Cartridge-based locking mechanism for right-angle surgical staplers
By introducing a locking member into the surgical stapler, the actuation of the unused nail cartridge unit is prevented and multiple use of the nail cartridge unit is prevented, which solves the problem of accidental incision of the nail wire in the prior art, and improves the operation Safety and efficiency.
Patent Information
- Application Number
- CN202080031282.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-04-26
- Filing Date
- 2020-04-14
- Publication Date
- 2025-01-10
- Estimated Expiration
- 2040-04-14
AI Technical Summary
When existing surgical staplers suture and cut tissue, it is difficult to effectively prevent the multiple use of the nail cartridge unit, resulting in accidental incision of the nail threads, affecting the surgical effect and safety.
A surgical stapler including a locking member is designed that prevents actuation of the closure system and the firing system when the unused nail cartridge unit is loaded, and automatically returns to the locked position after the nail cartridge unit is used to prevent it from being re-opened. Actuation.
Effectively prevent multiple use of the nail cartridge unit, ensure that the nail wire is not accidentally cut through, and improve the safety and efficiency of the operation.
Smart Images

Figure CN113766884B_ABST
Abstract
Description
Background Art
[0001] Some surgical staplers are operable to clamp on one or more layers of patient tissue, shape the staples through the tissue layers to substantially seal the tissue layers together near the formed staples, and cut through the layers of the clamped tissue for shaping the cut ends of the operably sealed tissue. An exemplary suturing instrument includes a pair of cooperating elongated jaw members, wherein each jaw member is adapted to be inserted into the patient and positioned relative to the tissue to be sutured. One of the jaw members supports a staple cartridge containing at least two laterally spaced rows of staples, and the other jaw member supports an anvil having a staple forming recess configured to align with the rows of staples in the staple cartridge. Generally speaking, the suturing instrument also includes one or more push rods, which can be actuated relative to the jaw members to drive the staples from the staple cartridge through the tissue clamped between the jaw members, and against the anvil for shaping, and also drive the knife member through the clamped tissue, thereby cutting the tissue while or after suturing. Like this, suturing instrument can be operated to form a plurality of laterally spaced deformed nail rows in clamped tissue, wherein such rows may include linear rows and / or arcuate rows.Blade can cut tissue along linear path or arcuate path, and this linear path or arcuate path extends between adjacent nail rows formed in clamped tissue.
[0002] Exemplary surgical staplers are disclosed in the following documents: U.S. Patent 5,605,272, entitled “Trigger Mechanism for Surgical Instruments”, published on February 25, 1997; U.S. Patent 5,697,543, entitled “Linear Stapler with Improved Firing Stroke”, published on December 16, 1997; U.S. Patent 6,988,650, entitled “Retaining Pin Lever Advancement Mechanism for a Curved Cutter Stapler”, published on January 24, 2006; U.S. Patent 7,134,587, entitled “Knife Retraction Arm for a Curved Cutter Stapler”, published on November 14, 2006; U.S. Patent 7,134,587, entitled “Closure Plate Lockout for a Curved Cutter Stapler”, published on December 12, 2006; and U.S. Patent No. 10,045,780, entitled “Method of Applying Staples in Lower Anterior Bowel Resection”, published on August 14, 2018; the disclosures of each of the above-referenced U.S. patents and U.S. patent publications are incorporated herein by reference.
[0003] 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
[0004] 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.
[0005] Figure 1A A perspective view of an exemplary surgical stapler having a handle assembly, a shaft assembly, and an end effector is shown, showing a tissue retaining pin actuation system in a retracted position and the end effector in an open state;
[0006] Figure 1B Shows Figure 1A A perspective view of a surgical stapler of , showing a tissue retaining pin actuation system in an extended position when the end effector is held in an open state;
[0007] Figure 1C Shows Figure 1A A perspective view of a surgical stapler showing the end effector in a closed state via actuation of a closure system while the tissue retaining pin actuation system is maintained in an extended position;
[0008] Figure 1D Shows Figure 1A A perspective view of a surgical stapler showing an end effector in a fired state via actuation of a firing system to achieve stapling and cutting of tissue captured by the end effector, while a tissue retaining pin actuation system is maintained in an extended position;
[0009] Figure 2 Shows Figure 1A A partially disassembled perspective view of a surgical stapler;
[0010] Figure 3 Shows Figure 1A A disassembled perspective view of the actuatable components of the shaft assembly of the surgical stapler, including a closing rod of the closing system, a nail rod of the firing system, and a knife rod of the firing system;
[0011] Figure 4A Shows Figure 1A A side elevation view of a handle assembly of a surgical stapler of , with various components omitted for clarity, showing a tissue retaining pin actuation system in an extended position to retain tissue when the closure system and the firing system are in an unactuated state;
[0012] Figure 4B Shows Figure 1A A side elevation view of a handle assembly of a surgical stapler of , with various components omitted for clarity, illustrating actuation of a closure system via a closure trigger to close the end effector and thereby clamp tissue;
[0013] Figure 4C Shows Figure 1AA side elevation view of a handle assembly of a surgical stapler of , with various components omitted for clarity, illustrating actuation of a firing system via a firing trigger to fire the end effector and thereby staple and cut tissue while the end effector is held in a closed state;
[0014] Figure 5 Shows Figure 1A A perspective view of a surgical stapler showing a staple cartridge unit of an end effector separated from a distal support structure of the end effector;
[0015] Figure 6 Shows Figure 1A A distal left perspective view of a staple cartridge unit of a surgical stapler;
[0016] Figure 7 Shows Figure 1A A proximal right side perspective view of a staple cartridge unit of a surgical stapler;
[0017] Figure 8 Shows Figure 1A A disassembled perspective view of a staple cartridge unit of a surgical stapler;
[0018] Fig.9A Shows Figure 1A A side elevation view of an end effector of a surgical stapler, showing a locking member of the end effector in a locked position when a staple cartridge unit is not present in the distal support structure;
[0019] Fig. 9B Shows Figure 1A A side elevation view of an end effector of a surgical stapler showing a lockout member in a bypass position when an unused staple cartridge unit is disposed within the distal support structure;
[0020] Fig.10 The nail magazine unit is shown after being inserted into the distal support structure. Figure 1A A side elevation view of a distal portion of an end effector of a surgical stapler;
[0021] Fig.11 Shows Figure 1A A cross-sectional view of a distal portion of an end effector of a surgical stapler showing the interaction between a tissue cutting washer of a staple cartridge unit and a distal support structure;
[0022] Fig. 12A Shows Figure 1A A side cross-sectional view of an end effector of a surgical stapler showing a tissue retaining pin in a retracted position when the end effector is in an open state;
[0023] Fig. 12B Shows Figure 1AA side cross-sectional view of an end effector of a surgical stapler showing a tissue retaining pin in an extended position to retain tissue when the end effector is held in an open state;
[0024] Fig. 12C Shows Figure 1A A side cross-sectional view of an end effector of a surgical stapler showing the end effector being actuated to a closed state to clamp tissue while the tissue retaining pin is maintained in an extended position;
[0025] Fig.12D Shows Figure 1A A side cross-sectional view of an end effector of a surgical stapler showing the end effector being further actuated to a fired state to staple and cut tissue while remaining in a closed state;
[0026] Fig.13 Shows Figure 1A An enlarged perspective view of a handle assembly of a surgical stapler, with various components omitted for clarity, illustrating a firing system actuated via pivoting of a firing trigger;
[0027] Fig.14 Shows Figure 1A A disassembled perspective view of a firing trigger of a surgical stapler;
[0028] Fig.15 Shows Figure 1A A perspective view of a rotatable cam pin of a firing trigger of a surgical stapler;
[0029] Fig.16 Shows Figure 1A A side cross-sectional view of a proximal end of a firing system of a surgical stapler showing engagement of an outer portion of a cam pin with a proximal edge of a staple rod of the firing system;
[0030] Fig.17 Shows Figure 1A Another side cross-sectional view of the proximal end of the firing system of the surgical stapler, showing the engagement of the inner portion of the cam pin with the proximal edge of the knife bar of the firing system;
[0031] Fig.18 Shows Figure 1A A perspective view of a distal portion of a firing system of a surgical stapler, with various components omitted for clarity, illustrating an exemplary distal lockout mechanism operable to prevent actuation of a closure system and a firing system;
[0032] Fig.19 Shows Figure 1A A perspective view of a double locking lever of a distal locking mechanism of a surgical stapler;
[0033] Fig. 20 Shows Figure 1A A perspective view of a stop member of a distal locking mechanism of a surgical stapler;
[0034] Fig.21 Shows Figure 1A An enlarged perspective view of a double lockout lever of a distal lockout mechanism of a surgical stapler, the double lockout lever being driven from a first lockout position to a bypass position by a staple driver member of an unused staple cartridge unit loaded into an end effector;
[0035] Fig.22A Shows Figure 1A A side elevation view of a distal portion of a firing system and a distal lockout mechanism of a surgical stapler of the present invention, showing a double lockout lever in a first lockout position, in which the double lockout lever blocks distal actuation of a closure system to prevent closure of the end effector in the absence of an unused staple cartridge unit in the end effector;
[0036] Fig. 22B Shows Figure 1A A side elevation view of a distal portion of a firing system and distal lockout mechanism of a surgical stapler of the present invention, showing a dual lockout lever pivoted to a bypass position in which the dual lockout lever permits distal actuation of the closing system and the firing system to close and fire the end effector when loaded with an unused staple cartridge unit;
[0037] Fig. 22C Shows Figure 1A A side elevation view of a distal portion of a firing system and a distal lockout mechanism of a surgical stapler, showing the firing system and dual lockout levers actuated distally during closure of the end effector;
[0038] Fig.22D Shows Figure 1A A side elevation view of a distal portion of a firing system and a distal lockout mechanism of a surgical stapler, showing the firing system and the dual lockout levers being further distally actuated during firing of the end effector;
[0039] Fig.22E Shows Figure 1A An enlarged side elevation view of an end effector of a surgical stapler of , showing the double lockout lever pivoted to a second lockout position after the end effector has been fired, such that the double lockout lever prevents further firing of the end effector with the now spent staple cartridge unit;
[0040] Fig.23 Shows the suitability for Figure 1A A perspective view of another exemplary double locking lever for use with a distal locking mechanism of a surgical stapler;
[0041] Fig.24shows a perspective view of another exemplary surgical stapler end effector having a distal lockout mechanism operable to prevent actuation of a closing system and a firing system of the surgical stapler;
[0042] Fig.25 Shows Fig.24 A perspective view of an end effector of a surgical stapler of , wherein various components are omitted for clarity, showing a double locking lever and a stop member of a distal locking mechanism;
[0043] Fig.26 Shows Fig.24 A perspective view of a double locking lever of a distal locking mechanism of a surgical stapler;
[0044] Fig. 27 Shows Fig.24 A perspective view of a stop member of a distal locking mechanism of a surgical stapler;
[0045] Fig.28A Shows Fig.24 a side elevation view of an end effector of a surgical stapler of , with various components omitted for clarity, showing the end effector in an open state, with the double lockout lever in a first lockout position, in which the double lockout lever engages a stop member to prevent the end effector from closing in the absence of an unused staple cartridge unit;
[0046] Fig.28B Shows Fig.24 a side elevation view of an end effector of a surgical stapler of , with various components omitted for clarity, showing an unused staple cartridge unit loaded into the end effector, thereby pivoting the double lockout lever from a first lockout position to a bypass position allowing closure and firing of the end effector;
[0047] Fig.28C Shows Fig.24 A side elevation view of an end effector of a surgical stapler of , with various components omitted for clarity, showing the end effector actuated to a closed state by a closure system when the double lockout lever is held in a bypass position; and
[0048] Fig.28D Shows Fig.24 A side elevation view of the end effector of a surgical stapler with various components omitted for clarity showing the double lockout lever pivoted to a second lockout position after the end effector has been fired such that the double lockout lever prevents further firing of the end effector with the now spent staple cartridge unit.
[0049] 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
[0050] 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.
[0051] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to a position where an element is disposed closer to the surgeon, and the term "distal" refers to a position where an element is disposed closer to the surgical end effector of the surgical instrument and further away from the surgeon. In addition, to the extent that spatial terms such as "top", "bottom", "upper", "lower", "vertical", "horizontal", "left side", "right side", etc. are used herein with reference to the accompanying drawings, it should be understood that such terms are used only for exemplary descriptive purposes and are not intended to be restrictive or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein can be used in a variety of orientations and positions that are not limited to those shown and described herein.
[0052] As used herein, the terms "about" and "approximately" in connection with any numerical values or ranges are intended to encompass the exact value recited and a suitable dimensional tolerance such that the recited feature or combination of features can be used for the intended purpose described herein.
[0053] I. Overview of Exemplary Right-Angled Surgical Staplers
[0054] Figure 1AAn exemplary right-angle linear surgical stapler (10) configured to be capable of suturing and cutting tissue in various non-endoscopic ("open") surgical procedures, including, for example, colorectal, thoracic, and bariatric surgeries, is shown. The right-angle linear surgical stapler (10) (also referred to as a "right-angle linear cutter") generally includes a handle assembly (12), a shaft assembly (14) extending distally from the handle assembly (12), and an end effector (16) located at the distal end of the shaft assembly (14). As described below, the end effector (16) is provided with a "right-angle" configuration such that the end effector (16) clamps, suturing, and cutting tissue in a plane extending transversely at right angles to the longitudinal axis defined by the shaft assembly (14).
[0055] As described in more detail below, the surgical stapler (10) includes several actuation systems for operating the end effector (16) via the handle assembly (12) during a surgical procedure on a patient. Specifically, the surgical stapler (10) includes a tissue retaining pin actuation system (20) operable to initially retain tissue within the end effector (16); a closing system (22) operable to clamp tissue with the end effector (16); and a firing system (24) operable to subsequently staple and cut tissue with the end effector (16).
[0056] Although the teachings herein are shown and described in the context of a "linear" surgical stapler (10) configured to apply linear rows of staples and linear cut lines in tissue, it should be understood that any one or more of the teachings herein may be applicable to surgical staplers configured to apply rows of staples and tissue cut lines having non-linear (e.g., curved) configurations, such as surgical staplers of the type disclosed in any one or more of the references incorporated herein by reference.
[0057] A. Handle Assembly and Shaft Assembly of Surgical Stapler
[0058] like Figure 1A As shown, the handle assembly (12) includes a housing (30) defining a pistol grip (32), a saddle-shaped slide (34) slidably disposed on an upper portion of the handle housing (30), a pivotable closing trigger (36), and a pivotable firing trigger (38). The closing trigger (36) and the firing trigger (38) are operably coupled to the end effector (16) via the shaft assembly (14), such that the end effector (16) is configured to close and thereby clamp tissue in response to actuation of the closing trigger (36), and subsequently staple and cut tissue (i.e., "fire") in response to actuation of the firing trigger (38). Figure 1AThe slide (34) and closure trigger (36) are shown in an unactuated configuration such that the end effector (16) is configured to receive (or "reload") tissue laterally within a gap (G) (or "aperture") defined between a cartridge housing (162) and anvil (210) of a replaceable cartridge unit (160) mounted within the end effector (16). Figure 1B As shown, translating the slider (34) distally toward the end effector (16) causes the tissue retaining pins (176) of the staple cartridge unit (160) to extend distally for capturing tissue between the anvil (210) and the cartridge housing (162). Figure 1C As shown, actuation of the closure trigger (36) toward the pistol grip (32) then drives the cartridge housing (162) distally toward the anvil (210), thereby clamping tissue between the anvil and the cartridge housing. Figure 1D As shown, the firing trigger (38) is then actuated toward the pistol grip (32) to drive the staple distally into the clamped tissue and also with the knife member (194) (see Figure 8 ) cutting the tissue between the formed staple lines, as described in more detail below.
[0059] like Figure 2 As shown, the surgical stapler (10) includes a pair of longitudinally extending side plates (40) that cooperate to define a frame structure of the stapler (10), which supports a tissue retaining pin actuation system (20), a closure system (22), and a firing system (24). Each side plate (40) includes: a proximal frame portion (42) that is housed in a handle housing (30); an intermediate shaft portion (44) that defines a corresponding outer side of the shaft assembly (14); and a distal jaw portion (46) that has an upwardly extending distal hook (47). The distal jaw portion (46) cooperates with the distal end of the closure rod (50), as described below, to define a U-shaped distal support structure (48) of the end effector (16) that removably receives a staple cartridge unit (160). As used herein, the term "U-shaped" refers to the shape assumed by end effector (16) in any of the side elevation views depicted herein.
[0060] like Figure 3As shown, slidably disposed between and supported by the side plates (40) is an elongated actuatable component of an actuation system (20, 22, 24) that operably couples the handle assembly (12) with the staple cartridge unit (160); the elongated actuatable component includes a closing rod (50), a staple rod (60), and a knife rod (70). The closing rod (50) includes a cartridge receiving distal portion (52) configured to receive and support the staple cartridge unit (160). The closing rod (50) and the staple rod (60) are each configured as a double-sided structure having a first side and a second side spaced apart from each other, and an internal channel extending longitudinally between the first side and the second side. This configuration enables the shaft assembly (14) to be arranged such that the knife rod (70) is nested and slidably disposed within the longitudinal internal channel of the staple rod (60), and wherein the staple rod (60) is in turn nested and slidably disposed within the longitudinal internal channel of the closing rod (50). In addition, the nail rod (60) and the knife rod (70) are capable of longitudinally translating independently of the closing rod (50) within a longitudinal range of motion that enables independent closing and firing of the end actuator (16). As described in more detail below, the closing rod (50) is operable to longitudinally actuate the cartridge housing (162) relative to the anvil (210) in response to actuation of the closing trigger (36) to clamp tissue. The nail rod (60) is operable to longitudinally actuate the nail driver member (186) relative to the cartridge housing (162) (see Figure 8 ) for suturing the clamped tissue. The knife bar (70) is operable to actuate the knife member (194) longitudinally relative to the cartridge housing (162) and the staple driver member (186) (see Figure 8 ) for cutting the clamped tissue.
[0061] The tissue retaining pin actuation system (20) of the surgical stapler (10) includes a slide (34) of a handle assembly (12), a tissue retaining pin (176) of a staple cartridge unit (160), an elongated push rod (80) extending longitudinally along the upper side of the shaft assembly (14), and a push rod driver (82) slidably disposed within the handle assembly (12). The distal end of the push rod (80) is configured to be releasably coupled to the tissue retaining pin (176) when the staple cartridge unit (160) is inserted into the distal support structure (48) of the end effector (16). The proximal end of the push rod (80) is coupled to the push rod driver (82), which in turn is coupled to the slide (34). Thus, the longitudinal translation of the slide (34) between the proximal position and the distal position drives the longitudinal translation of the tissue retaining pin (176) between the retracted position and the extended position relative to the cartridge housing (162). Figure 1AAs shown, the tissue retaining pin (176) is configured to occupy a retracted position when the slide (34) is in the proximal position, wherein the retaining pin (176) is housed within the cartridge housing (162). Figure 1B As shown, the tissue retaining pin (176) is configured to occupy an extended position when the slide (34) is advanced to the distal position, wherein the distal end of the retaining pin (176) engages the anvil (210) to retain tissue positioned within the gap (G) of the staple cartridge unit (160).
[0062] The closure system (22) of the surgical stapler (10) includes a closure trigger (36) and a closure rod (50) of the handle assembly 12. Figure 2 and Figures 4A-4C As shown, the closing trigger (36) is pivotally coupled to the handle housing (30) around a pair of laterally extending posts (90). The upper arm (92) of the closing trigger (36) having a vertically slotted distal portion is operably coupled to the proximal end of the closing rod (50) through a pair of closing links (96). The proximal end of each closing link (96) is pivotally coupled to the laterally extending post (93) of the closing trigger upper arm (92). The distal end of each closing link (96) is pivotally coupled to the proximal end of the closing rod (50) around the laterally extending post (54) of the closing rod (50).
[0063] like Figure 4A-4B As shown, pivoting of the closing trigger (36) toward the pistol grip (32) causes the closing trigger upper arm (92) to advance distally and downwardly, thereby driving the closing rod (50) distally via the closing link (96). In turn, the cartridge receiving distal portion (52) of the closing rod (50) drives the cartridge housing (162) distally toward the anvil (210). In this way, the end effector (16) is moved from the open state ( Figure 1A-1B ) actuated to the closed state ( Figure 1C ), in the open state, tissue can be positioned within the end effector (16), and in the closed state, tissue is clamped between the cartridge housing (162) and the anvil (210). A closure return spring (98) housed within the pistol grip (32) of the handle assembly (12) resiliently biases the closure trigger (36) toward the unactuated state, and thus resiliently biases the end effector (16) toward the open state.
[0064] In this version, the closure rod (50) is further configured to cooperate with the tissue retaining pin actuation system (20) to automatically actuate the retaining pin (176) distally to its extended position when the operator squeezes the closure trigger (36). Figure 4A-4BAs best shown, the handle assembly (12) further includes a pair of cam yokes (100) rotatably disposed along the outer side of the closing link (96). Each cam yoke (100) includes an angled slot (102) that slidably receives a corresponding proximal post (54) of the closing rod (50). When the closing trigger (36) is actuated toward the pistol grip (32), the proximal post (54) rotatably drives the cam yoke (100) distally so that the cam lobe (104) of the yoke (100) engages the corresponding side post (84) of the push rod driver (82), thereby actuating the push rod (80) distally and thus actuating the tissue retaining pin (176) distally. This automatic extension of the tissue retaining pin (176) during the closing of the end effector (16) may be useful in the case where the operator does not manually actuate the retaining pin (176) distally via the slide (34) before actuating the closing trigger (36).
[0065] The closure system (22) of the present example is further configured to releasably lock the closure trigger (36) in an actuated position to provide effective clamping of tissue using the end effector (16) without having to continuously squeeze the closure trigger (36). Figure 4A-4B As best shown, the release button (110) is pivotally disposed at the proximal end of the handle assembly (12). The locking pawl (112) extends distally from the upper end of the release button (110) and includes a pawl lug (114) that is resiliently biased into contact with the upper end of the closure trigger upper arm (92) via a release button spring (116). Thus, the pawl lug (114) is configured to slide along the upper surface of the closure trigger upper arm (92) when the closure trigger (36) is squeezed toward the pistol grip (32). Figure 4B As shown, when the closure trigger (36) reaches the fully actuated position, the pawl lug (114) falls into the proximal upper notch (94) of the closure trigger upper arm (92), thereby locking the closure trigger (36) in the fully actuated position. If the operator wishes to subsequently reopen the end effector (16), for example to reposition tissue within the end effector (16) or otherwise release tissue once firing is complete, the operator can press the release button (110) to disengage the pawl lug (114) from the closure trigger (36). Via the resilient bias provided by the closure return spring (98), the closure trigger (36) then returns to the unactuated state, and the end effector (16) returns to the open state, as shown. Figure 1A and Figure 4A shown.
[0066] The firing system (24) of the surgical stapler (10) includes a firing trigger (38) of the handle assembly (12), a staple rod (60), a knife rod (70), and a staple driver component (186) and a knife component (194) of the staple cartridge unit (160). Figure 8 The features of knife bar (70) and staple driver assembly (186) are described in greater detail. Figure 2 and Figure 4A As shown, the firing trigger (38) of this example is constructed as an assembly having: a lower shield (120) extending downwardly from the handle housing (30) and capable of being engaged by an operator; a pair of plates having an arcuate upper arm (122) extending upwardly and distally from the lower shield (120) and positioned together with the handle housing (30); a rotatable cam pin (124) extending laterally between the free distal upper ends of the arcuate upper arm (122); and a firing lockout protrusion (126) extending distally from the lower end of the arcuate upper arm (122) within the handle housing (30). The cam pin (124) and other features of the firing trigger (38) are described in detail below in conjunction with the description of the embodiment of the present invention. Figure 13-17 Describe in more detail.
[0067] The firing trigger (38) is pivotally coupled to the handle housing (30) via a laterally extending pivot pin (128). In addition, the firing trigger (38) is positioned distally of the closing trigger (36) such that when the closing trigger (36) is actuated toward the pistol grip (32), the arcuate upper arm (122) of the firing trigger (38) is received in the slotted distal portion of the closing trigger upper arm (92). Figure 4A-4B As shown, when the operator fully squeezes the closure trigger (36) toward the pistol grip (32), the distally facing flange (95) disposed within the distal slotted portion of the closure trigger upper arm (92) engages the cam pin (124) of the firing trigger (38) and drives the cam pin (124) distally an initial amount. This causes the lower end of the firing trigger (38) to partially pivot toward the pistol grip (32) simultaneously with the closure trigger (36), as shown in FIG. Figure 4B shown.
[0068] like Figure 4C As shown, once the end effector (16) has reached the fully closed state, further actuation of the firing trigger (38) toward the pistol grip (32) operates to "fire" the end effector (16). Specifically, the outer portion of the cam pin (124) engages the proximal edge (62) of the nail rod (60), thereby driving the nail rod (60) distally relative to the closing rod (50). As described below in conjunction with Figures 12A-12DDescribed in more detail, the distal edge (64) of the nail rod (60) engages the proximal end of the nail driver member (186) within the nail magazine housing (162), thereby driving the nail driver member (186) distally through the nail magazine housing (162) to drive the nail into the tissue clamped by the end actuator (16). Actuation of the firing trigger (38) toward its fully actuated state also causes the intermediate portion of the cam pin (124) disposed between the arcuate upper arms (122) of the firing trigger (38) to engage the rounded proximal edge (72) of the knife rod (70), thereby driving the knife rod (70) distally relative to the closing rod (50). As described below in conjunction with Figures 12A-12D Described in more detail, the distal edge (74) of the knife bar (70) engages the proximal end of the knife member (194) within the staple cartridge housing (162), thereby driving the knife member (194) distally through the staple driver member (186) to cut tissue clamped by the end effector (16).
[0069] The firing system (24) of the present example is suitably configured such that when the firing trigger (38) is actuated through the primary range of motion toward the pistol grip (32), the nail rod (60) and the knife rod (70) translate together distally; and such that when the firing trigger (38) is further actuated through the final range of motion toward the pistol grip (32), the knife rod (70) continues to translate distally relative to the nail rod (60). Advantageously, such a configuration ensures that the tissue clamped by the end effector (16) is completely stapled and that proper hemostasis is achieved along the intended tissue cutting line before the tissue is cut by the knife member (194).
[0070] like Figure 2 As shown, the firing system (24) further includes a knife return spring (130) housed within the handle assembly (12). The knife return spring (130) is anchored at its distal end to the distal end of the knife rod (70) and at its proximal end to the distal end of the closing rod (50). Therefore, the knife return spring (130) is operable to elastically bias the knife rod (70) proximally relative to the closing rod (50) and the nail rod (60) when the firing trigger (38) is released. Figure 3 and Figures 12A-12D As shown, the knife bar (70) includes a distal hook (76) captured by the knife member (194), thereby axially fixing the knife member (194) to the knife bar (70). Therefore, when the operator releases the firing trigger (38) after completing the firing stroke, the knife bar (70) and the knife member (194) automatically retract proximally to safely contain the distal cutting edge (200) of the knife member (194) within the staple cartridge housing (162).
[0071] like Figure 2As shown, the surgical stapler (10) of this example also includes a proximal firing lockout mechanism in the form of a pivotable lever (140), which is operable to prevent actuation of the firing trigger (38) until the end effector (16) has been fully closed by the closing trigger (36). The firing lockout lever (140) is housed in the handle assembly (12) and is pivotally mounted to the outside of the proximal frame portion (42) of the left side plate (40). The firing lockout lever (140) is elastically biased by a spring (146) toward a position in which the lower tab (142) of the proximal locking lever (140) prevents the firing lockout protrusion (126) of the firing trigger (38) from moving downward, thereby preventing actuation of the firing trigger (38) when the closing trigger (36) has not been fully actuated to close the end effector (16). When the closure trigger (36) reaches the fully actuated state, the upper arm (144) of the firing lockout lever (140) is driven downward by the detent lug (114) of the release button (110), thereby rotating the lower tab (142) away from the firing lockout protrusion (126) and allowing actuation of the firing trigger (38). The firing lockout lever (140) and other locking features of the surgical stapler (10) can be further constructed and operated according to at least some of the teachings of the following patents: U.S. patent application entitled "Clamping Based Lockout Mechanism for Right Angle Surgical Stapler" filed on the same date as this application [Attorney Reference No. END9087USNP1], the disclosure of which is incorporated herein by reference.
[0072] Although not shown, the shaft assembly (14) of the surgical stapler (10) may include various additional components, such as an articulation joint, or may include a rearrangement of various components such that the shaft assembly (14) may be modular relative to the handle assembly (12).
[0073] B. End Effector of Surgical Stapler
[0074] The end effector (16) of the surgical stapler (10) includes a distal support structure (48) defined by a distal portion of a side plate (40), a cartridge receiving distal portion (52) of a closing rod (50), distal portions of a staple rod (60) and a knife rod (70), and a replaceable staple cartridge unit (160). Figure 5-8As best shown, the staple cartridge unit (160) of the present version includes a cartridge housing (162) and anvil (210) spaced apart from each other so as to define an axial gap (G) between the cartridge housing and the anvil for receiving patient tissue to be stapled and cut. The cartridge housing (162) includes a distally facing platform (164) configured to clamp tissue against the anvil (210) and extend transversely to the longitudinal axis of the shaft assembly (14) together with the anvil (210), thereby providing a "right angle" configuration for the end effector (16).
[0075] The cartridge platform (164) includes: an elongated linear knife slot (166) configured to slidably receive a knife (198) therethrough; and a plurality of staple openings (168) arranged in linear rows along either side of the elongated linear knife slot (166) and configured to accommodate a plurality of unformed staples (170) therein. The platform (164) of this example further includes a plurality of support features (172) interposed with the staple openings (168) and configured to optimize gripping and compression of patient tissue when the tissue is clamped between the platform (164) and the anvil (210). The platform (164) may be further constructed according to at least some of the teachings of the following patent: U.S. patent application 16 / 234,740, entitled "Surgical Stapler with Sloped Staple Deck for Varying Tissue Compression," filed on January 14, 2019, the disclosure of which is incorporated herein by reference.
[0076] The elongated upper body portion (174) of the cartridge housing (162) slidably accommodates a tissue retaining pin (176) and a coupling (180) secured to the proximal end of the tissue retaining pin (176). The coupling (180) is configured to releasably couple the tissue retaining pin (176) to the distal end of a push rod (80) of a tissue retaining pin actuation system (20) when the cartridge unit (160) is positioned within the distal support structure (48) of the end effector (16). The end cap member (182) secured to the proximal end of the upper body portion (174) is configured to proximally constrain the tissue retaining pin (176) and the coupling (180) within the cartridge housing (162) while allowing the tissue retaining pin (176) to be in its proximal retracted position (see Figure 1A and Fig. 12A ) and its distal extension (see Figure 1B and Fig. 12B). Tissue retaining pin (176) includes a tapered distal tip (178) configured to pierce tissue as retaining pin (176) is extended toward anvil (210).
[0077] The lower body portion (184) of the cartridge housing (162) slidably receives the staple driver member (186) and the knife member (194) therein. Figure 8 As best shown, the staple driver assembly (186) of the present version includes a base portion (188), a plurality of staple driver elements (190) projecting distally from the base portion (188), and an internal passage (192) extending axially through the staple driver assembly (186) and configured to slidably receive a knife member (194). Each staple driver element (190) is configured to be slidably received within a corresponding staple opening (168) of the cartridge housing (162) and to drive a corresponding staple (170) from the opening (168) in response to actuation of the closure trigger (36). While the staple driver elements (190) of the present version are securely attached to the base portion (188), it should be understood that in other versions, the base portion (188) and staple driver elements (190) may be provided separately.
[0078] The knife member (194) includes a base portion (196) and a knife (198) fixed to the base portion (196) and extending distally from the base portion and having a distal cutting edge (200). The knife (198) is formed to have a flat plate-like shape that enables the knife (198) to perform linear cuts on patient tissue. The knife member (194) is slidably received within the internal channel (192) of the staple driver member (186) so that the knife (198) is configured to be able to longitudinally translate through the staple driver member (186) and the elongated linear knife slot (166) of the cartridge housing (162) to cut tissue clamped by the end effector (16) in response to full actuation of the firing trigger (38).
[0079] like Figure 8 As best shown, the anvil (210) of the staple cartridge unit (160) includes a distal plate portion (212) and a coupling arm (214) extending proximally from the lower end of the distal plate portion (212). The distal plate portion (212) is configured to cooperate with the cartridge platform (164) to clamp tissue to be sutured and cut. The distal plate portion (212) includes an elongated linear slot (216) and a plurality of staple forming recesses (218) arranged in a linear row along each side of the slot (216). The recesses (218) are configured to receive and deform the legs of the staples (170) ejected from the cartridge housing (162) so that the staples (170) are formed in the tissue clamped between the distal plate portion (212) and the cartridge platform (164).
[0080] Guide pin (230) extends longitudinally between anvil plate portion (212) and cartridge housing (162) and is configured to guide cartridge housing (162) in a proximal open position (see Figure 1A and Fig. 12A ) and distal closed position (see Figure 1C and Fig. 12C The proximal end of the guide pin (230) is constrained by the proximal tab (220) of the anvil coupling arm (214), such as Figure 8 As shown, the distal end of the guide pin (230) is constrained in the lower opening (222) formed in the anvil plate portion (212). The upper opening (224) formed in the anvil plate portion (212) is configured to receive the tapered distal end (178) of the tissue retaining pin (176) and constrain it in an extended position so that the tissue retaining pin (176) can cooperate with the guide pin (230) to guide the longitudinal translation of the cartridge housing (162) relative to the anvil (210). Figure 6-8 As shown, the inner side of the guide pin (230) may include a longitudinal groove (232) configured to mate with a similar groove (234) (see Figures 12A-12D ) cooperate to slidably guide the knife (198) between a retracted position and an extended position relative to the cartridge housing (162).
[0081] The staple cartridge unit (160) further includes a tissue cutting washer (240) fixed to the anvil (210) and configured to cooperate with the knife (198) to cut tissue clamped by the end effector (16). Figure 8 and Figure 10-11 As best shown, the tissue cutting gasket (240) includes an elongated plate-like body (242) extending distally of the anvil plate portion (212). The gasket body (242) includes an elongated cutting element (244) that protrudes proximally through the elongated slot (216) of the anvil plate portion (212). The cutting element (244) serves as a cutting plate by providing a flat surface for the knife cutting edge (200) to abut against which the cutting edge (200) cuts tissue. At least the cutting element (244) of the tissue cutting gasket (240) may include a polymer material, such as high-density polyethylene (HDPE). In this regard, when cutting tissue, the knife (198) may axially cut into the cutting element (244) along its longitudinal centerline. Although the cutting element (244) of the present version provides a generally flat cutting surface, it should be understood that the cutting element (244) may be alternatively constructed in other versions.
[0082] The tissue cutting gasket (240) further includes a rounded tip (246) at the upper end of the gasket body (242), and a coupling arm (248) extending proximally from the lower end of the gasket body (242). The gasket tip (246) captures and thereby constrains the upper end of the anvil plate portion (212), and its rounded configuration promotes atraumatic interaction with patient tissue. The crimping pin (250) is configured to be inserted through an opening formed in the proximal coupling arm (214, 248) of the anvil (210) and the tissue cutting gasket (240), thereby securely coupling the anvil (210) and the cutting gasket (240) together.
[0083] The tissue cutting washer (240) also includes a pair of side flanges (252) extending along the entire length of the anvil plate portion (212). Fig.10 and Fig.11 As shown, each side flange (252) extends proximally to cover a corresponding side edge of the anvil plate portion (212), and extends distally to cover at least a portion of the distal hook (47) of the corresponding side plate (40) defining the distal support structure (48). Therefore, and advantageously, the side flange (252) is used to cover the axial gap (254) that may be formed between the anvil plate portion (212) and the distal hook (47), thereby preventing tissue from entering the axial gap (254) and being squeezed within the circumferential gap, which may otherwise cause undesirable trauma to the tissue. Fig.11 As shown, the outer surface of the side flange (252) may be rounded to further enhance the atraumatic nature of the outer periphery of the tissue cutting washer (240). The tissue cutting washer (240) may be further constructed and operated in accordance with any of the teachings of the following patents: U.S. Patent Application [Attorney Reference No. END9086USNP1], entitled "Tissue Cutting Washer for Right Angle Surgical Stapler," filed on the same date as the present application, the disclosure of which is incorporated herein by reference.
[0084] C. Exemplary Loading of a Cartridge Unit into the Distal Support Structure of an End Effector
[0085] Fig.9A and Fig. 9B The staple cartridge unit (160) is shown loaded into the distal support structure (48) of the end effector (16) in its unused (or "virgin") state. Fig.9AAs shown, and as briefly described above, the distal support structure (48) is constructed to have a U-shaped side profile having a distal side defined by the distal hook (47), a proximal side defined by the proximal portion of the distal jaw portion (46) and the distal end of the magazine receiving distal portion (52) of the closing rod (50), and an upwardly opening axial gap arranged between the distal and proximal sides.
[0086] Figures 9A-9B The illustrated staple cartridge unit (160) is provided with a staple retainer (260) that is removably positioned between the platform (164) and the anvil plate portion (212) to retain the staples (170) within the staple openings (168) and to ensure proper axial spacing between the platform (164) and the anvil plate portion (212) when the staple cartridge unit (160) is inserted into the distal support structure (48). When the staple retainer (260) is removed, the staple cartridge unit (160) presents a U-shaped side profile similar to the distal support structure (48), the U-shaped side profile having a distal side defined by the anvil plate portion (212) and the tissue cutting washer (240), a proximal side defined by the cartridge platform (164), and an upwardly open axial gap (G) disposed between the proximal and distal sides. The staple retainer (260) may be further constructed and operated in accordance with any of the teachings of the following patents: U.S. patent application entitled "Staple Retainer for Right Angle Surgical Stapler" [Agent Reference No. END9090USNP1] filed on the same date as the present application, the disclosure of which is incorporated herein by reference.
[0087] like Fig.9A As shown, the user first aligns the proximal guide rail (202) formed on the lower body portion (184) of the cartridge housing (162) with the internal channel (56) formed in the cartridge receiving distal portion (52) of the closure rod (50) (see Figure 3 ).like Fig. 9B As shown, the user then presses the staple cartridge unit (160) downward into the distal support structure (48) of the end effector (16), causing the proximal guide rail (202) of the cartridge housing (162) to slide downward into the internal channel (56) of the closure rod (50), and causing the distal hook (47) of the side plate (40) to slide into the groove formed in the distal side of the tissue cutting washer body (242) (see Fig.11When the cartridge unit (160) is fully seated within the distal support structure (48), a stopper protrusion (204) formed on the lower body portion (184) of the cartridge housing (162) is received within a corresponding opening (58) formed in the cartridge receiving distal portion (52) of the closure rod (50), thereby removably securing the cartridge unit (160) within the distal support structure (48). The engagement of the cartridge stopper protrusion (204) with the opening (58) may provide tactile and / or audible feedback to the user to confirm that the cartridge unit (160) has been fully seated within the distal support structure (48).
[0088] like Fig.9A As shown, the distal locking lever (270) is pivotally connected to the distal end of the nail rod (60). The distal locking lever (270) extends distally toward the distal edge (64) of the nail rod (60) and the knife rod (70), and is configured to releasably engage a fixed distal pin (280) extending laterally through the distal portion of the side plate (40), the closing rod (50), the nail rod (60) and the knife rod (70). The distal locking lever (270) is moved toward Fig.9A The raised position shown is resiliently biased and is capable of being moved toward the distal support structure (48) in response to engagement of the proximal end of the staple driver member (186) when an unused staple cartridge unit (160) is inserted into the distal support structure (48). Fig. 9B In the raised position, the distal lockout lever (270) lockingly engages the fixed distal pin (280) and thereby prevents distal actuation of the nail rod (60) and the knife rod (70), and thus prevents firing of the nail magazine unit (160). In the lowered position, the distal lockout lever (270) disengages the fixed distal pin (280) and thereby allows distal actuation of the nail rod (60) and the knife rod (70) to fire the nail magazine unit (160). Figure 18-22E Distal lockout lever (270) is described in greater detail.
[0089] D. Exemplary Actuation of a Surgical Stapler
[0090] Having described above various structural features of the surgical stapler (10), including the staple cartridge unit (160), an exemplary actuation of the surgical stapler (10) during a surgical procedure will now be described below. After loading an unused staple cartridge unit (160) into the distal support structure (48) in the manner described above, the end effector (16) is then appropriately manipulated within the patient's body cavity to position the patient's tissue within the staple cartridge gap (G) between the anvil plate portion (212) and the cartridge platform (164). Fig. 12A and Fig. 12BAs shown, the push rod (80) is then actuated distally via the slide (34) to drive the push rod (80) distally, thereby extending the tissue retaining pin (176) from the cartridge housing (162) so that its distal tip (178) pierces any tissue covering the upper end of the cartridge platform (164) and is seated within the upper end of the anvil plate portion (212). In this way, the patient's tissue is securely held within the cartridge gap (G) prior to closure.
[0091] like Fig. 12C As shown, the closing rod (50) is then actuated distally via the closing trigger (36), thereby driving the cartridge housing (162) distally along the guide pin (230) and the tissue retaining pin (176) to clamp the tissue between the cartridge platform (164) and the anvil plate portion (212). As shown in this example, the nail rod (60) and the knife rod (70) are actuated distally together with the closing rod (50) and the cartridge housing (162), so that the nail driver member (186) and the knife member (194) are appropriately positioned to fire when the end actuator (16) is fully closed. As described above, the end actuator (16) is releasably held in a fully closed state by the locking pawl (112) of the release button (110) of the handle assembly (12).
[0092] like Fig.12D As shown, the nail rod (60) and the knife rod (70) are then actuated distally via the firing trigger (38), thereby driving the nail driver member (186) and the knife rod (70) distally through the cartridge housing (162). The nail driver element (190) of the nail driver member (186) is advanced distally through the nail opening (168), thereby driving the nail (170) contained in the nail opening distally through the clamped tissue and into the nail forming recess (218) of the anvil plate portion (212), so that the nail (170) is formed in the tissue. The knife member (194) drives the knife (198) distally through the elongated knife slot (166) of the cartridge platform (164), through the clamped tissue, and against the cutting element (244) of the tissue cutting washer (240), thereby severing the clamped tissue along the linear cutting line between the innermost row of formed nails (170). Upon completely cutting through the clamped tissue, the knife cutting edge (200) may penetrate distally into the cutting element (244) of the tissue cutting washer (240). Optionally, in response to such penetration, the tissue cutting washer body (242) may break along the knife cutting edge (200), thereby providing the surgeon with an audible indication (e.g., via a "snap" sound) that the firing stroke is complete and the clamped tissue has been completely stapled and severed.
[0093] As mentioned above, and as Fig.12DAs shown, when firing trigger (38) is actuated through a primary range of motion resulting in tissue stapling, staple driver member (186) and knife member (194) can translate distally together through staple cartridge housing (162). Fig.12D As shown, when the firing trigger (38) is further actuated through the final range of motion resulting in the cutting of the stapled tissue with the knife (198), the knife member (194) can then continue to translate distally relative to the fixed staple driver member (186). In this way, the tissue clamped by the end effector (16) is completely stapled before being severed.
[0094] like Figure 7 As best shown, a first side of the lower body portion (184) of the cartridge housing (162) includes a stop arm (185) having a plurality of axially spaced grooves. Additionally, a first side of the base portion (188) of the staple driver member (186) includes a laterally extending stop post (189) configured to axially stop along the stop arm (206) when the staple driver member (186) is driven distally through the cartridge housing (162) during suturing of the clamped tissue. Figure 8 As best shown, the second side of the base portion (188) of the staple driver member (186) includes a stop arm (191) having a plurality of axially spaced grooves. Additionally, the second side of the base portion (196) of the knife member (194) includes a laterally extending stop post (197) that is configured to axially stop along the stop arm (191) when the knife member (194) is driven distally through the staple driver member (186) while cutting the clamped tissue. Such a stop feature can provide tactile feedback to the surgeon when the staple driver member (186) has been fully extended to staple tissue, and subsequently when the knife member (194) has been fully extended to cut the stapled tissue.
[0095] Once the surgical stapler (10) has been fully fired, the surgeon releases the firing trigger (38), which enables the knife bar (70) and the knife member (194) to automatically retract proximally relative to the closing rod (50) via the resilient bias of the knife return spring (130). In this version, the knife bar (70) is operably coupled to the nail rod (60) so that the proximal retraction of the knife bar (70) relative to the closing rod (50) also drives the proximal retraction of the nail rod (60) relative to the closing rod (50); for example, by engaging the lower tab (78) formed on the distal portion of the knife bar (70) with the lower slot (66) formed in the lower side of the distal portion of the nail rod (60). At the same time, the above-mentioned suturing stopper features (185, 189) operate to maintain the staple driver member (186) in its fully extended position within the cartridge housing (162), disengaging the distal lockout lever (270) from engaging the staple driver member (186). This allows the distal lockout lever (270) to return to the raised locked position and prevents re-actuation of the firing trigger (38) in the event that the staple cartridge unit (160) has been used. In this way, the distal lockout lever (270) prevents the surgeon from accidentally re-firing a used staple cartridge unit (160) into tissue in a manner that would sever the tissue with the knife (198) without applying staples.
[0096] After releasing the firing trigger (38), the surgeon then depresses the release button (110) on the handle assembly (12) to allow the closing trigger (36) and the closing rod (50) to return to their unactuated state via the resilient bias of the above-mentioned closing return spring (98). Such proximal retraction of the closing rod (50) pulls the cartridge housing (162) proximally away from the anvil (210) so that the stapled and cut tissue can be released from the end effector (16). The proximal retraction of the closing rod (50) also pulls the nail rod (60) and the knife rod (70) further proximally to their proximal original positions so that the spent nail cartridge unit (160) can be removed from the distal support structure (48) and replaced with a new nail cartridge unit (160).
[0097] E. Additional Features of the Firing System
[0098] Figure 13-17 Additional features of the firing trigger (38) and its engagement with the nail rod (60) and knife rod (70) during the firing stroke for firing the end effector (16) are shown. Figure 13-14As shown in and as briefly described above, the firing trigger (38) is constructed as an assembly comprising: a trigger guard (120); a pair of trigger side plates (121) nested within the trigger guard (120) and each having an arcuate upper arm (122); a cam pin (124) spanning laterally between and rotatably supported by the distal ends of the arcuate upper arms (122); a firing lockout element (126) disposed on a side of the left trigger side plate (121); and a trigger pivot pin (128) extending laterally through the trigger guard (120), the trigger side plates (121) and the firing lockout element (126) to pivotally connect the firing trigger (38) to the handle assembly body (30).
[0099] like Fig.15 As best shown, the rotatable cam pin (124) of the firing trigger (38) includes features defining a plurality of stepped diameters spaced laterally apart along the central axis of rotation of the cam pin (124). These features of the cam pin (124) include: a circular center body (132); a circular recessed shoulder (134) disposed on each side of the center body (132); an annular groove (136) disposed laterally outward of each recessed shoulder (134); and an end cap (138) disposed laterally outward of each annular groove (136). As described below, these features enable the cam pin (124) to simultaneously engage the proximal ends of the nail rod (60) and the knife rod (70) in response to squeezing the firing trigger (38) toward the pistol grip (32) to fire the end effector (16).
[0100] like Fig.16As shown, the circular center body (132) of the cam pin (124) is configured to engage the rounded proximal edge (72) of the knife bar (70) in response to squeezing the firing trigger (38). At the same time, each annular groove (136) of the cam pin (124) is configured to engage the corresponding proximal edge (62) of the nail rod (60) in response to squeezing the firing trigger (38). Therefore, squeezing the firing trigger (38) toward the pistol grip (32) to perform the firing stroke causes the cam pin (124) to drive the nail rod (60) and the knife bar (70) distally, thereby firing the end actuator (16) in the above-described manner. Since the cam pin (124) is rotatably mounted to the trigger side plate (121), the cam pin (124) is configured to roll along the proximal edge (62) of the nail rod (60) and the knife bar (70) when the firing trigger (38) is squeezed. Advantageously, such rolling minimizes friction between the cam pin (124) and the proximal edge (62), and thereby minimizes the input force (also referred to as the "firing force") that an operator must apply to the firing trigger (38) to fully actuate the rods (60, 70) distally to fire the end actuator (16).
[0101] The forces exerted by the cam pin (124) on the nail rod (60) and the knife rod (70) during the firing stroke may cause the proximal portions of the rods (60, 70) to experience a downward bending moment about their most proximal support point within the shaft assembly (14). Fig.13 As best seen in the drawings, the support pin (150) is positioned below the proximal ends of the nail rod (60) and the knife rod (70). The support pin (150) is configured to support the rod on the underside of the rod (60, 70) to offset such bending moments and prevent the rod (60, 70) from deflecting downward during firing. In this example, the support pin (150) spans laterally between the proximal frame portion (42) of the stapler side plate (40) and is fixed in the longitudinal direction of the stapler side plate (40), and in some versions, the support pin (150) can rotate relative to the side plate (40).
[0102] F. Distal locking mechanism of surgical stapler
[0103] like Fig.18 As shown, the surgical stapler includes a distal locking mechanism including a double locking member in the form of a locking lever (270) and a stop member in the form of a fixing pin (280). As briefly described above and described in more detail below, the distal locking lever (270) and the fixing pin (280) are configured to cooperate to prevent the closure of the end effector (16) when there is no unused staple cartridge (160) in the end effector (16), and are configured to prevent the end effector (16) from being fired more than once with the same staple cartridge unit (160).
[0104] like Figure 18-20 As shown, the distal locking lever (270) of this example is constructed as a double-sided structure, which has a first side and a second side (272) spaced apart and parallel to each other, and a lower bridge (273) interconnecting the proximal portion of the side (272) along its lower edge. The proximal end of the locking lever (270) includes a pair of openings (274) configured to receive a pivot pin (279) therethrough, and the distal end of the locking lever (270) includes a pair of tabs (275) extending distally. Along its middle portion, the locking lever (270) also includes a proximal pair of locking teeth (276) extending upward from the lever side (272), and a distal pair of locking teeth (278) extending upward from the lever side (272) and spaced distally from the proximal locking teeth (276). As described below, the lockout teeth (276, 278) are configured to engage the proximally facing flat surface (282) of the retaining pin (280) to establish a lockout position that prevents closing and firing of the end effector (16) in the absence of an unused staple cartridge unit (160).
[0105] like Fig.18 and Figure 3 As shown in FIG. 1 , the lever pivot pin (279) extends laterally through the proximal opening (274) of the distal locking lever (270), a corresponding pair of openings (67) formed in the distal portion of the nail rod (60) (see FIG. Figure 3 ), and a corresponding slot (77) formed in the distal portion of the knife bar (70) (see Figure 3 Thus, the distal lockout lever (270) is longitudinally fixed but rotatable relative to the nail rod (60), while the slot (77) allows the knife rod (70) to translate longitudinally relative to the nail rod (60) and the distal lockout lever (270), thereby actuating the knife member (194) of the nail cartridge unit (160) independently of the nail driver member (186) in the manner described above. Fig.18 and Figure 3 As shown, the fixing pin (280) extends laterally through the elongated slot (79) formed in the distal portion of the knife bar (70), and a corresponding pair of elongated slots (69) formed in the distal portion of the nail bar (60). As described above, the opposite lateral ends of the fixing pin (280) are fixed in the distal jaw portion (46) of the stapler side plate (40). Therefore, the elongated slots (69, 79) enable the nail bar (60) and the knife bar (70) to be longitudinally translated relative to the fixing pin (280) together with the distal locking lever (270) to achieve the closing and firing of the end actuator (16) loaded with an unused staple cartridge unit (160).
[0106] like Figure 21-22EAs shown, the distal locking lever (270) is configured to pivot relative to the nail rod (60) and the knife rod (70) between a generally horizontal raised position and a lowered position, in which the proximal locking tooth (276) or the distal locking tooth (278) is configured to engage the fixed pin (280), and in the lowered position, the locking teeth (276, 278) are configured to bypass the fixed pin (280). The distal locking lever (270) can be biased toward the raised position by any suitable biasing element, such as a resilient member (not shown).
[0107] Fig.22A The distal lockout lever (270) is shown in a first raised lockout position, the distal lockout lever (270) being configured to occupy and maintain the first raised lockout position when the end effector (16) is in an open state (i.e., when the closure system (22) and the firing system (24) are not actuated) and when there is no unused cartridge unit (160) in the end effector (16), for example, when there is no cartridge unit (160) in the end effector (16) at all, or when the end effector (16) is loaded with a used cartridge unit (160). In the first raised lockout position, the distal lockout tooth (278) is positioned to engage the flat surface (282) of the retaining pin (280), thereby preventing distal actuation of the firing system (24). Since the firing system (24) is operably connected to the closing system (22) in the manner described above, this locking of the firing system (24) in its unactuated state also prevents actuation of the closing system (22), so that the end actuator (16) is locked in the open state.
[0108] like Fig.21 and Fig. 22B As shown, loading an unused staple cartridge unit (160) into the end effector (16) is configured to pivot the distal lockout lever (270) to its lowered bypass position. Specifically, the staple driver member (186) of the unused staple cartridge unit (160) is positioned proximally within the cartridge housing (162) such that the proximal base portion (188) of the staple driver member (186) is configured to drive downwardly the distally extending tab (275) of the distal lockout lever (270) when the unused staple cartridge unit (160) is positioned into the distal support structure (48) of the end effector (16). This engagement forces the distal lockout lever (270) from its first raised locked position ( Fig.22A ) pivots downward to the lowered bypass position ( Fig. 22B ).
[0109] like Fig. 22CAs shown, with the distal lockout lever (270) in the lowered bypass position, in response to the operator squeezing the closing trigger (36), the nail rod (60) and knife rod (70) of the firing system (24) are allowed to be actuated distally along with the closing rod (50). Figure 1B-1C As described above, the end effector (16) is closed to clamp the tissue between the anvil (210) and the cartridge platform (164) of the unused cartridge unit (160). Fig.22D As shown, with the distal lockout lever (270) maintained in the lowered bypass position, in response to squeezing of the firing trigger (38), the nail rod (60) and the knife rod (70) are further driven distally relative to the closing rod (50) through a firing stroke, thereby firing the end actuator (16) with an unused nail magazine unit (160) to staple and cut the clamped tissue.
[0110] Fig.22E The end effector (16) is shown after completing a firing stroke on the staple cartridge unit (160), such that the staple cartridge unit (160) is now spent. Figure 7 As described, after the staple cartridge unit (160) is fired, the suturing stop features (185, 189) retain the staple driver member (186) in a distal position within the cartridge housing (162). Thus, when the staple rod (60) and the knife rod (70) retract proximally in response to the operator releasing the firing trigger (38), the distally extending tab (275) of the distal lockout lever (270) disengages the proximal base portion (188) of the staple driver member (186). Thus, via the bias imparted by the biasing member, the distal lockout lever (270) automatically pivots upward to occupy a second raised locked position, as shown in FIG. Fig.22E As shown. In the second raised locked position, the proximal locking tooth (276) is positioned to engage the proximal flat surface (282) of the retaining pin (280) and thereby prevent further actuation of the firing system (24) while the end effector (16) remains clamped with the now spent staple cartridge unit (160). In this way, while the end effector (16) remains clamped, the distal locking lever (270) prevents the firing system (24) from being actuated more than once with the same staple cartridge unit (160). Advantageously, this prevents the knife (198) from being accidentally re-activated in a manner that could cut through and destroy the established staple line after the staples (170) have been formed in the clamped tissue. Thus, this function of the distal locking lever (270) reminds the operator that the spent staple cartridge unit (160) must be replaced with another new, unused staple cartridge unit (160) in order to perform another firing on the tissue.
[0111] As described above, after firing the end effector (16) and releasing the firing trigger (38), the operator may depress the release button (see Figures 1A-1Dand Figures 4A-4C ) to return the closure system (22) to the unactivated state and reopen the end effector (16) to release the nail and cut the tissue. When the nail rod (60) and the knife rod (70) are retracted toward the proximal side, the distal locking lever (270) moves toward the proximal ratchet along the lower side of the fixing pin (280), thereby returning the distal locking lever (270) to the Fig.22A The distal locking lever (270) is configured to prevent actuation of both the closure system (22) and the firing system (24) in the absence of an unused staple cartridge unit (160). In addition, the distal locking lever (270) is configured to cooperate with the proximal firing locking lever (140) described above to ensure safe use of the surgical stapler (10).
[0112] G. Exemplary Alternative Distal Lockout Lever with Downward-Angled Distal Tab
[0113] Fig.23 An exemplary alternative distal locking lever (290) suitable for use with a surgical stapler (10) to replace the distal locking lever (270) described above is shown. The distal locking lever (290) is similar to the distal locking lever (270) in that the distal locking lever (290) is configured as a double-sided structure having a first side and a second side (292) spaced apart from each other and parallel to each other. In addition, the distal locking lever (290) includes a pair of openings (294) configured to receive a pivot pin (not shown) therethrough, and the distal end of the locking lever (290) includes a pair of distally extending tabs (295). Unlike the upwardly inclined distally extending tabs (275) of the distal locking lever (270), the distally extending tabs (295) are downwardly inclined. Thus, distal lockout lever (290) may be adapted for use with other types of staple cartridge units having a proximal end portion of a staple driver member having a shape that differs from the shape of the proximal base portion (188) of staple driver member (186) described above.
[0114] Similar to the distal locking lever (270), the distal locking lever (290) also includes a proximal pair of locking teeth (296) extending upward from the lever side (292), and a distal pair of locking teeth (298) extending upward from the lever side (292). The locking teeth (296, 298) of the distal locking lever (290) are configured to cooperate with the fixed distal pin (280) in a manner similar to the locking teeth (276, 278) of the distal locking lever (270) described above. Similar to the locking lever (270), the locking lever (290) is pivotable between an elevated locking position and a lowered bypass position. The locking lever (290) is shown as having a resilient member in the form of a leaf spring (299) that operates to resiliently bias the locking lever (290) toward the elevated locking position.
[0115] II. Exemplary Alternative Distal Locking Mechanisms
[0116] In some circumstances, it may be desirable to alternatively configure the distal lockout mechanism of the surgical stapler end effector (16) such that the lockout member (270) is mounted to the closure rod (50) rather than to the staple rod (60). Figure 24-28D A right angle linear surgical stapler (310) having an exemplary alternative distal locking mechanism of such a configuration is shown. Unless otherwise specified, the surgical stapler (310) is similar to the surgical stapler (10). As described in more detail, the distal locking mechanism includes a movable locking member (380) and a fixed stop member (390) that can be operated in a manner similar to the movable locking member (270) and the stop member (280) of the surgical stapler (10) described above. Specifically, the locking member (380) and the stop member (390) are configured to cooperate to prevent the closure of the end actuator (316) when there is no unused staple cartridge unit (460) in the end actuator (316), and are configured to prevent the end actuator (316) from being fired more than once with the same staple cartridge unit (460). Unless otherwise specified, the surgical stapler (310) is similar to the surgical stapler (10) described above.
[0117] like Fig.24 and Fig.25As shown, the surgical stapler (310) includes a shaft assembly (314) extending distally from a handle assembly (not shown), and an end actuator (316) located at the distal end of the shaft assembly (314). The surgical stapler (310) also includes a pair of longitudinally extending side plates (340) each having a distal jaw portion (346), and an inner jaw member (347) positioned laterally between the distal jaw portions (346). The closing system of the surgical stapler (310) includes an elongated closing rod (350) slidably disposed between the stapler side plates (340). The firing system of the surgical stapler (310) includes an elongated actuable nail rod (360) slidably nested in the closing rod (350) and an elongated actuable knife rod (370) slidably nested in the nail rod (360). The cartridge receiving distal portion (352) of the closure rod (350) cooperates with the distal jaw portion (346) of the stapler side plate (340) and the inner jaw member (347) to define a U-shaped distal support structure (348) of the end effector (316). Fig.24 As shown, distal support structure (348) is configured to receive a staple cartridge unit (460) therein, which may be similar to staple cartridge unit (160) described above.
[0118] like Figure 25-27 As shown, the distal lockout mechanism of the surgical stapler (310) includes a movable lockout member in the form of a lockout lever (380) pivotally mounted to the cartridge receiving distal portion (352) of the closure rod (350), and a fixed stop member in the form of a proximally facing lug (390) attached to the proximal end of the inner jaw member (347). Fig.26 As shown, the distal locking lever (380) includes a first locking feature in the form of a proximal hook (382) at the proximal end of the locking lever (380), and a second locking feature in the form of a distal hook (384) at the distal end of the locking lever (380). A tab (386) protrudes distally from the distal hook (384) and is configured to be engaged by the proximal end of the staple driver member (486) of the staple cartridge unit (460) to lock the locking lever (380) in the locked position (see, e.g., Fig.28A and Fig.28D ) and bypass locations (see e.g. Fig.28B and Fig.28C). The locking lever (380) further includes a pair of pivot posts (388) extending laterally outward from opposite sides of the locking lever (380) at a midpoint of the locking lever (380) between the proximal hook (382) and the distal hook (384). The pivot posts (388) are rotatably received in corresponding openings formed in opposite sides of the cartridge-receiving distal portion (352) of the closure lever (350), thereby pivotally mounting the locking lever (380) to the closure lever (350) about a lateral pivot axis.
[0119] like Figures 28A-28D As shown, the locking lever (380) is configured to pivot about the pivot post (388) between an angled position and a substantially horizontal bypass position, in which the locking lever (380) is configured to prevent actuation of the closing system and / or firing system of the surgical stapler (310); in the substantially horizontal bypass position, the locking lever (380) is configured to allow actuation of the closing system and firing system of the stapler (310) to allow closure and firing of the end effector (316) loaded with an unspent staple cartridge unit (460). The locking lever (380) of this example is biased toward the angled position by any suitable type of biasing member, such as a resilient member similar to the leaf spring (299) described above.
[0120] Fig.25 and Fig.28A The distal locking lever (380) is shown in a first angled locking position, and the distal locking lever (380) is configured to occupy and maintain the first angled locking position when the end actuator (316) is in an open state (i.e., when the closure system and the firing system are not actuated) and when there is no unused staple cartridge unit (460) in the end actuator (316), for example, when there is no staple cartridge unit (460) at all in the end actuator (316), or when the end actuator (316) is loaded with a used staple cartridge unit (460). In the first angled locking position, the distal hook (384) captures the distal ends of the staple rod (360) and the knife rod, and the proximal hook (382) captures the proximal end of the lug (390). As shown in FIG. Fig. 27As shown, the proximal end of the lug (390) includes a groove (392) configured to receive the proximal hook (382) of the distal locking lever (380) in a first angled locked position. In the absence of an unused staple cartridge unit (460) in the end effector (316), the simultaneous engagement of the distal locking lever (380) with the lug (390) and the nail rod (360) prevents the distal actuation of both the closing system and the firing system of the surgical stapler (310), thereby preventing the closure of the end effector (316). Specifically, the proximal hook (382) grounds the closing rod (350) longitudinally to the stapler side plate (340) and the inner jaw member (347), and the distal hook (384) grounds the nail rod (360) and the knife bar (370) longitudinally to the closing rod (350).
[0121] like Fig.28B As shown, loading an unused staple cartridge unit (460) into the end effector (316) causes the distal locking lever (380) to pivot from the first locking position to the horizontal bypass position. Specifically, the proximal end of the staple driver member (486) of the unused staple cartridge unit (460) engages the distal tab (386) of the locking lever (380) and drives the distal tab of the locking lever downward. This forces the locking lever (380) to pivot to a horizontal position, causing the proximal hook (382) to disengage the engagement lug (390) and the distal hook (384) to disengage the staple rod (360).
[0122] like Fig.28C As shown, when the distal locking lever (380) is now in the horizontal bypass position, the closing rod (350), the nail rod (360) and the knife rod (370) are freely actuated distally relative to the stapler side plate (340) to close the end actuator (316) and thus clamp the tissue. As shown, the distal locking lever (380) translates with the closing rod (350) so that the proximal hook (382) translates distally beyond the proximal side of the lug (390). In addition, once the end actuator (316) is fully closed, the nail rod (360) and the knife rod (370) are freely further actuated distally relative to the closing rod (350) by the firing stroke to fire the end actuator (316) with the unused staple cartridge unit (460), thereby suturing and cutting the clamped tissue.
[0123] Fig.28DThe end effector (316) is shown after a firing stroke is completed on the staple cartridge unit (460), such that the staple cartridge unit (460) is now spent. Similar to the staple driver assembly (186) of the staple cartridge unit (160), the staple driver assembly (486) of the cartridge unit (460) is configured to be maintained in a distal position within the cartridge housing (462) upon completion of the firing stroke. Thus, when the staple rod (360) and the knife rod (370) retract proximally in response to the operator releasing the firing trigger (not shown) of the surgical stapler (310), the distal tab (386) of the distal locking lever (380) disengages the proximal end of the staple driver assembly (486). Thus, via the bias imparted by the biasing member, the distal locking lever (380) automatically pivots relative to the closing rod (350) to occupy a second angled locked position, as shown. Fig.22D In the second angled locked position, the distal hook (384) of the locking lever captures the distal ends of the nail rod (360) and the knife rod (370), thereby preventing the rods (360, 370) from being actuated distally relative to the closing rod (350) and preventing re-firing while the end effector (316) remains clamped with the now spent nail magazine unit (460). Similar to the benefits provided in the end effector (16), this function in the end effector (316) prevents the knife (not shown) of the nail magazine unit (460) from being accidentally re-activated in a manner that can cut through and destroy the established nail line after the nails have been formed in the clamped tissue.
[0124] When the closure rod (350), the nail rod (360) and the knife rod (370) are retracted proximally and the spent nail cartridge unit (460) is removed from the end effector (316), the distal locking lever (380) is configured to automatically re-engage the distal locking lever (380). Fig.25 and Fig.28A The first angled lock position is shown. In this example, the distal end of the lug (390) includes a first ramp surface (394), and the opposite side of the proximal hook (382) of the distal lockout lever (380) includes a second ramp surface (396). The ramp features are configured to cam against each other when the rods (350, 360, 370) are retracted proximally to pivot the lockout lever (380) into the bypass position, thereby enabling the distal lockout lever (380) to retract proximally with the closure rod (350) and re-occupy the first angled lock position until another new, unused staple cartridge unit (460) is loaded into the end effector (316).
[0125] III. Exemplary Combinations
[0126] 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.
[0127] Example 1
[0128] A surgical stapler, comprising: (a) a body; (b) a shaft assembly, the shaft assembly extending distally from the body; (c) an end actuator, the end actuator being located at the distal end of the shaft assembly, wherein the end actuator is actuable between an open state for receiving tissue and a closed state for clamping the tissue, wherein the end actuator is configured to receive a staple cartridge having staples; (d) a closing system, the closing system being operably coupled to the end actuator, wherein the closing system is operable to actuate the end actuator from the open state to the closed state; (e) a firing system operably connected to the end actuator, wherein the firing system is capable of being actuated to fire the end actuator and thereby suturing and cutting the clamped tissue; and (f) a locking member operably connected to the closing system and the firing system, wherein the locking member is configured to prevent actuation of the closing system to prevent closing of the end actuator when an unused staple cartridge is not present in the end actuator, wherein the locking member is further configured to prevent actuation of the firing system to prevent repeated firing of the end actuator with the same staple cartridge.
[0129] Example 2
[0130] A surgical stapler according to Example 1, wherein the end effector is configured to clamp and staple tissue in a plane extending transverse to the longitudinal axis of the shaft assembly, wherein the surgical stapler is configured to be used in open surgical procedures.
[0131] Example 3
[0132] The surgical stapler according to any of the preceding embodiments, wherein the end effector comprises a knife, wherein the lockout member is configured to prevent distal actuation of the knife after initial firing of the end effector with the staple cartridge.
[0133] Example 4
[0134] A surgical stapler according to any of the aforementioned embodiments, wherein the locking member is capable of moving between a first position and a second position, wherein in the first position, the locking member is configured to prevent actuation of the closing system and the firing system when there is no unused staple cartridge in the end actuator, and in the second position, the locking member is configured to allow actuation of the closing system and the firing system.
[0135] Example 5
[0136] A surgical stapler according to any of Example 4, wherein the locking member is elastically biased toward the first position.
[0137] Example 6
[0138] A surgical stapler according to any one of embodiments 4 to 5, wherein the lockout member is configured to transition from the first position to the second position in response to an unused staple cartridge being received by the end actuator.
[0139] Example 7
[0140] A surgical stapler according to Example 6, wherein the nail magazine includes a nail driver assembly, which is configured to eject the nails from the nail magazine in response to actuation of the firing system, wherein the lockout member includes a protrusion, which is configured to be engaged by the nail driver assembly when the unused nail magazine is first received by the end actuator, wherein the engagement is configured to drive the lockout member from the first position to the second position.
[0141] Example 8
[0142] A surgical stapler according to any one of embodiments 6 to 7, wherein the lockout member is configured such that when the unused staple cartridge is disposed within the end actuator, the lockout member is capable of translating distally together with the closure system while maintaining the second position.
[0143] Example 9
[0144] A surgical stapler according to any one of embodiments 6 to 8, wherein the lockout member is configured to automatically return to the first position from the second position after the end actuator is fired with the unused staple cartridge.
[0145] Example 10
[0146]
[0026] The surgical stapler according to Examples 4 to 9, wherein the locking member comprises a lever configured to pivot between the first position and the second position.
[0147] Embodiment 11
[0148]
[00136] In accordance with embodiment 10, the surgical stapler wherein the shaft assembly extends along a longitudinal axis, wherein the lever is configured to be pivotable about a transverse axis extending transversely to the longitudinal axis.
[0149] Example 12
[0150] A surgical stapler according to any of the preceding embodiments, wherein the lockout member is configured to translate distally relative to the body together with the closure system when the closure system actuates the end effector from the open state to the closed state.
[0151] Embodiment 13
[0152] The surgical stapler according to any one of Embodiment 12 further includes a stop member fixed longitudinally relative to the body, wherein the locking member is configured to engage the stop member when no unused staple cartridge is present in the end actuator in the open state to prevent distal actuation of the closure system.
[0153] Embodiment 14
[0154] A surgical stapler according to any of the aforementioned embodiments, wherein the locking member comprises: (i) a first locking feature portion, which is capable of being operated to prevent actuation of the closing system when there is no unused staple cartridge in the end actuator, thereby preventing closing of the end actuator, and (ii) a second locking feature portion, which is capable of being operated to prevent actuation of the firing system, thereby preventing repeated firing of the end actuator with the same staple cartridge.
[0155] Embodiment 15
[0156] Embodiment 14 provides a surgical stapler wherein the first lockout feature and the second lockout feature are longitudinally spaced apart along a longitudinal axis of the shaft assembly.
[0157] Example 16
[0158] A surgical stapler, comprising: (a) a body; (b) a shaft assembly, the shaft assembly extending distally from the body; (c) an end actuator, the end actuator being located at the distal end of the shaft assembly, wherein the end actuator is actuable between an open state for receiving tissue and a closed state for clamping the tissue, wherein the end actuator is configured to receive a staple cartridge having staples; (d) a closing system, the closing system being operably connected to the end actuator, wherein the closing system is operable to actuate the end actuator from the open state to the closed state; and (e) a firing system, the firing system system is operably connected to the end actuator, wherein the firing system is capable of being actuated distally through a firing stroke to eject the nail from the nail magazine into the clamped tissue; and (f) a locking member, which is operably connected to the closing system and the firing system, wherein the locking member includes: (i) a first locking feature, which is capable of being operated to prevent actuation of the closing system when an unused nail magazine is not present in the end actuator, and (ii) a second locking feature, which is capable of being operated to prevent repeated actuation of the firing system through multiple firing strokes with the same nail magazine.
[0159] Embodiment 17
[0160]
[00136] The surgical stapler of Example 16, wherein the first lockout feature and the second lockout feature are spaced apart along the length of the lockout member.
[0161] Embodiment 18
[0162] A surgical stapler according to any one of embodiments 16 to 17, wherein the first locking feature comprises a first protrusion, and wherein the second locking feature comprises a second protrusion.
[0163] Embodiment 19
[0164] A surgical stapler, comprising: (a) a body; (b) a shaft assembly, the shaft assembly extending distally from the body; (c) an end actuator, the end actuator being located at the distal end of the shaft assembly, wherein the end actuator is actuable between an open state for receiving tissue and a closed state for clamping the tissue, wherein the end actuator is configured to receive a staple cartridge having staples; (d) a closing system operably coupled to the end actuator, wherein the closing system is operable to actuate the end actuator from the open state to the closed state; and (e) a triggering mechanism. a firing system operably connected to the end actuator, wherein the firing system is capable of being actuated distally through a firing stroke to eject the nail from the nail magazine into the clamped tissue; and (f) a locking lever operably connected to the closing system and the firing system, wherein the locking lever is capable of pivoting between a first position and a second position, and the locking lever is configured such that: in the first position, the locking lever is capable of preventing the actuation of the closing system and the firing system, and in the second position, the locking lever is capable of allowing the actuation of the closing system and the firing system.
[0165] Embodiment 20
[0166] A surgical stapler according to Example 19, wherein the locking lever is disposed within the end actuator.
[0167] IV. Miscellaneous
[0168] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered isolated from each other. With reference to the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.
[0169] In addition, any one or more of the teachings, expressions, implementations, examples, etc. described in this document may be combined with any one or more of the teachings, expressions, implementations, examples, etc. described in the following patents: U.S. patent application entitled "Tissue Cutting Washer for Right Angle Surgical Stapler" filed on the same date as the present application [Agent Reference Number END9086USNP1]; U.S. patent application entitled "Clamping Based Lockout Mechanism for Right Angle Surgical Stapler" filed on the same date as the present application in 2018 [Agent Reference Number END9087USNP1]; and U.S. patent application entitled "StapleRetainer for Right Angle Surgical Stapler" filed on the same date as the present application [Agent Reference Number END9090USNP1], the disclosures of which are incorporated herein by reference.
[0170] 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.
[0171] 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). TMSimilarly, one of ordinary skill in the art will recognize that the various teachings herein may be readily combined with the various teachings of any of the following patents: U.S. Pat. No. 5,792,135, entitled “Articulated Surgical Instrument For Performing Minimally Invasive Surgery With Enhanced Dexterity and Sensitivity,” issued on August 11, 1998, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 8,783,541, entitled “Robotically-Controlled Surgical End Effector System,” issued on July 22, 2014, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 8,479,969, entitled “Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a Robot,” issued on July 9, 2013, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 8,479,969, entitled “Robotically-Controlled Cable-Based Surgical End Effector System,” issued on August 12, 2014, the disclosure of which is incorporated herein by reference; Effectors”, the disclosure of which is incorporated herein by reference; and / or U.S. Patent 8,573,465, entitled “Robotically-Controlled Surgical End Effector System with Rotary Actuated Closure Systems”, published on November 5, 2013, the disclosure of which is incorporated herein by reference.
[0172] 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.
[0173] 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.
[0174] 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 surgical stapler, comprising: (a) Subject; (b) a shaft assembly extending distally from the body along the longitudinal axis; (c) an end effector located at a distal end of the shaft assembly, wherein the end effector is actuatable between an open state and a closed state, wherein the end effector is configured to receive tissue between a first suturing surface and a second suturing surface in the open state, and wherein the end effector is configured to bring the first suturing surface and the second suturing surface into close proximity in the closed state for clamping tissue between the first suturing surface and the second suturing surface, wherein the end effector is configured to receive a staple cartridge having staples; (d) a closure system operably coupled to the end effector, wherein the closure system is operable to actuate the end effector from the open state to the closed state; (e) a firing system operably coupled to the end effector, wherein the firing system is actuatable to fire the end effector and thereby staple and cut the clamped tissue; as well as (f) a lockout member operably coupled to the closure system and the firing system, the lockout member being movable between a first position and a second position, and comprising: (i) a first lockout feature operable, when the lockout member is in the first position, to prevent actuation of the closure system when an unused staple cartridge is not present in the end effector, thereby preventing closure of the end effector, and (ii) a second lockout feature operable to prevent actuation of the firing system when the lockout member is in the second position, thereby preventing repeated firing of the end effector with the same staple cartridge, Wherein, the first locking feature and the second locking feature are longitudinally spaced apart along a longitudinal axis of the shaft assembly.
2. The surgical stapler of claim 1 , wherein the end effector is configured to clamp and staple tissue in a plane extending transverse to the longitudinal axis of the shaft assembly, wherein the surgical stapler is configured for use in an open surgical procedure.
3. The surgical stapler of Claim 1, wherein the end effector comprises a knife, wherein the lockout member is configured to prevent distal actuation of the knife after initial firing of the end effector with the staple cartridge.
4. The surgical stapler of Claim 1, wherein said lockout member is elastically biased toward said first position.
5. The surgical stapler of Claim 1, wherein the lockout member is configured to transition from the first position to the second position in response to an unused staple cartridge being received by the end effector.
6. A surgical stapler according to Claim 5, wherein the staple magazine includes a staple driver assembly, which is configured to eject the staples from the staple magazine in response to actuation of the firing system, wherein the lockout member includes a protrusion, which is configured to be engaged by the staple driver assembly when the unused staple magazine is first received by the end actuator, and wherein the engagement is configured to drive the lockout member from the first position to the second position.
7. The surgical stapler of Claim 5, wherein said lockout member is configured to be distally translated with said closure system while maintaining said second position when said unused staple cartridge is disposed within said end effector.
8. The surgical stapler of Claim 5, wherein said lockout member is configured to automatically return from said second position to said first position after said end effector is fired with said unused staple cartridge.
9. The surgical stapler of Claim 1, wherein the lockout member comprises a lever configured to pivot between the first position and the second position.
10. The surgical stapler of Claim 9, wherein said shaft assembly extends along a longitudinal axis, wherein said lever is configured to pivot about a transverse axis extending transverse to said longitudinal axis.
11. The surgical stapler of Claim 1, wherein said lockout member is configured to translate distally relative to said body together with said closure system when said closure system actuates said end effector from said open state to said closed state.
12. The surgical stapler according to claim 11 further includes a stop member fixed longitudinally relative to the body, wherein the locking member is configured to engage the stop member when there is no unused staple cartridge in the end actuator in the open state to prevent distal actuation of the closure system.
13. A surgical stapler, comprising: (a) the subject; (b) a shaft assembly extending distally from the body; (c) an end effector located at a distal end of the shaft assembly, wherein the end effector is actuatable between an open state and a closed state, wherein the end effector is configured to receive tissue between a first suturing surface and a second suturing surface in the open state, and wherein the end effector is configured to bring the first suturing surface and the second suturing surface into close proximity in the closed state for clamping tissue between the first suturing surface and the second suturing surface, wherein the end effector is configured to receive a staple cartridge having staples; (d) a closure system operably coupled to the end effector, wherein the closure system is operable to actuate the end effector from the open state to the closed state; (e) a firing system operably coupled to the end effector, wherein the firing system is actuable distally through a firing stroke to eject staples from the staple cartridge into the clamped tissue; as well as (f) a locking lever operably coupled to the closure system and the firing system, wherein the locking lever is pivotable between a first position and a second position, The locking lever comprises a first locking feature and a second locking feature, wherein: (i) the locking lever is configured such that in the first position the first locking feature is operable to prevent movement of: (A) the closure system and the firing system are actuated distally together when the end effector is in the open state; and (B) the firing system is actuated distally relative to the closing system when the firing stroke is completed and when the end effector is maintained in the closed state; (i) in the second position, the second lockout feature is operable to permit distal actuation of the closure system and the firing system, Wherein, the first lockout feature and the second lockout feature are longitudinally spaced apart along a longitudinal axis of the shaft assembly.
14. The surgical stapler of Claim 13, wherein said lockout lever is disposed within said end effector.
Citation Information
Patent Citations
Method of applying staples in lower anterior bowel resection
US10045780B2
Surgical stapler with sloped staple deck for varying tissue compression
US20200205811A1
Trigger mechanism for surgical instruments
US5605272A
Linear stapler with improved firing stroke
US5697543A
Articulated surgical instrument for performing minimally invasive surgery with enhanced dexterity and sensitivity
US5792135A