Systems and methods for mounting and using a surgical buttress on an end effector

Abstract

Buttress device 10 includes an applicator assembly 14 including a flexible applicator body 22 and a release liner 24 with a sacrificial tab 30. Release liner 24 is coupled to applicator body 22. Buttress device 10 includes a buttress 12 disposed on applicator body 22 and a buttress fastener 26 configured to couple buttress 12 to end effector 16. Buttress fastener 26 is configured to be releasably secured to release liner 24. Buttress device 10 has a first configuration in which buttress 12 is coupled to applicator assembly 14 and a second configuration in which buttress 12 is decoupled from applicator assembly 14, and sacrificial tab 30 is removed from applicator assembly 14 in the second configuration.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 181,711, filed April 29, 2021, which is incorporated herein by reference. [Background technology]

[0002] Embodiments of the present technology relate generally to surgical buttressing technology and, more particularly, to systems and methods for mounting a surgical buttress onto an end effector for use in a surgical procedure. Summary of the Invention

[0003] In embodiments, the buttress device includes an applicator assembly including a flexible applicator body and a release liner with a sacrificial tab. The release liner is coupled to the applicator body. The buttress device also includes a buttress disposed on the applicator body and a buttress fastener configured to couple the buttress to an end effector. The buttress fastener is configured to be releasably secured to the release liner. The buttress device has a first configuration in which the buttress is coupled to the applicator assembly and a second configuration in which the buttress is decoupled from the applicator assembly, and the sacrificial tab is removed from the applicator assembly in the second configuration.

[0004] In embodiments, a surgical stapling system includes a buttress device and a surgical stapler including an end effector having a first jaw and a second jaw, the buttress device may be inserted through the first jaw and the second jaw.

[0005] In embodiments, a method of assembling a buttress device includes placing a buttress onto an applicator body, placing a release liner over the buttress and adhering a buttress fastener to the buttress. The release liner is bonded to the applicator body.

[0006] In embodiments, a method of applying a buttress to an end effector includes placing a buttress device onto the end effector, removing a sacrificial tab from an applicator assembly to expose a buttress fastener, and manipulating the applicator body to adhere the buttress fastener to the end effector.

[0007] In an embodiment, a method of stapling a patient's anatomical structure during a minimally invasive procedure includes providing an end effector comprising: a first jaw having a first end, a second end, a longitudinal axis, and an anvil, the anvil having an anvil face; a second jaw having a first end, a second end, a longitudinal axis, and a cartridge holding a plurality of staples, the cartridge having a cartridge face, the first end of the first jaw being coupled to the first end of the second jaw; and a buttress including a removable portion and a remainder portion releasably coupled by a pierce tie, the remainder portion being coupled to the first jaw or the second jaw during the minimally invasive procedure. The method may also include inserting the end effector through the trocar to access the anatomical structure, positioning a cartridge face on a first side of the anatomical structure, positioning an anvil face on a second side of the anatomical structure, clamping the end effector on the anatomical structure, manipulating the end effector to actuate a plurality of staples from the cartridge to staple the anatomical structure, and releasing the end effector to tear the pierce tie.

[0008] The present disclosure will be more readily understood from the detailed description of several sample embodiments considered in conjunction with the following figures. [Brief description of the drawings]

[0009] [Figure 1]FIG. 1 is a top view of a buttress device according to an exemplary embodiment. [Diagram 2] FIG. 2 is an exploded view of the buttress device of FIG. [Diagram 3] FIG. 13 is a top view of a buttress member having discrete sections along its length in accordance with an illustrative embodiment; [Figure 4] FIG. 13 is a top view of a buttress member according to an exemplary embodiment having a distal slit; [Diagram 5] FIG. 2 is a perspective view of the buttress device of FIG. 1 with the buttress assembly mounted on an end effector; [Figure 6] FIG. 2 is a perspective view of a buttress of the buttress device of FIG. 1 coupled to an end effector; [Figure 7] FIG. 2 is a perspective view of the buttress device of FIG. 1 illustrating manipulation of an applicator assembly coupling the buttress to an end effector; [Figure 8] FIG. 2 is a perspective view of the buttress of the buttress device of FIG. 1 installed on an end effector, showing perforations in the buttress member; [Figure 9] FIG. 13 is a perspective view of an embodiment of a stand for holding instruments during installation of a buttress assembly. [Figure 10] FIG. 10 is a front view of the stand of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Various non-limiting examples of the present disclosure are now described to provide a general understanding of the principles of the structure, function, and use of the devices, systems, methods, and processes disclosed herein. One or more examples of these non-limiting examples are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the systems and methods specifically described herein and illustrated in the accompanying drawings are non-limiting examples. Features illustrated or described in connection with one non-limiting example may be combined with features of other non-limiting examples. Such modifications and variations are intended to be included within the scope of the present disclosure. When reference is made throughout this specification to "various examples," "several examples," "one example," "several exemplary examples," "one exemplary example," or "an example," this means that a particular feature, structure, or characteristic described in connection with any example is included in at least one example. Thus, when the phrases "various examples," "some examples," "one example," "some exemplary examples," "in one exemplary example," or "in an example" appear in places throughout this specification, they are not necessarily all referring to the same example. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments.

[0011] During stapling, it may be advantageous to provide a supporting buttress material through which the staples can be deployed. The buttress or supporting material can help distribute the pressure of the rows of staples, improve the staple hold in tissue, or maintain the integrity of the staple line. For example, a bioabsorbable or biological material can be provided on the face of the anvil and / or cartridge through which the staples are deployed during use. This buttress material, which holds the staples, can then be cut with a blade or knife and left in the patient.

[0012] Described herein are examples of support buttresses that may be inserted through a trocar and are intended for a stapling device used during laparoscopic surgery, which may include, but is not limited to, a sleeve gastrectomy or gastric resection.

[0013] 1 and 2 , in an exemplary embodiment, a buttress device 10 includes a buttress 12 removably coupled to an applicator assembly 14. The applicator assembly 14 is designed to carry and align the buttress 12 on an end effector 16. The applicator assembly 14 can aid in placing the buttress 12 on first and second jaws 18, 20 of the end effector 16. The applicator assembly 14 can include an applicator body 22 and a release liner 24. The release liner 24 can include a buttress fastener 26 releasably secured thereto. The release liner 24 is configured to removably couple the buttress 12 to the applicator body 22. The buttress 12 can be disposed on the applicator body 22 (or on an intermediate component such as an applicator substrate 28). The release liner 24 can then be disposed over the buttress 12 such that the buttress fastener 26 is secured to the buttress 12. The adhesive on the applicator body secures the release liner 24 in place over a portion of the buttress 12 .

[0014] The applicator assembly 14 is designed to be inserted into and aligned with the jaws 18, 20 of the end effector 16. Once the applicator assembly 14 is aligned with the end effector 16, the jaws 18, 20 of the end effector may clamp the buttress 12. The release liner 24 may include a sacrificial tab 30 that, when removed, exposes the buttress fastener 26. In this configuration, the buttress 12 may be severed from the applicator assembly 14 and coupled to the end effector 16. The applicator assembly 14, or another tool, may then be used to wrap or press the buttress 12 around the end effector 16 to attach the buttress 12 to the end effector 16. For example, the applicator body 22 may be manipulated to press the buttress fastener 26 against the end effector 16 to adhere the buttress 12 to the end effector 16. Buttress device 10 may be provided to a user with buttress 12 coupled to applicator assembly 14, and an end user may place buttress 12 onto end effector 16 at the point of use. Alternatively, buttress device 10 may be provided to a user pre-installed onto end effector 16. During a surgical procedure, removable portion 32 of buttress 12 may be released from end effector 16 when end effector 16 is tightened about tissue, while remaining portion 34 remains on end effector 16. Buttress device 10 includes a mechanism, such as perforations, a drawstring, or the like, to allow a user to release removable portion 32 of buttress 12 from end effector 16. Removable portion 32 of buttress 12 may be released from end effector 16 before or after stapling adjacent tissue.

[0015] 1 and 2, buttress device 10 may include multiple subassemblies. Buttress 12 may include one or more buttress members 36. For example, buttress device 10 may include a first buttress member 36a for a first jaw 18 (e.g., anvil) of end effector 16 and a second buttress member 36b for a second jaw 20 (e.g., cartridge) of end effector 16. As used herein, terms such as "top" and "bottom" used to describe components of buttress device 10 are relative to the respective jaws of the end effector. For example, "top" may refer to the side of a component that faces the respective jaw. Thus, to apply the buttress to an anvil, the top surface of the buttress may face the anvil surface, while the bottom surface faces away from the anvil surface. Where buttress 12 includes multiple buttress members 36, applicator assembly 14 may include applicator subassemblies 14a, 14b corresponding to each buttress member 36a, 36b.

[0016] As described above, the buttress 12 includes at least one buttress member 36. Each buttress member 36 may include a distal end 38, a proximal end 40, a first side 42, and a second side 44 opposite the first side. The buttress member 36 may include a top surface 46 and a bottom surface 48. During a procedure, the buttress member 36 is stapled to tissue. The buttress member 36 may include a portion that is intended to remain attached to the tissue after the procedure and a portion that is removed with the end effector. For example, the buttress member 36 may include a removable portion 32 and one or more remaining portions 34. The remaining portion 34 may be coupled to the end effector 16 during the procedure, while the removable portion 32 remains attached to the tissue after the procedure is completed. The removable portion 32 may be releasably coupled to the remaining portion 34. For example, the buttress member 36 may include a series of perforations 50 separated by perforated ties 52 that releasably couple the removable portion 32 and the remainder portion 34. In an embodiment, the removable portion 32 may be disposed between the two remainder portions 34. For example, the buttress member 36 may include a first remainder portion 34a coupled to a first side of the removable portion 32 and a second remainder portion 34b coupled to a second side of the removable portion 32 opposite the first side. In such a configuration, the buttress member 36 may include two sets of perforations 50 coupling the removable portion 32 to the first and second remainder portions 34a, 34b.

[0017] Buttress member 36 may be made of any suitable buttress material, such as polymers (both permanent and bioabsorbable) and biological membranes. Exemplary materials for buttress members include copolymers of polyglycolide (PGA) and trimethylene carbonate (TMC). When buttress device 10 includes multiple buttress members 36, buttress members 36 may be the same or different. For example, buttress device 10 may include different "anvil" and "cartridge" buttress members 36. Having identical buttress members 36 would minimize the number of different components included in buttress 12. Buttress members 36 may be symmetrical or asymmetrical (e.g., having distinct "top" and "bottom" sides). Buttress member 36 may include a proximal tab that allows buttress member 36 to enter a tissue stop proximal to end effector 16. Alternatively or additionally, buttress member 36 may include a distal tab for entering a tissue stop distal to end effector 16. The buttress member 36 may span the length and at least the width of the end effector anvil plate in a single continuous member to capture all staples fired from the end effector 16. In some embodiments, the buttress member 36 may include discrete adjacent sections, segmented longitudinally (FIG. 3) or laterally, that are grouped together via the applicator assembly. The adjacent sections may also be "bridged" together such that the full width of the buttress member is not continuous. The buttress member 36 may be positioned to one side of the cut line, depending on the procedure, since it may not be necessary to reinforce the staple line in the resected tissue. In some embodiments, the buttress member 36 may include a slit 54 at its distal end to initiate the cut line (FIG. 4). The slit 54 may be positioned adjacent to the cut line. For example, the slit 54 may be in the center of the distal end of the buttress member 36. The slit 54 may be rectangular, triangular (bird's beak), etc. In instances, slits 54 may be segmented (e.g., to form a series of perforations) or may traverse the length of buttress member 36 to eliminate the need to cut buttress member 36 during a surgical procedure.

[0018] The dimensions of the buttress 12 may vary based on the intended application. The widths of the buttress members 36a, 36b may be the same or different. For example, the width of the anvil buttress member 36a may be designed to wrap around the sides and / or top of the anvil to provide sufficient contact with the end effector to adequately bond the buttress to the end effector. The distance the buttress wraps around the sides of the jaws may vary. In an embodiment, the anvil buttress completely wraps around the anvil to maximize the bonding contact area. Wrapping the jaws with less than the entire jaw may improve the ability of the end effector to slide through the trocar. The width of the cartridge buttress member 36b may be wider than the anvil buttress member 36a to compensate for the difference in width of the anvil and cartridge jaws. The same buttress may be used for both the anvil and cartridge to minimize component and assembly complexity. In various embodiments, the thickness may range, for example, from about 0.1 to about 0.5 mm, from about 0.2 to about 0.3 mm. The thickness may be about 0.26 mm. The average density may range, for example, from about 0.1 to about 1.7 g / cm. 3 , or about 0.25 to about 1.34 g / cm 3 In various embodiments, the tensile stress of the buttress material may range from about 4.83 to about 8.96 N / mm 2 (approx. 700~approx. 1300psi), approx. 6.21~approx. 7.58N / mm 2 (about 900 to about 1100 psi), or about 6.55 to about 6.89 N / mm 2 (about 950 to about 1000 psi). The tensile stress may be, for example, about 6.78 N / mm 2 (approximately 983 psi) may also be used.

[0019] The number and size of the perforations 50 and perforation ties 52 may vary. The perforation ties 52 are configured to have a relatively high burst strength and a relatively low tear strength. The relatively high burst strength helps prevent the perforation ties 52 from unintentionally tearing, for example, when tissue is disposed between the jaws 18 and 20 of the end effector 16. The relatively low tear strength facilitates separation of the removable portion 32 of the buttress member 36 from the remainder portion 34 when the jaws 18, 20 of the end effector 16 are opened. The distal end of the line of perforations 50 may begin with a lead-in perforation (e.g., the distal edge of the buttress member 36 may be discontinuous).

[0020] The width and spacing of the perforated ties 52 may vary. The perforated ties 52 are configured to resist side loading during tissue manipulation and / or actuation of the end effector. The width of the perforated ties 52 may range, for example, from about 0.005 to about 0.1 inches, about 0.01 to about 0.05 inches, or about 0.01 to about 0.03 inches, or may be about 0.02 inches. The width of perforations 50 (e.g., openings) may be, for example, in the range of about 0.01 to about 1 inch, about 0.1 to about 0.5 inch, or about 0.1 to about 0.3 inch, or may be about 0.24 inch. The ratio of the width of perforations 50 to the width of perforation ties 52 may be, for example, in the range of about 5 to about 20, or about 10 to about 15, or may be about 12. In embodiments, buttress member 36 may include perforation ties 52 having different widths. For example, buttress member 36 may include alternative perforation ties 52 having a first width and a second width different from the first width.

[0021] The mechanical properties of the perforated tie 52, such as burst strength and tear strength, may vary. The burst strength (% hold) of the perforated tie 52 may be calculated based on the number of teeth per inch (the number of perforated teeth that create a "break" in the perforation pattern per inch) times the tie width. In various embodiments, the burst strength (% hold) may range, for example, from about 5 to 100%, from about 5 to about 50%, from about 5 to about 20%, from about 5 to about 10%, or from about 7 to 100%. The burst strength may be, for example, about 7.7%. In various embodiments, the teeth per inch (TPI) may range from about 1 to about 10, about 1 to about 5, about 3 to about 4 (about 0.394 to about 3.94, about 0.394 to about 1.97, about 1.18 to about 1.57 teeth per cm). The TPI may be, for example, about 3.4 (about 1.34 / cm). Tear strength is a function of the tie width, the thickness of the material, and the maximum tensile stress of the material. Tear strength may be equal to the cross-sectional area (thickness x width) of the perforated tie 52 x the tensile stress of the buttress material. In various embodiments, the puncture tear strength of a single perforated tie 52 may range from greater than 0 to about 4.45 N (greater than 0 to about 1 lbF), greater than 0 to about 2.22 N (greater than 0 to about 0.5 lbF), to about 0.445 N to about 1.33 N (about 0.1 to about 0.3 lbF). The puncture tear strength may be, for example, about 0.876 N (about 0.197 lbF). Tear strength can vary based on variations in perforated tie width, material thickness, and maximum material tensile stress.

[0022] 1 and 2 , applicator assembly 14 is used to apply buttress 12 to end effector 16. In embodiments, applicator assembly 14 may include an applicator body 22 and an applicator substrate 28. If applicator assembly 14 includes subassemblies, each subassembly may include an applicator body 22 and an applicator substrate 28. Applicator assembly 14 may be disposable. In various embodiments, applicator assembly 14 may include a pull tab. For example, if a buttress device includes multiple applicator subassemblies, one or both of the applicator subassemblies may include a pull tab to facilitate separation of the applicator body. The pull tab may be, for example, rectangular or circular. Applicator body 22 may alternatively include a recess that may facilitate easier separation of applicator body 22.

[0023] Each applicator body 22 may include a distal end 56, a proximal end 58, a first side 60, and a second side 62 opposite the first side. The applicator body 22 may include a top surface 64 and a bottom surface 66. The applicator body 22 may include lateral and longitudinal alignment features, such as notches 67, to ensure proper alignment when the buttress device is installed on the end effector 16. The applicator body 22 may be made of, for example, flexible cardstock of any thickness, suture board, plywood such as solid bleached sulfite (SBS), or any other semi-flexible member such as semi-compliant foam, rubber, silicone, or plastic. An exemplary material for the applicator body 22 may be polyester. The applicator body 22 may include an adhesive over a portion or the entirety of the top surface 64. The adhesive may be, for example, an acrylic adhesive. An adhesive may be used to bond the release liner 24 to the applicator body 22. To further secure the release liner 24 in place, a portion of the applicator body 22 may be folded over an edge of the release liner 24. For example, an outer edge 68 of the applicator body 22 may be folded over the top surface 64 of the applicator body 22, resulting in a folded portion 70. The folded portion 70 does not extend over the sacrificial tab 30, i.e., the sacrificial tab 30 remains uncovered. In the folded configuration, a portion of the bottom surface 66 of the applicator body 22 is visible from the top of the applicator body 22. In an embodiment, the bottom surface 66 of the applicator body 22 is configured to include printed indicia, such as symbols or instructions. The indicia may be visible on the folded portion 70.

[0024] 2, each applicator substrate 28 may include a distal end 72, a proximal end 74, a first side 76, and a second side 78 opposite the first side. Applicator substrate 28 may include a top surface 80 and a bottom surface 82. Applicator substrate 28 may be made from any thin, flexible, hypoallergenic and / or biocompatible material, such as 4 mil LDPE. An exemplary material for applicator substrate 28 is polyester. The applicator substrate may add strength to applicator body 22. In an embodiment, applicator substrate 28 spans the width and length of buttress member 36. If applicator body 22 includes adhesive, applicator substrate 28 may cover a portion of the adhesive and prevent buttress 12 from adhering to applicator body 22. Adhesive on both sides of top surface 64 of applicator body 22 may remain uncovered by applicator substrate 28. Buttress member 36 may be disposed on applicator substrate 28. In embodiments in which applicator assembly 14 does not include an applicator substrate 28, the portions of applicator body 22 configured to contact buttress member 36 may not include an adhesive. In some embodiments, one or more of the applicator substrate or adhesive are discontinuous.

[0025] When buttress device 10 includes multiple applicator subassemblies, the applicator subassemblies may be secured together. In some embodiments, the applicator subassemblies may be secured together in the area where the jaws of the end effector are fastened together. The applicator subassemblies may be secured together by glue, tape, staples, stitches, etc.

[0026] 2, in various embodiments, buttress device 10 may include a compliant member 84 disposed between applicator subassemblies. When jaws 18, 20 are tightened, buttress members 36a, 36b and applicator subassemblies 14a, 14b compress compliant member 84, which helps hold buttress device 10 in place between jaws 18 and 20. Compliant member 84 is designed to provide thickness to the area adjacent end effector 16 such that jaws 18, 20 of end effector 16 compress buttress 12 upon deployment. Compliant member 84 may be adhered to applicator body 22. If applicator assembly 14 includes multiple applicator subassemblies, compliant member 84 may be adhered to each applicator body 22. Compliant member 84 may include adhesive on top surface 86 and bottom surface 88, and may initially include a temporary liner to prevent unintentional adhesion. A user may remove the temporary liner and adhere the compliant member 84 to each applicator body 22. In various embodiments, the compliant member 84 may be continuous along the area adjacent to the end effector 16, segmented longitudinally, or segmented transversely. The compliant member 84 may extend along the length of the applicator body 22, extend along the proximal portion, or extend along the distal portion. In embodiments, the thickness of the compliant member 84 may be tapered longitudinally, for example.

[0027] The compliant member 84 may include a distal end, a proximal end, a first side, and a second side opposite the first side. The compliant member may be made of foam, such as adhesive-backed cross-linked polyethylene foam (e.g., 2A Volara®), or any other hypoallergenic compliant member, such as folded (fluted) plywood, rubber, or silicone. In an embodiment, the applicator bodies are each die-cut and bleached 0.009 inch card stock pieces, and the compliant members are strips of foam that are 3 / 32 inch thick and 3 / 8 inch wide. Compression may vary. For example, the compression of the foam at 25% deflection is approximately 0.00689 N / mm 2~ approx. 0.0689N / mm 2 (about 1 psi to about 10 psi), or about 0.0345 N / mm 2 (approximately 5 psi) may also be acceptable.

[0028] 1, 2, and 5, in various embodiments, release liners 24 are configured to temporarily couple buttress 12 to applicator body 22. Each release liner 24 may include a distal end 90, a proximal end 92, a first side 94, and a second side 96 opposite the first side. Release liner 24 may include a top surface 98 and a bottom surface 100. Release liner 24 may include a side 102 configured to couple to applicator body 22 as described above, and a sacrificial tab 30 removably secured to side 102 via perforations 103. Side 102 may include alternating protrusions 104 and recesses 106. For purposes of illustration, protrusions 104 and recesses 106 are shown on only one side of top release liner 24 in FIG. 2, although the technology is not so limited. When the edges of the applicator body 22 are folded over the sides 102 of the release liner 24, the recesses 106 provide areas where the applicator body 22 will be adhered to itself, while the protrusions 104 of the release liner adhere to the applicator body 22. The release liner 24 may further include a removable central portion 108 that is releasably secured (e.g., via perforations) to the sacrificial tabs 30. After the buttress device 10 is assembled and before it is placed on the end effector 16, the removable central portion 108 may be removed to expose a portion of the buttress 12. The sides 102, sacrificial tabs 30, and removable central portion 108 may be releasably joined (e.g., stitched together) using features other than perforations. The sacrificial tabs 30 may each include a grip 110. For example, the sacrificial tab 30 may include a longitudinal portion 112 that extends along the length of the buttress device 10 and an extension portion 114 that extends laterally from the longitudinal portion 112. The extension portion 114 may be folded over on itself for added strength. A grip 110 may be disposed on the end of the extension portion 114. The grips 110 of adjacent sacrificial tabs 30 may be joined. For example, the grips 110 may be adhered together using, for example, an adhesive tab. The grips 110 may be shaped to indicate the direction in which the grips 110 should be pulled to remove the sacrificial tab 30 from the buttress device 10. For example, the grips 110 may be shaped as an arrow.In embodiments in which the top surface 98 of the release liner 24 does not include a release coating, the adhesive tabs may provide better adhesion to the folded over grip 110 than the buttress fasteners 26 provided on the bottom surface 100 of the release liner 24.

[0029] The release liner 24 may be made of, for example, kraft paper or a plastic such as polyester. The release liner 24 may include a release coating, for example, a silicone release coating or a fluorosilicone release coating. The release coating may be on one or both sides of the release liner 24. The release coating may be continuous or discontinuous. Upon assembly of the buttress device 10, the buttress fastener 26 may be releasably adhered to the release liner 24. In an illustrative example, the buttress fastener 26 releasably adheres to the side of the release liner 24 that includes the release coating.

[0030] Still referring to FIG. 2, as described above, buttress 12 may be attached to the end effector by buttress fastener 26. Buttress fastener 26 ensures that buttress 12 is taut and aligned with respect to lateral and longitudinal alignment features on applicator assembly 14. In some embodiments, buttress fastener 26 may be a medical grade transfer adhesive. In other embodiments, buttress fastener 26 may include a high tack, hypoallergenic double sided tape, such as Medical Tape 1567 from 3M™, a single sided tape, a glue such as a cyanoacrylate, a staple, or the like. An exemplary medical grade transfer adhesive is a synthetic rubber based adhesive, such as 1504XL High Tack Medical Transfer Adhesive from 3M, or an acrylic adhesive. Buttress fastener 26 may include discrete segments. For example, buttress fastener 26 may include two longitudinal strips of adhesive. As mentioned above, the top of the buttress fastener 26 may be releasably adhered to a release liner 24, which is used to position the buttress fastener 26 onto the buttress 12 during assembly of the buttress device 10. A temporary liner may be removed from the bottom of the buttress fastener 26 opposite the release liner 24 prior to positioning it onto the buttress 12. The temporary liner may prevent the buttress fastener 26 from unintentionally adhering to anything other than the buttress 12.

[0031] In various embodiments, the buttress fasteners 26 may be continuous, longitudinally segmented, or transversely segmented along the length of the buttress 12 to maximize adhesion. The buttress fasteners may alternatively not include an adhesive and may include a row of staples, rivets, tacks, etc. to secure the buttress to the applicator. The buttress fasteners 26 are designed not only to secure the buttress 12 to the end effector 16, but also to provide a securing force to the end effector that is greater than the force required to tear a perforation, as discussed herein. Additionally, the properties of the release liner 24 and the adhesive properties of the buttress fasteners 26 are designed such that the buttress fasteners 26 will not peel away from the buttress 12 when the release liner 24 is removed. The jaws 18, 20 of the end effector 16 may have a non-stick coating (e.g., PTFE) so that the buttress fastener 26 is configured to have a tack strong enough to hold the remainder 34 of the buttress to the end effector 16 when the perforated tie 52 is torn away. The 90° peel force ("peel force") of the adhesive to the jaws 18, 20 of the end effector 16 may be varied by changing the surface area over which the buttress fastener 26 extends, such as by using a higher surface energy substrate. In various embodiments, the peel force may be in the range of about 0.1 to about 5 lbF, about 0.5 to about 5 lbF, about 0.5 to about 3 lbF, about 0.6 to about 5 lbF, or about 0.6 to about 2 lbF, or about 0.6 lbF. In embodiments, the minimum 90° peel force of buttress fastener 26 to jaws 18, 20 of end effector 16 is greater than the tear strength of perforated tie 52.

[0032] To assemble the buttress device 10, the temporary liner(s) (FIG. 2) may be removed from the applicator body 22 to expose the adhesive. If an applicator substrate 28 is used, it may be placed over the applicator body 22. The buttress 12 may then be placed over the applicator substrate 28 (or applicator body 22). The temporary liner may be removed from the buttress fastener 26, and the release liner 24 may be placed over the buttress member 36 with the buttress fastener 26 facing the upper surface 46 of the buttress member 36. The outer edge 68 of the applicator body 22 may be folded over the side 102 of the release liner 24. If the release liner 24 extends entirely over the buttress 12, the removable central portion 108 may be removed to expose a portion of the buttress 12. The sacrificial tab 30 remains in place over the buttress fastener 26. The extensions 114 of the sacrificial tabs 30 may be folded over and adjacent grips 110 may be adhered to one another. Multiple buttress and applicator subassemblies may be similarly constructed. When used, the compliant member 84 may be coupled to one or more applicator bodies 22. To do so, the temporary liner may be removed from the compliant member 84 and adhered to the applicator body 22.

[0033] The components may include features that are used during assembly but removed prior to application. For example, the applicator body, applicator substrate, buttress, and release liner may include punctured tabs. The punctures on the punctured tabs may be positioned over alignment features, such as dowel rods, during assembly. This helps ensure that the components are properly aligned. After assembly, the puncture tabs may be removed.

[0034] To apply the buttress 12 to the end effector 16, the buttress device 10 is inserted between the jaws 18 and 20. When the buttress device 10 is positioned on the end effector 16, the buttress 12 may be separated from the applicator assembly 14, as shown in FIG. 5. To remove the sacrificial tab 30, a user grasps the grip 110 of the sacrificial tab 30 and pulls along the length of the buttress device 10 to split the perforation and expose the buttress fastener 26. At this point, the buttress 12 is positioned on, but not attached to, the applicator assembly 14. The top of the buttress 12 may be entirely exposed. The buttress 12 may be secured to the end effector 16 by bending both sides of the applicator assembly 14 around the jaws and adhering the buttress fastener 26 to the jaws 18, 20. FIG. 6 shows the buttress 12 adhered to the end effector 16.

[0035] The perforations 103 may traverse the length of the release liner 24 or the ends of the release liner 24 may be cut to provide a "start" or lead-in perforation to ensure reliability of the mechanism. The sacrificial tabs 30 may be designed to be pulled laterally and proximally at the same time, as seen by the directed arrow grips 110. This helps ensure that the perforations 103 tear and the release liner 24 peels away from the buttress fastener 26. Instead of the user pulling on several grips 110 on each side of the buttress device 10, the top and bottom grips 110 may be secured together so that they separate with one pulling motion. Other mechanisms, such as chain stitching, release liners (as found in consumer foam mounting tapes, e.g., Command™ strips), may be used to release the buttress from the applicator assembly.

[0036] After the sacrificial tab 30 of the release liner 24 is separated from the buttress 12, the buttress 12 may be coupled to the end effector. The technique used to couple the buttress to the end effector may vary. As discussed above, a buttress fastener 26 may adhere the buttress to the end effector. For another example, the buttress may be coupled to the jaws via adhesion, such as with tape, glue, or by mechanical fastening, such as tying, clipping, or the like. With reference to FIG. 7, an applicator assembly 14 may be used to couple the buttress 12 to the end effector 16. The sides of the applicator assembly 14 may be folded around the jaws 18, 20 to press the buttress fastener 26 against the jaws 18, 20.

[0037] During a surgical procedure, a user may separate a detachable portion of the buttress member from the end effector such that the detached portion remains attached to the tissue. As discussed above, the buttress member may include perforations that tear to separate the detachable portion of the buttress member from the end effector. The perforations in the buttress member may be separated by a variety of techniques. In the example shown in FIGS. 2 and 8, buttress member 36 includes perforations 50 along its length. In an embodiment, perforations 50 may be positioned such that when buttress member 36 is coupled to jaws 18, 20, perforations 50 are located on the sides of jaws 18, 20. Releasing jaws 18, 20 of end effector 16 tears perforations 50. In some embodiments, buttress device 10 may include a mechanism that allows a user to selectively tear perforations 50. An example includes a suture looped around perforations 50. In use, the ends of the suture extend outwardly from the patient. A user may pull the sutures from outside the patient's body, causing the sutures to sever the perforations 50. In another example, the two sets of perforations 50 are separated by tabs, and the sutures are attached to the ends of the tabs. Pulling the sutures tears the tabs from the buttress member 36. Components other than sutures may also be used to selectively tear the perforations 50. For example, the ends of the tabs may extend outward from the patient during a procedure and be pulled away from the buttress member 36.

[0038] In embodiments, a method of stapling a patient's anatomical structure during a minimally invasive procedure may include providing an end effector, the anatomical structure having a first side and a second side. The end effector may include a first jaw having a first end, a second end, a longitudinal axis, and an anvil, the anvil having an anvil face, and a second jaw having a first end, a second end, a longitudinal axis, and a cartridge holding a plurality of staples, the cartridge having a cartridge face. The first end of the first jaw may be coupled to the first end of the second jaw, and the second end of the first jaw may be coupled to the second end of the second jaw. The end effector further comprises a buttress including a removable portion and a remainder portion releasably coupled by a punch tie, the remainder portion being coupled to the first jaw or the second jaw during a minimally invasive procedure, and a knife coupled to and slidable relative to the first jaw or the second jaw. The method may include inserting the end effector through a trocar to access the anatomical structure, positioning a cartridge face on a first side of the anatomical structure, positioning an anvil face on a second side of the anatomical structure, fastening the end effector on the anatomical structure, manipulating the end effector to actuate a plurality of staples from the cartridge to staple the anatomical structure, actuating the knife to cut the anatomical structure, and releasing the end effector such that the punch tie is torn. The end effector may then be removed from the trocar, leaving the detachable portion stapled to the anatomical structure and the remaining portion still attached to the end effector.

[0039] When an end user places the buttress device on the end effector, an exemplary embodiment includes a stand that aids in placement by keeping the end effector upright, stable, and openable. FIGS. 9 and 10 show a stapling device 150 including an end effector 16 disposed on a stand 152. The stand may be reusable and made of a material that can withstand repeated sterilization processes. For example, the stand may be made of a metal, such as stainless steel, or a sterilizable or autoclavable plastic. The stand may be disposable, such as a thermoformed stand, built into the device tray, or may already be installed on the device. As shown in FIG. 9, the tip of the end effector 16 may rest on the same plane (e.g., a table top) on which the stand 152 rests. In other embodiments, the stand may hold the end effector horizontally or at an angle, such as 90 degrees. In an embodiment, the stand may include two separate parts, one part that restrains the handle of the device and one part that restrains the tip of the end effector. In embodiments, the width of the applicator body can be determined based on a stand. For example, when stapling device 150 is placed on a stand and a buttress device is inserted between the jaws, the applicator body can be sized such that when the buttress is pressed against the lower jaw, the applicator body does not contact the surface.

[0040] In various embodiments, the applicator may include labeling, such as instructions. Installation errors can be mitigated by using instructions printed on the applicator to remind the user of the correct technique and sequence of operations for placing the buttress on the end effector. The instructions may be incorporated into the applicator by printing, attaching a sticker, or the like. The instructions may communicate to the user using warning fonts, colors, custom or universal action symbols, or any font, color, or symbol. For example, labeling may be included on the folded surface of the upper applicator body. In an embodiment, a sequential numbering scheme represents the sequence of operations in large red text. Each step informs the user of the technique for the current step in medium sized black text. A custom symbol on the end effector orients the applicator in a yaw orientation. A custom symbol on the film pull tab informs the user of the pulling characteristics. Exemplary labeling on the top of the bottom applicator body is revealed when the top of the upper applicator body is folded over. The sequential numbering and instruction step scheme continues. A universal "pinch" symbol instructs the user to pinch the applicator assembly. A universal "wrap" symbol accompanies the instruction step and instructs the user to wrap the applicator over the jaws of the end effector. A warning, in a warning color such as yellow and oversized text, alerts the user if the applicator assembly is upside down.

[0041] In an embodiment, the buttress may include a buttress and base film assembly. The buttress member may be releasably secured to the base film member. The mechanism for securing the buttress member to the base film member may be any stitch that allows the members to be freely separated, a release string or liner to separate the adhesive (as found in consumer foam mounting tapes, e.g., Command™ strips), a perforation mechanism where perforations are cut into the film, such as the mechanisms suggested above for separating the stapled buttress portion from the applicator, or a perforation mechanism where perforations are cut into the buttress member. This mechanism allows the user to separate the buttress member from the end effector at will, such as by providing a tail for pulling from outside the patient's body or by incorporating a mechanism into the end effector that allows the buttress member to be separated from the end effector. The buttress member may be separated from the end effector manually or automatically, via direct user action from outside the patient's body, or internally by a mechanism on the end effector. For example, the knife / firing mechanism (or other closure system) may be configured to automatically separate the buttress member from the end effector. In embodiments, the applicator substrate of the applicator assembly may be configured to be attached to the end effector. In various embodiments, the substrate film member may be attached to the end effector via another fastening component, such as single sided tape, double sided tape, a transfer adhesive, an adhesive such as cyanoacrylate, or the like.

[0042] In embodiments where the buttress member has portions stitched together, the stitches may be untied to release the stapled portions of the buttress member from the end effector. The buttress fastener that couples the buttress to the end effector may also temporarily secure the suture tails. As discussed above, once the tail ends of the stitches are secured, the stitches provide a robust fixation. During assembly, shipping, and installation, it may be desirable to prevent the stitches on the buttress from unraveling. In use, unraveling the stitches allows for an easy, reliable, and controlled release of the buttress member from the end effector outside the patient's body. To perform both functions, the tail ends of the stitches may be temporarily held in place by the buttress fastener (or another component). For example, the distal and proximal ends of the suture may be secured by the buttress fastener. A component other than the buttress fastener may be used to temporarily secure the end (or ends) of the suture. For example, a knot or ball may be included in the suture or thread that is pulled through the buttress or applicator substrate. Another method of terminating the thread is to adhere a double-sided tape member to the length of thread. This method adheres the buttress assembly to the end effector and captures the end of the thread in the double-sided tape, securing it and increasing the pulling force of the stitch. It will be appreciated that other techniques may be used to ensure the integrity of the assembly and prevent accidental initiation of the peel mechanism. In an embodiment, the tail end of the stitch may be released from the buttress fixture and pulled to separate the buttress member from the applicator substrate.

[0043] In an embodiment, the applicator assembly may be designed to fold from a flat configuration into a three-dimensional structure that aids in placing the buttress onto the jaws of an end effector. For example, pinching the sides of the applicator assembly and folding the applicator over to form walls to adhere the buttress double-sided tape to the jaws of an end effector. The applicator body may be a static die cut member that aligns the buttress to the end effector while it is being adhered to the jaws of the end effector by another mechanism, such as a tool that allows the jaws of the end effector to slide off, or by a sacrificial "handle" on the applicator base that the user can manipulate to allow the buttress to wrap around the jaws of the end effector. After the buttress is secured to the end effector, the handle may be torn off, such as via perforation, and discarded.

[0044] In various embodiments disclosed herein, a single component may be replaced with multiple components and multiple components may be replaced with a single component to perform a given function or functions, and except where such a substitution would not be valid, such substitution is within the intended scope of the embodiment.

[0045] The above description of the embodiments and examples has been presented for purposes of illustration and description. It is not intended to be exhaustive or to be limited to the forms described. Many variations are possible in light of the above teachings. Some of these variations have been discussed, and others will be appreciated by those skilled in the art. The embodiments have been chosen and described in order to best illustrate the principles of the various embodiments as suited to the particular applications contemplated. The scope is, of course, not limited to the examples described herein, but may be utilized by those skilled in the art in any number of applications and equivalent devices. Rather, it is intended that the scope of the invention be defined by the appended claims.

Claims

1. 1. A buttress device, comprising: an applicator assembly, A flexible applicator body; and Release Liner with Sacrificial Tab Equipped with the release liner is bonded to the applicator body; an applicator assembly; a buttress disposed on the applicator body; a buttress fastener configured to couple the buttress to an end effector and configured to be releasably secured to the release liner; and Equipped with the buttress device has a first configuration in which the buttress is coupled to the applicator assembly and a second configuration in which the buttress is disposed on the applicator assembly and the buttress is secured to the end effector, the sacrificial tab being removed from the applicator assembly in the second configuration; The edges of the applicator body are folded over the sides of the release liner. Buttress device.

2. the buttress comprises a removable portion and a remainder portion, the remainder portion being coupled to the removable portion by a punch tie; the pierce ties separating perforations in the buttress; 10. The buttress device of claim 1.

3. The buttress device of claim 2 , wherein the buttress fastener is coupled to the remaining portion of the buttress.

4. The buttress device of claim 1 , wherein the buttress fastener comprises an adhesive.

5. The buttress device of claim 1 , wherein the buttress comprises longitudinally separated discrete sections.

6. the applicator assembly further comprising an applicator substrate; the applicator substrate is disposed between the applicator body and the buttress in the first configuration.

10. The buttress device of claim 1.

7. The buttress device of claim 1 , wherein the applicator body has an adhesive upper surface that bonds the release liner to the applicator body.

8. the sides of the release liner include alternating protrusions and recesses; the edges of the applicator body are folded over the alternating protrusions and recesses; 10. The buttress device of claim 1.

9. The buttress device of claim 1 , wherein the release liner comprises a release coating.

10. The buttress device of claim 1 , wherein the sacrificial tab is removably secured to a side of the release liner via a perforation.

11. 2. The buttress device of claim 1, wherein the sacrificial tab comprises a longitudinal portion, an extension portion extending laterally from the longitudinal portion and folded back upon itself, and a grip at an end of the extension portion.

12. the applicator assembly is a first applicator assembly; the buttress device further comprises a second applicator assembly and a conformable member; the compliant member is coupled to the first applicator assembly and to the second applicator assembly.

10. The buttress device of claim 1.

13. The buttress device of claim 1 ; a surgical stapler comprising the end effector having a first jaw and a second jaw; Equipped with the buttress device is interposed between the first jaw and the second jaw. Surgical stapling system.

14. 10. A method of assembling the buttress device of claim 1, comprising: placing the buttress onto the applicator body; placing the release liner over the buttress to adhere the buttress fastener to the buttress, the release liner being bonded to the applicator body; A method comprising:

15. The method of claim 14, further comprising folding an edge of the applicator body over a side of the release liner.

16. the applicator assembly is a first applicator assembly; the buttress device further comprises a second applicator assembly and a conformable member; The method further includes coupling the compliant member to the first applicator assembly and to the second applicator assembly. The method of claim 14.

17. The method of claim 14 , further comprising removing a temporary liner from the buttress fastener prior to the step of placing the release liner over the buttress.

18. The method of claim 14, further comprising removing a temporary liner from the applicator body to expose an adhesive top surface of the applicator body.

19. further comprising disposing an applicator substrate over the applicator body; the step of disposing the buttress on the applicator body includes disposing the buttress on the applicator substrate. The method of claim 14.

20. 1. A method of applying a buttress to an end effector, comprising the steps of: placing a buttress device on the end effector, the buttress device comprising: The applicator assembly: A flexible applicator body; and Release Liner with Sacrificial Tab Equipped with the release liner is bonded to the applicator body; an applicator assembly; the buttress disposed on the applicator body; a buttress fastener coupled to the buttress and releasably secured to the sacrificial tab of the release liner; a buttress device comprising: removing the sacrificial tab from the applicator assembly to expose the buttress fastener; manipulating the applicator body to adhere the buttress fastener to the end effector; and Folding an edge of the applicator body over a side of the release liner. A method comprising:

21. The method of claim 20, further comprising removing the applicator assembly from the end effector.

Images