Apparatus and method for applying a buttress to an end effector of a surgical stapler via a stationary base
By introducing a support assembly and a static wedge-shaped applicator into an endoscopic surgical stapler, the stability issues of the stapler during tissue fixation and cutting are addressed, suturing outcomes are improved, the risk of tearing is reduced, and the loading process of the support assembly is simplified.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- CILAG GMBH INTERNATIONAL
- Filing Date
- 2021-09-14
- Publication Date
- 2026-06-02
AI Technical Summary
Existing endoscopic surgical staplers are difficult to effectively fix and cut tissues while providing structural support, resulting in poor suturing results and an increased risk of tissue tearing.
A surgical suture device is designed, equipped with a support assembly and a support applicator cartridge. The support assembly is secured to the staple cartridge and anvil via an adhesive layer. Staples are driven through the tissue using a wedge-shaped slider and a staple driver, and cut and sutured by a firing beam. The support is applied without closing the jaws using a static wedge-shaped auxiliary applicator.
It improves the structural stability of the suture, reduces the risk of tissue tearing, enhances the suture effect, and simplifies the process of repeated support loading.
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Figure CN116507292B_ABST
Abstract
Description
Background Technology
[0001] In some surgical settings, endoscopic surgical instruments may be superior to traditional open surgical devices in creating smaller incisions within the patient, which can reduce postoperative recovery time and complications. Some endoscopic surgical instruments are adapted to place distal end-effectors at desired surgical sites via cannulation of a trocar. These distal end-effectors (e.g., internal cutters, grippers, scalpels, suture devices, clamps, entry devices, drug / gene therapy delivery devices, and energy delivery devices using ultrasound, RF, lasers, etc.) can engage tissue in various ways to achieve diagnostic or therapeutic effects. Endoscopic surgical instruments may include an axis located between the end-effector and a handle portion manipulated by the clinician. This axis allows insertion to the desired depth and rotation about the longitudinal axis of the axis, thereby facilitating the positioning of the end-effector within the patient. Positioning of the end-effector can be further facilitated by including one or more articulation joints or features that allow the end-effector to selectively articulate or otherwise deflect relative to the longitudinal axis of the axis.
[0002] Examples of endoscopic surgical instruments include surgical staplers. Some of these staplers are operable to clamp tissue layers, cut through the clamped tissue layers, and drive staples through the tissue layers to substantially seal the cut tissue layers together near the cut ends. Exemplary surgical staplers are disclosed only in U.S. Patent No. 7,380,696, published June 3, 2008, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-BeamFiring Mechanism”; U.S. Patent No. 8,408,439, published April 2, 2013, entitled “Surgical Stapling Instrument with An Articulatable End Effector”; and U.S. Patent No. 8,453,914, published June 4, 2013, entitled “Motor-Driven Surgical Cutting Instrument with Electric Actuator Directional Control Assembly”. The disclosures of each of the above-cited U.S. patents and U.S. patent publications are incorporated herein by reference.
[0003] Surgical staplers can also be used in open abdominal surgeries and / or other non-endoscopic procedures. By way of example only, in thoracic surgery, a surgical stapler can be inserted via a thoracotomy and thus positioned between the patient's ribs to reach one or more organs, in which a trocar is not used as the catheter for the stapler. For example, blood vessels leading to an organ can be severed and closed using a stapler before it is removed from the thoracic cavity. Of course, surgical staplers can be used in a variety of other situations and procedures.
[0004] Although various surgical suturing instruments and associated components have been manufactured and used, it is believed that no one had manufactured or used the invention described in the appended claims prior to the inventors. Attached Figure Description
[0005] 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.
[0006] Figure 1 A perspective view of an exemplary surgical suturing instrument is shown;
[0007] Figure 2 It shows Figure 1 A side front view of the instrument;
[0008] Figure 3 It shows that it is in the open state. Figure 1 A perspective view of the end effector of the instrument;
[0009] Figure 4A It shows Figure 3 end effector along Figure 3 The side section view taken from line 4-4, with the firing beam in a near-side position;
[0010] Figure 4B It shows Figure 3 end effector along Figure 3 The side section view taken from line 4-4, with the firing beam in the far side position;
[0011] Figure 5 It shows Figure 3 end effector along Figure 3 The end cross-sectional view taken from line 5-5;
[0012] Figure 6 It shows Figure 3 Exploded perspective view of the end effector;
[0013] Figure 7 It shows Figure 3A perspective view of an end effector located at the tissue and already actuated once within the tissue;
[0014] Figure 8 A perspective view of an exemplary pair of support components is shown, wherein each support component can be applied to... Figure 3 The jaws of the end effector;
[0015] Figure 9A It shows Figure 3 A cross-sectional end view of a portion of the end effector, wherein Figure 8 The support assembly is applied to the upper and lower jaws of the end effector, showing the end effector jaws in the open state, with tissue positioned between the upper and lower jaws;
[0016] Figure 9B It shows Figure 9A A cross-sectional end view of the end effector and support assembly, showing the end effector jaws in a tissue-closed state;
[0017] Figure 9C The formed nail and the nail that has been passed are shown. Figure 3 The end effector is fixed to the tissue afterward. Figure 9A A cross-sectional view of the support assembly;
[0018] Figure 10 The formed nail and the nail that has been passed are shown. Figure 3 The end effector is fixed to the tissue afterward. Figure 9A A perspective view of the support components;
[0019] Figure 11 It shows that it can be used for carrying and application Figure 8 A perspective view of an exemplary support applicator compartment of the support assembly;
[0020] Figure 12 It shows Figure 11 A top plan view of the support application device compartment;
[0021] Figure 13A It shows Figure 3 end effector and Figure 11 A perspective view of the support applicator compartment, showing the end effector and the support applicator compartment aligned with each other;
[0022] Figure 13B It shows Figure 3 end effector and Figure 11 A perspective view of the support applicator compartment, in which the end effector jaws are closed on the platform of the support applicator compartment;
[0023] Figure 14A perspective view of an exemplary auxiliary application device in a folded configuration and connected to the base is shown;
[0024] Figure 15 The slot is shown in a folded configuration and positioned relative to the base. Figure 14 A perspective view of the auxiliary application device;
[0025] Figure 16 It shows an unfolded configuration Figure 14 A plan view of the auxiliary application device;
[0026] Figure 17A It shows Figure 3 A perspective view of the jaws of an end effector, the jaws being in the open and engaged position. Figure 14 The auxiliary application device is in a first folded configuration that defines a first angle;
[0027] Figure 17B It shows Figure 3 A perspective view of the jaws of an end effector, the jaws being in the open and engaged position. Figure 14 The auxiliary application device, while the application device is in a second folded configuration defining a second angle, shows the application device connected to the base via a pair of slots;
[0028] Figure 18 A plan view of a second exemplary auxiliary application device in an unfolded configuration is shown;
[0029] Figure 19 The first fold configuration at a defined first angle is shown. Figure 18 A perspective view of the auxiliary application device;
[0030] Figure 20 This shows a pair of slots positioned in the first fold configuration and relative to the base. Figure 18 A perspective view of the auxiliary application device;
[0031] Figure 21 The second fold configuration at the defined second angle is shown. Figure 18 A perspective view of the auxiliary application device, showing the application device connected to the base via a pair of slots;
[0032] Figure 22 A side sectional view of a third exemplary auxiliary application device is shown, illustrating the application device in a non-expanded storage configuration;
[0033] Figure 23 It shows Figure 3 A side sectional view of the end effector, which is engaged. Figure 22 The auxiliary application device is in the first expanded angle configuration;
[0034] Figure 24 It shows Figure 3 A side sectional view of the end effector, which is engaged. Figure 22 The auxiliary application device is in a second expanded angle configuration;
[0035] Figure 25 A perspective view of another exemplary auxiliary application device is shown, which illustrates the wedge-shaped portion of the application device in a first longitudinal position;
[0036] Figure 26A It shows along Figure 25 The line 26A-26A cut Figure 25 A side sectional view of the auxiliary application device, showing the engagement. Figure 3 The wedge-shaped portion of the application device of the end effector in the proximal position (shown in dashed lines); and
[0037] Figure 26B It shows Figure 25 A side sectional view of the auxiliary application device compartment, showing the engagement. Figure 3 The wedge-shaped portion of the application device of the end effector in the distal position (shown in dashed lines).
[0038] The accompanying drawings are not intended to be limiting in any way, and various embodiments of the invention can be conceived to be implemented in many other ways, including those not necessarily shown in the drawings. The 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 explicit arrangements shown. Detailed Implementation
[0039] The following description of certain examples of the present technology is not intended to limit the scope of the present technology. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is given by way of example, representing one of the best ways contemplated for implementing the present technology. As will be appreciated, the technology described herein can have other different and obvious aspects, all of which are not departing from the present technology. Therefore, the accompanying drawings and descriptions should be considered substantially illustrative rather than restrictive.
[0040] Furthermore, 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 following teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.
[0041] For clarity of disclosure, the terms "proximal" and "distal" are defined herein with respect to a human or robotic operator of the surgical instrument. The term "proximal" refers to the element location of the surgical end effector that is closer to the human or robotic operator of the surgical instrument and further away from the surgical instrument. The term "distal" refers to the element location of the surgical end effector that is closer to the surgical instrument and further away from the human or robotic operator of the surgical instrument. Furthermore, the terms "upper," "lower," "lateral," "transverse," "bottom," and "top" are relative terms to provide additional clarity to the figures provided below. Therefore, the terms "upper," "lower," "lateral," "transverse," "bottom," and "top" are not intended to unnecessarily limit the invention described herein.
[0042] I. Exemplary Surgical Stapler
[0043] Figures 1 to 7 An exemplary surgical suturing and cutting instrument (10) is shown, sized to be inserted through a trocar cannula or incision (e.g., thoracotomy, etc.) into a patient's surgical site to perform surgery. The instrument (10) of this example includes a shank portion (20) connected to a shaft (22) that terminates distally in an articulation joint (11), which is further coupled to an end effector (12). Once the articulation joint (11) and the end effector (12) are inserted through the cannula's insertion channel, the articulation joint (11) can be remotely articulated via articulation controls (13), such as... Figure 1 The end effector (12) is depicted as a virtual image, such that the end effector (12) can be deflected from the longitudinal axis (LA) of the shaft (22) at a desired angle (α). The end effector (12) of this example includes a lower jaw (16) and an upper jaw in the form of a pivotable anvil (18), the lower jaw including a staple cartridge (37).
[0044] The handle portion (20) includes a pistol grip (24) and a closing trigger (26). The closing trigger (26) is pivotable toward the pistol grip (24) so that the anvil (18) clamps or closes toward the lower jaws (16) of the end effector (12). Such closure of the anvil (18) is provided by a closing tube (32) and a closing ring (33), both of which translate longitudinally relative to the handle portion (20) in response to the pivoting of the closing trigger (26) relative to the pistol grip (24). The closing tube (32) extends along the length of the shaft (22); and the closing ring (33) is positioned distal to the articulated joint (11). The articulated joint (11) is operable to transfer / transmit longitudinal motion from the closing tube (32) to the closing ring (33).
[0045] like Figure 2 As shown, the handle portion (20) also includes a firing trigger (28). An elongated member (not shown) extends longitudinally through the shaft (22) and, in response to actuation of the firing trigger (28), transmits longitudinal firing motion from the handle portion (20) to the firing beam (14). This distal translation of the firing beam (14) causes the tissue clamped in the end effector (12) to be sutured and cut, as will be described in more detail below.
[0046] like Figures 3 to 6 As shown, the end effector (12) employs a firing beam (14) comprising a laterally oriented upper pin (38), a firing beam top cap (44), a laterally oriented middle pin (46), and a distal cutting edge (48). The upper pin (38) is positioned within a longitudinal anvil slot (42) of the anvil (18) and is translatable within said longitudinal anvil slot. The firing beam top cap (44) extends the firing beam (14) through a lower jaw slot (45) (…). Figure 4B (As shown) The lower surface of the lower jaw (16) is slidably engaged, and the lower jaw groove (45) is formed through the lower jaw (16). The central pin (46) slidably engages the top surface of the lower jaw (16), thereby cooperating with the firing beam top cover (44).
[0047] Figure 3 This example illustrates the proximal-positioned firing beam (14) and the anvil (18) pivoting to an open configuration, allowing the unexploded cartridge (37) to be removably inserted into the channel of the lower jaws (16). Figures 5 to 6 As best seen in this example, the staple cartridge (37) includes a cartridge body (70) that presents an upper deck (72) and is coupled to a lower cartridge tray (74). Figure 3 As best seen, a vertical slot (49) extends longitudinally through a portion of the staple cartridge body (70). Similarly... Figure 3As best seen, three rows of nail holes (51) are formed through the upper deck (72) on each transverse side of the vertical slot (49). Figures 4A to 6 As shown, a wedge-shaped slider (41) and multiple nail actuators (43) are held between the cartridge (70) and the tray (74), wherein the wedge-shaped slider (41) is positioned close to the nail actuators (43). The wedge-shaped slider (41) is capable of longitudinal movement within the nail cartridge (37); while the nail actuators (43) are capable of vertical movement within the nail cartridge (37). The nails (47) are also positioned within the cartridge (70), above the corresponding nail actuators (43). Each nail (47) is vertically driven within the cartridge (70) by the nail actuator (43) to drive the nail (47) outward through the associated nail hole (51). Figures 4A to 4B and Figure 6 As is best seen, the wedge slider (41) has an inclined cam surface that pushes the nail driver (43) upward as the wedge slider (41) is driven toward the distal end through the nail cartridge (37).
[0048] By advancing the closed tube (32) and closed ring (33) to the distal end of the actuator (12) as... Figures 4A to 4B In the closed configuration shown, by engaging the upper pin (38) into the longitudinal anvil slot (42), the firing beam (14) is pushed distally until it engages with the anvil (18). Push block (80) Figure 5 Located at the distal end of the firing beam (14), when the firing trigger (28) is actuated, the wedge-shaped slider (41) is pushed distally as the firing beam (14) advances distally through the staple cartridge (37). During this firing, the cutting edge (48) of the firing beam (14) enters the vertical slot (49) of the staple cartridge (37), thereby severing the tissue clamped between the staple cartridge (37) and the anvil (18). Figures 4A to 4B As shown, the intermediate pin (46) and the pusher (80) actuate the nail cartridge (37) together by entering the slot (49) within the nail cartridge (37), thereby driving the wedge-shaped slider (41) into an upward-pushing contact with the nail actuator (43), which in turn drives the nail (47) outward through the nail hole (51) and causes the nail to contact the nail forming recess (53) on the inner surface of the anvil (18). Figure 3 (As shown in the diagram) to form a contact. Figure 4B The firing beam (14) is shown after the tissue has been cut and sutured, and then completely translated distally. From Figures 4A to 4B The nail-shaped recess (53) is intentionally omitted in the view, but... Figure 3 As shown in [the image]. Figure 5 The anvil is intentionally omitted in the view (18).
[0049] Figure 7An end effector (12) is shown, actuated through tissue (90) by a single firing stroke. Cutting blade (48) Figure 7 The tissue (90) has been cut through (the obscured area), and the staple driver (43) has driven three rows of alternating staples (47) through the tissue (90) on each side of the cut line created by the cutting edge (48). After the first firing stroke is completed, the end effector (12) is withdrawn from the patient and the empty staple cartridge (37) is replaced with a new staple cartridge (37). The end effector (12) is then reinserted into the patient to reach the suture site for further cutting and suturing. This process can be repeated until the desired number and pattern of firing strokes across the tissue (90) have been completed.
[0050] The device (10) may be further constructed and operated based on any of the teachings of the following references, the disclosures of which are incorporated herein by reference: U.S. Patent No. 8,210,411, entitled “Motor-Driven Surgical Instrument,” published July 3, 2012; U.S. Patent No. 9,186,142, entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks,” published November 17, 2015; U.S. Patent No. 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” published December 13, 2016; U.S. Patent No. 9,622,746, entitled “Distal Tip Features for End Effector of Surgical Instrument,” published April 18, 2017; and U.S. Patent No. 9,622,746, entitled “Lockout Feature for Movable,” published August 1, 2017. U.S. Patent No. 9,717,497, entitled “Cutting Member of Surgical Instrument”; U.S. Patent No. 9,795,379, entitled “Surgical Instrument with Multi-Diameter Shaft”, published on October 24, 2017; U.S. Patent No. 9,808,248, entitled “Installation Features for Surgical Instrument End Effector Cartridge”, published on November 7, 2017; U.S. Patent No. 9,839,421, entitled “Jaw Closure Feature for End Effector of Surgical Instrument”, published on December 12, 2017; and / or U.S. Patent No. 10,092,292, entitled “StapleForming Features for Surgical Stapling Instrument”, published on October 9, 2018.
[0051] II. Exemplary support assembly and support applicator compartment
[0052] In some cases, it may be desirable to equip the end effector (12) of the surgical instrument (10) with an adjunct material (such as a support) to reinforce the tissue mechanical fastening provided by the staples (47). This support prevents the applied staples (47) from being pulled through the tissue and may otherwise reduce the risk of tissue tearing at or near the site of the applied staples (47). In addition to providing structural support and integrity for a row of staples (47) or as an alternative, the support may provide a variety of other effects, such as filling of gaps or spaces, administration of therapeutic agents, and / or other effects. In some cases, the support may be disposed on the upper deck (72) of the staple cartridge (37). As described above, the deck (72) houses the staples (47) driven by the staple actuator (43). In some other cases, the support may be disposed on the surface of the anvil (18) facing the staple cartridge (37). It should also be understood that a first support may be disposed on the deck (72) of the staple cartridge (37), while a second support may be disposed on the anvil (18) of the same end effector (12).
[0053] Various examples of the forms in which the support may take will be described in more detail below. Various ways in which the support may be attached to the staple cartridge (37) or the anvil (18) will also be described in more detail below. Exemplary support assemblies, exemplary materials and techniques for applying the support assembly, and exemplary support applicator cartridges may be constructed in accordance with at least some of the teachings of the following patents, the disclosures of which are incorporated herein by reference: U.S. Patent No. 10,166,023, entitled “Method of Applying a Buttress to a Surgical Stapler End Effector,” published January 1, 2019, and / or U.S. Patent No. 10,349,939, entitled “Method of Applying a Buttress to a Surgical Stapler,” published July 16, 2019.
[0054] A. Exemplary components of the support assembly
[0055] Figure 8An exemplary pair of support assemblies (110, 112) (each also individually referred to as a “support”) are shown. The support assembly (110) of this example includes a support body (114) and an upper adhesive layer (116). Similarly, the support assembly (112) includes a support body (118) and a lower adhesive layer (120). In this example, each support body (114, 118) includes a strong yet flexible material configured to structurally support a row of nails (47). By way of example only, each support body (114, 118) may include a mesh of polyglactin 910 material from Ethicon Ltd. (Somerville, New Jersey). Alternatively, in addition to polyglactin 910 material, or as an alternative, any other suitable material or combination of materials may be used to form each support body (114, 118).
[0056] Each support body (114, 118) may include materials including, for example, hemostatic agents such as fibrin to aid in blood clotting and reduce bleeding at surgical sites along tissue (T1, T2). As another illustrative example only, each support body (114, 118) may include other adjuvants or hemostatic agents such as thrombin, which may be used to enable each support body (114, 118) to aid in blood clotting and reduce bleeding at surgical sites. Other adjuvants or agents that may be incorporated into each support body (114, 118) may also include, but are not limited to, medical fluids or matrix components.
[0057] In this example, an adhesive layer (116) is applied to the support body (114) to adhere the support body (114) to the underside (124) of the anvil (18). Similarly, an adhesive layer (120) is applied to the support body (118) to adhere the support body (118) to the upper deck (72) of the staple cartridge (37). Such adhesive material provides proper positioning of the support bodies (114, 118) before and during actuation of the end effector (12); and then allows the support bodies (114, 118) to separate from the end effector (12) after the end effector (12) has been actuated without damaging the support bodies (114, 118) to a degree sufficient to impair their proper subsequent function.
[0058] B. Exemplary suturing of tissue and support components
[0059] Figures 9A to 9CAn exemplary sequence is shown in which an end effector (12) already loaded with support assemblies (110, 112) is actuated to drive a nail (47) through two opposing tissue layers (T1, T2), wherein the support assemblies (110, 112) are secured to the same tissue layers (T1, T2) by the nail (47). Specifically, Figure 9A Tissue layers (T1, T2) positioned between the anvil (18) and the cartridge (37) are shown, with the anvil (18) in the open position. A support assembly (110) is adhered to the underside (424) of the anvil (18) via an adhesive layer (116); while a support assembly (112) is adhered to the upper deck (72) of the cartridge (37) via an adhesive layer (120). Thus, tissue layers (T1, T2) are inserted between the support assemblies (110, 112). Next, a closing trigger (26) pivots toward the pistol grip (24) to drive the closing tube (32) and closing ring (33) distally. This drives the anvil (18) to... Figure 9B The closed position is shown. At this stage, the tissue layers (T1, T2) are compressed between the anvil (18) and the staple cartridge (37), where the support assemblies (110, 112) engage the opposing surfaces of the tissue layers (T1, T2). The end effector (12) is then actuated as described above, thereby driving the staple (47) through the support assemblies (110, 112) and the tissue (T1, T2). Figure 9C As shown, the crown (122) of the driven nail (47) abuts against the tissue layer (T2) to capture and retain the support assembly (112). The deformable leg (126) of the nail (47) abuts against the tissue layer (T1) to capture and retain the support assembly (110).
[0060] Similarly, a series of pins (47) abut against the tissue layers (T1, T2) to capture and retain the support assembly (110, 112), thereby securing the support assembly (110, 112) to the tissue (T1, T2), as... Figure 10 As shown. Because the end effector (12) is pulled away from the tissue (T1, T2) after the deployment of the pins (47) and the support assembly (110, 112), the support assembly (110, 112) disengages from the end effector, so that the support assembly (110, 112) is held fixed to the tissue (T1, T2) by the pins (47). The support assembly (110, 112) thus provides structural reinforcement for the rows of pins (47) formed in the tissue (T1, T2). Additionally, as... Figure 10It can be seen that the cutting edge (48) of the firing beam (14) on the far side also cuts through the centerline of the support assembly (110, 112), thereby dividing each support assembly (110, 112) into a corresponding pair of segments, such that each segment remains fixed to the corresponding cut area of the tissue (T1, T2).
[0061] C. An exemplary support applicator compartment with a movable retainer arm
[0062] Because the end effector (12) of the surgical instrument (10) can be actuated multiple times during a single surgical procedure, it may be desirable to enable the operator to repeatedly and easily load the support assembly (110, 112) onto the lower jaws and anvil (16, 18) during that single surgical procedure. Figures 11 to 13B An exemplary chamber (210) (also referred to as a “support application device”) is shown, which can be used to support, protect, and apply auxiliary materials, such as support assemblies (110, 112), to the end effector (12). Figures 11 to 12 As best shown, the compartment (210) of this example includes an open end (212) and a closed end (214). The open end (212) is configured to receive an end actuator (12), as will be described in more detail below. The compartment (210) also includes a first housing (216a) and a second housing (216b), which together generally define a “U” shape to present the open end (212). A platform (218) and a slider retainer (220) are interposed between the first housing (216a) and the second housing (216b).
[0063] The platform (218) of this example is configured to support a pair of support assemblies (110) on one side of the platform (218) and another pair of support assemblies (112) on the other side of the platform (218). The platform (218) is exposed in a recess formed between the forks of the “U” configuration of the first housing (216a) and the second housing (216b). Each support assembly (110, 112) is respectively disposed in a separate corresponding pair of portions to avoid crossing the slots (42, 49) of the anvil (18) and the staple cartridge (37), but the platform (218) can equally easily support a wide-type support assembly (110, 112) that crosses the slots (42, 49) of the anvil (18) and the staple cartridge (37) individually, respectively. More specifically, the outer edge of the platform (218) includes a ridge-shaped retaining feature (530) that further engages the first housing (216a) and the second housing (216b) to prevent the platform (218) from sliding relative to the first housing (216a) and the second housing (216b).
[0064] The first housing (216a) and the second housing (216b) include an integral gripping feature (222) and an indicator plate (224) positioned to correspond to a window (226) formed in the first housing (216a) and the second housing (216b), such that the indicator plate (224) is visible through the window (226) at different times. The arm (228) of this example is configured to selectively secure the support assemblies (110, 112) to the platform (218). The arm (228) of this example is resilient and is therefore configured to resiliently abut against the support assemblies (110, 112), thereby causing the support assemblies (110, 112) to retract against the platform (218). The compartment (210) includes a pair of cam surfaces (232) with gradually changing cross-sections and a corresponding pair of housing engagement features (234) positioned to engage corresponding surfaces of the first housing (216a) and the second housing (216b). The first housing (216a) and the second housing (216b) include a proximal guide feature (236) and a distal guide feature (238) configured to assist in providing proper alignment of the end effector (40) with the housing (210).
[0065] Figure 13A A compartment (210) is shown in which the retainer arm (228) is positioned against the platform (218) to hold the support assembly (110, 112); while Figure 13B A compartment (210) is shown in which the retainer arm (228) is positioned to release the support assembly (110, 112) from the platform (218). Figures 13A to 13B Only the support assembly (110) on the platform (218) is shown; the support assembly (112) is held on and released from the platform (218) in the same manner. To use the bin (210) to load the end effector (12), the operator will first position the bin (210) and the end effector (12) such that the end effector is aligned with the open end (212) of the bin (210), as shown. Figure 13A As shown. The operator then advances the distal end effector (12) and / or the proximal end chamber (210) to position the platform (218) and support assemblies (110, 112) between the anvil (18) and the staple cartridge (37), as shown. Figure 13BAs shown. Then, the operator squeezes the closing trigger (26) of the instrument (10) to close the lower jaws and anvil (16, 18) on the platform (218), thereby adhering the support assembly (110, 112) to the anvil (18) and the cartridge (37), and simultaneously presses the cam surface (232). The pressing of the cam surface (232) laterally actuates the retainer arm (228), thereby releasing the support assembly (110, 112) from the platform (218), so that the lower jaws and anvil (16, 18) can disengage from the platform (218), while the support assembly (110, 112) remains adhered to the anvil (18) and the cartridge (37).
[0066] III. An exemplary static wedge for applying an accessory to a surgical stapler end effector with an open jaw. Auxiliary application device and method
[0067] In some cases, it may be desirable to provide an application device configured to apply a staple-reinforcing accessory to one or both jaws of a surgical stapler end effector while the jaws remain open, or otherwise prevent the jaws from closing via actuation of the end effector closure system of the stapler (such as via actuation of the closure trigger (26) of the surgical stapler (10). The exemplary application devices described below provide such functionality, such that each application device is configured to be manipulated relative to the end effector to apply the accessory to one or both jaws without requiring the aforementioned... Figures 13A to 13B The jaws are actuated and closed as shown.
[0068] It should be understood that any of the exemplary application devices described below can be configured to apply the auxiliary element in the form of a support (such as the support assembly (110, 112) described above) or a tissue thickness compensator (e.g., of the type disclosed in U.S. Patent Publication No. 2012 / 0080336 entitled “Staple Cartridge Comprising Staples Positioned Within A Compressible Portion Thereof,” published April 5, 2012 and now abandoned, the disclosure of which is incorporated herein by reference). Additionally, the application of the nail reinforcement element to the end effector jaws can be achieved using adhesive features as described above and / or mechanically connected features (e.g., of the type disclosed in U.S. Patent No. 7,665,646 entitled “Interlocking Buttress Material Retention System,” published February 23, 2010, the disclosure of which is incorporated herein by reference). Furthermore, any of the exemplary application devices described below can be suitably configured for single or multiple use.
[0069] A. Exemplary static wedge-shaped auxiliary application device
[0070] In some cases, it may be desirable to provide a compact application device configured to apply the staple reinforcement accessory to one or both jaws of the surgical stapler end actuator while the jaws remain open, or otherwise prevent the jaws from closing via actuation of the end actuator closure system of the stapler (such as via actuation of the closure trigger (26) of the surgical stapler (10)).
[0071] Figures 14 to 16 An exemplary accessory application device assembly (300) is shown, comprising a wedge-shaped application device component (308) and a base (302). The wedge-shaped application device component (308) includes a body (309), a first accessory element (304), and a second accessory element (306). The body (309) may be disposable or reusable. In a disposable type, the body (309) may be constructed from foam board, cardboard, plastic, or any other low-cost material known in the art that is sufficiently rigid, planar, and provides support. This type of body (309) intended for disposal may be discarded after a single use. In some types, the body (309) may be constructed from cardboard that can be treated with a surgically safe surface coating (334). The body (309) may include a rigid outer layer (such as plastic or any other low-cost material known in the art) to provide a rigid corrugated or foamed center within a thin layer. In some reusable forms, the body (309) may be constructed of a reusable material (such as stainless steel) or any other material known in the art to provide a sufficiently rigid surface that can be configured to present sterilizable surfaces at different angles. In some forms, such reusable materials may be pre-formed into a folded configuration and can be sterilized using methods further described below.
[0072] In this example, the body (309) of the wedge-shaped application device component (308) has a first panel (313), a second panel (315) opposite to the first panel (313), and a connecting panel (340) that engages the proximal end of the first panel (313) with the proximal end of the second panel (315). The first panel (313) defines a first contact surface (314). The first contact surface (314) is generally rectangular and is located on the outside of the first panel (313). The first panel (313) extends from the connecting panel (340) to a first foot (320). The first foot (320) has a trapezoidal shape, the wider base of which abuts the first panel (313), and the narrower apex of which extends distally from the center portion of the end opposite to the connecting panel (340) away from the first panel (313). The second panel (315) is also generally rectangular and defines a second contact surface (316) located on the outer surface opposite to the second panel (315). The second panel (315) extends from the connecting panel (340) to the second foot (322). The second foot (322) has a trapezoidal shape with a base adjacent to the second panel (315) and a top extending distally away from the second panel (315).
[0073] Each first and second accessory element (304, 306) has a corresponding first side (310) and a corresponding second side (312). In this embodiment, the first side (310) of each first and second accessory element (304, 306) is configured to be releasably attached to the first and second contact surfaces (314, 316) respectively via a first attachment feature (342). For example, the first attachment feature (342) includes an adhesive (not shown) and / or a mechanical attachment such as a retainer arm 228 (in Figure 12 (As shown in the diagram). The first attachment feature (342) is configured to removably attach the first and second attachment elements (304, 306) to the first and second contact surfaces (314, 316). In some forms, the adhesive may be a glue, cement, viscous liquid, or paste. In some forms, in view of the teachings herein, the first attachment feature (342) may be of any type readily apparent to a person skilled in the art for removably attaching attachments to an application device assembly.
[0074] The second side (312) of each of the first and second auxiliary elements (304, 306) includes a second attachment feature (344) configured to attach to the open lower jaws and anvils (16, 18) of the end effector (12). The second attachment feature (344) has stronger adhesive properties than the first attachment feature (342). Similar to the first attachment feature (342), the second attachment feature (344) may also include an adhesive (not shown) and / or a second mechanical attachment feature (not shown). Any combination of adhesive or mechanical attachment may be used for the first and second attachment features (342, 344), provided that the second attachment feature (344) has stronger adhesive properties than the first attachment feature (342). The first and second auxiliary elements (304, 306) may be in the form of a support assembly, such as the support assembly (110, 112) described above; or alternatively, a thickness compensator (not shown). The second side (312) of the first and second auxiliary elements (304, 306) may have a membrane (346) covering and protecting the second attachment feature (344). The membrane (346) may include a gripping portion (347) that extends proximally when the wedge-shaped application device member (308) is in a folded configuration, allowing the user to easily remove the membrane (346) without interfering with the attachment characteristics of the first and second auxiliary elements (304, 306).
[0075] In some forms, the first and second auxiliary elements (304, 306) may be supports comprising a three-layer polymer structure including a core layer sandwiched between two outer layers to provide a robust yet flexible support for a row of studs. In this example, the core layer is polyglactin 910, while each outer layer is a poly(p-dioxanone) or p-dioxanone (PDO) film material. The auxiliary elements (304, 306) of this example are formed by laminating the core layer between the outer layers over a predetermined time. The auxiliary elements (304, 306) are further mechanically cut to a specific size to suppress rough edges, such as burrs and / or delamination, that could damage sensitive tissue. It should be understood that alternative methods for cutting the auxiliary elements (304, 306), such as laser cutting or hot knife cutting, may be used similarly.
[0076] The base (302) may be constructed of foam, cardboard, plastic, or any other low-cost material known in the art to protect the article from damage during transport and to provide additional structural support. The base (302) is configured to be placed on a working surface such that the sides (324) face upward. The sides (324) of the base (302) include a first slot, a second slot, and a third slot (328, 330, 332) configured to receive a first foot and a second foot (320, 322). The slots (328, 330, 332) are spaced apart along the centerline of the sides (324) and aligned with each other. The slots (328, 330, 332) extend laterally relative to the centerline (not shown) and are sized to receive the feet (320, 322). In some configurations, the base (302) may include a recess (not shown) configured to receive the auxiliary application device assembly (300) and the first and second auxiliary elements (304, 306) within the base (302) to protect the auxiliary application device assembly (300) and the first and second auxiliary elements (304, 306) during transport.
[0077] Figure 15 This shows that the wedge-shaped application device component (308) has been deployed from its unfolded position. Figure 16 The auxiliary application device assembly (300) is transformed into a folded position and aligned for assembly with the base (302). In the folded position, the lateral distance between the first panel (313) and the second panel (315) gradually increases in the direction away from the connecting panel (340), thus providing a body (309) with a wedge shape that tapers in the direction towards the connecting panel (340). To transform the auxiliary application device assembly (300) from the unfolded position to the folded position, the connecting panel (340) is folded such that the first panel (313) and the second panel (315) define a first angle (θ1) between them, which may range, for example, from about 20 degrees to about 45 degrees. Figure 15 As shown, the auxiliary application device assembly (300) is vertically aligned with the base (302) by aligning the first handle (320) with the first slot (328) and the second handle (322) with the second slot (330). In other embodiments, the base (302) may include one or more additional slots configured to set the first and second panels (313, 315) at one or more additional angles ranging from about 20 degrees to a maximum of 45 degrees.
[0078] In other configurations, the base (302) may include one or more pairs of slots (not shown) similar to slots (328, 330, 332), which are equidistant from each other around a center point (not shown) along a centerline on the side (324) such that the feet (320, 322) can be inserted into the first pair of slots. When the feet (320, 322) are inserted into the first pair of slots, a first angle (θ1) is formed between the first panel and the second panel (313, 315). The distance between the first panel (313) and the second panel (315) increases as the first panel (313) and the second panel (315) extend distally away from the connecting panel (340). The second pair of slots is further spaced apart from the first pair of slots around the center point, such that when the first and second shanks (320, 322) are inserted into the second pair of slots which are further spaced apart from each other relative to the first pair of slots, the first panel (313) and the second panel (315) define a larger second angle (θ2).
[0079] Figure 16 A wedge-shaped application device component (308) in a planar unfolded configuration is shown. In the unfolded position, the wedge-shaped application device component (308) lies flat and extends longitudinally from a first handle (320) to a first panel (313). The first panel (313) extends further distally to a connecting panel (340). A second panel (315) extends from the connecting panel (340) to a second handle (322). The auxiliary application device assembly (300) is configured to be contained within a sealed sterile barrier (not shown) of the product packaging during transport and storage, such that the body (309), the first and second auxiliary elements (304, 306), and the base (302) remain sterile. By way of example only, such product packaging may be of the type disclosed in U.S. Patent Publication No. 2020 / 0205825, entitled “Method of Applying Buttresses to Surgically Cut and Stapled Sites,” published July 2, 2020, the disclosure of which is incorporated herein by reference. To house these components within a sterile barrier, it may be advantageous to minimize the size of the adjunct application device assembly (300) or otherwise provide the adjunct application device assembly (300) with the ability to assemble from a collapsed state. It may also be advantageous to use the base (302) as part of the packaging material to protect the adjunct application device assembly (300) during transport.
[0080] The connecting panel (340) of this example is configured as a joint or hinge to facilitate folding of the wedge-shaped application device member (308). The connecting panel (340) is flat in the unfolded position and extends from a first crease (336) to a second crease (338). The first crease (336) abuts a first panel (313), and the second crease (338) abuts a second panel (315). The first and second creases (336, 338) include perforations or release portions transverse to the length of the wedge-shaped application device member (308). The perforations or release portions are configured to facilitate flexure of the connecting panel (340) relative to each of the first panel (313) and the second panel (315). As another example, the connecting panel (340) may include only the first crease (336) or may include multiple creases and multiple end plates for engaging the first panel (313) and the second panel (315). In yet another example, the body (309) can be transported in a partially folded configuration. In the partially folded configuration, the first crease (336) is folded to 180 degrees and the second crease (338) remains straight, such that the rear side of the first panel (313) is folded and engages the rear side of the second panel (315) to preserve longitudinal space within the sterile barrier.
[0081] Figure 17A A wedge-shaped applicator component (308) is shown attached to a base (302), wherein the end actuator (12) is longitudinally aligned with the resulting auxiliary applicator assembly (300). The base (302) is positioned on a working surface with the side face (324) facing upwards such that the slots (328, 330, 332) face upwards. The wedge-shaped applicator component (308) is attached to the base (302) by inserting a first foot (320) into the first slot (328) and a second foot (322) into the second slot (330) and by pressing the wedge-shaped applicator component (308) downwards. The first foot and the second foot (320, 322) attached to the first slot and the second slot (330, 332) thereby fix the angular relationship between the first panel and the second panel (313, 315) to define a first angle (θ1) opening to the distal side. As described above, the base (302) may include one or more additional slots configured such that the first angle (θ1) of the distal opening defined by the first panel and the second panel (313, 315) can be set to any desired angle.
[0082] Figure 17BThe lower jaws and anvils (16, 18) of the end effector (12) in the open position are shown, engaging the wedge-shaped application device member (308) of the auxiliary application device assembly (300). Before engaging the auxiliary application device assembly (300) with the lower jaws and anvils (16, 18) of the end effector (12), the membrane (346) has been removed from the first and second auxiliary elements (304, 306). The lower jaws (16) of the end effector (12) engage the second side (312) of the first auxiliary element (304) while the anvil (18) simultaneously engages the second side (312) of the second auxiliary element (306). The aforementioned second attachment features (344) of the first and second auxiliary elements (304, 306) are attached to the lower jaws and anvils (16, 18), respectively. When held in the open position, the end effector (12) is then pulled upwards away from the auxiliary application device assembly (300). The second attachment feature (344) of the first and second auxiliary elements (304, 306) remains attached to the lower jaw and anvil (16, 18) because the first attachment feature (342) allows the auxiliary elements (304, 306) to be released from the first and second contact surfaces (314, 316) of the wedge-shaped application device member (308). The first and second auxiliary elements (304, 306) attached to the lower jaw and anvil (16, 18) are prepared for use in surgical procedures. It should be understood that by keeping the lower jaws and anvil (16, 18) in the open state, while attaching the auxiliary elements (304, 306) to the lower jaws and anvil (16, 18) via the auxiliary application device assembly (300), the operator can control the force used to place the auxiliary elements (304, 306) onto the lower jaws and anvil (16, 18) by selectively advancing the end actuator (12) longitudinally toward the auxiliary application device assembly (300) which can be kept stationary as shown in this example.
[0083] B. An exemplary static wedge-shaped auxiliary application device with corner wings
[0084] In some cases, it may be desirable to modify the above-described auxiliary application device assembly (300) to include additional structural supports to provide additional rigidity to the first and second panels (313, 315), thereby preventing the first and second panels (313, 315) from bending inward or outward, so that the auxiliary elements (304, 306) adhere uniformly to the lower jaws and anvil (16, 18). Figures 18 to 21 A second exemplary accessory application device assembly (400) is shown, which has a pair of first and second corner wings (446, 448) that can provide the beneficial effects of such functionality.
[0085] Figure 18A wedge-shaped application device member (408) of the auxiliary application device assembly (400) in the deployed position is shown. The auxiliary application device assembly (400) is constructed similarly to the auxiliary application device assembly (300) described above, except as further described below. Similar to the auxiliary application device assembly (300), the auxiliary application device assembly (400) includes a wedge-shaped application device member (408) and a base (302). The wedge-shaped application device member (408) includes a body (409) and a first auxiliary element and a second auxiliary element (304, 306). The wedge-shaped application device member (408) and the base (302) are constructed of a material similar to that of the wedge-shaped application device member (308) and the base (302) of the auxiliary application device assembly (300). Figure 18 As shown, the main body (409) of the auxiliary application device assembly (400) in the unfolded position extends longitudinally from the first handle (420) to the first panel (413). The first panel (413) extends toward the connecting panel (440). The second panel (415) extends from the connecting panel (440) toward the second handle (422). The first panel and the second panel (413, 415) define a first contact surface and a second contact surface (414, 416), respectively, similar to the first contact surface and the second contact surface (314, 316) of the auxiliary application device assembly (300). A first auxiliary element and a second auxiliary element (304, 306) are attached to the first contact surface and the second contact surface (414, 416) on their first side (310), respectively.
[0086] The body (409) of the wedge-shaped application device component (308) differs from the body (309) of the wedge-shaped application device component (408) in that the body (409) also includes a first diagonal wing and a second diagonal wing (446, 448) formed on the side portions of the first panel and the second panel (413, 415). Specifically, the first diagonal wing (446) is formed on the side portion of the first panel (413) and is configured as a trapezoidal planar panel extending laterally from the edge (450) of the first panel. The edge (450) of the first panel extends parallel to the length of the unfolding body (409) along the outer edge of the first panel (413). The edge (450) of the first panel can be perforated or released to facilitate bending or tearing of the first wing (446) relative to the first panel (413). In this embodiment, the first diagonal wing (446) forms a pair of trapezoidal planar panels. The right angle of the trapezoidal shape is located at the end near the first foot (420). Each of the first corner wings (446) defines a first outer edge (452) configured to abut the inner surface of the second panel (415) to define a first predetermined angle (θ1) between the first panel and the second panel (413, 415), the first predetermined angle opening to the distal side and being within the range of approximately 20 degrees to approximately 45 degrees.
[0087] The second diagonal wing (448) extends laterally from the second panel edge (454) of the second panel (415) to form a trapezoidal planar panel with a right angle. The right angle of each first wing (448) is located at the end near the first foot (420). The second panel edge (454) extends parallel to the length of the unfolding body (409) along the edge of the second panel (415). Similar to the first panel edge (450), the second panel edge (454) may be perforated or released to facilitate bending or tearing of the second diagonal wing (448) relative to the second panel (315). The second diagonal wing (448) is a mirror version of the first diagonal wing (446), and each second wing (448) defines a second outer edge (456) to define a second predetermined angle (θ2) between the first panel and the second panel (413, 415) from approximately 20 degrees to approximately 45 degrees (see See Figure 21 The second angle (θ2) can be the same as or different from the first angle (θ1).
[0088] In this example, the second diagonal wing (448) is suitably shaped such that the resulting second angle (θ2) is greater than the first angle (θ1) defined by the first wing (446) between the first panel and the second panel (413, 415), for example as Figure 21 and Figure 19 As shown above, the user can selectively deploy the first wing (446) in the manner described above to define a relatively small first angle (θ1) between the first panel and the second panel (413, 415) for use with an end actuator (12) having a relatively small jaw opening (also referred to as an "orifice") between the anvil (18) and the deck (72) of the staple cartridge (37) in the open state. Alternatively, the user can selectively deploy the second diagonal wing (448) in the manner described above to define a relatively large second angle (θ2) between the first panel and the second panel (413, 415) for use with an end actuator (12) having a relatively large jaw opening in the open state.
[0089] Figure 19 The wedge-shaped applicator component (408) is shown in a folded configuration after being transformed from an unfolded configuration. The wedge-shaped applicator component (408) is transformed into a folded configuration by folding the first and second panels (413, 415) relative to the connecting panel (440) along the first and second creases (436, 438). Figure 16 The unfolded configuration transforms into Figure 19 and Figure 20In one of the folding configurations shown, the first diagonal wing (446) or the second diagonal wing (448) folds along the edge of the first panel or the edge of the second panel (450, 454), respectively. The first outer edge or the second outer edge (452, 456) engages the inside of the second panel (415) or the first panel (413), respectively. For example, if the user wishes to set the auxiliary application device assembly (400) to a first angle (θ1), the user can fold the first diagonal wing (446) inward along the edge of the first panel (450) to engage the inside of the second panel (415). The second diagonal wing (448) can be folded away, remaining unfolded, or torn off along the edge of the second panel (454) such that when the first diagonal wing (448) is folded to engage the inside of the first panel (413), the second diagonal wing (446) does not interfere with the first diagonal wing (446).
[0090] In order to set the auxiliary application device assembly (400) at the second angle (θ2), the second diagonal wing (448) is folded inward along the edge (454) of the second panel so that the second outer edge (456) engages the inside of the first panel (413). The first diagonal wing (446) can be folded away and left unfolded, or torn open and discarded along the edge (450) of the first panel, such that the first diagonal wing (448) does not interfere with the second diagonal wing (448) when the second diagonal wing (446) is folded to engage the inside of the first panel (413).
[0091] Figure 20 A subordinate applicator assembly (400) is shown prior to the connection of the wedge applicator member (408) to the base (302), wherein the wedge applicator member (408) is in a first folded configuration, in which a first panel and a second panel (413, 415) define a first angle (θ1) therebetween. The base (302) rests on a working surface, wherein the side (324) faces upward. When the wedge applicator member (408) is set to the first angle (θ1), the first slot (328) and the second slot (330) are longitudinally spaced apart by a distance equal to the distance between the first foot and the second foot (420, 422). The first and second handles (420, 422) are aligned with the first and second slots (428, 430), and then the wedge-shaped application device member is pressed down (408), thereby inserting the first and second handles (420, 422) into the first and second slots (428, 430).
[0092] Figure 21The diagram shows a wedge-shaped applicator component (408) in a second folded configuration, wherein the wedge-shaped applicator component (408) is coupled to an auxiliary applicator assembly (400) of a base (302), in which a first panel and a second panel (413, 415) define a second angle (θ2) therebetween. When the wedge-shaped applicator component (408) is set to the second angle (θ2), a first slot (328) and a third slot (332) in the base (302) are spaced apart by a distance equal to the distance between the first foot and the second foot (420, 422). The wedge applicator component (408) is attached to the base (302) by aligning the first handle (420) with the first slot (328) and inserting the first handle (420) into the first slot (328), while aligning the second handle (422) with the third slot (332) and inserting the second handle (422) into the third slot (332) by pressing the wedge applicator component (408) downward in the direction of downward.
[0093] As described above, it should be understood that the wedge-shaped application device component (408) can be suitably configured to present a wedge shape at various predetermined angles, and in each of such predetermined configurations, the slots (328, 330, 332) of the base (302) can be suitably spaced apart to receive the shank (420, 422) of the wedge-shaped application device component (408). Thus, the user can easily modify and adapt the wedge-shaped application device component (408) for use with an end effector (12) having a jaw opening between the platform (72) of the anvil (18) and the cartridge (37) in the fully open state.
[0094] C. An exemplary static wedge-shaped auxiliary application device with an adjustable support column
[0095] In some cases, it may be desirable to attach the appendage to the open lower jaws and anvil (16, 18) of the end effector (12) via a compact, sterile, disposable appendage application device assembly. Additionally, it may be advantageous to configure such appendage application device assemblies at different predetermined angles, allowing them to be used with different end effectors and / or at an optimal angle for a particular appendage. It may also be desirable to have an appendage application device assembly that can be manipulated by the user to engage the open lower jaws and anvil (16, 18) of the end effector (12) without requiring a base of working surface, such as the base (302) described above. Figures 22 to 24 A third exemplary accessory application device assembly (500) is shown that can provide the beneficial effects of such functionality.
[0096] Figure 22An accessory application device assembly (500) in a non-expandable storage configuration is shown. The accessory application device assembly (500) is similar to the accessory application device assembly (300) described above, except as further described below. Similar to the accessory application device assembly (300), the accessory application device assembly (500) includes a wedge-shaped application device member (508), a first accessory element (304), and a second accessory element (306). The accessory application device assembly (500) is also configured to be contained within a sealed sterile barrier (not shown) of the product packaging during transport and storage, such that it is sealed within a sterile bag (not shown) during transport and storage. The accessory application device assembly (500) may be constructed from a material similar to that of the accessory application device assembly (300). The accessory application device assembly (500) includes a body (509) that may be disposable or reusable. The auxiliary application device assembly (500) is configured to transfer the first auxiliary element and the second auxiliary element (304, 306) to the open lower jaw and anvil (16, 18) of the end effector (12).
[0097] The difference between the auxiliary application device assembly (500) and the auxiliary application device assembly (300) is that the auxiliary application device assembly (500) is configured to be manually operated and inserted into the open lower jaws and anvils (16, 18) of the end effector (12) without being coupled to the base (302), and the body (509) can be folded into a storage configuration to minimize the space occupied by the body (509) within the sterile barrier of the product packaging.
[0098] The body (509) includes a first panel (513), a second panel (515), a third panel (502), a first curved notch (504), a second curved notch (506), a connecting portion (518), and a support (520). In the non-expanded storage position, the body (509) extends proximally from the third panel (502) to the first curved notch (504). The third panel (502) serves as a handle configured to be ergonomically gripped by a user with their thumb and / or fingers. The third panel (502) engages with the first panel (513) at the first curved notch (504). The first curved notch (504) is a V-shaped notch located on the outer surface (522) of the body (509) between the third panel (502) and the first panel (513). The outer surface (522) is the outward-facing surface of the body (509). The first curved notch (504) may include an adhesive (not shown) configured to hold the third panel (502) in a lateral position relative to the longitudinally extending first panel (513). Figure 23 (As shown).
[0099] The first panel (513) includes a first angular notch (544), a second angular notch (546), and a third angular notch (548) located on the distal portion of the inner surface (524). The inner surface (524) is the inward-facing surface of the body (509). The first panel (513) extends proximally from the first curved notch (504) to the connecting portion (518). The connecting portion (518) engages the proximally end of the first panel (513) with the proximally end of the second panel (515). The connecting portion (518) may be in the form of a flexible U-bend or a V-bend and is configured to allow the first panel and the second panel (513, 515) to be angularly deflected relative to each other between a plurality of angular configurations. The connecting portion (518) may include one or more flexural features (538), which may be in the form of creases or interconnecting plates (not shown) similar to the first and second creases (336, 338) and the connecting panel (340) of the auxiliary application device assembly (300). A second panel (515) extends distally from the connecting portion (518) to a second curved notch (506). The second curved notch (506) is located on the inner surface (554) of the second panel (515) and engages a support (520) to the second panel (515). The support (520) extends distally from the second curved notch (506) to a support end (540). The second curved notch (506) may be a V-shaped notch located on the inner surface (554) of the second panel (515). The support end (540) is configured to selectively engage one of the angled notches (544, 546, 548). The first and second auxiliary elements (304, 306) are releasably attached to the first and second panels (513, 515) on the outer surface (522).
[0100] Figure 23 The attached application device assembly (500) is shown in a first expanded angle configuration with the open lower jaws and anvils (16, 18) of the engaging end actuator (12). The attached application device assembly (500) has been moved from the storage configuration by bending the third panel (502) at the first curved notch (504) and the support column (520) at the second curved notch (506). Figure 22The third panel (502) is laterally bent downward relative to the first panel (513) toward the outer surface (522) at the first curved notch (504). The pillar (520) is laterally bent downward relative to the second panel (515) toward the inner surface (524) of the first panel (513) at the second curved notch (506). In the example shown, the end of the pillar (540) engages with and is held by the first angle notch (544). The first angle notch (544) is positioned distally relative to the second and third angle notches (546, 548). The end of the pillar (540) is held by the first angle notch (544) such that the first panel (513) and the second panel (515) define a first angle (θ1) between them, which may range, for example, from about 20 degrees to about 45 degrees. In the first folded position, the lateral distance between the first panel (513) and the second panel (515) gradually increases in the direction away from the connecting portion (518), thus providing a wedge-shaped application device member (508) with a wedge shape that tapers in the direction toward the connecting portion (518).
[0101] Before the lower jaws and anvils (16, 18) of the end effector (12) engage the wedge-shaped applicator component (508), the membrane (346) is removed from the second side (312) of the first and second auxiliary elements (304, 306). The user can grasp or hold the third panel (502) between the fingers and thumb of one hand while using the other hand to press the wedge-shaped applicator component (508) into the open lower jaws and anvils (16, 18) of the end effector (12). The open lower jaws and anvils (16, 18) of the end effector (12) will engage the first and second auxiliary elements (304, 306). The second side (312) of the first and second auxiliary elements (304, 306) is attached to the open lower jaws and anvils (16, 18). The user then removes the end effector (12) from the wedge-shaped application device component (508), which causes the first and second auxiliary elements (304, 306) to detach from the application device component (508) while remaining fixed to the open lower jaws and anvil (16, 18).
[0102] Figure 24 The attached application device assembly (500) is shown with the open lower jaws of the engagement end actuator (12) and the anvil (16, 18) in a second expanded angular position. The wedge-shaped application device component (508) is positioned similarly to the first angular position described above. Figure 23 (as shown) from the storage location ( Figure 22(As shown) it transforms into a second angle configuration. Specifically, the third panel (502) bends around the first curved notch (504) and the support (520) bends around the second curved notch (506). The third panel (502) bends laterally downward relative to the first panel (513) toward the outer surface (522) at the first curved notch (504). The support (520) bends laterally downward relative to the second panel (515) toward the inner surface (524) of the first panel (513) at the second curved notch (506). The end of the support (540) engages with and is held by the second angle notch (546). The second angle notch (546) is proximal to the first angle notch (544) and distal to the third angle notch (548). Once the support end (540) is held by the second angle notch (546), the first panel (513) and the second panel (515) define a second angle (θ2) between them, which can range from approximately 20 degrees to approximately 45 degrees. In this example, in the second folded position, the second angle (θ2) is greater than the first angle (θ1). Figure 23 As shown), and therefore the lateral distance between the first panel (513) and the second panel (515) gradually increases toward the far side at a greater rate than in the first folded position.
[0103] Although not shown, the support (520) may also be placed in a third angle notch (548) such that the first panel (513) and the second panel (515) define a third angle between the first panel (513) and the second panel (515), which is greater than the second angle (θ2) and may be approximately 20 degrees to approximately 45 degrees. As another example, which is only illustrative, the inner surface (524) of the first panel (513) may include one or more additional angle notches configured to define an additional predetermined angle between the first panel and the second panel (513, 51) ranging from approximately 20 degrees to approximately 45 degrees.
[0104] D. An exemplary accessory application device assembly having a force-limiting feature
[0105] In some cases, it may be desirable to limit the force of the open lower jaws and anvils (16, 18) used to attach the accessory to the end effector (12) to a predetermined force, thereby avoiding excessive force that could otherwise damage the end effector (12) and / or the accessory (304, 306). Figures 25 to 26B A fourth exemplary accessory application device component (600) is shown that can provide the beneficial effects of such functionality.
[0106] like Figure 25As shown, the auxiliary application device assembly (600) includes a wedge-shaped application device member (608), which may be structurally and functionally similar to any of the exemplary wedge-shaped application device members (308, 408, 508) described above. The application device member (608) includes a body (610) and first and second attachments (304, 306) disposed on opposite sides of the body (610). The auxiliary application device assembly (600) also includes an elastic member in the form of a helical spring (602), a housing (604), and a linking feature (606). The housing (604) may be configured as a combination of the first and second housings (216A, 216B) of the support applicator compartment (210) described above, and in this example is configured as a chassis that provides a rigid support structure capable of supporting the wedge-shaped application device member (608). The wedge-shaped application device member (608) is slidably connected to the housing (604) via the linking feature (606). The helical spring (602) biases the body (610) toward the proximal side. Figure 26A The proximal position is shown. The body (610) may be made of surgically safe plastic, stainless steel, or other materials known in the art that can be sterilized.
[0107] Similar to the auxiliary application device assembly (300), the wedge-shaped application device member (608) includes: a first contact feature (613) including a first contact surface (614), a second contact feature (615) including a second contact surface (616), and a connecting feature (640) interconnecting the first contact feature and the second contact feature (613, 615) at least at their proximal ends. A first auxiliary element (304) is mounted to the first contact surface (614) of the first contact feature (613), and a second auxiliary element (306) is mounted to the second contact surface (616) of the second contact feature (614). In some embodiments, the connecting feature (640) may be suitably configured to allow the first contact feature and the second contact feature (613, 615) to move toward and away from each other about their proximal ends via a range of angular positions in which the body (610) defines a distal opening angle. In other forms, the body (610) may be a static structure in which the first contact feature and the second contact feature (613, 615) are fixed at an angle relative to each other so that the body (610) is configured to define a single distal opening angle.
[0108] The wedge-shaped application device component (608) is slidably coupled to the housing (604) via a movable member in the form of a plurality of support arms (642) and a roller (644). Each support arm (642) is fixedly attached to the wedge-shaped application device component (608) at a first end (646) and rotatably coupled to the roller (644) at a second end. This type includes up to four support arms (642), with two support arms (642) attached to each lateral side of the wedge-shaped application device component (608). In other types, a variety of other numbers and arrangements of support arms (642) may be employed. In still other types, the movable member may take the form of a slider, a disc, a slide, or any other structure known in the art that facilitates linear translation of the body relative to the chassis.
[0109] The housing (604) extends longitudinally from an open end (650) to a closed end (652) and has a “U” shape. The open end (650) is configured to receive the open lower jaws and anvils (16, 18) of the end effector (12). The housing (604) also includes a longitudinally extending first housing side portion and a second housing side portion (654, 658). The first housing side portion (654) has a first channel (656) and the second housing side portion (658) has a second channel (660) laterally opposite to the first channel (656). The first housing side portion and the second housing side portion (654, 658) together define the “U” shape of the housing (604). Each channel (656, 660) accommodates one or more rollers (644). Each channel (656, 660) extends longitudinally along the corresponding first or second housing side portion (654, 658) and is configured to allow the roller (644) to rotate, thereby enabling the wedge-shaped application device member (608) to translate proximally and distally relative to the housing (604).
[0110] A coil spring (602), shown as a tension coil spring, is operatively attached between a housing (604) and a linking feature (606). In this embodiment, the linking feature (606) is connected to the proximal portion of the wedge-shaped applicator member (608) within the first housing side portion (654). In other embodiments, an additional coil spring (602) may be located within a second housing side portion (658) and attached between the additional linking feature (606) and the proximal portion of the housing (604). In still other embodiments, the linking feature (606) may be fitted between the coil spring (602) and the distal portion of the housing (604). In all such embodiments, the coil spring (602) is in a contracted, relaxed state when the wedge-shaped applicator member (608) is in a proximal position relative to the housing (604).
[0111] Figure 26AThe open lower jaws and anvil (16, 18) of the end effector (12) are shown, engaging with first and second accessory elements (304, 306) on first and second contact surfaces (614, 616), with the wedge-shaped applicator member (608) in a proximal position relative to the housing (604) and the coil spring (602) in a retracted state. In the proximal position, the coil spring (602) biases the wedge-shaped applicator member (608) in a proximal direction. The open lower jaws and anvil (16, 18) of the end effector (12) are forced distally against the first and second accessory elements (304, 306), which are supported by first and second contact features (613, 615), respectively.
[0112] Figure 26B This demonstrates how the elastic bias of the helical spring (602) is sufficient to overcome and how the wedge-shaped application device component (608) is moved from a proximal position ( Figure 26A The force actuated to the distal position where the helical spring (602) extends presses the open lower jaws and anvil (16, 18) of the end effector (12) distally. To move the application device member (608) to the distal position, the user applies sufficient longitudinal input force to overcome the predetermined biasing force applied proximally to the wedge-shaped application device member (608) by the helical spring (602). Once the distal input force applied by the user to the application device member (608) via the end effector (12) overcomes the proximal biasing force applied by the helical spring (602), the wedge-shaped application device member (608) moves distally relative to the housing (604). This distal translational capability of the application device member (608) relative to the housing (604) and the elastic biasing of the extended helical spring (602) effectively limit the magnitude of the force that the end effector (12) can apply to the application device member (608) in response to the user's input force. This configuration ensures that the longitudinal compressive force applied between the lower jaws and anvil (16, 18) and the application device component (608) is sufficient to effectively position the auxiliary elements (304, 306) on the lower jaws and anvil (16, 18), while also limiting this compressive force to protect the lower jaws and anvil (16, 18) and the application device component (608) from damage caused by additional excessive compressive force.
[0113] Roller (644) facilitates distal translation of the wedge-shaped applicator component (608) and maintains longitudinal alignment of the wedge-shaped applicator component (608) so that the first and second appendages (304, 306) do not become misaligned when applied to the lower jaws and anvils (16, 18) of the end effector (12). A portion of the end effector (12) engages a stop feature of the housing 604 to prevent the helical spring (602) from overextending beyond its designed range of motion and applying a force greater than predetermined to the first and second appendages (304, 306). This allows the helical spring (602) to apply a predetermined force proximally against the lower jaws and anvils (16, 18) of the end effector (12). As described above, this predetermined force is sufficient to attach the second side (312) of the first and second appendages (304, 306) to the open lower jaws and anvils (16, 18) of the end effector (12). Once a portion of the end effector (12) engages the stop feature of the housing (604), the end effector (12) moves proximally away from the auxiliary application device assembly (600). The attachment force of the second attachment feature (344) being greater than that of the first attachment feature (342) causes the first and second auxiliary elements (304, 306) to attach to the open lower jaws and anvils (16, 18) of the end effector (12).
[0114] IV. Exemplary Combinations
[0115] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated 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, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.
[0116] Example 1
[0117] An apparatus comprising: (a) a body including: (i) a first body portion; (ii) a second body portion opposite to the first body portion; and (iii) a connecting portion connecting a proximal end of the first body portion to a proximal end of the second body portion, wherein the connecting portion is configured to allow the first body portion and the second body portion to move toward and away from each other among a plurality of angular orientations, in each of the plurality of angular orientations the body defines a distal opening angle; (b) a first accessory element disposed on an outwardly facing surface of the first body portion; and (c) a second accessory element disposed on an outwardly facing surface of the second body portion, wherein the first body portion and the second body portion are fixable relative to each other in each of the angular orientations such that the first body portion is configured to apply the first accessory element to a first jaw of a surgical suture end effector and the second body portion is configured to simultaneously apply the second accessory element to a second jaw of the surgical suture end effector.
[0118] Example 2
[0119] According to the device of embodiment 1, the range of the distal opening angle defined by the body in the plurality of angular orientations is between approximately 20 degrees and approximately 45 degrees.
[0120] Example 3
[0121] The device according to any one of the foregoing embodiments further includes a base removably coupled to the body, wherein the base is configured to support the body at the plurality of angular orientations.
[0122] Example 4
[0123] According to the device of embodiment 3, the main body further includes a first tab extending from the first main body portion and a second tab extending from the second main body portion, wherein the first tab and the second tab are configured to engage with a plurality of slots in the base.
[0124] Example 5
[0125] The device according to any one of the foregoing embodiments further includes a first pair of wings coupled to the first body portion, wherein the first pair of wings is configured to engage and support the second body portion relative to the first body portion to define and maintain the distal opening angle.
[0126] Example 6
[0127] The device according to embodiment 5 further includes a second pair of wings coupled to the second main body portion, wherein the second pair of wings is configured to engage the first main body portion to define the distal opening angle.
[0128] Example 7
[0129] According to any one of Embodiments 3 to 4, the base includes a first slot configured to set the angular orientation of the body to define a first distal opening angle.
[0130] Example 8
[0131] According to the device of embodiment 7, the base includes a second slot configured to set the angular orientation of the body to define a second distal opening angle different from the first distal opening angle.
[0132] Example 9
[0133] The device according to any one of the foregoing embodiments, wherein the first main body portion includes a first panel and the second main body portion includes a second panel.
[0134] Example 10
[0135] The device according to any one of the foregoing embodiments, wherein at least one of the first auxiliary element or the second auxiliary element includes a support.
[0136] Example 11
[0137] The device according to any one of the foregoing embodiments, wherein at least one of the first accessory element or the second accessory element includes a tissue thickness compensator.
[0138] Example 12
[0139] The device according to any one of the foregoing embodiments, wherein the first accessory element and the second accessory element are releasably attached to the first body portion and the second body portion, respectively, by an adhesive.
[0140] Example 13
[0141] The device according to any one of the foregoing embodiments, wherein the main body includes a third main body portion configured to be gripped by a user.
[0142] Example 14
[0143] The device according to any one of the foregoing embodiments further includes a base having a first pair of slots and a second pair of slots, wherein the first pair of slots is configured to define a first distal opening angle of the body, and wherein the second pair of slots is configured to define a second distal opening angle of the body.
[0144] Example 15
[0145] A surgical assembly includes: (a) an end effector, wherein the end effector includes a first jaw and a second jaw, the first jaw having a plurality of stud-forming recesses and the second jaw having a plurality of openings configured to receive a plurality of studs; and (b) a device according to any of the preceding embodiments, wherein a first body portion is configured to apply a first accessory element to the first jaw, and wherein a second body portion is configured to apply a second accessory element to the second jaw.
[0146] Example 16
[0147] An assembly includes: (a) a surgical suture end effector including a first jaw and a second jaw; and (b) an auxiliary application device including: (i) a connecting portion; (ii) a first body portion extending distally from the connecting portion; (iii) a second body portion opposite to the first body portion and extending distally from the connecting portion, wherein the first body portion and the second body portion are configured to define a distal opening angle; (iv) a first auxiliary element positioned on the first body portion; and (v) a second auxiliary element positioned on the second body portion, wherein when the surgical suture end effector is in an open state, the first body portion is configured to apply the first auxiliary element to the first jaw and the second body portion is configured to apply the second auxiliary element to the second jaw.
[0148] Example 17
[0149] According to the assembly of embodiment 16, the device further includes a strut hinged to the second body portion, wherein the first body portion includes one or more retaining recesses arranged along the distal length of the first body portion, wherein the strut is configured to engage with a selected retaining recess to define a corresponding distal opening angle between the first body portion and the second body portion.
[0150] Example 18
[0151] According to any one of embodiments 16 to 17, the device further includes a third body portion hingedly connected to the distal end of the first body portion, wherein the third body portion is configured to be laterally deflected relative to a longitudinal axis defined by the distal length of the first body portion, and wherein the third body portion is configured to be gripped by a user.
[0152] Example 19
[0153] A method for applying an accessory element to the jaws of a surgical instrument end effector via an application device, wherein the application device includes a first body portion and a second body portion, the first body portion and the second body portion being fixable relative to each other in a non-parallel arrangement such that the first body portion and the second body portion define a distally opening angle, wherein the accessory element is positioned on one of the first body portion or the second body portion, the method comprising: (a) providing the end effector in an open position, wherein the end effector is configured to receive tissue between a first jaw and a second jaw of the end effector; (b) positioning the end effector around the application device in the open position such that the first jaw engages the first body portion and the second jaw simultaneously engages the second body portion; (c) moving the end effector and the application device toward each other to apply the accessory element to one of the first jaw or the second jaw; and (d) moving the end effector and the application device away from each other to disengage the accessory element from the application device while the accessory element remains attached to one of the first jaw or the second jaw.
[0154] Example 20
[0155] The method according to embodiment 19 further includes moving the first body portion and the second body portion relative to each other to change the distal opening angle defined by the first body portion and the second body portion.
[0156] V. Miscellaneous
[0157] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the foregoing teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.
[0158] Furthermore, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. Patent Application No. END9286USNP2, filed on the same date as this application, entitled “Apparatus and Method to Apply Buttress to End Effector of Surgical Stapler via DrivenMember”; U.S. Patent Application No. END9286USNP3, filed on the same date as this application, entitled “Apparatus and Method to Apply Buttresses Separately to Jaws of End Effector of Surgical Stapler”; U.S. Patent Application No. END9286USNP4, filed on the same date as this application, entitled “Apparatus and Method to Close End Effector of Surgical Stapler to Buttress”; and U.S. Patent Application No. END9286USNP4, filed on the same date as this application, entitled “Apparatus and Method to Detect Full Seating of Buttress Applicator in End Effector of Surgical Stapler”. The following U.S. patent applications were filed on the same date as this application: “Stapler” (Attorney File No. END9286USNP5); “Apparatus and Method to Apply Buttress to End Effector of Surgical Stapler with Authentication” (Attorney File No. END9286USNP6); and / or “Method of Applying Buttress to End Effector of Surgical Stapler” (Attorney File No. END9286USNP7). The disclosure of each of these U.S. patent applications is incorporated herein by reference.
[0159] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other public material set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with any existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that the incorporated material does not conflict with any existing public material.
[0160] The aforementioned devices can be applied to both traditional medical treatments and surgeries performed by medical professionals and robot-assisted medical treatments and surgeries. By way of example only, the various teachings herein can be readily incorporated into robotic surgical systems, such as the DAVINCI system from Intuitive Surgical, Inc. (Sunnyvale, California). ™ system.
[0161] Devices of the types described above may be designed for single-use and disposal, or they may be designed for multiple uses. In either or both cases, these types may be repaired for reuse after at least one use. Repair may include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts, and subsequently reassembling. Specifically, some types of devices may be disassembled, and any combination may be used to selectively replace or remove any number of specific parts or portions of the device. While cleaning and / or replacing specific components, some types of devices may be reassembled at a repair facility or by the user prior to surgery for subsequent use. Those skilled in the art will appreciate that device repair can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired devices are within the scope of this application.
[0162] By way of example only, the types described herein can 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 can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.
[0163] Various embodiments of the invention have been shown and described, and further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.
Claims
1. A surgical device comprising: (a) A subject, said subject comprising: (i) First main body, (ii) A second main body portion, which is opposite to the first main body portion, and (iii) A connecting portion that connects the proximal end of the first body portion to the proximal end of the second body portion, wherein the connecting portion is configured to allow the first body portion and the second body portion to move toward and away from each other among a plurality of angular orientations, in each of the plurality of angular orientations the body portion defines a distal opening angle; (b) A first auxiliary element disposed on the outward-facing surface of the first main body portion; and (c) A second auxiliary element, the second auxiliary element being disposed on the outward-facing surface of the second main body portion. The first main body portion and the second main body portion are fixed relative to each other in each of the angular orientations, such that the first main body portion is configured to apply the first auxiliary element to the first jaw of the surgical stapler end effector and the second main body portion is configured to simultaneously apply the second auxiliary element to the second jaw of the surgical stapler end effector. The surgical device is characterized in that it further includes: (d) Removably coupled to the base of the body, wherein the base is configured to support the body at the plurality of angular orientations, or (e) A strut hinged to the second body portion, wherein the first body portion includes one or more retaining recesses arranged distally along the length of the first body portion at the connection portion, wherein the strut is configured to engage with a selected retaining recess to define a corresponding distal opening angle between the first body portion and the second body portion.
2. The surgical device according to claim 1, wherein, The range of the distal opening angle defined by the body in the plurality of angular orientations is between approximately 20 degrees and approximately 45 degrees.
3. The surgical device according to claim 1, wherein, The body also includes a first tab extending from the first body portion and a second tab extending from the second body portion, wherein the first tab and the second tab are configured to engage with a plurality of slots in the base.
4. The surgical device of claim 3, further comprising a first pair of wings coupled to the first main body portion, wherein, The first pair of wings are configured to engage and support the second body portion relative to the first body portion to define and maintain the distal opening angle.
5. The surgical device of claim 4, further comprising a second pair of wings coupled to the second main body portion, wherein, The second pair of wings is configured to engage the first body portion to define the distal opening angle.
6. The surgical device according to claim 3, wherein, The base includes a first slot configured to set the angular orientation of the body to define a first distal opening angle.
7. The surgical device according to claim 6, wherein, The base includes a second slot configured to set the angular orientation of the body to define a second distal opening angle that is different from the first distal opening angle.
8. The surgical device according to claim 1, wherein, The first main body portion includes a first panel and the second main body portion includes a second panel.
9. The surgical device according to claim 1, wherein, At least one of the first or second auxiliary element includes a support.
10. The surgical device according to claim 1, wherein, At least one of the first or second accessory element includes a tissue thickness compensator.
11. The surgical device according to claim 1, wherein, The first and second accessory elements are releasably attached to the first and second body portions respectively by adhesive.
12. The surgical device according to claim 1, wherein, The main body includes a third main body portion configured to be gripped by a user.
13. The surgical device according to claim 1, wherein, The base has a first pair of slots and a second pair of slots, wherein the first pair of slots is configured to define a first distal opening angle of the body, and wherein the second pair of slots is configured to define a second distal opening angle of the body.
14. A surgical component comprising: (a) An end effector, wherein the end effector includes a first jaw and a second jaw, the first jaw having a plurality of nail-forming recesses and the second jaw having a plurality of openings configured to receive a plurality of nails; and (b) The surgical device of claim 1, wherein the first body portion is configured to apply the first accessory element to the first jaw, and wherein the second body portion is configured to apply the second accessory element to the second jaw.
15. A surgical component comprising: (a) A surgical stapler end effector, the surgical stapler end effector including a first jaw and a second jaw; and (b) The surgical device according to claim 1, When the surgical stapler end actuator is in the open state, the first main body portion is configured to apply the first auxiliary element to the first jaw, and the second main body portion is configured to apply the second auxiliary element to the second jaw.
16. The surgical component of claim 15, wherein, The device further includes a third body portion hingedly connected to the distal end of the first body portion, wherein the third body portion is configured to deflect laterally relative to a longitudinal axis defined by the distal length of the first body portion, and wherein the third body portion is configured to be gripped by a user.