Adhesive distribution on the buttress of a surgical stapler
By introducing support assembly and asymmetric adhesive distribution into the end effector of surgical stapler, the problems of nail pulling and tissue tearing during surgical stapler are solved, and the stability and safety of the stapler process are improved.
Patent Information
- Application Number
- CN201980093006.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2018-12-28
- Filing Date
- 2019-12-09
- Publication Date
- 2025-01-03
- Estimated Expiration
- 2039-12-09
AI Technical Summary
Existing surgical stapling devices are difficult to effectively prevent nail pulling and tissue tearing during use, resulting in an increased risk of postoperative complications.
A support application device is designed to enhance the mechanical fastness of the tissue layer by introducing a support assembly into the end effector of the surgical stapler, using the contact of the adhesive with the staple cartridge and the anvil, and through the Symmetric adhesive distribution optimizes the attachment and release characteristics of the support assembly.
It effectively reduces the risk of nail pulling and tissue tearing, improves the stability and safety of the suture process, extends the attachment time between the support assembly and the surgical stapler, and simplifies the operation process.
Smart Images

Figure CN113473920B_ABST
Abstract
Description
Background Art
[0001] In some environments, endoscopic surgical instruments are preferred over traditional open surgical devices because smaller incisions can reduce postoperative recovery time and complications. Therefore, some endoscopic surgical instruments may be suitable for placing the distal end effector at the desired surgical site through the cannula of a trocar. These distal end effectors (e.g., endoscopic cutters, graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy delivery devices, and energy delivery devices using ultrasonic vibrations, RF, lasers, etc.) can engage tissue in a variety of ways to achieve diagnostic or therapeutic effects. Endoscopic surgical instruments may include an axis between the end effector and the handle portion manipulated by a clinician. Such an axis may enable insertion into a desired depth and rotation around the longitudinal axis of the axis, so as to facilitate positioning the end effector in the patient's body. It may also be further advantageous to position the end effector by including one or more articulation joints or features so that the end effector can selectively articulate or otherwise deflect relative to the longitudinal axis of the axis.
[0002] Examples of endoscopic surgical instruments include surgical staplers. Some such staplers are operable to clamp tissue layers, cut through the clamped tissue layers, and drive staples through the tissue layers to substantially seal the severed tissue layers together near the severed ends of the tissue layers. Surgical staplers, for exemplary purposes only, are disclosed in the following U.S. patents: U.S. Patent 4,805,823, entitled "Pocket Configuration for Internal Organ Staplers," issued on February 21, 1989; U.S. Patent 5,415,334, entitled "Surgical Stapler and Staple Cartridge," issued on May 16, 1995; U.S. Patent 5,465,895, entitled "Surgical Stapler Instrument," issued on November 14, 1995; U.S. Patent 5,597,107, entitled "Surgical Stapler Instrument," issued on January 28, 1997; U.S. Patent 5,632,432, entitled "Surgical Instrument," issued on May 27, 1997; U.S. Patent 5,632,432, entitled "Surgical Instrument," issued on October 7, 1997; U.S. Patent 5,632,432, entitled "Surgical Stapler Instrument," issued on October 7, 1997; U.S. Patent 5,632,432, entitled "Surgical Stapler Instrument," issued on October 7, 1997; U.S. Patent 5,632,432, entitled "Surgical Stapler Instrument," issued on October 14 ... U.S. Patent No. 5,673,840, entitled "Instrument"; U.S. Patent No. 5,704,534, entitled "Articulation Assembly for Surgical Instruments", issued on January 6, 1998; U.S. Patent No. 5,814,055, entitled "Surgical Clamping Mechanism", issued on September 29, 1998; U.S. Patent No. 6,978,921, entitled "Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism", issued on December 27, 2005; U.S. Patent No. 7,000,818, entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems", issued on February 21, 2006; U.S. Patent No. 7,143,923, entitled "Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil", issued on December 5, 2006;U.S. Patent No. 7,303,108, published on December 4, 2007, entitled “Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack”; U.S. Patent No. 7,367,485, published on May 6, 2008, entitled “Surgical Stapling Instrument Incorporatinga Multistroke Firing Mechanism Having a Rotary Transmission”; U.S. Patent No. 7,380,695, published on June 3, 2008, entitled “Surgical Stapling Instrument Having a SingleLockout Mechanism for Prevention of Firing”; U.S. Patent No. 7,380,696, published on June 3, 2008, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism”; U.S. Patent No. 7,380,696, published on July 29, 2008, entitled “Surgical Stapling and Cutting Device”; U.S. Patent 7,404,508, entitled “Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout”, published on October 14, 2008; U.S. Patent 7,721,930, entitled “Disposable Cartridgewith Adhesive for Use with a Stapling Device”, published on May 25, 2010; U.S. Patent 8,408,439, entitled “Surgical Stapling Instrument with An Articulatable End Effector”, published on April 2, 2013;and U.S. Patent No. 8,453,914, entitled "Motor-Driven Surgical Cutting Instrument with Electric Actuator Directional Control Assembly," issued on June 4, 2013. The disclosure of each of the above-referenced U.S. patents is incorporated herein by reference. ;
[0003] Although the surgical stapler involved above is described as being used in endoscopic surgery, it should be understood that such surgical staplers can also be used in laparotomy and / or other non-endoscopic surgeries. By way of example only, in thoracic surgery, the surgical stapler can be inserted through thoracotomy and thus be located between the patient's ribs to reach one or more organs, and the thoracic surgery does not use a trocar as the conduit of the stapler. Such surgery may include using a stapler to cut off and close the blood vessels leading to the lungs. For example, before removing an organ from the chest cavity, the blood vessels leading to the organ can be cut off and closed by a stapler. Of course, the surgical stapler can be used in various other situations and operations.
[0004] Examples of surgical staplers that may be particularly suitable for use in thoracotomy are disclosed in the following U.S. patents: U.S. Patent 9,186,142, entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks,” issued on November 17, 2015; U.S. Patent 9,717,497, entitled “Lockout Feature for Movable Cutting Member of Surgical Instrument,” issued on August 1, 2017; U.S. Patent 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” issued on December 13, 2016; U.S. Patent 9,839,421, entitled “Jaw Closure Feature for End Effector of Surgical Instrument,” issued on December 12, 2017; U.S. Patent 9,839,421, entitled “Surgical Instrument with Articulation Lock having a Detenting Binary and U.S. Patent No. 9,808,248, entitled “Installation Features for Surgical Instrument End Effector Cartridge”, published on November 7, 2017. The disclosure of each of the above-referenced U.S. patent publications is incorporated herein by reference.
[0005] Additional surgical stapling instruments are disclosed in the following U.S. patents: U.S. Patent 8,801,735, entitled “Surgical Circular Stapler with Tissue Retention Arrangements”, published on August 12, 2014; U.S. Patent 8,141,762, entitled “Surgical Stapler Comprising a Staple Pocket”, published on March 27, 2012; U.S. Patent 8,371,491, entitled “Surgical End Effector Having Buttress Retention Features”, published on February 12, 2013; U.S. Patent 9,597,082, entitled “Method and Apparatus for Sealing End-to-End Anastomosis”, published on March 21, 2017; U.S. Patent 9,597,082, entitled “Rotary Powered Surgical Instruments with Multiple Degrees of U.S. Patent Publication No. 2013 / 0206813, entitled “Linear Stapler,” published on August 15, 2013; U.S. Patent Publication No. 2008 / 0169328, entitled “Buttress Material for Use with a Surgical Stapler,” published on July 17, 2008; U.S. Patent No. 9,848,871, entitled “Woven and Fibrous Materials for Reinforcing a Staple Line,” published on December 26, 2017; U.S. Patent No. 9,936,954, entitled “Devices and Methods for Sealing Staples in Tissue,” published on April 10, 2018; and U.S. Patent Publication No. 2016 / 0089146, entitled “Radially Expandable Staple Line,” published on March 31, 2016. The disclosures of each of the above-cited U.S. patents, U.S. patent publications, and U.S. patent applications are incorporated herein by reference.
[0006] In some cases, it may be desirable to equip surgical stapling instruments with buttress materials to enhance the mechanical fastening of tissue provided by staples. Such buttresses can prevent applied staples from pulling through tissue and can otherwise reduce the risk of tissue tearing at or near the site of applied staples.
[0007] While various surgical stapling instruments and associated components have been made and used, it is believed that no one prior to the inventor has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.
[0009] Figure 1 A perspective view of an exemplary buttress applicator and an exemplary end effector of a surgical stapler is shown, with the end effector proximate the buttress applicator;
[0010] Figure 2 Shows Figure 1 A perspective view of an end effector and a buttress applicator of , wherein the buttress applicator is positioned in the end effector;
[0011] Figure 3A Shows Figure 1 A cross-sectional end view of a portion of an end effector, wherein Figure 1 applying a buttress assembly to an end effector, wherein tissue is positioned between the buttresses in the end effector, and wherein the anvil is in an open position;
[0012] Figure 3B Shows Figure 3A a cross-sectional end view of a combined end effector and buttress assembly of wherein tissue is positioned between buttresses in the end effector and wherein the anvil is in a closed position;
[0013] Figure 3C Shows that it has passed Figure 1 The end effector is fixed to the tissue by a staple and Figure 3A A cross-sectional view of a support assembly;
[0014] Figure 4 Shows that it has passed Figure 1 The end effector is fixed to the tissue by a staple and Figure 3A A perspective view of a support assembly;
[0015] Figure 5 Shows that Figure 1 A perspective view of another exemplary support applicator for use with an end effector of;
[0016] Figure 6 Shows Figure 5 An exploded view of a support application device;
[0017] Figure 7 Shows Figure 5 a top plan view of a support assembly;
[0018] Fig. 8A Shown along Figure 7 The line 8A-8A is intercepted Figure 7 a cross-sectional view of a support assembly;
[0019] Figure 8B Shown along Figure 7 The line 8B-8B is intercepted Figure 7 a cross-sectional view of a support assembly;
[0020] Figure 8C Shown along Figure 7 The line 8C-8C is intercepted Figure 7 a cross-sectional view of a support assembly;
[0021] Fig.8D Shown along Figure 7 The line 8D-8D is intercepted Figure 7 a cross-sectional view of a support assembly;
[0022] Fig. 8E Shown along Figure 7 The line 8E-8E intercepts Figure 7 a cross-sectional view of a support assembly;
[0023] Fig.8F Shown along Figure 7 The line 8F-8F is intercepted Figure 7 a cross-sectional view of a support assembly;
[0024] Figure 8G Shown along Figure 7 The line 8G-8G is intercepted Figure 7 a cross-sectional view of a support assembly;
[0025] Fig. 9 shows a top plan view of an exemplary buttress assembly configured for use with a circular surgical stapler;
[0026] Fig.10 Shows Figure 1 A cross-sectional view of a staple cartridge of an end effector;
[0027] Fig.11 shows a top plan view of another exemplary buttress assembly illustrating an exemplary asymmetric adhesive distribution;
[0028] Fig.12 A side elevation view of an end effector of a surgical stapler is shown in an open position showing a stapler released from the jaws of the end effector. Fig.11 Support components;
[0029] Fig.13 showing a top plan view of another exemplary buttress assembly illustrating another exemplary asymmetric adhesive distribution; and
[0030] Fig.14 Shown in open position Fig.12 A side elevation view of an end effector of a surgical stapler showing a stapler released from the jaws of the end effector Fig.13 Support components.
[0031] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be performed in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION
[0032] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. According to the following description shown by way of example, other examples, features, aspects, embodiments and advantages of the present invention will be apparent to those skilled in the art, and a best mode is contemplated for implementing the present invention. As will be appreciated, the present invention can have other different and obvious aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative and non-restrictive in nature.
[0033] I. Exemplary Support Loading and Application
[0034] Figure 1 and Figure 2 An exemplary end effector (40) configured to apply a buttress to a tissue site for performing a cutting and stapling operation is shown. The end effector (40) is connected to the shaft assembly (30). The end effector (40) includes an anvil (60), a lower jaw (50), and a staple cartridge (70) received by the lower jaw (50).
[0035] Figure 1 and Figure 2An exemplary support applicator (200) is also shown. Support applicator (200) is configured to selectively retain support assemblies (100, 110). In this example, support assembly (100) is selectively retained on the top side of applicator (200), and support assembly (110) is selectively retained on the bottom side of applicator (200). In some other versions, applicator (200) may be configured so that only one support assembly (100, 110) is selectively retained by support applicator (200).
[0036] To load the buttress assembly (100, 110) for the end effector (40) using the buttress applicator (200), the operator will first position the applicator (200) and the end effector (40) so that the end effector (40) is aligned with the open end (202) of the applicator (200), such as Figure 1 The operator will then advance the end effector (40) distally (and / or retract the applicator (200) proximally to position the buttress assembly (100, 110) between the anvil (60) and the staple cartridge (70), as shown. Figure 2As shown. To load the buttress assembly (100, 110) onto the end effector (40), the operator can simply close the end effector (40) by pivoting the staple cartridge (70) toward the anvil (60). Closing of the end effector (40) causes the distal ends of the anvil (60) and the staple cartridge (70) to abut against a retaining feature of the buttress applicator (200), which is configured to selectively retain the buttress assembly (100, 110) with the buttress applicator (200). This contact deflects such retaining features of the buttress applicator (200), thereby allowing contact between the surface of the anvil (60) and the buttress assembly (100) on one side of the buttress applicator (200), and contact between the surface of the staple cartridge (70) and the buttress assembly (110) on the other side of the buttress applicator (200). The buttress assemblies (100, 110) include adhesive on their respective surfaces so that when the end effector (40) is clamped on the two buttress assemblies (100, 110), the buttress assemblies (100, 110) are adhered to the underside of the anvil (60) and the platform surface of the staple cartridge (70), respectively. The end effector (40) can then be reopened (i.e., the anvil (60) is pivoted away from the staple cartridge (70)) and pulled away from the buttress applicator (200). With the retaining features of the applicator (200) disengaged from the buttress assemblies (100, 110), the end effector (40) can freely pull the buttress assemblies (100, 110) away from the buttress applicator (200) when the end effector (40) is pulled away from the buttress applicator (200). With buttress assemblies (100, 110) loaded onto end effector (40), end effector (40) may then be used as described below with reference to FIG. 3A to FIG. 4 Further described.
[0037] FIG. 3A to FIG. 3C The sequence of an end effector (40) loaded with a buttress assembly (100, 110) being actuated to drive a staple (90) through two juxtaposed tissue layers (T1, T2) is shown, wherein the buttress assembly (100, 110) is secured to the same tissue layer (T1, T2) by the staple (90). Specifically, Figure 3A The present invention shows tissue layers (T1, T2) positioned between anvil (60) and staple cartridge (70), wherein anvil (60) is in an open position. As shown, anvil (60) includes staple forming recesses (64). Support assembly (100) is adhered to the underside (65) of anvil (60) via an adhesive; and support assembly (110) is adhered to the platform (73) of staple cartridge (70) via an adhesive. Thus, tissue layers (T1, T2) are interposed between support assemblies (100, 110). Next, the end actuator (40) is closed, which drives the anvil (60) to a position such as Figure 3B , and the staple cartridge (70) is shown in the closed position. At this stage, the tissue layers (T1, T2) are compressed between the anvil (60) and the staple cartridge (70), wherein the buttress assemblies (100, 110) engage opposing surfaces of the tissue layers (T1, T2). The end effector (40) is then actuated, whereby the staple driver (75) drives the staples (90) through the buttress assemblies (100, 110) and the tissue layers (T1, T2). Figure 3C As shown, the crown (92) of the driven staple (90) captures and holds the buttress assembly (110) against the tissue layer (T2). The deformed leg (94) of the staple (90) captures and holds the buttress assembly (100) against the tissue layer (T1).
[0038] It should be appreciated that series of staples (90) will similarly capture and hold buttress assembly (100, 110) against tissue layers (T1, T2), thereby securing buttress assembly (100, 110) to tissue (T1, T2), such as Figure 4 As shown. Because the end effector (40) is pulled away from the tissue (90) after the deployment of the staples (90) and the support assembly (100, 110), the support assembly (100, 110) is disengaged from the end effector, so that the support assembly (100, 110) remains fixed to the tissue (T1, T2) with the staples (90). Therefore, the support assembly (100, 110) provides structural reinforcement for the rows of staples (90). In addition, as shown Figure 4 It can be seen that the knife member (not shown) passes through the end actuator (40) and in doing so also cuts through the centerline of the support assembly (100, 110), thereby dividing each support assembly (100, 110) into a corresponding pair of segments, so that each segment remains fixed to the corresponding severed area of the tissue (T1, T2).
[0039] In the above examples, the buttress assembly (100) is sized to span the entire width of the underside (65) of the anvil (60) so that the knife member (not shown) cuts through the buttress assembly (100) during actuation of the end effector (40). In some other examples, the buttress assembly (100) is disposed in two separate laterally spaced portions, one of which is disposed on the underside (65) of the anvil (60) on one half of the anvil (60) and the other portion is disposed on the underside (65) of the anvil (60) on the other half of the anvil (60). In this type of arrangement, the knife member (not shown) does not cut through the buttress assembly (100) during actuation of the end effector (40).
[0040] Likewise, buttress assembly (110) may be sized to span the entire width of platform (73) such that a knife member (not shown) cuts through buttress assembly (110) during actuation of end effector (40). Alternatively, buttress assembly (110) may be disposed in two separate laterally spaced apart portions, with one portion disposed on one half of platform (73) and the other portion disposed on the other half of platform (73). In this type of arrangement, knife member (not shown) does not cut through buttress assembly (110) during actuation of end effector (40).
[0041] In addition to the above, it should be understood that any of the various support components described herein may be further constructed and operated according to at least some of the teachings of the following patent publication: U.S. Patent Publication 2016 / 0278774, entitled "Method of Applying a Buttress to a Surgical Stapler," published on September 29, 2016, the disclosure of which is incorporated herein by reference.
[0042] II. Exemplary Support Application Devices
[0043] Figure 5 and Figure 6 An alternative buttress applicator (300) for use with an end effector (40) is shown. The buttress applicator (300) includes a first housing portion (302) and a second housing portion (304). Each of the housing portions (302, 304) is connected to a frame (306). A compression pad (308) is configured to fit within a central portion (310) of the frame (306). A first pair of clamping arms (312) is located on a first side of the frame (306) between the frame (306) and the housing portion (302). A second pair of clamping arms (314) is located on a second side of the frame (306) between the frame (306) and the housing portion (304). In this version, the clamping arms (312) include a left clamping arm (311) and a right clamping arm (313). Similarly, the clamping arms (314) include a left clamping arm (311) and a right clamping arm (313). The buttress assemblies (316, 318) are located on respective sides of the compression pad (308), and when the buttress applicator (300) is fully assembled, the pair of clamping arms (312, 314) selectively hold the buttress assemblies (316, 318) against the compression pad (308). In this example, the buttress assemblies (316, 318) are identical, with each buttress assembly including an adhesive (320) located on a buttress (322), as will be described in more detail below.
[0044] Buttress applicator (300) may be used with end effector (40) in the same manner as described above with respect to buttress applicator (200). For example, buttress assembly (316, 318) is loaded into end effector (40) in the same manner as described above, wherein once anvil (60) and lower jaw (50) are positioned over central portion (310) of frame (308), end effector (40) is moved to a closed or clamped position, e.g., as Figure 2 More specifically, the clamping action of the end effector (40) when it is above the buttress assembly (316, 318) and the compression pad (308) causes the anvil (60) and the staple cartridge (70) of the lower jaw (50) to contact the retaining feature (324) on the left clamp arm (311) and the retaining feature (325) on the right clamp arm (313). This contact drives the clamp arms (311, 313) laterally away from the buttress assembly (316, 318), thereby disengaging the retaining features (324, 325) from the buttress assembly (316, 318). With the retaining features (324, 325) disengaged, the adhesive (320) of the buttress assembly (316) contacts either the underside (65) of the anvil (60) or the platform (73) of the staple cartridge (70), while the adhesive (320) of the buttress assembly (318) contacts the other of the underside (65) of the anvil (60) or the platform (73) of the staple cartridge (70), depending on the clamping orientation used with the end effector (40). This causes the buttress assemblies (316, 318) to be attached to the end effector (40) and to remain with the end effector (40) when the end effector is opened and moved away from the buttress applicator (300). From this point on, the buttress assemblies (316, 318) can be applied to a tissue site for cutting and suturing, as described above with respect to Figure 4 Said and shown.
[0045] III. Exemplary Support Components
[0046] Figure 7 A support assembly (316) is shown, it being understood that support assembly (318) is identical. As described above, support assembly (316) includes a support (322) and an adhesive (320) located on one side of support (322). Support (322) includes one or more material layers. Where multiple layers are used, the layers may be laminated together. In some examples, support (322) includes a mesh layer and one or more film layers laminated together. In some other examples, support (322) includes one or more film layers without a mesh layer. Various other materials for one or more layers of support (322) will be apparent to one of ordinary skill in the art in light of the teachings herein.
[0047] In this example, buttress (322) is comprised of an absorbable material that is configured to be completely absorbed by the patient's body when used to reinforce a cut and suture site. In some examples, buttress (322) is comprised of poly(lactic-co-glycolic acid) 910, which is 90% glycolide and 10% L-lactide. Examples of poly(lactic-co-glycolic acid) 910 are manufactured by Ethicon Inc. under the trade name Manufacturing. Other absorbable synthetic materials for use with buttress (322) will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0048] A. Exemplary Adhesive Placement
[0049] The support (322) includes a first surface (326) and a second surface (328) opposite the first surface (326). The support also includes a proximal end (330) and a distal end (332). Figure 4 and Figure 5 As can be seen, the support assembly (316) is held by the applicator (300) so that when the support assembly (316, 318) is loaded into the end effector (40), the distal end (332) of the support (322) is aligned with the distal end (41) of the end effector (40). With this configuration, the support (322) defines a length extending from the proximal end (330) to the distal end (332). The support (322) also defines a longitudinal axis (A1) extending between the proximal end (330) and the distal end (332). The support (322) includes a first edge region (334), a second edge region (336), and a center region (338) located between the first edge region (334) and the second edge region (336) and separating the first edge region and the second edge region. The support (322) defines a width extending orthogonally to its length as defined above, wherein its width extends from the first edge region (334) across the central region (338) and through the second edge region (336).
[0050] In this example, adhesive (320) is applied to a first surface (326) of support (322). In some other versions of support assembly (316), adhesive (320) may be applied to a second surface (328) of support (322). Returning to this example, adhesive (320) extends from a proximal end (330) to a distal end (332) of support (322). Furthermore, in this example, adhesive (320) extends continuously or in an uninterrupted manner. Figure 7As shown, adhesive (320) is positioned along a first edge region (334) and a second edge region (336), wherein a central region (338) is substantially free of adhesive (320). As will be further described below, adhesive (320) is applied to the buttress in a manner such that the adhesive (320) has a height that causes the adhesive (320) to protrude beyond the buttress (322). The height of the adhesive (320) is configured to facilitate good contact of the adhesive (320) with the underside (65) of the anvil (60) of the end effector (40) or the platform (73) of the staple cartridge (70) of the end effector (40), depending on the orientation of the end effector (40) when loading the buttress assembly (316).
[0051] The continuous nature of the adhesive (320) together with the height of the adhesive (320) is used to seal the edge of the buttress (322) to the portion of the end effector (40) to which the buttress (322) is attached. For example, where the buttress assembly (316) is located on the anvil (60) side of the end effector (40), the continuous adhesive (320) having its height forms a seal along the edge of the buttress (322) of the buttress assembly (316), wherein the adhesive (320) contacts the underside (65) of the anvil (60). Similarly, where the buttress assembly (318) is located on the staple cartridge (70) side of the end effector (40), the continuous adhesive (320) having its height forms a seal along the edge of the buttress (322) of the buttress assembly (318), wherein the adhesive (320) contacts the platform (73) of the staple cartridge (70). With this sealed attachment, the amount of moisture that can reach the buttress assembly (316) during use is reduced. For example, moisture is sealed out of the interior of buttress assembly (316), which keeps at least a portion of adhesive (320) free of moisture. By controlling moisture migration in this manner, buttress assemblies (316, 318) can have a longer attachment time with end effector (40). This can provide a user with more time to position and manipulate end effector (40) prior to performing cutting and stapling actions, thereby applying buttress (322) as a reinforcement structure to the cutting and stapling site.
[0052] See also Fig. 9, which shows an exemplary support component (416), the above-mentioned sealing attachment may also be applicable to a support component configured to be used with a circular surgical stapler. For example, the support component (416) has a circular shape and is configured to be used with a circular surgical stapler. The support component (416) includes a support (422) and an adhesive (420). As shown, the adhesive (420) is applied to the support (422) in a concentric circle pattern. In this way, as will be understood by those of ordinary skill in the art with reference to the teachings of this article, the outer adhesive ring (424) forms a sealing attachment with the end actuator component of the circular stapler. This slows down or prevents moisture from contacting most of the support component (416) (including the inner adhesive ring (426)) in the same or similar manner as described above with respect to the support component (316,318).
[0053] B. Exemplary Adhesive Patterns and Distributions
[0054] Still see Figure 7 , and now also see FIG. 8A to FIG. 8G Additional details regarding the support components (316, 318) are described below with respect to the adhesive (320) and its pattern and amount. Figure 7 As shown, the central region (338) of the support (322) includes a slit (340). In the illustrated version, the slit (340) includes a proximal slit (342), a distal slit (344), and an intermediate slit (346) located between the proximal slit and the distal slit (342, 344). The slit (340) is configured to facilitate or facilitate the cutting and separation of the support (322) into substantially equal halves during the cutting and suturing operations as described above. As shown in this example, the support assembly (316, 318) includes slits (342, 344) located at both the proximal end (330) and the distal end (332) of the support (322), wherein these slits (342, 344) extend all the way to the respective ends of the support (322). This configuration helps to ensure complete cutting and separation of the support (322) at its ends during the cutting and suturing sequence. Also in this example, the longitudinal axis (A1) passes through the slit (340), and on each side of the central region (338), the adhesive (320) defines a pattern that is substantially symmetrical to the other side about the longitudinal axis (A1).
[0055] Consider now the adhesive (320) as applied to the first edge region (334), the adhesive (320) comprising a first line (348) and a second line (350). Each line (348, 350) of adhesive generally extends from the proximal end (330) of the support (322) to the distal end (332) of the support (322). FIG. 8A to FIG. 8GAs shown, the first line of adhesive (348) partially overlaps the second line of adhesive (350) along at least a portion of the length of the support (322). In other areas, the first line of adhesive (348) is spaced apart from the second line of adhesive (350) along at least a portion of the length of the support (322). Figure 7 As best shown, the second line of adhesive (350) extends further proximally than the first line of adhesive (348). In addition, the first and second lines of adhesive (348, 350) extend distally relative to the buttress (322) to substantially the same extent.
[0056] Consider now the adhesive (320) as applied to the second edge region (336), the adhesive (320) including a third line (352) and a fourth line (354). Each line (352, 354) of adhesive generally extends from the proximal end (330) of the support (322) to the distal end (332) of the support (322). FIG. 8A to FIG. 8G As shown, the third line of adhesive (352) partially overlaps the fourth line of adhesive (354) along at least a portion of the length of the support (322). In other areas, the third line of adhesive (352) is spaced apart from the fourth line of adhesive (354) along at least a portion of the length of the support (322). Figure 7 As best shown, the fourth line of adhesive (354) extends further proximally than the third line of adhesive (352). Furthermore, the third and fourth lines of adhesive (352, 354) extend distally to substantially the same extent relative to the buttress (322). As described above, the first and second lines of adhesive (348, 350) are co-symmetrical with the third and fourth lines of adhesive (352, 354) about a longitudinal axis (A1) defining a centerline of the buttress (322).
[0057] Consider now the adhesive (320) as applied at the proximal and distal ends (330, 332) of the support (322), in this example, an uneven distribution of the adhesive (320) is used. This uneven distribution of the adhesive (320) includes more adhesive at the distal end (332) of the support (322) than at the proximal end (330) of the support (322). In this example, this is the case when comparing the support (322) before being cut in half or when comparing the halves of the cut support (322). This uneven distribution of the adhesive (320) is at least partially formed by the second line (350) and the fourth line (354) of the adhesive extending further proximally into the proximal end (330) of the support (322) than the first line (348) and the third line (352) of the adhesive, respectively. And further, at the distal end (332), both the first and second lines (348, 350) of adhesive and both the third and fourth lines (352, 354) of adhesive extend to the same extent. This arrangement results in more adhesive (320) at the distal end (332) compared to the proximal end (330) of the support (322). In examples similar to the present example where there is more adhesive (320) at the distal end (332) of the support (322), this helps the support (322) remain attached to and aligned with the corresponding portion of the end effector (40) when actively manipulating the end effector (40) (i.e., when piercing a stoma, sliding axially onto tissue, etc.).
[0058] As described above, the distal end (332) of the buttress (322) is aligned with the distal end (41) of the end effector (40). Because the distal end (41) of the end effector (40) is the first portion of the end effector (40) to contact tissue when the end effector (40) is positioned, the distal end (41) of the end effector (40) may be subjected to greater forces during use than the proximal end of the end effector (40). Therefore, having a stronger attachment of the buttress assembly (316, 318) at the distal end (41) of the end effector (40) may be beneficial in maintaining the attachment and alignment of the buttress assembly (316, 318) with the corresponding components of the end effector (40). One way to achieve such a stronger attachment at the distal end (332) of the buttress assembly (316, 318) is by placing more adhesive at the distal end (332) of the buttress (322). More adhesive (320) may be provided on a volume basis, a mass basis, a surface area or contact area basis, or an areal density basis. Other ways of providing a stronger attachment between buttress assemblies (316, 318) at distal end (332) and corresponding components at distal end (41) of end effector (40) will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0059] In use, the release of the buttress (322) from the end effector (40) is also a consideration. The buttress (322) should be released from the end effector (40) so that it is transferred to the tissue cutting and suturing site so that the buttress (322) can provide structural reinforcement to the site. Utilizing the clamping action of the jaws of the end effector (40), after the end effector (40) has been fired and is being opened to remove the end effector (40) from the cutting and suturing site, a large hole or opening exists at the distal end (41). Even if the buttress (322) initially has more adhesive (320) at its distal end (332) than its proximal end (330), this movement of the distal end (41) with the large hole or opening will enable the buttress (322) to be released from the distal end (41) of the end effector (40).
[0060] The adhesive pattern and distribution described above can be found in FIG. 8A to FIG. 8G , which shows a cross-section of adhesive (320) along the length of support (322). For example, Fig. 8A Taken along the proximal end (330) of the buttress assembly (316). Fig. 8A As shown, the second and fourth lines (350, 354) of adhesive extend further proximally than the first and third lines (348, 352) of adhesive. Fig. 8A Also evident is the proximal slit (342). Figure 7 and Fig. 8A As shown, support (322) comprises a taper at a proximal end (330) thereof, wherein the width of support (322) decreases as support (322) extends proximally.
[0061] Figure 8B An area is shown where a first line of adhesive (348) partially overlaps a second line of adhesive (350), and similarly where a third line of adhesive (352) partially overlaps a fourth line of adhesive (354). Figure 8B as well as Fig. 8A and FIG. 8C to FIG. 8G As shown in other views of FIG. 1 , the adhesive ( 320 ) is symmetrical about the longitudinal axis ( A1 ).
[0062] Figure 8C It is shown how, as adhesive (320) is examined further distally along the length of support (322), a first line of adhesive (348) is spaced from a second line of adhesive (350). Similarly, a third line of adhesive (352) is spaced from a fourth line of adhesive (354). Figure 8C As shown, the central region (338) is free of any slits in this example.
[0063] Fig.8D The adhesive pattern and distribution is shown approximately midway along the length of the support assembly (316, 318). Likewise, the first line of adhesive (348) partially overlaps the second line of adhesive (350), and similarly, the third line of adhesive (352) partially overlaps the fourth line of adhesive (354). Fig.8D and Figure 8B When compared, in the present example, the degree of adhesive overlap is greater approximately in the middle of the length of buttress components (316, 318), as evidenced by the greater width of the overlap.
[0064] Fig. 8E It shows that Figure 8C Similar arrangement as shown. Fig. 8E The only difference is that the slit (346) is along Fig. 8E The length shown divides the support (322) into two halves, and the central region (338) is along Figure 8C The lengths shown are without any slits.
[0065] Fig.8F It shows that Fig.8D Similar arrangement as shown. Fig.8F The only difference is that the central area (338) includes Fig.8F The distal slit (344) of the length shown, while the central region (338) includes a Fig.8DAn intermediate slit (346) of the length shown.
[0066] Figure 8G The adhesive (320) is shown at the distal end (332) of the support (322). Figure 7 and Figure 8G As shown, the second wiring (350) of the adhesive extends away from the central region (338) at the distal end (332) of the support (322). Similarly, the fourth wiring (354) of the adhesive extends away from the central region (338) at the distal end (332) of the support (322). In this example, the second wiring (350) of the adhesive extends away from the central region (338) so that the second wiring (350) of the adhesive is connected or in contact with the first wiring (348) of the adhesive at the distal end (332) of the support (322). In addition, the fourth wiring (354) of the adhesive extends away from the central region (338) so that the fourth wiring (354) of the adhesive is connected or in contact with the third wiring (352) of the adhesive at the distal end (332) of the support (322). Similarly, Figure 8G As shown, support (322) includes a gap (356) located at distal end (332), wherein gap (356) is aligned with central region (338). Figure 7 , in this example, there is also a gap ( 358 ) at the proximal end ( 330 ).
[0067] C. Exemplary Adhesive Heights
[0068] As described above, adhesive height is a feature or property that facilitates the attachment and release of the support (322) to the anvil (60) and nail magazine (70) components of the end actuator (40). In this regard, the height of the adhesive (320) is understood to be the distance that the adhesive (320) protrudes from the surface of the support (322) to which it is applied. In this example, the wiring (348, 350, 352, 354) of the adhesive has a minimum height. In one example, the minimum height is configured to approximate, match or exceed the height of the pit extension (74) on the platform (73) of the nail magazine (70). Fig.10A cross-sectional view of a type of staple cartridge (70) having a dimple extension (74) is shown. The dimple extension (74) protrudes above the platform (73) of the staple cartridge (70) and can assist in grasping tissue captured by the end effector (40). By configuring the adhesive strands (348, 350, 352, 354) to have a minimum height that approximates, matches, or exceeds the distance that the dimple extension (74) protrudes above the platform (73), the adhesive (320) can contact the surface of the dimple extension (74), but can also contact the surface of the platform (73) between the dimple extensions (74). This provides for good attachment of one of the support assemblies (316, 318) to the staple cartridge (70) during the support loading process, and increases retention of the support (322) to that component of the end effector (40) when working with and positioning the end effector (40). Although the dimple extension (74) and the end effector (40) are not necessarily identical, the adhesive (320) can be used to secure the staple cartridge (70) to the end effector (40). Fig.10 The illustrated version of staple cartridge (70) may be used together, however in other versions of staple cartridge (70), the dimple extension (74) is omitted so that the platform (73) is flat except for the opening for driving staples (90).
[0069] In one example, the adhesive wires (348, 350, 352, 354) have a height between about 0.010 inches (0.254 mm) and about 0.050 inches (1.27 mm). In another example, the adhesive wires (348, 350, 352, 354) have a height between about 0.016 inches (0.4064 mm) and about 0.030 inches (0.762 mm). Other heights of the adhesive wires (348, 350, 352, 354) will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0070] In another example of minimum adhesive height, the lines of adhesive (348, 350, 352, 354) have a minimum height that is configured to approximate, match, or exceed the depth of the staple forming pockets (64) of the anvil (60). By way of reference, the staple forming pockets (64) are FIG. 3A to FIG. 3B By configuring the adhesive wires (348, 350, 352, 354) to have a minimum height that approximates, matches, or exceeds the depth of the staple forming recesses (64), the adhesive (320) can contact the underside (65) of the anvil (60), but also extend into the staple forming recesses (64). This provides for good attachment of one of the buttress assemblies (316, 318) to the anvil (60) during the buttress loading process, and increases retention of the buttress (322) to that component of the end effector (40) when working with and positioning the end effector (40).
[0071] In some examples, similar to end effector (40) having anvil (60) and staple cartridge (70), the depth of staple forming pockets (64) of anvil (60) may be different than the distance that pocket extensions (74) protrude above platform (73) of staple cartridge (70). In such cases where buttress assemblies (316, 318) are identical, the lines of adhesive (348, 350, 352, 354) may be configured such that the minimum height is based on the greater distance. For example, in an example where the staple forming pocket (64) is shallower than the pocket extension (74) (such that the depth of the staple forming pocket (64) is less than the distance that the pocket extension (74) protrudes from the platform (73)), the adhesive connections (348, 350, 352, 354) can be configured such that the minimum height is based on the distance that the pocket extension (74) protrudes above the platform (73) because this distance is a greater distance than the depth of the staple forming pocket (64) of the anvil (60). In other versions, the buttress assemblies (316, 318) can be configured differently in terms of adhesive height to configure adhesive heights that are specific to the anvil side or the staple cartridge side of the end effector. However, by setting the minimum adhesive height based on the larger distance, good attachment and retention results can be obtained in a symmetrical configuration that allows the applicator (300) to be universal and not specific to any particular side of the end effector when the buttress assembly is loaded thereon.
[0072] In the present example where adhesive (320) is applied in a wire pattern, various adhesive heights can be achieved in a more efficient manner than applying a uniform adhesive spray across the entire surface of the support (322). This efficiency is achieved in terms of both material usage and cost. Additionally, while the above examples illustrate and describe adhesive heights with respect to linear pattern support assemblies (316, 318), adhesive heights can be varied with respect to circular supports such as Fig. 9 The support assembly (416) is controlled and constructed in the same manner.
[0073] D. Exemplary Asymmetric Adhesive Distribution
[0074] When loading buttress assemblies into end effectors and applying them to tissue cutting and stapling sites, in addition to good attachment and retention of the buttress assemblies to the end effectors, another consideration is the release of the buttress assemblies from the end effectors after the cutting and stapling operations are performed. For example, if the release is poor, the buttress assemblies may adhere to the end effectors instead of transferring to the tissue, or the buttress assemblies may bunch or fold instead of lying smoothly against the tissue site. See now Figures 11 to 14 , a buttress assembly is shown that uses an asymmetric adhesive distribution to achieve both desired attachment and retention and release of the buttress assembly.
[0075] Fig.11 A buttress assembly (516) having an asymmetric adhesive distribution is shown. Buttress assembly (516) is configured to be similar to buttress assemblies (316, 318) described above, except that it has a different adhesive application pattern. Therefore, two buttress assemblies (516) can be used in place of buttress assemblies (316, 318) described above. This includes use in place of buttress assemblies (316, 318) having an applicator (300) and an end effector (40).
[0076] exist Fig.11 In this example, the support assembly (516) includes a support (522) and an adhesive (520) located on one side of the support (522). The support (522) includes a first surface (526) and a second surface opposite to the first surface (526). The support also includes a proximal end (530) and a distal end (532). As with the support assembly (316, 318), when the support assembly (516) is attached to the end effector (40), the distal end (532) of the support (522) is aligned with the distal end (41) of the end effector (40). With this configuration, the support (522) defines a length extending from the proximal end (530) to the distal end (532). The support (522) also defines a longitudinal axis (A2) extending between the proximal end (530) and the distal end (532). The support (522) includes a first edge region (534), a second edge region (536), and a central region (538) located between and separating the first edge region (534) and the second edge region (536). The support (522) defines a width extending orthogonally to its length as defined above, wherein its width extends from the first edge region (534) across the central region (538) and through the second edge region (536).
[0077] In this example, adhesive (520) is applied to a first surface (526) of a support (522). Adhesive (520) extends from a proximal end (530) of the support (522) to a distal end (532). In addition, in this example, at least a portion of adhesive (520) extends continuously or in an uninterrupted manner. Adhesive (520) is positioned along a first edge region (534) and a second edge region (536), wherein a central region (538) is substantially free of adhesive (520). As described above, adhesive (520) is applied to the support in a manner such that adhesive (520) has a height that causes adhesive (520) to protrude from the support (522). The height of the adhesive (520) is configured to facilitate good contact between the adhesive (520) and the underside (65) of the anvil (60) of the end actuator (40) or the platform (73) of the nail magazine (70) of the end actuator (40), depending on the orientation of the end actuator (40) when the support assembly (516) is loaded onto the end actuator (40) using the application device (300).
[0078] The continuous nature of the adhesive (520) along with the height of the adhesive (520) serves to seal the edge of the buttress (522) to the portion of the end effector (40) to which the buttress (522) is attached. With this sealed attachment, the amount of moisture that can reach the buttress assembly (516) is reduced during use. By controlling moisture migration in this manner, the buttress assembly (516) can have a longer attachment time to the end effector (40). This can provide the user with more time to position and manipulate the end effector (40) before performing cutting and stapling actions, thereby applying the buttress (522) as a reinforcement structure to the cutting and stapling site.
[0079] Still see Fig.11 , the central region (538) of the buttress (522) includes a slit (540) that is structurally and functionally identical to the slit (340) of the buttress assembly (316, 318). In the illustrated version, the slit (540) includes a proximal slit (542), a distal slit (544), and an intermediate slit (546) located between the proximal and distal slits (542, 544). In this example, the longitudinal axis (A2) passes through the slit (540), and on each side of the central region (538), the adhesive (520) defines a pattern that is asymmetric about the longitudinal axis (A2) from the other side. The adhesive (520) is further asymmetric about a lateral axis (A3) that extends orthogonally to the longitudinal axis (A2) through the midpoint of the buttress assembly (516), as measured between the proximal end and the distal end (330, 332).
[0080] Consider now the adhesive (520) as applied to the first edge region (534), the adhesive (520) comprising a first line (548) and a second line (550). Each line (548, 550) of adhesive generally extends from the proximal end (530) of the support (522) to the distal end (532) of the support (522). The first line (548) of adhesive partially overlaps the second line (550) of adhesive along at least a portion of the length of the support (522), specifically in this example, near the proximal end (530) and near a mid-region along the length of the support (522), as shown in FIG. Fig.11 As shown. In other areas, the first line (548) of adhesive is spaced apart from the second line (550) of adhesive along at least a portion of the length of the support (522). The second line (550) of adhesive extends further toward the proximal side than the first line (548) of adhesive. In addition, the first and second lines (548, 550) of adhesive extend to substantially the same extent toward the distal side relative to the support (522). The first line (548) of adhesive is discontinuous near the distal end (532) of the support (522), wherein there is a space or gap (560) in the first line (548) of adhesive. In contrast, the second line (550) of adhesive extends continuously from the proximal end (530) of the support (522) to the distal end (532).
[0081] Now consider the adhesive (520) as applied to the second edge region (536), the adhesive (520) includes a third wire (552) and a fourth wire (554). Each wire (552, 554) of the adhesive generally extends from the proximal end (530) of the support (522) to the distal end (532) of the support (522). The third wire (552) of the adhesive partially overlaps the fourth wire (554) of the adhesive along at least a portion of the length of the support (522), specifically in this example, near the distal end (532) and near the middle region along the length of the support (522). In other areas, the third wire (552) of the adhesive is spaced apart from the fourth wire (554) of the adhesive along at least a portion of the length of the support (522). Compared to the third wire (552) of the adhesive, the fourth wire (554) of the adhesive extends farther toward the proximal side. In addition, the third and fourth lines of adhesive (552, 554) extend distally to substantially the same extent relative to the support (522). In this example, although the third and fourth lines of adhesive (552, 554) have different shapes or patterns, both extend continuously from the proximal end (530) of the support (522) to the distal end (532).
[0082] As described above, the first and second lines of adhesive (548, 550) are asymmetric with the third and fourth lines of adhesive (552, 554) about the longitudinal axis (A2) and the lateral axis (A3). Also as described above, the support (522) is configured to be cut into two halves about the longitudinal centerline of the support (522). The first half of the cut support (522) will include approximately half of the central area (538) and the first edge area (534), while the second half of the cut support (522) will include approximately the other half of the central area (538) and the second edge area (536).
[0083] Consider now the adhesive (520) as applied at the proximal and distal ends (530, 532) of respective halves of a support (522), in this example, an uneven distribution of adhesive (520) is used. Relative to a first half of the cut support (522), there is more adhesive (520) at the proximal end (530) of the support (522) than at the distal end (532) of the support (522). However, relative to a second half of the cut support (522), there is more adhesive (520) at the distal end (532) of the support (522) than at the proximal end (530) of the support (522). See Fig.11 , these differences in the amount of adhesive (520) are shown by the circled areas, where the first region (R1) has more adhesive (520) than the second region (R2).
[0084] When two buttress assemblies (516) are used, each buttress assembly (516) is oriented relative to each other when applied to the end effector (40), with the first surfaces (526) containing the adhesive (520) facing away from each other. In this arrangement, the first edge region (534) of the buttress assembly (516) attached to the anvil (60) will be located above and aligned with the second edge region (536) of the buttress assembly (516) attached to the staple cartridge (70). Similarly, the second edge region (536) of the buttress assembly (516) attached to the anvil (60) will be located above and aligned with the first edge region (534) of the buttress assembly (516) attached to the staple cartridge (70). In this arrangement, the first region (R1) having more adhesive (520) will be oriented relative to and aligned with the second region (R2) having less adhesive (520). By way of example only, at the proximal end (530), the buttress assembly (516) attached to the anvil (60) will have a first region (R1) that is positioned and aligned relative to a second region (R2) of another buttress assembly (516) attached to the staple cartridge (70). Similarly, and still at the proximal end (530), the buttress assembly (516) attached to the anvil (60) will have a second region (R2) that is positioned and aligned relative to the first region (R1) of another buttress assembly (516) attached to the staple cartridge (70). At the distal end (532), the buttress assembly (516) attached to the anvil (60) will have a second region (R2) that is positioned and aligned relative to the first region (R1) of another buttress assembly (516) attached to the staple cartridge (70). Similarly, and still at the distal end (532), the buttress assembly (516) attached to the anvil (60) will have a first region (R1) that is positioned and aligned relative to a second region (R2) of another buttress assembly (516) attached to the nail magazine (70).
[0085] When considering the buttress assembly (516) before it is cut in half, in this example, there are two first regions (R1) of the buttress assembly (516) attached to the anvil (60) side of the end effector (40). One such first region (R1) is located within a first edge region (534) at the proximal end (530), and the other first region is located within a second edge region (536) at the distal end (532). This is the same relative to the buttress assembly (516) on the staple cartridge (70) side attached to the end effector (40). When the end effector (40) is actively manipulated (i.e., when piercing a stoma, sliding axially onto tissue, etc.), these first regions (R1) with more adhesive help the buttress (522) remain attached to and aligned with the corresponding portion of the end effector (40). Furthermore, since buttress assembly (516) has not yet been cut, these areas of more adhesive serve to attach and hold together the entire buttress assembly (516) and its corresponding portion of end effector (40).
[0086] Still considering the buttress assembly (516) before it is cut in half, in this example, there are two second regions (R2) of the buttress assembly (516) attached to the anvil (60) side of the end effector (40). One such second region (R2) is located within the first edge region (534) at the proximal end (530), and the other second region is located within the second edge region (536) at the distal end (532). This is the same relative to the buttress assembly (516) on the nail magazine (70) side attached to the end effector (40). These second regions (R2) with less adhesive help to properly release the buttress (522) from the end effector (40) after the cutting and stapling operation. However, because the buttress assembly (516) has not yet been cut, these less adhesive regions are still attached and retained on their corresponding portions of the end effector (40) in part due to those first regions (R1) with more adhesive (520), as described above.
[0087] See also Fig.12, shows a side view of the end effector (40) during an exemplary opening operation after a cutting and stapling action, and thus after the buttress assembly (516) has been cut in half. Utilizing the asymmetric distribution of the adhesive (520) described above, when the end effector (40) is opened after cutting and stapling, the first region (R1) having more adhesive (520) and the second region (R2) having less adhesive (520) have relatively reduced adhesive attachment to corresponding surfaces on the anvil (60) and the staple cartridge (70). For example, when the end effector (40) is opened after a cutting and stapling action, the second region (R2) having less adhesive (520) is separated or released from the end effector (40) before the first region (R1) having more adhesive (520). As described above, prior to buttress assembly (516) being cut in half, buttress assembly (516) operates as a unit and thus the combined first region (R1) having more adhesive provides attachment and retention of buttress assembly (516). However, once buttress assembly (516) is cut in half, this will change as the second region (R2) will now be released from end effector (40).
[0088] For ease of explanation, Fig.12 The end effector (40) is shown loaded with a single buttress assembly (516) on the staple cartridge (70) side, wherein a cutting and stapling operation has occurred such that the knife of the end effector (40) has cut the buttress assembly (516) in half. Fig.12 , the first half (562) and the second half (564) of the support assembly (516) are shown with their attachment and release profiles. The first half (562) represents half of the central region (538) and the first edge region (534), as shown in FIG. Fig.11 As shown. As shown, the first half (562) has a first region (R1) having more adhesive (520) located at the proximal end of the staple cartridge (70). Therefore, when the end actuator (40) is initially opened, the first half (562) remains attached to the staple cartridge (70) near the proximal end of the staple cartridge (70). The first half (562) has a second region (R2) having less adhesive (520) located at the distal end of the staple cartridge (70). Therefore, when the end actuator (40) is initially opened, the first half (562) is released from the staple cartridge (70) near the distal end of the staple cartridge (70). The second half (564) represents half of the center region (538) and the second edge region (536), as shown Fig.11As shown. As shown, the second half (564) has a first region (R1) having more adhesive (520) located at the distal end of the staple cartridge (70). Therefore, when the end actuator (40) is initially opened, the second half (564) remains attached to the staple cartridge (70) near the distal end of the staple cartridge (70). The second half (564) has a second region (R2) having less adhesive (520) located at the proximal end of the staple cartridge (70). Therefore, when the end actuator (40) is initially opened, the second half (564) is released from the staple cartridge (70) near the proximal end of the staple cartridge (70). For the buttress assembly (516) loaded onto the anvil (60), this attachment and release pattern after cutting and suturing will also be apparent on the anvil (60) side of the end actuator (40).
[0089] In addition to the above-mentioned differences in adhesive (520), another factor that contributes to the release of support assembly (516) from end effector (40) is the large aperture or large movement of the distal end (41) of end effector (40) when it opens after the cutting and stapling action. This large range of movement of the distal end (41) of end effector (40) also accommodates the fact that after the cutting and stapling action, the two opposing halves of the two support assemblies (516) are now sutured together with the tissue between them. Therefore, these factors provide for the release of support assembly (516) even at the first region (R1) with more adhesive adhering support assembly (516) to the corresponding portion of end effector (40).
[0090] See now Fig.13 and Fig.14 , Fig.13 A buttress assembly (616) having another exemplary asymmetric adhesive distribution is shown. Buttress assembly (616) is configured to be similar to buttress assemblies (316, 318) described above, except that it has a different adhesive application pattern. Therefore, two buttress assemblies (616) can be used to replace buttress assemblies (316, 318) described above. This includes use in place of buttress assemblies (316, 318) having an applicator (300) and an end effector (40).
[0091] exist Fig.13In this example, the support assembly (616) includes a support (622) and an adhesive (620) located on one side of the support (622). The support (622) includes a first surface (626) and a second surface opposite to the first surface (626). The support also includes a proximal end (630) and a distal end (632). As with the support assembly (316, 318), when the support assembly (616) is attached to the end effector (40), the distal end (632) of the support (622) is aligned with the distal end (41) of the end effector (40). With this configuration, the support (622) defines a length extending from the proximal end (630) to the distal end (632). The support (622) also defines a longitudinal axis (A4) extending between the proximal end (630) and the distal end (632). The support (622) includes a first edge region (634), a second edge region (636), and a central region (638) located between and separating the first edge region (634) and the second edge region (636). The support (622) defines a width extending orthogonally to its length as defined above, wherein its width extends from the first edge region (634) across the central region (638) and through the second edge region (636).
[0092] In this example, the adhesive (620) is applied to a first surface (626) of a support (622). The adhesive (620) extends from a proximal end (630) of the support (622) to a distal end (632). In addition, in this example, at least a portion of the adhesive (620) extends continuously or in an uninterrupted manner. The adhesive (620) is positioned along a first edge region (634) and a second edge region (636), wherein a central region (638) is substantially free of the adhesive (620). As described above, the adhesive (620) is applied to the support in a manner such that the adhesive (620) has a height that allows the adhesive (620) to protrude from the support (622). The height of the adhesive (620) is configured to facilitate good contact between the adhesive (620) and the underside (65) of the anvil (60) of the end actuator (40) or the platform (73) of the nail magazine (70) of the end actuator (40), depending on the orientation of the end actuator (40) when the support assembly (616) is loaded onto the end actuator (40) using the application device (300).
[0093] The continuous nature of the adhesive (620) along with the height of the adhesive (620) serves to seal the edge of the buttress (622) to the portion of the end effector (40) to which the buttress (622) is attached. With this sealed attachment, the amount of moisture that can reach the buttress assembly (616) is reduced during use. By controlling moisture migration in this manner, the buttress assembly (616) can have a longer attachment time to the end effector (40). This can provide the user with more time to position and manipulate the end effector (40) before performing cutting and stapling actions, thereby applying the buttress (622) as a reinforcement structure to the cutting and stapling site.
[0094] Still see Fig.13 , the central region (638) of the buttress (622) includes a slit (640) that is structurally and functionally identical to the slit (340) of the buttress assembly (316, 318). In the illustrated version, the slit (640) includes a proximal slit (642), a distal slit (644), and an intermediate slit (646) located between the proximal and distal slits (642, 644). In this example, the longitudinal axis (A4) passes through the slit (640), and on each side of the central region (638), the adhesive (620) defines a pattern that is asymmetric about the longitudinal axis (A4) from the other side. The adhesive (620) is further asymmetric about a lateral axis (A5) that extends orthogonally to the longitudinal axis (A4) through the midpoint of the buttress assembly (616), as measured between the proximal end and the distal end (630, 632).
[0095] Consider now the adhesive (620) as applied to the first edge region (634), the adhesive (620) comprising a first line (648) and a second line (650). Each line (648, 650) of adhesive generally extends from the proximal end (630) of the support (622) to the distal end (632) of the support (622). The first line (648) of adhesive partially overlaps the second line (650) of adhesive along at least a portion of the length of the support (622), specifically in this example, near the proximal end (630), near a mid-region along the length of the support (622), and near the distal end (632), as shown in FIG. Fig.13As shown. In other areas, the first wiring (648) of the adhesive is spaced apart from the second wiring (650) of the adhesive along at least a portion of the length of the support (622). The second wiring (650) of the adhesive extends further toward the proximal side than the first wiring (648) of the adhesive. In addition, the first wiring and the second wiring (648, 650) of the adhesive extend to substantially the same extent toward the distal side relative to the support (622). In this example, although the first wiring and the second wiring (648, 650) of the adhesive have different shapes or patterns, both extend continuously from the proximal end (630) of the support (622) to the distal end (632).
[0096] Consider now the adhesive (620) as applied to the second edge region (636), the adhesive (620) including a third wiring (652) and a fourth wiring (654). Each wiring (652, 654) of the adhesive generally extends from the proximal end (630) of the support (622) to the distal end (632) of the support (622). The third wiring (652) of the adhesive partially overlaps the fourth wiring (654) of the adhesive along at least a portion of the length of the support (622), specifically in this example, near the distal end (632) and near the proximal end (630). In other areas, the third wiring (652) of the adhesive is spaced apart from the fourth wiring (654) of the adhesive along at least a portion of the length of the support (622). The fourth wiring (654) of the adhesive extends further toward the proximal side than the third wiring (652) of the adhesive. In addition, the third and fourth lines of adhesive (652, 654) extend distally to substantially the same extent relative to the support (622). The third line of adhesive (652) is discontinuous near the middle section of the support (622), wherein there is a space or gap (660) in the third line of adhesive (652). In contrast, the fourth line of adhesive (654) extends continuously from the proximal end (630) of the support (622) to the distal end (632).
[0097] As described above, the first and second lines of adhesive (648, 650) are asymmetric with the third and fourth lines of adhesive (652, 654) about the longitudinal axis (A4) and the lateral axis (A5). Also as described above, the support (622) is configured to be cut into two halves about the longitudinal centerline of the support (622). The first half of the cut support (622) will include approximately half of the central area (638) and the first edge area (634), while the second half of the cut support (622) will include approximately the other half of the central area (638) and the second edge area (636).
[0098] Consider now the adhesive (620) as applied at the proximal and distal ends (630, 632) of respective halves of the support (622), in this example, an uneven distribution of adhesive (620) is used. With respect to the first half of the cut support (622), there is more adhesive (620) at the middle region of the support (622) than at the proximal and distal ends (630, 632) of the support (622). However, with respect to the second half of the cut support (622), there is more adhesive (620) at the proximal and distal ends (630, 632) of the support (522) than at the middle region of the support (622). See Fig.13 , these differences in the amount of adhesive (620) are shown by the circled areas, where the first region (R1) has more adhesive (620) than the second region (R2).
[0099] When two buttress assemblies (616) are used, each buttress assembly (616) is oriented relative to each other when applied to the end effector (40), with the first surfaces (626) containing the adhesive (620) facing away from each other. In this arrangement, the first edge region (634) of the buttress assembly (616) attached to the anvil (60) will be located above and aligned with the second edge region (636) of the buttress assembly (616) attached to the staple cartridge (70). Similarly, the second edge region (636) of the buttress assembly (616) attached to the anvil (60) will be located above and aligned with the first edge region (634) of the buttress assembly (616) attached to the staple cartridge (70). In this arrangement, the first region (R1) having more adhesive (620) will be oriented relative to and aligned with the second region (R2) having less adhesive (620). By way of example only, at the proximal end (630), the buttress assembly (616) attached to the anvil (60) will have a first region (R1) that is positioned and aligned relative to a second region (R2) of another buttress assembly (616) attached to the staple cartridge (70). Similarly, and still at the proximal end (630), the buttress assembly (616) attached to the anvil (60) will have a second region (R2) that is positioned and aligned relative to the first region (R1) of another buttress assembly (616) attached to the staple cartridge (70). At the distal end (632), the buttress assembly (616) attached to the anvil (60) will have a second region (R2) that is positioned and aligned relative to the first region (R1) of another buttress assembly (616) attached to the staple cartridge (70). Likewise, and still at the distal end (632), the buttress assembly (616) attached to the anvil (60) will have a first region (R1) that is positioned and aligned relative to a second region (R2) of another buttress assembly (616) attached to the staple cartridge (70). Near the intermediate region, the buttress assembly (616) attached to the anvil (60) will have a first region (R1) that is positioned and aligned relative to a second region (R2) of another buttress assembly (616) attached to the staple cartridge (70). Likewise, and still at the intermediate region, the buttress assembly (616) attached to the anvil (60) will have a second region (R2) that is positioned and aligned relative to a first region (R1) of another buttress assembly (616) attached to the staple cartridge (70).
[0100] When considering the buttress assembly (616) before it is cut in half, in this example, there are three first regions (R1) of the buttress assembly (616) attached to the anvil (60) side of the end effector (40). One such first region (R1) is located within a first edge region (634) at the middle region of the buttress (622), another first region (R1) is located within a second edge region (636) at the distal end (632), and another first region (R1) is also located within a second edge region (636) at the proximal end (630). This is the same relative to the buttress assembly (616) attached to the staple cartridge (70) side of the end effector (40). When the end effector (40) is actively manipulated (i.e., when piercing a stoma, sliding axially onto tissue, etc.), these first regions (R1) with more adhesive help the buttress (622) remain attached to and aligned with the corresponding portion of the end effector (40). Furthermore, since buttress assembly (616) has not yet been cut, these areas of more adhesive serve to attach and hold together the entire buttress assembly (616) and its corresponding portion of end effector (40).
[0101] Still considering the buttress assembly (616) before it is cut in half, in this example, there are three second regions (R2) of the buttress assembly (616) attached to the anvil (60) side of the end effector (40). One such second region (R2) is located within the first edge region (634) at the proximal end (630), another second region is located within the first edge region (634) at the distal end (632), and another second region is located within the second edge region (636) at the middle region of the buttress (622). This is the same relative to the buttress assembly (616) on the staple cartridge (70) side attached to the end effector (40). These second regions (R2) with less adhesive help to properly release the buttress (622) from the end effector (40) after the cutting and stapling operation. However, because the buttress assembly (616) has not yet been cut, these less adhesive regions remain attached and retained to their respective portions of the end actuator (40) due in part to those first regions (R1) having more adhesive (620), as described above.
[0102] See also Fig.14, shows a side view of the end effector (40) during an exemplary opening operation after a cutting and stapling action, and thus after the buttress assembly (616) has been cut in half. Utilizing the asymmetric distribution of the adhesive (620) described above, when the end effector (40) is opened after cutting and stapling, the first region (R1) having more adhesive (620) and the second region (R2) having less adhesive (620) have relatively reduced adhesive attachment to corresponding surfaces on the anvil (60) and the staple cartridge (70). For example, when the end effector (40) is opened after a cutting and stapling action, the second region (R2) having less adhesive (620) is separated or released from the end effector (40) before the first region (R1) having more adhesive (620). As described above, prior to buttress assembly (616) being cut in half, buttress assembly (616) operates as a unit and thus the combined first region (R1) having more adhesive provides attachment and retention of buttress assembly (616). However, once buttress assembly (616) is cut in half, this will change as the second region (R2) will now be released from end effector (40).
[0103] For ease of explanation, Fig.14 The end effector (40) is shown loaded with a single buttress assembly (616) on the staple cartridge (70) side, wherein a cutting and stapling operation has occurred such that the knife of the end effector (40) has cut the buttress assembly (616) in half. Fig.14 , the first half (662) and the second half (664) of the support assembly (616) are shown with their attachment and release profiles. The first half (662) represents half of the central region (638) and the first edge region (634), as shown in FIG. Fig.13 As shown, the first half (662) has a first region (R1) having more adhesive (620) located at the middle region of the staple cartridge (70). Thus, when the end effector (40) is initially opened, the first half (662) remains attached to the staple cartridge (70) near the middle region of the staple cartridge (70). The first half (662) has a second region (R2) having less adhesive (620) located at the proximal and distal ends of the staple cartridge (70). Thus, when the end effector (40) is initially opened, the first half (662) is released from the staple cartridge (70) near the proximal and distal ends of the staple cartridge (70).
[0104] The second half (664) represents half of the central area (638) and the second edge area (636), such as Fig.13As shown. As shown, the second half (664) has a first region (R1) having more adhesive (620) located at the proximal and distal ends of the staple cartridge (70). Therefore, when the end actuator (40) is initially opened, the second half (664) remains attached to the staple cartridge (70) near the proximal and distal ends of the staple cartridge (70). The second half (664) has a second region (R2) having less adhesive (620) located at the middle region of the staple cartridge (70). Therefore, when the end actuator (40) is initially opened, the second half (664) is released from the staple cartridge (70) near the middle region of the staple cartridge (70). For the buttress assembly (616) loaded onto the anvil (60), this attachment and release pattern after cutting and suturing will also be apparent on the anvil (60) side of the end actuator (40).
[0105] In addition to the above-mentioned differences in adhesive (620), another factor that contributes to the release of support assembly (616) from end effector (40) is the large aperture or large movement of the distal end (41) of end effector (40) when it opens after the cutting and stapling action. This large range of movement of the distal end (41) of end effector (40) also accommodates the fact that after the cutting and stapling action, the two opposing halves of the two support assemblies (616) are now sutured together with the tissue between them. Therefore, these factors provide for the release of support assembly (616) even at the first region (R1) with more adhesive adhering support assembly (616) to the corresponding portion of end effector (40).
[0106] As shown and described in the above examples, the asymmetric distribution of adhesive (520, 620) used on the buttress assembly (516, 616) allows the release force to be reduced or the force required to release the buttress assembly (516, 616) from the end actuator (40) after the buttress assembly (516, 616) is cut in half. This allows the buttress assembly (516, 616) to be configured to have a controlled release, wherein certain parts of the buttress assembly (516, 616) are configured to be able to release earlier or faster than other parts. In addition, the strategically positioned asymmetric adhesive distribution area provides sufficient attachment and retention of the uncut buttress assembly (516, 616). Although a variety of adhesive distributions have been shown and described herein, other adhesive distributions may also be used to achieve the desired attachment, retention and release characteristics of the buttress assembly described herein. With reference to the teachings of this article, such other adhesive distribution patterns for the buttress assembly described herein will be apparent to those of ordinary skill in the art.
[0107] IV. Exemplary Combinations
[0108] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or in the subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided only for illustrative purposes. It is expected that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive, unless otherwise, for example, by the inventor or the successor of the inventor concerned clearly indicates so at a later date. If any claim proposed in this patent application or in the subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.
[0109] Example 1
[0110] A support assembly for reinforcing tissue layers joined by surgical suturing, the support assembly comprising (a) a support, the support comprising a first surface and a second surface, wherein the support further comprises a proximal end and a distal end. The support defines a longitudinal axis extending between the proximal end and the distal end, wherein the support further comprises a central region, the central region being adjacent to a first edge region on one side of the central region and adjacent to a second edge region on the other side of the central region. The support assembly further comprises (b) an adhesive applied to a selected one of the first surface and the second surface of the support, wherein the adhesive extends continuously from the proximal end of the support to the distal end of the support. The adhesive is positioned along the first edge region and the second edge region so that the central region of the support is substantially free of the adhesive.
[0111] Example 2
[0112] A support assembly as described in Example 1, wherein the central region of the support includes one or more slits configured to facilitate separation of the support into two halves.
[0113] Example 3
[0114] A buttress assembly according to any one or more of embodiments 1 to 2, wherein the adhesive has a non-uniform distribution, wherein the non-uniform distribution includes more of the adhesive at the distal end of the buttress than at the proximal end of the buttress.
[0115] Example 4
[0116] A support assembly according to any one or more of embodiments 1 to 3, wherein the adhesive includes a first connection line of the adhesive extending from the proximal end of the support to the distal end of the support, and wherein the adhesive also includes a second connection line of the adhesive extending from the proximal end of the support to the distal end of the support.
[0117] Example 5
[0118] A buttress assembly as in Example 4 wherein the first line of adhesive partially overlaps the second line of adhesive along at least a portion of the length of the buttress.
[0119] Example 6
[0120] A buttress assembly as in any one or more of embodiments 4-5, wherein the first line of adhesive is spaced apart from the second line of adhesive along at least a portion of the length of the buttress.
[0121] Example 7
[0122] A buttress assembly as in any one or more of embodiments 4 to 6 wherein the second line of adhesive extends further proximally than the first line of adhesive.
[0123] Example 8
[0124] A buttress assembly as in any one or more of embodiments 4 to 7 wherein the first line of adhesive and the second line of adhesive extend distally relative to the buttress to substantially the same extent.
[0125] Example 9
[0126] A support assembly according to any one or more of Examples 4 to 8, wherein the adhesive includes a third connection of the adhesive extending from the proximal end of the support to the distal end of the support, and wherein the adhesive also includes a fourth connection of the adhesive extending from the proximal end of the support to the distal end of the support.
[0127] Example 10
[0128] A support assembly according to any one or more of embodiments 4 to 9, wherein the first and second wirings of the adhesive are symmetrical with the third and fourth wirings of the adhesive about the longitudinal axis of the support defining a center line of the support.
[0129] Embodiment 11
[0130] A support assembly according to any one or more of embodiments 1 to 10, wherein the adhesive has a minimum height such that when the adhesive is applied to the support, the adhesive is located above the support.
[0131] Example 12
[0132] The buttress assembly of Embodiment 11, wherein the minimum height of the adhesive is between about 0.254 mm and about 1.27 mm.
[0133] Example 13
[0134] A buttress assembly as described in any one or more of Examples 11-12, wherein the minimum height of the adhesive is between about 0.4064 mm and about 0.762 mm.
[0135] Embodiment 14
[0136] A buttress assembly according to any one or more of embodiments 11 to 13, wherein the minimum height of the adhesive is configured to substantially match the depth of a staple forming recess of an anvil of an end effector of a surgical stapler.
[0137] Embodiment 15
[0138] A buttress assembly according to any one or more of embodiments 11 to 14, wherein the minimum height of the adhesive is configured to substantially match the height of a recessed extension portion of a staple cartridge of an end effector of a surgical stapler.
[0139] Example 16
[0140] A support assembly for reinforcing tissue layers joined by surgical suturing, the support assembly comprising (a) a support, the support comprising a first surface and a second surface, wherein the support further comprises a proximal end and a distal end. The support defines a length from the proximal end to the distal end, wherein the support defines a longitudinal axis extending between the proximal end and the distal end. The support also includes a central region, the central region is adjacent to a first edge region on one side of the central region and adjacent to a second edge region on the other side of the central region, wherein the support is configured to be cut into substantially equal halves by cutting through the central region. The support assembly also includes (b) an adhesive applied to a selected one of the first surface and the second surface of the support, wherein the adhesive extends from the proximal end of the support to the distal end of the support. The adhesive is positioned along the first edge region and the second edge region so that the central region of the support is substantially free of the adhesive, wherein the adhesive has an asymmetric distribution along the length of the support.
[0141] Embodiment 17
[0142] A support assembly according to Example 16, wherein the adhesive on the first edge region and the second edge region varies between a region with more adhesive and a region with less adhesive along the length of the support, wherein the region with more adhesive on the first edge region is positioned relative to the region with less adhesive on the second edge region, and wherein the region with more adhesive on the second edge region is positioned relative to the region with less adhesive on the first edge region.
[0143] Embodiment 18
[0144] A support assembly according to any one or more of embodiments 16 to 17, wherein the asymmetric distribution of the adhesive is configured to reduce the force required to release the support assembly from a selected one of the anvil and the staple magazine of the end actuator of the surgical stapler when the end actuator is opened.
[0145] Embodiment 19
[0146] A device for reinforcing tissue layers joined by surgical suturing, comprising (a) a pair of buttress assemblies, each of the pair of buttress assemblies comprising (i) a buttress, the buttress comprising a first surface and a second surface, wherein the buttress further comprises a proximal end and a distal end, wherein the buttress defines a length from the proximal end to the distal end, wherein the buttress further comprises a central region, the central region being adjacent to a first edge region on one side of the central region and adjacent to a second edge region on the other side of the central region, wherein the buttress is configured to be cut into substantially equal halves by cutting through the central region, and (ii) an adhesive applied to the first surface and the second surface of the buttress. The device further comprises: (a) a plurality of support components, each of which is configured to be positioned relative to the other support components, wherein the adhesive extends from the proximal end of the support to the distal end of the support, wherein the adhesive is positioned along the first edge region and the second edge region such that the central region of the support is substantially free of the adhesive, wherein the adhesive has an asymmetric distribution along the length of the support, and the support has the adhesive varying between a more adhesive region and a less adhesive region on the first edge region and the second edge region, wherein the more adhesive region on the first edge region is positioned relative to the less adhesive region on the second edge region, and wherein the more adhesive region on the second edge region is positioned relative to the less adhesive region on the first edge region. The device further comprises: (b) each of the support components is configured to be positioned relative to the other support components, wherein the adhesive of one of the support components faces away from the adhesive of another of the support components, wherein when positioned relative to the other support components, the more adhesive region on one of the support components is aligned with the less adhesive region on the other of the support components.
[0147] Embodiment 20
[0148] A device as described in Example 19, wherein the central region of the support includes one or more slits configured to facilitate cutting the support into two halves.
[0149] V. Miscellaneous
[0150] Although the terms "support" and "support assembly" are used throughout the present disclosure, it should be understood that the terms are not intended to limit the scope of the present invention in any way. For example, the use of the terms "support" and "support assembly" is not intended to demonstrate the idea that a "support" or "support assembly" can only be used to provide structural support for a nail line or for any other specific purpose. It is conceivable that, in addition to or instead of providing structural support to a nail line, a "support" or "support assembly" can also be used for a variety of purposes. Therefore, the terms "support" and "support assembly" should be broadly understood to include any kind of auxiliary parts of a nail line for any suitable purpose.
[0151] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered isolated from each other. With reference to the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.
[0152] In addition to the foregoing, it should be understood that any of the various buttress assemblies described herein may be further constructed and operated in accordance with at least some of the teachings of the following patent publications: U.S. Patent Publication No. 2016 / 0278774, entitled “Method of Applying a Buttress to a Surgical Stapler,” published on September 29, 2016, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2017 / 0049444, entitled “Implantable Layers for a Surgical Instrument,” published on February 23, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2017 / 0086837, entitled “Compressible Adjunct with Crossing Spacer Fibers,” published on March 30, 2017, the disclosure of which is incorporated herein by reference; and U.S. Patent Publication No. 2017 / 0086837, entitled “Compressible Adjunct with Crossing Spacer Fibers,” published on March 30, 2017, the disclosure of which is incorporated herein by reference; Cartridge" is disclosed in U.S. Patent Publication No. 2017 / 0086842, the disclosure of which is incorporated herein by reference.Moreover, in addition to the methods described herein, any of the various buttress assemblies described herein may be applied to the end effector (40) in accordance with at least some of the teachings of the following patent publications: U.S. Patent Publication No. 2017 / 0056016, entitled “Surgical Stapler Buttress Applicator with End Effector Actuated Release Mechanism,” published on March 2, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2017 / 0056017, entitled “Surgical Stapler Buttress Applicator with Multi-Zone Platform for Pressure Focused Release,” published on March 2, 2017, the disclosure of which is incorporated herein by reference; and U.S. Patent Publication No. 2017 / 0056018, entitled “Surgical Stapler Buttress Applicator with Multi-Zone Platform for Pressure Focused Release,” published on March 2, 2017, the disclosure of which is incorporated herein by reference. and U.S. Patent Publication No. 2017 / 0055980, entitled “Surgical Stapler Buttress Applicator with State Indicator”, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2017 / 0056018, entitled “Surgical Stapler Buttress Applicator with State Indicator”, published on March 2, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2017 / 0055982, entitled “Surgical Stapler Buttress Applicator with Multi-Point Actuated Release Mechanism”, published on March 2, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2017 / 0055983, entitled “Surgical Stapler Buttress Applicator with Multi-Point Actuated Release Mechanism”, published on March 2, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2017 / 0055984, entitled “Method of Applying a Buttress to a Surgical Stapler End Effector”, the disclosure of which is incorporated herein by reference; and / or U.S. Patent Publication No. 2017 / 0086842, entitled “Method for Applying an Implantable Layer to a Fastener Cartridge”, published on March 30, 2017, the disclosure of which is incorporated herein by reference.Various suitable ways in which the teachings herein can be combined with the various teachings of the references cited above will be apparent to those of ordinary skill in the art.
[0153] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END8635USNP.0663976], entitled "Configuration of Buttress for Surgical Stapler", filed on the same date as the present application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END8635USNP.0663976] will be apparent to those of ordinary skill in the art.
[0154] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END8636USNP.0663978], entitled "Surgical Stapler Buttress with Tissue In-Growth Promotion", filed on the same day as the present application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END8636USNP.0663978] will be apparent to those of ordinary skill in the art.
[0155] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END8637USNP.0663981], entitled "Applicator for Surgical Stapler Buttress", filed on the same date as the present application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END8637USNP.0663981] will be apparent to those of ordinary skill in the art.
[0156] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END8638USNP.0663983], entitled "Packaging for Surgical Stapler Buttress", filed on the same date as the present application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END8638USNP.0663983] will be apparent to those of ordinary skill in the art.
[0157] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END8639USDP.0663985], entitled "Applicator for Surgical Stapler Buttress", filed on the same date as the present application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END8639USDP.0663985] will be apparent to those of ordinary skill in the art.
[0158] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket Number END8640USDP.0663994], entitled "Buttress for Surgical Stapler", filed on the same day as this application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket Number END8640USDP.0663994] will be apparent to those of ordinary skill in the art.
[0159] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket Number END8641USDP.0663996], entitled "Tray for Surgical Stapler Buttress Applicator", filed on the same day as the present application, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket Number END8641USDP.0663996] will be apparent to those of ordinary skill in the art.
[0160] It should also be understood that the teachings herein can be readily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END9071USNP1.0714576], entitled "Method of Applying Buttresses to Surgically Cut and Stapled Sites", filed on the same date as this application; the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END9071USNP1.0714576] will be apparent to those of ordinary skill in the art.
[0161] It should also be understood that the teachings herein can be readily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END9072USNP1.0714574], entitled "Curved Tip Surgical Stapler Buttress Assembly Applicator with Opening Feature for Curved Tip Alignment", filed on the same date as the present application; the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END9072USNP1.0714574] will be apparent to those of ordinary skill in the art.
[0162] It should also be understood that the teachings herein can be readily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END9073USNP1.0714572], entitled "Curved Tip Surgical Stapler Buttress Assembly Applicator with Proximal Alignment Features", filed on the same date as the present application; the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END9073USNP1.0714572] will be apparent to those of ordinary skill in the art.
[0163] It should also be understood that the teachings herein can be readily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END9075USNP1.0714570], entitled "Curved Tip Surgical Stapler Buttress Assembly Applicator with Compression Layer Pocket Feature", filed on the same date as the present application; the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END9075USNP1.0714570] will be apparent to those of ordinary skill in the art.
[0164] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END9080USDP1.0714568], entitled "Applicator for a Surgical Stapler Buttress", filed on the same date as the present application; the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END9080USDP1.0714568] will be apparent to those of ordinary skill in the art.
[0165] It should also be understood that the teachings herein can be easily combined with various teachings in the following U.S. patent application: U.S. Patent Application [Attorney Docket No. END9081USDP1.0714566], entitled "Buttress Assembly for a Surgical Stapler", filed on the same date as the present application; the disclosure of that patent application is incorporated herein by reference. Various suitable ways in which the teachings herein can be combined with the teachings of U.S. Patent Application [Attorney Docket No. END9081USDP1.0714566] will be apparent to those of ordinary skill in the art.
[0166] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials described in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein but conflicting with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.
[0167] The above-described device versions may be used in conventional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into a robotic surgical system, such as the DAVINCI® by Intuitive Surgical, Inc. (Sunnyvale, California). TM system.
[0168] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both, these types can be repaired to be reused after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.
[0169] By way of example only, the types described herein may be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
[0170] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.
Claims
1. A buttress assembly for reinforcing tissue layers joined by surgical suturing, wherein the buttress assembly comprises: (a) a support, the support comprising a first surface and a second surface, wherein the support further comprises a proximal end and a distal end, wherein the support defines a longitudinal axis extending between the proximal end and the distal end, wherein the support further comprises a central region adjacent to a first edge region on one side of the central region and adjacent to a second edge region on another side of the central region, wherein the support further defines a length from the proximal end to the distal end; and (b) an adhesive applied to a selected one of the first surface and the second surface of the buttress, wherein the adhesive extends continuously from the proximal end of the buttress to the distal end of the buttress, wherein the adhesive is positioned along the first edge region and the second edge region such that the central region of the buttress is free of the adhesive, wherein the adhesive has a non-uniform distribution including more of the adhesive at the distal end of the support than at the proximal end of the support, and wherein the adhesive includes a first thread of the adhesive extending from the proximal end of the support to the distal end of the support, and wherein the adhesive also includes a second thread of the adhesive extending from the proximal end of the support to the distal end of the support, and wherein the first line of adhesive partially overlaps the second line of adhesive along at least a portion of the length of the first edge region, wherein the adhesive includes a third line of adhesive extending from the proximal end of the support to the distal end of the support, and wherein the adhesive also includes a fourth line of adhesive extending from the proximal end of the support to the distal end of the support, wherein the third line of adhesive partially overlaps the fourth line of adhesive along at least a portion of the length of the second edge region, Wherein, the adhesive has an asymmetric distribution along the length of the support.
2. The support assembly according to claim 1, wherein: The central region of the support includes one or more slits configured to facilitate separation of the support into two halves.
3. The support assembly according to claim 1, wherein: The second line of adhesive extends proximally further than the first line of adhesive.
4. The support assembly according to claim 1, wherein: The first line of adhesive and the second line of adhesive extend distally to the same extent relative to the support.
5. The support assembly according to claim 1, wherein: The first and second lines of adhesive are co-symmetrical with the third and fourth lines of adhesive about the longitudinal axis of the support defining a centerline of the support.
6. The support assembly according to claim 1, wherein: The adhesive has a minimum height such that, when the adhesive is applied to the support, the adhesive is located above the support.
7. The support assembly according to claim 6, wherein: The minimum height of the adhesive is between 0.254 mm and 1.27 mm.
8. The support assembly according to claim 6, wherein: The minimum height of the adhesive is between 0.4064 mm and 0.762 mm.
9. The support assembly according to claim 6, wherein: The minimum height of the adhesive is configured to match the depth of a staple forming recess of an anvil of an end effector of a surgical stapler.
10. The support assembly according to claim 6, wherein: The minimum height of the adhesive is configured to match the height of a recessed extension of a staple cartridge of an end effector of a surgical stapler.
11. The support assembly according to claim 1, wherein: The support is configured to be capable of being cut along the central region to be divided into two substantially equal halves.
12. The support assembly according to claim 11, wherein: The adhesive on the first edge region and the second edge region varies between regions of more adhesive and regions of less adhesive along the length of the support, wherein the regions of more adhesive on the first edge region are positioned relative to the regions of less adhesive on the second edge region, and wherein the regions of more adhesive on the second edge region are positioned relative to the regions of less adhesive on the first edge region.
13. The support assembly of claim 1, wherein: The asymmetric distribution of the adhesive is configured to reduce the force required to release the buttress assembly from a selected one of an anvil and a staple cartridge of the end effector of a surgical stapler when the end effector is opened.
14. A device for reinforcing tissue layers joined by surgical suturing, wherein the device comprises: (a) a pair of support assemblies according to claim 12; (b) wherein each of the support components is configured to be positionable in a relative manner wherein the adhesive of one of the support components faces away from the adhesive of another of the support components, wherein when positioned in the relative manner, the adhesive-rich area on one of the support components is aligned with the adhesive-less area on the other of the support components.
15. The device according to claim 14, wherein: The central region of the support includes one or more slits configured to facilitate cutting the support in half.
