CN111970979B

CN111970979B - Suture assembly with three-dimensional attachment

Info

Publication number: CN111970979B
Application number: CN201980025817.5A
Authority: CN
Inventors: F·E·谢尔顿四世; J·L·哈里斯; C·O·巴克斯特三世; M·J·温德里
Original assignee: Ethicon LLC
Current assignee: Ethicon LLC
Priority date: 2018-02-21
Filing date: 2019-01-17
Publication date: 2024-05-07
Anticipated expiration: 2039-01-17
Also published as: CN111970979A; JP2021514257A; BR112020016824A2; JP2023154043A; MX2020008729A

Abstract

The present invention provides suturing assemblies for use with surgical staplers and methods of making the same. Three-dimensional appendages for use with surgical stapling assemblies and methods of making the same are also provided.

Description

Suture assembly with three-dimensional attachment

Technical Field

Three-dimensional appendages and methods of making the same are provided.

Background

Surgical staplers are used in surgery to close an opening in tissue, a blood vessel, a catheter, a shunt, or other object or body part involved in a particular procedure. These openings may be naturally occurring, such as blood vessels or passages in internal organs like the stomach, or they may be formed by the surgeon during surgery, such as by puncturing tissue or blood vessels to form bypasses or anastomoses or by cutting tissue during suturing.

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

In addition, staples and other objects and materials that may be implanted in connection with procedures similar to suturing often lack some of the characteristics of the tissue in which they are implanted. For example, staples and other objects and materials may lack the natural flexibility of the tissue in which they are implanted and thus cannot withstand varying in-tissue pressures at the implantation site. This can lead to undesirable tissue tearing at or near the suture site and thus leakage.

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

Disclosure of Invention

A suturing assembly for use with a surgical stapler is also provided.

In one exemplary embodiment, a suturing assembly is provided and may include a body having a plurality of staples disposed therein. The plurality of staples can be configured to be deployed into tissue. The suturing assembly may further comprise a three-dimensional compressible adjunct formed from a matrix comprising at least one molten bioabsorbable polymer. The adjunct can be configured to be releasably retained on the body such that the adjunct can be attached to tissue by the plurality of staples in the body. The adjunct can have a variable stiffness profile such that when the adjunct is in a tissue deployed state, the adjunct is configured to apply a stress to the tissue at or above a minimum stress threshold for at least about 3 days. In one embodiment, the minimum stress threshold may be at least about 3g/mm ².

In one aspect, the plurality of staples can have a height of about 0.130 inches or less when in a formed configuration.

In certain aspects, the at least one molten bioabsorbable polymer may be selected from the group consisting of: thermoplastic absorbable polyurethanes, ultraviolet curable absorbable polyurethanes, poly (lactic acid), polycaprolactone, polyglycolide, polydioxanone, poly (lactic-co-glycolic acid), polyglycolic acid, trimethylene carbonate, glycolide, polydioxanone, polyesters, copolymers thereof, and combinations thereof.

The appendage can have a variety of configurations. For example, the appendage may have a stiffness that increases as the appendage compresses. In one embodiment, the adjunct can have compressible inner struts, which can be substantially helical and can have a predetermined compression height to limit the amount of compression of the adjunct. In another embodiment, the adjunct can have a plurality of interconnecting struts, each having two bending zones. The first bending region may be configured to bend when the appendage is compressed under a first stress, and the second bending region may be configured to bend when the appendage is compressed under a second stress that is greater than the first stress.

In some aspects, the appendage can have an interior, substantially vertical plurality of posts. In one embodiment, the plurality of posts may include a first set of posts having a first length and a second set of posts having a second length that is less than the first length.

In one aspect, the adjunct can include at least one stop element that can be configured to limit an amount of compression of the adjunct.

In another exemplary embodiment, a suturing assembly may be provided that includes a body having a plurality of staples disposed therein. The plurality of staples can be configured to be deployed into tissue. The suturing assembly may further comprise a three-dimensional compressible adjunct formed from a matrix comprising at least one molten bioabsorbable polymer. The adjunct can be configured to be releasably retained on the body such that the adjunct can be attached to tissue by the plurality of staples in the body. The adjunct can have a first stiffness when compressed by a first amount and a second stiffness when compressed by a second amount greater than the first amount.

In one aspect, the adjunct can be configured to apply a stress of at least about 3g/mm ² to tissue sutured to the adjunct for at least 3 days when the adjunct is in a tissue-deployed state.

The appendage can have a variety of configurations. For example, the adjunct can have compressible inner struts, which can be substantially helical and can have a predetermined compression height to limit the amount of compression of the adjunct. In one embodiment, the adjunct can have a plurality of interconnecting struts each having two bending zones. The first bending zone may be configured to bend when the adjunct is compressed a first amount and the second bending zone may be configured to bend when the adjunct is compressed a second amount.

In some aspects, the appendage can have an interior, substantially vertical plurality of posts. The plurality of posts may include a first set of posts having a first length and a second set of posts having a second length that is less than the first length.

In another aspect, the adjunct can include at least one stop element that can be configured to limit an amount of compression of the adjunct.

Drawings

The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

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

FIG. 2 is a perspective view of a wedge sled of the staple cartridge of the surgical stapling and severing instrument of FIG. 1;

FIG. 3 is a perspective view of a knife and firing bar ("E-beam") of the surgical stapling and severing instrument of FIG. 1;

FIG. 4 is a longitudinal cross-sectional view of a surgical cartridge that may be disposed within the stapling and severing instrument of FIG. 1;

FIG. 5 is a top view of staples in an unfired (pre-deployed) configuration that can be disposed within the staple cartridge of the surgical cartridge assembly of FIG. 4;

FIG. 6 is a longitudinal cross-sectional view of an exemplary embodiment of a surgical cartridge assembly having an adjunct attached to a cartridge deck;

FIG. 7 is a schematic diagram showing the adjunct of FIG. 6 in a tissue deployment condition;

FIG. 8A is a perspective view of one exemplary embodiment of an adjunct having multiple repeating units interconnecting struts;

FIG. 8B is an enlarged view of the repeat unit of the attachment shown in FIG. 8A taken at 8B;

FIG. 9A is a schematic illustration of the repeat unit of FIG. 8B in a pre-compressed state;

FIG. 9B is a schematic illustration of the repeat unit of FIG. 8B in a first compressed state;

FIG. 9C is a schematic illustration of the repeat unit shown in FIG. 8B in a second compressed state;

FIG. 10 is a graphical illustration of the relationship between stiffness and compression of an attachment;

FIG. 11A is a perspective view of an exemplary embodiment of an adjunct having a plurality of interconnected struts and internal connectivity features;

FIG. 11B is a perspective cut-away view of the attachment shown in FIG. 11A taken at 11B;

FIG. 12A is a perspective view of another exemplary embodiment of an attachment having a plurality of interconnecting struts and a linking member;

FIG. 12B is an enlarged view of the repeat unit of the attachment shown in FIG. 12A taken at 12B;

FIG. 13A is a perspective view of another exemplary embodiment of an adjunct having a plurality of struts interconnecting a first material at joints or nodes of a second material;

FIG. 13B is an enlarged view of the repeat unit of the attachment shown in FIG. 13A taken at 13B;

FIG. 14 is a perspective view of yet another exemplary embodiment of a repeating unit of interconnected struts having an end shape;

FIG. 15 is a perspective view of an attachment having a plurality of struts and at least one stop element according to another embodiment;

FIG. 16 is a perspective view of an exemplary embodiment of an adjunct having a plurality of struts that are substantially helical;

FIG. 17 is a perspective view of another exemplary embodiment of an attachment including a plurality of struts in the form of vertical columns having different lengths;

FIG. 18A is a schematic view of the attachment shown in FIG. 17 in a pre-compressed height;

FIG. 18B is a schematic view of the attachment shown in FIG. 17 at a first compressed height;

FIG. 18C is a schematic view of the attachment shown in FIG. 17 at a second compressed height;

FIG. 19 is a side view of an exemplary embodiment of an attachment including a plurality of struts in the form of vertical posts and curved posts;

FIG. 20 is a graphical representation of the mechanical behavior of the attachment shown in FIG. 19 over a range of compression;

FIG. 21A is a perspective view of another exemplary embodiment of an adjunct having a channel configured to receive a cutting element and having a tab for attaching the adjunct to a staple cartridge;

FIG. 21B is an exemplary embodiment of a staple cartridge assembly having the adjunct shown in FIG. 21A attached to the cartridge body; and

Fig. 22 is an exemplary embodiment of an adjunct with a bridging member.

Detailed Description

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

Furthermore, in the present disclosure, components that are similar in name in each embodiment generally have similar features, and thus, in a particular embodiment, each feature of each component that is similar in name is not necessarily fully set forth. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, instruments, and methods, such dimensions are not intended to limit the types of shapes that may be used in connection with such systems, instruments, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be readily determined for any geometry. The size and shape of the systems and instruments and their components may depend at least on the anatomy of the subject in which the systems and instruments are to be used, the size and shape of the components with which the systems and instruments are to be used, and the methods and procedures in which the systems and instruments are to be used.

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

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

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

Surgical stapling assemblies, methods of making the same, and methods for stapling tissue are provided. Generally, a stapling assembly is provided having a body (e.g., a staple cartridge or end effector body) in which a plurality of staples are disposed. The suturing assembly also includes a three-dimensional compressible adjunct formed from a matrix, the matrix comprising at least one molten bioabsorbable polymer, and the adjunct being configured to releasably retain on the body. The adjunct can be releasably retained on the body such that when the staples are deployed from the body and into tissue, at least a portion of the adjunct can be attached to tissue captured by the staples. As discussed herein, the adjunct can be configured to compensate for changes in tissue characteristics (such as changes in tissue thickness) and/or promote tissue ingrowth when the adjunct is sutured to tissue. For example, the adjunct can be configured to apply a stress of at least about 3g/mm ² to tissue for at least 3 days when in a tissue-deployed state (e.g., when the adjunct is sutured to tissue in vivo).

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

Fig. 1 illustrates an exemplary surgical stapling and severing instrument 100 suitable for use with an implantable adjunct. The surgical stapling and severing instrument 100 illustrated includes a staple applying assembly 106 or end effector having an anvil 102 pivotally coupled to an elongate staple channel 104. The staple applying assembly 106 may be attached at its proximal end to an elongate shaft 108 forming a tool portion 110. When the staple applying assembly 106 is closed, or at least substantially closed, the tool portion 110 may present a sufficiently small cross-section that is suitable for inserting the staple applying assembly 106 through a trocar. Although instrument 100 is configured to suture and sever tissue, surgical instruments configured to suture but not sever tissue are also contemplated herein.

In various instances, the staple applying assembly 106 can be manipulated by a handle 112 that is coupled to the elongate shaft 108. The handle 112 may include user controls such as: a knob 114 that rotates the elongate shaft 108 and the staple applying assembly 106 about the longitudinal axis of the elongate shaft 108; and a closure trigger 116 that can pivot in front of the pistol grip portion 118 to close the staple applying assembly 106. For example, when the closure trigger 116 is clamped, a closure release button 120 may be present outwardly on the handle 112 such that the closure release button 120 may be depressed to unclamp the closure trigger 116 and open the staple applying assembly 106.

The firing trigger 122, which may be pivoted in front of the closure trigger 116, may allow the staple applying assembly 106 to sever and staple tissue clamped therein simultaneously. In various circumstances, the firing trigger 122 may be used to employ multiple firing strokes to reduce the amount of force that needs to be applied by the surgeon's hand per stroke. In certain embodiments, the handle 112 may include one or more rotatable indicator wheels, such as rotatable indicator wheel 124, which may indicate the progress of firing. If desired, the manual firing release lever 126 may allow the firing system to retract before the full firing travel is complete, and furthermore, in the event that the firing system jams and/or fails, the firing release lever 126 may allow the surgeon or other clinician to retract the firing system.

Additional details regarding surgical stapling and severing instrument 100 and other surgical stapling and severing instruments suitable for use with the present disclosure are described, for example, in U.S. patent No. 9,332,984 and U.S. patent application publication 2009/0090763, the disclosures of which are incorporated herein by reference in their entirety. Furthermore, the surgical stapling and severing instrument need not include a handle, but rather includes a housing that is configured to be coupled to a surgical robot, for example, as described in U.S. application Ser. No. 15/689,198, filed 8/29 of Frederick E.Shelton et al, the disclosure of which is incorporated herein by reference in its entirety.

Referring to fig. 2 and 3, a firing assembly, such as firing assembly 228, may be used with a surgical stapling and severing instrument, such as instrument 100 of fig. 1. The firing assembly 228 may be configured to advance a wedge sled 230 having a plurality of wedges 232 configured to deploy staples from a staple applying assembly (e.g., staple applying assembly 106 of fig. 1) into tissue captured between an anvil (e.g., anvil 102 of fig. 1) and an elongate staple channel (e.g., channel 104 of fig. 1). Further, an E-beam 233 at a distal portion of the firing assembly 228 can fire staples from the staple applying assembly and position the anvil relative to the elongate staple channel during firing. The illustrated E-beam 233 includes a pair of top pins 234, a pair of middle pins 236 that may follow portions 238 of the wedge sled 230, and bottom pins or feet 240. The E-beam 233 may also include a sharp cutting edge 242 configured to sever captured tissue as the firing assembly 228 is advanced distally. In addition, the proximally projecting integrally formed top and middle guides 244, 246 that cradle each vertical end of the cutting edge 242 may further define a tissue staging area 248 to help guide tissue to the sharp cutting edge 242 prior to severing the tissue. The intermediate guide 246 may also be used to engage and fire a staple applying assembly by a stepped center member 250 abutting a wedge sled 230 that affects staple formation by the staple applying assembly.

Referring to fig. 4, a staple cartridge 400 may be used with a surgical stapling and severing instrument, such as surgical stapling and severing instrument 100 of fig. 1, and may include a cartridge body 402 and a plurality of staple cavities 404 within cartridge body 402. Staples 406 may be removably positioned in each staple cavity 404. The staples 406 are shown in greater detail in fig. 5 in an unfired (pre-deployed, unshaped) configuration. The staple cartridge 400 can further comprise a longitudinal channel that can be configured to receive a firing and/or cutting member, such as an E-beam (e.g., E-beam 233 in FIG. 3).

Each staple 406 can include a crown (base) 406 _C and one or more legs 406 _L extending from the crown 406 _C. Prior to deploying the staples 406, the crowns 406 _C of the staples 406 can be supported by staple drivers 408 positioned within the staple cartridge 400 and, at the same time, the legs 406 _L of the staples 406 can be at least partially contained within the staple cavities 404. Further, the staple legs 406 _L of the staples 406 can extend beyond the tissue contacting surface 410 of the staple cartridge 400 when the staples 406 are in their unfired position. In some cases, as shown in fig. 5, the tips of the staple legs 406 _L can be sharp, which can cut into and penetrate tissue.

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

The staples 406 may be deformed from an unfired position to a fired position such that the legs 406 _L move through the staple cavities 404, penetrate tissue positioned between an anvil (such as the anvil 102 in fig. 1) and the staple cartridge 400, and contact the anvil. As the legs 406 _L deform against the anvil, the legs 406 _L of each staple 406 may capture a portion of tissue within each staple 406 and apply a compressive force to the tissue. In addition, the legs 406 _L of each staple 406 can deform downward toward the crown 406 _C of the staple 406 to form a staple entrapment area in which tissue can be captured. In various cases, a staple entrapment area can be defined between the inner surface of the deformed leg and the inner surface of the crown of the staple. The size of the staple entrapment area can depend on several factors, such as the length of the leg, the diameter of the leg, the width of the crown, and/or the extent of leg deformation.

In use, by depressing a closure trigger, such as closure trigger 116 in FIG. 1, an anvil, such as anvil 102 in FIG. 1, can be moved to a closed position to advance an E-beam, such as E-beam 233 in FIG. 3. The anvil can position tissue against a tissue contacting surface 410 of the staple cartridge 400. Once the anvil has been properly positioned, staples 406 may be deployed.

To deploy the staples 406, as described above, a staple firing sled, such as sled 230 in fig. 2, can be moved from the proximal end 400p toward the distal end 400d of the staple cartridge 400. When a firing assembly, such as firing assembly 228 of FIG. 3, is advanced, the sled can contact the staple drivers 408 and lift the staple drivers 408 upward within the staple cavities 404. In at least one example, the sled and staple drivers 408 can each include one or more ramps or sloped surfaces that can cooperate to move the staple drivers 408 upward from their unfired positions. As the staple drivers 408 are lifted upwardly within their respective staple cavities 404, the staples 406 are advanced upwardly so that the staples 406 emerge from their staple cavities 404 and penetrate into the tissue. In various circumstances, the sled can simultaneously move several staples upward as part of the firing sequence.

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

As noted above, with some surgical staplers, a surgeon is often required to select the appropriate staple for the tissue to be stapled with the appropriate staple height. For example, a surgeon may select a high staple for use with thick tissue and a short staple for use with thin tissue. However, in some cases, the stapled tissue does not have a consistent thickness, and thus the staples cannot achieve the desired firing configuration for each portion of stapled tissue (e.g., thick and thin tissue portions). When staples having the same or substantially the same height are used, particularly when the staple site is exposed to internal pressure at the staple site and/or along the staple line, the inconsistent thickness of tissue may also result in undesirable leakage and/or tearing of tissue at the staple site.

Accordingly, various embodiments of a three-dimensionally printed adjunct are provided that can be configured to compensate for varying thicknesses of tissue captured within a fired (deployed) staple to avoid the need to consider staple height when stapling tissue during surgery. That is, the appendages described herein may allow a set of staples having the same or similar heights to be used to staple tissue having different thicknesses (i.e., thin to thick tissue) while also providing, in combination with the appendages, sufficient tissue compression within and between the fired staples. Accordingly, the appendages described herein may maintain proper compression of thin or thick tissue stapled to the appendage to minimize leakage and/or tearing of tissue at the stapled site.

Alternatively or in addition, the three-dimensionally printed adjunct can be configured to promote tissue ingrowth. In various circumstances, it is desirable to promote tissue ingrowth in the implantable adjunct to promote healing of the treated tissue (e.g., sutured tissue and/or incised tissue) and/or to accelerate recovery of the patient. More specifically, tissue ingrowth in the implantable adjunct can reduce the incidence, extent, and/or duration of inflammation at the surgical site. Tissue ingrowth in and/or around the implantable adjunct can control spread of infection, for example, at the surgical site. Blood vessels, particularly white blood cells, for example, ingrowth in and/or around the implantable adjunct can resist infection in and/or around the implantable adjunct and adjacent tissues. Tissue ingrowth can also promote receipt of foreign objects (e.g., implantable appendages and staples) by the patient's body, and can reduce the likelihood of rejection of foreign objects by the patient's body. Rejection of foreign matter can lead to infection and/or inflammation at the surgical site.

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

Generally, the appendages provided herein are designed and positioned on top of a main body (such as cartridge body 402 in fig. 4). When the staples are fired (deployed) from the body, the staples penetrate the adjunct and into the tissue. When the legs of the staples are deformed against an anvil positioned opposite the cartridge assembly, the deformed legs capture a portion of the adjunct and a portion of the tissue within each staple. That is, as the staples are fired into the tissue, at least a portion of the adjunct becomes positioned between the tissue and the fired staples. While the appendages described herein may be configured to be attached to a cartridge body of a staple cartridge assembly, it is also contemplated herein that the appendages may be configured to mate with other instrument components, such as a jaw of a surgical stapler. Those of ordinary skill in the art will appreciate that the appendages provided herein may be used with replaceable cartridges or cartridge-based staple reloads.

Fig. 6 illustrates an exemplary embodiment of a staple cartridge assembly 600 that includes a staple cartridge 602 and an adjunct 604. Staple cartridge 602 may be similar to staple cartridge 400 (fig. 4) except for the differences described in detail below, and thus, will not be described in detail herein. As shown, the adjunct 604 is positioned against the staple cartridge 602. The staple cartridge may include a cartridge body 606 and a plurality of staples 608 disposed therein, such as the staples 406 shown in fig. 4 and 5. The peg 608 may be any suitable unformed (pre-deployed) height. For example, the pegs 608 may have an unformed height of between about 2mm to 4.8 mm. Prior to deployment, the crown of the staples 608 can be supported by a staple driver 610.

In the illustrated embodiment, the adjunct 604 can be mated to an outer surface 612 of the cartridge body 606, such as a tissue contacting surface. In some embodiments, the outer surface 612 of the cartridge body 606 can include one or more attachment features. The one or more attachment features can be configured to engage the adjunct 604 to avoid undesired movement of the adjunct 604 relative to the cartridge body 606 and/or premature release of the adjunct 604 from the cartridge body 606. Exemplary attachment features can be found in U.S. patent publication 2016/0106427, which is incorporated by reference herein in its entirety.

The appendages 604 are compressible to allow the appendages to compress to varying heights to compensate for different tissue thicknesses captured within the deployed staples. The appendage 604 has an uncompressed (undeformed) or pre-deployed height and is configured to be deformable to one of a plurality of compressed (deformed) or deployed heights. For example, the adjunct 604 can have an uncompressed height that is greater than the fired height of the staples 608 (e.g., the height (H) of the fired staples 608a in fig. 7). That is, the adjunct 604 can have an undeformed state wherein the maximum height of the adjunct 604 is greater than the maximum height of the fired staples 608a (i.e., staples in a formed configuration). In one embodiment, the uncompressed height of the adjunct 604 can be about 10% higher, about 20% higher, about 30% higher, about 40% higher, about 50% higher, about 60% higher, about 70% higher, about 80% higher, about 90% higher, or about 100% higher than the fired height of the staples 608. In certain embodiments, for example, the uncompressed height of the adjunct 604 can be more than 100% greater than the fired height of the staples 608.

The adjunct 604 can be releasably mated to an outer surface 612 of the cartridge body 606. As shown in fig. 7, when the staples are fired, tissue (T) and a portion of the adjunct 604 are captured by the fired (formed) staples 608 a. As described above, the fired staples 608a each define a entrapment zone therein for receiving the captured adjunct 604 and tissue (T). The entrapment area defined by the fired staples 608a is at least partially limited by the height (H) of the fired staples 608 a. For example, the height of the fired staples 608a can be about 0.160 inches or less. In some embodiments, the height of the fired staples 608a can be about 0.130 inches or less. In one embodiment, the height of the fired staples 608a can be about 0.020 inches to 0.130 inches. In another embodiment, the height of the fired staples 608a can be from about 0.060 inches to 0.160 inches.

As described above, the adjunct 604 can be compressed within a plurality of fired staples regardless of whether the thickness of tissue captured within the staples is the same or different within each fired staple. In at least one exemplary embodiment, the staples within the staple line or staple row can be deformed such that the firing height is, for example, about 2.75mm, wherein the tissue (T) and adjunct 604 can be compressed within that height. In some cases, tissue (T) may have a compressed height of about 1.0mm, and adjunct 604 can have a compressed height of about 1.75 mm. In some cases, tissue (T) may have a compressed height of about 1.50mm, and adjunct 604 can have a compressed height of about 1.25 mm. In some cases, tissue (T) may have a compressed height of about 1.75mm, and adjunct 604 can have a compressed height of about 1.00 mm. In some cases, tissue (T) may have a compressed height of about 2.00mm, and adjunct 604 can have a compressed height of about 0.75 mm. In some cases, tissue (T) may have a compressed height of about 2.25mm, and adjunct 604 can have a compressed height of about 0.50 mm. Thus, the sum of the compressed height of the captured tissue (T) and the adjunct 604 can be equal to, or at least substantially equal to, the height (H) of the fired staples 608 a.

As discussed in more detail below, the structure of the adjunct can be configured such that when the adjunct and tissue are captured within the fired staples, the adjunct can exert a stress that can withstand the pressure of circulating blood through the tissue. Hypertension is generally considered to be 210mmHg and, thus, it is desirable for the adjunct to apply a stress to the tissue equal to or greater than 210mmHg (e.g., 3g/mm ²) for a predetermined period of time (e.g., 3 days). As such, in certain embodiments, the adjunct can be configured to apply a stress of at least about 3g/mm ² to the captured tissue for at least 3 days. When the adjunct is sutured to tissue in the body, the adjunct is in a tissue deployed state. In one embodiment, the applied stress may be about 3g/mm ². In another embodiment, the applied stress may be greater than 3g/mm ². In yet another embodiment, the stress may be at least about 3g/mm ² and applied to the captured tissue for more than 3 days. For example, in one embodiment, the stress may be at least about 3g/mm ² and applied to the captured tissue for about 3 to 5 days.

In order to design an adjunct configured to apply a stress to captured tissue of at least about 3g/mm ² for a predetermined time, the principle of hooke's law (f=kd) may be used. For example, when the force (stress) applied to the captured tissue is known, an appendage having a stiffness (k) can be designed. The stiffness may be provided by adjusting the geometry of the appendages (e.g., the diameter of the struts and/or the interconnectivity of the struts, such as the angle and spacing between the struts). Furthermore, the adjunct can be designed to have a maximum amount of compressive displacement for a minimum tissue thickness (e.g., 1 mm), and thus the length of displacement D can be the combination of the minimum tissue thickness (e.g., 1 mm) plus the thickness of the adjunct when stapled to tissue at a given maximum staple height (e.g., 2.75 mm). For example, in one embodiment, the adjunct can be structured to have a maximum formed suture height of greater than 2.75mm and can be compressed to a height of 1.75mm when sutured to tissue having a minimum thickness of 1 mm. Thus, the adjunct can vary in compressibility to maintain a constant length of displacement D such that the stiffness (k) and total thickness (D) of the captured tissue and adjunct can apply a stress of 3g/mm ² to the captured tissue. It should be noted that one of ordinary skill in the art will appreciate that the foregoing formulas may be modified to account for changes in temperature, for example, when bringing the appendage from room temperature to body temperature after implantation.

In addition, the appendages may be further developed to provide a substantially continuous stress (e.g., 3g/mm ²) to the captured tissue for a predetermined period of time (e.g., 3 days). To achieve this, the degradation rate of the material of the adjunct and the rate of tissue ingrowth within the adjunct need to be considered in designing the adjunct. Thus, an adjunct can be designed such that the stiffness of the adjunct and/or the total thickness of the captured tissue and adjunct does not vary in a manner that may result in an applied stress of less than 3g/mm ².

The adjunct is sutured to the tissue under various suturing conditions (e.g., tissue thickness, height of the formed staples, intra-tissue pressure). Depending on the suturing conditions, it may be determined that the adjunct requires an effective amount of force that can be applied to the tissue to prevent tearing and leakage of the tissue. For example, in one embodiment, the effective amount is at least about 3g/mm ². In order for the adjunct to provide an effective amount of force to the tissue, the adjunct can be designed to effectively compensate for various suturing conditions. In this way, the geometry of the appendages can be customized to assume different compression heights when sutured to tissue. Because of the limited range of intra-tissue pressures, tissue thicknesses, and formed staple heights, an appropriate geometry can be determined for the adjunct that, when stapled to tissue, can effectively apply a substantially continuous desired stress (e.g., 3g/mm ²) to the tissue for a given amount of time (e.g., at least 3 days) under a range of stapling conditions. That is, as described in greater detail below, the appendages of the present invention are formed of a compressible material and are geometrically configured to allow the appendages to be compressed to different heights within a predetermined plane when sutured to tissue. In addition, the response of such changes by the adjunct can also allow the adjunct to maintain its continuous desired stress on the tissue when the adjunct is exposed to fluctuations in pressure within the tissue that can occur when the adjunct is sutured to the tissue (e.g., peaks in blood pressure).

The adjunct can be manufactured by additive manufacturing (also known as three-dimensional printing or 3D printing). 3D printing is a high-speed additive manufacturing technology that can deposit various types of materials in a manner similar to a printer. That is, 3D printing is achieved by laying down successive layers of material to form a shape. For printing, the printer reads the model design from a digital file and lays down successive layers of material to build up a series of cross sections. The layers determined by the model are joined or automatically melted to create the final shape. This technique allows the ability to create various shapes or geometric features in a controlled and precise manner. Non-limiting examples of suitable 3D printing processes (also referred to as additive manufacturing) classified by ASTM committee 42 include VAT photopolymerization (e.g., a stereolithography technique) in which liquid photopolymer in VAT is selectively cured by photoactivated polymerization; a material jet in which droplets of building material are selectively deposited; binder jetting, wherein a liquid binder is selectively deposited to bind the powder material; powder bed diffusion (e.g., selective laser sintering) wherein thermal energy selectively melts regions of the powder bed; direct energy deposition, wherein focused thermal energy is used to melt material by melting as it is deposited; direct energy deposition, wherein focused thermal energy is used to melt material by melting as it is deposited; material extrusion (e.g., fused deposition modeling) in which material is selectively dispensed through a nozzle or orifice; and sheet lamination, wherein the sheets of material are bonded together to form an object.

For example, in some embodiments, the method can include scanning a light beam to melt multiple layers of powder to form a compressible bioabsorbable adjunct having an elongated body with a tissue contacting surface, a cartridge contacting surface opposite the tissue contacting surface, and a plurality of struts forming repeating geometric units extending between the tissue contacting surface and the cartridge contacting surface. In one embodiment, the method may further comprise coating the adjunct with one or more antimicrobial agents.

The adjunct can be formed from one or more substrates. In certain embodiments, the one or more matrices may be in the form of a particulate matrix. In such cases, each particle matrix may be formed from fused particles (e.g., fused bioabsorbable polymer particles).

Generally, each matrix can be formed from at least one molten polymer. The at least one molten polymer may be selected so as to impart a desired compressibility to the adjunct. For example, in one embodiment, the matrix comprises a molten polymer, while in other embodiments, the matrix may comprise two or more different molten polymers. Alternatively or in addition, where the adjunct includes two or more matrices, each matrix can be formed from the same molten polymer or from different molten polymers from each other. For example, the first matrix may comprise a first molten polymer and the second matrix may comprise a second molten polymer that is more flexible or less flexible than the first molten polymer. In this way, the molten polymer may provide different flexibility to the adjunct. Furthermore, the molten polymers may have different degradation rates, such that the compressibility of the adjunct can be tailored to vary over time as a function of degradation rate.

While various types of materials may be used, in some embodiments, the at least one molten polymer is a bioabsorbable polymer. Non-limiting examples of suitable bioabsorbable polymers include thermoplastic absorbable polyurethanes, ultraviolet curable bioabsorbable polyurethanes, poly (lactic acid) (PLA), polycaprolactone (PCL), polyglycolide, polydioxanone (PDS), poly (lactic-co-glycolic acid) (PLGA), polyglycolic acid, trimethylene carbonate, glycolide, polydioxanone, polyesters, copolymers thereof, and combinations thereof. Additional non-limiting examples of suitable bioabsorbable polymers include macromers of tri-arm hydroxyl-terminated PCL or poly DL-lactide with acrylate or methacrylate end-groups modified, PLA-PEG or poly trimethylene carbonate, PEG dimethyl or trimethyl acrylate or methacrylate, polypropylene fumarate, L-lactide/caprolactone copolymers, collagen-infiltrated PLGA polymers, PCL-tricalcium phosphate (TCP), hyaluronic acid coated PLGA-TCP copolymers, PCL-PLGA-TCP, PLGA-PCL copolymers, PDS polymers and copolymers, PCL polymers and hyaluronic acid, PCL and beta-tricalcium phosphate with collagen coating, polyvinyl alcohol, calcium phosphate/poly (hydroxybutyrate-co-valerate) and hydroxyapatite calcium/poly L-lactide.

For example, in some embodiments, the appendages may be formed from various components, each formed from a matrix including at least one molten bioabsorbable polymer. In some embodiments, the adjunct can have a first component formed from a first matrix of at least one molten bioabsorbable polymer (e.g., a lactide-co-glycolide or a polydioxanone) and a second component formed from a second matrix comprising at least one molten bioabsorbable polymer (e.g., a polycaprolactone copolymer). The at least one molten bioabsorbable polymer of each matrix can comprise at least two different bioabsorbable polymers. In one embodiment, the first component may have a first color and the second component may have a second color different from the first color.

In some embodiments, the adjunct can be drug eluting. For example, one or more components of the adjunct can include a composition having a pharmaceutically active agent. The composition can release a therapeutically effective amount of the pharmaceutically active agent. In various embodiments, the pharmaceutically active agent may be released as the appendages desorb/absorb. In various embodiments, the pharmaceutically active agent may be released into a fluid, such as blood, passing through or across the adjunct. Non-limiting examples of pharmaceutically active agents include hemostatic agents and drugs such as fibrin, thrombin, and Oxidized Regenerated Cellulose (ORC); anti-inflammatory agents such as diclofenac, aspirin, naproxen, sulindac, and hydrocortisone; antibiotics and antimicrobial drugs or agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B and chloramphenicol; and anticancer agents such as cisplatin, mitomycin and doxorubicin.

The adjunct can also include an outer coating. The coating may be part of the 3D printing process or applied to the appendage a second time. For example, in some implementations, the adjunct can be partially or completely coated with an antimicrobial agent. Non-limiting examples of suitable antimicrobial agents include triclosan, chlorhexidine, silver formulations (e.g., nanocrystalline silver), arginine ethyl Laurate (LAE), octenidine, polyhexamethylene biguanide (PHMB), taurolidine; lactic acid, citric acid, acetic acid and salts thereof.

The adjunct, or any component thereof, can be at least partially coated with a bioabsorbable polymer that differs from the at least one melted bioabsorbable polymer of the adjunct. In this way, one or more properties of the adjunct can be different from the properties of its matrix material (e.g., molten bioabsorbable polymer). For example, the adjunct can be coated with a bioabsorbable polymer that improves structural stability. Alternatively or in addition, the adjunct can be coated with a bioabsorbable polymer having a slower degradation rate than the degradation rate of the at least one molten bioabsorbable polymer of the adjunct. In this way, the lifetime of the adjunct can be increased without sacrificing the desired compressibility of the adjunct provided at least in part by the at least one molten bioabsorbable polymer.

The appendage can have a variety of configurations. Generally, the adjunct can include a tissue contacting surface, an opposing body contacting surface (e.g., a cartridge contacting layer), and an elongate body (structural layer) positioned therebetween. In certain embodiments, the tissue contacting surface and the cartridge contacting surface can have a different structure than the structural layer, thereby forming a tissue contacting layer and a cartridge contacting layer. In some embodiments, the elongate body is formed from a plurality of struts. The struts may have various configurations, and in certain exemplary embodiments, the struts may form interconnected repeating geometric units.

In some embodiments, the tissue contacting layer may include a plurality of surface features thereon configured to engage tissue located between the adjunct and the anvil, thereby substantially preventing the tissue from sliding relative to the adjunct during stapling. The surface features may also be configured to minimize sliding movement of the adjunct relative to the tissue when suturing the adjunct to the tissue. These surface features may have a variety of configurations. For example, the surface features may extend a distance of about 0.007 inches to 0.015 inches from the tissue contacting surface.

Further, in some embodiments, these surface features can extend in a direction substantially transverse to the longitudinal axis (L) of the body, such as cartridge body 606 in fig. 6. In another embodiment, at least a portion of the surface features may include a plurality of ridges and a plurality of grooves defined between the plurality of ridges. In yet another embodiment, the surface features may include a plurality of bearing surfaces extending in a direction at least upward from the body, inward toward the central channel, and distally toward the second end of the body. Additional details of anti-slip features in the form of ridges and grooves or bearing surfaces can be found in U.S. patent publication 2015/0034696, which is incorporated herein by reference in its entirety.

In some embodiments, the plurality of surface features may be configured to pull tissue in opposite directions and thus provide opposing resistance (e.g., lateral bias) to prevent tissue slippage during suturing. For example, the tissue contacting layer may include a plurality of first surface features that may extend in a first direction and a plurality of second surface features that may extend in a second direction different from the first direction. Thus, the plurality of first surface features and the plurality of second surface features may create tension between the surface features that actively resists movement of tissue in at least one direction. In one embodiment, the plurality of first surface features may extend in a first direction and the plurality of second surface features may extend in an opposite second direction. In such cases, the surface features may be configured to simultaneously pull tissue in opposite directions.

Reverse resistance can also be created by surface bending. For example, the tissue contacting layer (or in the alternative, e.g., the entire adjunct) can be designed to have a resilient convex shape, and the surface features can extend radially outward from the tissue contacting layer. In use, as described above, as the anvil of the surgical stapler is moved from the open position to the closed position, the tissue contacting layer may deform (e.g., compress to a substantially straight configuration) and now the surface features extending substantially vertically outward from the tissue contacting layer engage the tissue. When the anvil is returned to its open position, the tissue contacting layer returns to its convex shape, creating a surface tension between the surface features that causes the engaged tissue to be pulled in opposite directions simultaneously.

On the other hand, in certain embodiments, it may be desirable to slide the tissue in a predefined plane during suturing. As such, in some embodiments, the tissue contacting layer may include surface features that may be designed to facilitate sliding movement (e.g., sliding movement) of tissue relative to the adjunct in a first predetermined direction and limit movement in a second direction different from the first direction. Alternatively or in addition, the tissue contacting layer may be coated with a material for increasing lubricity (e.g., sodium stearate or arginine ethyl laurate).

As described above, the adjunct is positioned on top of the main body, such as cartridge body 606 (FIG. 6). Fixation of the adjunct to the body can be enhanced prior to and during suturing. For example, a body contact layer (e.g., a cartridge contact layer) can include surface features configured to engage a body to substantially prevent an accessory from sliding relative to the body. These surface features may have a variety of configurations. For example, in embodiments in which the body includes attachment features, the body contact layer may have surface features in the form of recesses configured to receive the attachment features. Other attachment features will be discussed in more detail below.

As described above, the elongate body may be formed from a plurality of struts. These struts may form repeating geometric units interconnected with each other. As discussed in more detail below, the plurality of struts and/or the array of repeating units may be structurally configured to impart varying compressibility to the adjunct, and thus the adjunct may have a variable stiffness profile. For example, the appendage may have a first stiffness when compressed a first amount and a second stiffness when compressed a second amount. The second amount may be greater than the first amount and vice versa. Thus, the stiffness of the appendages may vary as a function of compression. As discussed in more detail below, the greater the amount of compression, the greater the stiffness of the appendage. Thus, a single adjunct can be tailored to provide a varying response that ensures that a minimum amount of stress (e.g., 3g/mm ²) is applied to tissue for at least a predetermined time (e.g., 3 days) under various suturing conditions (e.g., tissue thickness, height of the formed staples, intra-tissue pressure). In addition, the response to such changes by the adjunct can also desirably maintain a minimum amount of applied stress (e.g., 3g/mm ²) when the adjunct is sutured to tissue and exposed to fluctuations in pressure within the tissue.

These braces can be designed in various configurations. For example, the struts may produce a grid or truss like structure as shown in fig. 8A-9C and 11A-15, a spiral structure as shown in fig. 16, or a column as shown in fig. 17-19.

The geometry of the struts themselves and the repeating units formed thereby can control the movement of the appendages in different planes. For example, the interconnectivity of the struts may create a geometric unit that may be configured to allow the appendages to compress in a first predetermined direction and limit movement in a second direction different from the first direction. As discussed in more detail below, in some embodiments, the second direction may be transverse to the first predetermined direction. Alternatively or in addition, the geometric unit may be configured to limit rotational movement of the appendage about an axis perpendicular to the first predetermined direction.

In some embodiments, the struts may have a substantially uniform cross-section, while in other embodiments, the struts may have varying cross-sections. In addition, the material of the stay may also play a role in defining the movement of the appendage in a predetermined plane.

Fig. 8A-9C and 11A-19 illustrate various exemplary appendages including a tissue contacting surface, a cartridge contacting surface opposite the tissue contacting surface, and an elongate body formed from struts positioned therebetween. Each exemplary appendage is shown in partial form (e.g., not full length), so those of ordinary skill in the art will appreciate that the length of the appendage (i.e., along its longitudinal axis L) may be longer, as identified in each embodiment. The length may vary based on the length of the staple cartridge. Furthermore, each example adjunct is configured to be positionable atop the cartridge body such that a longitudinal axis L of each adjunct is aligned with and extends along a longitudinal axis (L _C) of the cartridge body. Each of these appendages may be formed from one or more matrices including at least one molten bioabsorbable polymer. These appendages are structured to compress when exposed to a compressive force (e.g., stress or load). As discussed in further detail below, these appendages are also designed to promote both tissue and cell ingrowth.

Fig. 8A-8B illustrate an exemplary embodiment of an adjunct 800 having a tissue contacting surface 802, an opposing cartridge contacting surface 804, and an elongate body 806. Although it is contemplated that the tissue contacting surface 802, the cartridge contacting surface 804, and the elongate body 806 can each be formed of different materials, in the illustrated embodiment they are formed of the same molten bioabsorbable polymer. That is, adjunct 800 is formed from a matrix of the same molten bioabsorbable polymer.

As shown in fig. 8A, the elongate body 806 includes a planar array 808 of repeating units 810 that are interconnected with one another at junctions or nodes 814. The repeating units 810 are each formed from a plurality of interconnected struts 816, each having a first portion 818 and a second portion 820. Some of the struts 816 may also include third portions 821 extending from respective second portions of the struts and interconnected with one another to form junctions or nodes 814. As discussed in more detail below, the adjunct 800 can exhibit varying stiffness and movement based on the amount and direction of stress applied to the adjunct during use. Thus, the adjunct has a variable stiffness profile such that when the adjunct is sutured to tissue, the adjunct can be configured to apply a stress at or above a minimum stress threshold for a predetermined time (e.g., a stress of 3g/mm ² over 3 days).

Further, as shown, the elongate body 806 includes a first planar array 808 of struts, and an additional planar array 808 _N positioned parallel to each other and to the planar array 808 (e.g., extending in the x-direction). In each array 808, 808 _N, braces 816 are substantially planar and extend coplanar with one another in a respective plane. Further, while each array 808, 808 _N may have a variety of configurations, in the illustrated embodiment, each array 808, _N is substantially symmetrical about a mid-plane. That is, each array 808, 808 _N has two substantially identical rows 824a, 824b of repeating units 810.

While braces 816 may have a variety of configurations, in this illustrated embodiment, each brace 816 has a generally elongated planar configuration in which a first portion 818 of each brace 816 has a narrower width than a width portion of a second portion 820. Thus, brace 816 is wider in the middle (preferably along a majority of the length) and narrower at the ends. Alternatively, the first portion 818 may have a cross-section equal to or greater than a cross-section of the second portion 820. Further, as shown in fig. 8B, the second portion 820 of each strut 816 may have a substantially rectangular cross-sectional shape. It should be noted that other cross-sectional shapes of the stays and portions thereof are also contemplated herein. The cross-sectional shape of the struts may be used to limit movement of the adjunct in certain directions.

In fig. 8A, braces 816 are interconnected to one another at the ends of first portions 818 thereof to form junctions or nodes 822. In the illustrated embodiment, brace 816 and junction or node 822 may be formed from the same material. Thus, to enhance compression of the adjunct 800 under stress, the cross-section of the first portion 818 (also referred to as the necked down region) can flex as described in more detail below. Furthermore, third portion 821 of respective strut 816 is similarly structured like first portion 818 of strut 816, and thus, third portion 821 (also referred to as a necked-down region) may also flex as described in more detail below.

The material (e.g., more or less flexible) of the joint or node 822 relative to the stay 816 may, in part, control the amount and/or direction that the adjunct 800 moves under stress during use. Also, the material of the joint or node 814 may partially control the amount and/or direction that the adjunct 800 moves under stress during use. The junctions or nodes 814, 822 may be of any suitable shape. For example, in certain embodiments, the joints or nodes 814, 822 may be in the form of spherical features. In other embodiments, the joints or nodes 814, 822 may take the form of other geometries.

Braces 816 may be interconnected to one another at various angles. For example, in the illustrated embodiment, struts 816 intersect at an approximately 90 degree angle relative to adjacent struts 816. In other embodiments, struts 816 may intersect at an angle in the range of about 40 degrees to 130 degrees. In another embodiment, struts 816 may intersect at an angle in the range of about 10 degrees to 90 degrees. The angle at which braces 816 are connected to one another may at least partially control the manner and amount by which adjunct 800 responds under stress. That is, the movement and stiffness of the adjunct 800 can be at least partially a function of these angles.

As described above, the first portion 818 (and the third portion 821, if present) of each strut 816 may act as a flexible region (e.g., deflection point) of the adjunct. The first portion 818 of each strut provides one or more bending zones for each repeating unit 812, as shown in fig. 9A-9C. That is, when adjunct 800 is under stress, these necked areas allow brace 816 to bend around or adjacent to junction or node 822, and thus repeat unit 810 may partially or fully collapse upon itself. Similarly, the necked area forming the third portion 821 allows the repeating unit to bend around or adjacent the junction or node 814 when the adjunct is under stress. Accordingly, the compressibility of the adjunct 800 can vary based on different amounts and directions of applied stress. Such a change in compressibility may be desirable, for example, when suturing an adjunct to tissue and exposing to fluctuations in pressure within the tissue.

Fig. 9A-9C illustrate the compressive behavior of one repeat unit 810 of an adjunct 800 described herein under varying stresses. In particular, the repeating unit 810 is shown in fig. 9A in a pre-compressed (undeformed) state, in fig. 9B in a first compressed state under a first stress (S ₁), and in fig. 9C in a second compressed state under a second stress (S ₂). In this way, the repeating unit 810, and thus the adjunct 800, has a variable stiffness profile under different stresses. Those of ordinary skill in the art will appreciate that the appendages may have a variety of deployment heights throughout their use, and that the deployment heights are at least partially a function of the particular stresses applied to the appendages throughout their use.

As shown in fig. 9A-9B, when the repeating unit 810, and thus the adjunct 800 in fig. 8A, is under a first stress S ₁, a first portion 818 (e.g., necked area) of each strut 816 may bend around the junction or node 822. This allows the repeat unit 810 to compress from the pre-compressed state (fig. 9A) to the first compressed state (fig. 9B), thereby compressing the adjunct 800 from the pre-compressed height to the first deployed height. Further, depending on the amount of stress applied to the appendages, the second portions 820 of adjacent struts 816 may contact each other. This is shown in fig. 9B. In such cases, the first portion 818 of each strut 816 has thus reached the point of maximum deflection, thereby creating a greater stiffness resistance within the repeating unit 810. This is because the stiffness of the repeating unit 810, and thus the stiffness of the adjunct 800, increases as the adjunct 800 compresses. FIG. 10 is an exemplary graphical representation of the relationship between compression and stiffness of an appendage. Thus, any further compression of repeat unit 810 and thus of adjunct 800 will require additional applied stress.

In the event that a greater stress (e.g., second stress S ₂) is applied to the repeating unit 810 and thus to the adjunct 800 in fig. 8A, the increase in stiffness resistance can be overcome. To achieve this, brace 816 may be configured such that brace 816 may further bend around joint or node 822 when additional stress is applied. As shown in fig. 9C, such further bending may cause struts 816 to extend further outward in a direction transverse (L) to the direction of the applied stress, thereby causing second portions 820 of adjacent struts 816 to further contact each other. Thus, this allows the repeat unit 810 to compress to a second compressed state (fig. 9C), and thus the adjunct 800 to a second deployment height.

In some embodiments, the adjunct can include additional features that can prevent movement of tissue stapled to the adjunct. For example, fig. 11A-11B illustrate an exemplary adjunct 1100 that includes a plurality of surface features 1128 defined within a tissue-contacting layer 1102. As described in more detail below, the surface features 1128 may prevent slidable movement of the adjunct relative to tissue stapled to the adjunct. In one embodiment, at least a portion of surface features 1128 may prevent lateral sliding of adjunct 1100 relative to tissue. Alternatively or in addition, at least a portion of surface features 1128 may prevent longitudinal sliding of adjunct 1100 relative to tissue.

The illustrated exemplary adjunct 1100 includes a tissue contacting layer 1102 and an opposing cartridge contacting layer 1104. Adjunct 1100 also includes an elongate body 1106 having a plurality of struts 1116 extending between tissue contacting layer 1102 and cartridge contacting layer 1104. As shown, the tissue contact layer 1102 includes a plurality of surface features 1128a, 1128b defined therein. These surface features 1128 have a grid-like pattern with a first series 1128a extending longitudinally (e.g., parallel to the longitudinal axis of the adjunct) and a second series 1128b extending transversely (e.g., transverse to the longitudinal axis of the adjunct). Each surface feature 1128a, 1128b may have a triangular profile, or at least two surfaces that are angled relative to each other and clustered together to form an edge to penetrate into and engage tissue. These edges collectively define the outermost surface of tissue contacting layer 1102. These surface features 1128a, 1128b may engage tissue as the tissue is compressed into the tissue-contacting layer 1102 as the adjunct is sutured to the tissue. The orientation of the edges of the first series 1128a may prevent lateral sliding of the adjunct relative to the tissue and the orientation of the edges of the second series 1128b may prevent longitudinal sliding of the adjunct 1100 relative to the tissue. In addition, tissue contact layer 1102 includes a plurality of openings 1144 formed between the surface features 1128. In this way, when the adjunct is sutured to tissue, the plurality of openings 1144 can receive tissue therein to allow the surface features 1128 to engage the tissue.

While multiple struts 1116 may be interconnected to form various configurations, in this illustrated embodiment, multiple struts 1116 form a repeating X-pattern. In particular, the plurality of struts 1116 form a repeating cube unit. Each cube cell includes a top surface 1130 and an opposing bottom surface 1132. In the illustrated embodiment, the top surface 1130 and the bottom surface 1132 are substantially identical. The cube unit also includes four side surfaces 1134 extending between and connecting the top surface 1130 and the bottom surface 1132. In the illustrated embodiment, the side surfaces 1134 are substantially identical. For clarity, not all surfaces of each illustrated cube cell are identified in fig. 11A-11B. The side surfaces 1134 may have various shapes, for example, as shown, each side surface 1134 has an X-shape that extends from the top surface 1130 to the bottom surface 1132. As such, a first end of each stay 1116, 1116a terminates at the tissue contacting layer 1102 and a second end of each stay 1116, 1116a terminates at the cartridge contacting layer 1104. Each X may be formed of two elongated, generally planar struts intersecting at a mid-section. In addition, each repeating cube unit may also include internal struts that extend between two opposing side surfaces 1134 of the cube unit to form internal connectivity features 1138. As shown, the internal connectivity features 1138 may extend from a top 1134a of one side surface 1134 to a bottom 1134b of the opposite side surface 1134. As further shown, the internal connectivity features 1138 may extend in alternating directions between adjacent cube units. For example, as shown in fig. 11B, a first internal connectivity feature 1138 may have an upper end 1138a that extends from a top 1134a of one side surface 1134 to a lower end 1138B at a bottom 1134B of the opposite side surface 1134, and an adjacent cube cell may have a second internal connection feature 1138 that has a lower end 1138c that extends from the same bottom 1134B of the side surface 1134 to an upper end 1138d at a top 1134c of the opposite side surface 1134. The internal connectivity features 1138 may provide geometry to the adjunct 1100 that may facilitate movement of the adjunct 1100 in a predetermined direction under an applied stress. For example, in one embodiment, the internal connectivity features 1138 may substantially prevent the adjunct 1100 from shearing under an applied stress.

While each strut and interconnectivity feature 1138 may have a variety of configurations, in this exemplary embodiment, each strut 1116, 1116a and interconnectivity feature 1138 is in the form of a beam or column having a width (W) that is greater than a depth (D) such that each strut/interconnectivity feature is constrained to bend in a predetermined direction, i.e., in and out of a plane extending along the width (W). Further, the struts 1116, 1116a and the interconnectivity feature 1138 may each include at least one opening 1140 extending therethrough to facilitate bending in a predetermined direction. For clarity, not all openings 1140 extending through each strut 1116 and interconnectivity feature 1138 are identified in fig. 11A-11B. The openings 1140 may be of various shapes, for example, as shown, the openings 1140 are diamond-shaped. It is also contemplated that the shape of the openings 1140 may vary between struts. The openings 1140 may also be aligned throughout the appendage. For example, openings in adjacent cube units extending through opposing sidewalls longitudinally spaced along the length of the adjunct can be longitudinally aligned, and similarly, openings in adjacent cube units extending through opposing sidewalls laterally spaced along the width of the adjunct can be laterally aligned.

Alternatively or in addition, the attachment may include a coupling member that connects at least a portion of the joints or nodes to one another, thereby increasing the rigidity of the attachment. That is, the coupling member may be incorporated into the adjunct so as to prevent movement (e.g., splaying) of the adjunct in a plane in which the coupling member extends.

For example, fig. 12A-12B illustrate an exemplary embodiment of an adjunct 1200 having a linking member 1246. In particular, the adjunct 1200 includes an elongated body 1206 formed from a plurality of struts 1216 that are interconnected at junctions or nodes 1222. The elongate body 1206 has a tissue contacting surface 1202 and an opposing cartridge contacting surface 1204. As shown, at least a portion of these joints or nodes 1222 are interconnected to one another by a linking member 1246. In this illustrated embodiment, the coupling member 1230 extends in a first direction (e.g., the y-direction as shown in fig. 12) and the struts 1216 extend in a second direction (e.g., a lateral direction, such as about 45 degrees relative to the y-direction, as shown in fig. 12) that is different from the first direction. Thus, the position of the coupling member 1246 relative to the struts 1216 can provide the attachment 1200 with a geometry that can be configured to prevent movement of the attachment 1200 in at least one direction (e.g., a direction parallel to the direction in which the coupling member 1246 extends).

In some embodiments, the joints or nodes may be formed of a material different from the material of the struts. For example, the material of the joints or nodes may be more flexible than the material of the struts, thereby increasing the compressibility of the appendages. Further, the more flexible joints or nodes may also allow the appendages to compress without substantial shearing. This is because the more flexible joints or nodes provide preferential bending areas for the appendages, thereby reducing the stiffness of the appendages. In one embodiment, the junctions or nodes may be formed from a polycaprolactone copolymer, while the struts may be formed from a lactide-glycolide copolyester or polydioxanone.

Fig. 13A-13B illustrate another exemplary embodiment of an adjunct 1300 that includes repeat units 1310 interconnected with each other at a junction or node 1314. The repeating units 1310 are each formed of a plurality of struts 1316 (e.g., four struts) interconnected at joints or nodes 1322. Adjunct 1300 can be similar to adjunct 800 (fig. 8A) except for the differences described in detail below, and thus will not be described in detail herein. In the illustrated embodiment, the junctions or nodes 1314, 1322 are formed of a material that is different from the material of the struts 1316. The material of the joints or nodes 1314, 1322 may be more flexible than the material of the struts 1316. As shown, each junction or node 1314, 1322 may be in the form of a rod 1348 that extends across all of the arrays 1308, 1308 _N in a direction that is generally perpendicular to the plane in which the struts extend (e.g., the rod may extend in the x-direction as shown in fig. 13A-13B). That is, the rod 1348 can extend transversely relative to the longitudinal axis of the cartridge body (e.g., cartridge body 606 in fig. 6) when the adjunct 1300 is attached to the cartridge body.

In some embodiments, as shown in fig. 13A-13B, the ends of the first portion 1318 of the struts 1316 may also be directly connected to one another within a junction or node 1322. Alternatively or in addition, ends of third portions 1321 of struts 816 may also be directly connected to one another within junction or node 1314. This direct connection may help prevent stay 1316 from pulling out of joint or node 1322 as stay 1316 flexes when adjunct 1300 is under stress. Due to this direct connection, the bending of one stay may also affect the bending of the other stay. Further, these joints or nodes 1322 may be more flexible, and therefore more compliant, than joints or nodes 822 in fig. 8A, and thus adjunct 1300 may be more easily compressed than adjunct 800. Thus, at the same given stress, the adjunct 1300 will achieve a greater displacement (i.e., compression to a lower deployment height) than the adjunct 800 in fig. 8A.

Alternatively, the struts may be unconnected relative to each other within the joints or nodes, for example, as shown in fig. 14. For simplicity only, fig. 14 shows a single repeating unit 1400. In the illustrated embodiment, the braces 1416 are not directly connected to each other within the junctions or nodes 1422. Thus, bending of one strut may occur independently of bending of another strut. To prevent the braces 1416 from pulling out of the joints or nodes when the braces 1416 are bent around the joints or nodes 1422, each brace 1416 may have an end shape 1450 configured to maintain the connection of the brace to the joint or node 1422. Further, the junction or node 1422 may be more flexible, and thus more compliant, than the junction or node 1322 in fig. 13A-13B, and thus the appendages formed by the various repeating units 1400 may be more easily compressed under a given stress. That is, an appendage having this illustrated strut and joint or node configuration can achieve greater displacement (i.e., compress to a lower height) than the appendage 800 in fig. 13-13A at the same given stress.

In some embodiments, the adjunct can further include at least one stop element configured to limit an amount of compression of the adjunct. Fig. 15 shows an exemplary embodiment of an attachment 1500 having at least one stop element 1552. The adjunct 1500 can be similar to the adjunct 1300 (fig. 13A-13B) except for the differences described in detail below, and thus will not be described in detail herein.

In fig. 15, each strut 1516 may have a stop element 1552 extending from or positioned adjacent to a surface of its second portion 1520. When adjunct 1500 is compressed, struts 1516 can bend around junctions or nodes 1514, 1522 until stop elements 1552 contact one another. Once these stop elements 1552 abut one another, any further bending of the struts 1516 will be inhibited. That is, these stop elements 1552 act as deflection stops that allow the adjunct 1500 to compress to a first deployment height at a first stiffness under a given stress. Upon reaching the first compressed height, stop element 1552 bottoms out and inhibits further deflection of struts 1516 and, thus, further compression of adjunct 1500. Once stop element 1552 bottoms out, more stress needs to be applied to effect further bending of stay 1516 about junctions or nodes 1514, 1522, thereby further compressing adjunct 1500.

It should be noted that while various stop elements 1552 are shown in fig. 15, it is contemplated herein that fewer or more stop elements may be included in the overall adjunct 1500. Further, the shape, size, and position of the stop element 1552 are not limited by this illustrated embodiment, and thus may be varied to control the amount of compression desired.

As described above, the elongate body may include a plurality of struts having a variety of shapes. For example, fig. 16 shows an exemplary appendage 1600 having an elongate body 1606 that includes a plurality of struts 1616 that are substantially helical. Thus, each repeating geometric unit is in the form of a spiral or coil. In this embodiment, elongate body 1606 is positioned between tissue contact layer 1602 and cartridge contact layer 1604. As shown, each layer 1602, 1604 is a generally planar solid layer having openings 1626. At least a portion of these openings 1626 are aligned with openings 1615 defined by each of the braces 1116. The thickness of each layer may vary. The stay 1616 is configured to have a predetermined compression height to limit the amount of compression of the adjunct. Furthermore, given their shape, these stays 1616 may be configured to function as springs. Thus, similar to the spring constant, a specific stiffness may be given to each stay 1616 based on its shape. Thus, the compressibility of the adjunct 1600 can also depend on the particular stiffness of each strut 1616, which depends on both the material and shape of the strut 1616.

As shown in fig. 8A, 11A-13B, and 15-16, each adjunct 800, 1100, 1200, 1300, 1500, 1600 can include an opening 826, 1140, 1144, 1226, 1326, 1526, 1626. The openings may be configured to promote cellular ingrowth within each adjunct. These openings may define the void fraction of the appendages. In some embodiments, the void fraction may be about 15% to 95%, while in other embodiments, the void fraction may be about 75% to 90%. As used herein, "opening" is used synonymously with "void". In addition, the adjunct can have a surface area to volume ratio of about 1:100 to 1:5. In some embodiments, the adjunct can have a surface area to volume ratio of about 1:10.

The openings may also be located in different parts of the attachment. Each opening may have a size that extends at least partially through the component. In certain embodiments, as shown in fig. 8A, 11A-13B, and 15-16, the openings 826, 1140, 1444, 1226, 1326, 1526, 1615, 1626 may be present within a tissue contacting surface or layer, a cartridge contacting surface or layer, and/or an elongate body. In the illustrated embodiments, the openings extend entirely through their respective components. Within the elongate body, these openings may be defined by interconnecting struts. Furthermore, the openings may also be interconnected throughout the adjunct to form a substantially continuous network of openings or channels. Further, as shown in fig. 11A-11B, an opening 1126 may also exist within the internal connectivity feature 1138.

The openings may have varying sizes and/or shapes. For example, larger openings may allow tissue (and cells) to penetrate into the appendages, while smaller openings may trap cells within the appendages to promote cell ingrowth. In this way, variable opening sizes throughout the appendages may promote extracellular remodeling. That is, when the appendages are implanted, the variable opening size may promote revascularization and mobility of cells within the appendages, thereby promoting both tissue and cell ingrowth. In addition, the variable opening size may also facilitate extraction of byproducts and cellular waste from the implanted appendages and thus from the implantation site. In some embodiments, the opening is substantially circular.

In embodiments in which the openings are located within the tissue contacting surface or layer and the elongate body, such as in fig. 8A, 11A-13B, and 15-16, the openings may each have a diameter of about 70% to 170% of the staple leg diameter of the staples (e.g., staples 406 in fig. 4-5). The openings in the tissue contacting surface and in the elongate body may be of various sizes. For example, in some embodiments, the openings in the tissue contacting surface may each have a diameter of about 100 μm to 1000 μm. In one embodiment, the openings in the tissue contacting surface may each have a diameter of at least about 14 μm. The openings in the elongate body may each have a diameter of about 200 μm to 610 μm or about 400 μm to 1000 μm. As used herein, the "diameter" of an opening is the maximum distance between any pair of vertices of the opening.

Further, in some embodiments, the openings in the tissue contacting surface or layer may be configured to allow one or more portions of tissue to penetrate or compress into the tissue contacting surface or layer (e.g., openings 1144, 1226, 1626). In this way, slidable movement of the adjunct relative to the tissue can be substantially prevented when the adjunct is sutured to the tissue and the tissue is compressed into the opening, as described above.

In other embodiments, the adjunct can be configured to enhance advancement of the staple legs through the adjunct. For example, the adjunct can have openings that align with the direction of advancement of the staple legs into and partially through the adjunct. The opening may extend partially or completely through the appendage. Thus, the openings can act as guides as the staple legs are advanced through the adjunct to minimize damage to the staples as well as the adjunct as the staples pass through the adjunct.

In some embodiments, as shown in fig. 17-19, the adjunct can include a plurality of struts in the form of posts. For example, in fig. 17, the posts may be substantially vertical and have different heights. Further, in other embodiments, as shown in fig. 19, the first set of posts may be substantially vertical and the second set of posts may be curved. The stays may be formed of the same or different materials. In some embodiments, the adjunct can include a plurality of first struts formed from a first material and a plurality of second struts formed from a second material.

In fig. 17, adjunct 1700 includes a plurality of struts 1716 in the form of substantially vertical posts. In particular, the struts 1716 extend from the cartridge contact layer 1704 toward, and in some cases to, the opposing tissue contact layer 1702. The plurality of struts 1716 includes a plurality of first vertical struts 1716a having a first height (Y), a plurality of second struts 1716b having a second height (Y ₁) that is less than the first height (Y), and a plurality of third struts 1716c having a third height (Y ₃) that is less than the second height (Y ₂). For simplicity, only a portion of the plurality of struts 1716 are shown in fig. 17. Although not shown, one of ordinary skill will appreciate that the tissue contacting layer 1702 and/or the cartridge contacting layer 1704 can include openings as described herein.

The different heights of these plurality of struts 1716 may provide different compressibility for the appendages. Fig. 18A-18C illustrate the compressive behavior of the attachment 1700 under different stresses. In particular, the adjunct 1700 is shown in fig. 18A at a pre-compressed height, in fig. 18B at a first compressed height (H ₁) at a first stress (S ₁), and in fig. 18C at a second compressed height (H ₂) at a second stress (S ₂). As shown, the first compression height (H ₁) is greater than the second compression height (H ₂), and thus the first stress (S ₁) is less than the second stress (S ₂). Those of ordinary skill in the art will appreciate that the appendages may have a variety of compression heights throughout their use, and that the compression heights are at least partially a function of the particular stresses applied to the appendages throughout their use.

As shown in fig. 18A-18C, as compression of the adjunct 1700 increases, the amount of stress required to achieve such compression increases. This is because additional struts are engaged as the adjunct 1700 compresses, thereby increasing the stiffness resistance of the adjunct 1700. For example, as shown in fig. 18B, under a first stress S ₁ applied to the adjunct 1700, a plurality of first struts 1716a and a plurality of second struts 1716B are joined. In contrast, when adjunct 1700 is under second stress S ₂, first plurality of struts 1716a, second plurality of struts 1716b, and third plurality of struts 1716c are joined, thereby creating a greater stiffness resistance.

Fig. 19 shows another exemplary embodiment of an adjunct 1900 having a plurality of struts 1916 in the form of substantially vertical posts 1916a or curved posts 1916 b. The substantially vertical column 1916a may be configured to support an initial stress applied to the adjunct 1900 and then deflect or buckle (e.g., at deflection point D in fig. 20) as the adjunct compresses. The curved post 1916b may be configured to provide a generally constant stiffness (i.e., substantially the offset of the entire curve shown in fig. 20 from the zero axis). This mechanical behavior of struts 1916 and, therefore, adjunct 1900 is graphically represented in fig. 20.

In other embodiments, the adjunct can include additional features. The following figures illustrate features that may be included on any of the appendages disclosed herein, and thus do not illustrate the specific configuration of the appendages, i.e., the configuration of the repeating units. Fig. 21A illustrates one embodiment of an adjunct 2100 having a channel 2108 formed therein that is configured to receive a cutting element, such as a knife.

As shown in fig. 21A, adjunct 2100 includes a first portion 2104 and a second portion 2106, each portion having an outer edge and an inner edge. The inner edges 2104a, 2106a define a channel 2108 extending between the first and second portions and along a longitudinal axis (L) of the adjunct 2100. The channel 2108 is configured to receive a cutting member, such as a knife. As shown in fig. 121B, the channel 21 does not extend completely through the height of the adjunct 2100. In particular, the channel 2108 does not extend through the cartridge contact surface 2110. In this manner, the adjunct 2100 can be configured with sufficient structural integrity to be effectively maneuvered and attached to a cartridge body, such as cartridge body 2214 in fig. 21B. In use, when the cutting member is initially fired and advanced along the adjunct, the cutting member cuts through the channel, separating the first and second portions, and thus separating the adjunct 2100 into two separate pieces.

Further, as shown in fig. 21A, the adjunct 2100 includes a flange 2112 that is configured to mate with the cartridge body 2214 in fig. 21B, as described further below. Although fig. 21A shows the adjunct 2100 having a flange 2112 on one side of the adjunct 2100, there can be additional flanges 2112 on the opposite side of the adjunct 2100. Those skilled in the art will appreciate that the number and placement of flanges 2112 is not limited to that shown in fig. 21A. While flange 2112 can be made of a variety of materials, in some embodiments, as shown in fig. 21A, flange 2112 can be an extension of the cartridge contact surface 2110. Those skilled in the art will appreciate that the flange may be formed in-line with the appendage (e.g., as part of a 3D printing process), or alternatively formed off-line and then applied to the appendage a second time.

Fig. 21B illustrates an embodiment of a staple cartridge assembly 2200. Cartridge assembly 2200 may be similar to cartridge assembly 600 (fig. 6) except for the differences described in detail below, and thus, will not be described in detail herein. Further, for simplicity, certain components of cartridge assembly 2200 are not shown in fig. 21B.

The staple cartridge assembly 2200 includes the adjunct 2100 of fig. 21A attached to the cartridge body 2214. The adjunct 2100 can be attached to the cartridge body 2214 using any suitable method, as described in more detail below. In this embodiment, cartridge body 2214 includes a recessed channel 2216 configured to receive flange 2112 on the appendages such that flange 2112 may engage a side of cartridge body 2214. In this way, the adjunct 2100 can be more securely attached to the cartridge body, preventing unwanted movement of the adjunct 2100 during use.

In another embodiment, as shown in fig. 22, adjunct 3000 can have a channel 3008 having one or more openings 3010 (e.g., perforated) extending therethrough, thereby forming at least one bridging member 3012. As such, the first and second portions 3014 and 3016 of the adjunct 3000 are selectively connected by the at least one bridging member 3012. In use, when the cutting member is initially fired and advanced along the adjunct 3000, the cutting member cuts through the at least one bridging member 3012, thereby separating the first and second portions 3014, 3016 and thus separating the adjunct 3000 into two separate pieces.

In some embodiments, the cartridge body (e.g., cartridge body 2214 in fig. 21B) and the adjunct (e.g., adjunct 3000 in fig. 22) can include complementary stiffening features that can be configured to prevent tearing of the adjunct outside the channel when the cutting element is moved through adjunct 3000. For example, the reinforcing features of the cartridge body can be cylindrical recessed openings positioned adjacent to slots in the cartridge body, and the reinforcing features of the adjunct can be cylindrical protrusions positioned adjacent to the at least one bridging member in the first and second portions of the adjunct. In this way, the cylindrical protrusions of the tag will extend into the recessed openings of the cartridge body when the tag is placed on top of the cartridge body. It is also contemplated that the protrusions and recessed openings may take the form of other various shapes.

The scaffold can be applied to the cartridge body using any suitable method to form a staple cartridge assembly. For example, in some embodiments, the method can include attaching the compressible bioabsorbable adjunct to a cartridge body of a surgical stapler. In one embodiment, attaching the adjunct to the cartridge body can include placing a cartridge contacting surface of the adjunct against a surface of the cartridge body, as described above, so as to insert a flange of the adjunct into a recessed channel of the cartridge body. In another embodiment, the method may further comprise coating a surface of the cartridge body with an adhesive prior to attaching the adjunct to the cartridge body.

The devices disclosed herein may be designed to be disposed of after a single use, or they may be designed for multiple uses. In either case, however, the device may be reused after at least one use, after repair. Dressing may include any combination of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly steps. In particular, the device is removable and any number of particular parts or components of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular parts, the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that the finishing assembly may be disassembled, cleaned/replaced, and reassembled using a variety of techniques. The use of such techniques and the resulting finishing assembly are within the scope of the application.

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

Claims

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

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

A three-dimensional compressible adjunct formed from a matrix comprising at least one molten bioabsorbable polymer and configured to be releasably retained on the body such that the adjunct can be attached to tissue by the plurality of staples in the body, wherein the adjunct has a first stiffness when compressed by a first amount and a second stiffness when compressed by a second amount greater than the first amount;

Wherein the adjunct has a plurality of interconnecting struts, each of the plurality of interconnecting struts having two bending regions, a first bending region configured to bend when the adjunct is compressed a first amount and a second bending region configured to bend when the adjunct is compressed a second amount; and

Wherein each of the plurality of interconnected struts includes a first section having a first width and a second section having a second width that is greater than the first width such that each strut is wider along a majority of its length.

2. The suturing assembly of claim 1, wherein the adjunct comprises at least one stop element configured to limit an amount of compression of the adjunct.

3. The suturing assembly of claim 1, wherein the at least one molten bioabsorbable polymer is selected from the group consisting of: thermoplastic absorbable polyurethanes, ultraviolet curable absorbable polyurethanes, poly (lactic acid), polycaprolactone, polyglycolide, polydioxanone, poly (lactic-co-glycolic acid), polyglycolic acid, trimethylene carbonate, glycolide, polydioxanone, polyesters, copolymers thereof, and combinations thereof.

4. The suturing assembly of claim 1, wherein the adjunct is configured to apply a stress of at least 3gf/mm ² to tissue being sutured to the adjunct for at least 3 days when the adjunct is in a tissue deployed state.