Compressible knitted auxiliary material with surface features

Abstract

An auxiliary material for use with a surgical stapler is provided. In one exemplary embodiment, the auxiliary material can include a first braided layer, a second braided layer, and a plurality of recesses extending within and defined in the second braided layer. The plurality of recesses can be arranged in a predetermined pattern that corresponds to a plurality of attachment features extending outward from a top surface of the cartridge, with each recess of the plurality of recesses configured to engage at least a portion of at least one attachment feature to form a friction fit therebetween, thereby retaining the auxiliary material on the cartridge prior to staple deployment. A stapling assembly for use with a surgical stapler is also provided.

Description

[Technical Field]

[0001] A compressible knitted support and methods of use thereof are provided. [Background technology]

[0002] Surgical stapling instruments are used in surgical procedures to close openings in tissue, vessels, ducts, shunts, or other objects or body parts relevant to a particular procedure. The opening may be naturally occurring, such as a passageway in a blood vessel or an internal organ such as the stomach, or may be created by a surgeon during a surgical procedure, such as by creating a bypass or anastomosis in tissue or a vascular puncture, or by tissue incision during the stapling procedure.

[0003] Some surgical stapling instruments require the surgeon to select the appropriate staples having the appropriate staple height for the tissue being stapled. For example, the 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 therefore the staples may not achieve the desired post-fire configuration at each staple site. As a result, the desired seal may not be formed at or near all stapled sites, which can allow blood, air, gastrointestinal fluids, and other fluids to seep through unsealed sites.

[0004] Additionally, staples and other objects and materials that may be implanted in conjunction with procedures such as staple fastening generally lack some of the properties of the tissue in which they are implanted. For example, staples and other objects and materials may lack the natural flexibility of the tissue in which they are implanted and, therefore, may not be able to withstand the fluctuations in intra-tissue pressure at the implantation site. This can lead to undesirable tissue tearing and, ultimately, leakage, at or near the staple site. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there remains a need for improved devices and methods that address the current problems of surgical staplers. [Means for solving the problem]

[0006] An auxiliary material for use with a surgical stapler is provided. In one exemplary embodiment, the auxiliary material includes a first braided layer, a second braided layer, and a plurality of recesses. The first braided layer can have a first fiber and can extend from a first upper surface to a first bottom surface, the first upper surface defining at least a portion of the tissue-contacting surface of the auxiliary material. The second braided layer can have a second fiber and can extend from a second upper surface to a second bottom surface, the second upper surface defining at least a portion of the cartridge-contacting surface of the braided auxiliary material. The plurality of recesses can extend into and be defined in the second braided layer, and the plurality of recesses can be arranged in a predetermined pattern that corresponds to a plurality of attachment features extending outward from the top surface of the cartridge, wherein each recess of the plurality of recesses is configured to engage at least a portion of at least one attachment feature to form a friction fit therebetween, thereby retaining the auxiliary material on the cartridge prior to staple deployment.

[0007] In some embodiments, at least one of the first fiber and the second fiber can be a multifilament fiber.

[0008] The spacer fibers can have a variety of configurations. For example, in some embodiments, the spacer fibers can be intertwined with and extend between the first and second knitted layers, thereby connecting the layers to one another. In other embodiments, the spacer fibers can be monofilament fibers.

[0009] In some embodiments, each recess in the plurality of recesses can be conical.

[0010] A staple fastening assembly for use with a surgical stapler is provided. In one exemplary embodiment, the staple fastening assembly includes a cartridge, a plurality of staples, and a braided support material. The cartridge extends from a top surface to a bottom surface opposite the top surface. The top surface can be a tissue-facing surface having a plurality of attachment features protruding therefrom. The plurality of staples can be disposed within the cartridge and configured to be deployed into tissue. The braided support material is configured to be releasably retained on the cartridge, such that the support material can be attached to tissue by the plurality of staples in the cartridge. The support material can include first and second braided outer layers formed from fibers, and spacer fibers intertwined with and extending between the first and second braided outer layers, thereby connecting the layers to one another. The second braided outer layer can have a plurality of preformed recesses defined therein, each recess configured to receive and engage at least a portion of an extension feature of at least one of the plurality of attachment features, thereby retaining the support material on the cartridge prior to staple deployment.

[0011] The extensions can have a variety of configurations. For example, in some embodiments, each extension feature can have a conical shape with a first maximum diameter and each recess can have an inverted conical shape with a second maximum diameter that is smaller than the first maximum diameter. In other embodiments, each extension feature can have a conical shape with a first maximum diameter and each recess can have an inverted conical shape with a second maximum diameter that is larger than the first maximum diameter.

[0012] In some embodiments, at least one recess of the plurality of recesses can have a perimeter defined by a fused portion of the fibers of the second braided outer layer. In other embodiments, at least one recess of the plurality of recesses can have a perimeter defined by the braided fibers of the second braided outer layer. In some embodiments, at least one recess of the plurality of recesses can have a minimum diameter that is smaller than the diameter of a staple leg of at least one staple of the plurality of staples. In other embodiments, at least one recess of the plurality of recesses can have a maximum diameter that is greater than the maximum diameter of the at least one extension feature.

[0013] In some embodiments, the fibers of at least one of the first outer braided layer and the second outer braided layer can be multifilament fibers.

[0014] In some embodiments, the spacer fiber can be a monofilament fiber.

[0015] In another exemplary embodiment, a stapling assembly for use with a surgical stapler includes a cartridge and a braided support member. The cartridge has a plurality of conical protrusions coupled to and extending outward therefrom. The braided support member is configured to be releasably retained on the cartridge, such that the support member can be attached to tissue by a plurality of staples disposed within the cartridge. The braided support member includes a first braided layer, a second braided layer, spacer fibers, and a plurality of conical recesses. The first braided layer has first fibers and extends from a first upper surface to a first bottom surface, the first upper surface defining at least a portion of the tissue-contacting surface of the support member. The second braided layer has second fibers and extends from a second upper surface to a second bottom surface, the second upper surface defining at least a portion of the cartridge-contacting surface of the support member. The spacer fibers are intertwined with the first fibers and the second fibers to connect the first braided layer to the second braided layer. Portions of the spacer fibers extend in a generally columnar configuration between the first and second layers. A plurality of conical recesses extend into and are defined within the second braided layer, each recess configured to receive and engage at least a portion of at least one conical projection of the plurality of conical projections, thereby retaining the support material on the cartridge prior to staple deployment.

[0016] The recesses can have a variety of configurations. For example, in some embodiments, each recess of the plurality of recesses can have a tapered diameter that decreases as the recess extends into the second braided layer. In other embodiments, at least one recess of the plurality of recesses can have a perimeter defined by a fused portion of the second fiber. In some embodiments, each recess of the plurality of recesses can have a perimeter defined by the braided second fiber. In other embodiments, each recess of the plurality of recesses can have a minimum diameter that is smaller than the diameter of a staple leg of each of the plurality of staples.

[0017] In some embodiments, at least one of the first fiber and the second fiber can be a multifilament fiber.

[0018] In some embodiments, the spacer fiber is a monofilament fiber. [Brief explanation of the drawings]

[0019] The present invention will be more fully understood from the following detailed description when read in conjunction with the accompanying drawings, in which: [Figure 1] 1 is a perspective view of one exemplary embodiment of a conventional surgical stapling and severing device; [Figure 2A] FIG. 2 is a top view of a staple cartridge for use with the surgical stapling and severing device of FIG. 1; [Figure 2B] FIG. 2B is a side view of the staple cartridge of FIG. 2A; [Figure 2C] FIG. 2B is a perspective view of a portion of the tissue contacting surface of the staple cartridge of FIG. 2A; [Figure 3] FIG. 2B is a side view of a staple in an unfired (pre-deployed) configuration that may be disposed within a staple cartridge of the surgical cartridge assembly of FIG. 2A; [Figure 4] FIG. 2 is a perspective view of a knife and firing bar ("E-beam") of the surgical stapling and severing device of FIG. 1; [Figure 5] FIG. 2 is a perspective view of a wedge sled of the staple cartridge of the surgical stapling and severing device of FIG. 1; [Figure 6] FIG. 10 is a longitudinal cross-sectional view of an exemplary embodiment of a surgical stapling assembly having a compressible braided aid attached to the top or deck surface of the staple cartridge. [Figure 7] FIG. 6C is a partial schematic view showing the support material of FIGS. 6A and 6B in a tissue-deployed state. [Figure 8A] FIG. 10 is a perspective view of an exemplary embodiment of a stapling assembly having a compressible braided aid releasably held on a staple cartridge; [Figure 8B] 8B is a cross-sectional view of a portion of the stapling assembly of FIG. 8A taken along line 8B-8B. [Figure 9A] FIG. 10 is a perspective view of another exemplary embodiment of a compressible knitted auxiliary material. [Figure 9B] 9B is a cross-sectional view of the support material of FIG. 9A taken along line 9B-9B. [Figure 10A] FIG. 10 is a perspective view of another exemplary embodiment of a stapling assembly having a compressible braided aid releasably held on a staple cartridge; [Figure 10B] FIG. 10B is a top view of the stapling assembly of FIG. 10A; [Figure 10C] FIG. 10C is a cross-sectional view of the stapling assembly of FIG. 10B taken along line 10C-10C. [Figure 10D] FIG. 10D is a cross-sectional view of the stapling assembly of FIG. 10B taken along line 10D-10D. [Figure 11A] FIG. 10 is a perspective view of another exemplary embodiment of a compressible knitted auxiliary material. [Figure 11B] 11B is a cross-sectional view of the support member of FIG. 11A taken along line 11B-11B. [Figure 12] FIG. 10 is a perspective view of another exemplary embodiment of a stapling assembly having a compressible braided aid; [Figure 13A] FIG. 10 is a cross-sectional view of another exemplary embodiment of a stapling assembly having a compressible braided aid releasably held on a staple cartridge; [Figure 13B] FIG. 13B is a cross-sectional view of the compressible braiding aid and staple cartridge of FIG. 13A in a detached configuration prior to being releasably retained. [Figure 14A] 1 is a cross-sectional view of an exemplary embodiment of a compressible knitted auxiliary material in an uncompressed state. [Figure 14B] 14B is a cross-sectional view of the auxiliary material of FIG. 14A in a first compressed state. [Figure 15A] 1 is a cross-sectional view of an exemplary embodiment of a compressible knitted auxiliary material in an uncompressed state. [Figure 15B]15B is a cross-sectional view of the auxiliary material of FIG. 15A in a first compressed state. [Figure 16A] 1 is a cross-sectional view of an exemplary embodiment of a compressible knitted auxiliary material in an uncompressed state. [Figure 16B] 16B is a cross-sectional view of the auxiliary material of FIG. 16A in a first compressed state. [Figure 17A] 1 is a cross-sectional view of an exemplary embodiment of a compressible knitted auxiliary material in an uncompressed state. [Figure 17B] 17B is a cross-sectional view of the auxiliary material of FIG. 17A in a first compressed state. [Figure 18A] 1A and 1B are side views of an exemplary embodiment of a compressible knitted auxiliary material having a reinforcing knot. [Figure 18B] 18B is a bottom view of the knitting support material of FIG. 18A. FIG. [Figure 19A] 1 is a side view of an exemplary embodiment of a compressible knitted auxiliary material without reinforcing knots. [Figure 19B] 19B is a bottom view of the knitting support material of FIG. 19A. FIG. [Figure 20] 10 is a cross-sectional view of another exemplary embodiment of a compressible knitted auxiliary material. [Figure 21A] FIG. 10 is a perspective view of another exemplary embodiment of a compressible knitted auxiliary material. [Figure 21B] 21B is a cross-sectional view of the support member of FIG. 21A taken along line 21B-21B. DETAILED DESCRIPTION OF THE INVENTION

[0020] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the auxiliary materials, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the auxiliary materials, systems, and methods detailed herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined solely by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present invention.

[0021] Surgical stapling assemblies and methods of making and using the same are provided. Generally, the surgical stapling assemblies can include a staple cartridge having staples disposed therein and a compressible braided support material configured to be releasably retained on the staple cartridge. As discussed herein, the various support materials provided can be configured to compensate for variations in tissue characteristics, such as variations in tissue thickness, and / or to promote tissue ingrowth when the support material is stapled to tissue. Furthermore, the various support materials can be designed to resist fraying and / or tearing, which can improve the aesthetics and / or structural integrity of the support material.

[0022] Exemplary stapling assemblies, as described herein and shown in the drawings, can include various features to facilitate the application of surgical staples. However, those skilled in the art will understand that a stapling assembly may include only some of these features and / or may include various other features known in the art. Any stapling assembly known in the art can be used. The stapling assemblies described herein are intended to be representative of certain exemplary embodiments only. Furthermore, although the aid is described in connection with a surgical staple cartridge assembly, the aid can be used in connection with staple reloads that are not cartridge-based or any type of surgical device.

[0023] FIG. 1 shows an exemplary surgical stapling and severing device 100 suitable for use with an implantable support. The illustrated surgical stapling and severing device 100 includes a staple applying assembly 106, or end effector, having an anvil 102 pivotally coupled to an elongated staple channel 104. As a result, the staple applying assembly 106 is movable between an open position, as shown in FIG. 1, and a closed position, in which the anvil 102 is positioned adjacent the elongated staple channel 104 to engage tissue therebetween. The staple applying assembly 106 may be attached at its proximal end to an elongated shaft 108 that forms an implement portion 110. When the staple applying assembly 106 is closed, or at least substantially closed (e.g., when the anvil 102 is moved from the open position of FIG. 1 toward the elongated staple channel), the implement portion 110 may present a sufficiently small cross-section suitable for inserting the staple applying assembly 106 through a trocar. Although device 100 is configured to staple and cut tissue, surgical devices configured to staple but not cut tissue are also contemplated herein.

[0024] In various circumstances, the staple applying assembly 106 can be operated by a handle 112 connected to the elongated shaft 108. The handle 112 can include a user control, such as a rotation knob 114, which can pivot relative to a pistol grip 118 to close the staple applying assembly 106, for rotating the elongated shaft 108 and staple applying assembly 106 about a longitudinal axis of the elongated shaft 108 and a closure trigger 116. For example, when the closure trigger 116 is clamped, a closure release button 120 can be provided on the exterior of the handle 112 such that the closure release button 120 can be depressed to unclamp the closure trigger 116 and open the staple applying assembly 106.

[0025] Firing trigger 122 can pivot relative to closure trigger 116, thereby enabling staple applying assembly 106 to simultaneously cut and staple tissue clamped therein. In various instances, multiple firing strokes can be employed using firing trigger 122 to reduce the amount of force required to be applied by the surgeon's hand per stroke. In certain embodiments, handle 112 can include one or more rotatable indicator wheels, such as rotatable indicator wheel 124, that can display firing progress. A manual firing release lever 126 allows the firing system to be retracted, if necessary, before the firing system completes its firing movement and also allows a surgeon or other clinician to retract the firing system if it becomes stuck and / or malfunctions.

[0026] Further details regarding the surgical stapling and severing device 100 and other surgical stapling and severing devices suitable for use with the present disclosure are described, for example, in U.S. Patent No. 9,332,984 and U.S. Patent Application Publication No. 2009 / 0090763, the disclosures of which are incorporated herein by reference in their entireties. Additionally, the surgical stapling and severing device need not include a handle, but instead can have a housing configured to couple to a surgical robot, as described, for example, in U.S. Patent Application Publication No. 2019 / 0059889, the disclosure of which is incorporated herein by reference in its entirety.

[0027] As further shown in FIG. 1, a staple cartridge 200 can be utilized with device 100. In use, staple cartridge 200 is disposed within and coupled to elongated staple channel 104. While staple cartridge 200 can have a variety of configurations, in the illustrated embodiment, shown in more detail in FIGS. 2A-2B, staple cartridge 200 has a proximal end 202a and a distal end 202b with a longitudinal axis L extending therebetween. C As a result, when staple cartridge 200 is inserted into elongated staple channel 104 (FIG. 1), longitudinal axis L C is the longitudinal axis L of the elongated shaft 108 S 4. Additionally, staple cartridge 200 includes longitudinal slot 210 defined by two opposing slot edges 210a, 210b and configured to receive at least a portion of a firing member of a firing assembly, such as firing assembly 400 of FIG. 4, as discussed further below. As shown, longitudinal slot 202 extends from proximal end 202a toward distal end 202b of staple cartridge 200. It is also contemplated herein that in other embodiments, longitudinal slot 202 can be omitted.

[0028] 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). The number, shape, and location of the staple cavities can vary and can depend at least on the size and shape of the staples to be removably disposed therein. In this illustrated embodiment, the staple cavities are arranged in two sets of three longitudinal rows, with the first set of staple cavities 212 positioned on a first side of the longitudinal slot 210 and the second set of staple cavities 214 positioned on a second side of the longitudinal slot 210. On each side of longitudinal slot 210, and therefore for each set of rows, a first longitudinal row of staple cavities 212a, 214a extends along longitudinal slot 210, a second row of staple cavities 212b, 214b extends along the first row of staple cavities 212a, 214b, and a third row of staple cavities 212c, 214c extends along the second row of staple cavities 212b, 214b. For each set of rows, the first row of staple cavities 212a, 214b, the second row of staple cavities 212b, 214b, and the third row of staple cavities 214c, 214c are parallel to each other and to longitudinal slot 210. Additionally, as shown, for each set of rows, the second row of staple cavities 212b, 214b is staggered relative to the first and third rows of staple cavities 212a, 212c, 214a, 214c. In other embodiments, the rows of staple cavities in each set 212, 214 are not parallel to each other and / or to the longitudinal slot 210.

[0029] The staples releasably stored within the staple cavities 212, 214 can have a variety of configurations. An exemplary staple 300 that can be releasably stored in each of the staple cavities 212, 214 is shown in its unfired (pre-deployed, unformed) configuration in FIG. 3 . The illustrated staple 300 includes a crown (base) 302 and two staple legs 304 extending from each end of the crown 302. In this embodiment, the crown 302 extends in a linear direction and the staple legs 304 have the same unformed height, although in other embodiments, the crown can be a step-up crown and / or the staple legs can have different unformed heights. Furthermore, before the staple 300 is deployed, the crown 302 can be supported by a staple driver positioned within the staple cartridge 200, while the staple legs 304 can be at least partially contained within the staple cavities 212, 214. Additionally, the staple legs 304 can extend beyond a top surface, such as top surface 206, of the staple cartridge 200 when the staples 300 are in the unfired position. In certain circumstances, as shown in FIG. 3, the tips 306 of the staple legs 304 can be sharpened to a point capable of cutting and penetrating tissue.

[0030] During use, the staples 300 can be deformed from an unfired position to a fired position such that the staple legs 304 travel through the staple cavities 212, 214, penetrate tissue positioned between the anvil 102 and the staple cartridge 200, and contact the anvil 102. As the staple legs 304 deform against the anvil 102, the staple 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 staple legs 304 of each staple 300 can deform downward toward the crown 302 of the staple 300 to form a staple entrapment area within which tissue can be captured. In various instances, the staple entrapment area can be defined between the inner surface of the deformed legs and the inner surface of the staple crown. The size of the staple entrapment area can depend on several factors, such as, for example, the leg length, the leg diameter, the crown width, and / or the degree of leg deformation.

[0031] In some embodiments, all of the staples disposed within staple cartridge 200 can have the same unfired (pre-deployed, unformed) configuration. In other embodiments, the staples can include at least two groups of staples, each having a different unfired (pre-deployed, unformed) configuration, e.g., different heights and / or shapes, different relative to one another, etc. For example, staple cartridge 200 can include a first group of staples having a first height disposed in a first row of staple cavities 212a, 214a, a second group of staples having a second height disposed in a second row of staple cavities 212b, 214b, and a third group of staples having a third height disposed in a third row of staple cavities 212c, 214c. In some embodiments, the first, second, and third heights can be different, with the third height being greater than the first and second heights. In other embodiments, the first and second heights are the same, but the third height is different and greater than the first and second heights. Those skilled in the art will appreciate that other combinations of staples are contemplated herein.

[0032] Additionally, the staples can include one or more exterior coatings, such as sodium stearate lubricant and / or antimicrobial agent(s). The antimicrobial agent(s) can 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.

[0033] 2A-2B, staple cartridge 200 extends from a top or deck surface 206 to a bottom surface 208. Top surface 206 is configured as a tissue-facing surface, and bottom surface 208 is configured as a channel-facing surface. As a result, as shown in FIG. 1 , when staple cartridge 200 is inserted into elongated staple channel 104, top surface 206 faces anvil 102 and bottom surface 208 (which is obstructed) faces elongated staple channel 104. Additionally, top surface 206 has two outermost terminal longitudinal edges 207 a, 207 b that are positioned distally relative to longitudinal slot 210 of staple cartridge 200.

[0034] In some embodiments, the upper surface 206 can include surface features defined therein. For example, the surface features can be recessed channels defined within the upper surface 206. As shown in more detail in FIG. 2C , a first recessed channel 216 surrounds each of the first staple cavities 212a, 214a. Each of the first recessed channels 216 is defined by a substantially triangular wall 216a having a proximally facing apex, a distally facing apex, and a laterally outward facing apex. Further, each of the first recessed channels 216 includes a first floor 206a at a first height from the upper surface 206. A second recessed channel 218 surrounds each of the second staple cavities 212b, 214b. Each second recess channel 218 is defined by a substantially diamond-shaped wall 218a with a proximal-facing apex, a distal-facing apex, an apex facing laterally inward relative to the longitudinal axis, and an apex facing laterally outward. Additionally, each second recess channel 218 includes a second floor 206b at a second height from the upper surface 206. Third recess channel 220 surrounds each third staple cavity 212c, 214c. Each third recess channel 220 is defined by a substantially triangular-shaped wall 220a with a proximal-facing apex, a distal-facing apex, and an apex facing laterally inward relative to the longitudinal axis. Additionally, each third recess channel 220 includes a third floor 206c at a third height from the upper surface 206. In some embodiments, the first height of first recessed channel 216, the second height of second recessed channel 218, and the third height of third recessed channel 220 can have the same height. In other examples, the first height, second height, and / or third height can be different. Further details regarding surface features and other exemplary surface features can be found in U.S. Patent Application Publication No. 2016 / 0106427, which is incorporated herein by reference in its entirety.

[0035] 4 and 5, a firing assembly such as firing assembly 400 can be utilized with a surgical stapling and severing device, such as device 100 of FIG. 1. Firing assembly 400 can be configured to advance a wedge sled 500 having wedges 502 configured to deploy staples from staple cartridge 200 into tissue captured between an anvil, such as anvil 102 of FIG. 1, and a staple cartridge, such as staple cartridge 200 of FIG. 1. Additionally, an E-shaped beam 402 at a distal portion of firing assembly 400 can fire the staples from the staple cartridge. During firing, E-shaped beam 402 can also pivot the anvil toward the staple cartridge, thus moving the staple applying assembly from an open position toward a closed position. The illustrated E-shaped beam 402 includes a pair of upper pins 404, a pair of middle pins 406 that can be along portion 504 of wedge sled 500, and a lower pin or foot 408. E-shaped beam 402 may also include a sharp cutting edge 410 configured to sever captured tissue as firing assembly 400 advances distally, and thus toward the distal end of the staple cartridge. Additionally, integrally formed, proximally projecting upper and middle guides 412, 414 bracketing each vertical end of sharp cutting edge 410 may further define a tissue staging area 416 that assists in guiding tissue toward sharp cutting edge 410 before it is severed. Middle guide 414 may also function to engage and fire staples within the staple cartridge by abutting stepped central member 506 of wedge sled 500, which enables staple formation by staple applying assembly 106.

[0036] In use, the anvil 102, FIG. 1, can be moved to a closed position by depressing the closure trigger, FIG. 1, to advance the E-beam 402, FIG. 4. The anvil can position tissue against at least the top surface 206 of the staple cartridge 200, FIG. 2A-2C. Once the anvil is properly positioned, the staples 300, FIG. 3, disposed within the staple cartridge, can be deployed.

[0037] To deploy staples from the staple cartridge, as described above, the wedge sled 500 of FIG. 5 can be moved from the proximal end toward the distal end of the cartridge body, and thus from the proximal end toward the distal end of the staple cartridge. As the firing assembly 400 of FIG. 4 advances, the sled can contact the staple drivers in the staple cartridge and lift them upwardly within the staple cavities 212, 214. In at least one example, the sled and staple drivers can each include one or more ramps, or angled surfaces, which cooperate to move the staple drivers upwardly from an unfired position. As the staple drivers are lifted upwardly within their respective staple cavities, the staples are advanced upwardly, causing the staples to exit the staple cavities and penetrate into tissue. In various instances, the sled can simultaneously move several staples upwardly as part of a firing sequence.

[0038] As mentioned above, the stapling device can be used in combination with a compressible auxiliary material. While an auxiliary material is shown and described below, those skilled in the art will understand that the auxiliary materials disclosed herein can be used with other surgical devices and need not be coupled to a staple cartridge as described. Furthermore, those skilled in the art will also understand that the staple cartridge need not be replaceable.

[0039] As discussed above, some surgical staplers often require the surgeon to select the appropriate staple having the appropriate staple height for the tissue being stapled. For example, the surgeon 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, and therefore the staples may not achieve the desired post-fire configuration for all portions of the stapled tissue (e.g., portions of thick tissue and portions of thin tissue). If staples having the same or substantially higher heights are used due to inconsistent tissue thickness, undesirable leakage and / or tearing of the tissue at the staple site may occur, particularly if the staple site is subjected to internal pressure at the staple site and / or along the staple row.

[0040] Thus, to avoid the need to consider staple height when stapling tissue during surgery, various embodiments of braided assist materials are provided that can be configured to compensate for varying thicknesses of tissue captured within fired (deployed) staples. That is, the assist materials described herein can provide appropriate tissue compression within and between fired staples, in combination with the assist materials, while allowing sets of staples having the same or similar heights to be used in stapling tissues of various thicknesses (e.g., from thin to thick tissue). Thus, the assist materials described herein can maintain appropriate compression for thin or thick stapled tissue, thereby minimizing leakage and / or tissue tearing at the staple site.

[0041] Alternatively or additionally, the braided support material can be configured to promote tissue ingrowth. In various situations, it is desirable to promote tissue ingrowth into the implantable support material to promote healing of treated tissue (e.g., stapled and / or incised tissue) and / or to accelerate patient recovery. More specifically, tissue ingrowth into the implantable support material can reduce the incidence, severity, and / or duration of inflammation at the surgical site. Tissue ingrowth into and / or around the implantable support material can, for example, manage the spread of infection at the surgical site. For example, ingrowth of blood vessels, particularly leukocytes, into and / or around the implantable support material can combat infection in and / or around the implantable support material and adjacent tissue. Tissue ingrowth can also aid in the patient's body's acceptance of foreign material (e.g., the implantable support material and staples) and reduce the likelihood that the patient's body will reject the foreign material. Rejection of the foreign material can result in infection and / or inflammation at the surgical site.

[0042] Generally, the braided support materials provided herein are designed and positioned on a staple cartridge, such as staple cartridge 200. When staples are fired (deployed) from the cartridge, they penetrate the support material and enter the tissue. When the staple legs are deformed against an anvil positioned on the opposite side of the staple cartridge, the deformed legs capture a portion of the support material and a portion of the tissue within each staple. That is, when the staples are fired into the tissue, at least a portion of the support material is disposed between the tissue and the fired staples. While the support materials described herein can be configured to be attached to a staple cartridge, it is also contemplated herein that the support materials can be configured to mate with components of other devices, such as the anvil of a surgical stapler. One skilled in the art will understand that the support materials provided herein can be used with replaceable cartridges or non-cartridge-based staple reloads.

[0043] FIG. 6 illustrates an exemplary embodiment of a stapling assembly 600 including a staple cartridge 602 and an auxiliary material 604. For simplicity, the auxiliary material 604 is illustrated schematically in FIGS. 6A-6B, and various structural configurations of the auxiliary material are described in more detail below. Other than the differences described in detail below, the staple cartridge 602 may be similar to the staple cartridge 200 (FIGS. 1-3), and thus, common features will not be described in detail here. As shown, the auxiliary material 604 is positioned relative to the staple cartridge 602. Although partially obscured in FIG. 6, the staple cartridge 602 includes staples 606, which may be similar to the staples 300 of FIG. 3, and are configured to be deployed within tissue. The staples 606 can have any suitable unformed (pre-deployed) height. For example, the staples 606 can have an unformed height of approximately 2 mm to 4.8 mm. Prior to deployment, the crowns of the staples can be supported by a staple driver (not shown).

[0044] In the illustrated embodiment, the support material 604 can be fitted onto at least a portion of the top surface or deck surface 608 of the staple cartridge 602. In some embodiments, the top surface 608 of the 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 can be configured to engage the support material 604 to avoid undesired movement of the support material 604 relative to the staple cartridge 602 and / or to prevent premature release of the support material 604 from the staple cartridge 602. Exemplary surface features are described in U.S. Patent Application Publication No. 2016 / 0106427, which is incorporated herein by reference in its entirety.

[0045] The auxiliary material 604 is compressible, allowing the auxiliary material to be compressed to various heights to compensate for different tissue thicknesses captured within the deployed staples. The auxiliary material 604 has an uncompressed (undeformed) or pre-deployed height and is configured to be deformed to one of a plurality of compressed (deformed) or deployed heights. For example, the auxiliary material 604 can have an uncompressed height that is greater than the fired height of the staples 606 disposed within the staple cartridge 602 (e.g., the height (H) of the fired staples 606a in FIG. 7 ). That is, the auxiliary material 604 can have an undeformed state in which the maximum height of the auxiliary material 604 is greater than the maximum height of the fired staples (e.g., the staples in their formed configuration). In one embodiment, the uncompressed height of the support material 604 can be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or about 100% higher than the fired height of the staples 606. In certain embodiments, the uncompressed height of the support material 604 can be greater than 100% higher than the fired height of the staples 606, for example.

[0046] 1 is directed at a surgical site, tissue is positioned between the anvil 612 and the stapling assembly 600 (e.g., the tissue can be positioned against the tissue contacting surface 604a of the adjunct member 604) such that the anvil 612 is positioned adjacent a first side of the tissue and the stapling assembly 600 is positioned adjacent a second side of the tissue. Once the tissue is positioned between the anvil 612 and the stapling assembly 600, the surgical stapler can be actuated, for example as described above, to clamp the tissue between the anvil 612 and the stapling assembly 600 (e.g., between the tissue compressing surface 612a of the anvil 612 and the tissue contacting surface 604a of the adjunct member 604) and deploy staples from the cartridge, through the adjunct member, and into the tissue to staple and attach the adjunct member to the tissue.

[0047] As shown in FIG. 7 , when the staples 606 are fired, the tissue (T) and a portion of the auxiliary material 604 are captured by the fired (formed) staples 606a. Each fired staple 606a defines a capture area therein, as described above, to accommodate the captured auxiliary material 604 and tissue (T). The capture area defined by the fired staples 606a is limited, at least in part, by the height (H) of the fired staples 606a. For example, the height of the fired staples 606a can be approximately 0.160 inches or less. In some embodiments, the height of the fired staples 606a can be approximately 0.130 inches or less. In one embodiment, the height of the fired staples 606a can be approximately 0.020 inches to 0.130 inches. In another embodiment, the height of the fired staples 606a can be approximately 0.060 inches to 0.160 inches.

[0048] As described above, the auxiliary material 604 can be compressed within a plurality of fired staples, regardless of whether the thickness of the tissue captured within the staples is the same or different within each fired staple. In at least one exemplary embodiment, the staples within a row of staples can be deformed to a post-fire height of, for example, approximately 2.75 mm, and the tissue (T) and auxiliary material 604 can be compressed within this height. In certain circumstances, the tissue (T) can have a compressed height of approximately 1.0 mm and the auxiliary material 604 can have a compressed height of approximately 1.75 mm. In certain circumstances, the tissue (T) can have a compressed height of approximately 1.50 mm and the auxiliary material 604 can have a compressed height of approximately 1.25 mm. In certain circumstances, the tissue (T) can have a compressed height of approximately 1.75 mm and the auxiliary material 604 can have a compressed height of approximately 1.00 mm. In certain circumstances, the tissue (T) can have a compressed height of approximately 2.00 mm and the auxiliary material 604 can have a compressed height of approximately 0.75 mm. In certain circumstances, the tissue (T) can have a compressed height of approximately 2.25 mm and the auxiliary material 604 can have a compressed height of approximately 0.50 mm. Thus, the sum of the compressed heights of the captured tissue (T) and the auxiliary material 604 can be equal to, or at least substantially equal to, the height (H) of the fired staples 606a.

[0049] The knitted support material can have a variety of configurations. Generally, as described in more detail below, the knitted support material is formed from fibers that are knitted or woven (e.g., intertwined) together.

[0050] While the knitting aid can be formed from the same fibers, in other embodiments, the knitting aid can be formed from different fibers. The fibers can differ in material, size (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament). In certain embodiments, the knitting aid can include monofilament and / or multifilament fibers. As used herein, the term "monofilament fiber" has its ordinary and customary meaning and can include fibers formed from a single filament. As used herein, the term "multifilament fiber" has its ordinary and customary meaning and can include fibers formed from two or more filaments associated (e.g., twisted or braided) with each other to form a unitary structure.

[0051] Multifilament fibers can have a variety of configurations. For example, in some embodiments, each multifilament fiber contains about 6-40 filaments. In one embodiment, each multifilament fiber contains about 14-28 filaments. The increased surface area and void space present between the filaments of multifilament fibers can facilitate improved tissue ingrowth within the support material.

[0052] Multifilament fibers can be formed from filaments made of the same material or from filaments made of different materials. For example, in some embodiments, a multifilament fiber can include a first filament of a first material and a second filament of a second material. In one embodiment, the second material degrades at a rate faster than the degradation rate of the first material. In this manner, degradation of the second material can activate macrophages, thereby promoting accelerated macrophage attraction and accelerating the inflammatory phase of healing, without substantially affecting the variable stiffness profile of the support material over time after implantation. Macrophage activation can induce an increase in the myofibroblast population and angiogenesis. Furthermore, degradation of the second material can promote tissue ingrowth within the support material. The first material can be, for example, at least one of poly-L-lactic acid, copolymers of glycolide and L-lactide, copolymers of glycolic acid and lactic acid, poly(lactic-co-glycolic acid), poly(lactic acid), polyglycolide, and copolymers of glycolide, caprolactone, trimethylene carbonate, and lactide. Non-limiting examples of suitable first materials can be formed from polyglactin 910, Lactomer™ 9-1, 75:25 or 50:50 lactic acid / glycolic acid, Polygytone™ 6211, or Caprosyn™. The second material can be, for example, a copolymer of glycolide and L-lactide, such as Vicryl Rapide™.

[0053] Multifilament fibers can contain second filaments in a variety of proportions, but in some embodiments, each multifilament fiber can contain about 15% to 85% or about 25% to 45% of second filaments. The second filaments can have a variety of fiber diameters. For example, in some embodiments, the second filaments can have a fiber diameter of about 0.0005 mm to 0.02 mm. In one embodiment, the second filaments have a fiber diameter of about 0.015 mm.

[0054] Monofilament fibers can have a variety of sizes. For example, monofilaments can have diameters of about 0.2 mm to 0.35 mm. In some embodiments, the monofilament fibers can each have a diameter smaller than the average fiber diameter of the multifilament fibers. The average fiber diameter (D) of a multifilament fiber can be calculated using the following formula:

[0055]

number

[0056] Multifilament fibers can have a variety of sizes. For example, each multifilament fiber can have an average fiber diameter of about 0.02 mm to 0.2 mm, about 0.05 mm to 0.2 mm, or about 0.15 mm to 0.2 mm. In some embodiments, each filament of a multifilament fiber has a diameter smaller than the fiber diameter of a monofilament fiber. For example, if the auxiliary material includes a first fiber that is a multifilament fiber and a second fiber that is a monofilament fiber, each filament of the multifilament fiber can have a diameter that is about 1 / 5 to 1 / 20 of the diameter of the monofilament fiber. In certain embodiments, each filament of a multifilament fiber can have a diameter that is about 1 / 10 of the diameter of the monofilament fiber.

[0057] As mentioned above, because a portion of the support material is captured with the tissue within the fired staple, it is desirable for the support material to be formed from a suitable bioabsorbable material. Accordingly, each of the fibers can be formed from one or more bioabsorbable materials. Non-limiting examples of suitable bioabsorbable materials include poly-L-lactic acid, copolymers of glycolide and L-lactide, copolymers of glycolic acid and lactic acid, poly(lactic acid-co-glycolic acid), poly(lactic acid), polyglycolide, copolymers of glycolide, caprolactone, trimethylene carbonate, and lactide, polydioxanone, copolymers of polydioxanone and polyglycolide, copolymers of lactide and polycaprolactone, copolymers of glycolide, dioxanone, and trimethylene carbonate, poly(trimethylene carbonate), polyhydroxyalkanoates, and polyglyconates.

[0058] In some embodiments, the knitting aid can include at least two different types of fibers. Non-limiting examples of materials suitable for the first type of fiber include at least one of poly-L-lactic acid, copolymers of glycolide and L-lactide, copolymers of glycolic acid and lactic acid, poly(lactic-co-glycolic acid), poly(lactic acid), polyglycolide, and copolymers of glycolide, caprolactone, trimethylene carbonate, and lactide. For example, the first type of fiber can be formed from polyglactin 910, Lactomer™ 9-1, 75:25 or 50:50 lactic acid / glycolic acid, Polygytone™ 6211, or Caprosyn™. Non-limiting examples of suitable materials for the second type of fibers include at least one of polydioxanone, copolymers of polydioxanone and polyglycolide, copolymers of lactide and polycaprolactone, copolymers of glycolide, dioxanone, and trimethylene carbonate, poly(trimethylene carbonate), polyhydroxyalkanoates, and polyglyconates. For example, the second type of fibers can be formed from 92:8 polydioxanone / polyglycolide, 25:75 lactide / polycaprolactone, Glycomer™ 631, or Maxon™. In one embodiment, the first type of fibers are formed from polyglactin 910 and the second type of fibers are formed from polydioxanone.

[0059] The knitted auxiliary material can have different sizes, shapes, and configurations. Generally, the auxiliary material includes at least a core or intermediate layer and at least one outer layer. For example, the auxiliary material can include a first outer layer (e.g., an upper layer or tissue-contacting layer) formed from at least a first fiber (e.g., a knitted layer) knitted or woven together, and a second outer layer (e.g., a lower layer or cartridge-contacting layer) formed from at least a second fiber (e.g., a knitted layer) knitted or woven together. The first and second fibers can be the same or different. The auxiliary material can also include spacer fibers, which can be the same or different from the first and second fibers. The spacer fibers intertwine with and extend between the first and second outer layers, thereby connecting these layers together so that the portion of the spacer fiber extending between the two outer layers forms at least one of the core or intermediate layers of the auxiliary material.

[0060] Each layer of the support material extends from a first surface (e.g., a top surface) to a second surface (e.g., a bottom surface). Depending on the overall structural configuration of the support material, at least a portion of the first surface of one layer can function as a tissue-contacting surface, and at least a portion of the second surface of another layer can function as a cartridge-contacting surface. Those skilled in the art will understand that the support material can have additional tissue-contacting surfaces (e.g., one or more lateral sides relative to the top surface).

[0061] In some embodiments, the spacer fibers are interconnected with the first and second fibers of the outer layer such that the spacer fibers are non-fixedly attached and slidably interconnected. Thus, the fibers can move relative to one another, thereby allowing the knitted support material to move and expand in the x-direction (e.g., stretch) and y-direction (e.g., compress). Additionally, the interconnections between the spacer fibers and the first and second fibers of the outer layer can, at least in part, affect the stiffness of the support material. For example, the denser the interconnections, the stiffer the support material will be.

[0062] Each of the first and second outer layers can include a plurality of openings formed therein. The perimeter of the openings in the first outer layer can be defined by portions of the first fibers and spacer fibers, and the perimeter of the openings in the second outer layer can be defined by portions of the second fibers and spacer fibers. In certain embodiments, the openings in the second outer layer can have a size that is less than about 1 / 4 of the width of the crown of a staple, such as staple 300 of FIG. 3. Thus, in such embodiments, the crown of a fired staple can span at least four openings in the second outer layer. In one embodiment, the openings can have a size that is about 1 / 8 of the width of the crown. While the crown of a staple can have a variety of widths, in some embodiments, the crown width can be between about 0.080 inches and 0.140 inches. In one embodiment, the crown width is about 0.12 inches.

[0063] In certain embodiments, the portions of the spacer fibers extending between the first and second outer layers can be arranged to form standing fibers and a plurality of voids therebetween. The standing fibers are non-fixedly attached to one another. Furthermore, the standing fibers are non-fixedly and slidably interconnected to the first type of fibers in the first and second outer layers. In some implementations, the plurality of voids can be larger than the plurality of openings in the first and second outer layers.

[0064] The standing fibers can be configured to flex under a force applied to the support material (e.g., when stapled to tissue). The resilience of the standing fibers allows, at least in part, the support material to be compressed to various heights, thereby accommodating tissue (T) having tissue portions of different thicknesses. That is, regardless of the thickness of a particular tissue, the combined compressed height of the captured tissue and support material within the fired staples can be maintained, and therefore can remain equal to, or at least substantially equal to, the height of the fired staples. In this manner, at least in part, the braided support material can maintain a compressive strength of at least about 3 gf / mm for at least a predetermined period of time (e.g., at least about 3 days). 2 The tissue may be configured to apply a stress of 0.05 to the captured tissue.

[0065] Generally, the material composition, height, and / or cross-sectional area of ​​each standing fiber at least partially controls its stiffness or ability to bend under compression, which in turn at least partially controls the overall compressibility of the support material. Thus, the standing fibers can be configured to adjust the compressibility of the support material to one or more desired values. For example, in some embodiments, the standing fibers can be formed from the same material, while in other embodiments, at least a portion of the standing fibers can be formed from different materials having different stiffnesses. Alternatively or additionally, the standing fibers, or at least a portion thereof, can have different heights and / or cross-sectional areas.

[0066] The amount of standing fibers in a particular region or section of the auxiliary material can also affect, among other things, the compressibility of such section and, therefore, the overall compressibility of the auxiliary material. In certain cases, for example, the standing fibers can be strategically concentrated in particular regions of the auxiliary material to increase compressive strength in such regions. In at least one case, the standing fibers can be concentrated in regions of the core layer or intermediate layer configured to receive staples when the staples are fired. Alternatively, the standing fibers can be concentrated in regions of the auxiliary material that will not receive staples when the staples are fired (e.g., regions overlapping the intended cut line of the auxiliary material).

[0067] The ratio of voids to standing fibers can vary. In some embodiments, this ratio can be in the range of at least about 3:1. In other embodiments, the ratio of voids to standing fibers can be in the range of at least about 5:1, or at least about 12:1. Furthermore, at least a portion of the voids can each have a different size. In this manner, variable pore size across the cross-section of the support material 804 can promote extracellular remodeling. That is, variable pore size can promote revascularization and cellular mobility within the support material when the support material is implanted, thereby promoting both tissue and cell ingrowth. Furthermore, variable pore size can also facilitate the extraction of by-products and cellular waste products from the implanted support material and, therefore, from the implantation site.

[0068] Edge Conditions As described above, a knitted auxiliary material is formed from fibers that are knitted or woven together. In certain embodiments, the knitted auxiliary material can be designed so that at least a portion of the free ends of the fibers are connected to each other to form one or more finished edges of the auxiliary material. The one or more finished edges are configured to substantially or completely prevent fraying or fiber separation along the edges. As a result, the structural integrity of the auxiliary material can be maintained when exposed to forces that would otherwise cause the fibers to fray or separate from each other. The one or more finished edges can also provide aesthetic benefits and / or reduce variability in both the structure and associated properties of the auxiliary material compared to conventional auxiliary materials (e.g., auxiliary materials without finished edges).

[0069] The one or more finished edges can be formed in a variety of ways. For example, in some embodiments, additional fiber(s) (e.g., fibers different from those used to form the main body of the supplemental material) can be used to interconnect the terminal edges of opposing layers of the supplemental material to one another (see FIGS. 8A-10D). In such embodiments, the additional fiber(s) can be knitted or woven into the terminal edges in a variety of configurations (e.g., as an overcast stitch, an over-edge stitch, a zigzag stitch, etc.).

[0070] 8A-8B illustrate one exemplary embodiment of a stapling assembly 800 including a staple cartridge 802 and a braided support material 804 disposed on an upper surface or deck surface 803 of the staple cartridge 802. Staple cartridge 802 is similar to staple cartridge 200 of FIGS. 1-2C and therefore, common features will not be described in detail herein.

[0071] In this illustrated embodiment, as shown in more detail in FIG. 8B , the support material 804 includes an upper layer 806 (e.g., a tissue-contacting layer) formed from at least first fibers 808, a lower layer 810 (e.g., a cartridge-contacting layer) formed from at least second fibers 812, and spacer fibers 814 that intertwine with and extend between the upper layer 806 and the lower layer 810, thereby connecting the upper layer 806 and the lower layer 810 to each other. In this illustrated embodiment, the spacer fibers 814 are multiplexed around the first fibers 808 and the second fibers 812. The portions of the spacer fibers 814 that extend between the upper layer 806 and the lower layer 810 form an intermediate or core layer 816 of the support material 804. For simplicity, only one first fiber 808, second fiber 812, and spacer fiber 814 are shown in FIG. 8B . Those skilled in the art will understand that the following description is also applicable to the remaining first fibers, second fibers, and spacer fibers of the auxiliary material.

[0072] The upper layer 806 and the lower layer 810 can have a variety of structural configurations. As shown, the upper layer 806 has two outermost longitudinal end edges 806a, 806b, and the lower layer has two outermost longitudinal end edges 810a, 810b. In some embodiments, the first fibers 808 of the upper layer 806 can be knitted or woven into a first predetermined pattern and / or the second fibers 812 of the lower layer 810 can be knitted or woven into a second predetermined pattern. In certain embodiments, the first and second predetermined patterns can be generally identical (e.g., nominally identical within manufacturing tolerances), while in other embodiments, the first and second predetermined patterns can be different. While the first fibers 808 and the second fibers 812 can be knitted or woven in a variety of patterns, in certain embodiments, the first fibers 808 can be knitted in a first Raschel knit pattern and the second fibers 812 can be knitted in a second Raschel knit pattern that is the same as or different from the first Raschel knit pattern. Further, in some embodiments, the fiber density of the top layer 806 can be different from the fiber density of the bottom layer 810. Those skilled in the art will appreciate that the first fibers 808 and the second fibers 812 can be knitted or woven in a random or repeating manner within the top layer 806 and the bottom layer 810, respectively. Therefore, for simplicity, the top layer 806 and the bottom layer 810 are shown generically, and therefore, the specific structural configurations of the top layer 806 and the bottom layer 810 are not limited to those shown in the figures.

[0073] The first fibers 808, the second fibers 812, and the spacer fibers 814 can have a variety of configurations. For example, in some embodiments, the first fibers 808, the second fibers 812, and the spacer fibers 814 can be generally identical in material and / or structural configuration (e.g., nominally identical within manufacturing tolerances). In other embodiments, the first fibers 808 and the second fibers 812 can be generally identical in material and / or structural configuration (e.g., nominally identical within manufacturing tolerances) relative to one another, and the spacer fibers 814 can be different therefrom. For example, in certain embodiments, the first fibers 808 and the second fibers 812 can be multifilament fibers, and the spacer fibers 814 can be monofilament fibers. Therefore, the specific structural configuration of each of the first fibers 808, the second fibers 812, and the spacer fibers 814, apart from their general overall shapes, is not shown.

[0074] While the auxiliary material 804 can have various configurations, in the embodiment shown in FIG. 8B , the auxiliary material 804 includes an innermost segment 820 including first fibers 808, second fibers 812, and spacer fibers 814, and a longitudinal axis L of the auxiliary material on either side (e.g., longitudinal side) of the innermost segment 820. A (e.g., in the z direction) along the top or deck surface 803 of the staple cartridge 802. As a result, when the support material 804 is releasably coupled to the top or deck surface 803 of the staple cartridge 802, the first outermost segment 822 is adjacent to and extends along the first outermost longitudinal edge 805a of the top surface 803 and the second outermost segment 824 is adjacent to and extends along the second outermost longitudinal edge 805b of the top surface 803 of the cartridge 802.

[0075] Although the first outermost segment 822 and the second outermost segment 824 can have different structural configurations, in this illustrated embodiment, the first outermost segment 822 and the second outermost segment 824 are generally identical (e.g., nominally identical within manufacturing tolerances). The first outermost segment 822 and the second outermost segment 824 each include only the first fibers 808 and the second fibers 812, and thus only include portions of the top layer 806 and the bottom layer 810. That is, in this illustrated embodiment, the spacer fibers 814 are not present in the first outermost segment 822 and the second outermost segment 824, such that the mechanical behavior of the supplemental material 804 can be primarily controlled by the innermost segment 820, and therefore by the mechanical behavior of the spacer fibers 814. In other embodiments, the first outermost segment 822 and / or the second outermost segment 824 can include the spacer fibers 814. Additionally, as shown, the first outermost segment 822 includes first outermost longitudinal end edges 806a, 810a of the upper and lower layers 806, 810, each of which includes a portion of the free ends of the first and second fibers 808, 812. Similarly, the second outermost segment 824 includes second outermost longitudinal end edges 806b, 810b of the upper and lower layers 806, 810, each of which includes a portion of the free ends of the first and second fibers 808, 812.

[0076] As shown in more detail in FIG. 8B, the portions of the upper layer 806 and lower layer 810 within the innermost segment 820 are aligned along the longitudinal axis L of the support material 804. A , extending parallel to one another (e.g., extending in the z direction) and spaced apart by a respective distance D. Similarly, the respective portions of the top layer 806 and bottom layer 810 within the first outermost segment 822 and the second outermost segment 824 are spaced apart by a respective distance D along the longitudinal axis L of the support material 804. A, extending parallel to one another along the outermost segment 822 (e.g., extending in the z-direction) and spaced apart by respective distances D1, D2. Thus, portions of the upper layer 806 and the lower layer 810 in the first outermost segment 822 at least partially overlap one another, and portions of the upper layer 806 and the lower layer 810 in the second outermost segment 824 at least partially overlap one another. In particular embodiments, distances D, D1, D2 can all be the same or all different; in the illustrated embodiment, distance D is different from distances D1 and D2, and distances D1 and D2 are generally identical (nominally identical within manufacturing tolerances).

[0077] The difference between distance D and distances D1 and D2 is due to the tapered transition between the innermost segment 820 of the support material 804 and the first and second outermost segments 822 and 824 via the first and second intermediate segments 826 and 828. The first intermediate segment 826 extends from the innermost segment 820 to the first outermost segment 822, and the second intermediate segment 828 extends from the innermost segment 820 to the second outermost segment 824. The first and second intermediate segments 826 and 828 are tapered such that the respective portions of the upper layer 806 extend at an angle relative to the respective portions of the lower layer 810. As shown, the respective portions of the upper layer 806 extend toward the respective portions of the lower layer 810 within the first and second intermediate segments 826 and 828. As a result, the distance D between the portion of the upper layer 806 and the portion of the lower layer 810 of the innermost segment 820 is greater than the distances D1, D2 between the portions of the upper layer 806 and the portion of the lower layer 810 of the first outermost segment and the second outermost segment, respectively. This relationship between the distance D and the distances D1, D2 may enable additional fiber(s), such as first additional fiber 830 and second additional fiber 832, to be used to interconnect one or more terminal edges of the upper layer 806 and the lower layer 810 without adversely affecting the overall mechanical behavior of the supplemental material 804.

[0078] As further shown, the supplemental material 804 includes first additional fibers 830 (FIG. 8B) and second additional fibers 832 (FIGS. 8A-8B). The first additional fibers 830 and second additional fibers 832 form respective first finished edges 834 and second finished edges 836, each configured to prevent fraying of the top layer 806 and bottom layer 810 therealong, and thus fraying and / or fiber separation of the first fibers 808 and second fibers 812.

[0079] The first additional fiber 830 and the second additional fiber 832 can have a variety of configurations. In some embodiments, the first additional fiber 830 and the second additional fiber 832 can be generally identical (nominally identical within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimension(s) (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament). In particular embodiments, the first additional fiber 830 and / or the second additional fiber 832 can be monofilament fibers. In other embodiments, the first additional fiber 830 and / or the second additional fiber 832 can be multifilament fibers. Thus, aside from their general overall shapes, the specific structural configurations of the first additional fiber 830 and the second additional fiber 832 are not shown. Furthermore, although only one first additional fiber and one second additional fiber are shown in Figures 8A-8B, one skilled in the art will understand that two or more first additional fibers and / or two or more second additional fibers and / or other additional fiber(s) may be used to form the finished edge of the auxiliary material.

[0080] The first additional fiber 830 and the second additional fiber 832 can be incorporated into the supplemental material 804 in various ways to form the first finished edge 834 and the second finished edge 836. In the illustrated embodiment, the first additional fiber 830 interconnects the upper layer 806 and the lower layer 810 along their first outermost longitudinal end edges 806a, 810a to form the first finished edge 834. As a result, the first finished edge 834 is formed from the first fiber 808, the second fiber 812, and the first additional fiber 830 and is positioned along and thus defines at least a portion of the first outermost longitudinal edge 838 of the supplemental material 804. The second additional fiber 832 interconnects the upper layer 806 and the lower layer 810 along their respective second outermost longitudinal end edges 806b, 810b to form the second finished edge 836. As a result, the second finished edge 836 is formed from the first fibers 808, the second fibers 812, and the second additional fibers 832 and is positioned along and therefore defines at least a portion of the second outermost longitudinal edge 840 of the auxiliary material 804. Thus, at least a portion of the outermost periphery of the auxiliary material is defined by the first finished edge 834 and the second finished edge 836.

[0081] Furthermore, the first additional fiber 830 and / or the second additional fiber 832 can be configured as an overcast stitch. For example, as shown in more detail in FIG. 8B , the first additional fiber 830 and the second additional fiber 832 are wrapped in the form of loops (e.g., in a spiral or zigzag configuration) around the first outermost longitudinal end edges 806 a, 810 a and the second outermost longitudinal end edges 806 b, 810 b, respectively. As a result, the free end portions of the first fiber 808 and the second fiber 812 at the first outermost longitudinal end edges 806 a, 810 a are secured to each other by the first additional fiber 830, and the free end portions of the first fiber 808 and the second fiber 812 at the second outermost longitudinal end edges 806 b, 810 b are secured to each other by the second additional fiber 832. In other embodiments, the first additional fiber 830 and the second additional fiber 832 can be configured in other suitable stitch configurations. Furthermore, in certain embodiments, the first additional fiber 830 and the second additional fiber 832 can be configured in different stitch configurations.

[0082] 9A-9B show another exemplary embodiment of a knitted auxiliary material 900 having one or more finished edges formed by respective additional fibers. Other than the differences discussed below, auxiliary material 900 is similar to auxiliary material 804 of FIGS. 8A-8B, and therefore common features will not be described in detail here.

[0083] The support material 900 includes an upper layer 906 (e.g., a tissue-contacting layer) formed from first fibers 908, a lower layer 910 (e.g., a cartridge-contacting layer) formed from second fibers 912, and spacer fibers 914 that intertwine with and extend between the upper and lower layers 906, 910, thereby connecting the upper and lower layers 906, 910 to each other. As shown in FIG. 9A , the upper layer 906 has at least two outermost longitudinal end edges 906 a, 906 b and at least two outermost lateral end edges 906 c, 906 d. The lower layer 910 has at least two outermost longitudinal end edges (only one outermost longitudinal end edge 910 b is shown in FIG. 9A ) and at least two outermost lateral end edges 910 c, 910 d.

[0084] In addition to first and second outermost segments 915 and 916 (see FIG. 9A), which are similar to first and second outermost segments 822 and 824 of FIGS. 8A-8B, the support material 900 includes third and fourth outermost segments 918 and 920 (see FIG. 9B). The third and fourth outermost segments 918 and 920 are positioned on either side (e.g., lateral sides) of the innermost segment 922 and are aligned along the longitudinal axis L of the support material (e.g., extending in the z-direction). A Other than their location within the support material 900, the third outermost segment 918 and the fourth outermost segment 920 are structurally similar to the first outermost segment 915 and the second outermost segment 916.

[0085] Furthermore, in addition to first and second intermediate segments 924 and 926 (see FIG. 9A ), which are similar to first and second intermediate segments 826 and 828 in FIGS. 8A-8B , auxiliary material 900 includes third and fourth intermediate segments 928 and 930 (see FIG. 9B ). As shown, third intermediate segment 928 extends from innermost segment 922 to third outermost segment 918, and fourth intermediate segment 930 extends from innermost segment 922 to fourth outermost segment 920. Other than their locations within auxiliary material 900, third and fourth intermediate segments 928 and 930 are structurally similar to first and second intermediate segments 924 and 926.

[0086] 9A-9B, the supplemental material 900 includes first, second, third, and fourth additional fibers 932, 934, 936, 938, which form first, second, third, and fourth finished edges 940, 942, 944, 946, respectively, that are configured to prevent fraying of the top layer 906 and bottom layer 910 therealong, and thus fraying and / or fiber separation of the first fiber 908 and second fiber 912. Each additional fiber 932, 934, 936, 938 can be incorporated into the supplemental material in a variety of ways to form the respective finished edges 940, 942, 944, 946. First finished edge 940 and second finished edge 942 are similar to first finished edge 834 and second finished edge 836 of Figures 8A-8B and therefore will not be described in detail here.

[0087] The third and fourth additional fibers 936, 938 can be incorporated into the supplemental material 900 in various ways to form the third and fourth finished edges 944, 946. In the illustrated embodiment, the third additional fiber 936 interconnects the top layer 906 and the bottom layer 910 along their first outermost lateral end edges 906c, 910c to form the third finished edge 944. As a result, the third finished edge 944 is formed from the first fiber 908, the second fiber 912, and the third additional fiber 936 and is positioned along and thus defines at least a portion of the first outermost lateral edge 948 of the supplemental material 900. The fourth additional fiber 938 interconnects the top layer 906 and the bottom layer 910 along their respective second outermost lateral end edges 906d, 910d to form the fourth finished edge 946. As a result, a fourth finished edge 946 is formed from the first fibers 908, the second fibers 912, and the fourth additional fibers 938 and is positioned along and therefore defines at least a portion of a second outermost lateral edge 950 of the auxiliary material 900. Thus, at least a portion of the outermost periphery of the auxiliary material 900 is defined by the first, second, third, and fourth finished edges 940, 942, 944, 946. In certain embodiments, for example, as shown in FIG. 9A , the outermost periphery of the auxiliary material 900 can be completely defined by the finished edges.

[0088] Additionally, the third additional fiber 936 and / or the fourth additional fiber 938 can be configured as an overcast stitch. For example, as shown, the third additional fiber 936 and the fourth additional fiber 938 are wrapped in the form of loops (e.g., in a spiral configuration) around the first outermost lateral end edges 906c, 910c and the second outermost lateral end edges 906d, 910d, respectively. As a result, the free end portions of the first fiber 908 and the second fiber 912 at the first outermost lateral end edges 906c, 910c are secured to one another by the third additional fiber 936, and the free end portions of the first fiber 908 and the second fiber 912 at the second outermost lateral end edges 906d, 910d are secured to one another by the fourth additional fiber 938. In other embodiments, the third additional fiber 936 and the fourth additional fiber 938 can be configured as other suitable stitch configurations. Additionally, in certain embodiments, the third additional fiber 936 and the fourth additional fiber 938 can be configured as different stitch configurations.

[0089] Alternatively, or additionally, the support material can include innermost longitudinal terminal edge(s) relative to its outermost longitudinal terminal edge (e.g., first and second outermost longitudinal terminal edges 806a, 806b, 810a, 810b in FIGS. 8A-8B ). In such embodiments, the support material can include additional fibers incorporated therein, and finished edge(s) can also be formed along and thus define at least a portion of the innermost longitudinal terminal edge(s). For example, the support material can include an innermost longitudinal terminal edge configured to bound a longitudinal slot, such as longitudinal slot 210 in FIGS. 2A-2C , of a staple cartridge. In such embodiments, the support material can include at least one bridge element extending between and connecting spaced apart portions of the support material (e.g., portions configured to be positioned on either side of the longitudinal slot when the support material is coupled to the cartridge). In certain embodiments, the at least one bridge element can be designed to overlap at least a portion of the cutting line of the support material and thus at least a portion of the longitudinal slot, such that the at least one bridge element is severed by advancement of the cutting element through the longitudinal slot.

[0090] In some embodiments, the at least one bridge element can include two or more bridge elements spaced apart from one another to provide separate attachments between the sections of support material. In embodiments in which such sections are configured to be positioned on opposite sides of the cartridge's longitudinal slot, the separate attachments can reduce the amount of support material positioned within the cutting element's advancement path. This reduction can help minimize the support material's resistance to the cutting element's advancement, improving the cutting element's lifespan and / or reducing the force required to advance the cutting element through the support material, among other things. In certain embodiments, the at least one bridge element can be formed from a portion of at least one of the upper and lower layers of support material, while in other embodiments, the at least one bridge element can be formed from a separate material. Alternatively, one or more of the at least one bridge element can be positioned outside the cutting element's advancement path and thus continue to connect the sections of support material after the cutting element has advanced through the longitudinal slot.

[0091] 10A-10D show another exemplary embodiment of a stapling assembly 1000 having a staple cartridge 1002 and a braided support material 1004 disposed on an upper or deck surface 1003 of the staple cartridge 1002 and having one or more finished edges. The staple cartridge 1002 is similar to the staple cartridge 200 of FIGS. 1-2C, and therefore, the common features will not be described in detail herein. Furthermore, other than the differences described below, the support material 1004 is similar to the support material 804 of FIGS. 8A-8B, and therefore, the common features will not be described in detail herein.

[0092] The support material 1004 can have a variety of configurations. For example, in the illustrated embodiment, the support material 1004 includes a first longitudinal portion 1006 and a second longitudinal portion 1008, each including a respective upper layer 1010, 1012 (e.g., tissue-contacting layer) formed from a first fiber 1014, a lower layer 1016, 1018 (e.g., cartridge-contacting layer) formed from a second fiber 1020, and spacer fibers 1022 intertwined with and extending between the respective upper layer 1010, 1012 and lower layer 1016, 1018, thereby connecting the upper and lower layers. The upper and lower layers 1010, 1012 are similar in structure to the upper and lower layers 806, 810 of Figures 8A-8B, and the spacer fibers 1022 are similar to the spacer fibers 814 of Figures 8A-8B, and therefore, comment features will not be described in detail here. Furthermore, at least a portion of the fibers in the first longitudinal portion 1006 can be the same as or different from at least a portion of the fibers in the second longitudinal portion 1008. In this illustrated embodiment, the first fibers 1014 in the first and second longitudinal portions 1006, 1008 are the same type of fiber, the second fibers 1020 in the first and second longitudinal portions 1006, 1008 are the same type of fiber, and the spacer fibers 1022 in the first and second longitudinal portions 1006, 1008 are the same type of fiber.

[0093] The first longitudinal portion 1006 and the second longitudinal portion 1008 can each include additional fibers forming a respective finished edge configured to prevent fraying of the respective upper and lower layers 1010, 1012 therealong and thus fraying and / or fiber separation of the first fibers 1014 and second fibers 1020. As shown in more detail in FIG. 10B , the first longitudinal portion 1006 includes eight additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h, and the second longitudinal portion 1008 includes eight additional fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h. As a result, the first longitudinal portion 1006 includes finished edges 1028a, 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, and 1028h, and the second longitudinal portion 1008 includes finished edges 1030a, 1030b, 1030c, 1030d, 1030e, 1030f, 1030g, and 1030h. The first longitudinal portion 1006 and the second longitudinal portion 1008 are each shown to have eight additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h and fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h, respectively, and therefore eight respective finished edges 1028a, 1028b, 1028c, 1028d, 1028e, 1028f, 1026g, 1026h. While shown having additional fibers 1028f, 1028g, 1028h, 1030a, 1030b, 1030c, 1030d, 1030e, 1030f, 1030g, and 1030h, those skilled in the art will understand that the amount of additional fibers can depend at least on the size and shape of the staple cartridge and / or anvil to which the support material is applied, and therefore, first longitudinal portion 1006 and second longitudinal portion 1008 are not limited to the number of additional fibers shown in the figures.

[0094] The additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h and the fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h can have various configurations. In some embodiments, two or more of the additional fibers can be generally identical (nominally identical within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimension(s) (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament). In certain embodiments, at least one of the additional fibers can be a monofilament fiber. Alternatively, or additionally, at least one of the additional fibers can be a multifilament fiber. In one embodiment, a portion of the additional fibers are monofilament fibers and another portion are multifilament fibers. Therefore, apart from the general overall shape, the specific structural configuration of each of the additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h and the fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h is not shown.

[0095] Further, as shown, the additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h are similar in construction and stitch configuration to the additional fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h, and therefore, for simplicity, the following description will refer to the additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h. However, one skilled in the art will understand that the following description is also applicable to additional fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h.

[0096] The additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h can be incorporated into the first longitudinal portion 1006 in various ways to form respective finished edges 1028a, 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, 1028h. In the illustrated embodiment, as shown in more detail in FIG. 10C , the first additional third fiber 1024a is configured as an overcast stitch, interconnecting the top layer 1010 and the bottom layer 1016 along their first outermost longitudinal terminal edges 1010a, 1016a to form the first finished edge 1028a. As a result, the first finished edge 1028a of the first longitudinal portion 1006 is formed from the first fiber 1014, the second fiber 1020, and the first additional third fiber 1024a and is positioned along and thus defines at least a portion of the outermost longitudinal edge 1032 of the first longitudinal portion 1006. Each remaining additional third fiber 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h is also configured as an overcast stitch, interconnecting the upper layer 1010 and the lower layer 1016 along respective portions of the second outermost longitudinal terminal edges 1010b, 1014b of the upper layer 1010 and the lower layer 1016 to form a respective separate finished edge 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, 1028h. As a result, each remaining finished edge 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, 1028h is formed from the first fiber 1014, the second fiber 1020, and each additional third fiber 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h and is positioned along and thus defines a respective portion of the innermost longitudinal edge 1034 of the first longitudinal portion 1006.

[0097] As further shown, the support material 1004 includes bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, and 1036f that extend between and connect the first longitudinal portion 1006 and the second longitudinal portion 1008 of the support material 1004. While the support material 1004 is shown as having six bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, and 1036f, one skilled in the art will understand that the number and structural configuration of the bridge element(s) of the support material can depend at least on the size and shape of the staple cartridge and / or anvil to which the support material is applied and / or the size and shape of the longitudinal slot (e.g., knife slot) within the cartridge, and thus the support material 1004 is not limited to the number and / or structural configuration of the bridge elements shown in the figures.

[0098] The bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, and 1036f can have various configurations. For example, in the illustrated embodiment, distinct portions of the first fibers 1014 and the second fibers 1020 extend between the first longitudinal portion 1006 and the second longitudinal portion 1008, thereby functioning as bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, and 1036f. This creates a central zone 1040 within the support material that is formed solely from the first fibers 1014 and the second fibers 1020. This results in a reduced amount of material along the cut line of the support material compared to other portions of the support material. In some embodiments, a portion of the spacer fibers can be present within the central zone (e.g., the spacer fiber density within the central zone is lower than the spacer fiber density within other portions of the support material).

[0099] 10A-10D , when the support material 1004 is releasably secured to the cartridge 1002, the first longitudinal portion 1006 is positioned on a first side of a longitudinal slot 1007 of the cartridge 1002, and the second longitudinal portion 1008 is positioned on a second, opposite side of the longitudinal slot 1007. With respect to the first longitudinal portion 1006, the first finished edge 1028a is positioned adjacent to and along a portion of the first outermost longitudinal edge 1005a of the top surface 1003 of the cartridge 1002, and each of the remaining finished edges 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, 1028h is positioned adjacent to and along a respective portion of the first slot edge 1007a of the longitudinal slot 1007. Similarly, with respect to the second longitudinal portion 1008, the first finished edge 1030a is positioned adjacent to and along a portion of the second outermost longitudinal edge 1005b of the top surface 1003 of the cartridge 1002, and each of the remaining finished edges 1030b, 1030c, 1030d, 1030e, 1030f, 1030g, 1030h is positioned adjacent to and along a respective portion of the second slot edge 1007b of the longitudinal slot 1007. Furthermore, as shown in more detail in Figures 10B and 10D, the bridge element at least partially overlaps the longitudinal slot 1007 of the cartridge 1002.

[0100] 10A-10D , in certain embodiments, the support material can also include one or more attachment features extending at least partially along the length of the support material (e.g., extending in the z-direction) and configured to engage the staple cartridge, thereby retaining the support material on the cartridge prior to staple deployment. The one or more attachment features can have a variety of configurations. For example, the one or more attachment features can be channel attachments configured to engage (e.g., press-fit or snap-fit) with a longitudinal slot (e.g., knife slot) formed between opposing longitudinal slot edges in the staple cartridge.

[0101] In other embodiments, instead of incorporating additional fiber(s) into the auxiliary material (e.g., additional fibers 830, 832 in FIGS. 8A-8B ) to create one or more finished edges of the auxiliary material, existing fibers of the auxiliary material (e.g., first fiber 1102, second fiber 1104, and spacer fiber 1106 in FIGS. 11A-11B ) can be intertwined with one another. Alternatively, or additionally, heat can be applied to at least a portion of the existing fibers. For example, a hot blade can be used to melt and thus fuse at least a portion of the existing fibers, for example, along at least a portion of the periphery of the auxiliary material. This can avoid the need for additional material (e.g., additional fiber(s) other than those needed to form the top, bottom, and core layers of the auxiliary material), and thus, among other things, can reduce the overall material and / or manufacturing costs of the auxiliary material.

[0102] 11A-11B illustrate one exemplary embodiment of a knitted auxiliary material 1100 having at least one finished edge formed from fibers that also form other portions of the auxiliary material. In this illustrated embodiment, the auxiliary material 1100 includes an upper layer 1110 (e.g., a tissue-contacting layer), a lower layer 1112 (e.g., a cartridge-contacting layer), and first fibers 1102, second fibers 1104, and spacer fibers 1106 intertwined to form at least one finished edge (only three finished edges 1114a, 1114b, and 1114c are shown) extending between the upper layer 1110 and the lower layer 1112. For simplicity, only one first fiber 1102, second fiber 1104, and spacer fiber 1106 are shown in FIG. 11B. Those skilled in the art will understand that the following description is also applicable to the remaining first fibers, second fibers, and spacer fibers of the auxiliary material.

[0103] The first fiber 1102, the second fiber 1104, and the spacer fiber 1106 can have a variety of configurations. For example, in some embodiments, the first fiber 1102, the second fiber 1104, and the spacer fiber 1106 can be generally identical (e.g., nominally identical within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimension(s) (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament), while in other embodiments, they can be different. In certain embodiments, the first fiber 1102 and the second fiber 1104 can be generally identical (e.g., nominally identical within manufacturing tolerances), and the spacer fiber 1106 can be different. For example, in certain embodiments, the first fiber 1102 and the second fiber 1104 are multifilament fibers, and the spacer fiber 1106 is a monofilament fiber. Therefore, apart from the general overall shape, the specific structural configuration of each of the first fiber 1102, second fiber 1104, and spacer fiber 1106 is not shown.

[0104] The top layer 1110 and the bottom layer 1112 can have a variety of configurations. As shown in more detail in FIG. 11B , the first fibers 1102 and the spacer fibers 1106 are entangled to form the top layer 1110, and the second fibers 1104 and the spacer fibers 1106 are entangled to form the bottom layer 1112. Thus, in this illustrated embodiment, the first fibers 1102 are absent from the bottom layer 1112, and the second fibers 1104 are absent from the top layer 1110. In other embodiments, at least a portion of the first fibers 1102 can be present in the bottom layer 1112 and / or at least a portion of the second fibers 1104 can be present in the top layer 1110.

[0105] In some embodiments, the first fibers 1102 of the top layer 1110 and / or the second fibers 1104 of the bottom layer 1112 can be woven in respective predetermined patterns. In certain embodiments, the predetermined pattern of the first fibers 1102 in the top layer 1110 and the predetermined pattern of the second fibers 1104 of the bottom layer 1112 can be generally identical (e.g., nominally identical within manufacturing tolerances), while in other embodiments, the predetermined patterns can be different. While the first fibers 1102 of the top layer 1110 and the second fibers 1104 of the bottom layer 1112 can each be woven in various patterns, in certain embodiments, the first fibers 1102 can be woven in a first raschel knit pattern and the second fibers 1104 can be woven in a second raschel knit pattern that is the same as or different from the first raschel knit pattern. Furthermore, in some embodiments, the fiber density of the top layer 1110 can be different from the fiber density of the bottom layer 1112. Those skilled in the art will appreciate that the first fibers 1102 and second fibers 1104 may be randomly or repeatedly knitted or woven within the upper and lower layers 1110, 1112, respectively. Thus, for simplicity, the upper and lower layers 1110, 1112 are shown generically, and thus the particular structural configurations of the upper and lower layers 1110, 1112 are not limited to those shown in the figures.

[0106] The portions of the spacer fibers 1106 that extend between the upper layer 1110 and the lower layer 1112 can form a middle layer 1116, and are therefore positioned between the upper layer 1110 and the lower layer 1112. These portions can have a variety of configurations, but in the illustrated embodiment, are arranged to form standing fibers 1118, as shown in Figure 1 IB. The standing fibers 1118 can be configured to bend or compress in response to a force applied to the support material 1100.

[0107] The standing fibers 1118 can have various orientations within the middle layer. For example, in some embodiments, as shown in FIG. 11B , the standing fibers 1118 have a generally columnar configuration, meaning that they are generally oriented in adjacent rows. In other embodiments, the standing fibers 1118 can be tilted or skewed to favor collective collapse or bending in a first direction in response to force(s) applied to the support material (e.g., a compressive force through tissue (T) positioned against the top layer 1110). Alternatively, the standing fibers 1118 can be tilted or skewed to favor collective collapse in a second direction opposite the first direction in response to applied force(s). Alternatively, the standing fibers 1118 can include a first group of standing fibers tilted or skewed to favor bending in a first direction and a second group of standing fibers tilted or skewed to favor bending in a second direction.

[0108] 11A-11B, the auxiliary material 1100 includes four finished edges (only three finished edges 1114a, 1114b, 1114c are shown), each of which extends between the upper layer 1110 and the lower layer 1112. Furthermore, one or more of the finished edges 1114a, 1114b, 1114c can be positioned at least partially along and thus at least partially define the outer edge of the auxiliary material 1100. For example, in the illustrated embodiment, the auxiliary material 1100 has four outermost edges (only three outermost edges 1120a, 1120b, 1120c), with the first finished edge 1114a positioned entirely along the first outermost edge 1120a, the second finished edge 1114b positioned entirely along the second outermost edge 1120b, the third finished edge 1114c positioned entirely along the third outermost edge 1120c, and the fourth finished edge (which is interrupted) positioned entirely along the fourth outermost edge (which is interrupted). As a result, the four finished edges define the entire outermost perimeter of the auxiliary material 1100.

[0109] Each finished edge is formed from respective portions of the first fiber 1102, the second fiber 1104, and the spacer fiber 1106. The first fiber 1102, the second fiber 1104, and the spacer fiber 1106 can interact in various ways to achieve the finished edge. In the illustrated embodiment, each finished edge is structurally similar and includes respective portions of the first fiber, the second fiber, and the spacer fiber intertwined with one another. While only the first and second finished edges are shown in detail, those skilled in the art will understand that the following description is also applicable to the third finished edge 1114c and the fourth finished edge.

[0110] 11B, the first finished edge 1114a includes the intertwined first portion 1122a of the first fiber 1102, the first portion 1124a of the second fiber 1104, and the first portion 1126a of the spacer fiber 1106. In addition, the free end 1128a of the first portion 1122a of the first fiber 1102, the free end 1130a of the first portion 1124a of the second fiber 1104, and the free end 1132a of the first portion 1126a of the spacer fiber 1106 can be tied together, as shown in FIG. 11B, the second finished edge 1114b includes the intertwined second portions 1122b of the first fibers 1102, the second portions 1124b of the second fibers 1104, and the second portions 1126b of the spacer fibers 1106. Additionally, the free ends 1128b of the second portions 1122b of the first fibers 1102, the free ends 1130b of the second portions 1124b of the second fibers 1104, and the free ends 1132b of the second portions 1126b of the spacer fibers 1106 can be tied together, as shown in FIG.

[0111] Although not shown, in certain embodiments, the auxiliary material 1100 may also include additional finished edge(s) configured to be positioned adjacent to and along respective slot edges of longitudinal slots formed in the cartridge to which the auxiliary material is intended to be releasably attached. In such embodiments, for example, at least one additional finished edge may be formed from each portion of the first fiber 1102, the second fiber 1104, and the spacer fiber 1106.

[0112] While the auxiliary materials 804, 900, and 1004 in Figures 8A-10D each include a finished edge formed by additional fibers, and the auxiliary material 1100 in Figures 11A-11B includes a finished edge formed by existing fibers, in other embodiments, the auxiliary material can have a combination of different types of finished edges. For example, in certain embodiments, the auxiliary material can have at least one finished edge formed by additional fiber(s) (e.g., first finished edge 34 in Figure 8B) and at least one finished edge formed by a portion of existing fibers otherwise present in the auxiliary material (e.g., first finished edge 1114a in Figures 11A-11B).

[0113] Alternatively, or in addition, the support material can include an absorbent film disposed on at least a portion of the tissue-facing surface of the outer layer and / or inner layer. The absorbent film can substantially protect the fibers of the underlying layer(s), which would otherwise be exposed to forces that would lead to fraying, pulling, and / or separation. For example, in certain embodiments, the absorbent film can be used to form at least a portion of one or more finished edges of the support material. Furthermore, the absorbent film can substantially prevent tissue from prematurely separating the support material from the cartridge as the tissue slides across the support material. That is, the absorbent film can minimize edge conditions, thereby reducing friction that would otherwise exist on the tissue-contacting surface(s) of the support material.

[0114] The absorbent film can have a variety of configurations. In some embodiments, the absorbent film can have a thickness of about 15 microns or less, e.g., about 5 microns to 15 microns, or about 8 microns to 11 microns. In one embodiment, the absorbent film can be formed from polydioxanone. The absorbent film can be attached to the knitted structure in a variety of ways. For example, in one embodiment, the absorbent film can be attached by heating the film (e.g., above the glass transition temperature of the film material) and then pressing the film onto the knitted structure, thereby creating a bond between the film and the knitted structure. Alternatively, at least a portion of the knitted structure (e.g., a portion of the fibers of the bottom layer) can be heated (e.g., above 85°C) and then pressed against the film.

[0115] 12 illustrates one exemplary embodiment of a stapling assembly 1200 including a staple cartridge 1202 and a braided support material 1204 disposed on an upper or deck surface 1203 of the cartridge 1202. The staple cartridge 1202 is similar to the staple cartridge 200 of FIGS. 1-2C and therefore, common features will not be described in detail herein.

[0116] The support material 1204 includes a knitted structure 1206 having an absorbent film 1208 disposed on at least a portion thereof. The knitted structure includes an upper layer 1210, a lower layer 1212, and a core layer 1214 extending between the upper and lower layers. The upper layer 1210, lower layer 1212, and core layer 1214 are similar to the upper layer 1110, lower layer 1112, and middle layer 1116 of Figures 11A-11B, and therefore common features will not be described here. As shown, the absorbent film 1208 is disposed on all tissue-facing surfaces of the knitted structure 1206, which in this illustrated embodiment includes an upper tissue-facing surface 1216 (e.g., extending in the YZ plane), a first longitudinal side 1218a (e.g., extending in the XZ plane), a second opposing longitudinal side 1218b, a first lateral side 1220a (e.g., extending in the XY plane), and a second opposing lateral side (interrupted). In other embodiments, the absorbent film is not disposed on all tissue-facing surfaces of the knitted structure, e.g., the first lateral side and / or the second lateral side.

[0117] Mounting Features Generally, the braided auxiliary materials described herein are designed and positioned on a staple cartridge for use in a stapling procedure. When the staples are fired (deployed) from the cartridge, they penetrate the auxiliary material and enter the tissue. Before the auxiliary material is penetrated by the staples, the auxiliary material may become dislodged or displaced from the staple cartridge. That is, when the staple cartridge is in place, the auxiliary material may become dislodged by contact with a portion of the surgical site. One or more surface features may be disposed within the auxiliary material to align and secure the auxiliary material onto the staple cartridge prior to firing the staples. The one or more surface features (e.g., one or more recesses) may be woven, thermoformed, or mechanically positioned within the auxiliary material.

[0118] As described above, a braided support material is formed from fibers that are knitted or woven together. In certain embodiments, the support material can be designed to have one or more surface features formed therein. The one or more surface features are configured to substantially or completely align and secure the support material to the cartridge deck prior to staple deployment. As a result, the support material can remain secured to the cartridge deck even when subjected to forces that would otherwise cause the support material to separate from the cartridge deck prior to stapling the tissue. The one or more surface features can also reduce the likelihood of the support material becoming misaligned prior to stapling, compared to conventional support materials (e.g., support materials without one or more surface features).

[0119] The one or more surface features can be formed in a variety of ways. For example, in some embodiments, the surface features can be created into the support material after manufacturing, such as using solvents, knitting, heat, die-cutting, laser cutting, ultrasonic cutting, stamping or punching (e.g., mechanical pressing), or a combination of these techniques. In some embodiments, the surface features can be knit into the bottom layer of the support material (e.g., the cartridge contact layer). In other embodiments, the surface features can be thermoformed into the support material using a heated mold. Alternatively, or additionally, the surface features can be thermoformed into the support material by heating the stapling cartridge and positioning the support material on the heated cartridge deck, so that the support material conforms to the shape of the cartridge deck, including any one or more attachment features (e.g., protrusions) of the cartridge deck.

[0120] In some embodiments, one or more surface features can have a minimum diameter that is smaller than the diameter of the staple legs. Alternatively, or additionally, one or more surface features can have a maximum diameter that is greater than the circumference (e.g., outer diameter) of one or more attachment features of the cartridge to form a friction or press fit. In certain embodiments, one or more surface features can be sized to receive two or more attachment features of the cartridge.

[0121] Figure 13A shows a portion of another exemplary embodiment of a stapling assembly 1300 including a braided support material 1302 disposed on an upper surface or deck surface 1306 of a staple cartridge 1304, and Figure 13B shows the support material and cartridge prior to being releasably coupled to one another. The support material 1302 includes a first braided layer 1308 (e.g., an upper layer or tissue-contacting layer) formed from at least first fibers 1310, a second braided layer 1312 (e.g., a lower layer or cartridge-contacting layer) formed from at least second fibers 1314, and spacer fibers 1316 intertwined with and extending between the first and second braided layers 1308, 1312, thereby connecting the first and second braided layers 1308, 1312 to one another. The portion of the spacer fiber 1316 extending between the first knitted layer 1308 and the second knitted layer 1312 forms a core layer 1318 of the auxiliary material 1302. For simplicity, only one first fiber 1310, second fiber 1314, and spacer fiber 1316 are shown. Those skilled in the art will understand that the following description is also applicable to the remaining first fibers, second fibers, and spacer fibers of the auxiliary material.

[0122] In some embodiments, the first fibers 1310 of the first knitted layer 1308 can be knitted or woven into a first predetermined pattern, and / or the second fibers 1314 of the second knitted layer 1312 can be knitted or woven into a second predetermined pattern. In certain embodiments, the first and second predetermined patterns can be generally identical (e.g., nominally identical within manufacturing tolerances), while in other embodiments, the first and second predetermined patterns can be different. Further, in some embodiments, the fiber density of the first knitted layer 1308 can be different from the fiber density of the second knitted layer 1312. While the first fibers 1310 and the second fibers 1314 can be knitted or woven in a variety of patterns, in certain embodiments, the first fibers 1310 can be knitted into a first Russell knit pattern and the second fibers 1314 can be knitted into a second Russell knit pattern that is the same as or different from the first Russell knit pattern. Those skilled in the art will appreciate that the first fibers 1310 and second fibers 1314 may be randomly or repeatedly knitted or woven within the first knitted layer 1308 and second knitted layer 1312, respectively. Therefore, for simplicity, the first knitted layer 1308 and second knitted layer 1312 are illustrated generically, and thus the specific structural configurations of the first knitted layer 1308 and second knitted layer 1312 are not limited to those shown in the figures.

[0123] The first fibers 1310, the second fibers 1314, and the spacer fibers 1316 can have a variety of configurations. For example, in some embodiments, the first fibers 1310, the second fibers 1314, and the spacer fibers 1316 can be generally identical (e.g., nominally identical within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimension(s) (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament), while in other embodiments, they are different. In other embodiments, the first fibers 1310 and the second fibers 1314 can be generally identical (e.g., nominally identical within manufacturing tolerances), and the spacer fibers 1316 can be different. For example, in certain embodiments, the first fibers 1310 and the second fibers 1314 can be multifilament fibers, and the spacer fibers 1316 can be monofilament fibers. Therefore, apart from the general overall shape, the specific structural configuration of each of the first fibers 1310, second fibers 1314, and spacer fibers 1316 is not shown.

[0124] As further shown in FIG. 13B , the support material includes one or more surface features formed in the second knitted layer 1312, which in this illustrated embodiment are in the form of recesses (only two recesses 1322 a, 1322 b are shown). The one or more recesses are configured to receive and engage respective mounting features of the cartridge 1304, as shown in FIG. 13A , which in this illustrated embodiment are in the form of protrusions 1324 a, 1324 b, each extending outward from the top or deck surface 1306 of the cartridge 1304. The recesses 1322 a, 1322 b can be formed by processing (e.g., melting or further knitting) portions of the second fibers 1314 in the second knitted layer 1312. In this illustrated embodiment, the perimeters of the recesses 1322 a, 1322 b are defined by the melted portions of the second fibers 1314.

[0125] The recesses 1322a, 1322b and protrusions 1324a, 1324b can have a variety of configurations. For example, in the illustrated embodiment, the recesses 1322a, 1322b have an inverted cone shape and therefore have varying diameters that decrease as the recesses 1322a, 1322b extend into the second knitted layer 1312. Thus, each recess 1322a, 1322b has a maximum diameter X 1a , X 2a to minimum diameter X 1b , X 2b Furthermore, the protrusions 1324a, 1324b have a conical shape with a varying diameter that decreases as the protrusions 1324a, 1324b extend outward from the top or deck surface 1306. Thus, each protrusion 1324a, 1324b has a maximum diameter X 1c , X 1c to minimum diameter X 2c , X 2d The recesses 1322a, 1322b and protrusions 1324a, 1324b are illustrated as having complementary conical shapes, although one skilled in the art will understand that the recesses can have other complementary shapes, such as square, semicircular, triangular, etc. Furthermore, while the recesses 1322a, 1322b are illustrated as generally uniform (e.g., uniform within manufacturing tolerances), in other embodiments, at least a portion of the recesses can vary.

[0126] Maximum diameter 1a , X 1b and maximum diameter X 2a , X 2bThe difference between the maximum diameters of the recesses 1322a, 1322b and the protrusions 1324a, 1324b can allow a friction fit to form between the recesses 1322a, 1322b and the protrusions 1324a, 1324b. In the illustrated embodiment, the maximum diameter of the recesses 1322a, 1322b is smaller than the maximum diameter of the protrusions 1324a, 1324b prior to engagement. As a result, an interference fit can occur between the portions of the second fibers 1314 that contact the protrusions 1324a, 1324b. This frictional force can help secure the support material 1302 to the staple cartridge 1304. In other embodiments, the maximum diameter of the recesses 1322a, 1322b can be greater than the maximum diameter of the protrusions 1324a, 1324b prior to engagement.

[0127] Furthermore, although not shown, the minimum diameter X of the recesses 1322a and 1322b in the support material 1302 1a , X 1b can be smaller than the diameter of the staple legs (e.g., the largest diameter of the wire forming the staple legs) that are at least partially disposed within the staple cartridge 1304. As a result, when the support material 1302 is releasably coupled to the cartridge 1304 and the recesses 1322a, 1322b are also configured to overlap the staple cavities of the cartridge 1304, such as staple cavities 212, 214 in FIGS. 2A-2C , the portions of the staple legs that extend beyond the top or deck surface 1306 of the cartridge 1304 can also engage the recesses of the support material 1302. This, in turn, can create a friction fit therebetween, further securing the support material to the staple cartridge prior to staple deployment.

[0128] As further shown in FIG. 13B , the spacing of recesses 1322a and 1322b in second knitted layer 1312 forms protrusion 1326 between recesses 1322a and 1322b, with a maximum diameter D1. Additionally, the spacing of protrusions 1324a and 1324b on top surface 1306 of cartridge 1304 forms complementary recess 1328 between protrusions 1326a and 1326b, with a maximum diameter D2. As shown in FIG. 13A , protrusion 1326 is received within and engages recess 1328 when auxiliary material 1302 is coupled to cartridge 1304. In this illustrated embodiment, maximum diameter D1 of protrusion 1326 is greater than maximum diameter D2 of recess 1328 prior to engagement. As a result, this can create an additional interference fit between auxiliary material 1302 and cartridge 1304. The difference in diameter causes the second fibers 1314 around the recesses 1322a, 1322b to be pressed further towards and against the protrusions 1324a, 1324b (e.g., in the y direction), which can also increase friction between the recesses 1322a, 1322b and the protrusions 1324a, 1324b.

[0129] In certain embodiments, the recesses are formed in the second knitted layer of support material by thermoforming the second knitted layer over a heated mold having mold features that are the inverse of the desired shape of the recesses. The mold features are similar in shape to the attachment features, but may be larger or smaller in size than the attachment features. When the mold features have smaller dimensions than the attachment features, this ensures a snug friction fit between the support material and the staple cartridge.

[0130] To form recesses in the auxiliary material, the heated mold is heated to a particular temperature (e.g., above the glass transition temperature of the second fiber of the second knitted layer), and then the auxiliary material is pressed onto, into, and / or against the heated mold. In some embodiments, the mold features can be the same or different compared to one another.

[0131] Upon engagement with the heated mold, the support material is formed or molded into the mold features of the heated mold, creating a recess in the second knitted layer. The portion of the second knitted layer that contacts the mold features of the heated mold is thermoformed to the shape of the mold features. When the heated mold is released from the second knitted layer, the second knitted layer retains the shape of the mold features. The recess is configured to allow for gradual release of the support material from the staple cartridge. One advantage of thermoformed recesses can include, for example, having a support material with a more complex shape that fits snugly with a corresponding staple cartridge while maintaining a simpler manufacturing process. In certain embodiments, the cartridge deck and mold features correspond to the shape of the attachment features of the staple cartridge.

[0132] In other embodiments, thermoforming of the support material can be accomplished by heating the staple cartridge deck. The cartridge can be heated to a temperature above, equal to, or near the glass transition temperature of one or more materials in the lower layer (e.g., cartridge contact layer) of the support material. The support material can then be placed over the staple cartridge and staples disposed therein and pressed down. Because the support material is heated to a temperature above, equal to, or slightly below the glass transition temperature of the material from which it is formed, the support material can assume a new, permanent shape around the attachment features of the staple cartridge and / or around any of the staple legs extending from the top surface of the cartridge.

[0133] For example, the staple cartridge can include protrusions extending from the cartridge deck, and when the support material is pressed onto the heated cartridge deck and attachment feature, the support material can be permanently deformed around the attachment feature. In such a case, the support material firmly grips the attachment feature until it is forced out of the attachment feature by the staple. Similarly, the support material can permanently deform to surround and firmly support the heated staple legs. In one embodiment, the minimum diameter of the newly formed recesses in the support material can be smaller than the diameter of the staple legs. During the recess formation process, pressure is applied to the support material until the temperature of the staple cartridge, staples, and / or support material is well below, or at least below, the glass transition temperature of the material comprising the support material. Alternatively, pressure can be released when the temperature of the stapling assembly is at or above the glass transition temperature of the material comprising the support material.

[0134] In other embodiments, the support material can include a knitted recess configured to receive and engage one or more attachment features of the staple cartridge. For example, when the support material is knitted, a portion of the second fiber of the second knitted layer can be knitted to define a perimeter of a recess in the second knitted layer. Alternatively, or additionally, additional fiber can be incorporated into the lower layer to at least partially define a perimeter of the recess.

[0135] Fiber interconnectivity and auxiliary material compressibility The support material is stapled to the tissue under various stapling conditions (e.g., tissue thickness, formed staple height, intra-tissue pressure). Depending on the stapling condition, an effective amount of stress that the support material needs to apply to the tissue to prevent the tissue from tearing or leaking can be determined. For example, in one embodiment, the effective amount of stress is at least about 3 gf / mm 2In order for the auxiliary material to impart an effective amount of stress to the tissue, the auxiliary material can be designed to effectively compensate for various stapling conditions. Thus, the auxiliary material can be tailored to assume different compression heights when stapled to the tissue.

[0136] Thus, the compressibility profile of the support material can be controlled by at least the structural configuration of the fibers and the interconnectivity between the fibers. As a result, by adjusting the structural configuration of the fibers, a support material having desirable mechanical properties for stapling tissue can be achieved. Because there are finite ranges of intra-tissue pressure, tissue thickness, and formed staple height, it is possible to achieve a substantially continuous desired stress (e.g., 3 gf / mm) when the support material is stapled to tissue over a range of stapling conditions and for a given time (e.g., at least 3 days). 2 It is possible to determine an appropriate material and / or geometric structure for the support material that can be effective in applying a stress to tissue. That is, as described in more detail below, the support material is formed of a compressible material and is geometrically configured so that the support material can compress to various heights in a predetermined plane when stapled to tissue. Furthermore, because the support material can respond differently in this way, it can be possible for the support material to continue to apply a continuous, desired stress to tissue even when exposed to fluctuations in intra-tissue pressure (e.g., blood pressure spikes) that can occur when the support material is stapled to tissue.

[0137] As described above, the spacer fibers are intertwined with the first and second fibers of the upper and lower layers, respectively, thereby connecting the upper and lower layers in a spaced-apart relationship. Thus, the spacer fibers are interconnected with the first fibers at first interconnections and with the second fibers at second interconnections. The portions of the spacer fibers extending between the upper and lower layers thereby form the middle layer of the support material. While these portions can have various configurations, they can be arranged to form standing fibers. The standing fibers can be configured to bend or compress in response to forces applied to the support material. As a result, the manner in which the spacer fibers interact with the first and second fibers (e.g., the first and second interconnections) can at least partially control the stiffness or ability to bend under compression of the standing fibers, which in turn at least partially controls the overall compressibility of the support material. Thus, in some embodiments, the number, location, and tightness of the interconnections can be varied laterally, longitudinally, or throughout the thickness of the support material to achieve different stiffnesses within the support material.

[0138] In some embodiments, the first and second interconnects can be generally identical (e.g., nominally identical within manufacturing tolerances), while in other embodiments, the first and second interconnects can be different. The first and second interconnects can have a variety of configurations. For example, in some embodiments, the first and / or second interconnects can be single-loop knots. In other embodiments, the first and / or second interconnects can be multi-loop knots, as shown, for example, in FIGS. 14A-17B. In particular embodiments, the first interconnect can be a single-loop knot and the second interconnect can be a multi-loop knot (see FIG. 20).

[0139] The first interconnection and / or the second interconnection can be in the form of any suitable knot type. The type of knot used can affect the stiffness of the intermediate layer and, therefore, the compressive behavior of the support material. For example, if a loose knot is used, the intermediate layer can be less stiff or have a lower modulus of elasticity. Alternatively, if a tight knot is used, the intermediate layer can be more stiff or have a higher modulus of elasticity. The intermediate layer can utilize any suitable type of knot.

[0140] 14A-14B are another exemplary embodiment of a knitted support material 1400, including a first fiber 1402, a second fiber 1404, and a spacer fiber 1406. For simplicity, only one first fiber 1402, a second fiber 1404, and a spacer fiber 1406 are shown. Those skilled in the art will understand that the following description is also applicable to the remaining first fibers, second fibers, and spacer fibers of the support material.

[0141] The spacer fiber 1406 and the first fiber 1402 are interconnected at first interconnects 1408 to form an upper layer 1410. The spacer fiber 1406 and the second fiber 1404 are interconnected at second interconnects 1412 to form a lower layer 1414. The first interconnects 1408 and the second interconnects 1412 can have a variety of configurations. For example, as shown, the first interconnect 1408 is in the form of a first knot having the spacer fiber 1406 looped multiple times around the first fiber 1402, and the second interconnects 1412 are each in the form of a second knot having the spacer fiber 1406 looped multiple times around the second fiber 1404. While the first knot 1408 and the second knot 1412 are shown as being structurally similar, in other embodiments, the first knot and the second knot can be different. Additionally, as will be explained in more detail below, the first knot 1408 and the second knot 1412 are shown schematically as having a loose knot configuration.

[0142] Additionally, the portions of the spacer fibers 1406 that extend between the upper layer 1410 and the lower layer 1414 form a middle layer 1418 that is positioned between the upper layer 1410 and the lower layer 1414. These portions can have a variety of configurations, but in the illustrated embodiment, are arranged to form standing fibers 1416. The standing fibers 1416 can have a variety of orientations within the middle layer 1418, for example, as shown, in a generally columnar configuration, meaning that they are oriented in generally adjacent rows. The standing fibers 1416 can be configured to bend or compress in response to a force applied to the support material 1400, as shown schematically in FIG. 14B.

[0143] As shown in FIG. 14B , when a given force F is applied to the auxiliary material 1400 (e.g., in the x-direction), the spacer fibers 1406 slide along the first fibers 1402 and the second fibers 1404 (e.g., in the ±y-direction). This sliding action is due to the loose knot configuration of the first knot 1408 and the second knot 1412. As a result, the standing fibers 1416 slide, moving the upper layer 1410 toward the lower layer 1414. As a result, the auxiliary material 1400 is compressed from an uncompressed state having an uncompressed height H1 ( FIG. 14A ) to a first compressed state having a first compressed height H2 ( FIG. 14B ). Therefore, under a given force, the sliding of the spacer fibers 1406, and therefore the standing fibers 1416, primarily achieves the compression of the auxiliary material 1400 from the uncompressed height H to the first compressed height H2.

[0144] In some embodiments, for example, as shown in Figures 15A-15B, tighter knots can be used to interconnect the spacer fibers with the first and second fibers, thereby increasing the stiffness of the standing fibers and, therefore, the auxiliary material. The auxiliary material 1500 is similar to the auxiliary material 1400 of Figures 14A-14B, except that the first knot 1508 and the second knot 1512 have a tighter knot configuration, and therefore the common features will not be described in detail here.

[0145] 15B, when a given force F is applied to the auxiliary material 1500 (e.g., in the x-direction), the tighter configuration of the knots 1508, 1512 constrains the spacer fibers 1506 from sliding along the first fibers 1502 and the second fibers 1504, and therefore prevents the standing fibers 1516 from sliding along, respectively. This imparts stiffness to the standing fibers 1516, thereby increasing their stiffness. As a result, the standing fibers 1516 are stiffer compared to the standing fibers 1416 of FIGS. 14A-14B, and therefore, this results in a stiffer auxiliary material 1500 when compared to the auxiliary material 1400 of FIGS. 14A-14B. For example, when the same amount of force is applied to auxiliary material 1500, auxiliary material 1500 is compressed from an uncompressed state (FIG. 14A) having an uncompressed height H3 similar to the uncompressed height H1 of auxiliary material 1400 to a second compressed state (FIG. 14B) having a second compressed height H4 greater than the first compressed height H2 of auxiliary material 1400. This illustrates the effect that the tightness of the knot can have on the compression of the auxiliary material.

[0146] Similarly, the tightness of the knot can impart local stiffness to thinner spacer fibers, thus increasing the overall stiffness of the auxiliary material, such as auxiliary material 1600 of Figures 16A-16C. Auxiliary material 1600 is similar to auxiliary material 1500 of Figures 15A-15B, except that spacer fibers 1606 are thinner compared to spacer fibers 1506.

[0147] In some embodiments, the middle layer of the auxiliary material can include reinforcing fibers interconnected with the standing fibers, which can further increase the stiffness of the auxiliary material, as shown, for example, in Figures 17A-17B. Auxiliary material 1700 is similar to auxiliary material 1500 of Figures 15A-15B, except that the standing fibers 1716 are multiplexed around the reinforcing fibers 1720 at third interconnections 1722, and each of the reinforcing fibers 1720 extends to the middle of the middle layer 1718 (e.g., in the y-direction). As a result, for a given amount of force F, as shown in Figure 17B, auxiliary material 1700 compresses from an uncompressed state (Figure 17A) having an uncompressed height H5 similar to the uncompressed height H3 of auxiliary material 1500 to a second compressed state (Figure 17B) having a third compressed height H6 greater than the second compressed height H4 of auxiliary material 1500.

[0148] 18A-18B show another exemplary embodiment of a knitted auxiliary material 1800. The auxiliary material 1800 includes a layer 1802 formed from at least first fibers 1808 and a core layer formed from spacer fibers 1804 intertwined with and extending therefrom. The layer 1802 can be an upper layer (e.g., a tissue-contacting layer) or a lower layer (e.g., a cartridge-contacting layer) of the auxiliary material 1800, with a portion of the spacer fibers 1804 forming the core layer disposed between the upper and lower layers. In this exemplary embodiment, the portion of the spacer fibers 1804 forming the core layer extends between the upper and lower layers in a generally columnar configuration, meaning that they are oriented in generally adjacent rows. For simplicity, only a portion of the first fibers 1808 and the spacer fibers 1804 are shown. Those skilled in the art will understand that the following description is also applicable to the remaining first fibers and spacer fibers of the auxiliary material.

[0149] As shown in FIGS. 18A-18B , the spacer fibers 1804 extend outward from the layer 1802 along a central axis CA. The layer 1802 includes reinforcing fibers 1806 knotted to the spacer fibers 1804 and first fibers 1808. The knots in the reinforcing fibers 1806 can limit the lateral movement LM of each spacer fiber 1804 from the central axis CA. This interaction between the spacer fibers 1804 and the reinforcing fibers 1806 affects the stiffness of the auxiliary material 1800. Because the spacer fibers 1804 have limited lateral movement LM, the spacer fibers 1804 have limited deformation capacity when the auxiliary material 1800 is compressed.

[0150] 19A-19B show another exemplary embodiment of a braided support material 1900. The support material 1900 can be disposed on the top or deck surface of a staple cartridge. The support material 1900 includes a layer 1902 formed from at least first fibers 1908 and a core layer formed from spacer fibers 1904 intertwined with and extending therefrom. The layer 1902 can be an upper layer (e.g., a tissue-contacting layer) or a lower layer (e.g., a cartridge-contacting layer) of the support material 1900, with the spacer fibers 1904 forming the core layer disposed between the upper and lower layers. In this illustrated embodiment, the portions of the spacer fibers 1904 forming the core layer extend between the upper and lower layers in a generally columnar configuration, meaning that they are oriented in generally adjacent rows. For simplicity, only portions of the first fibers 1908 and the spacer fibers 1904 are shown. Those skilled in the art will understand that the following description is also applicable to the remaining first fibers and spacer fibers of the auxiliary material.

[0151] As shown in FIGS. 19A-19B , the spacer fibers 1904 extend outward from the layer 1902 along the central axis CA. The layer 1902 does not include any reinforcing fibers in contact with the spacer fibers 1904. Due to the absence of reinforcing fibers, the spacer fibers are less restricted in lateral movement LM from the central axis CA of each spacer fiber 1904 when compared to the auxiliary material 1800 of FIG. 18A . This interaction between the spacer fibers 1904 and the first fibers 1908, along with any reinforcing fibers, affects the stiffness of the auxiliary material 1900. Because the spacer fibers 1904 have an extended lateral movement LM, the spacer fibers 1904 have a greater deformation capacity when the auxiliary material 1900 is compressed when compared to the auxiliary material 1800 of FIG. 18A .

[0152] 20 illustrates another exemplary embodiment of a knitted support material 2000. The support material 2000 includes an upper layer 2002 (e.g., a tissue-contacting layer) formed from at least a first fiber 2008, a lower layer 2004 (e.g., a cartridge-contacting layer) formed from at least a second fiber 2012 and a third fiber 2014, and spacer fibers 2016 intertwined with and extending between the upper layer 2002 and the lower layer 2004, thereby connecting the upper layer 2002 and the lower layer 2004. The portion of the spacer fibers 2016 extending between the upper layer 2002 and the lower layer 2004 forms a core layer 2006. For simplicity, only one first fiber 2008, second fiber 2012, third fiber 2014, and spacer fiber 2016 are shown. Those skilled in the art will understand that the following description is also applicable to the remaining first fibers, second fibers, third fibers, and spacer fibers of the auxiliary material.

[0153] The top layer 2002 and the bottom layer 2004 can have a variety of configurations. For example, as shown in FIG. 20 , the bottom layer 2004 has a higher fiber density than the top layer 2002. In other embodiments, the top layer 2002 can have a higher fiber density than the bottom layer 2004. In some embodiments, the first fibers 2008 of the top layer 2002 can be knitted or woven into a first predetermined pattern, and / or the second fibers 2012 and third fibers 2014 of the bottom layer 2004 can be knitted or woven into a second predetermined pattern. In certain embodiments, the first and second predetermined patterns can be generally identical (e.g., nominally identical within manufacturing tolerances), while in other embodiments, the first and second predetermined patterns can be different. Those skilled in the art will appreciate that the first fibers 2008 and the second and third fibers 2012, 2014 may be randomly or repeatedly knitted or woven within the upper and lower layers 2002, 2004, respectively. Thus, for simplicity, the upper and lower layers 2002, 2004 are shown generally, and thus the particular structural configurations of the upper and lower layers 2002, 2004 are not limited to those shown in the figures.

[0154] The first fibers 2008, the second fibers 2012, the third fibers 2014, and the spacer fibers 2016 can have a variety of configurations. For example, in some embodiments, the first fibers 2008, the second fibers 2012, the third fibers 2014, and the spacer fibers 2016 can be generally identical in material and / or structural configuration (e.g., nominally identical within manufacturing tolerances). In other embodiments, the first fibers 2008, the second fibers 2012, and the third fibers 2014 can be generally identical in material and / or structural configuration (e.g., nominally identical within manufacturing tolerances) relative to one another, and the spacer fibers 2016 can be different therefrom. For example, in certain embodiments, the first fibers 2008, the second fibers 2012, and the third fibers 2014 can be multifilament fibers, and the spacer fibers 2016 can be monofilament fibers. Therefore, apart from the general overall shape, the specific structural configuration of each of the first fiber 2008, second fiber 2012, third fiber 2014, and spacer fiber 2016 is not shown.

[0155] In certain embodiments, the first fiber 2008 can be formed from low-friction fibers (e.g., monofilament fibers) that are knitted or woven to achieve a substantially smooth pattern to help hold the support material 2000 on the top or deck surface of the cartridge as tissue slides across the support material 2000, for example, when the support material 2000 is positioned at the staple fastening site. Thus, employing low-friction fibers in the top layer (e.g., tissue contact layer) of the support material can minimize friction that would otherwise occur between the tissue and the support material as the tissue slides across the support material prior to staple deployment.

[0156] As further shown, the bottom layer 2004 includes fourth fibers 2019, which can be configured to increase friction between the support material 2000 and the top or deck surface of the cartridge. This can help retain the support material 2000 in the cartridge prior to staple deployment. The fourth fibers 2019 can have a variety of configurations. For example, in some embodiments, the fourth fibers can be multifilament fibers. Thus, aside from the general overall shape, the specific structural configuration of the fourth fibers 2019 is not shown. Furthermore, for simplicity, only one fourth fiber 2019 is shown.

[0157] The spacer fibers 2016 are interconnected within the first fibers 2008 at first interconnections 2018 and second interconnections 2022 in the top layer 2002, and the spacer fibers 2016 are interconnected with at least the second fibers 2012 and the third fibers 2014 at third interconnections 2020 and fourth interconnections 2024 in the bottom layer 2004. This interaction between the top layer 2002 and bottom layer 2004, together with the interaction with the core layer 2006, therefore secures the top layer 2002 to the bottom layer 2004. Furthermore, the portions of the spacer fibers forming the core layer 2006 are arranged to form standing fibers 2026. The standing fibers 2026 can have various orientations within the core layer 2006, for example, as shown, in a generally columnar configuration, meaning that they are oriented in generally adjacent rows. The standing fibers 2026 can be configured to bend or compress in response to a force applied to the support material 2000.

[0158] 20, the interconnects 2018, 2020 and 2022, 2024 can be identical between the top layer 2002 and the bottom layer 2004. The interconnects 2018, 2020 are represented as tight knots, with the spacer fiber 2016 wrapping multiple times around the first fiber 2008 of the top layer 2002 and simultaneously wrapping around the second fiber 2012 and the third fiber 2014 of the bottom layer 2004. In some embodiments, the interconnects 2018, 2020 are shown as tight knots formed by wrapping the spacer fiber 2016 around the first fiber 2008, the second fiber 2012, and the third fiber 2014, however, other types of tight knots for the interconnects 2018, 2020 can be used, such as any knot that prevents the spacer fiber 2016 from sliding along the first fiber 2008, the second fiber 2012, and the third fiber 2014.

[0159] Additionally, the interconnects 2022, 2024 are depicted as loose knots, with the spacer fiber 2016 passing only once through the first fiber 2008 of the top layer 2002, and simultaneously passing only once through the second fiber 2012 and the third fiber 2014 of the bottom layer 2004. In some embodiments, the interconnects 2022, 2024 are shown as loose knots formed by wrapping the spacer fiber 2016 around the first fiber 2008, the second fiber 2012, and the third fiber 2014, although other types of loose knots for the interconnects 2022, 2024 can be used, such as any knot that prevents the spacer fiber 2016 from sliding along the first fiber 2008, the second fiber 2012, and the third fiber 2014.

[0160] Due to the presence of two different types of interconnects, the auxiliary material 2000 can have a first compression zone 2028 and a second compression zone 2030. Even if both compression zones are made from the same fibers, each compression zone can have a different stiffness when compressed. This is because, when the auxiliary material 2000 is compressed, the interconnects 2018, 2020 inhibit the spacer fiber 2016 from sliding along the first fiber 2008, the second fiber 2012, and the third fiber 2014, while, in contrast, the interconnects 2022, 2024 allow the spacer fiber 2016 to slide along the first fiber 2008, the second fiber 2012, and the third fiber 2014. Thus, each different compression zone 2028, 2030 has a respective stiffness such that the auxiliary material 2000 can have, for example, variable compressive strength along its width (e.g., in the y-direction).

[0161] In certain embodiments, the spacer fibers can interact with at least a portion of the remaining fibers of a lower layer (e.g., cartridge contact layer) of the support material to allow the spacer fibers to extend beyond the remaining fibers (e.g., in the form of loops) when the support material is compressed. Alternatively, or additionally, the spacer fibers can interact with at least a portion of the remaining fibers of an upper layer (e.g., tissue contact layer) of the support material to allow the spacer fibers to extend beyond the remaining fibers (e.g., in the form of loops) when the support material is compressed.

[0162] In addition to fiber connectivity, the overall compressive behavior of the auxiliary material can depend, at least in part, on the type of spacer fibers incorporated therein. Thus, a desired compressive behavior of the auxiliary material can be achieved by incorporating at least spacer fibers having a particular structural configuration (e.g., monofilament or multifilament) and / or dimension (e.g., diameter), and / or a particular compositional configuration (e.g., a first polymeric material having a low modulus, a second polymeric material having a high modulus, or a blend of two or more polymeric materials). Furthermore, the compressive behavior can be a function of the orientation of the portion of the spacer fibers within the core layer or intermediate layer of the auxiliary material (e.g., the direction in which the standing fibers extend relative to the longitudinal axis of the auxiliary material).

[0163] In some embodiments, different spacer fibers can be incorporated into different portions of the auxiliary material to achieve different compression zones within the auxiliary material. For example, a first type of spacer fiber (e.g., first spacer fiber) can be selected to create a first compression zone, and a second type of spacer fiber (e.g., second spacer fiber) different from the first type of spacer fiber can be selected to create a second compression zone. The first type of fiber can differ from the second type of fiber in structure (e.g., structural type, e.g., monofilament or multifilament, and / or dimensions, e.g., height and / or diameter) and / or composition. Thus, the first compression zone has a first compression strength, and the second compression zone has a second compression strength that is different from the second compression strength. As a result, the auxiliary material has various compression strengths.

[0164] For example, the first compression zone can have a greater compressive strength than the second compression zone, and thus the first compression zone can be more rigid. During use, the first compression zone can at least partially overlap a longitudinal slot formed in the cartridge configured to receive a cutting member, and the second compression zone can at least partially overlap a staple cavity defined in the cartridge. Such an arrangement can facilitate cutting of the supplemental material while providing a desired tissue thickness compensation characteristic within the staple that captures the supplemental material against the tissue. In certain cases, the second compression zone can also partially overlap one or more portions of the longitudinal slot. In one embodiment, the second compression zone can be the zone closest to the beginning and / or end of the longitudinal slot.

[0165] 21A-21B illustrate an exemplary embodiment of a knitted support material 2100 having two different types of spacer fibers. The support material 2100 includes first fibers 2102, second fibers 2104, first spacer fibers 2106, and a second, different spacer fiber 2108 intertwined to form an upper layer 2110 (e.g., a tissue-contacting layer), a lower layer 2112 (e.g., a cartridge-contacting layer), and a middle layer 2114 positioned between the upper layer 2110 and the lower layer 2112. As shown in FIG. 21A, the first spacer fibers 2106 are concentrated within a central portion (represented as a dotted box 2114a) of the middle layer 2114, defining a first compression zone of the support material 2100. The second spacer fibers 2108 are concentrated in the remaining portion of the middle layer 2114, defining a second compression zone within the support material 2100.

[0166] The first fibers 2102, the second fibers 2104, the first spacer fibers 2106, and the second spacer fibers 2108 can have a variety of configurations. For example, in some embodiments, the first fibers 2102 and the second fibers 2104 can be generally identical (e.g., nominally identical within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimension(s) (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament). In other embodiments, the first fibers 2102 and the second fibers 2104 can be different. Furthermore, the first fibers and / or the second fibers can be the same as the first spacer fibers or the second spacer fibers. In some embodiments, the first fibers 2102, the second fibers 2104, the first spacer fibers 2106, and / or the second spacer fibers 2108 can be monofilament fibers. In other embodiments, the first fibers 2102, the second fibers 2104, the first spacer fibers 2106, and / or the second spacer fibers 2108 can be monofilament fibers. In certain embodiments, the first fibers 2102, the second fibers 2104, and the first spacer fibers 2106 can be monofilament fibers, and the second spacer fibers 2108 are multifilament fibers. Therefore, apart from the general overall shape, the specific structural configurations of the first fibers 2102, the second fibers 2104, the first spacer fibers 2106, and the second spacer fibers 2108 are not shown.

[0167] In some embodiments, the first fibers 2102 of the top layer 2110 and / or the second fibers 2104 of the bottom layer 2112 can be woven in respective predetermined patterns. In certain embodiments, the predetermined pattern of the first fibers 2102 in the top layer 2110 and the predetermined pattern of the second fibers 2104 of the bottom layer 2112 can be generally identical (e.g., nominally identical within manufacturing tolerances), while in other embodiments, the predetermined patterns can be different. Furthermore, in some embodiments, the fiber density of the top layer 2110 can be different from the fiber density of the bottom layer 2112. The first fibers 2102 of the top layer 2110 and the second fibers 2104 of the bottom layer 2112 can each be woven in a variety of patterns, although in certain embodiments, the first fibers 2102 can be woven in a first Russell knit pattern and the second fibers 2104 can be woven in a second Russell knit pattern that is the same as or different from the first Rachel knit pattern. Those skilled in the art will appreciate that the first fibers 2102 and second fibers 2104 can be woven or knitted randomly or repeatedly within the top layer 2110 and bottom layer 2112, respectively. Therefore, for simplicity, the top layer 2110 and bottom layer 2112 are shown generically, and therefore, the specific structural configurations of the top layer 2110 and bottom layer 2112 are not limited to those shown in the figures.

[0168] 21A-21B, the portions of the first spacer fibers 2106 and the portions of the second spacer fibers 2108 that extend between the top layer 2110 and the bottom layer 2112 form the middle layer 2114. While these portions can have various configurations, in this illustrated embodiment they are arranged in a generally columnar configuration, i.e., they are oriented in generally adjacent rows. Thus, the compressive behavior of the supplemental material 2100 may be primarily driven by the buckling characteristics of the first spacer fibers 2106 and the second spacer fibers 2108.

[0169] As further shown, the first compression zone 2114a is completely bounded by the second compression zone, and therefore the intended cutting line C of the auxiliary material 2100.L is across the first and second compression zones and along the longitudinal axis L of the auxiliary material 2100 A In this illustrated embodiment, the intended cutting line C L The majority of the spacer fibers 2106 are defined by the first compression zone 2114a and can therefore be configured to be more rigid and therefore exhibit a higher resistance to compression compared to the second compression zone. For example, the first spacer fibers 2106 can be monofilament fibers and the second spacer fibers 2108 can be multifilament fibers. Thus, the resulting auxiliary material 2100 can be cut along the cutting line C of the auxiliary material 2100. L The auxiliary material 2100 may have variable compressive strength in a direction transverse to the y-axis (e.g., the y-axis). Furthermore, the start and end of the cutting line CL are defined by the second compression zone, thus making it easier to cut the auxiliary material 2100.

[0170] In some embodiments, the bottom layer 2112 can also be formed from one or more additional fibers 2116, as shown in more detail in FIG. 21B . The one or more additional fibers 2116 can have a variety of configurations, but in the illustrated embodiment, the one or more additional fibers are interconnected within the bottom layer 2112 to form loops (e.g., traction loops) that provide traction against the top or deck surface of the cartridge, thereby helping to hold the support material to the cartridge prior to staple deployment. Alternatively, or additionally, the one or more additional fibers 2116 can be incorporated into the support material for purposes of thermoforming or bonding the support material to the cartridge. The one or more additional fibers 2116 can be multifilament or monofilament fibers. In one embodiment, the one or more additional fibers 2116 are multifilament fibers. In certain embodiments, the one or more additional fibers 2116 can include at least two, first and second additional fibers, where the first additional fiber differs from the second additional fiber in compositional configuration (e.g., formed from the same material(s)), dimension(s) (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament).

[0171] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, the device can be disassembled, and any number of particular parts or portions of the device can be selectively replaced or removed in any combination. Following cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0172] Furthermore, in this disclosure, like-named components of embodiments generally have similar characteristics, and therefore, in particular embodiments, every feature of each like-named component will not necessarily be described in full detail. Additionally, to the extent that linear or circular dimensions are used in describing the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions to such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and devices and their components may depend, at least, on the anatomical structure of the subject within which the systems and devices are to be used, the size and shape of the components with which the systems and devices are to be used, and the method and procedure for which the systems and devices are to be used.

[0173] It will be understood that the terms "proximal" and "distal" are used herein with reference to a user, such as a clinician, holding the handle of the device. Other spatial terms, such as "forward" and "rearward," similarly correspond to distal and proximal, respectively. It will further be understood that for convenience and clarity of explanation, spatial terms such as "vertical" and "horizontal" are used herein with respect to the drawings. However, the device is used in many orientations and positions, and these spatial terms are not intended to be limiting and absolute.

[0174] Values ​​or ranges can be expressed herein as "about" and / or "approximately" from one particular value to another particular value. When values ​​or ranges are so expressed, other disclosed embodiments include the recited particular value and / or from the one particular value to the other particular value. Similarly, when values ​​are expressed in an approximation format by use of the antecedent "about," it will be understood that a number of disclosed values ​​are recited, and that the particular value forms another embodiment. It will be further understood that there are a number of disclosed values, and that each value is herein disclosed as "about" in addition to the particular 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.

[0175] For purposes of describing and defining the present teachings, unless otherwise indicated, it should be noted that the term "substantially" is utilized herein to represent the inherent degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The term "substantially" is also utilized herein to represent the degree to which a quantitative representation may vary from the stated standard without resulting in a change in the basic functionality of the object in question.

[0176] Those skilled in the art will recognize further features and advantages of the present invention based on the above-described embodiments. Accordingly, the present invention is not limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication, or information incorporated herein by reference in whole or in part is incorporated only to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosed material set forth in this document. Therefore, the disclosures expressly set forth herein shall take precedence over any conflicting documents incorporated herein.

[0177] [Embodiment] (1) An auxiliary material for use with a surgical staple cartridge, comprising: a first knitted layer having first fibers, the first knitted layer extending from a first top surface to a first bottom surface, the first top surface defining at least a portion of the tissue contact surface of the support material; a second knitted layer having second fibers, the second knitted layer extending from a second top surface to a second bottom surface, the second top surface defining at least a portion of a cartridge contact surface of the knitted aid; an auxiliary material comprising: a plurality of recesses extending within the second knitted layer and defined therein, the plurality of recesses being arranged in a predetermined pattern that corresponds to a plurality of attachment features extending outward from the top surface of the cartridge, with each recess of the plurality of recesses being configured to engage with at least a portion of at least one attachment feature to form a friction fit therebetween, thereby retaining the auxiliary material on the cartridge prior to staple deployment. (2) The auxiliary material described in embodiment 1, wherein at least one of the first fiber and the second fiber is a multifilament fiber. (3) The auxiliary material described in embodiment 1, further comprising spacer fibers intertwined with and extending between the first knitted layer and the second knitted layer, thereby connecting the layers to one another. (4) The auxiliary material according to claim 3, wherein the spacer fiber is a monofilament fiber. (5) The auxiliary material according to embodiment 1, wherein each recess of the plurality of recesses is conical.

[0178] (6) A stapling assembly for use with a surgical stapler, comprising: a cartridge extending from a top surface to a bottom surface opposite the top surface, the top surface being a tissue-facing surface having a plurality of attachment features protruding therefrom; a plurality of staples disposed within the cartridge, the plurality of staples being configured to be deployed into tissue; a braided auxiliary material configured to be releasably retained on the cartridge, wherein the auxiliary material can be attached to tissue by the plurality of staples in the cartridge, the auxiliary material including first and second braided outer layers formed from fibers and spacer fibers intertwining with and extending between the first and second braided outer layers, thereby connecting the layers to one another, the second braided outer layer having a plurality of preformed recesses defined therein, each recess configured to receive and engage at least a portion of an extension feature of at least one of the plurality of attachment features, thereby retaining the auxiliary material on the cartridge prior to staple deployment. (7) The staple fastening assembly of embodiment 6, wherein each extension feature has a conical shape with a first maximum diameter and each recess has an inverted conical shape with a second maximum diameter smaller than the first maximum diameter. (8) The staple fastening assembly of embodiment 6, wherein each extension feature has a conical shape with a first maximum diameter and each recess has an inverted conical shape with a second maximum diameter greater than the first maximum diameter. (9) The staple fastening assembly of claim 6, wherein at least one recess of the plurality of recesses has a perimeter defined by fused portions of the fibers of the second knitted outer layer. (10) The staple fastening assembly of claim 6, wherein at least one recess of the plurality of recesses has a perimeter defined by the braided fibers of the second braided outer layer.

[0179] (11) The staple fastening assembly of claim 6, wherein at least one recess of the plurality of recesses has a minimum diameter that is smaller than a diameter of a staple leg of at least one staple of the plurality of staples. (12) The staple fastening assembly of claim 6, wherein at least one recess of the plurality of recesses has a maximum diameter greater than a maximum diameter of the at least one extension feature. (13) The staple fastening assembly according to claim 6, wherein the fibers of at least one of the first outer braided layer and the second outer braided layer are multifilament fibers. (14) The staple fastening assembly of claim 6, wherein the spacer fibers are monofilament fibers. (15) A stapling assembly for use with a surgical stapler, comprising: a cartridge having a plurality of conical projections coupled to and extending outwardly therefrom; a knitting aid configured to be releasably held on the cartridge, the aid being attachable to tissue by a plurality of staples disposed within the cartridge, the knitting aid comprising: a first knitted layer having first fibers, the first knitted layer extending from a first top surface to a first bottom surface, the first top surface defining at least a portion of the tissue contact surface of the support material; a second knitted layer having second fibers, the second knitted layer extending from a second top surface to a second bottom surface, the second top surface defining at least a portion of a cartridge contact surface of the support material; spacer fibers intertwined with the first fibers and the second fibers to connect the first knitted layer to the second knitted layer, a portion of the spacer fibers extending in a generally columnar configuration between the first layer and the second layer; a braided support material extending into the second braided layer and including a plurality of conical recesses defined therein, each recess configured to receive and engage at least a portion of at least one conical projection of the plurality of conical projections, thereby retaining the support material on the cartridge prior to staple deployment.

[0180] (16) The staple fastening assembly of claim 15, wherein each recess of the plurality of recesses has a tapered diameter that decreases as the recess extends into the second knitted layer. (17) The staple fastening assembly of claim 15, wherein at least one recess of the plurality of recesses has a perimeter defined by a fused portion of the second fiber. (18) The staple fastening assembly of claim 15, wherein each recess of the plurality of recesses has a perimeter defined by a braided second fiber. (19) The staple fastening assembly of claim 15, wherein each recess of the plurality of recesses has a minimum diameter that is less than a diameter of a staple leg of each of the plurality of staples. (20) The staple fastening assembly of claim 15, wherein at least one of the first fiber and the second fiber is a multifilament fiber.

[0181] 21. The staple fastening assembly of claim 15, wherein the spacer fibers are monofilament fibers.

Claims

1. 1. A stapling assembly for use with a surgical stapler, comprising: a cartridge extending from a top surface to a bottom surface opposite the top surface, the top surface being a tissue-facing surface having a plurality of attachment features protruding therefrom; a plurality of staples disposed within the cartridge, the plurality of staples being configured to be deployed into tissue; a knitted auxiliary material configured to be releasably held on the cartridge, the auxiliary material being attachable to tissue by the plurality of staples in the cartridge, the auxiliary material including first and second knitted outer layers formed from fibers and spacer fibers intertwining with and extending between the first and second knitted outer layers, thereby connecting the first and second knitted outer layers to one another, the second knitted outer layer having a plurality of preformed recesses defined therein, each recess configured to receive and engage at least a portion of at least one attachment feature of the plurality of attachment features, thereby retaining the auxiliary material on the cartridge prior to staple deployment; a staple fastening assembly, wherein each attachment feature has a conical shape that decreases in diameter as it extends upward from the top surface of the cartridge, each recess has an inverted conical shape that decreases in diameter as it extends upward from the second bottom surface of the second knitted outer layer into the second knitted outer layer, each recess does not reach the second top surface of the second knitted outer layer, the top surface of each recess is closed and not open, and each attachment feature is not in contact with the first knitted outer layer and the spacer fibers.

2. The stapling assembly of claim 1, wherein each mounting feature has the conical shape with a first maximum diameter and each recess has the inverted conical shape with a second maximum diameter that is smaller than the first maximum diameter.

3. The stapling assembly of claim 1, wherein each mounting feature has the conical shape with a first maximum diameter and each recess has the inverted conical shape with a second maximum diameter that is larger than the first maximum diameter.

4. The staple fastening assembly of claim 1 , wherein at least one recess of said plurality of recesses has a perimeter defined by fused portions of said fibers of said second braided outer layer.

5. The staple fastening assembly of claim 1 , wherein at least one recess of said plurality of recesses has a perimeter defined by braided fibers of said second braided outer layer.

6. The stapling assembly of claim 1, wherein at least one recess of said plurality of recesses has a minimum diameter that is less than a diameter of a staple leg of at least one staple of said plurality of staples.

7. The staple fastening assembly of claim 1 , wherein the fibers of at least one of the first outer braided layer and the second outer braided layer are multifilament fibers.

8. The stapling assembly of claim 1 , wherein said spacer fibers are monofilament fibers.

9. The first knitted outer layer has first fibers, the first knitted outer layer extends from a first top surface to a first bottom surface, the first top surface defining at least a portion of the tissue contact surface of the support material; the second knitted outer layer having second fibers, the second knitted outer layer extending from the second top surface to the second bottom surface, the second top surface defining at least a portion of a cartridge contact surface of the support material; 2. The staple fastening assembly of claim 1, wherein the spacer fibers are intertwined with the first fibers and the second fibers to connect the first braided outer layer to the second braided outer layer, and a portion of the spacer fibers extend between the first braided outer layer and the second braided outer layer in a generally columnar configuration.

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