Compressible adjunct with different behavior zones

Abstract

Compressible adjuncts for use with a staple cartridge are provided. In one exemplary embodiment, the compressible adjunct includes a non-fibrous adjunct material formed from at least one fused bioabsorbable polymer. The adjunct material is configured to be releasably retained on a staple cartridge and configured to be delivered to tissue by deployment of staples in the cartridge. The adjunct material includes a lattice macrostructure having at least one medicament contained therein. The lattice macrostructure is formed from a plurality of cells, wherein each cell is configured to expel a predetermined amount of medicament from the adjunct material, and the predetermined amount of medicament is a function of a compression profile of the respective cell.

Description

Technical Field

[0001] This disclosure relates in general to compressible appendages and methods of using compressible appendages. Background Technology

[0002] Surgical sutures are used in surgical procedures to close openings in tissues, blood vessels, catheters, shunts, or other objects or body parts involved in a particular surgical procedure. These openings can be naturally occurring, such as passages in blood vessels or internal organs similar to the stomach, or they can be created by a surgeon during the surgical procedure, such as by puncturing tissue or blood vessels to create bypasses or anastomoses or by cutting tissue during suturing.

[0003] Most suture devices have a handle with an elongated shaft having a pair of movable, opposing jaws formed at its ends for holding and shaping staples between the jaws. The staples are typically housed in a staple cartridge that holds multiple rows of staples and is usually positioned in one of the two jaws for ejecting the staples to the surgical site. During use, the jaws are positioned such that the object to be sutured is positioned between the jaws, and the staples are ejected and shaped when the jaws are closed and the device is actuated. Some suture devices include a blade configured to travel between staple rows in the staple cartridge to longitudinally cut and / or open sutured tissue between staple rows.

[0004] Although surgical staplers have been improved over the years, they still have several problems. One common problem is leakage that can occur when the staple penetrates tissue or other objects in which it is placed, due to the hole formed by the staple. Blood, air, gastrointestinal fluids, and other fluids can leak through the opening formed by the staple, even after the staple has fully formed. The treated tissue can also become inflamed due to the trauma caused by the suture.

[0005] Various implantable materials have been developed for use in conjunction with sutured tissue; however, improved materials are still needed to address some of the aforementioned issues. Summary of the Invention

[0006] A compressible appendage is provided for use with a staple cartridge. In one exemplary embodiment, the compressible appendage comprises a non-fibrous appendage material formed of at least one fused bioabsorbable polymer. The appendage material is configured to be releasably retained on the staple cartridge and is configured to be delivered to tissue by deployment of staples within the cartridge. The appendage material includes a lattice macrostructure containing at least one drug. The lattice macrostructure is formed of a plurality of cells, each cell being configured to expel a predetermined amount of drug from the appendage material, and the predetermined amount of drug is a function of the compression distribution of the corresponding cell.

[0007] The plurality of cells can have various configurations. In some embodiments, at least one of the plurality of cells can have a variable wall thickness. In some embodiments, the plurality of cells can include a first cell and a second cell. The first cell can have a first compression distribution and the second cell can have a second compression distribution different from the first compression distribution. In some embodiments, each cell can have a plurality of compression zones. The plurality of compression zones can include a first compression zone and a second compression zone. The first compression zone can have a first compression strength, and the second compression zone can have a second compression strength different from the first compression strength. The first compression zone can be configured to compress from a first uncompressed height to a first compressed height. The second compression zone can be configured to compress from a second uncompressed height to a second compressed height different from the first compressed height.

[0008] In some embodiments, each cell may include a plurality of substructures formed therein. These substructures may be configured to control the deformation behavior of the respective cell when the attached material is compressed. The plurality of substructures may include a first substructure and a second substructure. The first substructure may be a protrusion extending inward from the wall of the cell, and the second substructure may be a recess formed in the wall of the cell. In some embodiments, the plurality of substructures may include at least one internal stop member.

[0009] In some embodiments, the plurality of cells may include Schwarz-P structures. In such embodiments, the lattice macrostructure may include a plurality of interconnecting structures. The plurality of interconnecting structures may extend between adjacent Schwarz-P structures and connect adjacent Schwarz-P structures to each other.

[0010] In another embodiment, the compressible appendage for use with a staple cartridge comprises a non-fibrous appendage material formed of at least one fused bioabsorbable polymer. The appendage material is configured to be releasably retained on the staple cartridge and to be delivered to tissue via deployment of staples within the cartridge. The appendage material includes a lattice master structure containing at least one drug. The lattice master structure may include a first substructure formed in at least one first portion of the lattice master structure and a second substructure formed in at least one second portion of the lattice master structure. The first and second substructures are configured to control a first release rate and a second release rate of at least one drug from the appendage material, respectively, when the appendage material is compressed and in a tissue-deployed state, the first release rate being different from the second release rate.

[0011] The first and second portions of the lattice principal structure can have various configurations. In some embodiments, the first portion of the lattice principal structure can have a first wall thickness, and the second portion of the lattice principal structure can have a second wall thickness different from the first wall thickness. In some embodiments, the first portion of the lattice principal structure can be configured to deform from a first undeformed state to a first deformed state. In such embodiments, the second portion of the lattice principal structure can be configured to deform from a second undeformed state to a second deformed state different from the first deformed state.

[0012] The first and second substructures can have various configurations. In some embodiments, the first substructure may include at least one of a first protrusion and a first recess, the first protrusion extending inward from the wall of the main lattice structure, and the first recess formed in the wall of the main lattice structure. In some embodiments, the second substructure may include at least one of a second protrusion and a second recess, the second protrusion extending inward from the wall of the main lattice structure, and the second recess formed in the wall of the main lattice structure. In some embodiments, at least one of the first and second substructures may include at least one internal stop member.

[0013] The first lattice master structure can have various configurations. In some embodiments, the lattice master structure may include multiple Schwarz-P structures. In such embodiments, the lattice master structure may include multiple interconnecting structures. The interconnecting structures may extend between adjacent Schwarz-P structures and connect adjacent Schwarz-P structures to each other. Attached Figure Description

[0014] The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0015] Figure 1 This is a perspective view of an exemplary embodiment of a conventional surgical suturing and cutting instrument;

[0016] Figure 2 Is with Figure 1 A top view of a staple cartridge used in conjunction with surgical suturing and cutting instruments;

[0017] Figure 3 for Figure 1 A perspective view of the firing pin of a surgical stapler, with an electron beam at its distal end;

[0018] Figure 4 This is a perspective view of another embodiment of the surgical suture device;

[0019] Figure 5 This is a perspective view of yet another implementation of the surgical suture device;

[0020] Figure 6A longitudinal sectional view of an exemplary embodiment of a staple cartridge having an exemplary appendage attached to the top surface or platform surface of the staple cartridge;

[0021] Figure 7 It is shown Figure 6 A partial schematic diagram of an appendage in an organized deployment state;

[0022] Figure 8 This is a cross-sectional front view of an exemplary embodiment of a surgical end effector having an anvil and a suture assembly having an accessory releasably retained on a staple cartridge. The figure illustrates a surgical end effector in a closed position where there is no positioning tissue between the anvil and the suture assembly.

[0023] Figure 9 yes Figure 8 A cross-sectional front view of the surgical end effector shows tissue held between the anvil and the suture assembly and sutured to the tissue between compressible non-fibrous appendages;

[0024] Figure 10 yes Figure 8 A front view of the cross-section of only the stitched components;

[0025] Figure 11 A partial sectional perspective view that is part of another embodiment of the appendage;

[0026] Figure 12 This is an enlarged cross-sectional side view of another embodiment of the appendage, showing the appendage in its initial state (t=0);

[0027] Figure 13 yes Figure 12 The appendages are shown in a partially degraded state (t>0);

[0028] Figure 14 This is a cross-sectional view of an exemplary implementation of a multi-layered cell;

[0029] Figure 15 This is a cross-sectional view, part of another embodiment of the appendage, showing the appendage in an uncompressed state;

[0030] Figure 16 yes Figure 15 The appendages are shown in a compressed state;

[0031] Figure 17 A cross-sectional front view of another embodiment of a surgical end effector having an anvil and a suture assembly, the suture assembly having an appendage releasably retained on the staple cartridge, illustrating a surgical end effector in a closed position without positioning tissue between the anvil and the suture assembly; and

[0032] Figure 18 A front cross-sectional view of another embodiment of a surgical end effector having an anvil and a suture assembly, the suture assembly having an appendage releasably held on a staple cartridge, the figure illustrating a surgical end effector in a closed position without positioning tissue between the anvil and the suture assembly. Detailed Implementation

[0033] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of the structure, function, manufacture, and use of the apparatuses 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 apparatuses and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and the scope of this disclosure is defined only by the claims. Features shown or described in conjunction 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 invention.

[0034] Furthermore, in this disclosure, components with similar names in various embodiments generally have similar features; therefore, in specific embodiments, not every feature of every component with a similar name is necessarily fully described. Additionally, the extent to which linear or circular dimensions are used in the description of the disclosed systems, devices, and methods is not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be readily determined for any geometry. The size and shape of systems and devices and their components may depend at least on the anatomy of the patient in which the system and device will be used, the size and shape of the components with which the system and device will be used, and the method and procedure in which the system and device will be used.

[0035] It should be understood that the terms "proximal" and "distal" are used in this article in relation to the user who grips the instrument handle, such as a clinician. Other spatial terms such as "anterior" and "posterior" similarly correspond to distal and proximal, respectively. It should also be understood that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used in the illustrations. However, surgical instruments are used in many orientations and positions, and these spatial terms are not restrictive or absolute.

[0036] Various exemplary devices and methods for performing surgical procedures are provided. In some embodiments, the devices and methods are configured for open surgery, and in other embodiments, they are configured for laparoscopic, endoscopic, and other minimally invasive surgical procedures. These devices can be fired directly by a human user or remotely under the direct control of a robot or similar manipulator. However, those skilled in the art will understand that the various methods and devices disclosed herein can be used in many surgical procedures and applications. Those skilled in the art will further understand that the various instruments disclosed herein can be inserted into the body in any manner, such as through natural orifices, through incisions or perforations formed in tissue, or through an access device (such as a cannula). For example, the working portion or end effector portion of the instrument can be inserted directly into the patient's body or can be inserted through an access device having an end effector of the surgical instrument and a working channel through which an elongated shaft can be advanced.

[0037] It is anticipated that the use of one or more biomaterials and / or synthetic materials (referred to herein as “appendages”) in conjunction with surgical instruments can help improve surgical procedures. “Appendages” are also referred to herein as “appendage materials.” While a variety of different surgical end effectors can benefit from the use of appendages, in some exemplary embodiments, the end effector may be a surgical stapler. When used in conjunction with a surgical stapler, the one or more appendages may be positioned between and / or on the stapler jaws, integrated into a staple cartridge disposed within the jaws, or otherwise placed adjacent to the staple. When the staple is deployed, the one or more appendages can remain at the treatment site with the staple, thereby providing numerous benefits. For example, the one or more appendages can reinforce the tissue at the treatment site, preventing it from being torn or ripped apart by the staple. If the tissue is diseased, healing, and / or undergoing another change in tissue properties, tissue reinforcement may be required to prevent the staple from tearing the tissue. In some cases, appendages can minimize tissue movement (e.g., lung expansion, gastrointestinal distension, etc.) in and around the staple perforation site, which can occur due to tissue deformation that occurs after suturing. Those skilled in the art will recognize that the nail puncture site can act as a stress concentration point, and the size of the hole formed by the nail will increase when the surrounding tissue is under tension. Restricting the movement of the tissue around these puncture sites minimizes the size to which the hole can increase under tension. In some cases, the one or more appendages may be configured to wick or absorb beneficial fluids that further promote healing, such as sealants, blood, glue, etc., and in some cases, the one or more appendages may be configured to degrade to form gels that further promote healing, such as sealants. In some cases, the one or more appendages may be used to help seal the hole formed by the nail when it is implanted in tissue, blood vessels, and various other objects or body parts.

[0038] In other embodiments, the one or more appendages may be used with surgical instruments configured to seal tissue without the use of nails (e.g., by using energy, such as RF or ultrasound), for example, as described in U.S. Patent No. 10,172,611, the entire contents of which are incorporated herein by reference.

[0039] In some cases, the one or more appendages may be configured to compensate for changes in tissue thickness as the appendages are sutured to the tissue. In such cases, the appendage may also be referred to as a "tissue thickness compensator." The tissue thickness compensator has an uncompressed (undeformed) or pre-deployed height that is greater than the height of the staple in its shaped configuration. Additional details regarding exemplary tissue thickness compensators can be found, for example, in U.S. Patent No. 8,864,007, the entire contents of which are incorporated herein by reference. The tissue thickness compensator may be attached to and released from the staple cartridge in a variety of ways, for example, as described in U.S. Patents Nos. 9,272,406 and 10,136,890, each of which is incorporated herein by reference in its entirety.

[0040] In addition to the disclosure herein, further details relating to the one or more of these appendages and other exemplary appendages can be found, for example, in U.S. Patent Nos. 10,172,611 and 10,433,846 and U.S. Patent Application No. 17 / 009,769, filed September 1, 2020, entitled “Compressible Non-Fibrous Adjuncts,” each of which is incorporated herein by reference in its entirety.

[0041] Alternatively or additionally, the one or more appendages may be configured to promote inward tissue growth. In various cases, it is desirable to promote inward tissue growth within the implantable appendage to facilitate the healing of treated tissue (e.g., sutured tissue and / or cut tissue) and / or accelerate patient recovery. More specifically, inward tissue growth within the implantable appendage can reduce the incidence, extent, and / or duration of inflammation at the surgical site. Inward tissue growth within and / or around the implantable appendage can control the spread of infection at the surgical site, for example. Inward growth of blood vessels, particularly leukocytes, within and / or around the implantable appendage can resist infection in and / or surrounding the implantable appendage and adjacent tissues. Inward tissue growth can also facilitate the acceptance of foreign bodies (e.g., implantable appendages and nails) by the patient's body and reduce the likelihood of the patient's body rejecting the foreign body. Rejection of foreign bodies can lead to infection and / or inflammation at the surgical site.

[0042] Alternatively or additionally, one or more agents may be present on and / or therein of the one or more appendages. The one or more agents may vary depending on the desired effect of the one or more agents on the surrounding tissue. As a non-limiting example, the one or more agents may be provided to affect hemostasis, inflammation, macrophages, and / or fibroblasts. Also depending on the desired effect on the tissue, one or more agents may be mixed or combined in any combination, or a single agent may be provided. The one or more agents may be eluted from the one or more appendages in a variety of different ways. As a non-limiting example, the coating on the one or more appendages may be varied to be absorbed at different time points, thereby releasing the one or more agents at different time points; the one or more appendages may be varied to allow the one or more agents to diffuse through the one or more appendages at different rates; the one or more appendages may differ in molecular weight and / or physical properties, thereby causing the one or more agents to be released at different time points; etc. In addition to the disclosure herein, further details regarding drug-eluting appendages can be found in U.S. Patents 9,232,941 and 10,569,071, each of which is incorporated herein by reference in its entirety.

[0043] Surgical suture instruments

[0044] Various surgical instruments can be used in conjunction with one or more appendages and / or one or more agents disclosed herein. Surgical instruments may include surgical staplers. A variety of surgical staplers can be used, such as linear surgical staplers and circular staplers. Typically, linear staplers are configured to produce longitudinal staple sutures and may include elongated jaws having a magazine connected thereto to receive longitudinal staple rows. The elongated jaws may include a blade or other cutting element capable of making incisions between staple rows along tissue held within the jaws. Typically, circular staplers are configured to form annular staple sutures and may include circular jaws having a magazine receiving annular staple rows. Circular jaws may include a blade or other cutting element capable of making incisions within the staple rows to define an opening through tissue held within the jaws. Staplers can be used in a variety of different surgical procedures on a variety of tissues, such as thoracic surgery or gastric surgery.

[0045] Figure 1An example of a linear surgical stapler 10 suitable for use with one or more appendages and / or one or more agents is shown. The stapler 10 typically includes a handle assembly 12, a shaft 14 extending distally from a distal end 12d of the handle assembly 12, and an end effector 30 located at the distal end 14d of the shaft 14. The end effector 30 has opposing lower jaws and upper jaws 32, 34, but other types of end effectors may be used with the shaft 14, the handle assembly 12, and associated components. The lower jaw 32 has a staple channel 56 configured to support a staple cartridge 40, and the upper jaw 34 has an anvil surface 33 facing the lower jaw 32 and configured to operate as an anvil to aid in the deployment of staples from the staple cartridge 40. Figure 1 and Figure 2 (The central nail is obstructed). At least one of the opposing lower jaws and upper jaws 32, 34 is movable relative to the other to clamp tissue and / or other objects disposed therebetween. In some embodiments, at least one of the opposing lower jaws and upper jaws 32, 34 may be fixed or otherwise immovable. In some embodiments, both the opposing lower jaws and upper jaws 32, 34 may be movable. Components of the firing system may be configured to pass through at least a portion of the end effector 30 to eject the nail into the clamped tissue. In various embodiments, a blade 36 or other cutting element may be associated with the firing system to cut tissue during suturing.

[0046] Operation of the end effector 30 can begin with input from a user (e.g., a clinician, surgeon, etc.) at the handle assembly 12. The handle assembly 12 can have many different configurations designed to manipulate and operate the associated end effector 30. In the illustrated example, the handle assembly 12 has a pistol grip housing 18 with various mechanical and / or electronic components disposed therein to operate the instrument 10. For example, the handle assembly 12 may include a knob 26 mounted adjacent to its distal end 12d, which may facilitate rotation of the shaft 14 and / or the end effector 30 about the longitudinal axis L of the shaft 14 relative to the handle assembly 12. The handle assembly 12 may also include a clamping element as part of a clamping system actuated by a clamping trigger 22 and a firing element as part of a firing system actuated by a firing trigger 24. The clamping trigger 22 and the firing trigger 24 may be biased, for example, by a torsion spring to an open position relative to the fixed handle 20. Movement of the clamping trigger 22 toward the fixed handle 20 actuates the clamping system, as described below, which causes the jaws 32, 34 to collapse toward each other and thereby clamp the tissue between them. Movement of the firing trigger 24 actuates the firing system, as described below, which ejects the nail from the nail magazine 40 in which it is disposed and / or advances the blade 36 to cut the tissue trapped between the jaws 32, 34. Those skilled in the art will recognize that various configurations (mechanical, hydraulic, pneumatic, electromechanical, robotic, or other) of the firing system can be used to eject the nail and / or cut the tissue.

[0047] like Figure 2 As shown, the end effector 30 of the illustrated embodiment has a lower jaw 32 that serves as a cartridge assembly or carrier and an opposing upper jaw 34 that serves as an anvil. A staple cartridge 40, containing a plurality of staples, is supported in a staple tray 37, which in turn is supported within a cartridge channel of the lower jaw 32. The upper jaw 34 has a plurality of staple-forming recesses (not shown), each positioned above a corresponding staple from the plurality of staples housed within the staple cartridge 40. Although in the illustrated embodiment, the upper jaw 34 has a proximal pivoting end 34p only on its distal side of engagement with the shaft 14, which is pivotally received within the proximal end 56p of the staple channel 56, the upper jaw 34 can be connected to the lower jaw 32 in various ways. When the upper jaw 34 pivots downward, it moves the anvil surface 33 and causes the staple-forming recesses formed thereon to move toward the opposing staple cartridge 40.

[0048] Various clamping components can be used to open and close the jaws 32 and 34 to selectively clamp tissue between them. As shown, the pivoting end 34p of the upper jaw 34 includes a closing feature structure 34c distal to its pivot attachment to the pin channel 56. Thus, in response to the clamping trigger 22, the closing tube 46 selectively imparts an opening action to the upper jaw 34 during proximal longitudinal movement and a closing action to the upper jaw 34 during distal longitudinal movement, the distal end of which includes a horseshoe-shaped hole 46a engaging the closing feature structure 34c. As described above, in various embodiments, the opening and closing of the end effector 30 can be achieved by the relative movement of the lower jaw 32 relative to the upper jaw 34, the relative movement of the upper jaw 34 relative to the lower jaw 32, or by the movement of both jaws 32 and 34 relative to each other.

[0049] The firing mechanism shown in the specific implementation includes, for example: Figure 3 The figure shows a firing lever 35 with an electron beam 38 at its distal end. The firing lever 35 is included within a shaft 14, for example, in a longitudinal firing lever slot 14s of the shaft 14, and is guided by a firing action from the shank 12. Actuation of the firing trigger 24 can affect the distal action of the electron beam 38 through at least a portion of the end effector 30, thereby causing the firing of a nail housed in the nail cartridge 40. As shown, a guide 39 protruding from the distal end of the electron beam 38 can engage... Figure 2 The wedge-shaped slider 47 shown in the diagram then pushes the nail driver 48 upward through the nail cavity 41 formed in the nail magazine 40. The upward movement of the nail driver 48 applies an upward force to each of the plurality of nails in the magazine 40, thereby pushing the nail upward against the anvil surface 33 of the upper jaw 34 and producing a shaped nail.

[0050] In addition to firing the nail, the electron beam 38 is also configured to facilitate the closure of jaws 32, 34, the separation of the upper jaw 34 relative to the nail cartridge 40, and / or the cutting of tissue captured between jaws 32, 34. Specifically, a pair of top pins and a pair of bottom pins can engage one or both of the upper and lower jaws 32, 34 to compress jaws 32, 34 toward each other as the firing rod 35 advances through the end effector 30. Simultaneously, a blade 36 extending between the top and bottom pins is configured to cut the tissue captured between jaws 32, 34.

[0051] In use, the surgical stapler 10 can be placed in a cannula or mouth and positioned at the surgical site. The tissue to be cut and sutured can be placed between the jaws 32, 34 of the surgical stapler 10. The characteristic structure of the stapler 10 can be manipulated by the user as needed to achieve the desired position of the jaws 32, 34 at the surgical site and the tissue relative to the jaws 32, 34. After proper positioning has been achieved, the clamping trigger 22 can be pulled toward the fixed handle 20 to actuate the clamping system. The trigger 22 actuates a component of the clamping system, causing the closing tube 46 to be advanced distally through at least a portion of the shaft 14 to cause at least one of the jaws 32, 34 to collapse toward the other to clamp the tissue positioned between them. The trigger 24 can then be pulled toward the fixed handle 20 to actuate a component of the firing system, causing the firing rod 35 and / or the electron beam 38 to be advanced distally through at least a portion of the end effector 30 to fire the staple and optionally sever the tissue trapped between the jaws 32, 34.

[0052] Another example of a surgical instrument in the form of a linear surgical suture device 50 is shown in Figure 4 In the middle. The suture device 50 can usually be used with Figure 1 The suture device 10 is similarly constructed and used. Similar to... Figure 1 The surgical instrument 10, surgical instrument 50 includes a handle assembly 52 having a shaft 54 ​​extending distally from the handle assembly and having an end effector 60 for treating tissue at the distal end of the shaft. The upper and lower jaws 64, 62 of the end effector 60 are configured to capture tissue between them, suture the tissue by firing a pin from a cartridge 66 disposed in the lower jaw 62, and / or create an incision in the tissue. In this specific embodiment, an attachment portion 67 on the proximal end of the shaft 54 ​​is configured to allow the shaft 54 ​​and the end effector 60 to be removably attached to the handle assembly 52. ​​Specifically, a mating feature structure 68 of the attachment portion 67 can mate with a complementary mating feature structure 71 of the handle assembly 52. ​​The mating features structures 68, 71 can be configured to be coupled together via, for example, snap-fit ​​couplings, bayonet couplings, etc., but any number of complementary mating features and any type of coupling can be used to removably attach the shaft 54 ​​to the handle assembly 52. While the entire shaft 54 ​​in the illustrated embodiment is configured to be detachable from the handle assembly 52, in some embodiments, the attachment portion 67 is configured to allow only the distal portion of the shaft 54 ​​to be detached. This detachable connection of the shaft 54 ​​and / or the end effector 60 allows for selective attachment of the desired end effector 60 for a specific procedure, and / or reuse of the handle assembly 52 for multiple different procedures.

[0053] The handle assembly 52 may have one or more features located thereon for manipulating and operating the end effector 60. As a non-limiting example, a knob 72 mounted on the distal end of the handle assembly 52 may facilitate rotation of the shaft 54 ​​and / or the end effector 60 relative to the handle assembly 52. ​​The handle assembly 52 may include a clamping member as part of a clamping system actuated by a movable trigger 74 and a firing member as part of a firing system also actuated by the trigger 74. Thus, in some embodiments, movement of the trigger 74 toward the fixed handle 70 through a first range of motion actuates the clamping member, causing opposing jaws 62, 64 to approach each other to a closed position. In some embodiments, only one of the opposing jaws 62, 64 may move to the closed position. The trigger 74 moves further toward the fixed handle 70 through the second action range to actuate the firing member, causing the nail to be ejected from the nail magazine 66 and / or causing the advance of a knife or other cutting element (not shown) to cut the tissue captured between the jaws 62, 64.

[0054] An example of a surgical instrument in the form of a circular surgical suture device 80 is shown in Figure 5 In the middle. The suture device 80 is typically compatible with... Figure 1 and Figure 4 The linear suture devices 10 and 50 are similarly constructed and used, but some of their features are adapted to their function as circular suture devices. Similar to surgical instruments 10 and 50, surgical instrument 80 includes a handle assembly 82 and a shaft 84 extending distally from the handle assembly, with an end effector 90 for treating tissue at the distal end of the shaft. The end effector 90 may include a cartridge assembly 92 and an anvil 94, each having a tissue contact surface that is substantially circular in shape. The cartridge assembly 92 and anvil 94 may be coupled together via a shaft 98 extending from the anvil 94 to the handle assembly 82 of the suture device 80, and an actuator 85 on the handle assembly 82 may retract and advance the shaft 98 to move the anvil 94 relative to the cartridge assembly 92. The anvil 94 and cartridge assembly 92 can perform various functions and can be configured to capture tissue between them, suture tissue by firing staples from a cartridge 96 of the cartridge assembly 92, and / or create incisions in the tissue. Generally speaking, the chamber assembly 92 can accommodate a chamber containing nails, and the nails can be deployed against the anvil 94 to form a circular nail pattern, such as nails surrounding the periphery of a tubular main organ.

[0055] In one embodiment, shaft 98 may be formed of a first portion and a second portion (not shown) configured to be releasably coupled together to allow disengagement of the anvil 94 from the storage chamber assembly 92, allowing greater flexibility in positioning the anvil 94 and storage chamber assembly 92 within the patient's body. For example, the first portion of shaft may be disposed within the storage chamber assembly 92 and extend distally beyond it, terminating in a distal mating feature. The second portion of shaft may be disposed within the anvil 94 and extend proximally beyond it, terminating in a proximal mating feature. In use, the proximal and distal mating features may be coupled together to allow movement of the anvil 94 and storage chamber assembly 92 relative to each other.

[0056] The shank assembly 82 of the stapler 80 may have various actuators disposed thereon capable of controlling the movement of the stapler. For example, the shank assembly 82 may have a knob 86 disposed thereon for positioning the end effector 90 by rotation, and / or a trigger 85 for actuating the end effector 90. Movement of the trigger 85 toward the fixed shank 87 through a first range of motion may actuate a component of the clamping system toward the jaws, for example, moving the anvil 94 toward the cartridge assembly 92. Movement of the trigger 85 toward the fixed shank 87 through a second range of motion may actuate a component of the firing system to deploy a staple from the cartridge assembly 92 and / or advance the blade to cut tissue captured between the cartridge assembly 92 and the anvil 94.

[0057] The illustrated examples of surgical suturing instruments 10, 50, and 80 are merely a few examples of many different configurations and associated methods of use that can be used in conjunction with the disclosure provided herein. While the illustrated examples are all configured for use in minimally invasive surgery, it should be understood that instruments configured for use in open surgery, such as the open linear suture device described in U.S. Patent No. 8,317,070, filed February 28, 2007, entitled “Surgical Stapling Devices That Produce Formed Staples Having Different Lengths,” can be used in conjunction with the disclosure provided herein. Further details of the examples shown, as well as additional examples of surgical suture devices, their components, and related methods of use, are provided in the following patents: U.S. Patent Publication No. 2013 / 0256377, filed February 8, 2013, entitled "Layer Comprising Deployable Attachment Members"; U.S. Patent No. 8,393,514, filed September 30, 2010, entitled "Selectively Orientable Implantable Fastener Cartridge"; U.S. Patent No. 8,317,070, filed February 28, 2007, entitled "Surgical Stapling Devices That Produce Formed Staples Having Different Lengths"; and U.S. Patent No. 7,143, filed June 21, 2005, entitled "Surgical Instrument Incorporating EAP Blocking Lockout Mechanism".U.S. Patent No. 925, filed November 8, 2013, entitled "Sealing Materials For Use in Surgical Stapling"; U.S. Patent No. 2015 / 0134077, filed November 8, 2013, entitled "Sealing Materials for Use in Surgical Procedures"; U.S. Patent No. 2015 / 0134076, filed November 8, 2013, entitled "Hybrid Adjunct Materials for Use in Surgical Stapling"; U.S. Patent No. 2015 / 0133996, filed November 8, 2013, entitled "Positively Charged Implantable Materials and Method of Forming the Same"; and U.S. Patent No. 2015 / 0133996, filed November 8, 2013, entitled "Tissue Ingrowth Materials and Method of Using the U.S. Patent Publication No. 2015 / 0129634 entitled "Same", U.S. Patent Publication No. 2015 / 0133995 entitled "Hybrid Adjunct Materials for Use in Surgical Stapling" filed November 8, 2013, U.S. Patent Application No. 14 / 226,142 entitled "Surgical Instrument Comprising a Sensor System" filed March 26, 2014, and U.S. Patent Application No. 14 / 300,954 entitled "Adjunct Materials and Methods of Using Same in Surgical Methods for Tissue Sealing" filed June 10, 2014, are all incorporated herein by reference in their entirety.

[0058] Implantable appendages

[0059] As noted above, various implantable appendages are provided for use in conjunction with surgical suture instruments. When used in conjunction with a surgical suture device, one or more of these appendages may be positioned between and / or on the jaws of the suture device, integrated into a staple cartridge disposed within the jaws, or otherwise placed adjacent to the staples. For example, as... Figure 6 As shown, the accessory 104 is positioned against the staple cartridge 102. For simplicity, the accessory 104 is typically located... Figure 6 The various structural configurations of the appendages are shown below, and are described in more detail below. Although in Figure 6 The center is partially obscured, but the staple cartridge 102 includes staples 106 configured to be deployed into tissue. Staples 106 may have any suitable unformed (pre-deployed) height. For example, staples 106 may have an unformed height between approximately 2 mm and 4.8 mm. Prior to deployment, the crown of the staple may be supported by a staple driver (not shown).

[0060] In the illustrated embodiments, the appendage 104 may releasably engage with at least a portion of the top surface or platform surface 108 of the staple cartridge 102. In some embodiments, the top surface 108 of the staple cartridge 102 may include one or more surface feature structures. Alternatively or additionally, one or more adhesives may be used to releasably engage the appendage with the staple cartridge 102. The one or more surface feature structures and / or the one or more adhesives may be configured to engage the appendage 104 to prevent undesired movement of the appendage 104 relative to the staple cartridge 102 and / or to prevent premature release of the appendage 104 from the staple cartridge 102. Exemplary surface feature portions are described in U.S. Patent Publication 2016 / 0106427, the entire contents of which are incorporated herein by reference. Additional details regarding adhesives and other exemplary adhesives for temporary attachment to devices can be found in U.S. Patents 9,282,962, 10,172,617, 10,172,618, 10,258,332, 10,517,592, 10,548,593, 10,568,621, and 10,588,623, each of which is incorporated herein by reference in its entirety. Additional details regarding attachment methods and other exemplary methods can be found in U.S. Patents 10,166,023 and 10,349,939 and U.S. Patent Application 17 / 022,520, filed September 16, 2020, entitled “Method of Applying Buttress to End Effector of Surgical Stapler,” each of which is incorporated herein by reference in its entirety.

[0061] In some cases, the appendage can be compressible to allow it to compress to different heights, thereby compensating for varying tissue thicknesses trapped within the deployed nail. For example, as... Figure 6 As shown, the appendage 104 has an uncompressed (undeformed) or pre-deployed height and is configured to deform to one of a plurality of compressed (deformed) or deployment heights. Therefore, the appendage 104 may have a firing height greater than that of the nail 106 disposed within the nail magazine 102 (e.g., Figure 7The uncompressed height (H) of the firing pin 106a. That is, the appendage 104 may have an undeformed state in which the maximum height of the appendage 104 is greater than the maximum height of the firing pin (e.g., a pin in a shaped configuration). In such cases, the appendage may be referred to as a "tissue thickness compensation member". In one embodiment, the uncompressed height of the appendage 104 may be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or about 100% higher than the firing height of the pin 106. In some embodiments, for example, the uncompressed height of the appendage 104 may be more than 100% higher than the firing height of the pin 106.

[0062] The appendage can have various configurations and can be formed from a variety of materials. Typically, the appendage can be formed from one or more of the following: membranes, foams, injection-molded thermoplastics, vacuum thermoforming materials, fibrous structures, additive manufacturing materials, and mixtures thereof. The appendage may also include one or more bio-derived materials and one or more pharmaceuticals. Each of these materials is discussed in more detail below.

[0063] The appendages can be formed from foams, such as closed-cell foams, open-cell foams, or sponges. An example of how such appendages can be manufactured is from animal-derived collagen (such as porcine tendons), which can then be processed and freeze-dried into a foam structure. Examples of various foam appendages are further described in the previously mentioned U.S. Patent No. 8,393,514, entitled “Selectively Orientable Implantable Fastener Cartridge,” filed September 30, 2010, the entire contents of which are incorporated herein by reference.

[0064] The appendage may also be formed from a membrane of any suitable material or combination thereof discussed below. The membrane may comprise one or more layers, each layer having a different degradation rate. Furthermore, the membrane may have various regions formed therein, for example, reservoirs capable of releasably retaining one or more different forms of a pharmaceutical agent. One or more different coatings may be used to seal the reservoir containing at least one pharmaceutical agent; these coatings may comprise absorbable or non-absorbable polymers. The membrane may be formed in various ways, for example, it may be an extruded molding membrane or a compression molding membrane.

[0065] The appendage may also be formed from injection-molded thermoplastic or vacuum-formed materials. Examples of various molded appendages are further described in U.S. Patent Publication 2013 / 0221065, filed February 8, 2013, entitled “Fastener Cartridge Comprising Aleasably Attached Tissue Thickness Compensator,” the entire contents of which are incorporated herein by reference. The appendage may also be a fiber-based lattice, which may be woven, knitted, or nonwoven, such as a loosely woven fabric constructed by meltblowing, needle punching, or thermal bonding. The appendage may have multiple regions that can be formed from lattices of the same type or different types, which can be combined to form the appendage in a variety of different ways. For example, fibers may be woven, braided, knitted, or otherwise interconnected to form regular or irregular structures. Fibers may be interconnected such that the resulting appendage is relatively loose. Alternatively, the appendage may comprise tightly interconnected fibers. The appendage may be in the form of a sheet, tube, spiral, or any other structure that may include flexible portions and / or more rigid reinforcing portions. Appendages can be configured to allow for denser fibers in certain areas and lower-density fibers in other areas. Depending on the intended application of the appendage, the fiber density can vary in different directions along one or more dimensions of the appendage.

[0066] In other embodiments, the appendages may be formed using a 3D printing process compatible with the absorbable polymer. Non-limiting examples of suitable 3D printing processes include stereolithography (SLA or SL), material jetting, selective laser sintering (SLS), and filament fabrication as understood by those skilled in the art.

[0067] The appendages can also be hybrid constructs, such as laminated composites or melt-interlocked fibers. Examples of various hybrid constructs are further described in the following patents: U.S. Patent Publication 2013 / 0146643, filed February 8, 2013, entitled "Adhesive FilmLaminate," and U.S. Patent Publication 7,601,118, filed September 12, 2007, entitled "Minimally Invasive Medical Implant And Insertion Device And Method For Using The Same," the entire contents of which are incorporated herein by reference.

[0068] Material

[0069] The appendages according to the technology can be formed from a variety of materials. These materials can be used in various embodiments for different purposes. These materials can be selected according to the desired treatment to be delivered to the tissue in order to facilitate tissue ingrowth. The materials described below can be used to form appendages in any desired combination.

[0070] These materials may include bioabsorbable polymers and biocompatible polymers, including homopolymers and copolymers. Non-limiting examples of homopolymers and copolymers include p-dioxane (PDO or PDS), polyglycolic acid (PGA) (e.g., Dexon and Neoveil), poly(lactic-co-glycolic acid copolymer) (PLGA), polycaprolactone (PCL), polyglycolic acid (PGL), trimethylene carbonate (TMC), polylactic acid (PLA) (e.g., Linvatec Bioscrew and Bionx Implants SmartScrew), poly(trimethylene carbonate) (PTMC), polyethylene diglycolate (PEDG), poly(propylene fumarate) (PPF), polyvinyl ether (PEE), poly(ethylene glycol) (PEG), poly(N-isopropylacrylamide), poly(amino acids), poly(epoxy carbonate), poly(propylene 2-oxide carbonate), poly(diol citrate), polymethacrylate anhydride, poly(ethoxyethylene diglycolate), poly(glycolic acid-lactic acid copolymer) (PLA / PGA) (e.g., for Vicryl, Vicryl PLA / PGA materials from Rapide, PolySorb, and Biofix, polyurethanes (such as Elastane, Biospan, Tecoflex, Bionate, and Pellethane fibers), polyorthoesters, polyanhydrides (e.g., Gliadel and Biodel polymers), polyoxyesters, polyesteramides (e.g., REVA ReZolve scaffolds), and tyrosine-based polyesteramides (e.g., TYRX). Copolymers may also include poly(lactic acid-polycaprolactone copolymer) (PLA / PCL) (e.g., hydrolyzed for 16-18 months), poly(L-lactic acid-polycaprolactone copolymer) (PLLA / PCL), poly(glycolic acid-trimethylene carbonate copolymer) (PGA / TMC) (e.g., Maxon), poly(glycolic acid-caprolactone copolymer) (PCL / PGA) (e.g., Monocryl and Capgly), PDS / PGA / TMC (e.g., Biosyn), PDS / PLA, PGA / PCL / TMC / PLA (e.g., Caprosyn), LPLA / DLPLA (e.g., Optima), PLGA-PCL (e.g., 15:85 (PCL: 50% D,L-lactide: 50% glycolide), 40:60 (PCL: 50% D,L-lactide: 50% glycolide), and 40:60 (PCL: 85%). D,L-lactide (15% glycolide), PLGA-PCL-PLGA and PLGA-PEG-PLGA.

[0071] The appendages may also include specialty polymer end groups, including (meth)acrylates and organically derived polymers. Non-limiting examples of organically derived polymers include those derived from collagen (e.g., Avitene, Endoavitene, Instat, Integran, Veritas, and microfibrillary collagen (MFC)).

[0072] The appendages may also include active agents, such as viable cell cultures (e.g., excised autologous tissue, reagents for stem cell therapy (e.g., Biosutures and Cellerix SL), hemostatic agents, and tissue healing agents). Non-limiting examples of hemostatic agents may include cellulose such as oxidized regenerated cellulose (ORC) (e.g., Surgicel and Interceed), fibrin / thrombin (e.g., Thrombin-JMI, TachoSil, Tiseel, Floseal, Evicel, TachoComb, Vivostat, and Everest), autologous platelet plasma, gelatin (e.g., Gelfilm and Gelfoam), hyaluronic acid such as microfibers (e.g., yarns and textile fabrics) or other hyaluronic acid-based structures or hyaluronic acid-based hydrogels. Hemostatic agents may also include polymeric sealants, such as, for example, bovine serum albumin and glutaraldehyde, human serum albumin and polyethylene crosslinking agents, and ethylene glycol and trimethylene carbonate. Polymer sealants may include FocalSeal surgical sealant developed by Focal Inc.

[0073] The appendages described herein are capable of releasably retaining at least one pharmaceutical agent, selectable from a large number of different agents. The agents include, but are not limited to, drugs or other agents having the desired function contained within or associated with the appendages. The agents include, but are not limited to, antimicrobial agents (such as antibacterial agents and antibiotics), antifungal agents, antiviral agents, anti-inflammatory agents, growth factors, analgesics, anesthetics, tissue matrix degradation inhibitors, anticancer agents, hemostatic agents, and other agents that induce biological responses.

[0074] Non-limiting examples of antimicrobial agents include ionic silver, aminoglycosides, streptomycin, polypeptides, bacitracin, triclosan, tetracycline, doxycycline, minocycline, demeclocycline, tetracycline, oxytetracycline, chloramphenicol, nitrofurans, furazolidone, nitrofurantoin, β-lactams, penicillin, amoxicillin, amoxicillin + clavulanic acid, azlocillin, flucloxacillin, ticarcillin, piperacillin + tazobactam, tebuconazole, and Biopiper. TZ, Piperacillin, Carbapenems, Imipenem, Meropenem, Ertapenem, Donipenem, Biapenem, Panipenem / Betamilon, Quinolones, Ciprofloxacin, Enoxacin, Gatifloxacin, Gemimifloxacin, Levofloxacin, Lomefloxacin, Moxifloxacin, Naproxic Acid, Norfloxacin, Sulfonamides, Sulfamiron, Sulfaacetyl, Sulfadiazine, Silver Sulfadiazine, Sulfamethazine, Sulfamethazine, Sulfamethoxazole, Sulfasylpyridinium, Sulfamethoxazole, Compound Sulfamethoxazole, Prontocillin, Lodosin, Geldermycin, Atrazine, Fidamycin, Glycopeptides Teicoplanin, vancomycin, tervanomycin, dabazomycin, orivoxil, lincosamides, clomacromycin, lincomycin, lipopeptides, dapoxetine, macrolides, azithromycin, clarithromycin, erythromycin, roxithromycin, tebuconazole, spiramycin, oxazolidinone, linezolid, aminoglycosides, amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin, paromomycin, cephalosporins, cefbiprexa, cefoloza, cefixime, fluoxetine, monoclonal cyclophosphamide, aztreonam, colistin, and polymyxin B.

[0075] Non-limiting examples of antifungal agents include triclosan, polyene, amphotericin B, candidiasis, ferulic acid, haramicin, natamycin, nystatin, sclerotinib, azoles, imidazoles, triazoles, thiazoles, allylamine, amorolfine, butenafine, naftifine, terbinafine, echinococcins, anisoflurane, caspoflurane, miafungin, ciclopirox olamine, and benzoic acid.

[0076] Non-limiting examples of antiviral agents include: uncoated inhibitors, such as, for example, amantadine, rimantadine, and pleconaril; reverse transcriptase inhibitors, such as, for example, acyclovir, lamivudine, antisense, fomivirsen, morpholino compounds, ribosylase, and rifampin; and virucidal agents, such as, for example, cyanovirin-N, griffithsin, scytovirin, α-lauroyl-L-arginine ethyl ester (LAE), and ionic silver.

[0077] Non-limiting examples of anti-inflammatory agents include nonsteroidal anti-inflammatory agents (e.g., salicylates, aspirin, diflunisal, propionic acid derivatives, ibuprofen, naproxen, fenolofen, and cloxoprofen), acetic acid derivatives (e.g., tometidine, sulindac, diclofenac sodium), enolic acid derivatives (e.g., piroxicam, meloxicam, doxicoxicam, and lornoxicam), anthranilic acid derivatives (e.g., mefenamic acid, meclofenamic acid, and flufenamic acid), selective COX-2 inhibitors (e.g., celecoxib (Celebrex), parecoxib, rofecoxib (Vox), sulfonylureas, nimesulide, and clotrimazole), immunoselective anti-inflammatory derivatives, corticosteroids (e.g., dexamethasone), and iNOS inhibitors.

[0078] Non-limiting examples of growth factors include cellular signaling molecules that stimulate cell growth, healing, remodeling, proliferation, and differentiation. Exemplary growth factors can be short-range (paracrine), long-range (endocrine), or autostimulatory (autocrine). Further examples of growth factors include growth hormones (e.g., recombinant growth factor, Nutropin, Humatrope, Genotropin, Norditropin, serotonin, omeprazole, and biosynthetic growth factors), epidermal growth factor (EGF) (e.g., inhibitors, gefitinib, erlotinib, afatinib, and cetuximab), heparin-bound EGF-like growth factors (e.g., epidermal regulatory factors, β-cytokinin, bimodalin, and Epigen protein), transforming growth factor α (TGF-α), neuromodulators 1-4, fibroblast growth factor (FGF), etc. FGFs (e.g., FGF1-2, FGF2, FGF11-14, FGF18, FGF15 / 19, FGF21, FGF23, FGF7 or keratinocyte growth factor (KGF), FGF10 or KGF2 and phenytoin), insulin-like growth factor (IGFs) (e.g., IGF-1, IGF-2 and platelet-derived growth factor (PDGF)), vascular endothelial growth factor (VEGFs) (e.g., inhibitors, bevacizumab, ranibizumab, VEGF-A, VEGF-B, VEGF-C, VEGF-D and becapprenomy).

[0079] Additional non-limiting examples of growth factors include cytokines such as granulocyte-macrophage colony-stimulating factor (GM-CSF) (e.g., inhibitors that suppress inflammatory responses and GM-CSF manufactured using recombinant DNA technology and via recombinant yeast-derived sources), granulocyte colony-stimulating factor (G-CSF) (e.g., filgrastim, levofloxacin, and eubrazol), tissue growth factor β (TGF-B), leptin, and interleukins (ILs) (e.g., IL-1a, IL-1b, konnabidiol, IL-2, adelin, interking, dentine, IL-3, IL-6, IL-8, IL-10, IL-11, and olprespin). Non-limiting examples of growth factors also include erythropoietin (e.g., dabepoetin, epcept, dynepo, epmax, neorecormon, silapo, and retacrit).

[0080] Non-restrictive examples of analgesics include anesthetics, opioids, morphine, codeine, oxycodone, hydrocodone, buprenorphine, tramadol, non-anesthetics, acetaminophen, paracetamol, nonsteroidal anti-inflammatory drugs, and flupirtine.

[0081] Non-limiting examples of anesthetics include local anesthetics (e.g., lidocaine, benzocaine, and ropivacaine) and general anesthetics.

[0082] Non-limiting examples of tissue matrix degeneration inhibitors that inhibit the action of metalloproteinases (MMPs) and other proteases include MMP inhibitors (e.g., exogenous MMP inhibitors, hydroxamic acid-based MMP inhibitors, barmasta (BB-94), ilomastasta (GM6001), marimastasta (BB2516), thiols, periodat (doxycycline), squaric acid, BB-1101, hydroxyurea, hydrazine, endogenous carbamoyl phosphate, β-lactams, and tissue inhibitors of MMPs (TIMPs)).

[0083] Non-limiting examples of anticancer agents include monoclonal antibodies, bevacizumab (Avastin), cell / chemical inducers, alkylating agents (e.g., bifunctional, cyclophosphamide, dichloromethyldiethylamine, chlorambucil, melphalan, monofunctional, nitrosourea, and temozolomide), anthracyclines (e.g., doxorubicin, epirubicin, idarubicin, mitoxantrone, and pentorubicin), cytoskeleton disruptors (e.g., paclitaxel and docetaxel), epothilone agents that limit cell division by inhibiting microtubule function, inhibitors of various enzymes required to block cell division or certain cellular functions, histone deacetylase inhibitors (e.g., vorinostat and romidesin), and topoisomers. Enzyme I inhibitors (e.g., irinotecan and topotecan), topoisomerase II inhibitors (e.g., etoposide, teniposide, and tafluposide), kinase inhibitors (e.g., bortezomib, erlotinib, gefitinib, imatinib, vemurafenib, and vemodigine), nucleotide analogs (e.g., azacitidine, azathioprine, capecitabine, cytarabine, deoxyfluorouridine, fluorouracil, 5-FU, Adrucil, Carac, Efudix, Efudex, Fluoroplex, gemcitabine, hydroxyurea, mercaptopurine, and thioguanine), and peptide antibiotics that cleave DNA and disrupt DNA unwinding / entanglement (e.g., bortezomib, erlotinib, gefitinib, imatinib, vemurafen ... Platinum-based antitumor agents that inhibit DNA repair and / or synthesis of cross-linked DNA (e.g., carboplatin, cisplatin, oxaliplatin, and eloxatin), retinoids (e.g., retinoic acid, retinoic acid, and besalodin), vinblastines that inhibit mitosis and microtubule formation (e.g., vincristine, vinorelbine, vinorelbine, vinorelbine), and angiogenesis inhibitors that inhibit cell growth or cell expansion (e.g., axitinib (Inritar), bevacizumab (Avastin), cabozantinib (Cometriq), everolimus (Afinil, Zortress), lenalidomide (Lepril), pazopanib (Vitrant), and remoxicillin). Rucizumab (Cyramza), Regorafenib (Stivarga), Sorafenib (Nexavar), Sunitinib (Sutent), Thalidomide (Cilavir, Sesylvaline), Vandertanib (Caprelsa), Zib-Aflibercept (Zaltrapezil), Anti-angiogenic polysaccharides, Alpradine (Dehydrometasine B), Saponins (20(S)-Protopanaxadiol and 20(S)-Protopanaxtriol), Anti-intestinal obstruction agents, Prokinetic agents, Immunosuppressants (e.g., Tacrolimus), Blood modulators (e.g., Vasodilators, Viagra and Nifedipine), 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitors (e.g., Atorvastatin), and Anti-angiogenic agents.

[0084] Exemplary agents also include agents that passively promote wound healing, such as nutrients, oxygen-removing agents, amino acids, collagen-synthesizing agents, glutamine, insulin, butyrate, and dextran. Exemplary agents also include anti-adhesion agents, non-limiting examples of which include hyaluronic acid / carboxymethyl cellulose (seprafilm), oxidized regenerated cellulose (Interceed), and 4% icodextrin (Extraneal, Adept).

[0085] Exemplary agents also include those that promote coronary artery disease (CAD) (e.g., VEGF). 165 Protein, AdVEGF 165 ,AdVEGF 121 and VEGF 165 Plasmids) or peripheral artery disease (PAD) (e.g., VEGF) 165 plasmids, AdVEGF 121 SB-509 (SFP-VEGF plasmid), AdVEGF 165 A blood supply regeneration agent following Ad2-HIF1α-VP16 (WALK trial).

[0086] Drug release

[0087] The appendage according to the technology can be associated with at least one agent in a variety of different ways to provide a desired effect, such as promoting inward growth of tissue. The at least one agent can be configured to be released from the appendage in a variety of spatial and temporal patterns to trigger a desired healing process at the treatment site. The agent can be disposed in, combined with, incorporated into, dispersed within, or otherwise associated with the appendage. For example, the appendage may have one or more regions that releasably hold one or more different agents. These regions can be different reservoirs of various sizes and shapes that hold agents in various ways, or other different or continuous regions within the appendage. In some aspects, a particular configuration of the appendage allows it to releasably hold one or more different agents.

[0088] Regardless of how the drug is disposed within the appendage, an effective amount of at least one drug can be encapsulated in a container, such as a microcapsule, a pellet in the form of microbeads, or any other container. The container may be formed from a bioabsorbable polymer.

[0089] Targeted delivery and release of at least one agent from an appendage can be accomplished in a variety of ways depending on various factors. Typically, the at least one agent can be released from the appendage material as a bolus dose, such that the agent is released substantially immediately upon delivery of the appendage material to the tissue. Alternatively, the at least one agent can be released from the appendage over a period of time, which can be minutes, hours, days, or longer. The rate of timed release and the dose of drug released can depend on various factors, such as the degradation rate of the area where the agent is released, the degradation rate of one or more coatings or other structures used to retain the agent in the appendage, environmental conditions at the treatment site, and various other factors. In some aspects, when the appendage has more than one agent disposed therein, the bolus dose release of the first agent can modulate the release of a second agent that begins to be released after the release of the first agent. The appendage may include multiple agents, each of which can influence the release of one or more other agents in any suitable manner.

[0090] The release of at least one agent, as a bolus dose or a timed release, may occur or begin substantially immediately after the adjuvant material is delivered to the tissue, or may be delayed for a predetermined time. The delay may depend on the structure and properties of the adjuvant or one or more regions thereof.

[0091] The adjuvant material can be configured to facilitate the dispensing of an effective amount of one or more agents carried within the adjuvant to provide the desired effect. For example, targeted delivery of the agent can be achieved by incorporating the agent into a patterned region (e.g., a reservoir such as a hole or other structure) within the adjuvant, the pattern allowing the agent to form a spatial distribution during delivery. The agent disposed within the reservoir can be incorporated into different containers. The reservoir can include more than one type of different agent. The one or more agents can be eluted from the adjuvant in a homogeneous or non-homogeneous spatial and / or temporal manner to deliver the desired treatment. The structure of the adjuvant and the manner in which the agent is released from it can be used to influence or control tissue regeneration. Furthermore, tissue regeneration can be promoted at certain locations at the treatment site, while not at other locations.

[0092] Drug release characteristic structure

[0093] In some embodiments, the appendage may have a configuration designed to control drug movement through and out of the appendage when the appendage is in a tissue-deployed state (e.g., sutured to tissue in vivo). As described below, the appendage may include active drug-release features designed to achieve drug release from the appendage in a controlled and customized manner when these features are activated (e.g., thermal and / or mechanical activation). That is, unless activated, the active drug-release feature is configured to encapsulate the drug and thus inhibit drug release from the appendage. In this way, the active drug-release feature helps prevent premature drug release from the appendage.

[0094] The appendage may typically be formed of at least one fused bioabsorbable polymer configured to be releasably retained on a staple cartridge and configured to be delivered to tissue via deployment of staples within the cartridge. In one exemplary embodiment, the appendage material may include a lattice macrostructure having drug delivery microstructures formed within it, and each drug delivery microstructure may have a drug disposed therein. The drug delivery microstructures may be configured to encapsulate the drug, thereby preventing drug release until the plurality of drug delivery microstructures thermally rupture in response to changes in body temperature and / or mechanically rupture (e.g., mechanical failure) in response to at least one of clamping, suturing, and cutting of the appendage material. In some embodiments, the drug delivery microstructure may have an interior lumen (e.g., a microreservoir) defined therein. As used herein, the term “lattice macrostructure” is used synonymously with the term “lattice master structure.”

[0095] To enable the formation of both macrostructures and microstructures, the appendages can be non-fibrous appendages. Unlike conventional appendages (e.g., non-3D printed appendages such as foam appendages and woven / nonwoven non-fibrous appendages), these non-fibrous appendages are 3D printed and therefore can be formed with consistent and reproducible microstructures (units). That is, unlike other manufacturing methods, 3D printing significantly improves control over microstructural features such as the placement and connection of elements. Therefore, the variability of both the microstructure and associated properties of the appendages of the present invention is reduced compared to conventional appendages. Furthermore, 3D printing can produce appendages with microstructural features that cannot be formed or produced in conventional appendages in other ways. The non-fibrous appendages of the present invention are also suitable for use with a variety of nails and tissue types.

[0096] In some embodiments, the drug delivery microstructure may thermally decompose in response to a variety of temperature-related events, such as temperature increases or decreases. In some embodiments, the drug delivery microstructure may be configured to thermally decompose in response to an increase in temperature.

[0097] An increase in temperature can be in response to infection of the sutured tissue. That is, once the appendage is in a tissue-deployed state (e.g., sutured to tissue in vivo), the temperature at or near the sutured appendage can increase due to infected tissue (e.g., due to swelling and / or locally increased blood flow). Therefore, such an increase in temperature can trigger the release of a drug from one or more drug delivery microstructures within a drug delivery microstructure. For example, in some embodiments, the drug delivery microstructure may be in the form of a micro-container sealed with a material configured to decompose or liquefy at elevated body temperatures (e.g., greater than about 37°C). Once the micro-container is opened, the drug can be released from the appendage, and in some embodiments, the drug (e.g., an antibiotic) can be used to treat an infection. In some embodiments, the micro-container is sealed with a stopper formed of a material. Alternatively or additionally, in cases where the initial release of the drug from one or more drug delivery microstructures has already thermally ruptured, an increase in temperature can be used to accelerate the release of the drug from the drug delivery microstructure.

[0098] In some embodiments, the drug delivery microstructure may be configured to thermally rupture when the appendage is at or above an activation temperature. The activation temperature may be associated with body temperature (e.g., about 37°C). Therefore, body temperature can serve as a gating key that can trigger the release of a drug from one or more drug delivery microstructures. For example, in some embodiments, the drug delivery microstructure may be in the form of a micro-container sealed with a material configured to decompose or liquefy upon exposure to body temperature and / or the presence of humidity. In some embodiments, the micro-container may be sealed with a stopper formed of material. In other embodiments, the drug delivery microstructure may be formed of a structure with an initially sealed pore (e.g., formed of a shape memory material), and once the appendage is in a tissue-deployed state, exposure to body temperature can cause the sealed pore to open and release the drug therefrom.

[0099] In some embodiments, daily temperature variations at or near the suture site can be used to control the rate of drug release from the drug delivery microstructure. For example, a combination of time- and temperature-dependent release features can allow for multi-day drug administration to a patient at approximately the same time. In one embodiment, the temperature-activated release feature may be encapsulated in a time-dependent release material of varying thicknesses. In another embodiment, the drug delivery microstructure may be in the form of microcapsules sealed with different materials or material thicknesses configured to release at body temperature. These microcapsules may be sealed with stoppers of varying thicknesses and / or formed of materials different from each other. In one embodiment, a first microcapsule may be sealed with a first stopper, and a second microcapsule may be sealed with a second stopper of a different material and / or thickness than the first stopper.

[0100] In other embodiments, the drug delivery microstructure may mechanically rupture (e.g., mechanical failure) in response to clamping, suturing, and / or cutting of the appendage. For example, in use, once the appendage is releasably held to the cartridge of a surgical end effector, clamping of the appendage between the opposing jaws of the end effector (e.g., compression of the first jaw (e.g., anvil) of the appendage prior to cannula introduction, or initial compression of tissue between the jaws) may cause at least a portion of the drug delivery microstructure to rupture (e.g., shear, break, or otherwise open). Once ruptured, a drug otherwise encapsulated within these drug delivery microstructures may be released. The encapsulated drug can be in various forms, such as powder form (e.g., dry or lyophilized), polymer-interacting form (e.g., side-chain molecules on a polymer chain), or liquid form (e.g., a liquid interacting with the base polymer of the appendage (e.g., an oil-based polymer for hydrolysis or an water-based polymer for enzymatic degradation). Alternatively or additionally, once the appendage is releasably held on the chamber, any drug delivery microstructure overlapping with a peg disposed within the chamber can be punctured during the suturing of the appendage. Thus, drug release from the overlapping drug delivery microstructure can be achieved by advancing the peg through the appendage. Alternatively or additionally, once the appendage is releasably held on the chamber, any drug delivery microstructure overlapping with a slot of the chamber configured to receive a cutting element can be cut by the cutting element as it advances through the slot during cutting of the appendage. Thus, drug release from the overlapping drug delivery microstructure can be achieved by advancing the cutting element through the appendage.

[0101] The medication can be incorporated into the appendage in various ways and at different times. In some embodiments, the medication can be incorporated into the appendage before it is releasably held on the staple cartridge and / or anvil. In other embodiments, the medication can be incorporated into the appendage after it has been releasably held on the staple cartridge and / or anvil appendage. For example, in one embodiment, once the appendage is applied to the staple cartridge and / or anvil (e.g., via an appendage applicator), a user can clamp onto a medication delivery device (e.g., a sponge containing medication (e.g., in liquid form) removably attached to the appendage) to apply at least one medication to the appendage. In another embodiment, the medication delivery device can be a 3D-printed bottle or container in which at least one medication is disposed. The 3D-printed container can be attached to the appendage and configured to deliver medication to the appendage upon compression (e.g., squeezing). In some embodiments, the 3D-printed container is attached to the appendage and remains attached when the appendage is sutured to tissue. In one embodiment, the 3D-printed container includes a one-way valve that retains at least one medication within the container and allows only that medication to exit when the container is compressed. Alternatively or additionally, the 3D-printed container may include a top cover configured to be cut off by the cutting element as it is advanced through the staple cartridge. Alternatively or additionally, compression of the 3D-printed container may be achieved by swelling of tissue sutured to the appendage during healing or during infection.

[0102] Drug delivery microstructures can have various configurations. In some embodiments, a drug delivery microstructure can be a strut-based cell characterized by the presence of sharp or acute angles, a strutless cell characterized by a curved surface, or a combination thereof. For strutless cells, the cell may be based, for example, on a triple periodic minimal surface (TPMS). A TPMS is a minimal surface that repeats itself in three dimensions. As used herein, the term “minimal surface” refers to a minimal surface as known in mathematics. Thus, in some embodiments, the cell may be a triple periodic minimal surface structure (e.g., Schwarz-P, Schwarz diamond, etc.) having pathways extending through it. For example, a strutless cell may be a hollow structure. Additional details regarding triple periodic minimal surface structures such as the Schwarz-P structure can be found in U.S. Patent Application No. 17 / 009,740, filed September 1, 2020, entitled “Compressible Non-Fibrous Adjuncts,” the entire contents of which are incorporated herein by reference. In some embodiments, the lattice master structure may include a combination of strut-based cells (e.g., hollow struts) and strutless cells (e.g., one or more triple-periodic minimal surface structures). In one embodiment, strutless cells are interconnected via interconnecting structures. These interconnecting structures may take the form of hollow tubes or struts. In some embodiments, cells may include interconnecting structures.

[0103] Each exemplary appendage described below is shown in partial form (e.g., not in full length), and therefore those skilled in the art will understand that the appendage (e.g., along its longitudinal axis (L) as identified in each embodiment) A The length of the appendage can be longer. This length can vary based on the length of the staple cartridge or anvil. The width can also vary as needed. Additionally, each exemplary appendage is configured to be positioned on the surface of the cartridge or anvil such that the longitudinal axis L of each appendage is aligned with the longitudinal axis (L...) of the cartridge or anvil. A They are aligned and extend along the longitudinal axis. These appendages are structured to compress when exposed to compressive forces (e.g., stress or load).

[0104] Figure 8 and Figure 9An exemplary embodiment of a surgical end effector 2000 having an anvil 2002 and a suture assembly 2004 is shown. The suture assembly 2004 includes an appendage 2006 releasably retained on the top surface or platform surface 2007 (e.g., the cartridge surface facing the anvil) of a staple cartridge 2008. The cartridge 2008 has two sets of three rows of staples disposed within the cartridge 2008 (only three staples 2010a, 2010b, 2010c, 2012a, 2012b, 2012c are shown in each set), and a slot 2014 defined within the cartridge 2008, the slot being configured to receive a cutting element 2016 (see [link to documentation]). Figure 9 ). Figure 8 The surgical end effector 2000 in a fully closed position and the anvil 2002 therefrom are shown. Figure 9 The illustration shows tissue T held between an anvil 2002 and suture assembly 2004, sutured to appendage 2006 via staples 2010a, 2010b, 2010c, 2012a, 2012b, and 2012c, and tissue T and appendage 2006 being cut via cutting element 2016. Although not shown, anvil 2002 is pivotally coupled to an elongated staple channel, and suture assembly 2004 is positioned within and coupled to the elongated staple channel.

[0105] Although the appendage 2006 can have various configurations, such as Figure 8 As shown, and in more detail as Figure 10 As shown, the appendage 2006 has a lattice macrostructure 2019 in which drug delivery microstructures are formed (only nine drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, 2022c, 2024a, 2024b are shown). Although the drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, 2022c, 2024a, and 2024b may have various configurations, in this illustrated embodiment, the lattice macrostructure 2019 includes first drug delivery microstructures 2020a, 2020b, 2020c, and 2020d and second drug delivery microstructures 2022a, 2022b, 2022c, 2024a, and 2024b, each first drug delivery microstructure having a first drug 2026 disposed therein and each second drug delivery microstructure having a second drug 2028 disposed therein. The first drug delivery microstructure and the second drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, 2022c, 2024a, and 2024b are each configured to encapsulate the corresponding first drug and second drug 2026 and 2028 therein. Figure 8 and Figure 10), until the first drug delivery microstructure and the second drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, 2022c, 2024a, and 2024b are mechanically broken. Figure 9 In some embodiments, the first drug and the second drug may be different, while in other embodiments, the first drug and the second drug may be the same. Furthermore, in embodiments where the first drug and the second drug are different, a portion of the first drug delivery microstructure and / or the second drug delivery microstructure may include the first drug, and another portion of the first drug delivery microstructure and / or the second drug delivery microstructure may include the second drug.

[0106] The first and second drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, 2022c, 2024a, and 2024b can have various configurations. In this illustrated embodiment, the first drug delivery microstructures 2020a, 2020b, 2020c, and 2020d are in the form of hollow cells, each hollow cell having an internal cavity (e.g., a microreservoir) defined therein. The second drug delivery microstructure is in the form of an inner hollow tube (drug delivery microstructures 2022a, 2022b, and 2022c) and an outer hollow tube (drug delivery microstructures 2024a and 2024b), each having an internal cavity (e.g., a microreservoir). The inner hollow tubes 2022a, 2022b, and 2022c extend between adjacent hollow cells and connect adjacent hollow cells to each other, while the outer hollow tubes 2024a and 2024b extend outward from the outermost hollow cells (drug delivery microstructures 2020a and 2020d). Therefore, the hollow cells (drug delivery microstructures 2020a, 2020b, 2020c, and 2020d) are fluidly connected to each other, creating a continuous path network within the appendage 2006. Those skilled in the art will understand that the structural configuration and number of the first and second drug delivery microstructures can depend at least on the size and shape of the lattice macrostructure and the structural configuration of the stapled cartridge to which the appendage will be releasably held, and therefore, the appendage is not limited to the structure and number of drug delivery microstructures shown in the figure. Furthermore, although two different drug delivery microstructures are shown, in other embodiments, the lattice macrostructure may include any suitable type and number of drug delivery microstructures.

[0107] The first drug delivery microstructure and the second drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, 2022c, 2024a, and 2024b can be positioned in different regions of the appendage 2006, such that drug release from the microstructure can be achieved by different activation mechanisms (e.g., clamping, suturing, and / or cutting of the appendage). In this illustrated embodiment, the first drug delivery microstructures 2020a, 2020b, 2020c, and 2020d are positioned in the region of the appendage 2006 that overlaps with the inner and outer rows of staples 2010a, 2010c, 2012a, and 2012c of the staple cartridge 2008. More specifically, the outermost hollow cells (first drug delivery microstructures 2020a and 2020d) overlap with the outermost pin rows 2010a and 2012a, respectively, and the innermost hollow cells (first drug delivery microstructures 2020b and 2020c) overlap with the innermost pin rows 2010c and 2012c, respectively. Furthermore, the outermost inner hollow tubes (second drug delivery microstructures 2022a and 2022c) overlap with the intermediate pin rows 2010b and 2012b, respectively. Therefore, as... Figure 9 As shown, when nails 2010a, 2010b, 2010c, 2012a, 2012b, and 2012c advance through the corresponding overlapping drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, and 2022c, the nails puncture, thus causing mechanical breakage of these drug delivery microstructures. Therefore, as Figure 9 As shown, drugs can subsequently be released from these drug delivery microstructures 2020a, 2020b, 2020c, 2020d, 2022a, 2022b, and 2022c into the tissue (e.g., at or around the nail hole created within the tissue). Furthermore, during nail deployment, the clamping of the appendage 2006 between the anvil 2002 and the nail cartridge 2008 can help facilitate drug release from the punctured drug delivery microstructures 2022a, 2022b, 2020c, 2020d, 2022a, 2022b, and 2022c.

[0108] like Figure 8 and Figure 10 As further shown, the innermost hollow tube (drug delivery microstructure 2022b) is positioned in the area of ​​the appendage 2006 that overlaps with the slot 2014 of the staple cartridge 2008. Therefore, in use, as... Figure 9 As shown, as the cutting element 2016 advances through the slot 2014, the overlapping drug delivery microstructures 2022b are severed and thus mechanically broken. Therefore, as... Figure 9 As shown, the drug can be released from the drug delivery microstructure 2022b and enter the tissue (e.g., along the cut edge T of tissue T). E ).

[0109] Furthermore, in this illustrated embodiment, the outer hollow tubes (drug delivery microstructures 2024a, 2024b) are positioned within the outermost region of the appendage and are therefore adjacent to the outermost pin rows 2010a, 2012a. Thus, in use, as... Figure 9 As shown, when the appendage 2006 and tissue T are clamped between the anvil 2002 and the cartridge 2008, the resultant force applied to the appendage 2006 can thereby cause the drug disposed within the external hollow tube (drug delivery microstructures 2024a, 2024b) to be released from it and enter the tissue T. Those skilled in the art will understand that in other embodiments, the clamping of the appendage itself can cause mechanical breakage of any drug delivery microstructure within the appendage.

[0110] In some embodiments, the appendage may include drug-release features configured to control dose-release of a drug from the appendage when it is in a tissue-deployed state. For example, in some embodiments, the drug-release features may be configured to influence the dose of a dosed drug over time while the appendage is in a tissue-deployed state. In other embodiments, the drug-release features may be configured to influence a variable dose of a drug over time while the appendage is in a tissue-deployed state. For example, the drug-release features may allow for an initial bolus dose of a drug, followed by subsequent doses of the drug (e.g., based on a time frame relative to the expected healing curve of the tissue sutured to the appendage). Alternatively or additionally, the appendage may include one or more materials (e.g., hydrogels) located within the pathways that form the appendage. These materials may serve as a type of drug-release feature configured to inhibit drug movement through the corresponding pathways over a predetermined time period.

[0111] For example, in one exemplary embodiment, the appendage may be formed of at least one fused bioabsorbable polymer and may have a lattice macrostructure having a primary microreservoir and an auxiliary microreservoir formed therein. The primary and auxiliary microreservoirs are different in size from each other and may contain a drug disposed therein. The primary microreservoir may be configured to release a drug therefrom upon activation, and the auxiliary microreservoir may be configured to release a drug therefrom upon degradation of at least one of the at least fused bioabsorbable polymers, such that when the appendage is in a tissue-deployed state, the combination of the primary and auxiliary microreservoirs controls the dose of drug to be released from the appendage. Thus, the primary microreservoir can serve as an active drug release feature structure, and the auxiliary microreservoir can serve as a passive drug release feature structure.

[0112] Activation of the main microreceptor (e.g., mechanical failure) can occur in a variety of ways. For example, the main receptor can be configured to be punctured (e.g., by sewing the appendage as described above), ruptured (e.g., by clamping the appendage as described above, cut off (e.g., by cutting the appendage as described above), or any combination thereof.

[0113] In some embodiments, the lattice macrostructure may include at least one internal stop member formed in each master microreservoir. The at least one internal stop member may be configured to limit the amount of deformation of the corresponding master microreservoir when the appendage material is compressed. In some embodiments, the at least one internal stop member may be configured to degrade over time when the appendage material is in a tissue-deployed state, thereby allowing greater deformation of the corresponding master microreservoir when the appendage material is compressed. In some embodiments, the master microreservoir may be formed of a first fused bioresorbable polymer, and the at least one internal stop member may be formed of a second fused bioresorbable polymer that degrades faster than the first fused bioresorbable polymer.

[0114] Depending on the form of the drug contained within the master microreservoir, the master microreservoir can be sealed or otherwise capped. For example, in embodiments where the drug is in liquid form, the master microreservoir can be sealed to prevent premature release of the drug from the appendage. The master microreservoir can be sealed by any suitable method (e.g., the seal can be 3D printed or jet / extrusion / roll-in-place (BAM)). In embodiments where the drug is in powder form, the master microreservoir can be unsealed or otherwise opened. Furthermore, in some embodiments, the master microreservoir can be opened when the drug is in a malignant liquid form.

[0115] The primary micro-repository and the auxiliary micro-repository can each be defined by a corresponding microstructure formed within the lattice macrostructure. In some embodiments, the primary micro-repository can be defined by a corresponding hollow cell or hollow tube. That is, the cavity of the hollow cell or hollow tube can be used as the primary micro-repository. In some embodiments, the auxiliary micro-repository can be a void or opening defined within the wall of the lattice macrostructure.

[0116] Figure 11Another embodiment of an appendage 2100 is shown, having an appendage 2102 formed by cell 2104 (e.g., a Schwarz-P structure) connected to each other by connecting structures 2106. For simplicity, only one cell 2104 and a portion of the two connecting structures 2106 are shown. While the cell 2104 and the two connecting structures 2106 can have various configurations, in this illustrated embodiment, the cell 2104 is a hollow structure defining an inner cavity 2105, and each of the two connecting structures 2106 is a hollow tube. Thus, the cell 2104 is in fluid communication with each other, allowing a continuous path network to exist or form within the appendage 2100.

[0117] As shown in the figure, a first drug (depicted as a shading mark) is disposed within the cavity 2105 (e.g., a master microreservoir) of cell 2104. Cell 2104 may be configured to encapsulate the first drug within its cavity 2105 until the cell is activated. Thus, in use, once cell 2104 is activated (e.g., in response to at least one of clamping, suturing, or cutting of appendage 2100, from a non-compressed state to a compressed state or rupture), the first drug can be released from the cell and enter the tissue.

[0118] like Figure 11 As further shown, voids 2010 (e.g., auxiliary microreservoirs) are defined within the walls 2108 of the lattice macrostructure 2102. Each void 2010 has a second drug disposed therein, and each void 2010 is configured to release the second drug therefrom in response to at least partial degradation or corrosion of the defined portion of the corresponding wall 2108. In other words, each void 2010 is configured to encapsulate the second drug, thereby preventing the drug from being released therefrom until at least a portion of the defining wall 2108 undergoes structural degradation. Therefore, when the appendage 2100 is in a tissue-deployed state, the combination of the cavity 2105 of the cell 2104 (e.g., the main microreservoir) and the voids 2010 (e.g., auxiliary microreservoirs) within the walls 2108 of the lattice macrostructure 2102 can control the dosage of the drug released from the appendage 2100.

[0119] While the cavity 2105 (e.g., the primary microreservoir) and the void 2110 (e.g., the auxiliary microreservoir) can have various shapes and sizes, as shown in the figure, the cavity 2105 is relatively large, thus allowing for a larger drug loading capacity compared to the void 2110. This allows for the release of a large dose of the first drug upon activation of cell 2104, followed by the release of a smaller dose of the second drug as the wall 2108 of the lattice macrostructure 2102 undergoes structural degradation.

[0120] Furthermore, although not shown, the appendage 2100 may include at least one internal stop member formed within the cell 2104 (e.g., similar to...). Figure 14 (See internal stop members 2314, 2316). This at least one internal stop member may be configured to limit the amount of deformation of the corresponding cell when the appendage is compressed. For example, in some embodiments, with at least one internal stop member in place, each activation of the cell may release a small dose of the first drug. In other embodiments, at least one internal stop member may be configured to degrade over time while the appendage is in a tissue-deployed state. Therefore, during one or more subsequent activations of the cell, this degradation may allow for the release of a larger amount of drug (e.g., compared to the amount of drug before degradation). In other words, drug release may increase as degradation proceeds. Thus, the dose of drug released from the appendage 2100 may vary in response to changes in the geometry of the cell during activation. In some embodiments, the appendage 2100 may include one or more hydrogels (e.g., disposed within one or more pathways of the appendage) that may be used to inhibit flow through the appendage over a predetermined time period.

[0121] In some embodiments, the appendages may include first and second voids (e.g., auxiliary micro-repositories) located in different regions of the walls of the lattice macrostructure. For example, Figure 12 It shows the relationship with Figure 11 The appendix 2100 is part of the cell connector of the appendix 2200, similar to the appendix 2200, except that the appendix 2200 includes a first cavity 2202 in which a first drug 2204 is disposed and a second cavity 2206 in which a second drug 2208 is disposed.

[0122] like Figure 12 As shown, the first gap 2202 is positioned near the outer surface 2212 of the wall 2210, and the second gap 2206 is positioned near the inner surface 2214 of the wall 2210. In this illustrated embodiment, the first gap 2202 (e.g., the outer gap) surrounds the second gap 2206 (e.g., the inner gap). Furthermore, as shown, the distance D1 between the first gap 2202 and the outer surface 2212 of the wall 2210 is greater than the distance D2 between the second gap 2206 and the inner surface 2214 of the wall 2210. Therefore, as... Figure 13As shown, as the wall 2210 degrades, the second drug 2208 is released from the appendage 2100 before the first drug. That is, the drug release from the first pore 2202 and the second pore 2206 can therefore be a function of their respective locations within the wall 2210 (e.g., relative to the inner or outer wall surface). In some embodiments, the first and second drugs can be the same, having a metered release from the appendage. In other embodiments, the first and second drugs can be different to meet different needs based on different time periods or events during the suturing of the appendage to the tissue (e.g., time periods relative to the expected healing curve of the sutured tissue).

[0123] In some embodiments, the appendage may be formed of multiple layers of cells, such that the drug dosage can vary in response to polymer erosion of one or more layers of the cells. For example, Figure 14 An exemplary embodiment of a multi-layered cell 2300 that can be used to form any of the appendages described herein is shown. While the cell 2300 may have various configurations, in this illustrated embodiment, the cell 2300 is a Schwarz-P structure having an inner layer 2302 and an outer layer 2304. As shown, the illustrated Schwarz-P structure is hollow, with the inner layer 2302 defining a cavity 2306 within the Schwarz-P structure.

[0124] The inner layer 2302 and the outer layer 2304 can be formed of various materials. The inner layer 2302 can be formed of a blend of a first fused bioabsorbable polymer 2308 and a drug 2310. In some embodiments, such as Figure 14 As shown, drug 2310 can be discretely embedded within portions of inner layer 2302. In other embodiments, drug can be uniformly dispersed throughout the first fused bioabsorbable polymer. In any embodiment, the first fused bioabsorbable polymer 2308 can be configured to undergo degradation when the appendage is sutured to tissue, so as to release discrete amounts of drug into the lumen 2305 of cell 2300 over time.

[0125] The outer layer 2304 may be formed of a second fused bioabsorbable polymer 2312, which is different from the first fused bioabsorbable polymer 2308. In some embodiments, the second fused bioabsorbable polymer 2312 may be configured to degrade at a lower degradation rate than the first fused bioabsorbable polymer 2308. In such embodiments, the outer layer 2304 may maintain the structural integrity of the entire cell 2300 as the inner layer 2302 degrades. Therefore, the cell 2300 can act as a pump when the appendage is compressed. That is, when force is applied to the appendage, the cell 2300 may be configured to deform or compress so that at least a portion of the drug present in the lumen 2306 (e.g., due to corrosion of at least a portion of the inner layer 2302) is expelled from the appendage and discharged into adjacent tissue when the appendage is in a tissue-deployed state.

[0126] like Figure 14 As further shown, cell 2300 may include internal stop members 2314, 2316 formed therein and extending into cavity 2306. These internal stop members 2314, 2316 are configured to contact each other when cell 2300 is compressed to limit the amount of deformation of cell 2300. While cell 2300 may include any number of internal stop members, in this illustrated embodiment, cell 2300 includes a set of internal stop members 2314, 2316.

[0127] The internal stop members 2314 and 2316 can have various configurations. Furthermore, the internal stop members can have the same or different structural configurations. For example... Figure 14 As shown, a set of components includes opposing first and second stop members 2314, 2316, each stop member having a V-shaped configuration, wherein the first stop member 2314 is positioned near the top portion 2318 of the cell 2300, and the second stop member 2316 is positioned near the bottom portion 2320 of the cell 2300. Those skilled in the art will understand that the number and configuration of the internal stop members depend at least on the structural configuration and size of the cell, and therefore, in other embodiments, the cell may have a different number of internal stop members and / or have internal stop members with other suitable shapes and sizes.

[0128] In other embodiments, an appendage is provided having microstructures (units) with substructures formed within the microstructures, thereby creating distinct zones within the appendage exhibiting different mechanical properties when the appendage is in a tissue-deployed state. For example, the interconnections or geometry of the microstructures may have predetermined bending zones, buckling shapes, deflection stops, elongation zones, or other variable geometries, thereby causing a first portion of the appendage to move or deform differently from other portions. Thus, the structural configuration of the microstructure can be tailored to have a corresponding compressive distribution that controls the flow rate (e.g., volume and / or velocity) of the drug ejected from it. Therefore, the microstructure can generate different drug release responses in different portions of the appendage.

[0129] For example, in one exemplary embodiment, the appendage may be formed of at least one fused bioabsorbable polymer and may have a lattice macrostructure containing at least one drug therein. The lattice macrostructure may be formed of cells, and each cell may be configured to discharge a predetermined amount of drug from the appendage, the predetermined amount of drug being a function of the compression distribution of the corresponding cell. Thus, drug delivery can be controlled by the compression distribution of the cells.

[0130] These cells can have various configurations. For example, in some embodiments, the cells are Schwarz-P structures. In one embodiment, the Schwarz-P structure is hollow. In some embodiments, the lattice macrostructure includes connecting structures that extend between adjacent Schwarz-P structures and connect adjacent Schwarz-P structures to each other. In one embodiment, the connecting structure is in the form of a hollow tube. In such embodiments, the Schwarz-P structures can be fluidly connected to each other, such that a continuous path network exists or forms within the appendage.

[0131] In some embodiments, the appendage may include a first cell having a first compression distribution and a second cell having a second compression distribution different from the first compression distribution. Therefore, different portions of the appendage may have different drug release rates. For example, a portion of the appendage formed by the first cell may have a first drug release rate as a function of the first compression distribution, and a portion of the appendage formed by the second cell may have a second drug release rate as a function of the second compression distribution.

[0132] One or more cells of the appendage may have different compression zones. For example, in some embodiments, a cell may include a first compression zone having a first compression strength; and a second compression zone having a second compression strength different from the first compression strength. The first compression zone may be configured to compress from a first uncompressed height to a first compressed height. The second compression zone may be configured to compress from a second uncompressed height to a second compressed height different from the first compressed height. Those skilled in the art will understand that the compression strength of a corresponding compression zone of a cell may depend at least on the cell's location within the appendage (e.g., relative to the intended cut line of the appendage) and / or the intended drug delivery site.

[0133] In some embodiments, the deformability of the appendage can be controlled by substructures formed within one or more cells. For example, the substructures can be configured to alter the deformability, deformation limits, bulk modulus, etc., of the cells relative to the intended suture line and / or intended cut line of the appendage, thereby producing different mechanical responses in different portions of the appendage. This allows for a non-uniform pressure distribution on the tissue sutured to the appendage. Furthermore, since the drug is contained within one or more cells, this can produce transversely different drug release characteristics relative to the intended cut line of the appendage. The healing zone from the cut line to the unrestricted portion of the tissue may require different drugs and dosages to induce proper healing. In one embodiment, the cells may differ in size, release mechanism (e.g., high-dose versus stepwise release), and / or drug or drug combination (e.g., cells may differ transversely along the appendage in the y-direction).

[0134] In one embodiment, the substructures may be configured to contact each other when the appendage is compressed. This resulting contact may increase the appendage's deviation (e.g., stiffness) or, alternatively, inhibit or stop any further compression or collapse of the appendage. Alternatively or additionally, the overall geometry of the cells may affect the deformation characteristics of the appendage. For example, in one embodiment, one or more cells may have variable wall thicknesses. In another embodiment, one or more cells may have thinner wall thicknesses and may have an integral structure (e.g., a movable hinge or similar structure) configured to induce bending at predetermined locations.

[0135] Figure 15 and Figure 16An exemplary embodiment of a cell 2400 (e.g., a microstructure) is shown, which may be configured to spray a predetermined amount of drug (not shown). While the cell 2400 may have various configurations, in this illustrated embodiment, the cell 2400 is hollow and has a base structure 2402 with first side structures and second side structures 2404, 2406. The first and second side structures 2404, 2406 extend outward from opposite sides of the base structure 2402. While the structural configurations of the base structure 2402 and the first and second side structures 2404, 2406 can vary, in this illustrated embodiment, the base structure 2402 has a generally spherical shape, and the first and second side structures 2404, 2406 each have a generally cylindrical shape. Furthermore, the cell 2400 may have a variable wall thickness, wherein the base structure 2402 has a maximum wall thickness W greater than that of the first side structure 2404. S1 The maximum wall thickness W of the second side structure 2406 S2 Maximum wall thickness W B .

[0136] As further shown, cell 2400 includes substructures formed in different portions of cell 2400. More specifically, cell 2400 includes first substructures 2408a, 2408b, second substructures 2410a, 2410b, and third substructures 2412a, 2412b formed in base structure 2402, fourth substructures 2414a, 2414b, 2414c formed in first side structure 2404, and fifth substructures 2416a, 2416b, 2416c formed in second side structure 2406. These substructures are configured to perform different mechanical behaviors within cell 2400 when cell 2400 is compressed (see [link to documentation]). Figure 16 Therefore, cell 2400 has three distinct compression zones Z1, Z2, and Z3, each with a different compression intensity. These three compression zones Z1, Z2, and Z3 together define the compression distribution of cell 2400. It can be understood that the amount of compression experienced by the respective compression zones Z1, Z2, and Z3 will thus determine the driving force applied to the drug held within them. Therefore, the compression distribution can be used to control the rate of drug release from cell 2400.

[0137] The substructures can have various configurations. In this illustrated embodiment, the first, second, and third substructures 2408a, 2408b, 2410a, 2410b, 2412a, and 2412b are all internal stop members, the fourth substructures 2414a, 2414b, and 2414c are recesses defined within the wall 2404a of the first side structure 2404, and the fifth substructures 2416a, 2416b, and 2416c are protrusions extending partially inward from the wall 2406a of the second side structure 2406. The internal stop members are configured to limit the amount of compression of the base structure when the cell is compressed. In use, such as Figure 16 As shown, the first internal stop members 2408a and 2408b are in contact with each other, and the second internal stop members 2410a and 2410b and the third internal stop members 2412a and 2412b are in contact with each other, so that when the base structure 2402 is uncompressed, the height H1 ( Figure 15 When compressed to the compression height H2, the stiffness of the base structure 210 is increased. The recesses 2414a, 2414b, and 2414c create weakened portions within the wall 2406a and are therefore configured to reduce the stiffness of the first side structure 2404. In use, such as Figure 16 As shown, the first side structure 2404 has an uncompressed height H3 ( Figure 15 Fully compressed to the compression height H4. The protrusions 2416a, 2416b, and 2416c within the second side structure 2406 form partial walls, which are configured to limit the amount of compression of the second side structure 2406 when the cell 2400 is compressed. In use, such as... Figure 16 As shown, the free ends 2418a, 2418b, 2416c of the protrusions 2416a, 2416b, 2416c contact the corresponding facing portions of the wall 2406a. Therefore, the protrusions 2416a, 2416b, 2416c thus reach the uncompressed height H5 of the second side structure 2406. Figure 15 When compressed to the compression height H6, the stiffness of the second side structure 200 is increased.

[0138] In some embodiments, the appendages may be designed to have rate-dependent compressibility. For example, the appendages may comprise a series of interconnected fluid-filled dimples configured to transfer volume from one fluid dimple to another, for example, during compression, thereby overcoming or preventing tissue flow. In one embodiment, two interconnected dimples exhibiting different stiffnesses may transfer volume from the less stiff dimple to the more stiff dimple during tissue compression. This volume transfer can be used to prevent tissue from flowing out of the cutting element when the appendages and tissue are being cut. In some embodiments, a one-way valve between adjacent dimples may be configured to prevent backflow.

[0139] Figure 17 Another exemplary embodiment of a surgical end effector 2500 having an anvil 2502 and a suture assembly 2504 is shown. The suture assembly 2504 includes an appendage 2506 releasably retained on the top surface or platform surface 2508 of a staple cartridge 2510 (e.g., the cartridge surface facing the anvil). As shown, the cartridge 2510 has a slot 2512 defined within the cartridge 2510 and configured to receive a cutting element (not shown). Although not shown, the anvil 2502 is pivotally coupled to an elongated staple channel, and the suture assembly 2504 is positioned within and coupled to the elongated staple channel.

[0140] The appendage 2506 can have various configurations. In this illustrated embodiment, the appendage 2506 has a first longitudinal segment 2514 and an opposing second longitudinal segment 2516, which are connected to each other by a connecting structure 2518 extending therebetween. Figure 17 As shown, the first longitudinal segment 2514 is positioned on the first side 2520 of the slot 2512, the second longitudinal segment 2516 is positioned on the opposite second side 2522 of the slot 2512, and the connecting structure 2518 overlaps with the slot 2512.

[0141] The first longitudinal segment 2514 and the second longitudinal segment 2516 may have various configurations. In this illustrated embodiment, the first longitudinal segment 2514 includes first interconnecting recesses and second interconnecting recesses 2525, 2526 defined therein, and the second longitudinal segment 2516 includes third interconnecting recesses and fourth interconnecting recesses 2528, 2530 defined therein. The first interconnecting recesses 2525 and the second interconnecting recesses 2526 are fluid-filled and configured to transfer volumes of fluid between each other during compression of the appendage 2506 (e.g., during clamping, suturing, and / or cutting, and / or when the appendage is in a tissue deployment state). Thus, fluid transfer between the first interconnecting recesses 2525 and the second interconnecting recesses 2526 can inhibit or prevent tissue from flowing in undesired directions (e.g., away from the slot 2512 and / or the cutting element).

[0142] Similarly, the third interconnecting recess 2528 and the fourth interconnecting recess 2530 are fluid-filled and configured to transfer volumes of fluid between each other during compression of the appendage 2506 (e.g., during clamping, suturing, and / or cutting, and / or when the appendage is in a tissue deployment state). Therefore, fluid transfer between the third interconnecting recess 2528 and the fourth interconnecting recess 2530 can inhibit or prevent tissue from flowing in undesired directions (e.g., away from the slot 2512 and / or the cutting element).

[0143] In some embodiments, the first interconnect recess 2525 and the second interconnect recess 2526 can be configured to exhibit different stiffnesses. For example, as Figure 17 As shown, the first interconnecting recess 2525 is defined by a first wall 2532 formed of a first material (shown in dots) and a second material (shown in shaded areas), while the second interconnecting recess 2526 is defined by a second wall 2534 formed solely of the second material (shown in shaded areas). In some embodiments, the first material is harder than the second material, while in other embodiments, the second material is harder than the first material. In this illustrated embodiment, the second material is harder than the first material. Furthermore, to prevent backflow, a one-way valve 2536 (e.g., a baffle valve, duckbill valve, etc.) may be positioned between the first and second interconnecting recesses. As shown, the one-way valve 2532 is configured to allow fluid to transfer only from the second interconnecting recess 2526 to the first interconnecting recess 2525.

[0144] Similarly, in some embodiments, the third interconnect recess and the fourth interconnect recess 2528, 2530 can be configured to exhibit different stiffnesses. For example, as Figure 17 As shown, the third interconnecting recess 2528 is defined by a third wall 2538 formed of a first material (shown in dots) and a second material (shown in shaded areas), while the fourth interconnecting recess 2530 is defined by a fourth wall 2540 formed solely of the second material (shown in shaded areas). In some embodiments, the first material is harder than the second material, while in other embodiments, the second material is harder than the first material. In this illustrated embodiment, the second material is harder than the first material. Furthermore, to prevent backflow, a one-way valve 2542 (e.g., a baffle valve, duckbill valve, etc.) may be positioned between the first and second interconnecting recesses. As shown, the one-way valve 2542 is configured to allow fluid to transfer only from the fourth interconnecting recess 2530 to the third interconnecting recess 2528.

[0145] Appendages can be configured to exhibit rate-dependent compressibility, which can be used as a mechanism to control tissue flow during compression. For example, Figure 18 A surgical end effector 2600 is shown, which is similar to Figure 17 The surgical end effector 2500, except for the differences described below.

[0146] like Figure 18 As shown, a first appendage 2602 with rate-dependent compressibility is disposed on a first side 2604 of the slot 2606, and a second appendage 2608 without rate-dependent compressibility is shown on the opposite second side 2609 of the slot 2606. The first appendage 2602 is structurally similar to Figure 17The first longitudinal segment 2414 of the appendage 2506 is therefore not described in detail here. As shown, when tissue T is clamped between the anvil 2610 and the first appendage 2602, the rate-dependent compressibility of the first appendage 2602 minimizes tissue outflow from the slot 2606. More specifically, during compression, a transfer of fluid occurs from the second interconnecting recess 2614 to the first interconnecting recess 2612, causing the first interconnecting recess 2612 to expand. Thus, tissue flow (as indicated by the dashed arrow) can be partially redirected back to the slot 2606. By comparison, when the second appendage 2608 is compressed, as... Figure 18 As shown, the redirection of tissue flow (e.g., toward slot 2606) will not occur in any other way.

[0147] Those skilled in the art will understand that the present invention has been applied to conventional minimally invasive and open surgical instruments, as well as robot-assisted surgical procedures.

[0148] Based on the above embodiments, those skilled in the art will recognize further features and advantages of the present invention. Therefore, the present invention should not be limited to what has been specifically shown and described, unless indicated by the appended claims. All publications and references cited herein are expressly incorporated by reference in their entirety.

Claims

1. A compressible appendage for use with a staple cartridge, the compressible appendage comprising: A non-fibrous adjunct material, formed from at least one fused bioabsorbable polymer and configured to be releasably held on a staple cartridge and configured to be delivered to tissue by deployment of staples in the cartridge, the adjunct material comprising a lattice macrostructure containing at least one drug, the lattice macrostructure being formed of a plurality of cells, wherein each cell is configured to discharge a predetermined amount of drug from the adjunct material and the predetermined amount of drug is a function of the compressed distribution of the corresponding cell; Each cell includes multiple substructures, which are formed in each cell and configured to control the deformation behavior of the corresponding cell when the attached material is compressed.

2. The appendage according to claim 1, wherein, The plurality of cells includes a first cell having a first compression distribution and a second cell having a second compression distribution different from the first compression distribution.

3. The appendage according to claim 1, wherein, Each cell contains multiple compressed areas.

4. The appendage according to claim 3, wherein, The plurality of compression zones include a first compression zone having a first compression strength and a second compression zone having a second compression strength, the second compression strength being different from the first compression strength.

5. The accessory according to claim 4, wherein, The first compression zone is configured to compress from a first uncompressed height to a first compression height, and wherein the second compression zone is configured to compress from a second uncompressed height to a second compression height different from the first compression height.

6. The appendage according to claim 1, wherein, The plurality of substructures includes a first substructure and a second substructure, wherein the first substructure is a protrusion extending inward from the wall of the cell, and the second substructure is a recess formed in the wall of the cell.

7. The appendage according to claim 1, wherein, The plurality of substructures include at least one internal stop member.

8. The appendage according to claim 1, wherein, The multiple cells include a Schwarz-P structure.

9. The appendage according to claim 8, wherein, The lattice macrostructure includes multiple interconnecting structures that extend between adjacent Schwarz-P structures and connect adjacent Schwarz-P structures to each other.

10. The appendage according to claim 1, wherein, At least one of the plurality of cells has a variable wall thickness.

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