Surgical stapler with clamping force sensor

Abstract

The invention discloses a surgical instrument. The surgical instrument includes a handle assembly, a shaft assembly, an end effector, and a clamping force sensor. The handle assembly includes a closure trigger pivotable between a released position and an actuated position. The end effector is coupled with the shaft assembly and includes a cartridge including an anvil and a cartridge housing. The cartridge housing is slidable relative to the anvil between an unclamped position and a clamped position to facilitate selective clamping of patient tissue between the anvil and the cartridge housing. The clamping force sensor is associated with the end effector and is configured to detect a clamping force between the anvil and the cartridge housing and to facilitate generation of a notification based on the detected clamping force.

Description

Background Art

[0001] Some surgical staplers can be operated to clamp on one or more layers of patient tissue, shape the nail through the tissue layer to seal the tissue layer substantially together near the formed nail, and cut through the tissue layer for shaping the cut end of the operably sealed tissue. An exemplary suturing instrument may include a pair of cooperating elongated jaw members, wherein each jaw member may be adapted to be inserted into the patient and positioned relative to the tissue to be sutured and / or incised. One of the jaw members may support a nail magazine containing at least two laterally spaced rows of nails, and another jaw member may support an anvil having a nail forming pit aligned with the rows of nails in the nail magazine. Generally speaking, the suturing instrument may also include a push rod and a blade, which can slide relative to the jaw member to eject the nails sequentially or simultaneously from the nail magazine via a cam action surface on the push rod and / or a cam action surface on a wedge-shaped slide pushed by the push rod. These camming surfaces can be configured to actuate one or more nail drivers carried by the magazine and associated with the nails so as to push the nails against the anvil and form laterally spaced rows of deformed nails in the tissue grasped between the jaw members. Such rows can be arranged in linear rows and / or arcuate rows for sequentially or simultaneously suturing and cutting the patient's tissue in a predetermined pattern. The blade can follow the camming surface and cut the tissue along a straight line or arcuate line formed between the rows of nails in the tissue.

[0002] Exemplary surgical staplers are disclosed in U.S. Pat. No. 6,988,650, entitled “Retaining Pin Lever Advancement Mechanism for a Curved Cutter Stapler”, issued on January 24, 2006; U.S. Pat. No. 7,134,587, entitled “Knife Retraction Arm for a Curved Cutter Stapler”, issued on November 14, 2006; U.S. Pat. No. 7,147,139, entitled “Closure Plate Lockout for a Curved Cutter Stapler”, issued on December 12, 2006; U.S. Pat. No. 7,147,140, ​​entitled “Cartridge Retainer for a Curved Cutter Stapler”, issued on April 17, 2007; U.S. Pat. No. 7,147,141, entitled “Slotted Pins Guiding Knife in a Curved Cutter Stapler”, issued on December 12, 2006; and U.S. Patent No. 7,207,472, published on April 24, 2007, entitled “Cartridge with Locking Knife for a Curved Cutter Stapler.” The disclosure of each of the above-cited U.S. patents is incorporated herein by reference. Additional merely exemplary surgical staplers are disclosed in U.S. Patent Publication No. 2005 / 0139636, published on June 30, 2005, entitled “Replaceable Cartridge Module for a Surgical Stapling and Cutting Instrument”; U.S. Patent Publication No. 2005 / 0143759, published on June 30, 2005, entitled “Curved Cutter Stapler Shaped for Male Pelvis”; and U.S. Patent Publication No. 2005 / 0145672, published on July 7, 2005, entitled “Curved Cutter Stapler with Aligned Tissue Retention Feature.” The disclosures of each of the above-cited US Patent Publications are incorporated herein by reference.

[0003] A surgical stapler can be inserted into a patient to perform colorectal surgery. Such surgery can include using a stapler to operably seal, cut, and remove a patient's colon in whole or in part. For example, a proctocolectomy can be performed during a lower anterior resection ("LAR") to treat and inhibit the spread of colorectal cancer cells. Of course, surgical staplers can be used in a variety of other situations and surgeries.

[0004] 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

[0005] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0006] Figure 1A shows a right front perspective view of an exemplary surgical stapling instrument with the pin actuation mechanism in an open position and the staple cartridge in an open position;

[0007] Figure 1B Shows Figure 1A A right front perspective view of a surgical stapling instrument of , wherein the pin actuation mechanism is in a closed position and the staple cartridge is in an open position;

[0008] Figure 1C Shows Figure 1A A right front perspective view of a surgical stapling instrument of , wherein the pin actuation mechanism is in a closed position and the staple cartridge is in a closed position via actuation of the closing mechanism;

[0009] Figure 1D Shows Figure 1A A right front perspective view of a surgical stapling instrument of , wherein the pin actuation mechanism and the staple cartridge are in a closed position and the firing trigger is in a fired position for stapling and cutting tissue of a patient;

[0010] Figure 2A Shows Figure 1A A right side elevation view of a handle assembly of a surgical stapling instrument of with various components removed for clarity and with the pin actuation mechanism in a closed position and the staple cartridge in an open position;

[0011] Figure 2B Shows Figure 1A A right side elevation view of a handle assembly of a surgical stapling instrument of with various components removed for clarity and with the pin actuation mechanism in a closed position and the staple cartridge in a closed position via actuation of the closing mechanism;

[0012] Figure 2CShows Figure 1A a right side elevation view of a handle assembly of a surgical stapling instrument with various components removed for clarity and with the pin actuation mechanism and staple cartridge in a closed position and the firing trigger in a fired position for stapling and cutting tissue of a patient;

[0013] Figure 3 Shows Figure 1A A partially exploded right front perspective view of a surgical stapling instrument showing a staple cartridge removed from the remainder of an end effector;

[0014] Figure 4 Shows Figure 3 A right front perspective view of a nail magazine;

[0015] Figure 5 Shows Figure 3 A rear perspective view of a nail magazine;

[0016] Figure 6 Shows Figure 3 An exploded perspective view of a nail magazine;

[0017] Fig. 7A Shows Figure 1A a left side elevation view of an end effector of with various components removed for clarity;

[0018] Figure 7B Shows Figure 1A a left side elevational view of an end effector of with various components removed for clarity and with the pin actuation mechanism in a closed position and the staple cartridge in an open position;

[0019] Figure 7C Shows Figure 1A , with various components removed for clarity, and wherein the pin actuation mechanism is in a closed position and the staple cartridge is in a closed position via actuation of the closing mechanism;

[0020] Fig.7D Shows Figure 1A a left side elevational view of an end effector of with various components removed for clarity and with the pin actuation mechanism and staple cartridge in a closed position and the firing trigger in a fired position for stapling and cutting tissue of a patient;

[0021] Figure 8 Shown along Fig.7D The section line 8-8 is taken Fig.7D A cross-sectional view of an end effector;

[0022] Fig. 9 Shows Figure 8 An enlarged cross-sectional view of a portion of an end effector;

[0023] Fig. 10A Shows Figure 1A , with various components removed for clarity, with the staple cartridge returned to an open position after actuation of the firing trigger;

[0024] Fig. 10B Shows Figure 1A A left side view of an end effector of with various components removed for clarity, with the staple cartridge removed from the remainder of the end effector;

[0025] Fig.11 shows a perspective view of a handle assembly of another exemplary surgical stapling instrument with various components removed for clarity;

[0026] Fig. 12A Shows Fig.11 A right side elevation view of a handle assembly of a surgical stapling instrument of with various components removed for clarity and with the pin actuation mechanism in a closed position and the staple cartridge in an open position;

[0027] Fig. 12B Shows Fig.11 A right side elevation view of a handle assembly of a surgical stapling instrument of with various components removed for clarity and with the pin actuation mechanism in a closed position and the staple cartridge in a closed position via actuation of the closing mechanism;

[0028] Fig. 12C Shows Fig.11 a right side elevation view of a handle assembly of a surgical stapling instrument with various components removed for clarity and with the pin actuation mechanism and staple cartridge in a closed position and the firing trigger in a fired position for stapling and cutting tissue of a patient;

[0029] Fig.13 shows a right side view of a handle assembly of another exemplary surgical stapling instrument with various components removed for clarity;

[0030] Fig.14 shows a left side elevation view of another exemplary end effector associated with a clamping force sensor;

[0031] Fig.15 Shows Fig.14 A bottom plan view of an end effector;

[0032] Fig.16A Shown with Fig.14 and Fig.15 a right side elevation view of an applicator for use with a clamping force sensor;

[0033] Fig. 16B Shown with Fig.14 and Fig.15 The clamping force sensor is associated with Fig.16A an application device;

[0034] Fig. 16C Shows from Fig.14 and Fig.15 a right side elevation view of the applicator with the clamping force sensor removed;

[0035] Fig.17 shows a left side elevation view of another exemplary end effector including a staple cartridge having a clamping force sensor housed therein;

[0036] Fig.18 shows a left side elevation view of another exemplary end effector including a clamping force sensor housed therein;

[0037] Fig.19 shows a left side elevation view of another exemplary end effector including a clamping force sensor having a sensing component disposed between a firing rod and a knife;

[0038] Fig. 20 shows an exploded perspective view of another exemplary end effector and smart sleeve;

[0039] Fig.21 The end effector is shown mounted on Fig. 20 a perspective view of the smart sleeve; and

[0040] Fig. 22 Shown is the installation Fig.21 A perspective view of the anvil on the smart sleeve.

[0041] 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

[0042] 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.

[0043] It should also be understood that any one or more of the teachings, expressions, implementations, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, implementations, examples, etc. described herein. Therefore, the following teachings, expressions, implementations, examples, etc. should not be considered isolated from each other. According to the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0044] For clarity of the disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic operator of a surgical instrument. The term "proximal" refers to a position of an element that is closer to a human or robotic operator of a surgical instrument and further away from a surgical end effector of the surgical instrument. The term "distal" refers to a position of an element that is closer to a surgical end effector of a surgical instrument and further away from a human or robotic operator of a surgical instrument. It should also be understood that for simplicity and clarity, spatial terms such as "vertical", "horizontal", "lower", "upper", "front", and "rear" are used herein in conjunction with the illustrations. However, surgical instruments are used in many orientations and orientations, and these terms are not restrictive and / or absolute.

[0045] I. Exemplary Surgical Stapler

[0046] Figure 1A An exemplary surgical stapling and cutting instrument (10) is shown, which includes a handle assembly (12), a shaft assembly (14), and an end effector (16) protruding distally from the shaft assembly (14). It should be understood that the terms used herein, such as "proximal" and "distal", "right" and "left", are relative to the handle assembly (12) of the surgical stapling instrument (10) gripped by the clinician. Therefore, the end effector (16) is located distally relative to the relatively proximal handle assembly (14).

[0047] Unless otherwise indicated, the instrument (10) may be constructed and operated in accordance with at least some of the teachings of the following patent publications: U.S. Patent Publication No. 2005 / 0143759, entitled “Curved Cutter Stapler Shaped for Male Pelvis,” published on June 30, 2005, the disclosure of which is incorporated herein by reference; U.S. Patent No. 10,045,780, entitled “Method of Applying Staples in Lower Anterior Bowel Resection,” published on August 14, 2018, the disclosure of which is incorporated herein by reference; U.S. Patent No. 10,194,913, entitled “Surgical Instrument Comprising Systems for Assuring the Proper Sequential Operation of the Surgical Instrument,” published on February 5, 2019, the disclosure of which is incorporated herein by reference; and / or U.S. Patent No. 10,194,913, entitled “Cartridge Retention Features for Curved Surgical Stapler" U.S. Patent Publication No. 2023 / 0007859.

[0048] The handle assembly 12 includes a number of actuation mechanisms for operating the end effector (16) during a surgical procedure. To this end, the exemplary handle assembly (12) includes a saddle slide (18), a closure trigger (20), and a firing trigger (22) that communicates with the end effector (16) via the shaft assembly (14). Figure 1A As shown, the slide (18) and the closure trigger (20) are in an open configuration such that the end effector (16) is configured to receive tissue laterally within the gap (25) between the anvil (26) and the cartridge (28) of the end effector (16). The slide (18) is translated distally to the end effector (16) so that the retaining pin (30) of the end effector (16) is engaged. Figure 1B The anvil (26) and the cartridge (28) are shown sliding distally for capturing tissue between the anvil (26) and the cartridge (28). Figure 1C and Figure 1D The closing trigger (20) and the firing trigger (22) are sequentially actuated to compress the tissue between the anvil (26) and the cartridge (28) in the closed configuration, and then a plurality of staples (not shown) are formed in the tissue, and the tissue is cut with a knife (32) (see Figure 6 ) for processing. Additional details about these exemplary actuation mechanisms will be provided in more detail below.

[0049] A. Exemplary Handle and Shaft Assemblies

[0050] like Figure 1A and Figure 2A As shown, the handle assembly (12) has a handle housing (34), a pair of handle frame plates (35, 36) within the handle housing (34) extending along the shaft assembly (14), a saddle slide (18), a closing trigger (20) and a firing trigger (22), as briefly described above. The handle housing (34) defines a handle (38) that an operator, such as a surgeon, grasps with the palm of at least one hand. The handle housing (34) is formed by a right cover handle portion (40) and a left cover handle portion (42). The closing trigger (20) is positioned proximally relative to the firing trigger (22) and is each pivotally mounted to the frame plates (35, 36) to extend below the rest of the handle assembly (12) for manipulation by the operator's fingers. Between the closing end actuator (16) and the firing nail (not shown) and / or knife (32) (see Figure 6 ), the closing trigger (20) and the firing trigger (22) are shown in an unactuated position. Thus, the cartridge (28) is spaced apart from the anvil (26) for receiving tissue in the gap (25) therebetween.

[0051] Prior to actuating the closure trigger (20) and the firing trigger (22), the surgical stapling instrument (10) captures tissue via a tissue retaining pin actuation mechanism (37). Figure 1A A retaining pin actuation mechanism (37) is shown in an open configuration, the retaining pin actuation mechanism comprising a slide (18) and Figure 2A The retaining pin actuation mechanism (37) is shown in more detail in the closed configuration. Figure 2A The slide (18) is mounted on the upper surface of the handle housing (34) and is configured to be linearly translated between a proximal position and a distal position. The slide (18) is connected to a cylindrical member (44) that extends laterally outward from the push rod driver (46) through a narrow slot 48 (see Figure 1A ). The push rod driver (46) is constrained in the handle housing (34) along longitudinal movement by the slot (48). The push rod driver (46) is connected to the proximal end of the push rod (50). The distal end of the push rod (50) is connected to the retaining pin (30) (see Figure 6 ), so that the distal movement of the slide (18) causes the push rod (50) to similarly slide proximally along the shaft assembly (14) to move the retaining pin (30) (see Figure 6 ) to a closed configuration, which will be discussed in more detail below.

[0052] The closing mechanism (52) including the closing trigger (20) is configured to selectively move the cartridge (28) toward tissue positioned between the anvil (26) and the cartridge (28) in a closed configuration in the event of desired suturing and / or cutting of tissue. The closing mechanism (52) also includes an elongated closing member (54) having a generally U-shaped cross-section that extends distally from the handle assembly (12), through the shaft assembly (14), and into the end effector (16) for receiving the cartridge (28) at its distal end portion (see Figure 3 ), as discussed below. The proximal end portion of the closing member (54) is operably connected to the closing trigger (20) by a plurality of links that are configured to convert pivotal motion of the closing trigger (20) into translation of the closing member (54). More specifically, the intermediate end portion and the proximal end portion of the closing member (54) extend through the handle assembly (12) between the left handle frame plate (35) and the right handle frame plate (36). The right and left closing links (56) are pivotally attached to the right proximal end and the left proximal end of the closing member (54), respectively, by an integral closing link pin (58). At the opposite end of the closing link (56), the closing link (56) is pivotally attached to another integral closing link pin (60). A closure link pin (60) connects the closure link (56) to a slotted closure arm link (62) which is pivotally mounted to the handle frame plates (35, 36) at a closure trigger pin (64). The closure trigger (20) is lowered from the slotted closure arm link (62) to pivotally rotate toward and away from the handle (38) about the closure trigger pivot pin 64. A closure spring (66) housed within the handle (38) is secured to the slotted closure arm link (62) to provide a desired resistance when an operator squeezes the closure trigger (20) toward the handle (38) and biases the closure trigger (20) toward the open position.

[0053] The closing member (54) is further configured to guide the movement of the tissue retaining pin actuating mechanism (37) to automatically guide the retaining pin (30) to move to the closed configuration when the operator squeezes the closing trigger (20). Such automation may be useful in situations where the operator does not manually move the slide (18) to the distal position before actuating the trigger (20). The closing member (54) includes a cylindrical member (68) that extends laterally on each opposite side of the closing member (54) within the handle housing (34). The cylindrical member (68) is slidably connected to the bracket (70) via an L-shaped slot (72). The bracket (70) is pivotally mounted within the handle housing (34) by a pivot pin (74). The bracket (70) also includes a cam pin (76) that is configured to push a cam surface (78) on the push rod driver (46). Thus, actuating the closing trigger (20) to the distal position Figure 2A The intermediate position shown directs the closure member (52) distally and in turn causes the carriage (70) to engage the push rod driver (46) and force the retaining pin (30) (see Figure 1B ) reaches the closed position. Therefore, without the operator manually manipulating the slide (18) to the distal position before actuating the trigger (20), the slide (18) is dragged along the handle housing (34) from the proximal position to the distal position.

[0054] The operator also squeezes the closure trigger (20) to the handle (38), as Figure 1C and Figure 2B As shown, the surgical stapling instrument (10) is effectively set to a closed configuration before forming staples (not shown) and severing tissue, as briefly described above. The exemplary handle assembly (12) is configured to form staples (not shown) and sever tissue via the firing mechanism (80) when the operator manipulates the firing trigger (22) toward the closing trigger (20), as shown. Figure 1D and Figure 2C As shown. Combined Figure 1C , Figure 1D , Figure 2B and Figure 2C The firing mechanism (80) including the firing trigger (22) has a firing rod (82) extending distally from the handle assembly (12) and within the end effector (16). The distal end of the firing rod (82) cooperates with the cartridge (28), as discussed in more detail below, while the proximal end of the firing rod (82) is operably connected to the firing trigger (80) for selectively firing it.

[0055] The firing rod (82) has a rectangular receiving slot (84) in a portion of the firing rod 82 that is positioned within the handle housing (34) (see Figure 2A). An integral closure connector pin (58) extends through the receiving slot (84). The underside of the proximal end portion of the firing rod (82) has a sliding surface (86). The proximal end portion of the firing rod (82) also has a terminal side engagement surface (82) extending from the sliding surface (86). The firing trigger (22) is pivotally mounted to the handle frame plate (35, 36) by a firing trigger pin (90), which is spaced apart from the closure trigger pin (64) so ​​that each of the pins (90, 64) pivots about an independent axis. The firing trigger (22) includes an arcuate firing trigger connector (92) extending from the firing trigger (22) to a vertex (94) at the firing trigger pin (90), which rests on the sliding surface (86) of the proximal end portion of the firing rod (82). Within the handle assembly (12), the firing trigger (22) is attached to firing trigger spring arms (95, 96), respectively. The firing trigger spring arms (95, 96) support a torsion spring (not shown) on the right half of the firing trigger (22). Finally, a firing rod return spring (98) is fixed to the underside of the firing rod (82) at the portion of the firing rod (82) within the handle assembly (12) to bias the firing rod (82) toward its unactuated position.

[0056] When the operator squeezes the closure trigger (20) toward the handle (38), the slotted closure arm link (62) and the closure link (56) move distally within the receiving slot (84) of the firing rod (82). This distal movement causes the closure member (54) to move distally accordingly. Similarly, the firing rod (82) moves distally simultaneously with the closure member (54) because the integral closure link pin (58) to which the closure link (56) is attached extends through the receiving slot (84) in the firing rod (82) (see FIG. Figure 2A ). Thus, the firing rod (82) is pushed distally to form a staple (not shown) in the tissue and / or to sever the tissue with the knife (32) (see Figure 6 Finally, the operator may fully squeeze the firing trigger (22) toward the handle (38) to "fire" the surgical stapling instrument (10) and further push the firing rod (82) distally to form staples (not shown) and sever tissue. This distal movement of the firing rod (82) may also be referred to herein as "firing" the firing rod (82) to an actuated or "fired" position.

[0057] The surgical stapling instrument (10) may be further configured to be releasably locked in one of a variety of configurations when the operator releases one or both of the closing trigger (20) and the firing trigger (22) while one or both of the triggers (20, 22) are in the fired position or in an intermediate position between the unactuated position and the fired position. The operator may then release the handle (38) during the surgical procedure to free one or more hands for another task and, if desired, release the surgical stapling instrument (10) from its locked position by releasing the button (24). For example, the surgical stapling instrument (10) has an intermediate closing stop position and a closing stop position. In combination FIG. 2A to FIG. 2C The top side of the slotted closing arm link (62) has a clamping slide surface (102) showing an intermediate stop (104) and a closing stop (106). A release pawl (108) slides on the clamping slide surface (102) and can engage the intermediate and closing stops (104, 106). The release pawl (108) has a laterally extending pawl ear (110) at its distal end.

[0058] A release pawl (108) is located within the handle assembly (12) and is integrally formed with a release button (24) that is located outside the handle housing (34) for manipulation by an operator. The release button (24) has a thumb rest (112) pivotally attached to the handle housing (34) by a release trunnion (114). The release button (24) is biased outwardly from the handle housing (34) and thus the release pawl (108) is biased downwardly toward the clamping slide surface (102) by a release spring (116). The release spring (116) is mounted to the handle housing (34) by a spring retaining pin (118) and to the release button (24) by a button spring column (120). The slotted closing arm connector (62) has an arcuate recess (122) between the intermediate stop (104) and the closing stop (106). Receiving for rotational movement within the arcuate recess (122) are integrally connected left and right hand toggles (124). Each toggle (124) has a toggle arm (126) that is engageable with the detent ear (110).

[0059] To releasably lock the handle assembly (12), when the closing trigger (20) is squeezed toward the handle (38), the toggle arm (126) disengages from the ratchet ear (110). Thus, as the toggle (124) continues to rotate in a clockwise direction, the release ratchet ear (108) travels up the toggle arm (126) and, as the closing trigger (20) continues to move, falls into one of the intermediate stop (104) and the closing stop (106) depending on the position of the closing trigger (20) in use. As the release ratchet (108) travels up the toggle arm (126), the release ratchet (108) rotates the release button (24) clockwise. The release ratchet (108) thus falls into one of the intermediate and stop (104, 106) and generates an audible click, alerting the surgeon that one of the intermediate and closed positions has been reached.

[0060] To release the handle assembly (12) from the intermediate or closed position discussed herein, the surgeon depresses the release button (24). Subsequently, the release pawl (108) pivots in a clockwise direction about the release ear axis (114) to move the pawl ear (110) away from one of the intermediate stop (104) and the closed stop (106). As the pawl ear (110) moves away, the pawl ear (110) moves up the toggle arm (126) to another position, such as the unactuated position. Thus, the operator can release the closing trigger (20) and the firing trigger (22) so that they can each return to the unactuated position ( Figure 1A and Figure 3 ).

[0061] The surgical stapling instrument (10) of this example includes each of a handle frame plate (35, 36), a push rod (50), a closing member (54) and a firing rod (82), each of which extends continuously from the handle assembly (12) to the end effector (16), thereby defining an axis assembly (14) extending therebetween. The handle frame plates (35, 36), the push rod (50), the closing member (54) and the firing rod (82) of the surgical stapling instrument (10) only provide a subset of the elongated components extending distally from the handle assembly (12) as the axis assembly (14). Alternatively, the axis assembly (14) may include additional components, such as an articulation joint, or may include a rearrangement of various components so that the axis assembly (14) can be modular relative to the handle assembly (12). In any case, it should be understood that the present invention is not intended to be limited to the shaft assembly (14) described herein, and may include various alternative arrangements for operably connecting the end effector (16) to the handle assembly (12). Of course, the handle assembly (12) and the shaft assembly (14) may have a variety of other components, features, and operability in addition to or in lieu of any of those described above. Other suitable configurations of the handle assembly (12) and the shaft assembly (14) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0062] B. Exemplary End Effectors

[0063] Also like Figures 3 to 5 As shown and briefly discussed above, the end effector (16) of the present example includes an anvil (26), a replaceable cartridge (28) including a plurality of staples (not shown), and a knife (32) (see Figure 6 ), and a retaining pin (30). While the end effector (16) of the present example is adapted for use with a replaceable cartridge (28) having various components, it should be understood that the underlying concepts of the present invention may be applied to a variety of end effectors and cartridge configurations for treating a patient.

[0064] The end effector (16) provides a surgical fastening assembly that includes a cartridge (28) received within a C-shaped support structure (128). The term C-shaped is used throughout the specification to describe the concave nature of the support structure (128) and cartridge (28). The C-shaped configuration facilitates enhanced functionality and access to tissue within a patient's body. As used herein, the term "C-shaped" should be understood to include a variety of concave shapes that will similarly enhance the functionality of surgical stapling and cutting instruments. By way of example only, the C-shaped support structure (128) may be sized to facilitate access to the lower colon within a patient's pelvic cavity, such as for performing a LAR during a colectomy.

[0065] The support structure (128) of the end effector (16) is attached to the handle frame plates (35, 36) of the shaft assembly (14) by shoulder rivets (129) and cylindrical members (130) extending from the support structure (128) into receiving holes in the handle frame plates (35, 36). The distal end of the closing member (54) is configured to receive the cartridge (28) thereon to guide the cartridge (28) to a closed configuration. The cartridge (28) also includes a safety lockout mechanism (131) (see FIG. 1 ) when the cartridge (28) is returned from the closed configuration to the open configuration. Fig. 7A ), the safety lockout mechanism is configured to inhibit accidental re-firing of the cartridge (28). The safety lockout mechanism (131) will be discussed in more detail below.

[0066] The cartridge (28) includes an anvil (26) coupled to a cartridge housing (132). The cartridge (28) also includes a retaining pin (30) and a tissue contacting surface (34) defining a plurality of staple receiving slots (136) in one or more staggered rows on either side of the knife (32) (see Figure 6 The staples (not shown) are fired from the cartridge housing (132) against a staple forming surface (138) of the anvil (26) facing the tissue contacting surface (134) of the cartridge housing (132). The cartridge (28) may further include a removable retainer (not shown) for storage between the anvil (26) and the tissue contacting surface (34) before and / or after use to inhibit unintended contact with various portions of the cartridge (28).

[0067] like Figures 4 to 6 As shown, the magazine (28) includes a nail driver assembly (140) within the magazine housing (132) and positioned proximally behind a plurality of nails (not shown) within the nail receiving slots (136). The driver assembly (140) of the present example is formed as an integral structure defining a plurality of nail drivers (141). Thus, the term "assembly" is not intended to be limited to an assembly of a single component, but may also include integrally formed components having an integral structure. The driver assembly (140) is capable of pushing nails (not shown) out of the nail receiving slots (136) and toward the anvil (26) for formation. The knife holder (142) is directly disposed proximal to the driver assembly (140) in the magazine housing (132) and defines a slot (144) and a flange (146) for interacting with a knife retractor hook (148) (see Fig. 10B), which will be discussed in more detail below. The blade holder (142) is attached to the blade (32) such that the blade (32) extends distally from the blade holder (142) through a slot (150) in the driver assembly (140) and through another slot (152) in the cartridge housing (132). Although the blade (32) is disclosed as being within the cartridge housing (132) in the present example, other configurations may be used. For example, it should be understood that the cartridge (28) may alternatively not include a blade (32) for an alternative treatment.

[0068] The blade holder (142) has a stop column (154) extending through a slot (155) in the cartridge housing (132). The stop column (154) is positioned so as to contact a stop protrusion (156) of the blade holder slot (155) during longitudinal travel of the blade (132) and the blade holder (142). Similarly, the driver assembly (140) has a stop column (158) positioned so as to contact proximal and distal stop protrusions (159, 160) of the cartridge slot (155).

[0069] The knife (32) and slots (150, 152) are positioned so that there is at least one row of staples (not shown) on either side of the knife (132). In some versions, two rows of staple slots (136) containing corresponding rows of staples (not shown) are provided on each side of the slot (152) of the cartridge housing (132).

[0070] The cartridge housing (132) defines two longitudinally extending generally circular holes (162, 164) at respective ends of the knife slot (152). More specifically, the hole (162) at the lower portion of the cartridge housing (132) is shaped and sized to receive a guide pin (166) passing through the cartridge housing (132). The hole (164) at the upper portion of the cartridge housing (132) is shaped and sized to slidably receive a retaining pin (30) passing through the cartridge housing (132). The staple slot (136) of the present example is arranged so that a staple (not shown) extends transversely through the generally circular holes (162, 164).

[0071] The anvil (26) of this example includes a plastic cutting washer (168) and a metal nail forming surface (138). The anvil (26) is configured to keep the nail forming surface (138) aligned with the nail (not shown) to receive and form the nail (not shown) thereon. The retaining pin (30) is connected to the coupling (170) via a circumferential slot (172) in the retaining pin (30) and a groove (not shown) in the coupling (170). The coupling (170) is disposed within an arm (176) of the cartridge housing (132) and is secured to the arm (176) via an end cap (178).

[0072] The guide pin (166) and the retaining pin (30) include corresponding slots (180, 182) (see also Figures 8 to 9 ), the lower and upper ends (184, 186) of the knife (32) are slidably disposed in these grooves. The proximal end (188) of the guide pin (166) is connected to the anvil (26), and the distal end (190) of the guide pin (166) extends from the cartridge housing (132) and extends through the narrow slot (192) in the anvil (26). The cutting washer (168) slides onto the anvil (26) via the groove (194). Therefore, the cutting washer (168) is configured to be able to capture the guide pin (166) in the opening formed by the narrow slot (192) in the anvil (26) and the cutting surface (157) of the anvil 26 for connecting the anvil (26) to the cartridge housing (132).

[0073] The locking mechanism (131) Fig. 7A . The locking mechanism (131) is configured to inhibit full proximal movement of the cartridge housing (132) to its unactuated position after firing. To this end, the locking mechanism (131) of this example includes a locking lever (196) pivotally mounted to the distal end of the closing member (54) by a pin (198). The locking lever (196) is spring-biased toward the proximal end portion of the support structure (128) by a spring (not shown). The proximal end portion of the locking lever (196) has a cam surface (200) and a locking groove (202). The support structure (128) of the end actuator (16) also has a flange (204) that is configured to cooperate with the locking groove (202) when the locking mechanism (131) is engaged. In contrast, the support structure (128) has a base surface (206) that is configured to cooperate with the cam surface (200) when the latch lever (131) is not engaged.

[0074] C. Exemplary Use of Surgical Stapler

[0075] In this example, the bin (28) is driven toward the anvil (26) via the closing member (54) until a closed configuration is reached, wherein the tissue is positioned between the bin (28) and the anvil (26), as discussed above with respect to the handle assembly (12). From the closed configuration, the knife (32) and the nail driver assembly (140) are further moved toward the anvil (26) via the firing rod (82) to form nails (not shown) in the tissue, fluid-sealed tissue, and cut off the tissue to treat the patient. Although the actuation of the bin (28) in this example includes suturing and cutting off tissue, it should be understood that one or more of these steps can be omitted from treatment according to the needs of the operator. In addition, it should be understood that the surgical stapling instrument (10) can be reconfigured to be able to perform these steps simultaneously or sequentially as needed. For example, in this example, the actuation of the firing rod (82) causes the driver assembly (140) and the knife (32) to move distally toward the anvil (26). Alternatively, surgical stapling instrument (10) can be reconfigured to selectively fire one of the staples (not shown) or the knife (32), or selectively fire the staples (not shown) and then the knife (32), or vice versa. Therefore, it should be understood that the present invention is not intended to be limited to a specific operation or related treatment of surgical stapling instrument (10).

[0076] like Fig. 7A As shown, the cartridge (28) is proximally spaced from the anvil (26) to receive tissue within the gap (25) in the open configuration. With the tissue received between the cartridge (28) and the anvil (26), the operator manually directs the push rod (50) distally via the slide (18), as discussed above and as shown in the drawings. Figure 7B The push rod (50) is operably connected to the connecting member (70) (see Figure 6 ), which is connected to the retaining pin (30). Thus, translating the push rod (50) distally similarly translates the retaining pin (30) to extend from the cartridge (28) to the anvil (26) and capture tissue between the retaining pin (30) and the guide pin (166).

[0077] like Figure 7C As shown, the closing trigger (20) is operated (see Figure 1C ) forces the closure member (54) to translate distally relative to the support structure (128) of the end effector (16). The closure member (54) supports the cartridge (28) thereon such that distal translation of the closure member (54) similarly moves the firing rod (82) and the cartridge (28) toward the anvil (26). With the cartridge (28) in the closed configuration and tissue effectively captured in the end effector (16), the operator manipulates the firing trigger (22) (see Figure 1D) toward the anvil (26) to a fired position. Distal translation of the firing rod (82) causes the firing rod (82) to engage a knife holder (142) that supports the driver assembly (140) and the knife (32) extending through the driver assembly (140), such as Fig.7D As shown. Then, the driver assembly (140) guides the nail (not shown) from the nail slot (136) and forms the nail (not shown) in the tissue against the nail forming surface (138) for fluid-sealed tissue. When the nail (not shown) is formed, the knife (32) continues to translate distally through the tissue and enters the anvil (26) to cut the fluid-sealed tissue. Figures 8 to 9 The fired cartridge (28) is shown in greater detail, wherein the knife (32) is guided along the cartridge housing slot (152), the guide pin slot (180); and wherein the retaining pin slot (182) is between the rows of staple slots (136) facing the anvil (26).

[0078] Once fired, the operator can depress the release button (24) (see Figure 2C ) and withdrawing the closure member (54) and firing rod (82) proximally from the actuated firing position to FIG. 10A to FIG. 10B The unactuated position shown. More specifically, the retractor hook (148) engages the knife holder (142) to pull the knife (32) proximally. Almost simultaneously, as the cartridge (28) and the closing member (54) translate proximally, the locking lever 196 of the locking mechanism (131) engages the cartridge housing (132) to hold the cartridge housing (132) in place. Thus, continued pulling of the knife (32) causes the knife (32) to retract within the cartridge housing (132) to inhibit unintentional contact between the operator and the knife (32). The cartridge (28) can then be removed from the support structure (128) of the end effector (16), discarded, and, if necessary, replaced for further processing. Of course, various suitable situations and surgeries in which the surgical stapling instrument (10) may be used will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0079] It should also be understood that any other parts or features of the surgical stapling instrument (10) can be constructed and operated according to any of the various references used herein. Other exemplary modifications that can be provided for the surgical stapling instrument (10) will be described in more detail below. The various suitable ways in which the following teachings can be incorporated into the surgical stapling instrument (10) will be obvious to those of ordinary skill in the art. Similarly, the various suitable ways in which the following teachings can be combined with the various teachings of the references cited herein will be obvious to those of ordinary skill in the art. It should also be understood that the following teachings are not limited to the surgical stapling instruments (10) or devices taught in the references cited herein. The following teachings can be easily applied to various other types of instruments, including instruments that will not be classified as surgical staplers. According to the teachings of this article, various other suitable devices and situations in which the following teachings can be applied will be obvious to those of ordinary skill in the art.

[0080] II. Exemplary Surgical Stapler with Alternative Clamping Force Sensor

[0081] In general, when tissue is clamped in the end effector, the thickness and position of the tissue may affect the ability of the stapler to correctly cut and suture the tissue. If the tissue is too thick and / or improperly positioned in the end effector, the tissue may be improperly cut, or the staples may not be properly implanted or formed, which may potentially lead to problematic surgical sites, such as surgical sites where the tissue is cut by the knife (32) but not completely sealed along the cut line by the properly formed staples. Therefore, it may be desirable to detect improper clamping of the tissue and notify the user accordingly to prevent the tissue from being improperly cut and / or sutured. The following description relates to examples of different feature parts that can be incorporated into the end effector or bin to achieve the desired function. Although these examples are provided separately from each other, the feature parts described in any of the following examples may be combined with the feature parts described in the following other examples. Therefore, the following feature parts may be combined in various arrangements, as will be apparent to those skilled in the art with reference to the teachings of this article.

[0082] A. Force sensing connection between actuator stem and handle

[0083] Figures 11 to 12CAnother exemplary surgical stapling instrument (310) is shown that is similar to the surgical stapling instrument (10) described above except as otherwise described below. The surgical stapling instrument (310) includes a handle assembly (312), an axis assembly (314), and an end effector (e.g., 16) that protrudes distally from the axis assembly (314). The handle assembly (312) includes a saddle-shaped slide (318), a closing trigger (320), and a firing trigger (322) that is connected to the end effector via the axis assembly (314). Distally translating the slide (318) toward the end effector causes the retaining pin (e.g., 30) of the end effector to slide distally (e.g., see Figure 1B ), to capture tissue between anvil (e.g., 26) and cartridge (e.g., 28). Sequentially actuating the closing trigger (320) and firing trigger (322) compresses the tissue between the anvil and cartridge in the closed configuration, then forms a plurality of staples in the tissue, and cuts the tissue with a knife.

[0084] The closure member (354) extends distally from the handle assembly (312), through the shaft assembly (314), and into the end effector for operably coupling with the cartridge. A proximal end portion of the closure member (354) is operably coupled to the closure trigger (320) via a sensing link (510) that is pivotally attached to the closure member (354) at an opposite end. As will be described in further detail below, the sensing link (510) may be used as a clamping force sensor. Fig. 12A and Fig. 12B As shown, the closure trigger (320) is operable to be in a released position ( Fig. 12A ) and actuation position ( Fig. 12B ), which may facilitate corresponding sliding of the closure member (354) to facilitate selective clamping of tissue at the end effector, as described above. Fig. 12A As shown, when closure trigger (320) is in the released position, closure member (354) is in the retracted position, thereby opening the cartridge relative to the anvil to allow tissue to be provided therebetween. Fig. 12B As shown, when closure trigger (320) is pivoted to the actuated position, the closure member slides to a fully extended position, thereby urging the cartridge toward the anvil to facilitate clamping tissue between the anvil and the cartridge.

[0085] Sensing connection (510) is a spring-actuated connection and is configured to detect a force applied between closure trigger (320) and closure member (354). As will be described in further detail below, this detected force may be a function of the clamping force applied by the cartridge on the tissue and may be used to determine if the tissue is improperly clamped to facilitate generating a notification accordingly.

[0086] like Fig.11As shown, the sensing connection (510) includes a support (512) and a plunger (514) that are slidable relative to each other and biased apart by a spring (516). The support (512) includes a connector pin (360) and a sleeve (518) that defines a receptacle (520). The plunger (514) includes a connector pin (358) and a rod (522). The connector pin (358, 360) operably couples the sensing connection (510) to the closing member (354) and the closing trigger (320). The spring (516) is disposed in the receptacle (520), and the rod (522) contacts the spring (516) and partially extends into the receptacle (520) to compress the spring (516) within the receptacle (520), so that the spring (516) biases the support (512) and the plunger (514) apart. The rod (522) is slidable relative to the sleeve (518), which allows the sensing link (510) to be selectively compressed against the bias of the spring (516).

[0087] The sensing link (510) further includes a switch assembly (524) that is selectively activated when the support (512) and the plunger (514) are compressed together beyond a predefined distance, as will be described in further detail below. The switch assembly (524) includes a switch (526) coupled to the rod (522) and a pin (528) coupled to the sleeve (518) and generally aligned with the switch (526). Sufficient compression of the sensing link (510) may cause the pin (528) to depress the switch (526) to facilitate its activation.

[0088] The response of the sensing link (510) to the clamping force applied to the tissue by the cartridge via the closure trigger (320) may depend on whether the tissue is properly clamped. Fig. 12B As shown, when tissue is properly clamped, the clamping force applied to the tissue by the closure trigger (320) and the cartridge is insufficient to overcome the biasing force of the spring (516) applied to the rod (522) to prevent compression of the sensing link (510). As a result, the sensing link remains substantially uncompressed, causing the switch (526) to remain open as an indication that the tissue is properly clamped. However, when tissue is improperly clamped, such as when the tissue is improperly clamped, the switch (526) may be opened. Fig. 12C As shown, the clamping force applied to the tissue by the closure trigger (320) and the cartridge exceeds the biasing force of the spring (516) applied to the rod (522), which causes the closure member (354) to extend slightly rearwardly sufficient to compress the sensing connector (510) and depress the switch (526) as an indication that the tissue is being improperly clamped.

[0089] The microprocessor (530) is communicatively coupled to the switch (526) and the feedback generator (532). The microprocessor (530) may be embodied as any type of processor capable of performing the functions described herein. For example, the microprocessor (530) may be embodied as a single-core or multi-core processor, a digital signal processor, a microprocessor, a general-purpose central processing unit (CPU), a reduced instruction set computer (RISC) processor, a processor with a pipeline, a complex instruction set computer (CISC) processor, an application-specific integrated circuit (ASIC), a programmable logic device (PLD), a field programmable gate array (FPGA), or other processors or processing / control circuits or controllers. The feedback generator (532) may be embodied as any type of generator processor capable of generating notifications, such as light, a speaker, a display, or some combination thereof. The switch (526), ​​the microprocessor (530), and the feedback generator (532) may be powered from a remote power source connected to the surgical stapling instrument (310) via a cable (not shown) or from an internal power source (e.g., a battery) located on the surgical stapling instrument (310).

[0090] The microprocessor (530) is configured to facilitate generating an audible notification and / or a visual notification from the feedback generator (532) based on the state of the switch (526) to warn the user when the tissue is improperly clamped. For example, when the tissue is properly clamped so that the switch (526) is deactivated, the microprocessor (530) recognizes that the switch (526) is deactivated and provides a suitable notification via the feedback generator (532) that indicates to the user that the tissue is properly clamped and the surgical stapling instrument (310) is ready to fire. In some examples, the microprocessor (530) may deactivate the feedback generator (532) to provide such an indication. In an alternative example, the microprocessor (530) may activate the feedback generator (532) to generate a notification that is understood to indicate that the surgical stapling instrument (310) is ready to fire, such as a green light. When the tissue is improperly clamped so that the switch (526) is activated, the microprocessor (530) recognizes that the switch (526) is activated and can provide a suitable notification via the feedback generator (532) to warn the user that the tissue is improperly clamped to prevent the surgical stapling instrument (310). It should be understood that various characteristics of the spring (516), such as the spring constant, can be selected to achieve indication generation at a desired clamping force to adapt to a specific surgical setting. It should also be understood that the sensing connection (510) may include any of a variety of suitable alternative sensors that are conducive to detecting excessive clamping force, such as a Hall effect sensor or an optical sensor. In some cases, the microprocessor (530) is capable of recording certain information during surgery to provide a historical record for the surgical stapling instrument (310), which can be accessed later to view the performance of the surgical stapling instrument (310).

[0091] Fig.13 An exemplary surgical stapling instrument (610) similar to the surgical stapling instrument (310) described above except as otherwise described below is shown. The surgical stapling instrument (310) includes a handle assembly (612), an axis assembly (614), and an end effector (e.g., 16) protruding distally from the axis assembly (614). The handle assembly (612) includes a saddle slide (618), a closing trigger (620), and a firing trigger (622) that is connected to the end effector via the axis assembly (614). The closing member (654) extends distally from the handle assembly (612), passes through the axis assembly (614), and enters the end effector for operably connecting the cartridge. The proximal end portion of the closing member (654) is operably connected to the closing trigger (620) by a sensing connection (810), which is pivotally attached to the closing member (354) at the opposite end.

[0092] The sensing connection (810) includes a support (812), a plunger (814), and a switch assembly (824). The switch assembly (824) includes a switch (826) coupled to the rod (822) and a pin (828) coupled to the sleeve (818) and substantially aligned with the switch (826). The microprocessor (830) is communicatively coupled to the switch (826). The microprocessor (830) is communicatively coupled to a wireless communication module (836) that facilitates wireless communication with a console (not shown) via any of a variety of wireless communication protocols, such as, for example, Wi-Fi, cellular, or wireless personal area network (WPAN) (e.g., IrDA, Bluetooth, Bluetooth low energy, Zigbee, wireless USB). The anvil insert surgical stapler (610) may be additionally or alternatively configured to support wired communication via a communication port (not shown) (such as, for example, a USB port). A console (not shown) may receive messages from the wireless communication module (836) and facilitate generating notifications to a user of the surgical stapler (610). By way of example only, the console may include a data processor and a display that collaborate to generate notifications. In addition, the console may be a component of a robotic electrosurgical system. In accordance with the teachings herein, various suitable forms that the console of the surgical stapler (610) may take will be apparent to those skilled in the art. The switch (826), microprocessor (830), and wireless communication module (836) are powered by an onboard power supply (838), which may include a disposable battery, a rechargeable battery, a supercapacitor, or any of a variety of suitable alternative power storage arrangements.

[0093] The microprocessor (830) can monitor the state of the switch (826) and is conducive to generating an audible notification and / or a visual notification on the console via the wireless communication module (836) to warn the user that the tissue is improperly clamped to prevent the user from firing the stapler. For example, when the tissue is improperly clamped so that the switch (826) is activated, the microprocessor (830) identifies the switch (826) as being activated and can send a message to the console via the wireless communication module (836), which causes the console to generate a notification to warn the user that the tissue is improperly clamped to prevent the user from firing the surgical stapler (610). The user can then reposition the stapler on the tissue until proper clamping is achieved. Once the tissue is properly clamped, the microprocessor (830) can stop sending messages to terminate the notification on the console, thereby indicating to the user that the surgical stapling instrument (610) is ready to fire. In one example, the microprocessor (830) can alternatively send a different message to the console, which causes the console to display a notification to the user to indicate that the surgical stapler (610) is ready to fire. The notification presented by the console may be a visual notification (such as a message displayed on a screen or a flashing light), an audible notification (such as a chime or a recorded verbal message), or a combination thereof.

[0094] B. Gripping force sensor attached to the end effector

[0095] Fig.14 and Fig.15 An exemplary end effector (916) similar to the end effector (16) except as described below is shown. The end effector (916) includes a cartridge (928) and a retaining pin (930). The cartridge (928) includes an anvil (926), a plurality of staples (not shown), a knife (e.g., 32), and a cartridge housing (1032) that can slide between a clamped (closed) position and an unclamped (open) position relative to the anvil (932) in response to actuation of a closing trigger (e.g., 20, 320, 620) to facilitate clamping tissue at the end effector (916). The end effector (916) includes a support structure (1028) that supports the cartridge (928) and is attached to a handle frame plate (935).

[0096] A clamping force sensor (1210) is associated with the end effector (916) to facilitate detection of improper clamping of tissue between the anvil (926) and the cartridge housing (1032) based on deflection of the distal end of the end effector (916). The clamping force sensor (1210) includes a sensing component in the form of a microprocessor (1230), a wireless communication module (1236), an onboard power supply (1238), and a strain gauge (1240). The microprocessor (1230), the wireless communication module (1236), and the onboard power supply (1238) are generally similar to the microprocessor (830), the wireless communication module (836), and the onboard power supply (838) described above, except as otherwise described below. The strain gauge (1240) is communicatively coupled to the microprocessor (1230) via a wire (1242) and sends deflection data to the microprocessor (1230), as will be described in more detail below. The microprocessor (1230f) is communicatively coupled to the wireless communication module (1236) to facilitate wireless communication with a remote control console. The microprocessor (1230), the wireless communication module (1236), the onboard power supply (1238), the strain gauge (1240), and the wire (1242) are contained within a housing (1244) coupled to the end effector (916). The microprocessor (1230), the wireless communication module (1236), the onboard power supply (1238), and the strain gauge (1240) are arranged within the housing (1244) such that the microprocessor (1230), the wireless communication module (1236), and the onboard power supply (1238) are disposed above the cartridge housing (1032), and the strain gauge (1240) is disposed at the distal end of the end effector 916 and adjacent to the anvil (932).

[0097] Strain gauge (1240) is capable of detecting deflection of anvil (932) imparted indirectly to the distal end of end effector (916). Fig.15 As shown, the strain gauge (1240) includes a plurality of sensing pads (1246) distributed along the distal end of the end effector (916) and capable of detecting the deflection of the anvil (932) according to the extension of the sensing pads (1246) when the anvil (932) is bent. It should be understood that the strain gauge (1240) can be any other configuration that is conducive to measuring deflection and can be additionally or alternatively mounted anywhere on the end effector (916).

[0098] The microprocessor (1230) can detect improper clamping of tissue indirectly from the deflection of the distal end of the end effector (916) based on the deflection of the anvil (932). When tissue is clamped between the anvil (932) and the cartridge housing (1032) (e.g., by closing the closure trigger 20, 320, 620), the tissue may be too thick and / or improperly positioned between the anvil (932) and the cartridge housing (1032) and not allow them to be properly clamped together. This improper clamping can result in excessive deflection of the distal end of the anvil (932) and the end effector (916). Therefore, the microprocessor (1230) can indirectly monitor the deflection of the anvil (932) via the strain gauge (1240) to determine whether the tissue is improperly clamped and thus causes excessive deflection of the anvil (932). If the microprocessor (1230) determines that the anvil (932) is being excessively deflected by the tissue, the microprocessor (1230) may send a message to the console via the wireless communication module (1236), which causes the console to generate a notification warning the user that the tissue is improperly clamped to prevent the user from firing the stapler. The user can then reposition the stapler on the tissue until appropriate clamping is achieved. Once the tissue is properly clamped, the microprocessor (1230) may stop sending messages to terminate the notification on the console, thereby indicating to the user that the surgical stapling instrument (e.g., 10, 310, 610) is ready to fire. In one example, the microprocessor (1230) may send different messages to the console, which causes the console to display a notification to the user indicating that the surgical stapling instrument is ready to fire. The notification presented by the console may be a visual notification (such as a message displayed on a screen or a flashing light), an audible notification (such as a bell or a recorded verbal message), or a combination thereof.

[0099] In one example, the microprocessor (1230) may compare the deflection detected by the strain gauge (1240) with a threshold value to determine whether the tissue is improperly clamped. The threshold value may be understood as representing the minimum deflection that the anvil (932) can withstand before cutting and / or suturing will be adversely affected. If the detected deflection is below the threshold value, thereby indicating that the tissue is properly clamped, the microprocessor (1230) suppresses sending a warning message to the console, or alternatively, sends a permission message to the console so that the console notifies the user that the surgical stapling instrument is ready to fire. If the detected deflection is above the threshold value, thus indicating that the tissue is improperly clamped, the microprocessor (1230) sends a warning message to the console, and in response, the console notifies the user to suppress firing the surgical stapling instrument before releasing the tissue and re-clamping.

[0100] In one configuration, the strain gauge (1240) and microprocessor (1230) may be selectively activated in response to the clamping of tissue in an attempt to save power consumption. For example, prior to the clamping of tissue, such as when the closure trigger (20, 320, 620) is opened, the strain gauge (1240) and microprocessor (1230) are deactivated (i.e., in sleep mode). Once the tissue is clamped between the anvil (932) and the chamber housing (1032), the strain gauge (1240) and microprocessor (1230) may be activated to begin sensing the deflection of the anvil (932), as described above. The activation of the strain gauge (1240) and microprocessor (1230) may be based on the position of the closure trigger. When the closure trigger is opened, the strain gauge (1240) and microprocessor (1230) may be deactivated. When the closure trigger is closed to clamp tissue, the microprocessor may identify the closure of the closure trigger and may initiate sensing of the deflection of the anvil (932) with the strain gauge (1240). In one example, the microprocessor (1230) may identify the closure trigger state via a switch (not shown) associated with the closure trigger and indicate whether the closure trigger is open or closed. Additionally or alternatively, the anvil (932) may include a manual switch (such as a button or micro switch) that allows a user to manually control the activation of the strain gauge (1240) and the microprocessor (1230) through the activation of the switch.

[0101] The clamping force sensor (1210) is intended to be provided as a stand-alone device that can be incorporated into a conventional end effector (e.g., 16) to add the above-described sensing functionality to a surgical stapling instrument (e.g., 10). In some cases, the clamping force sensor (1210) can be provided as an aftermarket solution for adding the above-described sensing functionality to an existing surgical stapling instrument, such as a surgical stapling instrument that is already in use. Thus, the clamping force sensor (1210) provides a cost-effective and simple solution for providing the above-described sensing functionality to a surgical stapling instrument that may not have the sensing functionality.

[0102] to this end, FIG. 16A to FIG. 16C An applicator (1248) is shown that may be configured as an attachment to the clamping force sensor (1210) that facilitates mounting the clamping force sensor (1210) to the end effector (916). Fig.16A As shown, the applicator (1248) includes a central body (1250) and a pair of gripping features (1252) extending from the central body (1250) and spaced apart from each other. A protrusion (1254) extends laterally from the central body (1250). The central body (1250) and the gripping features (1252) have an overall inner contour that generally conforms to the outer contour of the housing (1244).

[0103] Now refer to FIG. 16A to FIG. 16C A method of installing a clamping force sensor (1210) using an applicator (1248) is described. First, the clamping force sensor (1210) can be pressed into the applicator (1248) so that the gripping features (1252) initially spread apart to receive the clamping force sensor (1210), and then once the clamping force sensor (1210) is fully installed on the applicator 1248), it is clamped on the clamping force sensor to hold it in place, such as Fig.16A As shown. The protective layer (1256) that is disposed along and adhered to the inner surface of the clamping force sensor (1210) is then removed from the adhesive tape (1258) to expose the adhesive outer surface of the adhesive tape (1258). With the protective layer (1256) removed, the user can push the clamping force sensor (1210) into position above the end effector (916) with sufficient force to properly adhere the adhesive tape (1258) to the end effector (916), as shown. Fig. 16B With the clamping force sensor (1210) adhered to the end effector (916), the applicator (1248) can then be removed from the clamping force sensor (1210) by pulling on the gripping protrusion (1254) with sufficient force to cause the gripping features (1252) to spread apart and disengage from the clamping force sensor (1210).

[0104] C. Clamping force sensor integrated into the bin

[0105] Fig.17 An exemplary end effector (1316) similar to the end effector (916) except as described below is shown. The end effector (1316) includes a cartridge (1328) and a retaining pin (1330). The cartridge (1328) includes an anvil (1326), a plurality of staples (not shown), a knife (e.g., 32), and a cartridge housing (1432) that can slide between a clamped (closed) position and an unclamped (open) position relative to the anvil (1326) in response to actuation of a closing trigger (e.g., 20, 320, 620) to facilitate clamping tissue at the end effector (1316). The end effector (1316) includes a support structure (1428) that supports the cartridge (1328) and is attached to the handle frame plate (1335).

[0106] A clamping force sensor (1610) is incorporated into the cartridge (1328) to facilitate detection of improper clamping of tissue between the anvil (1326) and the cartridge housing (1432). The clamping force sensor (1610) includes a microprocessor (1630), a wireless communication module (1636), an onboard power source (1638), and a sensing component in the form of a strain gauge (1640). The strain gauge (1640) is communicatively coupled to the microprocessor (1630) via a wire (1642). The microprocessor (1630) is communicatively coupled to the wireless communication module (1636) to facilitate wireless communication with a remote console. The microprocessor (1630), wireless communication module (1636) and on-board power supply (1638) are disposed within an internal chamber (1660) defined by the bin housing (1432), such that the microprocessor (1630), wireless communication module (1636) and on-board power supply (1638) are disposed above the bin housing (1432).

[0107] Strain gauge (1640) is capable of detecting deflection of anvil (1326) that occurs as a result of clamping tissue between anvil (1326) and cartridge housing (1432). Fig.17 As shown, strain gauge (1640) is disposed within interior chamber (1662) defined by anvil (1326) and extends along anvil (1326) to facilitate detecting deflection of anvil (1326) directly from anvil (1326). Microprocessor (1630) is capable of detecting improper clamping of tissue based on the deflection of anvil (1326) and facilitates generating a notification on a remote console when tissue is improperly clamped to prevent a user from firing the surgical stapler instrument.

[0108] By integrating the clamping force sensor (1610) into the bin (1328), the bin (1328) can be configured as a stand-alone device that can be incorporated into a conventional end effector (e.g., 16) to add the above-described sensing functionality to a surgical stapler instrument (e.g., 10). In some cases, the bin (1328) can be configured as an aftermarket solution for adding the above-described sensing functionality to an existing surgical stapling instrument, such as a surgical stapling instrument that is already in use. Thus, the bin (1328) provides a cost-effective and simple solution for providing the above-described sensing functionality to a surgical stapling instrument that may not have the above-described sensing functionality.

[0109] D. Gripping force sensor integrated into the end effector

[0110] Fig.18An exemplary end effector (1716) similar to the end effector (916) except as described below is shown. The end effector (1716) includes a cartridge (1728) and a retaining pin (1730). The cartridge (1728) includes an anvil (1726), a plurality of staples (not shown), a knife (e.g., 32), and a cartridge housing (1832) that can slide between a clamped (closed) position and an unclamped (open) position relative to the anvil (1726) in response to actuation of a closing trigger (e.g., 20, 320, 620) to facilitate clamping tissue at the end effector (1716). The end effector (1716) includes a support structure (1828) that supports the cartridge (1728) and is attached to a handle frame plate (1735).

[0111] A clamping force sensor is incorporated into the support structure (1828) of the end effector (1716) to facilitate detection of improper clamping of tissue between the anvil (1726) and the cartridge housing (1832). The clamping force sensor includes a sensing component in the form of a microprocessor (2030), a wireless communication module (2036), an onboard power supply (2038), and a strain gauge (2040). The strain gauge (2040) is communicatively coupled to the microprocessor (2030) via a wire (2042). The microprocessor (2030) is communicatively coupled to the wireless communication module (2036) to facilitate wireless communication with a remote control console. The microprocessor (2030), the wireless communication module (2036), and the onboard power supply (2038) are disposed within an internal chamber (2060) defined by the support structure (1828), such that the microprocessor (2030), the wireless communication module (2036), and the onboard power supply (2038) are disposed above the cartridge housing (1832).

[0112] Strain gauge (2040) is capable of detecting deflections that occur at the interface between anvil (1326) and the distal end of support structure (1828) as a result of clamping tissue between anvil (1726) and cartridge housing (1432). Fig.17 As shown, strain gauges (2040) are disposed at the contact surface between anvil (1726) and an extension along anvil 1726 to facilitate detecting deflection of anvil (1326) from beneath anvil (1726). Microprocessor (2030) can detect improper clamping of tissue based on the deflection beneath anvil (1726) and facilitate generating a notification on a remote console when tissue is improperly clamped to prevent a user from firing the surgical stapler instrument.

[0113] E. Clamping force sensor integrated into the firing rod

[0114] Fig.19An exemplary end effector (2116) similar to end effector (916) except as described below is shown. End effector (2116) includes a cartridge (2128) including an anvil (2126), a plurality of staples (not shown), a knife (e.g., 32), and a cartridge housing (2132) that can slide between a clamped (closed) position and an unclamped (open) position relative to anvil (2126) in response to actuation of a closure trigger (e.g., 20, 320, 620) to facilitate clamping tissue at end effector (2116). End effector (2116) also includes a firing rod (e.g., 82) that interacts with cartridge (2128) to facilitate forming staples (not shown) in tissue and / or severing tissue with a knife (e.g., 32).

[0115] A clamping force sensor (2410) is incorporated into the cartridge (2128) to facilitate detection of improper clamping of tissue between the anvil (1326) and the cartridge housing (1432). The clamping force sensor (2410) includes a microprocessor (2430), a wireless communication module (2436), an onboard power supply (2438), and a sensing component in the form of a strain gauge (2440). The strain gauge (2440) is incorporated between the firing rod and the knife and is configured to facilitate detection of the distance and clamping force between the anvil (2126) and the cartridge housing (2132) during firing of the surgical stapling instrument.

[0116] F. Clamping force sensor incorporated into the sleeve attached to the support structure

[0117] Figure 20 to Figure 22 An exemplary support structure (2628) for an end effector (e.g., 16, 616, 916) is shown, which is substantially similar to the support structures (128, 1028, 1428) described above except as otherwise described below. The support structure (2628) includes a smart sleeve (2860) configured to be mounted over the distal end of the support structure (2628), such as Fig. 20 and Fig.21 As shown. Sleeve (2860) includes a strain gauge (not shown) that facilitates detecting the clamping force at the distal end of support structure (2628). Sleeve (2860) is communicatively coupled to a microprocessor (not shown) and a wireless communication module (not shown) that cooperate to provide clamping force feedback to the user in a manner similar to that described above. Fig. 22 As shown, anvil (2526) is attached to sleeve (2860) to facilitate the formation of staples thereon.

[0118] III. Exemplary Combinations

[0119] 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.

[0120] Example 1

[0121] A device comprising (a) a handle assembly comprising a closed trigger capable of pivoting between a release position and an actuated position; (b) an axis assembly; (c) an end actuator coupled to the axis assembly and comprising a cartridge, the cartridge comprising an anvil and a cartridge housing, the cartridge housing being capable of sliding relative to the anvil between an unclamped position and a clamped position to facilitate selective clamping of patient tissue between the anvil and the cartridge housing; and (d) a clamping force sensor associated with the end actuator and configured to detect a clamping force between the anvil and the cartridge housing and to facilitate generating a notification based on the detected clamping force.

[0122] Example 2

[0123] The apparatus of embodiment 1, wherein the clamping force sensor includes a sensing component, a controller in signal communication with the sensing component, a communication module that facilitates communication with a remote computing device, and a power module that facilitates powering the clamping force sensor.

[0124] Example 3

[0125] A device according to Example 2, wherein: (a) the end actuator also includes a support structure, which is configured to facilitate selective retention of the magazine, (b) the clamping force sensor is connected to the support structure so that the sensing component is located at the distal end of the end actuator adjacent to the anvil, and (c) the controller, the communication module and the power module are located at the proximal end of the end actuator adjacent to the magazine housing.

[0126] Example 4

[0127] A device as described in Example 3, wherein the sensing component, the controller, the communication module and the power module are disposed within a housing that is releasably coupled to the support structure.

[0128] Example 5

[0129] A device as described in Example 4, wherein the housing is releasably coupled to the support structure using an adhesive.

[0130] Example 6

[0131]

[00136] The device according to Example 5 is combined with an applicator configured to releasably grasp the housing to facilitate selective mounting of the housing on the support structure.

[0132] Example 7

[0133] The apparatus of any one of Embodiments 6 and 7, wherein the sensing component comprises a strain gauge, the power module comprises a battery, and the communication module comprises a wireless communication module that facilitates wireless communication with the remote computing device.

[0134] Example 8

[0135] The apparatus according to any one of embodiments 4-7, wherein the support structure defines an internal chamber, and the sensing component, the controller, the communication module and the power module are arranged in the internal chamber.

[0136] Example 9

[0137] A device according to Example 8, wherein (i) the sensing component is positioned at the distal end of the end actuator adjacent to the anvil and the controller, (ii) the communication module and the power module are positioned at the proximal end of the end actuator adjacent to the magazine housing, and (iii) the sensing component is connected to the communication module via a wire extending between the sensing component and the communication module, and the sensing component is disposed in the internal chamber.

[0138] Example 10

[0139] The apparatus of any one of Embodiments 8 and 9, wherein the sensing component comprises a strain gauge, the power module comprises a battery, and the communication module comprises a wireless communication module that facilitates wireless communication with the remote computing device.

[0140] Embodiment 11

[0141] An apparatus according to any one of embodiments 2-10, wherein the sensing component, the controller, the communication module and the power module are connected to the warehouse.

[0142] Example 12

[0143] A device as described in Example 11, wherein (i) the bin housing defines a first interior chamber, and (ii) the controller, the communication module, and the power module are disposed within the first interior chamber.

[0144] Embodiment 13

[0145] Embodiment 12 The apparatus of embodiment 12, wherein the sensing component is coupled to the anvil.

[0146] Embodiment 14

[0147] A device according to Example 13, wherein (i) the anvil defines a second internal chamber, (ii) the sensing component is disposed in the first internal chamber, and (iii) the sensing component is connected to the communication module via a wire extending between the first internal chamber and the second internal chamber.

[0148] Embodiment 15

[0149] The apparatus of any one of embodiments 11-14, wherein the sensing component comprises a strain gauge, the power module comprises a battery, and the communication module comprises a wireless communication module that facilitates wireless communication with the remote computing device.

[0150] Example 16

[0151] A device comprises (a) a handle assembly, the handle assembly including a closing trigger capable of pivoting between a release position and an actuated position; (b) a shaft assembly; (c) an end actuator, the end actuator being connected to the shaft assembly and including an anvil and a cartridge housing, the cartridge housing being capable of sliding relative to the anvil between an unclamped position and a clamped position to facilitate selective clamping of patient tissue between the anvil and the cartridge housing; and (d) a clamping force sensing connection operably connected to the shaft assembly and the closing trigger, such that pivoting of the closing trigger from the release position to the actuated position facilitates actuating the end actuator from the unclamped position to the clamped position via the clamping force sensing connection and the shaft assembly, wherein the clamping force sensing connection is configured to detect a force applied to the end actuator by the closing trigger to facilitate generating a notification based on the detected force.

[0152] Embodiment 17

[0153] A device as described in Example 16, wherein the clamping force sensing connection is configured to facilitate generating an alarm when the detected force exceeds a threshold.

[0154] Embodiment 18

[0155] A device according to embodiment 17, wherein the clamping force sensing connection includes: (i) a rod and a sleeve respectively connected to the closing trigger and the opposite one of the shaft assembly; (ii) a spring, which biases the rod and the sleeve apart; and (iii) a switch assembly, which is selectively activated when the rod and the sleeve are compressed together beyond a predefined distance.

[0156] Embodiment 19

[0157] Embodiment 16: The device of any one of Embodiments 16-18, wherein the notification comprises one of a visual alarm or an audible alarm.

[0158] Embodiment 20

[0159] A magazine for a surgical stapler, the magazine comprising (a) an anvil; (b) a magazine housing, the magazine housing being capable of sliding between an unclamped position and a clamped position relative to the anvil to facilitate selective clamping of patient tissue between the anvil and the magazine housing; and (c) a clamping force sensor, the clamping force sensor comprising a sensing component, a controller for communicating signals with the sensing component, a communication module for facilitating communication with a remote computing device, and a power module for facilitating powering the clamping force sensor, wherein the clamping force sensor is configured to detect a clamping force between the anvil and the magazine housing and to facilitate generating a notification based on the detected clamping force.

[0160] 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.

[0161] 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.

[0162] The surgical instrument systems described herein have been described in conjunction with the deployment and deformation of staples; however, the embodiments described herein are not limited thereto. For example, various embodiments are contemplated that deploy fasteners other than staples, such as clamps or tacks. In addition, various embodiments are contemplated that utilize any suitable device for sealing tissue. For example, an end effector according to various embodiments may include an electrode configured to heat and seal tissue. Additionally, for example, an end effector according to certain embodiments may apply vibration energy to seal tissue.

[0163] 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 operator 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.

[0164] 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.

[0165] 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 handle assembly comprising a closure trigger pivotable between a release position and an actuated position; (b) shaft assembly; (c) an end effector coupled to the shaft assembly and comprising a cartridge, the cartridge comprising an anvil and a cartridge housing, the cartridge housing being slidable relative to the anvil between an unclamped position and a clamped position to facilitate selective clamping of patient tissue between the anvil and the cartridge housing; and (d) a clamping force sensor associated with the end effector and configured to detect a clamping force between the anvil and the cartridge housing and facilitate generating a notification based on the detected clamping force.

2. The device according to claim 1, wherein The clamping force sensor includes a sensing component, a controller in signal communication with the sensing component, a communication module to facilitate communication with a remote computing device, and a power module to facilitate powering the clamping force sensor.

3. The apparatus according to claim 2, wherein: (a) the end effector further comprises a support structure configured to facilitate selective retention of the cartridge, (b) the clamping force sensor is coupled to the support structure such that the sensing component is located at a distal end of the end effector adjacent to the anvil, and (c) The controller, the communication module and the power module are located at a proximal end of the end actuator adjacent to the cartridge housing.

4. The device according to claim 3, wherein: The sensing component, the controller, the communication module, and the power module are disposed within a housing that is releasably coupled to the support structure.

5. The device according to claim 4, wherein: The housing is releasably coupled to the support structure using an adhesive.

6. The apparatus of claim 5 in combination with an applicator configured to releasably grasp the housing to facilitate selective mounting of the housing on the support structure.

7. The device according to claim 5, wherein: The sensing component includes a strain gauge, the power module includes a battery, and the communication module includes a wireless communication module that facilitates wireless communication with the remote computing device.

8. The device according to claim 3, wherein: The support structure defines an internal chamber, and the sensing component, the controller, the communication module, and the power module are disposed within the internal chamber.

9. The apparatus of claim 8, wherein: (i) the sensing component is located at a distal end of the end effector adjacent to the anvil and the controller, (ii) the communication module and the power module are located at a proximal end of the end effector adjacent to the cartridge housing, and (iii) The sensing component is coupled to the communication module via a wire extending between the sensing component and the communication module, and the sensing component is disposed in the internal chamber.

10. The device according to claim 8, wherein: The sensing component includes a strain gauge, the power module includes a battery, and the communication module includes a wireless communication module that facilitates wireless communication with the remote computing device.

11. The device according to claim 2, wherein: The sensing component, the controller, the communication module and the power module are connected to the warehouse.

12. The apparatus of claim 11, wherein: (i) the bin housing defines a first interior chamber, and (ii) The controller, the communication module and the power module are disposed in the first internal chamber.

13. The device according to claim 12, wherein: The sensing component is coupled to the anvil.

14. The apparatus of claim 13, wherein: (i) the anvil defines a second interior chamber, (ii) the sensing component is disposed within the first internal chamber, and (iii) The sensing component is coupled to the communication module via a wire extending between the first internal chamber and the second internal chamber.

15. The apparatus according to claim 11, wherein: The sensing component includes a strain gauge, the power module includes a battery, and the communication module includes a wireless communication module that facilitates wireless communication with the remote computing device.

16. A device comprising: (a) a handle assembly comprising a closure trigger pivotable between a release position and an actuated position; (b) shaft assembly; (c) an end effector coupled to the shaft assembly and comprising an anvil and a cartridge housing, the cartridge housing being slidable relative to the anvil between an unclamped position and a clamped position to facilitate selective clamping of patient tissue between the anvil and the cartridge housing; and (d) a clamping force sensing connection operably connected to the shaft assembly and the closing trigger such that pivoting of the closing trigger from the released position to the actuated position facilitates actuating the end actuator from the unclamped position to the clamped position via the clamping force sensing connection and the shaft assembly, wherein the clamping force sensing connection is configured to detect a force applied by the closing trigger to the end actuator to facilitate generating a notification based on the detected force.

17. The device according to claim 16, wherein: The clamping force sensing connection is configured to facilitate generating an alarm when the detected force exceeds a threshold value.

18. The apparatus according to claim 17, wherein: The clamping force sensing connection member comprises: (i) a rod and a sleeve, the rod and the sleeve are respectively connected to the opposite one of the closure trigger and the shaft assembly; (ii) a spring biasing the rod and the sleeve apart; and (iii) a switch assembly that is selectively activated when the rod and the sleeve are compressed together beyond a predefined distance.

19. The apparatus according to claim 16, wherein: The notification includes one of a visual alarm or an audible alarm.

20. A cartridge for a surgical stapler, the cartridge comprising: (a) anvil; (b) a cartridge housing slidable relative to the anvil between an unclamped position and a clamped position to facilitate selective clamping of patient tissue between the anvil and the cartridge housing; and (c) A clamping force sensor comprising a sensing component, a controller for signal communication with the sensing component, a communication module for facilitating communication with a remote computing device, and a power module for facilitating powering the clamping force sensor, wherein the clamping force sensor is configured to detect the clamping force between the anvil and the chamber housing and to generate a notification based on the detected clamping force.

Images