Surgical stapler with deflectable distal tip
The surgical stapler with an articulating joint and angled anvil design addresses the challenge of precise end effector positioning, improving tissue sealing and reducing recovery time by ensuring complete clamping and stapling.
Patent Information
- Application Number
- CN202080011968.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-12-30
- Filing Date
- 2020-01-29
- Publication Date
- 2025-01-03
- Estimated Expiration
- 2040-01-29
AI Technical Summary
Existing surgical staplers lack the ability to efficiently and precisely position the distal end effector at the desired surgical site, particularly in endoscopic and laparoscopic procedures, due to limitations in articulation and visibility, which can lead to incomplete sealing and increased recovery time.
A surgical stapler with an articulating joint that allows the end effector to deflect from the longitudinal axis of the shaft, combined with an angled anvil and cartridge design for improved maneuverability and visibility, enabling precise tissue engagement and sealing.
Enhances the ability to accurately position the end effector, facilitating complete tissue sealing and reducing postoperative complications by ensuring proper clamping and stapling, thus minimizing bleeding and leakage.
Smart Images

Figure CN113543728B_ABST
Abstract
Description
[0001] priority
[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 798,651, filed on January 30, 2019, entitled “Surgical Stapler with Adjustable Tip Angulation,” and U.S. Provisional Patent Application No. 62 / 840,602, filed on April 30, 2019, entitled “Surgical Stapler with Adjustable Tip Angulation,” the disclosures of which are incorporated herein by reference. Background Art
[0003] In some environments, endoscopic surgical instruments are preferred over traditional open surgical devices because smaller incisions can reduce postoperative recovery time and complications. Therefore, some endoscopic surgical instruments may be suitable for placing the distal end effector at the desired surgical site through the cannula of a trocar. These distal end effectors (e.g., internal cutters, graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy delivery devices, and energy delivery devices using ultrasound, RF, lasers, etc.) can engage tissue in a variety of ways to achieve diagnostic or therapeutic effects. Endoscopic surgical instruments may include an axis between the end effector and the handle portion manipulated by a clinician. Such an axis may enable insertion into a desired depth and rotation around the longitudinal axis of the axis, so as to facilitate positioning the end effector in the patient's body. It may also be further advantageous to position the end effector by including one or more articulation joints or features so that the end effector can selectively articulate or otherwise deflect relative to the longitudinal axis of the axis.
[0004] Examples of endoscopic surgical instruments include surgical staplers. Some such staplers are operable to clamp tissue layers, cut through the clamped tissue layers, and drive staples through the tissue layers to substantially seal the severed tissue layers together near the severed ends of the tissue layers. Surgical staplers, for exemplary purposes only, are disclosed in the following U.S. patents: U.S. Patent 4,805,823, entitled "Pocket Configuration for Internal Organ Staplers," issued on February 21, 1989; U.S. Patent 5,415,334, entitled "Surgical Stapler and Staple Cartridge," issued on May 16, 1995; U.S. Patent 5,465,895, entitled "Surgical Stapler Instrument," issued on November 14, 1995; U.S. Patent 5,597,107, entitled "Surgical Stapler Instrument," issued on January 28, 1997; U.S. Patent 5,632,432, entitled "Surgical Instrument," issued on May 27, 1997; U.S. Patent 5,632,432, entitled "Surgical Instrument," issued on October 7, 1997; U.S. Patent 5,632,432, entitled "Surgical Stapler Instrument," issued on October 7, 1997; U.S. Patent 5,632,432, entitled "Surgical Stapler Instrument," issued on October 7, 1997; U.S. Patent 5,632,432, entitled "Surgical Stapler Instrument," issued on October 14 ... U.S. Patent No. 5,673,840, entitled "Instrument"; U.S. Patent No. 5,704,534, entitled "Articulation Assembly for Surgical Instruments", issued on January 6, 1998; U.S. Patent No. 5,814,055, entitled "Surgical Clamping Mechanism", issued on September 29, 1998; U.S. Patent No. 6,978,921, entitled "Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism", issued on December 27, 2005; U.S. Patent No. 7,000,818, entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems", issued on February 21, 2006; U.S. Patent No. 7,143,923, entitled "Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil", issued on December 5, 2006;U.S. Patent No. 7,303,108, published on December 4, 2007, entitled “Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack”; U.S. Patent No. 7,367,485, published on May 6, 2008, entitled “Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission”; U.S. Patent No. 7,380,695, published on June 3, 2008, entitled “Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing”; U.S. Patent No. 7,380,696, published on June 3, 2008, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism”; U.S. Patent No. 7,380,696, published on July 29, 2008, entitled “Surgical Stapling and Cutting Mechanism”; Device”; U.S. Patent 7,404,508, entitled “Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout”, published on October 14, 2008; U.S. Patent 7,721,930, entitled “Disposable Cartridgewith Adhesive for Use with a Stapling Device”, published on May 25, 2010; U.S. Patent 8,408,439, entitled “Surgical Stapling Instrument with An Articulatable End Effector”, published on April 2, 2013;and U.S. Patent No. 8,453,914, entitled “Motor-Driven Surgical Cutting Instrument with Electric Actuator Directional Control Assembly,” issued on June 4, 2013. The disclosures of each of the above-referenced U.S. patents, U.S. patent publications, and U.S. patent applications are incorporated herein by reference. ;
[0005] Although the surgical stapler involved above is described as being used in endoscopic surgery, it should be understood that such surgical staplers can also be used in laparotomy and / or other non-endoscopic surgeries. By way of example only, in thoracic surgery, the surgical stapler can be inserted by thoracotomy, and thus be located between the patient's ribs to reach one or more organs, and the thoracic surgery does not use a trocar as the conduit of the stapler. Such surgery may include using a stapler to cut off and close the blood vessels leading to the lungs. For example, before removing an organ from the chest cavity, the blood vessels leading to the organ can be cut off and closed by a stapler. Of course, the surgical stapler can be used in various other situations and operations.
[0006] While various surgical stapling instruments and associated components have been made and used, it is believed that no one prior to the inventor has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0007] 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.
[0008] Figure 1 shows a perspective view of an exemplary articulating surgical stapling instrument;
[0009] Figure 2 Shows Figure 1 A side view of the device;
[0010] Figure 3 Shows Figure 1 A perspective view of an end effector opened in an instrument;
[0011] Figure 4A Shows Figure 3 The end effector along Figure 3 A side cross-sectional view taken along line 4-4 of the embodiment of the present invention, wherein the firing beam is in a proximal position;
[0012] Figure 4B Shows Figure 3 The end effector along Figure 3A side cross-sectional view taken along line 4-4 of the embodiment of the present invention, wherein the firing beam is in a distal position;
[0013] Figure 5 Shows Figure 3 The end effector along Figure 3 an end cross-sectional view taken along line 5-5 of ;
[0014] Figure 6 Shows Figure 3 An exploded perspective view of an end effector;
[0015] Figure 7 Shows Figure 3 A perspective view of an end effector positioned at tissue and having been actuated once in the tissue;
[0016] Figure 8 shows a perspective view of an alternative version of an end effector having an angled anvil and an angled cartridge;
[0017] Fig. 9 Shows Figure 8 An enlarged side view of an end effector;
[0018] Fig.10 Shows Figure 8 An enlarged top view of the end effector;
[0019] Fig.11 shows a perspective view of an exemplary surgical stapling instrument having an end effector with a bent, elastically deformable end section;
[0020] Fig. 12A Shows Fig.11 An enlarged side view of a distal portion of an end effector;
[0021] Fig. 12B Shows something like Fig.11 An enlarged side view of a distal portion of an alternative end effector of the end effector;
[0022] Fig.13 shows a partial top view of an alternative anvil for an end effector for use with the surgical instruments described herein;
[0023] Fig.14A Shown along Fig.13 The line 14-14 is intercepted Fig.13 sectional side view of an anvil of and showing an end of the anvil in a first position;
[0024] Fig. 14B Shows Fig.14A An enlarged perspective view of an anvil of , wherein a portion of the anvil is shown in phantom;
[0025] Fig.15 Shows Fig.13 4. A side view of the anvil showing an end of rotation of the anvil to a second position;
[0026] Fig.16 shows a cross-sectional side view of an alternative anvil for use with the surgical instruments described herein, the anvil being similar to the anvil of FIG. 14 but having a plurality of rotatable end portions;
[0027] Fig.17 shows a perspective view of an alternative anvil for an end effector for use with the surgical instruments described herein;
[0028] Fig.18 Shows Fig.17 A cross-sectional side view of an anvil of , wherein the elastomeric overmold is shown in phantom and showing a pivot member capable of pivoting about a fulcrum feature;
[0029] Fig.19 A perspective view of an alternative tip of an anvil of an end effector for use with the surgical instruments described herein is shown, showing the tip in a first position;
[0030] Fig. 20 Shows Fig.19 A perspective view of the end of the embodiment of the present invention, showing the end in a second position;
[0031] Fig.21 A perspective view of an exemplary alternative end effector for use with the surgical instruments described herein is shown, showing a distal end of an anvil in a first position;
[0032] Fig. 22 Shows Fig.21 An enlarged side view of an end effector;
[0033] Fig.23 Shows Fig.21 An enlarged side view of the end effector of , showing a distal end of the anvil in a second position;
[0034] Fig.24 Shows Fig.21 an enlarged perspective view of an end effector of showing the elastomeric overmold in phantom to reveal the internal clamps and showing the distal end of the anvil in a first position;
[0035] Fig.25 Shows Fig.24 ' side view of the end effector showing the distal end of the anvil in a second position;
[0036] Fig.26 Shows Fig.24 A perspective view of an internal fixture of an end effector;
[0037] Fig. 27 Shows Fig.26 a perspective view of an inner clamp of FIG. 1 showing a pair of arms of the inner clamp prior to engaging their distal ends;
[0038] Fig.28 Shows Fig.21 An enlarged side view of the end effector of , showing the distal end of the anvil in an alternative second position;
[0039] Fig.29 Shows Fig.28 A side view of an end effector of , showing the elastomeric overmold in phantom to illustrate the internal clamp;
[0040] Fig.30 A perspective view of an exemplary alternative end effector for use with the surgical instruments described herein is shown, showing a distal end of an anvil in a first position;
[0041] Fig.31 Shows Fig.30 an enlarged perspective view of a distal end of an anvil of an end effector of the invention, showing an elastomeric overmold in phantom to reveal an internal clamp;
[0042] Fig.32 Shows Fig.31 A top view of the distal end of an anvil of an end effector;
[0043] Fig.33 shows a bottom view of an alternative anvil for an end effector for use with the surgical instruments described herein;
[0044] Fig.34 Shows Fig.33 an enlarged perspective view of a distal end of an anvil showing the distal end in a first position;
[0045] Fig.35 Shows Fig.33 an enlarged perspective view of the end of the anvil showing the end in a second position; and
[0046] Fig.36 A plurality of alternative internal clamps are shown, each of which is capable of being used within the distal end of an anvil of an end effector for use with the surgical instruments described herein.
[0047] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be performed in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION
[0048] The following description of some examples of the present invention should not be used to limit the scope of the present invention. According to the following description shown by way of example, other examples, features, aspects, embodiments and advantages of the present invention will be apparent to those skilled in the art, and a best mode is contemplated for implementing the present invention. As will be appreciated, the present invention can have other different and obvious aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered as illustrative and non-restrictive in nature.
[0049] I. Exemplary Surgical Stapler
[0050] Figures 1 to 7 An exemplary surgical stapling and severing instrument (10) is depicted. Figure 1 In the non-articulated state depicted in the figure, the cannula is sized to be inserted into the surgical site of the patient through the trocar in order to perform the surgical procedure. By way of example only, such a trocar can be inserted into the patient's abdomen from between two ribs of the patient or elsewhere. In some cases, the instrument (10) is used in the absence of a trocar. For example, the instrument (10) can be directly inserted through a thoracotomy or other type of incision. The instrument (10) of this example includes a handle portion (20) connected to a shaft (22). The shaft (22) terminates in an articulation joint (11) at the distal end, which is further connected to the end effector (12). It should be understood that the terms used herein, such as "proximal" and "distal", refer to the handle portion (20) of the clinician grasping the instrument (10). Therefore, the end effector (12) is located distally relative to the more proximal handle portion (20). It should also be understood that for convenience and clarity, the spatial terms such as "vertical" and "horizontal" are used in the diagrams of this article. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
[0051] In some versions, shaft (22) is constructed in accordance with at least some of the teachings of U.S. Pat. No. 9,795,379, entitled “Surgical Instrument with Multi-Diameter Shaft,” issued on Oct. 24, 2017, the disclosure of which is incorporated herein by reference. Other suitable configurations for shaft (22) will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0052] Once the articulation joint (11) and end effector (12) are inserted through the cannula channel of the trocar, the articulation joint (11) can be remotely articulated via the articulation control (13), such as Figure 1 , so that the end effector (12) can be deflected from the longitudinal axis (LA) of the shaft (22) at a desired angle (α). As a result, the end effector (12) can reach the back of the organ or approach the tissue from a desired angle or for other reasons. In some versions, the articulation joint (11) is capable of deflecting the end effector (12) along a single plane. In some other versions, the articulation joint (11) is capable of deflecting the end effector along more than one plane. The articulation joint (11) and the articulation control (13) can be constructed according to the teachings of any of the multiple references cited herein. Alternatively, the articulation joint (11) and / or the articulation control (13) can have any other suitable configuration. By way of example only, the articulation control (13) can be alternatively constructed as a knob that rotates around an axis perpendicular to the longitudinal axis (LA) of the shaft (22).
[0053] In some versions, the articulation joint (11) and / or articulation control (13) are constructed and operated in accordance with at least some of the teachings of the following U.S. patent application: U.S. Patent No. 9,186,142, filed on November 17, 2015, entitled "Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks", the disclosure of which is incorporated herein by reference. The articulation joint (11) may also be constructed and operated in accordance with at least some of the teachings of the following U.S. patent application: U.S. Patent No. 9,795,379, published on October 24, 2017, entitled "Surgical Instrument with Multi-Diameter Shaft", the disclosure of which is incorporated herein by reference. In view of the teachings herein, various other suitable forms that the articulation joint (11) and articulation control (13) may take will be apparent to those of ordinary skill in the art.
[0054] The end effector (12) of the present example includes a lower jaw (16) and an upper jaw in the form of a pivotable anvil (18). In some versions, the lower jaw (16) is constructed in accordance with at least some of the teachings of the following U.S. Patent: U.S. Patent 9,808,248, entitled "Installation Features for Surgical Instrument End Effector Cartridge", issued on November 7, 2017, the disclosure of which is incorporated herein by reference. The anvil (18) may be constructed in accordance with at least some of the teachings of the following U.S. patent applications: U.S. Patent No. 9,517,065, entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler," published on December 13, 2016, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,839,421, entitled "Jaw Closure Feature for End Effector of Surgical Instrument," published on December 12, 2017, the disclosure of which is incorporated herein by reference. And / or U.S. Patent No. 10,092,292, entitled "Staple Forming Features for Surgical Stapling Instrument," published on October 9, 2018, the disclosure of which is incorporated herein by reference. Various other suitable forms that the lower jaw (16) and anvil (18) may take will be apparent to one of ordinary skill in the art in light of the teachings herein.
[0055] The handle portion (20) includes a pistol grip (24) and a closure trigger (26). The closure trigger (26) is capable of pivoting toward the pistol grip (24) so that the anvil (18) is clamped or closed toward the lower jaw (16) of the end effector (12). Such closure of the anvil (18) is provided by a closure tube (32) and a closure ring (33), both of which are longitudinally translated relative to the handle portion (20) in response to pivoting of the closure trigger (26) relative to the pistol grip (24). The closure tube (32) extends along the length of the shaft (22); and the closure ring (33) is positioned distally of the articulation joint (11). The articulation joint (11) is operable to transmit / transmit longitudinal motion from the closure tube (32) to the closure ring (33).
[0056] The handle portion (20) also includes a firing trigger (28). An elongated member (not shown) extends longitudinally through the shaft (22) and transmits a longitudinal firing motion from the handle portion (20) to the firing beam (14) in response to actuation of the firing trigger (28). This distal translation of the firing beam (14) causes the tissue clamped in the end effector (12) to be stapled and severed, as will be described in more detail below. The trigger (26, 28) is then released to release the tissue from the end effector (12).
[0057] Figures 3 to 6 The end effector (12) is shown to use a firing beam (14) in the form of an electron beam to perform various functions. It should be understood that the electron beam form is merely an illustrative example. The firing beam (14) may take any other suitable form, including but not limited to non-electron beam forms. As best seen in FIG. 4A to FIG. 4B The firing beam (14) includes a transversely oriented upper pin (38), a firing beam cap (44), a transversely oriented middle pin (46), and a distally located cutting edge (48). The upper pin (38) is positioned in a longitudinal anvil slot (42) of the anvil (18) and is capable of translating in the longitudinal anvil slot. The firing beam cap (44) is formed by extending the firing beam (14) through the lower jaw slot (45) ( Figure 4B The lower jaw slot (45) is formed through the lower jaw (16) and slidably engages the lower surface of the lower jaw (16). The middle pin (46) slidably engages the top surface of the lower jaw (16) to cooperate with the firing beam top cover (44). Therefore, the firing beam (14) is necessarily spaced apart from the end effector (12) during firing.
[0058] Some non-electron beam versions of the firing beam (14) may lack the upper pin (38), the middle pin (46), and / or the firing beam cap (44). Some such versions of the instrument (10) may rely solely on the closed ring (33) or some other feature structure to pivot the anvil (18) to the closed position and maintain the anvil (18) in the closed position when the firing beam (14) is advanced to the distal position. By way of example only, the firing beam (14) and / or associated lockout features may be constructed and operated in accordance with at least some of the teachings of the following U.S. Patents: U.S. Patent No. 9,717,497, entitled “Lockout Feature for Movable Cutting Member of Surgical Instrument,” published on August 1, 2017, the disclosure of which is incorporated herein by reference. Other suitable forms that the firing beam (14) may take will be apparent to one of ordinary skill in the art in light of the teachings herein.
[0059] Figure 3The present example is shown with the firing beam (14) positioned proximally and the anvil (18) pivoted to an open position, thereby allowing an unspent staple cartridge (37) to be removably installed into the channel of the lower jaw (16). Figure 5 to Figure 6 The staple cartridge (37) of this example includes a cartridge body (70) having an upper platform (72) and connected to a lower cartridge tray (74). Figure 3 As best shown in FIG. 1 , a vertical slot (49) is formed through a portion of the staple cartridge (37). Figure 3 As best shown in FIG. 1 , three rows of nail holes (51) are formed through the upper platform (72) on one side of the vertical slot (49), and another set of three rows of nail holes (51) are formed through the upper platform (72) on the other side of the vertical slot (49). Of course, any other suitable number of nail rows (e.g., two rows, four rows, or other numbers) may be provided. See again FIG. 4A to FIG. 6 , a wedge-shaped slide (41) and a plurality of nail drivers (43) are captured between the magazine body (70) and the tray (74), wherein the wedge-shaped slide (41) is located proximal to the nail driver (43). The wedge-shaped slide (41) is capable of moving longitudinally within the nail magazine (37); and the nail driver (43) is capable of moving vertically within the nail magazine (37). The nails (47) are also positioned within the magazine body (70), above the corresponding nail drivers (43). Specifically, each nail (47) is driven vertically within the magazine body (70) by the nail driver (43) to drive the nail (47) out through the associated nail hole (51). As shown FIG. 4A to FIG. 4B and Figure 6 As best shown in FIG. 4 , wedge sled ( 41 ) presents an inclined cam surface that pushes the staple drivers ( 43 ) upwardly as the wedge sled ( 41 ) is driven distally through the staple cartridge ( 37 ).
[0060] In some versions, staple cartridge (37) is constructed and operated in accordance with at least some of the teachings of U.S. Patent No. 9,517,065, issued December 13, 2016, entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler," the disclosure of which is incorporated herein by reference. Additionally or alternatively, staple cartridge (37) may be constructed and operated in accordance with at least some of the teachings of U.S. Patent No. 9,808,248, issued November 7, 2017, entitled "Installation Features for Surgical Instrument End Effector Cartridge," the disclosure of which is incorporated herein by reference. Other suitable forms that staple cartridge (37) may take will be apparent to one of ordinary skill in the art in light of the teachings herein.
[0061] By advancing the closure tube (32) and the closure ring (33) distally so that the end effector (12) is FIG. 4A to FIG. 4B In the closed position shown, the firing beam (14) is advanced into engagement with the anvil (18) by allowing the upper pin (38) to enter the longitudinal anvil slot (42). Figure 5 ) is located at the distal end of the firing beam (14) and is configured to engage the wedge slide (41) so that when the firing trigger (28) is actuated, the push block (80) pushes the wedge slide (41) distally as the firing beam (14) is advanced distally through the staple cartridge (37). During such 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). FIG. 4A to FIG. 4B As shown, the intermediate pin (46) and the push block (80) actuate the nail magazine (37) together by entering the narrow slot (49) in the nail magazine (37) to drive the wedge-shaped sliding member (41) into upward lifting contact with the nail driver (43), thereby driving the nail (47) outward through the nail hole (51) and causing the nail to engage with the nail forming recess (53) on the inner surface of the anvil (18) ( Figure 3 ) to form contact. Figure 4B The firing beam (14) is shown fully translated distally after severing and stapling tissue. FIG. 4A to FIG. 4B The nail forming recess (53) is intentionally omitted in the view in FIG. Figure 3 It should also be understood that Figure 5The anvil (18) is intentionally omitted from the view.
[0062] Figure 7 The end effector (12) is shown having been actuated through tissue (90) in a single stroke. As shown, the cutting edge (48) ( Figure 7 4 and 5. In one embodiment, the staples (47) of the present invention are arranged such that the staples (47) of the present invention are arranged in a manner that is consistent with the present invention. The ...
[0063] It will be appreciated that during each actuation stroke, cutting blade (48) may sever tissue substantially simultaneously with the staples (47) being driven through the tissue. In the present example, cutting blade (48) lags only slightly behind the driving of staples (47) such that staples (47) are driven through the same area of tissue just before cutting blade (48) is driven through the tissue, but it will be appreciated that this sequence may be reversed or cutting blade (48) may be synchronized directly with an adjacent staple. Although Figure 7 The end effector (12) is shown being actuated in two layers (92, 94) of tissue (90), but it should be understood that the end effector (12) may be actuated through a single layer of tissue (90) or more than two layers (92, 94) of tissue. It should also be understood that the formation and positioning of the staples (47) adjacent to the cut line created by the cutting edge (48) may substantially seal the tissue at the cut line, thereby reducing or preventing bleeding and / or leakage of other body fluids at the cut line. Furthermore, although Figure 7 The end effector (12) is shown actuating in two substantially flat opposing planar layers (92, 94) of tissue, but it should be understood that the end effector (12) may also be actuated on tubular structures such as blood vessels, portions of the gastrointestinal tract, etc. Therefore, it should not be construed as Figure 7 No limitations are to be construed as to the contemplated uses of end effector (12). Various suitable situations and procedures in which instrument (10) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0064] In one version, the instrument (10) provides motorized control of the firing beam (14). Exemplary components that may be used to provide motorized control of the firing beam (14) are shown and described in U.S. Patent No. 9,622,746, entitled "Distal Tip Features for End Effector of Surgical Instrument," published on April 18, 2017, the disclosure of which is incorporated herein by reference. In addition to or in lieu of the foregoing, at least a portion of the motorized control may be constructed in accordance with at least some of the teachings of U.S. Patent Publication No. 8,210,411, entitled "Motor-Driven Surgical Instrument," published on July 3, 2012, the disclosure of which is incorporated herein by reference. In addition to or in lieu of the foregoing, features operable to drive the firing beam (14) may be constructed in accordance with at least some of the teachings of U.S. Pat. No. 8,453,914, the disclosure of which is incorporated herein by reference; and / or constructed in accordance with at least some of the teachings of U.S. Pat. No. 8,453,914, the disclosure of which is incorporated herein by reference. Other suitable components, features, and configurations for providing motorization of the firing beam (14) will be apparent to one of ordinary skill in the art in light of the teachings herein. It will also be appreciated that some other versions may provide for manual actuation of the firing beam (14) such that a motor may be omitted. By way of example only, the firing beam (14) may be actuated in accordance with at least some of the teachings of any other patent / publication reference cited herein.
[0065] The instrument (10) may also include a lockout switch and a lockout indicator, as shown and described in U.S. Patent No. 9,622,746, entitled “Distal Tip Features for End Effector of Surgical Instrument,” issued on April 18, 2017, the disclosure of which is incorporated herein by reference. Additionally, the lockout switch and / or lockout indicator and associated components / functionality may be constructed in accordance with at least some of the teachings of U.S. Patent No. 7,644,848, entitled “Electronic Lockouts and Surgical Instrument Including Same,” issued on January 12, 2010, the disclosure of which is incorporated herein by reference.
[0066] The instrument (10) also includes a manual return switch (116) that is configured to act as a "panic" feature, allowing an operator to quickly retract the firing beam (14) proximally during the firing stroke. In other words, the manual return switch (116) can be manually actuated when the firing beam (14) is only partially advanced distally. The manual return switch (116) can provide additional functionality in accordance with at least some of the teachings of U.S. Patent No. 9,622,746, entitled "Distal Tip Features for End Effector of Surgical Instrument," published on April 18, 2017, the disclosure of which is incorporated herein by reference.
[0067] When describing the operation of the instrument (10), the use of the term "pivot" (and similar terms to the underlying "pivot") should not be interpreted as necessarily requiring pivotal movement about a fixed axis. In some versions, the anvil (18) pivots about an axis defined by a pin (or similar feature) that slides along an elongated slot or channel as the anvil (18) moves toward the lower jaw (16). In this type of version, the pivot axis translates along a path defined by the slot and channel while the anvil (18) simultaneously pivots about the axis. In addition or as an alternative, the pivot axis may first slide along the slot / channel and then the anvil (18) pivots about the pivot axis after the pivot axis has slid a certain distance along the slot / channel. It should be understood that such sliding / translational pivoting movement is included in terms such as "pivot", "pivoting", "pivotable", etc. Of course, some versions may provide for pivotal movement of anvil (18) about an axis that remains fixed and does not translate within the slot or channel, etc.
[0068] It will be appreciated that the apparatus (10) may be constructed and operated in accordance with the teachings of the following U.S. Patents: U.S. Patent 4,805,823; U.S. Patent 5,415,334; U.S. Patent 5,465,895; U.S. Patent 5,597,107; U.S. Patent 5,632,432; U.S. Patent 5,673,840; U.S. Patent 5,704,534; U.S. Patent 5,814,055; U.S. Patent 6,978,921; U.S. Patent 7,000,818; U.S. Patent 7,143,923; U.S. Patent 7,303,108; U.S. Patent 7,367,485; U.S. Patent 7,380,695; U.S. Patent 7,380,696; U.S. Patent 7,404,508; U.S. Patent 7,434,715; U.S. Patent 7,721,930; U.S. Patent 8,408,439; and / or 8,453,914. As mentioned above, the disclosure of each of these patents is incorporated herein by reference. Other exemplary modifications that may be provided for the apparatus (10) will be described in more detail below. The various suitable ways in which the following teachings may be incorporated into the apparatus (10) will be apparent to one of ordinary skill in the art. Similarly, the various suitable ways in which the following teachings may be combined with the various teachings of the patents / publications cited herein will be apparent to one of ordinary skill in the art. It should also be understood that the following teachings are not limited to the apparatus (10) or devices taught in the patents cited herein. The following teachings may be easily applied to various other types of apparatus, including apparatus that will not be classified as surgical staplers. According to the teachings herein, various other suitable devices and situations in which the following teachings may be applied will be apparent to one of ordinary skill in the art.
[0069] II. Exemplary End Effectors with Visualization, Introduction, and Collection Features
[0070] In some cases, it may be desirable to provide the user with a clearer view of the end effector (12). Specifically, after the user inserts the end effector (12) into the surgical site, the user may rotate the shaft (22) of the instrument (10) during the operation. The end effector (12) thereby also rotates. As the end effector (12) rotates, the user may wish to see the surgical site. For example, the user may want to see the contact surface or contact point between the tissue (90) and the end effector (12). Because the end effector (12) can be rotated about the longitudinal axis (LA) relative to the handle portion (20), the user may see the lower jaw (16) of the end effector, rather than the anvil (18), when observing the surgical site. Alternatively, the end effector (12) can be rotated to a position such that the user can see the anvil (18) when observing the end effector (12). The user may desire to be able to see more of the surgical site than when using a handheld device. Figure 1The range of the surgical site that can be seen when the instrument (10) is used is large. For example, in the case where the user uses the device to perform some surgical procedures involving cutting and then suturing a vessel through which body fluids flow, it may be desirable to visually determine that the anvil (18) and the lower jaw (16) have completely covered the vessel to be cut, thereby ensuring that the vessel can be completely cut and sutured with a single actuation of the device. In other words, the user may want to avoid a situation where only a portion of the vessel is cut and sutured. Therefore, it may be desirable to take some visual monitoring and / or feedback measures to let the user know that the end effector (12) is properly positioned in the surgical site, and then the user can manipulate the end effector to allow the anvil (18) and the lower jaw (16) to fully clamp the vessel. A possible way to monitor the surgical site may include improving the visibility of the area adjacent to the distal end of the lower jaw (16) and the anvil (18). Furthermore, not only may visualization of the distal end of the end effector (12) be desired, but it may also be desired to construct the end effector (12) so that the distal end of the anvil (18) is configured to be capable of pushing tissue (e.g., a large blood vessel) proximally into the space between the anvil (18) and the lower jaw (16) when the anvil (18) is closed toward the lower jaw (16).
[0071] Figure 8 An exemplary end effector (212) is shown including an anvil (218) and a lower jaw (216). It should be understood that end effector (212) may be used in place of end effector (12) of instrument (10). End effector (212) may be integrally formed with instrument (10) or, alternatively, may be interchangeable with end effector (12) of instrument (10).
[0072] The anvil (218) is operable to pivot relative to the lower jaw (216). The anvil (218) and the lower jaw (216) may be similar to those of Figure 1 The anvil (18) and lower jaw (16) are shown to clamp tissue (90). The end effector (212) also includes a cartridge (237) that is coupled to the end effector (212). Figure 3 The illustrated cartridge (37) is similarly operable to be placed within lower jaw (216).
[0073] If available Figures 8 to 10The anvil (218) seen in the drawings has an elongated shape, wherein the distal portion of the anvil (218) approaches the chamber (237) at a certain angle. The distal portion of the anvil (218) approaches the chamber (237) at an angle such that the distal-most end (219) of the anvil (218) extends distally beyond the chamber (237) in the longitudinal direction. However, in some versions, the distal end (219) may extend longitudinally to be vertically flush with the chamber (237), or to a position proximal to the distal-most point of the chamber (237). In addition, the anvil (218) approaches the chamber (237) at a gentle slope. As shown in FIG. Fig.10 As best shown in FIG. 1 , the anvil (218) includes a side surface (241) that tapers toward the distal end (219) of the anvil (218). For example, the anvil (218) may be tapered toward the distal end (219) of the anvil (218). Figure 8 The anvil (218) is shaped like an inverted ski top. An anvil (218) having an angled shape can make it easier to insert the end effector (212) into the surgical site. For example, an anvil (218) having a gentle slope or an inverted ski top shape can provide an atraumatic tissue flexing surface when contacting or moving through tissue. This atraumatic tissue deflection can include pushing tissue (e.g., a large blood vessel) proximally into the space between the anvil (218) and the lower jaw (216) when the anvil (218) is closed toward the lower jaw (216). Once placed at the surgical site, the angled shape of the anvil (218) can also provide better maneuverability of the end effector (212) and better visibility of the distal end of the end effector (212) relative to the anatomical structure at the surgical site. A person of ordinary skill in the art can easily conceive of other suitable forms of anvils (218) based on the teachings of this article.
[0074] The bin (237) is operable to hold Figure 4A A staple similar to the staple (47) shown in FIG. 1 is used to drive into tissue. Fig. 9 As shown, the distal end of the cartridge (237) has a triangular profile. Specifically, the distal end of the cartridge (237) includes an upper tapered surface (239) and a lower tapered surface (238). Additionally, the distal end of the cartridge (237) includes a tapered side surface (243) on each side. In this example, each tapered side surface (243) of the cartridge (237) is generally aligned with the taper presented by the side (241) of the anvil (218). Thus, as shown in FIG. Fig.10As shown, the side surface (243) of the cartridge (237) does not extend outward from the longitudinal axis (LA) of the end effector (212) beyond the side (241) of the anvil (218). The upper tapered surface (239) and the lower tapered surface (238) are closed at the distal end of the cartridge (237). The lower tapered surface (238) defines a sight line (240) so that once the user inserts the end effector (212) into the surgical site, the sight line (240) can be observed. The sight line (240) extends along the edge of the lower tapered surface (238). It should be understood that the lower tapered surface (238) is operated to have a planar shape to allow the user to see and / or roughly see the distal end (219) of the anvil (218). Specifically, the sight line (240) intersects with the longitudinal axis (LA) extending longitudinally through the end effector (212) to form a viewing angle (θ).
[0075] The viewing angle (θ) may determine the user's relative visibility of the distal tip (219). Specifically, the user may be in front of the distal tip (219) along any line of sight that passes through the intersection of the sight line (240) and the longitudinal axis (LA) within the viewing angle (θ). For example, as the viewing angle (θ) increases, the user may have greater visibility of the area directly in front of the distal tip (219) from a proximal vantage point; however, as the viewing angle (θ) decreases, the user may have less visibility of the area in front of the distal tip (219) from a proximal vantage point. In some embodiments, the viewing angle (θ) defines an angle greater than 90 degrees. Additionally, in some embodiments, the viewing angle (θ) defines an angle greater than 135 degrees. Other suitable angles for the viewing angle (θ) can be readily envisioned by a person of ordinary skill in the art based on the teachings herein. In the illustrated version, the user typically views along the sight line (240) or along some other line of sight within the viewing angle (θ), so that the user can view not only the area along the sight line, but also any area within the viewing angle (θ). The underside of the distal tip (219) may also be slightly rounded to help the user see the intersection of the longitudinal axis (LA) and the sight line (240).
[0076] When the tissue (90) is clamped between the closed bin (237) and the anvil (218), the user can observe along the sight line (240) or at other positions within the viewing angle (θ), for example, clearly see where the anvil (218) clamps the tissue (90). In addition, the user will be able to determine whether the tissue is completely clamped between the anvil (218) and the bin (237). Only by determining that the tissue is completely clamped can the tissue be ensured not to overflow the end of the end effector (212). It is also possible to visually present to the user the extent to which the anvil (218) and the bin (237) clamp the tissue (90). It should be understood that in some cases, the end effector (212) can be rotated before, during, or after clamping the tissue (90). Therefore, the tapered shape of the anvil (218) also allows the user to more easily observe the distal end (219), or the area generally adjacent to the distal end (219). The tapered anvil (218) together with the lower tapered surface (238) of the cartridge (237) can further facilitate the easy insertion of the end effector (212) into the tissue in an atraumatic manner. In addition, because the end effector (212) has a tapered end, it is easier to push the end effector (212) through a trocar or other device operable to guide the end effector (212) into the surgical site. For example, once the user loads the distal end (219) into the trocar, the lower tapered surface (238) and the tapered anvil (218) can be used as an introduction end to guide the rest of the end effector (212) into the trocar. According to the teachings of this article, a person of ordinary skill in the art will further understand that the tapered design of the two sides (241) of the anvil (218) and each side (243) of the cartridge (237) can enhance visibility and maneuverability.
[0077] In addition to the foregoing, the end effector (212) and the type of instrument (10) incorporating the end effector (212) may be constructed and operated in accordance with at least some of the teachings of the following: U.S. Patent No. 9,186,142, entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks,” issued on November 17, 2015, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,717,497, entitled “Lockout Feature for Movable Cutting Member of Surgical Instrument,” issued on August 1, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” issued on December 13, 2016, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” issued on December 12, 2017, the disclosure of which is incorporated herein by reference; and / or U.S. Patent No. 9,839,421, entitled “Closure Feature for End Effector of Surgical Instrument”, issued on April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,622,746, entitled “Distal Tip Features for End Effector of Surgical Instrument”, issued on April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent No. 10,092,292, entitled “Staple Forming Features for Surgical Stapling Instrument”, issued on October 9, 2018, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,795,379, entitled “Surgical Instrument with Multi-Diameter Shaft”, issued on October 24, 2017, the disclosure of which is incorporated herein by reference; and / or U.S. Patent No. 9,839,421, entitled “Closure Feature for End Effector of Surgical Instrument”, issued on April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,622,746, entitled “Distal Tip Features for End Effector of Surgical Instrument”, issued on April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent No. 10,092,292, entitled “Staple Forming Features for Surgical Stapling Instrument”, issued on October 9, 2018, the disclosure of which is incorporated herein by reference; Cartridge", the disclosure of which is incorporated herein by reference.Additional modifications that may be incorporated into end effector (212) are described in greater detail below.
[0078] III. End Effector with Angled Elastically Deformable Anvil Tip
[0079] In some procedures, it may be necessary to cut along or through tissue where more than one cutting sequence is required to complete the procedure - in other words, sequential cuts are made along a continuous path. In such procedures, this sequential cutting technique may be defined as "marching". For procedures involving marching, the instrument (10) may be placed at the surgical site, activated to cut and suture, then removed from the surgical site for installation of a new cartridge (37), and then placed back at the surgical site again to make the next cut and suture along the same path where the previous cutting and suturing cycle occurred. This process is repeated until the cutting and suturing procedure is complete. FIG. 4A to FIG. 4B and Figure 7 As can be seen in the figure, the distal end configuration of the end effector (12) provides a gap between the distal end of the anvil (18) and the distal end of the cartridge (37). This gap can facilitate advancement by providing tissue with an atraumatic space for access to the distal end of the end effector (12) at the beginning of each advancement step.
[0080] As described above, the distal end configuration of the end effector (212) is different from the distal end configuration of the end effector (12); wherein the different configurations of the end effector (212) provide different potential advantages. Specifically, the distal end configuration of the end effector (212) can improve maneuverability and improve visibility of the relationship between the distal end of the end effector (212) and adjacent anatomical structures. In addition, the distal end configuration of the end effector (212) can provide a tissue harvesting effect by pushing tissue proximally into the space between the anvil (218) and the lower jaw (216) when the anvil (218) is closed toward the lower jaw (216). However, in a version in which all structures of the end effector (212) are rigid, the curved configuration of the distal tip (219) of the anvil (218) may not be suitable for advancing operations because the distal tip (219) may traumatize tissue that is not collected in the space between the anvil (218) and the lower jaw (216) when the anvil (218) is closed toward the lower jaw (216). Therefore, in a version in which all structures of the end effector (212) are rigid, the end effector (212) may be most suitable for cutting and stapling operations (e.g., vessel transection) in which all tissue to be cut and stapled is collected proximal to the distal tip (219).
[0081] In view of the foregoing, it may be desirable to provide a variation of an end effector (12, 212) that provides travel capabilities of the end effector (12), improved visibility associated with the end effector (212), and tissue acquisition capabilities of the end effector (212) without increasing the risk of trauma that may otherwise be associated with a completely rigid version of the end effector (212). Several merely illustrative examples of such variations of the end effector (12, 212) are described below. In the following examples, the anvil has a distal tip that is resiliently biased to present a curved or angled configuration similar to the distal tip (219); however, the resiliently biased distal tip can be deflected away from the lower jaw in response to a sufficient load on the distal tip. Based on the teachings herein, it should be understood that providing an anvil having an angled distal tip portion that is resiliently deformable can provide an additional level of maneuverability benefit in navigating through tissue to a surgical site. In this manner, the deformable distal tip portion can be deflected or deformed to facilitate smooth and atraumatic movement of the end effector through tissue, particularly during advancement operations. Additionally, with the anvil having a bias to an angled position when not in a loaded state or in contact with surrounding tissue, enhanced visualization during tissue capture and cutting can be achieved compared to using an end effector with a straight or non-angled anvil. Furthermore, an anvil with a distal tip biased to an angled position can provide a degree of tissue collection effect until a load point associated with advancement is reached, rather than being associated with simply collecting relatively small tissue structures between the anvil and the lower jaw.
[0082] Fig.11Another exemplary instrument (310) configured as a surgical stapler is shown. The instrument (310) includes a handle portion (320) and a shaft (322). The instrument (310) has a modular configuration so that the shaft (322) can be selectively removed from the handle portion (320) and can be attached to the handle portion. The instrument (310) is constructed similarly to the instrument (10) so that the operability and use of the instrument (310) are the same as those described above for the instrument (10), wherein an additional feature of the instrument (310) is a modular configuration. Through its modular configuration, the instrument (310) provides a method for replacing an end effector. Such changes can be made in the end effector to replace an otherwise worn end effector, or to provide different end effector configurations based on the procedure or user preference. In addition to or in lieu of the foregoing, features operable to provide a modular configuration of the apparatus (310) may be constructed in accordance with at least some of the teachings of the following U.S. Patent No. 10,182,813, entitled "Surgical Stapling Instrument with Shaft Release, Powered Firing, and Powered Articulation," issued on January 22, 2019, the disclosure of which is incorporated herein by reference. Other suitable components, features, and configurations for providing an apparatus (310) having a modular configuration will be apparent to one of ordinary skill in the art in light of the teachings herein. Furthermore, one of ordinary skill in the art will appreciate that the apparatus (10) may be modified to incorporate a modular configuration, as shown and described with respect to the apparatus (310) or other apparatus incorporated herein by reference, in light of the teachings herein.
[0083] exist Fig.11 In the example shown in FIG. 3 , the instrument ( 310 ) includes an end effector ( 312 ) having an anvil ( 318 ) having an angled distal end ( 319 ). In addition, the distal end ( 319 ) of the anvil ( 318 ) is elastically deformable. In this manner, and as Fig. 12A and Fig. 12BAs best shown in , the angled distal tip (319) is operable to elastically deform from a first angled position to a second position. The second position of the angled distal tip (319) may be substantially straight in some versions, but may be angled to a certain degree (e.g., slightly above or slightly below the longitudinal axis (A1)) in other versions. It should be understood that the second position of the angled distal tip (319) may be defined by the characteristics (e.g., thickness, density, etc.) of the tissue captured between the anvil (318) and the lower jaw (16). In the present example, the end effector (312) is disposed on a shaft (322) that is removable from the handle portion (320). By way of example only, shaft (322) may be detachable from handle portion (320) in accordance with at least some of the teachings of U.S. Patent 9,913,642, entitled “Surgical Instrument Comprising a Sensor System,” which issued on Mar. 13, 2018, the disclosure of which is incorporated herein by reference. In some other versions, shaft (322) may not be detachable from handle portion (320).
[0084] It should be understood that the end effector (312) may be used instead of Figure 1 . In some versions, the end effector (312) may be integrally formed with the shaft (22), or alternatively, the end effector may be formed separately and then assembled. In some versions, the end effector (312) may be provided for use in a robotic system. In such a robotic system, a modular shaft (322) having an end effector (312) can be attached to a portion of the robotic system for use, so that the handle portion (320) is replaced by a component of the robotic system. Still in other examples, the end effector (312) may be adapted for use with a robotic system in a manner in which the end effector (312) is connected to the robotic system without having to connect the entire modular shaft (322). In accordance with the teachings herein, other ways of incorporating an end effector having an angled, elastically deformable anvil tip into a user-operated or robot-operated instrument will be apparent to one of ordinary skill in the art.
[0085] Fig. 12AAn enlarged side view of the distal end of the end effector (312) is shown. The end effector (312) includes an anvil (318) and a lower jaw (16) which receives a cartridge (37) as described above with respect to the instrument (10). As described above with respect to the instrument (10), the anvil (318) is pivotally rotatable toward the lower jaw (16) in the same manner as the anvil (18). In this configuration, the end effector (312) is similar to the end effector (12), however, the anvil (318) includes an angled distal tip (319) that is elastically deformable. As Fig. 12A As shown, the tip (319) is biased to an angled position that is Fig.11 is shown in and Fig. 12A When the end effector (312) is not clamping tissue and is open, the tip (319) adopts this angled position, as shown in dashed lines. Fig.11 as shown; or closed without clamping the tissue, as Fig. 12A 312 is shown as a dotted line in FIG. 31. With end effector (312) in this angled state or position, end effector (312) may be considered unloaded or in an unloaded state or position. Conversely, when end effector (312) is clamping tissue, end effector (312) may be considered loaded or in a loaded state or position.
[0086] When closed and not clamping tissue between the anvil (318) and the lower jaw (16), the end (319) contacts the cartridge (37). In this position, the lower side surface (324) of the end (319) defines a plane that intersects the longitudinal axis (A1) defined by the shaft (322) to form an angle (θ1). When closed and clamping tissue (90) between the anvil (318) and the lower jaw (16), the lower side surface (324) of the end (319) contacts the tissue (90). In this position, the lower side surface (324) of the end (319) defines a plane that intersects the longitudinal axis (A1) to form an angle (θ2). Fig. 12AIn the illustrated example, the angles (θ1, θ2) are relative to the longitudinal axis (A1), and the sum of the angles (θ1, θ2) represents the range of movement experienced by the distal tip (319). By way of example only and not limitation, in some examples, in the downward direction from the longitudinal axis (A1) toward the bin (37), the angle (θ1) is between about 20 and about 70 degrees, or more specifically between about 30 and about 50 degrees. By way of example only and not limitation, in some examples, in the upward direction away from the longitudinal axis (A1) from the bin (37), the angle (θ2) is between about 0 and about 90 degrees. By way of example only and not limitation, in some examples, the range of movement experienced by the tip (319) is between about 20 and about 110 degrees. The angles described for angles (θ1, θ2) are exemplary only and not limiting. Other suitable angles will be apparent to one of ordinary skill in the art based on the teachings herein.
[0087] Additionally, in some cases, the longitudinal axis (A1) represents a zero degree reference and the angle relative to it can be positive or negative. For example, in the case where the angle is in a downward direction from the longitudinal axis (A1) toward the bin (37), the angle can be characterized as a negative angle. Similarly, in the case where the angle is in an upward direction away from the longitudinal axis (A1) away from the bin (37), the angle can be characterized as a positive angle. When using these provisions, the range of movement of the distal tip (319) due to deformation can be understood as the sum of the absolute value of the angle when the distal tip (319) is in a position to contact the bin (37) and the angle when the distal tip (319) is in a deformed state (when clamping tissue).
[0088] Fig. 12B Shown with Fig. 12A 1 and 12. With respect to the end effector (312), when the anvil (318) is in its angled and undeformed state (e.g., in Fig. 12A When the anvil (318) is deformed so that it deflects upward, the end of the distal tip (319) extends to the far side of the far end of the cartridge (37). Fig. 12B As shown, when the anvil (318) is in its angled and undeformed state (e.g., in Fig. 12B318) extends to a point flush with or close to the most distal end of the cartridge (37). When the anvil (318) is deformed so that it deflects upward, the end of the distal tip (319) of the anvil (318) extends to a point flush with or close to the most distal end of the cartridge (37). In this way, when the anvil (318) is in its angled state or deformed state, the anvil (318) of the end actuator (412) is flush with or close to the most distal end of the cartridge (37), so that whether the anvil (318) is in an angled and undeformed state or in a deformed state, the anvil (318) does not extend beyond the most distal end of the cartridge (37). In some cases, this can be achieved by modifying the anvil (318) so that the length of the distal tip (319) of the anvil is shortened. In other cases, instrument (10, 310) may be modified to provide slight proximal retraction of anvil (318) when clamping.Other ways to modify end effector (412) as it relates to controlling the position of anvil (318) will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0089] IV. Exemplary End Effectors with Discrete Position Pivoting Tips
[0090] In some cases, it may be desirable to provide a user with a universal end effector having a tip that can be configured differently for different applications. For example, it may be desirable or beneficial for a user to use an end effector having an angled (or "bent") tip to obtain visualization and placement benefits as described above. In addition, not only visualization of the distal end of the end effector may be desired, but also the end effector may be constructed so that the distal end of the anvil is configured to be able to push tissue (e.g., a large blood vessel) toward the proximal side into the space between the anvil and the lower jaw when the anvil is closed toward the lower jaw. In addition, in other cases, it may be desirable or beneficial for a user to use an end effector having a straight or expanded tip so that the end effector is better adapted to procedures involving advancement as also described above. In addition, it may be desirable or beneficial for a user to be able to switch the end of the end effector to move away from the tissue when the user is concerned about pressure on the tissue under the tip of the end effector during use.
[0091] It should be understood that, as used herein in conjunction with the various exemplary anvil tips disclosed, the terms "angled" and "curved" encompass tip configurations in which the tip defines a flat, planar outer surface that extends angularly in a distal direction from the distal end of the anvil body; and tip configurations in which the tip defines a bent outer surface that extends arcuately in a distal direction from the distal end of the anvil body (e.g., wherein the tip is referred to as being in a "bent" configuration). In both types of configurations, the distal end of the anvil tip is perpendicularly offset from the longitudinal axis of the anvil body along an axis that extends transverse to the longitudinal axis of the anvil body and passes through the corresponding staple cartridge, such that the tip is "angled" or "curved" relative to the anvil body as a whole.
[0092] A. Exemplary End Effector Pinned Pivoting Tip with Pawl
[0093] Figures 13 to 16 Exemplary anvils (518, 118) that can be used with the end effectors and other end effectors described herein are shown. For example, the anvils (518, 118) can be interchangeable or used to replace the anvils (18, 218, 318) of the corresponding end effectors (12, 212, 312, 412) described above. It should be understood that the end effectors (12, 212, 312, 412) in combination with any of the anvils (518, 118) can be used with the instrument (10, 310) and other surgical instruments described herein. In this regard, the end effectors (12, 212, 312, 412) in combination with any of the anvils (518, 118) can be integrally formed with the instrument (10, 310) and other surgical instruments described herein, or alternatively can be interchangeable end effectors of the instrument (10, 310) and other surgical instruments described herein.
[0094] As part of any of the end effectors (12, 212, 312, 412), the anvil (518, 118) is operable to pivot relative to the lower jaw (16, 216). The anvil (518, 118) and the lower jaw (16, 216) may be similar to those of Figure 7 The anvil (18) and lower jaw (16) shown are used to clamp tissue (90). The anvil (518, 118) and lower jaw (16, 216) can also be similar to those of Figure 7 The cutting and suturing performed by the anvil (18) and the lower jaw (16) shown are used to cut and suturing the clamped tissue (90). As described above, in order to achieve cutting and suturing, the end actuator (12,212,312,412) in conjunction with any one of the anvils (518,118) also includes a cartridge (37,237) containing staples, wherein the cartridge (37,237) is operable to be placed in the lower jaw (16,216).
[0095] 1. Single section pinned pivot end
[0096] The anvil (518) includes a body (520) and a distal end (519) extending distally from the body (520). On the proximal side of the distal end (519), the anvil (518) includes an extension (502) on the body (520). The anvil (518) also includes a pair of spaced-apart pawls (504). A portion of the pawl (504) located on the extension (502) is configured as a raised portion or protrusion (510), as shown in the illustrated embodiment. Another portion of the pawl (504) is located on the distal end (519) and is configured as a recessed portion (523), as will be further described below. The anvil (518) also includes an aperture (506) extending through the side of the body (520) of the anvil (518), and the aperture (506) is configured to receive the pin (508). As will be discussed further below, pin (508) defines an axis of rotation about which tip (519) is rotatable.
[0097] The end (519) includes an aperture (521) extending through the side of the end (519), and the aperture (521) is configured to also receive the pin (508). In this way, the end (519) can be operated to rotate around the pin (508), and thus rotate relative to the longitudinal axis (A2) of the anvil (518). The apertures (506, 521) have a circular shape, but have an elongated shape in other examples. In some cases, the elongated shape of the apertures (506, 521) provides or helps the end (519) to present different discrete positions, as further discussed below. As described above, the end (519) includes a pair of recessed portions (523) configured to selectively engage with the raised portion or protrusion (510) of the pawl (504). At the proximal portion of the end (519), the end (519) includes a pair of slots (525) extending longitudinally and defining an elastic portion (527). In this example, the elastic portion (527) includes a recess (523) along the underside of the elastic portion (527).
[0098] Reference now Fig.14A and Fig.15 , the anvil (518) is configured to have a tip (519) that is movable into discrete positions. The pawl (504) provides selective engagement between a raised portion (510) of the pawl (504) and a recessed portion (523) of the pawl (504), which allows the tip (519) to move into different discrete positions. Fig.14A The tip (519) is shown in a first position in which the tip (519) is in a straight orientation such that the longitudinal axis of the tip (519) is generally parallel to or coincident with the longitudinal axis (A2) of the anvil (518). Fig.15The tip (519) is shown in a second position in which the tip (519) is in an angled orientation such that the longitudinal axis of the tip (519) forms an angle of less than about 180 degrees with the longitudinal axis (A2) of the anvil (518).
[0099] As mentioned above and Figures 13 to 15 As shown, the slot (525) defines a resilient portion (527) such that the resilient portion (527) acts as a spring, thereby allowing the end (519) to change position by engaging the protruding portion (510) in different ways via the recess (523). Fig.14A When in the straight orientation shown, the most proximal recessed portion (523) engages with the most proximal raised portion (510). Similarly, in this straight orientation, the most distal recessed portion (523) engages with the most distal raised portion (510). Fig.15 In the angled orientation shown, the most proximal recess (523) engages with the most distal protrusion (510). In addition, in this angled orientation, the most distal recess (523) does not engage with any protrusion (510). However, the anvil (518) includes a stop feature (500) that is configured to contact the proximal end of the end (519) and prevent the end (519) from moving to an even further angled position. In the case of engagement between one or more recesses (523) and one or more protrusions (510) of each in a straight orientation, the end (519) can be adjusted or positioned in discrete positions rather than having a continuous orientation. Therefore, the end (519) is configured to take discrete positions, wherein the end (519) remains in one of the discrete positions until it is subjected to a force sufficient to overcome the interference connection established between the recess (523) and the protrusion (510) of the pawl (504).
[0100] refer to Fig.15 , when tip (519) is rotated or pivoted to the angled orientation shown, in some versions there may be a gap (529). An optional sleeve (not shown) may be added to anvil (518) to cover gap (529) or extend over the gap to eliminate the possibility that gap (529) may provide a compression point for surrounding tissue. In some examples, such a sleeve may extend to reach the end of tip (519) and return to a position as far as the suture line of anvil (518), although this is not required in all versions.
[0101] In one version of anvil (518), anvil (518) is constructed of a single material, such as stainless steel, although other materials may be used in place of stainless steel in other versions. Additionally, in some other versions, anvil (518) may be coated with another material to provide visualization, sliding, or other material characteristics or properties, as would be apparent to one of ordinary skill in the art in light of the teachings herein.
[0102] In other examples of the anvil (518), three pawls (504) may be used so that three discrete positions of the end (519) can be defined. In this type of configuration with three pawls (504), the end (519) can be configured to be able to take a straight orientation, an angled orientation (which can form a bent configuration), or an expanded or open orientation in which the end (519) is bent upward away from the lower jaw (16, 216). In addition, in other examples of the anvil (518), the pawls (504) may be located on the side of the end (519) and the body (520) of the anvil (518) instead of the top. However, in some other examples, the position of the feature of the pawl (504) can be opposite. For example, instead of the raised portion (510) being located on the body (520) of the anvil (518), the raised portion is located on the end (519). In such examples, instead of slot (525) and resilient portion (527) with recess (523) being located on tip (519), slot (525) and resilient portion (527) with recess (523) are located on body (520) of anvil (518). In such examples, these features still cooperate in the same manner as described above to provide discrete positioning of tip (519). Other ways of constructing anvil (518) and pawl (504) to achieve multiple discrete positions of tip (519) will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0103] 2. Multiple sections pinned to pivot ends
[0104] Fig.16 Another exemplary anvil (118) that can be used with the end effectors and other end effectors described herein is shown. Except for the differences mentioned below, anvil (118) is similar to anvil (518) described above. Therefore, the above description of anvil (518) also applies to anvil (118).
[0105] The anvil (118) includes a body (520) and a terminal end (119) extending distally from the body (520). The features and functions of the anvil (518) are also applicable to the anvil (118), including the features and functions of the terminal end (519) are also applicable to the terminal end (119). However, the terminal end (119) includes additional features and functions. Specifically, the terminal end (119) includes a distal portion (131) and a proximal portion (133). In addition, the terminal end (119) is configured so that not only the proximal portion (133) can be rotated to a discrete position relative to the body (520) of the anvil (118), as described above with respect to the anvil (118), but also the distal portion (131) can be rotated to a discrete position relative to the proximal portion (133) of the terminal end (119).
[0106] Furthermore, in the illustrated version, rotatability of distal portion (131) relative to proximal portion (133) occurs in the same manner as rotatability of proximal portion (133) relative to body (520) of anvil (118). Fig.16 As shown, a pin (135) extends through and connects the distal portion (131) and the proximal portion (133). And an additional pin (135) provides and defines an axis of rotation about which the distal portion (131) can rotate. In this way, the tip (119) is composed of multiple pinned parts or sections. This configuration allows for greater angles and, in some versions, also allows the overall curvature-like shape to be achieved using an originally straight but angled section of the tip (119).
[0107] As mentioned, the same or similar configuration of pawl (504) may be used with the distal and proximal portions (131, 133) of tip (119) to achieve rotation to discrete positions. For example, in one version, the first discrete position of distal portion (131) is a straight orientation relative to proximal portion (133), such as Fig.16 As shown. The second discrete position of the distal portion (131) is an angled or bent orientation relative to the proximal portion (133), wherein the distal portion (131) is bent or angled downward toward the lower jaw (16, 216) of the associated end effector. Of course, in some other versions, the second discrete position of the distal portion (131) may be expanded or bent upward relative to the proximal portion (133). In view of the teachings herein, other configurations and methods for achieving such a configuration of the tip (119) having multiple rotatable pinned sections will be apparent to those of ordinary skill in the art.
[0108] B. Exemplary End Effector Pivot Tip Having Fulcrum Features
[0109] Fig.17 and Fig.18A portion of an exemplary anvil (618) that can be used with the end effectors and other end effectors described herein is shown. For example, the anvil (618) can be interchangeable or used to replace the anvil (18, 218, 318) of the corresponding end effectors (12, 212, 312, 412) described above. It should be understood that the end effector (12, 212, 312, 412) in combination with the anvil (618) can be used with the instrument (10, 310) and other surgical instruments described herein. In this regard, the end effector (12, 212, 312, 412) in combination with the anvil (618) can be integrally formed with the instrument (10, 310) and other surgical instruments described herein, or alternatively can be an interchangeable end effector of the instrument (10, 310) and other surgical instruments described herein.
[0110] As part of any of the end effectors (12, 212, 312, 412), the anvil (618) is operable to pivot relative to the lower jaw (16, 216). The anvil (618) and the lower jaw (16, 216) may be similar to those of Figure 7 The anvil (18) and lower jaw (16) shown are used to clamp tissue (90). The anvil (618) and lower jaw (16, 216) can also be similar to the clamping performed by Figure 7 The cutting and suturing performed by the anvil (18) and the lower jaw (16) shown are used to cut and suturing the clamped tissue (90). As described above, in order to achieve cutting and suturing, the end actuator (12,212,312,412) in conjunction with the anvil (618) also includes a cartridge (37,237) containing staples, wherein the cartridge (37,237) is operable to be placed in the lower jaw (16,216).
[0111] The anvil (618) includes a body (620), a tip (619), and a connecting member (621). The tip (619) includes a polymer or metal covering (shown as an elastomeric overmold (623)) and a pivot member 625, such as Fig.18 Best seen. The connecting member (621) is configured to be attached to the body (620). In one version, the connecting member (621) includes a metal stamping that is configured to be welded to the body (620) of the anvil (618). In another version, the connecting member (621) is configured to be press-fit or snap-fit to the body (620). In this type of version, the connecting member (621) may include a feature that engages with a slot (627) of the body (620). In view of the teachings herein, other ways of attaching the connecting member (621) to the body (620) of the anvil (618) will be apparent to one of ordinary skill in the art.
[0112] The connecting member (621) includes arms (629) extending distally. The arms (629) each include an aperture (631) configured to receive a projection (633) of the pivot member (625). In this manner, the aperture (631) provides a pivot axis or rotation axis for the end (619). The connecting member (621) also includes a bent lip (635) that functions like a fulcrum feature. The bent lip (635) projects distally and is configured to interact with a proximal end (637) of the pivot member (625) of the end (619).
[0113] The pivot member (625) can be connected to the connecting member (621) as described above, wherein the protrusion (633) is received within the aperture (631) of the connecting member (621). With this configuration, the pivot member (625) can be rotationally adjusted relative to the connecting member (621) and the body (620) of the anvil (618). When the protrusion (633) is located within the aperture (631), the proximal end (637) of the pivot member (625) is positioned in a slightly overlapping orientation relative to the bent lip (635). The remainder of the pivot member (625) extends distally from the connecting member (621). Fig.18 As shown, an elastomeric overmold (623) (shown in phantom to illustrate internal components) covers the pivot member (625) and the connecting member (621).
[0114] With the above-described configuration of anvil (618), tip (619) is configured to be rotatable or pivotable about a pivot axis defined by aperture (631), whereby proximal end (637) of pivot member (625) can assume discrete positions relative to bent lip (635), such that tip (619) assumes discrete positions relative to body (620). For example, Fig.18 As shown by the solid lines in the figure, in the first position, the pivot member (625) can have an angled orientation. In the illustrated version, this corresponds to the situation where the proximal end (637) of the pivot member (625) is above the bent lip (635). Fig.18 As shown by the dotted lines in the figure, in the second position, the pivot member (625) can have a straight or slightly expanded orientation. In the illustrated version, this corresponds to the situation where the proximal end (637) of the pivot member (625) is below the bent lip (635).
[0115] In this example, the elastomeric overmold (623) acts as a spring that holds the pivot member (625) in position on either side of the bent lip (635) until sufficient force is applied to the tip (619) to overcome the bias provided by the elastomeric overmold (623) and the contact between the proximal end (637) and the bent lip (635). For example, when in an angled or bent orientation, when sufficient upward force is applied to the tip (619), the proximal end (637) of the pivot member (625) will rotate downward and snap past the bent lip (635), thereby allowing the tip (619) to assume another discrete position. Similarly, when in a straight or expanded orientation, when sufficient downward force is applied to the tip (619), the proximal end (637) of the pivot member (625) will rotate upward and snap past the bent lip (635), thereby allowing the tip (619) to assume another discrete position.
[0116] In this example, the proximal end (637) is rounded and toleranced so that it snaps past the bent lip (635) that acts as a fulcrum feature. In some other versions, the bent lip (635) may be combined with a rounded and toleranced distal end to facilitate movement of the proximal end (637) from one side of the bent lip (635) to the other side of the bent lip (635). Also, as mentioned, once on either side of the bent lip (635) or other fulcrum feature, the tip (619) will remain in place because the elastomeric overmold (623) acts as a spring to hold the pivot member (625) in place.
[0117] In one version of anvil (618), tuning for force feedback or acoustic feedback may be achieved by configuring the fulcrum feature to have a deformable dome-type geometry through which the proximal end (637) moves when changing discrete positions. In other words, greater or lesser deformations may be used with the fulcrum feature so that the user obtains tactile and / or audible feedback confirming that the tip (619) has changed position. Other ways of modifying the anvil (618), connecting member (621), and tip (619) to achieve a pivoting tip that assumes discrete positions will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0118] C. Exemplary End Effector Pivoting Tip Having Triangular Pivot Member
[0119] Fig.19 and Fig. 20A portion of an exemplary anvil (718) that can be used with the end effectors and other end effectors described herein is shown. For example, the anvil (718) can be interchangeable or used to replace the anvil (18, 218, 318) of the corresponding end effectors (12, 212, 312, 412) described above. It should be understood that the end effector (12, 212, 312, 412) in combination with the anvil (718) can be used with the instrument (10, 310) and other surgical instruments described herein. In this regard, the end effector (12, 212, 312, 412) in combination with the anvil (718) can be integrally formed with the instrument (10, 310) and other surgical instruments described herein, or alternatively can be an interchangeable end effector of the instrument (10, 310) and other surgical instruments described herein.
[0120] As part of any of the end effectors (12, 212, 312, 412), the anvil (718) is operable to pivot relative to the lower jaw (16, 216). The anvil (718) and the lower jaw (16, 216) may be similar to those of Figure 7 The anvil (18) and lower jaw (16) shown are used to clamp tissue (90). The anvil (718) and lower jaw (16, 216) can also be similar to the clamping performed by Figure 7 The cutting and suturing performed by the anvil (18) and the lower jaw (16) shown are used to cut and suturing the clamped tissue (90). As described above, in order to achieve cutting and suturing, the end actuator (12,212,312,412) in conjunction with the anvil (718) also includes a cartridge (37,237) containing staples, wherein the cartridge (37,237) is operable to be placed in the lower jaw (16,216).
[0121] The anvil (718) includes a body (720), an end (719), and a connecting member (721). The end (719) includes a polymer or metal covering (shown as an elastomeric overmold (723)) and a pivot member 725. The connecting member (721) is configured to be attached to the body (720). In one embodiment, the connecting member (721) includes a metal stamping configured to be welded to the body (720) of the anvil (718). In another embodiment, the connecting member (721) is configured to be press-fit or snap-fit to the body (720). In this type of embodiment, the connecting member (721) may include a feature that engages with a slot (similar to the slot (627) of the body (620)) of the body (720). In view of the teachings of this article, other ways of attaching the connecting member (721) to the body (720) of the anvil (718) will be apparent to those of ordinary skill in the art.
[0122] The connecting member (721) includes a distally extending double lug feature (735). As shown in the illustrated version, the connecting member (721) also includes a space or gap (739) located between the lugs of the double lug feature (735). In this example, but not necessarily in all versions, the double lug feature (735) is rigid. The pivot member (725) includes a triangular body (741) and an elongated member (743) connected to the triangular body (741) and extending distally from the triangular body. In this example, but not necessarily in all versions, the pivot member (725) includes a metal structure.
[0123] In this example, the double lug feature (735) is sized and toleranced to interact with the triangular body (741) of the pivot member (725). For example, the double lug feature (735) defines base corners (745, 747) and the triangular body (741) defines vertices (749, 751). Fig.19 As shown, when the tip (719) is in a first discrete position in which the tip (719) has a downwardly angled orientation, the apex (749) is biased into the base corner (745). At the same time, the apex (751) is pivoted away from the base corner (747) and instead approaches the distal end of the double lug feature (735). Fig. 20 As shown, when the tip (719) is in a second discrete position in which the tip (719) has a straight or upwardly angled orientation, the apex (751) is biased into the base corner (747). At the same time, the apex (749) is pivoted away from the base corner (745) and close to the distal end of the double lug feature (735).
[0124] In this example, the elastomeric overmold (723) biases the triangular body (741) proximally. Thus, the elastomeric overmold (723) acts as a spring to hold the triangular body (741) of the pivot member (725) in position against the double lug features (735). However, when sufficient force is applied to the distal end (719) to overcome the proximal bias applied by the elastomeric overmold (723), the triangular body (741) pivots between the double lug features (735), as shown in FIG. Fig.19 and Fig. 20 For example, when in an angled or bent orientation, as shown in FIG. Fig.19As shown, when sufficient upward and / or distally directed force is applied to the tip (719), the vertex (749) of the triangular body (741) moves distally along the lower lug of the double lug feature (735). At the same time, the vertex (751) of the triangular body (741) of the pivot member (725) moves proximally along the upper lug of the double lug feature (735) until it locks into the base corner (747). Similarly, when in Fig. 20 When sufficient downwardly and / or distally directed force is applied to the tip (719) in the straight or upwardly curved orientation shown, the vertex (749) of the triangular body (741) travels proximally along the lower lug of the double lug feature (735) until locking into the base corner (745). At the same time, the vertex (751) of the triangular body (741) of the pivot member (725) travels distally along the upper lug of the double lug feature (735). In one version, switching the position of the tip (719) may involve a user squeezing and pulling distally on the tip (719) to temporarily deform the elastomeric overmold (723) while repositioning the tip (719). In other versions, switching the position of the tip (719) may involve a user pushing upward or downward so that a force is applied substantially orthogonally to the longitudinal axis of the anvil (718).
[0125] D. Exemplary End Effector Tip with Internal Snap-Fit Clamp
[0126] Figure 21 to Figure 29 and Figure 30 to Figure 32 An exemplary end effector (812, 912) with a corresponding anvil (818, 918) is shown. The end effector (812, 912) may be interchangeable or used in place of the end effectors (12, 212, 312, 412) described above. It should be understood that the end effector (812, 912) may be used with the instrument (10, 310) and other surgical instruments described herein. In this regard, the end effector (812, 912) with a corresponding anvil (818, 918) may be integrally formed with the instrument (10, 310) and other surgical instruments described herein, or alternatively may be an interchangeable end effector of the instrument (10, 310) and other surgical instruments described herein.
[0127] The end effectors (812, 912) are operable to clamp tissue (90), similar to the Figure 7 The end effector (812, 912) is further operable to cut and staple the clamped tissue (90), similar to the method performed by the end effector (12). Figure 7 The end effector (12) shown performs cutting and suturing.
[0128] 1. Internal snap-on clamp with distal rivet connection
[0129] Figure 21 to Figure 23 An exemplary end effector (812) is shown that includes an anvil (818), a lower jaw (16), and a staple cartridge (37) positioned within the lower jaw (16). The lower jaw (16) and cartridge (37) are described above with respect to other end effectors, and these descriptions apply equally here to the end effector (812). The anvil (818) includes a tip (819). The tip (819) includes a flexible, deformable member that enables the tip (819) to move relative to the anvil (818) between a first discrete position and a second discrete position. For example, the first discrete position is Fig.21 and Fig. 22 , where the tip (819) has an angled or bent orientation relative to the longitudinal axis (A3) of the anvil (818) until the deformable member is subjected to an external input force. Fig.23 A second discrete position is shown in which the tip (819) has a straight orientation relative to the longitudinal axis (A3) until the deformable member is subjected to an external input force. In the case of the straight orientation, the tip (819) is generally aligned with the remainder of the anvil (818), and the tip (819) extends parallel to the longitudinal axis (A3). In the case of the angled orientation, the tip (819) is angled relative to the longitudinal axis (A3) so that the tip (819) extends toward the lower jaw (16) and the cartridge (37). In some embodiments, the angled orientation can form a bent orientation.
[0130] When using the end effector (812), the user can select a desired discrete position for the end (819). This can be done, for example, when a new bin (37) is reloaded onto the end effector (812). When the user attempts to position and navigate the anvil (818) around tissues such as blood vessels and other tubular structures, the user can select an angled orientation of the end (819). When the user attempts to pass through tissue, the user can select a straight orientation of the end (819) because the straight orientation of the end (819) provides a larger hole than the angled orientation of the end (819). When the user performs a procedure involving advancement as described above, the user can also select a straight orientation of the end (819).
[0131] The deformable member may include a polymer or metal covering and an internal support structure. Fig.24 An enlarged perspective view of the distal end of end effector (812) is shown, wherein the polymer or metal covering of tip (819) (shown as elastomeric overmold (823)) is shown transparently to show the internal components of tip (819). The deformable member of tip (819) may include an internal support structure (in Fig.24819 is shown as an internal fixture (821) so that the end (819) remains in a desired discrete position until subjected to an external input force. Although the internal fixture (821) shows a suitable support structure of this type, other support structures of various shapes and sizes are also conceivable. In the illustrated embodiment, the internal fixture (821) is connected to the body (820) of the anvil (818) and extends distally from the body. The internal fixture (821) includes a base (825) and a pair of arms (827) extending distally from the base (825). The arms (827) converge when they extend distally, and the arms (827) are joined at their respective distal ends by rivets (829), as shown in this example. The internal fixture (821) also includes a space (831) located between the arms (827), and in this example, the space (831) has a triangular shape.
[0132] The inner clamp (821) is configured as an eccentric snap-fit clamp having two discrete positions corresponding to the angled orientation and the straight orientation of the tip (819) as described above. In addition, the inner clamp (821) can be overmolded with an elastomeric material such that the tip (819) includes an elastomeric overmold (823), as described above. In still other versions, the inner clamp (821) can be inserted into an otherwise formed flexible tip such that the inner clamp (821) does not need to be overmolded to be surrounded by an elastomeric material.
[0133] When using end effector (812) having anvil (818) and end (819) to switch or transform the discrete positions of end (819), the user will apply force to end (819) in the direction the user wants end (819) to move. Fig.24 In the case of the first discrete position shown having an angled orientation, by opening the end actuator (812) and applying an upward force from the underside of the end (819), the internal clamp (821) will snap into its straight orientation associated with the second discrete position as described above. Fig.25 The tip (819) is shown in a straight orientation, and the elastomeric overmold (823) is shown as transparent to show the internal clamp (821) in this state or position. Similarly, the deformable member at the tip (819) is in a straight orientation as shown. Fig.25In the case of the second discrete position with a straight orientation shown, when sufficient downward force is applied from the top side of the end (819), the inner clamp (821) will snap into its angled (e.g., bent or curved) orientation associated with the first discrete position as described above. In this manner, the inner clamp (821) is deflectable and includes a biasing member to assume the first position associated with the angled orientation of the end (819), or the second discrete position associated with the straight orientation of the end (819).
[0134] Fig.26 and Fig. 27 The internal clamp (821) and its additional features are shown. As shown, the rivet (829) is Fig.26 and Fig. 27 827, arms (827) are shown each including an aperture (833) at a distal end thereof. Apertures (833) are each configured and sized to receive rivet (829), thereby engaging arms (827). Fig.26 The inner clamp (821) is shown in its assembled or formed form, wherein the arms (827) have been forced toward each other to align the apertures (833) of each arm to ultimately receive the rivet (829). Fig. 27 The inner clamp (821) is shown in its unassembled or stamped form, with the arms (827) not converging and the apertures (833) not aligned. Fig.26 and Fig. 27 In the illustrated version of FIG. 8 , the inner clamp ( 821 ) comprises a stamped metal structure. However, in other examples, other materials besides metal may be used to construct the inner clamp ( 821 ).
[0135] refer to Fig.26 In some embodiments, the proximal extension (835) of the inner clamp (821) is configured to be received by and connected to the body (820) of the anvil (818). In this manner, the inner clamp (821) is secured to the anvil (818). In some versions, the inner clamp (821) may be welded to the body (820) of the anvil (818), for example, by welding the proximal extension (835) to the body (820). Various other ways of connecting the inner clamp (821) to the anvil (818) will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0136] Fig.28 and Fig.29 Another version of the end effector 812 is shown, wherein the inner clamp (821) is configured with a biasing member to assume a first discrete position associated with a bent orientation of the tip (819), as described above with respect to Fig.21 , Fig. 22 and Fig.24As shown and described, or presenting a second discrete position associated with the expanded orientation of the tip (819), such as Fig.28 and Fig.29 As shown. In some examples, the expanded orientation may also be referred to as an arched orientation. In the expanded orientation, the tip (819) is angled upward relative to the longitudinal axis (A3) of the anvil (818). Compared to the straight orientation of the tip (819) shown and described above, the expanded orientation provides an even larger hole, which may be useful when attempting to penetrate tissue and / or when performing procedures involving advancement. In addition to changing the second discrete position from straight to expanded, as shown Fig.28 and Fig.29 The remaining features and functions of the illustrated end effector (812) are similar to those described above with respect to Figure 21 to Figure 27 Same as shown and described.
[0137] In some examples, the geometry and material of both the elastomeric overmold (823) and / or the internal fixture (821) can contribute to the discrete position of the end (819). For example, in one example, changing the elastomeric overmold (823) to a more flexible elastomer can allow the internal fixture (821) to change position to a greater extent. In one version, this is a way to change the configuration of the end (819) from having an angled and straight orientation to having an angled and expanded orientation on the contrary. In another example, the internal fixture (821) can be made stiffer by increasing the mass of the internal fixture (821), changing its material, or changing the geometry of the internal fixture (821). Such an increase in stiffness can overcome the reaction force or bias applied to the end (819) by the elastomeric overmold (823). This can be another way to change the configuration of the end (819) from having an angled and straight orientation to having an angled and expanded orientation on the contrary. However, in some versions of end effector (812) having anvil (818), tip (819) may be configured to provide angled, straight, and expanded orientations, and thus tip (819) will have three discrete positions available to a user. Various other ways to configure components of tip (819) to achieve the desired discrete positions of tip (819) will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0138] 2. Internal snap-fit clamp pinned proximally
[0139] Figure 30 to Figure 32An exemplary end effector (912) is shown that includes an anvil (918), a lower jaw (16), and a staple cartridge (37) positioned within the lower jaw (16). The lower jaw (16) and cartridge (37) are described above with respect to other end effectors, and these descriptions apply equally here to the end effector (912). The anvil (918) includes a tip (919). The tip (919) includes a flexible, deformable member that enables the tip (919) to move relative to the anvil (918) between a first discrete position and a second discrete position. For example, the first discrete position is Fig.30 and Fig. 22 , where the tip (919) has an angled (eg, bent) or curved orientation relative to the longitudinal axis (A3) of the anvil (918) until the deformable member is subjected to an external input force. Fig.23 A second discrete position is shown in which the tip (919) has a straight orientation relative to the longitudinal axis (A3) until the deformable member is subjected to an external input force. In the case of the straight orientation, the tip (919) is generally aligned with the remainder of the anvil (918), and the tip (919) extends parallel to the longitudinal axis (A3). In the case of the angled orientation, the tip (919) is angled relative to the longitudinal axis (A3) so that the tip (919) extends toward the lower jaw (16) and the cartridge (37). In some embodiments, the angled orientation can form a bent orientation, as described above.
[0140] When using the end effector (912), the user can select a desired discrete position for the end (919). This can be done, for example, when a new cartridge (37) is reloaded onto the end effector (912). When the user attempts to position and navigate the anvil (918) around tissues such as blood vessels and other tubular structures, the user can select an angled orientation of the end (919). When the user attempts to penetrate tissue, the user can select a straight orientation of the end (919) because the straight orientation of the end (919) provides a larger hole than the angled orientation of the end (919). The user can also select a straight orientation of the end (919) when the user performs a procedure involving advancement as described above.
[0141] The deformable member may include a polymer or metal covering and an internal support structure. Fig.31An enlarged perspective view of the distal end of the anvil (918) of the end effector (912) is shown, wherein the polymer or metal covering (shown as an elastomeric overmold (923)) of the end (919) and the body (920) of the anvil (918) is transparently shown to show the internal components. The deformable member of the end (919) may include an internal support structure (shown as an internal clamp (921)) connected to the body (920) of the anvil (918) and extending distally from the body. The internal clamp (921) includes a tip portion (925) and a pair of arms (927) extending proximally from the tip portion (925). The arms (927) initially diverge as they extend proximally and then converge as they approach their respective proximal ends. The arms (927) are joined at their respective proximal ends by pins (929) within the body (920) of the anvil (918), which extend through respective alignment apertures (933) of the arms (927), as shown in this example. In some versions, the pins (929) may be replaced with rivets or screw pins. The internal clamp (921) also includes a space (931) between the arms (927), and in this example, the space (931) has a triangular shape.
[0142] The inner clamp (921) is configured as an eccentric snap-fit clamp having two discrete positions corresponding to the angled orientation and the straight orientation of the tip (919) as described above. In addition, the inner clamp (921) can be overmolded with an elastomeric material such that the tip (919) includes an elastomeric overmold (923), as described above. In still other versions, the inner clamp (921) can be inserted into an otherwise formed flexible tip such that the inner clamp (921) does not need to be overmolded to be surrounded by an elastomeric material.
[0143] When using an end effector (912) having an anvil (918) and a distal end (919) to switch or convert the discrete positions of the distal end (919), the user will apply a force to the distal end (919) in the direction in which the user wants the distal end (919) to move. Fig.30 In the case of the first position having an angled orientation as shown, by opening the end effector (912) and applying an upward force from the underside of the tip (919), the inner clamp (921) will snap into its straight orientation associated with the second discrete position as described above. Fig.23In the case of the second discrete position with a straight orientation shown, when sufficient downward force is applied from the top side of the end (919), the inner clamp (921) will snap into its bent or curved orientation associated with the first discrete position as described above. In this manner, the inner clamp (921) is deflectable and includes a biasing member to assume a first position associated with an angled orientation of the end (919), or a second discrete position associated with a straight orientation of the end (919).
[0144] Fig.32 A top view of the internal clamp (921) and its additional features is shown. As shown, the pin (929) extends orthogonally relative to the longitudinal axis of the body (920) of the anvil (918). The arms (927) are positioned to align with the apertures (933) such that the apertures (933) are each configured and sized to receive the pin (929) and thereby engage the arms (927). Fig.32 As shown, the internal fixture (921) is in its assembled or formed form, wherein the arms (927) have been forced toward each other to align the orifices (933) of each arm, thereby ultimately receiving the pin (929). Similar to the internal fixture (821) described above, the internal fixture (921) also has an unassembled or stamped form, wherein the arms (927) do not converge and the orifices (933) are initially misaligned. In one version, the internal fixture (921) includes a stamped metal structure. However, in other examples, other materials besides metal can be used to construct the internal fixture (921). In view of the teachings herein, various other ways of connecting the internal fixture (921) to the anvil (918) will be apparent to those of ordinary skill in the art.
[0145] Fig.28 Another version of the end effector 912 is shown, wherein the inner clamp (921) is configured with a biasing member to assume a first discrete position associated with a bent orientation of the tip (919), as described above with respect to Fig.30 As shown and described, or presenting a second discrete position associated with the expanded orientation of the tip (919), such as Fig.28 In some examples, the expanded orientation may also be referred to as an arched orientation. In the expanded orientation, the tip (919) is angled upward relative to the longitudinal axis (A3) of the anvil (918). Compared to the straight orientation of the tip (919) shown and described above, the expanded orientation provides an even larger hole, which may be useful when attempting to penetrate tissue and / or when performing procedures involving advancement. In addition to changing the second discrete position from straight to expanded, as Fig.28 The remaining features and functions of the illustrated end effector (912) are similar to those described above with respect to Figure 30 to Figure 32 Same as shown and described.
[0146] In order to change the discrete positions that the internal fixture (921) can adopt, in some examples, the geometry and material of both the elastomeric overmold (923) and / or the internal fixture (921) can contribute to the discrete positions that the end (919) will adopt. For example, in one example, changing the elastomeric overmold (923) to a more flexible elastomer can allow the internal fixture (921) to change positions to a greater extent. In one version, this is a way to change the configuration of the end (919) from having a bent and straight orientation to having a bent and expanded orientation in contrast. In another example, the internal fixture (921) can be made stiffer by increasing its mass, changing its material, and / or changing its geometry. Such an increase in stiffness can overcome the reaction force or bias applied by the elastomeric overmold (923) on the end (919). This can be another way to change the configuration of the end (919) from having a bent and straight orientation to having a bent and expanded orientation in contrast. However, in some versions of end effector (912) having anvil (918), tip (919) may be configured to provide a bent, straight, and expanded orientation, and thus tip (919) will have three discrete positions available to a user. Various other ways to configure components of tip (919) to achieve the desired discrete positions of tip (919) will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0147] Another consideration of the end (919) in terms of configuring the discrete positions relates to the proximal portion of the arm (927) that ultimately engages the pin (929). More specifically, the freedom of movement of the proximal portion of the arm (927) relative to the pin (929) affects the position that the internal fixture (921) will take when changing from a first discrete position to a second discrete position. For example, when the internal fixture (921) is snapped from one discrete position to another discrete position, the orifice (933) of the arm (927) may travel to a certain extent along the pin (929). In one example, when the internal fixture (921) is snapped from one discrete position to another discrete position, a larger travel length of the orifice (933) of the arm (927) along the pin (929) is equivalent to a larger position difference from the first discrete position to the second discrete position. Furthermore, where the pin (929) is located within the body (920) of the anvil (918), the body (920) may be configured to allow greater or lesser freedom of movement of the orifice (933) along the pin (929), depending on the available space for the orifice (933) to travel along the pin (929). Similarly, having the connection of the arm (927) within the body (920) of the anvil (918) rather than within the elastomeric overmold (923) may facilitate greater freedom of movement of the arm (927) along the pin (929). Additionally, the diameter of the pin (929) may affect the friction between the pin (929) and the orifice (933), and therefore the freedom of movement of the arm (927) relative to the pin (929).
[0148] refer to Fig.32Another feature that helps control the lateral movement of the arm (927) and thus the discrete positions taken by the end (919) is the geometry of the slot in the body (920) of the anvil (918). For example, in the illustrated embodiment, the anvil (918) includes a slot (935) in the body (920), wherein the slot (935) is defined as a space between two walls (937) extending in the body (920). As shown, the proximal portions of the arm (927) move close enough to each other to fit in the slot (935) and ultimately connect with the pin (929). With this configuration, the size of the slot (935) defined by the wall (937) is used to limit the ability of the arm (927) to move laterally. When the internal clamp (921) is snapped from its first discrete position to its second discrete position, this limited lateral movement affects the degree of change in position. Thus, varying the width of the slot (935) can provide another way to control the range of motion of the inner clamp (921). Additionally, the height of the slot (935) can affect the range that the motion arm (927) must travel along the pin (929). For example, a small height can be more restrictive and thereby prevent the arm (927) from traveling along the pin (929) when the tip (919) moves from a first discrete position to a second discrete position. Similarly, a larger height can have a less restrictive nature and allow the arm (927) to travel further along the pin (929) when the tip (919) is switched.
[0149] 3. Bind the elastomer end to the cut window
[0150] Figure 33 to Figure 35 An exemplary anvil (1018) is shown that can be used with the end effectors and other end effectors described herein. For example, the anvil (1018) can be interchangeable or used to replace the anvil (18, 218, 318) of the corresponding end effectors (12, 212, 312, 412) described above. It should be understood that the end effector (12, 212, 312, 412) in combination with the anvil (1018) can be used with the instrument (10, 310) and other surgical instruments described herein. In this regard, the end effector (12, 212, 312, 412) in combination with the anvil (1018) can be integrally formed with the instrument (10, 310) and other surgical instruments described herein, or alternatively can be an interchangeable end effector of the instrument (10, 310) and other surgical instruments described herein.
[0151] As part of any of the end effectors (12, 212, 312, 412), the anvil (1018) is operable to pivot relative to the lower jaw (16, 216). The anvil (618) and the lower jaw (16, 216) may be similar to those of Figure 7The anvil (18) and lower jaw (16) shown are used to clamp tissue (90). The anvil (1018) and lower jaw (16, 216) can also be similar to the clamping performed by Figure 7 The cutting and suturing performed by the anvil (18) and the lower jaw (16) shown are used to cut and suturing the clamped tissue (90). As described above, in order to achieve cutting and suturing, the end actuator (12,212,312,412) in conjunction with the anvil (1018) also includes a cartridge (37,237) containing staples, wherein the cartridge (37,237) is operable to be placed in the lower jaw (16,216).
[0152] Still reference Figure 33 to Figure 35 , the anvil (1018) includes a body (1020) and a tip (1019). The tip (1019) is connected to the body (1020) and extends distally from the body. The tip (1019) includes a support structure (shown in phantom as an internal clamp (1021)) and a polymer or metal covering (shown as an elastomeric overmold (1023)). As with the previous anvil tip, the tip (1019) is configured so that the internal clamp (1021) can be moved by applying an external input force from a Fig.34 The first discrete position of the angled orientation shown is switched to a position having a Fig.35 A second discrete position of a straight orientation is shown.
[0153] The inner clamp (1021) includes arms (1027) and a space (1031) located between the arms (1027). In addition, the elastomeric overmold (1023) includes an opening (1033) extending through the end (1019). The opening (1033) is aligned with the space (1031) of the inner clamp (1021). By changing the size and shape of the opening (1033) and the space (1031), the deflection of the end (1019) to discrete positions can be controlled to achieve a desired bend and a straight or expanded orientation. In view of the teachings herein, other ways of controlling the discrete positions of the inner clamp (1021) will be apparent to those of ordinary skill in the art.
[0154] 4. Internal clamp with center deflection rib
[0155] Fig.36A plurality of alternative internal clamps (1121) are shown, each of which is capable of being used within the end of an anvil of an end effector used with the surgical instruments described herein. For example, the internal clamp (1121) can be used to replace the internal clamps (821, 921, 1021). The internal clamp (1121) includes a resilient intermediate rib (1122) extending longitudinally between a pair of arms (1127) of the internal clamp (1121). The intermediate rib (1122) is deflectable and includes a biasing member to adopt a discrete position. In this example, the internal clamp (1121) is configured as a hairpin clamp. As described above, in the case where the internal clamp (1121) replaces the internal clamp (821, 921, 1021), the internal clamp (1121) can be overmolded with an elastomeric overmold, as described above. Additionally, various ways of controlling the discrete positions of inner clamp (1121), and thereby controlling the discrete positions of the tip using inner clamp (1121), will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0156] E. Exemplary Elastomeric Overmolding Configurations
[0157] With respect to the above-mentioned end in combination with an elastomeric overmold, as described above, the various properties of the elastomeric overmold can be configured to provide various functional parameters. In addition, as described above, the elastomeric overmold works as a system or assembly with certain internal fixtures and pivot members to provide multiple discrete end positions. The end can be switched or adjusted between these discrete positions by applying an external force (i.e., by a user, a user's hand tool, a robotic manipulator, or a patient's anatomical structure). In this way, modifications to the various configurations and designs of the elastomeric overmold can affect the ease or difficulty of moving or switching the end from one discrete position to another discrete position. As described above, one example thereof involves the use of an elastomer with different stiffnesses. Another example mentioned above involves changing the mass and / or geometry of the elastomer, for example by including an opening, such as the opening (1033) described above.
[0158] In addition, there are other considerations and ways to configure the elastomeric overmold to be able to work with internal clamps and / or pivot members to provide a desired range of terminal functions. In one version, the terminal described herein includes an elastomeric overmold that can surround all structures of the terminal and can be coupled to all structures of the terminal. However, in other versions of the terminal described herein with an elastomeric overmold, the overmold is configured to not surround and / or be coupled to all structures of the terminal. Below are some additional exemplary configurations of the elastomeric overmold of the terminal. Among other things, these configurations may also be applicable to any of the terminals having the elastomeric overmold described herein, which include at least the terminal (219, 319, 619, 719, 819, 919, 1019) and at least the elastomeric overmold (623, 723, 823, 923, 1023).
[0159] In one example, the elastomeric overmold (623, 723, 823, 923, 1023) of the tip (219, 319, 619, 719, 819, 919, 1019) is directly bonded to the anvil (218, 318, 618, 718, 818, 918, 1018), or directly bonded to an intermediate connector such as a connecting member (621, 721) so that it forms a continuous smooth surface without openings or gaps when the tip is deformed. In such examples, bonding to certain locations allows the elastomer to have a spring bias and act as a spring, and therefore act as a source of tension, which can help provide discrete positions for the tip.
[0160] In another example, the elastomeric overmold (623, 723, 823, 923, 1023) of the tip (219, 319, 619, 719, 819, 919, 1019) may be specifically prevented from bonding to certain locations. By way of example only and not limitation, for a tip having a pivot member (625, 725) or an internal clamp (821, 921, 1021, 1121), bonding of the elastomeric overmold (623, 723, 823, 923, 1023) is partially or completely prevented such that the pivot member (625, 725) or the internal clamp (821, 921, 1021, 1121) does not bond to the elastomeric overmold (623, 723, 823, 923, 1023). In this way, the dynamics of the switch can be changed by allowing relative sliding between the pivot member (625, 725) or the internal clamp (821, 921, 1021, 1121) and the elastomeric overmold (623, 723, 823, 923, 1023). For example, one way to prevent binding in this manner is to dip the pivot member (625, 725) or the internal clamp (821, 921, 1021, 1121) in wax or another coating so that the elastomer does not bind to the pivot member or internal clamp, thereby allowing relative sliding.
[0161] refer to Fig.17 and Fig.26 , the pivot member (625) includes a coating (628), and the internal fixture (821) includes a coating (828). In this example, the coating (628, 828) comprises wax, but other coating materials may also be used. In addition, in some versions, the coating (628, 828) may be applied to the entire pivot member (625) and the internal fixture (821). However, in other versions, the coating (628, 828) may be applied to portions of the pivot member (625) and the internal fixture (821). For example, relative to the internal fixture (821), in one example, the coating (828) is only applied to a pair of arms (827). However, in other examples of the pivot member (625) and the internal fixture (821), the coating (628, 828) is omitted entirely. In view of the teachings herein, other ways to prevent the elastomeric overmold from being combined with certain structures of the end will be apparent to those of ordinary skill in the art.
[0162] In another example, the elastomeric overmold (623, 723, 823, 923, 1023) of the end (219, 319, 619, 719, 819, 919, 1019) of some portions of the pivot member (625, 725) or internal clamp (821, 921, 1021, 1121) may not be covered by elastomeric material at all. In such examples, this represents an opportunity to reduce or decrease the size of the end and allow the pivot member (625, 725) or internal clamp (821, 921, 1021, 1121) to have a stronger or more powerful detenting switch. By way of example only and not limitation, in one version, a base or proximal portion of the tip (619, 719, 819, 919, 1019) is covered, while an original or partially original pivot member (625, 725) or inner clamp (821, 921, 1021, 1121) extends distally. As used herein, the terms "original" or "partially original" should be understood to mean that such portions of the pivot member (625, 725) or inner clamp (821, 921, 1021, 1121) are not covered by an elastomeric overmold or otherwise exposed to the surrounding environment.
[0163] F. Exemplary Switching or Detent Mechanisms
[0164] With respect to the internal clamp (821, 921, 1021, 1121), in one example, such internal clamp (821, 921, 1021, 1121) is described as being configured with a hairpin design so that the internal clamp (821, 921, 1021, 1121) contains elastic energy after being riveted. In this way, the internal clamp (821, 921, 1021, 1121) may have stored elastic energy. After being assembled and connected with the main body of the anvil, an external force is applied. For example, the external force may be applied by a user, a hand tool of the user, a robotic manipulator, or an anatomical structure of the patient. During the application of the external force, the arm of the internal clamp (821, 921, 1021, 1121) is elastically deformed and a reaction force accumulates until it reaches a state instability. If the force continues in the same direction, the arm of the inner clamp (821, 921, 1021, 1121) will cross or pass through the instability region to reach another lower energy state. Therefore, in this way, the inner clamp (821, 921, 1021, 1121) has bistability in some cases and even multistability in other cases. In the case of bistability, the inner clamp (821, 921, 1021, 1121) includes two positions with low energy states, wherein the inner clamp will maintain its shape and position without applying external forces to the inner clamp (821, 921, 1021, 1121). In the case of multistability, the inner clamp (821, 921, 1021, 1121) includes more than two positions with low energy states, wherein the inner clamp will maintain its shape and position without applying external forces to the inner clamp (821, 921, 1021, 1121). In some examples of bi-stability and multi-stability, the internal clamp (821, 921, 1021, 1121) can be described as including the ability to twist, bend, or flex from one state or position to another state or position. In view of the teachings herein, various ways to modify and control the stability and positioning of the internal clamp (821, 921, 1021, 1121) will be apparent to those of ordinary skill in the art.
[0165] V. Exemplary Combinations
[0166] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or in the subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided only for illustrative purposes. It is expected that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive, unless otherwise, for example, by the inventor or the successor of the inventor concerned clearly indicates so at a later date. If any claim proposed in this patent application or in the subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.
[0167] Example 1
[0168] A device comprising: (a) a body; (b) a shaft extending from the body, wherein the shaft defines a longitudinal axis; and (c) an end actuator connected to the shaft, wherein the end actuator is operable to compress, staple and cut tissue, wherein the end actuator comprises: (i) a first jaw, wherein the first jaw is configured to hold a cartridge, wherein the cartridge is configured to hold one or more staples, (ii) a second jaw, wherein the second jaw comprises an anvil, wherein at least one of the first jaw or the second jaw is configured to move between an open position and a closed position relative to the other of the first jaw or the second jaw, and (iii) a tip, wherein the tip is connected to the anvil, wherein the tip comprises a deformable member, wherein using the deformable member, the tip is capable of moving between a first discrete position and a second discrete position relative to the anvil, wherein the tip remains in the first discrete position positioned closer to the cartridge until the deformable member is subjected to an external input force, and wherein the tip remains in the second discrete position positioned farther from the cartridge until the deformable member is subjected to the external input force.
[0169] Example 2
[0170] The apparatus of Example 1 wherein, in the first discrete position, the tip comprises an angled orientation relative to the longitudinal axis of the anvil, and wherein in the second discrete position, the tip comprises a straight orientation relative to the longitudinal axis of the anvil.
[0171] Example 3
[0172] The apparatus of Example 1 wherein, in the first discrete position, the tip comprises an angled orientation relative to a longitudinal axis of the anvil, and wherein in the second discrete position, the tip comprises an expanded orientation relative to the longitudinal axis of the anvil.
[0173] Example 4
[0174] The apparatus of any one or more of Examples 1 to 3, wherein the deformable member comprises a polymer covering and an internal support structure.
[0175] Example 5
[0176] The apparatus of Embodiment 4, wherein the internal support structure comprises an internal clamp.
[0177] Example 6
[0178] According to the device of embodiment 4, the internal clamp is deflectable and includes a biasing member to assume a selected one of a first orientation and a second orientation, and wherein the internal clamp includes a pair of arms that converge and join at corresponding distal ends or proximal ends.
[0179] Example 7
[0180] A device according to Example 6, wherein the pair of arms are joined at their respective distal ends or proximal ends by rivets or by pins extending within the anvil.
[0181] Example 8
[0182] The apparatus of any one or more of Examples 6-7, wherein the inner clamp includes a space between the pair of arms.
[0183] Example 9
[0184] The apparatus according to any one or more of Examples 6 to 8, wherein the internal clamp further comprises a resilient intermediate rib extending longitudinally between the pair of arms, wherein the intermediate rib is deflectable and comprises a biasing member to present two or more discrete positions.
[0185] Example 10
[0186] The apparatus of any one or more of Embodiments 4 to 9, wherein the polymeric covering comprises an elastomeric overmold.
[0187] Embodiment 11
[0188] A device as in Example 10, wherein the elastomeric overmold includes an opening extending through the distal end, wherein the opening is aligned with the space of the inner fixture between the pair of arms.
[0189] Example 12
[0190] The apparatus according to any one or more of Examples 4 to 9, wherein the elastomeric overmold is bonded to the anvil and the internal clamp, or the elastomeric overmold is bonded to the anvil and is at least partially prevented from bonding to the internal clamp.
[0191] Example 13
[0192] A device as described in any one or more of Examples 10 to 12, wherein the inner clamp includes a coating configured to prevent the elastomeric overmold from bonding to the inner clamp where the coating is disposed.
[0193] Embodiment 14
[0194] Embodiment 13: The apparatus of embodiment 13, wherein the coating comprises wax.
[0195] Embodiment 15
[0196]
[00136] The apparatus of any one or more of Examples 10 to 13, wherein the inner clamp is partially exposed at the distal end such that the elastomeric overmold does not cover the entire inner clamp.
[0197] Example 16
[0198] The apparatus of any one or more of Examples 5 to 15, wherein the internal clamp comprises a bi-stable configuration.
[0199] Embodiment 17
[0200] The apparatus of any one or more of Examples 5 to 15, wherein the internal clamp comprises a multi-stable configuration.
[0201] Embodiment 18
[0202] A device comprising: (a) a body; (b) a shaft extending from the body, wherein the shaft defines a longitudinal axis; and (c) an end actuator in communication with the shaft, wherein the end actuator is operable to compress, staple and cut tissue, wherein the end actuator comprises: (i) a first jaw configured to hold a cartridge configured to hold one or more staples, (ii) a second jaw comprising an anvil configured to move relative to the cartridge between an open position and a closed position, and (iii) a tip, the The end is connected to the anvil, wherein the end includes a deformable member, wherein the end is configured to be switchable between two or more discrete positions relative to the anvil by applying an external input force, wherein in a first discrete position, the end is configured to be maintained in a first angled orientation relative to the longitudinal anvil axis until acted upon by the external input force, and wherein in a second discrete position, the end is configured to be maintained in a selected one of a straight orientation relative to the longitudinal anvil axis and a second angled orientation relative to the longitudinal anvil axis until acted upon by the external input force.
[0203] Embodiment 19
[0204] A device according to Example 18, wherein the deformable member includes an elastomeric overmold and an internal support structure, wherein the internal support structure includes a pair of arms that converge and join at respective distal ends and a space located between the pair of arms.
[0205] Embodiment 20
[0206] A device as in Example 19 wherein the elastomeric overmold includes an opening extending through the distal end, wherein the opening is aligned with the space between the pair of arms of the internal support structure.
[0207] Embodiment 21
[0208] 1. A device comprising: (a) a body; (b) a shaft extending from the body, wherein the shaft defines a longitudinal axis; and (c) an end effector in communication with the shaft, wherein the end effector is operable to compress, staple and cut tissue, wherein the end effector comprises: (i) a first jaw configured to hold a cartridge configured to hold one or more staples, (ii) a second jaw comprising an anvil, wherein at least one of the first jaw or the second jaw is configured to be movable relative to the other of the first jaw or the second jaw between an open position and a closed position. and (iii) an end operatively coupled to the anvil, wherein the end is capable of moving between a first discrete position and a second discrete position relative to the anvil, wherein the end is configured to remain in the first discrete position positioned closer to the bin until acted upon by an external input force, and wherein the end is configured to remain in the second discrete position positioned farther from the bin until acted upon by the external input force, wherein the end includes a clamp comprising: (1) a pair of arms that converge and engage at respective distal ends, and (2) a space between the pair of arms.
[0209] Embodiment 22
[0210]
[00136] The apparatus of Embodiment 21 further comprises an elastomeric overmold surrounding the clamp, wherein the elastomeric overmold comprises an opening extending through the end, wherein the opening is aligned with the space of the clamp between the pair of arms.
[0211] Embodiment 23
[0212] The present invention discloses an apparatus comprising: a body; a shaft extending from the body, wherein the shaft defines a longitudinal axis; and an end effector, the end effector being in communication with the shaft, wherein the end effector is operable to compress, staple and cut tissue. The end effector comprises: (i) a first jaw, the first jaw being configured to hold a cartridge, the cartridge being configured to hold one or more staples, (ii) a second jaw, the second jaw comprising an anvil, the anvil being configured to move between an open position and a closed position relative to the cartridge, and (iii) a tip, the tip being connected to the anvil, wherein the tip is configured to rotate relative to the anvil between a first discrete position and a second discrete position. In the first discrete position, the tip is rotated toward the cartridge, and in the second discrete position, the tip is rotated away from the cartridge.
[0213] Embodiment 24
[0214] A device as described in Example 23, wherein when the tip is not subjected to an external force, the tip will remain in either of the first discrete position and the second discrete position.
[0215] Embodiment 25
[0216] A device as described in any one or more of Examples 23-24, wherein the tip includes an elastomeric overmold.
[0217] Embodiment 26
[0218] The device according to any one or more of Examples 23 to 25 further includes a pair of pawls, wherein the pair of pawls are configured to selectively position the end in the first discrete position and the second discrete position.
[0219] Embodiment 27
[0220] A device as described in Example 26, wherein the pair of pawls includes a pair of raised portions configured to engage with a corresponding pair of recessed portions.
[0221] Embodiment 28
[0222] A device as described in Example 27, wherein the tip includes a pair of slots defining a resilient portion.
[0223] Embodiment 29
[0224] The apparatus according to any one or more of Examples 23 to 28 further includes a pin defining a pivot axis about which the tip rotates relative to the anvil.
[0225] Embodiment 30
[0226]
[00136] The device of any one or more of Examples 23 to 29, wherein the tip further comprises a rotatable distal portion configured to be rotatable relative to a proximal portion of the tip.
[0227] Embodiment 31
[0228] According to any one or more of Examples 23 to 30, the end includes: a connecting member, which is configured to be connectable to the anvil; a pivot member, which is configured to be pivotally connected to the connecting member; and an elastomeric overmolding, which is configured to cover the connecting member and the pivot member, wherein the connecting member includes a fulcrum feature portion, which extends distally and selectively engages the proximal end of the pivot member, so that the pivot member can pivot about the fulcrum feature portion to position the end at the first discrete position and the second discrete position.
[0229] Embodiment 32
[0230] A device as in Example 31 wherein the elastomeric overmold is configured to retain the tip in a selected one of the first discrete position and the second discrete position.
[0231] Embodiment 33
[0232] A device as described in any one or more of Examples 23 to 32, wherein moving the tip between the first discrete position and the second discrete position provides tactile feedback or auditory feedback to a user.
[0233] Embodiment 34
[0234] According to any one or more of Examples 23 to 30, the end includes: a connecting member, which is configured to be connectable to the anvil; a pivot member, which is configured to be pivotally engaged with the connecting member; and an elastomeric overmold, which is configured to cover the connecting member and the pivot member, wherein the connecting member includes a double lug feature portion, which extends distally and engages the pivot member so that the pivot member can pivot between the double lug features to position the end at the first discrete position and the second discrete position.
[0235] Embodiment 35
[0236] A device as described in Example 34, wherein the pivot member includes a triangular body configured to engage with the dual lug feature in a selected one of two states corresponding to the end being in the first discrete position or the second discrete position.
[0237] Embodiment 36
[0238] A device according to any one or more of Examples 34 to 35, wherein the elastomeric overmold is configured to maintain the engagement between the pivot member and the dual lug feature to maintain the end in a selected one of the first discrete position and the second discrete position.
[0239] Embodiment 37
[0240] An apparatus according to any one or more of Examples 34 to 36, wherein the end is capable of adjusting between the first discrete position and the second discrete position by deforming the elastomeric overmold to reposition the pivot member relative to the dual lug feature from a first state to a second state.
[0241] VI. Miscellaneous
[0242] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered isolated from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art based on the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[0243] In addition, any one or more of the teachings of this document may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. patent application entitled “Surgical Stapler with Rotatable Distal Tip” filed on the same date as the present application [Agent Reference Number END9103USNP2]; and / or U.S. patent application entitled “Surgical Stapler with Toggling Distal Tip” filed on the same date as the present application [Agent Reference Number END9103USNP3]; the disclosures of each of these U.S. patent applications are incorporated herein by reference.
[0244] It should also be understood that the teachings herein can be readily combined with the various teachings of the following U.S. patent applications: U.S. Patent D836,198, published on December 18, 2018, entitled “Surgical Stapler End Effector with Varying Deck Height and Tissue Gripping Features”; U.S. Patent D833,010, published on November 6, 2018, entitled “Circular Surgical Stapler End Effector with Varying Deck Height and Tissue Gripping Features”; U.S. Patent Publication 2018 / 0235610, published on August 23, 2018, entitled “Surgical Stapler with Insertable Distal Anvil Tip”; U.S. Patent Publication 2018 / 0235611, published on August 23, 2018, entitled “Surgical Stapler with Cooperating DistalTip Features on Anvil and Staple Cartridge”; U.S. Patent Publication 2018 / 0235612, published on December 18, 2018, entitled “Surgical Stapler U.S. Patent No. D836,199 entitled “Surgical Stapler with Bent Anvil Tip and Angled Staple Cartridge Tip”; U.S. Publication No. 2018 / 0235619 entitled “Surgical Stapler with Bent Anvil Tip, Angled Staple Cartridge Tip, and Tissue Gripping Features” published on August 23, 2018; U.S. Patent Publication No. 2019 / 0000481 entitled “Method of Surgical Stapling with End Effector Component Having a Curved Tip” published on January 3, 2019; U.S. Patent Application No. 16 / 235,617 entitled “Method of Applying Buttresses to Surgically Cut and Stapled Sites” filed on December 28, 2018;U.S. Patent Application No. 16 / 035,872, filed on July 16, 2018, entitled “Permanent Attachment Means for Curved Tip of Component of Surgical Stapling Instrument”; U.S. Patent Application No. 16 / 035,803, filed on July 16, 2018, entitled “Surgical Stapling End Effector Component with Deformable Tip Having Void”; U.S. Patent Application No. 16 / 035,821, filed on July 16, 2018, entitled “Surgical Stapling End Effector Component with Deformable Tip Skewing in Multiple Planes”; U.S. Patent Application No. 16 / 035,825, filed on July 16, 2018, entitled “Surgical Stapling End Effector Componentwith Articulation and Asymmetric Deformable Tip”; U.S. Patent Application No. 16 / 035,830, filed on July 16, 2018, entitled “Surgical Stapling End Effector Componentwith Articulation and Asymmetric Deformable Tip”; U.S. Patent Application No. 16 / 035,873, filed on July 16, 2018, entitled “Permanent Attachment Means for Curved Tip of Component of Surgical Stapling U.S. Patent Application No. 16 / 035,831, entitled “Instrument”; U.S. Patent Application No. 16 / 035,834, entitled “Buttress Applier Cartridge for Surgical Stapler Having End Effector with Deflectable Curved Tip”, filed on July 16, 2018. Various suitable ways in which the teachings herein can be combined with the teachings of the above-mentioned U.S. patents, U.S. patent publications, and U.S. patent applications will be apparent to those of ordinary skill in the art. The disclosures of each of the above-cited U.S. patents, U.S. patent publications, and U.S. patent applications are incorporated herein by reference.;
[0245] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials described in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein but conflicting with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.
[0246] The above-described device versions may be used in conventional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into a robotic surgical system, such as the DAVINCI® by Intuitive Surgical, Inc. (Sunnyvale, California). TM system.
[0247] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both, these types can be repaired to be reused after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.
[0248] By way of example only, the types described herein may be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
[0249] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.
Claims
1. A device comprising: (a) Subject; (b) a shaft extending from the body, wherein the shaft defines a longitudinal axis; as well as (c) an end effector in communication with the shaft, wherein the end effector is operable to compress, staple, and cut tissue, wherein the end effector comprises: (i) a first jaw configured to hold a cartridge configured to hold one or more staples, (ii) a second jaw comprising an anvil, wherein at least one of the first jaw or the second jaw is configured to be movable between an open position and a closed position relative to the other of the first jaw or the second jaw, and (iii) a tip coupled to the anvil, wherein the tip includes a deformable member, wherein the deformable member is configured to enable the tip to move between a first discrete position and a second discrete position relative to the anvil, wherein the tip remains in the first discrete position positioned closer to the cartridge until the deformable member is acted upon by an external input force, and wherein the tip remains in the second discrete position positioned farther from the cartridge until the deformable member is acted upon by the external input force, wherein, in the first discrete position, the tip comprises an angled orientation relative to a longitudinal axis of the anvil, and wherein in the second discrete position, the tip comprises a straight orientation or an expanded orientation relative to a longitudinal axis of the anvil, and wherein the deformable member comprises a polymer cover or a metal cover and a deflectable internal support structure, and wherein the deflectable internal support structure comprises a deflectable internal clamp including a biasing member to assume a selected one of a first orientation and a second orientation, and wherein the deflectable internal clamp comprises a pair of arms that converge and engage at respective distal ends or proximal ends.
2. The device according to claim 1, wherein The pair of arms are joined at their respective distal or proximal ends by rivets or by pins extending within the anvil.
3. The device according to claim 2, wherein: The deflectable inner clamp includes a space between the pair of arms.
4. The device according to claim 1, wherein: The deflectable inner clamp also includes a resilient center rib extending longitudinally between the pair of arms, wherein the center rib is deflectable and includes a bias to assume two or more discrete positions.
5. The device according to claim 1, wherein: The polymeric covering comprises an elastomeric overmold.
6. The device according to claim 5, wherein: The elastomeric overmold is bonded to the anvil and the deflectable inner jaw, or the elastomeric overmold is bonded to the anvil and is at least partially blocked from bonding to the deflectable inner jaw.
7. The device according to claim 5, wherein: The deflectable inner clamp includes a coating configured to inhibit bonding of the elastomeric overmold to the deflectable inner clamp where the coating is disposed.
8. The device according to claim 5, wherein: The deflectable inner clip is partially exposed at the distal end such that the elastomeric overmold does not cover the entire deflectable inner clip.
9. The device according to claim 1, wherein: The deflectable inner clamp includes a bi-stable configuration.
10. The device according to claim 1, wherein: The deflectable inner clamp includes a multi-stable configuration.
11. A device comprising: (a) Subject; (b) a shaft extending from the body, wherein the shaft defines a longitudinal axis; as well as (c) an end effector in communication with the shaft, wherein the end effector is operable to compress, staple, and cut tissue, wherein the end effector comprises: (i) a first jaw configured to hold a cartridge configured to hold one or more staples, (ii) a second jaw comprising an anvil, wherein at least one of the first jaw or the second jaw is configured to be movable between an open position and a closed position relative to the other of the first jaw or the second jaw, and (iii) a tip coupled to the anvil, wherein the tip comprises a deformable member, wherein the tip is configured to be switchable between two or more discrete positions relative to the anvil by application of an external input force, wherein in the first discrete position, the tip is configured to remain in a first angled orientation relative to the longitudinal anvil axis until acted upon by the external input force, and wherein in the second discrete position, the tip is configured to be maintained in a selected one of a straight orientation relative to the longitudinal anvil axis and a second angled orientation relative to the longitudinal anvil axis until acted upon by the external input force, and wherein the deformable member comprises a polymer cover or a metal cover and a deflectable internal support structure, and wherein the deflectable internal support structure comprises a deflectable internal clamp including a biasing member to assume a selected one of a first orientation and a second orientation, and wherein the deflectable internal clamp comprises a pair of arms that converge and engage at respective distal ends or proximal ends.
12. The device according to claim 11, wherein The polymeric covering comprises an elastomeric overmold, wherein the deflectable inner clamp further comprises a space between the pair of arms.
13. The device according to claim 12, wherein: The elastomeric overmold includes an opening extending through the distal end, wherein the opening is aligned with the space of the deflectable inner clamp between the pair of arms.
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