost surfaces 854a, 854b of the appendage are furthest from a bisector extending in the XY plane. Additionally, as shown, the top and bottom outermost surfaces 850a, 850b are generally planar (e.g., planar within manufacturing tolerances) and offset in the x-direction relative to each other, the left and right outermost surfaces 852a, 852b are generally planar (e.g., planar within manufacturing tolerances) and offset in the y-direction relative to each other, and the front and back outermost surfaces 854a, 854b are generally planar (e.g., planar within manufacturing tolerances) and offset in the z-direction relative to each other. Thus, these outermost surfaces 850a, 850b, 852a, 852b, 854a, 854b form a planar segment of the outer surface of the adjunct 800. It will be appreciated that the portions of the adjunct 800 extending between these outermost surfaces 850a, 850b, 852a, 852b, 854a, 854b are defined by the exterior surfaces 820 of adjacent cells 810, thereby forming a non-planar surface of the exterior surface of the adjunct 800.

As further shown, six connection interfaces 826 define respective circular openings in fluid communication with the interior volume 824 of the cell 810. Thus, the cell 810 has openings in all six cartesian sides (represented as arrows 1, 2, 3, 4, 5, 6 in fig. 9B). These openings can provide a variety of functions, such as: facilitating connection to adjacent cells; creating an opening that can allow for immediate tissue growth when the adjunct is sutured to the tissue; allowing for the discharge of manufacturing materials used in the production of the resulting adjunct, such as materials used during the 3D manufacturing process; allowing bodily fluids to readily transfer the entire adjunct; mechanical properties that contribute to the adjunct, e.g., mechanical properties that produce a compression profile that blocks densification of the adjunct; and/or to minimize the solids height of the fully compressed adjunct.

Further, when the cells 810 are interconnected to one another at corresponding connection interfaces (e.g., at least two connection interfaces), hollow tubular interconnects 828 (e.g., lumens) are formed therebetween that allow the internal volumes 824 of the interconnected cells 810 to be in fluid communication with one another, as shown in fig. 8D-8E. Thus, a continuous network of channels or paths exists within the adjunct. Thus, when the adjunct 800 is sutured to tissue (T) and in a tissue deployed state, as shown in fig. 8G, one or more fluids (including cells entering the adjunct 800), for example, through the opening of the connection interface 826a of the top portion 812 of at least one cell 810, can thus migrate through the adjunct 800 through the interconnected cells in the tissue deployed state, as shown in fig. 8G, and can thus ultimately accelerate tissue ingrowth within the adjunct 800. That is, while the adjunct 800 is in a tissue deployed state, at least a portion of the hollow tubular interconnects 828 can at least partially maintain fluid communication between at least a portion of the cells 810 or through all of the interior volume, and thereby encourage cell mobility throughout the adjunct 800.

While the hollow tubular interconnects 828 define openings that can have various sizes (e.g., diameters), in some embodiments, the openings can be about 100 microns to 3500 microns in diameter. For example, the diameter of the opening may be about 100 microns to 2500 microns or about 500 microns to 2500 microns. In certain embodiments, the diameter of the openings may be about 945 microns to 1385 microns. In one embodiment, the diameter of the opening may be greater than 2000 microns. In certain embodiments, the diameter of all openings is substantially the same (e.g., nominally the same within manufacturing tolerances). As used herein, the "diameter" of an opening is the maximum distance between any pair of vertices of the opening.

Because the repeating cells 810 are interconnected to one another at the corresponding connection interfaces 826, the adjunct 800 is in the form of a lattice structure having predetermined compressed regions 830 and predetermined uncompressed regions 840, as shown more clearly in fig. 8C. While the predetermined compressed regions 830 and the predetermined uncompressed regions 840 may have various configurations, in the illustrated embodiment, the predetermined compressed regions 830 are defined by the cells 810 and the predetermined uncompressed regions 840 are in the form of voids 845 defined between the cells 810. In this embodiment, each void 845 is formed between four adjacent interconnected cells 810. For example, as shown in fig. 8F, a void 845a is defined between four adjacent cells 810a, 810b, 810c, 810 d. Thus, the space existing between the adjacent cells defines a predetermined non-compressed region. In other words, the non-compressed region 840 of the adjunct is not defined by the interior volume of the cell.

As described in more detail below, repeating the structural configuration of the unit cell may allow the unit cell to continuously deform or buckle at different locations along its height H (see fig. 9A) over a period of time under an applied stress (e.g., until opposing sides of the interior surface of the unit cell contact each other). Thus, during such times, the cells may deform or buckle at a constant or substantially constant rate when under an applied stress (e.g., 30kPa to 90 kPa). In other words, in certain embodiments, when the adjunct is under an applied stress, the structure of the repeating unit cell can result in a stress plateau, for example, as schematically illustrated in fig. 11.

Fig. 10A-10D schematically illustrate the compressive behavior of one repeating cell (e.g., cell 810 in fig. 8A-9B) under a range of applied stresses. Specifically, the repeating cell 1010 is shown in a pre-compressed (undeformed) state in fig. 10A; the repeating cell is shown in a first compressed state in fig. 10B, where each of the top portion 1012 and the bottom portion 1014 of the cell 1010 begin to compress toward the middle portion 1016 of the cell 1010, such that the middle portion 1016 begins to deflect; the repeating cell is shown in a second compressed state in fig. 10C, with the middle portion 1016 continuing to deflect outward; and is shown in a dense state in fig. 10D, with opposing sides 1018a, 1018b of the interior surface 1018 of the intermediate portion 1016 contacting each other such that the unit cell 810 reaches its solid height.

The relationship between the undeformed state U (fig. 10A), the compressed states C1, C2 (fig. 10B-10C), and the dense state D (fig. 10D) of the repeating cell 1010 and the stress-strain curve of the resulting appendage is schematically illustrated in fig. 11.

The stress-strain response of the appendage begins with elastic deformation (bending) characterized by young's modulus, e.g., as the repeating unit begins to deform from its uncompressed state toward its first compressed state. This elastic deformation continues until a yield stress is reached. Once the yield stress is reached, a stress plateau may occur that corresponds to progressive cell collapse by elastic buckling, e.g., as the repeating cells continue to deform through their first and second compressive states. Those skilled in the art will appreciate that the stress plateau depends at least on the nature of the material from which the cell is fabricated. The stress plateau continues until densification occurs, which indicates that the cells have collapsed throughout the adjunct, e.g., as the repeating cells reach their densified state, and thus, the adjunct has reached its solid height.

Those skilled in the art will appreciate that the stress-strain curve of an appendage depends on various factors such as the uncompressed height, the composition (including material properties), and/or the structural configuration. For example, table 1 below shows the stress-strain response of an exemplary appendage, differing only in the Uncompressed Height (UH), and the appendage was compressed to a first compressed height of 1.75mm (CH1) under an applied stress of 30kPa, to a second compressed height of 0.75mm (CH2) under an applied stress of 90kPa, and to a third compressed height of 0.45mm (CH3) under an applied stress of 90 kPa.

Table 1: stress-strain relationships for various appendage heights

In another embodiment, the repeating strut-free cell based can be a modified Schwarz-P structure. For example, the Schwarz-P structure can be stretched in one or more directions to form a stretched Schwarz-P structure, e.g., as shown in fig. 12A. Alternatively or additionally, in certain embodiments, the wall thickness of the Schwarz-P structure may be thinned. For example, as shown in FIG. 12B, the Schwarz-P structure is stretched and thinned. In yet another embodiment, as shown in FIG. 12C, the Schwarz-P structure can be tailored, for example, where the top portion H of the Schwarz-P structure_T(see FIG. 9A) and/or a bottom portion H_B(see fig. 9A) is reduced in height. Alternatively or in addition to the foregoing exemplary modifications, additional openings can be added through the wall of the Schwarz-P structure, for example, as shown in fig. 12D, which can help densify the resulting adjunct.

The repeating studless cell based may take the form of other TPMS structures. For example, as shown in fig. 13A, a studless-based cell 1300 may be formed from a sheet diamond structure having a diamond minimum area with a Schwarz D surface grid structure. This particular minimal surface is called "diamond" because it has two congruent labyrinths interwoven with each other, each of which has the shape of a tubular form of a diamond-bonded structure. Schwarz D can be expressed functionally as:

sin(x)sin(y)sin(z)+sin(x)cos(y)cos(z)+cos(x)sin(y)cos(z)+cos(x)cos(y)sin(z)＝0。

An exemplary appendage 1310 formed by repeating unit cell 1300 and thus the sheet diamond structure is shown in fig. 13B.

In another embodiment, a studless-based cell 1400 may be a spiral structure, as shown in fig. 14A. The helical minimum surface can be expressed functionally as:

sin(x)cos(y)+sin(y)cos(z)+sin(z)cos(x)＝0。

an exemplary appendage 1410 formed by the repeating cell 1500 and thus the helical structure is shown in fig. 14B. In other embodiments, the stackless-based cell can be in the form of a cosine structure 1500 (fig. 15A) or in the form of a coke drum structure 1600 (fig. 16A), each of the two forms being defined by a curved minimal surface. Fig. 15B and 16B show exemplary appendages 1510, 1610 formed from respective repeating cells 1500 (cosine structure), 1600 (coke drum structure).

Edge condition

In some embodiments, certain strut-free based cells, when interconnected to form an adjunct, can create undesirable edge conditions for tissue suturing. For example, as tissue slides across the adjunct during use, the edge condition can interact with the tissue in a manner that causes at least a portion of the adjunct to prematurely disengage from the staple cartridge. These edge conditions may be the result of geometry (e.g., having substantially planar (e.g., planar within manufacturing tolerances) and non-planar exterior surfaces) and the interconnectivity of the strut-free-based cells that make up the appendages. Thus, to improve these edge conditions, and thus inhibit premature detachment of the adjunct, outer layers having different geometries can be placed on top of one or more tissue contacting surfaces of the adjunct.

Referring back to fig. 9A-9B, as described above, the Schwarz-P structure 810 has a non-planar exterior surface forming arcuate sides 821 extending between connection interfaces 826 of the cells 810. Thus, when Schwarz-P structures 810 are interconnected to form an adjunct, such as adjunct 800 in fig. 8A-8F, a tissue contacting surface can be formed having planar and non-planar surfaces, such as tissue contacting surface 802 in fig. 8A-8B. This is a result of the structural configuration of at least the top portion 812 of each cell 810 (e.g., the exposed topmost outer surface 827a and the arcuate sides 821 of the top portion 812) and the spaced relationship therebetween. Thus, the edge condition of the adjunct can be minimized by applying an outer layer having a generally planar (e.g., planar within manufacturing tolerances) geometry positioned on at least one additional tissue contacting surface of the adjunct, such as tissue contacting surface 802 of adjunct 800 in fig. 8A-8F. This may therefore reduce the tissue load (applied stress) on the adjunct during placement of the stapling apparatus. In addition, this may simplify the attachment requirements between the accessory and the cartridge.

While the outer layer can have various configurations, in some embodiments, the outer layer can be formed from one or more planar arrays of struts (fig. 17A-17C), while in other embodiments, the outer layer can be in the form of a film (fig. 18).

Fig. 17A-17C illustrate an exemplary appendage 1700 having a first grating structure 1702 formed of interconnected repeating cells 1704 and at least one planar array 1706, 1708. Each cell 1704 is similar to cell 810 in fig. 9A-9B, and thus common features are not described in detail herein. In this illustrated embodiment, there are two planar arrays 1706, 1708, where a first planar array 1706 extends (e.g., in the YZ plane) across the top, tissue-facing surface 1712 of the first grating structure 1702 and a second planar array 1706 extends (e.g., in the XZ plane) across at least one side, tissue-facing surface 1714 of the first grating structure 1702. In other embodiments, the first planar array 1706 or the second planar array 1708 may be omitted. In further embodiments, appendage 1700 can include additional planar arrays.

Although planar arrays 1706, 1708 can have various configurations, in this illustrated embodiment, first planar array 1706 and second planar array 1708 each include a longitudinal axis (L) parallel to appendage 1700_A) And a longitudinal strut 1716 extending along the longitudinal axis. Although not shown, it is also contemplated that additional struts may be added to the first and second planar arrays 1706, 170 8. For example, in one embodiment, the first planar array 1706 and/or the second planar array 1708 may include cross-struts that extend at an angle relative to the longitudinal axis and intersect the first longitudinal struts and/or the second longitudinal struts (e.g., thereby creating a repeating X-pattern).

In use, when the adjunct 1700 is releasably retained on a cartridge, such as the cartridge 200 of fig. 1-2C, the adjunct 1700 overlaps a row of staples disposed within the cartridge. Thus, the first planar array 1706 can be added to the final solid height of the adjunct 1700 and thus accelerate its densification. However, to minimize the effect of the first planar array 1706 on densification, the first planar array 1706 may be designed in such a way that it does not overlap with the rows of staples. For example, as shown in fig. 17A-17C, a first planar array 1706 is divided into four spaced-apart portions 1706a, 1706b, 1706C, 1706d such that three gaps 1718, 1720, 1722 are formed therebetween and along the longitudinal axis (L) of the appendage 1700_A). As shown in fig. 17C, these three gaps 1718, 1720, 1722 may coincide with the three staple rows 1724, 1726, 1728 of the cartridge (not shown), and thus the first planar array 1706 will not be captured or minimized by the staples during deployment.

As described above, in some embodiments, a resorbable membrane may be positioned over at least a portion of at least one of the non-planar tissue-facing surfaces of the lattice structure to thereby substantially prevent tissue from causing the adjunct to prematurely detach from the cartridge as the tissue slides across the adjunct. That is, the resorbable membrane may minimize edge conditions, thereby reducing friction that would otherwise exist on the tissue contacting surface of the adjunct.

Fig. 18 illustrates an exemplary embodiment of an appendage 1800 disposed on a cartridge 1801. The adjunct 1800 includes a lattice structure 1802 having a resorbable membrane 1804 disposed over at least a portion of the lattice structure. A grid structure 1802 similar to the grid structure of the adjunct 800 in fig. 8A is formed from interconnected repeating cells 1806, each of which is similar to the cell 810 in fig. 9A-9B, and therefore common features are not described in detail herein. As shown, the resorbable membrane 1804 may be disposed over all of the tissue-facing surfaces of the lattice structure 1802, and in the illustrated embodiment, includes a top tissue-facing surface 1808 (e.g., extending in the x-direction), a first longitudinal side surface 1810a (e.g., extending in the z-direction), a second opposing longitudinal side surface 1810b, a first lateral side surface 1812a (e.g., extending in the y-direction), and a second opposing lateral side surface (obscured). In other embodiments, the resorbable membrane is not disposed on all tissue-facing surfaces of the lattice structure, e.g., the first lateral side surface and/or the second lateral side surface.

The absorbable film may have a variety of configurations. For example, in some embodiments, the resorbable membrane is designed to have a thickness that nominally affects the densification of the adjunct when the adjunct is under an applied stress and/or is formed from one or more materials that help reduce friction of the tissue contacting layer for tissue manipulation. In some embodiments, the thickness of the resorbable membrane may be less than or equal to about 15 microns, such as about 5-15 microns, or about 8-11 microns. In one embodiment, the absorbable film may be formed from polydioxanone.

Attachment feature

In some embodiments, the non-strut based adjunct includes one or more attachment features extending at least partially along a length of the adjunct and configured to engage the staple cartridge to retain the adjunct on the cartridge prior to staple deployment. The one or more attachment features can have a variety of configurations. For example, the one or more attachment features can be a channel attachment (fig. 19A-21), (fig. 22A-22B), and/or an end attachment (fig. 24-25) configured to engage (e.g., crimp or snap into) an elongate cutting slot formed between opposing longitudinal edges in the staple cartridge, the end attachment configured to engage a recessed end channel defined within the staple cartridge. The appendages 1900, 2000, 2100, 2200 are substantially similar to the appendage 800 in fig. 8A-8F except for the differences discussed in detail below, and thus common features are not discussed in detail herein.

In some embodiments, the channel attachment member can include one or more compressible members structurally configured to be inserted into the longitudinal slot of the staple cartridge to engage opposing walls of the longitudinal slot. In certain embodiments, the one or more compressible members can include a compressible opening extending therethrough in a longitudinal direction, for example, along the length of the cartridge contacting surface of the adjunct.

Fig. 19A-19B illustrate an exemplary embodiment of an adjunct 1900 that includes a channel attachment 1910 having two compressible members 1912, 1914 interconnected by at least one common elongate joint 1916. While the two compressible members 1912, 1914 can have a variety of configurations, in this illustrated embodiment, each compressible member 1912, 1914 is in the form of an elongated rod having a triangular cross-sectional shape taken across its width (e.g., in the y-direction), with hollow triangular channels 1912a, 1914a extending therethrough along its length (e.g., in the z-direction). As shown, two elongate rods 1912, 1914 are interconnected at corresponding vertices, forming an elongate joint 1916 that defines a central connection region having a narrow thickness (e.g., in the x-direction). As shown in fig. 19B, when the adjunct 1900 is disposed on a cartridge 1901 similar to the cartridge 200 in fig. 1-2C, the at least one elongate joint 1916 (and thus the central connection region) is positioned equidistant from the opposing walls 1903a, 1903B of the longitudinal slot 1903, as shown in fig. 19. Thus, the central connection region is aligned with the advancement line of the cutting member, and thus the risk of jamming the cutting member as it advances through the adjunct 1900 may be minimized or prevented due to the narrow width of the central connection region. That is, the central connection region minimizes the additional appendages that the cutting member would otherwise need to cut as it advances through the longitudinal slot 1903. In addition, the hollow triangular channels 1912a, 1914a reduce the amount of material on each side of the pusher wire, which may also minimize binding of the cutting edge of the adjunct with the cutting member as the adjunct is advanced further through the longitudinal slot 1903.

Although the overall width W of the channel attachment 1910_CVariations may occur, but in the illustrated embodiment, the total width W_CIs greater than the width W of the longitudinal slot 1903_L(e.g., the distance between two opposing slot walls 1903a, 1903 b). Thus, when the channel attachment 1910 is inserted into the longitudinal slot 1903, the compressible member deforms and engages (e.g., compresses against) the respective slot walls 1903a, 1903b due to the outward lateral forces generated by the hollow triangular channels 1912a, 1914 a. Thus, a pressure or friction fit is created between the compressible members 1912, 1914 and the respective slot walls 1903a, 1903b of the cartridge 1901.

The channel attachment can have other configurations (e.g., shapes and/or sizes). For example, as shown in fig. 20, the adjunct 2000 is similar to the adjunct 800 shown in fig. 8A-8X, except that the adjunct 2000 further includes a channel attachment 2010 in the form of an elongated tab that extends outwardly from the cartridge contacting surface 2004 of the adjunct 2000 and is positioned between two inner row of repeating cells 2010a, 2012 a. The elongated projections 2010 are configured to be inserted into the longitudinal slots of the cartridge, such as the longitudinal slots 210 of the cartridge 200 in fig. 2A and 2C.

While the elongated projections 2010 can have a variety of configurations, in this illustrated embodiment, the elongated projections 2010 are formed from two compressible longitudinal rods 2010a, 2010b with a cross bar 2010c extending therebetween. In some embodiments, the width of the elongated protrusion 2010 (e.g., in the y-direction) is greater than the width of the longitudinal slot of the staple cartridge (e.g., the distance between two opposing slot walls). Thus, when the elongated protrusion 2010 is inserted into a longitudinal slot, such as the longitudinal slot 210 of the cartridge 200 in fig. 2A-2C, the two longitudinal bars are configured to engage (e.g., compress against) opposing slot walls as a result of the outward lateral force generated by the cross bar 2010C. Thus, a press or friction fit is formed between the elongated projections 2010 and the slot walls of the cartridge.

Fig. 21 shows another embodiment of an adjunct 2100 with a channel attachment. Accessory 2100 is similar to accessory 2000 shown in FIG. 20, except for the channel attachmentIn the form of discrete protrusions 2110 (only two shown in fig. 21) that lie along the longitudinal axis L of the adjunct 2100_ASpaced relative to each other. While the protrusions 2110 can have a variety of configurations, in the illustrated embodiment, each protrusion 2110 is in the form of an annular boss having an oval shape. In other embodiments, the protrusions 2110 can be any other suitable shape and/or vary in size/shape with respect to each other. Each annular boss 2110 can be configured to be compressible and, in some embodiments, sized such that the width of each boss (e.g., in the y-direction) can be greater than the width of the longitudinal slot (e.g., the distance between two opposing slot walls) of a staple cartridge, such as longitudinal slot 210 in staple cartridge 200 in fig. 2A-2C. Thus, when the discrete annular bosses 2110 are inserted into the longitudinal slots of the cartridge, their outer surfaces 2110a are configured to engage (e.g., compress against) the opposing slot walls due to the outward radial force of the annular bosses. Thus, a press fit or friction fit is formed between the annular boss 2110a and the slot wall of the longitudinal slot.

Alternatively or additionally, in some embodiments, the adjunct can include an edge attachment feature configured to engage a corresponding edge attachment feature of the adjunct. For example, as shown in fig. 22A-22C, an adjunct 2200 can include three sets of opposing clamps 2202A, 2202b, 2204a, 2204b, 2206a, 2206b that each extend laterally outward and away from opposing outer side surfaces 2200a, 2200b of the adjunct 2200. While the three sets of clamps 2202a, 2202b, 2204a, 2204b, 2206a, 2206b can have a variety of configurations, in this illustrated embodiment, the three sets of clamps 2202a, 2202b, 2204a, 2204b, 2206a, 2206b each have a hook-shaped configuration that engages with a respective edge attachment feature 2208a, 2208b, 2210a, 2210b, 2212a, 2212b of the cartridge 2201. In this illustrated embodiment, each edge attachment feature 2208a, 2208B, 2210a, 2210B, 2212a, 2212B has an inverted L-shaped configuration, creating flanges extending laterally outward from the staple cartridge 2201 (only one flange is shown in detail in fig. 22B-22C).

The engagement of one clamp 2204a of an appendage 2200 with one flange 2210a of a cartridge 2201 is shown in FIG. 22C. The repeating cells of the appendage 2200 are omitted for simplicity. As shown, the inner surface 2214a of the end portion 2214 of the clamp 2204 engages the outer bottom surface 2216 of the flange 2210a, thereby nesting a portion of the outer surface 2218 of the flange 2210a against a corresponding portion of the inner surface 2220 of the clamp 2204a (e.g., male/female engagement). In addition, as shown in fig. 22C, the flanges 2210a are biased outwardly, and thus, when a portion of the outer surface 2218 of the flanges 2210a are engaged, they are pressed against a corresponding portion of the inner surface 2220a of the clamp 2204 a.

Fig. 23A-23B illustrate another embodiment of an adjunct having three sets of opposing clips 2302a, 2302B (partially obscured), 2304a, 2304B (partially obscured), 2306a, 2306B (partially obscured) configured to engage a corresponding set of opposing receiving members 2308, 2310 (partially obscured), 2312, 2314 (partially obscured), 2316, 2318 (partially obscured) of a staple cartridge 2301.

In the illustrated embodiment, each clamp is structurally identical and has an inverted T-shaped configuration. Additionally, as shown, each set of receiving members is identical in structure and includes two inverted L-shaped members that are spaced apart and face each other to form a t-shaped gap therebetween. For example, the engagement of one clamp 2302a with its corresponding set of receiving members 2308a, 2308B is shown in more detail in fig. 23B. As shown, the lateral segments 2316a, 2316b (e.g., extending in the z-direction) of the clamp 2302a are configured to engage with respective inner surfaces (only one inner surface 3118 shown) of each L-shaped member 2308a, 2308b, and the vertical segment 2320 (e.g., extending in the x-direction) of the clamp 2302a is configured to be positioned between two facing surfaces (only one facing surface 2322 shown) of the L-shaped members 2308a, 2308 b. Accordingly, vertical segment 2320 can help maintain the longitudinal alignment of adjunct 2300 with respect to staple cartridge 2301 (and thus with respect to staples (not shown) disposed therein). During use, the vertical segment 2320 may also help prevent premature disengagement of the clamp 2302a from a corresponding set of receiving members 2308a, 2308b, and thus the adjunct 2300 from the cartridge 2301.

Alternatively or additionally, in some embodiments, the adjunct can include end attachment features, such as opposing proximal and distal sets of bosses configured to engage (e.g., press fit) into corresponding proximal and distal sets of recesses defined in the staple cartridge. For example, in one embodiment, the adjunct can have rectangular bosses configured to engage the proximal and distal sets of rectangular recesses 2402a, 2402b, 2404a, 2404b of the staple cartridge 2400 in fig. 24. In another embodiment, the adjunct can have a circular boss configured to engage the proximal and distal sets of circular recesses 2502a, 2502b, 2504a, 2504b of the staple cartridge 2500 in fig. 25.

As described above, in certain embodiments, a staple cartridge can comprise surface features in the form of recessed channels, for example, recessed channels 216, 218, 220 as shown in fig. 2A and 2C. In such embodiments, the adjunct can be designed to engage with the recessed channel to effect a releasable attachment mechanism between the adjunct and the staple cartridge even when the frequency of staples within a longitudinal row of staples (e.g., the number of staples per length row of staples) is different from (e.g., greater than) the frequency of repeating cells within a corresponding longitudinal row of cells (e.g., the number of cells per length row of cells).

Fig. 26A-26C illustrate an adjunct 2600 disposed on a staple cartridge 2602 that is similar to staple cartridge 200 of fig. 2A-2C and, therefore, common features are not described in detail herein. The staple cartridge 2602 includes staple cavities arranged in longitudinal rows 2604a, 2604b, 2604c, 2606a, 2606b, 2606c and recessed channels surrounding each staple cavity 2604a, 2604b, 2604c, 2606a, 2606b, 2606 c. As shown, a first recessed channel 2608 surrounds each first staple cavity 2604a, 2606a, a second recessed channel 2610 surrounds each second staple cavity 2604b, 2606b, and a third recessed channel 2612 surrounds each third staple cavity 2604c, 2606 c. The first, second, and third recessed channels each include a respective bottom plate 2614, 2616, 2618 located at a respective height (e.g., extending in the x-direction) from the top surface 2602a of the staple cartridge 2602. In this illustrated embodiment, the respective heights are the same, while in other embodiments, the respective heights may be different.

While adjunct 2600 can have various configurations, in this illustrated embodiment, adjunct 2600 is formed from a repeating cell 2620 and attachment features 2622 extending from at least a portion of plurality of cells 2620. The attachment features 2622 are each configured to be inserted into and engage at least a portion of the recessed channels 2608, 2610, 2612 of the staple cartridge 2602 to retain the adjunct 2600 to the staple cartridge 2602 prior to staple deployment.

While the attachment features 2622 can have various configurations, each attachment feature has a different geometry such that each attachment feature can engage a respective recessed channel. This difference in geometry is due to the difference in frequencies of the unit cells, as compared to the frequencies of the staples 2605 of the staple cavities 2604a, 2604b, 2604c, 2606a, 2606b, 2606c of the staple cartridge 2602. Thus, the attachment features 2622 are positioned on the respective cells 2620 at predetermined positions corresponding to the recessed channels 2608, 2610, 2612. As shown in fig. 26A, and half (e.g., left half) of the adjunct 2600 shown in more detail in fig. 26B-26C, the respective geometries of the attachment features 2622 are configured to engage the longitudinal axis L of the recessed channels 2608, 2610, 2612 relative to the staple cartridge 2602_ALaterally outwardly directed respective vertices 2608a, 2610b, 2612 a. In other embodiments, the geometry of the attachment feature may be configured to engage other portions of the recessed channel.

The geometry of the attachment features 2622 can vary laterally and/or longitudinally relative to the longitudinal axis of the cartridge. The geometric variation depends at least on the frequency of the cells 2620 relative to the frequency of the staples 2605 and the shape of the staple cavities 2604a, 2604b, 2604c, 2606a, 2606b, 2606 c. For example, the attachment features 2622 can vary in at least one of height (e.g., in the x-direction), width (e.g., in the y-direction), length (e.g., in the z-direction), and shape relative to each other. For example, as shown in fig. 26B, the height H of the first attachment feature 2622a extending from the first repeating cell 2620a ₁Is greater than a height H of a second attachment feature 2622b extending from a second repeating cell 2620b₂And thus the height of the first and second attachment features 2622a, 2622b relative to the longitudinal axis L of the cartridge 2602_ALaterally differently. In this illustrated embodiment, as further shown in fig. 26A and 26B, the shape of each of the first and second attachment features 2622a and 2622B is also relative to the longitudinal axis L of the cartridge 2602_ALaterally varying. The first attachment feature 2622a has a cylindrical configuration and the second attachment feature 2622b has an arcuate configuration. Alternatively or additionally, the length of two or more attachment features may be along the longitudinal axis of the cartridge 2602_AL varies. For example, as shown in fig. 26A, the third and fourth repeating cells 2620c and 2620d include third and fourth attachment features 2622c and 2622d, respectively, that are along the longitudinal axis L of the cartridge 2602_AVarying in length (e.g., extending in the z-direction) and shape. In this illustrated embodiment, the third attachment feature 2622c has a cylindrical configuration and the fourth attachment feature 2622d has a triangular configuration.

In certain embodiments, the lateral variation in the shape and/or height of the attachment features may correspond to the lateral variation in the recessed channel. For example, although not shown, in some embodiments, the walls of at least a portion of the recessed channel can extend at an angle relative to the longitudinal axis of the cartridge, and thus one or more attachment features can vary in shape and/or height to correspond to the recessed channel. In other embodiments, the length of the recessed channel may vary laterally, and the one or more attachment features may vary in shape and/or height to correspond to the recessed channel.

Frequency of cell

The non-strut based appendages may vary longitudinally (e.g., along their length, e.g., in the z-direction) and/or laterally (e.g., along their width, e.g., in the y-direction) in thickness. Thus, in the event that the frequency of staples within a longitudinal row of staples (e.g., the number of staples per length row of staples) is different from (e.g., greater than) the frequency of repeating cells within a corresponding longitudinal cell row (e.g., the number of cells per length row of cells), the legs of each staple can be advanced through different portions of the adjunct, wherein each portion has a relative thickness difference, as shown in fig. 27.

FIG. 27 illustrates an exemplary embodiment of a stapling assembly 2700 having a staple cartridge 2702, such as the staple cartridge 200 of FIGS. 1-2C, and having staples arranged in longitudinal rows (only four staples 2704, 2706, 2708, 2710 of a portion of the first longitudinal staple row 2712 are shown). An adjunct 2714 is disposed on the top surface 2702a of the staple cartridge 2702. The adjunct 2714 includes interconnected repeating studless cells arranged in a longitudinal axis (only a portion of the first longitudinal cell row 2717 is shown), such as the repeating cell 810 in fig. 8A-9C (only five repeating cells 2716a, 2716b, 2716C, 2716d, 2716e are shown). As shown, the first longitudinal cell row 2717 overlaps the first longitudinal staple row 2712 and the frequency of the staples 2704, 2706, 2708, 2710 is different than the frequency of the cells 2716a, 2716b, 2716c, 2716d, 2716e (e.g., not multiple). Thus, for example, when the adjunct 2714 is sutured to tissue, each staple leg 2704b, 2706a, 2706b, 2708a, 2708b, 2710a of the respective staple 2704, 2706, 2708, 2710 is aligned with, and thus will penetrate, a different respective portion 2718, 2720, 2722, 2724, 2726 (and thus the adjunct 2714) of the first longitudinal cell row 2712. Additionally, as shown in fig. 27, due to the structural configuration (e.g., generally not square) of the repeating unit cells 2716a, 2716b, 2716c, 2716d, 2716e, at least two or more of the different portions 2718, 2720, 2722, 2724, 2726, 2728 may have different relative thicknesses T ₁、T₂、T₃、T₄、T₅(e.g., thick and thin thickness), and thus the thickness of the appendages 2714 captured within the firing staples, will vary between adjacent staples stapled to consistent tissue.

In some embodiments, the difference in relative thickness of the adjunct can be paired with a corresponding difference in staple leg length. For example, when the staple and cell frequencies are the same, the leg of any staple configured to be advanced through a thicker portion of the adjunct may be longer in length than the leg of any staple configured to be advanced through a thinner portion of the adjunct. Alternatively or in addition, the difference in relative thickness can be paired with a corresponding difference in anvil pocket depth, or, if the staple drivers are at the same height, can be paired with a difference in tissue gap between the first staple leg to the second staple leg (if the staple drivers are at the same height).

Fig. 28A shows an exemplary embodiment of a stapling assembly 2800 that is similar to the stapling assembly 2700 of fig. 27, except that the structural configuration of the adjunct 2801 has been modified such that the staple frequency and the cell frequency are the same. Thus, the first staple legs 2804a, 2806a, 2808a of each staple 2804, 2806, 2808 are configured to pass through staples having the same first thickness T ₁And the second staple leg 2804b, 2806b, 2808b of each staple 2804, 2806, 2808 is configured to pass through a corresponding portion of the adjunct having a same second thickness T₂Corresponding portion of appendage 2801. As shown, a first thickness T₁Greater than the second thickness T₂And thus the first leg length L of each staple 2804, 2806, 2808 to offset the difference in thickness₁May be greater than the second leg length L₂. In the illustrated embodiment, the crowns 2804c, 2806c, 2808c of each staple 2804, 2806, 2808 have a non-planar configuration (e.g., a stepped configuration) to achieve the difference in staple leg lengths. In addition, when the staples 2804, 2806, 2808 are deployed and the adjunct 2801 is stapled to tissue T, each staple will have two different staple heights H formed₁、H₂As shown in fig. 28B. Fig. 29 illustrates another exemplary embodiment of a stapling assembly 2900 that is similar to the stapling assembly 2800, except that the crowns 2904c, 2906c, 2908c of each staple 2904, 2906, 2908 are substantially planar (e.g., generally linear or linear within manufacturing tolerances), and thus, the formed staple height of the first staple will be substantially uniform (e.g., nominally the same within manufacturing tolerances).

Stay-based appendages

As described above, the adjunct can include a lattice structure formed from strut-based cells (e.g., defined by planar interconnecting struts). Typically, such appendages can include a tissue-contacting layer, a cartridge-contacting layer, and an internal structure (e.g., a flexure structure). The internal structure typically includes struts (e.g., spacing struts) that connect the tissue contacting layer and the cartridge contacting layer together in a spaced apart relationship. The struts may be configured to collapse without contacting each other when the adjunct compresses under stress. As a result, densification of the adjunct may be delayed, and thus may occur at higher strains.

The tissue contacting layer and the cartridge contacting layer can have various configurations. In some embodiments, at least one of the tissue contacting layer and the cartridge contacting layer can comprise a plurality of struts defining openings. In some embodiments, the tissue contacting layer and the cartridge contacting layer are both substantially planar (e.g., planar within manufacturing tolerances). The tissue contacting layer and the cartridge contacting layer can be oriented parallel to each other along a longitudinal axis extending from the first end to the second end of the adjunct and can further define a vertical axis extending therebetween.

The struts can have various configurations. For example, in some embodiments, the struts may have a substantially uniform (uniform within manufacturing tolerances) cross-section, while in other embodiments, the struts may have different cross-sections. In some embodiments, the adjunct can have an average strut thickness in a range of about 0.1mm to 0.5mm, about 0.1mm to 0.4mm, or about 0.1mm to 0.3 mm.

Fig. 30A-30B illustrate an exemplary strut-based appendage 3000. The adjunct 3000 includes a tissue contacting layer 3002, a cartridge contacting layer 3004, and an inner structure 3006 extending therebetween. The internal structure 3006 is configured to collapse (compress) when the adjunct 3000 is under an applied stress, and thus cause the adjunct 3000 to compress when sutured to tissue.

While the tissue contacting layer 3002 and the cartridge contacting layer 3004 can have various configurations, in this illustrated embodiment they are both generally planar (e.g., planar within manufacturing tolerances). In addition, the tissue contact layer 3002 and the cartridge contact layer 3004 are along a longitudinal axis (L) that extends from the first end 3000a to the second end 3000b of the adjunct 3000_A) Parallel to each other. As shown, the tissue contacting layer 3002 and the cartridge contacting layer 3004 are inverted images of each other, with the thickness (T) of the cartridge contacting layer 3004 _C) Greater than the thickness (T) of tissue contacting surface 3002_T). Thus, for simplicity, the following description is with respect to tissue contacting layer 3002. However, one skilled in the art will appreciate that the following discussion also applies to the bin contact layer 3004.

Tissue-contacting layer 3002 has first, second, and third longitudinal struts 3008a, 3010a, 3012a extending along the longitudinal axis (L) of adjunct 3000, with second longitudinal strut 3010a positioned between but spaced apart from first and third longitudinal struts 3008a, 3012 a. Tissue-contacting layer 3002 further includes first cross-struts 3014a and second cross-struts 3016 a. Each of first cross-braces 3014a is connected to first longitudinal brace 3008a and second longitudinal brace 3010 a. While first cross-brace 3014a may be oriented at a variety of different locations, in the illustrated embodiment, first cross-brace 3014a is oriented orthogonally with respect to first longitudinal brace 3008a and second longitudinal brace 3010 a. Similarly, each of second cross-struts 3016a is connected to a second longitudinal strut 3010a and a third longitudinal strut 3012 a. While second cross-brace 3016a may be oriented at a variety of different positions, in the illustrated embodiment, second cross-brace 3016a is oriented orthogonally with respect to second longitudinal brace 3010a and third longitudinal brace 3012 a. In addition, as shown, first cross brace 3014a is aligned with second cross brace 3016a in the y-direction.

In addition, first cross brace 3014a is at first distance D₁Are longitudinally spaced from each other and the second cross braces are at a second distance D₂Are longitudinally spaced from each other. Thus, an opening 3018a is created in tissue contacting layer 3002. Although opening 3018a can have various sizes and shapes, in this illustrated embodiment, D₁And D₂Identical or substantially identical, and thus, in combination with the orientation of first cross-brace 3014a and second cross-brace 3016a, resulting opening 3018a is of substantially uniform size (e.g., during manufacture)Nominally the same within tolerance) of a rectangular form.

While the inner structure 3006 can have a variety of configurations, in this illustrated embodiment, the inner structure 3006 includes spacing struts 3020 that extend between the tissue contacting layer 3002 and the cartridge contacting layer 3004. The spacing struts 3020 include a first set of angled struts 3022a, 3022b and a second set of angled struts 3024a, 3024b, each of which extends at an angle (e.g., 45 degrees) relative to the tissue-contacting layer 3002 and the cartridge-contacting layer 3004. The first set of angled struts includes a first angled strut 3022a extending from a first longitudinal strut 3008a of the tissue-contacting surface 3002 to a second longitudinal strut 3010b of the cartridge-contacting layer 3004, and a second angled strut 3022b extending from the first longitudinal strut 3008b of the cartridge-contacting layer 3004 to the second longitudinal strut 3010a of the tissue-contacting layer 3002. Thus, first angled struts 3022a and second angled struts 3022b alternate along the length (L) of the appendage. The second set of alternating angled struts includes third angled struts 3024a and fourth angled struts 3024 b. The third angled struts 3024a are similar to the first angled struts 3022a except that the third angled struts 3024a extend from the second longitudinal strut 3010a of the tissue contact layer 3002 to the third longitudinal strut 3012b of the cartridge contact layer 3004. The fourth angled struts 3024b are similar to the second angled struts 3022b except that the fourth angled struts 3024b extend from the second longitudinal strut 3010b of the cartridge contact layer 3004 to the third longitudinal strut 3012a of the tissue contact layer 3002. Thus, in the illustrated embodiment, first angled strut 3022a and third angled strut 3024a extend in the same direction relative to each other, and second angled strut 3022b and fourth angled strut 3024b extend in the same direction relative to each other.

As further shown in fig. 30A, openings 3018b are created within the cartridge contact layer 3004 between the first cross-struts 3014b and between the second cross-struts 3016 b. In addition, the angled struts 3022a, 3022b, 3024a, 3024b substantially overlap with at least the corresponding openings 3018b in the cartridge contact layer 3004, and as described above, the cartridge contact layer 3004 has a thickness T greater than the tissue contact layer 3002_TThickness T of_C. Thus, the opening 3018b defined in the cartridge contact layer 3004 can be configured to receive at least a portion of a corresponding angled strut as the adjunct 3000 bends when compressed under an applied stress. This creates additional space within the inner structure 3006 for flexion and thus reduces the solid height of the appendage 3000. Thus, in use, densification of the adjunct 3000 can be delayed such that the adjunct 3000 can undergo a wider range of deformation without reaching its solid height.

Additionally, a concentrated region 3030 within interior structure 3006 is created by alternating angled struts 3022a, 3022b, 3024a, 3024 b. As shown, this focusing region 3030 extends in a longitudinal direction along the appendage between first and second sets of angled struts 3022a, 3022b, 3024a, 3024 b. Accordingly, no struts 3020 within interior structure 3006 overlap this focal zone 3030, as shown in more detail in fig. 30B. In other words, this focusing region 3030 is designed as a void free of struts into which no struts cross before or during compression of the adjunct. Thus, the presence of this focusing region 3030 can increase the point of densification of the adjunct 3000 while suturing the adjunct to tissue (e.g., reducing the solid height of the adjunct). In addition, the concentration zone may overlap the cut line of the adjunct, and thus the amount of material along the cut line may be reduced. This may help facilitate advancement of the cutting element of the stapling device and, thus, make cutting of the adjunct easier.

Fig. 31A, 32A, 33A, and 34A illustrate various other exemplary strut-based attachments 3100, 3200, 3300, and 3400. Each exemplary appendage has a lattice structure formed of repeatedly interconnected strut-based cells, which are shown in more detail in fig. 31B-31D, 32B-32D, 33B-33E, and 34B-34E. These appendages are structured so as to compress when exposed to a compressive force (e.g., a stress applied when sutured to tissue).

Fig. 31A illustrates another example appendage 3100 in the form of a grid structure including a top portion 3102, a bottom portion 3104, and an inner structure 3106 extending therebetween. The top portion 3102 is configured to contact tissue, and thus form a tissue contact layer of the appendage 3100, while the bottom portion 3104 is configured to attach to the cartridge, and thus form a cartridge contact layer of the appendage 3100. The inner structure 3106 may be configured to be compressed into a deformed state under load, for example, when sutured to tissue. The grid is formed of an array of repeating cells 3110, one of which is shown in more detail in fig. 31B-31D. Thus, for simplicity, the following description is with respect to the top portion 3102, bottom portion 3104, and internal structure 3106 of one cell.

While the top portion 3102 and the bottom portion 3104 may have various configurations, in this illustrated embodiment, the top portion 3102 and the bottom portion 3104 are inverted images of each other, and thus, for simplicity, the following description is with respect to the top portion 3102 of one cell 3110. However, those skilled in the art will appreciate that the following discussion also applies to bottom portion 3104.

As shown in fig. 31A-31D, top portion 3102 includes first and second cross-braces 3112 and 3114 and first and second angled braces 3116 and 3118 extending therebetween. In this illustrated embodiment, a first angled strut 3116 extends at a first angle from a first end of the first cross strut 3112 and terminates at a middle portion of the second cross strut 3114, and a second angled strut 3118 extends at a second angle from a second opposing end of the first cross strut 3112 and terminates at a middle portion of the second cross strut 3114. Thus, first angled strut 3116 and second angled strut 3118 converge and join at a center section 3114a of second cross strut 3114. In other embodiments, the first angled stay 3116 and the second angled stay 3118 may extend at any other suitable angle.

While inner structure 3106 may have various configurations, in the illustrated embodiment, inner structure 3106 includes three spaced struts 3120a, 3120b, 3120 c. As shown in fig. 31B-31D, first and third spacing braces 3120a and 3120c each interconnect first cross brace 3112 of top portion 3102 to first cross brace 3112 of bottom portion 3104, and second spacing brace 3120B interconnects central section 3114a of second cross brace 3114 of top portion 3102 to central section 3114a of second cross brace 3114 of bottom portion 3104.

Fig. 32A illustrates another example appendage 3200 in the form of a lattice structure comprising a top portion 3202, a bottom portion 3204, and an inner structure 3206 extending therebetween. Top portion 3202 is configured to contact tissue, and thus form a tissue-contacting layer of adjunct 3200, while bottom portion 3204 is configured to attach to a cartridge, and thus form a cartridge-contacting layer of adjunct 3200. Adjunct 3200 is similar to adjunct 3100 illustrated in fig. 31A-31D, except for the differences described below. The grid is formed by an array of repeating cells 3201, one of which is shown in more detail in fig. 32B-32D. Thus, for simplicity, the following description is with respect to the top portion 3202, bottom portion 3204, and internal structure 3206 of one cell.

As shown in fig. 32B-32D, the top portion 3202 is offset from the bottom portion 3204 in the first and second dimensions (X, Z). Top portion 3202 includes two separate sets of interconnecting struts 3202a, 3202b, which are connected to each other by connecting struts 3203. The bottom portion 3204 includes eight interconnecting struts 3204a, six of which form a first hexagonal face of the cell 3201. The internal structure 3206 includes two sets of spacer bars 3208a, 3208B, 3208c, 3210a, 3210B, 3210c extending from the top portion 3202 to the bottom portion, forming two additional hexagonal faces of the cell 3201, as shown in fig. 32B.

Fig. 33A illustrates another exemplary appendage 3300 in the form of a lattice structure that includes a top portion 3302, a bottom portion 3304, and an internal structure 3306 extending therebetween. Top section 3302 is configured to contact tissue and thus form a tissue-contacting layer of adjunct 3300, while bottom section 3304 is configured to attach to a cartridge of a surgical stapler and thus form a cartridge-contacting layer of adjunct 3300. The appendage 3300 is similar to appendage 3100 shown in fig. 31A through 31D, except for the differences described below. The grid is formed of an array of repeating cells 3310, one of which is shown in more detail in fig. 33B-33E. Thus, for simplicity, the following description is with respect to the top portion 3302, bottom portion 3304, and internal structure 3306 of one cell 3310.

Although the top section 3302 and the bottom section 3304 may have various configurations, in the illustrated embodiment, the top section 3302 and the bottom section 3304 are substantially identical to one another, and thus, for simplicity, the following description is with respect to the top section 3302 of one cell 3310. However, one skilled in the art will appreciate that the following discussion also applies to the bottom portion 3304.

As shown in fig. 33A-33E, top portion 3302 includes a first pair of opposing outer struts 3312a, 3312b and a second pair of opposing outer struts 3312c, 3312 d. The first and second pairs of outer struts 3312a, 3312b, 3312c, 3312d are connected in a manner in which the top section 3302 is in the form of a parallelogram having four corners 3316a, 3316b, 3316c, 3316 d. In the illustrated embodiment, the parallelogram is a square. Top section 3302 also includes a first cross brace 3318 connecting a first pair of opposing outer braces 3312a, 3312b and a second cross brace 3320 connecting a second pair of opposing outer braces 3312c, 3312 d. As shown, first cross brace 3318 and second cross brace 3320 intersect at 90 degrees relative to each other in the middle of top section 3302.

While the internal structure 3306 can have various configurations, in this illustrated embodiment, the internal structure 3306 includes a first side 3322a, a second adjacent side 3322b, a third side 3322c opposite the first side 3322a, and a fourth side 3322D opposite the second side 3322b (see fig. 33D). While each side can have a variety of configurations, in the illustrated embodiment, the first side 3322a and the third side 3322c are substantially identical to one another, and the second side 3322 and the fourth side 3322d are substantially identical to one another.

As shown in fig. 33B-33E, the first side 3322a of the internal structure 3306 includes first and second angled spacing struts 3324a, 3324B that extend in opposite directions from a central section 3313 of the outer struts 3312a of the bottom section 3304 to first and second corners 3316a, 3316B, respectively, of the top section 3302. Similarly, third side 3322c of the interior structure includes third and fourth angled spacing struts 3326a and 3326b that extend in opposite directions from an outer side strut 3312b (obscured) center section (obscured) of bottom section 3304 to third and fourth corners 3316c and 3316c, respectively, of top section 3302.

In addition, second side 3322b of interior structure 3306 includes fifth and sixth angled spacing struts 3328a, 3328b that extend in opposite directions from a central section 3315 of outer struts 3312c of top portion 3302 to first and fourth corners 3316a, 3316d, respectively, of bottom portion 3304. Similarly, fourth side 3322d of interior structure 3306 includes seventh and eighth angled spacing struts 3330a and (obscured) that extend in opposite directions from a center section 3317 of outside strut 3312d of top section 3302 to second and third corners 3316b and 3304, respectively, of bottom section 3304 (with the third corner of bottom section 3304 obscured).

The internal structure 3306 also includes a first pair of angled spacing struts 3332a, 3332 b. First angled spacing struts 3332a extend from the middle of top section 3302 to a center section 3334 of outer struts 3312c of bottom section 3304. Similarly, second spacer 3332b extends from the middle of top section 3302 to the center section (obscured) of outside struts 3312d of bottom section 3304. Thus, a first pair of angled spacing struts 3332a, 3332b extend in opposite directions from the middle of top section 3302.

Additionally, the internal structure 3306 includes a second pair of angled spacer struts 3336a, 3336 b. First angled spacing struts 3336a extend from the middle of bottom section 3304 to a center section 3338 of outer struts 3312b of top section 3302. Similarly, second spacer bar 3336b extends from the middle of bottom section 3304 to a center section (obscured) of outside bar 3312a of top section 3302. Thus, a second pair of angled spacing struts 3336a, 3336b extend in opposite directions from the middle of bottom section 3304.

FIG. 34A shows another exemplary appendage 3400 in the form of a lattice structure including a top portion 3402, a bottom portion 3404, and an internal structure 3406 extending therebetween. The top portion 3402 is configured to contact tissue and thus form a tissue-contacting layer of the adjunct 3400, while the bottom portion 3404 is configured to attach to a cartridge of a surgical stapler and thus form a cartridge-contacting layer of the adjunct 3400. The appendage 3400 is similar to appendage 3100 shown in fig. 31A through 31D, except for the differences described below. The grid is formed of an array of repeating cells 3410, one of which is shown in more detail in fig. 34B-34E. Therefore, for simplicity, the following description is with respect to the top portion 3402, the bottom portion 3404, and the internal structure 3406 of one cell.

While the top portion 3402 and the bottom portion 3404 may have various configurations, in the illustrated embodiment, the top portion 3402 and the bottom portion 3404 are substantially identical to one another, and thus, for simplicity, the following description is with respect to the top portion 3402 of one cell 3410. However, those skilled in the art will appreciate that the following discussion also applies to the bottom portion 3404.

As shown in fig. 34B-34E, the top portion 3402 includes four cross-braces 3408a, 3408B, 3408c, 3408d connected together at the middle of the top portion 3402. Although the four cross-struts 3408a, 3408b, 3408c, 3408d may be connected together at different angles with respect to each other, in the illustrated embodiment, the four cross-struts 3408a, 3408b, 3408c, 3408d are connected at 90 degrees with respect to each other and thus form a cross shape having four outer ends 3411a, 3411b, 3411c, 3411 d. Top portion 3402 also includes four struts 3412a, 3412b, 3412c, 3412d connected in a manner to form a square having four corners 3414a, 3414b, 3414c, 3414 d. Each support strut 3412a, 3412b, 3412c, 3412D of the square shape intersects a central section 3416a, 3416b, 3416c, 3416D (see fig. 34D) of one of the four cross-shaped support struts 3408a, 3408b, 3408c, 3408D.

While internal structure 3406 may have various configurations, in this illustrated embodiment, internal structure 3406 includes four sets of angled outer struts, where each set of angled outer struts includes two angled struts 3418a, 3418b, 3420a, 3420b, 3422a, 3422b, 3424a, 3424 b. The four sets of angled outer struts may have various configurations. As shown, in this illustrated embodiment, the first and second sets of outer struts are mirror images of each other, and the third and fourth sets of outer struts are mirror images of each other.

As shown in fig. 34B, first and second angled struts 3418a, 3418B of the first set of angled outer struts each extend in opposite directions from a first corner 3414a of the square of bottom portion 3404 to one of first and second intersecting corners 3411a, 3411B, respectively, of top portion 3402. Similarly, first angled struts 3420a and second angled struts 3420b of the second set of angled outer struts each extend in opposite directions from a third corner 3414c (obscured) of the square of bottom portion 3404 to the remaining corners of the cross (e.g., third corner 3411c and fourth corner 3411d, respectively) of top portion 3402.

As further shown in fig. 34B, first and second angled struts 3422a and 3422B of the third set of angled outer struts each extend in opposite directions from a second corner 3414B of the square of top portion 3404 to one of a second corner 3411B and a third corner 3411c, respectively, of the cross-shape of bottom portion 3404. Similarly, first and second angled struts 3424a and 3424b of the fourth set of angled outer struts each extend in opposite directions from a fourth corner 3414d of the square of top portion 3404 to one of the first and fourth corners 3411a and 3411d (obscured), respectively, of the intersection of bottom portion 3404.

The internal structure 3406 also includes two sets of angled internal struts, where each set includes two angled struts 3426a, 3426b, 3428a, 3428 b. The two sets of angled inner struts can have various configurations. As shown in fig. 34B, first angled strut 3426a and second angled strut 3426B of the first set of angled inner struts each extend in opposite directions from the middle of the cross-shape of top portion 3402 to one of the square second corner 3414B and fourth corner 3414d (obscured) of bottom portion 3404. In the illustrated embodiment, first angled struts 3428a and second angled struts 3428b of the second set of angled inner struts are opposite first angled struts 3426a and second angled struts 3426 b. That is, as shown in fig. 34B, first and second angled struts 3428a and 3428B of the second set of angled inner struts each extend in opposite directions from the middle of the square of the bottom portion 3404 to one of the first and third corners 3414a and 3414c (obscured) of the square of the top portion 3402.

As shown in fig. 30A-34E, the strut-based configuration of the adjunct creates a plurality of openings throughout the adjunct, thereby creating a less cell infiltration barrier compared to a non-strut based adjunct configuration. That is, these multiple openings may allow cells to flow into the adjunct more quickly when the adjunct is sutured to tissue. This increased rate of the adjunct can thus enhance the rate of tissue ingrowth as compared to other adjuncts.

While the openings in the top and bottom portions of the appendages shown in fig. 31A-34E are regular and symmetrically defined by struts, in other embodiments, the top and bottom portions may instead be a planar sheet having regular or irregular openings formed therein (e.g., a "swiss cheese" sheet) or a non-planar (e.g., corrugated or wave-shaped) sheet having regular or irregular openings formed therein. These openings in the planar and non-planar appendage configurations can also promote cell ingrowth within the appendage when the appendage is sutured to tissue.

In other embodiments, the repeating units of the strut-based appendages can have other structural configurations. For example, fig. 35 illustrates an exemplary strut-based cell 3500 that can be used to form the appendages described herein. Cell 3500 includes a top portion 3502, a bottom portion 3504, and an interior portion 3506 extending therebetween.

Although the top portion 3502 and the bottom portion 3504 can have various configurations, in this illustrated embodiment, the top portion 3502 and the bottom portion 3504 are substantially identical to one another, and thus, for simplicity, the following description is with respect to the top portion 3502. However, those skilled in the art will appreciate that the following discussion also applies to the bottom portion 3504.

As shown in fig. 35, top portion 3502 includes a first pair of opposing outer struts 3512a, 3512b and a second pair of opposing outer struts 3514a, 3514 b. First and second pairs of outboard struts 3512a, 3512b, 3514a, 3514b are connected in a manner wherein top portion 3502 is in the form of a parallelogram having four corners 3516a, 3516b, 3516c, 3516 d. In the illustrated embodiment, the parallelogram is a square. Top section 3502 also includes a first cross brace 3518 connecting a first pair of opposing outer braces 3512a, 3512b and a second cross brace 3520 connecting a second pair of opposing outer braces 3514a, 3514 b. As shown, first cross brace 3518 and second cross brace 3520 intersect at 90 degrees relative to each other in the middle of top portion 3502.

While the interior structure 3506 can have various configurations, in this illustrated embodiment, the interior structure 3506 includes a first side 3522a, a second adjacent side 3522b, and a third side 3522c opposite the second side 3522b, and a fourth side 3522d opposite the first side 3522 a. Although each side can have various configurations, in the illustrated embodiment, the first side 3522a, the second side 3522b, the third side 3522c, and the fourth side 3522d are different. In the illustrated embodiment, fourth side 3522d does not include any spacing struts.

As shown in fig. 35, first side 3522a of interior structure 3506 includes first angled spacing struts 3524a and second angled spacing struts 3524b that extend parallel to each other. First angled spacing struts 3524a extend from first corners 3516a of bottom portion 3504 to central sections 3513a of first outboard struts 3512a of top portion 3502, and second angled spacing struts extend from central sections 3513b of first outboard struts 3512a of bottom portion 3504 to second corners 3516b of top portion 3502.

Second side 3522b of interior structure 3506 includes third and fourth angled spacing struts 3526a, 3526b that extend parallel to each other. Third angled spacing struts 3526c extend from second corners 3516b of bottom portion 3504 to central section 3515 of second outboard strut 3514b of top portion 3502, and fourth angled spacing struts 3526b extend from central sections of second outboard struts (obscured) of bottom portion 3504 to third corners 3516c of top portion 3502.

Additionally, the third side 3522c of the interior structure 3506 includes fifth and sixth angled spacing struts 3528a, 3528b that extend parallel to each other. Fifth angled spacing struts 3528a extend from fourth corner 3516d of bottom portion 3504 to central section 3517 of second outer side strut 3514a of top portion 3502, and sixth angled spacing struts 3528b extend from central section 3517 of first outer side strut 3514a of bottom portion 3504 to first corner 3516a of top portion 3502.

The inner structure 3506 also includes two sets of inner angled struts. The first set includes three inner angled struts 3530a, 3530b, 3530c, each extending from the middle of top portion 3502 to a center section 3513, 3517, 3519 of outer struts 3512a, 3514a, 3512b, respectively, of bottom portion 3504. Thus, in the first set, first and third inner angled struts 3530a, 3530c extend in opposite directions, and second inner angled strut 3530b extends in a different direction relative to first and third inner angled struts 3530a, 3530 c. The second set includes three inner angled struts 3532a, 3532b, 3532c, each extending from the middle of bottom portion 3504 to a central section 3513, 3515, 3519 of outer struts 3512a, 3514b, 3512b, respectively, of top portion 3502. Thus, in the second set, first and third inner angled struts 3532a, 3532c extend in opposite directions, and second inner angled strut 3532b extends in a different direction relative to first and third inner angled struts 3532a, 3532 b.

In other embodiments, the repeating units of the strut-based appendages can have other structural configurations. For example, fig. 36 illustrates an exemplary strut-based cell 3600 that can be used to form the appendages described herein. The cell 3600 includes a top portion 3602, a bottom portion 3604, and an inner portion 3606 extending therebetween.

Although the top portion 3602 and the bottom portion 3604 may have various configurations, in the illustrated embodiment, the top portion 3602 and the bottom portion 3604 are substantially identical to each other, and thus, for simplicity, the following description is with respect to the top portion 3602. In an embodiment, the bottom portion 3604 is an inverted image of the top portion 3602. However, one skilled in the art will understand that the following discussion also applies to the bottom portion 3604.

As shown in fig. 36, top portion 3602 includes a first pair of cross struts 3612a, 3612b and a second pair of cross struts 3612c, 3612 d. The first and second pairs of cross struts 3612a, 3612b, 3612c, 3612d are connected in a manner in which the top portion 3602 is in the form of a sparse tetrahedron having five corners 3616a, 3616b, 3616c, 3616d, 3616 e. A first pair of cross struts 3612a, 3612b intersect at an intersection point 3617 on the top portion. Cross brace 3612a is connected to cross brace 3612c at corner 3616d and cross brace 3612b is connected to cross brace 3612d at corner 3616 c. As shown, cross-struts 3612a, 3612b intersect at 90 degrees relative to each other at intersection point 3617 in the middle of top portion 3602.

As shown in fig. 36, inner structure 3606 includes first angled spacing struts 3620a and second angled spacing struts 3620b that extend parallel to each other. First angled spacing struts 3620a extend from a first corner 3616a of top portion 3602 to a corner 3616e of bottom portion 3604, and second angled spacing struts 3620b extend from a third corner 3616c of top portion 3602 to an intersection 3617 of bottom portion 3604. Additionally, inner structure 3606 includes third and fourth angled spacing struts 3622a, 3622b that extend parallel to each other. Third angled spacing struts 3622a extend from second corners 3616b of top portion 3602 to corners 3616e of bottom portion 3604, and fourth angled spacing struts 3622b extend from fourth corners 3616d of top portion 3602 to intersections 3617 of bottom portion 3604. Thus, first and third angled spacing struts 3620a and 3622a extend in opposite directions, and second and fourth angled spacing struts 3620b and 3622b extend in opposite directions.

Outer layer

In some embodiments, the adjunct can include a lattice structure (e.g., a first lattice structure or an inner lattice structure) extending from a top surface to a bottom surface and at least one outer layer, each outer layer having a different compression ratio (e.g., a ratio of pre-compression height to compression height). Thus, the compression characteristics of the grid structure and the at least one outer layer are different, and thus can be tailored to perform different functions (e.g., tissue ingrowth, cartridge attachment, etc.), while also achieving, in combination, a total compression profile of the adjunct that is desirable for varying staple conditions and/or staple heights. For example, the adjunct is configured to experience a strain in a range of about 0.1kPa to 0.9kPa when under an applied stress in a range of about 30kPa to 90kPa, based on the total compression profile of the resulting adjunct. In other embodiments, the strain may be in a range of about 0.1 to 0.8, about 0.1 to 0.7, about 0.1 to 0.6, about 0.2 to 0.8, about 0.2 to 0.7, about 0.3 to 0.8, about 0.3 to 0.9, about 0.4 to 0.8, about 0.4 to 0.7, about 0.5 to 0.8, or about 0.5 to 0.9.

While the lattice structure and the at least one outer layer can have various configurations, in some embodiments, the compression ratio of the first lattice structure is greater than the compression ratio of the at least one outer layer. For example, in one embodiment, the first lattice structure may be configured to be compressible in the range of about 3mm to 1mm, and thus its compression ratio may be 3, under an applied stress, while at least the outer layer may be configured to be compressible in the range of about 2mm to 1mm, and thus its compression ratio may be 2, under the same applied stress.

In certain embodiments, the adjunct can include an outer layer in the form of a second lattice structure or an absorbable film positioned on at least a portion of the top surface of the first lattice structure and configured to be positioned against tissue. This outer layer can be configured to promote tissue ingrowth within the adjunct and/or to create a smooth or substantially smooth tissue contacting surface that can easily slide against tissue and thus reduce tissue loading (applied stress) on the adjunct during suture device placement and/or simplify attachment requirements between the adjunct and the cartridge. Alternatively or additionally, the adjunct can include an outer layer in the form of a film or a third lattice structure positioned on at least a portion of the bottom surface of the first lattice structure and configured to be positioned against the cartridge. Thus, the outer layer can be configured to attach an appendage to the cartridge. For example, this outer layer may be in the form of an adhesive film and/or include one or more attachment features designed to releasably mate with the staple cartridge. In certain embodiments, the compression ratio of the lattice structure is greater than the compression ratio of the at least one outer layer.

Fig. 37A-37B illustrate an exemplary embodiment of an adjunct 3700 disposed on a cartridge 3800. The bin 3800 is similar to the bin 200 in fig. 1-2C, and thus common features are not described in detail herein. The appendage 3700 includes an inner grid structure 3702 and two outer layers 3704, 3710, each having a different compression ratio relative to one another. The inner grid structure 3702 is typically formed of interconnected repeating cells, and when repeating cells are omitted from this illustration, any of the repeating cells disclosed herein may be used, for example, a studless-based repeating cell or a strut-based repeating cell. In addition, a first outer layer 3704 is disposed on a top surface 3702a of the inner grid structure 3702 and configured to contact tissue, and a second outer layer 3706 is disposed on a bottom surface 3702b of the inner grid structure 3702 and configured to contact the bin 3800.

While the first outer layer 3704 can have a variety of configurations, in this illustrated embodiment, the first outer layer 3704 is a grid structure formed by struts 3710 interconnected in a manner that creates hexagonal openings 3712 that extend through the first outer layer 3704. These openings 3712 may be configured to promote tissue ingrowth. Those skilled in the art will appreciate that the struts may be interconnected in a variety of other ways that will achieve different sizes and shapes of openings, and thus, the grid structure of the first outer layer is not limited to the grid structure shown in the figures. Additionally, the first outer layer 3704 may have a lower compression ratio, and thus may be less compressible, than at least the inner grid structure 3702. Thus, when the adjunct 3700 is sutured to tissue, this can allow further penetration of tissue into the opening 3712, and thus the adjunct 3700, further facilitating tissue ingrowth (see fig. 38A and 38B).

While the second outer layer 3706 can have a variety of configurations, in this illustrated embodiment, the second outer layer 3706 is in the form of a film 3714 having a protrusion 3716 extending outwardly therefrom. The tabs 3716a, 3716b, 3716C are configured to mate with the surface features 3802, 3804, 3806 of the cartridge 3800, such as the surface features 216, 218, 220 of the cartridge 200 in fig. 1-2C. As shown in fig. 37B and 38A, this mating interaction substantially prevents slidable movement of the adjunct 3700 relative to the cartridge 3800. The shape and size of the protrusions 3716a, 3716b, 3716c (which may be triangular or diamond shaped) are complementary to the shape and size of the corresponding surface features 3802, 3804, 3806 (which may be triangular or diamond shaped recessed channels). In other embodiments, the shape and size of the protrusions and surface features may be different.

Alternatively or in addition, the second outer layer 3706 can include an elongated tab 3730 that is configured to be inserted into the longitudinal slot 3808 of the cartridge 3800. While the elongated protrusion can have a variety of configurations, in this illustrated embodiment, the elongated protrusion 3730 has a rectangular shape. In some embodiments, the elongated protrusion 3730 can extend along the entire length of the adjunct (e.g., in the z-direction), while in other embodiments, the elongated protrusion 3730 can extend along a portion of the length. In certain embodiments, the elongated protrusion 3730 may be broken down into smaller elongated discrete portions.

In other embodiments, as shown in fig. 39A, second outer layer 3900 can include four sets of tabs 3902a, 3902B, 3904a, 3904B, 3906a, 3906B, 3908a, 3908B (partially obscuring 3902B, 3904B, 3906B, and 3908B in fig. 39A), each of which extends outward and away from opposing lateral surface 3900a, 3900B (fig. 39B) of second outer layer 3900. While the four sets of tabs 3902, 3904, 3906, 3908 can have a variety of configurations, in the illustrated embodiment, the four sets of tabs 3902, 3904, 3906, 3908 each have a hook-shaped configuration that engages respective portions of the opposing outer flanges 3910a, 3910b, 3914a, 3914b of the cartridge 3901. In addition, when the cartridge 3901 includes a longitudinal slot 3918, such as a knife slot, the second outer layer 3900 can include a pin feature 3912 configured to engage the longitudinal slot 3918. For example, the pin feature 3912 may include sets of two opposing pins (only one set of two opposing tabs 3912A, 3912B shown in fig. 39A-39B) intermittently spaced relative to each other along the longitudinal slot 3918. As shown in more detail in fig. 39B, first pin 3912a engages a first wall 3918a of longitudinal slot 3918 and second pin 3912B engages a second opposing wall 3918B of longitudinal slot 3918.

As described above, in some embodiments, the second outer layer may be an adhesive film. In one exemplary embodiment, as shown in fig. 40, an appendage 4000 is disposed on a top surface 4001a of a cartridge 4001 (e.g., cartridge 200 in fig. 1-2 c). Appendage 4000 includes an inner structure 4002, a first outer layer 4004 disposed on a top surface 4002a of inner structure 4002, and a second outer layer 4006 disposed on an opposite bottom surface 4000b opposite top surface 4002a of inner structure 4002. Adjunct 4000 can be similar to adjunct 3700 in fig. 37A-38A, except for the differences discussed below, and thus common features are not described in detail herein. As shown, the internal structure 4002 is formed from interconnected repeating cells 4008 (such as cells 810 in fig. 8A-9B). In addition, the second outer layer 4006 is in the form of an adhesive film that is attached to the top surface 4001a of the bin 4001. In this illustrated embodiment, the second layer 4006 is an adhesive film formed from a pressure sensitive adhesive. Additional details regarding adhesive films and other attachment methods may be found in U.S. patent No. 10,349,939, which is incorporated herein by reference in its entirety.

Nail pit grid

In some embodiments, the adjunct can further include a lattice structure extending from the second outer layer and configured to be inserted into the staple pockets or recessed channels of the staple cartridge. For example, as shown in fig. 41A, the appendage 4100 includes an inner grid structure 4102 extending between two outer layers 4104, 4106. The inner grid structure 4102 is typically formed of interconnected repeating cells, and when repeating cells are omitted from this illustration, any of the repeating cells disclosed herein may be used. In addition, each of the two outer layers 4104, 4106 may be formed of a lattice structure or as a film, and thus, each of the two outer layers is generally shown in fig. 41A to 41C. The first outer layer 4106 is configured to contact tissue, and as shown in fig. 41B-41C, the second outer layer 4104 is configured to contact the cartridge 4101. The cartridge 4101 is similar to the cartridge 200 in fig. 1-2C, and therefore common features are not described in detail herein.

As further shown in fig. 41A-41C, the adjunct 4100 includes a grid of peg wells 4110a, 4110b, 4110C extending outward from the second outer layer 4104. A grid of staple pockets can be used as a separate compression zone for the adjunct 4100, for example, the grid of staple pockets 4110a, 4110b, 4110c can have a different compression ratio than the entirety of the adjunct so as not to substantially increase the solids height of the total adjunct. While the grid of staple pockets can have a variety of configurations, in this illustrated embodiment there are two sets of three longitudinal rows of grids of staple pockets 4110a, 4110b, 4110c on opposite sides of the intended cut line of the adjunct. While the peg-pit grid can have a variety of configurations, each peg-pit grid is formed from five U-shaped struts. The shape and size of the perimeter around each pin dimple grid 4110a, 4110b, 4110c may be triangular or diamond shaped, and may be complementary to the shape and size (which may be triangular or diamond shaped) of the corresponding pin dimple 4112a, 4112b, 4112 c. In other embodiments, the grid structure and the peg wells may differ in shape and size. As shown in fig. 41B-41C, once the adjunct 4100 is disposed on the cartridge 4101, at least a portion of the staples 4114a, 4114B, 4114C within the cartridge 4101 extend through the respective staple pocket grids 4110a, 4110B, 4110C and are thus captured by the staple crowns when the adjunct is stapled to tissue. Thus, the grid of staple pockets can also aid in attaching the adjunct to the staple cartridge and/or alignment of the adjunct relative to the staples.

The structural configuration of the cells disclosed herein can also be tailored to achieve variable mechanical responses within the same appendage, for example, in the lateral and/or longitudinal directions (e.g., the y-direction and/or z-direction, respectively). For example, in certain embodiments, an adjunct can be formed from at least two or more different lattice structures positioned side-by-side so as to produce at least two substantially different compression characteristics within the same adjunct.

As generally shown in fig. 42A, the accessory 4200 may have an inner grid structure 4202 and two outer grid structures 4204, 4206, wherein each grid structure 4202, 4204, 4206 defines a respective compression zone C of the accessory 4200₁、C₂、C₃. In this embodiment, the first and second outer grid structures are structurally identical, and thus C₂And C₃The same is true. As shown, the grid structures 4202, 4204, 4206 are laterally offset from one another relative to a longitudinal axis of the attachment 4200. That is, the first outer grill structure 4204 is positioned directly adjacent to a first longitudinal side (obscured) of the inner grill structure 4202, and the second outer grill structure 4206 is positioned directly adjacent to a second, opposite longitudinal side (obscured) of the inner grill structure 4202. As each grid structure may be formed of any repeating unit cell disclosed herein, three grid structures 4202, 4204, 4206 are shown without any unit cells. One skilled in the art will appreciate that each grid structure may be formed from strut-based repeating cells or strut-free based repeating cells.

As further shown, the prospective cut line C of the appendage 4200_LIs defined across the inner grid structure 4202 and along the longitudinal axis of the appendage 4200To the axis L_AAnd (4) limiting. Thus, in this illustrated embodiment, the inner grill structure 4202 may be configured to be stiffer, and thus exhibit a higher resistance to compression, than the outer grill structures 4204, 4206. Thus, the resulting adjunct 4200 can be positioned relative to the cut line C of the adjunct 24200_LWith variable compressive strength in the transverse direction (e.g., the y-direction). Thus, this variable compressive strength can thus ease the transition of tissue compression at the outermost row 4210 of staples when the adjunct is stapled to tissue, as shown in fig. 42B.

FIGS. 43A-43B illustrate the longitudinal axis L relative thereto_AAnother embodiment of an adjunct 4300 having a variable compressive strength along a transverse direction (e.g., y-direction). In this illustrated embodiment, the adjunct 4300 is formed from three different grating structures 4310, 4320, 4330, each formed from a different repeating unit. More specifically, the first grid structure 4310 is formed of interconnected first repeating cells 4310a, one of which is shown in fig. 43A, the second grid structure 4320 is formed of interconnected second repeating cells 4320a, one of which is shown in fig. 43A, and the third grid structure 4330 is formed of interconnected third repeating cells 4330a, one of which is shown in fig. 43A. As described in more detail below, by designing each of the lattice structures differently, the resulting appendage may have a variety of lateral compression responses.

Although the repeating unit cells 4310a, 4320a, 4330a may have various configurations, in this illustrated embodiment, the repeating unit cells 4310a, 4320a, 4330a are all strut-based unit cells. In addition, depending on the location of the corresponding grid structure, the repeating cells may be structurally configured such that they are harder or less hard than repeating cells of other grid structures, as described in more detail below.

While the three grating structures 4310, 4320, 4330 may be positioned relative to one another in a variety of different configurations, the first grating structure 4310 is where the intended cut line C of the adjunct 4300 is_LExtends therethrough and along the longitudinal axis L_AThe most central lattice structure of the appendage of (a). Thus, with respect toThe first repeating unit cell 4310a may have a less compact structural configuration, and thus be more flexible, than the second repeating unit cell, for example, as shown in fig. 43A. In addition, the first lattice structure 4310 extends along the entire length L of the adjunct 4300. The second grid structure 4320 is divided into two longitudinal portions 4325a, 4325 b. The first longitudinal portion 4325a of the second grid structure 4320 abuts the first longitudinal side wall L of the first grid structure 4310 ₁Is positioned and the second longitudinal portion 4325b of the second grid structure 4320 abuts against the second opposite longitudinal side wall L of the first grid structure 4310₂Positioning (see fig. 43B). Based on it relative to the cutting line C_L Second repeating cell 4320a may be configured to be the closest, and thus the hardest, as compared to first repeating cell 4310a and third repeating cell 4330a, e.g., as shown in fig. 43A.

As further shown in fig. 43A, the third grid structure is divided into two U-shaped portions 4335a, 4335b, wherein each U-shaped portion is positioned against an outer wall of a respective first longitudinal portion 4325a and second longitudinal portion 4325b of the second grid structure 4320. (FIG. 43B shows only the outer longitudinal wall L of each section 4325a, 4325B₃And L₄). Thus, the third lattice structure 4320 defines at least a portion of the outer circumference of the adjunct 4300. Based on the position of the third lattice structure 4330, the third repeating lattice can be configured to impart an intermediate density, and thus intermediate stiffness, as compared to the first repeating lattice 4310a and the second repeating lattice 4320a, which can help facilitate the transition of tissue compression, as shown in fig. 43A. Additionally, the structural configuration of third repeating unit cell 4330a may be configured such that tissue growth is promoted. In certain embodiments, a third grid structure may also be disposed on at least a portion of the top surface of the second grid structure, which may further enhance tissue ingrowth into the appendage.

In some embodiments, the dimensions (e.g., wall thickness and/or height) of the repeating unit cell may vary between other repeating unit cells. For example, fig. 44A-44C illustrate another embodiment of an appendage 4400 having a variable compressive strength along a transverse direction (e.g., y-direction) relative to its longitudinal axis (e.g., z-direction) due to varying dimensions based on a studless repeating cell. As shown in fig. 44A-44B, only half (e.g., the left half) of the adjunct 4400 is shown on a staple cartridge 4401 having three rows of staples 4405a, 4405B, 4405 c. Although the three rows of staples 4405a, 4405b, 4405c can be substantially uniform (e.g., nominally the same within manufacturing tolerances), in the illustrated embodiment, the staple height of the third row of staples 4405c (e.g., the outermost row of staples) is greater than the staple height of the first and second rows of staples 4405a, 4405 b. This difference in staple height may contribute to the overall compression behavior of the adjunct. In this illustrated embodiment, the third row of staples 4405c will apply a compressive force to the captured tissue and appendages within, for example, the staple entrapment areas that is less than the compressive force applied by the first and second rows of staples 4405a and 4405b to the respective captured tissue and appendages within, for example, the respective staple entrapment areas. The appendage 4400 includes two sets of three longitudinal arrays of repeating unit cells. Since both sets are identical, fig. 44A-44C show only one set of three arrays 4410, 4412, 4414 and only one repeat cell 4410a, 4412a, 4414A for each of the three arrays.

The repeating cells 4410a, 4412a, 4414a may have various configurations. In this illustrated embodiment, the repeat cells 4410a, 4412a, 4414a are similar in overall shape to the repeat cell 810 of fig. 9A-9B. However, the wall thickness and height between at least two repeating cells may vary. As shown, the wall thickness W of the innermost repeat cell 4410a (e.g., first repeat cell) to the outermost repeat cell 4414a (e.g., third repeat cell)_TAnd decrease. That is, the wall thickness W of the innermost repeating cell 4410a_T1Greater wall thickness W than intermediate repeat cell 4412a_T2And the wall thickness W of the middle repetition lattice 4412a_T2Greater than wall thickness W of outermost repeat cell 4414_T3. In addition, although the height H of each of the innermost repeating cell 4410a and the intermediate repeating cell 4412a₁、H₂Same, but height H₁、H₂Greater than height H of outermost repeat cell 4414a₃. In other embodiments, only the wall thickness or height varies between the arrays, or the wall thickness varies between only two of the three arrays, or the height varies between all three arrays.

Alternatively or additionally, where the repeating unit cells are similar in shape to a Schwarz-P structure (such as Schwarz-P structure 810 in fig. 8A-9B), the length of the hollow tubular interconnects between different arrays of repeating unit cells may vary. For example, as further shown in fig. 44A, the hollow tubular interconnects 4416 between the innermost repeat cell 4410a and the middle repeat cell 4412a are at a first length L ₁Extend, and the hollow tubular interconnects 4418 between the intermediate repeat cells 4412a and the outermost repeat cells 4414a are greater than the first length L₁Second length L₂And (4) extending.

The compressive behavior of the repeating cells 4410, 4410a of the adjunct 4400 as the adjunct 4400 is sutured to tissue is schematically illustrated in fig. 44B-44C. Thus, the variation in the dimensions of the repeating cells in the transverse direction results in three different compressed regions having different compressive strengths, a first region being defined by a first longitudinal array 4410 of first repeating cells 4410a having a first compressive strength (e.g., the ability of the structure to withstand compressive forces in the x-direction), a second region being defined by a second longitudinal array 4412 of second repeating cells 4412a, and a third region being defined by a third longitudinal array 4414 of third repeating cells 4414a having a third compressive strength. Although the compressive strength in each array may vary, in the illustrated embodiment, the first compressive strength is greater than the second compressive strength, and the second compressive strength is greater than the third compressive strength. Accordingly, the first repeating cell 4410a is harder than the second repeating cell 4412a, and the second repeating cell 4412a is harder than the third repeating cell 4414 a.

Bin surface features

In some embodiments, the staple cartridge can comprise surface features (e.g., staple pocket protrusions) that can be configured to interact with the adjunct to help retain the adjunct to the staple cartridge prior to staple deployment. For example, in certain embodiments, the surface features can comprise protrusions extending outwardly from a top surface of the staple cartridge. Alternatively or in addition, the outer surface features may comprise recessed channels defined within the top surface of the staple cartridge. Thus, the adjunct described herein can be designed in a variety of different configurations that are adapted to interact with surface features of a staple cartridge (if present) and thereby enable a releasable attachment mechanism between the adjunct and the staple cartridge. Alternatively or additionally, the adjunct described herein can be designed in various configurations suitable for interacting with staple legs that extend outwardly from their respective cavities within a staple cartridge.

Fig. 45A-45C illustrate an exemplary embodiment of a stackless-based adjunct 4500 that can be configured to interact with surface features 4504 of a staple cartridge 4502. Alternatively or in addition, the adjunct 4500 can be configured to interact with the legs of staples 4506, 4507, 4508 (see fig. 45B-45C) disposed at least partially within the staple cartridge 4502. While the staple cartridge 4502 can have a variety of configurations, in this illustrated embodiment, the staple cartridge 4502 is similar to the staple cartridge 200 of fig. 1-2C, except that the surface features 4504 are U-shaped projections that extend outwardly from a top surface 4502a of the staple cartridge and are positioned around respective end portions of a staple cavity defined within the staple cartridge 4502. As shown, staple cavities are disposed in first and second sets of three longitudinal rows 4510a, 4510b, 4510c, 4512a, 4512b, 4512c and are positioned on first and second sides, respectively, of the longitudinal slot 4514. In addition, for each set, the first and third longitudinal rows 4510a, 4510c, 4512a, 4512c are parallel to one another, while the second longitudinal rows 4510b, 4512b are staggered with respect thereto.

As further shown in fig. 45A-45C, appendage 4500 is formed by interconnected repeat cells 4516, wherein each cell is similar in structure to repeat cell 810 in fig. 9A-9B. Thus, appendage 4500 is similar to appendage 800 in fig. 8A-8F, except that repeating cell 4515 is rotated 45 degrees about the X-axis relative to fig. 8A. In other words, the attachment 800 is shown in a 0 to 90 degree configuration, while the attachment 4500 is shown in a ± 45 degree orientation. Thus, the repeating unit cell 4516 is oriented in a manner (e.g., a repeating pattern) that may coincide with the location of the surface features 4504 and/or the staple cavities 4510a, 4510b, 4510c, 4512a, 4512b, 4512 c.

As shown in fig. 45A, the repeating cells 4516 are interconnected with one another and arranged in seven longitudinal rows 4516a, 4516B, 4516C, 4516d, 4516e, 4516f, 4516g, with each longitudinal row having voids defined between adjacent cells (only voids 4518a, 4518B, 4518C, 4520a, 4520B, 4520C are shown in fig. 45 and only voids 4518a, 4518B, 4518C, 4522a, 4522B, 4524a, 4524B, 4524C are shown in fig. 45B through 45C). The first three longitudinal rows 4516a, 4516b, 4516c are configured to overlap respective staple cavity rows 4510a, 4510b, 4510c, the middle-most row 4516d is configured to overlap the longitudinal slot 4514, and the last three longitudinal rows 4516e, 4516f, 4516g are configured to overlap respective staple cavity rows 4512a, 4512b, 4512 c. Thus, as partially shown in fig. 45B-45C, each surface feature 4504 overlaps and extends at least partially through a corresponding void based on the position of the surface feature 4504 relative to the staple cavity. Thus, each void is configured to receive and engage at least one surface feature, thereby retaining the adjunct 4500 on the cartridge 4502 prior to staple deployment. In other embodiments, all or some of the voids may be replaced with thinner regions of material into which at least one surface feature may penetrate.

In addition, as partially shown in fig. 45B-45C, for each staple cavity row and corresponding row of repeating cells, each staple disposed within a staple cavity (only staples 4506, 4507, 4508 and corresponding staple cavity rows 4510a, 4510B, 4510C are shown in fig. 45B) extends across the corresponding repeating cell such that each staple leg overlaps a corresponding void positioned on one side of the repeating cell. For example, as shown in fig. 45B, with respect to repeat cell 4515a and corresponding staple 4508 in first cell row 4516a, first and second legs 4508a, 4508B of staple 4508 overlap first and second interstices 4518a, 4518B, respectively, that are on opposite sides of repeat cell 4515B in second cell row 4516B. As further shown in fig. 45C, when the adjunct 4500 is positioned on the top surface 4502a of the staple cartridge 4502, the staple legs 4507a, 4507b extend through the voids 4522a, 4522b, respectively. This can further retain the adjunct 4500 to the cartridge 4502 prior to staple deployment. Thus, the repeating unit cell of the adjunct can be configured to be positioned between and engaged with the first and second legs of a corresponding staple.

Fig. 46A-46B illustrate another exemplary embodiment of a strut-based adjunct 4600 that can be configured to interact with surface features of a staple cartridge 4602. The staple cartridge 4602 is similar to staple cartridge 3901 in fig. 39A, and thus common features are not described in detail herein. Each surface feature has a U-shaped configuration and is positioned around a respective end portion of each staple cavity, and thus extends along a respective longitudinal row of staple cavities (fig. 46A-46B show only three longitudinal rows of staple cavities 4603a, 4603B, 4603c, and thus three longitudinal rows of surface features).

As shown in more detail in fig. 46B, the first surface features of the longitudinal rows (only four first surface features 4604a, 4604B, 4604c, 4604d are shown) and the third surface features of the longitudinal rows (only four third surface features 4608a, 4608B, 4608c, 4608d are shown) are aligned transversely to each other in the y-direction and thus form a set of first transverse rows 4605a, 4605B, 4605c, 4605d, each transverse row having a respective first and third surface feature. The longitudinal rows of second surface features (only four second surface features 4606a, 4606b, 4606c, 4606d are shown) are laterally offset in the z-direction relative to the first and second surface features and thus form a set of second lateral rows 4607a, 4607b, 4607c, 4607d, each having a respective second surface feature.

Additionally, adjunct 4600 is similar to adjunct 3000 in fig. 30A-30B, except for the differences described in detail below. The adjunct 4600 includes a tissue contacting layer 4616, a cartridge contacting layer 4618, and an inner structure 4620 extending therebetween.

As shown in fig. 46, and in more detail in fig. 46B, each opening (only eight openings 4622a, 4622B, 4622c, 4622d, 4622e, 4622f, 4622g, 4622h are shown) within the cartridge contact layer 4618 is configured to receive at least one respective surface feature. Thus, when the adjunct 4600 is positioned on the staple cartridge 4602, the respective surface features extend into and engage respective openings within the cartridge contact layer 4618. For example, as shown in fig. 46, first surface features 4604a and third surface features 4608a of a first transverse row 4605a extend into a first opening 4622a and engage at least a first cross strut 4624a, while second surface features 4606a of a second transverse row 4607a extend into a second opening 4622b and engage at least a first cross strut 4624a and an opposing cross strut 4624 b.

The cross-struts of the cartridge contact layer 4618 (only eight cross-struts 4624a, 4624B, 4624c, 4624d, 4624e, 4624f, 4624g are shown in fig. 46B) may have a variety of configurations. For example, in some embodiments, the width of the cross-struts (e.g., in the z-direction) may be substantially uniform (e.g., uniform within manufacturing tolerances), while in other embodiments, the width of the cross-struts may be non-uniform. In this illustrated embodiment, the width of the cross-struts 4624a, 4624c, 4624e, 4624g is uniform, while the width of the remaining cross-struts 4624b, 4624d, 4624f is non-uniform. Those skilled in the art will appreciate that the structural configuration of the cross-struts of the cartridge contact layer may depend at least on the structural configuration of the surface features. For example, in the exemplified embodiment, at least a portion of the cross-struts include a curved section to accommodate the U-shaped configuration of the surface features. Some of the curved segments have a convex configuration and others have a concave configuration, depending on the orientation of the U-shaped configuration. Additionally, while the tissue-contacting layer 4616 of the cross struts 4626A, 4626b, 4626c, 4626d, 4626e, 4626f, 4626g may have a variety of configurations, as shown in fig. 46A, the cross struts 4626A, 4626b, 4626c, 4626d, 4626e, 4626f, 4626g are similar in structure to the corresponding cross struts 4624a, 4624b, 4624c, 4624d, 4624e, 4624f, 4624g of the cartridge-contacting layer 4618.

Variable tissue gap

In some embodiments, it may be desirable to have a variable tissue gap between the adjunct and the anvil to enhance the grasping and stability of the tissue during stapling and/or cutting of the tissue. However, variable tissue gaps may adversely affect the ability of the adjunct to apply substantially uniform pressure to the stapled tissue. Accordingly, and as described in greater detail below, the adjunct disclosed herein can be configured to create a variable tissue gap for tissue manipulation, and when sutured to tissue, the adjunct can be further configured to apply a substantially uniform pressure (e.g., a pressure in a range of about 30kPa to 90 kPa) to the tissue sutured thereto for a predetermined period of time (e.g., at least 3 days). In certain embodiments, the adjunct can apply a pressure of at least about 30kPa for at least three days. In such embodiments, after 3 days, the adjunct can be configured to apply an effective amount of pressure to the tissue (e.g., about 30kPa or less) such that the tissue can remain sealed through a healing cycle of the tissue (e.g., about 28 days). For example, the adjunct can be configured to apply pressure to the stapled tissue, wherein the pressure is reduced (e.g., linearly reduced) from about 30kPa to 0kPa over a predetermined period of about 3 days to 28 days, respectively.

In general, the adjunct can comprise a tissue contacting surface, a cartridge contacting surface, and an inner structure extending therebetween, wherein the inner structure comprises at least two lattice structures, each lattice structure having a different compressive strength. The at least two lattice structures may vary longitudinally in structure, shape or interconnection, laterally along their width and/or along their length, to form a variable tissue gap. In some embodiments, the base geometry of the adjunct can be formed from a strut-free based cell. In such embodiments, the exterior geometry of the appendage may be formed from a strut-based grid structure. In other embodiments, the base geometry may be formed from strut-based cells.

Fig. 47A-47B illustrate an exemplary embodiment of a surgical end effector 4700 having an anvil 4702 and a stapling assembly 4704. The stapling assembly 4704 includes an adjunct 4706 that is releasably retained on a top surface or deck surface 4707a of the staple cartridge 4707 (e.g., a staple cartridge surface facing the anvil). The staple cartridge 4707 is similar to the cartridge 200 of fig. 1-2C and, therefore, common features are not described in detail herein. Although not shown, the anvil 4702 is pivotally coupled to an elongate staple channel, such as the elongate staple channel 104 of fig. 1, and the stapling assembly 4704 is positioned within and coupled to the elongate staple channel. While the anvil 4702 can have a variety of configurations, as shown in fig. 47A-47B, the anvil includes a cartridge-facing surface having staple pockets 4708 defined therein, wherein a generally planar tissue-compression surface 4710 (e.g., flat within manufacturing tolerances) extends between the staple pockets 4708 (e.g., extends in the y-direction). Fig. 47A shows the surgical end effector 4700 in a fully closed position, and thus the anvil 4702, while fig. 47B shows tissue T clamped between the anvil 4702 and the stapling assembly 4704 and stapled to an adjunct 4706 via staples (only two sets of three staples 4712a, 4712B, 4712c, 4714a, 4714B, 4714c are shown). Prior to deployment, in some embodiments, as shown in fig. 47A and 47C, the staples can be disposed entirely within the staple cartridge 4707 while in other embodiments, some or all of the staples can be disposed partially within the staple cartridge 4707. While the staples 4712a, 4712b, 4712c, 4714a, 4714b, 4714c can have various configurations, in this illustrated embodiment the staples 4712a, 4712b, 4712c, 4714a, 4714b, 4714c have at least a substantially uniform pre-deployed (e.g., unformed) staple height (e.g., nominally the same within manufacturing tolerances). In some embodiments, the spikes 4712a, 4712b, 4712c, 4714a, 4714b, 4714c may be substantially uniform (e.g., nominally identical within manufacturing tolerances).

As shown in fig. 47A, and in more detail in fig. 47C, the adjunct 4706 has a tissue-contacting surface 4716, a cartridge-contacting surface 4718, and an internal structure 4720 extending therebetween. While the inner structure 4720 can have a variety of configurations, in this illustrated embodiment, the inner structure comprises two lattice structures 4722, 4724, each having a different compressive strength such that the adjunct 4706, when in a tissue deployed state, is configured to apply a substantially uniform pressure to stapled tissue for a predetermined period of time. In the illustrated embodiment, the first lattice structure 4722 is configured to have a first compressive strength and the second lattice structure 4724 is configured to have a second compressive strength that is greater than the first compressive strength.

Each of the first and second grid structures 4722 and 4724 can generally be formed of cells, such as those disclosed herein, e.g., strut-free based cells and/or strut-based cells. For example, in certain embodiments, one or more unit cells may include at least one triply periodic minimal surface structure, such as those disclosed herein. Alternatively or additionally, one or more cells can be defined by interconnecting struts (e.g., planar struts), such as the strut-based cells disclosed herein. In certain embodiments, the first and second grating structures 4722 and 4724 may vary in density (e.g., number of cells) and/or shape. Thus, the specific structural configuration of each of the first and second grating structures 4722 and 4724 is not shown, except for the general shape and thickness.

The first and second grid structures 4722 and 4724 each extend from a top surface 4722a, 4724a to a bottom surface 4722b, 4724 b. At least a portion of the top surface of the at least one grid structure can serve as a tissue contacting surface of the adjunct and at least a portion of the bottom surface of the at least one grid structure can serve as a cartridge contacting surface of the adjunct, depending on the overall structural configuration of the adjunct. In this illustrated embodiment, the first grating structure 4722 is positioned on top of the second grating structure 4724 such that a bottom surface 4722b of the first grating structure 4722 is in contact with a top surface 4724a of the second grating structure 4724. Thus, the top surface 4722a of the first grating structure 4722 thus forms the tissue-contacting surface 4716, and the bottom surface 4724b of the second grating structure 4724 thus forms the bin-contacting surface 4718. Thus, the shape of the top surface 4722a of the first grid structure 4722 may create a tissue gap between the anvil 4702 and the stapling assembly 4704 that is independent of the shape of the top surface or deck surface 4707a of the staple cartridge 4707.

Top and bottom surfaces of each grid structure 4722, 4724The faces 4722a, 4724b may have a variety of different shapes. In this illustrated embodiment, the top and bottom surfaces 4722a, 4722b of the first grid structure 4722 each have a convex configuration. Thus, the top surface 4724a of the second grating structure 4724 has a concave configuration. In addition, because the top surface or platform surface 4707a of the staple cartridge 4707 has a generally planar configuration (e.g., in the YZ plane), the bottom surface 4724b of the second grid structure 4724 also has a generally planar configuration (e.g., in the YZ plane). Thus, the resulting overall geometry of the adjunct 4706 creates a curved tissue contacting surface 4716 relative to the tissue-compressing surface 4710 of the anvil 4702 and, thus, a variable tissue gap (e.g., two different gap amounts are shown as T) between the anvil 4702 and the stapling assembly 4704 _G1、T_G2)。

In this illustrated embodiment, due to the concave shape of the top surface 4722a of the first grid structure 4722, the overall thickness T of the appendage 4706 at the center (represented by dashed line 4726, e.g., equidistant from the two opposing end laterally facing edges 4728a, 4728 b) is overall_CGreater (e.g., in the x-direction) than an overall thickness T of the appendage 4706 at each of the distal transversely facing edges 4728a, 4728b (e.g., the outer longitudinal perimeter of the appendage 4706 extending in the z-direction)_P1、T_P2(e.g., in the x-direction). Accordingly, the total uncompressed thickness of adjunct 4706 varies laterally outward (e.g., in the y-direction) along its width relative to its center, and thus varies laterally relative to the longitudinal axis (e.g., extending in the z-direction) of adjunct 4706. Thus, the uncompressed thickness of the adjunct decreases in the lateral direction as the tissue gap increases. In addition, because the two end laterally-facing edges 4728a, 4728b are shown as having the same thickness, the change in lateral thickness from the center of the adjunct 4706 to each edge is the same. In other embodiments, the two terminal laterally-facing edges may have different thicknesses, and thus, the change in lateral thickness from the center of the adjunct to the respective edge will be different.

As further shown, due to the first grating structure 4722 and the second grating structure 4724The thickness of each grid structure (e.g., in the x-direction) also varies laterally outward (e.g., in the y-direction) along its respective length relative to its respective center (which in this embodiment is also the center of appendage 4706 (represented by dashed line 4726)). Thus, in this illustrated embodiment, the first grating structure 4722 is thicker than the second grating structure 4724 at the center of the appendage, and the second grating structure 4724 is thicker than the first grating structure 4722 at each of the lateral-facing edges 4728a, 4728b of the appendage 4706. Thus, the adjunct 4706 is most compressible at its center and least compressible at its end laterally facing edges 4728a, 4728B, and thus, when in a tissue deployed state, the adjunct 4706 can be compressed to a substantially uniform thickness T_Compression(see FIG. 47B). This allows appendage 4706 to exert a pressure that is not proportional to its uncompressed variable thickness. Thus, when the adjunct is stapled to substantially uniform tissue T (e.g., tissue having the same or substantially the same thickness across the width of the adjunct in the y-direction) with the staples 4712a, 4712B, 4712c, 4714a, 4714B, 4714c, the adjunct 4706 can apply a substantially uniform pressure P to the stapled tissue T (see fig. 47B).

Fig. 48A-48B illustrate another exemplary embodiment of a surgical end effector 4800 having an anvil 4802 and a stapling assembly 4804. Stapling assembly 4804 includes an adjunct 4806 releasably retained on a top or deck surface 4807a (e.g., a staple cartridge surface facing the anvil) of the staple cartridge 4807. Except for the differences described below, the anvil 4802 is similar to the anvil 4702 of fig. 47A-47B, and the staple cartridge 4807 is similar to the cartridge 200 of fig. 1-2C, except that the top or deck surface 4807A is curved, and thus common features are not described in detail herein. Fig. 48A shows the surgical end effector 4800 in a fully closed position, and thus the anvil 4802, while fig. 48B shows tissue T clamped between the anvil 4802 and the stapling assembly 4802 and stapled to an adjunct 4806 via staples (only two sets of three staples 4812a, 4812B, 4812c, 4814a, 4814B, 4814c are shown). Prior to deployment, in some embodiments, as shown in fig. 48A and 48C, the staples can be disposed entirely within staple cartridge 4807, while in other embodiments, some or all of the staples can be disposed partially within staple cartridge 4807. While the two groups of staples 4812a, 4812b, 4812c, 4814a, 4814b, 4814c can have various configurations, in this illustrated embodiment, the two groups of staples are identical, and thus for each group, a first staple 4812a, 4814a (e.g., the innermost row of staples) has a first height, a second staple 4812b, 4814b (e.g., the middle row of staples) has a second height greater than the first height, and a third staple 4812c, 4814c (e.g., the outermost row of staples) has a third height greater than the second height.

As shown in fig. 48A, and in more detail in fig. 48C, the adjunct 4806 has a tissue contacting surface 4816, a cartridge contacting surface 4818, and an internal structure 4820 extending therebetween. While the inner structure 4820 can have various configurations, in this illustrated embodiment, the inner structure 4820 includes two grating structures 4822, 4824, each having a different compressive strength such that the adjunct 4806, when in a tissue deployed state, is configured to apply a substantially uniform pressure to stapled tissue for a predetermined period of time. In the illustrated embodiment, the first grating structure 4822 is configured to have a first compressive strength and the second grating structure 4824 is configured to have a second compressive strength that is greater than the first compressive strength.

Each of the first and second grid structures 4822, 4824 can generally be formed of cells, such as those disclosed herein, e.g., studless-based cells and/or strut-based cells. For example, in certain embodiments, one or more unit cells may include at least one triply periodic minimal surface structure, such as those disclosed herein. Alternatively or additionally, one or more cells can be defined by interconnecting struts (e.g., planar struts), such as the strut-based cells disclosed herein. Thus, the specific structural configuration of each of the first and second grating structures 4822, 4824 is not shown, except for the general shape and thickness.

The first grating structure 4822 and the second grating structure 4824 each extend from the top surface 4822a, 4824a to the bottom surface 4822b, 4824 b. At least a portion of the top surface of the at least one grid structure can serve as a tissue contacting surface of the adjunct and at least a portion of the bottom surface of the at least one grid structure can serve as a cartridge contacting surface of the adjunct, depending on the overall structural configuration of the adjunct. In this illustrated embodiment, the first grating structure 4822 is narrower in width (e.g., in the y-direction) than the second grating structure, and is therefore positioned only on top of the central region 4823 of the second grating structure 4824. Thus, the entire bottom surface 4822b of the first grating structure 4822 contacts only a portion of the top surface 4824a of the second grating structure 4824, e.g., only the top surface 4823a of the central region 4823. Thus, the two exposed portions 4825a, 4825b of the top surface 4822a of the first grating structure 4822 and the top surface 4824a of the second grating structure 4824 form a tissue-contacting surface 4816, and the bottom surface 4824b of the second grating structure 4824 forms a bin-contacting surface 4818.

The top and bottom surfaces 4822a, 4824b of each grid structure 4822, 4824 can have a variety of different shapes. Those skilled in the art will appreciate that the shape of the top and bottom surfaces may depend at least on the top or deck surface of the staple cartridge on which the adjunct will be releasably retained. In this illustrated embodiment, the top and bottom surfaces 4822a, 4822b of the first grating structure 4822 each have a convex configuration. Thus, the top surface 4823a of the central region 4823 of the second grating structure 4824 has a convex configuration, while the two exposed portions 4825a, 4825b of the top surface 4824a of the second grating structure 4824 each have a substantially planar configuration (e.g., extending in the y-direction). In addition, because the top or deck surface 4807a of the staple cartridge 4807 has a convex configuration, the bottom surface 4824b of the second grid structure 4824 has a concave configuration.

In this illustrated embodiment, due to the structural interconnection between the first grating structure 4822 and the second grating structure 4824 and the resulting shape of the tissue contacting surface 4816, the appendage 4806 is centered (represented by dashed line 4826, e.g., edge 48 transverse to the outermost end facing28a, 4828b equidistant) of total thickness T_C(e.g., in the x-direction) is less than the total thickness T of the appendage at the outermost laterally facing edges 4828a, 4828b (e.g., the outer longitudinal perimeter of the appendage 4806 extending in the z-direction)_P1、T_P2(e.g., in the x-direction). Thus, the total uncompressed thickness of the adjunct 4806 can vary laterally outward along its width (e.g., the ± y-direction) relative to its center. Thus, the overall uncompressed thickness of the adjunct varies laterally (e.g., extends in the z-direction) relative to the longitudinal axis of the adjunct 4806.

As further shown, due to the structural relationship between the first and second grid structures 4822, 4824 and their compressive strength relative to each other in combination with the curved configuration of the top surface 4807a of staple cartridge 4807, the thickness of each grid (e.g., in the x-direction) also varies laterally outward along its respective length relative to its respective center (e.g., ± y-direction), which in this embodiment is also the center of the adjunct 4806 (represented by dashed line 4826). Thus, in this illustrated embodiment, the first grating structure 4822 is thicker than the second grating structure 4824 at the center of the appendage 4806. Thus, the appendage 4806 is most compressible at its center and least compressible at its outermost end facing the lateral edges 4828a, 4828 b. This allows the adjunct 4806 to exert a substantially uniform pressure despite variations in its compressed thickness. Thus, when the adjunct is stapled to substantially uniform tissue T (e.g., tissue having the same or substantially the same thickness in the y-direction, e.g., across the width of the adjunct (e.g., in the x-direction)) with staples 4812a, 4812B, 4812c, 4814a, 4814B, 4814c, the adjunct 4806 compresses to a non-uniform compressed thickness while still applying a substantially uniform pressure P to the stapled tissue T (see fig. 48B). As further shown, in this illustrated embodiment, only the second grid 4824 overlaps the outermost spikes 4812c, 4814 c.

In other embodiments, the width of the second grating structure may be narrower than the width of the first grating structure. For example, as shown in fig. 49, the adjunct 4900 includes a first lattice structure 4906 and a second lattice structure 4908 having a semi-circular concentric configuration, wherein the first lattice structure 4906 surrounds the second lattice structure 4908. Thus, the top surface 4906a of the first grid structure 4906 forms a tissue contacting surface 4902 of the adjunct 4900, and the bottom surfaces 4906b, 4908b of the first and second grid structures 4906, 4908 form a bin contacting surface 4904 of the adjunct 4900.

As described above, the adjunct can have two lattice structures that vary longitudinally (e.g., in the z-direction) in structure, shape, or interconnection along the length of the adjunct. For example, as shown in fig. 50A-50B, the adjunct 5002 includes two lattice structures 5004, 5006, each lattice structure relative to one another and along a length of the adjunct (e.g., along the longitudinal axis L)_AExtended, in the z direction) vary in structure and shape.

Fig. 50A-50B illustrate an exemplary embodiment of a surgical end effector 5000 that is similar to the surgical end effector 5000 except for an adjunct 5002 having a variable compressive strength along a length thereof along a longitudinal axis L _AExtend (e.g., in the z direction). As shown in fig. 50A, and in more detail in fig. 50C, an adjunct 5002 is positioned on a top surface or deck surface 5003a of a staple cartridge 5003. The staple cartridge 5003 is similar to the staple cartridge 4707 in fig. 47A-47C in that the staples 4712a, 4712b, 4712C, 4714a, 4714b, 4714C are disposed therein, and thus common features are not described herein.

The adjunct 5002 has a tissue-contacting surface 5008, a cartridge-contacting surface 5010, and an internal structure 5012 extending therebetween. While the inner structure 5012 can have a variety of configurations, the first lattice structure 5004 and the second lattice structure 5006 each have different compressive strengths such that the adjunct 5002, when in a tissue deployed state, is configured to apply a substantially uniform pressure (e.g., a pressure in the range of 30kPa to 90 kPa) to tissue stapled thereto for a predetermined period of time (e.g., at least 3 days). In the illustrated embodiment, the first grating structure 5004 is configured to have a first compressive strength and the second grating structure 5006 is configured to have a second compressive strength that is greater than the first compressive strength. Thus, the second grating structure 5004 is harder than the first grating structure 5006. In other embodiments, the first lattice structure may be stiffer than the second lattice structure.

Each of the first grid structure 5004 and the second grid structure 5006 may generally be formed from cells, such as those disclosed herein, e.g., strut-free based cells and/or strut-based cells. For example, in certain embodiments, one or more unit cells may include at least one triply periodic minimal surface structure, such as those disclosed herein. Alternatively or additionally, one or more cells can be defined by interconnecting struts (e.g., planar struts), such as the strut-based cells disclosed herein. In certain embodiments, the first grating structure 5004 and the second grating structure 5006 may vary in density (e.g., number of cells) and/or shape. Thus, the specific structural configuration of each of the first grating structure 5004 and the second grating structure 5006 is not shown, except for the general shape and thickness.

The first 5004 and second 5006 grating structures each extend from the top 5004a, 5006a to the bottom 5004b, 5006b surfaces. At least a portion of the top surface of the at least one grid structure can serve as a tissue contacting surface of the adjunct and at least a portion of the bottom surface of the at least one grid structure can serve as a cartridge contacting surface of the adjunct, depending on the overall structural configuration of the adjunct. In this illustrated embodiment, the first grating structure 5004 is positioned on top of the second grating structure 5006 such that the bottom surface 5004b of the first grating structure 5004 and the top surface 5006a of the second grating structure 5006 are in contact. Thus, the top surface 5004a of the first grating structure 5004 forms the tissue-contacting surface 5008 and the bottom surface 5006b of the second grating structure 5006 forms the cartridge-contacting surface 5010.

While the first 5004 and second 5006 grating structures can have various configurations, each grating structure has an uncompressed thickness (e.g., in the x-direction) that varies along the length of the appendage (e.g., extending in the z-direction). As shown, the top surface 5004a of the first grid structure 5004 extends fromThe proximal end 5002a to the distal end 5002b of the appendage 5002 slopes. Additionally, because the top surface or deck surface 5003a of the staple cartridge 5003 has a generally planar configuration (e.g., in the XZ plane), the bottom surface 5006b of the second grid structure 5006 also has a generally planar configuration (e.g., in the XZ plane). Thus, a variable tissue gap (e.g., two different gap amounts are shown as T)_G1、T_G2) Created between the anvil 5001 and the adjunct 5002, this variable tissue gap is independent of the shape of the top surface or deck surface 5003a of the staple cartridge 5003.

When the adjunct is sutured to tissue, as shown in fig. 50B, the variation in uncompressed thickness of each lattice structure along the length of the adjunct, in combination with the first and second compressive strengths and the variable tissue gap, can allow the adjunct to apply a substantially uniform pressure P to the sutured tissue T (see fig. 50B).

Consistent tissue spacing

In some embodiments, it may be desirable to have a consistent tissue gap between the adjunct and the anvil to enhance the grip and stability of the tissue during stapling and/or cutting of the tissue. However, a consistent tissue gap may adversely affect the ability of the adjunct to apply a generally uniform pressure to the stapled tissue. Accordingly, and as described in greater detail below, the adjunct disclosed herein can be configured to create a consistent tissue gap for tissue manipulation, and when sutured to tissue, the adjunct can be further configured to apply a substantially uniform pressure (e.g., a pressure in a range of about 30kPa to 90 kPa) to the tissue sutured thereto for a predetermined period of time (e.g., at least 3 days). In certain embodiments, the adjunct can apply a pressure of at least about 30kPa for at least three days. In such embodiments, after 3 days, the adjunct can be configured to apply an effective amount of pressure to the tissue (e.g., a linear decrease in pressure, such as about 30kPa or less) such that the tissue can remain sealed by a healing cycle of the tissue (e.g., about 28 days). For example, the adjunct can be configured to apply pressure to the stapled tissue, wherein the pressure is reduced (e.g., linearly reduced) from about 30kPa to 0kPa over a predetermined period of about 3 days to 28 days, respectively.

In some embodiments, the adjunct can be designed with a tissue-contacting surface at least a portion of which is substantially planar (e.g., in the y-direction) and an opposing cartridge-contacting surface that is non-planar (e.g., along a width of the adjunct, e.g., in the y-direction). The non-planar surface of the cartridge contacting surface can vary proportionally along and relative to, for example, a curved or stepped top surface or deck surface of the staple cartridge (e.g., a cartridge surface facing the anvil) or a stepped tissue-compression surface of the anvil.

In general, the adjunct can include a tissue-contacting surface, a cartridge-contacting surface, and an internal structure extending therebetween. In some embodiments, the appendage can be formed from at least two grid structures, wherein a first grid structure has a non-planar bottom surface defining at least a portion of the cartridge contacting surface; and the second lattice structure (e.g., the primary lattice structure) has a top surface having at least a portion that is substantially planar and defines at least a portion of the tissue contacting surface. In other embodiments, the internal structure may be formed by a single lattice structure formed by repeating unit cells that vary in shape and/or size in a transverse direction relative to the longitudinal axis of the adjunct. Thus, the adjunct can have an overall geometry that produces a tissue contacting surface having planar and non-planar surfaces and a non-planar staple cartridge contacting surface (e.g., a staple cartridge surface facing the anvil) configured to fit to a curved or stepped top surface or deck surface of the staple cartridge. Thus, a generally uniform tissue gap can be created independent of the shape of the top surface or deck surface of the staple cartridge.

In some embodiments, the size (e.g., wall thickness and/or height) of the repeating cells may vary such that when the adjunct is sutured to tissue, the adjunct can apply a substantially uniform pressure (e.g., a pressure in the range of 30kPa to 90 kPa) to the sutured tissue for a predetermined period of time (e.g., at least three days). For example, the repeating cells of one longitudinal row may vary relative to the repeating cells of an adjacent longitudinal row. Thus, the attachment can be designed in the following way: the adjunct can create a tissue gap that is consistent with the anvil prior to staple deployment, and can apply a substantially uniform pressure (e.g., a pressure in the range of 30kPa to 90 kPa) to stapled tissue for a predetermined period of time (e.g., at least three days) when in a tissue deployed state.

Fig. 51A shows an exemplary embodiment of a surgical end effector 5100 having an anvil 5102 and stapling assembly 5104. Stapling assembly 5104 includes an adjunct 5106 releasably retained on a top or deck surface 5108a of staple cartridge 5108 (e.g., the staple cartridge surface facing the anvil). The staple cartridge 5108 is similar to the cartridge 4807 of fig. 48A-48C except for the differences described below, and thus common features are not described in detail herein. Although not shown, the anvil 5102 is pivotally coupled to an elongate staple channel, such as the elongate staple channel 104 of fig. 1, and the stapling assembly 5104 is positioned within and coupled to the elongate staple channel. While the anvil 5102 can have a variety of configurations, in the embodiment illustrated in fig. 51A, the anvil 5102 includes a cartridge-facing surface having staple pockets 5110 defined therein, wherein generally planar tissue-compressing surfaces 5112 extend between the staple pockets 5110. Fig. 51A shows the surgical end effector 5100 in a fully closed position, and thus illustrates an anvil 5102 with tissue not positioned between the anvil 5102 and an adjunct 5106 and with staples not disposed within the staple cartridge 5108 (only two sets of three staples 5114a, 5114b, 5114c, 5116a, 5116b, 5116c are shown). Prior to deployment, in some embodiments, as shown in fig. 51A, the staples 5114a, 5114b, 5114c, 5116a, 5116b, 5116c can be partially disposed within the staple cartridge 5108, while in other embodiments, some or all of the staples can be fully disposed within the staple cartridge 5108. While the staples 5114a, 5114c, 5116a, 5116b, 5116c can have a variety of configurations, in this illustrated embodiment, the staples 5114a, 5114c, 5116a, 5116b, 5116c have at least a substantially uniform pre-deployed (e.g., unformed) staple height (e.g., nominally the same within manufacturing tolerances). In some embodiments, the staples 5114a, 5114c, 5116a, 5116b, 5116c can be substantially uniform (e.g., nominally identical within manufacturing tolerances).

As shown in fig. 51B, and in more detail in fig. 51C, the adjunct 5106 has a tissue-contacting surface 5118, a cartridge-contacting surface 5120, and an internal structure 5122 extending therebetween. While the inner structure 5122 can have a variety of configurations, in this illustrated embodiment, the inner structure 5122 includes two different lattice structures 5124, 5126. The first and second grid structures 5124, 5126 each extend from the top surface 5124a, 5126a to the bottom surface 5124b, 5126 b.

The first grid structure 5124 can be generally formed from struts 5228a, 5228B, 5228c, 5228d, 5230a, 5230B, 5230c, 5230d as in fig. 52A-52B or cells such as those disclosed herein (e.g., strut-free based cells and/or strut-based cells). Thus, the specific structural configuration of the first lattice structure 5124 is not shown, except for the general overall shape and thickness.

The first grid structure 5124 extends between the second grid 5126 structure and a top surface or deck surface 5108a of the staple cartridge 5108. As shown, the uncompressed thickness of the first lattice structure 5124 is relative to the longitudinal axis L of the longitudinal appendage 5106_A(e.g., L extending in the z-direction_A) Laterally varying. These lateral variations may be proportional along the curved top or platform surface 5108a of the staple cartridge 5108 such that a portion of the staple cartridge contact surface 5120 of the adjunct 5106 formed by the bottom surface 5124b of the first grid structure 5124 is complementary in shape to the curved top or platform surface 5108a of the staple cartridge 5108 (e.g., a concave configuration). Thus, the variation in thickness of the first grating structure 5124 may conform to the variation in the top or platform surface 5108 a. In addition, this results in the compression ratio of the first lattice structure 5124 also varying in the lateral direction, which in the illustrated embodiment increases due to the lateral increase in uncompressed thickness, such that the compression behavior of the appendages 5106 is driven primarily by the compressive properties of the second lattice structure 5126.

The second lattice structure 5126 is formed of interconnected repeating unit cells arranged in two sets of three longitudinal arrays, wherein a first set is positioned on one side of the intended cut line of the adjunct and a second set is positioned on a second side of the intended cut line of the adjunct. For simplicity, only three cells from each group 5132a, 5132b, 5132c, 5134a, 5134b, 5134c are shown. Although the repeating cells may have various configurations, in this illustrated embodiment, all of the repeating cells are of substantially uniform size (e.g., are nominally the same within manufacturing tolerances) and are similar to the repeating cells 810 in fig. 9A-9B, and thus common features are not described in detail herein. Thus, the second grid structure is similar to the adjunct 800 in fig. 8A-8F, and thus common features are not described herein.

As shown, at least a portion of the top surface 5126a is generally planar and, thus, includes generally planar faces 5127 (e.g., each face in the y-direction) with a non-planar face 5129 extending therebetween. Top surface 5126a defines tissue-contacting face 5118 of appendage 5106, and thus tissue-contacting face 5118 is formed from a planar face 5127 and a non-planar face 5129. Because the generally planar face 5127 and the non-planar face 5129 of the top surface (and thus the tissue-contacting face 5118) alternate along the width (extending in the y-direction) of the second lattice structure 5126, a consistent tissue gap (e.g., alternating between a generally uniform tissue gap and a variable tissue gap) is created between the anvil 5102 and the adjunct 5106. In the illustrated embodiment, each substantially uniform tissue gap T _GOccurs between the tissue-compressing surface 5112 of the anvil 5102 and the generally planar surface 5127 of the tissue contacting surface 5118. Variable tissue gap (only two variable gaps are shown as T)_G1、T_G2) Occurs between the tissue-compressing surface 5112 of the anvil 5102 and the non-planar surface 5129 of the tissue contacting surface 5118 that extends between adjacent cells of the second lattice structure 5126. Those skilled in the art will appreciate that the length of the generally uniform and variable tissue gap (extending in the x-direction) may depend at least on the structural configuration of the tissue contacting surface, and thus the structural configuration of the second lattice structure.

While the height between the repeating cells 5132a, 5132b, 5132c, 5134a, 5134b, 5134c is generally uniform, the wall thickness may vary and therefore result in different compression ratios. In the illustrationIn an embodiment, the two sets of three longitudinal arrays are the same, and thus for each set, the wall thickness W from the first repeating cell 5132a, 5134a (e.g., the innermost repeating cell) to the third repeating cell 5132c, 5134c (e.g., the outermost repeating cell)_TAnd similarly decreases. Thus, only one set of three longitudinal arrays is shown in FIG. 51B. Wall thickness W of first repeating unit cell 5132a (not shown) _T1Greater than a wall thickness W of the second repeat cell 5132b (e.g., intermediate repeat cells)_T2And the wall thickness W of the second repeating lattice 5132b_T2A wall thickness W greater than that of the third repeating unit cells 5132c, 5134c_T3. Accordingly, the compression ratio from the first repeating cell 5132a, 5134a to the third repeating cell 5132c, 5134c increases, and thus the first repeating cell 5132a, 5134a will compress the least (e.g., be hardest) and the third repeating cell 5132c, 5134c will compress the most (e.g., the hardest). That is, the first compression ratio of the first repeating cells 5132a, 5134a is smaller than each of the second compression ratio and the third compression ratio of the second and third repeating cells 5132b, 5134b, 5132c, 5134c, and the second compression ratio is smaller than the third compression ratio. Thus, these compression ratios in combination with the laterally varying compression ratio of the first grid structure 5124 will result in a varying overall compression ratio of the adjunct 5106 such that when the adjunct is stapled to tissue using substantially uniform staples 5114a, 5114b, 5114c, 5116a, 5116b, 5116c (e.g., nominally the same within manufacturing tolerances), the adjunct 5106 is configured to apply substantially uniform pressure to the stapled tissue for a predetermined period of time.

In certain embodiments, the first lattice structure may be configured in such a way that: when the adjunct is releasably retained on the staple cartridge, it does not overlap the staple rows. Thus, the first lattice structure will not be captured or will be minimally captured by the pegs during deployment. Thus, the first lattice structure will not contribute or will contribute minimally to the solids height of the adjunct when in the tissue deployed state. Thus, densification of the adjunct can be delayed.

Fig. 52A illustrates another exemplary embodiment of a surgical end effector 5200 having an anvil 5202 and a stapling assembly 5204. The stapling assembly 5204 includes an adjunct 5206 releasably retained on a top or deck surface 5208a of the staple cartridge 5208 (e.g., the staple cartridge surface facing the anvil). Except for the differences described below, the anvil 5202 and the staple cartridge 5208 are similar to the anvil 5102 and the staple cartridge 5208 in fig. 52A-52B, and therefore common features are not described in detail herein.

The adjunct 5204 is similar to the adjunct 5104 in fig. 51A-51B, except that the first grid structure 5224 is formed from two sets of four longitudinal rows of spaced apart vertical planar struts (e.g., in the x-direction) that extend between the second grid structure 5226 and a top or deck surface 5208a of the staple cartridge 5208. As shown, the first set is positioned at the intended cut line C of the appendage 5206 _LAnd a second set is positioned at the intended cut line C of the appendage 5206_LOn the second side of (a). For simplicity, only four struts from each group 5228a, 5228b, 5228c, 5228d, 5230a, 5230b, 5230c, 5230d are shown. While the two sets of struts can have various configurations, in the illustrated embodiment, the two sets of struts are identical, and thus for each set, first struts 5228a, 5230a (e.g., the innermost row of struts) have a first height, second struts 5228b, 5228b (e.g., the innermost intermediate row of struts) have a second height that is greater than the first height, third struts 5228c, 5230c (e.g., the outermost intermediate row of struts) have a third height that is greater than the second height, and fourth struts 5228d, 5230d (e.g., the outermost row of struts) have a fourth height that is greater than the second height. Thus, the uncompressed thickness of the first lattice structure 5224 (e.g., along the width of the adjunct, in the y-direction) is relative to the longitudinal axis L of the longitudinal adjunct 5206_A(e.g., L extending in the z-direction_A) Laterally varying. These lateral variations may be proportional along the curved top surface or deck surface 5208a of the staple cartridge 5208 such that a portion of the staple cartridge contact surface 5220 of the adjunct 5206 formed by the bottom surface 5224b of the first grating structure 5224 is complementary in shape to the curved top surface or deck surface 5208a of the staple cartridge 5208 (e.g., a concave configuration). Thus, of the first lattice structure 5224 The thickness variation may conform to variations in the top surface or platform surface 5208 a.

As further shown in fig. 52A, to minimize the effect of the first grating structure 5224 on the densification of the adjunct 5206, the first grating structure 5224 can be designed in such a way that it does not overlap the pegs 5214a, 5214c, 5216a, 5216b, 5216 c. For example, in the illustrated embodiment, none of the struts 5228a, 5228b, 5228c, 5228d, 5230a, 5230b, 5230c, 5230d overlap any of the pegs 5214a, 5214b, 5214c, 5216a, 5216b, 5216c, and thus, the first grid structure 5224 will not be captured by the pegs during deployment. Thus, when the adjunct 5206 is sutured to tissue, the pressure applied by the adjunct 5206 to the sutured tissue can be completely or substantially completely dependent on the compression characteristics of the second lattice structure 5226.

In some embodiments, the wall thickness and height of each repeating cell may vary between other repeating cells. For example, fig. 53 illustrates another exemplary embodiment of an adjunct 5300 releasably retained on a top or deck surface 5302a (e.g., a cartridge surface facing an anvil) of a staple cartridge 5302. The staple cartridge 5302 is similar to the cartridge 5108 of fig. 51A-51B except for the differences described below, and thus common features are not described in detail herein. As shown in fig. 53, only half of the adjunct 5300 (e.g., the right half) is shown on the staple cartridge 5302 with the three rows of staples 5304, 5306, 5308 partially disposed therein, with the innermost row of staples 5304 having the smallest staple height and the outermost row of staples 5308 having the largest staple height. As described above, the difference in staple height can contribute to the overall compression behavior of the adjunct when it is sutured to tissue.

While adjunct 5300 can have various configurations, adjunct 5300 is formed of interconnected repeating cells arranged in two sets of three longitudinal arrays, wherein a first set is positioned at an intended cut line C of adjunct 5300_LAnd a second set (not shown) is positioned at the intended cut line C of the tag 5300_LOn the second side of the substrate. Since both sets are identical, only one of the sets of three longitudinal arrays is shown in FIG. 53The unit cells 5310, 5312, 5314 are repeated.

The repeating cells 5310, 5312, 5314 may have a variety of configurations. In this illustrated embodiment, the repeating cells 5310, 5312, 5314 are similar in overall shape, except that the wall thickness and height varies between the three repeating cells 5310, 5312, 5314. As shown, each repeating cell has a varying height (e.g., in the X-direction) from their respective outermost top surfaces 5310a, 5312a, 5314a (laterally offset in the y-direction and aligned relative to each other) to their respective outermost bottom surfaces 5310b, 5312b, 5314b, and thus for simplicity, the minimum height H of the repeating unit cell 5310 is shown_1AAnd a maximum height H_1BMinimum height H of repeating cell 5312 _2AAnd a maximum height H_2BAnd minimum height H of repeating cell 5314_3AAnd a maximum height H_3B。

As shown, a portion of top surface 5300a of appendage 5300 is substantially planar and, thus, includes substantially planar surfaces 5316 (e.g., each surface in the y-direction) with non-planar surfaces 5318 extending therebetween. Top surface 5300a defines a tissue-contacting surface 5320 of appendage 5300, and thus tissue-contacting surface 5320 is formed from planar surface 5316 and non-planar surface 5318. Because the generally planar surface 5316 and the non-planar surface 5318 of the top surface 5300a (and thus the tissue contacting surface 5320) alternate along the width (extending in the y-direction) of the adjunct 5300, a uniform tissue gap (e.g., alternating between a generally uniform tissue gap and a variable tissue gap) is created between the anvil and the adjunct 5300, such as the anvil 5102 in fig. 51. In the illustrated embodiment, each generally uniform tissue gap occurs between a tissue-compressing surface (such as tissue-compressing surface 5112 of anvil 5102 in fig. 51) and a generally planar surface 5316 of tissue contacting surface 5320. A variable tissue gap occurs between a tissue-compressing surface (such as tissue-compressing surface 5112 of anvil 5102 in fig. 51) and a non-planar surface 5318 of tissue-contacting surface 5320 (which extends between adjacent cells of adjunct 5300). Those skilled in the art will appreciate that the length of the generally uniform and variable tissue gap (extending in the x-direction) may depend at least on the structural configuration of the tissue contacting surface, and thus the structural configuration of the adjunct.

In addition, the wall thickness and height between at least two repeating lattices may vary and thus lead to different compression ratios. In this illustrated embodiment, the wall thickness W from the first repeating cell 5310 (e.g., the innermost repeating cell) to the third repeating cell 5314 (e.g., the outermost repeating cell)_TAnd H increases. That is, the wall thickness W of the first repeating cell 5310_T1And height H₁A wall thickness W less than that of the second repeat cell 5312 (e.g., an intermediate repeat cell)_T2And height H₂And the wall thickness W of the second repeat lattice 5312_T2And height H₂Wall thickness W less than third repeating cell 5314_T3And height H₃. Therefore, the compression ratio from the first repetitive cell 5310 to the third repetitive cell 5314 decreases. That is, the first compression ratio of the first repeating cell 5310 is greater than each of the second and third compression ratios of the second and third repeating cells 5312 and 5314, and the second compression ratio is greater than the third compression ratio. Thus, these compression ratios will result in a varying overall compression ratio of adjunct 5300 such that, when the adjunct is stapled to tissue with staples 5304, 5306, 5308 having different staple heights (e.g., the innermost staple 5304 having the smallest peak height and the outermost staple 5308 having the largest peak height), adjunct 5300 is configured to apply a substantially uniform pressure to the stapled tissue for a predetermined period of time.

As described above, the adjunct can include a combination of stay-free based cells and stay-based cells and/or spaced stays. For example, fig. 54 illustrates an exemplary embodiment of an adjunct 5400 that is releasably retained on a top surface or deck surface 5402a of a staple cartridge 5402 (e.g., a cartridge surface facing an anvil). Staple cartridge 5402 is similar to cartridge 200 in fig. 1-2C except for the differences described below, and thus common features are not described in detail herein. As shown in fig. 54, only half of an adjunct 5400 is shown on staple cartridge 5402 (e.g., the left half) with three longitudinal rows 5303a, 5303b, 5303c of substantially uniform staples 5404a, 5404b, 5404c disposed therein.

While the adjunct 5400 can have various configurations, as shown, the adjunct has an inner grid structure 5406 formed from two sets of two longitudinal arrays of repeating studless cells, wherein a first set is positioned at an intended cut line C of the adjunct 5400_LAnd a second set (not shown) is positioned at the intended cut line C of the appendage 5400_LOn the second side of the substrate. Since both sets are identical, only one repeat cell 5408, 5410 of one set of two longitudinal arrays is shown in fig. 54. In addition, the appendage 5400 includes a first outer grid structure and a second outer grid structure that are similar in structure and positioned on opposite sides of the inner grid structure (only the first outer grid structure 5412 is shown). While only the first outer grid structure 5412 and the first and second repeating cells 5408, 5410 of the appendage 5400 are shown, one skilled in the art will appreciate that the following discussion also applies to the second grid structure and the second set of longitudinal arrays of repeating cells.

The first repeating cell 5408 and the second repeating cell 5410 can have a variety of configurations. In this illustrated embodiment, the repeat cells 5408, 5410 are substantially uniform (e.g., are nominally identical within manufacturing tolerances) and are similar in structure to the repeat cell 810 in fig. 9A-9B, and thus common features are not described in detail herein. As shown, the first repeat cell 5408 and the second repeat cell 5410 are oriented similar to repeat cell 4516 in fig. 45A-45C, and thus the inner grid structure 5406 may have a similar configuration to the adjunct 4500 structure in fig. 45A-45C. Thus, the repeating cells 5408, 5410 are oriented in a manner (e.g., in a repeating pattern) that can coincide with the positions of the staples of one or more of the rows of staples that the inner grid structure 5406 overlaps. As further shown, the first outer grid structure 5412 includes strut-based cells (only two grids 5414a, 5414b are fully shown). While the strut-based cells can have a variety of configurations, the first strut-based cell 5414a has a triangular configuration and the second strut-based cell 5414b has an inverted triangular configuration. As further shown, a portion of second strut-based cell 5414b crosses over first strut-based cell 5414 a.

As shown, the grid structures 5406, 5412 are relative to the longitudinal axis L of the appendage 5400_A(e.g., L extending in the z-direction_A) Adjacent and laterally offset from each other. That is, the first outer grid structure 5412 is positioned directly adjacent the first longitudinal side 5406a of the inner grid structure 5406. In addition, inner grid structure 5406 overlaps with first and second rows of staples 5403a and 5303b (e.g., the innermost and middle rows of staples), and thus first and second rows of staples 5404a and 5404b, respectively, while first outer grid structure 5412 overlaps with third row of staples 5404c (e.g., the outermost row of staples), and thus third staple 5404 c. In this illustrated embodiment, first longitudinal array of first repeating cells 5408 and second longitudinal array of second repeating cells 5410 are staggered with respect to each other and are thus oriented in a manner (e.g., a repeating pattern) that coincides with the position of first and second staples 5404a and 5404 b.

This alignment of the lattice structures 5406, 5412 relative to the first, second, and third staples 5404a, 5404b, 5404c, combined with the different structural configurations of the lattice structures 5406, 5412, can result in at least two different stress-strain curves when the adjunct is sutured to tissue. The resulting stress-strain curves of the adjunct at the first staple and the second staple can be the same or substantially the same in view of the orientation of the first repeating cell and the second repeating cell relative to the first staple and the second staple. The compressive behavior of adjunct 5300 at each of first tack 5404a, second tack 5404b, and third tack 5404c is schematically illustrated in fig. 55, where S1 represents a stress-strain curve of the adjunct at first tack 5404a, S2 represents a stress-strain curve of the adjunct at second tack 5404b, and S3 represents a stress-strain curve at third tack 5404 c. In this schematic, the stress-strain curve at the first staple S1 and the stress-strain curve at the second staple S2 are shown as the same curve. Those skilled in the art will appreciate that the stress-strain curve at each staple may vary.

Accessory system

In general, the adjunct systems described herein can include at least two different adjuncts, wherein each adjunct is configured to undergo a respective strain within a respective stress range under a respective applied stress within a range of about 30kPa to 90 kPa. In some embodiments, at least two respective ranges of strain may at least partially overlap, while in other embodiments, at least two respective ranges do not overlap. Additionally or alternatively, a combination of respective strain ranges may yield a combined range of at least 0.1 to 0.9. In other embodiments, the combination range may be about 0.1 to 0.8, about 0.1 to 0.7, about 0.1 to 0.6, about 0.1 to 0.5, about 0.1 to 0.4, about 01.to 0.3, about 0.2 to 0.8, about 0.2 to 0.7, about 0.3 to 0.8, about 0.3 to 0.9, about 0.4 to 0.8, about 0.4 to 0.7, about 0.5 to 0.8, or about 0.5 to 0.9. While the accessory system may include at least two different accessories, for simplicity, the following description is with respect to an accessory system having only a first accessory and a second accessory. However, one skilled in the art will appreciate that the following discussion also applies to additional appendages of the appendage system.

In some embodiments, an adjunct system can include a first adjunct and a second adjunct, wherein the first adjunct experiences a strain in a first range under an applied stress in a range of about 30kPa to 90kPa, and the second adjunct experiences a strain in a second range under an applied pressure in a range of about 30kPa to 90 kPa. The stress-strain response of each appendage is dependent upon at least the structural configuration and composition of each appendage. Accordingly, the first appendage and the second appendage can be tailored to achieve a desired strain response over an applied stress and/or a range of applied stresses. For example, in some embodiments, a first adjunct can be configured such that the first adjunct experiences a strain in a first range of about 0.2 to 0.5 under an applied stress in a range of about 60kPa to 90kPa, while a second adjunct can be configured such that the second adjunct experiences a strain in a second range of about 0.3 to 0.7 under an applied stress in a range of about 40kPa to 70 kPa. In another embodiment, the first adjunct can be configured such that the first adjunct experiences a strain in a first range of about 0.1 to 0.7 under an applied stress in a range of about 30kPa to 90kPa, and the second adjunct can be configured to experience a strain in a second range of about 0.3 to 0.9 under an applied stress in a range of about 30kPa to 90 kPa. In another embodiment, the first adjunct can be configured such that the first adjunct experiences a strain in a first range of about 0.2 to 0.6 under an applied stress in a range of about 30kPa to 90kPa, and the second adjunct can be configured such that the second adjunct experiences a strain in a second range of about 0.4 to 0.8 under an applied stress in a range of about 30kPa to 90 kPa. In another embodiment, the first adjunct can be configured such that the first adjunct experiences a strain in a first range of about 0.1 to 0.7 under an applied stress in a range of about 40kPa to 80kPa, and the second adjunct can be configured such that the second adjunct experiences a strain in a second range of about 0.2 to 0.8 under an applied stress in a range of about 30kPa to 90 kPa.

The first appendage and the second appendage can have a variety of structural configurations. For example, a first adjunct can have a configuration similar to any one of the example adjuncts described herein, and a second adjunct can have a different configuration than the first adjunct and be similar to another one of the example adjuncts described herein. In some embodiments, the first appendage may be a non-strut-based appendage and the second appendage may be another non-strut-based appendage or a strut-based appendage described herein. In other embodiments, the first appendage may be a strut-based appendage and the second appendage may be another strut-based appendage or a non-strut-based appendage.

In some embodiments, the first adjunct has a first internal structure formed from a first plurality of repetitively interconnected cells, and the second adjunct has a second internal structure formed from a second plurality of repetitively interconnected cells. In certain embodiments, the first plurality of repeating interconnected cells may be formed of a first material and the second plurality of repeating interconnected cells may be formed of a second material different from the first material. The first material and the second material may be any of the materials described herein and in more detail below. Additionally or alternatively, each cell of the first plurality of repetitively interconnected cells has a first geometric shape and each cell of the second plurality of repetitively interconnected cells has a second geometric shape different from the first geometric shape.

In some embodiments, each cell of at least one of the first plurality of repeating interconnected cells and the second plurality of repeating interconnected cells is a triply periodic minimal surface structure (e.g., a Schwarz P structure). In one embodiment, each unit cell of the first plurality of repeating interconnected unit cells is a first triply periodic minimum surface structure and each unit cell of the second plurality of repeating interconnected unit cells is a second triply periodic minimum surface structure different from the first triply periodic minimum surface structure. For example, the first and second triply periodic minimum surface structures may differ in geometry (e.g., shape, dimension (e.g., height, wall thickness, etc.), or a combination thereof).

In some embodiments, each cell of a first plurality of repeating interconnected cells can include a first top portion formed from a first plurality of struts defining a first plurality of openings therebetween, a first bottom portion formed from a second plurality of struts defining a second plurality of openings therebetween, and a first spacing strut interconnecting the first top portion and the first bottom portion. In such embodiments, each cell of the second plurality of repeating interconnected cells may be a Schwarz-P structure. In other embodiments, each cell of a second plurality of repeating interconnected cells can include a second top portion formed from a third plurality of struts defining a third plurality of openings therebetween, a second bottom portion formed from a fourth plurality of struts defining a fourth plurality of openings therebetween, and a second spacing strut interconnecting the second top portion and the second bottom portion.

Material

The adjunct described herein can be formed from one or more polymers, such as bioabsorbable polymers, non-bioabsorbable polymers, bioresorbable polymers, or any combination thereof. For clarity only, as used herein, "polymer" may be understood to encompass one or more polymers, including one or more macromers. Non-limiting examples of suitable polymers include: polylactide (PLA), Polycaprolactone (PCL), Polyglycolide (PGA), Polydioxanone (PDO), polytrimethylene carbonate (PTMC), polyethylene glycol (PEG), polyethylene diglycolate (PEDG), polypropylene fumarate (PPF), poly (ethoxyethylene diglycolate), poly (ether ester) (PEE), poly (amino acid), poly (epoxy carbonate), poly (2-oxypropylene carbonate), poly (glycol citrate), polymethacrylic anhydride and poly (N-isopropylacrylamide), copolymers of any one thereof, or any combination thereof. Non-limiting examples of suitable copolymers include: random copolymers such as PLGA-PCL, block copolymers such as poly (lactide-co-glycolide) (PLGA), triblock copolymers such as PLGA-PCL-PLGA or PLGA-PEG-PLGA, or any combination thereof. Additional non-limiting examples of suitable polymers are disclosed in, for example, U.S. patent nos. 9,770,241, 9,873,790, 10,085,745, and 10,149,753; and U.S. patent publication No. 2017/0355815, each of which is incorporated by reference herein in its entirety.

In some embodiments, the polymer may be formed from a resin. In general, the resins described herein may be suitable for use in additive manufacturing techniques such as bottom-up and top-down stereoillumination-type techniques, (b) to produce bioresorbable appendages, and/or (c) to produce flexible or elastic appendages (e.g., at about 25 ℃, about 37 ℃, and/or any temperature therebetween).

In some embodiments, the polymer may be formed from a photopolymerizable resin that includes an oligomeric prepolymer. The oligomer prepolymer may be linear or branched (e.g., "star" oligomers, such as three-armed oligomers). Non-limiting examples of suitable end groups of such oligomer prepolymers include: acrylates, methacrylates, fumarates, vinyl carbonates, methyl esters, ethyl esters, and the like. Non-limiting examples of suitable components of exemplary resins that can be used to form the polymers, and thus the appendages provided herein, are listed in table 2 below. The components in each column of table 2 may be combined with the components of the other columns in any combination.

TABLE 2 exemplary resin compositions

While various types of resins can be used to form the polymer, in some embodiments, the polymer is formed from a resin based on a bioabsorbable polyester oligomer (e.g., a methacrylate-terminated oligomer having bioabsorbable polyester linkages). For example, the bioabsorbable polyester oligomer can be present in an amount of about 5% to 90%, 5% to 80%, about 10% to 90%, or about 10% to 80% by weight of the resin. Unlike conventional resins (e.g., polycaprolactone dimethacrylate-based resins and poly (D, L-lactide) dimethacrylate-based resins), this resin can form an adjunct with rubbery elastic behavior, short-term retention of mechanical properties (e.g., 1 month or less), and/or long-term total absorption (e.g., over a period of about 4 to 6 months) at physiological temperatures.

In some embodiments, the oligomers may comprise linear oligomers. Alternatively or in addition, the oligomers may comprise branched oligomers (e.g., star oligomers, such as three-armed oligomers).

In some embodiments, the bioabsorbable polyester oligomer described herein is a bioabsorbable oligomer having methacrylate end groups. Such oligomers typically include biodegradable ester linkages between components such as caprolactone, lactide, glycolide trimethylene carbonate, dioxanone, and propylene glycol fumarate monomers in ABA blocks, BAB blocks, CBC blocks, BCB blocks, AB random compositions, BC random compositions, homopolymers, or any combination thereof, wherein: a ═ poly (lactide) (PLA), poly (glycolide) (PGA), poly (lactide-co-glycolide) (PLGA), or polypropylene fumarate (PPF), B ═ Polycaprolactone (PCL), poly (lactide-co-caprolactone) (placcl), poly (glycolide-co-caprolactone) (PGACL), poly (trimethylene carbonate) (PTMC), or poly (caprolactone-co-lactide) (PCLLA), and C ═ Polydioxanone (PDO). The molecular weight (Mn) of the copolymer in a linear or star configuration can be about 2 kilodaltons to 6 kilodaltons, about 2 kilodaltons to 10 kilodaltons, about 2 kilodaltons to 15 kilodaltons, about 2 kilodaltons to 20 kilodaltons, about 2 kilodaltons to 50 kilodaltons, about 5 kilodaltons to 6 kilodaltons, about 5 kilodaltons to 10 kilodaltons, about 5 kilodaltons to 15 kilodaltons, about 5 kilodaltons to 20 kilodaltons, about 5 kilodaltons to 50 kilodaltons, about 10 kilodaltons to 15 kilodaltons, about 10 kilodaltons to 20 kilodaltons, or about 10 kilodaltons to 50 kilodaltons. The monomers used to prepare such oligomers may optionally incorporate branching, for example to enhance elasticity, one example being γ -methyl-e-caprolactone and γ -ethyl-e-caprolactone.

In some embodiments, the lactide can comprise L-lactide, D-lactide, or mixtures thereof (e.g., D, L-lactide). For example, in some embodiments with PLA blocks, L-lactide can be used for better regularity and higher crystallinity.

In some embodiments, the oligomer may comprise ABA blocks, BAB blocks, CBC blocks, or BCB blocks in linear and/or branched (e.g., star or three-armed) form.

In some embodiments, a may be: (i) poly (lactide); (ii) poly (glycolide); (iii) a poly (lactide-co-glycolide) comprising a lactide to glycolide (e.g., lactide-rich ratio) in a molar ratio of 90:10 to 55:45, a lactide to glycolide (e.g., glycolide-rich ratio) of 45:55 to 10:90, or a lactide to glycolide of 50: 50; or any combination thereof. In such embodiments, the oligomers may be in linear and/or branched (e.g., star or three-armed) form. In some embodiments, the D, L-lactide mixture may be used to prepare PLGA random copolymers.

In some embodiments, B may be: (i) polycaprolactone; (ii) polytrimethylene carbonate; polytrimethylene carbonate; (iii) a poly (caprolactone-co-lactide) comprising caprolactone to lactide in a molar ratio of 95:5 to 5: 95; or any combination thereof.

In some embodiments, the molecular weight (Mn) of a (PLA, PGA, PLGA, PPF, or any combination thereof) may be about 1 to 4 kilodaltons, about 1 to 6 kilodaltons, about 1 to 10 kilodaltons, about 2 to 4 kilodaltons, about 2 to 6 kilodaltons, or about 2 to 10 kilodaltons; and B (PCL, plcl, PGACL, PTMC, PCLLA, or any combination thereof) may have a molecular weight (Mn) of about 1 kilodalton to 4 kilodalton, about 1 kilodalton to 6 kilodalton, about 1 kilodalton to 10 kilodalton, about 1 kilodalton to 50 kilodalton, about 1.6 kilodalton to 4 kilodalton, about 1.6 kilodalton to 6 kilodalton, about 1.6 kilodalton to 10 kilodalton, or about 1.6 kilodalton to 50 kilodalton.

The resin may also include additional components, such as additional crosslinking agents, non-reactive diluents, photoinitiators, reactive diluents, fillers, or any combination thereof.

In some embodiments, the resin may include additional crosslinking agents. For example, the additional crosslinking agent may be present in an amount of about 1% to 5%, about 1% to 10%, about 2% to 5%, or about 2% to 10% by weight of the resin. Any suitable additional crosslinking agent may be used, including bioabsorbable crosslinking agents, non-absorbable crosslinking agents, or any combination thereof. Non-limiting examples of suitable bioabsorbable crosslinkers include: divinyl adipate (DVA), poly (caprolactone) trimethacrylate (PCLDMA, e.g., at a molecular weight MW of about 950 to 2400 daltons), and the like. Non-limiting examples of suitable non-absorbable crosslinking agents include: trimethylolpropane trimethacrylate (TMPTMA), poly (propylene glycol) dimethacrylate (PPGDMA), poly (ethylene glycol) dimethacrylate (PEGDMA), and the like.

In some embodiments, the resin may include a non-reactive diluent. For example, the non-reactive diluent may be present in an amount of about 1% to 70%, about 1% to 50%, about 5% to 70%, or about 5% to 50% by weight of the resin. Non-limiting examples of non-reactive diluents include: dimethylformamide, dimethylacetamide, N-methylpyrrolidone (NMP), dimethylsulfoxide, cyclic carbonates (e.g., propylene glycol carbonate), diethyl adipate, methyl ether ketone, ethanol, acetone, or any combination thereof.

In some embodiments, the resin may include a photoinitiator. For example, the photoinitiator may be present in an amount of about 0.1% to 4%, about 0.1% to 2%, about 0.2% to 4%, or about 0.2% to 2% by weight of the resin. The photoinitiator included in the resin may be any suitable photoinitiator. Non-limiting examples of suitable photoinitiators include: type I and type II photoinitiators, as well as UV photoinitiators (e.g., acetophenones (e.g., diethoxyacetophenone), phosphine oxides (e.g., diphenyl (2,4, 6-trimethylbenzoyl) phosphine oxide, phenyl bis (2,4, 6-trimethylbenzoyl) phosphine oxide, phosphine oxide (PPO)),

369) and the like. Additional exemplary photoinitiators can be found in U.S. patent No. 9,453,142, which is incorporated herein by reference in its entirety.

In one embodiment, the resin may include: a bioabsorbable polyester oligomer, which can be present in an amount of about 5% to 90%, 5% to 80%, about 10% to 90%, or about 10% to 80% by weight of the resin; a non-reactive diluent, which may be present in an amount of about 1% to 70%, about 1% to 50%, about 5% to 70%, or about 5% to 50% by weight of the resin; and a photoinitiator, which may be present in an amount of about 0.1% to 4%, about 0.1% to 2%, about 0.2% to 4%, or about 0.2% to 2% by weight of the resin.

In some embodiments, the resin may include a reactive diluent (including difunctional and trifunctional reactive diluents). For example, the reactive diluent may be present in an amount of about 1% to 50%, about 1% to 40%, about 5% to 50%, or about 5% to 40% by weight of the resin. Non-limiting examples of reactive diluents include: acrylates, methacrylates, styrene, vinyl amides, vinyl ethers, vinyl esters, polymers containing any one or more of the foregoing, or any combination thereof (e.g., acrylonitrile, styrene, divinylbenzene, vinyltoluene, methyl acrylate, ethyl acrylate, butyl acrylate, methyl (meth) acrylate, isobornyl acrylate (IBOA), isobornyl methacrylate (IBOMA), alkyl ethers of mono, di, or triethylene glycol acrylates or methacrylates, fatty alcohol acrylates or methacrylates such as lauryl (meth) acrylate, and mixtures thereof).

In one embodiment, the resin may include: a bioabsorbable polyester oligomer, which can be present in an amount of about 5% to 90%, about 5% to 80%, about 10% to 90%, or about 10% to 80% by weight of the resin; a non-reactive diluent present in an amount of about 1% to 70%, about 1% to 50%, about 5% to 70%, or about 5% to 50% by weight of the resin; a photoinitiator, which may be present in an amount of about 0.1% to 4%, about 0.1% to 2%, about 0.2% to 4%, or about 0.2% to 2% by weight of the resin; and a reactive diluent, which may be present in an amount of about 1% to 50%, about 1% to 40%, about 5% to 50%, or about 5% to 40% by weight of the resin.

In some embodiments, the resin may include a filler. For example, the filler may be present in an amount of about 1% to 50%, about 1% to 40%, about 2% to 50%, or about 2% to 40% by weight of the resin. Any suitable filler may be used in connection with the present invention including, but not limited to, bioabsorbable polyester particles, sodium chloride particles, calcium triphosphate particles, sugar particles, and the like.

In one embodiment, the resin may include: a bioabsorbable polyester oligomer, which can be present in an amount of about 5% to 90%, about 5% to 80%, about 10% to 90%, or about 10% to 80% by weight of the resin; a non-reactive diluent present in an amount of about 1% to 70%, about 1% to 50%, about 5% to 70%, or about 5% to 50% by weight of the resin; a photoinitiator, which may be present in an amount of about 0.1% to 4%, about 0.1% to 2%, about 0.2% to 4%, or about 0.2% to 2% by weight of the resin; a reactive diluent, which may be present in an amount of about 1% to 50%, about 1% to 40%, about 5% to 50%, or about 5% to 40% by weight of the resin; and a filler, which may be present in an amount of about 1% to 50%, about 1% to 40%, about 2% to 50%, or about 2% to 40% by weight of the resin.

In addition, the resin may have additional components in some embodiments, depending on the particular use of the adjunct. For example, in certain embodiments, the resin may include one or more additional components, which may be present in an amount of about 0.1% to 10% by weight of the resin, about 0.1% to 10% by weight, about 1% to 20% by weight, or about 1% to 10% by weight. Non-limiting examples of suitable additional components include: pigments, dyes, diluents, active or pharmaceutical compounds, detectable compounds (e.g., fluorescent, phosphorescent, radioactive), proteins, peptides, nucleic acids (DNA, RNA) such as siRNA, sugars, and the like, including any combination thereof.

In some embodiments, the resin may include a non-reactive pigment or dye that absorbs light, particularly UV light. Non-limiting examples of suitable non-reactive pigments or dyes include: (i) titanium dioxide (e.g., present in an amount of about 0.05% to 5%, about 0.05% to 1%, about 0.1% to 1%, or about 0.1% to 5% by weight of the resin), (ii) carbon black (e.g., present in an amount of about 0.05% to 5%, about 0.05% to 1%, about 0.1% to 1%, or about 0.1% to 5% by weight of the resin), and/or (iii) an organic ultraviolet absorber such as hydroxybenzophenone, hydroxyphenylbenzotriazole, oxanilide, oxalanilide, thioxanthone, hydroxyphenyltriazine, and/or benzotriazole ultraviolet absorber (e.g., Mayzo BLS1326) (e.g., present in an amount of about 0.001% to 1%, 0.001% to 2%, about 0.001% to 4%, about 0.005% to 1%, about 0.005% to 2%, or about 0.005% to 4% by weight of the resin). Additional exemplary non-reactive pigments or dyes are disclosed in U.S. patent nos. 3,213,058, 6,916,867, 7,157,586, and 7,695,643, each of which is incorporated herein by reference in its entirety.

In some embodiments, the resin may include: (a) a (meth) acrylate terminated bioresorbable polyester oligomer present in an amount of about 5% to 80%, about 5% to 90%, about 10% to 80%, or about 10% to 90% by weight of the resin; (b) a non-reactive diluent present in an amount of about 1% to 50%, about 1% to 70%, about 5% to 50%, or about 5% to 70% by weight of the resin; and (c) a photoinitiator present in an amount of about 0.1% to 2%, about 0.1% to 4%, about 0.2% to 2%, or about 0.2% to 4% by weight of the resin. In such embodiments, the resin may further comprise (d) a reactive diluent present in an amount of about 1% to 40%, about 1% to 50%, about 5% to 40%, or about 5% to 50%, by weight of the resin; (e) a filler present in an amount of about 1% to 40%, about 1% to 50%, about 2% to 40%, or about 2% to 50% by weight of the resin; (f) additional ingredients (e.g., active agents, detectable groups, pigments or dyes, etc.) present in an amount of about 0.1% to 10%, about 0.1% to 20%, about 1% to 10%, or about 1% to 20% by weight of the resin; and/or (g) an additional crosslinker (e.g., trimethylolpropane trimethacrylate (TMPTMA)) present in an amount of about 1% to 5%, about 1% to 10%, about 2% to 5%, or about 2% to 10% by weight of the resin.

In some embodiments, the resin may include:

(a) (meth) acrylate terminated linear or branched bioresorbable polyester oligomer in ABA block, BAB block, CBC block or BCB block, present in an amount of about 5% to 80%, about 5% to 90%, about 10% to 80%, or about 10% to 90% by weight of resin, wherein: a is poly (lactide) (PLA), poly (glycolide) (PGA), poly (lactide-co-glycolide) (PLGA), or any combination thereof, wherein the PLGA contains lactide to glycolide in a molar ratio of 90:10 to 60:40 or 40:60 to 10:90 lactide to glycolide, and the molecular weight (Mn) of A is about 1 kilodaltons to 4 kilodaltons, about 1 kilodaltons to 10 kilodaltons, about 2 kilodaltons to 4 kilodaltons, or about 2 kilodaltons to 10 kilodaltons; b is polycaprolactone (PCL, PTMC, and PCLLA), poly (lactide-co-caprolactone) (placcl), poly (glycolide-co-caprolactone) (PGACL), poly (trimethylene carbonate) (PTMC), and the molecular weight (Mn) of B is about 1 kilodaltons to 4 kilodaltons, about 1 kilodaltons to 10 kilodaltons, about 1.6 kilodaltons to 4 kilodaltons, or about 1.6 kilodaltons to 10 kilodaltons; and C is Polydioxanone (PDO), and the molecular weight (Mn) of C is about 1 kilodaltons to 4 kilodaltons, about 1 kilodaltons to 10 kilodaltons, about 2 kilodaltons to 4 kilodaltons, or about 2 kilodaltons to 10 kilodaltons;

(b) Propylene glycol carbonate present in an amount of about 1% to 50%, about 1% to 70%, about 5% to 50%, or about 5% to 70% by weight of the resin;

(c) a photoinitiator present in an amount of about 0.1% to 2%, about 0.1% to 4%, about 0.2% to 2%, or about 0.2% to 4% by weight of the resin;

(d) optionally a reactive diluent present in an amount of about 1% to 40%, about 1% to 50%, about 5% to 40%, or about 5% to 50% by weight of the resin; and

(e) optionally a filler present in an amount of about 1% to 40%, about 1% to 50%, about 2% to 40%, or about 2% to 50% by weight of the resin.

Manufacturing method

The non-fibrous adjunct described herein can be formed from a matrix comprising at least one molten bioabsorbable polymer, and thus can be formed using any additive manufacturing process. In some embodiments, the additive manufacturing process may be continuous liquid interface generation (CLIP) involving the use of ultraviolet curing liquid plastic resins. Details of the CLIP process are disclosed in the following: for example, U.S. patent nos. 9,211,678, 9,205,601, and 9,216,546; U.S. patent publication nos. 2017/0129169, 2016/0288376, 2015/0360419, 2015/0331402, 2017/0129167, 2018/0243976, 2018/0126630, and 2018/0290374; tumbleston et al, Continuous liquid interface production of 3D Objects, science 347, pp.1349-1352 (2015); janus ziewcz et al, Layerless failure with continuous liquid interface production, Proc. Natl. Acad. Sci. USA 113, page 11703-; each of the above is incorporated by reference herein in its entirety. Non-limiting examples of other additive manufacturing apparatuses and methods that can be used to form the non-fibrous adjunct described herein (and thus form a matrix including at least one molten bioabsorbable polymer) can include bottom-up and top-down additive manufacturing methods (e.g., in U.S. Pat. nos. 5,236,637, 5,391,072, 5,529,473, 7,438,846, 7,892,474, and 8,110,135 and U.S. patent publication nos. 2013/0292862 and 2013/0295212, each of which is incorporated herein by reference in its entirety), as well as melt deposition modeling (e.g., heating a thermoplastic filament and extruding a layer of the molten filament layer by layer), material jetting, 2-photon polymerization, and holographic multi-focus polymerization as understood by those skilled in the art.

In certain embodiments, one or more post-processing steps may be performed after the additive manufacturing process. For example, in some embodiments, one or more post-treatment steps may include washing the adjunct (e.g., in an organic solvent such as acetone, isopropanol, glycol ether such as dipropylene glycol methyl ether or DPM), wiping the adjunct (e.g., with an absorbent material, blowing with a compressed gas or air knife, etc.), centrifuging the residual resin, extracting the residual solvent, additional curing such as by flood exposure with ultraviolet light or the like to, for example, further react the unpolymerized components of the adjunct, drying the adjunct (e.g., under vacuum) to remove the extraction solvent therefrom, or any combination thereof, in accordance with known techniques. One or more post-processing steps can shrink the adjunct and, thus, in some embodiments, the adjunct can be produced in an enlarged form to counteract such shrinkage.

In other embodiments, the non-fibrous adjunct can be partially or fully formed using any suitable non-additive manufacturing process (such as injection molding, foaming, and molding processes as understood by those skilled in the art).

The seaming assembly may be manufactured in various ways. For example, in some embodiments, as discussed above, a non-fibrous adjunct can be releasably attached to a staple cartridge by placing a cartridge-contacting surface of the adjunct against a surface of the cartridge (e.g., a surface facing the anvil, e.g., a top surface or a deck surface) in order to insert at least one attachment feature of the adjunct into at least one surface feature of the cartridge (e.g., a recessed channel) (see, e.g., fig. 19A-26C, 37A-39B, and 41A-41C). Alternatively or additionally, as discussed above, the non-fibrous adjunct can be configured to receive one or more cartridge projections (e.g., staple pocket projections) and/or staple legs (see, e.g., fig. 45A-46B). Additional details regarding surface features and other exemplary surface features may be found in U.S. patent No. 2016/0106427, which is incorporated herein by reference in its entirety. Alternatively or additionally, as discussed above, the non-fibrous adjunct can include an outer layer in the form of an adhesive film for releasably retaining the adjunct on the staple cartridge (see, e.g., fig. 40). Additional details regarding adhesive films and other attachment methods may be found in U.S. patent No. 10,349,939, which is incorporated herein by reference in its entirety.

The adjunct and methods can be further understood with the following non-limiting examples.

Examples

Examples 1 to 3: preparation of difunctional Methacrylate (MA) -terminated polyester oligomers

Examples 1-3 describe the preparation of difunctional methacrylate-terminated polyester oligomers. The midblock is PLGA-PCL-PLGA, the molecular weight is 6 kilodaltons, and PCL represents 40 wt.% of the total Molecular Weight (MW). PLGA is a random copolymer of lactide (L) and glycolide (G) with a L: G weight ratio of 1: 1.

The molar ratio and mass of each reagent used to synthesize a 1kg batch of HO-PLGA-b-PCL-b-PLGA-OH as discussed in example 1 and example 2 is provided in Table 3 below.

Table 3: molar ratio and mass of reagents for example 1 and example 2

Example 1: HO-PCL-OH Synthesis

Round bottom flask was dried in dry box overnight and in N₂Cooled to room temperature under reduced flow. Caprolactone and stannous octoate were added to the round bottom flask via a glass syringe and syringe needle. The reaction flask contents were heated to 130 ℃. At the same time, diethylene glycol was heated to 130 ℃. After preheating, diethylene glycol was added as initiator to the reaction flask and allowed to react until monomer conversion was complete. Using H ¹NMR monitored monomer conversion. Once full monomer conversion was achieved, the reaction was stopped and the reaction contents were cooled to room temperature. HO-PCL-OH was precipitated from chloroform into cold MeOH to obtain a white solid. H¹NMR, DSC, FTIR, and THF GPC were used to characterize HO-PCL-OH.

Example 2: HO-PLGA-b-PCL-b-PLGA-OH synthesis

HO-PCL-OH prepared in example 1 and varying amounts of D, L-lactide and glycolide in N₂Next was added to a round bottom flask and heated to 140 ℃ to melt the reaction contents. After melting, the temperature was reduced to 120 ℃ and stannous octoate was added. The reaction is continued with stirring while simultaneously reacting with H¹NMR and THF GPC monitor monomer conversion. Once the reaction reached the desired molecular weight, the reaction contents were cooled to room temperature, dissolved in chloroform, and precipitated three times in cold ether. The precipitate was dried under vacuum.

Example 3: MA-PLGA-b-PCL-b-PLGA-MA Synthesis

The molar ratio and mass of each reagent used to synthesize a 1kg batch of MA-PLGA-b-PCL-b-PLGA-MA is provided in Table 4 below.

Table 4: molar ratio and mass for each reagent of example 3

In N₂Next, HO-PLGA-b-PCL-b-PLGA-OH prepared in example 2 was dissolved in anhydrous DCM in a round bottom flask. Triethylamine and BHT were added to the reaction flask, and the reaction flask was cooled to 0 ℃ in an ice water bath. The reaction flask was equipped with a pressure equalizing addition funnel containing methacryloyl chloride. Once the reaction flask reached 0 ℃, methacryloyl chloride was added dropwise over 2 hours. The reaction was carried out at 0 ℃ for 12 hours, and then at room temperature for 24 hours. Once the reaction was complete, the reaction contents were washed 2 times with distilled water to remove triethylamine hydrochloride, and saturated Na was used₂CO₃Washed and then dried over magnesium sulfate. The collected and dried DCM layer was dried by rotary evaporation. Using THF GPC, H¹NMR, FTIR and DSC to characterize the final product.

Examples 4 to 6: preparation of three-arm MA-terminated polyester oligomer

Examples 4-6 describe the preparation of three-armed or star shaped bioabsorbable polyester oligomers. Each arm is terminated with methacrylate. Each arm has a molecular weight of 2 kilodaltons and is a block copolymer of random poly (lactide-co-glycolide) (PLGA) segments and poly (caprolactone) (PCL) segments, where PCL is the core of the oligomer. PCL represents 40 wt.% of the total Molecular Weight (MW). The PLGA is a random copolymer of lactide (L) and glycolide (G) in a L: G weight ratio of 1: 1.

Example 4: synthesis of PCL-3oh

The molar ratio and mass of each reagent used to synthesize a 1kg batch of (PLGA-b-PCL) -3OH as discussed in example 4 and example 5 are provided in Table 5 below.

Table 5: examples of molar ratios and masses for each of the reagents of examples 4 and 5

Round bottom flask was dried in dry box overnight and in N₂Cooled to room temperature under reduced flow. Caprolactone and stannous octoate were added to the round bottom flask via a glass syringe and syringe needle. The reaction flask contents were heated to 130 ℃. At the same time, willTrimethylolpropane (TMP) was heated to 130 ℃. After preheating, TMP was added as initiator to the reaction flask and allowed to react until monomer conversion was complete. Using H¹NMR monitored monomer conversion. Once full monomer conversion was achieved, the reaction was stopped and the reaction contents were cooled to room temperature. (PCL) -3OH was precipitated from chloroform into cold MeOH to afford a white solid. H1 NMR, DSC, FTIR, and GPC were used to characterize (PCL) -3 OH.

Example 5: (PCL-b-PLGA) -3OH Synthesis

(PCL) -3OH prepared in example 4 and varying amounts of D, L-lactide and glycolide in N₂Next was added to a round bottom flask and heated to 140 ℃ to melt the reaction contents. After melting, the temperature was reduced to 120 ℃ and stannous octoate was added. The reaction is continued with stirring while simultaneously reacting with H ¹NMR and THF GPC monitor monomer conversion. Once the reaction reached the desired molecular weight, the reaction contents were cooled to room temperature, dissolved in chloroform, and precipitated three times in cold ether. The precipitate was dried under vacuum.

Example 6: (PCL-b-PLGA) -3MA Synthesis

The molar ratio and mass of each reagent used to synthesize the 1kg batches of (PLGA-b-PCL) -3MA are provided in Table 6 below.

Table 6: molar ratio and mass for each reagent of example 6

In N₂Next, (PCL-b-PLGA) -3OH prepared in example 5 was dissolved in anhydrous DCM in a round bottom flask. Triethylamine (TEA) and BHT were added to the reaction flask, and the reaction flask was cooled to 0 ℃ in an ice-water bath. The reaction flask was equipped with a pressure equalizing addition funnel containing methacryloyl chloride. Once the reaction flask reached 0 ℃, methacryloyl chloride was added dropwise over 2 hours. The reaction was carried out at 0 ℃ for 12 hours, and then at room temperature for 24 hours. After the reaction is finished, the reaction is carried outThe precipitate was removed by vacuum filtration. The filtrate was collected and DCM was removed by rotary evaporation. The resulting viscous oil was dissolved in THF and precipitated into cold methanol. The precipitate was dissolved in DCM and washed with aqueous HCl (3%, 2 times), saturated aqueous sodium bicarbonate and saturated aqueous sodium chloride, then dried over magnesium sulfate. The magnesium sulfate was filtered by vacuum filtration and the filtrate was collected. DCM was removed by rotary evaporation and the solid product was collected and purified by GPC, H ¹NMR, FTIR and DSC to characterize the solid product.

Example 7: bifunctional oligomer resin formulations

The following components were mixed together in the following weight percentages (wt% of resin) to provide an exemplary resin for additive manufacturing:

(1) 66.2% of the difunctional oligomer as prepared in examples 1 to 3 above;

(2) 3.5% trimethylolpropane trimethacrylate (TMPTMA) reactive diluent;

(3) 28.4% of an N-methylpyrrolidone (NMP) non-reactive diluent; and

(4) 1.89% of

819 photoinitiator.

Example 8: three-arm oligomer resin formulation

The following components were mixed together in the following weight percentages (wt% of resin) to provide an exemplary resin for additive manufacturing:

(1) 68.6% of a three-arm oligomer as prepared in examples 4 to 6 above;

(2) 29.4% of an N-methylpyrrolidone (NMP) non-reactive diluent; and

(3) 1.96% of

819 photoinitiator.

Example 9: additive manufacturing and post-processing

Five exemplary adjuncts were prepared. The first exemplary adjunct (adjunct 1) is similar in structure to the adjunct 800 in fig. 8A-8F, except that the first adjunct is formed of two longitudinal rows of 20 cells. Four other exemplary appendages are similar in structure to appendage 3100 (appendage 2) as shown in fig. 31A-31D, appendage 3200 (appendage 3) as shown in fig. 32A-32D, appendage 3300 (appendage 4) as shown in fig. 33A-33E, and appendage 3400 (appendage 5) as shown in fig. 34A-34E, respectively. Five appendages were prepared according to standard techniques by additive manufacturing on Carbon inc. M1 or M2 devices available from Carbon company (zip code: 94063) of 1089Mills Way, Redwood City, California. The resin formulation for each adjunct is provided in table 7 below.

Table 7: exemplary adjunct resin formulations

When the resin comprises a non-reactive diluent, the object may undergo global shrinkage at the level of the non-reactive diluent loading upon washing/extraction. Accordingly, a size scaling factor is applied to the part stereolithography (. stl) file or the 3D fabrication format (3MF) file to enlarge the printing appendages and intentionally account for subsequent shrinkage during post-processing steps.

Post-treatment of each adjunct was performed as follows: after removing the build platform from the apparatus, excess resin was wiped from the flat surface around the appendages, and the platform was left to drain on its sides for about 10 minutes. The appendage is carefully removed from the platform. The adjunct was washed 3 times in acetone, each time on an orbital shaker at 280rpm for 30 seconds, followed by drying for 5 minutes between washes. After the third wash, the adjunct was allowed to dry for 30 minutes and then washed in PrimeCure^TMEach side of the uv flood cure apparatus was flood cured for 20 seconds.

Next, the residual non-reactive diluent (e.g., N-methylpyrrolidone or propylene carbonate) was extracted from the adjunct by immersing the adjunct in acetone and shaking on an orbital shaker at room temperature for about 18 hours, with the solvent being replaced once after 12 hours. The adjunct was then removed from the acetone and dried under vacuum at 60 ℃ overnight. The satellites were then checked for residual solvent using extraction for GCMS and FTIR. If no residual solvent is detected, the part is checked for tackiness. If the attachment remains tacky, a flood cure is carried out under nitrogen in an LED-based flood lamp (such as the PCU LED N2 flood lamp available from Dreve Group of Unna, Germany).

Example 10: stress-strain analysis of representative samples

The stress-strain curves for appendage 1 of example 9 are shown in fig. 56, and the stress-strain curves for appendages 2 through 5 of example 9 are shown in fig. 57.

The stress-strain curves shown in fig. 56 and 57 are generated by: the appendages were placed between a pair of 25 mm diameter circular stainless steel compression plates (available from TA Instruments, 159Lukens Drive, New Castle, Delaware 19720 USA) of an RSA-G2 solid analyser, the compression plates were lowered at a rate of 0.1mm per step until the initial axial force reached between 0.03N and 0.05N, equilibrated at a temperature of 37 ℃ for 120 seconds, and compression tested (lowering the compression plates at 10mm/min for 14 seconds until a gap height of 0.7mm or an overload force of about 17N was reached, whichever occurred first, while recording the real time compressive stress) to produce a stress-strain curve for each appendage. Thus, the stress-strain curve is generated by compressing each appendage from its respective uncompressed height of 3mm (within manufacturing tolerances) to its respective compressed height. The compressive height and strain of each appendage under applied stress for the appendage are provided in table 8 below. These measurements are based on actual manufactured appendages (including any measurement errors of the measurement system, e.g., a 50 μm to uncompressed height deviation and/or manufacturing tolerances, e.g., a 100 μm to uncompressed height deviation).

TABLE 8 needlesCompressive height and strain measurements for appendages 1 through 5

	Measurement conditions	Height of compression (mm)	Strain of
				Accessories 1	Applied stress of 90kPa	0.81	73
Accessories 2	Applied stress of 30kPa	1.53	49
				Accessories 3	An applied stress of 9.43kPa	1.2	60
Accessories 4	Applied stress of 30kPa	1.5	50
				Accessories 5	Applied stress of 30kPa	1.35	55

As shown in fig. 56, an appendage formed from stay-free based cells, such as appendage 800 in fig. 8A-8F, illustrates: (i) a sufficiently stable cell structure such that even with wall thicknesses of about 0.2 mm, the structure can be successfully printed and post-processed as described above; (ii) the appendage undergoes extensive buckling deformation and achieves a stress plateau between about 0.1 strain (about 10% deformation) to about 0.73 strain (73% deformation); and (iii) the adjunct has a bi-stable nature, so the cell structure can deform and achieve a new stable form that does not change until additional force is applied, potentially providing the surgeon with tactile feedback of the deformed state of the adjunct.

As shown in fig. 57, appendages formed from strut-based cells, such as appendage 3100 in fig. 31A-31D, appendage 3200 in fig. 32A-32D, appendage 3300 in fig. 33A-33E, and appendage 34A-34E, exhibit a stress "plateau" in 5kPa to 20kPa at 10% to 60% strain. The result is based at least in part on the structural configuration of the cell. In particular, each cell is designed such that the spacing struts (e.g., struts of the internal structure) fold inward without contacting each other during compression of the adjunct. As a result, densification of the adjunct (e.g., to a solid height) can be delayed (e.g., occurs at higher strains).

Example 11: stress-strain analysis of representative samples

Six exemplary adjuncts, referred to herein as sample 1, sample 2, sample 3, sample 4, sample 5, and sample 6, respectively, were prepared in a similar manner as described in example 9, except that the resin formulation for each of samples 1 to 6 was: trifunctional oligomer (methacrylate end groups) with PCL midblock and PLGA end blocks (85: 15L: G weight ratio); the target molecular weight was 6,000 daltons. Sample 1 was formed from a unit cell of repeating interconnected Schwarz-P structures, and samples 2 to 5 were formed from corresponding repeating interconnected modified Schwarz-P structures, with the top and/or bottom of the original Schwarz-P structure being trimmed. Thus, the geometric characteristics of the repeating unit cell are different for each sample. A list of geometric cell characteristics based on ideal/expected dimensions for each appendage is provided in table 9 below.

TABLE 9 exemplary cell geometry

Using the cell 810 in fig. 9A-9B as a reference, the height extends in the x-direction, the width extends in the y-direction, and the length extends in the z-direction.

Total height reflects the uncompressed (no clipping) cell height of sample 1 and the uncompressed but clipped height of samples 2-6.

Stress-strain curves for samples 1 to 6 were generated in a similar manner as set forth in example 10, and these curves are shown in fig. 58. As shown, each sample has a different stress-strain curve, although each cell is formed of the same resin. Thus, these different stress-strain curves illustrate the relationship between the geometric characteristics of the cells (e.g., height, width, length, and wall thickness) and the stress-strain response of the resulting appendage when compressed from a corresponding uncompressed height (listed as the overall height in table 9 above) to a corresponding compressed height. Thus, in addition to the compositional composition of the cells, various geometric characteristics thereof need to be considered, and thus the geometric features tailored, to achieve an adjunct having a desired stress-strain response (such as the stress-strain response described herein). The compressive height and strain of each sample under an applied stress of 90kPa is provided in table 10 below. These measurements are based on actual manufactured appendages (including any measurement errors of the measurement system, e.g., a 50 μm to uncompressed height deviation and/or manufacturing tolerances, e.g., a 100 μm to uncompressed height deviation).

TABLE 10 compressive height and Strain measurements of samples 1 through 6 at 90kPa

Examples 12 to 14: preparation of three-arm MA-terminated polyester oligomer

Examples 12-14 describe the preparation of three-armed or star shaped bioabsorbable polyester oligomers. Each arm is terminated with methacrylate. The molecular weight of each arm is 2 kilodaltons and is a block copolymer of poly (L-lactic acid) (PLLA) and poly (caprolactone-r-L-lactic acid) (PCLA), where PCLA is the core of the oligomer. PCLLA accounted for 70 w.t% of the total Molecular Weight (MW) and the CL: L ratio was 60: 40.

The molar ratio and mass of each reagent used to synthesize a 1kg batch of (PLLA-b-PCLLA) -3OH as discussed in example 12 and example 13 is provided in Table 11 below.

Table 11: examples of molar ratios and masses for each of the reagents of examples 12 and 13

Example 12: PCLA-3 OH Synthesis

Round bottom flask was dried in dry box overnight and in N₂Cooled to room temperature under reduced flow. Caprolactone, L-lactide and stannous octoate were added to the round bottom flask. The reaction flask contents were heated to 130 ℃. At the same time, Trimethylolpropane (TMP) was heated to 130 ℃. After preheating, TMP was added as initiator to the reaction flask and allowed to react until monomer conversion was complete. Using H ¹NMR monitored monomer conversion. Once full monomer conversion was achieved, the reaction was stopped and the reaction contents were cooled to room temperature. (PCLLA) -3OH was precipitated from chloroform into cold MeOH to obtain a white colorAnd (3) a solid. H¹NMR, DSC, FTIR, and THF GPC were used to characterize (PCLLA) -3 OH.

Example 13: (PLLA-b-PCLLA) -3OH Synthesis

(PCLLA) -3OH and L-lactide, prepared in example 12, were reacted in N₂Next was added to a round bottom flask and heated to 140 ℃ to melt the reaction contents. After melting, the temperature was reduced to 120 ℃ and stannous octoate was added. The reaction is continued with stirring while simultaneously reacting with H¹NMR and THF GPC monitor monomer conversion. Once the reaction reached the desired molecular weight, the reaction contents were cooled to room temperature, dissolved in chloroform, and precipitated three times in cold ether. The precipitate was dried under vacuum.

Example 14: (PLLA-b-PCLLA) -3MA Synthesis

The molar ratio and mass of each reagent used to synthesize a 1kg batch of (PLLA-b-PCLLA) -3MA is provided in Table 12 below.

Table 12: molar ratio and mass for each reagent of example 14

In N₂Next, (PLLA-b-PCLLA) -3OH prepared in example 13 was dissolved in anhydrous DCM in a round-bottomed flask. Triethylamine (TEA) and 400ppm BHT were added to the reaction flask, and the reaction flask was cooled to 0 ℃ in an ice-water bath. The reaction flask was equipped with a pressure equalizing addition funnel containing methacryloyl chloride. Once the reaction flask reached 0 ℃, methacryloyl chloride was added dropwise over 2 hours. The reaction was carried out at 0 ℃ for 12 hours, and then at room temperature for 24 hours. After completion of the reaction, the precipitate was removed by vacuum filtration. The filtrate was collected and DCM was removed by rotary evaporation. The resulting viscous oil was dissolved in THF and precipitated into cold methanol. The precipitate was dissolved in DCM and washed with aqueous HCL (3%, 2 times), saturated aqueous sodium bicarbonate and saturated aqueous sodium chloride, then dried over magnesium sulfate. Filtration of magnesium sulfate by vacuum filtration And collecting the filtrate. DCM was removed by rotary evaporation and the solid product was collected and washed with THF GPC, H¹NMR, FTIR and DSC to characterize the solid product.

Example 15: bifunctional oligomer resin formulations

The following components were mixed together in the following weight percentages (wt% of resin) to provide an exemplary photopolymerizable resin for additive manufacturing:

(1) 58.82% of the difunctional oligomer as prepared in examples 12 to 13 above;

(2) 39.22% Propylene Carbonate (PC) non-reactive diluent; and

(3) 1.96% of

819 photoinitiator.

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

Moreover, in the present disclosure, similarly named components in various embodiments typically have similar features, and thus, in particular embodiments, each feature of each similarly named component is not necessarily fully described. Further, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that may be used in connection with such systems, devices, and methods. Those skilled in the art will recognize that the equivalent dimensions of such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and devices and their components may depend at least on the anatomy of the subject in which the systems and devices are to be used, the size and shape of the components with which the systems and devices are to be used, and the methods and procedures in which the systems and devices are to be used.

It should be understood that the terms "proximal" and "distal" are used herein with respect to a user, such as a clinician, grasping a handle of an instrument. Other spatial terms such as "anterior" and "posterior" similarly correspond to distal and proximal, respectively. It will also be appreciated that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein in connection with the illustrations. However, surgical instruments are used in many orientations and positions, and these spatial terms are not intended to be limiting and absolute.

Values or ranges can be expressed herein as "about" and/or from "about" one particular value to another particular value. When such values or ranges are expressed, other embodiments disclosed include the particular values recited and/or from one particular value to another particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the various values disclosed herein and the particular value forms another embodiment. It will also be understood that numerous values are disclosed herein, and that each value is also disclosed herein as "about" that particular value in addition to the value itself. In embodiments, "about" can be used to indicate, for example, within 10% of the recited value, within 5% of the recited value, or within 2% of the recited value.

For the purposes of describing and defining the present teachings it is noted that the term "substantially" is utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation, unless otherwise specified. The term "substantially" may also be used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

Those skilled in the art will recognize additional features and advantages of the present invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication, or information, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth herein. As such, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference.

Claims (19)

1. A stapling assembly for use with a surgical stapler, comprising:

a cartridge having a plurality of staples disposed therein, the plurality of staples configured to be deployed into tissue; and

a non-fibrous adjunct formed of at least one melted bioabsorbable polymer and configured to be releasably retained on the cartridge such that the adjunct can be attached to tissue by the plurality of staples in the cartridge, the adjunct having a first end, a second end, and a longitudinal axis extending between the first end and the second end, wherein the adjunct comprises at least two distinct compression zones, each compression zone defined by a distinct lattice structure of repeating geometric units of interconnected struts, and wherein each lattice structure has a distinct compressive strength such that the adjunct has a variable compressive strength in a transverse direction relative to its longitudinal axis.

2. The suturing assembly according to claim 1, wherein said at least two distinct compression zones comprise a first compression zone having a first compressive strength and a second compression zone having a second compressive strength, said second compressive strength being less than said first compressive strength.

3. The stapling assembly of claim 2, wherein said cartridge comprises a slot extending into and along at least a portion of said cartridge and configured to receive a cutting element, and wherein said second compression zone is configured to at least partially overlap said slot when said adjunct is attached to said cartridge.

4. The suturing assembly according to claim 2, wherein at least a portion of said first compression zone is positioned around a perimeter of said adjunct.

5. The suturing assembly according to claim 2, wherein said at least two distinct compression zones comprises a third compression zone having a third compression strength, said third compression strength being less than said second compression strength.

6. The suturing assembly according to claim 5, wherein at least a portion of said third compression zone is positioned around a perimeter of said adjunct.

7. The stapling assembly of claim 5, wherein said cartridge comprises a slot extending into and along at least a portion of said cartridge and configured to receive a cutting element, and wherein said third compression zone is configured to be at least partially aligned with said slot when said adjunct is attached to said cartridge.

8. The stapling assembly of claim 1, wherein the adjunct has a tissue contacting surface and a cartridge contacting surface opposite the tissue contacting surface, the cartridge contacting surface having a plurality of attachment features extending outwardly from the cartridge contacting surface and configured to extend into recesses defined within the cartridge.

9. The stapling assembly of claim 8, wherein the plurality of attachment features are arranged in a repeating pattern across the cartridge contacting surface, the repeating pattern configured to substantially overlap with a repeating pattern of the depressions defined within the cartridge.

10. A stapling assembly for use with a surgical stapler, comprising:

a cartridge having a plurality of staples disposed therein, the plurality of staples configured to be deployed into tissue; and

A non-fibrous adjunct formed of at least one melted bioabsorbable polymer and configured to be releasably retained on the cartridge such that the adjunct can be attached to tissue by the plurality of staples in the cartridge, the adjunct comprising:

a first compression zone having a first compression strength, the first compression zone defined by a first lattice structure formed of a first plurality of repeating unit cells, and

a second compression zone having a second compressive strength different from the first compressive strength, the second compression zone defined by a second lattice structure formed of a second plurality of repeating cells different from the first repeating cells;

wherein the first and second compression zones are positioned adjacent to one another relative to a longitudinal axis of the adjunct and are laterally offset from one another.

11. The suturing assembly according to claim 10, wherein said first repeating unit cell is a first ternary periodic minimal surface structure, and wherein said second plurality of repeating unit cells is a second ternary periodic minimal surface structure.

12. The suturing assembly according to claim 11, wherein the first ternary periodic minimal surface structures vary in at least one of height and wall thickness as compared to the height and wall thickness of the second ternary periodic minimal surface structures.

13. The suturing assembly according to claim 10, wherein said adjunct includes a third compression zone having a third compressive strength different from said first compressive strength and said second compressive strength, said third compression zone defined by a third lattice structure formed of a plurality of third repeating cells, and wherein said third compression zone is laterally offset from said first compression zone and said second compression zone.

14. The suturing assembly according to claim 13, wherein said first repeating unit cell is a first triply periodic minimal surface structure, said second plurality of repeating unit cells is a second triply periodic minimal surface structure, and said third plurality of repeating unit cells is a third triply periodic minimal surface structure.

15. The suturing assembly of claim 14, wherein the first, second, and third ternary periodic minimal surface structures vary in at least one of height and wall thickness relative to one another.

16. The suturing assembly according to claim 14, wherein the first, second and third triply periodic minimal surface structures are Schwarz-P structures.

17. The suturing assembly according to claim 13, wherein said first compression zone is an innermost compression zone of said adjunct and said third compression zone is an outermost compression zone of said adjunct.

18. The suturing assembly according to claim 17, wherein said third compressive strength is less than said first and second compressive strengths.

19. The stapling assembly of claim 18, wherein said cartridge comprises a slot extending into and along at least a portion of said cartridge and configured to receive a cutting element, and wherein said first compression zone is a proximal-most compression zone relative to said slot.

Images