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

Abstract

A support plate device (10) includes an applicator assembly (14) including an applicator body (22) and a release liner (24), the applicator body (22) being flexible, the release liner (24) including a sacrificial sheet (30). A release pad (24) is coupled to the applicator body (22). The distraction plate device (10) includes a distraction plate (12) positioned on the applicator body (22) and includes a distraction plate fastener (26) configured to couple the distraction plate (12) to the end effector (16). The bracing plate fastener (26) is configured to be releasably fastened to the release pad (24). The strut device (10) has a first configuration in which the strut (12) is coupled to the applicator assembly (14) and a second configuration in which the strut (12) is decoupled from the applicator assembly (14), in which the sacrificial sheet (30) is removed from the applicator assembly (14).

Description

Parent Case Information

[0001] This application is a divisional application of a Chinese patent application with the application number "202280007866.8" and the title "Systems and Methods for Mounting and Using a Surgical Retractor on an End Effector". Cross - Reference to Related Applications

[0002] This application claims the priority of U.S. Provisional Patent Application No. 63 / 181,711, filed on April 29, 2021, which is hereby incorporated by reference in its entirety. Technical Field

[0003] Embodiments of the present invention generally relate to surgical retractor technology, and more particularly to systems and methods for mounting and using a surgical retractor on an end effector during a surgical procedure. Summary of the Invention

[0004] In one embodiment, a retractor device includes an applicator assembly that includes an applicator body and a release liner, where the applicator body is flexible and the release liner includes a sacrificial sheet. The release liner is coupled to the applicator body. The retractor device further includes: a retractor positioned on the applicator body; and a retractor fastener configured to couple the retractor to an end effector. The retractor fastener is configured to releasably fasten to the release liner. The retractor device has a first configuration and a second configuration, where in the first configuration, the retractor is coupled to the applicator assembly, and in the second configuration, the retractor is separated from the applicator assembly, where in the second configuration, the sacrificial sheet is removed from the applicator assembly.

[0005] In one embodiment, a surgical suturing system includes a retractor device and a surgical stapler that includes an end effector having a first jaw and a second jaw. The retractor device can be inserted through the first jaw and the second jaw.

[0006] In one embodiment, a method of assembling a retractor device includes positioning a retractor on an applicator body and positioning a release liner on the retractor to adhere a retractor fastener to the retractor. The release liner is coupled to the applicator body.

[0007] In one embodiment, a method of applying a retractor to an end effector includes mounting a retractor device on the end effector, removing a sacrificial sheet from the applicator assembly to expose the retractor fastener, and manipulating the applicator body to adhere the retractor fastener to the end effector.

[0008] In one embodiment, a method of suturing a patient's anatomical structure during a minimally invasive procedure includes providing an end effector that includes: a first jaw having a first end, a second end, a longitudinal axis, and an anvil, where the anvil includes an anvil face; a second jaw having a first end, a second end, a longitudinal axis, and a staple cartridge that holds a plurality of staples, the staple cartridge having a staple cartridge face, where the first end of the first jaw is coupled to the first end of the second jaw; and a spreader plate that includes a removable portion and a remaining portion, where the removable portion and the remaining portion are removably coupled by a perforated tape, and the remaining portion is coupled to the first jaw or the second jaw during the duration of the minimally invasive procedure. The method may further include: inserting the end effector through a trocar to access the anatomical structure, positioning the staple cartridge face on a first side of the anatomical structure, positioning the anvil face on a second side of the anatomical structure, clamping the end effector onto the anatomical structure, operating the end effector to urge the plurality of staples from the staple cartridge to suture the anatomical structure, and opening the end effector to tear the perforated tape. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present invention will be more readily understood from the following detailed description of some exemplary embodiments in conjunction with the following drawings:

[0010] Figure 1 is a top view of a spreader plate device in accordance with an exemplary embodiment.

[0011] Figure 2 is Figure 1 an exploded view of the spreader plate device of

[0012] Figure 3 is a top view of a spreader plate member in accordance with an exemplary embodiment, the spreader plate member having discrete segments along its length.

[0013] Figure 4 is a top view of a spreader plate member having a distal slit in accordance with an exemplary embodiment.

[0014] Figure 5 is Figure 1 a perspective view of the spreader plate device of

[0015] Figure 6 is a Figure 1 perspective view of the spreader plate of the spreader plate device coupled to an end effector.

[0016] Figure 7 is Figure 1 a perspective view of the spreader plate device of

[0017] Figure 8 is a Figure 1Perspective view of a splint of a splint device, showing perforations in the splint member.

[0018] Figure 9 Is a perspective view of a bracket according to one embodiment, the bracket being for holding an instrument during the installation of a splint assembly.

[0019] Figure 10 Is Figure 9 Front view of the bracket of. Detailed Description

[0020] Various non - limiting embodiments of the present invention will now be described to provide an overall understanding of the structure, function, and principles of use of the devices, systems, methods, and processes disclosed herein. One or more examples of these non - limiting embodiments are shown in the accompanying drawings. Those of ordinary skill in the art will understand that the systems and methods specifically described and shown in the drawings are non - limiting embodiments. Features shown or described in connection with one non - limiting embodiment can be combined with the features of other non - limiting embodiments. Such modifications and variations are intended to be included within the scope of the present invention. References throughout the specification to "various embodiments", "some embodiments", "one embodiment", "some exemplary embodiments", "one exemplary embodiment", or "an embodiment" mean that the particular features, structures, or characteristics described in connection with any embodiment are included in at least one embodiment. Thus, the phrases "in various embodiments", "in some embodiments", "in one embodiment", "in some exemplary embodiments", "in one exemplary embodiment", or "in an embodiment" appearing throughout the specification do not necessarily all refer to the same embodiment. Additionally, in one or more embodiments, specific features, structures, or characteristics can be combined in any suitable manner.

[0021] During the suturing process, it may be advantageous to provide support for the splint material through which staples can be deployed. The splint or support material can help distribute the pressure of multiple rows of staples to improve staple grip in tissue or maintain the integrity of the staple line. For example, a bioabsorbable material or a biological material can be provided on the anvil surface and / or the cartridge surface, through which staples can be deployed during use. Then, this splint material that holds the staples can be cut with a blade or a tool, and the material can be left in the patient's body.

[0022] Embodiments of a support splint for a suturing device for use during laparoscopic surgery are described herein, wherein the suturing device can be inserted through a trocar. Laparoscopic surgery can include, for example, sleeve gastrectomy or gastrectomy, but is not limited to these procedures.

[0023] Refer to Figure 1 And Figure 2, in an exemplary embodiment, the spreader device 10 includes a spreader 12 removably coupled to the applicator assembly 14. The applicator assembly 14 is designed to carry the spreader 12 and align the spreader 12 on the end effector 16. The applicator assembly 14 can assist in mounting the spreader 12 on the first jaw 18 and the second jaw 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 spreader fastener 26 releasably fastened to the release liner 24. The release liner 24 is configured to removably couple the spreader 12 to the applicator body 22. The spreader 12 can be positioned on the applicator body 22 (or on an intermediate member such as an applicator base 28). Then, the release liner 24 can be positioned above the spreader 12 such that the spreader fastener 26 is fastened to the spreader 12. An adhesive on the applicator body secures the release liner 24 in place on a portion of the spreader 12.

[0024] 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 can clamp onto the spreader 12. The release liner 24 can include a sacrificial tab 30 that, when removed, exposes the spreader fastener 26. In this configuration, the spreader 12 is separated from the applicator assembly 14 and can be coupled to the end effector 16. Then, the spreader 12 can be wrapped or pressed around the end effector 16 using the applicator assembly 14 or a separate tool to attach the spreader 12 to the end effector 16. For example, the applicator body 22 can be manipulated to press the spreader fastener 26 against the end effector 16, thereby adhering the spreader 12 to the end effector 16. The spreader device 10 can be provided to the user with the spreader 12 coupled to the applicator assembly 14, allowing the end user to mount the spreader 12 on the end effector 16 during use. Alternatively, the spreader device 10 can be provided to the user in a state pre-mounted on the end effector 16. During a surgical procedure, when the end effector 16 is clamped around tissue, a removable portion 32 of the spreader 12 can be released from the end effector 16 while a remaining portion 34 remains on the end effector 16. To allow the user to release the removable portion 32 of the spreader 12 from the end effector 16, the spreader device 10 includes a mechanism such as a perforated tape, a pull cord, etc. The removable portion 32 of the spreader 12 can be released from the end effector 16 before or after suturing adjacent tissue.

[0025] Still referring to Figure 1 and Figure 2, the spreader device 10 can include more than one sub - assembly. The spreader 12 can include one or more spreader members 36. For example, the spreader device 10 can include a first spreader member 36a (e.g., an anvil) for the first jaw 18 of the end - effector 16 and a second spreader member 36b (e.g., a staple cartridge) for the second jaw 20 of the end - effector 16. As used herein, terms such as "top" and "bottom" used to describe the components of the spreader device 10 are relative to the respective jaws of the end - effector. For example, "top" can refer to the side of the component facing the respective jaw. Thus, for a spreader that will be applied to the anvil, the top surface of the spreader can face the anvil surface, while the bottom surface faces away from the anvil surface. In the case where the spreader 12 includes multiple spreader members 36, the applicator assembly 14 can include applicator sub - assemblies 14a, 14b corresponding to each spreader member 36a, 36b.

[0026] As described above, the spreader 12 includes at least one spreader member 36. Each spreader member 36 can include a distal end 38, a proximal end 40, a first side 42, and a second side 44 opposite the first side. The spreader member 36 can include a top surface 46 and a bottom surface 48. During a surgical procedure, the spreader member 36 is sutured to tissue. The spreader member 36 can include a portion for remaining attached to the tissue after surgery and a portion that is removed with the end - effector. For example, the spreader member 36 can include a detachable portion 32 and one or more remaining portions 34. The remaining portions 34 can be coupled to the end - effector 16 for the duration of the surgery, while the detachable portion 32 remains attached to the tissue after the surgery is complete. The detachable portion 32 is removably coupled to the remaining portions 34. For example, the spreader member 36 can include a series of perforations 50 separated by a perforation strip 52 that removably couples the detachable portion 32 to the remaining portions 34. In one embodiment, the detachable portion 32 can be located between two remaining portions 34. For example, the spreader member 36 can include: a first remaining portion 34a that is coupled to the first side of the detachable portion 32; and a second remaining portion 34b that is coupled to the second side of the detachable portion 32 opposite the first side. In such a configuration, the spreader member 36 can include two sets of perforations 50 that couple the detachable portion 32 to the first remaining portion 34a and the second remaining portion 34b.

[0027] The buttress member 36 can be made of any suitable buttress material, such as (permanent and bioabsorbable) polymers and biological membranes. Exemplary materials for the buttress member include copolymers of polyglycolide (PGA) and trimethylene carbonate (TMC). In cases where the buttress device 10 includes more than one buttress member 36, these buttress members 36 can be the same or different. For example, the buttress device 10 can include different "anvil" and "staple cartridge" buttress members 36. Having the same buttress members 36 will minimize the number of different components included in the buttress 12. The buttress member 36 can be symmetric or asymmetric (e.g., having different "top" and "bottom" sides). The buttress member 36 can include a proximal tab to allow the buttress member 36 to enter the proximal tissue stop of the end effector 16. Alternatively or additionally, the buttress member can include a distal tab to enter the distal tissue stop of the end effector 16. The buttress member 36 can span the length and at least the width of the end effector anvil plate in a single continuous member to capture each staple ejected from the end effector 16. In some embodiments, the buttress member 36 can include discrete adjacent segments that are combined together by an applicator assembly and are segmented longitudinally ( Figure 3 ) or transversely. The adjacent segments can also be "bridged" together such that the entire width of the buttress member is not continuous. The buttress member 36 can be positioned on one side of the cut line, depending on the surgery, as the sutures in the excised tissue may not need to be reinforced. In some embodiments, the buttress member 36 can include a slit 54 ( Figure 4 ) at its distal end to initiate the cut line. The slit 54 can be positioned adjacent to the cut line. For example, the slit 54 can be located at the center of the distal end of the buttress member 36. The slit 54 can be rectangular, triangular (beak-shaped), etc. In one example, the slit 54 can be segmented (e.g., to form a series of perforations) or can span the length of the buttress member 36, thereby eliminating the need to cut the buttress member 36 during the surgery.

[0028] The size of the backing plate 12 can vary according to the intended application. The widths of the backing plate members 36a, 36b can be the same or different. For example, the width of the anvil backing plate member 36a is designed to wrap around the sides and / or top of the anvil, thereby providing sufficient contact with the end effector to properly adhere the backing plate to the end effector. The distance that the backing plate wraps around both sides of the jaws can vary. In one embodiment, the anvil backing plate completely wraps around the anvil, thereby maximizing the adhesion contact area. Insufficient wrapping of the backing plate over the entire jaw can improve the ability of the end effector to slide within the trocar. The width of the cartridge backing plate member 36b can be wider than that of the anvil backing plate member 36a to compensate for the width difference between the anvil jaws and the cartridge jaws. To minimize the complexity of the components and assemblies, the same backing plate can be used for the anvil and the cartridge. In various embodiments, the thickness can be in the range of, for example, about 0.1 mm to about 0.5 mm, about 0.2 mm to about 0.3 mm. The thickness can be about 0.26 mm. The average density can be in the range of, for example, about 0.1 g / cm 3 to about 1.7 g / cm 3 、or about 0.25 g / cm 3 to about 1.34 g / cm 3 . In various embodiments, the tensile stress of the backing plate material can be in the range of about 700 psi to about 1300 psi, about 900 psi to about 1100 psi, or about 950 psi to about 1000 psi. The tensile stress can be, for example, about 983 psi.

[0029] The number and size of the perforations 50 and the perforation strip 52 can vary. The perforation strip 52 is configured to have a relatively high burst strength and a relatively low tear strength. The relatively high burst strength helps prevent the perforation strip 52 from accidentally splitting, for example, when tissue is positioned between the jaws 18, 20 of the end effector 16. The relatively low tear strength improves the ease with which the detachable portion 32 of the backing plate member 36 separates from the remaining portion 34 when the jaws 18, 20 of the end effector 16 are opened. The distal ends of the lines of the perforations 50 can be initiated with an introduced perforation (e.g., the distal edge of the backing plate member 36 can be discontinuous).

[0030] The width and pitch of the perforated tape 52 can vary. The perforated tape 52 is configured to resist lateral loads during tissue manipulation and / or actuation of the end effector. The width of the perforated tape 52 can be, for example, in the range of about 0.005 inches to about 0.1 inches, about 0.01 inches to about 0.05 inches, or about 0.01 inches to about 0.03 inches, or can be about 0.02 inches. The width of the perforations 50 (e.g., openings) can be, for example, in the range of about 0.01 inches to about 1 inch, about 0.1 inches to about 0.5 inches, or about 0.1 inches to about 0.3 inches, or can be about 0.24 inches. The ratio of the width of the perforations 50 to the width of the perforated tape 52 can be, for example, in the range of about 5 to about 20, or about 10 to about 15, or can be about 12. In one embodiment, the splint member 36 can include perforated tapes 52 having different widths. For example, the splint member 36 can include alternative perforated tapes 52 having a first width and a second width different from the first width.

[0031] The mechanical properties of the perforated tape 52, such as burst strength and tear strength, can vary. The burst strength (% hold) of the perforated tape 52 can be calculated based on the number of teeth per inch (the number of perforating teeth that create a "cut" in the perforation pattern per inch) multiplied by the tape width. In various embodiments, the burst strength (% hold) can be, for example, in the range of about 5% to 100%, about 5% to about 50%, about 5% to about 20%, about 5% to about 10%, or about 7% to 100%. The burst strength can be, for example, about 7.7%. In various embodiments, the teeth per inch (TPI) can be in the range of about 1 to about 10, about 1 to about 5, about 3 to about 4. The TPI can be, for example, about 3.4. The tear strength is a function of the tape width, material thickness, and maximum material tensile stress. The tear strength can be equal to the cross-sectional area of the perforated tape 52 (thickness multiplied by width) multiplied by the tensile stress of the splint material. In various embodiments, the perforation tear strength of a single perforated tape 52 can be in the range of greater than 0 to about 1 lbf, greater than 0 to about 0.5 lbf, about 0.1 lbf to about 0.3 lbf. The perforation tear strength can be, for example, about 0.197 lbf. The tear strength can vary depending on changes in the perforated tape width, material thickness, and maximum material tensile stress.

[0032] Referring again to Figure 1 and Figure 2, an applicator assembly 14 is used to apply the spreader 12 to the end effector 16. In one embodiment, the applicator assembly 14 may include an applicator body 22 and an applicator base 28. In cases where the applicator assembly 14 includes multiple sub-components, each sub-component may include an applicator body 22 and an applicator base 28. The applicator assembly 14 may be disposable. In various embodiments, the applicator assembly 14 may include a tab. For example, when the spreader device includes more than one applicator sub-component, one or both of the applicator sub-components may include a tab to facilitate separation of the applicator body. The tab may be, for example, rectangular or circular. Alternatively, the applicator body 22 may have a recess that allows the applicator body 22 to be more easily separated.

[0033] 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 cutouts 67, to ensure proper alignment when the spreader device is installed on the end effector 16. The applicator body 22 may be made of, for example, flexible cardstock of any thickness, a stitched plate, particle board (such as SBS (solid bleached sulfite)), or any other semi-flexible member (such as semi-flexible foam, rubber, silicone, or plastic). An exemplary material for the applicator body 22 may be polyester. The applicator body 22 may include an adhesive on a portion or all of the top surface 64. The adhesive may be, for example, an acrylic adhesive. The adhesive may be used to couple the release liner 24 to the applicator body 22. To further secure the release liner 24 in place, some portions of the applicator body 22 may be folded over the edge of the release liner 24. For example, the outer edge 68 of the applicator body 22 may be folded over the top surface 64 of the applicator body 22 to form a folded portion 70. The folded portion 70 does not extend over the sacrificial sheet 30. In other words, the sacrificial sheet 30 remains uncovered. In the folded configuration, a portion of the bottom surface 66 of the applicator body 22 can be seen from the top of the applicator body 22. In one embodiment, the bottom surface 66 of the applicator body 22 is configured to include printed markings, such as symbols or instructions. The markings can be seen on the folded portion 70.

[0034] Still referring to Figure 2, each applicator base 28 can include a distal end 72, a proximal end 74, a first side 76, and a second side 78 opposite the first side. The applicator base 28 can include a top surface 80 and a bottom surface 82. The applicator base 28 can be made of any thin, flexible, hypoallergenic, and / or biocompatible material such as 4mil LDPE. An exemplary material for the applicator base 28 is polyester. The applicator base can provide additional strength to the applicator body 22. In one embodiment, the applicator base 28 spans the width and length of the spreader member 36. In the case where the applicator body 22 includes an adhesive, the applicator base 28 can cover a portion of the adhesive to prevent the spreader 12 from adhering to the applicator body 22. The adhesive on the side of the top surface 64 of the applicator body 22 can remain uncovered by the applicator base 28. The spreader member 36 can be positioned on the applicator base 28. In embodiments where the applicator assembly 14 does not include the applicator base 28, the portion of the applicator body 22 configured to contact the spreader member 36 can be free of adhesive. In some embodiments, one or more of the applicator base or the adhesive is discontinuous.

[0035] If the spreader device 10 includes more than one applicator sub-assembly, then the applicator sub-assemblies can be fastened together. In some embodiments, the applicator sub-assemblies can be fastened together in the region where the jaws of the end effector will clamp together. The applicator sub-assemblies can be fastened together by glue, tape, staples, sutures, etc.

[0036] Referring Figure 2 , in various embodiments, the spreader device 10 can include a flexible member 84 located between the applicator sub-assemblies. When the jaws 18, 20 are clamped, the spreader members 36a, 36b and the applicator sub-assemblies 14a, 14b compress the flexible member 84, which helps to hold the spreader device 10 in place between the jaws 18, 20. The flexible member 84 is designed to provide thickness to the region adjacent the end effector 16 and to cause the jaws 18, 20 of the end effector 16 to provide compression to the spreader 12 during installation. The flexible member 84 can be adhered to the applicator body 22. In the case where the applicator assembly 14 includes multiple applicator sub-assemblies, the flexible member 84 can be adhered to each applicator body 22. The flexible member 84 can include an adhesive on the top surface 86 and the bottom surface 88 and can initially include a temporary liner to prevent accidental adhesion. The user can remove the temporary liner to adhere the flexible member 84 to the corresponding applicator body 22. In various embodiments, the flexible member 84 can be continuous along the region adjacent to the end effector 16, longitudinally segmented, or transversely segmented. The flexible member 84 can extend along the length of the applicator body 22, along the proximal portion, or along the distal portion. In one embodiment, the thickness of the flexible member 84 can gradually decrease, for example, longitudinally.

[0037] The flexible member 84 may include a distal end, a proximal end, a first side, and a second side opposite the first side. The flexible member may be made of foam, such as cross-linked polyethylene foam coated with an adhesive (e.g., 2A ), or any other hypoallergenic flexible member, such as corrugated (grooved) particle board, rubber, or silicone. In one embodiment, the applicator body is a die-cut, bleached 0.009-inch cardstock member, and the flexible member is a 3 / 32-inch thick, 3 / 8-inch wide foam strip. The compression can vary. For example, the foam compression at 25% deflection can be in the range of about 1 psi (pounds per square inch) to about 10 psi, or it can be about 5 psi.

[0038] Referring to Figure 1 、 Figure 2 and Figure 5 , in various embodiments, the release liner 24 is configured to temporarily couple the backer 12 to the 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. The release liner 24 may include a top surface 98 and a bottom surface 100. The release liner 24 may include a side portion 102 and a sacrificial tab 30, the side portion 102 being configured to couple to the applicator body 22 as described above, and the sacrificial tab 30 being removably fastened to the side portion 102 via a perforation 103. The side portion 102 may include alternating protrusions 104 and recesses 106. For purposes of illustration, in Figure 2In [the figure], the protrusions 104 and the recesses 106 are only shown on one side of the top release liner 24, but the technique is not limited thereto. When the edge of the applicator body 22 is folded onto the side portion 102 of the release liner 24, the recesses 106 allow areas where the applicator body 22 adheres to itself when the applicator body 22 adheres to the protrusions 104 of the release liner 24. The release liner 24 may also include a removable central portion 108 that is removably fastened to the sacrificial sheet 30 (e.g., by perforation). After the spreader device 10 is assembled and before it is positioned on the end effector 16, the removable central portion 108 may be removed to expose a portion of the spreader 12. The side portions 102, the sacrificial sheet 30, and the removable central portion 108 may be releasably coupled using features other than perforation (e.g., stitched together). Each sacrificial sheet 30 may include a grip portion 110. For example, the sacrificial sheet 30 may include a longitudinal portion 112 that extends along the length of the spreader device 10 and an extension portion 114 that extends transversely from the longitudinal portion 112. The extension portion 114 may be folded onto itself to provide additional strength. The grip portion 110 may be located at the end of the extension portion 114. The grip portions 110 of adjacent sacrificial sheets 30 may be coupled together. For example, the grip portions 110 may be adhered together using an adhesive sheet, for example. The grip portion 110 may be shaped to provide a direction indication of how the grip portion 110 should be pulled to remove the sacrificial sheet 30 from the spreader device 10. For example, the grip portion 110 may be shaped like an arrow. In embodiments where the top surface 98 of the release liner 24 does not include a release coating, the adhesive sheet may provide better adhesion to the folded grip portion 110 compared to the adhesion provided by the spreader fastener 26 to the bottom surface 100 of the release liner 24.

[0039] The release liner 24 may be made of, for example, kraft paper or plastic (such as polyester). The release liner 24 may include a release coating, such as 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. During the assembly of the spreader device 10, the spreader fastener 26 is capable of releasably adhering to the release liner 24. In one example, the spreader fastener 26 is removably adhered to the side of the release liner 24 that includes the release coating.

[0040] Still referring to Figure 2 , as described above, the spreader 12 may be attached to the end effector by the spreader fastener 26. The spreader fastener 26 ensures that the spreader 12 is taut and aligned relative to the lateral and longitudinal alignment features on the applicator assembly 14. In some embodiments, the spreader fastener 26 may be a medical-grade transfer adhesive. In other embodiments, the spreader fastener 26 may include a highly adhesive, hypoallergenic double-sided tape (e.g., 3M TMMedical tapes 1567), single-sided tapes, glues such as cyanoacrylate, staples, etc. Exemplary medical-grade transfer adhesives are synthetic rubber-based adhesives, such as the 1504XL high-tack medical transfer adhesive from 3M, or acrylic adhesives. The splint fastener 26 can include discrete segments. For example, the splint fastener 26 can include two longitudinal adhesive strips. As described above, the top of the splint fastener 26 is capable of releasably adhering to the release liner 24, which is used to position the splint fastener 26 on the splint 12 during the assembly of the splint device 10. The temporary liner can be removed from the bottom of the splint fastener 26 opposite the release liner 24 and then positioned on the splint 12. The temporary liner can prevent the splint fastener 26 from accidentally adhering to something other than the splint 12.

[0041] In various embodiments, the splint fastener 26 can be continuous along the length of the splint 12 to maximize adhesion, where the splint fastener 26 is segmented longitudinally or transversely. The splint fastener can alternatively not include an adhesive and can include a row of staples, rivets, tacks, etc. to fasten the splint to the applicator. The splint fastener 26 is designed to fasten the splint 12 to the end effector 16, but also provides a fastening force to the end effector that is greater than the force to tear the perforations, as discussed herein. Additionally, the properties of the release liner 24 and the adhesion of the splint fastener 26 are designed such that when the release liner 24 is removed, the splint fastener 26 does not delaminate from the splint 12. Since the jaws 18, 20 of the end effector 16 can have a non-stick coating (e.g., PTFE), the splint fastener 26 is configured to have a strong enough adhesion to hold the remaining portion 34 of the splint on the end effector 16 when the perforated tape 52 is torn. By using a higher surface energy substrate, etc., the 90° peel force ("peel force") of the adhesive to the jaws 18, 20 of the end effector 16 can vary with the surface area over which the splint fastener 26 extends. In various embodiments, the peel force can be in the range of about 0.1 lbF to about 5 lbF, about 0.5 lbF to about 5 lbF, about 0.5 lbF to about 3 lbF, about 0.6 lbF to about 5 lbF, or about 0.6 lbF to about 2 lbF, or can be about 0.6 lbF. In one embodiment, the minimum 90° peel force of the splint fastener 26 to the jaws 18, 20 of the end effector 16 is greater than the tear strength of the perforated tape 52.

[0042] To assemble the splint device 10, a temporary liner ( Figure 2) Removed from the applicator body 22 to expose the adhesive. If the applicator base 28 is being used, it can be positioned above the applicator body 22. Then the spreader 12 can be positioned on the applicator base 28 (or the applicator body 22). The temporary liner can be removed from the spreader fastener 26, and the release liner 24 can be positioned on the spreader member 36, with the spreader fastener 26 facing the top surface 46 of the spreader member 36. The outer edge 68 of the applicator body 22 can be folded over the side portion 102 of the release liner 24. If the release liner 24 extends completely over the spreader 12, the removable central portion 108 can be removed to expose a portion of the spreader 12. The sacrificial piece 30 remains in place on the spreader fastener 26. The extension portion 114 of the sacrificial piece 30 can be folded, and the adjacent gripping portions 110 can be adhered to each other. Multiple spreader and applicator sub-assemblies can be made in the same manner. If a flexible member 84 is used, it can be coupled to one or more applicator bodies 22. To do this, the temporary liner can be removed from the flexible member 84 to adhere it to the applicator body 22.

[0043] Various components can include features that are used during assembly but removed prior to application. For example, the applicator body, applicator base, spreader, and release liner can include a perforated sheet. During assembly, the perforations in the perforated sheet can be positioned over alignment features (such as alignment pins). This helps ensure that the components are correctly positioned. After assembly, the perforated sheet can be removed.

[0044] To apply the spreader 12 to the end effector 16, the spreader device 10 is inserted between the jaws 18, 20. When the spreader device 10 is positioned within the end effector 16, as Figure 5 shown, the spreader 12 can be separated from the applicator assembly 14. To remove the sacrificial piece 30, the user grasps the gripping portion 110 of the sacrificial piece 30 and pulls it along the length of the spreader device 10 to tear the perforations and expose the spreader fastener 26. At this point, the spreader 12 is positioned on the applicator assembly 14 but not coupled to the applicator assembly 14. The top of the spreader 12 can be fully exposed. The spreader 12 can be fastened to the end effector 16 by bending the side portions of the applicator assembly 14 around the jaws to adhere the spreader fastener 26 to the jaws 18, 20. Figure 6 The spreader 12 adhered to the end effector 16 is shown.

[0045] Perforation 103 can span the length of release liner 24 and cut through the end of release liner 24, providing a "starting" or introduction perforation to ensure the reliability of the mechanism. The sacrificial sheet 30 can be designed to be pulled both laterally and proximally simultaneously, as shown by the directional arrow-shaped gripping portions 110. This will help ensure that perforation 103 tears and release liner 24 peels away from the retainer fastener 26. As an alternative to the user pulling on multiple gripping portions 110 on each side of the retainer device 10, the upper gripping portion 110 and the lower gripping portion 110 can be fastened together so as to be separated by a single pulling action. Other mechanisms can be used to release the retainer from the applicator assembly, such as a chain stitch, a release liner (which can be found on consumer foam mounting strips, such as Command TM Strip), etc.

[0046] After the sacrificial sheet 30 of release liner 24 separates from the retainer 12, the retainer 12 can be coupled to the end effector. The techniques for coupling the retainer to the end effector can vary. As described above, the retainer fastener 26 can adhere the retainer to the end effector. As another example, the retainer can be coupled to the jaws by adhesion with tape, glue, etc. or by mechanical fastening (such as tying, clamping, etc.). Referring Figure 7 to, the applicator assembly 14 can be used to couple the retainer 12 to the end effector 16. The sides of the applicator assembly 14 can be folded upwardly around the jaws 18, 20 to press the retainer fastener 26 against the jaws 18, 20.

[0047] During the surgical procedure, the user can separate the detachable portion of the retainer member from the end effector so that the detached portion remains attached to the tissue. As described above, the retainer member can include a perforation that tears to separate the detachable portion of the retainer member from the end effector. The perforation in the retainer member can be separated by various techniques. In Figure 2 and Figure 8 the example shown, the retainer member 36 includes a perforation 50 along its length. In one embodiment, the perforation 50 can be positioned such that when the retainer member 36 is coupled to the jaws 18, 20, the perforation 50 is positioned on one side of the jaws 18, 20. Opening the jaws 18, 20 of the end effector 16 will cause the perforation 50 to tear. In some embodiments, the retainer device 10 can include a mechanism by which the user can selectively tear the perforation 50. One example includes a suture that surrounds the perforation 50. In use, one end of the suture extends outside the patient's body. The user can pull on the suture from outside the patient's body such that the suture cuts the perforation 50. In another example, two sets of perforations 50 are separated by a tab and the suture is coupled to the end of the tab. Pulling on the suture will cause the tab to tear away from the retainer member 36. Components other than suture can be used to selectively tear the perforation 50. For example, during the surgical procedure, the end of the tab can extend outside the patient's body and can be pulled away from the retainer member 36.

[0048] In one embodiment, a method of suturing a patient's anatomical structure during minimally invasive surgery may include providing an end effector, wherein the anatomical structure has 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, wherein the anvil includes an anvil face; a second jaw having a first end, a second end, a longitudinal axis, and a staple cartridge that holds a plurality of staples, the staple cartridge having a staple 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 may further include: a spreader plate including a detachable portion and a remaining portion, wherein the detachable portion and the remaining portion are removably coupled by a perforated tape, and the remaining portion is coupled to the first jaw or the second jaw during the duration of the minimally invasive surgery; and a cutter coupled to or integral with the first jaw and capable of sliding relative to the first jaw. The method may include: inserting the end effector through a trocar to access the anatomical structure, positioning the staple cartridge face on the first side of the anatomical structure, positioning the anvil face on the second side of the anatomical structure, clamping the end effector onto the anatomical structure, operating the end effector to urge the plurality of staples from the staple cartridge to suture the anatomical structure, actuating the cutter to cut the anatomical structure, and opening the end effector to cause the perforated tape to tear. The end effector may then be removed from the trocar such that the detachable portion remains sutured to the anatomical structure while the remaining portion remains attached to the end effector.

[0049] In the case where the end user mounts the spreader plate device on the end effector, an exemplary embodiment includes a bracket that aids in the mounting by keeping the end effector upright, stable, and allowing it to open and close. Figure 9 and Figure 10 A suturing device 150 is shown including an end effector 16 positioned on a bracket 152. The bracket is reusable and made of a material capable of withstanding repeated sterilization processes. For example, the bracket may be made of a metal such as stainless steel, or of a sterilizable or autoclaveable plastic. The bracket may be disposable, such as a thermoformed bracket, and may be incorporated into a device tray that is already mounted on the device. As Figure 9As shown, the tip of the end effector 16 can be positioned on the same plane as the placement bracket 152 (e.g., a tabletop). In other embodiments, the bracket can hold the end effector horizontal or at an angle, such as 90 degrees. In one embodiment, the bracket can include two separate parts: one part that constrains the handle of the device and another part that constrains the tip of the end effector. In one embodiment, the width of the applicator body can be determined based on the bracket. For example, when the splint device is inserted between the jaws while the suturing device 150 is positioned on the bracket, the dimensions of the applicator body can be set such that the applicator body does not contact the surface when the splint presses against the lower jaw.

[0050] In various embodiments, the applicator can include a label, such as an instruction manual. By using the instruction manual printed on the applicator, reminding the user of the correct technique and operating sequence for installing the splint on the end effector can reduce installation errors. The instruction manual can be incorporated onto the applicator by printing, stickers, etc. The instruction manual can use warning fonts, colors, custom or generic action symbols, or any font, color, or symbol to inform the user. For example, the label can be included on the folded surface of the top applicator body. In one embodiment, a sequential numbering scheme depicts the operating sequence in large red text. Each step has medium-sized black text to convey the technique for the current step to the user. A custom symbol for the end effector will orient the applicator in the yaw direction. A custom symbol for the film tab conveys to the user the feature to pull. Once the top of the top applicator body is folded up, an exemplary label on the top of the bottom applicator body is uncovered. The sequential numbering and instruction manual step scheme continue. A generic "pinch" symbol indicates to the user to pinch the applicator assembly. A generic "wrap" symbol accompanies the instruction manual step, indicating to the user to wrap the applicator around the jaws of the end effector. If the applicator assembly is inverted, a warning will appear to the user, with a warning color such as yellow and extra-large text.

[0051] In one embodiment, the splint can include a splint - base film assembly. The splint member can be removably fastened to the base film member. The mechanism for fastening the splint member to the base film member can be any suture that can arbitrarily separate these members, a peel line for separating an adhesive, or a liner (which can be found on consumer foam mounting strips, such as Command TMa) a perforating mechanism, in which in the perforating mechanism, a perforation is cut in the membrane - for example the mechanism proposed above for separating the sutured splint part from the applicator, or a perforation is cut in the splint member. This mechanism may allow the user to optionally separate the splint member from the end effector, for example by providing a tail that can be pulled from outside the patient's body, or by incorporating the mechanism into the end effector, the splint member can be separated from the end effector. The splint member can be manually or automatically separated from the end effector from outside the patient's body by the user's direct action or by a mechanism on the end effector from the inside. For example, the cutter / firing mechanism (or other closing system) can be configured to automatically separate the splint member from the end effector. In one embodiment, the applicator base of the applicator assembly can be configured to attach to the end effector. In various embodiments, the base membrane member can be attached to the end effector by separate fastening components (such as single-sided tape, double-sided tape, transfer adhesives, cyanoacrylate adhesives, etc.).

[0052] In embodiments where the splint member has parts sutured together, the sutures can be untied to release the sutured part of the splint member from the end effector. The splint fastener for coupling the splint to the end effector can also temporarily secure the suture tail. As described above, when the tail end of the suture is secured, the suture provides a firm fastening. During assembly, transportation, and installation, it may be desirable to prevent the sutures on the splint from untying. During use, untying the sutures can provide an easy, reliable, and controlled release of the splint member from outside the patient's body from the end effector. To achieve both functions, the tail end of the suture can be temporarily secured in place by the splint fastener (or a separate component). For example, the distal and proximal ends of the suture can be secured by the splint fastener. Components other than the splint fastener can be used to temporarily secure the ends of the suture. For example, a knot or bead can be included in the suture or thread pulled through the splint or the applicator base. Another way to terminate the thread is to adhere a double-sided tape member to the length of the thread. This method adheres the splint assembly to the end effector, secures the ends of the thread by capturing the ends of the thread in the double-sided tape, and increases the force required to pull the suture. It will be recognized that other techniques can be used to ensure the integrity of the assembly and prevent accidental activation of the release mechanism. In one embodiment, to separate the splint member from the applicator base, the tail end of the suture can be released from the splint fastener and pulled.

[0053] In one embodiment, the applicator assembly can be designed to fold from a planar configuration into a three-dimensional configuration to assist in mounting the spreader on the jaws of the end effector. For example, the sides of the applicator assembly are pinched to fold the applicator, thereby forming a wall for adhering the double-sided tape of the spreader to the jaws of the end effector. The applicator body can be a static die-cut member that aligns the spreader with the end effector when the spreader is adhered to the jaws of the end effector by a separate mechanism (such as a tool that slides along the jaws of the end effector) or by a sacrificial "handle" on the applicator substrate that a user can manipulate to wrap the spreader around the jaws of the end effector. After the spreader is fastened to the end effector, the handle can be torn off and discarded by perforation or the like.

[0054] In the various embodiments disclosed herein, a single component can be replaced by multiple components, and multiple components can be replaced by a single component to perform a given one or more functions. Such replacements fall within the scope of the embodiments unless such replacements do not work.

[0055] The foregoing description of the embodiments and examples has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the forms described. Given the above teachings, many modifications are possible. Some of these modifications have been discussed, and others will be understood by those skilled in the art. The embodiments were chosen and described in order to best illustrate the principles of the various embodiments suitable for a particular intended use. Of course, the scope is not limited to the examples set forth herein, but they can be used in any number of applications and equivalent devices by those of ordinary skill in the art. Instead, the scope of the invention is intended to be defined by the appended claims.

Claims

1. A spreader device, comprising: An applicator assembly, the applicator assembly comprising: An applicator body, the applicator body being flexible; and A release liner, Wherein the release liner is coupled to the applicator body; and A spreader positioned on the applicator body; and A spreader fastener configured to couple the spreader to an end effector, wherein the spreader fastener is configured to releasably fasten to the release liner; Wherein the spreader device has a first configuration and a second configuration, wherein in the first configuration, the spreader is coupled to the applicator assembly, and in the second configuration, the spreader is separated from the applicator assembly.

2. The stay plate device according to claim 1, wherein, The spreader includes a detachable portion and a remaining portion.

3. The support plate device according to claim 2, wherein, The detachable portion and the remaining portion are joined by a perforated strip, wherein the tear strength of the perforated strip is less than the peel force of the spreader fastener on the end effector.

4. The stay plate device according to claim 3, wherein, The tear strength of a single perforated strip is in the range of greater than 0 to about 1 lbF.

5. The stay plate device according to claim 3, wherein, The peel force is in the range of about 0.1 lbF to about 5 lbF.

6. The stay plate device according to claim 2, wherein, The spreader fastener is coupled to the remaining portion of the spreader.

7. The stay plate device according to claim 1, wherein, The spreader fastener includes an adhesive.

8. The support plate device according to claim 1, wherein, The spreader includes longitudinally separated discrete segments.

9. The stay plate device according to claim 1, wherein, The applicator assembly further includes an applicator base.

10. The gusset plate device according to claim 9, wherein, The applicator body has an adhesive top surface that couples the release liner to the applicator body.

11. The stay plate device according to claim 10, wherein, An edge of the applicator body is folded over a side of the release liner.

12. The stay plate device according to claim 11, wherein, Sides of the release liner include alternating protrusions and recesses, wherein the edge of the applicator body is folded over the alternating protrusions and recesses.

13. The stay plate device according to claim 1, wherein, A first surface of the release liner includes a release coating.

14. The stay plate device according to claim 1, wherein The release liner includes a sacrificial sheet.

15. The stay plate device according to claim 14, wherein, The sacrificial sheet includes a longitudinal portion, an extension portion extending laterally from the longitudinal portion, and a grip portion at an end of the extension portion, wherein the extension portion is folded upon itself.

16. The stay plate device according to claim 1, wherein, The applicator assembly is a first applicator assembly, and the spreader device further includes a second applicator assembly and a flexible member that couples the first applicator assembly and the second applicator assembly.

17. The stay plate device according to claim 1, wherein, The spreader device has a third configuration, wherein in the third configuration, the spreader is removed from the applicator assembly.

18. A surgical suturing system, comprising: The spreader device according to claim 1; And A surgical stapler, the surgical stapler including the end effector having a first jaw and a second jaw, wherein the spreader device is inserted through the end effector.

19. A method of assembling the spreader device according to claim 1, the method comprising: Positioning the spreader on the applicator body; And Positioning the release liner on the spreader to adhere the spreader fastener to the spreader, wherein the release liner is coupled to the applicator body.

20. The method according to claim 19, further comprising folding an edge of the applicator body over a side of the release liner.

21. The method according to claim 19, wherein The applicator assembly is a first applicator assembly, and the backing plate device further includes a second applicator assembly and a flexible member, and the method further includes coupling the flexible member to the first applicator assembly and the second applicator assembly.

22. The method according to claim 19, further comprising removing a temporary liner from the backing plate fastener before positioning the release liner on the backing plate.

23. The method according to claim 19, further comprising removing a temporary liner from the applicator body to expose the adhesive top surface of the applicator body.

24. The method according to claim 19, further comprising positioning an applicator base on the applicator body, and wherein, Positioning the backing plate on the applicator body includes positioning the backing plate on the applicator base.

25. A method of applying a backing plate to an end effector, the method comprising: mounting a backing plate device on the end effector, the backing plate device including: an applicator assembly, the applicator assembly including: an applicator body, the applicator body being flexible; and a release liner, wherein the release liner is coupled to the applicator body; the backing plate positioned on the applicator body; and a backing plate fastener, wherein the backing plate fastener is coupled to the backing plate and releasably fastened to the release liner; exposing the backing plate fastener; and manipulating the applicator body to adhere the backing plate fastener to the end effector.

26. The method according to claim 25, further comprising removing the applicator assembly from the end effector.

27. The method according to claim 25, wherein the release liner includes a sacrificial sheet.

28. The method according to claim 27, wherein, The sacrificial sheet includes a longitudinal portion, an extension portion extending laterally from the longitudinal portion, and a gripping portion at an end of the extension portion, wherein the extension portion is folded upon itself.

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