Independent powered anvil for circular surgical stapler

Abstract

A surgical stapler, the surgical stapler comprising: a body assembly; a shaft assembly extending distally from the body assembly; a stapling head assembly disposed at a distal end of the shaft assembly, where the stapling head assembly is operable to drive a plurality of staples into tissue, where the stapling head assembly includes a closure shaft that is selectively longitudinally movable; a stapling apparatus includes a stapling shaft configured to form staples, and an anvil configured to form staples, where the anvil is selectively coupleable with and actuatable by the stapling shaft, where the anvil includes one or more sensors, each sensor configured to detect a parameter associated with at least one of closing or firing of an end effector, and an anvil configured to form staples, where the anvil is selectively coupleable with and actuatable by the stapling shaft, where the anvil includes one or more sensors, each sensor configured to detect a parameter associated with at least one of closing or firing of the end effector; a processor configured to receive a signal from the one or more sensors, where the signal is indicative of a parameter detected by the one or more sensors; a transmitter configured to be capable of transmitting a signal; and a battery configured to be capable of supplying power to the processor.

Description

Background Art

[0001] In some surgical procedures (e.g., colorectal, bariatric, thoracic, etc. related surgeries), portions of a patient's digestive tract (e.g., gastrointestinal tract and / or esophagus, etc.) may be cut and removed to remove unwanted tissue or for other reasons. Once the tissue is removed, the remaining portions of the digestive tract may be joined together in an end-to-end, end-to-side, or side-to-side anastomosis. The anastomosis may provide a substantially unobstructed flow path from one portion of the digestive tract to another portion of the digestive tract without causing any type of leakage at the site of the anastomosis.

[0002] An example of an apparatus that can be used to provide anastomosis is a circular stapler. Some such staplers can operate to clamp tissue layers, cut through the clamped tissue layers, and drive staples through the clamped tissue layers, so that the tissue layers are basically sealed together near the cut ends of the tissue layers, thereby joining the two cut ends of the anatomical cavity together. The circular stapler is configured to be able to cut off tissue and seal tissue substantially at the same time. For example, the circular stapler can cut off the redundant tissue in the annular array of staples at the anastomosis portion, so as to provide a substantially smooth transition portion between the anatomical cavity segments engaged at the anastomosis portion. The circular stapler can be used in laparotomy or endoscopic surgery. In some cases, a part of the circular stapler is inserted through the naturally occurring orifice of the patient.

[0003] Examples of circular staplers are described in the following patents: U.S. Pat. No. 5,205,459, entitled "Surgical Anastomosis Stapling Instrument," issued on April 27, 1993; U.S. Pat. No. 5,271,544, entitled "Surgical Anastomosis Stapling Instrument," issued on December 21, 1993; U.S. Pat. No. 5,275,322, entitled "Surgical Anastomosis Stapling Instrument," issued on January 4, 1994; U.S. Pat. No. 5,285,945, entitled "Surgical Anastomosis Stapling Instrument," issued on February 15, 1994; U.S. Pat. No. 5,292,053, entitled "Surgical Anastomosis Stapling Instrument," issued on March 8, 1994; U.S. Pat. No. 5,292,053, entitled "Surgical Anastomosis Stapling Instrument," issued on August 2, 1994; and U.S. Patent Publication No. 8,910,847, entitled “Low Cost Anvil Assembly for a Circular Stapler,” published on December 16, 2014. The disclosure of each of the above-referenced U.S. patents is incorporated herein by reference.

[0004] Some circular staplers may include an electric actuation mechanism. Examples of circular staplers with electric actuation mechanisms are described in the following patents: U.S. Publication 2015 / 0083772, entitled "Surgical Stapler with Rotary Cam Drive and Return," published on March 26, 2015; U.S. Patent 9,936,949, entitled "Surgical Stapling Instrument with Drive Assembly Having Toggle Features," published on April 10, 2018; U.S. Patent 9,907,552, entitled "Control Features for Motorized Surgical Stapling Instrument," published on March 6, 2018; U.S. Patent 9,713,469, entitled "Surgical Stapler with Rotary Cam Drive," published on July 25, 2017; and U.S. Publication 2017 / 0258471, entitled "Methods and Systems for Performing Circular Stapling," published on September 14, 2017. The disclosures of each of the above-cited US Patent Publications are incorporated herein by reference.

[0005] 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

[0006] While this specification results in claims that particularly point out and distinctly claim such technology, it is believed that such technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein like reference numerals indicate the same elements, and wherein:

[0007] Figure 1 shows a perspective view of an exemplary circular surgical stapler;

[0008] Figure 2 Shows Figure 1 A perspective view of a circular stapler with the battery pack removed from the handle assembly and the anvil removed from the stapling head assembly;

[0009] Figure 3 Shows Figure 1 A perspective view of an anvil of a circular stapler;

[0010] Figure 4 Shows Figure 1A perspective view of a suturing head assembly of a circular stapler;

[0011] Figure 5 Shows Figure 4 An exploded perspective view of a suture head assembly;

[0012] Figure 6 Shows Figure 1 An exploded perspective view of a circular stapler of FIG. 1 , wherein the various parts of the shaft assembly are shown separated from each other;

[0013] Fig. 7A Shown is the first segment of the digestive tract. Figure 3 The anvil and the anvil positioned in the second segment of the digestive tract Figure 4 a cross-sectional side view of a stapling head assembly of , wherein the anvil is separated from the stapling head assembly;

[0014] Figure 7B Shown is the first segment of the digestive tract. Figure 3 The anvil and the anvil positioned in the second segment of the digestive tract Figure 4 a cross-sectional side view of a stapling head assembly of , wherein the anvil is secured to the stapling head assembly;

[0015] Figure 7C Shown is the first segment of the digestive tract. Figure 3 The anvil and the anvil positioned in the second segment of the digestive tract Figure 4 A cross-sectional side view of a stapling head assembly of , wherein the anvil is retracted toward the stapling head assembly, thereby clamping tissue between the anvil and the stapling head assembly;

[0016] Fig.7D Shown is the first segment of the digestive tract. Figure 3 The anvil and the anvil positioned in the second segment of the digestive tract Figure 4 A cross-sectional side view of a suturing head assembly of , wherein the suturing head assembly is actuated to cut and suturing the clamped tissue;

[0017] Fig. 7E Shows Fig. 7A A cross-sectional side view of a first segment and a second segment of the digestive tract of being joined together at an end-to-end anastomosis;

[0018] Figure 8 shows an exploded perspective view of an alternative anvil having a shield surrounding certain electronic components of the anvil;

[0019] Fig.9A Shown in Figure 4 Before the trocar connection of the suture head assembly Figure 8 A perspective view of an anvil showing the shield being partially cut away to reveal enclosed electronic components; and

[0020] Fig. 9B Shown in Figure 4 Before the trocar connection of the suture head assembly Figure 8 Perspective view of the anvil.

[0021] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology 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 technology and, together with the description, serve to explain the principles of the technology; however, it should be understood that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0022] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments and advantages of the present technology will become apparent to those skilled in the art from the following description, which is by way of example, one of the best ways contemplated for implementing the present technology. As will be appreciated, the technology described herein can have other different and obvious aspects, all of which do not depart from the present technology. Therefore, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0023] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to a position where an element is disposed closer to the surgeon, and the term "distal" refers to a position where an element is disposed closer to the surgical end effector of the surgical instrument and further away from the surgeon. In addition, to the extent that spatial terms such as "top," "bottom," "upper," "lower," "vertical," "horizontal," and the like are used herein with reference to the accompanying drawings, it should be understood that such terms are used only for illustrative descriptive purposes and are not intended to be limiting or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.

[0024] I. Overview of Exemplary Circular Surgical Stapling Instruments

[0025] Figure 1 to Figure 2An exemplary circular surgical stapling instrument (10) is shown, which can be used to provide an end-to-end, side-to-side, or end-to-side anastomosis between two segments of an anatomical cavity (such as a portion of a patient's digestive tract). The instrument (10) of this example includes: a body assembly (e.g., a handle assembly (100)); a shaft assembly (200) extending distally from the handle assembly (100); a suturing head assembly (300) at the distal end of the shaft assembly (200); and an anvil (400) configured to be releasably coupled and cooperated with the suturing head assembly (300) to clamp, suturing and cutting tissue. The instrument (10) also includes: a removable battery pack (120) operable to provide power to a motor (160) housed within the handle assembly (100), as will be described in more detail below; and a control module (170) housed within the handle assembly (100) and configured to control the motor (160) based on user input.

[0026] The shaft assembly (200) extends distally from the handle assembly (100) and includes a preformed bend. In some versions, the preformed bend is configured to facilitate positioning of the suture head assembly (300) within the colon of the patient. In view of the teachings herein, various suitable bend angles and radii that can be used will be apparent to those skilled in the art. In some other versions, the shaft assembly (200) is straight, such that the shaft assembly (200) lacks a preformed bend. Various illustrative components that may be incorporated into the shaft assembly (200) will be described in more detail below.

[0027] The suturing head assembly (300) is located at the distal end of the shaft assembly (200). Figure 1 to Figure 2 As shown and as will be described in more detail below, the anvil (400) is configured to be removably coupled to the shaft assembly (200) adjacent to the suturing head assembly (300). Moreover, as will be described in more detail below, the anvil (400) and the suturing head assembly (300) are configured to cooperate to manipulate tissue in three ways, including clamping tissue, cutting tissue, and suturing tissue. The knob (130) at the proximal end of the handle assembly (100) can be rotated relative to the housing (110) to provide precise clamping of tissue between the anvil (400) and the suturing head assembly (300). When the safety trigger (140) of the handle assembly (100) pivots away from the firing trigger (150) of the handle assembly (100), the firing trigger (150) can be actuated to provide cutting and suturing of tissue.

[0028] A. Illustrative Anvil

[0029] As in Figure 3As best seen in the anvil (400) of this example, the anvil (400) includes a head (420) and a handle (410). The head (410) includes a proximal surface (412) that defines a plurality of nail forming pockets (414). In this example, the nail forming pockets (414) are arranged in two concentric annular arrays. In some other versions, the nail forming pockets (414) are arranged in three or more concentric annular arrays. The nail forming pockets (414) are configured to deform the nails when they are driven into the nail forming pockets (414). For example, as is known in the art, each nail forming pocket (414) can deform a generally "U"-shaped nail into a "B"-shaped shape. The proximal surface (412) terminates at an inner edge (416) that defines the outer boundary of an annular recess (418) surrounding the handle (420).

[0030] The handle (420) defines a hole (422) and includes a pair of pivoting latch members (430). The latch member (430) is positioned within the hole (422) so that the distal end is positioned at the proximal end of a transverse opening (424) formed through the side wall of the handle (420). The transverse opening (424) thus provides clearance for the distal end and the latch shelf (436) to deflect radially outward from the longitudinal axis defined by the handle (420). However, the latch member (430) is configured to be able to resiliently bias the distal end and the latch shelf (436) to pivot radially inward toward the longitudinal axis defined by the handle (420). The latch member (430) thus acts as a retaining fixture. This allows the anvil (400) to be removably fixed to an actuable closing member (also referred to as a closing shaft) in the form of a trocar (330) of the suture head assembly (300), as will be described in more detail below. It should be appreciated, however, that latch member (436) is merely optional. Any other suitable components, features, or techniques may be used to removably secure anvil (400) to trocar (330).

[0031] B. Exemplary Suturing Head Assembly

[0032] like Figure 4 and Figure 5As best seen in the drawings, the suture head assembly (300) of the present example is coupled to the distal end of the shaft assembly (200) and includes a main body member (310) and a staple drive member (350) slidably received therein. The main body member (310) includes a cylindrical inner core member (312) extending distally. The main body member (310) is securely fixed to the outer sheath (210) of the shaft assembly (200), and thus the main body member (310) and the outer sheath (210) together serve as a mechanical ground for the suture head assembly (300). In some versions, the suture head assembly (300) can be configured to be releasably coupled to the distal end of the shaft assembly (200), for example, as disclosed in U.S. Patent No. 9,597,081, entitled "Motor Driven Rotary Input Circular Stapler with Modular End Effector," published on March 21, 2017, the disclosure of which is incorporated herein by reference.

[0033] The trocar (330) is coaxially positioned within the inner core member (312) of the main body member (310). As will be described in more detail below, the trocar (330) is operable to translate distally and proximally relative to the main body member (310) in response to the rotation of the knob (130) relative to the housing (110) of the handle assembly (100). The trocar (330) includes a shaft (332) and a head (334). The head (334) includes a pointed end (336) and a proximal surface (338) extending inwardly. Therefore, the shaft (332) provides a reduced outer diameter adjacent to the head (334), wherein the surface (338) provides a transition between the reduced outer diameter of the shaft (332) and the outer diameter of the head (334). Although the end (336) is pointed in this example, the end (336) is not sharp. Thus, the tip (336) will not be susceptible to trauma to tissue due to accidental contact with the tissue. The head (334) and the distal portion of the shaft (332) are configured for insertion into the hole (422) of the anvil (400). The proximal surface (338) and the latch shelf (436) have complementary positions and configurations such that the latch shelf (436) engages the proximal surface (338) when the handle (420) of the anvil (400) is fully seated on the trocar (330). Thus, the anvil (400) is secured to the trocar (330) by the snap fit provided by the latch member (430).

[0034] The staple drive member (350) is operable to longitudinally actuate within the body member (310) in response to activation of the motor (160), as will be described in more detail below. The staple drive member (350) of this example includes two concentric annular arrays presented distally of the staple drivers (352). The staple drivers (352) are arranged to correspond to the arrangement of the staple forming recesses (414) of the anvil (400). Thus, each staple driver (352) is configured to drive the corresponding staple into the corresponding staple forming recess (414) when the suture head assembly (300) is actuated. It should be understood that the arrangement of the staple drivers (352) and the staple forming recesses (414) shown herein can be modified in any suitable manner, provided that the staple drivers (352) and the staple forming recesses (414) are configured to be aligned with each other to provide appropriate staple formation. The staple drive member (350) further defines a bore (354) configured to coaxially receive the core member (312) of the body member (310). An annular array of bolts (356) project distally from a distally presented surface surrounding the bore (354).

[0035] The cylindrical knife member (340) is coaxially positioned within the nail driving member (350). The knife member (340) includes a sharp circular cutting edge (342) presented distally. The size of the knife member (340) is designed to allow the knife member (340) to define an outer diameter that is smaller than the diameter defined by the inner annular array of the nail driver (352). The knife member (340) also defines an opening configured to coaxially receive the core member (312) of the main body member (310). The opening (346) of the annular array formed in the knife member (340) is configured to be complementary to the bolt (356) of the annular array of the nail driving member (350), so that the knife member (340) is securely fixed to the nail driving member (350) via the bolt (356) and the opening (346). By way of example only, the stud (356) can be heat-riveted to the knife member (340) using techniques known in the art. Other suitable structural relationships between knife member (340) and staple drive member (350) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0036] The platform member (320) is securely fixed to the distal end of the body member (310). The platform member (320) includes a platform surface (322) that is presented distally of two concentric annular arrays of nail openings (324). The nail openings (324) are arranged to correspond to the arrangement of the nail drivers (352) and nail forming recesses (414) described above. Therefore, each nail opening (324) is configured to provide a path for the corresponding nail driver (352) to drive the corresponding nail through the platform member (320) and into the corresponding nail forming recess (414) when the suture head assembly (300) is actuated. It should be understood that the arrangement of the nail openings (324) can be modified to correspond to the arrangement of the above-mentioned drivers (352) and nail forming recesses (414). It should also be understood that various structures and techniques can be used to accommodate the nails in the suture head assembly (300) before the suture head assembly (300) is actuated. Such structure and techniques for containing staples within stapling head assembly (300) may prevent staples from inadvertently falling through staple openings (324) before stapling head assembly (300) is actuated. Various suitable forms that such structure and techniques may take will be apparent to those skilled in the art in view of the teachings herein.

[0037] refer to Figure 5 The inner diameter defined by the platform member (320) is only slightly larger than the outer diameter defined by the knife member (340). Therefore, the platform member (320) is configured to allow the knife member (340) to translate distally to a point where the cutting edge (342) is away from the platform surface (322).

[0038] In some versions of the instrument (10), it may be desirable to provide an instrument (10) having features that are configured to indicate whether the anvil (400) is correctly or incorrectly attached to the trocar (330) of the suture head assembly (300). For example, if the anvil (400) is not correctly attached to the trocar (330), the operator may receive audible and / or tactile feedback indicating incorrect attachment. Additionally, if the anvil (400) is correctly attached to the trocar (330), the operator may receive audible, tactile, and / or visual feedback indicating correct attachment. In addition or alternatively, the features may be configured to prevent the suture head assembly (300) from firing unless the anvil (400) is correctly attached to the trocar (330). For example, if the anvil (400) is not correctly attached to the trocar (330), the suture head assembly (300) may be prevented from firing. If the anvil (400) is properly attached to the trocar (330), the firing head suturing head assembly (300) can be activated. Such features may include various types of visual markers, sensors, switches, etc. By way of example only, such features may include features of the type disclosed in the following patents: U.S. Patent No. 10,307,157, entitled "Surgical Stapler with Anvil Seating Detection" published on June 4, 2019 and U.S. Patent Publication No. 2017 / 0258471, entitled "Methods and Systems for Performing Circular Stapling" published on September 14, 2017, the disclosures of which are incorporated herein by reference.

[0039] C. Exemplary Shaft Assemblies

[0040] Figure 6 Various components of the shaft assembly (200) are shown coupling components of the suture head assembly (300) with components of the handle assembly (100). Specifically, and as described above, the shaft assembly (200) includes an outer sheath (210) extending between the handle assembly (100) and the body member (310). In this example, the outer sheath (210) is rigid and includes a preformed curved segment as described above.

[0041] The shaft assembly (200) further includes a trocar actuation rod (220) and a trocar actuation band assembly (230). The distal end of the trocar actuation band assembly (230) is securely secured to the proximal end of the trocar shaft (332). The proximal end of the trocar actuation band assembly (230) is securely secured to the distal end of the trocar actuation rod (220). It should therefore be understood that the trocar (330) translates longitudinally relative to the outer sheath (210) in response to translation of the trocar actuation band assembly (230) and the trocar actuation rod (220) relative to the outer sheath (210). The trocar actuation band assembly (230) is configured to bend so that the trocar actuation band assembly (230) can advance along a preformed curve in the shaft assembly (200) as the trocar actuation band assembly (230) translates longitudinally relative to the outer sheath (210). However, the trocar actuation band assembly (230) has sufficient column strength and tensile strength to transmit distal and proximal forces from the trocar actuation rod (220) to the trocar shaft (332). The trocar actuation rod (220) is rigid. The clamp (222) is securely secured to the trocar actuation rod (220) and is configured to cooperate with complementary features within the handle assembly (100) to prevent the trocar actuation rod (220) from rotating within the handle assembly (100) while still allowing the trocar actuation rod (220) to translate longitudinally within the handle assembly (100). The trocar actuation rod (220) also includes a coarse helical thread (224) and a fine helical thread (226).

[0042] The shaft assembly (200) further includes a suturing head assembly driver (240) slidably received within the outer sheath (210). The distal end of the suturing head assembly driver (240) is fixed to the proximal end of the staple drive member (350). The proximal end of the suturing head assembly driver (240) is fixed to the drive bracket (250) via a pin (242). It should be understood that the staple drive member (350) will translate longitudinally relative to the outer sheath (210) in response to the translation of the suturing head assembly driver (240) and the drive bracket (250) relative to the outer sheath (210). The suturing head assembly driver (240) is configured to bend so that when the suturing head assembly driver (240) is translated longitudinally relative to the outer sheath (210), the suturing head assembly driver (240) can advance along a preformed curve in the shaft assembly (200). However, stapling head assembly driver (240) has sufficient column strength to transmit distal forces from drive bracket (250) to staple driving member (350).

[0043] D. Exemplary Handle Assembly and User Input Features

[0044] like Figure 1As shown, the handle assembly (100) includes a housing (110) and receives a battery pack (120), the housing having a lower portion defining a pistol grip (112) with an oblique orientation and an upper portion supporting a user interface feature (114), as described in more detail below. The handle assembly (100) also includes several features operable to actuate anvil (400) and suture head assembly (300). Specifically, the handle assembly (100) includes a rotatable knob (130), a safety trigger (140), a firing trigger (150), a motor (160), and a motor activation module (180). The knob (130) is coupled to the trocar actuation rod (220) via a nut (not shown) so that the coarse helical thread (224) will selectively engage the threaded engagement feature of the interior of the nut; and so that the fine helical thread (226) will selectively engage the threaded engagement feature within the interior of the knob (130). These complementary structures are configured such that trocar actuation rod (220) will translate proximally first at a relatively slow rate, and then at a relatively fast rate, in response to rotation of knob (130).

[0045] It will be appreciated that when anvil (400) is coupled to trocar (330), rotation of knob (130) will provide a corresponding translation of anvil (400) relative to stapling head assembly (300). It will also be appreciated that knob (130) may be rotated in a first angular direction (e.g., clockwise) to retract anvil (400) toward stapling head assembly (300); and may be rotated in a second angular direction (e.g., counterclockwise) to advance anvil (400) away from stapling head assembly (300). Thus, knob (130) may be used to adjust the gap distance (d) between opposing surfaces (412, 322) of anvil (400) and stapling head assembly (300) until a suitable gap distance (d) is achieved, such as described below. Figure 7C shown.

[0046] The firing trigger (150) is operable to activate the motor (160) to actuate the suture head assembly (300). The safety trigger (140) is operable to selectively obstruct actuation of the firing trigger (150) based on the longitudinal position of the anvil (400) relative to the suture head assembly (300). The handle assembly (100) further includes a component operable to selectively lock both triggers (140, 150) based on the position of the anvil (400) relative to the suture head assembly (300). For example, the safety trigger (140) may be obstructed from rotating from an engaged position to a disengaged position until the position of the anvil (400) relative to the suture head assembly (300) is within a predefined range. Thus, actuation of the firing trigger (150) is obstructed by the safety trigger (140), thereby preventing the firing of the suture head assembly (300) until the anvil position is within a predefined range.

[0047] The firing trigger (150) of the present example includes an integral actuation paddle (not shown) that may be similar to the paddle disclosed in U.S. Patent Publication No. 2017 / 0258471, which is incorporated herein by reference. The paddle is configured to actuate a switch (not shown) of the motor activation module (180) when the firing trigger (150) is pivoted to the firing position. Figure 1 ). The motor activation module (180) is in communication with the battery pack (120) and the motor (160) such that the motor activation module (180) is configured to provide power from the battery pack (120) for activation of the motor (160) in response to the switch of the paddle-actuated motor activation module (180). Thus, the motor (160) will be activated when the firing trigger (150) is pivoted. Such activation of the motor (160) will actuate the suturing head assembly (300) via the drive bracket (250), as described in more detail below. Although not shown, by way of example only, the motor (160) may be operably coupled to the drive bracket (250) via the following components: a gear box coupled to the output shaft of the motor (160), a rotating cam member coupled to the output shaft of the gear box, and a cam follower coupled to the rotating cam member, such as disclosed in U.S. Patent Publication No. 2017 / 0258471, which is incorporated herein by reference.

[0048] like Figure 1 to Figure 2 As best seen in the figure, handle assembly (100) is also configured to releasably receive a battery pack (120) operable to provide power to motor (160), as described above. It should be appreciated that battery pack (120) and handle assembly (100) may have complementary electrical contacts, pins and sockets, and / or other features that provide a path for electrical communication from battery pack (120) to powered components in handle assembly (100) when battery pack (120) is coupled to handle assembly (100). It should also be appreciated that in some versions, battery pack (120) may be integrally integrated within handle assembly (100) such that battery pack (120) cannot be removed from handle assembly (100).

[0049] E. Exemplary Anastomosis Procedure Using a Circular Stapling Instrument

[0050] 7A to 7E An apparatus (10) is shown for forming an anastomosis (70) between two tubular anatomical structures (20, 40). By way of example only, the tubular anatomical structures (20, 40) may include a segment of a patient's esophagus, a segment of a patient's colon, other segments of a patient's digestive tract, or any other tubular anatomical structure. In some versions, one or more diseased portions of a patient's colon are removed, wherein 7A to 7EThe tubular anatomical structure (20, 40) represents the remaining severed portion of the colon.

[0051] like Fig. 7A As shown, anvil (400) is positioned in one tubular anatomical structure (20), and suturing head assembly (300) is positioned in another tubular anatomical structure (40). In versions where tubular anatomical structures (20, 40) include segments of a patient's colon, suturing head assembly (300) may be inserted via the patient's rectum. It should also be understood that 7A to 7E The procedure shown is an open surgical procedure, although the procedure may alternatively be performed laparoscopically. Various suitable ways in which instrument (10) may be used to form anastomosis (70) during laparoscopic surgery will be apparent to those skilled in the art in view of the teachings herein.

[0052] like Fig. 7A As shown, the anvil (400) is positioned in the tubular anatomical structure (20) so that the handle (420) protrudes from the open severed end (22) of the tubular anatomical structure (20). In this example, the purse-string suture (30) is arranged around the middle area of ​​the handle (420) to generally fix the position of the anvil (400) in the tubular anatomical structure (20). In some other variations, the purse-string suture (30) is tightened around the proximal end of the handle (420). In some such variations, the proximal end of the handle (420) may include a notch or other feature to securely capture the purse-string suture (30). Continuing with this example, the suture head assembly (300) is positioned in the tubular anatomical structure (40) so that the cannula needle (330) protrudes from the open severed end (42) of the tubular anatomical structure (20). The purse-string suture (50) is disposed around the middle region of the shaft (332) to substantially fix the position of the suture head assembly (300) in the tubular anatomical structure (40). The suture head assembly (300) is then pushed distally to ensure that the suture head assembly (300) is fully seated at the distal end of the tubular anatomical structure (40).

[0053] Next, anvil (400) is secured to trocar (330) by inserting trocar (330) into aperture (422), as shown. Figure 7B As shown. Latch member (430) engages head (334) of trocar (330), thereby providing a secure fit between anvil (400) and trocar (330). The operator then rotates knob (130) while holding housing (110) stationary via pistol grip (112). This rotation of knob (130) causes trocar (330) and anvil (400) to retract proximally. Figure 7CAs shown, this proximal retraction of the trocar (330) and the anvil (400) compresses the tissue of the tubular anatomical structure (20, 40) between the anvil (400) and the surface (412, 322) of the stapling head assembly (300). When this occurs, the operator can perceive tactile resistance or feedback via the knob (130) when turning the knob (130), wherein such tactile resistance or feedback indicates that the tissue is being compressed. When the tissue is compressed, the operator can visually observe the position of the indicator needle (522) within the user interface feature (114) of the handle assembly (100) to determine whether the gap distance (d) between the anvil (400) and the opposing surface (412, 322) of the stapling head assembly (300) is appropriate; and make any necessary adjustments via the knob (130).

[0054] Once the operator has appropriately set the gap distance (d) via the knob (130), the operator pivots the safety trigger (140) toward the pistol grip (112) to initiate actuation of the firing trigger (150). The operator then pivots the firing trigger (150) toward the pistol grip (112), thereby causing a paddle (not shown) to actuate a switch of the motor activation module (180) and thereby activate the motor (160) to rotate. This rotation of the motor (160) causes actuation (or "firing") of the stapling head assembly (300) by actuating the drive bracket (250) distally, thereby driving the knife member (340) and the staple drive member (350) distally, as shown. Fig.7D As knife member (340) translates distally, cutting edge (342) of knife member (340) cuts excess tissue positioned within annular recess (418) of anvil (400) and the interior of knife member (340).

[0055] like Figure 3 As shown, the anvil (400) of this example includes a breakaway washer (417) positioned within an annular recess (418). Figure 7C The location shown to Fig.7D When the position shown completes the complete distal range of movement, this gasket (417) is disconnected by the knife member (340). When the knife member (340) reaches the end of its distal movement, the feature of the stapler (10) can be configured to provide an increased mechanical advantage, thereby providing a greater force to disconnect the gasket (417). Of course, in some versions, the disconnectable gasket (417) can be completely omitted. In versions that include a gasket (417), it should be understood that the gasket (417) can also serve as a cutting plate for the knife member (340) to help cut tissue.

[0056] When the nail driving member (350) is Figure 7C The location shown to Fig.7DWhen the position shown is translated distally, the staple driving member (350) drives the staples (90) through the tissue of the tubular anatomical structures (20, 40) and into the staple forming recesses (414) of the anvil (400). The staple forming recesses (414) deform the driven staples (90) into, for example, a "B" shape or a three-dimensional shape, so that the formed staples (90) secure the ends of the tissue together, thereby coupling the tubular anatomical structures (20) and (40).

[0057] The operator has Fig.7D After actuating the suturing head assembly (300) as shown, the operator rotates the knob (130) to drive the anvil (400) distally away from the suturing head assembly (300), thereby increasing the gap distance (d) to facilitate the release of tissue between the surfaces (412, 322). The operator then removes the instrument (10) from the patient's body, with the anvil (400) still secured to the cannula needle (330). Referring again to the example in which the tubular anatomical structure (20, 40) includes a segment of the patient's colon, the instrument (10) can be removed via the patient's rectum. With the instrument (10) removed, the tubular anatomical structure (20, 40) is secured together at the anastomosis (70) by two annular arrays of staples (90), as shown. Fig. 7E The inner diameter of the stapling portion (70) is defined by the severed edge (60) left by the knife member (340).

[0058] II. Exemplary Wirelessly Powered Anvils and Methods of Use

[0059] In some cases, it may be beneficial to transmit load and position data from the anvil to a controller that can be housed within the rest of the surgical stapler or external to the surgical stapler, such as the control module / center taught in U.S. Patent No. 11,490,891, entitled "LoadSensor for CircUlar Surgical Staler," published on November 8, 2022, which is hereby incorporated by reference in its entirety. In addition, it may also be beneficial to transmit load and position data remotely from the anvil to a control center or receiver.

[0060] As mentioned above, some features provide a method to confirm that the anvil is connected to the cannula needle, while other features provide a method to measure the degree of staple formation based on the distance between the lower anvil surface having the suture forming recess and the platform surface having the staple opening. In some cases, it is desirable to be able to confirm that the circumferential load applied to the tissue is uniform or substantially uniform before firing or driving the staples, either alone or in addition. In at least some versions, "substantially uniform" means that the load is within an acceptable level of variation, wherein the quality of the suture head assembly (300) actuation avoids defects such as deformed staples; or wherein the washer (417) is not completely destroyed by the knife member (340). In view of the teachings of this article, the substantial uniformity of this aspect will be apparent to those skilled in the art.

[0061] In some such cases, it may be desirable to utilize an anvil that is capable of performing in the manner described above and is furthermore powered independently of the rest of the circular stapler and capable of wirelessly transmitting data to a controller such that the anvil can be used with a variety of different circular staplers. Figures 8 to 9B An exemplary alternative anvil constructed and operated in this manner is shown, as described in more detail below.

[0062] A. Wireless Power Anvil

[0063] Figure 8 An example of anvil (1500) is shown that is configured for use with instrument (10) and is substantially similar to anvil (400) and the anvils described in U.S. Patent No. 11,490,891, which has been incorporated by reference above unless otherwise described below. In some versions, anvil (1500) may be used with stapling head assembly (300) in place of anvil (400).

[0064] The anvil (1500) includes a head (1510) and a handle (1520). The handle (1520) can be selectively coupled to the trocar (330) and can include one or more handle sensors (1522). The handle sensor (1522) can be a strain gauge capable of measuring or determining strain within the handle (1520) when the anvil (1500) compresses the tissue (12) against the platform member (320). The handle sensors (1522) can be equally spaced around the handle (1520) circumferentially so that they can determine a disproportionate amount of strain across the entire cross-section of the handle (1520). The handle sensor (1522) can include a wire or electrical conduit routed distally through a central opening in both the handle (1520) and the head (1510) to a proximal portion of the head (1510). The handle (1520) can include three or more handle sensors (1522). The handle sensor (1522) may include one or more load sensors.

[0065] The head (1510) may include a distal surface that may include one or more head sensors (1502) arranged circumferentially and substantially similar to the strain gauges (1402) of U.S. Patent 11,490,891, incorporated by reference above. The head (1510) may include three or more head sensors (1502). The head sensors (1502) may include one or more load sensors.

[0066] The anvil (1500) may also include a processor (1540), a transmitter (1545), a battery (1550), and a power switch (1570). The processor (1540) may be in electrical communication with each of the handle sensor (1522), the head sensor (1502), the transmitter (1546), the battery (1550), and the power switch (1570). The processor (1540) may be capable of performing the functions of the control module (170) of U.S. Patent 11,490,891. The processor (1540) may be capable of converting signals from the handle sensor (1522), the head sensor (1502), and the battery (1550) into data signals and then transmitting those data signals to the transmitter (1545).

[0067] The head sensor (1502) and the handle sensor (1522) may be substantially similar to the strain gauge (1402) of U.S. Patent No. 11,490,891, in that they may define a load zone. Each load zone corresponds to an area or region surrounding and including a corresponding sensor (1502, 1522). Each sensor (1502, 1522) may be associated with a corresponding load zone and may be operable to detect a parameter associated with the corresponding load zone. By way of example only, the detected parameter may be a strain associated with the corresponding load zone. The head sensor (1502) and the handle sensor (1522) may be capable of measuring strain, which indicates a force applied to the tissue at the head (1510) or the handle (1520) during tissue compression and / or firing, wherein such a force is therefore also experienced by the closing system components and firing system components of the stapler (10). A predetermined threshold may be defined, which represents an acceptable deviation from the median strain measured on all sensors (1502, 1522). In the event that the strain measured by either of sensors (1502, 1522) is outside of this predetermined threshold deviation from the median value, the processor (1540) and / or control module (170) will output a result indicating that uniform loading has not been achieved, or in other words, there is an uneven or non-uniform load applied to the tissue between the anvil (1500) and the platform member (320).

[0068] The transmitter (1545) may be a device capable of receiving data signals from the processor (1540) via an electrical conduit and wirelessly transmitting those data signals to an external control module via a short-range wireless network. By way of example only, the transmitter (1545) may have or Wi-Fi functionality, and may be capable of operating at 2.45 or 5 GHz frequencies. The transmitter (1545) may be located far from the battery (1550) and processor (1540), or located in a manner that the battery (1550) and processor (1540) do not interfere with wireless transmissions.

[0069] The battery (1550) may be in electrical communication with and capable of powering the head sensor (1502), the handle sensor (1522), the processor (1540), the transmitter (1545), and the power switch (1570). The size of the battery (1550) may be smaller than the outer diameter of the head (1510) so that the battery (1550) does not extend from the outer edge of the head (1510). The battery (1550) may include sufficient energy storage to power the anvil (1500) throughout the entire surgery or operation. The battery (1550) may be positioned between the head sensor (1502) and the processor (1540) and may be mounted to the head (1510) so as not to interfere with the reading of the head sensor (1502). To achieve this, the battery (1550) may be spaced apart distally from the head sensor (1502) while still being mounted to the head (1510). Optionally, battery (1550) may be selectively removable and replaceable to allow for continued use of anvil (1500).

[0070] Power switch (1570) may be positioned within or proximal to handle (1520) and directed proximally such that it is configured to be capable of switching on and off based on whether it is in contact with trocar (330) (at Figure 9A-9B) or another feature of the suture head assembly (300) to transition between an electrically open configuration and an electrically closed configuration. In other words, the power switch (1570) can be configured to be able to transition between an open state when the anvil (1500) is coupled to the trocar (330) and a closed state when the anvil (1500) is disconnected from the trocar (330). The power switch (1570) can be a normally open switch or a normally closed switch, and can be a maintained switch or a momentary switch. The electrical contacts of the power switch (1570) can be positioned between the battery (1550) and the remaining electrical components of the anvil (1500). In this way, the power switch (1570) can be transitioned to a closed configuration to power any remaining components, and the anvil (1500) can enter a high power configuration. Alternatively, processor 1540 may be in continuous electrical communication with battery 1550, and processor 1540 may be configured to detect attachment of anvil 1510 to trocar 330, and thereby enter a high power configuration upon detection of such attachment.

[0071] When the anvil (1500) is disconnected from the suture head assembly (300) so that the power switch (1570) does not contact the trocar (330), the anvil (1500) can remain in the low power configuration to save energy and the life of the battery (1550). The high power configuration powers the electronic components of the anvil (1500) and makes them operable. The maintaining type power switch (1570) can be configured to maintain the anvil (1500) in the high power configuration even if the anvil (1500) is subsequently disconnected from the suture head assembly (300). The momentary type power switch (1570) can be configured to enable the anvil (1500) to be converted from the high power configuration to the low power configuration when the anvil (1500) is subsequently disconnected from the suture head assembly (300).

[0072] The anvil (1500) may also include a shield (1562) positioned distally of the head (1510) and sealingly coupled to the head. The shield (1562) may include a circular distal end that can be used to minimize trauma to tissue in the patient's body. The shield (1562) may fluid-seal the distal portion of the head (1410) to prevent the processor (1540), the battery (1550), the transmitter (1555), and the head sensor (1502) from being exposed to external fluids. To prevent fluid from entering, the head (1510) or the shield (1560) may include a seal (1564) between the head (1510) and the shield (1560). The shield (1560) may include one or more shield pins (1562) that fit into the head pin hole (1514) of the head (1510). The shield pins (1562) can assist in the alignment and positioning of the shield (1560) relative to the head (1510). The head pin holes (1514) can be blind holes or through holes in the head (1510). When the head pin holes (1514) are in a through hole configuration, at least one head pin hole (1514) can also be used to ventilate the area within the shield (1560) that accommodates the electronic device. Whether ventilated or not, the anvil (1500) can be sterilized. The shield (1562) can be selectively removed from the head (1510) and includes metal or plastic.

[0073] B. Methods of Using Wireless Powered Anvils

[0074] Fig.9A and Fig. 9B Anvil (1500) is shown coupled to trocar (330) of stapling head assembly (300). Fig.9A As shown, with anvil (1500) and instrument (10) separated, power switch (1570) and the remainder of anvil (1500) may be in a low power configuration such that no wireless or sensor communications are performed. When trocar (330) of instrument (10) is advanced into handle (1520), trocar (330) may depress power switch (1570), such as Fig. 9B Once depressed, power switch (1570) may communicate with the remainder of anvil (1500), thereby transitioning anvil (1500) to a high power configuration, as described above. Once anvil (1500) has entered the high power configuration, the anvil (1500) may be switched back to the high power configuration, even when anvil (1500) and instrument (10) are disconnected, e.g. Fig.9A The anvil may also remain in the high power configuration, even with the arrangement of disconnection shown in FIG. This may help to exhaust any remaining energy in the battery (1550) and ensure a single use of the anvil (1500). Alternatively, the anvil (1500) may return to the low power configuration to maintain the energy in the battery (1550) in order to perform a subsequent procedure.

[0075] III. Example of combination

[0076] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. The following examples are not intended to limit the coverage of any claims that may be proposed 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.

[0077] Example 1

[0078] A surgical stapler comprises: a main body assembly; an axis assembly extending distally from the main body assembly; a suturing head assembly disposed at the distal end of the axis assembly, wherein the suturing head assembly is operable to drive a plurality of staples into tissue, wherein the suturing head assembly comprises a closing axis that is selectively capable of longitudinal movement; and an anvil configured to form staples, wherein the anvil is selectively capable of being coupled to and actuated by the closing axis, wherein the anvil comprises: one or more sensors, each sensor being configured to detect a parameter associated with at least one of the closing or firing of an end effector; a processor configured to receive a signal from the one or more sensors, wherein the signal indicates the parameter detected by the one or more sensors; a transmitter configured to transmit the signal received by the processor; and a battery configured to power the processor and the transmitter.

[0079] Example 2

[0080] A surgical stapler according to Example 1, wherein the one or more sensors include three or more sensors.

[0081] Example 3

[0082] A surgical stapler according to Example 2, wherein the three or more sensors are arranged circumferentially on the anvil to define a plurality of load zones.

[0083] Example 4

[0084] A surgical stapler according to Example 3, wherein each of the three or more sensors is associated with a corresponding one of the multiple load zones, and wherein the parameters detected by each corresponding one of the three or more sensors are associated with the corresponding one of the multiple load zones.

[0085] Example 5

[0086] A surgical stapler according to any of the preceding embodiments, wherein the one or more sensors include one or more strain gauges.

[0087] Example 6

[0088]

[00136] The surgical stapler of Example 5, wherein the parameters sensed by the one or more strain gauges include the strain experienced by the anvil during tissue compression.

[0089] Example 7

[0090] According to the surgical stapler of any of the aforementioned embodiments, the anvil also includes a power switch, which is configured to enable the anvil to transition between a low-power configuration and a high-power configuration, wherein the anvil in the low-power configuration consumes less energy from the battery than the anvil in the high-power configuration.

[0091] Example 8

[0092] A surgical stapler according to Example 7, wherein the power switch is configured to contact the closing axis of the stapling head assembly and thereby transition the anvil from the low-power configuration to the high-power configuration.

[0093] Example 9

[0094] A surgical stapler according to any of the preceding embodiments, wherein the one or more sensors include one or more load sensors.

[0095] Example 10

[0096] A surgical stapler according to Example 9, wherein the parameters detected by the one or more load sensors include the force applied to the tissue during tissue compression.

[0097] Embodiment 11

[0098] The surgical stapler according to any of the preceding embodiments, wherein the one or more sensors are in electrical communication with the processor, and wherein the one or more sensors are configured to transmit one or more signals to the processor.

[0099] Example 12

[0100] A surgical stapler according to Example 11, wherein the processor is configured to compare the one or more signals with a predetermined threshold.

[0101] Embodiment 13

[0102] A surgical stapler according to Example 12, wherein the predetermined threshold comprises a deviation from a median value of the parameter detected by each of the one or more sensors.

[0103] Embodiment 14

[0104] A surgical stapler according to any one of the preceding embodiments, wherein the transmitter is configured to be capable of The signal is transmitted at a frequency.

[0105] Embodiment 15

[0106] A surgical stapler according to any of the aforementioned embodiments, wherein the anvil further comprises a shield, a head and a handle, wherein one or more of the one or more sensors, the processor, the transmitter and the battery are mounted to a distal surface of the head and surrounded by the shield, and wherein the stapling head assembly is configured to be selectively coupled to the handle.

[0107] Example 16

[0108] A surgical stapler according to Example 15, wherein the shield is sealingly connected to the head and is thereby configured to prevent fluid from contacting one or more of the one or more sensors, the processor, the transmitter, and the battery.

[0109] Embodiment 17

[0110] An anvil configured for use with a surgical stapler, the anvil configured to form staples and comprising: one or more sensors, each sensor configured to detect a parameter associated with at least one of closing or firing the surgical stapler; a processor configured to receive a signal from the one or more sensors, wherein the signal indicates the parameter detected by the one or more sensors; a transmitter configured to transmit the signal received by the processor; a battery configured to power the processor and the transmitter; and a power switch configured to transition the anvil between a low-power configuration and a high-power configuration, wherein the anvil in the low-power configuration consumes less energy from the battery than the anvil in the high-power configuration.

[0111] Embodiment 18

[0112] An anvil according to Example 17, wherein the anvil further includes a shield, a head and a handle, wherein one or more of the one or more sensors, the processor, the transmitter and the battery are mounted to a distal surface of the head and surrounded by the shield, and wherein the suturing head assembly is configured to be selectively connected to the handle.

[0113] Embodiment 19

[0114] An anvil configured to be used with a surgical stapler, the anvil comprising: a head configured to form a staple; a handle configured to be coupled to a stapling assembly of the surgical stapler; one or more sensors mounted to the handle or the head, wherein each sensor is configured to detect a parameter associated with at least one of closing or firing the surgical stapler; a processor configured to receive a signal from the one or more sensors, wherein the signal indicates the parameter detected by the one or more sensors; a transmitter configured to transmit the signal received by the processor; a battery configured to power the processor and the transmitter; and a shield configured to cover the processor, the transmitter, and the battery.

[0115] Embodiment 20

[0116] According to the anvil of Example 19, the anvil also includes a power switch, which is configured to enable the anvil to transition between a low-power configuration and a high-power configuration, wherein the anvil in the low-power configuration consumes less energy from the battery than the anvil in the high-power configuration.

[0117] IV. Miscellaneous

[0118] 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.

[0119] 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.

[0120] Versions of the above-described devices may be applied to traditional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into robotic surgical systems, such as those provided by Auris Health, Inc. (Redwood City, Ca) or by Intuitive Surgical, Inc. (Sunnyvale, California).

[0121] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both, these types can be repaired to be reused after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.

[0122] 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.

[0123] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.

Claims

1. A surgical stapler, comprising: (a) Main assembly; (b) a shaft assembly extending distally from the body assembly; (c) a suturing head assembly disposed at a distal end of the shaft assembly, wherein the suturing head assembly is operable to drive a plurality of staples into tissue, wherein the suturing head assembly includes a closure shaft, the closure shaft being selectively movable longitudinally; and (d) an anvil configured to form the staples, wherein the anvil is selectively couplable to and actuatable by the closure shaft, wherein the anvil comprises: (i) one or more sensors, each sensor configured to detect a parameter associated with at least one of closing or firing of the end effector; (ii) a processor configured to receive a signal from the one or more sensors, wherein the signal is indicative of the parameter detected by the one or more sensors; (iii) a transmitter configured to transmit the signal received by the processor; and (iv) a battery configured to power the processor and the transmitter.

2. The surgical stapler according to claim 1, wherein: The one or more sensors include three or more sensors.

3. The surgical stapler according to claim 2, wherein: The three or more sensors are circumferentially arranged on the anvil to define a plurality of load zones.

4. The surgical stapler according to claim 3, wherein: Each of the three or more sensors is associated with a corresponding one of the plurality of load zones, and wherein the parameter detected by each corresponding one of the three or more sensors is associated with the corresponding one of the plurality of load zones.

5. The surgical stapler according to claim 1, wherein: The one or more sensors include one or more strain gauges.

6. The surgical stapler according to claim 5, wherein: The parameters sensed by the one or more strain gauges include the strain experienced by the anvil during tissue compression.

7. The surgical stapler according to claim 1, wherein the anvil further comprises a power switch configured to enable the anvil to transition between a low power configuration and a high power configuration, wherein: The anvil in the low power configuration consumes less energy from the battery than the anvil in the high power configuration.

8. The surgical stapler according to claim 7, wherein: The power switch is configured to contact the closing axis of the stapling head assembly and thereby transition the anvil from the low-power configuration to the high-power configuration.

9. The surgical stapler according to claim 1, wherein: The one or more sensors include one or more load sensors.

10. The surgical stapler according to claim 9, wherein: The parameters detected by the one or more load sensors include the force applied to the tissue during tissue compression.

11. The surgical stapler according to claim 1, wherein: The one or more sensors are in electrical communication with the processor, and wherein the one or more sensors are configured to transmit one or more signals to the processor.

12. The surgical stapler according to claim 11, wherein: The processor is configured to compare the one or more signals to a predetermined threshold.

13. The surgical stapler according to claim 12, wherein: The predetermined threshold comprises a deviation from a median value of the parameter detected by each of the one or more sensors.

14. The surgical stapler according to claim 1, wherein: The transmitter is configured to The signal is transmitted at a frequency.

15. The surgical stapler according to claim 1, wherein: The anvil also includes a shield, a head and a handle, wherein one or more of the one or more sensors, the processor, the transmitter and the battery are mounted to a distal surface of the head and surrounded by the shield, and wherein the suturing head assembly is configured to be selectively coupled to the handle.

16. The surgical stapler according to claim 15, wherein: The shield is sealingly coupled to the head and is thus configured to prevent fluid from contacting one or more of the one or more sensors, the processor, the transmitter, and the battery.

17. An anvil configured for use with a surgical stapler, the anvil configured to form staples and comprising: (a) one or more sensors, each sensor being configured to detect a parameter associated with at least one of closing or firing of the surgical stapler; (b) a processor configured to receive a signal from the one or more sensors, wherein the signal is indicative of the parameter detected by the one or more sensors; (c) a transmitter configured to transmit the signal received by the processor; (d) a battery configured to power the processor and the transmitter; and (e) a power switch configured to enable the anvil to transition between a low power configuration and a high power configuration, wherein the anvil in the low power configuration consumes less energy from the battery than the anvil in the high power configuration.

18. An anvil according to claim 17, wherein: The anvil also includes a shield, a head and a handle, wherein one or more of the one or more sensors, the processor, the transmitter and the battery are mounted to a distal surface of the head and surrounded by the shield, and wherein the suturing head assembly is configured to be selectively coupled to the handle.

19. An anvil configured to be used with a surgical stapler, comprising: (a) a head configured to form a nail; (b) a handle configured to be coupled to a suturing assembly of the surgical stapler; (c) one or more sensors mounted to the handle or the head, wherein each sensor is configured to detect a parameter associated with at least one of closing or firing of the surgical stapler; (d) a processor configured to receive a signal from the one or more sensors, wherein the signal is indicative of the parameter detected by the one or more sensors; (e) a transmitter configured to transmit the signal received by the processor; (f) a battery configured to power the processor and the transmitter; and (g) A shield configured to cover the processor, the transmitter, and the battery.

20. The anvil of claim 19, further comprising a power switch configured to enable the anvil to transition between a low power configuration and a high power configuration, wherein: The anvil in the low power configuration consumes less energy from the battery than the anvil in the high power configuration.

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