Smart anvil for circular surgical stapler

Abstract

A surgical instrument includes a body assembly, a shaft assembly, a stapling head assembly disposed at a distal end of the shaft assembly, and an anvil. The stapling head assembly has a platform member and a closing shaft movable relative to the platform member. The anvil includes a head, a shank, a biasing body, and an electronics unit having a distance sensor. The head and the handle are movable relative to each other. The biasing body is interposed between the head and the shank at a known spring constant. The distance sensor is capable of measuring a relative distance between the handle and the head while the electronics unit is capable of communicating a parameter associated with the relative distance to a console.

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 head, handle and shield surrounding certain electronic components of the anvil;

[0019] Fig. 9 Shows Figure 8 Another exploded perspective view of the anvil of the embodiment of the present invention, wherein the shank is partially inserted into the central through hole of the head;

[0020] Fig. 10AShown is the first segment of the digestive tract. Figure 8 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;

[0021] Fig. 10B Shown is the first segment of the digestive tract. Figure 8 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;

[0022] Fig. 10C Shown is the first segment of the digestive tract. Figure 8 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;

[0023] Fig. 10D Shown is the first segment of the digestive tract. Figure 8 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 handle of the anvil is actuated proximally relative to the head of the anvil, thereby compressing a spring interposed therebetween;

[0024] Fig. 10E Shown is the first segment of the digestive tract. Figure 8 The anvil and the anvil positioned in the second segment of the digestive tract Figure 4 A cross-sectional side view of a suture head assembly, wherein Fig. 10D The spring expands to drive the handle of the anvil distally relative to the head of the anvil;

[0025] Fig.10F Shown is the first segment of the digestive tract. Figure 8 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;

[0026] Fig.11 shows a cross-sectional side view of an alternative anvil having a head, stem, shield, and pressure measurement assembly surrounding certain electronic components of the anvil;

[0027] Fig.12 Shows the measurement Fig.11 A perspective view of an assembly of a pressure sensor;

[0028] Fig.13A Shown is the first segment of the digestive tract. Fig.11 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 an anvil is secured to the stapling head assembly;

[0029] Fig. 13B Shown is the first segment of the digestive tract. Fig.11 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;

[0030] Fig. 13C Shown is the first segment of the digestive tract. Fig.11 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 wherein the anvil is retracted toward the stapling head assembly thereby clamping tissue between the anvil and the stapling head assembly, wherein the pressure measurement assembly extends away from the head of the anvil thereby indicating a decrease in clamping pressure;

[0031] Fig.13D Shown is the first segment of the digestive tract. Fig.11 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 further retracted toward the stapling head assembly, thereby further clamping the tissue between the anvil and the stapling head assembly;

[0032] Fig.13E Shown is the first segment of the digestive tract. Fig.11 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;

[0033] Fig.14 shows a side elevation view of an alternative suturing head assembly;

[0034] Fig.15 shows a perspective view of a load cell positioned within an alternative handle assembly; and

[0035] Fig.16 A perspective view of another load sensor positioned within another alternative handle assembly is shown.

[0036] 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

[0037] 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.

[0038] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator grasping a surgical instrument having a distal surgical end effector. The term "proximal" refers to a position where an element is disposed closer to the surgeon, and the term "distal" refers to a position where an element is disposed closer to the surgical end effector of the surgical instrument and further away from the surgeon. In addition, to the extent that spatial terms such as "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.

[0039] I. Overview of Exemplary Circular Surgical Stapling Instruments

[0040] 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.

[0041] 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.

[0042] 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.

[0043] A. Illustrative Anvil

[0044] 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).

[0045] 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).

[0046] B. Exemplary Suturing Head Assembly

[0047] 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.

[0048] 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).

[0049] 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).

[0050] 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.

[0051] 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.

[0052] 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).

[0053] 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.

[0054] C. Exemplary Shaft Assemblies

[0055] 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.

[0056] 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).

[0057] 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).

[0058] D. Exemplary Handle Assembly and User Input Features

[0059] 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).

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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).

[0064] E. Exemplary Anastomosis Procedure Using a Circular Stapling Instrument

[0065] 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.

[0066] 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.

[0067] 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).

[0068] 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).

[0069] 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).

[0070] 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 motion, this gasket (417) is disconnected by the knife member (340). When the knife member (340) reaches the end of its distal motion, 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.

[0071] 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).

[0072] 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).

[0073] II. Exemplary Wirelessly Powered Anvils and Methods of Use

[0074] In some cases, it may be beneficial to transmit tissue compression data and / or visual data from the anvil to a controller that may be contained within the remainder of the surgical stapler or outside the surgical stapler. In addition, it may also be beneficial to transmit tissue compression data and / or visual data remotely from the anvil to a control center or a receiver.

[0075] As mentioned above, some features provide a method to confirm that the anvil is connected to the trocar, while other features provide a method to measure the extent 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, before firing or driving the staple, it is desirable to have the ability to visually confirm that the trocar is properly connected to the anvil and that the tissue is properly compressed between the platform surface and the lower anvil surface, either alone or in addition. For example, in some cases, the tissue may be inserted between the trocar (330) and the pivot latch member (430) so that when the pivot latch member (430) provides tactile feedback via engagement with the trocar (330), the tissue is still inserted between the two. In this case, when the anvil (400) is actuated toward the platform surface (320), the trocar (330) and the pivot latch member (430) may slide relative to each other so as to define a suitable gap distance between the two while clamping the tissue. As another example, in some cases, tissue between the proximal surface (412) and the platform surface (320) of the anvil (400) may not be in continuous annular engagement with the surfaces (412, 320) of sufficient thickness (i.e., when the tissue is clamped, the tissue is not interposed between portions of the surfaces (412, 320) that are directly adjacent to each other). In such cases, if the device is fired to staple and sever tissue, the recently formed anastomosis may leak due to gaps in the grasped tissue and / or excessive thinness of the tissue at certain locations.

[0076] In some cases, it may be desirable to confirm that the tissue compression between the surfaces (412, 320) has not deviated by an undesirable amount from the moment when the appropriate gap distance is generated and the device is fired to suture and cut the tissue. In some cases, the tissue held between the surfaces (412, 320) may be "squeezed out" due to prolonged exposure to the compressive force, thereby releasing the retained fluid. If the held tissue releases too much fluid, the tissue compression force may deviate from the moment when the appropriate gap distance is generated, which may result in less than ideal nail formation quality.

[0077] 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 10F An exemplary alternative anvil constructed and operated in this manner is shown, as described in more detail below.

[0078] A. Wireless Power Anvil

[0079] Figures 8 to 10FAn exemplary anvil (500) 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 (500) can be used with stapling head assembly (300) in place of anvil (400).

[0080] The anvil (500) includes a head (510), a handle (520), a biasing element in the form of a multi-wave spring (526), ​​and an electronic unit (540) associated with a portion of the handle (520). As will be described in more detail below, the electronic unit (540) is configured to capture visual images when the anvil (500) is coupled to the trocar (330) and actuated toward the nail platform (320) to compress tissue according to the description herein; and communicate the captured visual images to a suitable controller (such as a surgeon's console having computing capabilities and a display screen). In addition, according to the description herein, the electronic unit (540) together with the multi-wave spring (526) is configured to measure tissue compression applied by the anvil (500) and the nail platform (320) on the grasped tissue; and communicate the measured tissue compression data to a suitable controller (such as a surgeon's console having computing capabilities and a display screen).

[0081] The head (510) and the handle (520) may be substantially similar to the head (410) and the handle (420) described above, but with the differences detailed below. The head (510) includes a proximal surface (512) that defines a plurality of staple forming pockets (514) (see FIG. 10A to FIG. 10F ) and an annular recess (519); they can be substantially similar to the proximal surface (412), nail forming recess (414) and annular recess (418) described above, respectively, but with the differences detailed herein. Thus, the proximal surface (512) of the head (510) can be used in conjunction with the nail platform (320) to appropriately compress tissue; while the nail forming recess (514) can deform the generally "U"-shaped nail into a "B"-shaped nail. The head (510) also includes a distal surface (502). A shield (516) is attached to the head (510) to accommodate the spring (526) and the electronic unit (540). The head (510) also defines a pair of lateral through holes (517) that are sized to receive the side cameras (554) of the electronic unit (540); and a central through hole (515) that is sized to receive the handle (520). The head (510) also includes a distal surface (502). The distal surface (502) and the shield (516) cooperatively define an interior (518) that slidably receives the electronics unit (540).

[0082] Additionally, the handle (520) defines a central aperture (522) and a pair of lateral openings (524) that receive respective pivoting latch members (530) (see FIG. 10A to FIG. 10F ); they may be substantially similar to the aperture (422), lateral openings (424), and pivoting latch member (430) described above, but with the differences detailed herein. Thus, central aperture (522) may receive trocar (330), while pivoting latch member (530) may act as a retaining clip to allow anvil (500) to be removably secured to trocar (330).

[0083] Spring (526) is interposed between head (510) and handle (520) and allows head (510) and handle (520) to move along longitudinal axis LA (see Fig. 9 ) translate relative to each other. The ends of spring (526) are fixed to corresponding portions of head (510) and handle (520), and this translation of head (510) and handle (520) relative to each other drives spring (526) to compress and / or expand from its rest length. Spring (526) is coupled to head (510) and handle (520) by any suitable means, which will be apparent to those skilled in the art in view of the teachings herein. For example, the ends of spring (526) may be welded to corresponding portions of head (510) and handle (520).

[0084] The spring (526) has a known spring constant such that a change in the length of the spring (526) from its rest length indicates the force acting on the spring (526). Since the spring (526) couples the handle (520) to the head (510), when the handle (520) is pulled proximally via the trocar (330) to drive the proximal surface (512) of the head (510) against the platform member (320) to clamp tissue, the clamped tissue applies a reaction force to the head (510), which in turn drives the head (510) to translate relative to the handle (520). The reaction force provided by the clamped tissue indicates the tissue compression force applied by the head (510) and the platform member (320) on the grasped tissue.

[0085] Using the known spring constant of the spring (526), ​​the distance that the head (510) moves relative to the handle (520) when grasping the tissue can be used to calculate the compressive force applied by the head (510) and the platform member (320) on the grasped tissue. As described above, if the tissue is clamped between the head (510) and the platform member (320) for a long time, the fluid retained in the tissue may begin to "squeeze out" and leave the clamped tissue. This tissue squeeze-out may result in a reduction in the tissue compression force applied to the tissue by the head (510) and the platform member (320). The reduction in tissue compression force causes the length of the spring (526) to increase. As will be described in more detail below, the electronic unit (520) is configured to be able to measure these changes in the distance between the head (510) and the handle (520) so as to provide the ability to calculate tissue compression forces via the known spring constant of the spring (526).

[0086] The electronics unit (540) is attached to the handle (520) and is housed within an interior recess (518) defined by a shield (516) secured to the head (510). Thus, when the handle (520) is actuated relative to the head (510) as described herein, so is the electronics unit (540). The electronics unit (540) includes a control unit (542), a wireless transmitter (544), a battery (546), a base (548), at least one distance sensor (550) (see FIG. 10A to FIG. 10F ), a bore camera (552) and a pair of side cameras (554). The control unit (542), wireless transmitter (544) and battery (546) are each in appropriate communication with each other.

[0087] The battery (546) is configured to be capable of supplying power to the necessary components of the electronic unit (540), such as the cameras (552, 554), the distance sensor (550), the wireless transmitter (544), and the control unit (542). The battery (546) may include any suitable components, as will be apparent to those skilled in the art in view of the teachings herein. In some cases, the battery (546) may be connected to a switch (or other suitable mechanism) that is configured to selectively activate the battery (546) so that a user can selectively activate the electronic unit (540). Such a switch may be present on an outer surface of the shield (516) or in any other suitable location. Thus, the user may activate the electronic unit (540) prior to illustrative use. Of course, the battery (546) may be configured to be capable of activating the electronic unit (540) in response to any other suitable activation method, as will be apparent to those skilled in the art in view of the teachings herein.

[0088] The control unit (542) is configured to appropriately process data from the cameras (552, 554) and the distance sensor (550) as described herein, while the wireless transmitter (544) is configured to appropriately transmit information (e.g., visual images, changes in the length of the spring (526), ​​tissue compression between the proximal surface (512) and the platform member (520), etc.) between the control unit (542) and a suitable controller (such as a surgeon's console with computing capabilities and a display screen). The control unit (542) and the wireless transmitter (544) include any suitable electronic components necessary to perform the functions described herein. The control unit (542) may include a printed circuit board (PCB), appropriate memory, and / or appropriate processing devices to function as described herein. The wireless transmitter (544) may include a Bluetooth transmitter, Wi-Fi, or any other suitable wireless technology, as will be apparent to those skilled in the art based on the teachings herein.

[0089] like FIG. 10A to FIG. 10F As best shown in FIG. 5 , the distance sensor (550) is located on the underside of the base (548) such that the distance sensor (550) faces the distal surface (502) of the head (510). The distal surface (502) of the head includes at least one reference (504) aligned with the repeating distance sensor (550). The distance sensor (550) is configured to measure the distance between itself and the reference (504) of the distal surface (502). Therefore, the distance sensor 550 is configured to measure the relative movement between the head (510) and the handle (520). As described above, the distance between the head (510) and the handle (520) can be used to determine the tissue compression force applied to the grasped tissue between the proximal surface (512) and the platform member (320) via the known spring constant of the spring (526). Therefore, the measurement results of the distance sensor (550) can be used to determine the tissue compression force applied to the grasped tissue.

[0090] The distance sensor (550) is configured to communicate the measurement to the control unit (542), which can appropriately process the measurement and transmit the processed measurement to the wireless transmitter (544). In some cases, the control unit (542) has a stored value of the spring constant of the spring (526) and can calculate the tissue compression distribution based on the length and spring constant of the spring (526). The wireless transmitter (544) is configured to send the processed measurement to a suitable controller (such as a surgeon's console with computing capabilities and a display); the controller can then further process the measurement to display or otherwise communicate tissue compression data based on the length and spring constant of the spring (526), ​​thereby enabling the user to make an informed decision in the preparation of the firing device (10).

[0091] The distance sensor (550) and the reference (504) may include any suitable components, as will be apparent to those skilled in the art based on the teachings herein. For example, the distance sensor (550) may be a Hall effect sensor, and the reference (504) may be a magnet. For another example, the distance sensor (550) may be a light sensor, and the reference (504) may be a reflective surface.

[0092] The central camera (552) extends from the underside of the base (548) and is located within the central hole (522) of the handle (522). The central camera (552) is configured to capture images of objects located within the central hole (522) and extending away from the central hole. The camera (552) communicates with the control unit (542) so that the control unit (542) appropriately processes the image and transmits the processed image to the wireless transmitter (544). The wireless transmitter (544) is configured to send the processed image to a suitable controller (such as a surgeon's console having computing power and a display screen); the console can then further process the image so as to display the image on the display screen. The central camera (552) may include a light source configured to illuminate objects within the image captured from the camera (552).

[0093] The user may utilize images captured from camera (552) in order to ensure that pivoting latch member (530) is properly coupled to trocar (330) during exemplary use. Images from camera (552) may be helpful in assisting the user in docking trocar (330) with handle (520). Additionally, once coupled together, the user may confirm that tissue or other objects are not interposed between pivoting latch member (530) and trocar (330). Thus, the user may visually confirm the coupling between latch member (530) and trocar (330); rather than relying solely on audible / tactile feedback provided by latch member (530) engaging trocar (330).

[0094] A lateral camera (554) also extends from the underside of the base (548) and is located within a corresponding lateral through hole (517) defined by the head (510). According to the description herein, the lateral camera (554) is configured to capture an image of an object positioned adjacent to the platform member (320) when the anvil (500) is coupled to the trocar (330). The camera (554) communicates with the control unit (542) so that the control unit (542) appropriately processes the image and transmits the processed image to the wireless transmitter (544). The wireless transmitter (544) is configured to transmit the processed image to a suitable controller (such as a surgeon's console having computing power and a display screen); the console can then further process the image so as to display the image on the display screen.

[0095] During exemplary use, side-pointing camera (554) is configured to capture the annular portion of platform member (320) intended to engage tissue in order to properly perform a fluid-tight anastomosis. Thus, a user can confirm that sufficient tissue is placed between platform member (320) and proximal surface (512) in order to form a suitable anastomosis.

[0096] The camera (554) includes a light source that is configured to illuminate tissue resting on the platform member (320) during exemplary use. The light irradiated from the camera (554) can be strong enough to transmit thin tissue portions, thereby allowing a user to identify thin tissue portions resting on the platform member (320). Such thin tissue portions may not easily form a fluid-tight anastomosis because thin tissue may be easily damaged after suturing and cutting. Therefore, the light emitted from the camera (554) can allow the user to adjust the tissue placement between the platform member (320) and the proximal surface (512) to help obtain the appropriate tissue thickness.

[0097] FIG. 10A to FIG. 10F An exemplary use of anvil (500) and staple cartridge assembly (300) is shown to perform an anastomosis. Fig. 10A As shown, anvil (500) may be aligned with trocar (330) such that central hole (522) is positioned adjacent to trocar (330). A central camera (552) may be utilized to assist in aligning central hole (522) with trocar (330). Next, as shown in FIG. Fig. 10B As shown, trocar (330) may be inserted into central aperture (522) such that pivoting latch member (530) properly engages trocar (330). Central camera (552) may be utilized to visually confirm that no tissue is interposed between trocar (330) and pivoting latch member (530).

[0098] Next, if FIG. 10C to FIG. 10D As shown, the user can actuate anvil (500) proximally toward platform member (320) so that proximal surface (512) and platform member (320) clamp tissue with increasing clamping force. It should be understood that spring (526) compresses as the clamping force increases. Distance sensor (550) detects the compression of spring (526) as described herein, and control unit (542) uses the known spring constant of spring (526) to determine the tissue compression force applied by anvil (500) and platform member (320) on the grasped tissue. The tissue compression force can be communicated to the user via wireless transmitter (544) in accordance with the teachings herein. In some cases, Fig. 10C The gap distance (d1) shown is maintained with Fig. 10D The gap distance (d2) shown is the same. In other cases, the gap distance (d1, d2) also changes as the clamping force increases.

[0099] In some cases, such as FIG. 10D to FIG. 10E As shown, the tissue compression force can be reduced due to the milking effect. In this case, the tissue compression force can be reduced, thereby allowing the spring (526) to be Fig. 10E The distance sensor (550) detects the extension of the spring (526) as described herein, and the control unit (542) uses the known spring constant of the spring (526) to determine the tissue compression force applied by the anvil (500) and the platform member (320) on the grasped tissue. The user can make necessary adjustments based on this information before firing.

[0100] Next, if Fig.10F Shown, the user can fire the nail and cut off the tissue according to the description of this article. In addition, the user can remove both the anvil (500) and the nail head assembly (300), thereby leaving a complete anastomosis.

[0101] Fig.11 Another exemplary anvil (600) is shown that may be used with instrument (10) to replace anvils (400, 500) described above. Thus, anvil (600) may be substantially similar to anvils (400, 500) described above, but with the differences described in detail below.

[0102] The anvil (600) includes a head (610), a handle (620), a tissue load measurement assembly (660), and an electronics unit (640). As will be described in more detail below, the electronics unit (640), in conjunction with the tissue load measurement assembly (660), is configured to measure tissue forces, pressures, and / or loads applied by the anvil (600) and the staple platform (320) to the grasped tissue as described herein; and to communicate the measured tissue force, pressure, and / or load data to a suitable controller (such as a surgeon's console having computing capabilities and a display screen).

[0103] The head (610) and handle (620) can be substantially similar to the head (410) and handle (420) described above, but with differences as detailed below. In this example, the head (610) and handle (620) are fixed to each other. The head (610) includes a proximal surface (612) that defines a plurality of staple forming pockets (614) and an annular recess (619); they can be substantially similar to the proximal surfaces (412, 512), staple forming pockets (414, 514), and annular recesses (418, 519) described above, respectively, but with differences as detailed herein. Thus, the proximal surface (612) of the head (610) can be used in conjunction with the staple platform (320) to appropriately compress tissue; while the staple forming pockets (614) can deform a generally "U"-shaped staple into a "B"-shaped staple. A shield (616) is attached to the head (610) to accommodate the electronics unit (640). Head (610) also defines a pair of lateral through-holes (617) sized to slidably receive the translating body (654) of the tissue compression measurement assembly (660).

[0104] Additionally, the handle (620) defines a central aperture (622) and a pair of lateral openings (624) that receive respective pivoting latch members (630) (see FIG. 10A to FIG. 10F ); they may be substantially similar to the apertures (422, 522), lateral openings (424, 524), and pivoting latch members (430, 530) described above, but with the differences detailed herein. Thus, central aperture (622) receives trocar (330), while pivoting latch member (630) acts as a retaining clip to allow anvil (600) to be removably secured to trocar (330).

[0105] Electronics unit (640) is attached to shroud (616) within interior recess (618). Electronics unit (640) includes a control unit (642), a wireless transmitter (644), and a battery (646); which may be substantially similar to control unit (542), wireless transmitter (544), and battery (546), respectively, described above, but with the differences detailed below. Thus, battery (646) is configured to be able to power essential components of electronics unit (640) as well as essential components of tissue loading measurement assembly (660).

[0106] The control unit (642) is in communication with the sensor (650) of the tissue loading measurement assembly (660) such that the control unit (642) is configured to receive measurements from the sensor (650) during exemplary use. The control unit (642) is configured to appropriately process data from the sensor (650) as described herein, and the wireless transmitter (644) is configured to appropriately transmit information (e.g., measurements from the sensor (650), etc.) between the control unit (642) and a suitable controller (such as a surgeon's console having computing capabilities and a display screen).

[0107] The tissue load measurement assembly (660) includes a sensor (650), a spring (652) extending proximally for the pressure sensor (650), a translating body (654) attached to the spring (652) and slidably disposed within a lateral through hole (617) of the head (610), and a separation washer (656) attached to the proximal end of the translating body (654). The sensor (650) is configured to measure the force applied to the sensor (650) via the spring (652) and communicate the measurement result to the control unit (642). Fig.12 As shown, the sensor (650) in this example has an annular shape and can measure different forces in different areas along the annular shape. As will be described in more detail below, the force applied to the sensor (650) via the spring (652) indicates the force applied to the tissue grasped between the anvil (600) and the platform member (520). The sensor (650) can be any suitable type of sensor, as will be apparent to those skilled in the art based on the teachings herein. For example, the sensor (650) can be a strain gauge, a pressure gauge, a force sensor, a displacement gauge, a magnetic sensor, an electromagnetic sensor, a resistor, etc.

[0108] The spring (652) is interposed between the sensor (650) and the translation body (654). The spring (652) is directed toward Fig.11The position shown biases the translation body (654) so ​​that the separation gasket (656) is proximal relative to the proximal surface (612) of the head (610). Therefore, when the anvil (610) is combined with the platform member (320) to grasp the tissue according to the description herein, the separation gasket (656) engages the tissue. The translation body (654) is configured to be able to translate relative to the head (610) along the path defined by the through hole (617). The translation body (654) is configured to be able to translate relative to the head (610) in response to the force generated from the separation gasket (656) engaging the tissue, while the proximal surface (612) of the head (610) and the platform member (320) clamp the tissue according to the description herein. This movement of the translating body (652) compresses the spring (652), which in turn applies a force, load, and / or pressure to the sensor (650) (which can be measured by the sensor (650)) that is proportional to the compression applied to the tissue by the separation gasket (656). The measurements from the sensor (650) in response to the separation gasket (656) engaging the tissue can be used to calculate the compressive force, load, and / or pressure distribution applied by the head (610) and platform member (320) on the grasped tissue. This information can be transmitted to a suitable controller (such as a surgeon's console having computing capabilities and a display screen) and displayed to the user, thereby enabling the user to make an informed decision in the preparation of the firing device (10).

[0109] As described above, if tissue is clamped between the head (610) and the platform member (320) for a long time, the fluid retained in the tissue may begin to "squeeze out" and leave the clamped tissue. This tissue squeeze-out may result in a reduction in the tissue compression force applied to the tissue by the head (610) and the platform member (320). The reduction in tissue compression force results in an increase in the length of the spring (652) and a reduction in the measured compression force, load, and / or pressure distribution. The sensor (650) may measure this reduction in compression force, load, and / or pressure distribution and communicate the measurement results to the electronic unit (640); the electronic unit may in turn communicate such measurement results to a suitable controller (such as a surgeon's console having computing power and a display screen), thereby enabling the user to make an informed decision in the preparation of the firing device (10).

[0110] FIG. 13A to FIG. 13E Illustrative use of anvil (600) with cartridge assembly (300) is shown in order to perform a stapling. Fig.13ATrocar (330) is shown inserted into central aperture (622) such that pivot latch member (630) properly engages trocar (330), thereby coupling trocar (330) with anvil (600). With trocar (330) and anvil (600) coupled, a user may actuate anvil (600) proximally toward platform member (320) such that proximal surface (612) and platform member (320) clamp tissue with increased clamping force, as shown. Fig. 13B As shown. It should be understood that when the clamping force increases due to the separation gasket (656) engaging the tissue, the spring (652) is compressed. The separation gasket (656) can engage the tissue and compress the spring (656) until the separation gasket (656) is substantially coplanar with the proximal surface (612). The sensor (650) detects the compression of the spring (656) as described herein, and the control unit (642) determines the tissue compression force, load and / or pressure distribution applied by the anvil (600) and the platform member (320) on the grasped tissue. In accordance with the teachings herein, the tissue compression force, load and / or pressure distribution can be communicated to the user via a wireless transmitter (644), thereby allowing the user to make an informed decision based on the determined tissue compression force, load and / or pressure distribution. As Fig. 13B As shown, a tissue gap distance (d4) is formed.

[0111] In some cases, such as FIG. 13B to FIG. 13C As shown, the tissue compression force can be reduced due to the extrusion effect. In this case, the tissue compression force can be reduced, thereby allowing the spring (656) to be Fig. 13C The spring (656) is extended as shown, thereby creating a smaller clamping distance (d5) between the separation gasket (656) and the platform member (320). The sensor (650) detects the extension of the spring (656) as described herein, and the control unit (642) uses the information from the sensor (650) to determine the new tissue compression force applied by the anvil (600) and the platform member (320) on the grasped tissue. The user can make necessary adjustments based on this information before firing, such as further actuating the anvil (600) toward the platform member (320) until the appropriate tissue compression force, load and / or pressure distribution is achieved, such as Fig.13D Position shown.

[0112] Next, if Fig.13E Shown, the user can fire the nail and cut off the tissue according to the description of this article. In addition, the user can remove both the anvil (600) and the nail head assembly (300), thereby leaving a complete anastomosis.

[0113] Fig.14An alternative outer sheath (210'), main body member (310') and platform member (320') are shown that can be used to replace the outer sheath (210), main body member (310) and platform member (320) described above. A force sensor (700) is interposed between the platform member (320') and the main body member (310') and is configured to detect the compressive force generated by the anvil (400, 500, 600) compressing the tissue against the platform member (320'). The platform member (320') compresses against the main body member (310') in response to the tissue being compressed against the platform member (320'). Therefore, the sensor (700) detects this compression and communicates the measured compression to a suitable controller (such as a surgeon's console with computing power and a display screen). The sensor (702) operates similarly, but measures the compression of the main body member (310') against the outer sheath (210') in response to the tissue being compressed against the platform member (320').

[0114] Figure 15 to Figure 16 Other placements of load sensors (704, 708) are shown that may be respectively placed, wherein load sensors (704, 708) measure compressive forces generated between other mechanical components of handle assembly (100) in response to grasping tissue as described herein. Fig.15 A load cell (704) is shown positioned between a portion of the handle assembly (100) and the rotatable knob (130); Fig.16 A load cell (706) is shown positioned between handle assembly (100) and outer sheath (210).

[0115] III. Example of combination

[0116] 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.

[0117] Example 1

[0118] A surgical stapler comprises: (a) a main body assembly; (b) an axis assembly extending distally from the main body assembly; (c) 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 and a platform member, wherein the closing axis is selectively movable longitudinally relative to the platform member; and (d) an anvil, wherein the anvil comprises: (i) a head, wherein the head comprises a proximal presentation surface defining a plurality of staple forming recesses, wherein the plurality of staple forming recesses are configured to enable staples to be formed, wherein the proximal presentation surface and the platform member of the suturing head assembly are configured to cooperatively grasp tissue; (ii) a handle extending proximally from the head, the handle being configured to selectively couple with the closing axis; (iii) a biasing body having a known spring constant, wherein the biasing body is interposed between the handle and the head so that the handle and the head are configured to move relative to each other; and (iv) an electronic unit comprising a distance sensor configured to measure a relative distance between the handle and the head, wherein the electronic unit is configured to communicate parameters associated with the relative distance to a console.

[0119] Example 2

[0120] A surgical stapler according to Example 1, wherein the electronic unit is fixed relative to the handle.

[0121] Example 3

[0122] A surgical stapler according to embodiment 1 or 2, wherein the distance sensor includes a Hall effect sensor, wherein the distal presentation surface of the head includes a magnet, and the magnet is configured to interact with the Hall effect sensor to measure the relative distance between the handle and the head.

[0123] Example 4

[0124] A surgical stapler according to embodiment 1 or 2, wherein the distance sensor includes a light sensor, wherein the distal presentation surface of the head includes a reflective surface, and the reflective surface is configured to interact with the light sensor to measure the relative distance between the handle and the head.

[0125] Example 5

[0126] A surgical stapler according to any one or more of the preceding embodiments, wherein the electronic unit further comprises a central camera located within a central hole defined by the handle.

[0127] Example 6

[0128] The surgical stapler according to any one or more of the preceding embodiments, wherein the electronic unit further comprises a first lateral camera facing in a proximal direction.

[0129] Example 7

[0130] A surgical stapler according to Example 6, wherein the first lateral camera includes a light source.

[0131] Example 8

[0132] A surgical stapler according to embodiment 7, wherein the electronic unit also includes a second lateral camera facing in a proximal direction.

[0133] Example 9

[0134] The surgical stapler according to any one or more of the preceding embodiments, wherein the biasing body comprises a spring, wherein the spring is secured to the head at a first end, and wherein the spring is secured to the handle at a second end.

[0135] Example 10

[0136] A surgical stapler according to any one or more of the preceding embodiments, wherein the electronic unit includes a control unit, wherein the control unit stores a known spring constant of the biasing body, wherein the control unit is configured to receive a signal from the distance sensor indicating the measured relative distance.

[0137] Embodiment 11

[0138] A surgical stapler according to embodiment 10, wherein the electronic unit further comprises a transmitter configured to transmit a signal received by the control unit.

[0139] Example 12

[0140] A surgical stapler according to Example 11, wherein the electronic unit further comprises a battery configured to supply power to the control unit and the transmitter.

[0141] Embodiment 13

[0142] The surgical stapler according to any one or more of the preceding embodiments, wherein the proximal presentation surface of the anvil comprises an annular shape.

[0143] Embodiment 14

[0144] The surgical stapler according to any one or more of the preceding embodiments, wherein the handle includes a pair of pivoting latch members configured to engage the closure axis.

[0145] Embodiment 15

[0146] The surgical stapler according to any one or more of the preceding embodiments, wherein the closure axis comprises a trocar.

[0147] Example 16

[0148] A surgical stapler, comprising: (a) a main body assembly; (b) a shaft assembly, the shaft assembly extending distally from the main body assembly; (c) a suturing head assembly, the suturing head assembly being arranged at the 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 comprises a closing shaft and a platform member, wherein the closing shaft is selectively movable longitudinally relative to the platform member; and (d) an anvil, the anvil comprising: (i) a head, the head comprising a proximal presentation surface defining a plurality of staple forming recesses, the plurality of staple forming recesses being configured to enable staples to be formed, wherein the proximal presentation surface and the suturing head assembly are ... The platform member of the engaging head assembly is configured to cooperatively grasp tissue; (ii) a handle extending proximally from the head, the handle being configured to be selectively connected to the closing axis; (iii) a translating body, the translating body being configured to translate between a proximal position relative to the proximal presentation surface of the head and a flush position relative to the proximal presentation surface of the head in response to engaging tissue; (iv) a sensor, the sensor being configured to measure a force generated by the translating body engaged with tissue; and (v) an electronic unit, the electronic unit being configured to communicate parameters associated with the measured force of the sensor to a console.

[0149] Embodiment 17

[0150] According to Example 16, the surgical instrument also includes a spring inserted between the translating body and the sensor, wherein the spring biases the translating body into the proximal position.

[0151] Embodiment 18

[0152] A surgical instrument according to embodiment 16 or 17, wherein the translating body also includes a separation washer.

[0153] Embodiment 19

[0154] A surgical instrument according to embodiment 16, 17 or 18, wherein the sensor includes an annular shape.

[0155] Embodiment 20

[0156] A surgical stapler comprises: (a) a body assembly; (b) an axis assembly extending distally from the body assembly; (c) a stapling head assembly disposed at a distal end of the axis assembly, wherein the stapling head assembly is operable to drive a plurality of staples into tissue, wherein the stapling head assembly comprises a closing axis and a platform member, wherein the closing axis is selectively movable longitudinally relative to the platform member; and (d) an anvil, wherein the anvil comprises: (i) a head comprising a proximal presentation surface defining a plurality of staple forming recesses, wherein the plurality of staple forming recesses are configured to form staples, wherein the proximal presentation surface and the platform member of the stapling head assembly are configured to cooperatively grasp tissue; (ii) a handle extending proximally from the head, wherein the handle is configured to selectively couple with the closing axis; (iii) a camera associated with the head and facing in a proximal direction; and (iv) an electronic unit configured to wirelessly communicate images captured by the camera to a console.

[0157] IV. Miscellaneous

[0158] 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.

[0159] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials listed in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein by reference but conflicting with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.

[0160] 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).

[0161] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both, these types can be repaired to be reused after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.

[0162] By way of example only, the types described herein may be sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

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

Claims

1. A 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 and a platform member, wherein the closure shaft is selectively movable longitudinally relative to the platform member; and (d) an anvil, the anvil comprising: (i) a head comprising a proximal presentation surface defining a plurality of staple forming pockets, the plurality of staple forming pockets being configured to enable staple forming, wherein the proximal presentation surface and the platform member of the stapling head assembly are configured to cooperatively grasp tissue; (ii) a handle extending proximally from the head, the handle being configured to be selectively coupled to the closure shaft; (iii) a biasing body having a known spring constant, wherein the biasing body is interposed between the handle and the head such that the handle and the head are configured to move relative to each other; and (iv) an electronics unit comprising a distance sensor configured to measure a relative distance between the handle and the head, wherein the electronics unit is configured to communicate a parameter associated with the relative distance to a console.

2. The surgical stapler according to claim 1, wherein: The electronics unit is fixed relative to the handle.

3. The surgical stapler according to claim 2, wherein: The distance sensor comprises a Hall effect sensor, wherein the distal presentation surface of the head comprises a magnet configured to interact with the Hall effect sensor to measure the relative distance between the handle and the head.

4. The surgical stapler according to claim 2, wherein: The distance sensor comprises a light sensor, and wherein the distal presentation surface of the head comprises a reflective surface configured to interact with the light sensor to measure the relative distance between the handle and the head.

5. The surgical stapler according to claim 1, wherein: The electronics unit also includes a central camera positioned within a central aperture defined by the stem.

6. The surgical stapler according to claim 1, wherein: The electronics unit also includes a first side-pointing camera facing in a proximal direction.

7. The surgical stapler according to claim 6, wherein: The first side-pointing camera includes a light source.

8. The surgical stapler according to claim 7, wherein: The electronics unit further comprises a second side-pointing camera facing in the proximal direction.

9. The surgical stapler according to claim 1, wherein: The biasing body includes a spring, wherein the spring is secured to the head at a first end, wherein the spring is secured to the handle at a second end.

10. The surgical stapler according to claim 1, wherein: The electronic unit comprises a control unit, wherein the control unit stores a known spring constant of the biasing body, wherein the control unit is configured to be able to receive a signal from the distance sensor indicating the measured relative distance.

11. The surgical stapler according to claim 10, wherein: The electronic unit further comprises a transmitter configured to transmit a signal received by the control unit.

12. The surgical stapler according to claim 11, wherein: The electronic unit further comprises a battery configured to be able to power the control unit and the transmitter.

13. The surgical stapler according to claim 1, wherein: The proximal presentation surface of the anvil comprises an annular shape.

14. The surgical stapler according to claim 1, wherein: The handle includes a pair of pivoting latch members configured to engage the closure shaft.

15. The surgical stapler according to claim 1, wherein: The closure axis includes a trocar.

16. 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 and a platform member, wherein the closure shaft is selectively movable longitudinally relative to the platform member; and (d) an anvil, the anvil comprising: (i) a head comprising a proximal presentation surface defining a plurality of staple forming pockets, the plurality of staple forming pockets being configured to enable staple forming, wherein the proximal presentation surface and the platform member of the stapling head assembly are configured to cooperatively grasp tissue; (ii) a handle extending proximally from the head, the handle being configured to be selectively coupled to the closure shaft; (iii) a translating body configured to translate between a proximal position relative to the proximal presentation surface of the head and a flush position relative to the proximal presentation surface of the head in response to engaging tissue; (iv) a sensor configured to measure a force generated by the translating body engaging tissue; and (v) an electronics unit configured to communicate parameters associated with the measured force of the sensor to a console.

17. The surgical instrument of claim 16, further comprising a spring interposed between the translating body and the sensor, wherein The spring biases the translating body into the proximal position.

18. The surgical instrument of claim 16, wherein: The translating body also includes a release washer.

19. The surgical instrument of claim 16, wherein: The sensor comprises a ring shape.

20. 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 and a platform member, wherein the closure shaft is selectively movable longitudinally relative to the platform member; and (d) an anvil, the anvil comprising: (i) a head comprising a proximal presentation surface defining a plurality of staple forming pockets configured to form staples, wherein the proximal presentation surface and the platform member of the stapling head assembly are configured to cooperatively grasp tissue; (ii) a handle extending proximally from the head, the handle being configured to be selectively coupled to the closure shaft; (iii) a camera associated with the head and facing in a proximal direction; and (iv) an electronics unit configured to wirelessly communicate images captured by the camera to a console.

Images