Compressible Knitting Aid with Finished Edges

Abstract

A staple fastening assembly for use with a surgical stapler is provided. In one exemplary embodiment, the staple fastening assembly can include a cartridge and a braided support material configured to be releasably held on the cartridge. The support material includes first fibers, second fibers, and spacer fibers, the first fibers and spacer fibers intertwined to form an upper layer of the support material, the second fibers and spacer fibers intertwined to form a lower layer of the support material, and the first fibers, second fibers, and spacer fibers intertwined to form at least one finished edge extending between the upper and lower layers, the at least one finished edge substantially preventing fraying.

Description

Technical Field

[0001] A compressible knitting aid and a method of using the same are provided.

Background Art

[0002] Surgical stapling instruments are used to close openings in tissue, blood vessels, ducts, shunts, or other objects or body parts associated with a particular procedure in a surgical procedure. The opening may be one that naturally exists, such as within a blood vessel or a passage within a viscus such as the stomach, or may be formed by a surgeon during a surgical procedure, such as by forming a bypass or anastomosis by tissue or blood vessel puncture, or by tissue incision during a stapling procedure.

[0003] In some surgical stapling instruments, the surgeon needs to select an appropriate staple having an appropriate staple height for the tissue being stapled. For example, the surgeon can select a tall staple for use on thick tissue and a short staple for use on thin tissue. However, depending on the situation, the tissue being stapled does not have a consistent thickness, and thus the staples may not be able to achieve the desired post-firing configuration at each staple site. As a result, it is not possible to form a desired seal at or near all of the stapled sites, which can cause blood, air, gastrointestinal fluid, and other fluids to leak through unsealed sites.

[0004] Furthermore, staples and other objects and materials that can be implanted along with procedures such as stapling generally lack some of the properties of the tissue into which they are implanted. For example, staples and other objects and materials may lack the natural flexibility of the tissue into which they are implanted and thus may not be able to withstand fluctuations in tissue pressure at the implantation site. This can lead to undesirable tearing and, ultimately, leakage of tissue at or near the staple site.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Therefore, there is still a need for improved devices and methods to address the current problems of surgical staplers.

Means for Solving the Problems

[0006] A staple fastening assembly for use with a surgical stapler is provided. In one exemplary embodiment, the staple fastening assembly includes a cartridge and a braiding aid. The cartridge has a plurality of staples disposed therein and configured to be deployed within tissue. The braiding aid is configured to be releasably held on the cartridge, and the aid can be attached to the tissue by the plurality of staples within the cartridge. The aid includes a first fiber, a second fiber, and spacer fibers. The first fiber and the spacer fibers can be intertwined to form an upper layer of the aid, and the second fiber and the spacer fibers can be intertwined to form a lower layer of the aid. The first fiber, the second fiber, and the spacer fibers can also be intertwined to form at least one finished edge extending between the upper layer and the lower layer, and the at least one finished edge substantially prevents fraying.

[0007] The spacer fibers can have various configurations. For example, in some embodiments, the spacer fibers can extend from the upper layer to the lower layer to form an intermediate layer between the upper layer and the lower layer. In other embodiments, only the spacer fibers can be present in the intermediate layer. In some embodiments, the spacer fibers can be intertwined with the first fiber in a repeating pattern within the upper layer. In other embodiments, the spacer fibers can be intertwined with the second fiber in a repeating pattern within the lower layer. In some embodiments, the spacer fibers can be monofilament fibers.

[0008] In some embodiments, at least one of the first fiber and the second fiber can be a multifilament fiber.

[0009] The at least one finished edge can have various configurations. For example, in some embodiments, the at least one finished edge can be positioned along at least a portion of the outermost edge of the auxiliary material. In other embodiments, the at least one finished edge can define the entire outermost periphery of the auxiliary material. In some embodiments, the at least one finished edge can include a first finished edge and a second finished edge.

[0010] In some embodiments, the cartridge can include a slot formed inside the cartridge and extending along at least a portion of the longitudinal axis of the cartridge. The slot is defined between opposing first slot edges and second slot edges and can be configured to receive a cutting element. The first finished edge can be positioned adjacent to and along the first slot edge, and the second finished edge can be positioned adjacent to and along the second slot edge.

[0011] In another exemplary embodiment, a staple retention assembly for use with a surgical stapler includes a cartridge and a braiding aid. The cartridge has a plurality of staples disposed therein and configured to be deployed into tissue. The braiding aid is configured to be releasably retained on the cartridge such that the aid can be attached to the tissue by the plurality of staples within the cartridge. The aid has a tissue contact surface and a cartridge contact surface opposite the tissue contact surface. The aid includes an upper layer, a lower layer, an intermediate layer, and at least one finished edge. The upper layer can be formed from a first fiber intertwined with spacer fibers and can define at least a portion of the tissue contact surface. The lower layer can be formed from a second fiber intertwined with spacer fibers, is opposite the upper layer, and can define at least a portion of the cartridge contact surface. The intermediate layer is positioned between the upper layer and the lower layer and can be formed from a portion of the spacer fibers extending between the upper layer and the lower layer. The portion of the spacer fibers can be arranged to form standing fibers configured to bend in response to a force applied to the braiding aid. The at least one finished edge can include a first fiber, a second fiber, and spacer fibers that intertwine with each other and are positioned along at least a portion of the outermost periphery of the aid to prevent fraying of the fibers therealong.

[0012] The spacer fibers can have various configurations. For example, in some embodiments, the spacer fibers can intertwine with the first fiber in a repeating pattern within the upper layer. In other embodiments, the spacer fibers can intertwine with the second fiber in a repeating pattern within the lower layer. In some embodiments, the spacer fibers can be monofilament fibers.

[0013] In some embodiments, at least one of the first fiber and the second fiber can be a multifilament fiber.

[0014] In some embodiments, at least one finished edge can include a plurality of finished edges that are combined to define the entire outermost periphery of the auxiliary material.

Brief Description of the Drawings

[0015] The present invention will be more fully understood by reading the following embodiments for carrying out the invention in conjunction with the accompanying drawings.

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[0016] Here, specific exemplary embodiments will be described so that the structures, functions, manufacture, and principles of use of the aids, systems, and methods disclosed herein are generally understood. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the aids, systems, and methods described in detail herein and shown in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the present invention is defined only by the claims. Features illustrated or described in connection with an exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0017] A surgical stapling assembly, as well as a method of manufacturing and using the same, are provided. Generally, a surgical stapling assembly can include a staple cartridge having staples disposed therein and a compressible braiding aid configured to be releasably held on the staple cartridge. As discussed herein, the various aids provided can be configured to compensate for changes in tissue characteristics, such as changes in tissue thickness, and / or to promote ingrowth of the tissue when the aid is stapled to the tissue. Further, the various aids can be designed to suppress fraying and / or tearing thereof. Thereby, the aesthetic and / or structural integrity of the aid can be improved.

[0018] Exemplary stapling assemblies are described herein and can include various features for facilitating the application of surgical staples, as shown in the drawings. However, one of ordinary skill in the art will understand that the 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 represent only specific exemplary embodiments. Further, although the aid is described in connection with a surgical staple cartridge assembly, the aid can be used in connection with a staple reload that is not a cartridge base or any type of surgical device.

[0019] Figure 1 shows an exemplary surgical stapling and cutting device 100 suitable for use with implantable aids. The illustrated surgical stapling and cutting device 100 includes a staple application assembly 106 or end effector having an anvil 102 pivotally coupled to an elongated staple channel 104. As a result, the staple application assembly 106 can move between an open position as shown in Figure 1 and a closed position where the anvil 102 is positioned adjacent to the elongated staple channel 104 and engages tissue therebetween. The staple application assembly 106 can be attached at its proximal end to an elongated shaft 108 that forms an implementation portion 110. When the staple application assembly 106 is closed or at least substantially closed (e.g., when the anvil 102 moves from the open position of Figure 1 towards the elongated staple channel), the implementation portion 110 can present a sufficiently small cross-section suitable for inserting the staple application assembly 106 through a trocar. The device 100 is configured to staple and cut tissue, although surgical devices configured to staple tissue but not cut it are also contemplated herein.

[0020] In various situations, the staple application 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 rotary knob 114 that rotates the elongated shaft 108 and the staple application assembly 106 about the longitudinal axis of the elongated shaft 108 and a closure trigger 116 to close the staple application assembly 106 relative to the pistol grip 118. For example, when the closure trigger 116 is clamped, a closure release button 120 may be provided on the outside of the handle 112, whereby the closure release button 120 can be pressed to release the clamp of the closure trigger 116 and open the staple application assembly 106.

[0021] The firing trigger 122 can pivot relative to the closure trigger 116, thereby enabling the staple application assembly 106 to simultaneously cut and staple the tissue clamped therein. In various cases, multiple firing strokes can be used with the firing trigger 122 to reduce the amount of force per stroke that is required to be applied by the surgeon's hand. In certain embodiments, the handle 112 can include one or more rotary indicator wheels, such as the rotary indicator wheel 124, that can display the progress of the firing. The manual firing release lever 126 enables the firing system to be retracted, if desired, before the firing system completes its movement for firing, and further enables a surgeon or other clinician to retract the firing system if the firing system becomes stuck and / or non-functional.

[0022] Further details regarding the surgical stapling and cutting device 100 suitable for use with the present disclosure and other surgical stapling and cutting devices 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. Further, the surgical stapling and cutting device need not include a handle and, 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.

[0023] 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 a 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.

[0024] The illustrated staple cartridge 200 includes staple cavities 212, 214 defined therein, and each staple cavity 212, 214 is configured to removably accommodate at least a portion of staples (not shown). The number, shape, and location of the staple cavities can vary and can depend at least on the size and shape of the staples removably disposed therein. In this illustrated embodiment, the staple cavities are arranged in two sets of three longitudinal columns, 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 the longitudinal slot 210, and thus for each set of columns, the first longitudinal column of staple cavities 212a, 214a extends along the longitudinal slot 210, the second column of staple cavities 212b, 214b extends along the first column of staple cavities 212a, 214b, and the third column of staple cavities 212c, 214c extends along the second column of staple cavities 212b, 214b. For each set of columns, the first column of staple cavities 212a, 214b, the second column of staple cavities 212b, 214b, and the third column of staple cavities 214c, 214c are parallel to each other and to the longitudinal slot 210. Further, as shown, for each set of columns, the second column of staple cavities 212b, 214b is staggered with respect to the first and third columns of staple cavities 212a, 212c, 214a, 214c. In other embodiments, the columns of staple cavities within each set 212, 214 are not parallel to each other and / or to the longitudinal slot 210.

[0025] The staples releasably stored within the staple cavities 212, 214 can have various configurations. An exemplary staple 300 that can be releasably stored in each of the staple cavities 212, 214 is shown in FIG. 3 in its un-fired (pre-deployment, unformed) configuration. 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 stepped-up crown and / or the staple legs can have different unformed heights. Further, before the staple 300 is deployed, the crown 302 can be supported by a staple driver positioned within the staple cartridge 200, while at the same time, the staple legs 304 can be at least partially received within the staple cavities 212, 214. Additionally, the staple legs 304 can extend beyond an upper surface, such as the upper surface 206 of the staple cartridge 200, when the staple 300 is in the un-fired position. In certain situations, as shown in FIG. 3, the tip 306 of the staple legs 304 can be sharp and pointed to be able to incise and penetrate tissue.

[0026] In use, staple 300 can be deformed from an un-fired position to a fired position such that staple legs 304 move through staple cavities 212, 214 and penetrate tissue positioned between anvil 102 and staple cartridge 200 and contact anvil 102. When staple legs 304 deform relative to anvil 102, staple legs 304 of each staple 300 can capture a portion of the tissue within each staple 300 and apply a compressive force to the tissue. Further, staple legs 304 of each staple 300 can deform downwardly toward crown 302 of staple 300 to form a staple capture region in which tissue can be captured therein. In various instances, the staple capture region can be defined between the inner surface of the deformed legs and the inner surface of the crown of the staple. The size of the staple capture region can depend on several factors such as, for example, the length of the legs, the diameter of the legs, the width of the crown, and / or the degree of deformation of the legs.

[0027] In some embodiments, all staples disposed within staple cartridge 200 can have the same un-fired (pre-deployment, unformed) configuration. In other embodiments, the staples can include at least two staple groups each having a different un-fired (pre-deployment, unformed) configuration, e.g., different from one another in height and / or shape, such as different heights. For example, staple cartridge 200 can include a first staple group having a first height disposed within a first row of staple cavities 212a, 214a, a second staple group having a second height disposed within a second row of staple cavities 212b, 214b, and a third staple group having a third height disposed within a third row of staple cavities 212c, 214c. In some embodiments, the first, second, and third heights can be different, and the third height can be greater than the first and second heights. In other embodiments, the first and second heights can be the same, but the third height is different and greater than the first and second heights. Those skilled in the art will understand that other combinations of staples are contemplated herein.

[0028] Furthermore, the staple can include one or more external coatings, such as sodium stearate lubricant and / or an antibacterial agent(s). The antibacterial 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 antibacterial agents include 5-chloro-2-(2,4-dichlorophenoxy)phenol, chlorhexidine, silver formulations (e.g., nanocrystalline silver), ethyl laurate (LAE), octenidine, polyhexamethylene biguanide (PHMB), taurolidine, lactic acid, citric acid, acetic acid, and salts thereof.

[0029] Referring back to FIGS. 2A - 2B, the staple cartridge 200 extends from an upper or deck surface 206 to a bottom surface 208. The upper surface 206 is configured as the surface facing the tissue and the bottom surface 208 is configured as the surface facing the channel. As a result, as shown in FIG. 1, when the staple cartridge 200 is inserted into the elongate staple channel 104, the upper surface 206 faces the anvil 102 and the bottom surface 208 (which is obscured) faces the elongate staple channel 104. Further, the upper surface 206 has two outermost end longitudinal edges 207a, 207b that are positioned distally with respect to the longitudinal slot 210 of the staple cartridge 200.

[0030] 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 first recessed channel 216 is defined by a substantially triangular wall portion 216a having a proximal-facing apex, a distal-facing apex, and a laterally-outward-facing apex. Further, each first recessed channel 216 includes a first floor 206a that is a first height from the upper surface 206. A second recessed channel 218 surrounds each of the second staple cavities 212b, 214b. Each second recessed channel 218 is defined by a wall portion 218a having a substantially diamond shape with a proximal-facing apex, a distal-facing apex, an apex facing inwardly laterally with respect to the longitudinal axis, and a laterally-outward-facing apex. Further, each second recessed channel 218 includes a second floor 206b that is a second height from the upper surface 206. A third recessed channel 220 surrounds each of the third staple cavities 212c, 214c. Each third recessed channel 220 is defined by a substantially triangular wall portion 220a having a proximal-facing apex, a distal-facing apex, and an apex facing inwardly laterally with respect to the longitudinal axis. Further, each third recessed channel 220 includes a third floor 206c that is a third height from the upper surface 206. In some embodiments, the first height of the first recessed channel 216, the second height of the second recessed channel 218, and the third height of the third recessed channel 220 can have the same height. In other examples, the first height, the second height, and / or the third height can be different. Further details regarding the 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.

[0031] Referring to FIGS. 4 and 5, for example, a firing assembly, such as firing assembly 400, can be utilized with a surgical stapling and cutting device, such as device 100 of FIG. 1. The firing assembly 400 can be configured to advance a wedge thread 500 having a wedge 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. Further, an E-shaped beam portion 402 at the distal portion of the firing assembly 400 can fire staples from the staple cartridge. During firing, the E-shaped beam portion 402 can also pivot the anvil toward the staple cartridge, and thus move the staple application assembly from an open position to a closed position. The illustrated E-shaped beam portion 402 includes a pair of upper pins 404, a pair of intermediate pins 406 that may be along a portion 504 of the wedge thread 500, and a lower pin or foot 408. The E-shaped beam portion 402 can also include a sharp cutting edge 410 configured to cut the captured tissue as the firing assembly 400 advances in a distal direction, and thus toward the distal end of the staple cartridge. Additionally, integrally formed and proximally projecting upper guide 412 and intermediate guide 414 that bracket each vertical end of the sharp cutting edge 410 may further define a tissue staging area 416 that aids in guiding the tissue to the sharp cutting edge 410 before the tissue is cut. The intermediate guide 414 can also function to engage and fire staples within the staple cartridge by abutting a stepped central member 506 of the wedge thread 500 that effects staple forming by the staple application assembly 106.

[0032] In use, the anvil 102 of FIG. 1 can be moved to the closed position by depressing the closing trigger of FIG. 1, and the E-shaped beam portion 402 of FIG. 4 can be advanced. The anvil can position tissue relative to at least the upper surface 206 of the staple cartridge 200 of FIGS. 2A-2C. When the anvil is properly positioned, the staples 300 of FIG. 3 disposed within the staple cartridge can be deployed.

[0033] To deploy staples from the staple cartridge, as described above, the wedge thread 500 of FIG. 5 can be moved from the proximal end to the distal end of the cartridge body, and thus from the proximal end to the distal end of the staple cartridge. As the firing assembly 400 of FIG. 4 advances, the thread contacts a staple driver within the staple cartridge and can lift upward within staple cavities 212, 214. In at least one example, the thread and staple driver can each include one or more inclined surfaces, i.e., surfaces that are angled, such that they cooperate to move the staple driver upward from the unfired position. When the staple driver is lifted upward within each staple cavity, the staples advance upward and the staples exit the staple cavity and penetrate into the tissue. In various instances, the thread can move several staples upward simultaneously as part of the firing sequence.

[0034] As described above, the stapling device can be used in combination with a compressible auxiliary material. Although the 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. Further, those skilled in the art will also understand that the staple cartridge need not be replaceable.

[0035] As described above, in some surgical staplers, the surgeon is often required to select an appropriate staple having an appropriate staple height for the tissue to be stapled. For example, the surgeon utilizes tall staples for use with thick tissue and short staples for use with thin tissue. However, depending on the situation, the tissue being stapled does not have a consistent thickness, and thus, the staples may not be able to achieve the desired post-firing configuration for all portions of the stapled tissue (e.g., portions of thick tissue and portions of thin tissue). Due to the inconsistent tissue thickness, when staples having the same or substantially greater height are used, particularly when the staple site is subjected to internal pressure at that staple site and / or along the staple row, there may be undesirable leakage and / or tearing of the tissue at the staple site.

[0036] Accordingly, various embodiments of a knitting aid are provided that can be configured to compensate for the various thicknesses of tissue captured within a fired (deployed) staple in order to avoid the need to consider staple height when stapling tissue during surgery. That is, the aids described herein enable a set of staples having the same or similar height to be used when stapling tissue of various thicknesses (e.g., from thin tissue to thick tissue), and in combination with the aid, can provide appropriate compression of the tissue within and between the fired staples. Accordingly, the aids described herein can maintain suitable compression for stapled thin or thick tissue, thereby minimizing leakage and / or tearing of the tissue at the staple site.

[0037] Alternatively or additionally, the knitting aid can be configured to promote ingrowth of tissue. In various situations, it is desirable to promote ingrowth of tissue into an implantable aid in order to facilitate healing of the tissue being treated (e.g., tissue being stapled and / or incised) and / or to accelerate the patient's recovery. More specifically, ingrowth of tissue into the implantable aid can reduce the incidence, degree, and / or duration of inflammation at the surgical site. Ingrowth of tissue into and / or around the implantable aid can, for example, manage the spread of infection at the surgical site. For example, ingrowth of blood vessels, particularly white blood cells, into and / or around the implantable aid can combat infection within and / or around the implantable aid and adjacent tissue. Ingrowth of tissue can also assist the patient's body in accepting foreign bodies (e.g., implantable aids and staples) and can also reduce the likelihood that the patient's body will reject the foreign bodies. Rejection of foreign bodies can result in infection and / or inflammation at the surgical site.

[0038] Generally, the knitting aids provided herein are designed and positioned on a staple cartridge, such as staple cartridge 200. When staples are fired (deployed) from the cartridge, the staples penetrate the aid and enter the tissue. When the legs of the staples strike an anvil positioned on the opposite side of the staple cartridge and are deformed, the deformed legs capture a portion of the aid 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 aid is disposed between the tissue and the fired staples. The aids described herein can be configured to be attached to a staple cartridge, but it is also contemplated herein that the aids can be configured to mate with components of other devices, such as an anvil of a surgical stapler. One of ordinary skill in the art will understand that the aids provided herein can be used with replaceable cartridges or reloads of staples that are not cartridge-based.

[0039] FIG. 6 shows an exemplary embodiment of a stapling assembly 600 that includes a staple cartridge 602 and an auxiliary member 604. For simplicity, the auxiliary member 604 is schematically shown in FIGS. 6A-6B, and various structural configurations of the auxiliary member are described in more detail below. Except for 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 are not described in detail herein. As shown, the auxiliary member 604 is disposed relative to the staple cartridge 602. Although partially obscured in FIG. 6, the staple cartridge 602 includes staples 606 that may be similar to the staples 300 of FIG. 3 and are configured to be deployed into tissue. The staples 606 can have any suitable unformed (prior to deployment) height. For example, the staples 606 can have an unformed height of about 2 mm to 4.8 mm. Prior to deployment, the crown of the staple can be supported by a staple driver (not shown).

[0040] In the illustrated embodiment, the auxiliary member 604 can be fitted to at least a portion of the upper or deck surface 608 of the staple cartridge 602. In some embodiments, the upper surface 608 of the staple cartridge 602 can include one or more surface features such as the recessed channels 216, 218, 220 as shown in FIGS. 2A and 2C. The one or more surface features can be configured to engage the auxiliary member 604 to avoid unwanted movement of the auxiliary member 604 relative to the staple cartridge 602 and / or to prevent premature release of the auxiliary member 604 from the staple cartridge 602. Exemplary surface features are described in U.S. Patent Application Publication No. 2016 / 0106427, which is hereby incorporated by reference in its entirety.

[0041] The auxiliary material 604 is compressible and can compensate for different tissue thicknesses captured within the staples deployed thereby as the auxiliary material is compressed to various heights. The auxiliary material 604 has an uncompressed (undeformed) or pre-deployment height and is configured to deform to one of a plurality of compressed (deformed) or deployment heights. For example, the auxiliary material 604 can have an uncompressed height that is higher than the post-firing height of the staples 606 disposed within the staple cartridge 602 (e.g., the height (H) of the fired staple 606a in FIG. 7). That is, the auxiliary material 604 can have an undeformed state where the maximum height of the auxiliary material 604 is higher than the maximum height of the fired staples (e.g., the staples in the formed configuration). In one embodiment, the uncompressed height of the auxiliary 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 post-firing height of the staples 606. In certain embodiments, the uncompressed height of the auxiliary material 604 can be, for example, 100% higher than the post-firing height of the staples 606.

[0042] In use, when a surgical stapling and cutting device, such as the device 100 of FIG. 1, is oriented towards the surgical site, the anvil 612 is positioned adjacent to a first side of the tissue and the stapling assembly 600 is positioned adjacent to a second side of the tissue such that the tissue is positioned between the anvil 612 and the stapling assembly 600 (e.g., the tissue can be positioned against the tissue contact surface 604a of the auxiliary material 604). When the tissue is positioned between the anvil 612 and the stapling assembly 600, the surgical stapler is actuated, for example, as described above, thereby clamping the tissue between the anvil 612 and the stapling assembly 600 (e.g., between the tissue compression surface 612a of the anvil 612 and the tissue contact surface 604a of the auxiliary material 604) and deploying staples from the cartridge through the auxiliary material into the tissue to staple and attach the auxiliary material to the tissue.

[0043] As shown in FIG. 7, when staple 606 is fired, a portion of the tissue (T) and the auxiliary material 604 is captured by the fired (formed) staple 606a. Each of the fired staples 606a defines a capture region therein, as described above, for accommodating the captured auxiliary material 604 and tissue (T). The capture region defined by the fired staple 606a is at least partially limited by the height (H) of the fired staple 606a. For example, the height of the fired staple 606a can be about 0.160 inches or less. In some embodiments, the height of the fired staple 606a can be about 0.130 inches or less. In one embodiment, the height of the fired staple 606a can be about 0.020 inches to 0.130 inches. In another embodiment, the height of the fired staple 606a can be about 0.060 inches to 0.160 inches.

[0044] 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 staple is the same or different within each fired staple. In at least one exemplary embodiment, the staples in a row of staples can be deformed to a height of, for example, about 2.75 mm after firing, and the tissue (T) and the auxiliary material 604 can be compressed within this height. In certain situations, the tissue (T) can have a compression height of about 1.0 mm, and the auxiliary material 604 can have a compression height of about 1.75 mm. In certain situations, the tissue (T) can have a compression height of about 1.50 mm, and the auxiliary material 604 can have a compression height of about 1.25 mm. In certain situations, the tissue (T) can have a compression height of about 1.75 mm, and the auxiliary material 604 can have a compression height of about 1.00 mm. In certain situations, the tissue (T) can have a compression height of about 2.00 mm, and the auxiliary material 604 can have a compression height of about 0.75 mm. In certain situations, the tissue (T) can have a compression height of about 2.25 mm, and the auxiliary material 604 can have a compression height of about 0.50 mm. Thus, the sum of the compression 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 staple 606a.

[0045] The knitting auxiliary material can have various configurations. Generally, as described in more detail below, the knitting auxiliary material is formed from fibers that are knitted or woven (e.g., intertwined) with each other.

[0046] The knitting auxiliary material can be formed from the same fiber, but in other embodiments, the knitting auxiliary material can be formed from different fibers. The fibers can differ in material, dimensions (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament). In certain embodiments, the knitting auxiliary material 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 with each other (e.g., twisted or braided) to form an integral structure.

[0047] Multifilament fibers can have various configurations. For example, in some embodiments, each multifilament fiber includes from about 6 to 40 filaments. In one embodiment, each multifilament fiber includes from about 14 to 28 filaments. The increased surface area and voids present between the filaments of the multifilament fiber can facilitate the improvement of the ingrowth of tissue within the auxiliary material.

[0048] Multifilament fibers can be formed from filaments made of the same material or from filaments 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 faster rate than the degradation rate of the first material. In this way, the degradation of the second material can activate macrophages, thus promoting the accelerated attraction of macrophages, accelerating the inflammatory phase of healing, and substantially not affecting the variable stiffness profile over time after the implant of the prosthesis. The activation of macrophages can cause an increase in the myofibroblast population and angiogenesis. Further, the degradation of the second material can promote the ingrowth of tissue within the prosthesis. The first material can be, for example, at least one of poly-L-lactic acid, a copolymer of glycolide and L-lactide, a copolymer of glycolic acid and lactic acid, poly(lactic-co-glycolic acid), poly(lactic acid), polyglycolide, and a copolymer of glycolide, caprolactone, trimethylene carbonate, and lactide. Non-limiting examples of suitable first materials can be formed from Polyglyactin 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™.

[0049] Multifilament fibers can include the second filament in various percentage ranges. In some embodiments, however, each multifilament fiber can include the second filament in the range of about 15% to 85% or in the range of about 25% to 45%. The second filament can have various fiber diameters. For example, in some embodiments, the second filament can have a fiber diameter in the range of about 0.0005 mm to 0.02 mm. In one embodiment, the second filament has a fiber diameter of about 0.015 mm.

[0050] Monofilament fibers can have various sizes. For example, the monofilament can have a diameter of about 0.2 mm to 0.35 mm. In some embodiments, each monofilament fiber can have a diameter smaller than the average fiber diameter of the multifilament fiber. The average fiber diameter (D) of the multifilament fiber can be calculated using the following formula.

[0051]

Number

[0052] Multifilament fibers can have various 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 the multifilament fiber has a diameter smaller than the fiber diameter of the monofilament fiber. For example, when 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 the multifilament fiber can have a diameter that is about 1 / 10 of the diameter of the monofilament fiber.

[0053] As described above, since a portion of the auxiliary material is captured with the tissue within the fired staple, it is desirable for the auxiliary material to be formed from a suitable bioabsorbable material. Thus, each of the fibers can be formed from a bioabsorbable material(s). 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-co-glycolic acid), poly(lactic acid), polyglycolide, and copolymers of glycolide and caprolactone and trimethylene carbonate and lactide, polydioxanone, copolymers of polydioxanone and polyglycolide, copolymers of lactide and polycaprolactone, copolymers of glycolide and dioxanone and trimethylene carbonate, poly(trimethylene carbonate), polyhydroxyalkanoate, and polyglyconate.

[0054] 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, a copolymer of glycolide and L-lactide, a copolymer of glycolic acid and lactic acid, poly(lactic-co-glycolic acid), poly(lactic acid), polyglycolide, and a copolymer of glycolide and caprolactone and trimethylene carbonate and lactide. For example, the first type of fiber can be formed from Polygactin 910, Lactomer™ 9-1, 75:25 or 50:50 lactic acid / glycolic acid, Polygytone™ 6211, or Caprosyn™. Non-limiting examples of materials suitable for the second type of fiber include at least one of polydioxanone, a copolymer of polydioxanone and polyglycolide, a copolymer of lactide and polycaprolactone, a copolymer of glycolide and dioxanone and trimethylene carbonate, poly(trimethylene carbonate), polyhydroxyalkanoate, and polyglyconate. For example, the second type of fiber can be formed from 92:8 polydioxanone / polyglycolide, 25:75 lactide / polycaprolactone, Glycomer™ 631, or Maxon™. In one embodiment, the first type of fiber is formed from Polygactin 910 and the second type of fiber is formed from polydioxanone.

[0055] The knitting auxiliary material can have different sizes, shapes, and configurations. Generally, the auxiliary material includes at least a core layer or an 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 a tissue contact layer) formed from at least a first fiber (e.g., a knitted layer) knitted or woven with each other, and a second outer layer (e.g., a lower layer or a cartridge contact layer) formed from at least a second fiber (e.g., a knitted layer) knitted or woven with each other. The first fiber and the second fiber can be the same or different. The auxiliary material can also include spacer fibers that can be the same as or different from the first fiber and the second fiber. The spacer fibers intermesh with the first outer layer and the second outer layer and extend therebetween, whereby a portion of the spacer fibers extending between the two outer layers forms at least one of at least one core layer or intermediate layer of the auxiliary material, connecting these layers to each other.

[0056] Each layer of the auxiliary material extends from a first surface (e.g., the upper surface) to a second surface (e.g., the bottom surface). Depending on the overall structural configuration of the auxiliary material, at least a portion of the first surface of one layer can function as a tissue contact surface, and at least a portion of the second surface of another layer can function as a cartridge contact surface. Those skilled in the art will understand that the auxiliary material can have additional tissue contact surfaces (e.g., one or more lateral sides with respect to the upper surface).

[0057] In some embodiments, the spacer fibers interconnect 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 each other, thereby enabling movement and expansion of the knitting auxiliary material in the x-direction (e.g., stretching) and y-direction (e.g., compression). In addition, the interconnecting portions between the spacer fibers and the first and second fibers of the outer layer can at least partially affect the rigidity of the auxiliary material. For example, as the interconnecting portions become denser, the auxiliary material has higher rigidity.

[0058] Each of the first outer layer and the second outer layer can include a plurality of openings formed therein. The periphery of the opening in the first outer layer can be defined by portions of the first fiber and the spacer fiber, and the periphery of the opening in the second outer layer can be defined by portions of the second fiber and the spacer fiber. In certain embodiments, the openings in the second outer layer can have a size of less than about 1 / 4 of the width of the crown of staples such as staple 300 in FIG. 3. Thus, in such embodiments, the crown of the 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. The crowns of staples can have various widths, but in some embodiments, the width of the crown can be from about 0.080 inches to 0.140 inches. In one embodiment, the width of the crown is about 0.12 inches.

[0059] In certain embodiments, portions of the spacer fibers extending between the first outer layer and the second outer layer can be arranged to form upstanding fibers and a plurality of voids therebetween. The upstanding fibers are non-fixedly attached to each other. Further, the upstanding fibers are non-fixedly and slidably interconnected to the first type of fibers of the first outer layer and the second outer layer. In some embodiments, the plurality of voids can be larger than the plurality of openings in the first outer layer and the second outer layer.

[0060] The upright fibers can be configured to bend under the force applied to the auxiliary material (e.g., when stapled to tissue). Due to the elasticity of the upright fibers, at least in part, the auxiliary material can be compressed to various heights, thereby enabling accommodation of tissue (T) having tissue portions of different thicknesses. That is, regardless of the thickness of a particular tissue, the total compressed height of the captured tissue and the auxiliary material within the fired staple can be maintained, and thus a state equal to or at least substantially equal to the height of the fired staple can be maintained. In this way, at least in part, the knitting auxiliary material applies a stress of at least about 3 gf / mm 2 to the captured tissue over at least a predetermined period (e.g., at least about 3 days).

[0061] Generally, the material composition, height, and / or cross-sectional area of each upright fiber at least partially controls its rigidity or ability to bend under compression, and then that ability at least partially controls the overall compressibility of the auxiliary material. Thus, the upright fibers can be configured to adjust the compressibility of the auxiliary material to one or more desired values. For example, in some embodiments, the upright fibers can be formed from the same material, while in other embodiments, at least a portion of the upright fibers can be formed from different materials having different rigidities. Alternatively or additionally, the upright fibers or at least a portion thereof can have different heights and / or cross-sectional areas.

[0062] The amount of standing fibers within a particular region or section of the auxiliary material can also, among other things, affect the compressibility of such a section and, by extension, the overall compressibility of the auxiliary material. In certain cases, for example, the standing fibers can be strategically concentrated in a particular region of the auxiliary material to increase the compressive strength in such a region. In at least one case, the standing fibers can be concentrated in a region of the core layer or intermediate layer configured to receive staples when the staples are fired. Alternatively, the standing fibers can be concentrated in a region of the auxiliary material that does not receive staples when the staples are fired (e.g., a region that overlaps with an intended cut line of the auxiliary material).

[0063] The ratio of voids to standing fibers can be variable. 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. Further, at least a portion of the voids can each have a different size. In this way, the variable void diameter across the cross-section of the auxiliary material 804 can promote extracellular remodeling. That is, the variable void diameter can, when the auxiliary material is implanted, promote angiogenesis and mobility of cells within the auxiliary material, thereby promoting both tissue and cell ingrowth. Further, the variable void diameter can also facilitate the extraction of by-products and cell waste from the implanted auxiliary material and thus from the implantation site.

[0064] Edge conditions As described above, the knitting auxiliary material is formed from fibers knitted or woven together. In certain embodiments, the knitting auxiliary material can be designed such that the free ends of at least a portion 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 them. As a result, the structural integrity of the auxiliary material can be maintained when subjected to forces that would otherwise cause the fibers to fray or separate from each other. The one or more finished edges can also provide an aesthetic effect and / or reduce variability in both the structure and the associated properties of the present auxiliary material as compared to conventional auxiliary materials (e.g., auxiliary materials without finished edges).

[0065] The one or more finished edges can be formed in various ways. For example, in some embodiments, additional fiber(s) (e.g., fiber(s) different from those used to form the body of the auxiliary material) can be used to interconnect the opposing layer end edges of the auxiliary material to each other (see FIGS. 8A - 10D). In such embodiments, the additional fiber(s) can be knitted or woven onto the end edges in various configurations (e.g., as an overcast stitch, an overedge stitch, a zigzag stitch, etc.).

[0066] FIGS. 8A - 8B show an exemplary embodiment of a stapling assembly 800 that includes a staple cartridge 802 and a knitting auxiliary material 804 disposed on the upper or deck surface 803 of the staple cartridge 802. The staple cartridge 802 is similar to the staple cartridge 200 of FIGS. 1 - 2C, and thus common features are not described in detail herein.

[0067] In this illustrated embodiment, as shown in more detail in FIG. 8B, the auxiliary material 804 includes an upper layer 806 (e.g., a tissue contact layer) formed from at least a first fiber 808, a lower layer 810 (e.g., a cartridge contact layer) formed from at least a second fiber 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 looped multiple times around the first fiber 808 and around the second fiber 812. The portion of the spacer fibers 814 that extends between the upper layer 806 and the lower layer 810 forms an intermediate or core layer 816 of the auxiliary 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.

[0068] The upper layer 806 and the lower layer 810 can have various 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 in a first predetermined pattern and / or the second fibers 812 of the lower layer 810 can be knitted or woven in a second predetermined pattern. In certain embodiments, the first and second predetermined patterns can generally be the same (e.g., nominally the same within manufacturing tolerances), and in other embodiments, the first and second predetermined patterns can be different. The first fibers 808 and the second fibers 812 can be knitted or woven in various patterns, but in a particular embodiment, the first fibers 808 can be knitted in a first Raschel knitting pattern and the second fibers 812 can be knitted in a second Raschel knitting pattern that is the same as or different from the first Raschel knitting pattern. Further, in some embodiments, the fiber density of the upper layer 806 can be different from the fiber density of the lower layer 810. Those skilled in the art will understand that the first fibers 808 and the second fibers 812 can be knitted or woven randomly or repetitively within the upper layer 806 and the lower layer 810, respectively. Thus, for simplicity, the upper layer 806 and the lower layer 810 are generally shown, and thus the specific structural configurations of the upper layer 806 and the lower layer 810 are not limited to those shown in the figures.

[0069] The first fiber 808, the second fiber 812, and the spacer fiber 814 can have various configurations. For example, in some embodiments, the first fiber 808, the second fiber 812, and the spacer fiber 814 can be generally the same (e.g., nominally the same within manufacturing tolerances) in terms of material and / or structural configuration. In other embodiments, the first fiber 808 and the second fiber 812 can be generally the same (e.g., nominally the same within manufacturing tolerances) in terms of material and / or structural configuration relative to each other, and the spacer fiber 814 can be different from them. For example, in certain embodiments, the first fiber 808 and the second fiber 812 can be multifilament fibers, and the spacer fiber 814 can be a monofilament fiber. Thus, apart from the general overall shape, the specific structural configuration of each of the first fiber 808, the second fiber 812, and the spacer fiber 814 is not shown.

[0070] The auxiliary member 804 can have various configurations, but in the embodiment shown in FIG. 8B, the auxiliary member 804 includes an innermost segment 820 that includes the first fiber 808, the second fiber 812, and the spacer fiber 814, and on both sides (e.g., longitudinal sides) of the innermost segment 820, along the longitudinal axis L of the auxiliary member A positioned along (e.g., in the z-direction) the first outermost segment 822 and the second outermost segment 824. As a result, when the auxiliary member 804 is releasably coupled to the upper surface 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 upper surface 803, and the second outermost segment 824 is adjacent to and extends along the second outermost longitudinal edge 805b of the upper surface 803 of the cartridge 802.

[0071] The first outermost segment 822 and the second outermost segment 824 can have different structural configurations, but in this illustrated embodiment, the first outermost segment 822 and the second outermost segment 824 are generally the same (e.g., nominally the same within manufacturing tolerances). The first outermost segment 822 and the second outermost segment 824 each include only the first fiber 808 and the second fiber 812, and thus include only portions of the upper layer 806 and the lower layer 810. That is, in this illustrated embodiment, the spacer fibers 814 are not present within the first outermost segment 822 and the second outermost segment 824, and as a result, the mechanical behavior of the auxiliary material 804 can be mainly controlled by the innermost segment 820 and thus 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. Further, as shown, the first outermost segment 822 includes the first outermost longitudinal end edges 806a, 810a of the upper layer 806 and the lower layer 810, each of which includes a portion of the free ends of the first fiber 808 and the second fiber 812. Similarly, the second outermost segment 824 includes the second outermost longitudinal end edges 806b, 810b of the upper layer 806 and the lower layer 810, each of which includes a portion of the free ends of the first fiber 808 and the second fiber 812.

[0072] As shown in more detail in FIG. 8B, the portions of the upper layer 806 and the lower layer 810 within the innermost segment 820 extend parallel to each other (e.g., extend in the z direction) along the longitudinal axis L of the auxiliary material 804 A and are spaced apart from each other by a respective distance D. Similarly, the respective portions of the upper layer 806 and the lower layer 810 within the first outermost segment 822 and the second outermost segment 824 extend parallel to each other (e.g., extend in the z direction) along the longitudinal axis L of the auxiliary material 804 A and are spaced apart from each other by a respective distance D 1 、D 2are only separated. Therefore, the portions of the upper layer 806 and the lower layer 810 within the first outermost segment 822 at least partially overlap each other, and the portions of the upper layer 806 and the lower layer 810 within the second outermost segment 824 at least partially overlap each other. In certain embodiments, the distances D, D 1 , D 2 can all be the same or all different, and in this illustrated embodiment, the distance D is different from the distance D 1 and the distance D 2 , and the distances D 1 and the distance D 2 are generally the same (nominal same within manufacturing tolerances).

[0073] The difference between the distance D and the distances D 1 , D 2 is due to the tapered transition between the innermost segment 820 of the auxiliary member 804 and the first outermost segment 822 and the second outermost segment 824 via the first intermediate segment 826 and the second intermediate segment 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 intermediate segment 826 and the second intermediate segment 828 are tapered such that respective portions of the upper layer 806 extend at an angle with respect to respective portions of the lower layer 810. As shown, respective portions of the upper layer 806 extend toward respective portions of the lower layer 810 within the first intermediate segment 826 and the second intermediate segment 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 D 1 , D 2 between the portion of the upper layer 806 and the portion of the lower layer 810 of the first outermost segment and the second outermost segment, respectively. The distance D and the distances D 1 , D 2This relationship between them can enable the interconnection of one or more end edges of the upper layer 806 and the lower layer 810 using additional fiber(s) such as the first additional fiber 830 and the second additional fiber 832 without adversely affecting the overall mechanical behavior of the auxiliary material 804.

[0074] As further shown, the auxiliary material 804 includes a first additional fiber 830 (FIG. 8B) and a second additional fiber 832 (FIGS. 8A - 8B). The first additional fiber 830 and the second additional fiber 832 form respective first finished edges 834 and second finished edges 836, and each finished edge is configured to prevent fraying of the upper layer 806 and the lower layer 810 along it, and thus fraying and / or fiber separation of the first fiber 808 and the second fiber 812.

[0075] The first additional fiber 830 and the second additional fiber 832 can have various configurations. In some embodiments, the first additional fiber 830 and the second additional fiber 832 can be generally the same (nominal 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, 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, apart from the general overall shape, the specific structural configuration of the first additional fiber 830 and the second additional fiber 832 is not shown. Further, only one first additional fiber and one second additional fiber are shown in FIGS. 8A - 8B, but those 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) can be used to form the finished edges of the auxiliary material.

[0076] The first additional fiber 830 and the second additional fiber 832 can be incorporated into the auxiliary material 804 in various ways to form the first finished edge 834 and the second finished edge 836. In this 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 at least a portion of the first outermost longitudinal edge 838 of the auxiliary material 804 and thus defines it. 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 fiber 808, the second fiber 812, and the second additional fiber 832 and is positioned along at least a portion of the second outermost longitudinal edge 840 of the auxiliary material 804 and thus defines it. Accordingly, 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.

[0077] 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 in the form of loops (e.g., in a spiral or zigzag configuration) and are respectively wound around the first outermost longitudinal end edges 806a, 810a and the second outermost longitudinal end edges 806b, 810b. As a result, the free end portions of the first fiber 808 and the second fiber 812 at the first outermost longitudinal end edges 806a, 810a are fixed 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 806b, 810b are fixed 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 as other suitable stitch forms. Further, in certain embodiments, the first additional fiber 830 and the second additional fiber 832 can be configured as different stitch forms.

[0078] FIGS. 9A-9B show another exemplary embodiment of a knitting auxiliary material 900 having one or more finished edges formed by respective additional fibers. Except for the differences discussed below, the auxiliary material 900 is similar to the auxiliary material 804 of FIGS. 8A-8B, and thus the common features are not described in detail here.

[0079] The auxiliary material 900 includes an upper layer 906 (e.g., a tissue contact layer) formed from a first fiber 908, a lower layer 910 (e.g., a cartridge contact layer) formed from a second fiber 912, and spacer fibers 914 that intertwine with the upper layer 906 and the lower layer 910 and extend therebetween, thereby connecting the upper layer 906 and the lower layer 910 to each other. As shown in FIG. 9A, the upper layer 906 has at least two outermost longitudinal end edges 906a, 906b and at least two outermost transverse end edges 906c, 906d. The lower layer 910 has at least two outermost longitudinal end edges (only one outermost longitudinal end edge 910b is shown in FIG. 9A) and at least two outermost transverse end edges 910c, 910d.

[0080] In addition to the first outermost segment 915 and the second outermost segment 916 (see FIG. 9A) similar to the first outermost segment 822 and the second outermost segment 824 of FIGS. 8A-8B, the auxiliary material 900 includes a third outermost segment 918 and a fourth outermost segment 920 (see FIG. 9B). The third outermost segment 918 and the fourth outermost segment 920 are positioned on both sides (e.g., the transverse sides) of the innermost segment 922 and extend orthogonally (e.g., in the z direction) to the longitudinal axis L of the auxiliary material (e.g., extending in the z direction). Except for their positions within the auxiliary 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. A As shown in FIG. 9A, the upper layer 906 has at least two outermost longitudinal end edges 906a, 906b and at least two outermost transverse end edges 906c, 906d. The lower layer 910 has at least two outermost longitudinal end edges (only one outermost longitudinal end edge 910b is shown in FIG. 9A) and at least two outermost transverse end edges 910c, 910d.

[0081] Furthermore, in addition to the first intermediate segment 924 and the second intermediate segment 926 (see FIG. 9A) similar to the first intermediate segment 826 and the second intermediate segment 828 of FIGS. 8A-8B, the auxiliary member 900 includes a third intermediate segment 928 and a fourth intermediate segment 930 (see FIG. 9B). As shown, the third intermediate segment 928 extends from the innermost segment 922 to the third outermost segment 918, and the fourth intermediate segment 930 extends from the innermost segment 922 to the fourth outermost segment 920. Except for their positions within the auxiliary member 900, the third intermediate segment 928 and the fourth intermediate segment 930 are structurally similar to the first intermediate segment 924 and the second intermediate segment 926.

[0082] As further shown in FIGS. 9A-9B, the auxiliary member 900 includes first, second, third, and fourth additional fibers 932, 934, 936, 938, which respectively form first, second, third, and fourth finished edges 940, 942, 944, 946, and these finished edges are configured to prevent fraying of the upper layer 906 and the lower layer 910 along them, and thus fraying and / or fiber separation of the first fiber 908 and the second fiber 912. Each additional fiber 932, 934, 936, 938 can be incorporated into the auxiliary member in various ways to form their respective finished edges 940, 942, 944, 946. The first finished edge 940 and the second finished edge 942 are similar to the first finished edge 834 and the second finished edge 836 of FIGS. 8A-8B, and thus will not be described in detail here.

[0083] The third and fourth additional fibers 936, 938 can be incorporated into the auxiliary material 900 in various ways to form the third and fourth finished edges 944, 946. In this illustrated embodiment, the third additional fiber 936 interconnects the upper layer 906 and the lower 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 at least a portion of the first outermost lateral edge 948 of the auxiliary material 900 and thus defines it. The fourth additional fiber 938 interconnects the upper layer 906 and the lower layer 910 along their respective second outermost lateral end edges 906d, 910d to form the fourth finished edge 946. As a result, the fourth finished edge 946 is formed from the first fiber 908, the second fiber 912, and the fourth additional fiber 938 and is positioned along at least a portion of the second outermost lateral edge 950 of the auxiliary material 900 and thus defines it. 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 finished edges.

[0084] Furthermore, 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 each wound around the first outermost lateral end edges 906c, 910c and the second outermost lateral end edges 906d, 910d in the form of a loop (e.g., in a helical configuration). 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 fixed to each other 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 fixed to each other 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 forms. Furthermore, in certain embodiments, the third additional fiber 936 and the fourth additional fiber 938 can be configured as different stitch forms.

[0085] Alternatively, or additionally, the auxiliary member can include an innermost longitudinal end edge (s) (e.g., the first and second outermost longitudinal end edges 806a, 806b, 810a, 810b of FIGS. 8A-8B) relative to its outermost longitudinal end edge. In such embodiments, the auxiliary member can include additional fibers incorporated into the auxiliary member, and the finished edge (s) can also be formed along at least a portion of the innermost longitudinal end edge (s), and thus can define it. For example, the auxiliary member can include an innermost longitudinal end edge configured to bound a longitudinal slot such as the longitudinal slot 210 of FIGS. 2A-2C of the staple cartridge. In such embodiments, the auxiliary member can include at least one bridge element that extends between spaced portions of the auxiliary member (e.g., portions configured to be positioned on opposite sides of the longitudinal slot when the auxiliary member is coupled to the cartridge) and joins them together. In certain embodiments, the at least one bridge element can be designed to overlap at least a portion of the cutting line of the auxiliary member, and thus at least a portion of the longitudinal slot. As a result, the at least one bridge element is cut by the advancement of the cutting element through the longitudinal slot.

[0086] In some embodiments, at least one bridge element can include two or more bridge elements spaced apart from one another to provide separate attachment portions between portions of the auxiliary material. In embodiments configured such that such portions are positioned on opposite sides of a longitudinal slot of the cartridge, the separate attachment portions can reduce the amount of auxiliary material positioned within the forward path of the cutting element. This reduction in material can serve to minimize the resistance of the auxiliary material to the forward movement of the cutting element, and in particular, can improve the life of the cutting element and / or reduce the force required to advance the cutting element through the auxiliary material. In certain embodiments, at least one bridge element can be formed from at least a portion of at least one of an upper layer and a lower layer of the auxiliary material, while in other embodiments, 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 of the forward path of the cutting element, and thus, can continue to join portions of the auxiliary material after the cutting element has advanced through the longitudinal slot.

[0087] Figures 10A - 10D illustrate another exemplary embodiment of a stapling assembly 1000 having a staple cartridge 1002 and a braided auxiliary material 1004 disposed on the 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 thus common features are not described in detail herein. Further, except for the differences described below, the auxiliary material 1004 is similar to the auxiliary material 804 of FIGS. 8A - 8B and thus common features are not described in detail herein.

[0088] The auxiliary material 1004 can have various configurations. For example, in this illustrated embodiment, the auxiliary material 1004 includes a first longitudinal portion 1006 and a second longitudinal portion 1008, each having respective upper layers 1010, 1012 (e.g., tissue contact layers) formed from a first fiber 1014, lower layers 1016, 1018 (e.g., cartridge contact layers) formed from a second fiber 1020, and spacer fibers 1022 that intertwine with and extend between the respective upper layers 1010, 1012 and lower layers 1016, 1018, thereby connecting the upper layer and the lower layer. The upper layer and the lower layers 1010, 1012 have the same structure as the upper layer 806 and the lower layer 810 in FIGS. 8A-8B, and the spacer fibers 1022 are the same as the spacer fibers 814 in FIGS. 8A-8B, and thus the (comment) features of the comments are not described in detail here. Further, 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.

[0089] The first longitudinal portion 1006 and the second longitudinal portion 1008 can each include additional fibers configured to prevent fraying of their respective upper and lower layers 1010, 1012 therealong, and thus fraying and / or fiber separation of the first fibers 1014 and the second fibers 1020, and form respective finished edges. 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, 1028h, and the second longitudinal portion 1008 includes finished edges 1030a, 1030b, 1030c, 1030d, 1030e, 1030f, 1030g, 1030h. The first longitudinal portion 1006 and the second longitudinal portion 1008 are each shown as having eight additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h, and fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h, and thus are shown as having eight respective finished edges 1028a, 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, 1028h, 1030a, 1030b, 1030c, 1030d, 1030e, 1030f, 1030g, 1030h, but one of ordinary skill 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 auxiliary material is applied, and thus the first longitudinal portion 1006 and the second longitudinal portion 1008 are not limited to the number of additional fibers shown in the figures.

[0090] 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 (nominal within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimensions (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 is monofilament fiber and another portion is multifilament fiber. Thus, aside 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.

[0091] Furthermore, as shown, the additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h are similar in structure and stitch pattern to the additional fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h, and thus, for the sake of simplicity, the following description relates to the additional third fibers 1024a, 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h. However, those skilled in the art will understand that the following description is also applicable to the additional fourth fibers 1026a, 1026b, 1026c, 1026d, 1026e, 1026f, 1026g, 1026h.

[0092] 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 to interconnect the upper layer 1010 and the lower layer 1016 along their first outermost longitudinal end 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 at least a portion of the outermost longitudinal edge 1032 of the first longitudinal portion 1006 and thus defines it. Each of the remaining additional third fibers 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h is also configured as an overcast stitch to interconnect the upper layer 1010 and the lower layer 1016 along respective portions of the second outermost longitudinal end edges 1010b, 1014b of the upper layer 1010 and the lower layer 1016 to form respective separate finished edges 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, 1028h. As a result, each of the remaining finished edges 1028b, 1028c, 1028d, 1028e, 1028f, 1028g, 1028h is formed from the first fiber 1014, the second fiber 1020, and the respective additional third fibers 1024b, 1024c, 1024d, 1024e, 1024f, 1024g, 1024h and is positioned along respective portions of the innermost longitudinal edge 1034 of the first longitudinal portion 1006 and thus defines it.

[0093] As further shown, the auxiliary member 1004 includes bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, 1036f that extend between and connect the first longitudinal portion 1006 and the second longitudinal portion 1008 of the auxiliary member 1004 to each other. The auxiliary member 1004 is shown as having six bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, 1036f, but those skilled in the art will understand that the number and structural configuration of the bridge element(s) of the auxiliary member can depend at least on the size and shape of the staple cartridge and / or anvil to which the auxiliary member is applied, and / or the size and shape of the longitudinal slot (e.g., knife slot) within the cartridge, and thus the auxiliary member 1004 is not limited to the number and / or structural configuration of the bridge elements shown in the figures.

[0094] The bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, 1036f can have various configurations. For example, in the illustrated embodiment, distinct portions of the first fiber 1014 and the second fiber 1020 extend between the first longitudinal portion 1006 and the second longitudinal portion 1008, such that these portions function as the bridge elements 1036a, 1036b, 1036c, 1036d, 1036e, 1036f. Thereby, a central zone 1040 formed only from the first fiber 1014 and the second fiber 1020 is created within the auxiliary member. As a result, the amount of material along the cutting line of the auxiliary member is reduced compared to other portions of the auxiliary member. 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 auxiliary member).

[0095] As shown in FIGS. 10A - 10D, when the auxiliary member 1004 is releasably fixed to the cartridge 1002, the first longitudinal portion 1006 is positioned on the first side of the longitudinal slot 1007 of the cartridge 1002, and the second longitudinal portion 1008 is positioned on the second side opposite 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 upper 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 upper 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. Further, as shown in more detail in FIGS. 10B and 10D, the bridge element at least partially overlaps the longitudinal slot 1007 of the cartridge 1002.

[0096] Although not shown in FIGS. 10A - 10D, in certain embodiments, the auxiliary member may also include one or more attachment features configured to at least partially extend along the length of the auxiliary member (e.g., extend in the z - direction), engage the staple cartridge, and thereby hold the auxiliary member on the cartridge prior to staple deployment. The one or more attachment features can have various configurations. For example, the one or more attachment features can be a channel attachment configured to engage (e.g., press - fit or snap - fit) a longitudinal slot (e.g., a knife slot) formed between opposing longitudinal slot edges within the staple cartridge.

[0097] In other embodiments, instead of incorporating additional fiber(s) (e.g., additional fibers 830, 832 of FIGS. 8A - 8B) into the auxiliary material 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 of FIGS. 11A - 11B) can be intertwined with each other. 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 at least a portion of the existing fibers, e.g., along at least a portion around the auxiliary material, and thus fuse them. This can avoid the need for additional materials (e.g., additional fiber(s) other than the fibers required to form the upper layer, lower layer, and core layer of the auxiliary material), and thus, in particular, can reduce the overall material cost and / or manufacturing cost of the auxiliary material.

[0098] FIGS. 11A - 11B are one exemplary embodiment of a braiding 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 contact layer), a lower layer 1112 (e.g., a cartridge contact layer), and first fiber 1102, second fiber 1104, and spacer fiber 1106 intertwined to form at least one finished edge (only three finished edges 1114a, 1114b, 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. One of ordinary skill in the art will understand that the following description is applicable to the remaining first fibers, second fibers, and spacer fibers of the auxiliary material as well.

[0099] The first fiber 1102, the second fiber 1104, and the spacer fiber 1106 can have various configurations. For example, in some embodiments, the first fiber 1102, the second fiber 1104, and the spacer fiber 1106 can be generally the same (e.g., nominally the same within manufacturing tolerances) in terms of compositional configuration (e.g., formed from the same material(s)), dimensions (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 the same (e.g., nominally the same 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. Thus, apart from the general overall shape, the specific structural configuration of each of the first fiber 1102, the second fiber 1104, and the spacer fiber 1106 is not shown.

[0100] The upper layer 1110 and the lower layer 1112 can have various forms. As shown in more detail in FIG. 11B, the first fiber 1102 and the spacer fiber 1106 are intertwined to form the upper layer 1110, and the second fiber 1104 and the spacer fiber 1106 are intertwined to form the lower layer 1112. Thus, in this illustrated embodiment, the first fiber 1102 is not present in the lower layer 1112 and the second fiber 1104 is not present in the upper layer 1110. In other embodiments, at least a portion of the first fiber 1102 can be present within the lower layer 1112 and / or at least a portion of the second fiber 1104 can be present within the upper layer 1110.

[0101] In some embodiments, the first fibers 1102 of the upper layer 1110 and / or the second fibers 1104 of the lower layer 1112 can be knitted in respective predetermined patterns. In certain embodiments, the predetermined pattern of the first fibers 1102 within the upper layer 1110 and the predetermined pattern of the second fibers 1104 of the lower layer 1112 can generally be the same (e.g., nominally the same within manufacturing tolerances), although in other embodiments, the predetermined patterns can be different. The first fibers 1102 of the upper layer 1110 and the second fibers 1104 of the lower layer 1112 can each be knitted in various patterns, although in certain embodiments, the first fibers 1102 can be knitted in a first lace knitting pattern and the second fibers 1104 can be knitted in a second lace knitting pattern that is the same as or different from the first lace knitting pattern. Further, in some embodiments, the fiber density of the upper layer 1110 can be different from the fiber density of the lower layer 1112. Those skilled in the art will understand that the first fibers 1102 and the second fibers 1104 can be knitted or woven randomly or repetitively within the upper layer 1110 and the lower layer 1112, respectively. Thus, for simplicity, the upper layer 1110 and the lower layer 1112 are generally shown, and thus, the specific structural configurations of the upper layer 1110 and the lower layer 1112 are not limited to those shown in the figures.

[0102] The portions of the spacer fibers 1106 that extend between the upper layer 1110 and the lower layer 1112 can form an intermediate layer 1116 and are thus positioned between the upper layer 1110 and the lower layer 1112. These portions can have various configurations, although in this illustrated embodiment, as shown in FIG. 11B, they are arranged to form upstanding fibers 1118. The upstanding fibers 1118 can be configured to bend or compress in response to a force applied to the reinforcement 1100.

[0103] The upstanding fibers 1118 can have various orientations within the intermediate layer. For example, in some embodiments, as shown in FIG. 11B, the upstanding fibers 1118 generally have a columnar configuration, which means that they are generally oriented in adjacent columns. In other embodiments, the upstanding fibers 1118 can be inclined or skewed so as to advantageously act on a coherent crushing or buckling in a first direction in response to a force (forces) applied to the auxiliary material (e.g., a compressive force through a tissue (T) positioned against the upper layer 1110). Alternatively, the upstanding fibers 1118 can be inclined or skewed so as to advantageously act on a coherent crushing in a second direction opposite to the first direction in response to the applied force (forces). Alternatively, the upstanding fibers 1118 can include a first group of upstanding fibers that are inclined or skewed so as to advantageously act on buckling in the first direction and a second group of upstanding fibers that are inclined or skewed so as to advantageously act on buckling in the second direction.

[0104] As further shown in FIGS. 11A - 11B, the auxiliary material 1100 includes four finished edges (only three finished edges 1114a, 1114b, 1114c are shown), and each finished edge extends between the upper layer 1110 and the lower layer 1112. Further, one or more of the finished edges 1114a, 1114b, 1114c are at least partially positioned along the outer edge of the auxiliary material 1100 and can thus at least partially define its outer edge. For example, in this illustrated embodiment, the auxiliary material 1100 has four outermost edges (only three outermost edges 1120a, 1120b, 1120c), the first finished edge 1114a is positioned completely along the first outermost edge 1120a, the second finished edge 1114b is positioned completely along the second outermost edge 1120b, the third finished edge 1114c is positioned completely along the third outermost edge 1120c, and the fourth finished edge (hidden) is positioned completely along the fourth outermost edge (hidden). As a result, the four finished edges define the entire outermost perimeter of the auxiliary material 1100.

[0105] 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 this illustrated embodiment, each finished edge structurally resembles and includes respective portions of the first fiber, the second fiber, and the spacer fiber that are intertwined with each other. Only the first and second finished edges are shown in detail, but 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.

[0106] As shown in more detail in FIG. 11B, the first finished edge 1114a includes a first portion 1122a of the first fiber 1102 that is intertwined with a first portion 1124a of the second fiber 1104 and a first portion 1126a of the spacer fiber 1106. Additionally, the free ends 1128a of the first portion 1122a of the first fiber 1102, the free ends 1130a of the first portion 1124a of the second fiber 1104, and the free ends 1132a of the first portion 1126a of the spacer fiber 1106 can be joined to each other as shown in FIG. 11B. Similarly, as shown in FIG. 11B, the second finished edge 1114b includes a second portion 1122b of the first fiber 1102 that is intertwined with a second portion 1124b of the second fiber 1104 and a second portion 1126b of the spacer fiber 1106. Additionally, the free ends 1128b of the second portion 1122b of the first fiber 1102, the free ends 1130b of the second portion 1124b of the second fiber 1104, and the free ends 1132b of the second portion 1126b of the spacer fiber 1106 can be joined to each other as shown in FIG. 11B.

[0107] Although not shown, in certain embodiments, the auxiliary member 1100 may also include additional finished edge(s) configured to be positioned adjacent to and along each slot edge of longitudinal slots formed within a cartridge in which the auxiliary member is intended to be releasably attached. In such embodiments, for example, at least one additional finished edge can be formed from respective portions of the first fiber 1102, the second fiber 1104, and the spacer fiber 1106.

[0108] The auxiliary members 804, 900, 1004 of FIGS. 8A - 10D each include a finished edge formed by additional fibers, and the auxiliary member 1100 of FIGS. 11A - 11B includes a finished edge formed by existing fibers. However, in other embodiments, the auxiliary member can have a combination of different types of finished edges. For example, in certain embodiments, the auxiliary member can have at least one finished edge (e.g., the first finished edge 34 in FIG. 8B) formed by additional fiber(s) and at least one finished edge (e.g., the first finished edge 1114a in FIGS. 11A - 11B) formed by a portion of existing fibers otherwise present within the auxiliary member.

[0109] Alternatively, or additionally, the auxiliary member can include an absorbent film disposed over at least a portion of the surface facing the fabric of the outer layer and / or the inner layer. The absorbent film can substantially protect the fibers of the underlying layer(s). Without the absorbent film, the fibers would 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 auxiliary member. Further, the absorbent film can substantially prevent the fabric from prematurely separating the auxiliary member from the cartridge while the fabric slides across the auxiliary member. That is, the absorbent film can minimize the edge condition and thus reduce the friction that would otherwise be present on the fabric contact surface(s) of the auxiliary member.

[0110] The absorbent film can have various configurations. In some embodiments, the absorbent film can have a thickness of about 15 microns or less, for example, 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 various 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 lower layer) can be heated (e.g., above 85° C.) and then pressed against the film.

[0111] FIG. 12 shows an exemplary embodiment of a stapling assembly 1200 including a staple cartridge 1202 and a knitting aid 1204 disposed on the 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 thus the common features are not described in detail herein.

[0112] The auxiliary material 1204 includes a knitting structure 1206 having an absorbent film 1208 disposed on at least a portion thereof. The knitting 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, the lower layer 1212, and the core layer 1214 are similar to the upper layer 1110, the lower layer 1112, and the intermediate layer 1116 of FIGS. 11A-11B, and thus common features are not described herein. As shown, the absorbent film 1208 is disposed on the surface facing all the tissues of the knitting structure 1206. In this illustrated embodiment, the surface 1216 facing the upper tissue (e.g., extending in the YZ plane), the first longitudinal side surface 1218a (e.g., extending in the XZ plane), the second opposing longitudinal side surface 1218b, the first lateral side surface 1220a (e.g., extending in the XY plane), and the second opposing lateral side surface (which is blocked). In other embodiments, the absorbent film is not disposed on the surface facing all the tissues of the knitting structure, e.g., the first lateral side surface and / or the second lateral side surface.

[0113] Attachment features Generally, the knitting auxiliary material described herein is designed and positioned on a staple cartridge for use in a stapling procedure. When staples are fired (deployed) from the cartridge, the staples penetrate the auxiliary material and enter the tissue. Before the auxiliary material is penetrated by the staples, the auxiliary material may become detached or misaligned from the staple cartridge. That is, when the staple cartridge is in a fixed position, the auxiliary material may become detached by contacting 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 on the staple cartridge before 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.

[0114] As described above, the knitting aid is formed from fibers knitted or woven together. In certain embodiments, the aid can be designed such that one or more surface features can be formed within the aid. The one or more surface features are configured to substantially or fully align and secure the aid to the cartridge deck prior to staple deployment. As a result, the aid can be kept secured to the cartridge deck even when otherwise exposed to forces that would separate the aid from the cartridge deck prior to stapling the aid to tissue. The one or more surface features can also reduce the likelihood of misalignment of the aid prior to stapling as compared to conventional aids (e.g., aids having no one or more surface features).

[0115] The one or more surface features can be formed in a variety of ways. For example, in some embodiments, the surface features can be made within the aid after manufacture. For example, solvents, knitting operations, thermal operations, die-cutting operations, laser cutting operations, ultrasonic cutting operations, stamping or punching operations (e.g., mechanical presses), or combinations of these techniques can be used. In some embodiments, the surface features can be knitted into the bottommost layer of the aid (e.g., the cartridge contact layer). In other embodiments, the surface features can be thermoformed within the aid using a heated mold. Alternatively, or additionally, the surface features can be thermoformed within the aid by heating the staple cartridge and positioning the aid on the heated cartridge deck, whereby the aid conforms to the shape of the cartridge deck including any one or more attachment features (e.g., protrusions) of the cartridge deck.

[0116] 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 larger than the circumference (e.g., outer diameter) of one or more attachment features of the cartridge to form friction or press fit. In certain embodiments, one or more surface features can be dimensioned to receive two or more attachment features of the cartridge.

[0117] FIG. 13A shows a portion of another exemplary embodiment of a stapling assembly 1300 that includes a knitting aid 1302 disposed on the upper or deck surface 1306 of a staple cartridge 1304, and FIG. 13B shows the aid and cartridge before being releasably coupled to each other. The aid 1302 includes a first knitting layer 1308 (e.g., an upper layer or tissue contact layer) formed from at least a first fiber 1310, a second knitting layer 1312 (e.g., a lower layer or cartridge contact layer) formed from at least a second fiber 1314, and spacer fibers 1316 that intertwine between and extend between the first knitting layer 1308 and the second knitting layer 1312, thereby connecting the first knitting layer 1308 and the second knitting layer 1312 to each other. The portion of the spacer fibers 1316 that extends between the first knitting layer 1308 and the second knitting layer 1312 forms the core layer 1318 of the aid 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 aid.

[0118] In some embodiments, the first fibers 1310 of the first braided layer 1308 can be braided or woven in a first predetermined pattern and / or the second fibers 1314 of the second braided layer 1312 can be braided or woven in a second predetermined pattern. In certain embodiments, the first and second predetermined patterns can generally be the same (e.g., nominally the same 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 braided layer 1308 can be different from the fiber density of the second braided layer 1312. The first fibers 1310 and the second fibers 1314 can be braided or woven in various patterns, but in certain embodiments, the first fibers 1310 can be braided in a first basket weave pattern and the second fibers 1314 can be braided in a second basket weave pattern that is the same as or different from the first basket weave pattern. One of ordinary skill in the art will understand that the first fibers 1310 and the second fibers 1314 can be braided or woven randomly or repetitively within the first braided layer 1308 and the second braided layer 1312, respectively. Thus, for simplicity, the first braided layer 1308 and the second braided layer 1312 are generally illustrated, and thus, the specific structural configurations of the first braided layer 1308 and the second braided layer 1312 are not limited to those shown in the figures.

[0119] The first fiber 1310, the second fiber 1314, and the spacer fiber 1316 can have various configurations. For example, in some embodiments, the first fiber 1310, the second fiber 1314, and the spacer fiber 1316 can be generally the same (e.g., nominally the same within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimensions (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament), while in other embodiments, they can be different. In other embodiments, the first fiber 1310 and the second fiber 1314 can be generally the same (e.g., nominally the same within manufacturing tolerances), and the spacer fiber 1316 can be different. For example, in certain embodiments, the first fiber 1310 and the second fiber 1314 can be multifilament fibers, and the spacer fiber 1316 can be a monofilament fiber. Thus, aside from the general overall shape, the specific structural configuration of each of the first fiber 1310, the second fiber 1314, and the spacer fiber 1316 is not shown.

[0120] As further shown in FIG. 13B, the auxiliary material includes one or more surface features formed within the second braided layer 1312, which in the illustrated embodiment is in the form of recesses (only two recesses 1322a, 1322b are shown). The one or more recesses are configured to receive and engage respective attachment features of the cartridge 1304, as shown in FIG. 13A, which in the illustrated embodiment are in the form of protrusions 1324a, 1324b each extending outwardly from the upper or deck surface 1306 of the cartridge 1304. The recesses 1322a, 1322b can be formed by processing (e.g., melting or further braiding) a portion of the second fiber 1314 within the second braided layer 1312. In the illustrated embodiment, the perimeter of the recesses 1322a, 1322b is defined by a melted portion of the second fiber 1314.

[0121] The recesses 1322a, 1322b and the protrusions 1324a, 1324b can have various configurations. For example, in this illustrated embodiment, the recesses 1322a, 1322b have an inverted conical shape and thus have a varying diameter that decreases as the recesses 1322a, 1322b extend into the second knitting layer 1312. Thus, each recess 1322a, 1322b has a maximum diameter X 1a , X 2a to a minimum diameter X 1b , X 2b and extends. Further, the protrusions 1324a, 1324b have a conical shape with a varying diameter that decreases as the protrusions 1324a, 1324b extend outwardly from the upper surface or deck surface 1306. Thus, each protrusion 1324a, 1324b has a maximum diameter X 1c , X 1c to a minimum diameter X 2c , X 2d and extends. The recesses 1322a, 1322b and the protrusions 1324a, 1324b are illustrated as having complementary conical shapes, but those skilled in the art will understand that the recesses can have other complementary shapes such as square, semi - circular, triangular, etc. Further, the recesses 1322a, 1322b are illustrated as being generally uniform (e.g., uniform within manufacturing tolerances), but in other embodiments, at least a portion of the recesses can be different.

[0122] The maximum diameter X 1a , X 1b and the maximum diameter X 2a , X 2bThe difference between them can enable a friction fit to be formed between the recesses 1322a, 1322b and the protrusions 1324a, 1324b. In this illustrated embodiment, the maximum diameter of the recesses 1322a, 1322b is smaller than the maximum diameter of the protrusions 1324a, 1324b before engagement. As a result, an interference fit can be produced between the portions of the second fiber 1314 that contact the protrusions 1324a, 1324b. This frictional force can help to fix the auxiliary member 1302 to the staple cartridge 1304. In other embodiments, the maximum diameter of the recesses 1322a, 1322b can be larger than the maximum diameter of the protrusions 1324a, 1324b before engagement.

[0123] Furthermore, although not shown, the minimum diameter X of the recesses 1322a, 1322b within the auxiliary member 1302 1a , X 1b can be smaller than the diameter of the staple legs (e.g., the maximum diameter of the wire forming the staple legs) that are at least partially disposed within the staple cartridge 1304. As a result, when the auxiliary member 1302 is releasably connected to the cartridge 1304 and the recesses 1322a, 1322b are also configured to overlap with the staple cavities of the cartridge 1304 such as the staple cavities 212, 214 of FIGS. 2A-2C, the portions of the staple legs that extend beyond the upper surface or deck surface 1306 of the cartridge 1304 can also engage with the recesses of the auxiliary member 1302. Also, thereby, a friction fit occurs therebetween, and the auxiliary member can be further fixed to the staple cartridge before staple deployment.

[0124] As further shown in FIG. 13B, due to the spaced-apart arrangement of the recess 1322a and the recess 1322b in the second braided layer 1312, a protrusion 1326 having a maximum diameter D 1 is formed between the recess 1322a and the recess 1322b. In addition, due to the spaced-apart arrangement of the protrusion 1324a and the protrusion 1324b on the upper surface 1306 of the cartridge 1304, the maximum diameter D 2The complementary recess 1328 is formed between the protrusions 1326a and 1326b. As shown in FIG. 13A, when the auxiliary member 1302 is coupled to the cartridge 1304, the protrusion 1326 is received and engaged within the recess 1328. In this illustrated embodiment, the maximum diameter D of the protrusion 1326 1 is greater than the maximum diameter D of the recess 1328 before engagement 2 . As a result, this can create an additional interference fit between the auxiliary member 1302 and the cartridge 1304. Due to the difference in diameter, the second fiber 1314 around the recesses 1322a, 1322b will be pressed further towards and against the protrusions 1324a, 1324b (e.g., in the y direction), thereby increasing the friction between the recesses 1322a, 1322b and the protrusions 1324a, 1324b.

[0125] In certain embodiments, the recesses are formed in the second braided layer of the auxiliary member by thermoforming the second braided layer on a heated mold having mold features that are the inverse shape of the desired shape of the recesses. The mold features may have the same shape as the attachment features, but may be larger or smaller than the dimensions of the attachment features. When the mold features have dimensions smaller than the attachment features, this ensures a snug friction fit between the auxiliary member and the staple cartridge.

[0126] To form the recesses in the auxiliary member, the heated mold is heated to a specific temperature (e.g., above the glass transition temperature of the second fibers of the second braided layer), and then the auxiliary member is pressed onto, into, and / or against the heated mold. In some embodiments, the mold features can be the same or different compared to each other.

[0127] When engaged with the heated mold, the auxiliary material is formed or molded into the mold features of the heated mold, creating a recess within the second braided layer. The portion of the second braided 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 braided layer, the second braided layer retains the shape of the mold features. The recess is configured to allow for the gradual release of the auxiliary material from the staple cartridge. One advantage of the thermoformed recess can include, for example, having an auxiliary material with a more complex shape that fits precisely with the corresponding staple cartridge while maintaining a simpler manufacturing process. In certain embodiments, the cartridge deck and the mold features correspond to the shape of the attachment features of the staple cartridge.

[0128] In other embodiments, the thermoforming of the auxiliary material can be performed by heating the staple cartridge deck. The cartridge can be heated to a temperature that is higher than, equivalent to, or near the glass transition temperature of one or more materials of the lower layer of the auxiliary material (e.g., the cartridge contact layer). Next, the auxiliary material can be placed over the staple cartridge and the staples disposed therein and pressed down. Since the auxiliary material is heated to a temperature that is higher than, equivalent to, or slightly lower than the glass transition temperature of the material from which the auxiliary material is formed, the auxiliary material can take on a new permanent shape around the attachment features of the staple cartridge and / or around any of the staple legs extending from the upper surface of the cartridge.

[0129] For example, the staple cartridge can include a protrusion extending from the cartridge deck, and when the auxiliary material is pressed against the heated cartridge deck and attachment features, the auxiliary material can be permanently deformed around the attachment features. In such a case, the auxiliary material firmly grips the attachment features until the auxiliary material is pushed out from the attachment features by staples. Similarly, the auxiliary material can be permanently deformed to surround the heated staple legs and can firmly support the heated staple legs. In one embodiment, the minimum diameter of the newly formed recess in the auxiliary material may be smaller than the diameter of the staple legs. During the recess formation process, pressure is applied to the auxiliary material until the temperature of the staple cartridge, staples, and / or auxiliary material is well below or at least below the glass transition temperature of the material including the auxiliary material. Alternatively, the pressure can be removed when the temperature of the stapling assembly is above the glass transition temperature of the material constituting the auxiliary material.

[0130] In other embodiments, the auxiliary material can include knitted recesses configured to receive and engage one or more attachment features of the staple cartridge. For example, when the auxiliary material is knitted, portions of the second fibers of the second knitted layer can be knitted to define around the recesses in the second knitted layer. Alternatively, or additionally, additional fibers can be incorporated into the lower layer to at least partially define around the recesses.

[0131] Fiber interconnectivity and auxiliary material compressibility The auxiliary material is stapled to the tissue under various stapling conditions (e.g., tissue thickness, height of the formed staple, tissue internal pressure). Depending on the stapling state, an effective amount of stress can be determined that is necessary for the auxiliary material to be applied to the tissue to prevent the tissue from tearing or leaking. For example, in one embodiment, the effective amount of stress is at least about 3 gf / mm 2It is. In order for the auxiliary material to apply an effective amount of stress to the tissue, the auxiliary material can be designed to effectively compensate for various stapling conditions. Therefore, the auxiliary material can be adjusted to take different compression heights when stapled to the tissue.

[0132] Therefore, the compressibility profile of the auxiliary material can be controlled by at least the structural composition of the fibers and the interconnectivity between the fibers. As a result, by adjusting the structural composition of the fibers, an auxiliary material with desirable mechanical properties for stapling the tissue can be realized. Due to the finite range of the tissue pressure, the tissue thickness, and the formed staple height, over a range of stapling conditions, for a given time (e.g., at least 3 days), when the auxiliary material is stapled to the tissue, a substantially continuous desired stress (e.g., 3 gf / mm 2 ) can be effectively applied to the tissue. That is, as described in more detail below, the present auxiliary material is formed of a compressible material and is geometrically configured such that the auxiliary material can be compressed to various heights of a predetermined plane when stapled to the tissue. Further, since the auxiliary material can respond differently in this way, even when exposed to fluctuations in tissue pressure (e.g., blood pressure spikes) that can occur when the auxiliary material is stapled to the tissue, the auxiliary material can be enabled to continue to apply a continuous desired stress to the tissue.

[0133] 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 the first interconnecting portion and with the second fibers at the second interconnecting portion. Thereby, the portion of the spacer fibers extending between the upper layer and the lower layer forms an intermediate layer of the auxiliary material. These portions can have various configurations, but these portions can be arranged to form standing fibers. The standing fibers can be configured to bend or compress in response to the forces applied to the auxiliary material. As a result, the way the spacer fibers interact with the first and second fibers (e.g., the first and second interconnecting portions) can at least partially control the rigidity or the ability to bend under compression of the standing fibers, which in turn can at least partially control the overall compressibility of the auxiliary material. Thus, in some embodiments, the number, position, and tightness of the interconnecting portions can be varied through the lateral, longitudinal, or thickness of the auxiliary material to achieve different rigidities within the auxiliary material.

[0134] In some embodiments, the first and second interconnecting portions can be generally the same (e.g., nominally the same within manufacturing tolerances), but in other embodiments, the first interconnecting portion and the second interconnecting portion can be different. The first and second interconnecting portions can have various configurations. For example, in some embodiments, the first interconnecting portion and / or the second interconnecting portion can be a single-loop knot. In other embodiments, the first interconnecting portion and / or the second interconnecting portion can be a multi-loop knot, as shown, for example, in FIGS. 14A - 17B. In certain embodiments, the first interconnecting portion can be a single-loop knot and the second interconnecting portion can be a multi-loop knot (see FIG. 20).

[0135] The first interconnecting part and / or the second interconnecting part can be in the form of any suitable knot type. Depending on the type of knot used, it may affect the rigidity of the intermediate layer and thus the compression behavior of the auxiliary material. For example, if a loose knot is used, the intermediate layer can have a lower rigidity or a lower elastic modulus. Alternatively, if a tight knot is used, the intermediate layer can have a higher rigidity or a higher elastic modulus. The intermediate layer can utilize any suitable type of knot.

[0136] Figures 14A - 14B show another exemplary embodiment of a knitting auxiliary material 1400 including a first fiber 1402, a second fiber 1404, and a spacer fiber 1406. For simplicity, only one first fiber 1402, one second fiber 1404, and one spacer fiber 1406 are shown. Those skilled in the art will understand that the following description is applicable to the remaining first fibers, second fibers, and spacer fibers of the auxiliary material.

[0137] The spacer fiber 1406 and the first fiber 1402 are interconnected at a first interconnecting part 1408 to form an upper layer 1410. The spacer fiber 1406 and the second fiber 1404 are interconnected at a second interconnecting part 1412 to form a lower layer 1414. The first interconnecting part 1408 and the second interconnecting part 1412 can have various forms. For example, as shown, the first interconnecting part 1408 is in the form of a first knot having spacer fibers 1406 looped multiple times around the first fiber 1402, and the second interconnecting part 1412 is each in the form of a second knot having spacer fibers 1406 looped multiple times around the second fiber 1404. The first knot 1408 and the second knot 1412 are shown to be structurally similar, but in other embodiments, the first knot and the second knot can be different. Further, as will be described in more detail below, the first knot 1408 and the second knot 1412 are schematically shown as having a loose knot configuration.

[0138] Furthermore, the portions of the spacer fibers 1406 that extend between the upper layer 1410 and the lower layer 1414 form an intermediate layer 1418 positioned between the upper layer 1410 and the lower layer 1414. These portions can have various configurations, but in this illustrated embodiment, they are arranged to form upright fibers 1416. The upright fibers 1416 can have various orientations within the intermediate layer 1418 and, for example, as shown, are generally in a columnar configuration, which means that they are generally oriented in adjacent columns. The upright fibers 1416 can be configured to bend or compress in response to a force applied to the reinforcement 1400, as schematically shown in FIG. 14B.

[0139] As shown in FIG. 14B, when a given force F is applied to the reinforcement 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 upright fibers 1416 slide, moving the upper layer 1410 towards the lower layer 1414. As a result, the reinforcement 1400 is compressed from an uncompressed state (FIG. 14A) having an uncompressed height H 1 to a first compressed state (FIG. 14B) having a first compressed height H 2 . Thus, under a given force, the sliding of the spacer fibers 1406, and thus the upright fibers 1416, mainly achieves the compression of the reinforcement 1400 from the uncompressed height H to the first compressed height H 2 .

[0140] In some embodiments, for example, as shown in FIGS. 15A - 15B, a denser knot is used to interconnect the spacer fibers with the first and second fibers, thereby increasing the rigidity of the upright fibers and thus the rigidity of the reinforcement. The reinforcement 1500 is similar to the reinforcement 1400 of FIGS. 14A - 14B except that the first knot 1508 and the second knot 1512 have a denser knot configuration, and thus the common features are not described in detail here.

[0141] As shown in FIG. 15B, when a given force F is applied to the auxiliary member 1500 (e.g., in the x direction), due to the denser configuration of the knots 1508, 1512, the spacer fibers 1506 are suppressed from sliding along the first fiber 1502 and the second fiber 1504, and thus the upright fibers 1516 are prevented from sliding respectively. Thereby, rigidity is imparted to the upright fibers 1516, and thereby their rigidity is enhanced. As a result, the upright fibers 1516 are more rigid compared to the upright fibers 1416 in FIGS. 14A - 14B, and thus, this results in an auxiliary member 1500 that is more rigid when compared to the auxiliary member 1400 in FIGS. 14A - 14B. For example, when the same amount of force is applied to the auxiliary member 1500, the auxiliary member 1500 has an uncompressed height H 1 similar to the uncompressed height H 3 in the uncompressed state (FIG. 14A) and is compressed from the uncompressed state to a second compressed state (FIG. 14B) having a second compressed height H 2 greater than the first compressed height H 4 of the auxiliary member 1400. This shows the influence that the tightness of the knots can have on the compression of the auxiliary member.

[0142] Similarly, the tightness of the knots can impart partial rigidity to thinner spacer fibers, and thus can enhance the overall rigidity of an auxiliary member such as the auxiliary member 1600 in FIGS. 16A - 16C. The auxiliary member 1600 is similar to the auxiliary member 1500 in FIGS. 15A - 15B except that the spacer fibers 1606 are thinner compared to the spacer fibers 1506.

[0143] In some embodiments, the intermediate layer of the auxiliary material can include reinforcing fibers interconnected with the upright fibers, which can further enhance the rigidity of the auxiliary material, for example, as shown in FIGS. 17A-17B. The auxiliary material 1700 is similar to the auxiliary material 1500 of FIGS. 15A-15B, except that the upright fibers 1716 loop multiple times around the reinforcing fibers 1720 at the third interconnecting portion 1722, and each of the reinforcing fibers 1720 extends into the middle of the intermediate layer 1718 (e.g., extends in the y direction). As a result, for a given amount of force F, as shown in FIG. 17B, the auxiliary material 1700 has an uncompressed height H 3 similar to the uncompressed height H 5 of the uncompressed state (FIG. 17A), and is compressed from the uncompressed state to a second compressed state (FIG. 17B) having a third compressed height H 4 greater than the second compressed height H 6 of the auxiliary material 1500.

[0144] FIGS. 18A-18B show another exemplary embodiment of the knitting auxiliary material 1800. The auxiliary material 1800 includes a layer 1802 formed from at least a first fiber 1808 and a core layer formed from spacer fibers 1804 that intertwine with and extend from the layer 1802. The layer 1802 can be the upper layer (e.g., the tissue contact layer) or the lower layer (e.g., the cartridge contact layer) of the auxiliary material 1800, and a portion of the spacer fibers 1804 forms a core layer disposed between the upper layer and the lower layer. In this exemplary embodiment, the portion of the spacer fibers 1804 that forms the core layer generally extends between the upper layer and the lower layer in a columnar configuration, which means that they are generally oriented in adjacent columns. For simplicity, only a portion of the first fiber 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.

[0145] As shown in FIGS. 18A - 18B, the spacer fibers 1804 extend outwardly from the layer 1802 along the central axis CA. The layer 1802 includes reinforcing fibers 1806 that are coupled to the spacer fibers 1804 and the first fibers 1808. The knots of the reinforcing fibers 1806 can limit the lateral movement LM of the spacer fibers 1804 from the central axis CA of each spacer fiber 1804. This interaction between the spacer fibers 1804 and the reinforcing fibers 1806 affects the rigidity of the auxiliary material 1800. Since the spacer fibers 1804 have a limited lateral movement LM, the spacer fibers 1804 have a limited deformation ability when the auxiliary material 1800 is compressed.

[0146] FIGS. 19A - 19B show another exemplary embodiment of the braided auxiliary material 1900. The auxiliary material 1900 can be disposed on the upper surface or deck surface of the staple cartridge. The auxiliary material 1900 includes a layer 1902 formed from at least the first fibers 1908 and a core layer formed from spacer fibers 1904 that intertwine with and extend from the layer 1902. The layer 1902 can be the upper layer (e.g., the tissue contact layer) or the lower layer (e.g., the cartridge contact layer) of the auxiliary material 1900, and the spacer fibers 1904 form a core layer disposed between the upper layer and the lower layer. In the illustrated embodiment, the portions of the spacer fibers 1904 that form the core layer generally extend between the upper layer and the lower layer in a columnar configuration, which means that they are generally oriented in adjacent columns. For simplicity, only a portion 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.

[0147] As shown in FIGS. 19A - 19B, the spacer fibers 1904 extend outwardly from the layer 1902 along the central axis CA. The layer 1902 does not contain any reinforcing fibers in contact with the spacer fibers 1904. Due to the absence of reinforcing fibers, the spacer fibers have less restriction on the lateral movement LM from the central axis CA of each spacer fiber 1904 when compared with 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 rigidity of the auxiliary material 1900. Since the spacer fibers 1904 have an extended lateral movement LM, the spacer fibers 1904 have a greater deformation ability when the auxiliary material 1900 is compressed compared to the auxiliary material 1800 of FIG. 18A.

[0148] FIG. 20 shows another exemplary embodiment of the knitting auxiliary material 2000. The auxiliary material 2000 includes an upper layer 2002 (e.g., tissue contact layer) formed from at least first fibers 2008, a lower layer 2004 (e.g., cartridge contact layer) formed from at least second fibers 2012 and third fibers 2014, and spacer fibers 2016 that intertwine with and extend 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 that extends 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.

[0149] The upper layer 2002 and the lower layer 2004 can have various forms. For example, as shown in FIG. 20, the lower layer 2004 has a fiber density higher than that of the upper layer 2002. In other embodiments, the upper layer 2002 can have a higher fiber density than the lower layer 2004. In some embodiments, the first fibers 2008 of the upper layer 2002 can be knitted or woven in a first predetermined pattern, and / or the second fibers 2012 and the third fibers 2014 of the lower layer 2004 can be knitted or woven in a second predetermined pattern. In certain embodiments, the first and second predetermined patterns can generally be the same (e.g., nominally the same within manufacturing tolerances), but in other embodiments, the first and second predetermined patterns can be different. One of ordinary skill in the art will understand that the first fibers 2008 as well as the second fibers 2012 and the third fibers 2014 can be knitted or woven randomly or repeatedly within the upper layer 2002 and the lower layer 2004, respectively. Thus, for simplicity, the upper layer 2002 and the lower layer 2004 are generally shown, and thus, the specific structural configurations of the upper layer 2002 and the lower layer 2004 are not limited to those shown in the figures.

[0150] The first fiber 2008, the second fiber 2012, the third fiber 2014, and the spacer fiber 2016 can have various configurations. For example, in some embodiments, the first fiber 2008, the second fiber 2012, the third fiber 2014, and the spacer fiber 2016 can be generally the same (e.g., nominally the same within manufacturing tolerances) in terms of material and / or structural configuration. In other embodiments, the first fiber 2008, the second fiber 2012, and the third fiber 2014 can be generally the same (e.g., nominally the same within manufacturing tolerances) in terms of material and / or structural configuration relative to each other, and the spacer fiber 2016 can be different from them. For example, in certain embodiments, the first fiber 2008, the second fiber 2012, and the third fiber 2014 can be multifilament fibers, and the spacer fiber 2016 can be a monofilament fiber. Thus, apart from the general overall shape, the specific structural configuration of each of the first fiber 2008, the second fiber 2012, the third fiber 2014, and the spacer fiber 2016 is not shown.

[0151] In certain embodiments, the first fiber 2008 can be formed from a low-friction fiber (e.g., a monofilament fiber) that is knitted or woven to achieve a substantially smooth pattern to help hold the auxiliary material 2000 on the upper surface or deck surface of the cartridge when the tissue slides across the auxiliary material 2000, for example, when the auxiliary material 2000 is disposed at the staple attachment site. Thus, by employing low-friction fibers within the upper layer of the auxiliary material (e.g., the tissue contact layer), the friction that would otherwise occur between the tissue and the auxiliary material when the tissue slides across the auxiliary material before staple deployment can be minimized.

[0152] As further shown, the lower layer 2004 can include a fourth fiber 2019 configured to increase the friction between the auxiliary material 2000 and the upper surface or deck surface of the cartridge. This can serve to hold the auxiliary material 2000 to the cartridge prior to staple deployment. The fourth fiber 2019 can have various configurations. For example, in some embodiments, the fourth fiber can be a multifilament fiber. Thus, apart from the general overall shape, the specific structural configuration of the fourth fiber 2019 is not shown. Further, for simplicity, only one fourth fiber 2019 is illustrated.

[0153] The spacer fibers 2016 are interconnected within the first fiber 2008 at the first interconnect 2018 and the second interconnect 2022 in the upper layer 2002, and the spacer fibers 2016 are interconnected with at least the second fiber 2012 and the third fiber 2014 at the third interconnect 2020 and the fourth interconnect 2024 in the lower layer 2004. Thus, the interaction between this upper layer 2002 and the lower layer 2004, along with the interaction with the core layer 2006, secures the upper layer 2002 to the lower layer 2004. Further, the portion of the spacer fibers forming the core layer 2006 is arranged to form upstanding fibers 2026. The upstanding fibers 2026 can have various orientations within the core layer 2006 and, for example, as illustrated, are generally in a columnar configuration, which means they are generally oriented in adjacent columns. The upstanding fibers 2026 can be configured to bend or compress in response to a force applied to the auxiliary material 2000.

[0154] As shown in FIG. 20, the interconnecting portions 2018, 2020, and 2022, 2024 can be the same between the upper layer 2002 and the lower layer 2004. The interconnecting portions 2018, 2020 are shown as tight knots, with the spacer fiber 2016 wound around the first fiber 2008 of the upper layer 2002 multiple times and simultaneously around the second fiber 2012 and the third fiber 2014 of the lower layer 2004. In some embodiments, the interconnecting portions 2018, 2020 are shown as tight knots formed by winding the spacer fiber 2016 around the first fiber 2008, the second fiber 2012, and the third fiber 2014, but other types of tight knots for the interconnecting portions 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.

[0155] In addition, the interconnecting portions 2022, 2024 are shown as loose knots, with the spacer fiber 2016 passing through the first fiber 2008 of the upper layer 2002 only once and simultaneously passing through the second fiber 2012 and the third fiber 2014 of the lower layer 2004 only once. In some embodiments, the interconnecting portions 2022, 2024 are shown as loose knots formed by winding the spacer fiber 2016 around the first fiber 2008, the second fiber 2012, and the third fiber 2014, but other types of loose knots for the interconnecting portions 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.

[0156] Because there are 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 fiber, each compression zone can have a different rigidity when compressed. This is because when the auxiliary material 2000 is compressed, the interconnects 2018, 2020 inhibit the spacer fibers 2016 from sliding along the first fiber 2008, the second fiber 2012, and the third fiber 2014, whereas in contrast, the interconnects 2022, 2024 allow the spacer fibers 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 rigidity such that the auxiliary material 2000 can have a variable compression strength, e.g., along its width (e.g., in the y direction).

[0157] In certain embodiments, the spacer fibers can interact with at least a portion of the remaining fibers of a lower layer (e.g., the cartridge contact layer) of the auxiliary material such that when the auxiliary material is compressed, the spacer fibers can extend beyond the remaining fibers (e.g., in the form of loops). Alternatively or additionally, the spacer fibers can interact with at least a portion of the remaining fibers of an upper layer (e.g., the tissue contact layer) of the auxiliary material such that when the auxiliary material is compressed, the spacer fibers can extend beyond the remaining fibers (e.g., in the form of loops).

[0158] In addition to fiber connectivity, the overall compression behavior of the auxiliary material can depend, at least in part, on the type of spacer fibers incorporated therein. Thus, the desired compression 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 dimensions (e.g., diameter), and / or a particular compositional configuration (e.g., a first polymeric material having a low modulus of elasticity, a second polymeric material having a high modulus of elasticity, or a blend of two or more polymeric materials). Further, the compression 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).

[0159] 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., a first spacer fiber) can be selected to create a first compression zone, and a second type of spacer fiber different from the first type of spacer fiber (e.g., a second spacer fiber) can be selected to create a second compression zone. The first type of fiber can be different 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 different from the second compression strength. As a result, the auxiliary material has varying compression strengths.

[0160] For example, the first compression zone can have a greater compression strength than the second compression zone, and thus, the first compression zone can be more rigid. In use, the first compression zone can at least partially overlap a longitudinal slot formed within a cartridge configured to receive a cutting member, and the second compression zone can at least partially overlap a staple cavity defined within the cartridge. Such an arrangement can promote cutting of the auxiliary material while providing compensation characteristics for the desired tissue thickness within the staple that captures the auxiliary material against the tissue. In certain instances, the second compression can also at least partially overlap one or more portions of the longitudinal slot. In one embodiment, the second compression zone can be the zone closest to the start and / or end of the longitudinal slot.

[0161] Figures 21A-21B illustrate exemplary embodiments of an auxiliary braid 2100 having two different types of spacer fibers. The auxiliary braid 2100 includes first fibers 2102, second fibers 2104, first spacer fibers 2106, and second different spacer fibers 2108 that are intertwined to form an upper layer 2110 (e.g., a tissue contact layer), a lower layer 2112 (e.g., a cartridge contact layer), and an intermediate 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 of the intermediate layer 2114 (represented as the dotted box 2114a) and define a first compression zone of the auxiliary braid 2100. The second spacer fibers 2108 are concentrated within the remaining portion of the intermediate layer 2114 and define a second compression zone within the auxiliary braid 2100.

[0162] The first fiber 2102, the second fiber 2104, the first spacer fiber 2106, and the second spacer fiber 2108 can have various configurations. For example, in some embodiments, the first fiber 2102 and the second fiber 2104 can be generally the same (e.g., nominally the same within manufacturing tolerances) in compositional configuration (e.g., formed from the same material(s)), dimensions (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament). In other embodiments, the first fiber 2102 and the second fiber 2104 can be different. Further, the first fiber and / or the second fiber can be the same as the first spacer fiber or the second spacer fiber. In some embodiments, the first fiber 2102, the second fiber 2104, the first spacer fiber 2106, and / or the second spacer fiber 2108 can be monofilament fibers. In other embodiments, the first fiber 2102, the second fiber 2104, the first spacer fiber 2106, and / or the second spacer fiber 2108 can be monofilament fibers. In certain embodiments, the first fiber 2102, the second fiber 2104, and the first spacer fiber 2106 can be monofilament fibers, and the second spacer fiber 2108 can be a multifilament fiber. Thus, apart from the general overall shape, the specific structural configurations of the first fiber 2102, the second fiber 2104, the first spacer fiber 2106, and the second spacer fiber 2108 are not shown.

[0163] In some embodiments, the first fibers 2102 of the upper layer 2110 and / or the second fibers 2104 of the lower layer 2112 can be knitted in respective predetermined patterns. In certain embodiments, the predetermined pattern of the first fibers 2102 within the upper layer 2110 and the predetermined pattern of the second fibers 2104 of the lower layer 2112 can generally be the same (e.g., nominally the same within manufacturing tolerances), although in other embodiments, the predetermined patterns can be different. Further, in some embodiments, the fiber density of the upper layer 2110 can be different from the fiber density of the lower layer 2112. The first fibers 2102 of the upper layer 2110 and the second fibers 2104 of the lower layer 2112 can each be knitted in various patterns, although in certain embodiments, the first fibers 2102 can be knitted in a first Raschel knitting pattern and the second fibers 2104 can be knitted in a second Raschel knitting pattern that is the same as or different from the first Rachel knitting pattern. One of ordinary skill in the art will understand that the first fibers 2102 and the second fibers 2104 can be knitted or woven randomly or repetitively within the upper layer 2110 and the lower layer 2112, respectively. Thus, for simplicity, the upper layer 2110 and the lower layer 2112 are generally shown, and thus, the specific structural configurations of the upper layer 2110 and the lower layer 2112 are not limited to those shown in the figures.

[0164] As shown in FIGS. 21A - 21B, portions of the first spacer fibers 2106 and the second spacer fibers 2108 that extend between the upper layer 2110 and the lower layer 2112 form an intermediate layer 2114. These portions can have various configurations, although in this illustrated embodiment, they are generally arranged in a columnar configuration, i.e., they are generally oriented in adjacent columns. Thus, the compression behavior of the reinforcement 2100 can be primarily driven by the buckling characteristics of the first spacer fibers 2106 and the second spacer fibers 2108.

[0165] As further shown, the first compression zone 2114a is completely bounded by the second compression zone, and thus, the intended cut line C of the reinforcement 2100L extends across the first and second compression zones and along the longitudinal axis L of the auxiliary member 2100 A is defined. In this illustrated embodiment, most of the intended cut line C L is defined by the first compression zone 2114a and can thus be configured to be more rigid and thus exhibit higher resistance to compression compared to the second compression zone. For example, the first spacer fiber 2106 can be a monofilament fiber and the second spacer fiber 2108 can be a multifilament fiber. Thus, the resulting auxiliary member 2100 can have variable compressive strength in a direction transverse (e.g., the y-direction) to the cut line C of the auxiliary member 2100. Further, the start and end of the cut line CL are defined by the second compression zone and can thus facilitate the cutting of the auxiliary member 2100. L In some embodiments, the lower 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 various configurations, but in this illustrated embodiment, the one or more additional fibers form loops (e.g., traction loops) that provide a traction force against the upper surface or deck surface of the cartridge and thereby help hold the auxiliary member to the cartridge prior to staple deployment and are interconnected within the lower layer 2112. Alternatively, or additionally, the one or more additional fibers 2116 can be incorporated into the auxiliary member for the purpose of thermoforming or bonding the auxiliary member 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 first and second additional fibers, the first additional fiber being different from the second additional fiber in compositional configuration (e.g., formed from the same material(s)), dimensions (e.g., height and / or diameter), and / or structural configuration (e.g., monofilament or multifilament).

[0166] ​

[0167] The devices disclosed herein can be designed to be discarded after a single use or can be designed for multiple uses. However, in either case, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of a disassembly step of the device, followed by a cleaning step or a replacement step of specific parts, and a subsequent reassembly step. Specifically, the device can be disassembled, and any number of specific parts or portions of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, the device can be reassembled either at a reconditioning facility for later use or by the surgical team immediately prior to a surgical procedure. One of ordinary skill in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly can be utilized for reconditioning the device. The use of such techniques and the resulting reconditioned device are all within the scope of this application.

[0168] Furthermore, in the present disclosure, components with the same name in the embodiments generally have similar characteristics, and thus, in a particular embodiment, each characteristic of each component with the same name is not necessarily described in complete detail. Additionally, to the extent that linear dimensions or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in combination with such systems, devices, and methods. One of ordinary skill in the art will recognize that dimensions corresponding 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, can depend at least on the anatomical structure of the subject within which the systems and devices are used, the size and shape of the components with which the systems and devices are used, and the methods and procedures in which the systems and devices are used.

[0169] 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 "front" and "back" similarly correspond to distal and proximal, respectively. For convenience and to clarify the description, it will further be understood that 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 or absolute.

[0170] Values or ranges can be expressed herein as "about" and / or from one particular value to another particular value. When values or ranges are expressed in that manner, other disclosed embodiments include the recited particular values and / or from one particular value to another particular value. Similarly, when a value is expressed in approximate form by use of the preceding "about", it will be understood that many values are recited and other embodiments are formed by that particular value. It will further be understood that many values are disclosed and each value is disclosed herein as a value with "about" in addition to that 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.

[0171] For purposes of explaining and defining the present teachings, note that unless otherwise specified, the term "substantially" is used herein to represent the degree of inherent uncertainty that may be attributable to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to represent the degree to which a quantitative representation may vary from the stated reference without causing a change in the basic function of the subject matter in question.

[0172] Those skilled in the art will recognize additional features and advantages of the present invention based on the embodiments described above. Accordingly, the present invention is not limited to the specifically shown and described content, except as indicated by the appended claims. All publications and references cited herein are hereby expressly incorporated by reference in their entirety. Any patent, publication, or information that is incorporated by reference in whole or in part herein is incorporated only to the extent that the incorporated material does not conflict with the existing definitions, descriptions, or other disclosure material set forth in this document. Accordingly, the disclosure expressly set forth herein shall supersede any conflicting documents incorporated herein by reference.

[0173] 〔Embodiment〕 (1) A staple fastening assembly for use with a surgical stapler, comprising: a cartridge having a plurality of staples disposed therein, the plurality of staples being configured to be deployed within tissue; and a knitting auxiliary member configured to be releasably held on the cartridge, the auxiliary member being attachable to tissue by the plurality of staples within the cartridge, the auxiliary member including a first fiber, a second fiber, and spacer fibers, the first fiber and the spacer fibers being intertwined to form an upper layer of the auxiliary member, the second fiber and the spacer fibers being intertwined to form a lower layer of the auxiliary member, the first fiber, the second fiber, and the spacer fibers being intertwined to form at least one finished edge extending between the upper layer and the lower layer, the at least one finished edge substantially preventing fraying. (2) The staple fastening assembly according to Embodiment 1, wherein the spacer fibers extend from the upper layer to the lower layer to form an intermediate layer between the upper layer and the lower layer. (3) The staple fastening assembly according to Embodiment 2, wherein only the spacer fibers are present in the intermediate layer. (4) The staple retaining assembly according to Embodiment 1, wherein the spacer fibers are intertwined with the first fibers in a repeating pattern within the upper layer. (5) The staple retaining assembly according to Embodiment 1, wherein the spacer fibers are intertwined with the second fibers in a repeating pattern within the lower layer.

[0174] (6) The staple retaining assembly according to Embodiment 1, wherein at least one of the first fiber and the second fiber is a multifilament fiber. (7) The staple retaining assembly according to Embodiment 1, wherein the spacer fibers are monofilament fibers. (8) The staple retaining assembly according to Embodiment 1, wherein the at least one finished edge is positioned along at least a portion of the outermost edge of the auxiliary material. (9) The staple retaining assembly according to Embodiment 1, wherein the at least one finished edge defines the entire outermost periphery of the auxiliary material. (10) The staple retaining assembly according to Embodiment 1, wherein the cartridge includes a slot formed inside the cartridge and extending along at least a portion of the longitudinal axis of the cartridge, the slot being defined between opposing first slot edges and second slot edges and configured to receive a cutting element.

[0175] (11) The staple retaining assembly according to Embodiment 10, wherein the at least one finished edge includes a first finished edge and a second finished edge, the first finished edge being positioned adjacent to and along the first slot edge, and the second finished edge being positioned adjacent to and along the second slot edge. (12) A staple retaining assembly for use with a surgical stapler, a cartridge having a plurality of staples disposed therein, the plurality of staples being configured to be deployed within tissue, a cartridge, A knitting aid configured to be releasably held on the cartridge, wherein the aid can be attached to tissue by the plurality of staples in the cartridge, the aid having a tissue contact surface and a cartridge contact surface on the opposite side of the tissue contact surface, the aid being an upper layer formed of a first fiber intertwined with spacer fibers, the upper layer defining at least a portion of the tissue contact surface, a lower layer formed of a second fiber intertwined with the spacer fibers, the lower layer facing the upper layer and defining at least a portion of the cartridge contact surface, an intermediate layer positioned between the upper layer and the lower layer, the intermediate layer being formed from a portion of the spacer fibers extending between the upper layer and the lower layer, the portion of the spacer fibers being arranged to form upright fibers configured to bend in response to a force applied to the knitting aid, a knitting aid comprising at least one finished edge including the first fiber, the second fiber, and the spacer fibers that are intertwined with each other and positioned along at least a portion of the outermost periphery of the aid to prevent fraying of the fibers along it. A staple fastening assembly comprising the knitting aid. (13) The staple fastening assembly according to embodiment 12, wherein the spacer fibers are intertwined with the first fibers in a repeating pattern within the upper layer. (14) The staple fastening assembly according to embodiment 12, wherein the spacer fibers are intertwined with the second fibers in a repeating pattern within the lower layer. (15) The staple fastening assembly according to embodiment 12, wherein at least one of the first fiber and the second fiber is a multifilament fiber.

[0176] (16) The staple fastening assembly according to embodiment 12, wherein the spacer fibers are monofilament fibers. (17) The staple fastening assembly according to embodiment 12, wherein the at least one finished edge comprises a plurality of finished edges that are combined to define the entire outermost periphery of the auxiliary material.

Claims

**Claim 1** A staple - fastening assembly for use with a surgical stapler, comprising: A cartridge having a plurality of staples disposed therein, the plurality of staples being configured to be deployed within tissue, the cartridge; A knitting aid configured to be releasably held on the cartridge, the aid being attachable to tissue by the plurality of staples within the cartridge, the aid including a first fiber, a second fiber, and spacer fibers, the first fiber and the spacer fibers being intertwined to form an upper layer of the aid, the second fiber and the spacer fibers being intertwined to form a lower layer of the aid, the first fiber, the second fiber, and the spacer fibers being intertwined to form at least one finished edge extending between the upper layer and the lower layer, the at least one finished edge substantially preventing fraying, the knitting aid; The cartridge includes a slot formed within the cartridge and extending along at least a portion of the longitudinal axis of the cartridge, the slot being defined between opposing first slot edges and second slot edges and configured to receive a cutting element; The at least one finished edge includes a first finished edge and a second finished edge, the first finished edge being positioned adjacent to and along the first slot edge, the second finished edge being positioned adjacent to and along the second slot edge, the staple - fastening assembly. **Claim 2** The staple - fastening assembly according to claim 1, wherein the spacer fibers extend from the upper layer to the lower layer to form an intermediate layer between the upper layer and the lower layer. **Claim 3** The staple - fastening assembly according to claim 2, wherein only the spacer fibers are present within the intermediate layer. **Claim 4** The staple - fastening assembly according to claim 1, wherein the spacer fibers are intertwined with the first fiber in a repeating pattern within the upper layer. **Claim 5** The staple - fastening assembly according to claim 1, wherein the spacer fibers are intertwined with the second fiber in a repeating pattern within the lower layer. **Claim 6** The staple retaining assembly according to claim 1, wherein at least one of the first fiber and the second fiber is a multifilament fiber.

7. The staple retaining assembly according to claim 1, wherein the spacer fiber is a monofilament fiber.

8. The staple retaining assembly according to claim 1, wherein the at least one finished edge is positioned along at least a portion of the outermost edge of the auxiliary material.

9. The staple retaining assembly according to claim 1, wherein the at least one finished edge defines the entire outermost periphery of the auxiliary material.

10. A staple retaining assembly for use with a surgical stapler, a cartridge having a plurality of staples disposed therein, the plurality of staples being configured to be deployed within tissue, the cartridge; a knitting auxiliary material configured to be releasably held on the cartridge, the auxiliary material being attachable to tissue by the plurality of staples within the cartridge, the auxiliary material having a tissue contact surface and a cartridge contact surface opposite the tissue contact surface, the auxiliary material being an upper layer formed from a first fiber intertwined with a spacer fiber, defining at least a portion of the tissue contact surface, the upper layer; a lower layer formed from a second fiber intertwined with the spacer fiber, facing the upper layer, defining at least a portion of the cartridge contact surface, the lower layer; an intermediate layer positioned between the upper layer and the lower layer, formed from a portion of the spacer fiber extending between the upper layer and the lower layer, the portion of the spacer fiber being arranged to form an upstanding fiber configured to bend in response to a force applied to the auxiliary material, the intermediate layer; a knitting auxiliary material including at least one finished edge including the first fiber, the second fiber, and the spacer fiber that are intertwined with each other and positioned along at least a portion of the outermost periphery of the auxiliary material to prevent loosening of the first fiber, the second fiber, and the spacer fiber therealong. The cartridge includes a slot formed inside the cartridge and extending along at least a portion of the longitudinal axis of the cartridge, the slot being defined between opposing first and second slot edges and configured to receive a cutting element, The at least one finished edge includes a first finished edge and a second finished edge, the first finished edge being positioned adjacent to and along the first slot edge, and the second finished edge being positioned adjacent to and along the second slot edge, a stapling assembly. Claim 11 The stapling assembly according to claim 10, wherein the spacer fibers are intertwined with the first fibers in a repeating pattern within the upper layer. Claim 12 The stapling assembly according to claim 10, wherein the spacer fibers are intertwined with the second fibers in a repeating pattern within the lower layer. Claim 13 The stapling assembly according to claim 10, wherein at least one of the first fiber and the second fiber is a multifilament fiber. Claim 14 The stapling assembly according to claim 10, wherein the spacer fibers are monofilament fibers. Claim 15 The stapling assembly according to claim 10, wherein the at least one finished edge includes a plurality of finished edges that are combined to define the entire outermost periphery of the auxiliary material.

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