CN112040882A - Three-dimensional appendages - Google Patents

Abstract

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

Description

Three-dimensional appendages

Technical Field

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

Background

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

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

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

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

Disclosure of Invention

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

In an exemplary embodiment, a stapling assembly is provided and can include a body having a plurality of staples disposed therein. The plurality of staples can be configured to be deployed into tissue. The body may have a first end, a second end, and a longitudinal axis extending therebetween. The stapling assembly can also include a three-dimensional compressible adjunct formed from a matrix including 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 tissue contacting surface, a body contacting surface opposite the tissue contacting surface, and an internal structure extending between the tissue contacting surface and the body contacting surface. A void may be present in the tissue contacting surface and in the internal structure to allow a portion of the tissue to penetrate the tissue contacting surface and into the internal structure when the adjunct is attached to the tissue by the plurality of staples.

In one aspect, the adjunct can be configured to apply at least about 3g/mm to tissue sutured to the adjunct when the adjunct is in a tissue deployed state²For at least 3 days.

The voids may have a variety of configurations. For example, the voids may have varying sizes. In one embodiment, at least a portion of the voids may each have a diameter that is about 70% to 170% of the diameter of the leg of each staple of the plurality of staples. In another embodiment, the voids within the inner structure may each have a diameter in the range of about 200 μm to 610 μm. In yet another embodiment, the voids within the tissue contacting surface can each have a diameter of at least about 14 μm.

In some aspects, the internal structure may include a void extending vertically between the tissue-contacting surface and the body-contacting surface. The voids may be configured to enhance the advancement of the staple legs through the internal structure.

In certain aspects, the inner structure may include a plurality of interconnected struts that define voids in the inner structure. In one embodiment, the plurality of interconnecting struts may include a bending region, which may be configured to bend to allow the adjunct to compress. In another embodiment, at least a portion of the plurality of interconnecting struts may each have a variable cross-section.

In some aspects, the voids form a substantially continuous network of openings throughout the adjunct. In other aspects, the voids can be configured to limit movement of the tissue along the tissue contacting surface in a direction substantially parallel to the longitudinal axis of the body.

In one aspect, voids may be present in the body contacting surface, wherein each void may have a dimension that extends at least partially through the body contacting surface.

In another exemplary embodiment, a stapling assembly can 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 stapling assembly can also include a three-dimensional compressible adjunct formed from a matrix including 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 include a lattice structure having a tissue contacting surface and a body contacting surface. Openings of varying sizes may be present within the inner grid structure to form a substantially continuous network of channels to promote tissue growth.

In one aspect, at least a portion of the opening may extend through the body contact surface. In another aspect, the lattice structure can include a flexure zone configured to flex to allow the appendage to compress.

In certain aspects, the adjunct can be configured to apply at least about 3g/mm to tissue sutured to the adjunct when the adjunct is in a tissue deployed state²For at least 3 days.

Drawings

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

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

FIG. 2 is a perspective view of a wedge sled of a 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 may be disposed within a 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 platform;

FIG. 7 is a schematic view showing the adjunct of FIG. 6 in a tissue deployed condition;

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

FIG. 8B is an enlarged view of the repeating unit of the adjunct shown in FIG. 8A, taken at 8B;

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

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

FIG. 9C is a schematic view of the repeating 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 appendage;

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

FIG. 11B is a perspective cross-sectional view of the appendage shown in FIG. 11A taken at 11B;

FIG. 12A is a perspective view of another exemplary embodiment of an adjunct having a plurality of interconnecting struts and coupling members;

FIG. 12B is an enlarged view of the repeating unit of the adjunct 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 repeating unit of the appendage shown in FIG. 13A taken at 13B;

FIG. 14 is a perspective view of yet another exemplary embodiment of a repeating unit having end-shaped interconnecting struts;

FIG. 15 is a perspective view of an adjunct having a plurality of struts and at least one stop element in accordance with 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 adjunct including a plurality of struts in the form of vertical posts having different lengths;

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

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

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

FIG. 19 is a side view of an exemplary embodiment of an adjunct 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 appendage shown in FIG. 19 within a compression range;

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 a cartridge body; and is

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. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

Moreover, in the present disclosure, similarly named components in various embodiments typically have similar features, and thus, in a particular embodiment, each feature of each similarly named component is not necessarily fully set forth. Further, 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 the equivalent dimensions of such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and 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 a handle of an instrument. Other spatial terms such as "anterior" and "posterior" similarly correspond to distal and proximal, respectively. It will also be appreciated that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein in connection with the illustrations. However, surgical instruments are used in many orientations and positions, and these spatial terms are not intended to be limiting and absolute.

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

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

Surgical stapling assemblies, methods of making the same, and methods for stapling tissue are provided. In general, a stapling assembly is provided having a body (e.g., a staple cartridge or an end effector body) with a plurality of staples disposed therein. The suturing assembly also includes 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. The adjunct can be releasably retained on the body such that at least a portion of the adjunct can attach to tissue captured by the staples as the staples are deployed from the body and into the tissue. As discussed herein, the adjunct can be configured to compensate for changes in tissue properties (such as changes in tissue thickness), and/or to promote tissue ingrowth when the adjunct is sutured to tissue. For example, the adjunct can be configured to apply at least about 3g/mm to tissue when in a tissue deployed state (e.g., when the adjunct is sutured to tissue in vivo)²For at least 3 days.

An exemplary stapling assembly may include various features to facilitate the application of surgical staples, as described herein and shown in the figures. However, those skilled in the art will appreciate that the stapling assembly may include only some of these features and/or it may include a plurality of other features known in the art. The 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 recharger 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 illustrated surgical stapling and severing instrument 100 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 that forms 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 insertion of the staple applying assembly 106 through a trocar. While the instrument 100 is configured to staple and sever tissue, surgical instruments configured to staple but not sever tissue are also contemplated herein.

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

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

Additional details regarding the surgical stapling and severing 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. Further, the surgical stapling and severing instrument need not include a handle, but rather includes a housing configured to be connected to a surgical robot, for example, as described in U.S. application No. 15/689,198 filed 2017, 8, 29 to Frederick e.

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 in fig. 1. The firing assembly 228 can 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 in fig. 1) into tissue captured between an anvil (e.g., anvil 102 in fig. 1) and an elongate staple channel (e.g., channel 104 in fig. 1). Further, an E-beam 233 at a distal portion of the firing assembly 228 can fire staples from the staple applying assembly as well as 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 a bottom pin or foot 240. The E-beam 233 can further include a sharpened cutting edge 242 configured to sever captured tissue as the firing assembly 228 is advanced distally. In addition, a proximally projecting integrally formed top guide 244 and middle guide 246 that bracket 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 middle guide 246 can also be used to engage and fire the staple applying assembly through a stepped central member 250 that abuts a wedge sled 230 that effects staple formation through the staple applying assembly.

Referring to fig. 4, a staple cartridge 400 can be used with a surgical stapling and severing instrument, such as the surgical stapling and severing instrument 100 of fig. 1, and can comprise a cartridge body 402 and a plurality of staple cavities 404 within the 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, unformed) configuration. The staple cartridge 400 may further comprise a longitudinal channel that may be configured to receive a firing and/or cutting member, such as an E-beam (e.g., E-beam 233 in FIG. 3).

Each nail 406 may include a crown (base) 406_CAnd from crown 406_CExtended leg or legs 406_L. Crown 406 of staple 406 prior to deployment of staple 406_CCan be supported by staple drivers 408 positioned within the staple cartridge 400 and, at the same time, the legs 406 of the staples 406_LCan be at least partially received within the staple cavity 404. Further, when the staples 406 are in their unfired positions, the staple legs 406 of the staples 406_LMay extend beyond tissue contacting surface 410 of staple cartridge 400. In some cases, as shown in FIG. 5, the staple legs 406_LMay be sharp, which may 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 nail as its own coating or incorporated into another coating, such as a lubricant. Non-limiting examples of suitable antimicrobial agents include 5-chloro-2- (2, 4-dichlorophenoxy) phenol, chlorhexidine, silver preparations (such as nanocrystalline silver), arginine ethyl Laurate (LAE), octenidine, polyhexamethylene biguanide (PHMB), taurolidine, lactic acid, citric acid, acetic acid, and salts thereof.

The staples 406 can be deformed from an unfired position to a fired position such that the legs 406_LMoves through the staple cavities 404, penetrates tissue positioned between an anvil (such as the anvil 102 in fig. 1) and the staple cartridge 400, and contacts the anvil. When the leg 406_LUpon deformation against the anvil, the legs 406 of each staple 406_LA portion of tissue may be captured within each staple 406 and a compressive force applied to the tissue. In addition, the legs 406 of each peg 406_LMay be directed toward the crown 406 of the nail 406_CDeformed downwardly to form a staple trapping region in which tissue can be captured. In various instances, a staple entrapment area can be defined between an inner surface of the deformed leg and an inner surface of the crown of the staple. The size of the staple entrapment area may depend on several factors, such as the length of the legs, the diameter of the legs, the width of the crown, and/or the degree of leg deformation.

In use, an anvil, such as the anvil 102 of FIG. 1, may be moved to a closed position by depressing a closure trigger, such as the closure trigger 116 of FIG. 1, to advance an E-beam, such as the E-beam 233 of FIG. 3. The anvil can position tissue against the 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, 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, as described above. When the firing assembly, such as the firing assembly 228 of FIG. 3, is advanced, the sled can contact the staple drivers 408 and lift the staple drivers 408 upwardly within the staple cavities 404. In at least one example, the sled and staple drivers 408 can each comprise one or more ramps or inclined surfaces that can cooperate to move the staple drivers 408 upwardly from their unfired positions. As the staple drivers 408 are lifted upward within their respective staple cavities 404, the staples 406 are advanced upward such that the staples 406 emerge from their staple cavities 404 and penetrate into the tissue. In various instances, as part of the firing sequence, the sled can simultaneously move several staples upward.

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

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

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

Alternatively or additionally, the three-dimensional printed adjunct can be configured to promote tissue ingrowth. In various instances, it is desirable to promote tissue ingrowth in an implantable adjunct to promote healing of the treated tissue (e.g., sutured 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 implanted adjunct can control the spread of infection, for example, at the surgical site. The ingrowth of blood vessels, and particularly white blood cells, for example, in and/or around the implanted adjunct can counteract infection in and/or around the implanted adjunct and adjacent tissues. Tissue ingrowth can also facilitate the receipt of foreign objects (e.g., implantable appendages and staples) by the patient's body and can reduce the likelihood that the patient's body will reject foreign objects. Rejection of foreign material may result in 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 may 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, the variability of both the microstructure and the accompanying properties of the adjunct is reduced compared to conventional woven adjuncts. For example, these three-dimensional printed appendages may be structured such that they compress a predetermined amount in a substantially uniform manner. Fine control over the microstructure may also allow tailoring of the porosity of the adjunct to enhance tissue ingrowth. Further, these three-dimensional printed appendages may be adapted for use with a variety of staples and tissue types.

Generally, the appendages provided herein are designed and positioned on top of a body (such as the cartridge body 402 in fig. 4). When the staples are fired (deployed) from the body, the staples penetrate the adjunct and enter 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, when the staples are fired into the tissue, at least a portion of the adjunct becomes positioned between the tissue and the fired staples. While the adjunct described herein can be configured to attach to a cartridge body of a staple cartridge assembly, it is also contemplated herein that the adjunct can be configured to mate with other instrument components, such as jaws of a surgical stapler. One of ordinary skill in the art will appreciate that the adjunct provided herein can be used with replaceable cartridge or non-cartridge based staple reloaders.

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 therefore, will not be described in detail herein. As shown, adjunct 604 is positioned against staple cartridge 602. The staple cartridge can comprise a cartridge body 606 and a plurality of staples 608, such as staples 406 shown in fig. 4 and 5, disposed therein. The pins 608 may be of any suitable unformed (pre-deployed) height. For example, the pins 608 may have an unformed height of between about 2mm and 4.8 mm. Prior to deployment, the crowns of the staples 608 may be supported by staple drivers 610.

In the exemplified 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 comprise 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 may be found in U.S. patent publication 2016/0106427, which is incorporated herein by reference in its entirety.

The adjunct 604 can be compressed to allow the adjunct to compress to varying heights, thereby compensating for varying tissue thicknesses captured within the deployed staples. The adjunct 604 has an uncompressed (undeformed) or pre-deployed height and is configured to be deformable to one of a plurality of compressed (deformed) or deployed heights. For example, the adjunct 604 can have an uncompressed height that is greater than a fired height of the staples 608 (e.g., the height (H) of the fired staples 608a in fig. 7). That is, the adjunct 604 can have an undeformed state in which a maximum height of the adjunct 604 is greater than a maximum height of the fired staples 608a (i.e., staples in the formed configuration). In one embodiment, the uncompressed height of the adjunct 604 can be about 10% higher, about 20% higher, about 30% higher, about 40% higher, about 50% higher, about 60% higher, about 70% higher, about 80% higher, about 90% higher, or about 100% higher than the fired height of the staples 608. In certain embodiments, for example, the uncompressed height of the adjunct 604 can be more than 100% higher than the fired height of the staples 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, the 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 trapped region 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 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 the tissue captured within the staples is the same or different within each fired staple. In at least one exemplary embodiment, the staples within a staple line or row can be deformed such that the fired height is, for example, about 2.75mm, wherein the tissue (T) and adjunct 604 can be compressed within this height. In some cases, the tissue (T) may have a compressed height of about 1.0mm, and the adjunct 604 may have a compressed height of about 1.75 mm. In some cases, the tissue (T) may have a compressed height of about 1.50mm, and the adjunct 604 may have a compressed height of about 1.25 mm. In some cases, the tissue (T) may have a compressed height of about 1.75mm, and the adjunct 604 may have a compressed height of about 1.00 mm. In some cases, the tissue (T) may have a compressed height of about 2.00mm, and the adjunct 604 may have a compressed height of about 0.75 mm. In some cases, the tissue (T) may have a compressed height of about 2.25mm, and the adjunct 604 may have a compressed height of about 0.50 mm. Thus, the sum of the compressed heights of the captured tissue (T) and the adjunct 604 can be equal to, or at least substantially equal to, the height (H) of the 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 capable of withstanding 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 to the tissue equal to or greater than 210mmHg (e.g., 3 g/mm)²) For a predetermined period of time (e.g., 3 days). Thus, the device is provided withIn certain embodiments, the adjunct can be configured to apply at least about 3g/mm to captured tissue²For at least 3 days. The adjunct is in a tissue deployed state when the adjunct is sutured to tissue in vivo. In one embodiment, the applied stress may be about 3g/mm². In another embodiment, the applied stress may be greater than 3g/mm². In yet another embodiment, the stress may be at least about 3g/mm²And applied to the captured tissue for more than 3 days. For example, in one embodiment, the stress may be at least about 3g/mm²And applied to the captured tissue for about 3 to 5 days.

To design a tissue culture device configured to apply at least about 3g/mm to captured tissue²The principle of hooke's law (F ═ kD) can be used as an adjunct to the stress at a predetermined time. For example, appendages having a stiffness (k) may be designed when the force (stress) applied to the captured tissue is known. Stiffness can be set 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 struts). Further, the adjunct can be designed to have a maximum amount of compressive displacement for a minimum tissue thickness (e.g., 1mm), and thus the length of displacement D can be a combination of the minimum tissue thickness (e.g., 1mm) plus the thickness of the adjunct when stapled to tissue at a given maximum staple height (e.g., 2.75 mm). For example, in one embodiment, the adjunct can be structured to have a height greater than a maximum molded suture height of 2.75mm, and can be compressed to a height of 1.75mm when sutured to tissue having a minimum thickness of 1 mm. Thus, the adjunct can vary in compressibility to maintain a constant length of displacement D such that the stiffness (k) and overall thickness (D) of the captured tissue and adjunct can apply 3g/mm to the captured tissue²Of the stress of (c). It should be noted that one of ordinary skill in the art will appreciate that the foregoing formula may be modified to account for temperature changes, for example, when bringing the adjunct from room temperature to body temperature after implantation.

In addition, the adjunct can be further developed toThe captured tissue provides a substantially continuous stress (e.g., 3 g/mm)²) A predetermined 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 overall thickness of the captured tissue and adjunct does not yield less than 3g/mm as possible²The manner in which the stress is applied varies.

The adjunct is sutured to the tissue under various suturing conditions (e.g., tissue thickness, height of the shaped staples, pressure within the tissue). Depending on the suturing conditions, it may be determined that the adjunct needs to be capable of being applied to tissue to prevent the effective force of the tissue tearing and leaking. For example, in one embodiment, the effective stress amount is at least about 3g/mm². In order for the adjunct to provide an effective force to the tissue, the adjunct can be designed to effectively compensate for various suturing conditions. In this way, the geometry of the adjunct can be customized to assume different compressed heights when sutured to tissue. Because there is a limited range of in-tissue pressure, tissue thickness, and formed staple height, a suitable geometry can be determined for the adjunct that, when stapled to tissue, can effectively apply a substantially continuous desired stress to the tissue under a range of stapling conditions (e.g., 3 g/mm)²) For a given amount of time (e.g., at least 3 days). That is, as described in greater detail below, the adjunct of the present invention is formed of a compressible material and is geometrically configured to allow the adjunct to be compressed to different heights in a predetermined plane when sutured to tissue. Furthermore, the response of such changes by the adjunct may also allow the adjunct to maintain its application of a continuous desired stress to tissue when the adjunct is exposed to fluctuations in pressure within the tissue, which may occur when the adjunct is sutured to tissue (e.g., peaks in blood pressure).

The adjunct can be manufactured by additive manufacturing (also referred to as three-dimensional printing or 3D printing). 3D printing is a high-speed additive manufacturing technique that can deposit various types of materials in a manner similar to a printer. That is, 3D printing is achieved by laying up successive layers of material to form a shape. To print, the printer reads the model design from the digital file and lays down successive layers of material to build a series of cross-sections. The layers, as determined by the model, are joined or automatically fused 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., stereolithography), in which the liquid photopolymer in VAT is selectively cured by light activated polymerization; a material spray, wherein droplets of the construction material are selectively deposited; binder jetting, wherein a liquid binder is selectively deposited to bond the powder material; powder bed diffusion (e.g., selective laser sintering), in which thermal energy selectively melts regions of the powder bed; direct energy deposition, where focused thermal energy is used to melt the material by melting as it is deposited; direct energy deposition, where focused thermal energy is used to melt the 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, in which 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 can 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 substrates may be in the form of a particulate substrate. In such cases, each particle matrix may be formed from fused particles (e.g., fused bioabsorbable polymer particles).

Generally, each matrix may 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 additionally, where the adjunct includes two or more substrates, each substrate can be formed from the same molten polymer or molten polymers that are different 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 or less flexible than the first molten polymer. In this way, the molten polymer may provide varying flexibility to the adjunct. Further, 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 the degradation rate.

Although 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. Other non-limiting examples of suitable bioabsorbable polymers include macromonomers of three-armed hydroxyl terminated PCL or poly DL-lactide with acrylate or methacrylate end group modification, PLA-PEG or polytrimethylene carbonate, PEG dimethyl or trimethacrylate or methacrylate, polypropylene fumarate, L-lactide/caprolactone copolymer, collagen infiltrated PLGA polymer, PCL-tricalcium phosphate (TCP), hyaluronic acid coated PLGA-TCP copolymer, PCL-PLGA-TCP, PLGA-PCL copolymers, PDS polymers and copolymers, PCL polymers and hyaluronic acid, PCL and β -tricalcium phosphate with collagen coating, polyvinyl alcohol, calcium phosphate/poly (hydroxybutyrate-co-valerate) and calcium hydroxyapatite/poly L-lactide.

For example, in some embodiments, the adjunct can be formed from various components, each component being formed from a matrix comprising 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., lactide-glycolide copolyester or polydioxanone), and a second component formed from a second matrix comprising at least one molten bioabsorbable polymer (e.g., polycaprolactone copolymer). The at least one molten bioabsorbable polymer of each matrix can include 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 adjunct desorbs/absorbs. In various embodiments, the pharmaceutically active agent can be released into a fluid, such as blood, that passes through or past 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 adjunct 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 is different 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 base material (e.g., molten bioabsorbable polymer). For example, the adjunct can be coated with a bioabsorbable polymer that improves structural stability. Alternatively or additionally, 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 manner, the life 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 adjunct can have a variety of configurations. In general, the adjunct can include a tissue contacting surface, an opposing body contacting surface (e.g., a cartridge contacting layer), and an elongated 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 elongated body is formed from a plurality of struts. The struts can have various configurations, and in certain exemplary embodiments, the struts can form interconnected repeating geometric units.

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

Further, in some embodiments, these surface features can extend in a direction substantially transverse to the longitudinal axis (L) of the body, such as the 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 can include bearing surfaces extending in a direction at least upward from the body, inward toward the central groove, and distally toward the second end of the body. Additional details of slip-resistant features in the form of ridges and grooves or bearing surfaces may 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 can be configured to pull tissue in opposite directions and thus provide a reverse resistance (e.g., lateral bias) to prevent tissue from sliding during stapling. For example, the tissue contact 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 first plurality of surface features and the second plurality of surface features may create a 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 pull tissue in opposite directions simultaneously.

The counter resistance can also be produced by surface bending. For example, the tissue contacting layer (or in the alternative, the entire appendage, for example) may be designed to have an elastic convex shape, and the surface features may 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 the surface features that now extend substantially perpendicularly outward from the tissue contacting layer engage the tissue. When the anvil returns to its open position, the tissue contacting layer returns to its convex shape, creating surface tension between the surface features that causes the engaged tissue to be simultaneously pulled in opposite directions.

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 can include surface features that can be designed to promote slippage (e.g., sliding movement) of tissue relative to the adjunct in a first predetermined direction and restrict movement in a second direction different from the first direction. Alternatively or additionally, the tissue contact layer may be coated with a material for increasing lubricity (e.g., sodium stearate or ethyl arginine laurate).

As described above, the adjunct is positioned on top of a body, such as cartridge body 606 (fig. 6). The fixation of the adjunct to the body can be enhanced before and during suturing. For example, the body contact layer (e.g., the cartridge contact layer) can include surface features configured to engage the body to substantially prevent the adjunct 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 mentioned above, the elongated body may be formed by a plurality of struts. These struts may form interconnected repeating geometric units 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 adjunct can 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. Therefore, attachThe stiffness of the belonging 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., 3 g/mm) will be present under various stapling conditions (e.g., tissue thickness, height of the shaped staple, pressure within the tissue)²) Applied to the tissue for at least a predetermined time (e.g., 3 days). Furthermore, the response to such changes by the adjunct can also desirably maintain a minimum amount of applied stress (e.g., 3 g/mm) when the adjunct is sutured to tissue and exposed to fluctuations in pressure within the tissue²)。

The struts can be designed in various configurations. For example, the struts may produce a lattice 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 thus the repeating units, 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 adjunct to compress in a first predetermined direction and restrict 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 additionally, 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 a varying cross-section. In addition, the material of the struts may also play a role in defining the movement of the appendages in a predetermined plane.

Fig. 8A-9C and 11A-19 illustrate various exemplary appendages that include a tissue-contacting surface, a cartridge-contacting surface opposite the tissue-contacting surface, and an elongated body formed by struts positioned therebetween. Each exemplary adjunct is shown in partial formThe length of the appendage (i.e., along its longitudinal axis L) can be longer, as identified in each embodiment, as will be understood by one of ordinary skill in the art. The length may vary based on the length of the staple cartridge. Further, each exemplary adjunct is configured to be positioned on top of the cartridge body such that a longitudinal axis L of each adjunct is aligned with a longitudinal axis (L) of the cartridge body_C) Aligned with and extending along the longitudinal axis. Each of these appendages may be formed from one or more matrices comprising 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 cellular 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. While it is contemplated that the tissue contacting surface 802, the cartridge contacting surface 804, and the elongate body 806 can each be formed from different materials, in the illustrated embodiment they are formed from the same molten bioabsorbable polymer. That is, the 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 interconnected to one another at junctions or nodes 814. The repeating units 810 are each formed from a plurality of interconnected struts 816, each strut having a first portion 818 and a second portion 820. Some of the struts 816 may also include third portions 821 that extend from respective second portions of the struts and interconnect with one another to form joints 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 stress at or above a minimum stress threshold for a predetermined time (e.g., 3g/mm in 3 days)²Stress of).

Further, as shown, the elongated body 806 includes a first planar array 808 of struts, and additional planar arrays 808 positioned parallel to each other and to the planar array 808 (e.g., extending in the x-direction)_N. At each array 808, 808_NThe struts 816 are substantially planar and extend coplanar with one another in respective planes. In addition, although each array 808, 808_NCan have a variety of configurations, but in the illustrated embodiment, each array 808, 808_NSubstantially symmetrical about a mid-plane. That is, each array 808, 808_NThere are two substantially identical rows 824a, 824b of repeat units 810.

While the struts 816 can have a variety of configurations, in the illustrated embodiment, each strut 816 has a generally elongated planar configuration with a first portion 818 of each strut 816 having a width that is narrower than a width portion of the second portion 820. Thus, brace 816 is wider in the middle (preferably along most of the length) and narrower at the ends. Alternatively, the first portion 818 may have a cross-section equal to or greater than the cross-section of the second portion 820. Further, as shown in fig. 8B, 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 struts and portions thereof are also contemplated herein. The cross-sectional shape of the stay may be used to limit movement of the appendage in certain directions.

In fig. 8A, struts 816 are interconnected to one another at the ends of first portions 818 thereof to form a joint or node 822. In the illustrated embodiment, struts 816 and junctions or nodes 822 may be formed from the same material. Thus, to enhance compression of the appendage 800 under stress, a cross-section of the first portion 818 (also referred to as a necked region) may be curved as described in more detail below. Furthermore, the third portion 821 of the respective strut 816 is similarly structured like the first portion 818 of the strut 816, and thus this 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 joint or node 822 relative to struts 816 can, in part, control the amount and/or direction that appendage 800 moves under stress during use. Likewise, the material of the joint or node 814 may, in part, control the amount and/or direction that the appendage 800 moves under stress during use. The joints or nodes 814, 822 may be 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.

The struts 816 may be interconnected to each other 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 can intersect at an angle in a range of about 10 degrees to 90 degrees. The angle at which struts 816 are connected to one another can at least partially control the manner and amount in which appendage 800 responds under stress. That is, the motion and stiffness of the appendage 800 can be at least partially a function of these angles.

As described above, first portion 818 (and third portion 821, where present) of each strut 816 can act as a flexible region (e.g., a deflection point) for the appendage. First portion 818 of each strut provides one or more curved regions for each repeating unit 812, as shown in fig. 9A-9C. That is, these necked down regions allow struts 816 to bend around or adjacent to joint or node 822 and thus repeat unit 810 may partially or fully collapse upon itself when accessory 800 is under stress. Similarly, when the appendage is under stress, the necked down region forming third portion 821 allows the repeat unit to bend around or adjacent to joint or node 814. Thus, 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 an adjunct is sutured to tissue and exposed to fluctuations in pressure within the tissue.

FIGS. 9A-9C illustrate the attachments described hereinThe compressive behavior of one repeating unit 810 of the generic 800 under different stresses. In particular, the repeating unit 810 is shown in a pre-compressed (undeformed) state in FIG. 9A and in a first stress (S) in FIG. 9B₁) A first compressed state of, and is shown in fig. 9C at a second stress (S)₂) A second compressed state of. As such, the repeating unit 810, and thus the appendage 800, has a variable stiffness profile under different stresses. One of ordinary skill in the art will appreciate that an appendage can have a variety of deployed heights throughout its use, and that the deployed height is at least partially a function of the particular stress applied to the appendage throughout its use.

As shown in fig. 9A-9B, when the repeating unit 810, and thus the appendage 800 in fig. 8A, is at a first stress S₁When down, a first portion 818 (e.g., a necked down region) of each strut 816 may be bent around a joint or node 822. This allows the repeating unit 810 to compress from the pre-compressed state (fig. 9A) to the first compressed state (fig. 9B), thereby compressing the appendage 800 from the pre-compressed height to the first deployed height. Further, depending on the amount of stress applied to the adjunct, the second portions 820 of adjacent struts 816 can contact each other. This is shown in fig. 9B. In such cases, first portion 818 of each strut 816 has thus reached the point of maximum deflection, thereby creating greater stiffness resistance within repeating unit 810. This is because the stiffness of the repeating unit 810, and thus the stiffness of the appendage 800, increases as the appendage 800 compresses. FIG. 10 is an exemplary graphical representation of the relationship between compression and stiffness of an appendage. Thus, any further compression of the repeat unit 810, and thus of the appendage 800, will require additional applied stress.

At greater stress (e.g. second stress S)₂) Applied to the repeating unit 810 and thus to the appendage 800 in fig. 8A, an increase in stiffness resistance can be overcome. To accomplish this, struts 816 may be configured such that when additional stress is applied, struts 816 may further bend about joint or node 822. Such further bending may result in a brace, as shown in fig. 9CThe strips 816 are stretched further outward in a direction transverse (L) to the direction of the applied stress, thereby causing the second portions 820 of adjacent struts 816 to further contact each other. This, therefore, allows the repeating unit 810 to compress to a second compressed state (fig. 9C), and thus the adjunct 800 to compress to a second deployed height.

In some embodiments, the adjunct can include additional features that can prevent movement of tissue sutured 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 can prevent slidable movement of the adjunct relative to tissue sutured to the adjunct. In one embodiment, at least a portion of the surface features 1128 can prevent lateral sliding of the adjunct 1100 relative to tissue. Alternatively or additionally, at least a portion of the surface features 1128 can prevent longitudinal sliding of the adjunct 1100 relative to tissue.

The illustrated exemplary adjunct 1100 includes a tissue contacting layer 1102 and an opposing cartridge contacting layer 1104. The adjunct 1100 also includes an elongate body 1106 having a plurality of struts 1116 extending between the tissue contacting layer 1102 and the 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 that extends longitudinally (e.g., parallel to the longitudinal axis of the appendage) and a second series 1128b that extends transversely (e.g., transverse to the longitudinal axis of the appendage). Each surface feature 1128a, 1128b may have a triangular profile, or at least two surfaces that are angled with respect to each other and brought together to form an edge to penetrate into and engage tissue. These edges collectively define the outermost surface of the tissue contact layer 1102. These surface features 1128a, 1128b may engage tissue as the tissue is compressed into the tissue contact 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, the tissue contact layer 1102 includes a plurality of openings 1144 formed between the surface features 1128. In this manner, the plurality of openings 1144 may receive tissue therein to allow the surface features 1128 to engage the tissue when the adjunct is sutured to the tissue.

While the plurality of struts 1116 may be interconnected to form various configurations, in the illustrated embodiment, the plurality of struts 1116 form a repeating X pattern. In particular, a plurality of struts 1116 form repeating cubic units. 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. Side surfaces 1134 may have various shapes, for example, as shown, each side surface 1134 has an X-shape extending from top surface 1130 to bottom surface 1132. Thus, a first end of each strut 1116, 1116a terminates at tissue contact layer 1102 and a second end of each strut 1116, 1116a terminates at cartridge contact layer 1104. Each X may be formed by two elongated, generally planar struts that intersect at a middle portion. In addition, each repeating cubic unit may also include internal struts that extend between two opposing side surfaces 1134 of the cubic 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, internal connectivity features 1138 may extend in alternating directions between adjacent cube cells. 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 opposing side surface 1134, and an adjacent cubic unit 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 the top 1134c of the opposing side surface 1134. The internal connectivity features 1138 may provide a geometry for the appendage 1100 that may facilitate movement of the appendage 1100 in a predetermined direction under an applied stress. For example, in one embodiment, the internal connectivity features 1138 may substantially prevent the appendage 1100 from shearing under an applied stress.

While each strut and interconnecting feature 1138 may have a variety of configurations, in the illustrative embodiment, struts 1116, 1116a and interconnecting feature 1138 are each in the form of a beam or column having a width (W) that is greater than depth (D) such that each strut/interconnecting feature is constrained to flex in a predetermined direction, i.e., in and out of a plane extending along width (W). Further, struts 1116, 1116a and 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 interconnecting 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 opening 1140 may vary between struts. The openings 1140 may also be aligned throughout the appendage. For example, openings in adjacent cubic units extending through opposing side walls longitudinally spaced apart along the length of the adjunct can be longitudinally aligned, and similarly, openings in adjacent cubic units extending through opposing side walls laterally spaced apart along the width of the adjunct can be laterally aligned.

Alternatively or additionally, the adjunct can include a linking member that connects at least a portion of the junctions or nodes to one another, thereby increasing the stiffness of the adjunct. That is, the coupling member may be incorporated into the adjunct such that the adjunct is prevented from moving (e.g., splaying) within a plane in which the coupling member extends.

For example, fig. 12A-12B illustrate an exemplary embodiment of an appendage 1200 having a coupling member 1246. In particular, the adjunct 1200 includes an elongate body 1206 formed by a plurality of struts 1216 interconnected at joints 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 coupling member 1246. In the illustrated embodiment, coupling member 1230 extends in a first direction (e.g., the y-direction as shown in fig. 12) and strut 1216 extends in a second direction different from the first direction (e.g., a transverse direction, such as about 45 degrees relative to the y-direction as shown in fig. 12). Thus, the position of the coupling member 1246 relative to the strut 1216 can provide a geometry for the attachment 1200 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 that 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 appendage. In addition, the more flexible joints or nodes may also allow the appendage to compress without substantially shearing. This is because the more flexible joints or nodes provide preferential bending areas for the appendage, thereby reducing the stiffness of the appendage. In one embodiment, the junctions or nodes may be formed from polycaprolactone copolymers, while the struts may be formed from lactide-glycolide copolyesters or polydioxanone.

Fig. 13A-13B illustrate another exemplary embodiment of an adjunct 1300 including a repeating unit 1310 interconnected to one another at a junction or node 1314. The repeating units 1310 are each formed by interconnecting a plurality of struts 1316 (e.g., four struts) at joints or nodes 1322. The adjunct 1300 can be similar to the adjunct 800 (fig. 8A) except for the differences described in detail below, and therefore, will not be described in detail herein. In the illustrated embodiment, the joints or nodes 1314, 1322 are formed from a material that is different than the material of the struts 1316. The material of the joints or nodes 1314, 1322 may be different than the struts 1316 is more flexible. As shown, each joint or node 1314, 1322 may be in the form of a bar 1348 that extends across all of the arrays 1308, 1308 in a direction that is generally perpendicular to the plane in which the struts extend_N(for example, the rod may extend in the x-direction as shown in fig. 13A-13B). That is, the rods 1348 can extend transversely relative to the longitudinal axis of the cartridge body (e.g., the 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 first portion 1318 of struts 1316 may also be directly connected to each other within joints or nodes 1322. Alternatively or in addition, the ends of the third portion 1321 of the struts 816 can also be directly connected to each other within a joint or node 1314. This direct connection may help prevent struts 1316 from pulling out of joints or nodes 1322 as struts 1316 bend when appendage 1300 is under stress. Due to this direct connection, the bending of one strut may also influence the bending of the other strut. Further, these joints or nodes 1322 may be more flexible, and thus more compliant, than the joints or nodes 822 in fig. 8A, and the adjunct 1300 may therefore be more easily compressed than the adjunct 800. As such, the appendage 1300 will achieve greater displacement (i.e., compression to a lower deployment height) than the appendage 800 in fig. 8A under the same given stress.

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

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 adjunct 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 therefore, will not be described in detail herein.

In fig. 15, each strut 1516 can have a stop element 1552 extending from or positioned adjacent to a surface of its second portion 1520. As appendage 1500 is compressed, struts 1516 can bend about joints or nodes 1514, 1522 until stop elements 1552 contact one another. Once these stop elements 1552 abut each other, any further bending of 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 deployed height at a given stress with a first stiffness. Upon reaching the first compressed height, stop elements 1552 bottom out and inhibit further deflection of struts 1516 and, thus, inhibit further compression of adjunct 1500. Once stop element 1552 bottoms out, more stress needs to be applied to effect further bending of strut 1516 about joints 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 throughout the attachment 1500. Furthermore, the shape, size, and position of stop element 1552 is not limited by this illustrated embodiment and, therefore, may be varied to control the desired amount of compression.

As described above, the elongated body may include a plurality of struts having a variety of shapes. For example, fig. 16 shows an exemplary adjunct 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 substantially planar solid layer having openings 1626. At least a portion of these openings 1626 are aligned with the openings 1615 defined by each strut 1116. The thickness of each layer may vary. The struts 1616 are configured to have a predetermined compression height to limit the amount of compression of the adjunct. Further, given their shape, these struts 1616 may be configured to act as springs. Therefore, similar to the spring constant, a certain stiffness may be given to each stay 1616 based on its shape. Thus, the compressibility of appendage 1600 may also depend on the particular stiffness of each strut 1616, which depends on both the material and the shape of struts 1616.

As shown in fig. 8A, 11A-13B, and 15-16, each appendage 800, 1100, 1200, 1300, 1500, 1600 can include an opening 826, 1140, 1144, 1226, 1326, 1526, 1626. The openings can be configured to promote cell ingrowth within each appendage. These openings may define the void fraction of the appendage. In some embodiments, the void fraction may be from about 15% to 95%, while in other embodiments, the void fraction may be from 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 dimension that extends at least partially through the component. In certain embodiments, as shown in fig. 8A, 11A-13B, and 15-16, 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 completely through their respective components. Within the elongated body, the openings may be defined by interconnecting struts. Furthermore, the openings may also be interconnected throughout the appendage, thereby forming a substantially continuous network of openings or channels. Further, as shown in fig. 11A-11B, an opening 1126 may also be present within the internal connectivity feature 1138.

The openings may have varying sizes and/or shapes. For example, a larger opening may allow tissue (and cells) to penetrate into the adjunct, while a smaller opening may capture cells within the adjunct to promote cellular ingrowth. In this way, the variable opening size of the entire appendage may promote extracellular remodeling. That is, when the adjunct is implanted, the variable opening size can promote revascularization and mobility of cells within the adjunct, 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 adjunct 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 can each have a diameter that is about 70% to 170% of the diameter of the staple legs of the staple (e.g., staple 406 in fig. 4-5). The opening in the tissue contacting surface and in the elongated body can have a variety of 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 elongated 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 can 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 manner, as described above, 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.

In other embodiments, the adjunct can be configured to enhance the advancement of the staple legs through the adjunct. For example, the adjunct can have an opening that is aligned 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, as the staple legs advance through the adjunct, the openings can act as guides to minimize damage to the staple and the adjunct as the staple passes 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 varying 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, the adjunct 1700 includes a plurality of struts 1716 in the form of substantially vertical posts. In particular, these 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 include a plurality of first vertical struts 1716a having a first height (Y), a plurality of second vertical struts 1716a having a second height (Y) less than the first height (Y)₁) And a plurality of second struts 1716b having a height less than the second height (Y)₂) Third height (Y)₃) A plurality of third struts 1716 c. For simplicity, only a portion of plurality of struts 1716 are shown in fig. 17. Although not shown, one of ordinary skill will appreciate that the tissue contact layer 1702 and/or the cartridge contact layer 1704 may include openings as described herein.

The varying heights of the plurality of struts 1716 may provide varying compressibility for the appendage. Fig. 18A-18C illustrate the compressive behavior of the appendage 1700 under different stresses. In particular, appendages1700 is shown at a pre-compressed height in FIG. 18A and at a first stress (S) in FIG. 18B₁) First compression height (H) of₁) And is shown in fig. 18C at a second stress (S)₂) Second compressed height (H) of₂). As shown, a first compression height (H)₁) Greater than the second compressed height (H)₂) And thus the first stress (S)₁) Less than the second stress (S)₂). One of ordinary skill in the art will appreciate that the adjunct can have a variety of compressive heights throughout its use, and that the compressive height is at least partially a function of the particular stress applied to the adjunct throughout its use.

As shown in fig. 18A-18C, as the compression of appendage 1700 increases, the amount of stress required to achieve such compression increases. This is because additional struts are engaged as appendage 1700 compresses, thereby increasing the stiffness resistance of appendage 1700. For example, as shown in FIG. 18B, at a first stress S applied to an appendage 1700₁Next, the first plurality of struts 1716a and the second plurality of struts 1716b are engaged. In contrast, when appendage 1700 is at second stress S₂When down, the first, second, and third plurality of struts 1716a, 1716b, 1716c are engaged, creating greater stiffness resistance.

Fig. 19 shows another exemplary embodiment of an appendage 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 can be configured to support an initial stress applied to the appendage 1900 and then deflect or buckle as the appendage compresses (e.g., deflection point D in fig. 20). The curved columns 1916b may be configured to provide a substantially constant stiffness (i.e., substantially the offset of the entire curve from the zero axis shown in fig. 20). This mechanical behavior of the struts 1916, and thus the appendages 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 a particular configuration of an appendage, i.e., a configuration of a repeating unit. Fig. 21A shows 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, the adjunct 2100 includes a first portion 2104 and a second portion 2106, each portion having an outer edge and an inner edge. Inner edges 2104a, 2106a define a channel 2108 extending between the first portion and the second portion and along a longitudinal axis (L) of adjunct 2100. The channel 2108 is configured to receive a cutting member, such as a knife. As shown in fig. 121B, channel 21 does not extend completely through the height of 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 to have sufficient structural integrity to be effectively manipulated and attached to a cartridge body, such as the cartridge body 2214 in fig. 21B. In use, as 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 dividing the adjunct 2100 into two separate pieces.

Further, as shown in fig. 21A, the adjunct 2100 can comprise a flange 2112 that is configured to mate with the cartridge body 2214 of fig. 21B, as further described below. Although fig. 21A shows the adjunct 2100 with 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 the flanges 2112 is not limited to that shown in FIG. 21A. Although the flange 2112 can be made of a variety of materials, in some embodiments, as shown in fig. 21A, the 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 therefore, will not be described in detail herein. Moreover, for simplicity, certain components of the staple cartridge assembly 2200 are not shown in FIG. 21B.

The staple cartridge assembly 2200 includes the adjunct 2100 in 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 greater detail below. In this embodiment, the cartridge body 2214 comprises recessed channels 2216 which are configured to receive the flanges 2112 on the appendages such that the flanges 2112 can engage the sides of the cartridge body 2214. In this manner, the adjunct 2100 can be more securely attached to the cartridge body, thereby preventing undesired movement of the adjunct 2100 during use.

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

In some embodiments, the cartridge body (e.g., the cartridge body 2214 in fig. 21B) and the adjunct (e.g., the adjunct 3000 in fig. 22) can comprise complementary reinforcing features that can be configured to prevent the adjunct from tearing out of the channel as the cutting element moves through the adjunct 3000. For example, the reinforcement feature of the cartridge body can be a cylindrical recessed opening positioned adjacent to a slot in the cartridge body, and the reinforcement feature of the adjunct can be a cylindrical protrusion positioned within the first and second portions of the adjunct adjacent to the at least one bridge member. In this manner, when the appendages are placed on top of the cartridge body, the cylindrical protrusions of the appendages will extend into the recessed openings of the cartridge body. It is also contemplated that the protrusions and recessed openings may take the form of other various shapes.

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

The device disclosed herein may be designed to be disposed of after a single use, or it may be designed to be used multiple times. In either case, however, the device may be reconditioned for reuse after at least one use. Refurbishment 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 may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular components, 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 conditioning apparatus are within the scope of the present application.

Those skilled in the art will recognize additional features and advantages of the present invention in light of the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication, or information, in its entirety or 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 (17)

1. A stapling 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 the body having a first end, a second end, and a longitudinal axis extending therebetween; and

a three-dimensional compressible adjunct formed from a matrix comprising at least one melted 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, the adjunct having a tissue contacting surface, a body contacting surface opposite the tissue contacting surface, and an internal structure extending between the tissue contacting surface and the body contacting surface, wherein voids are present in the tissue contacting surface and in the internal structure to allow a portion of tissue to penetrate the tissue contacting surface and into the internal structure when the adjunct is attached to tissue by the plurality of staples.

2. The suturing assembly according to claim 1, wherein said voids are of varying sizes.

3. The stapling assembly of claim 1, wherein at least a portion of the voids each have a diameter that is about 70-170% of a diameter of a leg of each staple of the plurality of staples.

4. The stapling assembly of claim 1, wherein the internal structure comprises a void extending vertically between the tissue contacting surface and the body contacting surface, and wherein the void is configured to enhance advancement of staple legs through the internal structure.

5. The suturing assembly according to claim 1, wherein said voids within said inner structure each have a diameter in the range of about 200-610 μm.

6. The stapling assembly of claim 1, wherein said voids within said tissue contacting surface each have a diameter of at least about 14 μ ι η.

7. The suturing assembly according to claim 1, wherein said inner structure comprises a plurality of interconnecting struts defining said voids therein.

8. The suturing assembly according to claim 7, wherein said plurality of interconnecting struts comprise a curved region configured to flex to allow said adjunct to compress.

9. The suturing assembly according to claim 7, wherein at least a portion of said plurality of interconnected struts each have a variable cross-section.

10. The suturing assembly according to claim 1, wherein said voids form a substantially continuous network of openings throughout said adjunct.

11. The suturing assembly according to claim 1, wherein voids are present in said body contacting surface, each void having a dimension that extends at least partially through said body contacting surface.

12. The stapling assembly of claim 1, wherein the void is configured to limit movement of tissue along the tissue contacting surface in a direction substantially parallel to the longitudinal axis of the body.

13. The suturing assembly according to claim 1, wherein said adjunct is configured to be sutured thereto when said adjunct is in a tissue deployed stateTissue application of at least about 3g/mm²For at least 3 days.

14. A stapling 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 melted 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, the adjunct comprising a lattice structure having a tissue contacting surface and a body contacting surface, and wherein openings of varying sizes are present within the internal lattice structure to form a substantially continuous network of channels to promote tissue growth.

15. The suturing assembly according to claim 14, wherein at least a portion of said opening extends through said body contacting surface.

16. The suturing assembly according to claim 14, wherein said lattice structure includes a flex zone configured to flex to allow compression of said adjunct.

17. The suturing assembly according to claim 14, wherein said adjunct is configured to apply at least about 3g/mm to tissue sutured thereto when said adjunct is in a tissue deployed state²For at least 3 days.

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