Clamping force sensor for surgical stapler

Abstract

In one embodiment, an apparatus includes: a first elongate member and a second elongate member releasably coupleable together to cooperate to clamp and staple tissue; a latch member capable of latching the first elongate member and the second elongate member to grip tissue; the percussion assembly can be used for cutting off and suturing the clamped tissue; and a clamping force measuring assembly. The clamping force measurement assembly is configured to measure a parameter associated with a clamping force applied on the first stapling surface and the second stapling surface while clamping tissue, and process and communicate the measured parameter to compare to a predetermined limit associated with successful staple formation.

Description

Background Art

[0001] In some surgical procedures such as gastrointestinal anastomosis, it may be desirable to clamp one or more tissue layers, cut through the clamped layers, and simultaneously drive the nail through the layers to substantially seal the cut layers together near the cut ends of the tissue layers. A type of such instrument that can be used in such surgery is a linear surgical stapler, also referred to as a "linear cutter". A linear surgical stapler generally includes a first half (referred to as a "bin half" or "reload half") and a second half (referred to as an "anvil half"), the first half having a distal jaw configured to support a staple cartridge (or "reload"), and the second half having a distal jaw supporting an anvil surface with a staple forming feature structure. The stapler also includes a movable clamping lever, which is configured to releasably clamp these stapler halves together. These stapler halves are configured to releasably couple together and pivot relative to each other to clamp the tissue between the two distal jaws when the clamping lever is closed. The firing assembly of stapler is configured to be able to actuate to cut the clamped layer and drive nail to pass the tissue on either side of cutting line simultaneously.After stapler is fired, clamping lever can be opened and stapler half part separates to release the tissue of cutting off and stitching.

[0002] 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

[0003] 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.

[0004] Figure 1 A perspective view of an exemplary linear surgical stapler is shown showing the cartridge half and the anvil half of the stapler coupled together with the clamping levers of the cartridge half in a fully closed position;

[0005] Figure 2 Shows Figure 1 An exploded perspective view of a linear surgical stapler, further showing a staple cartridge;

[0006] Figure 3 Shows Figure 1 A perspective view of a distal end portion of an anvil half of a linear surgical stapler;

[0007] Figure 4 Shows Figure 2 A perspective view of a distal end portion of a staple cartridge;

[0008] Figure 5 Shows Figure 1 A cross-sectional perspective view of a proximal portion of a cartridge half of a linear surgical stapler with a clamping lever in an open position to show details of a firing assembly and a retaining assembly of the cartridge half;

[0009] Figure 6 Shows Figure 5 An exploded perspective view of a retaining assembly;

[0010] Figure 7 Shows Figure 5 Another exploded perspective view of the retaining assembly;

[0011] Figure 8 Shows Figure 5 A perspective view of a firing assembly;

[0012] Fig. 9A Shows Figure 1 A side elevation view of a linear surgical stapler showing the stapler halves separated from each other and the clamping lever in an open position;

[0013] Fig. 9B Shows Figure 1 A side elevation view of a linear surgical stapler of , showing the proximal ends of the stapler halves coupled together to provide the stapler in a "hanging open" state when the clamping lever is in an open position;

[0014] Fig. 9C Shows Figure 1 A side elevation view of a linear surgical stapler showing distal portions of stapler halves having been approximated such that a distal pin of anvil half is received by a clamping lever jaw of cartridge half;

[0015] Fig.9D Shows Figure 1 A side elevation view of a linear surgical stapler of , showing the closure of the clamping levers completely clamping the stapler halves together;

[0016] Fig.9E Shows Figure 1 A side elevation view of a linear surgical stapler of , showing distal actuation of the firing assembly when the stapler halves are in a fully clamped state;

[0017] Fig.10 A rear perspective view of a proximal portion of an alternative linear surgical stapler is shown showing the proximal ends of the cartridge half and the anvil half of the stapler coupled together with the clamping lever in an open position to provide the stapler in a "hanging open" condition;

[0018] Fig.11 Shown with Fig.10a perspective view of a portion of a clamping lever associated with a clamping lever strain measurement assembly;

[0019] Fig. 12A Shows Fig.10 A side elevation view of a linear surgical stapler showing distal portions of stapler halves having been approximated such that a distal pin of anvil half is received by a clamping lever jaw of cartridge half;

[0020] Fig. 12B Shows Fig.10 A side elevation view of a linear surgical stapler of , showing the closure of the clamping levers completely clamping the stapler halves together;

[0021] Fig.13 A flow chart showing an exemplary method of using a linear surgical stapler having a clamp lever strain measurement assembly;

[0022] Fig.14 A rear perspective view of a proximal portion of an alternative linear surgical stapler is shown showing the proximal ends of the cartridge half and the anvil half of the stapler coupled together with the clamping lever in an open position to provide the stapler in a "hanging open" condition;

[0023] Fig.15A Shown with Fig.14 The clamping lever is disengaged Fig.14 A perspective view of a clamping lever force measurement assembly of a linear surgical stapler;

[0024] Fig. 15B Shown attached to Fig.14 Clamping lever Fig.15A A perspective view of a clamping lever force measurement assembly;

[0025] Fig.16A Shows Fig.14 A side elevation view of a linear surgical stapler showing distal portions of stapler halves having been approximated such that a distal pin of anvil half is received by a clamping lever jaw of cartridge half;

[0026] Fig. 16B Shows Fig.14 A side elevation view of a linear surgical stapler of , showing the closure of the clamping levers completely clamping the stapler halves together;

[0027] Fig.17 A flow chart showing an exemplary method of using a linear surgical stapler having a clamp lever force measurement assembly;

[0028] Fig.18A Shows separation from each other Figure 1 A side elevation view of a linear surgical stapler and anvil strain measurement assembly;

[0029] Fig.18B operably attached to each other Figure 1 Linear surgical staplers and Fig.18A A side elevation view of an anvil strain measurement assembly;

[0030] Fig.19 is shown operably attached to Figure 1 The anvil half of the linear surgical stapler Fig.18A A top plan view of a portion of an anvil strain measurement assembly;

[0031] Fig. 20A is shown operably attached to Fig.18A Anvil strain measurement assembly Figure 1 A side elevation view of a linear surgical stapler showing distal portions of stapler halves having been approximated such that a distal pin of anvil half is received by a clamping lever jaw of cartridge half;

[0032] Fig. 20B is shown operably attached to Fig.18A Anvil strain measurement assembly Figure 1 A side elevation view of a linear surgical stapler of , showing the closure of the clamping levers completely clamping the stapler halves together;

[0033] Fig.21 Shows Figure 1 The linear surgical stapler is operably attached to Fig.18A Graphical display of the anvil strain gauge assembly for visual display of tissue loading;

[0034] Fig. 22 A flow chart showing an exemplary method of using a linear surgical stapler having an anvil strain measurement assembly;

[0035] Fig.23 shows an exploded perspective view of an exemplary strain measurement sensor;

[0036] Fig.24A A side elevation view of a linear surgical stapler is shown showing distal portions of stapler halves having been approximated such that a distal pin of anvil half is received by a clamping lever jaw of cartridge half; and

[0037] Fig. 24B Shows Fig.24A Side elevation view of a linear surgical stapler showing the closure of the clamping levers to fully clamp the stapler halves together.

[0038] 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

[0039] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. According to the following description shown by way of example, other examples, features, aspects, embodiments and advantages of the present invention will be apparent to those skilled in the art, and a best mode is contemplated for implementing the present invention. As will be appreciated, the present invention can have other different and obvious aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative and non-restrictive in nature.

[0040] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator grasping 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 "upper," "lower," "vertical," "horizontal," and the like are used herein with reference to the accompanying drawings, it should be understood that such terms are used for illustrative descriptive purposes only and are not intended to be limiting or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.

[0041] Additionally, the terms "about" and "approximately" as used herein in connection with any numerical values ​​or ranges represent a suitable dimensional tolerance that allows the referenced features to function for the intended purpose described herein.

[0042] I. Exemplary Linear Surgical Stapler

[0043] A. Overview of Linear Surgical Staplers

[0044] Figure 1 to Figure 2 An exemplary linear surgical stapler (10) (also referred to as a "linear cutter") suitable for use in a variety of cutting and stapling procedures (such as gastrointestinal anastomosis procedures) is shown. The linear surgical stapler (10) includes a cartridge half (12) (also referred to as a "reloading half") and an anvil half (14), which are configured to be releasably coupled together to clamp tissue therebetween for simultaneous cutting and stapling of the clamped tissue.

[0045] The cartridge half (12) includes a first elongated member in the form of an elongated cartridge channel (16) having a proximal frame portion (18) and a distal jaw portion (20). The proximal frame portion (18) slidably holds the firing assembly (110) and includes a pair of laterally opposed upright side flanges (22). Each side flange (22) includes a vertical slot (24) disposed at its distal end and a tapered recess (26) disposed at its proximal end. An outwardly projecting rigid rib (28) extends longitudinally between the distal slot (24) and the proximal recess (26) of each side flange (22) and is configured to provide enhanced rigidity to the side flange (22). An outwardly flared upper section (30) defines an upper edge of the proximal portion of each side flange (22) and is configured to facilitate the cartridge half (12) to receive the anvil half (14). Each side flange (22) also includes an elongated firing slot (32) extending longitudinally along the underside of the side flange (22) between the proximal notch (26) and the distal slot (24). The elongated firing slot (32) is configured to guide the firing assembly (110) between a proximal position and a distal position. Figure 8 Firing assembly (110) is described in greater detail.

[0046] The distal jaw portion (20) of the cartridge channel (16) is configured to releasably receive (or "reload") a staple cartridge (140). Figure 4 As shown, staple cartridge (140) includes a cartridge body (142) having an upper side defining a first stapling surface in the form of a deck (156) having a plurality of staple openings (166) for accommodating a plurality of staples and corresponding staple drivers.

[0047] The bin half (12) further includes a clamping member (also referred to as a "clamping arm" or "latch lever") in the form of a clamping lever (40) pivotably coupled to the bin channel (16) using a clamping lever pivot pin (42) disposed generally aligned with the distal slot (24) of the bin channel side flange (22). The clamping lever (40) includes an elongated lever arm (44) having a free proximal end (46) and a distal end pivotably coupled to a lower portion of the bin channel (16) using the pivot pin (42). A pair of opposed jaws (48) extend distally from the distal end of the lever arm (44) beside the bin channel side flange (22). Each jaw (48) includes a curved slot (50) having a closed proximal end and an open distal end configured to receive a latch pin (68) of anvil half-section (14), as described below.

[0048] The clamping lever (40) is operable to pivot relative to the cartridge channel (16) between an open position and a closed position, wherein the proximal end (46) of the lever arm (44) is spaced apart from the cartridge channel frame portion (18) (as described below). 9A to 9C In the closed position, the proximal end (46) faces the bin channel frame portion (18) (as described below). Fig.9D Actuation of the clamping lever (40) from the open position to the closed position serves to capture the opposite side ends of the latch pin (68) within the clamping lever jaw slot (50) and thereby clamp the anvil half (14) against the cartridge half (12), as described below in conjunction with FIG. 9C to FIG. 9D As shown and described. In this regard, the curvature of each jaw slot (50) defines a corresponding upper cam surface and a lower cam surface, which are configured to engage the corresponding side ends of the latch pin (68) and pull it toward the bin channel (16) when the clamping lever (40) is pivotally closed. A resilient member shown in the form of a leaf spring (52) biases the lever arm (44) toward the open position. Therefore, when the clamping lever (40) is initially advanced from the closed position toward the open position, the leaf spring (52) promotes the clamping lever jaws (48) to disengage from the anvil half latch pin (68).

[0049] like Figure 2 As best shown, the clamping lever (40) further includes a latch member (54) disposed at the proximal end (46) of the lever arm (44). The clamping lever latch member (54) is configured to resiliently and releasably engage the proximal end of the bin channel frame portion (18), and thereby releasably retain the clamping lever (40) in a closed position, for example, when the stapler (10) is fired. The clamping lever latch member (54) may also be constructed in accordance with the teachings of U.S. Patent No. 11,278,285, entitled “Clamping Assembly for Linear Surgical Stapler,” issued on March 22, 2022, the disclosure of which is incorporated herein by reference.

[0050] The anvil half (14) of the linear surgical stapler (10) includes a second elongated member in the form of an elongated anvil channel (60), the elongated anvil channel having a proximal frame portion (62) and a distal jaw portion (64). The proximal frame portion (62) includes a pair of transversely opposite upright side flanges (66), which are configured to be received between the chamber channel side flanges (22) when the anvil half (14) is connected to the chamber half (12). A distal latch projection in the form of a latch pin (68) extends transversely through the distal end of the anvil channel side flange (66), and a proximal pivot projection in the form of a proximal pin (70) extends transversely through the proximal end of the anvil channel side flange (66). The anvil half pins (68, 70) are configured to facilitate the connection of the anvil half (14) with the chamber half (12), as described below.

[0051] like Figure 2 and Figure 3As shown, the distal jaw portion (64) of the anvil half (14) supports an anvil plate (72), which defines a second suturing surface in the form of an anvil surface having a plurality of staple forming recesses (74), which are configured to deform the legs of the staples ejected from the staple cartridge (140) when the stapler (10) is fired. The staple forming recesses (74) of this example can be formed via an embossing process and are configured to enable each staple in the staple cartridge (140) to form a three-dimensional shape, wherein the legs of each formed staple are laterally offset from each other to provide a non-planar shape for the formed staples, for example, as disclosed in U.S. Patent No. 11,229,433, entitled “Linear Surgical Stapler”, published on January 25, 2022, the disclosure of which is incorporated herein by reference. The anvil channel (60), anvil plate (72) and staple forming pockets (74) may be formed in one or more of the ways disclosed in the following patents: U.S. Patent No. 11,229,433; U.S. Patent No. 11,045,193, entitled "Anvil Assembly for Linear Surgical Stapler" issued on June 29, 2021; and / or U.S. Publication No. 2022 / 0142641, entitled "System and Method for Forming Pockets in Anvil of Surgical Stapler" issued on May 12, 2022, the disclosures of which are incorporated herein by reference. For example, the distal jaw portion (64) of the anvil half (14) may be preformed with a certain curvature along its length, which accommodates the deflection of the distal jaw portion (64) and the anvil plate (72) when the stapler halves (12, 14) are clamped together by the clamping lever (40). The distal jaw portion (64) of the anvil half (14) further supports a tapered distal tip member (76). In some versions, the distal tip member (76) can be selectively extended relative to the distal jaw portion (64) in accordance with the teachings of U.S. Patent No. 11,033,266, entitled "Decoupling Mechanism for Linear Surgical Stapler," issued on June 15, 2021, the disclosure of which is incorporated herein by reference.

[0052] like Figure 2As shown, the linear surgical stapler (10) also includes a pair of covers (56, 78), which cover the selected portion of the stapler (10) and enhance the operator's effective grip and manipulation of the stapler (10) during use. In this example, the clamping lever cover (56) is attached to and covers the outward-facing side of the clamping lever (40), so that the clamping lever cover (56) is configured to pivot relative to the bin channel (16) with the clamping lever (40). In addition, the anvil cover (78) is attached to and covers the outward-facing side of the anvil channel (60). In some versions, the anvil cover (78) can be connected to the anvil channel (60) via the interaction between the pin (68, 70) and one or more tabs, ribs or other structures, which are arranged in the interior of the anvil cover (78) and include an opening, a slot, a key hole or other feature configured to receive a corresponding one of the pins (68, 70). By way of example only, covers (56, 78) may be attached using one or more of the teachings of U.S. Patent No. 11,278,285, which is incorporated by reference above. In other versions, covers (56, 78) may be coupled to clamp lever (40) and anvil channel (60) in various other suitable ways as would be apparent to one of ordinary skill in the art in light of the teachings herein.

[0053] like Figure 2 and Figures 5 to 7 As best shown, the proximal end of the magazine half (12) includes a retaining assembly (80) that is configured to releasably retain the anvil half (14) and a portion of the firing assembly (110). The retaining assembly (80) of this example includes a first movable retaining member in the form of an anvil latch member (82) and a second movable retaining member in the form of a stop member (84). The anvil latch member (82) and the stop member (84) are rotatably coupled to the proximal end of the magazine channel (16) via a transversely extending pin (85) disposed proximal to the firing slot (32), and the members (82, 84) are resiliently biased in opposite rotational directions by a resilient member in the form of a torsion spring (86) positioned between the members (82, 84).

[0054] The anvil latch member (82) includes a central body (88), a latch finger (90) extending upwardly from the central body (88), and a release button (92) extending downwardly from the central body (88) through the base wall of the proximal frame portion (18) of the chamber channel (16). The upper end of the latch finger (90) tapers distally and is configured to releasably capture the proximal anvil pin (70) of the anvil half (14) with an angled latch surface (94) that covers the proximal anvil pin (70) once captured. The anvil latch member (82) also includes a pin ejection feature in the form of an angled protrusion (96) extending distally from the base portion of the latch finger (90) and defining an ejection cam ramp (98) facing the latch finger (90) proximally.

[0055] The stop member (84) of the proximal retention assembly (80) includes a generally cylindrical central body (100), a distal finger (102) extending distally from the central body (100), and a proximal hook (104) extending proximally from the central body (100). The distal finger (102) is configured to releasably engage the proximal end of the firing assembly (110) and thereby retain the firing assembly (110) in a proximal home position. The proximal hook (104) is configured to cover and capture the upper end of the clamp lever latch member (54) when the clamp lever (40) is fully closed and the firing assembly (110) is translated distally from its proximal home position, thereby preventing the clamp lever (40) from opening during the firing stroke, for example, as described in more detail in U.S. Pat. No. 11,278,285, which is incorporated by reference above.

[0056] In use, with the stapler halves (12, 14) coupled together at their proximal ends so that the proximal anvil pin (70) is retained by the anvil latch member (82), and with the clamping lever (40) in the open position, distal actuation of the lower release button (92) causes the anvil latch member (82) to rotate about the pin (85), causing the ejector cam ramp (98) to advance proximally to drive the proximal anvil pin (70) upwardly out of the proximal tapered recess (26) of the cartridge channel (16). The cartridge half (12) of this version also includes a stationary finger gripping projection (106) extending downwardly from the base wall of the proximal frame portion (18) of the cartridge channel (16) at a location distal to the lower release button (92) and configured to facilitate actuation of the release button (92). Specifically, the user can apply his or her thumb to the proximal side of the release button (92) and one or more fingers to the distal side of the finger gripping protrusion (106), and then squeeze the release button (92) distally toward the stationary finger gripping protrusion (106) to rotate the latch finger (90) out of engagement with the proximal anvil pin (70) and eject the pin (70) upward from the magazine channel (16) using the ejection cam ramp (98).

[0057] The retaining assembly (80) and associated components of the cartridge half (12) may be constructed and operated in accordance with the teachings of one or more of: U.S. Patent No. 10,898,187, entitled “Firing System for Linear Surgical Stapler,” issued on January 26, 2021; and / or U.S. Patent No. 11,033,266, which are incorporated by reference above.

[0058] like Figure 8As shown, the firing assembly (110) of the cartridge half (12) includes a slide (112), a pair of actuators (114, 116) (or "firing knobs") pivotably coupled to the slide (112), and a set of elongated beams (118, 122) extending distally from the slide (112). A pair of side beams (118) are coupled to the distal end of the slide (112) at their proximal ends and terminate distally in a pair of cam ramps (120). The cam ramps (120) are configured to engage the underside of a staple driver (not shown) contained in the staple cartridge (140) and actuate the staple driver (not shown) upward, thereby driving (or "firing") staples from the staple cartridge (140) into tissue clamped between the staple cartridge (140) and the anvil plate (72). The central beam (122) is coupled to the side beams (118) via a bridging member (124) (or "knife block") that is distally spaced from the slide (112). The central beam (122) terminates distally in a distally angled knife member (126) having a distal cutting edge (128) configured to cut tissue clamped between the distal portions of the stapler halves (12, 14).

[0059] Each actuator (114, 116) of the firing assembly (110) is configured to be rotatable relative to the slide (112) between a deployed position and a retracted position so that only one actuator (114, 116) can be deployed at a time, for example, as disclosed in U.S. Pat. No. 10,898,187, which is incorporated by reference above. In the deployed position, the actuator (114, 116) can be driven distally by an operator to actuate the firing assembly (110) to pass distally through the stapler (10), thereby simultaneously cutting and suturing the tissue clamped between the stapler halves (12, 14).

[0060] B. Exemplary Use of a Linear Surgical Stapler

[0061] 9A to 9E An exemplary coupling of stapler halves (12, 14) and subsequent firing of the assembled stapler (10) during a surgical procedure is shown. Fig. 9A As shown, the clamping lever (40) of the cartridge half (12) is set in the open position so that the jaw slot (50) is aligned with the vertical slot (24) of the cartridge channel side flange (22). In addition, the firing assembly (110) is retained in its proximal original position by the stop member (84) of the retaining assembly (80), as described above. Figure 5At this stage, the tissue portion to be stapled and cut (not shown) can be positioned above the top of the staple cartridge (140) disposed in the distal jaw portion (20) of the cartridge half (12). Alternatively, after the proximal ends of the stapler half (12, 14) described below are coupled, the tissue can be positioned above the staple cartridge (140).

[0062] like FIG. 9A to FIG. 9B As shown, the proximal ends of the stapler halves (12, 14) are aligned with each other, and the proximal anvil pin (70) is guided downwardly into the proximal conical recess (26) of the cartridge channel (16) to engage the latch finger (90) of the anvil latch member (82). This engagement forces the anvil latch member (82) to resiliently rotate clockwise, thereby enabling the latch finger (90) to capture the anvil pin (70) and thereby releasably couple the proximal ends of the stapler halves (12, 14) together, as shown in FIG. Fig. 9B As shown. When the clamping lever (40) is still in the Fig. 9B In the open position shown, the stapler (10) is arranged in a "hanging open" state so that the stapler (10) can be held by the anvil half (14) in one hand while the cartridge half (12) remains coupled to the anvil half (14). Fig. 9C As shown, and with the clamping lever (40) maintained in the open position, the anvil half (14) is rotated about the proximal anvil pin (70) toward the anvil half (14), so that the distal latch pin (68) of the anvil half (14) is received in the vertical slot (24) of the cartridge channel side flange (22) and the jaw slot (50) of the clamping lever (40). The distal jaw portions (20, 64) of the stapler half (12, 14) are now in a partially approximated state, allowing final adjustment of the tissue received therebetween before clamping.

[0063] like Fig.9D As shown, the clamping lever (40) is closed to pull the anvil latch pin (68) against the closed proximal end of the jaw slot (50), and thereby completely clamp the anvil half (14) against the magazine half (12), wherein tissue (not shown) is clamped between the suturing surfaces defined by the staple magazine (140) and the anvil plate (72). The tissue gap column (162) of the staple magazine (140) defines a small lateral gap between the staple magazine (140) and the anvil plate (72), thereby accommodating the tissue therebetween at a predetermined degree of tissue compression. Fig. 9A and Fig. 9B As shown, the tissue gap post (162) is disposed at the distal end of the staple cartridge (140) and is configured to be able to be stapled when the stapler (10) is in Fig.9DIn the fully clamped state shown, the distal end of the anvil plate (72) is in contact. In response to the clamping lever (40) reaching the fully closed position, the clamping lever latch member (54) can rotate to capture the proximal end of the base wall of the cartridge channel (16) and thereby assume a latched state in which the clamping lever latch member (54) maintains the clamping lever (40) in the closed position.

[0064] like Fig.9E As shown, when the fully clamped state is reached, the deployed actuator (114, 116) of the firing assembly (110) can be driven distally along the proximal frame portion (18) of the magazine half (12) to fire the stapler (10). This action causes the elongated beams (118, 122) of the firing assembly (110) to translate distally through the corresponding channels formed in the staple magazine (140), and thereby the staples are fired into the clamped tissue via the cam ramp (120) and the staple driver (not shown), while the clamped tissue is cut using the knife member (126). After completing the firing stroke, the firing assembly (110) returns to its proximal original position via the actuator (114, 116). The clamping lever latch member (54) can then be pressed down to release the proximal end of the clamping lever (40) from the magazine channel (16), thereby allowing the clamping lever (40) to reopen. Then, the release button (92) of the retaining assembly (80) can be depressed to release the anvil half (14) from the cartridge half (12), so that the stapler halves (12, 14) can be separated from each other, thereby releasing the newly sutured and severed tissue. It should be understood that in some versions, the stapler (10) may include additional features that facilitate the disengagement of the stapler halves (12, 14), for example, as disclosed in U.S. Patent No. 11,033,266, which is incorporated by reference above.

[0065] C. Linear surgical stapler with clamp load measurement capability

[0066] As described above, the anvil latch pin (68) of the anvil half (14) is received in the curved slot (50) of the jaws (48), so that the clamping lever (40) can be pivoted from the open position toward the closed position, thereby clamping the anvil half (14) toward the magazine half (12) to grasp the tissue. In addition, the grasped tissue between the suturing surface of the nail magazine (140) and the anvil plate (72) can be cut and sutured.

[0067] In some cases, the tissue grasped and clamped between the staple cartridge (140) and the anvil plate (72) may be too thick, so that an undesirably large gap distance (d) is defined between the staple forming recess (74) of the anvil plate (72) and the platform (156) of the cartridge (140). If the gap distance (d) is too large, the staples fired from the staple cartridge toward the anvil plate (72) may not be properly formed, either resulting in poorly formed staples or "open" staples, both of which fail to properly engage the staple forming recess (74) of the anvil plate (72). In the case where the grasped tissue produces a large gap distance (d), the distal jaw portion (64) of the elongated anvil channel (60) and the components for clamping the distal jaw portion (64) (e.g., the clamping lever (40)) need to withstand a larger closing force in order to clamp thicker tissue than when clamping appropriate tissue thickness. Thus, when clamping tissue in accordance with the teachings herein, it may be desirable to monitor parameters indicative of a high closing force being exerted on distal jaw portion (64) in order to determine and / or indicate the risk of poorly formed staples or split staples.

[0068] As described above, the clamping lever (40) is used to drive the distal jaw portion (64) of the elongated anvil channel (60) to clamp tissue via engagement between the curved slot (50) of the jaw (48) and the anvil latch pin (68) of the anvil channel (60). Fig. 9C The position shown is driven to Fig.9D In the latched condition shown, the jaws (48) and other components of the clamping lever (40) are subject to forces associated with the clamping load exerted on the distal jaw portion (64) via the clamped tissue.

[0069] The forces experienced by the components of the jaws (48) and clamping lever (40) may result in strain deformation. The strain deformation value of the jaws (48) may indicate the closing force acting on the distal jaw portion (64) during exemplary use according to the teachings herein. As described above, if this closing force is too high, this may indicate an excessive gap distance (d) caused by excessively thick tissue.

[0070] Fig.10 An alternative exemplary linear surgical stapler (210) is shown, which is substantially similar to the above-mentioned linear surgical stapler (10), and the differences are described in detail below. Therefore, the linear surgical stapler (210) includes a magazine half (12'), anvil half 14, an elongated magazine channel (16), anvil channel (60), a firing assembly (110) and a replaceable staple magazine (140). The magazine half (12') is substantially similar to the above-mentioned magazine half (12), except that the magazine half (12') includes an alternative clamping lever (240) that replaces the above-mentioned clamping lever (40).

[0071] The clamping lever (240) is substantially similar to the clamping lever (40) described above, except that the differences are described in detail below. Thus, the clamping lever (240) includes a clamping lever pivot pin (242), an elongated lever arm (244), a free proximal end (246), a pair of opposing jaws (248) each defining a curved slot (250), a leaf spring (252), a latch member (254), and a cover (256); these components are substantially similar to the clamping lever pivot pin (42), the elongated lever arm (44), the free proximal end (46), the opposing jaws (48), the curved slot (50), the leaf spring (52), the latch member (54), and the cover (56) described above, respectively.

[0072] In addition, the clamping lever (240) includes a clamping lever strain measurement assembly (260). As will be described in more detail below, the clamping lever strain measurement assembly (260) is configured to be able to Fig. 12A The open position shown is pivoted to Fig. 12B The clamping lever (240) is provided with a clamping lever (240) and a control console (202) configured to measure the strain on at least one jaw (248) of the clamping lever (240) adjacent to the anvil latch pin (68) when in the closed position shown so as to clamp tissue during exemplary use. The strain measured on the jaw (248) of the clamping lever (240) can indicate the closing force acting on the distal jaw portion (64) when clamping tissue. In addition, the clamping lever strain measurement assembly (260) and / or the surgeon's console (202) are configured to compare the measured strain with one or more predetermined limit values ​​and determine / communicate the risk of improperly formed / opened nails based on the comparison.

[0073] Surgeon's console (202) may include a visual display that may be referenced by the surgeon during the surgical procedure. Console (202) may display appropriate information to the surgeon during the procedure. Console (202) may include the necessary computing power, storage, communication devices, display features, etc., as will be apparent to those skilled in the art in view of the teachings herein.

[0074] Steering Fig.11 , the clamping lever strain measurement assembly (260) includes a strain gauge (262) and an electronic unit (265) that are operably connected to each other via one or more electronic communication lines (264). The strain gauge (262) is suitably attached to a portion of the jaws (248) that defines the curved slot (250) such that the strain gauge (262) is positioned along a portion of the jaws (248) adjacent to the anvil latch pin (68) during exemplary tissue clamping in accordance with the teachings herein. The strain gauge (262) is configured to measure a strain value at a corresponding portion of the jaws (248) in response to the jaws (248) driving the anvil latch pin (68) into a clamping configuration (see Fig. 12B ). It should be understood that a greater clamping force required to properly grasp the tissue will result in a greater measured strain value; while a smaller clamping force required to properly grasp the tissue will result in a smaller strain value. The strain gauge (262) may include any suitable components and geometries, as would be apparent to one skilled in the art based on the teachings herein. In addition, the strain gauge (262) may be attached to the jaws (248) of the clamping lever (240) using any suitable manner, as would be apparent to one skilled in the art based on the teachings herein. Although one strain gauge (262) on one jaw (248) is used in the current example, any suitable number of strain gauges (262) may be used on one or both jaws (248), as would be apparent to one skilled in the art based on the teachings herein.

[0075] Deviations in strain measurements of the jaws (248) in response to actuating the elongated anvil (60) to grasp and clamp tissue may be greatest (i.e., more pronounced) at the portion of the jaws (248) adjacent the curved slot (250) that engages the anvil latch pin (68). Thus, strain gauges (262) located at or around the portion of the jaws (248) adjacent the curved slot (250) may provide the benefit of measuring strain deviations that are associated with or strongly indicative of the clamping lever (40) actuating the anvil channel (60) into a clamped configuration during exemplary use as described herein.

[0076] As described above, the strain gauge (262) is in operative communication with the electronic module (265) via the electronic communication line (264). Thus, the communication line (264) extends along the elongated lever arm (244) between the strain gauge (262) and the electronic module (265). The strain gauge (262) is configured to communicate a strain signal indicative of a measured strain value to the electronic module (265).

[0077] The electronics unit (265) is received within an internal recess (245) defined by the elongated lever arm (244). The electronics unit (265) is positioned within the internal recess (245) such that when the clamping lever (240) is moved relative to the proximal frame portion (18) from an open position (see Fig. 12A ) pivots to the closed position (see Fig. 12B ), the electronic unit (265) will not be damaged by contact with other components of the linear surgical stapler (210). The electronic unit (265) can be coupled to the elongated lever arm (244) via any suitable means, as will be apparent to those skilled in the art based on the teachings herein.

[0078] The electronic unit (265) includes a control unit (266), a wireless transmitter (268), and a battery (270), each of which communicates appropriately with each other. The battery (270) is configured to be able to power the necessary components of the anvil strain measurement assembly (260). The battery (270) may include any appropriate components, as will be apparent to those skilled in the art based on the teachings herein. In some cases, the battery (270) may be connected to a switch (or other appropriate mechanism) that is configured to selectively activate the battery (270) so that the user can selectively activate the anvil strain measurement assembly (260). Such a switch may be present on the outer surface of the electronic unit (265) or in any other appropriate location. Thus, the user may activate the clamping lever strain measurement assembly (260) prior to illustrative use. Of course, the battery (276) may be configured to be able to activate the clamping lever strain measurement assembly (260) in response to any other appropriate activation method, as will be apparent to those skilled in the art based on the teachings herein.

[0079] The control unit (266) is configured to appropriately process the measured strain from the strain gauge (262) as described herein, and the wireless transmitter (268) is configured to appropriately transmit information (e.g., the measured strain received by the control unit (266)) between the control unit (226) and the surgeon's console (202). The control unit (266) and the wireless transmitter (268) include any appropriate electronic components necessary to perform the functions described herein. The control assembly (224) may include a printed circuit board (PCB), appropriate memory, and / or appropriate processing devices to function as described herein. The wireless transmitter (268) may include a Bluetooth transmitter, or any other appropriate wireless technology, as would be apparent to one of ordinary skill in the art based on the teachings herein.

[0080] The first predetermined limit value stored on the control unit (266) may instruct the clamping lever (40) to apply the necessary clamping force to clamp tissue having a maximum acceptable tissue thickness associated with a generally acceptable maximum gap distance. If the measured strain value from the strain gauge (262) is above the first predetermined limit value, this may instruct the platform 156 (see Fig. 12B ) and the anvil plate (72) is too thick and produces a gap distance (d) that is greater than the maximum gap distance that is generally acceptable. In other words, if the measured strain value is above the first predetermined limit, this may indicate that the fired nail has an unacceptable high risk of poorly formed or opened.

[0081] The control unit (266) may store predetermined limits for the surgical stapler (210) and communicate the predetermined limits to the surgeon's console (202) via a wireless transmitter (268) so that the surgeon's console (202) can utilize the predetermined limits as described herein. Additionally or alternatively, the control unit (266) may utilize the predetermined limits from the storage and process the measured strain from the strain gauge (262) as described herein. In this case, the control unit (266) may pass its calculations to the surgeon's console (202) for display to the user. However, in other cases, the surgeon's console (202) may already have preloaded predetermined limits, so that the predetermined limits do not necessarily need to be communicated from the control unit (266) to the console (202).

[0082] FIG. 12A to FIG. 12B An exemplary use of a surgical stapler (210) for clamping tissue is shown, and Fig.14 An exemplary method 1000 of a clamping lever strain measurement assembly (260) and a console (202) is shown, which determines whether there is an appropriate gap distance (d) that makes the risk of poorly formed / open firing of nails lower; or whether there is an inappropriate gap distance (d) that makes the risk of poorly formed / open firing of nails higher. First, the user can clamp the tissue (1002) between the platform (156) of the nail magazine (140) and the anvil plate (72) of the elongated anvil channel (60) by utilizing the clamping lever (240) in accordance with the teachings of this article. In this case, the anvil latch pin (68) is driven into the clamping configuration via appropriate engagement with the curved slot (250) defined by the relative jaws (248) of the clamping lever (240). As described above, generally, thicker clamped tissue will result in a larger clamping force (and a larger strain on the anvil channel (60)) and a larger gap distance (d) between the anvil plate (72) and the platform (156).

[0083] When the tissue is properly clamped, the strain gauge (222) of the anvil strain measurement assembly (220) measures (1004) the resulting strain on the portion of the jaws (248) adjacent to the curved slot (250) that accommodates the anvil latch pin (68). The measured (1004) strain is communicated to the electronic module (265) so that the control unit (266) receives the measurement. The control unit (266) can then transmit the measurement to the wireless transmitter (268), which in turn wirelessly communicates (1006) the measurement to the surgeon's console (202). Next, the console (202) can process the received measurement by comparing (1008, 1012) the measured strain from the strain gauge (262) to a predetermined limit stored on the console (202). In this example, the console (202) determines whether the measured strain exceeds a predetermined limit (1008) and / or determines whether the measured strain is within a predetermined limit (e.g., below a predetermined limit) (1012). If the measured strain is above the predetermined limit, the console (202) communicates to the user (1010) that there is a high risk of poorly formed and / or split nails if the user actuates the firing assembly (110) in the current clamping state. Similarly, if the measured strain is outside the predetermined limit, the console (202) communicates to the user (1010) that there is a high risk of poorly formed and / or split nails if the firing assembly (110) is actuated distally (e.g., fired) in the current clamping state. However, if the measured strain is below a predetermined limit and / or within a predetermined range, the console (202) communicates (1014) to the user to actuate (e.g., fire) the firing assembly (110) distally in the current clamped state, and there is a low risk of a poorly formed and / or split nail.

[0084] In this exemplary use, it should be understood that the control unit (266) may transmit the item-specific predetermined limits determined during assembly of the particular item and stored on the control unit (266) to the surgeon's console (202). In some cases, the surgeon's console (202) and / or the control unit (266) may already have universal predetermined limits stored in association with the brand and model of the surgical stapler. Although the console (202) performs the comparisons (1008, 1012) in the current example, it should be understood that in some cases, the control unit (266) may perform these comparisons and communicate the results to the console (202) for display to the user.

[0085] In some cases, it may be desirable to modify an existing linear surgical stapler (10) to be operable in conjunction with a surgeon's console (202) to determine a low or high risk of poorly formed and / or open staple formation when the user-actuated assembly (110) is under such a clamping load. For example, it may be desirable to apply a measurement assembly to a linear surgical stapler (10) in preparation for a surgical procedure, the measurement assembly being configured to communicate with the surgeon's console (202) during illustrative use to provide feedback based on a measured clamping load detected by the measurement assembly. In some cases, such application of the measurement assembly may occur at or near the location of the intended surgical procedure prior to the surgical procedure being performed.

[0086] Figures 14 to 15B An exemplary clamping force measurement assembly (360) is shown, which is configured to be connected to a linear surgical stapler (10) so as to modify the stapler (10) for exemplary use with a surgeon's console (202). The force measurement assembly (360) is configured to measure appropriate parameters indicating the closing force of the distal jaw portion (64) and / or the gap distance (d) between the platform (156) and the anvil plate (72) once assembled on the linear surgical stapler (10). In addition, the clamping force measurement assembly (360) is configured to communicate the measurement results to the surgeon's console (202) so that information related to such measurement results (e.g., the risk level of poorly formed / open nail formation) is displayed to the user.

[0087] The clamping force measurement assembly (360) includes a sensor unit (362) operably attached to an electronics unit (365) housed within a flexible sleeve (372). The sensor unit (362) is attached to the flexible sleeve (272) via a coupling body (363). The sensor unit (362) operably communicates with the electronics unit (365) via an electronic communication line (364) extending between the sensor unit (362) and the electronics unit (365) via the coupling body (363). The coupling body (363) can be rigid, semi-rigid, flexible, elastically flexible, etc. The coupling body (363) ensures that the sensor unit (362) remains in operably electrical communication with the electronics unit (365). When the measurement assembly (360) is properly coupled to the clamping lever (40), the coupling body (363) extends within the interior of the elongated lever arm (44).

[0088] The flexible sleeve (372) defines a through hole (374). The through hole (374) of the flexible sleeve (372) is sized to fit over the free proximal end (46) of the clamping lever (40). FIG. 15A to FIG. 15BAs shown, to couple the measurement assembly (360) to the clamping lever (40), the user may insert the flexible sleeve (372) over the proximal end (46) of the clamping lever (40) and slide the flexible sleeve (372) distally until the sensor unit (362) engages the appropriate components of the linear stapler (10) according to the description herein. Fig. 15B As shown, the inner surface of the flexible sleeve (372) defining the through hole (374) is configured to engage a portion of the clamping lever (40) with sufficient friction braking force to facilitate coupling of the sleeve (372) with the clamping lever (40) once inserted to a desired longitudinal position along the length of the clamping lever (40). In this example, the flexible sleeve (372) is formed of an elastomeric material that facilitates friction braking force with the engaging portion of the clamping lever (40). In addition, the flexible sleeve (372) defines an internal chamber that houses the electronic unit (365).

[0089] The electronic unit (365) is substantially similar to the electronic unit (265) described above. Thus, the electronic unit (365) includes a control unit (366), a wireless transmitter (368), and a battery (370); these components are substantially similar to the control unit (266), the wireless transmitter (268), and the battery (270) described above, respectively. Thus, the control unit (366) may store one or more predetermined limit values ​​indicating the maximum acceptable gap distance (d); and the wireless transmitter (368) establishes communication with the console (202).

[0090] The sensor unit (362) includes a first leg (382) and a second leg (384), each leg being coupled to the sensor (380). The first leg (382) is configured to be selectively coupled to the underside of the proximal frame portion (18) when the measurement assembly (360) is operably attached to the stapler (10). The second leg (384) is configured to be selectively coupled to the leaf spring (52) of the clamping lever (40) when the measurement assembly (360) is operably attached to the stapler (10). The legs (382, 384) are configured to pivot relative to each other in response to the clamping lever (40) pivoting around the lever pivot pin (42) once the measurement assembly (360) is properly coupled to the stapler (10) so as to clamp tissue according to the description herein. Each leg (382, 384) is in operably communication with the sensor (380). The sensor (380) is configured to measure appropriate parameters indicative of the gap distance (d) and / or the closing force applied to the distal jaw portion (64) when clamping tissue. The sensor (380) communicates the measurement results to the electronic unit (365) via the electronic communication line (364).

[0091] As an example, the sensor (380) may measure the angle between the legs (382, 384), as the angle between the legs (382, 384) indicates the angle between the clamping lever (40) and the proximal frame portion (18). Since the angle between the clamping lever (40) and the proximal frame portion (18) is also indicative of the gap distance (d), such a measurement may be used to determine whether the gap distance (d) is within an acceptable range for proper formation of a nail (i.e., if the firing assembly (110) is actuated distally with the determined gap distance (d), the risk of a poorly formed or split nail is low). A predetermined limit value indicating a maximum acceptable gap distance (d) associated with the angle between the clamping lever (40) and the proximal frame portion (18) may be used in such examples.

[0092] As another example, the sensor (280) can be configured to measure the relative force applied to the legs (382, 384) when the clamping lever (40) is used to clamp tissue. The force acting on the clamping lever (40) when clamping tissue is related to the closing force acting on the distal jaw portion (64). Such measurements can be used to determine whether the gap distance (d) is within an acceptable range for proper formation of the nail (i.e., if the firing assembly (110) is actuated distally with the determined gap distance (d), the risk of poorly formed or open nails is low). The sensor (380) can have any suitable components, as will be apparent to those skilled in the art based on the teachings herein. The sensor (380) can include a strain gauge sensor, an angle sensor, a tilt sensor, etc. A predetermined limit value associated with the force acting on the clamping lever (40) indicating the maximum acceptable gap distance (d) can be used in such examples.

[0093] FIG. 16A to FIG. 16B An exemplary use of a surgical stapler (10) and a clamping lever force measurement assembly (360) for clamping tissue is shown, and Fig.17An exemplary method 1100 of a clamping lever force measurement assembly (360) and a console (202) is shown, which determines whether there is an appropriate gap distance (d) that makes the risk of poorly formed / open firing of nails lower; or whether there is an inappropriate gap distance (d) that makes the risk of poorly formed / open firing of nails higher. First, the user can clamp the tissue (1102) between the platform (156) of the nail magazine (140) and the anvil plate (72) of the elongated anvil channel (60) by utilizing the clamping lever (40) in accordance with the teachings of this article. In this case, the anvil latch pin (68) is driven into the clamping configuration via appropriate engagement with the curved slot (50) defined by the relative jaws (48) of the clamping lever (40). As described above, generally, thicker clamped tissue will result in a larger clamping force (and result in a larger strain on the anvil channel (60)) and a larger gap distance (d) between the anvil plate (72) and the platform (156).

[0094] When the tissue is properly clamped, the sensor (380) of the sensor unit (362) measures (1104) the resulting force of the clamping lever (40) and / or the angle between the clamping lever (40) and the proximal frame portion (18). The measured (1104) force and / or angle is communicated to the electronic module (365) so that the control unit (366) receives the measurement. The control unit (366) can then transmit the measurement to the wireless transmitter (368), which in turn wirelessly communicates (1106) the measurement to the surgeon's console (202). Next, the console (202) can process the received measurement by comparing (1108, 1112) the measured strain from the sensor unit (362) to predetermined limits stored on the console (202).

[0095] In this example, the console (202) determines whether the measured parameter exceeds a predetermined limit (1108) and / or determines whether the measured parameter is within a predetermined limit (e.g., below a predetermined limit) (1112). If the measured parameter is above the predetermined limit, the console (202) communicates (1110) to the user that there is a high risk of poorly formed and / or split nails if the user actuates the firing assembly (110) in the current clamping state. Similarly, if the measured parameter is outside the predetermined limit, the console (202) communicates (1110) to the user that there is a high risk of poorly formed and / or split nails if the firing assembly (110) is actuated distally (e.g., fired) in the current clamping state. However, if the measured parameters are below predetermined limits and / or within a predetermined range, the console (202) communicates (1114) to the user to actuate (e.g., fire) the firing assembly (110) distally in the current clamped state, and there is a low risk of a poorly formed and / or split nail.

[0096] In this exemplary use, it should be understood that the control unit (366) may transmit the item-specific predetermined limits determined during assembly of the particular item and stored on the control unit (366) to the surgeon's console (202). In some cases, the surgeon's console (202) and / or the control unit (366) may already have universal predetermined limits stored in association with the brand and model of the surgical stapler. Although the console (202) performs the comparisons (1108, 1112) in the current example, it should be understood that in some cases, the control unit (366) may perform these comparisons and communicate the results to the console (202) for display to the user.

[0097] FIG. 18A to FIG. 20B An exemplary anvil strain measurement assembly (460) is shown, which is configured to be connected to a linear surgical stapler (10) to form a modified stapler (10') for exemplary use with a surgeon's console (202). The anvil strain measurement assembly (460) is configured to measure the strain along the length of the distal jaw portion (64) once assembled on the linear surgical stapler (10). The measured strain indicates the closing force distribution along the length of the distal jaw portion (64); this may also indicate the gap distance (d) between the platform (156) and the anvil plate (72). In addition, the anvil strain measurement assembly (460) is configured to communicate the measurement results to the surgeon's console (202) so that information related to such measurement results (e.g., the risk level of poorly formed / open nail formation) is displayed to the user.

[0098] The anvil strain measurement assembly (460) includes a distal strain gauge portion (462) and a proximal electronic unit (480) stored within a housing (490). The distal strain gauge portion (462), the proximal electronic unit (480), and the housing (490) are attached to each other to form an integral device. The proximal electronic unit (480) is substantially similar to the above-described electronic unit (265, 265). Thus, the electronic unit (480) includes a control unit (482), a wireless transmitter (484), and a battery (486); these components are substantially similar to the above-described control unit (266, 366), wireless transmitter (268, 368), and battery (270, 370), respectively.

[0099] The distal strain gauge portion (462) includes a plurality of strain gauges (464), a plurality of flexible circuits (466), an outer coating (468), and an adhesive (470). The outer coating covers at least the outer surface of the strain gauges (464), and the flexible circuits (466) extend along the outer coating (468). The flexible circuits (466) are coupled to respective strain gauges (464) and extend to communicate with the proximal electronics unit (480). The flexible circuits (466) provide communication between the respective strain gauges (464) and the electronics unit (480), thereby allowing the electronics unit (480) to communicate measurements received from the strain gauges (464) and to send appropriate information related to such received measurements to the surgeon's console (202).

[0100] When the anvil strain measurement assembly (460) is properly coupled to the linear stapler (10) to form a modified linear stapler (10'), the strain gauges (464) are properly attached to corresponding portions of the distal jaw portion (64) such that the array of strain gauges (464) extends along the length of the distal jaw portion (64) and on corresponding lateral sides of the distal jaw portion (64), as shown in FIG. Fig.19 Strain gauge (464) is configured to measure strain within a corresponding portion of distal jaw portion (64) when properly coupled. Such measured strain is indicative of the closing force applied to distal jaw portion (64) when clamping tissue in accordance with the teachings herein.

[0101] The outer coating (468) extends along the length of the strain gauge portion (262) and is connected to the housing (490) such that the housing (490) and the coating (468) form an outer surface. As described above, the bottom side of the distal strain gauge portion (462) includes an adhesive (470), which can be in the form of an adhesive layer. The adhesive (470) can also extend over the underside of the housing (490) to selectively couple the housing (490) to an adjacent portion of the hood (78). Thus, as described above, the outer coating (468) can be attached to the housing (490) and the outer coating (468) can be attached to the housing (490). FIG. 18A to FIG. 18BAs shown in the figure, the underside of the housing (490) is placed on the top of the proximal portion of the cover (78); at the same time, the underside of the strain gauge portion (62) is placed on the top surface of the distal jaw portion (64), so that the adhesive at least fixes (at least temporarily, for illustrative purposes) the anvil strain measurement assembly (460) to the corresponding portions of the distal jaw portion (64) and the cover (78). Once the anvil strain measurement assembly (460) is properly attached to the linear stapler (10), thereby forming the modified linear stapler (10'), the strain gauge (462) is properly engaged with the distal jaw portion (64) to measure the strain within the corresponding portion of the jaw portion (64) when clamping tissue according to the description herein.

[0102] Although the currently illustrated example shows that the anvil strain measurement assembly (460) is configured to be selectively attached to a component of the linear stapler (10) to form a modified linear stapler (10'), it should be understood that the clamping force measurement assembly (460) can be integrated with the surgical stapler (10') so that no additional components are required after manufacturing (i.e., the measurement force assembly (460) is manufactured as an integral component of the stapler (10')). In this case, the housing (490) can be an integral component of the cover (78) or other suitable component of the linear stapler (10), as will be apparent to those skilled in the art based on the teachings of this document.

[0103] As described above, the electronics unit (480) is configured to transmit measurements received from the strain gauges (464) to the surgeon's console (202). Because multiple strain gauges (464) are positioned along the length of the distal jaw portion (64) and on the lateral sides of the distal jaw portion (64), the console (202) can use such data to display the clamping load at different locations of the distal jaw portion (64). For example, the surgeon's console (202) can receive strain measurements from the strain gauges (464) during exemplary use (e.g., when the stapler (10') clamps tissue), interpret the measurements as the clamping load applied to the distal jaw portion (64), and display the results on the digital representation (410) of the anvil plate (72) (see Fig.21 ) to visually display the clamping load.

[0104] FIG. 20A to FIG. 20B An exemplary use of a modified linear stapler (10') is shown, and Fig. 22 The use of a modified linear stapler (10') and a surgeon's console (202) to visually display the Fig.21 An exemplary method 1200 of graphically representing active clamping loads on anvil plate (72) is shown.

[0105] First, prior to exemplary use, the electronics unit (480) may establish appropriate communications with the console (202) via the wireless transmitter (484). During exemplary use, the surgical stapler (10') may be used to clamp tissue (1202) as described herein, such as FIG. 20A to FIG. 20B As shown. The strain gauge (464) measures (1204) the strain value at the corresponding position on the distal anvil jaw (64). The measured (1204) strain is communicated from the strain gauge (464) to the electronic unit (480) via the flexible circuit (466), and the electronic unit (480) then communicates (1206) the measured strain to the surgeon's console (202). The surgeon's console (202) then calculates (1208) the pressure distribution based on the measured (1204) strain, and displays (1211) the pressure distribution of the anvil plate (72) to the surgeon via the display of the console (202).

[0106] As mentioned above, Fig.21 An illustrative digital representation (410) of the pressure distribution (420) on the anvil plate (72) clamping tissue is shown. The current visual digital representation (410) shows the pressure distribution (410) of the acceptable clamping load (415) along the basic length of the anvil plate (72), with a relatively higher clamping load (420) along the more distal portion of the anvil plate (72). In addition, one lateral side of the anvil plate (72) is shown as experiencing a higher than desired clamping load (414), and an unacceptable clamping load (416) on one lateral side of the anvil plate (72) at the distal end. This may indicate that the stapler (10') is grasping tissue that is too thick or a foreign object that is not intended to be clamped, such as a previously fired staple. Thus, the user can view Fig.21 The exemplary numerals shown indicate (410) and attempt to re-clamp the tissue in order to achieve a more desired pressure distribution (420).

[0107] The console (202) may additionally or alternatively display any appropriate information or notification, as will be apparent to those skilled in the art based on the teachings herein. For example, the console (202) may display a suggestion to fire the stapler (10') or a suggestion to re-clamp the tissue; display the chance of successful staple formation based on the current pressure distribution, etc. The console (202) may alert the user based on such calculations.

[0108] The control unit (482) may include appropriate calibration information associated with the strain gauge (464) for a particular surgical stapler (10) (e.g., when the anvil strain measurement assembly (60) is integrated into the surgical stapler); or may include general calibration information for the strain gauge (464) for a specific configuration or model of the surgical stapler (10). In some cases, the surgeon's console (202) may include general calibration information for a specific configuration or model of the surgical stapler (10).

[0109] Fig.23 An exemplary piezoelectric sensor assembly (500) is shown. The sensor assembly (500) includes a first layer (502) and a second layer (504). Each layer (502, 504) includes a base player (510) and a plurality of arrays consisting of respective channels (512, 516), each channel having a respective array of piezoelectric sensors (514, 518) connected in series with each other via wiring (515). The arrays of channels (512, 516) are layered such that their channels (512, 516) are orthogonal with respect to each other and the sensors (514, 518) are aligned, such as Fig.23 As shown. Each channel (512, 516) is provided with a current source. The voltage drop across each channel (512, 516) determines the resistance characteristics of the corresponding sensor (514, 518). The force position can be identified on two axes by channel measurement. Aligning the position of the sensor with the nail pressure point can help identify successful and unsuccessful nail firing. These sensors can be placed on the side of the nail magazine or as an additional layer. The sensor array can also be used to determine changes in tissue thickness in the area of ​​interest. These measurements can inform the user about the potential quality of activation or suturing.

[0110] FIG. 24A to FIG. 24B An alternative surgical stapler (610) substantially similar to the above-described surgical staplers (10, 210, 310, 410) is shown, with the differences being described in detail below. The surgical stapler (610) includes a cartridge half (612), an anvil half (614), a clamping lever (640), a jaw (648), an anvil pin (668), and a cover (678); these components are substantially similar to the above-described cartridge half (12), anvil half (14), a clamping lever (40), a jaw (48), anvil pin (68), and a cover (678). The surgical stapler (610) also includes a Hall effect sensor (652) associated with the cover (678) and a magnet (650) associated with the jaw (650). The Hall effect sensor (652) communicates with an electronic unit (not shown) substantially similar to the above-described electronic unit (265, 365, 480). Thus, measurements obtained by Hall Effect sensor (652) may be communicated to the surgeon's console (202) via an electronics unit (not shown).

[0111] According to the description herein, when the clamping lever (640) is actuated toward the anvil half (614), the Hall effect sensor (652) can sense the position of the magnet (650). The position of the magnet (650) relative to the Hall effect sensor (652) indicates the gap distance (d) between the distal portion of the magazine half (612) and the anvil half (614). Therefore, the console (202) can use the measurement results from the Hall effect sensor (652) to determine whether there is an appropriate gap distance (d) before actuating the firing assembly of the stapler (610). The console (202) can warn the user of acceptable or unacceptable gap distances (d) based on the measurement results of the Hall effect sensor (652).

[0112] As described above, article-specific predetermined limits (e.g., predetermined strain limits) may be utilized to determine whether the risk of poorly formed or open staples is unacceptably high when clamping tissue according to the teachings herein. Such article-specific predetermined limits may be determined using an appropriate calibration process. Such a calibration process may include clamping a load cell with a surgical stapler (10, 210, 310, 410, 610) at an acceptable gap distance and / or force, measuring appropriate parameters with a sensor (262, 362, 464, 652), and using the measured appropriate parameters to calculate a specific predetermined limit when clamping the load cell at an acceptable gap distance and / or force.

[0113] II. Exemplary Combinations

[0114] 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 envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned 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 explicitly indicated by the inventor or the successor with an interest in the inventor 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.

[0115] Example 1

[0116] A device comprising: (a) a first elongated member having a distal portion configured to present a first suturing surface; (b) a second elongated member having a distal portion configured to present a second suturing surface, wherein the first elongated member and the second elongated member are configured to be releasably coupled together so that the first suturing surface and the second suturing surface cooperate to clamp tissue and suturing the tissue with a plurality of staples; and (c) a clamping member, wherein the clamping member is movable from a first position to a second position relative to the first elongated member and the second elongated member to approach the first suturing surface. and the second suturing surface to clamp tissue; (d) a latching member, the latching member being configured to transition from an unlatched state to a latched state to releasably hold the clamping member in the second position; (e) a firing assembly, wherein the firing assembly is actuable from an original position to fire the staple into the clamped tissue; and (f) a clamping force measuring assembly, wherein the clamping force measuring assembly is configured to: (i) measure parameters associated with the clamping force applied to the first and second suturing surfaces of the clamped tissue, and (ii) process and communicate the measured parameters for comparison with predetermined limits associated with successful staple formation.

[0117] Example 2

[0118] A device as in Example 1, wherein the clamping force measurement assembly includes a strain gauge attached to the latch member, wherein the measured parameter includes a strain measurement result.

[0119] Example 3

[0120] A device as described in Example 2, wherein the latch member includes a jaw defining a slot, wherein the strain gauge is directly adjacent to the portion of the jaw defining the slot.

[0121] Example 4

[0122] A device as described in Example 3, wherein the clamping force measurement assembly includes an electronic unit in communication with the strain gauge, wherein the electronic unit is configured to receive the measured strain from the strain gauge.

[0123] Example 5

[0124] The device of any one or more of embodiments 1 to 4, wherein the electronic unit includes a battery configured to power the strain gauge.

[0125] Example 6

[0126] The device according to any one or more of embodiments 1 to 5, wherein the electronic unit includes a wireless transmitter configured to communicate the processed measurement parameters to a surgeon's console.

[0127] Example 7

[0128] A device as described in Example 1, wherein the clamping force measurement assembly is configured to be selectively attached to the latch member.

[0129] Example 8

[0130]

[0046] The apparatus of embodiment 1 or embodiment 7, wherein the clamping force measurement assembly includes a sleeve housing an electronics unit.

[0131] Example 9

[0132] The apparatus according to embodiments 7 to 8, wherein the clamping force measurement assembly includes a first leg and a second leg, wherein the parameter includes a measured angle between the first leg and the second leg.

[0133] Example 10

[0134] A device as described in Example 8, wherein the clamping force measurement assembly includes a first leg and a second leg, wherein the parameter includes a force applied to either the first leg or the second leg.

[0135] Embodiment 11

[0136] The apparatus of claim 1, wherein the clamping force measurement assembly comprises a strain gauge assembly attached to a top surface of the first elongated member.

[0137] Example 12

[0138] A device as in Example 11, wherein the clamping force measurement assembly is further configured to measure a plurality of strain gauges along the top surface of the first elongated member.

[0139] Embodiment 13

[0140] A device as described in Example 11, wherein the plurality of strain gauges are configured to be selectively attached to the top surface of the first slender member.

[0141] Embodiment 14

[0142] The apparatus according to any one or more of embodiments 1 to 13, wherein the clamping force measurement assembly includes an electronic unit.

[0143] Embodiment 15

[0144] The device according to embodiment 14, wherein the electronic unit includes a control unit, a wireless transmitter and a battery, wherein the battery is configured to be able to supply power to the control unit and the wireless transmitter.

[0145] Example 16

[0146] A device comprising: (a) a first elongated member having a distal portion configured to present a first suturing surface; (b) a second elongated member having a distal portion configured to present a second suturing surface, wherein the first elongated member and the second elongated member are configured to be releasably coupled together at their proximal ends so that the first suturing surface and the second suturing surface cooperate to clamp tissue and suturing the tissue with a plurality of staples; (c) a clamping member, wherein the clamping member is movable from an open position to a closed position relative to the first elongated member and the second elongated member to approach the first suturing surface and the second suturing surface to clamp tissue; and (d) a strain measurement assembly configured to measure a strain value associated with either the first elongated member or the clamping member, wherein the strain measurement assembly is configured to communicate the measured strain to a console, the console being configured to generate a signal indicating whether a gap distance between the first suturing surface and the second suturing surface is within a predetermined range.

[0147] Embodiment 17

[0148] A device as described in Example 16, wherein the strain measurement assembly includes a control unit configured to generate the signal.

[0149] Embodiment 18

[0150] A device as described in Example 17, wherein the strain measurement assembly includes a battery configured to supply power to the control unit.

[0151] Embodiment 19

[0152]

[00136] In accordance with any one or more of embodiments 16 to 18, the apparatus wherein the first elongated member comprises an anvil surface defining a plurality of staple forming pockets.

[0153] Embodiment 20

[0154] A method for determining whether a gap distance between a first suturing surface and a second suturing surface is within a predetermined range, the method comprising: (a) measuring a strain value on the first slender member when the first slender member and the second slender member cooperate to clamp tissue; (b) communicating the measured strain value to a console; and (c) generating a pressure distribution on the first suturing surface using the measured strain value.

[0155] III. Miscellaneous

[0156] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered isolated from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art based on the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0157] In addition, any one or more of the teachings disclosed herein may be combined with any one or more of the teachings disclosed in the following patents: U.S. Patent No. 10,631,866, entitled “Release Mechanism for Linear Surgical Stapler”, issued on April 28, 2020; U.S. Patent No. 10,667,818, entitled “Lockout Assemblyfor Linear Surgical Stapler”, issued on June 2, 2020; U.S. Patent No. 10,932,781, entitled “Features to Align and Close Linear Surgical Stapler”, issued on March 2, 2021; U.S. Patent No. 10,898,197, entitled “Releasable Coupling Features for Proximal Portions of Linear Surgical Stapler”, issued on January 26, 2021; U.S. Patent No. 10,898,197, entitled “Firing Lever Assembly for Linear Surgical Stapler”, issued on December 29, 2020 No. 10,874,398, entitled “Clamping Mechanism for Linear Surgical Stapler”, issued on June 23, 2020; No. 10,687,819, entitled “Clamping Mechanism for Linear Surgical Stapler”, issued on January 26, 2021; No. 11,033,266, entitled “Decoupling Mechanism for Linear Surgical Stapler”, issued on June 15, 2021; No. 11,045,193, entitled “Anvil Assembly for Linear Surgical Stapler”, issued on June 29, 2021; and No. 11,045,193, entitled “Closure Assembly for Linear Surgical Stapler”, issued on February 2, 2021. No. 10,905,419, entitled “Clamping Assembly for Linear Surgical Stapler”; No. 11,278,285, issued on March 22, 2022;U.S. Patent No. 11,229,433, entitled “Linear Surgical Stapler,” issued on January 25, 2022; U.S. Publication No. 2022 / 0142641, entitled “System and Method for Forming Pockets in Anvil of Surgical Stapler,” issued on May 12, 2022; U.S. Patent No. 11,224,425, entitled “Surgical Linear Cutter Wishbone Separation Mechanism with Detent,” issued on January 18, 2022; U.S. Patent No. 11,219,454, entitled “Pin Trap Mechanism for Surgical Linear Cutter,” issued on January 11, 2022; U.S. Patent No. 11,219,454, entitled “Separation Mechanism for Surgical Linear Cutter,” issued on December 2, 2021; Cutter”; U.S. Patent Application No. 17 / 489,879, filed on September 30, 2021, entitled “Lockout Feature for Linear Surgical Stapler Cartridge”; U.S. Patent Application No. 29 / 842,580, filed on June 16, 2022, entitled “Staple Cartridge for Linear Surgical Stapler”; and / or U.S. Patent Application No. 29 / 842,581, filed on June 16, 2022, entitled “Linear Surgical Stapler”. The disclosure of each of these references is incorporated herein by reference in its entirety.;

[0158] In addition, any one or more of the teachings of this document may be combined with any one or more of the teachings of the following U.S. patent application No. [Agent Reference Number: END9511USNP1], entitled “Strain and Compression Force Measurement Features for Surgical Stapler,” filed on the same date as the present application, the disclosure of which is incorporated herein by reference in its entirety.

[0159] 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 listed 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 by reference 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.

[0160] The above-described device versions may be used in conventional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into a robotic surgical system, such as the DAVINCI® by Intuitive Surgical, Inc. (Sunnyvale, California). TM system.

[0161] 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.

[0162] By way of example only, the types described herein may be sterilized before and / or after a procedure. 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.

[0163] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.

Claims

1. A device, comprising: (a) a first elongated member having a distal portion configured to present a first suturing surface; (b) a second elongated member having a distal portion configured to present a second suturing surface, wherein the first elongated member and the second elongated member are configured to be releasably coupled together such that the first suturing surface and the second suturing surface cooperate to clamp tissue and suturing the tissue with a plurality of staples; (c) a clamping member, wherein the clamping member is movable from a first position to a second position relative to the first elongated member and the second elongated member to approximate the first suturing surface and the second suturing surface to clamp tissue; (d) a latch member configured to transition from an unlatched state to a latched state to releasably retain the clamping member in the second position; (e) a firing assembly, wherein the firing assembly is actuatable from an initial position to fire the staples into the clamped tissue; and (f) a clamping force measurement assembly, wherein the clamping force measurement assembly is configured to: (i) measuring a parameter associated with a clamping force applied to the first suturing surface and the second suturing surface clamping tissue, and (ii) Processing and communicating the measured parameters for comparison with predetermined limits associated with successful nail formation.

2. The device according to claim 1, wherein: The clamping force measurement assembly includes a strain gauge attached to the latch member, wherein the measured parameter includes a strain measurement.

3. The device according to claim 2, wherein: The latch member includes a jaw defining a slot, wherein the strain gauge is directly adjacent to a portion of the jaw defining the slot.

4. The device according to claim 3, wherein: The clamping force measurement assembly includes an electronics unit in communication with the strain gauge, wherein the electronics unit is configured to receive the measured strain from the strain gauge.

5. The device according to claim 4, wherein: The electronics unit includes a battery configured to power the strain gauge.

6. The device according to claim 5, wherein: The electronics unit includes a wireless transmitter configured to communicate the processed measurement parameters to a surgeon's console.

7. The device according to claim 1, wherein: The clamping force measurement assembly is configured to be selectively attachable to the latch member.

8. The device according to claim 7, wherein: The clamping force measurement assembly includes a sleeve that houses an electronics unit.

9. The device according to claim 8, wherein: The clamping force measurement assembly includes a first leg and a second leg, wherein the parameter includes a measured angle between the first leg and the second leg.

10. The device according to claim 8, wherein: The clamping force measurement assembly includes a first leg and a second leg, wherein the parameter includes a force applied to either the first leg or the second leg.

11. The device according to claim 1, wherein: The clamping force measurement assembly includes a strain gauge assembly attached to a top surface of the first elongated member.

12. The device according to claim 11, wherein The clamping force measurement assembly is further configured to measure a plurality of strain gauges along the top surface of the first elongated member.

13. The device according to claim 11, wherein: The plurality of strain gauges are configured to be selectively attachable to the top surface of the first elongated member.

14. The apparatus according to claim 1, wherein: The clamping force measurement assembly comprises an electronic unit.

15. The device according to claim 14, wherein: The electronic unit comprises a control unit, a wireless transmitter and a battery, wherein the battery is configured to be able to supply power to the control unit and the wireless transmitter.

16. A device, comprising: (a) a first elongated member having a distal portion configured to present a first suturing surface; (b) a second elongated member having a distal portion configured to present a second suturing surface, wherein the first and second elongated members are configured to be releasably coupled together at their proximal ends such that the first and second suturing surfaces cooperate to clamp tissue and suturing the tissue with a plurality of staples; (c) a clamping member, wherein the clamping member is movable from an open position to a closed position relative to the first elongated member and the second elongated member to approximate the first suturing surface and the second suturing surface to clamp tissue; and (d) a strain measurement assembly configured to measure a strain value associated with either the first elongated member or the clamping member, wherein the strain measurement assembly is configured to communicate the measured strain to a console, and the console is configured to generate a signal indicating whether a gap distance between the first suturing surface and the second suturing surface is within a predetermined range.

17. The apparatus according to claim 16, wherein: The strain measurement assembly comprises a control unit configured to generate the signal.

18. The apparatus according to claim 17, wherein: The strain measurement assembly includes a battery configured to supply power to the control unit.

19. The apparatus according to claim 16, wherein: The first elongated member includes an anvil surface defining a plurality of staple forming pockets.

20. A method for determining whether a gap distance between a first suturing surface and a second suturing surface is within a predetermined range, the method comprising: (a) measuring a strain value on the first elongated member when the first elongated member and the second elongated member cooperate to clamp tissue; (b) communicating the measured strain value to a control console; as well as (c) generating a pressure distribution on the first stitching surface using the measured strain values.

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