JP2022548129A - Compressible non-fibrous backing material - Google Patents

Abstract

A stapling assembly is provided for use with a surgical stapler. In one exemplary embodiment, a stapling assembly is formed of a cartridge having a plurality of staples disposed therein and at least one fused bioabsorbable polymer and is releasably retained in the cartridge. and a non-fibrous auxiliary material configured to: A support material system for use with a surgical stapler is also provided. A surgical end effector using the stapling assembly is also provided. A method for manufacturing a stapling assembly and a method for using same are also provided.

Description

(Cross reference to related applications)
This application is based on U.S. Provisional Patent Application No. 62/900,708, filed Sep. 16, 2019, entitled "Bioabsorbable Resin for Additive Manufacturing," entitled "Bioabsorbable Resin for Additive Manufacturing," U.S. Provisional Application No. 62/913,227, filed October 10, 2019, and U.S. Provisional Application No. 63, filed July 20, 2020, entitled "Compressible 3D Printed Scaffolds." No./053,863, the disclosures of which are incorporated herein by reference in their entirety.

(Field of Invention)
A compressible non-fibrous auxiliary material and methods of making and using same are provided.

Surgical staplers are used in surgical procedures to close openings in tissue, vessels, ducts, shunts, or other objects or body parts associated with a particular procedure. The opening may be naturally occurring, such as a passageway within a blood vessel or within an internal organ such as the stomach, or by forming a bypass or anastomosis with a tissue or vascular puncture, or during a tissue stapling procedure. It may be formed by a surgeon during a surgical procedure, such as through an incision.

Some surgical staplers require the surgeon to select the proper staples with the proper staple height for the tissue being stapled. For example, a surgeon may select tall staples for use with thick tissue and short staples for use with thin tissue. However, in some situations, the tissue being stapled does not have a consistent thickness and thus the staples fail to achieve the desired firing configuration at each staple site. As a result, not all stapled sites can form the desired seal at or near them, thereby preventing blood, air, gastrointestinal fluids and other fluids from being sealed. Exudation through the site can occur.

Further, staples such as recessed channels, like other objects and materials that may be implanted with procedures such as stapling, generally lack some 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 thus cannot withstand fluctuations in intra-tissue pressure at the implantation site. This can lead to undesired tissue tearing and even leakage at or near the site of the staple.

Accordingly, there remains a need for improved instruments and methods that address current problems with surgical staplers.

A stapling assembly is provided for use with a surgical stapler. In one exemplary embodiment, the stapling assembly extends from the first lateral end to the second lateral end and extends between the first lateral end and the second lateral end. A cartridge having a longitudinal axis extending therebetween, the cartridge having a plurality of staples disposed therein, the plurality of staples having a first lateral end and a second lateral end. with each longitudinal row having a frequency of staples, the staples arranged along the longitudinal axis and configured to be deployed in tissue and a cartridge formed of at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge so that it can be attached to tissue by staples within the cartridge. a fibrous auxiliary material, the auxiliary material comprising a lattice structure having a plurality of unit cells, each unit cell having a non-uniform thickness, and a plurality of repeating unit cells arranged in longitudinal rows. , and each longitudinal row has a certain frequency of unit cells. The unit cell frequency is different than the staple frequency, and the staple legs of the plurality of staples are configured to advance through different portions of the backing material, each portion having a relative thickness difference. .

Staples can have a variety of configurations. For example, in some embodiments, the frequency of staples may be greater than the frequency of unit cells in each corresponding longitudinal row. In other embodiments, each staple of the plurality of staples can include a first staple leg configured to advance through a first portion of a backing material having a first thickness. , the second staple leg may be configured to advance through a second portion of the backing material having a second thickness greater than the first thickness. In some embodiments, each staple of the plurality of staples can include a first staple leg configured to advance through a first portion of a backing material having a first thickness. Can and the second staple leg can be configured to advance through a second portion of the backing material having a second thickness that is less than the first thickness. In certain embodiments, at least a portion of the staples of the plurality of staples can include uniform staple legs. In other embodiments, at least a portion of the staples of the plurality of staples may include uneven staple legs.

A plurality of repeating unit cells can have various configurations. For example, in some embodiments, a plurality of repeating unit cells can include triple periodic minimal surface structures. In other embodiments, a plurality of repeating unit cells may include Schwartz P structures.

In some embodiments, the support material may be configured to undergo strains in the range of 0.1-0.9 while under applied stresses in the range of 30 kPa-90 kPa. In other embodiments, the strain may range from 0.1 to 0.7.

In another exemplary embodiment, the stapling assembly is a cartridge having a first longitudinal row of first staples disposed therein, the first staples being deployed into tissue. a cartridge formed of at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge such that it is attached to tissue by staples within the cartridge; a non-fibrous backing material comprising: a backing material comprising a lattice structure having a first longitudinal row of first repeating unit cells, each unit cell having a non-uniform thickness, so that the first staple leg and the second staple leg of the first staple pass through different portions of the assist material having different relative thicknesses when the first staple is deployed in tissue; move forward.

Staples can have a variety of configurations. For example, in some embodiments, the cartridge may include an amount of first staples that is greater than the amount of first repeating unit cells of the supplemental material. In other embodiments, the first staples and the first repeat unit cells may be arranged with the same frequency, such that the first leg of each first staple is a supplemental material having a first thickness. and the second leg of each first staple is aligned with a portion of the backing material having a second thickness less than the first thickness. In certain embodiments, the first leg can have a first height and the second leg can have a second height different from the first height. In other embodiments, each first staple can have a base crown extending between the first staple leg and the second staple leg, and the base crown can be non-planar. .

A plurality of repeating unit cells can have various configurations. For example, in some embodiments, a plurality of repeating unit cells can include triple periodic minimal surface structures. In other embodiments, a plurality of repeating unit cells may include Schwartz P structures.

In some embodiments, the support material may be configured to undergo strains in the range of 0.1-0.9 while under applied stresses in the range of 30 kPa-90 kPa. In other embodiments, the strain may range from 0.1 to 0.7.

The invention will be more fully understood from the following detailed description read in conjunction with the accompanying drawings.
1 is a perspective view of an exemplary embodiment of a conventional surgical stapling and severing instrument; FIG. 2 is a top view of a staple cartridge for use with the surgical stapling and severing instrument of FIG. 1; FIG. 2B is a side view of the staple cartridge of FIG. 2A; FIG. 2B is a partial perspective view of the tissue contacting surface of the staple cartridge of FIG. 2A; FIG. 5 is a side view of staples in an unfired (pre-deployment) configuration that may be disposed within the staple cartridge of the surgical cartridge assembly of FIG. 4; FIG. 2 is a perspective view of the knife and firing bar (“E-beam”) of the surgical stapling and severing instrument of FIG. 1; FIG. 2 is a perspective view of the wedge threads of the staple cartridge of the surgical stapling and severing instrument of FIG. 1; FIG. FIG. 18 is a longitudinal cross-sectional view of an exemplary embodiment of a surgical cartridge assembly having a compressible non-fibrous auxiliary material attached to the top or deck surface of the staple cartridge; 6B is a longitudinal cross-sectional view of a surgical end effector having an anvil pivotally coupled to an elongated staple channel and the surgical cartridge assembly of FIG. 6A positioned within and coupled to the elongated staple channel; FIG. , shows the anvil in the closed position without any tissue between the anvil and the support. 6B is a partial schematic showing the adjunct of FIGS. 6A-6B in a tissue deployed state; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; Figure 8B is a side view of the support material of Figure 8A; Figure 8B is a top view of the support material of Figure 8A; Figure 8D is a cross-sectional view of the support of Figure 8C along line 8D-8D; Figure 8E is a cross-sectional view of the support of Figure 8C along line 8E-8E; Figure 8F is an enlarged view of a portion of the support of Figure 8C taken at 8F; 8B is a partial schematic showing the adjunct of FIG. 8A in a tissue-deployed state; 8B is a side view of a single unit cell of the support of FIG. 8A; FIG. 9B is a perspective view of the single unit cell of FIG. 9A; FIG. 1 is a schematic diagram of an exemplary unit cell in a pre-compressed state; FIG. 10B is a schematic diagram of the unit cell of FIG. 10A in a first compressed state; FIG. 10B is a schematic diagram of the unit cell of FIG. 10A in a second compressed state; FIG. 10B is a schematic diagram of the unit cell of FIG. 10A in a densified state; FIG. 10A-10D is a schematic representation of the relationship between the condition of the unit cells of FIGS. 10A-10D and the stress-strain curve of the resulting compressible non-fibrous backing material; FIG. FIG. 10A is a top view of an exemplary embodiment of a compressible non-fibrous backing material formed from repeating unit cells of an embodiment of a modified Schwartz P structure. FIG. 10A is a top view of an exemplary embodiment of a compressible non-fibrous backing material formed from repeating unit cells of another embodiment of a modified Schwartz P structure. FIG. 10A is a top view of an exemplary embodiment of a compressible non-fibrous backing material formed from repeating unit cells of another embodiment of a modified Schwartz P structure. FIG. 10A is a top view of an exemplary embodiment of a compressible non-fibrous backing material formed from repeating unit cells of another embodiment of a modified Schwartz P structure. FIG. 10 is a perspective view of another exemplary embodiment of a single unit cell; 13B is a top down view of an exemplary embodiment of a compressible non-fibrous backing material formed from the repeating unit cells of FIG. 13A; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a single unit cell; 14B is a top down view of an exemplary embodiment of a compressible non-fibrous backing material formed from the repeating unit cells of FIG. 14A; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a single unit cell; 15B is a top down view of an exemplary embodiment of a compressible non-fibrous backing material formed from the repeating unit cells of FIG. 15A; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a single unit cell; 16B is a top down view of an exemplary embodiment of a compressible non-fibrous backing material formed from the repeating unit cells of FIG. 16A; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; Figure 17B is a cross-sectional view of the support of Figure 17A along line 17B-17B; Figure 17C is a cross-sectional view of the support of Figure 17A along line 17C-17C; FIG. 12 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material disposed in a staple cartridge; FIG. 11 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material having channel attachments; Figure 19B is a cross-sectional view of the support of Figure 19A along line 19B-19B; FIG. 11 is a partial perspective view of another exemplary embodiment of a compressible non-fibrous backing having channel attachments; FIG. 11 is a partial perspective view of another exemplary embodiment of a compressible non-fibrous backing having channel attachments; FIG. 14 is a partially exploded perspective view of an exemplary embodiment of a stapling assembly having compressible non-fibrous backing releasably retained on a staple cartridge, each having corresponding edge attachment features; 22B is an enlarged cross-sectional view of a portion of the stapling assembly along line 22B-22B showing the two edge attachment mechanisms prior to engagement; FIG. FIG. 22B is a cross-sectional view of a portion of the stapling assembly of FIG. 22B showing two edge attachment mechanisms engaged; FIG. 12 is a perspective view of another exemplary embodiment of a stapling assembly having compressible non-fibrous backing releasably retained on a staple cartridge, each having corresponding edge attachment features, engaged; Has rim mounting features. 23C is an enlarged view of a portion of the stapling assembly of FIG. 23B; FIG. FIG. 120 is a perspective view of another exemplary embodiment of a staple cartridge having end mounting features; FIG. 120 is a perspective view of another exemplary embodiment of a staple cartridge having end mounting features; FIG. 12 is an exploded view of another exemplary embodiment of a stapling assembly having a staple cartridge and a compressible non-fibrous backing material with attachment features releasably retained on the cartridge; 26B is a cross-sectional view of the stapling assembly of FIG. 26A along line 26B-26B; FIG. 26C is a cross-sectional view of the stapling assembly of FIG. 26A along line 26C-26C; FIG. FIG. 12 is a partial cross-sectional view of another exemplary embodiment of a stapling assembly having a compressible non-fibrous backing material releasably retained on a staple cartridge; FIG. 12 is a partial cross-sectional view of another exemplary embodiment of a stapling assembly having a compressible non-fibrous backing material releasably retained on a staple cartridge; 28B is a partial schematic showing the adjunct of FIG. 28A in a tissue deployed state; FIG. FIG. 12 is a partial cross-sectional view of another exemplary embodiment of a stapling assembly having a compressible non-fibrous backing material releasably retained on a staple cartridge; FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; 30B is a front plan view of the support material of FIG. 30A; FIG. 1 is a perspective view of one embodiment of a compressible non-fibrous auxiliary material; FIG. 31B is a perspective view of a single unit cell of the support of FIG. 31A; FIG. 31B is a side view of the single unit cell of FIG. 31B; FIG. Figures 31B-31C are alternative side views of the unit cell of Figures 31B-31C; FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; 32B is a perspective view of a single unit cell of the support of FIG. 32A; FIG. Figure 32B is a side view of the unit cell of Figure 32B; 32D is a cross-sectional top view of the unit cell of FIGS. 32B-32C along line 32D-32D of FIG. 32C; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; 33B is a perspective view of a single unit cell of the support of FIG. 33A; FIG. Figure 33B is a side view of the unit cell of Figure 33B; 33D is a cross-sectional top view of the unit cell of FIGS. 33B-33C along line 33D-33D of FIG. 33C; FIG. Figures 33B-33C are alternative side views of the unit cell; FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; 34B is a perspective view of a single unit cell of the support of FIG. 34A; FIG. Figure 34B is a side view of the unit cell of Figure 34B; 34C is a top view of the unit cell of FIGS. 34B-34C; FIG. Figures 34B-34C are alternative side views of the unit cell of Figures 34B-34C; FIG. 10 is a perspective view of another exemplary embodiment of a unit cell; FIG. 10 is a perspective view of another exemplary embodiment of a unit cell; FIG. 12 is a partially exploded perspective view of another exemplary embodiment of a stapling assembly having a staple cartridge and a compressible non-fibrous backing material; 37B is a cross-sectional view of a portion of the stapling assembly along line 37B-37B of FIG. 37A; FIG. FIG. 37C is a schematic view of a portion of the stapling assembly of FIG. 37B showing tissue disposed on a backing material; 37B is a partial schematic showing the adjunct of FIG. 37A in a tissue deployed state; FIG. 1 is an exploded view of an exemplary embodiment stapling assembly having a staple cartridge and backing material, showing only a second outer layer of backing material; FIG. 39B is a front view of the stapling assembly of FIG. 39A; FIG. FIG. 12 is a perspective view of another exemplary embodiment of a stapling assembly having a compressible non-fibrous backing material releasably retained on a staple cartridge; FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; 41B is a cross-sectional view of a portion of the support material of FIG. 41A releasably retained on the staple cartridge along line 41B-41B; FIG. 41C is a cross-sectional view of a portion of the support material of FIG. 41A releasably retained on the staple cartridge along line 41C-41C; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; 42B is a partial schematic showing the adjunct of FIG. 42A in a tissue deployed state; FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; Figure 43B is a cross-sectional view of the support of Figure 43A along line 43B-43B; FIG. 4 is a cross-sectional view of another exemplary embodiment of a compressible non-fibrous backing material, showing only a portion of the backing material releasably retained on the staple cartridge; 44B is a partial schematic showing tissue clamped between the anvil and a portion of the backing of FIG. 44A with staples partially deployed through the backing from the staple cartridge; Fig. 44B is a partial schematic showing the adjunct of Fig. 44A in a tissue deployed state; FIG. 14 is a partially exploded perspective view of another exemplary embodiment of a stapling assembly having a compressible non-fibrous backing material releasably retained on a staple cartridge; 45B is a top down view of a portion of the stapling assembly of FIG. 45A; FIG. 45C is a cross-sectional view of the stapling assembly of FIG. 45B along line 45C-45C; FIG. FIG. 14 is a perspective view of another exemplary embodiment of a portion of a stapling assembly having a compressible non-fibrous backing material releasably retained on a staple cartridge; 46B is a top down view of a portion of the stapling assembly of FIG. 46A; FIG. FIG. 12 is a cross-sectional front view of an exemplary embodiment of a surgical end effector having an anvil and stapling assembly, the stapling assembly having a compressible non-fibrous auxiliary material releasably retained on a staple cartridge; 10A and 10B show the surgical end effector in a closed position with no tissue positioned between the anvil and the stapling assembly; 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 assist material; FIG. 47B is a cross-sectional front view of only the stapling assembly of FIG. 47A; FIG. FIG. 100 is a cross-sectional front view of another exemplary embodiment of a surgical end effector having an anvil and stapling assembly having a compressible non-fibrous auxiliary material releasably retained on a staple cartridge; and shows the surgical end effector in the closed position with no tissue positioned between the anvil and the stapling assembly. 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 assist material; FIG. 48B is a cross-sectional front view of only the stapling assembly of FIG. 48A; FIG. FIG. 10 is a perspective view of another exemplary embodiment of a compressible non-fibrous backing material; FIG. 12 is a side view of an exemplary embodiment of a surgical end effector having an anvil and stapling assembly, the stapling assembly having a compressible non-fibrous auxiliary material releasably retained on a staple cartridge; Fig. 2 shows the surgical end effector in a closed position with no tissue positioned between the anvil and the stapling assembly; 50B is a side view of the surgical end effector of FIG. 50A showing tissue clamped between the anvil and the stapling assembly; FIG. 50B is a side view of only the stapling assembly of FIG. 50A; FIG. FIG. 100 is a cross-sectional front view of another exemplary embodiment of a surgical end effector having an anvil and stapling assembly having a compressible non-fibrous auxiliary material releasably retained on a staple cartridge; and shows the surgical end effector in the closed position with no tissue positioned between the anvil and the stapling assembly. 51B is a cross-sectional front view of the compressible non-fibrous backing alone of FIG. 51A. FIG. FIG. 100 is a cross-sectional front view of another exemplary embodiment of a surgical end effector having an anvil and stapling assembly having a compressible non-fibrous auxiliary material releasably retained on a staple cartridge; and shows the surgical end effector in the closed position with no tissue positioned between the anvil and the stapling assembly. 52B is a cross-sectional front enlarged view of only a portion of the stapling assembly of FIG. 52A; FIG. FIG. 14 is a partial cross-sectional view of another exemplary embodiment of a compressible non-fibrous auxiliary material releasably retained on a staple cartridge; FIG. 12 is a partial cross-sectional view of another exemplary embodiment of a compressible non-fibrous auxiliary material releasably retained on a staple cartridge, showing only three staples from three staple rows of the staple cartridge; 55 is a schematic illustration of the stress-strain curves of the support of FIG. 54 at each of three staples; FIG. FIG. 10 is a graph showing the stress-strain curve of an exemplary compressible non-fibrous backing material (Backing Material 1) of Examples 9 and 10; FIG. FIG. 10 is a graph showing the stress-strain curves of four exemplary compressible non-fibrous backings (backings 2-5) of Examples 9 and 10; FIG. 12 is a graph showing stress-strain curves for six exemplary embodiments of the compressible non-fibrous backing material of Example 11;

To provide a general understanding of the principles of construction, function, manufacture, and use of the auxiliary materials, systems, and methods disclosed herein, specific illustrative embodiments are now described. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the aids, systems, and methods described in detail herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the invention is It will be understood to be 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 same are provided. Generally, a surgical stapling assembly includes a staple cartridge having staples disposed therein and a compressible bioabsorbable non-fibrous adjunct configured to be releasably retained on the staple cartridge. , can include In some embodiments, the non-fibrous adjunct may be formed from a matrix comprising at least one fused bioabsorbable polymer and thus may be three-dimensionally printed. In other embodiments, the non-fibrous adjunct material is partially or wholly formed via any suitable additive manufacturing process, such as injection molding, foaming, and forming processes, as would be understood by those skilled in the art. obtain. As discussed herein, various adjuncts can be used to compensate for changes in tissue properties, such as changes in tissue thickness, and/or to internalize tissue when the adjuvant is stapled to tissue. can be configured to promote breeding. For example, the supplement is configured to undergo a strain in the range of about 0.1 (10% deformation) to 0.9 (90 percent deformation) while under an applied stress in the range of about 30 kPa to 90 kPa. can be That is, the adjuvant materials described herein are stressed when the adjuvant material is under an amount of stress between and/or including about 30 kPa to 90 kPa, e.g., when the adjuvant material is in a tissue deployed state. , can be configured to deform about 10% to 90%.

Exemplary stapling assemblies, as described herein and illustrated in the drawings, can include various features to facilitate application of surgical staples. However, those skilled in the art will appreciate that the stapling assembly may include only some of these features and/or may include various other features known in the art. The stapling assemblies described herein are intended to be representative of certain exemplary embodiments only. Further, the auxiliary material has been described in connection with a surgical staple cartridge assembly, and the auxiliary material may be used in connection with reloading staples that are not the cartridge base or any type of surgical instrument.

FIG. 1 shows an exemplary surgical stapling and cutting device 100 suitable for use with implantable aids. The illustrated surgical stapling and cutting device 100 includes a staple applying assembly 106 or end effector having an anvil 102 pivotally coupled to an elongated staple channel 104 . As a result, staple applying assembly 106 is positioned between an open position and a closed position in which anvil 102 is positioned adjacent elongated staple channel 104 to engage tissue therebetween, as shown in FIG. can move between Staple applying assembly 106 may be attached at its proximal end to elongated shaft 108 forming implementing portion 110 . When staple applying assembly 106 is closed, or at least substantially closed (e.g., anvil 102 moves from the open position of FIG. 1 toward the elongated staple channel), implementing portion 110 is used to apply staples. Assembly 106 may present a sufficiently small cross-section suitable for insertion through a trocar. Although device 100 is configured to staple and cut tissue, surgical devices configured to staple tissue but not cut tissue are also contemplated herein.

In various circumstances, staple applying assembly 106 may be manipulated by handle 112 connected to elongated shaft 108 . Handle 112 pivots relative to user controls, such as a rotation knob 114 that rotates elongate shaft 108 and staple applying assembly 106 about the longitudinal axis of elongate shaft 108 and a pistol grip 118 to rotate staple applying assembly 106 . may include a closure trigger 116 that may close the . For example, when the closure trigger 116 is clamped, the closure release button 120 may be exposed to the outside of the handle 112 such that the closure release button 120 is depressed to unclamp the closure trigger 116 and release the staple applying assembly 106 . can be opened.

Firing trigger 122 may pivot relative to closure trigger 116 to cause staple applying assembly 106 to simultaneously cut and staple tissue clamped therein. In various instances, multiple firing strokes may be employed using firing trigger 122 to reduce the amount of force per stroke required to be applied by the hand of the surgeon. In certain embodiments, handle 112 may include one or more rotatable indicator wheels, such as rotatable indicator wheel 124, that can indicate firing progress. A manual firing release lever 126 allows the firing system to be retracted, if desired, before the firing system completes its travel for firing, and a firing release lever 126 locks and/or locks the firing system. Or, if it fails, the surgeon or other clinician can retract the firing system.

Further details regarding surgical stapling and cutting device 100 and other surgical stapling and cutting devices suitable for use with the present disclosure can be found, for example, in US Pat. No. 9, the entire disclosure of which is incorporated herein by reference. , 332,984 and US Patent Application Publication No. 2009/0090763. Further, surgical stapling and cutting devices need not include a handle, but instead are described, for example, in US Patent Application No. 2019/0059889, the entire disclosure of which is incorporated herein by reference. As such, it can have a housing configured to couple to a surgical robot.

As further shown in FIG. 1, staple cartridge 200 may be utilized with instrument 100 . In use, staple cartridge 200 is positioned within elongated staple channel 104 and coupled thereto. In this illustrated embodiment, staple cartridge 200 can have a variety of configurations, but staple cartridge 200, shown in greater detail in FIGS. 2A-2B, has proximal end 202a and distal end 202b. and a longitudinal axis (L _C ) extends between the proximal end 202a and the distal end 202b. As a result, longitudinal axis (L _C ) is aligned with longitudinal axis (L _S ) of elongate shaft 108 when staple cartridge 200 is inserted into elongated staple channel 104 ( FIG. 1 ). Further, staple cartridge 200 is defined by two opposing walls 210a, 210b to receive at least a portion of a firing member of a firing assembly, such as firing assembly 400 of FIG. 4, as discussed in greater detail below. It includes longitudinal slots 210 that are configured. As shown, longitudinal slot 202 extends from proximal end 202a of staple cartridge 200 toward distal end 202b. It is also contemplated herein that longitudinal slot 202 may be omitted in other embodiments.

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

Staples releasably stored in staple cavities 212, 214 may have a variety of configurations. An exemplary staple 300 that may be releasably stored in each of staple cavities 212, 214 is shown in FIG. 3 in its unfired (pre-deployment, unformed) configuration. The illustrated staple 300 includes a crown (base) 302 and two legs 304 extending from each end of crown 302 . In this embodiment the crowns 302 extend in a straight direction and the staple legs 304 have the same unformed height, in other embodiments the crowns are, for example, crowns 2804c, 2806c in FIG. 28A. , 2808c, and/or the staple legs can have different unformed heights (see FIG. 29). Further, before staples 300 are deployed, staple crowns 302 may be supported by staple drivers positioned within staple cartridge 200 while staple legs 304 are positioned at least partially within staple cavities 212, 214. can be accommodated. Further, staple legs 304 may extend beyond a top surface, such as top surface 206, of staple cartridge 200 when staples 300 are in their unfired position. In certain instances, as shown in FIG. 3, tip 306 of staple leg 304 may be sharp and sharp, which may cut and penetrate tissue.

In use, staples 300 can be transformed from an unfired position to a fired position, with staple legs 304 traveling through staple cavities 212, 214 and positioned between anvil 102 and staple cartridge 200. Penetrate the tissue and bring it into contact with the anvil 102 . As the staple legs 304 deform against the anvil 102, the legs 304 of each staple 300 can capture a portion of tissue within each staple 300 and apply a compressive force to the tissue. Additionally, the legs 304 of each staple 300 may deform downwardly toward the crown 302 of the staple 300 to form a staple entrapment area within which tissue may be entrapped. In various instances, the staple entrapment region may be defined between the inner surface of the deformed leg and the inner surface of the crown of the staple. The size of the captured area of the staple may depend on several factors such as leg length, leg diameter, crown width and/or degree of leg deformation, for example.

In some embodiments, all staples disposed within staple cartridge 200 can have the same unfired (pre-deployed, unformed) configuration. In other embodiments, the staples may include at least two groups of staples that differ, for example, in height and/or shape relative to each other, each having a different unfired (pre-deployment, unformed) configuration. For example, the staple cartridge 200 includes a first group of staples having a first height disposed within the first row of staple cavities 212a, 214a and a second row of staple cavities 212b, 214b. A second group of staples having a second height disposed and a third group of staples having a third height disposed within the third row of staple cavities 212c, 214c. and may include In some embodiments, the first, second, and third heights can be different, with the third height being greater than the first height and the second height. In other embodiments, the first and second heights are the same, but the third height is different 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, staples may include one or more outer coatings, such as sodium stearate lubricants and/or antimicrobial agents. The antimicrobial agent may be applied to the staple 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 compounds (e.g. nanocrystalline silver), lauric acid ethyl ester (LAE), Octenidine, polyhexamethylene biguanide (PHMB), taurolidine, lactic acid, citric acid, acetic acid, and salts thereof.

2A-2B, staple cartridge 200 extends from a top or deck surface 206 to a bottom surface 208, with top surface 206 configured as a tissue-facing surface and bottom surface 208 configured as a channel-facing surface. is configured as As a result, top surface 206 faces anvil 102 and bottom surface 208 (blocking) faces elongate staple channel 104 when staple cartridge 200 is inserted into elongated staple channel 104, as shown in FIG.

In some embodiments, top surface 206 may include surface features defined therein. For example, the surface features can be recessed channels defined in top surface 206 . As shown in more detail in FIG. 2C, a first recessed channel 216 surrounds each first staple cavity 212a, 214a. Each first recessed channel 216 is defined by a substantially triangular wall 216a having a proximally facing apex, a distally facing apex, and a laterally outwardly facing apex. Additionally, each first recessed channel 216 includes a first floor 206 a at a first height from top surface 206 . A second recessed channel 218 surrounds each second staple cavity 212b, 214b. Each second recessed channel 218 comprises a proximally facing apex, a distally facing apex, a laterally inwardly facing apex, and a laterally outwardly facing apex with respect to the longitudinal axis. defined by wall 218a, which is generally diamond-shaped. Additionally, 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, 214c. Each third recessed channel 220 has a substantially triangular wall 220a with a proximally facing apex, a distally facing apex, and a laterally inward facing apex with respect to the longitudinal axis. defined by Additionally, each third recessed channel 220 includes a third floor 206 c at a third height from top surface 206 . In some embodiments, the first recessed channel 216 has a first height, the second recessed channel 218 has a second height, and the third recessed channel 220 has a third height. The heights can have the same height. In other cases, the first height, second height, and/or third height can be different. Additional details regarding surface features and other exemplary surface features can be found in US Patent Publication No. 2016/0106427, which is incorporated herein by reference in its entirety. Further, as discussed in more detail below, these recessed channels 216, 218, 220 may be used to interact with adjuncts, such as adjunct 2600 of FIGS. may be releasably retained on the top surface of the cartridge prior to staple deployment.

4 and 5, a firing assembly such as firing assembly 400, for example, may be utilized with a surgical stapling and cutting device such as device 100 of FIG. Firing assembly 400 combines a wedge sled 500 having wedges 502 configured to deploy staples from staple cartridge 200 into an anvil such as anvil 102 of FIG. 1 and staples such as staple cartridge 200 of FIG. It may be configured to be advanced into tissue captured between the cartridge. Additionally, an E-beam 402 at the distal portion of firing assembly 400 may fire staples from the staple cartridge. During firing, the E-beam 402 may also pivot the anvil toward the staple cartridge, thus moving the staple applying assembly from the open position toward the closed position. The E-beam 402 shown includes a pair of top pins 404 , a pair of middle pins 406 that may be along portion 504 of wedge sled 500 , and a bottom pin or foot 408 . E-beam 402 also includes a sharp cutting edge 410 configured to cut tissue captured as firing assembly 400 advances distally, and thus toward the distal end of the staple cartridge. obtain. Additionally, integrally formed, proximally projecting upper and intermediate guides 412 and 414 bracketing the vertical ends of cutting edge 410 provide a sharp cut through the tissue prior to severing the tissue. A tissue staging area 416 may also be defined to assist in navigating to edge 410 . The intermediate guide 414 is also used to engage and fire the staples in the staple applying cartridge by abutting the stepped central member 506 of the wedge sled 500 for staple forming by the staple applying assembly 106. obtain.

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

As discussed above, to deploy staples from a staple cartridge, the sled 500 of FIG. 5 is threaded from the proximal end to the distal end of the cartridge body and thus from the proximal end to the distal end of the staple cartridge. can be moved by As the firing assembly 400 of FIG. 4 is advanced, the sleds may contact staple drivers in the staple cartridges within the staple cavities 212, 214 and lift upward. In at least one example, the sled and staple driver may each include one or more ramped or angled surfaces that cooperate to move the staple driver upward from an unfired position. can be moved to As the staple drivers are lifted upwardly within their respective staple cavities, the staples are advanced upwardly and the staples exit their staple cavities and penetrate tissue. In various instances, the sled can simultaneously move several staples upward as part of the firing sequence.

As noted above, the stapling device may be used in combination with a compressible backing. While adjuncts are shown and described below, the adjuncts disclosed herein can be used with other surgical instruments and need not be coupled to a staple cartridge as described. are understood by those skilled in the art. Further, those skilled in the art will appreciate that the staple cartridge need not be replaceable.

As mentioned above, some surgical staplers often require the surgeon to select the appropriate staples with the appropriate staple height for the tissue to be stapled. For example, surgeons may utilize tall staples for use with thick tissue and short staples for use with thin tissue. However, in some situations, the tissue being stapled does not have a consistent thickness, so the staples are applied to all portions of the stapled tissue (e.g., thick tissue portions and thin tissue portions). In contrast, the desired launch configuration cannot be achieved. The inconsistency in tissue thickness is particularly susceptible to internal pressure at the staple site and/or along the row of staples, especially when staples of the same or substantially greater height are used. When exposed, it can result in unwanted leakage and/or tearing of tissue at the site of the staple.

Thus, compensating for different thicknesses of tissue captured within fired (deployed) staples to avoid having to consider staple height when stapling tissue during a surgical procedure. Various embodiments of non-fibrous supplements are provided that may be configured to: That is, the adjuncts described herein allow sets of staples having the same or similar height to be used in stapling tissue of different thicknesses (e.g., from thin tissue to thick tissue). can also be combined with adjuncts to provide adequate tissue compression within and between the fired staples while allowing for Accordingly, the adjuncts described herein are capable of maintaining suitable compression on stapled thin or thick tissue, thereby preventing tissue leakage and/or tearing at the site of the staple. can be minimized.

Alternatively or additionally, the non-fibrous adjunct may be configured to promote tissue ingrowth. In various instances, to promote healing of the treated tissue (e.g., stapled and/or incised tissue) and/or to accelerate patient recovery, the tissue is attached to the implantable adjunct. It is desirable to accelerate ingrowth. More specifically, tissue ingrowth into the implantable adjuvant may reduce the incidence, extent, and/or duration of inflammation at the surgical site. Tissue ingrowth into and/or around the implantable adjuvant may, for example, control the spread of infection at the surgical site. In-growth of blood vessels, particularly white blood cells, for example into and/or around the implantable adjuvant, can combat infection in and/or around the implantable adjuvant and adjacent tissues. Tissue ingrowth can also aid in the acceptance of foreign bodies (eg, implantable adjuncts and staples) by the patient's body and can reduce the likelihood that the patient's body will reject the foreign bodies. Rejection of the foreign body can result in infection and/or inflammation at the surgical site.

Unlike conventional backings (e.g. non-three-dimensional printed backings such as foam backings and woven/non-woven backings), these non-fibrous backings are three-dimensional (3D) printed and therefore , can be formed of microstructures (units) that are consistently reproducible. That is, unlike other manufacturing methods, 3D printing significantly improves control over microstructural features such as element positioning and connections, for example. As a result, the variability in both the microstructure and associated properties of the present adjuncts is reduced compared to conventional adjuncts. For example, the support material may be structured to compress a predetermined amount with a substantially uniform material. Fine control over the microstructure may also allow the porosity of the adjunct to be tailored to enhance tissue ingrowth. Also, the present non-fibrous auxiliary material can be adapted for use with a variety of staples and tissue types.

Generally, the aids provided herein are designed and positioned over a staple cartridge, such as cartridge 200. FIG. As the staples are fired (deployed) from the cartridge, the staples penetrate the support material and into the tissue. When the staple legs are deformed against an anvil disposed on the opposite side of the staple cartridge, the deformed legs capture a portion of the backing material and a portion of the tissue within each staple. That is, when the staples are fired into tissue, at least a portion of the assist material is positioned between the tissue and the fired staples. Although the assistants described herein may be configured to attach to a staple cartridge, here the assistants are adapted to mate with other instrument components, such as the anvil of a surgical stapler. It is also contemplated that the Those skilled in the art will appreciate that the aids provided herein can be used in replaceable cartridges or non-cartridge-based staple reloading.

Method of Stapling Tissue FIGS. 6A-6B illustrate an exemplary embodiment of a stapling assembly 600 including a staple cartridge 602 and a backing material 604. FIG. For the sake of brevity, the support material 604 is shown generally in FIGS. 6A-6B, and various structural configurations of the support material are described in greater detail below. Other than the differences described in detail below, staple cartridge 602 can be similar to staple cartridge 200 (FIGS. 1-3), and therefore common features will not be described in detail herein. As shown, backing material 604 is positioned against staple cartridge 602 . Although partially obstructed in FIG. 6, staple cartridge 602 includes staples 606 that can be similar to staples 300 of FIG. 3 configured to be deployed within tissue. Staples 606 may have any suitable green (pre-deployment) height. For example, staples 606 can have an unformed height of approximately 2 mm to 4.8 mm. Prior to deployment, the staple crowns may be supported by a staple driver (not shown).

In the illustrated embodiment, backing material 604 can be fitted to at least a portion of top or deck surface 608 of staple cartridge 602 . In some embodiments, top surface 608 of staple cartridge 602 can include one or more surface features, such as recessed channels 216, 218, 220, as shown in FIGS. 2A and 2C. The one or more surface features engage the backing material 604 to avoid unwanted movement of the backing material 604 relative to the staple cartridge 602 and/or premature release of the backing material 604 from the staple cartridge 602. can be configured as An exemplary attachment mechanism is described in US Patent Application Publication No. 2016/0106427, which is incorporated herein by reference in its entirety.

FIG. 6B shows stapling assembly 600 positioned within and coupled to elongated staple channel 610 of surgical end effector 601, similar to surgical end effector 106 of FIG. Anvil 612 is pivotally coupled to elongated staple channel 610 and thus movable relative to elongated staple channel 610 and thus staple cartridge 602 between an open position and a closed position. Anvil ₆₁₂ is shown in the closed position in FIG. More specifically, the tissue gap _TG is defined by the distance between the tissue compressing surface 612a of the anvil 612 (eg, the tissue engaging surface between staple forming pockets in the anvil) and the tissue contacting surface 604a of the backing 604. defined. In this illustrated embodiment, both the tissue-compressing surface 612a of the anvil 612 and the tissue-contacting surface 604a of the support member 604 are planar or substantially planar (eg, planar within manufacturing tolerances). . As a result, as shown in FIG. 6B, when the anvil 612 is in the closed position, the tissue gap _TG is substantially uniform (eg, nominally the same within manufacturing tolerances) when no tissue is disposed therein. is. In other words, the tissue gap _TG is substantially constant (eg, within manufacturing tolerances) across the end effector 601 (eg, in the y-direction). In other embodiments, the tissue-compressing surface of the anvil may include a stepped surface with longitudinal steps between adjacent longitudinal portions, thus creating a stepped profile (eg, in the y-direction). In such embodiments, the tissue gap _TG may be different.

The secondary material 604 is compressible such that the secondary material can be compressed to different heights to compensate for different tissue thicknesses captured within the deployed staples. Auxiliary member 604 has an uncompressed (undeformed) or pre-deployed height and is configured to deform to one of multiple compressed (deformed) or deployed heights. For example, the backing material 604 has an uncompressed height that is greater than the firing height of the staples 606 disposed within the staple cartridge 602 (eg, the height (H) of the fired staples 606a in FIG. 7). can. That is, the backing material 604 may have an undeformed state in which the maximum height of the backing material 604 is greater than the maximum height of the fired staples (eg, staples in the formed configuration). In one embodiment, the uncompressed height of the backing material 604 is about 10% higher, about 20% higher, about 30% higher, about 40% higher, about 50% higher than the fired height of the staples 606. , about 60% higher, about 70% higher, about 80% higher, about 90% higher, or about 100% higher. In certain embodiments, the uncompressed height of auxiliary material 604 may be, for example, more than 100% higher than the fired height of staples 606 .

In use, when a surgical stapling and severing device, such as device 100 of FIG. Tissue is positioned between anvil 612 and stapling assembly 600 so that it is positioned adjacent side two (eg, tissue may be positioned against support member 604 tissue contacting surface 604a). . Once tissue is positioned between anvil 612 and stapling assembly 600, a surgical stapler is thereby actuated, e.g., as described above, between anvil 612 and stapling assembly 600 (e.g., anvil 612 and tissue contacting surface 604a of the adjunct 604) and staples may be deployed from the cartridge through the adjuvant and into the tissue to attach the adjuvant to the tissue.

As shown in FIG. 7, as staples 606 are fired, a portion of tissue (T) and backing material 604 are captured by fired (formed) staples 606a. Fired staples 606a each define a capture region therein, as described above, to accommodate captured assisting material 604 and tissue (T). The capture area defined by fired staples 606a is limited, at least in part, by the height (H) of fired staples 606a. For example, the height of fired staples 606a can be about 0.160 inches or less. In some embodiments, the height of first stapled 606a can be about 0.130 inch or less. In one embodiment, the height of fired staples 606a can be between about 0.020 inches and 0.130 inches. In another embodiment, the height of fired staples 606a can be between about 0.060 inches and 0.160 inches.

As described above, the auxiliary material 604 can be compressed within multiple fired staples 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 row of staples can be deformed to a fired height of, for example, about 2.75 mm, and the tissue (T) and support material 604 can be compressed to within this height. can be In a particular case, the tissue (T) may have a compression height of approximately 1.0 mm and the support material 604 may have a compression height of approximately 1.75 mm. In a particular case, the tissue (T) can have a compression height of approximately 1.50 mm and the support material 604 can have a compression height of approximately 1.25 mm. In a particular case, the tissue (T) may have a compression height of approximately 1.75 mm and the support material 604 may have a compression height of approximately 1.00 mm. In a particular case, the tissue (T) can have a compression height of approximately 2.00 mm and the support material 604 can have a compression height of approximately 0.75 mm. In a particular case, the tissue (T) may have a compression height of approximately 2.25 mm and the support material 604 may have a compression height of approximately 0.50 mm. Accordingly, the sum of the captured tissue (T) and the compressed height of the backing material 604 can equal, or at least substantially equal, the height (H) of the fired staples 606a.

Furthermore, most structures typically behave in such a way that the strain (deformation) of the material increases as the stress applied to the material increases. However, for surgical stapling, the strain of the assisting material increases over a relatively narrow stress range, and therefore, as discussed in more detail below, the assisting materials described herein do not allow them to be flat or loose. It is desirable that it can be structured so that it can exhibit a sloping "stress plateau". In general, the stress plateau is the regime in the stress-strain curve of a cellular material in compression that corresponds to progressive cell collapse by elastic buckling, and depends on the properties of the solid in which the material is made. That is, when a given structure deforms under compression, strain can increase without a substantial increase in stress, thus leading to a stress plateau and thereby densification of the structure (e.g. solid height) is advantageously retarded. As a result, the adjuncts described herein have a stress range typically applied to the adjuvant while in a tissue deployed state (e.g., when the adjuvant is stapled to tissue in vivo). It can be designed to undergo compression over an extended period of time.

Therefore, the structure of the assist material is in the range of about 0.1 to 0.9 while under applied stress in the range of about 30 kPa to 90 kPa when the assist material and tissue are captured within the fired staples. can be designed to withstand the strain of The applied stress is the stress that the stapled tissue exerts on the adjunct when the adjunct is in the tissue deployed state. Those skilled in the art will appreciate that the stress applied by the tissue depends on various stapling conditions (eg, tissue thickness, height of staples formed, intra-tissue pressure). For example, high blood pressure is typically considered to be 210 mmHg, so it would be desirable for the adjuvant to withstand applied stress of 210 mmHg or greater for a period of time without reaching densification. In other embodiments, the strain is about 0.1-0.8, about 0.1-0.7, about 0.1-0.6, about 0.2-0.8, about 0.2- 0.7, about 0.3-0.7, about 0.3-0.8, about 0.3-0.9, about 0.4-0.9, about 0.4-0.8, about It can range from 0.4 to 0.7, from about 0.5 to 0.8, or from about 0.5 to 0.9. Accordingly, the support material described herein can be configured to deform such that it does not reach its solid height while under a predetermined amount of applied stress.

Hooke's Law (F=kD) to design a support that is configured to undergo a strain in the range of about 0.1 to 0.9 while under an applied stress of about 30 kPa to 90 kPa principle can be used. For example, knowing the force (stress) applied to a tissue-deployed adjunct, the adjunct can be designed to have a predetermined stiffness (k). Stiffness may be determined by the geometry of the support material (e.g., unit cell shape, wall thickness, height, and/or interconnectivity, e.g., angles and spacings between unit cells, and/or unit cell strut It can be set by adjusting the diameter and/or the interconnectivity of the struts of the unit cell (eg, the angles and spacing between struts). Additionally, the assist material can be designed to have a maximum amount of compressive displacement for a minimum tissue thickness of the tissue, e.g. When stapled to tissue, the length of displacement D can be a combination of the minimum thickness of the tissue, eg, 1 mm, and the thickness of the adjunct. By way of example, in one embodiment, the auxiliary material has a height greater than the maximum stapled height formed of 2.75 mm and a height of 1.75 mm when stapled to tissue of minimum thickness of 1 mm. It can be structured to compress to height. Therefore, the adjunct should be of a constant length such that the sum of the stiffness (k) and thickness (D) of the entrapped tissue and the adjunct can apply a stress of 3 gf/ ^mm2 to the entrapped tissue. In order to maintain the height displacement D, they can differ in terms of compressibility. It should be noted that those skilled in the art will appreciate that the above equations can be modified to account for changes in temperature, for example, as the adjunct goes from room temperature to body temperature after implantation. Moreover, the foregoing discussion of Hooke's law represents an approximation. Therefore, those skilled in the art can use the principle of large deformation mechanisms (also called finite elasticity) to obtain more accurate predictions of the relationship between stress and strain through the use of constitutive equations tailored to the material of interest. You will understand what you can get.

Therefore, the compressibility profile of the support material can be controlled by at least the structural configuration of the unit cells and the interconnections between them. As a result, the structural configuration of the unit cells can be tailored to affect the adjunct with desirable mechanical properties for stapling tissue. Due to the finite range of intra-tissue pressure, tissue thickness, and formed staple height, the support material will undergo the desired amount of strain at a substantially constant rate while the desired amount of stress is applied. Appropriate geometries, and therefore unit cells, can be determined for adjuncts that may be effective in allowing them to receive. In other words, the structural configuration of the unit cell applies a substantially continuous desired (eg, at least 3 gf/mm ² ) stress on the tissue to the stapled tissue for a given time over a range of stapling conditions. can be designed to produce adjuncts that can be effective in That is, as described in more detail below, the present assists are formed of a compressible material that allows the assists to compress to varying heights in a predetermined plane when stapled to tissue. It is geometrically configured to allow In addition, this differential response by the adjunct also means that when the adjuvant is exposed to intra-tissue pressure fluctuations (e.g., blood pressure spikes) that can occur when the adjunct is stapled to tissue, It may be possible to maintain a continuous desired stress application.

Auxiliary Materials Auxiliary materials can have a variety of configurations. The adjunct generally includes a tissue contacting surface and a cartridge contacting surface with an elongated body (eg, inner structure) positioned therebetween. The tissue contacting surface and/or cartridge contacting surface can, in certain embodiments, have a different structure than the elongated body to form a tissue contacting layer and a cartridge contacting layer, respectively. As described in more detail below, the support material may have a post-based configuration, a non-post-based configuration, or a combination thereof.

Further, each exemplary adjunct is shown in partial form (e.g., rather than a full length), and thus it will be appreciated by those skilled in the art that the adjunct, as specified in each embodiment, It will be appreciated that it may be longer in length, for example along its longitudinal axis (L _A ). The length can vary based on the length of the staple cartridge or anvil. The width can also vary as desired. Additionally, each exemplary backing is positioned over the cartridge or anvil such that the longitudinal axis L of each backing is aligned with and extends along the longitudinal axis (L _A ) of the cartridge or anvil. configured to be positioned. These supplements are structured to compress when subjected to compressive forces (eg, stress or load).

Auxiliary materials described herein can have varying average lengths, widths, and thicknesses. For example, in some embodiments, the supplemental material can have an average length ranging from about 20 mm to 100 mm, or from about 40 mm to 100 mm. In other embodiments, the supplement may have an average width in the range of approximately 5mm to 10mm. In still other embodiments, the adjunct may have an average thickness ranging from about 1 mm to 6 mm, from about 1 mm to 8 mm, from about 2 mm to 6 mm, or from about 2 mm to 8 mm. In one embodiment, an exemplary adjunct may have an average length in the range of approximately 20 mm to 100 mm, an average width of 5 mm to 10 mm, and an average thickness of approximately 1 mm to 8 mm.

The elongate body may be formed of one or more lattice structures each formed by interconnected unit cells. The unit cells may have a variety of configurations, but in some embodiments the unit cells may be pillar-less based unit cells, while in other embodiments the unit cells may be pillar-based unit cells. can be The struts may be solid rods or bars formed entirely or substantially of solid material. In certain embodiments, one or more lattice structures may be formed by interconnected repeating unit cells. Further, in certain embodiments, the elongate body can include at least one lattice structure formed of strutless unit cells and at least one lattice structure formed of strut-based unit cells (see FIG. 54). reference).

Each lattice structure extends from a first surface (eg, top surface) to a second surface (eg, bottom surface). Depending on the overall structural configuration of the adjunct, at least a portion of the first side of the at least one lattice structure may serve as the tissue-contacting surface of the adjunct and the second side of the at least one lattice structure. At least a portion may serve as a cartridge contact surface for the auxiliary material. Those skilled in the art will appreciate that each lattice structure may have additional tissue contacting surfaces (eg, one or more lateral sides to the top surface).

In certain embodiments, the adjunct may include a tissue contact layer disposed on at least a portion of the first surface of at least one lattice structure of the internal structure. The tissue contact layer has a thickness extending between a first surface (eg, top surface) and a second surface (eg, bottom surface). As a result, the first surface of the tissue contacting layer can serve as the tissue contacting surface of the resulting adjunct either alone or in combination with at least a portion of the first surface of the at least one lattice structure. The tissue contacting layer can have various configurations. For example, in some embodiments, the tissue contact layer is in the form of a lattice structure formed of interconnecting repeating cells that may differ from the lattice structure of the elongated body, while in other embodiments the tissue contact layer is , in the form of a film.

Alternatively or additionally, the support material may include 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 extending from a first side (eg, top surface) to a second side (eg, bottom surface). As a result, the second surface of the cartridge contact layer, alone or in combination with at least a portion of the second surface of the at least one lattice structure, can serve as the cartridge contact surface of the resulting supplement. The cartridge contact layer can have various configurations. For example, in some embodiments, the cartridge contact layer is in the form of a grid structure formed of interconnecting repeating cells, which may differ 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.

Strutless-Based Supports As noted above, the support may include a lattice structure formed of pillarless-based unit cells (eg, repeating pillarless-based unit cells). In other words, a pillar-less based unit cell can be characterized by curved surfaces, as opposed to a pillar-based unit cell characterized by the presence of sharp corners or angles. For example, a unit cell can be based on a triple periodic minimal surface (TPMS). A TPMS is a minimal surface that repeats itself in three dimensions. As used herein, the term "minimal surface" refers to a mathematically known minimal surface. Thus, in some embodiments, the unit cell is a Schwartz structure (e.g., Schwarz P, Schwarz Diamond), a modified Schwartz structure, a gyroid (e.g., Schoen Gyroid) structure, a cosine structure, and a coke can structure. obtain.

As discussed in more detail below, the strutless unit cells can have various structural configurations (eg, height, width, wall thickness, shape). In some embodiments, the unit cells of the backing pillarless base can be substantially uniform (eg, nominally identical within manufacturing tolerances), while in other embodiments the unit cells of the backing pillarless base are may differ in shape and/or size with respect to the remainder of the strut-based unit cell.

For example, in some embodiments, each of the pillarless base unit cells can have a wall thickness of about 0.05 mm to 0.6 mm. In certain embodiments, the wall thickness can be about 0.1 mm to 0.3 mm. In one embodiment, the wall thickness can be approximately 0.2 mm. In certain embodiments, the wall thickness of all the strutless base unit cells of the backing can be substantially uniform (eg, nominally the same within manufacturing tolerances). In other embodiments, for example, if the supplement is formed of two or more sets of unit cells, the unit cells of each set may have different wall thicknesses. For example, in one embodiment, the backing material comprises first repeating unit cells each having a first wall thickness and second repeating unit cells each having a second wall thickness greater than the first wall thickness. cells and third repeating unit cells each having a third wall thickness greater than the second wall thickness. Alternatively or additionally, the first repeating unit cell has a first height (e.g., maximum height) and a second height (e.g., maximum height) greater than the first height; It can have a third height (eg, maximum height) that is greater than the second height.

In some embodiments, each unit cell can have a surface area to volume ratio of about 5-30. In certain embodiments, each unit cell can have a surface area to volume ratio of about 7-20.

Schwartz P Structure FIGS. 8A-8F are an exemplary embodiment of a support 800 having a tissue contacting surface 802 and a cartridge contacting surface 804. FIG. The support member 800 includes interconnected repeating strutless unit cells 810, one of which is shown in more detail in FIGS. 9A-9B. Although the support material 800 is shown as having four longitudinal rows (L ₁ , L ₂ , L ₃ , L ₄ ), each having 20 repeating unit cells 810, those skilled in the art will For example, the number of rows and unit cells of backing material can depend at least on the size and shape of the staple cartridge and/or anvil to which the backing material is applied, thus the backing material can be arranged in the longitudinal rows and It will be appreciated that the number of unit cells is not limited. Furthermore, although only one type of repeating strutless unit cell is shown, in other embodiments, the auxiliary material comprises a first repeating strutless unit cell and a second repeating strutless unit cell that is different from the first, etc. It can be formed in combination with a pillarless unit cell.

Given that the backing material 800 is formed of repeating unit cells 810 having substantially the same (eg, nominally identical within manufacturing tolerances) structural configuration, the following discussion relates to one repeating unit cell 810 . As shown in Figures 9A-9B, the repeating unit cell 810 has a top portion 812, a bottom portion 814, and a middle portion 816 extending therebetween.

In this illustrated embodiment, the repeating unit cell 810 is configured as a Schwartz P structure, so the surface contours of the unit cell 810 are defined by minimal curved surfaces. That is, the outer surface 820 and the inner surface 822 of the unit cell 810 are each defined by a minimal curved surface. Thus, in this illustrated embodiment, outer surface 820 and inner surface 822 are generally concave in shape, thereby forming arcuate sides 821 of unit cell 810 . In addition, interior surface 822 defines an interior volume 824 of unit cell 810 . As a result, unit cell 810 may be characterized as hollow. The Schwartz P-minimum surface may be functionally expressed as cos(x)+cos(y)+cos(z)=0.

The unit cell 810 also includes a connection interface 826 that can be used to interconnect the unit cell 810 to other unit cells 810, thereby forming the auxiliary material 800 shown in Figures 8A-8E. In this illustrated embodiment, the unit cell has six connection interfaces 826 that form the six outermost surfaces of the unit cell 810, e.g., top outermost surface 827a and bottom outermost surface 827b, left outermost surface 829a. and right outermost surface 829b, and front outermost surface 831a and rear outermost surface 831b. The top and bottom outermost surfaces 827a, 827b are substantially planar (e.g., planar within manufacturing tolerances) relative to each other and offset in the x-direction, and the left and right outermost surfaces 829a, 829b are , are substantially planar with respect to each other (e.g., planar within manufacturing tolerances) and are offset in the y-direction, and front and rear outermost surfaces 831a, 831b are substantially planar with respect to each other (e.g., within manufacturing tolerances). planar within tolerance) and offset in the z-direction. Thus, the overall outer surface of the unit cell 810 includes a planar surface, e.g. 820 included. Further, because the adjunct 800 is formed only of repeating unit cells 810, the top portion 812, including the upper outermost surface 812a, forms the tissue-contacting surface 802 of the adjunct 800 and the bottom portion 814 of the unit cell. The outermost surface 814 a of the bottom (eg, in the x-direction) forms the cartridge contact surface 804 of the backing material 800 . As a result, tissue contacting surface 802 is formed of planar and non-planar surfaces.

Further, based on the overall geometry of the repeating unit cells 810 and their interconnectivity to each other at the corresponding connection interfaces 826, the overall outer surface of the resulting support material 800 is defined by non-planar surfaces. It is formed with discrete substantially planar surfaces (eg, planar within manufacturing tolerances). As shown, the top and bottom outermost surfaces 850a, 850b of the backing material 800 are furthest from the bisector extending in the YZ plane, and the left and right outermost surfaces 852a, 852b of the backing material 800 are , the bisector extending in the XZ plane, and the front and rear outermost surfaces 854a, 854b of the backing members are furthest from the bisector extending in the XY plane. Further, as shown, the outermost surfaces 850a, 850b of the top and bottom portions are substantially planar (e.g., planar within manufacturing tolerances) with respect to each other and are offset in the x-direction, leaving the left and right portions 850a, 850b The outermost surfaces 852a, 852b are substantially planar (e.g., planar within manufacturing tolerances) with respect to each other and offset in the y-direction, and the front and rear outermost surfaces 854a, 854b are substantially planar with respect to each other. It is planar (eg, planar within manufacturing tolerances) and offset in the z-direction. These outermost surfaces 850 a , 850 b , 852 a , 852 b , 854 a , 854 b thus form planar segments of the outer surface of the backing material 800 . The portions of the backing material 800 that extend between these outermost surfaces 850a, 850b, 852a, 852b, 854a, 854b are defined by the outer surfaces 820 of adjacent unit cells 810, thereby causing the outer surfaces of the backing material 800 to be non-planar. can be understood to form a facet.

As further shown, the six connection interfaces 826 define respective circular openings in fluid communication with the interior volume 824 of the unit cell 810 . As a result, unit cell 810 has openings on all six Cartesian sides (represented by arrows 1, 2, 3, 4, 5, 6 in FIG. 9B). These openings, for example, can serve multiple functions. namely, to facilitate connection to adjacent cells, to create openings that may allow immediate tissue ingrowth when the adjunct is stapled to tissue, the resulting adjunct, e.g. Allowing drainage of manufacturing materials used in the production of materials used during the 3D manufacturing process; Allowing movement of bodily fluids throughout the supporting material; Mechanical properties of the supporting material, e.g. Contributing mechanical properties creating a compression profile that retards densification and/or minimizing the solid height of the fully compressed adjunct.

Further, when the unit cells 810 are interconnected with each other at corresponding connection interfaces, for example, at least two connection interfaces, hollow tubular interconnects 828 (eg, lumens), are shown in FIGS. 8D-8E. In turn, are formed between the unit cells, which allow the internal volumes 824 of the interconnected unit cells 810 to be in fluid communication with each other. A continuous network of channels or pathways is therefore present within the auxiliary material. As a result, the support material 800 is stapled to the tissue (T) and, as shown in FIG. 8G, when in the tissue-deployed state, for example, through an opening in the connection interface 826a of the upper portion 812 of the at least one unit cell 810. , the one or more fluids containing cells that enter the adjunct 800 may flow through the adjunct 800, e.g., via interconnected unit cells, when in the tissue deployed state, as shown in FIG. 8G. can migrate across and eventually accelerate tissue ingrowth within the adjunct 800 . That is, while the adjunct 800 is in the tissue-deployed state, at least a portion of the hollow tubular interconnects 828 at least partially maintain fluid communication between at least a portion of the unit cells 810, or across all interior volumes; Therefore, cell mobility across the adjunct 800 may be facilitated.

Hollow tubular interconnects 828 define openings that can have various sizes (eg, diameters), but in some embodiments, the diameter of the openings is between about 100 micrometers and 3500 micrometers. obtain. For example, the diameter of the aperture can be from about 100 microns to 2500 microns, or from about 500 microns to 2500 microns. In certain embodiments, the diameter of the opening can be between about 945 microns and 1385 microns. In one embodiment, the aperture diameter may be greater than 2000 microns. In certain embodiments, the diameters of all openings are substantially the same (eg, nominally the same within manufacturing tolerances). As used herein, the "diameter" of an aperture is the maximum distance between the apexes of any pair of apertures.

Because the repeating unit cells 810 are interconnected with each other at corresponding connection interfaces 826, the support material 800 has a predefined compressed region 830 and a predefined uncompressed region 840, as shown more clearly in FIG. 8C. It is in the form of a lattice structure with Although predefined compressed regions 830 and predefined uncompressed regions 840 may have various configurations, in this illustrated embodiment predefined compressed regions 830 are defined by unit cells 810. The defined uncompressed regions 840 are in the form of voids 845 defined between the unit cells 810 . In this embodiment, each void 845 is formed between four adjacent interconnect unit cells 810 . For example, as shown in Figure 8F, an air gap 845a is defined between four adjacent unit cells 810a, 810b, 810c, 810d. Thus, the spaces that exist between adjacent unit cells define predefined uncompressed regions. In other words, the uncompressed region 840 of supplemental material is not defined by the internal volume of the unit cell.

As described in more detail below, the structural configuration of a repeating unit cell is such that, while under applied stress, the unit cell expands to its height H (see FIG. 9A) at different locations over a period of time. It may be allowed to deform or buckle along (eg, until opposite sides of the cell's inner surfaces contact each other). As a result, during such times the unit cell may deform or buckle at a constant or substantially constant rate while under an applied stress (eg, 30 kPa to 90 kPa). In other words, in certain embodiments, the structure of the repeating unit cell can lead to a stress plateau while the adjunct is under the applied stress, for example, as shown schematically in FIG.

Figures 10A-10D schematically illustrate the compressive behavior of one repeating unit cell of Figures 8A-9B, eg, unit cell 810, when under a range of applied stresses. In particular, the repeating unit cell 1010 is in the pre-compressed (undeformed) state of FIG. 10B, in which intermediate portion 1016 begins to deflect, in a second compressed state in FIG. Touching each other, the unit cells 810 are shown in the densified state of FIG. 10D reaching their solid height.

Relationship between the undeformed state U (FIG. 10A), the compressed states C1, C2 (FIGS. 10B-10C), and the densified state D (FIG. 10D) of the repeating unit cell 1010, and the resulting stress-strain of the support material. The curves are shown schematically in FIG.

The stress-strain response of the support begins with elastic deformation (bending) characterized, for example, by Young's modulus as the repeat unit begins to deform from its uncompressed state towards its first compressed state. This elastic deformation continues until the yield stress is reached. Once the yield stress is reached, a stress plateau can occur corresponding to progressive unit cell collapse by elastic buckling, for example, as the repeating unit cell continues to deform through its first and second states of compression. have a nature. Those skilled in the art will appreciate that the stress plateau depends at least on the properties of the material from which the unit cell is made. The stress plateau continues until densification, indicating, for example, the collapse of the unit cells throughout the adjunct as the repeating unit cell reaches its densified state, thus allowing the adjunct to reach its solid height. reached.

Those skilled in the art will appreciate that the stress-strain curve for a supplemental material depends on various factors, such as uncompressed height, compositional configuration (including material properties), and/or structural configuration. be. As an example, Table 1 below shows the results of compression to a first compression height (CH1) of 1.75 mm at an applied stress of 30 kPa and an applied stress of 90 kPa, differing only in uncompressed height (UH). for an exemplary backing that is compressed to a second compression height (CH2) of 0.75 mm with an applied stress of 90 kPa and a third compression height (CH3) of 0.45 mm with an applied stress of 90 kPa. Stress-strain response is shown.

In another embodiment, the unit cell without repeating struts can be a modified Schwartz P structure. For example, a Schwartz P structure may be stretched in one or more directions to form a stretched Schwartz P structure, as shown, for example, in FIG. 12A. Alternatively or additionally, in certain embodiments, the wall thickness of the Schwartz P structure can be reduced. For example, as shown in FIG. 12B, a Schwartz P structure is stretched and thinned. In yet another embodiment, as shown in FIG. 12C, the Schwartz P structure may be cropped such that the height of the top portion H _T of the Schwartz P structure (see FIG. 9A) and/or the bottom portion H _B (FIG. 9A) is reduced. Alternatively, or in addition to the exemplary modifications described above, additional openings may be added through the walls of the Schwarz P structure, for example, as shown in FIG. can help to make

Repeating strutless unit cells may take the form of other TPMS structures. For example, as shown in 13A, a pillarless unit cell 1300 can be formed from a sheet diamond structure with diamond minimal curves having a Schwartz D-plane lattice structure. This particular minimal curved surface is called a "diamond" because it has two intertwined congruent labyrinths, each having the shape of a tubular version of a diamond bond structure. Schwartz D.
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 may be functionally expressed as
An exemplary repeating unit cell 1300 and thus an exemplary support 1310 formed of a sheet diamond structure is shown in FIG. 13B.

In another embodiment, as shown in FIG. 14A, the pillarless base unit cell 1400 can be a gyroid structure. The gyroid minimal surface is
It may be functionally expressed as sin(x)cos(y)+sin(y)cos(z)+sin(z)cos(x)=0.
An exemplary support member 1410 formed of repeating unit cells 1500 and thus a gyroscopic structure is shown in FIG. 14B. In other embodiments, the pillarless base unit cell can be in the form of a cosine structure 1500 (FIG. 15A) or a coke can structure 1600 (FIG. 16A), each of which is defined by a curved minimal curved surface. be done. Exemplary supports 1510, 1610 formed of respective repeating unit cells 1500 (cosine structure), 1600 (coke can structure) are shown in FIGS. 15B and 16B.

Edge Conditions In some embodiments, certain strut-less base unit cells may create undesirable edge conditions for tissue stapling when interconnected to form a support material. . For example, as tissue slides across the backing material during use, edge conditions can interact with the tissue to cause at least a portion of the backing material to prematurely separate from the staple cartridge. These edge conditions include the geometry (e.g., substantially planar (e.g., planar without manufacturing tolerances) and non-planar outer surfaces) and the interconnection of the unit cells on a pillarless basis that constitutes the support material. can be a result of sexuality. Therefore, to improve these edge conditions and thus inhibit premature detachment of the adjuvant, outer layers with different geometries may be applied to one or more of the tissue-contacting surfaces of the adjuvant. can be positioned above.

Referring again to FIGS. 9A-9B, as noted above, the Schwartz P structure 810 has non-planar outer surfaces forming arcuate sides 821 extending between connection interfaces 826 of the unit cells 810 . As a result, when the Schwartz P structures 810 are interconnected to form a support member such as the support member 800 of FIGS. It can have planar and non-planar surfaces. This is a result of at least the structural configuration of the top portion 812 of each unit cell 810 (eg, the exposed top outer surface 827a and the arcuate sides 821 of the top portion 812) and the spaced relationship therebetween. Accordingly, the edge condition of the adjuvant is generally planar (or For example, it can be minimized by applying an outer layer that has a planar (within manufacturing tolerances) geometry. As a result, this may reduce the tissue load (applied stress) on the support during placement of the stapling device. Additionally, this may facilitate mounting requirements between the support material and the cartridge.

The outer layer can have a variety of configurations, but in some embodiments the outer layer can be formed of one or more planar arrays of struts (FIGS. 17A-17C), while other In embodiments, the outer layer may be in the form of a film (Figure 18).

17A-17C show an exemplary support 1700 having a first lattice structure 1702 formed of interconnecting repeating unit cells 1704 and at least one planar array 1706,1708. Each unit cell 1704 is similar to the unit cell 810 of FIGS. 9A-9B, and therefore the common features will not be described in detail here. In this illustrated embodiment, a first planar array 1706 (eg, in the YZ plane) extends across the upper tissue-facing surface 1712 of the first lattice structure 1702 (eg, in the XZ There are two planar arrays 1706 , 1708 with a second planar array 1706 extending across at least one side tissue-facing surface 1714 of the first lattice structure 1702 (in the plane). In other embodiments, the first or second planar arrays 1706, 1708 may be omitted. In further embodiments, support material 1700 may include additional planar arrays.

The planar arrays 1706, 1708 can have a variety of configurations, but in this illustrated embodiment, the first planar array and the second planar array 1706, 1708 are each a single layer of support material 1700. It includes longitudinal struts 1716 extending parallel to and along the longitudinal axis (L _A ). Although not shown, it is also contemplated that additional struts may be added to the first and second planar arrays 1706,1708. For example, in one embodiment, first planar array 1706 and/or second planar array 1708 extend at an angle to the longitudinal axis and have first and/or second longitudinal Cross struts may be included that intersect the directional struts thereby creating a repeating X pattern.

In use, when backing material 1700 is releasably retained on a cartridge, such as cartridge 200 of FIGS. 1-2C, backing material 1700 overlaps a row of staples disposed within the cartridge. As a result, the first planar array 1706 can add to the final solid height of the backing material 1700 and thus accelerate its densification. However, to minimize impact, the first planar array 1706 can have a high density, and the first planar array 1706 can be designed so that it does not overlap the rows of staples. For example, as shown in FIGS. 17A-17C, the first planar array 1706 is divided into four spaced apart portions 1706a, 1706b, 1706c, 1706d with three gaps 1718, 1720, 1722 therebetween. and along the longitudinal axis (L _A ) of the auxiliary member 1700 . 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), thus the first planar array 1706 is There will be no or minimal entrapment by staples during deployment.

As noted above, in some embodiments, an absorbent film is positioned on at least a portion of at least one of the non-planar tissue-facing surfaces of the lattice structure, thereby allowing the tissue to slide across the support while it slides across the support. Additionally, tissue can be substantially prevented from causing premature detachment of the adjunct from the cartridge. That is, the absorbent film can minimize edge conditions and thus reduce the friction that would otherwise exist on the tissue-contacting surface of the adjunct.

FIG. 18 shows an exemplary embodiment of support material 1800 disposed on cartridge 1801 . The support material 1800 includes a lattice structure 1802 with an absorbent film 1804 disposed over at least a portion thereof. A lattice structure 1802, similar to that of the support material 800 of FIG. 8A, is formed of interconnecting repeating unit cells 1806, each of which is similar to the unit cell 810 of FIGS. The features are not described in detail here. As shown, absorbent film 1804 is disposed on all tissue-facing surfaces of lattice structure 1802, and in this illustrated embodiment, upper tissue-facing surface 1808 (e.g., in the x-direction). ), a first longitudinal side 1810a (e.g., extending in the z-direction), a second opposing longitudinal side 1810b, a first lateral side 1812a (e.g., extending in the y-direction), and a second opposite lateral side (obstructed). In other embodiments, the absorbent film is not disposed on all tissue-facing sides of the lattice structure, eg, the first lateral side and/or the second lateral side.

Absorbent films can have a variety of configurations. For example, in some embodiments, the absorbent film is designed to have a thickness that nominally affects the densification of the adjunct when the adjunct is under applied stress; or made of one or more materials that help reduce tissue contact layer friction for tissue manipulation. In some embodiments, the absorbent film can have a thickness of about 15 micrometers or less, such as about 5 micrometers to 15 micrometers, or about 8 micrometers to 11 micrometers. In one embodiment, the absorbent film may be formed of polydioxanone.

Attachment Features In some embodiments, the non-post-based backing extends at least partially along the length of the backing to engage the staple cartridge, thereby attaching the backing to the staple cartridge prior to staple deployment. on the cartridge. The one or more attachment features may have various configurations. For example, one or more attachment features may engage (e.g., press fit or snap fit) elongated cutting slots formed between opposing longitudinal edges of the elongated cutting slots in the staple cartridge. and/or ends configured to engage recessed end channels defined in the staple cartridge. part attachment (Figs. 24-25). Other than the differences discussed in detail below, the support materials 1900, 2000, 2100, 2200 are substantially similar to the support material 800 of FIGS. Do not describe in detail.

In some embodiments, one or more of the channel fittings are structurally configured to be inserted into a longitudinal slot of the staple cartridge to engage opposing walls of the longitudinal slot. of compressible members. In certain embodiments, the one or more compressible members comprise compressible openings extending longitudinally therethrough, for example, along the length of the cartridge-contacting surface of the supplemental material. obtain.

19A-19B illustrate an exemplary embodiment of a secondary member 1900 including a channel attachment 1910 having two compressible members 1912, 1914 interconnected by at least one common elongated joint 1916. FIG. The two compressible members 1912, 1914 can have various configurations, but in this illustrated embodiment each compressible member 1912, 1914 spans its width (e.g., in the y-direction). ii) in the form of an elongated rod having a triangular cross-sectional shape, but with hollow triangular channels 1912a, 1914a extending through the interior along its length (eg, in the z-direction). As shown, two elongated rods 1912, 1914 are interconnected at corresponding vertices thereby forming an elongated junction 1916 that defines a central connection region having a narrow thickness (eg, in the x-direction). As shown in FIG. 19B, when the auxiliary material 1900 is disposed in a cartridge 1901 similar to the cartridge 200 of FIGS. Positioned equidistant from opposing walls 1903a, 1903b of longitudinal slot 1903 as shown. As a result, the central connecting region is aligned with the line of advancement of the cutting member, thus minimizing the risk of jamming of the cutting member as it advances through the auxiliary member 1900 due to the narrow width of the central connecting region. can be prevented. That is, the central connection region minimizes additional auxiliary material that would otherwise need to be cut as the cutting member advances through longitudinal slot 1903 . In addition, hollow triangular channels 1912a, 1914a reduce the amount of material on each side of the line of travel, which means that as the cutting member advances further through longitudinal slot 1903, the cutting edge of the auxiliary material cuts. Constraints on members can be minimized.

Although the overall width W _C of the channel mount 1910 can vary, in this illustrated embodiment, the overall width W _c is equal to the width W _L of the longitudinal slot 1903 (eg, the distance between two opposing slot walls 1903a, 1903b). ). As a result, when channel attachment 1910 is inserted into longitudinal slot 1903, the compressible member deforms due to the outward lateral force created by hollow triangular channels 1912a, 1914a, respectively. slot walls 1903a, 1903b of (eg, compressed against). A press or friction fit is thus created between the compressible members 1912 , 1914 and the respective slot walls 1903 a , 1903 b of the cartridge 1901 .

The channel fitting may have other configurations (eg, shape and/or dimensions). For example, as shown in FIG. 20, the backing material 2000 extends outwardly from the cartridge contacting surface 2004 of the backing material 2000 and is positioned between two inner rows of repeating unit cells 2010a, 2012a. 8A-8X, except that it also includes a channel attachment portion 2010 in the form of an elongated projection. Elongated protrusion 2010 is configured to be inserted into a longitudinal slot of a cartridge, such as longitudinal slot 210 of cartridge 200 of FIGS. 2A and 2C.

The elongated protrusion 2010 can have a variety of configurations, but in this illustrated embodiment the elongated protrusion 2010 is formed from two compressible longitudinal rods 2010a, 2010b, with a cross rod 2010c between them. extend in between. In some embodiments, the width of elongate projection 2010 (eg, y-direction) is greater than the width of a longitudinal slot of the staple cartridge (eg, the distance between two opposing slot walls). As a result, when elongate projection 2010 is inserted into a longitudinal slot, such as longitudinal slot 210 of cartridge 200 of FIGS. are configured to engage (e.g., compress against) opposing slot walls due to the lateral forces of the . Accordingly, a press fit or friction fit is formed between the elongate projection 2010 and the slot wall of the cartridge.

FIG. 21 shows another embodiment of a support material 2100 with channel attachments. The secondary member 2100 has the exception that the channel attachments are in the form of separate projections 2110 (only two are shown in FIG. 21) spaced apart from one another along the longitudinal axis _LA of the secondary member 2100. , similar to the auxiliary material 2000 shown in FIG. The protrusions 2110 can have a variety of configurations, but in the illustrated embodiment each protrusion 2110 is in the form of an annular boss having an elliptical shape. In other embodiments, the protrusions 2110 may be any other suitable shape and/or may differ in size/shape relative to each other. Each annular boss 2110 can be configured to be compressible, although in some embodiments the width of each boss is the length of a staple cartridge, such as longitudinal slot 210 of cartridge 200 of FIGS. 2A-2C. It can be dimensioned so that it can be larger than the width of the directional slot (eg, the distance between two opposing slot walls). As a result, when the discrete annular bosses 2110 are inserted into the longitudinal slots of the cartridge, their outer surfaces 2110a engage opposing slot walls due to the outward radial force of the annular bosses. (e.g. compressed for these). A press or friction fit is thus formed between the annular boss 2110a and the slot walls of the longitudinal slot.

Alternatively or additionally, in some embodiments, the support material may include edge attachment features configured to engage corresponding edge attachment features of the support material. For example, as shown in FIGS. 22A-22C, the backing member 2200 may include three sets of opposing surfaces, each extending in an outward lateral direction away from opposing outer surfaces 2200a, 2200b of the backing member 2200. Clips 2202a, 2202b, 2204a, 2204b, 2206a, 2206b may be included to hold. Although the three sets of clips 2202a, 2202b, 2204a, 2204b, 2206a, 2206b can have various configurations, in this illustrated embodiment the three sets of clips 2202a, 2202b, 2204a, 2204b, 2206a , 2206b each have a hook-shaped configuration that engages a respective edge attachment feature 2208a, 2208b, 2210a, 2210b, 2212a, 2212b of the cartridge 2201. As shown in FIG. In this illustrated embodiment, each edge attachment feature 2208a, 2208b, 2210a, 2210b, 2212a, 2212b has an inverted L-shaped configuration whereby flanges extend laterally outwardly from staple cartridge 2201. (only one flange is shown in detail in FIGS. 22B-22C).

FIG. 22C shows the engagement of one clip 2204a of backing material 2200 with one flange 2210a of cartridge 2201. FIG. Repeating unit cells of support material 2200 have been omitted for the sake of brevity. As shown, an inner surface 2214a of an end portion 2214 of clip 2204a engages an outer bottom surface 2216 of flange 2210a such that a portion of outer surface 2218 of flange 2210a nests against a corresponding portion of inner surface 2220 of clip 2204a. (e.g. male/female mating). Further, as shown in FIG. 22C, flange 2210a is biased outwardly such that portions of outer surface 2218 of flange 2210a press against corresponding portions of inner surface 2220a of clip 2204a when engaged. be done.

23A-23B show opposing receiving members 2308, 2310 (partially obstructed), 2312, 2314 (partially obstructed), 2316, 2318 (partially obstructed), 2316, 2318 (partially obstructed) of corresponding sets of staple cartridges 2301. three sets of opposing clips 2302a, 2302b (partially obstructed), 2304a, 2304b (partially obstructed) configured to engage a Another embodiment of the support material with 2306a, 2306b (partially obstructed) is shown.

In this illustrated embodiment, each clip is structurally identical and has an inverted T-shaped configuration. Further, as shown, each set of receiving members is structurally identical and includes two inverted L-shaped members spaced apart and facing each other forming a t-shaped gap therebetween. By way of example, the engagement of one clip 2302a with its corresponding set of receiving members 2308a, 2308b is shown in more detail in FIG. 23B. As shown, lateral segments 2316a, 2316b (eg, extending in the z-direction) of clip 2302a are attached to respective inner surfaces (only one inner surface 3118 is shown) of each L-shaped member 2308a, 2308b. Configured for engagement, a vertical segment 2320 (eg, extending in the x-direction) of clip 2302a is configured to be positioned between two opposing faces of L-shaped members 2308a, 2308b. (only one opposing surface 2322 is shown). Thus, the vertical segments 2320 can help maintain longitudinal alignment of the backing material 2300 with respect to the staple cartridge 2301 and thus the staples (not shown) disposed therein. In use, the vertical segment 2320 also helps prevent premature disengagement of the clip 2302a from the corresponding set of receiving members 2308a, 2308b and thus premature disengagement of the auxiliary material 2300 from the cartridge 2301. obtain.

Alternatively or additionally, in some embodiments, the backing material is configured to engage (eg, press fit) corresponding proximal and distal sets of recesses defined within the staple cartridge. It may include end mounting features such as opposing proximal and distal sets of bosses. For example, in one embodiment, the backing member has rectangular bosses configured to engage rectangular recesses 2402a, 2402b, 2404a, 2404b of the proximal and distal sets of staple cartridge 2400 of FIG. can. In another embodiment, the auxiliary member has circular bosses configured to engage circular recesses 2502a, 2502b, 2504a, 2504b of the proximal and distal sets of staple cartridge 2500 of FIG. obtain.

As noted above, in certain embodiments, the staple cartridge includes surface features in the form of recessed channels, such as recessed channels 216, 218, 220, as shown in FIGS. 2A and 2C. obtain. In such embodiments, the supplemental material is such that the frequency of staples in a longitudinal staple row (e.g., the number of staples per length of the staple row) is equal to the frequency of repeat unit cells in the corresponding longitudinal unit cell row ( A releasable attachment mechanism between the backing material and the staple cartridge that engages the recessed channel even when different (e.g., greater) than (e.g., the number of repeating unit cells per cell row length) can be designed to provide

Figures 26A-26C show a backing material 2600 disposed on a staple cartridge 2602 that is similar to the staple cartridge 200 of Figures 2A-2C and thus common features will not be described in detail herein. . Staple cartridge 2602 includes staple cavities 2604a, 2604b, 2604c, 2606a, 2606b, 2606c arranged in longitudinal rows and recessed channels surrounding each staple cavity 2604a, 2604b, 2604c, 2606a, 2606b, 2606c. . 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 staple cavity 2604b, 2606b. A recessed channel 2612 surrounds each third staple cavity 2604c, 2606c. The first, second, and third recessed channels each include respective floors 2614, 2616, 2618 at respective heights (eg, extending in the x-direction) from top surface 2602a of staple cartridge 2602. . In this illustrated embodiment, the respective heights are the same, but in other embodiments the respective heights may be different.

The secondary material 2600 can have a variety of configurations, but in this illustrated embodiment, the secondary material 2600 comprises repeating unit cells 2620 and attachment features 2622 extending from at least a portion of the plurality of unit cells 2620. formed by Attachment features 2622 are each inserted into and engage at least a portion of recessed channels 2608, 2610, 2612 of staple cartridge 2602, thereby retaining auxiliary material 2600 in cartridge 2602 prior to staple deployment. is configured as

The attachment features 2622 can have a variety of configurations, but 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 the frequency of unit cells compared to the frequency of staples 2605 in staple cavities 2604 a , 2604 b , 2604 c , 2606 a , 2606 b , 2606 c of staple cartridge 2602 . Accordingly, attachment features 2622 are positioned on respective unit cells 2620 at predefined positions corresponding to recessed channels 2608 , 2610 , 2612 . As shown in FIG. 26A and shown in more detail in FIG. Configured to engage respective vertices 2608a, 2610a, 2610b, _2612a of recessed channels 2608, 2610, 2612 pointing laterally outwardly with respect to directional axis LA. In other embodiments, the geometry of the mounting feature can be configured to engage other portions of the recessed channel.

The geometry of the mounting features 2622 can vary laterally and/or longitudinally with respect to the longitudinal axis of the cartridge. The geometric variation depends at least on the frequency of unit cells 2620 relative to the frequency of staples 2605 and the shape of staple cavities 2604a, 2604b, 2604c, 2606a, 2606b, 2606c. For example, attachment features 2622 may differ from each other in at least one of height (eg, x-direction), width (eg, y-direction), length (eg, z-direction), and shape. For example, as shown in FIG. 26B, the height H 1 of the first attachment feature 2622a extending from the first repeat unit cell 2620a is equal to the height H ₁ of the second attachment feature extending from the second repeat unit cell 2620b. The height H ₂ of _2622b is greater than the height H 2 of the first and second mounting features 2622 a , 2622 b and thus the heights of the first and second attachment features 2622 a , 2622 b differ transversely to the longitudinal axis LA of the cartridge 2602 . In this illustrated embodiment, as further shown in FIGS. 26A and 26B, the shape of each of the first and second attachment features 2622a, _2622b is also transverse to the longitudinal axis LA of the cartridge 2602. different in direction. First attachment feature 2622a has a cylindrical configuration and second attachment feature 2622b has an arcuate configuration. Alternatively or additionally, the lengths of two or more of the attachment features may vary along longitudinal axis _LA of cartridge 2602 . For example, as shown in FIG. 26A, third and fourth repeating unit cells 2620c, 2620d include third and fourth mounting features 2622c, 2622d, respectively, which extend along longitudinal axis L of cartridge 2602. They differ in length and shape along _A (eg, extending in the z-direction). In this illustrated embodiment, the third mounting feature 2622c has a cylindrical configuration, while the fourth mounting feature 2622d has a triangular configuration.

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

Unit cell frequency A non-strut-based support may vary in thickness longitudinally (e.g. its length, e.g. z-direction) and/or transversely (e.g. its width e.g. y-direction). obtain. As a result, the frequency of staples within a longitudinal staple row (e.g., the number of staples per length of the staple row) is greater than the frequency of repeat unit cells within the corresponding longitudinal unit cell row (e.g., per cell row). unit cells), the staple legs of each staple have different portions of backing material, with each portion having a relative thickness difference, as shown in FIG. You can move forward through

FIG. 27 shows 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 (first longitudinal Only four staples 2704, 2706, 2708, 2710 of a portion of directional staple row 2712 are shown). Auxiliary material 2714 is disposed on upper surface 2702 a of staple cartridge 2702 . Support material 2714 includes interconnected repeating strutless unit cells, such as repeating unit cell 810 of FIGS. ), which are arranged in longitudinal rows (only a portion of the illustrated first longitudinal unit cell row 2717 is shown). As shown, first longitudinal unit row 2717 overlaps first longitudinal staple row 2712 and staples 2704, 2706, 2708, 2710 have a frequency of unit cells 2716a, 2716b, 2716c, 2716d, 2716e. different from the frequency of (eg, non-multiple). As a result, each staple leg 2704b, 2706a, 2706b, 2708a, 2708b, 2710a of each staple 2704, 2706, 2708, 2710, for example, is oriented along a first longitudinal axis when the support material 2714 is stapled to tissue. The directional unit cell rows 2712 , and therefore align with and pass through different respective portions 2718 , 2720 , 2722 , 2724 , 2726 of the backing material 2714 . Further, as shown in FIG. 27, due to the structural configuration of repeating unit cells 2716a, 2716b, 2716c, 2716d, 2716e (eg, not generally square), these different portions 2718, 2720, 2722, 2724, At least two or more of 2726, 2728 have different relative thicknesses T ₁ , T ₂ , T ₃ , T ₄ , T ₅ (e.g., thickness versus thinness), and thus within the fired staples. The thickness of the captured auxiliary material 2714 will differ between adjacent staples stapled in consistent tissue.

In some embodiments, differences in the relative thicknesses of the backing material may be paired with corresponding differences in staple leg lengths. For example, when the staple and unit cell frequencies are the same, any staple leg configured to advance through the thicker portion of the backing material will advance through the thinner portion of the backing material. It can be of a length longer than the legs of any staple configured to. Alternatively or additionally, the relative thickness difference may be paired with a corresponding difference in anvil pocket depth, or if the staple drivers are at the same height, the first can be paired with the tissue gap difference between the staple leg of the second staple and the second staple.

FIG. 28A is an illustration of a stapling assembly 2800 similar to the stapling assembly 2700 of FIG. 27 except that the structural configuration of the backing material 2801 has been modified so that the staple and unit cell frequencies are the same. embodiment. As a result, first staple legs 2804a, 2806a, 2808a of each staple 2804, 2806, 2808 are configured to pass through respective portions of backing material having the same _first thickness T1, and each Second staple legs 2804b, 2806b, 2808b of staples 2804, 2806, 2808 are configured to pass through respective portions of backing material 2801 having the same _second thickness T2. As shown, the _first thickness T1 is greater than the _second thickness T2, so for each staple 2804, 2806, 2808, the first thickness T1 is greater than the second thickness T2 to offset the difference in thickness. The leg length L1 may be greater _than the _second leg length L2. In this illustrated embodiment, crowns 2804c, 2806c, 2808c of each staple 2804, 2806, 2808 have a non-planar configuration (eg, a stepped-up configuration) to provide staple leg length differentials. Further, when staples 2804, 2806, 2808 are deployed and auxiliary material 2801 is stapled to tissue T, each staple has two different formed staple heights H ₁ , H ₂ , as shown in FIG. 28B. have FIG. 29 illustrates that the crowns 2904c, 2906c, 2908c of each staple 2904, 2906, 2908 are substantially planar (eg, generally straight or linear within manufacturing tolerances) such that the formed height of the first staple is 29 shows another exemplary embodiment of a stapling assembly 2900 that is similar to stapling assembly 2800, except that the is substantially uniform (eg, nominally identical within manufacturing tolerances).

Strut-Based Supports As noted above, the support may include a lattice structure (eg, defined by planar interconnected struts) formed of strut-based unit cells. Generally, such support materials may include tissue contact layers, cartridge contact layers, and internal structures (eg, buckling structures). The internal structure generally includes struts (eg, spacer struts) that connect the tissue contacting layer and the cartridge contacting layer together in a spaced relationship. These struts may be configured to collapse without contacting each other while the support material compresses under stress. As a result, densification of the supplement may be delayed and thus occur at higher strains.

The tissue contact layer and cartridge contact layer can have various configurations. In some embodiments, at least one of the tissue contact layer and the cartridge contact layer can include a plurality of struts that define openings. In some embodiments, both the tissue contact layer and the cartridge contact layer are substantially planar (eg, planar within manufacturing tolerances). The tissue contact layer and the cartridge contact layer may be oriented parallel to each other along a longitudinal axis extending from the first end to the second end of the support, with a vertical axis extending therebetween. can be further defined.

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

30A-30B illustrate an exemplary post-based support 3000. FIG. Adjunct 3000 includes a tissue contact layer 3002, a cartridge contact layer 3004, and an internal structure 3006 extending therebetween. The internal structure 3006 is configured to collapse (compress) while the adjunct 3000 is under applied stress, thus causing the adjunct 3000 to compress when stapled to tissue.

The tissue contact layer 3002 and the cartridge contact layer 3004 can have various configurations, but in the illustrated embodiment both are generally planar (eg, planar within manufacturing tolerances). Further, tissue contact layer 3002 and cartridge contact layer 3004 are parallel to each other along a longitudinal axis (L _A ) that extends from first end 3000a to second end 3000b of backing material 3000 . As shown, the tissue contacting layer 3002 and cartridge contacting layer 3004 are inverted images of each other and the thickness (T _c ) of the cartridge contacting layer 3004 is greater than the thickness (T _T ) of the tissue contacting layer 3002 . Therefore, for the sake of brevity, the following description is for tissue contact layer 3002 . However, those skilled in the art will appreciate that the discussion below is also applicable to cartridge contact layer 3004 .

The tissue contacting layer 3002 has first, second, and third longitudinal struts 3008a, 3010a, 3012a parallel to and along the longitudinal axis (L) of the backing material 3000, and a second longitudinal strut 3010a. are positioned between but spaced apart from the first and third longitudinal struts 3008a, 3012a. Tissue contact layer 3002 also includes first cross struts 3014a and second cross struts 3016a. Each of the first cross struts 3014a is connected to first and second longitudinal struts 3008a, 3010a. Although the first cross strut 3014a can be oriented in a variety of different positions, in this illustrated embodiment the first cross strut 3014a is positioned relative to the first and second longitudinal struts 3008a, 3010a. are oriented orthogonally to each other. Similarly, each of the second cross struts 3016a is connected to second and third longitudinal struts 3010a, 3012a. Although the second cross strut 3016a can be oriented in a variety of different positions, in the illustrated embodiment the second cross strut 3016a is positioned relative to the second and third longitudinal struts 3010a, 3012a. Oriented orthogonally. Further, as shown, the first cross strut 3014a is aligned in the y-direction with the second cross strut 3016a.

Further, the first cross struts 3014a are longitudinally separated from each other by a _first distance D1 and the second cross struts are longitudinally separated from each other by a _second distance D2. As a result, openings 3018 a are created in tissue contact layer 3002 . The openings 3018a can have various sizes and shapes, but in this illustrated embodiment D ₁ and D ₂ are equal or substantially equal, thus the first and second cross struts Combined with the orientation of 3014a, 3016a, the resulting opening 3018a is in the form of a rectangle with substantially uniform (eg, nominally identical within manufacturing tolerances) dimensions.

The internal structure 3006 can have a variety of configurations, but in this illustrated embodiment the internal structure 3006 includes spacer struts 3020 extending between the tissue contacting layer 3002 and the cartridge contacting layer 3004 . Spacer struts 3020 include a first set of angled struts 3022a, 3022b and a second set of angled struts 3024a, 3024b, each of which is angled ( for example, 45 degrees). 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 first a second angled strut 3022b extending from a longitudinal strut 3008b to the long cartridge contact layer 3004 to a second longitudinal strut 3010a of the tissue contact layer 3002; As a result, the first and second angled struts 3022a, 3022b alternate along the length (L) of the backer. A second set of alternating angled struts includes a third angled strut 3024a and a fourth angled strut 3024b. Third angled struts 3024a are configured except that third angled struts 3024a extend from second longitudinal struts 3010a of tissue contact layer 3002 to third longitudinal struts 3012b of cartridge contact layer 3004. , similar to the first angled strut 3022a. Fourth angled struts 3024b are configured except that fourth angled struts 3024b extend from second longitudinal struts 3010b of cartridge contact layer 3004 to third longitudinal struts 3012a of tissue contact layer 3002. and similar to the second angled strut 3022b. As a result, in this illustrated embodiment, the first and third angled struts 3022a, 3024a extend in the same direction with respect to each other, and the second and fourth angled struts 3022b, 3024b are: extend in the same direction with respect to each other.

As further shown in FIG. 30A, openings 3018b are created in the cartridge contact layer 3004 between the first cross strut 3014b and the second cross strut 3016b. Further, the angled struts 3022a, 3022b, 3024a, 3024b substantially overlap at least corresponding openings 3018b in the cartridge contact layer 3004 and, as noted above, the cartridge contact layer 3004 extends the thickness of the tissue contact layer 3002. It has a thickness _TC that is greater than _TT . Accordingly, the openings 3018b defined in the cartridge contact layer 3004 cover at least a portion of corresponding angled struts as the angled struts bend while the backing material 3000 is compressed under applied stress. can be configured to receive This creates additional space within the internal structure 3006 for buckling, thus reducing the solid height of the support member 3000 . As a result, during use, densification of the backing material 3000 can be delayed so that the backing material 3000 can undergo a wider range of deformations without reaching its solid height.

Additionally, alternating angled struts 3022 a , 3022 b , 3024 a , 3024 b create concentration zones 3030 within internal structure 3006 . As shown, this concentration zone 3030 extends longitudinally along the backing member between sets of first and second angled struts 3022a, 3022b, 3024a, 3024b. As a result, none of the struts 3020 within the internal structure 3006 overlap this concentration zone 3030, as shown in more detail in FIG. 30B. In other words, this concentration zone 3030 is designed to be a space that does not contain any intersecting struts before or during compression of the auxiliary material. Thus, the presence of this concentration zone 3030 can increase the density points of the adjunct 3000 while the adjunct is stapled to tissue (eg, reducing the solid height of the adjunct). Additionally, the concentration zone may overlap the cutting line of the auxiliary material, thus reducing the amount of material along this cutting line. This helps facilitate advancement of the cutting element of the stapling device, thus facilitating cutting of the auxiliary material.

31A, 32A, 33A, and 34A show various other exemplary post-based supports 3100, 3200, 3300, and 3400. FIG. Each exemplary support has a lattice structure formed from repeatedly interconnected strut-based unit cells, which are shown in FIGS. 31B-31D, 32B-32D, 33B-33E, and It is shown in more detail in Figures 34B-34E. These auxiliary materials are structured to compress when subjected to compressive forces (eg, stresses applied when stapled to tissue).

FIG. 31A shows another exemplary support member 3100 in the form of a lattice structure including a top portion 3102, a bottom portion 3104, and an internal structure 3106 extending therebetween. The top portion 3102 is configured to contact tissue and thus form the tissue contacting layer of the adjunct 3100, while the bottom portion 3104 is configured to attach to the cartridge and thus the cartridge of the adjunct 3100. forming a contact layer; The internal structure 3106 can be configured to compress into a deformed state under load, eg, when stapled into tissue. The grid is formed of an array of repeating unit cells 3110, one of which is shown in more detail in Figures 31B-31D. Therefore, for the sake of brevity, the following description is for the top portion 3102, bottom portion 3104, and internal structure 3106 of one unit cell.

Top portion 3102 and bottom portion 3104 can have a variety of configurations, but in the illustrated embodiment top portion 3102 and bottom portion 3104 are inverted images of each other, and thus for the sake of brevity, the following is for the top portion 3102 of one unit cell 3110 . However, those skilled in the art will appreciate that the discussion below is also applicable to bottom portion 3104 .

As shown in FIGS. 31A-31D, the upper portion 3102 includes first and second cross struts 3112, 3114 and first and second angled struts 3116, 3118 extending therebetween. In this illustrated embodiment, the first angled strut 3116 extends at a first angle from the first end of the first cross strut 3112 and the central portion of the second cross strut 3114. , and a second angled strut 3118 extends at a second angle from a second opposite end of the first cross strut 3112 and terminates at a central portion of the second cross strut 3114. terminate. As a result, the first and second angled struts 3116 , 3118 converge and connect at the central segment 3114 a of the second cross strut 3114 . In other embodiments, the first and second angled struts 3116, 3118 may extend at any other suitable angle.

The internal structure 3106 can have a variety of configurations, but in this illustrated embodiment the internal structure 3106 includes three spacer struts 3120a, 3120b, 3120c. As shown in FIGS. 31B-31D, the first and third spacer struts 3120a, 3120c each interconnect the first cross struts 3112 of the top portion 3102 to the first cross struts 3112 of the bottom portion 3104; A second spacer strut 3120 b interconnects the middle segment 3114 a of the second cross strut 3114 of the top portion 3102 to the middle segment 3114 a of the second cross strut 3114 of the bottom portion 3104 .

FIG. 32A shows another exemplary support 3200 in the form of a lattice structure including a top portion 3202, a bottom portion 3204, and an internal structure 3206 extending therebetween. The top portion 3202 is configured to contact tissue and thus form the tissue contacting layer of the adjunct 3200, while the bottom portion 3204 is configured to attach to the cartridge and thus the cartridge of the adjunct 3200. forming a contact layer; Support material 3200 is similar to support material 3100 shown in FIGS. 31A-31D, except for the differences described below. The grid is formed of an array of repeating unit cells 3201, one of which is shown in more detail in Figures 32B-32D. Therefore, for the sake of brevity, the following description is for the top portion 3202, bottom portion 3204, and internal structure 3206 of one unit cell.

As shown in FIGS. 32B-32D, top portion 3202 is offset from bottom portion 3204 in first and second dimensions (X, Z). Upper portion 3202 includes two separate sets of interconnected struts 3202a, 3202b that are connected to each other via connecting struts 3203. FIG. Bottom portion 3204 includes eight interconnected struts 3204 a , six of which form the first hexagonal face of unit cell 3201 . The internal structure 3206 includes a set of two spacer struts 3208a, 3208b, 3208c, 3210a, 3210b, 3210c extending from the top portion 3202 to the bottom portion, thereby allowing the two columns of the unit cell 3201, as shown in FIG. 32B. Form additional hexagonal faces.

FIG. 33A shows another exemplary backing 3300 in the form of a lattice structure including a top portion 3302, a bottom portion 3304, and an internal structure 3306 extending therebetween. Top portion 3302 is configured to contact tissue, thus forming a tissue contacting layer of support 3300, while bottom portion 3304 is configured to attach to a cartridge of a surgical stapler, and thus provides support. A cartridge contact layer of material 3300 is formed. Support material 3300 is similar to support material 3100 shown in FIGS. 31A-31D, except for the differences described below. The grid is formed of an array of repeating unit cells 3310, one of which is shown in more detail in Figures 33B-33E. Therefore, for the sake of brevity, the following description is for the top portion 3302, bottom portion 3304, and internal structure 3306 of one unit cell 3310. FIG.

Top portion 3302 and bottom portion 3304 may have a variety of configurations, but in the illustrated embodiment top portion 3302 and bottom portion 3304 are substantially identical to each other and thus are illustrated for simplicity. , the following description is for the top portion 3302 of one unit cell 3310 . However, those skilled in the art will appreciate that the discussion below is also applicable to bottom portion 3304 .

As shown in FIGS. 33A-33E, the upper portion 3302 includes a first pair of opposing outer struts 3312a, 3312b and a second pair of opposing outer struts 3312c, 3312d. The first and second pairs of outer struts 3312a, 3312b, 3312c, 3312d are connected such that the upper portion 3302 is in the form of a parallelogram having four corners 3316a, 3316b, 3316c, 3316d. In this illustrated embodiment, the parallelogram is a square. The upper portion 3302 also includes a first cross strut 3318 connecting a first pair of opposing outer struts 3312a, 3312b and a second cross strut 3320 connecting a second pair of opposing outer struts 3312c, 3312d. and including. As shown, the first and second cross struts 3318 , 3320 cross each other at 90 degrees in the middle of the top portion 3302 .

The internal structure 3306 can have a variety of configurations, but in this illustrated embodiment, the internal structure 3306 comprises a first side 3322a, a second adjacent side 3322b, a first side 3322a and a first side 3322a. It includes an opposite third side 3322c and a fourth side 3322d (see FIG. 33D) opposite the second side 3322b. Although each side can have a variety of configurations, in the illustrated embodiment the first and third sides 3322a, 3322c are substantially identical to each other and the second and fourth sides are substantially identical to each other. 3322b and 3322d are substantially identical to each other.

As shown in FIGS. 33B-33E, the first side 3322a of the inner structure 3306 extends from the central segment 3313 of the outer strut 3312a of the bottom portion 3304 to the first and second corners 3316a, 3316b, respectively, of the top portion 3302. First and second angled spacer struts 3324a, 3324b extending in opposite directions to . Similarly, the third side 3322c of the internal structure extends from the central segment (obstructed) of the outer strut 3312b (obstructed) of the bottom portion 3304 to the third and fourth corners of the top portion 3302, respectively. It includes a third angled spacer post 3326a and a fourth angled spacer post 3326b extending in opposite directions to 3316c, 3316d.

In addition, the second side 3322b of the inner structure 3306 has a fifth ridge extending in the opposite direction from the central segment 3315 of the outer strut 3312c of the top portion 3302 to the first and fourth corners 3316a, 3316d of the bottom portion 3304. and sixth angled spacer posts 3328a, 3328b. Similarly, the fourth side 3322d of the internal structure 3306 extends from the central segment 3317 of the outer strut 3312d of the top portion 3302 to the second and third corners 3316b of the bottom portion 3304 (the third corner of the bottom portion 3304). are blocked) and a seventh spacer post 3330a and an eighth angled spacer post 3330a (blocked).

The internal structure 3306 also includes a first pair of angled spacer struts 3332a, 3332b. A first angled spacer post 3332 a extends from the center of top portion 3302 to a central segment 3334 of outer post 3312 c of bottom portion 3304 . Similarly, a second spacer post 3332b extends from the center of top portion 3302 to a central segment (obstructed) of outer post 3312d of bottom portion 3304. FIG. Accordingly, a first pair of angled spacer posts 3332a, 3332b extend from the center of upper portion 3302 in opposite directions.

In addition, internal structure 3306 includes a second pair of angled spacer struts 3336a, 3336b. A first angled spacer post 3336 a extends from the center of bottom portion 3304 to a central segment 3338 of outer post 3312 b of top portion 3302 . Similarly, a second spacer post 3336b extends from the center of bottom portion 3304 to a central segment (obstructed) of outer post 3312a of top portion 3302 . Accordingly, a second pair of angled spacer posts 3336a, 3336b extend from the center of bottom portion 3304 in opposite directions.

FIG. 34A shows another exemplary support 3400 in the form of a lattice structure including a top portion 3402, a bottom portion 3404, and an internal structure 3406 extending therebetween. Top portion 3402 is configured to contact tissue, thus forming the tissue contacting layer of support 3400, while bottom portion 3404 is configured to attach a surgical stapler to the cartridge, and thus provides support. A cartridge contact layer of material 3400 is formed. Support material 3400 is similar to support material 3100 shown in FIGS. 31A-31D, except for the differences described below. The grid is formed of an array of repeating unit cells 3410, one of which is shown in more detail in Figures 34B-34E. Therefore, for the sake of brevity, the following description is for the top portion 3402, bottom portion 3404, and internal structure 3406 of one unit cell.

Top portion 3402 and bottom portion 3404 may have a variety of configurations, but in the illustrated embodiment top portion 3402 and bottom portion 3404 are substantially identical to one another and thus are shown for brevity. , the following description is for the top portion 3402 of one unit cell 3410 . However, those skilled in the art will appreciate that the discussion below is also applicable to bottom portion 3404 .

As shown in FIGS. 34B-34E, the top portion 3402 includes four cross struts 3408a, 3408b, 3408c, 3408d that connect together at the center of the top portion 3402. As shown in FIGS. Although the four cross struts 3408a, 3408b, 3408c, 3408d can be connected together at different angles with respect to each other, in this illustrated embodiment the four cross struts 3408a, 3408b, 3408c, 3408d are: They connect at 90 degrees to each other, thus forming an intersection with four outer edges 3411a, 3411b, 3411c, 3411d. Top portion 3402 also includes four struts 3412a, 3412b, 3412c, 3412d connected to form a square having four corners 3414a, 3414b, 3414c, 3414d. Each square strut 3412a, 3412b, 3412c, 3412d intersects the central segment 3416a, 3416b, 3416c, 3416d of one of the four struts 3408a, 3408b, 3408c, 3408d of the intersection (see FIG. 34D).

Inner structure 3406 can have a variety of configurations, but in this illustrated embodiment, inner structure 3406 includes four sets of angled outer struts, each set of angled outer struts comprising two Includes angled struts 3418a, 3418b, 3420a, 3420b, 3422a, 3422b, 3424a, 3424b. The four sets of angled outer struts can 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 are mirror images of each other.

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

As further shown in FIG. 34B, the first and second angled struts 3422a, 3422b of the third set of angled outer struts each extend from the square second corner 3414b of the top portion 3404 to the bottom portion 3404. extend in opposite directions to one of the second and third corners 3411b, 3411c, respectively, of the intersection of the . Similarly, the first and second angled struts 3424 a , 3424 b of the fourth set of outer angled struts each extend from the square fourth corner 3414 d of the top portion 3404 to the intersection of the bottom portion 3404 at the fourth corner of the bottom portion 3404 . It extends in opposite directions to one of the first corner 3411a and the fourth corner 3411d (which is blocked).

Internal structure 3406 also includes two sets of inner angled struts, each set including two angled struts 3426a, 3426b, 3428a, 3428b. The two sets of angled inner struts can have various configurations. As shown in FIG. 34B, the first and second angled struts 3426a, 3426b of the first set of angled inner struts each extend from the center of the intersection of the top portion 3402 to the second square of the bottom portion 3404. It extends in opposite directions to one of corner 3414b and fourth corner 3414d (which is blocked). In this illustrated embodiment, the first and second angled struts 3428a, 3428b of the second set of angled inner struts are reversed to the first and second angled struts 3426a, 3426b. there is That is, as shown in FIG. 34B, the first and second angled struts 3428a, 3428b of the second set of angled inner struts each extend from the center of the intersection of the bottom portion 3404 to the square corner of the top portion 3402. It extends in opposite directions to one of the first corner 3414a and the third corner 3414c (which is blocked).

As shown in FIGS. 30A-34E, the strut-based configuration of the adjuvant creates multiple openings throughout the adjunct, thereby increasing the capacity for cell infiltration compared to non-strut-based adjuvant configurations. Create something with fewer barriers. That is, these multiple openings may allow for more rapid flow of cells into the adjunct when the adjunct is stapled to tissue. This increased rate may thereby enhance tissue ingrowth compared to other adjuvants.

Although the openings in the top and bottom portions of the support material shown in FIGS. 31A-34E are defined by struts in a regular and symmetrical manner, in other embodiments the top and bottom portions are alternatively include planar sheets having regular or irregular openings formed therein (e.g., "Swiss cheese" style) or non-planar sheets having regular or irregular openings formed therein; It may be a (eg rippled or wavy) sheet. These openings in planar and non-planar adjunct configurations may also promote cellular ingrowth within the adjuvant when the adjuvant is stapled to tissue.

In other embodiments, the repeating unit of post-based support may have other structural configurations. For example, FIG. 35 illustrates an exemplary strut-based unit cell 3500 that may be used to form the support materials described herein. Unit cell 3500 includes a top portion 3502, a bottom portion 3504, and an internal structure 3506 extending therebetween.

Although the top and bottom portions 3502, 3504 can have various configurations, in the illustrated embodiment the top and bottom portions 3502, 3504 are substantially identical to each other, thus for simplicity. Therefore, the following description is for upper portion 3502 . However, those skilled in the art will appreciate that the discussion below is also applicable to bottom portion 3504 .

As shown in FIG. 35, the upper portion 3502 includes a first pair of opposing outer struts 3512a, 3512b and a second pair of opposing outer struts 3514a, 3514b. The first and second pairs of outer struts 3512a, 3512b, 3514a, 3514b are connected such that the upper portion 3502 is in the form of a parallelogram having four corners 3516a, 3516b, 3516c, 3516d. In this illustrated embodiment, the parallelogram is a square. The upper portion 3502 also includes a first cross strut 3518 connecting a first pair of opposing outer struts 3512a, 3512b and a second cross strut 3520 connecting a second pair of opposing outer struts 3514a, 3514b. and including. As shown, the first and second cross struts 3518 , 3520 cross each other at 90 degrees in the middle of the top portion 3502 .

The internal structure 3506 can have a variety of configurations, but in this illustrated embodiment the internal structure 3506 comprises a first side 3522a, a second adjacent side 3522b, and a second side 3522b. It includes a third side 3522c opposite 3522b and a fourth side 3522d opposite first side 3522a. Each side can have a variety of configurations, but in this illustrated embodiment the first, second, third and fourth sides 3522a, 3522b, 3522c, 3522d are different. In this illustrated embodiment, the fourth side 3522d does not include any spacer struts.

As shown in FIG. 35, the first side 3522a of the internal structure 3506 includes first and second angled spacer posts 3524a, 3524b that extend parallel to each other. A first angled spacer post 3524a extends from a first corner 3516a of the bottom portion 3504 to a central segment 3513a of a first outer post 3512a of the top portion 3502, and a second angled spacer post extends from the bottom Extending from a central segment 3513b of first outer strut 3512a of portion 3504 to a second corner 3516b of upper portion 3502 .

A second side 3522b of the internal structure 3506 includes third and fourth angled spacer posts 3526a, 3526b that extend parallel to each other. A third angled spacer post 3526c extends from a second corner 3516b of the bottom portion 3504 to a central segment 3515 of a second outer post 3514b of the top portion 3502, and a fourth angled spacer post 3526b: It extends from the middle segment (obstructed) of the second outer strut (obstructed) of bottom portion 3504 to the third corner 3516 c of top portion 3502 .

Additionally, the third side 3522c of the internal structure 3506 includes fifth and sixth angled spacer posts 3528a, 3528b that extend parallel to each other. A fifth angled spacer post 3528a extends from a fourth corner 3516d of the bottom portion 3504 to a central segment 3517 of a second outer post 3514a of the top portion 3502, and a sixth angled spacer post 3528b: Extending from a central segment 3517 of first outer strut 3514 a of bottom portion 3504 to a first corner 3516 a of top portion 3502 .

Internal structure 3506 also includes two sets of internal angled struts. A first set includes three inner angled struts 3530a, 3530b, 3530c each extending from the center of top portion 3502 to central segments 3513, 3517, 3519 of outer struts 3512a, 3514a, 3512b, respectively, of bottom portion 3504. include. Thus, in a first set, a first inner angled strut 3530a and a third inner angled strut 3530c extend in opposite directions, and a second inner angled strut 3530b extends between the first and third angled struts 3530b. Extending in different directions for the internal angled struts 3530a, 3530c. A second set includes three inner angled struts 3532a, 3532b, 3532c each extending from the center of bottom portion 3504 to central segments 3513, 3515, 3519 of outer struts 3512a, 3514b, 3512b, respectively, of top portion 3502. include. Thus, in a second set, a first inner angled strut 3532a and a third inner angled strut 3532c extend in opposite directions, and a second inner angled strut 3532b extends between the first and third angled struts 3532b. Extending in different directions for the internal angled struts 3532a, 3532b.

In other embodiments, the repeating unit of post-based support may have other structural configurations. For example, FIG. 36 illustrates an exemplary strut-based unit cell 3600 that may be used to form the support materials described herein. Unit cell 3600 includes a top portion 3602, a bottom portion 3604, and an internal structure 3606 extending therebetween.

Although the top and bottom portions 3602, 3604 can have various configurations, in the illustrated embodiment the top and bottom portions 3602, 3604 are substantially identical to each other, thus for simplicity. For that reason, the following description is for upper portion 3602 . In one embodiment, bottom portion 3604 is an inverted image of top portion 3602 . However, those skilled in the art will appreciate that the discussion below is also applicable to bottom portion 3604 .

As shown in FIG. 36, the upper portion 3602 includes a first pair of cross struts 3612a, 3612b and a second pair of cross struts 3612c, 3612d. The first and second pairs of cross struts 3612a, 3612b, 3612c, 3612d are connected such that the upper portion 3602 is in the form of a loose tetrahedron having five corners 3616a, 3616b, 3616c, 3616d, 3616e. ing. A first pair of cross struts 3612a, 3612b intersect at intersection 3617 on the upper portion. Cross strut 3612a connects to cross strut 3612c at corner 3616d, and cross strut 3612b connects to cross strut 3612d at corner 3616c. As shown, cross struts 3612 a , 3612 b cross at 90 degrees to each other in the middle of top portion 3602 at cross point 3617 .

As shown in Figure 36, the internal structure 3606 includes first and second angled spacer posts 3620a, 3620b that extend parallel to each other. A first angled spacer post 3620 a extends from a first corner 3616 a of top portion 3602 to a corner 3616 e of bottom portion 3604 , and a second angled spacer post 3620 b extends from a third corner of top portion 3602 . It extends from corner 3616 c to intersection 3617 of bottom portion 3604 . Additionally, internal structure 3606 includes third and fourth angled spacer posts 3622a, 3622b that extend parallel to each other. A third angled spacer post 3622a extends from a second corner 3616b of the top portion 3602 to a corner 3616e of the bottom portion 3604, and a fourth angled spacer post 3622b extends from a fourth corner 3616b of the top portion 3602. It extends from corner 3616 d to intersection 3617 of bottom portion 3604 . Thus, first angled spacer post 3620a and third angled spacer post 3622a extend in opposite directions, and second angled spacer post 3620b and fourth angled spacer post 3622b extend in opposite directions. Extend.

Outer Layers In some embodiments, the supplemental material comprises a lattice structure extending from the top surface to the bottom surface (e.g., the first lattice structure or the inner lattice structure) and each having a different compression ratio (e.g., pre-compression height to compression ratio). height). As a result, the compression properties of the lattice structure and the at least one outer layer are different and thus can be tailored to perform different functions (e.g., tissue ingrowth, cartridge connection, etc.), but in combination, different stapling conditions and/or Provides an overall compaction profile of the backing material desired for staple height. For example, based on the overall compression profile of the resulting adjunct, the adjunct can develop a strain in the range of about 0.1 kPa to 0.9 kPa while under an applied stress in the range of about 30 kPa to 90 kPa. can be configured to receive In other embodiments, the strain is about 0.1-0.8, about 0.1-0.7, about 0.1-0.6, about 0.2-0.8, about 0.2- 0.7, about 0.3-0.7, about 0.3-0.8, about 0.3-0.9, about 0.4-0.9, about 0.4-0.8, about It can range from 0.4 to 0.7, from about 0.5 to 0.8, or from about 0.5 to 0.9.

The lattice structure and the at least one outer layer can have various configurations, but in some embodiments the first lattice structure has a compression ratio that 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 compress in the range of about 3 mm to 1 mm while under applied stress, and thus may have a compression ratio of 3. However, at least the outer layer may be configured to compress in the range of about 2 mm to 1 mm while under the same applied stress, and thus may have a compression ratio of two.

In certain embodiments, the auxiliary material is in the form of a second lattice structure or absorbent film positioned on at least a portion of the top surface of the first lattice structure and configured to be positioned against tissue. It may include an outer layer. This outer layer promotes tissue ingrowth within the adjunct and/or creates a smooth or substantially smooth tissue-contacting surface that can easily slide against tissue, thus stapling the device. It may be configured to lower tissue loading (applied stress) on the adjunct during deployment and/or facilitate attachment requirements between the adjunct and the cartridge. Alternatively or additionally, the auxiliary material is 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 relative to the cartridge. can include This outer layer can thus be configured to attach the auxiliary material 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 a 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.

37A-37B illustrate an exemplary embodiment of a support material 3700 disposed on cartridge 3800. FIG. Cartridge 3800 is similar to cartridge 200 of FIGS. 1-2C, and thus common features will not be described in detail herein. The support material 3700 includes an inner lattice structure 3702 and two outer layers 3704, 3710 each having a different compression ratio with respect to each other. The internal lattice structure 3702 is generally formed of interconnected repeating unit cells, which are omitted from this view, but any of the repeating unit cells disclosed herein; For example, strut-less based repeating unit cells or strut-based repeating unit cells can be used. Additionally, a first outer layer 3704 is disposed on a top surface 3702a of the inner lattice structure 3702 and is configured to contact tissue, and a second outer layer 3706 is disposed on a bottom surface 3702b of the inner lattice structure 3702. and configured to contact cartridge 3800 .

First outer layer 3704 can have a variety of configurations, but in the illustrated embodiment, first outer layer 3704 creates hexagonal openings 3712 that extend through first outer layer 3704 . It is a lattice structure formed from struts 3710 interconnected to do so. These openings 3712 can be configured to promote tissue ingrowth. Those skilled in the art will appreciate that the struts can be interconnected in a variety of other ways resulting in openings of different sizes and shapes, and thus the lattice structure of the first outer layer is not limited to that shown in the figures. would do. Additionally, the first outer layer 3704 may have a lower compression ratio, at least compared to the inner lattice structure 3702, and thus may be less compressible. As a result, this may allow tissue to further penetrate the openings 3712 and thus the adjunct 3700 when the adjunct 3700 is stapled to tissue, thereby further promoting tissue ingrowth ( 38A and 38B).

Second outer layer 3706 may have a variety of configurations, but in this illustrated embodiment, second outer layer 3706 is in the form of film 3714 having protrusions 3716 extending outwardly therefrom. Protrusions 3716a, 3716b, 3716c are configured to mate with surface features 3802, 3804, 3806 of cartridge 3800, such as surface features 216, 218, 220 of cartridge 200 of FIGS. 1-2C. . This mating interaction substantially prevents slidable movement of support member 3700 relative to cartridge 3800, as shown in FIGS. 37B and 38A. 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 differ.

Alternatively or additionally, second outer layer 3706 may include elongate projections 3730 configured to be inserted into longitudinal slots 3808 of cartridge 3800 . The elongated projections 3730 can have a variety of configurations, but in this illustrated embodiment the elongated projections 3730 have a rectangular shape, and in some embodiments the elongated projections 3730 span the entire length of the backing material. (eg, in the z-direction), but in other embodiments the elongated protrusion 3730 may extend along a portion of the length. In certain embodiments, the elongated projection 3730 can be broken down into smaller elongated discrete portions.

In other embodiments, as shown in FIG. 39A, the second outer layer 3900 each extends outwardly from and away from opposing outer surfaces 3900a, 3900b of the second outer layer 3900 (FIG. 39B). There may be four sets of tabs 3902a, 3902b, 3904a, 3904b, 3906a, 3906b, 3908a, 3908b (3902b, 3904b, 3906b, and 3908b partially obscured in FIG. 39A). The four sets of tabs 3902 , 3904 , 3906 , 3908 can have various configurations, but in this illustrated embodiment, the four sets of tabs 3902 , 3904 , 3906 , 3908 are each located on the cartridge 3901 . It has hook-shaped configurations that engage respective portions of the opposing outer flanges 3910a, 3910b, 3910a, 3910b, 3914a, 3914b, 3914a, 3914b. Additionally, when the cartridge 3901 includes a longitudinal slot 3918 , such as a knife slot, the second outer layer 3900 can include pin features 3912 configured to engage the longitudinal slot 3918 . For example, pin feature 3912 may comprise two opposing sets of pins intermittently spaced from each other along longitudinal slot 3918 (only two opposing tabs 3912a, 3912b of one set are shown in FIGS. 39B). As shown in more detail in FIG. 39B, a first pin 3912a engages a first wall 3918a of longitudinal slot 3918 and a second pin 3912b engages a second opposing wall 3918b of longitudinal slot 3918. engage with.

As noted above, in some embodiments, the second outer layer can be an adhesive film. In one exemplary embodiment, as shown in FIG. 40, support material 4000 is disposed on top surface 4001a of cartridge 4001, such as cartridge 200 of FIGS. 1-2C. The auxiliary material 4000 includes an inner structure 4002, a first outer layer 4004 disposed on the upper surface 4002a of the inner structure 4002, and a second outer layer 4004 disposed on the opposite bottom surface 4000b facing the upper surface 4002a of the inner structure 4002. 2 outer layers 4006; Other than the differences detailed below, the adjunct 4000 may be similar to the adjunct 3700 of FIGS. 37A-38B, and thus common features will not be described in detail herein. As shown, internal structure 4002 is formed of interconnected repeating unit cells 4008, such as unit cell 810 of FIGS. 8A-9B. Additionally, the second outer layer 4006 is in the form of an adhesive film attached to the top surface 4001 a of the cartridge 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 can be found in US Pat. No. 10,349,939, which is incorporated herein by reference in its entirety.

Staple Pocket Grid In some embodiments, the backing material can also include a grid structure extending from the second outer layer and configured to be inserted into staple pockets or recessed channels of the staple cartridge. For example, as shown in FIG. 41A, the support material 4100 includes an internal lattice structure 4102 extending between two outer layers 4104,4106. The internal lattice structure 4102 is generally formed of interconnected repeating unit cells, which are omitted from this figure, although any of the repeating unit cells disclosed herein can be used. can be Further, each of the two outer layers 4104, 4106 can be formed of either a lattice structure or a film, and thus the two outer layers are each generally shown in FIGS. 41A-41C. First outer layer 4106 is configured to contact tissue, and second outer layer 4104 is configured to generally contact cartridge 4101, as shown in FIGS. 41B-41C. Cartridge 4101 is similar to cartridge 200 of FIGS. 1-2C, and thus common features will not be described in detail herein.

As further shown in FIGS. 41A-41C, the support material 4100 includes staple pocket grids 4110a, 4110b, 4110c extending outwardly from the second outer layer 4104. As shown in FIGS. The staple pocket grids may serve as separate compression zones of the backing material 4100, e.g., the staple pocket grids 4110a, 4110b, 4110c reduce the bulk of the backing material so as not to substantially add solid height to the overall backing material. may have different compression ratios than The staple pocket grids can have a variety of configurations, but in this illustrated embodiment, two sets of three staple pocket grids 4110a, 4110b, 4110c are located on either side of the intended cut line of the backing material. There are longitudinal rows. Staple pocket grids can have a variety of configurations, but each staple pocket grid is formed of five U-shaped struts. The perimeter shape and size surrounding each staple pocket grid 4110a, 4110b, 4110c can be triangular or diamond-shaped and complementary to the shape and size of the corresponding staple pocket 4112a, 4112b, 4112c, which can also be triangular or diamond-shaped. could be. In other embodiments, the lattice structure and staple pocket shapes and sizes may vary. As shown in FIGS. 41B-41C, when the support material 4100 is disposed on the cartridge 4101, at least a portion of the staples 4114a, 4114b, 4114c within the cartridge 4101 are aligned with the respective staple pocket grids 4110a, 4110b, 4110c. Extends through and is thus captured by the staple crown when the auxiliary material is stapled into tissue. As such, the staple pocket grid can also aid in attachment of backing material to the staple cartridge and/or alignment of backing material with respect to the staples.

Structural configurations of the unit cells disclosed herein also provide variable mechanical response within the same support, e.g. can be adjusted to provide For example, in certain embodiments, the supplemental material is formed of at least two or more different lattice structures positioned side-by-side to create at least two substantially different compression properties within the same supplemental material. obtain.

As generally shown in FIG. 42A, the support material 4200 can have one inner lattice structure 4202 and two outer lattice structures 4204, 4206, each lattice structure 4202, 4204, 4206 having a respective compressive strength of the support material 4200. Zones C ₁ , C ₂ , C ₃ are defined. In this embodiment, the first and second outer lattice structures are structurally identical, so _C2 and C3 _are the same. As shown, lattice structures 4202 , 4204 , 4206 are laterally offset from each other with respect to the longitudinal axis of backing 4200 . That is, the first outer grid structure 4204 is positioned directly adjacent to the first longitudinal side (obstructed) of the inner grid structure 4202, and the second outer grid structure 4206 is located on the inner grid structure 4202. Positioned directly adjacent to the second opposite longitudinal side (blocked). Each lattice structure can be formed by any of the repeating unit cells disclosed herein, three lattice structures 4202, 4204, 4206 are shown without any unit cells. Those skilled in the art will appreciate that each lattice structure can be formed of pillar-based repeating unit cells or pillarless-based repeating unit cells.

As further shown, an intended cut line _{C L} of the backing member 4200 is defined across the internal lattice structure 4202 and along the longitudinal axis LA of the backing member 4200 . Accordingly, in this illustrated embodiment, the inner lattice structure 4202 may be configured to be stiffer and thus exhibit a higher resistance to compression compared to the outer lattice structures 4204,4206. Thus, the resulting backing material 4200 can have variable compressive strength in a direction transverse to the cut line CL of backing material ₂₄₂₀₀ (eg, y-direction). Thus, this variable compressive strength can facilitate tissue compression transitions in the outermost staple row 4210 as the auxiliary material is stapled to tissue, as shown in FIG. 42B.

Figures 43A-43B illustrate another embodiment of a support member 4300 having variable compressive strength along a direction (eg, y _- direction) transverse to its longitudinal axis LA. In this illustrated embodiment, the support material 4300 is formed of three different lattice structures 4310, 4320, 4330 each formed of a different repeating unit. More specifically, the first lattice structure 4310 is formed of interconnected first repeating unit cells 4310a, one of which is shown in FIG. 43A, and the second lattice structure 4320 consists of: Formed of interconnected second repeating unit cells 4320a, one of which is shown in FIG. 43A, a third lattice structure 4330 is formed of interconnected third repeating unit cells 4330a. , one of which is shown in FIG. 43A. As will be described in more detail below, by designing each lattice structure differently, the resulting assist material can have different lateral compression responses.

The repeating unit cells 4310a, 4320a, 4330a may have various configurations, but in this illustrated embodiment, the repeating unit cells 4310a, 4320a, 4330a are all pillar-based unit cells. Furthermore, depending on the position of the corresponding lattice structure, the repeating unit cells are constructed to be more or less rigid compared to repeating unit cells of other lattice structures, as described in more detail below. can be configured

Although the three lattice structures 4310, 4320, 4330 can be positioned relative to each other in a variety of different configurations, the first lattice structure 4310 has the intended cutting line C _L of the backing material 4300 through and It is the central most lattice structure of the support member extending along the longitudinal axis _LA . Thus, the first repeating unit cell 4310a can have a less dense and therefore more flexible structural configuration compared to the second and third repeating unit cells, for example as shown in FIG. 43A. . Additionally, the first lattice structure 4310 extends along the entire length L of the support member 4300 . The second lattice structure 4320 is divided into two longitudinal portions 4325a, 4325b. The first longitudinal portion 4325a of the second lattice structure 4320 is positioned against the _first longitudinal sidewall L1 of the first lattice structure 4310 and the second longitudinal side of the second lattice structure 4320 The directional portion 4325b is positioned against the _second opposing longitudinal sidewall L2 of the first lattice structure 4310 (see FIG. 43B). Based on their position relative to the cutting line C, the second repeating unit cell 4320a is the densest compared to the first and third repeating unit cells 4310a, 4330a, for example as shown in FIG. 43A, It can therefore be configured to be the most rigid.

As further shown in FIG. 43A, the third lattice structure is divided into two U-shaped portions 4335a, 4335b, each of which is a first and a second longitudinal portion 4325a of the second lattice structure 4320; 4325b (only outer longitudinal walls L3 and L4 of _each portion _4325a , 4325b are shown in FIG. 43B). As a result, the third lattice structure 4320 defines at least a portion of the perimeter of the support material 4300 . Based on the position of the third lattice structure 4330, the third repeating unit cell has an intermediate density and therefore an intermediate density compared to the first and second repeating cells 4310a, 4320a, as shown in FIG. 43A. It can be configured to impart stiffness, which can help facilitate tissue compression transitions. Further, the structural configuration of third repeat unit 4330a can be configured to promote tissue ingrowth. In certain embodiments, the third lattice structure can also be disposed on at least a portion of the top surface of the second lattice structure, which can further enhance tissue ingrowth into the adjunct.

In some embodiments, the dimensions (eg, wall thickness and/or height) of repeating unit cells may differ between other repeating unit cells. For example, FIGS. 44A-44C show variable compressive strength along a transverse direction (eg, y-direction) relative to its longitudinal axis (eg, z-direction) as a result of different dimensions of a repeating unit cell of a strutless base. Another embodiment of a support material 4400 is shown. As shown in FIGS. 44A-44B, only one half (eg, left half) of backing material 4400 is shown on staple cartridge 4401 having three rows of staples 4405a, 4405b, 4405c. Although the three rows of staples 4405a, 4405b, 4405c can be substantially uniform (eg, nominally identical within manufacturing tolerances), in this illustrated embodiment, the third row of staples 4405c (eg, the outermost staple row) is greater than the staple height of the first and second rows of staples 4405a, 4405b. This difference in staple height can contribute to the overall compression behavior of the backing material. In this illustrated embodiment, the third row of staples 4405c is applied by the first and second rows of staples 4405a, 4405b, for example, to each captured tissue and support material within the respective staple capture regions. A compressive force that is less than the compressive force applied is applied to the tissue and adjuncts captured within, for example, the staple capture region. The support material 4400 includes two sets of three longitudinal arrays of repeating unit cells. Since both sets are identical, only one set of three arrays 4410, 4412, 4414 and one repeating unit cell 4410a, 4412a, 4414a of each of the three arrays are shown in FIGS. 44A-44C. ing.

The repeating unit cells 4410a, 4412a, 4414a can have various configurations. In the illustrated embodiment, repeating unit cells 4410a, 4412a, 4414a are similar in general shape to repeating unit cell 810 of FIGS. 9A-9B. However, the wall thickness and height between at least two repeating cells may differ. As shown, the wall thickness WT from the innermost repeat unit cell 4410a (eg, first repeat unit cell) to the outermost repeat unit cell 4414a (eg, third repeat unit cell) decreases. That is, the wall thickness WT1 of the innermost repeat unit cell 4410a is greater than the wall thickness WT2 of the middle repeat cell 4412a, and the wall thickness WT2 of the middle repeat cell 4412a is less than the wall thickness WT3 of the outermost repeat unit cell 4414. bigger than Further, the heights H1, H2 of each of the innermost repeat unit cell 4410a and the middle repeat unit cell 4412a are the same, and the heights H1, H2 are greater than the height H3 of the outermost repeat unit cell 4414a. . In other embodiments, only wall thicknesses or heights differ between arrays, wall thicknesses differ between only two of the three arrays, or heights differ among all three arrays.

Alternatively or additionally, in cases where the repeating unit cells are shaped like Schwartz P structures, such as Schwartz P structure 810 of FIGS. may differ. For example, as further shown in FIG. 44A, the hollow tubular interconnect 4416 between the innermost repeat unit cell 4410a and the middle repeat unit cell 4412a extends a first length L1 and A hollow tubular interconnect 4418 between the unit cell 4412a and the outermost repeating unit cell 4414a extends a second length L2 that is greater than the first length L1.

The compression behavior of the repeating unit cells 4410, 4410a of the support material 4400 as the support material 4400 is stapled to tissue is schematically illustrated in Figures 44B-44C. Thus, different dimensions of the repeating unit cells in the lateral direction give rise to three different compression zones with different compressive strengths, the first zone having the first compressive strength (e.g., the structural ability to withstand compressive forces in the x-direction). and a second zone defined by a second longitudinal array 4412 of second repeating unit cells 4412a having a second compressive strength. and a third zone is defined by a third longitudinal array 4414 of third repeating units 4414a having a third compressive strength. The compressive strength between each array can be different, but in this 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. . Thus, the first repeating unit 4410a is stiffer than the second repeating untill unit 4412a, and the second repeating unit cell 4412a is stiffer than the third repeating unit cell 4414a.

Cartridge Surface Features In some embodiments, the staple cartridge may be configured with surface features (e.g., staple pocket projections) that may be configured to interact with the backing material that help retain the backing material to the staple cartridge prior to staple deployment. ). For example, in certain embodiments, the surface features may include protrusions extending outwardly from the top surface of the staple cartridge. Alternatively or additionally, the surface features may include recessed channels defined within the top surface of the staple cartridge. Accordingly, the backing material described herein, if present, can be designed in a variety of different configurations suitable for interacting with the surface features of the staple cartridge, thus providing a A releasable attachment mechanism may be provided. Alternatively or additionally, the assisting members described herein have various configurations suitable for interacting with staple legs extending partially outwardly from their respective cavities within the staple cartridge. can be designed with

45A-45C illustrate an exemplary embodiment of a strutless backing material 4500 that can be configured to interact with surface features 4504 of a staple cartridge 4502. FIG. Alternatively or additionally, the backing material 4500 can be configured to interact with legs of staples 4506, 4507, 4508 disposed at least partially within the staple cartridge 4502 (see FIGS. 45B-45C). ). The staple cartridge 4502 can have a variety of configurations, but in this illustrated embodiment, the staple cartridge 4502 has surface features 4504 extending outwardly from a top surface 4502a of the staple cartridge, and the cartridge 4502 Similar to staple cartridge 200 of FIGS. 1-2C, except for U-shaped projections positioned around respective end portions of staple cavities defined therein. As shown, the staple cavities are arranged in first and second sets of three longitudinal rows 4510a, 4510b, 4510c, 4512a, 4512b, 4512c in longitudinal slots 4514 on the first and second sides, respectively. positioned above. Further, for each set, the first and third longitudinal rows 4510a, 4510c, 4512a, 4512c are parallel to each other and the second longitudinal rows 4510b, 4512b are staggered relative to each other.

As further shown in FIGS. 45A-45C, the support material 4500 is formed of interconnected repeating unit cells 4516, each unit cell being structurally similar to the repeating unit cell 810 of FIGS. 9A-9B. . Thus, backing material 4500 is similar to backing material 800 of FIGS. 8A-8F, except that repeating unit cell 4515 is rotated 45 degrees about the X-axis with respect to FIG. 8A. In other words, supplement 800 is shown in a 0-90 configuration, while supplement 4500 is shown in ±45 degree orientation. As a result, repeating unit cells 4516 are oriented (eg, in a repeating pattern) to match the location of surface features 4504 and/or staple cavities 4510a, 4510b, 4510c, 4512a, 4512b, 4512c.

As shown in FIG. 45A, the repeating unit cells 4516 are interconnected with each other and arranged in seven longitudinal rows 4516a, 4516b, 4516c, 4516d, 4516e, 4516f, 4516g, each row having a Gaps are defined (gaps 4518a, 4518b, 4518c, 4520a, 4520b, 4520c are shown in Figure 45, and gaps 4518a, 4518b, 4518c, 4522a, 4522b, 4524a, 4524b, 4524c are shown in Figures 45B-45C. It is shown). The first three longitudinal rows 4516a, 4516b, 4516c are configured to overlap respective staple cavity rows 4510a, 4510b, 4510c and the middlemost row 4516d is configured to overlap longitudinal slots 4514. and the last three longitudinal rows 4516e, 4516f, 4516g are configured to overlap respective staple cavity rows 4512a, 4512b, 4512c. As a result, based on the position of the surface features 4504 relative to the staple cavities, each surface feature 4504 overlaps and at least partially extends through the corresponding void, as shown in part in FIGS. 45B-45C. Extend. Accordingly, each void is configured to receive and engage at least one surface feature, thereby retaining the auxiliary material 4500 in the cartridge 4502 prior to staple deployment. . In other embodiments, all or some of the voids can be replaced with thin areas of material that can be penetrated by at least the surface features.

45B-45C, for each staple cavity row and corresponding row of repeat unit cells, each staple disposed within a staple cavity (staples 4506, 4507, 4508 and corresponding staples 4506, 4507, 4508). (only cavity rows 4510a, 4510b, 4510c are shown in FIG. 45B) extend across each repeat unit cell such that each staple leg overlaps a corresponding void positioned on one side of the repeat unit cell. exist. For example, as shown in FIG. 45B, for a repeating unit cell 4515a and a corresponding staple 4508 in a first unit cell column 4516a, the first leg 4508a and second leg 4508b of the staple 4508 are the second unit. It overlaps the first and second voids 4518a and 4518b, respectively, on either side of the repeating unit cell 4515b in cell row 4516b. As further shown in FIG. 45C, staple legs 4507a, 4507b extend at least partially through gaps 4522a, 4522b, respectively, when backing material 4500 is positioned on top surface 4502a of staple cartridge 4502. . This may further retain the auxiliary material 4500 to the cartridge 4502 prior to staple deployment. Accordingly, the repeat unit cells of the backing material may be positioned between and configured to engage the first and second staple legs of the corresponding staple.

46A-46B illustrate another exemplary embodiment of a post-based assist 4600 that can be configured to interact with surface features of a staple cartridge 4602. FIG. Staple cartridge 4602 is similar to staple cartridge 3901 of FIG. 39A and thus common features will not be described in detail herein. Each surface feature has a U-shaped configuration and is positioned around a respective end of a respective staple cavity and thus a respective longitudinal row of staple cavities (three longitudinal rows of staple cavities 4603a, 4603b, 4603a, 4603b). 4603c only, thus three longitudinal rows of surface features are shown in FIGS. 46A-46B).

As shown in more detail in FIG. 46B, the first surface feature in the longitudinal row (only four first surface features 4604a, 4604b, 4604c, 4604d are shown) and the third surface feature in the longitudinal row. (only four third surface features 4608a, 4608b, 4608c, 4608d are shown) are laterally aligned with each other in the y-direction, so that each A set of first lateral rows 4605a, 4605b, 4605c, 4605d having surface features are formed. The second surface features in the longitudinal row (only four second surface features 4606a, 4606b, 4606c, 4606d are shown) are aligned in the z-direction with respect to the first and second surface features. Laterally offset, thus forming a set of second lateral rows 4607a, 4607b, 4607c, 4607d each having a respective second surface feature.

Further, except for the differences detailed below, the support material 4600 is similar to the support material 3000 of FIGS. 30A-30B. Adjunct 4600 includes a tissue contact layer 4616, a cartridge contact layer 4618 and an internal structure 4620 extending therebetween.

As shown in FIG. 46 and shown in more detail in FIG. 46B, each opening in the cartridge contact layer 4618 (only eight openings 4622a, 4622b, 4622c, 4622d, 4622e, 4622f, 4622g, 4622h are shown). are configured to receive at least one respective surface feature. As a result, when backing material 4600 is positioned over staple cartridge 4602, respective surface features extend into cartridge contact layer 4618 and engage respective openings. By way of example, as shown in FIG. 46, the first and third surface features 4604a, 4608a of the first lateral row 4605a extend into the first openings 4622a and extend into at least the first cross struts 4624a. while the second surface feature 4606a of the second lateral row 4607a extends into the second opening 4622b and engages at least the first cross strut 4624a and the opposing cross strut 4624b. do.

The cross struts of cartridge contact layer 4618 (only eight cross struts 4624a, 4624b, 4624c, 4624d, 4624e, 4624f, 4624g are shown in Figure 46B) can 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: can be uneven. In this illustrated embodiment, the widths of cross struts 4624a, 4624c, 4624e, 4624g are uniform, while the widths of the remaining cross struts 4624b, 4624d, 4624f are non-uniform. Those skilled in the art will appreciate that the structural configuration of the cross struts of the cartridge contact layer can depend on the structural configuration of at least the surface features. For example, in this illustrated embodiment, at least a portion of the cross struts include bowing segments to accommodate the U-shaped configuration of the surface features. Depending on the orientation of the U-shaped configuration, some of the bowing segments have a convex configuration while other bowing segments have a concave configuration. Further, the structural configuration of the cross struts 4626a, 4626b, 4626c, 4626d, 4626e, 4626f, 4626g of the tissue contact layer 4616 can have various configurations, but as shown in FIG. 4626c, 4626d, 4626e, 4626f, 4626g are structurally similar to corresponding cross struts 4624a, 4624b, 4624c, 4624d, 4624e, 4624f, 4624g of cartridge contact layer 4618;

Variable Tissue Gap In some embodiments, it is desirable to have a variable tissue gap between the assist material and the anvil to enhance tissue grasping and stabilization during tissue stapling and/or cutting. There is However, variable tissue spacing can adversely affect the ability of the support to apply substantially uniform pressure to the stapled tissue. Accordingly, as described in more detail below, the adjuncts disclosed herein can be configured to create variable tissue spacing for tissue manipulation and, when stapled into tissue, It can be further configured to apply a substantially uniform pressure (eg, a pressure in the range of about 30 kPa to 90 kPa) for a predetermined period of time (eg, at least 3 days) to the tissue stapled to the adjunct. In certain embodiments, the adjunct may apply a pressure of at least about 30 kPa for at least 3 days. In such embodiments, after 3 days, the adjuvant will apply an effective amount of pressure (e.g., about 30 kPa or less) to the tissue so that the tissue can remain sealed throughout the tissue's healing cycle (e.g., about 28 days). ). For example, the auxiliary material can be configured to apply pressure to the stapled tissue, the pressure decreasing from about 30 kPa to 0 kPa (eg, linear decrease) over a predetermined period of time from about 3 days to 28 days.

Generally, the adjunct may include a tissue contacting surface, a cartridge contacting surface, and an internal structure extending therebetween, the internal structure including at least two lattice structures each having a different compressive strength. The at least two lattice structures have a structure, shape, or point of interconnection laterally along the width of the lattice structure and/or longitudinally along the length of the lattice structure to form a variable tissue gap. can differ in In some embodiments, the geometry of the base of the support may be formed of unit cells on a pillarless base. In such embodiments, the outer geometry of the support may be formed with a strut-based lattice structure. In other embodiments, the geometry of the base may be formed of strut-based unit cells.

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

As shown in FIG. 47A and in more detail in FIG. 47C, the support member 4706 has a tissue contacting surface 4716, a cartridge contacting surface 4718, and an internal structure 4720 extending therebetween. The internal structure 4720 can have a variety of configurations, but in this illustrated embodiment, the internal structure includes two lattice structures 4722, 4724 each having a different compressive strength, and the support material 4706 is a tissue When in the deployed state, it is configured to apply substantially uniform pressure to the stapled tissue for a predetermined period of time. In this illustrated embodiment, first lattice structure 4722 is configured to have a first compressive strength and second lattice structure 4724 is configured to have a second compressive strength that is greater than the first compressive strength. It is configured to have compressive strength.

Each of the first and second lattice structures 4722, 4724 may generally be formed of unit cells such as those disclosed herein, e.g., pillarless-based unit cells and/or pillar-based unit cells. . For example, in certain embodiments, one or more unit cells may include at least one triple periodic minimal surface structure, such as those disclosed herein. Alternatively or additionally, one or more of the unit cells may be defined by interconnected struts (eg, planar struts), such as the strut-based unit cells disclosed herein. In certain embodiments, the first and second lattice structures 4722, 4724 may differ in density (eg, number of unit cells) and/or shape. Accordingly, other than general shapes and thicknesses, specific structural configurations of each of the first and second grating structures 4722, 4724 are not shown.

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

The top and bottom surfaces 4722a, 4724a, 4724a, 4724b of each lattice structure 4722, 4724 can have a variety of different shapes. In this illustrated embodiment, the top and bottom surfaces 4722a, 4722b of the first lattice structure 4722 each have a convex configuration. Accordingly, the top surface 4724a of the second grating structure 4724 has a concave configuration. Further, because the top or deck surface 4707a of the staple cartridge 4707 has a generally planar configuration (eg, in the YZ plane), the bottom surface 4724b of the second lattice structure 4724 is also generally planar (eg, in the YZ plane). It has a shape configuration. The overall geometry of the resulting assist member 4706 thus creates a curved tissue contacting surface 4716 against the tissue compressing surface 4710 of the anvil 4702, thus providing a variable tissue gap between the anvil 4702 and the stapling assembly 4704. (eg, two different gap amounts are denoted as TG1, TG2).

In this illustrated embodiment, due to the concave shape of the top surface 4722a of the first grating structure 4722, the total thickness T _C at the center (eg, in the x-direction) of the support member 4706 (eg, two opposing The distal lateral edges 4728a, 4728b of the backing member 4706 (e.g., the outer longitudinal edge of the backing member 4706 extending in the z-direction) are shown by dashed lines 4726 that are equidistant from the distal lateral edges 4728a, 4728b that extend in the z-direction. direction perimeter) is greater than the total thickness _P1 , T _P2 (eg, in the x-direction) in each. As a result, the overall uncompressed thickness of the backing member 4706 varies laterally outward (eg, ±y-directions) along its width relative to its center, and thus the longitudinal axis of the backing member 4706 (eg, , extending in the z-direction). Therefore, the uncompressed thickness of the adjunct decreases laterally while the tissue gap increases. Further, since the two distal lateral edges 4728a, 4728b are shown to be of the same thickness, the lateral thickness variation from the center of the backing 4706 to each edge is the same. In other embodiments, the two distal lateral edges can have different thicknesses, so that the lateral thickness variation from the center of the backing to each edge is different.

As further shown, due to the uneven surface relationship between the first and second lattice structures 4722, 4724 and their position and compressive strength relative to each other, the thickness (eg, x-direction) of each lattice structure is Also, in this embodiment, laterally outward (e.g., , ±y directions). Thus, in this illustrated embodiment, the first lattice structure 4722 is thicker than the second lattice structure 4724 at the center of the backing material, and the second lattice structure 4724 is thicker than the distal lateral edges of the backing material 4706. Thicker than the first grating structure 4722 at each of the portions 4728a, 4728b. As a result, the adjunct 4706 is most compressible at its center and least compressible at its distal lateral edges 4728a, 4728b; thickness T _compression (see FIG. 47B). This allows the support material 4706 to apply pressure that is not proportional to its uncompressed variable thickness. Therefore, the adjunct can be formed using staples 4712a, 4712b, 4712c, 4714a, 4714b, 4714c in a substantially uniform tissue T (e.g., tissue having the same or substantially the same thickness across the width of the adjunct, y-direction). When stapled, the support material 4706 may apply a substantially uniform pressure P to the stapled tissue T (see FIG. 47B).

48A-48B show another exemplary embodiment of a surgical end effector 4800 having an anvil 4802 and stapling assembly 4804. FIG. The stapling assembly 4804 includes a backing member 4806 that is releasably retained on a top or deck surface 4807a of the staple cartridge 4807 (eg, the cartridge surface facing the anvil). Except for the differences described below, anvil 4802 is similar to anvil 4702 of FIGS. 47A-47B, and staple cartridge 4807 is similar to that of FIG. 1, except that the top or deck surface 4807a is curved. It is similar to cartridge 200 of FIGS. 2C through 2C, and thus the common features will not be described in detail here. 48A shows surgical end effector 4800, and thus anvil 4802, in a fully closed position, while FIG. 48B shows tissue T clamped between anvil 4802 and stapling assembly 4802 with staples (two sets 4812a, 4812b, 4812c, 4814a, 4814b, 4814c (only three of 4812a, 4812b, 4812c, 4814a, 4814b, 4814c are shown). Prior to deployment, in some embodiments the staples may be fully disposed within the staple cartridge 4807, as shown in FIGS. 48A and 48C, while in other embodiments some or all of the staples may be , may be partially disposed within staple cartridge 4807 . Although the two sets of staples 4812a, 4812b, 4812c, 4814a, 4814b, 4814c may have various configurations, in this illustrated embodiment the two sets of staples are the same, thus each set , the first staples 4812a, 4814a (e.g., the innermost row of staples) have a first height and the second staples 4812b, 4814b (e.g., the middle row of staples) are: Having a second height greater than the first height, the third staples 4812c, 4814c (eg, the outermost rows of staples) have a third height greater than the second height.

As shown in FIG. 48A and in more detail in FIG. 48C, the support member 4806 has a tissue contacting surface 4816, a cartridge contacting surface 4818, and an internal structure 4820 extending therebetween. The internal structure 4820 can have a variety of configurations, but in this illustrated embodiment the internal structure 4820 includes two lattice structures 4822, 4824 each having a different compressive strength, and the support material 4806 is When in the tissue deployment state, it is configured to apply substantially uniform pressure to the stapled tissue for a predetermined period of time. In this illustrated embodiment, the first lattice structure 4822 is configured to have a first compressive strength and the second lattice structure 4824 is configured to have a second compressive strength that is greater than the first compressive strength. It is configured to have compressive strength.

Each of the first and second lattice structures 4822, 4824 may generally be formed of unit cells such as those disclosed herein, e.g., pillarless-based unit cells and/or pillar-based unit cells. . For example, in certain embodiments, one or more unit cells may include at least one triple periodic minimal surface structure, such as those disclosed herein. Alternatively or additionally, one or more unit cells may be defined by interconnected struts (eg, planar struts), such as the strut-based unit cells disclosed herein. Accordingly, the specific structural configuration of each of the first and second grating structures 4822, 4824 are not shown, other than their general shape and thickness.

The first and second grid structures 4822, 4824 each extend from top surfaces 4822a, 4824a to bottom surfaces 4822b, 4824b. Depending on the overall structural configuration of the adjunct, at least a portion of the top surface of the at least one lattice structure may serve as the tissue-contacting surface of the adjunct, and at least a portion of the bottom surface of the at least one lattice structure may serve as a tissue contacting surface of the adjunct. can function as the cartridge contact surface of the In this illustrated embodiment, the first lattice structure 4822 is narrower in width (eg, in the y-direction) compared to the second lattice structure; Positioned only at the top. Thus, the entire bottom surface 4822b of the first grid structure 4822 contacts only a portion of the top surface 4824a of the second grid structure 4824, eg, the top surface 4823a of the central region 4823 only. As a result, the two exposed portions 4825a, 4825b of the top surface 4822a of the first lattice structure 4822 and the top surface 4824a of the second lattice structure 4824 form the tissue contacting surface 4816, and the bottom surface 4824b of the second lattice structure 4824 , form the cartridge contact surface 4818 .

The top and bottom surfaces 4822a, 4824a, 4824a, 4824b of each lattice 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 backing material is releasably retained. In this illustrated embodiment, the top and bottom surfaces 4822a, 4822b of the first lattice structure 4822 each have a convex configuration. Thus, although the top surface 4823a of the central region 4823 of the second lattice structure 4824 has a convex configuration, the two exposed portions 4825a, 4825b of the top surface 4824a of the second lattice structure 4824 each extend (eg, in the y-direction ) has a generally planar configuration. Further, because the top or deck surface 4807a of the staple cartridge 4807 has a convex configuration, the bottom surface 4824b of the second lattice structure 4824 has a concave configuration.

In this illustrated embodiment, due to the structural connection of the first and second lattice structures 4822, 4824 and the resulting tissue contacting surface 4816, the center of the support member 4806 (eg, x A total thickness T _C (e.g., indicated by dashed line 4826 equidistant from the outermost distal lateral edges 4828a, 4828b) (in the direction of , the outer longitudinal perimeter of the support member 4806 extending in the z-direction) is less than the total thickness T _P1 , T _P2 (eg, in the x-direction) at each. As a result, the overall uncompressed thickness of the backing material 4806 varies laterally outward (eg, in the ±y direction) along its width relative to its center. Accordingly, the overall uncompressed thickness of the backing material varies transversely to the longitudinal axis of the backing material 4806 (eg, extending in the z-direction).

As further shown, due to the structural relationship of at least the first and second lattice structures 4822, 4824 and their compressive strength relative to each other in combination with the curved configuration of the upper surface 4807a of the staple cartridge 4807 (e.g., x The thickness of each grating (in the direction) is also laterally outward (e.g., ± y direction). Thus, in this illustrated embodiment, first lattice structure 4822 is thicker than second lattice structure 4824 at the center of backing material 4806 . As a result, the secondary material 4806 is most compressible at its center and least compressible at its outermost distal lateral edges 4828a, 4828b. This allows the support material 4806 to apply substantially uniform pressure despite variations in its compressed thickness. Thus, a substantially uniform tissue T staple 4812a in which the backing material has the same or substantially the same thickness (eg, in the x-direction) across the width of the backing material (eg, in the y-direction). , 4812b, 4812c, 4814a, 4814b, 4814c, the backing material 4806 is compressed to a non-uniform compression thickness while applying a substantially uniform pressure P to the stapled tissue T. (See FIG. 48B.) As further shown, in this illustrated embodiment, only the second grating 4824 overlaps the outermost rows of staples 4812c, 4814c.

In other embodiments, the second lattice structure can be narrower than the first lattice structure. For example, as shown in FIG. 49, the support material 4900 includes first and second lattice structures 4906, 4908 having semi-circular concentric configurations, the first lattice structure 4906 surrounding the second lattice structure 4908. do. As a result, the top surface 4906a of the first lattice structure 4906 forms the tissue contacting surface 4902 of the backing material 4900 and the bottom surfaces 4906b, 4908b of the first and second lattice structures 4906, 4908 are the cartridge contacting surfaces of the backing material 4900. A surface 4904 is formed.

As noted above, the support material may have two lattice structures that differ in structure, shape, or interconnection in the longitudinal direction (eg, in the z-direction) along the length of the support material. For example, as shown in FIGS. 50A-50B, the support material 5002 includes two lattice structures 5004, 5006, each different in structure and shape from each other and (eg, longitudinal axis L _A , extending in the z-direction).

FIGS. 50A-50B illustrate surgical end effector 5000, except that assist member 5002 has variable compressive strength along its length extending along longitudinal axis LA (eg, in the z _- direction). 5000 shows an exemplary embodiment of a surgical end effector 5000 similar to FIG. As shown in FIG. 50A and in more detail in FIG. 50C, backing material 5002 is positioned on top or deck surface 5003a of staple cartridge 5003. As shown in FIG. Staple cartridge 5003 is similar to staple cartridge 4707 of FIGS. 47A-47C with staples 4712a, 4712b, 4712c, 4714a, 4714b, 4714c disposed therein, and thus common features are not described herein. .

The support member 5002 has a tissue contacting surface 5008, a cartridge contacting surface 5010, and an internal structure 5012 extending therebetween. The internal structure 5012 can have a variety of configurations, but the first and second lattice structures 5004, 5006 each have different compressive strengths such that when the support material 5002 is in the tissue deployed state, a predetermined configured to apply a substantially uniform pressure (eg, a pressure in the range of 30 kPa to 90 kPa) to the tissue stapled to the support material for a period of time (eg, at least 3 days). In this illustrated embodiment, the first lattice structure 5004 is configured to have a first compressive strength and the second lattice structure 5006 has a second compressive strength greater than the first compressive strength. It is configured to have compressive strength. Therefore, the second lattice structure 5004 is stiffer compared to the first lattice structure 5006 . In other embodiments, the first lattice structure may be stiffer than the second lattice structure.

Each of the first and second lattice structures 5004, 5006 may generally be formed of unit cells such as those disclosed herein, e.g., pillar-less based unit cells and/or pillar-based unit cells. . For example, in certain embodiments, one or more unit cells may include at least one triple periodic minimal surface structure, such as those disclosed herein. Alternatively or additionally, one or more unit cells may be defined by interconnected struts (eg, planar struts), such as the strut-based unit cells disclosed herein. In certain embodiments, the first and second lattice structures 5004, 5006 may differ in density (eg, number of unit cells) and/or shape. Accordingly, other than general shapes and thicknesses, specific structural configurations of each of the first and second grating structures 5004, 5006 are not shown.

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

The first and second grating structures 5004, 5006 can have various configurations, but each grating structure is different (eg, x) along the length of the assist material (eg, extending in the z-direction). direction) has an uncompressed thickness. As shown, the top surface 5004a of the first lattice structure 5004 slopes from the proximal end 5002a of the backing 5002 to the distal end 5002b. Further, because the top or deck surface 5003a of the staple cartridge 5003 has a generally planar configuration (eg, in the XZ plane), the bottom surface 5006b of the second lattice structure 5006 is also generally planar (eg, in the XZ plane). It has a shape configuration. As a result, a variable tissue gap (e.g., two different gap amounts are shown in T _G1 , T _G2 ) is independent of the shape of the anvil 5001 and staple cartridge 5003 top or deck surface 5003a. created between

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

Consistent Tissue Gap In some embodiments, it is desirable to have a consistent tissue gap between the support and the anvil to enhance tissue grasping and stabilization during tissue stapling and/or cutting. It is desirable. However, consistent tissue spacing can adversely affect the ability of the support to apply substantially uniform pressure to the stapled tissue. Accordingly, as described in more detail below, the adjuncts disclosed herein can be configured to create a consistent tissue gap for tissue manipulation, and when stapled into tissue, , a substantially uniform pressure (eg, a pressure in the range of about 30 kPa to 90 kPa) for a predetermined period of time (eg, at least 3 days) to the tissue stapled to the adjunct. In certain embodiments, the adjunct may apply a pressure of about 30 kPa for at least 3 days. In such embodiments, after 3 days, the adjuvant applies an effective amount of pressure (e.g., linear pressure) to the tissue such that the tissue may remain sealed throughout the tissue's healing cycle (e.g., about 28 days). reduction, eg, about 30 kPa or less). For example, the auxiliary material can be configured to apply pressure to the stapled tissue, the pressure decreasing from about 30 kPa to 0 kPa (eg, linear decrease) over a predetermined period of time from about 3 days to 28 days.

In some embodiments, the adjunct has a tissue-contacting surface that is at least partially planar (e.g., in the y-direction) and non-planar (e.g., along the width of the adjunct, e.g., in the y-direction). can be designed with opposing cartridge contact surfaces that are The non-planar surface of the cartridge contacting surface may be along and against, for example, the curved or stepped top or deck surface of the staple cartridge (e.g., the cartridge surface facing the anvil) or the stepped tissue compression surface of the anvil. can vary proportionally.

In general, the adjunct may include a tissue contacting surface, a cartridge contacting surface, and internal structures extending therebetween. In some embodiments, the support material may be formed of at least two grid structures, a first grid structure having a non-planar bottom surface defining at least a portion of the cartridge contact surface, and a second grid structure. The (eg, primary lattice structure) has a top surface that is generally planar and has at least a portion that defines at least a portion of the tissue contacting surface. In other embodiments, the internal structure may be formed of a single lattice structure formed of repeating unit cells that differ in shape and/or size transversely to the longitudinal axis of the support material. As a result, the backing material has a tissue contacting surface having a planar surface and a non-planar surface, and a non-planar tao (e.g., a and a non-planar cartridge contact surface configured to mate with the anvil-facing cartridge surface). Accordingly, a substantially consistent tissue gap can be created independent of the shape of the top or deck surface of the staple cartridge.

In some embodiments, the dimensions (e.g., wall thickness and/or height) of the repeating unit cells can be varied so that when the auxiliary material is stapled to tissue, the auxiliary material has a predetermined A substantially uniform pressure (eg, a pressure in the range of 30 kPa to 90 kPa) can be applied to the stapled tissue for a period of time (eg, at least 3 days). For example, the repeat unit cells of one longitudinal row may differ compared to the repeat unit cells of an adjacent longitudinal row. Accordingly, the adjuvant may create a tissue gap consistent with the anvil prior to staple deployment and the stapled tissue for a predetermined period of time (e.g., at least 3 days) when in the tissue deployed state. can be designed to apply a substantially uniform pressure (for example, a pressure in the range of 30 kPa to 90 kPa).

FIG. 51A shows an exemplary embodiment of a surgical end effector 5100 having an anvil 5102 and stapling assembly 5104. FIG. The stapling assembly 5104 includes a backing member 5106 that is releasably retained on a top or deck surface 5108a of the staple cartridge 5108 (eg, the cartridge surface facing the anvil). Other than the differences described in detail below, staple cartridge 5108 is similar to cartridge 4807 of FIGS. 48A-48C, and therefore common elements will not be described in detail herein. Although not shown, anvil 5102 is pivotally coupled to elongated staple channel, such as elongated staple channel 104 in FIG. 1, and stapling assembly 5104 is positioned within and coupled to elongated staple channel. . The anvil 5102 can have a variety of configurations, but in the embodiment shown in FIG. 51A, the anvil 5102 includes a cartridge-facing surface having staple pockets 5110 defined therein and a generally planar tissue compression surface. 5112 extend between staple pockets 5110 . FIG. 51A shows the surgical end effector 5100, and hence the anvil 5102, in a fully closed position with no tissue positioned between the anvil 5102 and the support 5106, and the staples (two) disposed within the staple cartridge 5108. (only three staples 5114a, 5114b, 5114c, 5116a, 5116b, 5116c of the set are shown). Prior to deployment, in some embodiments, staples 5114a, 5114b, 5114c, 5116a, 5116b, 5116c may be partially disposed within staple cartridge 5108, as shown in FIG. , some or all of the staples may be completely disposed within staple cartridge 5108 . Although the staples 5114a, 5114a, 5114c, 5116a, 5116b, 5116c can have a variety of configurations, in this illustrated embodiment the staples 5114a, 5114a, 5114c, 5116a, 5116b, 5116c are at least substantially uniform ( For example, having a pre-deployed (eg, unformed) staple height that is nominally the same within manufacturing tolerances. In some embodiments, the staples 5114a, 5114a, 5114c, 5116a, 5116b, 5116c can be substantially uniform (eg, nominally identical within manufacturing tolerances).

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

The first lattice structure 5124 generally includes struts such as struts 5228a, 5228b, 5228c, 5228d, 5230a, 5230b, 5230c, 5230d of FIGS. 52A-52B or those disclosed herein, such as struts. It may be formed of unit cells such as void-based unit cells and/or pillar-based unit cells. Therefore, other than a general overall shape and thickness, no specific structural configuration of first lattice structure 5124 is shown.

A first lattice structure 5124 extends between a second lattice structure 5126 and a top or deck surface 5108a of staple cartridge 5108 . As shown, the uncompressed thickness of the first lattice structure 5124 varies laterally with respect to the longitudinal axis L _A of the support member 5106 (eg, L _A extends in the z-direction). These lateral differences are due to the fact that the portion of the cartridge contacting surface 5120 of the backing member 5106 formed by the bottom surface 5124b of the first lattice structure 5124 is less than the curved top or deck surface 5108a (eg, concave configuration) of the staple cartridge 5108. ) along the curved top surface or deck surface 5108a of the staple cartridge 5108. As a result, variations in the thickness of the first grating structure 5124 can accommodate variations in the top or deck surface 5108a. In addition, this also laterally changes the compression ratio of the first lattice structure 5124, which in this illustrated embodiment is such that the compression behavior of the auxiliary material 5106 is primarily that of the second lattice structure 5126. The increase is due to the lateral increase in uncompressed thickness as driven by the compressive properties.

A second lattice structure 5126 is formed of interconnected repeating unit cells arranged in two sets of three longitudinal arrays, the first set on one side of the intended cutting line of the support material. and the second set is positioned on the second side of the intended cutting line of the backing material. For simplicity, only three unit cells 5132a, 5132b, 5132c, 5134a, 5134b, 5134c from each set are shown. The repeating unit cells can have a variety of configurations, but in this illustrated embodiment all of the repeating unit cells have generally uniform dimensions (e.g., nominally identical within manufacturing tolerances) and are shown in FIG. 9A. 9B, and therefore the common features will not be described in detail here. Accordingly, the second lattice structure is similar to the support material 800 of FIGS. 8A-8F, and therefore common features will not be described herein.

As shown, at least a portion of upper surface 5126a is generally planar and thus includes generally planar surfaces 5127 (eg, each in the y-direction) with non-planar surfaces 5129 extending therebetween. Top surface 5126 a defines tissue contacting surface 5118 of support member 5106 , tissue contacting surface 5118 being formed of planar surface 5127 and non-planar surface 5129 . The upper surface, and therefore the substantially planar surfaces 5127 and non-planar surfaces 5129 of the tissue contacting surface 5118, alternate along the width of the second lattice structure 5126 (extending in the y-direction) to provide consistent tissue spacing. A (eg, alternating between substantially uniform tissue spacing and variable tissue spacing) is created between the anvil 5102 and the support member 5106 . In this illustrated embodiment, each substantially uniform tissue gap T _G is created between tissue compressing surface 5112 of anvil 5102 and substantially planar surface 5127 of tissue contacting surface 5118 . Variable tissue gaps (the only two variable gaps are T _G1 , T _G2 ) extend between tissue compression surface 5112 of anvil 5102 and adjacent unit cells of second lattice structure 5126 , tissue contacting surface 5118 . It occurs between the planar surface 5129 and the planar surface 5129 . Those skilled in the art will appreciate that the substantially uniform and variable tissue gap length (extending in the x-direction) can depend at least on the structural configuration of the tissue-contacting surface, and thus the structural configuration of the second lattice structure. will understand.

While the heights between repeating unit cells 5132a, 5132b, 5132c, 5134a, 5134b, 5134c are substantially uniform, the wall thicknesses may differ, thus resulting in different compression ratios. In this illustrated embodiment, the three longitudinal arrays of the two sets are identical, so for each set, from the first repeating unit cell 5132a, 5134a (eg, the innermost repeating unit cell) to the second The wall thickness _WT up to the 3 repeating unit cells 5132c, 5134c (eg, the outermost repeating unit cell) is similarly reduced. Therefore, only one set of three longitudinal arrays is shown in FIG. 51B. The wall thickness W _T1 of the first repeating unit cell 5132a (not shown) is greater than the wall thickness W _T2 of the second repeating unit cell 5132b (eg, the middle repeating unit cell), and the second repeating unit cell 5132b wall thickness WT2 is greater than wall thickness _WT3 of the third repeating unit cell _5132c , 5134c. As a result, the compression ratio from the first repeating unit cell 5132a, 5134a to the third repeating unit cell 5132c, 5134c increases, and thus the first repeating unit cell 5132a, 5134a is least compressed (e.g., most rigid), the third repeating unit cell 5132c, 5134c is most compressed (eg, least rigid). That is, the first compression ratio of the first repeating unit cell 5132a, 5134a is less than each of the second and third compression ratios of the second and third repeating unit cells 5132b, 5134b, 5132c, 5134c, respectively. , the second compression ratio is less than the third compression ratio. Accordingly, these compression ratios, in combination with the laterally differing compression ratios of the first lattice structure 5124, produce different overall compression ratios of the backing material 5106 such that the backing material is substantially uniform (e.g., within manufacturing tolerances). and nominally identical) staples 5114a, 5114b, 5114c, 5116a, 5116b, 5116c, the backing material 5106 applies substantially uniform pressure to the stapled tissue for a predetermined period of time. configured.

In certain embodiments, the first lattice structure can be configured to not overlap the staple rows when the backing material is releasably retained on the staple cartridge. Thus, the first lattice structure is not or minimally captured by the staples during deployment. As a result, the first lattice structure contributes no or minimally to the solid height of the adjunct when in the tissue deployed state. Therefore, the densification of the auxiliary material can be delayed.

FIG. 52A shows another exemplary embodiment of a surgical end effector 5200 having an anvil 5202 and stapling assembly 5204. FIG. The stapling assembly 5204 includes a backing material 5206 that is releasably retained on a top or deck surface 5208a of a staple cartridge 5208 (eg, the cartridge surface facing the anvil). Other than the differences described below, the anvil 5202 and staple cartridge 5208 are similar to the anvil 5102 and staple cartridge 5208 of FIGS. 52A-52B, and thus common features will not be described in detail herein. .

The backings 5204 are arranged in two sets of four spaced apart (eg, in the x-direction) in which the first lattice structure 5224 extends between the second lattice structure 5226 and the top or deck surface 5208a of the staple cartridge 5208. It is similar to support member 5104 of FIGS. 51A-51B except that it is formed of two longitudinal rows of vertical planar struts. As shown, the first set is positioned to one side of the intended cut line C _L of the backing material 5206 and the second set is a second size of the intended cutting line C of the backing material 5206. is positioned at For simplicity, only four struts 5228a, 5228b, 5228c, 5228d, 5230a, 5230b, 5230c, 5230d from each set are shown. Although the two sets of struts can have various configurations, in this illustrated embodiment the two sets of struts are the same, so for each set the first struts 5228a, 5230a (eg, the innermost row of struts) has a first height and the second struts 5228b, 5228b (eg, the innermost middle row of struts) have a first height greater than the first height. 2, the third struts 5228c, 5230c (e.g., the outermost middle row of struts) have a third height greater than the second height, and the fourth struts 5228d , 5230d (eg, 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 (eg, along the width of the backing material, in the y-direction) is the longitudinal axis L _A of the backing material 5206 (eg, L _A is along the z-direction). extending). These lateral differences are due to the fact that the portion of the cartridge-contacting surface 5220 of the backing member 5206 formed by the bottom surface 5224b of the first lattice structure 5224 is less than the curved top or deck surface 5208a (e.g., concave configuration) of the staple cartridge 5208. ) along the curved top surface or deck surface 5208a of the staple cartridge 5208. Accordingly, variations in the thickness of the first lattice structure 5224 can accommodate variations in the top or deck surface 5208a.

As further shown in FIG. 52A, the first lattice structure 5224 may have a densification of the backing material 5206 to minimize impact, and the first lattice structure 5224 may include staples 5214a, 5214a, 5214c. , 5216a, 5216b, 5216c. For example, in this illustrated embodiment, none of the struts 5228a, 5228b, 5228c, 5228d, 5230a, 5230b, 5230c, 5230d overlaps any of the staples 5214a, 5214b, 5214c, 5216a, 5216b, 5216c. The staples do not capture the first lattice structure 5224 during deployment. As a result, as the secondary material 5206 is stapled to tissue, the pressure exerted by the secondary material 5206 on the stapled tissue depends entirely or substantially entirely on the compressive properties of the second lattice structure 5226. can.

In some embodiments, the wall thickness and height of each repeating unit cell may differ between other repeating unit cells. For example, FIG. 53 illustrates another exemplary embodiment of a backing material 5300 releasably retained on a top or deck surface 5302a of a staple cartridge 5302 (eg, the cartridge surface facing the anvil). Other than the differences described in detail below, staple cartridge 5302 is similar to staple cartridge 5108 of FIGS. 51A-51B, and therefore common elements will not be described in detail herein. As shown in FIG. 53, only half (eg, right half) of backing material 5300 is shown on staple cartridge 5302 having three rows of staples 5304, 5306, 5308 partially disposed therein. The innermost staple row 5304 has the smallest staple height and the outermost staple row 5308 has the largest staple height. As noted above, staple height differences may contribute to the overall compressive behavior of the assistive material when the assistive material is stapled to tissue.

Although the backing material 5300 can have a variety of configurations, the backing material 5300 is formed of interconnected repeating unit cells arranged in three longitudinal arrays in two sets, the first set being the backing material. ₅₃₀₀ on one side of the intended cut line CL, and a second set (not shown) is positioned on a second side of the intended cut line _CL on the backing material 5300. there is Since both sets are identical, only one repeating unit cell 5310, 5312, 5314 of the three longitudinal arrays of one set is shown in FIG.

The repeating unit cells 5310, 5312, 5314 can have various configurations. In this illustrated embodiment, the repeating unit cells 5310, 5312, 5314 are sized in terms of overall shape, except that the wall thickness and height differ among the three repeating unit cells 5310, 5312, 5314. The same is true for As shown, each repeating cell is laterally offset and aligned with each other in the y-direction from their respective outermost top surfaces 5310a, 5312a, 5314a to their respective outermost bottom surfaces 5310b, 5312b. , 5314b have different heights (e.g., in the X direction), so for simplicity, the minimum and maximum heights H _1A , H _1B for repeating unit cell 5310 and the minimum and maximum heights for repeating unit cell 5312 heights H _2A , H _2B , minimum and maximum heights H _3A , H _3B for the repeating unit cell 5314 are shown.

As shown, a portion of top surface 5300a of backing member 5300 is generally planar and thus includes generally planar surfaces 5316 (eg, each in the y-direction) with non-planar surfaces 5318 extending therebetween. Top surface 5300 a defines a tissue contacting surface 5320 of support 5300 , tissue contacting surface 5320 being formed of planar surface 5316 and non-planar surface 5318 . The generally planar surface 5316 and the non-planar surface 5318 of the upper surface 5300a, and hence the tissue contacting surface 5320, alternate along the width of the support member 5300 (extending in the y-direction) to provide consistent tissue spacing (e.g. , alternating between substantially uniform tissue spacing and variable tissue spacing) is created between an anvil, such as anvil 5102 in FIG. In this illustrated embodiment, each substantially uniform tissue gap is created between a tissue-compressing surface, such as tissue-compressing surface 5112 of anvil 5102 in FIG. A variable tissue gap is between a tissue-compressing surface, such as tissue-compressing surface 5112 of anvil 5102 in FIG. occur. Those skilled in the art will appreciate that the substantially uniform and variable tissue gap length (extending in the x-direction) may depend on at least the structural configuration of the tissue contacting surface and thus the structural configuration of the adjunct. be.

Furthermore, the wall thicknesses and heights between at least two repeating cells may differ, thus resulting in different compression ratios. In this illustrated embodiment, the wall thickness W _T from the first repeating unit cell 5310 (eg, the innermost repeating unit cell) to the third repeating unit cell 5314 (eg, the outermost repeating unit cell) and H increase. That is, the wall thickness WT1 and height H1 of the _first repeating unit cell 5310 is less than the wall _{thickness WT2} and height H2 of the _second repeating unit cell 5312 (eg, the middle repeating unit cell). , the wall thickness W _T2 and height H ₂ of the second repeating unit cell 5312 are less than the wall thickness W _T3 and height H ₃ of the third repeating unit cell 5314 . As a result, the compression ratio from the first repeating unit cell 5310 to the third repeating unit cell 5314 decreases. That is, the first compression ratio of the first repeating unit cell 5310 is greater than each of the second and third compression ratios of the second and third repeating unit cells 5312, 5314, respectively, and the second compression ratio is greater than the third compression ratio. Therefore, these compression ratios are such that the backing material has staples 5304, 5306, 5308 having different staple lengths (e.g., the innermost staple 5304 has the smallest staple height and the outermost staple 5308 has the highest). The different heights of the backing material 5300 such that the backing material 5300 is configured to apply a substantially uniform pressure to the stapled tissue for a predetermined period of time when the backing material 5300 is stapled to tissue using a large height. Generates an overall compression ratio.

As noted above, the support may include a combination of strut-less based unit cells and strut-based unit cells and/or spacer struts. For example, FIG. 54 illustrates an exemplary embodiment of a backing member 5400 releasably retained on a top or deck surface 5402a of a staple cartridge 5402 (eg, the cartridge surface facing the anvil). Other than the differences described in detail below, staple cartridge 5402 is similar to staple cartridge 200 of FIGS. 1-2C, and therefore common elements are not described in further detail herein. As shown in FIG. 54, only one half (e.g., the left half) of the backing material 5400 has three longitudinal rows 5303a, 5303b, 5303c of substantially uniform staples 5404a, 5404b, 5404c disposed therein. Shown on staple cartridge 5402 .

The backing member 5400 can have a variety of configurations, but as shown, the backing member has an internal lattice structure 5406 formed of two sets of two longitudinal arrays of repeating strutless unit cells; One set is positioned on one side of the intended cut line C _L of the backing material 5400 and the second set (not shown) is positioned on the second side of the intended cutting line C _L of the backing material 5400 . positioned on the side. Since both sets are identical, only one repeating unit cell 5408, 5410 of the two longitudinal arrays of one set is shown in FIG. Further, the support member 5400 includes structurally similar first and second outer lattice structures, positioned on either side of the inner lattice structure (only the first outer lattice structure 5412 is shown). . Although only the first outer lattice structure 5412 and the first and second repeating unit cells 5408, 5410 of the support material 5400 are shown, those skilled in the art will appreciate the following discussion of the second lattice structure and the second lattice structure. It will be appreciated that it is also applicable to repeat cells of two sets of longitudinal arrays.

The first and second repeating unit cells 5408, 5410 can have various forms. In this illustrated embodiment, the repeating unit cells 5408, 5410 are substantially uniform (eg, nominally identical within manufacturing tolerances) and structurally similar to the repeating unit cell 810 of FIGS. 9A-9B. Therefore, common features will not be described in detail herein. As shown, the first and second repeating unit cells 5408, 5410 are oriented similarly to repeating unit cell 4516 of FIGS. It may have a structurally similar configuration to material 4500 . As a result, the repeat unit cells 5408, 5410 are oriented (eg, in a repeat pattern) such that the internal lattice structure 5406 can match the positions of staples in one or more overlapping staple rows. As further shown, the first outer lattice structure 5412 includes pillar-based unit cells (only two unit cells 5414a, 5414b are shown in full). The pillar-based unit cells can have various configurations, with a first pillar-based unit cell 5414a having a triangular configuration and a second pillar-based unit cell 5414b having an inverted triangular configuration. have. As further shown, a portion of the second stanchion-based unit cell 5414b intersects with the first stanchion-based unit cell 5414a.

_As shown, the lattice structures 5406, 5412 are adjacent to each other and laterally offset with respect to the longitudinal axis LA of the backing member 5400 (eg, LA extends in the z _- direction). That is, first outer lattice structure 5412 is positioned directly adjacent first longitudinal side 5406 a of inner lattice structure 5406 . Further, the internal lattice structure 5406 includes first and second staple rows 5403a, 5303b (e.g., innermost and middle staple rows), thus respectively the first and second staple rows 5404a, 5404b, the first outer lattice structure 5412 overlaps the third staple row 5404c (eg, the outermost staple row) and thus the third staples 5404c. In this illustrated embodiment, the first repeating unit cells 5408 of the first longitudinal array and the second repeating unit cells 5410 of the second longitudinal array are staggered with respect to each other, thus , are oriented (eg, in a repeating pattern) to match the positions of the first and second staples 5404a, 5404b, respectively.

This alignment of the lattice structures 5406, 5412 with respect to the first, second, and third lattice structures 5404a, 5404b, 5404c, in combination with different structural configurations of the lattice structures 5406, 5412, allows the supplemental material to be stapled to tissue. Sometimes it can lead to at least two different stress-strain curves. Considering the orientation of the first and second repeat unit cells with respect to the first and second staples, the resulting stress-strain curves of the auxiliary material at the first and second staples are the same. , or substantially the same. The compression behavior of the backing material 5300 on each of the first, second and third staples 5404a, 5404b, 5404c is shown schematically in FIG. , S2 represents the stress-strain curve of the assist material at the second staple 5404b, and S3 represents the stress-strain curve of the third staple 5404c. In this schematic, the stress-strain curves S1, S2 for the first staple and the second staple are shown as the same curve. Those skilled in the art will appreciate that the stress-strain curve for each staple can be different.

Auxiliary Material Systems In general, the auxiliary material systems described herein can include at least two different auxiliary materials, each under a respective applied stress ranging from about 30 kPa to 90 kPa, while It is configured to receive each strain in each strain range. In some embodiments, the at least two respective strain ranges may at least partially overlap, while in other embodiments the at least two respective ranges do not overlap. Additionally or alternatively, each strain range combination may result in a total range of at least 0.1 to 0.9. In other embodiments, the total range is about 0.1-0.8, about 0.1-0.7, about 0.1-0.6, about 0.1-0.5, about 0.1 ~0.4, about 01. ~0.3, about 0.2-0.8, about 0.2-0.7, about 0.3-0.7, about 0.3-0.8, about 0.3-0.9, It can be about 0.4-0.9, about 0.4-0.8, about 0.4-0.7, about 0.5-0.8, or about 0.5-0.9. A supplementary material system can include at least two different supplementary materials, but for the sake of brevity, the following description is for a supplementary material system having only a first supplemental material and a second supplemental material. However, those skilled in the art will appreciate that the discussion below is also applicable to additional aids in the aids system.

In some embodiments, the backing material system can include a first backing material and a second backing material, the first backing material while under an applied stress ranging from about 30 kPa to 90 kPa. , undergoes a first range of strain, and the second supplement undergoes a second range of strain while under an applied stress ranging from about 30 kPa to 90 kPa. The stress-strain response of each backing material depends at least on the structural and compositional make-up of each backing material. Accordingly, the first supplemental material and the second supplemental material can be tailored to provide a desired strain response under an applied stress and/or range of applied stresses. For example, in some embodiments, the first supplemental material has a first stress of about 0.2 to 0.5 while under an applied stress ranging from about 60 kPa to 90 kPa. , wherein the second supplemental member is subjected to a strain ranging from about 0.3 to 0.7 while under an applied stress ranging from about 40 kPa to 70 kPa. can be configured to undergo strain in a second range of . In another embodiment, the first supplemental material is stressed in a first range of about 0.1 to 0.7 while under an applied stress in a range of about 30 kPa to 90 kPa. The second supplement may be configured to undergo a strain, the second supplement having a second strain of about 0.3 to 0.9 while under an applied stress ranging from about 30 kPa to 90 kPa. can be configured to undergo strains in the range of In another embodiment, the first supplemental material is stressed to a first range of about 0.2 to 0.6 while under an applied stress in a range of about 30 kPa to 90 kPa. The second supplement may be configured to undergo strain, wherein the second supplement has a second strain of about 0.4 to 0.8 while under an applied stress ranging from about 30 kPa to 90 kPa. can be configured to undergo strains in the range of In another embodiment, the first supplemental material is stressed in a first range of about 0.1 to 0.7 while under an applied stress in a range of about 40 kPa to 80 kPa. The second supplement may be configured to undergo a strain, the second supplement having a second strain of about 0.2 to 0.8 while under an applied stress ranging from about 30 kPa to 90 kPa. can be configured to undergo strains in the range of

The first support material and the second support material can have various structural configurations. For example, a first supplemental material may have a configuration similar to any one of the exemplary supplemental materials described herein, and a second supplemental material may have a different configuration than the first supplemental material. and may be similar to another one of the exemplary adjuncts described herein. In some embodiments, the first assistive material can be a non-post-based assistive material and the second assistive material is another non-post-based assistive material or strut-based assistive material described herein. can be wood. In other embodiments, the first brace may be a strut-based brace and the second brace may be another strut-based brace or a non-strut-based brace.

In some embodiments, the first supplementary material has a first internal structure formed of a first plurality of interconnected repeating unit cells, and the second supplemental material comprises a second plurality of interconnected repeating unit cells. of interconnected repeating unit cells. In certain embodiments, a first plurality of interconnected repeating unit cells may be formed of a first material and a second plurality of interconnected repeating unit cells different from the first material. It may be formed of a second material. The first and second materials can be any of the materials described herein and in more detail below. Additionally or alternatively, each unit of the first plurality of interconnected repeating unit cells has a first geometric shape and each unit of the second plurality of interconnected repeating unit cells has a second geometry that is different from the first geometry.

In some embodiments, each unit cell of at least one of the first plurality of interconnected repeating unit cells and the second plurality of interconnected repeating unit cells comprises a triple periodic minimal surface structure ( For example, the Schwartz P structure). In one embodiment, each unit cell of the first plurality of interconnected repeating unit cells is a first triple periodic minimal surface structure and each unit of the second plurality of interconnected repeating unit cells The cell is a second triple periodic minimal surface structure that is different from the first triple periodic minimal surface structure. For example, the first triple periodic minimal curved structure and the second triple periodic minimal curved structure can differ in shape, eg, shape, size (eg, height, wall thickness, etc.), or a combination thereof.

In some embodiments, each unit cell of the first plurality of interconnected repeating unit cells is formed from a first plurality of struts defining a first plurality of openings therebetween. a top portion; a first bottom portion formed from a second plurality of struts defining a second plurality of openings therebetween; and a first bottom portion interconnecting the first top portion and the first bottom portion. 1 spacer strut. In such embodiments, each unit cell of the second plurality of interconnected repeating unit cells may be a Schwartz P structure. In another embodiment, each unit cell of the second plurality of interconnected repeating unit cells has a second upper wall 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 bottom portion interconnecting the second top portion and the second bottom portion. and spacer struts.

Materials The adjuncts described herein may be formed of one or more polymers such as bioabsorbable polymers, non-bioabsorbable polymers, bioabsorbable polymers, or any combination thereof. For clarity only, use of "polymer" herein may be understood to include one or more polymers comprising 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 diglyco (PEDG), polypropylene fumarate (PPF), poly(ethoxyethylene diglycolate), poly(ether ester) (PEE), poly(amino acid), poly(epoxy carbonate), poly(2-oxypropylene carbonate), poly(diol citrate), polymethacrylate anhydride, poly(N-isopropylacrylamide), copolymers thereof, or any combination thereof. Non-limiting examples of suitable copolymers are random copolymers such as PLGA-PCL, block copolymers such as poly(lactide-co-glycolide) (PLGA), triblocks such as PLGA-PCL-PLGA or PLGA-PEG-PLGA. copolymers, or any combination thereof. Further non-limiting examples of suitable polymers include, for example, US Pat. No. 9,770,241, US Pat. No. 9,873,790, US Pat. , 149,753, and US Patent Application Publication No. 2017/0355815, each of which is incorporated herein by reference in its entirety.

In some embodiments, the polymer can be formed of a resin. In general, the resins described herein are suitable for use in additive manufacturing techniques such as bottom-up and top-down stereolithography, and (b) produce adjuncts that are bioabsorbable, and/or (c) Flexible or elastic adjuncts can be produced (eg, at temperatures of about 25° C., about 37° C., and/or any temperature therebetween).

In some embodiments, the polymer can be formed from photopolymerizable resins, including oligomeric prepolymers. Oligomer prepolymers can be linear or branched (eg, "star" oligomers such as triarm oligomers). Non-limiting examples of suitable end groups for such oligomeric prepolymers include acrylates, methacrylates, fumarates, vinyl carbonates, methyl esters, ethyl esters, and the like. Suitable constituents of exemplary resins that may be used to form the polymers, and consequently adjuncts provided herein, are listed in Table 2 below. Components in each column of Table 2 can be combined with components in other columns in any combination.

Although various types of resins can be used to form the polymer, in some embodiments the polymer is formed from resins based on bioabsorbable polyester oligomers (e.g., methacrylate-terminated oligomers with bioabsorbable polyester linkages). be done. For example, the bioabsorbable polyester oligomer is 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. can. Unlike conventional resins (e.g., polycaprolactone dimethacylate-based resins and poly(D,L-lactide)dimethacrylate-based resins), this resin exhibits rubber-like elastic behavior at physiological temperatures, mechanical Adjuvants can be formed that have short-term retention of properties (eg, one month or less), and/or long-term complete absorption (eg, over a period of about 4-6 months).

In some embodiments, oligomers can include linear oligomers. Alternatively or additionally, oligomers may include branched oligomers (eg, star-shaped oligomers such as triarm oligomers).

In some embodiments, the bioabsorbable polyester oligomers described herein are bioabsorbable oligomers with methacrylate end groups. Such oligomers are typically caprolactone, lactide, tri-glycolide, in ABA blocks, BAB blocks, CBC blocks, BCB blocks, AB random compositions, BC random compositions, homopolymers, or any combination thereof. Contains biodegradable ester linkages between constituents such as methylene carbonate, dioxanone, and propylene fumarate monomers, A = poly(lactide) (PLA), poly(glycolide) (PGA), poly(lactide-co-glycolide) (PLGA), or polypropylene fumarate (PPF), where B = polycaprolactone (PCL), poly(lactide-co-caprolactone) (PLACL), poly(glycolide-co-caprolactone) (PGACL), poly(trimethylene carbonate) (PTMC), or poly(caprolactone-co-lactide) (PCLLA), where C=polydioxanone (PDO). The copolymers, in either a linear or star configuration, are about 2-6 kilodaltons, about 2-10 kilodaltons, about 2-15 kilodaltons, about 2-20 kilodaltons, About 2-50 kilodaltons, about 5-6 kilodaltons, about 5-10 kilodaltons, about 5-15 kilodaltons, about 5-20 kilodaltons, about 5-20 kilodaltons It can have a molecular weight (Mn) of 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 form such oligomers are optionally selected to enhance elasticity, illustratively gamma-methyl-epsilon carboxylate and gamma-ethyl-epsilon-caprolactone. Branching can be introduced.

In some embodiments, lactide can include L-lactide, D-lactide, or mixtures thereof (eg, D,L-lactide). For example, in some embodiments with PLA blocks, L-lactide may be used for better ordering and higher crystallinity.

In some embodiments, oligomers may comprise ABA, BAB, CBC, or BCB blocks in linear and/or branched (eg, star or triarm) form.

In some embodiments, A is (i) poly(lactide), (ii) poly(glycolide), (iii) lactide:glycolide (eg, lactide-rich ratio) from 90:10 to 55:45, 45 : 55 to 10:90 lactide:glycolide (e.g., glycolide-rich ratio), or poly(lactide-co-glycolide) containing lactide and glycolide in a lactide:glycolide molar ratio of 50:50, or any thereof can be a combination of In such embodiments, the oligomers may be linear and/or branched (eg, star or triarm) in form. In some embodiments, D,L-lactide mixtures may be used to make PLGA random copolymers.

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

In some embodiments, A (PLA, PGA, PLGA, PPF, or any combination thereof) is from about 1 kilodalton to 4 kilodaltons, from about 1 kilodalton to 6 kilodaltons, from about 1 kilodalton to 10 B (PCL, PLACL, PGACL, PTMC, PCLLA, or any combination thereof) is about 1 kilodalton to 4 kilodaltons, about 1 kilodalton to 6 kilodaltons, about 1 kilodalton to 10 kilodaltons, about 1 kilodalton to 50 kilodaltons, about 1 . having a molecular weight (Mn) of from 6 kilodaltons to 4 kilodaltons, from about 1.6 kilodaltons to 6 kilodaltons, or from about 1.6 kilodaltons to 10 kilodaltons, or from about 1.6 kilodaltons to 50 kilodaltons obtain.

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

In some embodiments, the resin may contain additional cross-linking agents. For example, the additional cross-linking agent is 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. can. Any suitable additional cross-linking agents may be used, including bioabsorbable cross-linking agents, non-absorbable cross-linking agents, or any combination thereof. Non-limiting examples of suitable bioabsorbable crosslinkers include divinyl adipate (DVA), poly(caprolactone) trimethacrylate (PCLDMA, eg, with a molecular weight MW of about 950-2400 Daltons), and the like. Non-limiting examples of suitable non-absorbable crosslinkers include trimethylolpropane trimethacrylate (TMPTMA), poly(propylene glycol) dimethacrylate (PPGDMA), poly(ethylene glycol) dimethacrylate (PEGDMA), and the like.

In some embodiments, the resin may contain a non-reactive diluent. For example, the non-reactive diluent 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. can exist. Non-limiting examples of non-reactive diluents are dimethylformamide, dimethylacetamide, N-methylpyrrolidone (NMP), dimethylsulfoxide, cyclic carbonates (eg propylene carbonate), diethyl adipate, methyl ether ketone, ethyl alcohol, acetone. , or any combination thereof.

In some embodiments, the system can include a photoinitiator. For example, the photoinitiator may be from about 0.1% to 4%, from about 0.1% to 2%, from about 0.2% to 4%, or from about 0.2% to 4%, by weight of the resin. It may be present in an amount of 2% by weight. The photoinitiator included in the resin can be any suitable photoinitiator. Non-limiting examples of suitable photoinitiators include Type I and Type II photoinitiators, and UV photoinitiators (e.g. acetophenones (e.g. diethoxyacetophenone), phosphine oxides (e.g. diphenyl(2,4, 6-trimethylbenzoyl)phosphine oxide, phenylbis(2,4,6-trimethylbenzoyl), phosphine oxide (PPO), Irgacure® 369), etc. Exemplary photoinitiators are incorporated herein by reference in their entirety. It can be found in US Pat. No. 9,453,142, incorporated herein.

In one embodiment, the resin is 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. the bioabsorbable polyester oligomer obtained and 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; about 0.1% to 4%, about 0.1% to 2%, about 0.2% to 4%, or about 0.2% by weight of the resin, and a non-reactive diluent which may be and a photoinitiator, which may be present in an amount of % to 2% by weight.

In some embodiments, the resin may include reactive diluents (including difunctional and trifunctional reactive diluents). For example, the reactive diluent is 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. can. Non-limiting examples of reactive diluents include acrylates, methacrylates, styrenes, vinylamides, vinyl ethers, vinyl esters, polymers containing 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), mono-, di- or triethylene glycol acrylate or methacrylate alkyl ethers, fatty alcohol acrylates, methacrylates such as lauryl (meth)acrylate, or mixtures thereof).

In one embodiment, the resin is 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 bioabsorbable polyester oligomer which can be used 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-reactive diluents that may be present and about 0.1% to 4%, about 0.1% to 2%, about 0.2% to 4%, or about 0.2% by weight of the resin; a photoinitiator which may be present in an amount of from about 1% to 50% by weight, from about 1% to 40% by weight, from about 5% to 50% by weight, or from about 5% to and a photoinitiator, which may be present in an amount of 40% by weight.

In some embodiments, the resin may contain fillers. For example, fillers can be present in amounts 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 is 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 bioabsorbable polyester oligomer that can be used in an amount of from about 1% to 70%, from about 1% to 50%, from about 5% to 70%, or from about 5% to 50% by weight of the resin; non-reactive diluent present and about 0.1% to 4%, about 0.1% to 2%, about 0.2% to 4%, or about 0.2% by weight of the resin; % to 2% by weight of the resin and about 1% to 50%, about 1% to 40%, about 5% to 50%, or about 5% by weight of the resin. a reactive diluent that may be present in an amount of ˜40% by weight of the resin, and about 1% to 50%, about 1% to 40%, about 2% to 50%, or about 2% and fillers, which may be present in an amount of ˜40% by weight.

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

In some embodiments, the resin may include non-reactive pigments or dyes that absorb light, particularly UV light. Non-limiting examples of suitable non-reactive pigments or dyes include: (i) titanium dioxide (eg, about 0.05% to 5%, about 0.05% to 1%, about 0.05% to 1%, by weight of the resin); 1 wt% to 1 wt%, or about 0.1 wt% to 5 wt%); (ii) carbon black (eg, about 0.05 wt% to 5 wt% of the resin; 05% to 1%, about 0.1% to 1%, or about 0.1% to 5%), and/or (iii) hydroxybenzophenone, hydroxyphenylbenzotriazole , oxanilide, benzophenone, thioxanthone, hydroxyphenyltriazine, and/or benzotriazole UV absorbers (eg, Mayzo BLS1326) (eg, about 0.001% to 1% by weight of the resin, 0.001 wt% to 2 wt%, about 0.001 wt% to 4 wt%, about 0.005 wt% to 1 wt%, about 0.005 wt% to 2 wt%, or about 0.005 wt% to 4 wt% % present). Additional exemplary non-reactive pigments or dyes are described in U.S. Pat. No. 3,213,058, U.S. Pat. No. 6,916,867, U.S. Pat. 643, each of which is incorporated herein by reference in its entirety.

In some embodiments, the resin comprises (a) about 5% to 80%, about 5% to 90%, about 10% to 80%, or about 10% to 90% by weight of the resin; and (b) from about 1% to 50%, from about 1% to 70%, from about 5% to 50% by weight of the resin. , or a non-reactive diluent present in an amount of about 5% to 70% by weight; and (c) about 0.1% to 2%, about 0.1% to 4%, about and a photoinitiator present in an amount from 0.2% to 2%, or from about 0.2% to 4% by weight. In such embodiments, the resin also comprises (d) from about 1% to 40%, from about 1% to 50%, from about 5% to 40%, or from about 5% to 50% by weight of the resin. (e) from about 1% to 40%, from about 1% to 50%, from about 2% to 40%, or from about 2% by weight of the resin; filler present in an amount of 50% by weight; (f) about 0.1% to 10%, about 0.1% to 20%, about 1% to 10%, or about 1% by weight of the resin additional components (e.g., active agents, detectable groups, pigments or dyes, etc.) present in amounts of from about 1% to 20% by weight; and/or (g) from about 1% to 5% by weight of the resin, about 1 Additional cross-linking agents (eg, trimethylolpropane trimethacrylate (TMPTMA)) present in amounts of from about 2% to 5%, or from about 2% to 10% by weight may be included.

In some embodiments, the resin is
(a) a (meth)acrylate-terminated, linear or branched, bioabsorbable polyester oligomer of monomers in the ABA block, BAB block, CBC block, or BCB block, wherein the oligomer is from about 5% to 80% by weight of the resin; %, about 5% to 90%, about 10% to 80%, or about 10% to 90% by weight, and A is poly(lactide) (PLA), poly(glycolide) (PGA), poly(lactide-co-glycolide) (PLGA), or any combination thereof, wherein PLGA is 90:10 to 60:40 lactide:lactide, or 40:60 to 10:90 lactide. Containing lactide and glycolide in any molar ratio, A is from about 1 kilodalton to 4 kilodaltons, from about 1 kilodalton to 10 kilodaltons, from about 2 kilodaltons to 4 kilodaltons, or from about 2 kilodaltons to 10 kilodaltons. has a molecular weight (Mn) of kilodaltons and B is polycaprolactone (PCL, PTMC, and PCLLA), poly(lactide-co-caprolactone) (PLACL), poly(glycolide-co-caprolactone) (PGACL) or poly (trimethylene carbonate) (PTMC) from about 1 kilodalton to 4 kilodaltons, from about 1 kilodalton to 10 kilodaltons, from about 1.6 kilodaltons to 4 kilodaltons, or from about 1.6 kilodaltons to 10 kilodaltons has a molecular weight (Mn) of Daltons, and C is polydioxanone (PDO), from about 1 kilodalton to 4 kilodaltons, from about 1 kilodalton to 10 kilodaltons, from about 2 kilodaltons to 4 kilodaltons, or from about 2 an oligomer having a molecular weight (Mn) between kilodaltons and 10 kilodaltons;
(b) propylene 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) 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; a photoinitiator present in an amount;
(d) optionally 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; a reactive diluent;
(e) optionally 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; and a filler.

Methods of Manufacture The non-fibrous adjuvant material described herein can be formed from a matrix comprising at least one fused bioabsorbable polymer, and thus can be formed using any additive manufacturing process. In some embodiments, the additive manufacturing process can be Continuous Liquid Interfacial Generation (CLIP), which involves curing a liquid plastic resin using ultraviolet light. Details of the CLIP process are described, for example, in US Pat. No. 9,211,678, US Pat. No. 9,205,601, and US Pat. US Patent Application Publication No. 2015/0360419, US Patent Application Publication No. 2015/0331402, US Patent Application Publication No. 2017/0129167, US Patent Application Publication No. 2018/0243976, United States Patent Application Publication No. 2018/0126630 and US Patent Application Publication No. 2018/0290374, J. Tumbleston et al., Continuous liquid interface production of 3D Objects, Science 347, 1349-1352 (2015); Janusziewcz et al., Layerless fabrication with continuous liquid interface production, Proc. Natl. Acad. Sci. USA 113:11703-11708 (2016), each of which is incorporated herein by reference in its entirety. As non-limiting examples of other additive manufacturing devices and methods that can be used to form the non-fibrous adjuncts described herein, and thus the matrix comprising at least one fused bioabsorbable polymer, are: U.S. Patent No. 5,236,637; U.S. Patent No. 5,391,072; U.S. Patent No. 5,529,473; U.S. Patent No. 7,438; 846, U.S. Patent No. 7,892,474, and U.S. Patent No. 8,110,135, and U.S. Patent Application Publication Nos. 2013/0292862 and 2013/0295212. , bottom-up and top-down additive manufacturing methods, and fused deposition modeling (e.g., heating thermoplastic filaments and extruding molten filaments layer by layer), material jetting, as understood by those skilled in the art. Two-photon polymerization and holographic multifocal polymerization can be mentioned.

In certain embodiments, one or more post-processing steps may be performed after the additive additive manufacturing process. For example, in some embodiments, one or more post-treatment steps are performed according to known techniques (e.g., in acetone, isopropanol, glycol ethers such as propylene glycol methyl ether, or organic solvents such as DPM). Cleaning the auxiliary material, wiping off the auxiliary material (e.g., using an absorbent material, blowing with compressed gas or an air blade, etc.), centrifuging residual resin, extracting residual solvent, ultraviolet light, etc. additional curing, such as by flood exposure using a method, to further react unpolymerized components of the auxiliary material, drying the auxiliary material (e.g., under vacuum) to remove extraction solvent, or any of the above. may include performing a combination of One or more post-processing steps can shrink the backing material, so in some embodiments the backing material can be manufactured in an expanded form to offset such shrinkage.

In other embodiments, the non-fibrous adjunct material is partially or wholly manufactured using any suitable non-additive manufacturing process, such as injection molding, foaming, and forming processes, as would be understood by those skilled in the art. can be formed.

Stapling assemblies can be manufactured in a variety of ways. For example, in some embodiments, the non-fibrous backing material, as described above, aligns the cartridge-contacting surface of the backing material against a cartridge surface (eg, anvil-facing surface, such as a top or deck surface). It can be releasably attached to a staple cartridge (e.g., FIG. 19A-26C, 37A-39B, and 41A-41C). Alternatively or additionally, as described above, the non-fibrous backing material may include one or more cartridge projections (eg, staple pocket projections) and/or staple legs (eg, FIGS. 45A-46B). see). Additional details regarding surface features and other exemplary surface features may be found in US Patent Publication No. 2016/0106427, which is incorporated herein by reference in its entirety. Alternatively or additionally, as discussed above, the non-fibrous backing material may include an outer layer in the form of an adhesive film that is used to releasably retain the backing material to the staple cartridge (e.g., see FIG. 40). reference). Additional details regarding adhesive films and other attachment methods can be found in US Pat. No. 10,349,939, which is incorporated herein by reference in its entirety.

The auxiliary materials and methods can be further appreciated in the following non-limiting examples.

Examples 1-3: Preparation of Difunctional Methacrylate (MA) Terminated Polyester Oligomers Examples 1-3 describe the preparation of difunctional methacrylate (MA) terminated polyester oligomers. The mid-block is PLGA-PCL-PLGA with a molecular weight of 6 kilodaltons, with PCL included as 40% by weight of the total molecular weight (MW). PLGA is a random copolymer of lactide (L) and glycolide (G) in a 1:1 L:G weight ratio.

The molar ratios and masses of each reagent used for the 1 kg batch of HO-PLGA-b-PCL-b-PLGA-OH synthesis as discussed in Examples 1 and 2 are provided in Table 3 below.

Example 1: HO-PCL-OH Synthesis A round bottom flask was dried in a drying oven overnight and cooled to room temperature under _N2 flow. Caprolactone and stannous octoate were added to the round bottom flask via a glass syringe and syringe needle. The contents of the reaction flask were heated to 130°C. Meanwhile, diethylene glycol was heated to 130°C. Once preheated, diethylene glycol was added to the reaction flask as an initiator and allowed to react to complete monomer conversion. Monomer conversion was monitored using H ¹ NMR. Once complete monomer conversion was reached, the reaction was stopped and the reaction contents were allowed to cool to room temperature. HO-PCL-OH was precipitated from chloroform into cold MeOH to give a white solid. H ¹ NMR, 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 different amounts of D,L-lactide, and glycolide were placed in a round bottom flask under _N2 . was added and heated to 140° C. to melt the reaction contents. After melting, the temperature was reduced to 120° C. and the stannous octoate was added. The reaction was continued with stirring while monitoring monomer conversion by H ¹ NMR and THF GPC. When the reaction reached the desired molecular weight, the reaction contents were cooled to room temperature, dissolved in chloroform, and precipitated into cold diethyl ether three times. 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 1 kg batch of MA-PLGA-b-PCL-b-PLGA-MA was , provided in Table 4 below.

HO-PLGA-b-PCL-b-PLGA-OH prepared in Example 2 was dissolved in anhydrous DCM in a round bottom flask under N ₂ . Triethylamine and BHT were added to the reaction flask and the reaction flask was cooled to 0° C. in an ice water bath. The reaction flask was equipped with a pressure equalization addition funnel filled with methacryloyl chloride. Once the reaction flask reached 0° C., methacryloyl chloride was added dropwise over 2 hours. The reaction was allowed to proceed at 0° C. for 12 hours and then at room temperature for 24 hours. Upon completion, the reaction contents were washed twice with distilled water to remove triethylamine hydrochloride, washed with saturated Na ₂ CO ₃ and then dried over magnesium sulfate. The collected and dried DCM layer was dried by rotary evaporation. The final product was characterized by THF GPC, H ¹ NMR, FTIR, and DSC.

Examples 4-6: Preparation of tri-arm MA-terminated polyester oligomers Examples 4-6 describe the preparation of tri-arm, 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, with PCL being the core of the oligomer. PCL is included as 40% by weight of total molecular weight (MW). PLGA is a random copolymer of lactide (L) and glycolide (G) with an L:G weight ratio of 1:1.

Example 4: PCL-3OH Synthesis The molar ratios and masses of each reagent used for a 1 kg batch of (PLGA-b-PCL)-3OH synthesis as discussed in Examples 4 and 5 are provided in Table 5 below. do.

The round bottom flask was dried in a drying oven overnight and cooled to room temperature under _N2 flow. Caprolactone and stannous octoate were added to the round bottom flask via a glass syringe and syringe needle. The contents of the reaction flask were heated to 130°C. Meanwhile, trimethylolpropane (TMP) was heated to 130°C. Once preheated, TMP was added to the reaction flask as an initiator and allowed to react to complete monomer conversion. Monomer conversion was monitored using H ¹ NMR. Once complete monomer conversion was reached, the reaction was stopped and the reaction contents were allowed to cool to room temperature. (PCL)-3OH was precipitated from chloroform into cold MeOH to give a white solid. (PCL)-3OH was characterized using H1 NMR, DSC, FTIR, and GPC.

Example 5: (PCL-b-PLGA)-3OH Synthesis The (PCL)-3OH prepared in Example 4 and different amounts of D,L-lactide, and glycolide were added to a round bottom flask under _N2 , Heating to 140° C. melted the reaction contents. After melting, the temperature was reduced to 120° C. and the stannous octoate was added. The reaction was continued with stirring while monitoring monomer conversion by H ¹ NMR and THF GPC. When the reaction reached the desired molecular weight, the reaction contents were cooled to room temperature, dissolved in chloroform, and precipitated into cold diethyl ether three times. The precipitate was dried under vacuum.

Example 6: (PCL-b-PLGA)-3MA Synthesis The molar ratios and masses of each reagent used to synthesize a 1 kg batch of (PLGA-b-PCL)-3MA are provided in Table 6 below. .

(PCL-b-PLGA)-3OH prepared in Example 5 was dissolved in anhydrous DCM in a round bottom flask under _N2 . Triethylamine (TEA) and BHT were added to the reaction flask and the reaction flask was cooled to 0° C. in an ice water bath. The reaction flask was equipped with a pressure equalization addition funnel filled with methacryloyl chloride. Once the reaction flask reached 0° C., methacryloyl chloride was added dropwise over 2 hours. The reaction was allowed to proceed at 0° C. for 12 hours and then at room temperature for 24 hours. Upon completion, 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, washed with aqueous HCl (3%, twice), saturated aqueous sodium bicarbonate, and saturated aqueous sodium chloride, then dried over magnesium sulfate. Magnesium sulfate was filtered off by vacuum filtration and the filtrate was collected. DCM was removed by rotary evaporation and the solid product was collected and characterized by GPC, H ¹ NMR, FTIR and DSC.

Example 7: Difunctional Oligomer Resin Formulation The following ingredients were mixed together in the following weight percentages (% by weight of resin) to provide an exemplary resin for additive manufacturing.
(1) 66.2% of the bifunctional oligomers prepared in Examples 1-3 above
(2) 3.5% trimethylolpropane triacrylate (TMPTMA) reactive diluent
(3) N-methylpyrrolidone (NMP) non-reactive diluent 28.4%
(4) Irgacure® 819 photoinitiator 1.89%

Example 8: Triarm Oligomer Resin Formulation The following ingredients were mixed together in the following weight percentages (% by weight of resin) to provide an exemplary resin for additive manufacturing.
(1) 68.6% triarm oligomer prepared in Examples 4-6 above
(2) N-methylpyrrolidone (NMP) non-reactive diluent 29.4%
(3) Irgacure® 819 photoinitiator 1.96%

Example 9: Additive Manufacturing and Post-Processing Five exemplary auxiliary materials were prepared. A first exemplary backing (backing 1) was similar to backing 800 in FIGS. 8A-8F, except that the first backing was formed of two longitudinal rows of 20 unit cells. was structurally similar to 31A-31D (auxiliary material 2), FIGS. 32A-32D (auxiliary material 3), FIGS. 33A-33E (auxiliary material 4), and FIGS. It was structurally similar to auxiliary materials 3100, 3200, 3300, and 3400, as shown in FIG. 34E (auxiliary material 5). The five adjuncts were manufactured by Carbon Inc. according to standard techniques. Carbon Inc., 1089 Mills Way, Redwood City California, 94063; Prepared by additive manufacturing performed on M1 or M2 equipment. The resin formulation for each adjuvant is provided in Table 7 below.

When the resin contains non-reactive diluents, the object may experience general shrinkage during washing/extraction due to the degree of non-reactive diluent loading. Therefore, dimensional scaling factors are applied to part stereolithography (.stl) files or 3D manufacturing format (3MF) files to enlarge printed aids and deliberately account for subsequent shrinkage during post-processing steps. do.

The post-treatment of each auxiliary material was carried out as follows. That is, after removing the build platform from the apparatus, excess resin is wiped off the flat surface around the backing, leaving the platform on its side to drain for about 10 minutes. The support material was carefully removed from the platform. The support was washed with acetone three times for 30 seconds each time on an orbital shaker at 280 rpm, followed by drying for 5 minutes between washes. After the third wash, the backing was allowed to dry for 30 minutes and then flood cured for 20 seconds per side in a PrimeCure™ UV flood curing unit.

Residual non-reactive diluent (eg, N-methylpyrrolidone or propylene carbonate) is then removed by immersing the adjuvant in acetone and after 12 hours with one solvent change on an orbital shaker for about 18 hours at room temperature. It was extracted from the adjuvant by time shaking. The backing material was then removed from the acetone and vacuum dried overnight at 60°C. The supplement was then checked for residual solvent using extractions for GCMS and FTIR. If no residue was detected, the tackiness of the part was confirmed. If the adjunct remained tacky, it was flood cured under nitrogen in an LED-based floodlamp (such as the PCU LED N2 floodlamp available from Dreve Group, Unna, Germany).

Example 10: Stress-Strain Analysis of Representative Samples The stress-strain curve of Adjunct 1 of Example 9 is shown in FIG. 56, and the stress-strain curves of Adjuncts 2-5 of Example 9 are shown in FIG. .

The stress-strain curves shown in FIGS. 56 and 57 were obtained using a pair of 25 mm diameter circular stainless steel RSA-G2 solid state analyzers (available from TA Instruments, 159 Lukens Drive, New Castle, Delaware 19720 USA). Position between the compression plates and lower the compression plates at 0.1 mm per step until an initial axial force of 0.03-0.05 N is applied, equilibrate at a temperature of 37° C. for 120 seconds, and perform the compression test. (lowering the compression plate at 10 mm/min for 14 seconds until a gap height of 0.7 mm or a loading force of about 17 N is reached while recording the real-time compressive stress), and stress- generated by generating a strain curve. A stress-strain curve was therefore generated by compressing each adjunct from its respective uncompressed height of 3 mm to its respective compressed height. The compression height and strain of each backing while the backing was under applied stress are provided in Table 8 below. These measurements are based on the actual manufactured support (any measurement error of the measurement system, e.g. 50 μm to uncompressed height bias, and/or manufacturing tolerances, e.g. 100 μm to uncompressed height). including biases).

As shown in FIG. 56, a strut-less base unit cell, such as a support member formed of support member 800 of FIGS. 8A-8F, demonstrated the following. (i) A unit structure that is sufficiently stable even when the wall thickness is about 0.2 millimeters, such that the structure can be successfully printed and post-processed as previously described. (ii) the supplement undergoes extensive buckling deformation to achieve a stress plateau between about 0.1 strain (about 10% deformation) and about 0.73 strain (73% deformation); (iii) the auxiliary material has the property of bistability, so that the unit structure can deform and achieve a new stable configuration that does not change until an additional force is applied, which reflects the deformation state of the auxiliary material; Provides tactile feedback to the surgeon.

As shown in FIG. 57, a strut-based strut unit cell, such as the strut base 3100 of FIGS. 31A-31D, the strut 3200 of FIGS. 32A-32D, the strut 3300 of FIGS. The brace formed with the brace of FIG. 34E exhibited a stress "plateau" within 5 kPa to 20 kPa of stress over strains of 10 to 60 percent. This result is based, at least in part, on the structural configuration of the unit cell. In particular, each unit cell is designed so that the spacer struts (eg, struts of the internal structure) fold inward without contacting each other during compression of the auxiliary material. As a result, densification of the supplement (eg, reaching solid height) may be delayed (eg, occurring at higher strains).

Example 11: Stress-Strain Analysis of Representative Samples Six exemplary supplements, referred to herein as Sample 1, Sample 2, Sample 3, Sample 4, Sample 5, and Sample 6, -6 each resin formulation is a trifunctional oligomer (methacrylate end groups) with PCL midblocks and PLGA endblocks (85/15 L:G ratio) with a target molecular weight of 6,000 Daltons. Each was prepared in the same manner as in Example 9, except for Sample 1 was formed from repeatedly interconnected Schwartz-P structure unit cells, and Samples 2-5 were each repeatedly interconnected modified Schwartz-P with the top and/or bottom of the initial Schwartz-P structure cropped. Formed from structure. Therefore, the geometry characteristics of the repeating unit cells of each sample were different. A list of geometry unit cell properties for each supplement is provided in Table 9 below and is based on theoretical/intended size.

The stress-strain curves for Samples 1-6 were generated in a manner similar to that described in Example 10 and are shown in FIG. As shown, each unit cell was made of the same resin, but each sample had a different stress-strain curve. Therefore, these different stress-strain curves are a function of unit cell geometry properties (e.g., height, width, length, and wall thickness) and their respective uncompressed heights (see full Table 9 above). Figure 3 shows the relationship between the resulting stress-strain responses of the adjuncts from the respective compression heights (listed as nominal heights). Thus, in addition to the compositional make-up of the unit cell, its various geometric properties are taken into account, thus resulting in an adjunct material with a desired stress-strain response, such as the stress-strain response described herein. need to be adjusted to The compression height and strain for each sample while the sample was under an applied stress of 90 kPa is provided in Table 10 below. These measurements are based on the actual manufactured support (any measurement error in the measurement system, e.g. 50 μm to uncompressed height bias, and/or manufacturing tolerances, e.g. 100 μm to uncompressed height). including biases).

Examples 12-14: Preparation of tri-arm MA-terminated polyester oligomers Examples 12-14 describe the preparation of tri-arm, 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 poly(L-lactic acid) (PLLA) and poly(caprolactone-rL-lactic acid) (PCLLA), PCLLA being the core of the oligomer. . PCLLA is included as total molecular weight (MW) and 70% by weight of CL with a CL:L ratio of 60:40.

The molar ratios and masses of each reagent used for the 1 kg batch of (PLLA-b-PCLLA)-3OH synthesis as discussed in Examples 12 and 13 are provided in Table 11 below.

Example 12: PCLLA-3OH Synthesis A round bottom flask was dried in a drying oven overnight and cooled to room temperature under _N2 flow. Caprolactone, L-lactide, and stannous octoate were added to a round bottom flask. The contents of the reaction flask were heated to 130°C. Meanwhile, trimethylolpropane (TMP) was heated to 130°C. Once preheated, TMP was added to the reaction flask as an initiator and allowed to react to complete monomer conversion. Monomer conversion was monitored using H ¹ NMR. Once complete monomer conversion was reached, the reaction was stopped and the reaction contents were allowed to cool to room temperature. (PCLLA)-3OH was precipitated from chloroform into cold MeOH to give a white solid. (PCLLA)-3OH was characterized using H ¹ NMR, DSC, FTIR, and THF GPC.

Example 13: (PLLA-b-PCLLA)-3OH Synthesis (PCLLA)-3OH and L-lactide prepared in Example 12 were added to a round-bottomed flask under _N2 and heated to 140°C to obtain the reaction content melted things. After melting, the temperature was reduced to 120° C. and the stannous octoate was added. The reaction was continued with stirring while monitoring monomer conversion by H ¹ NMR and THF GPC. When the reaction reached the desired molecular weight, the reaction contents were cooled to room temperature, dissolved in chloroform, and precipitated into cold diethyl ether three times. The precipitate was dried under vacuum.

Example 14: (PLLA-b-PCLLA)-3MA Synthesis The molar ratios and masses of each reagent used to synthesize a 1 kg batch of (PLLA-b-PCLLA)-3MA are provided in Table 12 below. .

(PLLA-b-PCLLA)-3OH prepared in Example 13 was dissolved in anhydrous DCM in a round bottom flask under N ₂ . Triethylamine (TEA) and 400 ppm BHT were added to the reaction flask and the reaction flask was cooled to 0° C. in an ice water bath. The reaction flask was equipped with a pressure equalization addition funnel filled with methacryloyl chloride. Once the reaction flask reached 0° C., methacryloyl chloride was added dropwise over 2 hours. The reaction was allowed to proceed at 0° C. for 12 hours and then at room temperature for 24 hours. Upon completion, 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, washed with aqueous HCl (3%, twice), saturated aqueous sodium bicarbonate, and saturated aqueous sodium chloride, then dried over magnesium sulfate. Magnesium sulfate was filtered off by vacuum filtration and the filtrate was collected. DCM was removed by rotary evaporation and the solid product was collected and characterized by THF GPC, H ¹ NMR, FTIR and DSC.

Example 15: Difunctional Oligomer Resin Formulation The following ingredients were mixed together in the following weight percentages (% by weight of resin) to provide an exemplary photopolymerizable resin for additive manufacturing.
(1) 58.82% of the bifunctional oligomers prepared in Examples 12-13 above
(2) Propylene carbonate (PC) non-reactive diluent 39.22%
(3) Irgacure® 819 photoinitiator 1.96%

The devices disclosed herein can be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned and reused after at least one use. Reconditioning can include any combination of the steps of disassembly of the instrument, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, the device can be disassembled and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the instrument can be reassembled for later 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 reconditioning of the instrument may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and instruments reconditioned thereby, are all within the scope of the present application.

Moreover, in the present disclosure, like-named components of the embodiments generally have like features, and thus in a particular embodiment, each feature of each like-named component is not necessarily fully described. I won't go into detail. Additionally, to the extent that linear or circular dimensions are used in describing disclosed systems, devices, and methods, such dimensions refer to the types of shapes that can be used in conjunction with such systems, devices, and methods. is not intended to limit Those skilled in the art will recognize that dimensions that correspond to such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the system and device and its components are at least the anatomical structure in which the system and device are used, the size and shape of the component in which the system and device are used, and the size and shape of the system and device. may depend on the method and surgery used.

It will be appreciated that the terms "proximal" and "distal" are used herein with reference to the user, such as the clinician, holding the handle of the 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 of description, spatial terms such as "vertical" and "horizontal" are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these spatial terms are not intended to be limiting or absolute.

Values or ranges can be expressed herein as "about" and/or "about" one particular value to another particular value. When such a value or range is expressed, another disclosed embodiment includes the specific value recited and/or from the one particular value to the other particular value. Similarly, when a value is expressed in approximation by the use of the antecedent "about," it is understood that many of the values disclosed are recited and that the particular value forms another embodiment. be. It will also be understood that there are a number of values disclosed and each value is disclosed herein as being "about" in addition to the specific value itself. In some embodiments, "about" can be used to mean, 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, unless stated otherwise, the term "substantially" herein is used herein to attribute any quantitative comparison, value, measurement, or other expression to an inherent Note that it is used to express the degree of uncertainty. The term "substantially" is also utilized herein to denote the degree to which a quantitative expression can vary from a stated baseline without resulting in a change in the underlying function of the subject matter in question. be.

Those skilled in the art will appreciate further features and advantages of the present invention based on the embodiments described above. 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 documents cited herein are expressly incorporated herein in their entirety. Any patent, publication or information herein incorporated by reference in whole or in part shall be deemed that the incorporated material contradicts any existing definitions, statements or other disclosure material contained in this document. only to the extent that it does not. Accordingly, the disclosure as expressly set forth herein shall supersede any conflicting documents incorporated herein.

[Mode of implementation]
(1) A stapling assembly for use with a surgical stapler comprising:
a cartridge extending from a first lateral end to a second lateral end with a longitudinal axis extending between said first lateral end and said second lateral end; wherein the cartridge has a plurality of staples disposed therein, the plurality of staples extending between the first lateral end and the second lateral end A cartridge arranged in longitudinal rows, each longitudinal row having a frequency of staples, said staples arranged along said longitudinal axis and configured to be deployed in tissue. When,
A non-fibrous adjunct formed of at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge so that it can be attached to tissue by the staples within the cartridge. and wherein the auxiliary material comprises a lattice structure having a plurality of repeating unit cells, each unit cell having a non-uniform thickness, the plurality of repeating unit cells arranged in longitudinal rows. , where each longitudinal row has a certain frequency of unit cells, and
The frequency of the unit cells is different than the frequency of the staples, such that the staple legs of the plurality of staples advance through different portions of the backing material, each portion having a relative thickness difference. Configured, stapling assembly.
(2) The stapling assembly of Claim 1, wherein the frequency of the staples is greater than the frequency of the unit cells in each corresponding longitudinal row.
(3) a first staple leg configured to advance each staple of the plurality of staples through a first portion of the backing material having a first thickness; A second staple leg configured to advance through a second portion of the backing material having a second thickness greater than the thickness of the staple leg. .
(4) a first staple leg configured to advance each staple of the plurality of staples through a first portion of the backing material having a first thickness; A second staple leg configured to advance through a second portion of the backing material having a second thickness that is less than the thickness of the stapling assembly of claim 1. .
Clause 5. The stapling assembly of clause 1, wherein at least a portion of the staples of the plurality of staples include uniform staple legs.

Clause 6. The stapling assembly of clause 1, wherein at least a portion of the staples of the plurality of staples include uneven staple legs.
Clause 7. The stapling assembly of clause 1, wherein the plurality of repeating unit cells comprises a triple periodic minimal surface structure.
Aspect 8. The stapling assembly of aspect 1, wherein the plurality of repeat unit cells comprises a Schwartz P structure.
9. The method of claim 1, wherein the support is configured to undergo a strain in the range of 0.1-0.9 while under an applied stress in the range of 30-90 kPa. Stapling assembly.
(10) The stapling assembly of Clause 9, wherein said strain is in the range of 0.1 to 0.7.

(11) A stapling assembly for use with a surgical stapler comprising:
a cartridge having a first longitudinal row of first staples disposed therein, the first staples configured to be deployed within tissue;
A non-fibrous adjunct formed from at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge so that it can be attached to tissue by the staples within the cartridge. and wherein said auxiliary material comprises a grid structure having a first longitudinal row of first repeating unit cells, each unit cell having a non-uniform thickness such that said first The first staple leg and the second staple leg of the first staple advance through different portions of the assist material having different relative thicknesses as the staples are deployed in tissue. , stapling assembly.
Clause 12. The stapling assembly of clause 11, wherein said cartridge comprises an amount of said first staples greater than an amount of said first repeating unit cells of said supplemental material.
(13) the first staples and the first repeating unit cells are arranged with the same frequency so that the first leg of each first staple is of the auxiliary material having a first thickness; 12. The stapling of claim 11, wherein the second leg of each first staple is aligned with a portion of the backing material having a second thickness less than the first thickness. assembly.
Aspect 14. Aspect 13, wherein the first leg has a first height and the second leg has a second height less than the first height. Stapling assembly.
(15) Practice wherein each first staple has a base crown extending between said first staple leg and said second staple leg, said base crown being non-planar. 14. The stapling assembly of aspect 13.

Clause 16. The stapling assembly of Clause 11, wherein the plurality of repeating unit cells comprises a triple periodic minimal curved surface structure.
Aspect 17. The stapling assembly of aspect 11, wherein the plurality of repeat unit cells comprises a Schwartz P structure.
18. The method of claim 11, wherein the supplement is configured to undergo a strain ranging from 0.1 to 0.9 while under an applied stress ranging from 30 kPa to 90 kPa. Stapling assembly.
(19) The stapling assembly of Clause 18, wherein said strain is in the range of 0.1 to 0.7.

Claims (19)

A stapling assembly for use with a surgical stapler comprising:
a cartridge extending from a first lateral end to a second lateral end with a longitudinal axis extending between said first lateral end and said second lateral end; wherein the cartridge has a plurality of staples disposed therein, the plurality of staples extending between the first lateral end and the second lateral end A cartridge arranged in longitudinal rows, each longitudinal row having a frequency of staples, said staples arranged along said longitudinal axis and configured to be deployed in tissue. When,
A non-fibrous adjunct formed of at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge so that it can be attached to tissue by the staples within the cartridge. and wherein the auxiliary material comprises a lattice structure having a plurality of repeating unit cells, each unit cell having a non-uniform thickness, the plurality of repeating unit cells arranged in longitudinal rows. , where each longitudinal row has a certain frequency of unit cells, and
The frequency of the unit cells is different than the frequency of the staples, such that the staple legs of the plurality of staples advance through different portions of the backing material, each portion having a relative thickness difference. Configured, stapling assembly. The stapling assembly of claim 1, wherein the staple frequency is greater than the unit cell frequency in each corresponding longitudinal row. a first staple leg configured to advance through a first portion of the backing material, each staple of the plurality of staples having a first thickness; and a second staple leg configured to advance through a second portion of the backing material having a second greater thickness. a first staple leg configured to advance through a first portion of the backing material, each staple of the plurality of staples having a first thickness; and a second staple leg configured to advance through a second portion of the backing material having a second reduced thickness. The stapling assembly of claim 1, wherein at least a portion of the staples of the plurality of staples include uniform staple legs. The stapling assembly of claim 1, wherein at least a portion of the staples of the plurality of staples include non-uniform staple legs. The stapling assembly of claim 1, wherein the plurality of repeating unit cells comprises a triple periodic minimal surface structure. The stapling assembly of Claim 1, wherein the plurality of repeat unit cells comprises a Schwartz P structure. The stapling assembly of claim 1, wherein the backing material is configured to undergo a strain ranging from 0.1 to 0.9 while under an applied stress ranging from 30 kPa to 90 kPa. . The stapling assembly of claim 9, wherein said strain ranges from 0.1 to 0.7. A stapling assembly for use with a surgical stapler comprising:
a cartridge having a first longitudinal row of first staples disposed therein, the first staples configured to be deployed within tissue;
A non-fibrous adjunct formed from at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge so that it can be attached to tissue by the staples within the cartridge. and wherein said auxiliary material comprises a grid structure having a first longitudinal row of first repeating unit cells, each unit cell having a non-uniform thickness such that said first The first staple leg and the second staple leg of the first staple advance through different portions of the assist material having different relative thicknesses as the staples are deployed in tissue. , stapling assembly. 12. The stapling assembly of claim 11, wherein the cartridge contains an amount of the first staples that is greater than the amount of the first repeating unit cells of the supplemental material. The first staples and the first repeat unit cells are arranged with the same frequency so that the first leg of each first staple is aligned with a portion of the backing material having a first thickness. and wherein the second leg of each first staple is aligned with a portion of the backing material having a second thickness less than the first thickness. 14. The stapling assembly of Claim 13, wherein the first leg has a first height and the second leg has a second height less than the first height. . 14. The method of claim 13, wherein each first staple has a base crown extending between said first staple leg and said second staple leg, said base crown being non-planar. A stapling assembly as described. The stapling assembly of Claim 11, wherein the plurality of repeating unit cells comprises a triple periodic minimal surface structure. 12. The stapling assembly of claim 11, wherein the plurality of repeat unit cells comprises a Schwartz P structure. The stapling assembly of claim 11, wherein the backing material is configured to undergo a strain ranging from 0.1 to 0.9 while under an applied stress ranging from 30 kPa to 90 kPa. . The stapling assembly according to claim 18, wherein said strain ranges from 0.1 to 0.7.

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