Method for controlling end effector closure of a powered surgical stapler

Abstract

An electric surgical stapler includes a motor unit, a movable member, a controller, a sensor assembly, an anvil, and an opposing deck surface. A method of operating a stapler includes controlling the motor unit to actuate the movable member to move from an open position toward a closed position. The method also includes sensing closure data using the sensor assembly. The closure data includes an initial tissue contact position, a gap formed between the anvil and the opposing deck surface, and an axial force on the anvil. The method also includes transmitting the closure data to the controller. The method also includes determining at least one of an adjusted closure rate or an adjusted closure travel using the closure data. The method also includes controlling the motor unit using at least one of the adjusted closure rate or the adjusted closure travel.

Description

Background Technology

[0001] In some surgical procedures (e.g., colorectal, obesity treatment, thoracic, etc.), portions of a patient's digestive tract (e.g., the gastrointestinal tract and / or esophagus) may be cut and removed to remove unwanted tissue or for other reasons. Once the tissue has been removed, the remaining portions of the digestive tract can be joined together via end-to-end, end-to-side, or side-to-side anastomosis. Anastomosis provides a substantially unobstructed flow path from one part of the digestive tract to another and does not cause any type of leakage at the anastomosis site.

[0002] An example of an instrument that can be used to provide anastomosis is a circular suture. Some such sutures are operable to clamp a layer of tissue, cut through the clamped tissue layer, and drive staples through the clamped tissue layer to substantially seal the tissue layer together near the cut ends, thereby joining the two cut ends of an anatomical lumen. Circular sutures are configured to cut and seal the tissue substantially simultaneously. For example, a circular suture can cut excess tissue at the anastomosis site within a circular array of staples to provide a substantially smooth transition between anatomical lumen segments joined at the anastomosis site. Circular sutures can be used in open or endoscopic procedures. In some cases, a portion of the circular suture is inserted through a naturally occurring orifice in the patient.

[0003] Examples of circular suture devices are described in U.S. Patent 5,205,459, entitled "Surgical Anastomosis Stapling Instrument," published April 27, 1993; U.S. Patent 5,271,544, entitled "Surgical Anastomosis Stapling Instrument," published December 21, 1993; U.S. Patent 5,275,322, entitled "Surgical Anastomosis Stapling Instrument," published January 4, 1994; U.S. Patent 5,285,945, entitled "Surgical Anastomosis Stapling Instrument," published February 15, 1994; U.S. Patent 5,292,053, entitled "Surgical Anastomosis Stapling Instrument," published March 8, 1994; and U.S. Patent 5,292,053, entitled "Surgical Anastomosis Stapling Instrument," published August 2, 1994. U.S. Patent 5,333,773 entitled “Surgical Anastomosis Stapling Instrument”, issued September 27, 1994; U.S. Patent 5,350,104 entitled “Surgical Anastomosis Stapling Instrument”, issued July 9, 1996; and U.S. Patent 8,910,847 entitled “Low Cost Anvil Assembly for a Circular Stapler”, issued December 16, 2014. The disclosure of each of the above-cited U.S. patents is incorporated herein by reference.

[0004] Some circular sutures may include electrically actuated mechanisms. Examples of circular sutures with electrically actuated mechanisms are described in the following patents: U.S. Patent Publication 2015 / 0083772, entitled "Surgical Stapler with Rotary Cam Drive and Return," published March 26, 2015; U.S. Patent Publication 2015 / 0083773, entitled "Surgical Stapling Instrument with Drive Assembly Having Toggle Features," published March 26, 2015; U.S. Patent Publication 2015 / 0083774, entitled "Control Features for Motorized Surgical Stapling Instrument," published March 26, 2015; and U.S. Patent Publication 2015 / 0083775, entitled "Surgical Stapler with Rotary Cam Drive," published March 26, 2015. The disclosure of each of the above-cited U.S. patent publications is incorporated herein by reference.

[0005] Although various surgical suturing instruments and associated components have been manufactured and used, it is believed that no one had manufactured or used the invention described in the appended claims before the inventors. Attached Figure Description

[0006] Although this specification provides for claims that specifically point out and expressly declare such technology, it is believed that such technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein similar reference numerals indicate the same elements, and wherein:

[0007] FIG. 1 A perspective view of an exemplary circular surgical suture is shown;

[0008] FIG. 2 It shows FIG. 1 A perspective view of a circular stitcher, in which the battery pack is removed from the handle assembly and the anvil is removed from the stitch head assembly;

[0009] FIG. 3 Show FIG. 1 A perspective view of the anvil of a circular sewing machine;

[0010] FIG. 4 It shows FIG. 1 A perspective view of the suture head assembly of a circular suture device;

[0011] FIG. 5 It shows FIG. 4Exploded perspective view of the sutured head assembly;

[0012] FIG. 6 It shows FIG. 1 An exploded perspective view of a circular stitcher, in which the parts of the shaft assembly are shown separately from each other;

[0013] FIG. 7A It shows FIG. 3 The anvil located in the first segment of the digestive tract and FIG. 4 A cross-sectional side view of the suture head assembly located in the second segment of the digestive tract, wherein the anvil is separate from the suture head assembly;

[0014] FIG. 7B It shows FIG. 3 The anvil located in the first segment of the digestive tract and FIG. 4 A cross-sectional side view of the suture head assembly located in the second segment of the digestive tract, wherein the anvil is fixed to the suture head assembly;

[0015] FIG. 7C It shows FIG. 3 The anvil located in the first segment of the digestive tract and FIG. 4 A cross-sectional side view of the suture head assembly located in the second segment of the digestive tract, wherein the anvil retracts toward the suture head assembly, thereby clamping the tissue between the anvil and the suture head assembly;

[0016] FIG. 7D It shows FIG. 3 The anvil located in the first segment of the digestive tract and FIG. 4 A cross-sectional side view of a suture head assembly located in the second segment of the digestive tract, wherein the suture head assembly is actuated to cut and suture the clamped tissue.

[0017] FIG. 7E It shows FIG. 7A A cross-sectional side view of the first and second segments of the digestive tract joined together at the end-to-end anastomosis.

[0018] FIG. 8 It shows FIG. 1 A perspective view of the user interface features of the handle assembly of a circular stitcher;

[0019] FIG. 9 A perspective view of another exemplary circular surgical suture is shown;

[0020] FIG. 10 It shows FIG. 9 A schematic diagram of a circular suture device, including the control system of the circular surgical suture device;

[0021] FIG. 11 It shows the use of via FIG. 10Control system to control FIG. 9 A schematic view of an exemplary method for using a circular stitcher;

[0022] FIG. 12 It shows the method of adjusting by FIG. 10 The control system executes an actuation algorithm to calibrate FIG. 9 A schematic view of an exemplary method for the closing rate and closing stroke of the movable component of a circular suture;

[0023] FIG. 13 The sutured head assembly and its connection to the head assembly are shown. FIG. 10 The control system is connected to the ground. FIG. 9 A schematic side cross-sectional view of the anvil of a circular suture device, wherein the first and second tissue layers are disposed between the cannula and the platform surface;

[0024] FIG. 14 The display shows FIG. 9 A line graph illustrating the exemplary relationships between the operating elements of a circular stitcher over time, including anvil displacement, blade displacement, and firing load on the motor unit;

[0025] FIG. 15A It shows the method of adjusting by FIG. 10 The control system executes an actuation algorithm to control FIG. 9 A schematic view of the first part of another exemplary method for a circular stitcher; and

[0026] FIG. 15B It shows the control FIG. 15A A schematic view of the second part of an exemplary method for a circular stitcher.

[0027] The accompanying drawings are not intended to be limiting in any way, and various embodiments of the present technology are contemplated to be implemented in a variety of other ways, including those not necessarily shown in the drawings. The drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the present technology and, together with the specification, serve to explain the principles of the present technology; however, it should be understood that the present technology is not limited to the precise arrangement shown. Detailed Implementation

[0028] The following description of certain examples of the present technology is not intended 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 given by way of example, representing 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 are not departing from the present technology. Therefore, the accompanying drawings and descriptions should be considered substantially illustrative rather than restrictive.

[0029] For clarity of disclosure, the terms "proximal" and "distal" are defined herein in relation to a surgeon or other operator holding a surgical instrument with a distal surgical end effector. The term "proximal" refers to a position where the element is positioned closer to the surgeon's placement, and the term "distal" refers to a position where the element is closer to the surgical end effector of the surgical instrument and further away from the surgeon's placement. Furthermore, the extent to which spatial terms such as "top," "bottom," "upper," "lower," "vertical," "horizontal," etc., are used herein with reference to the accompanying drawings should be understood to be for illustrative purposes only and 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.

[0030] I. Overview of an Example Circular Surgical Stapling Instrument

[0031] FIGS. 1-2 An exemplary circular surgical suturing instrument (10) is shown, which can be used to provide end-to-end, side-to-side, or end-to-side anastomosis between two segments of an anatomical lumen, such as a portion of a patient's digestive tract. The example instrument (10) includes a body assembly (e.g., a handle assembly (100)), a shaft assembly (200) extending distally from the handle assembly (100), a suture head assembly (300) located at the distal end of the shaft assembly (200), and an anvil (400) configured to releasably engage and cooperate with the suture head assembly (300) to clamp, suture, and cut 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.

[0032] The shaft assembly (200) extends distally from the handle assembly (100) and includes a pre-formed bend. In some embodiments, the pre-formed bend is configured to facilitate positioning of the suture head assembly (300) within the patient's colon. Various suitable bend angles and radii that may be used will be apparent to those skilled in the art from the teachings herein. In some other embodiments, the shaft assembly (200) is straight, thus lacking the pre-formed bend. Various exemplary components that may be incorporated into the shaft assembly (200) will be described in more detail below.

[0033] The suture head assembly (300) is located at the distal end of the shaft assembly (200). For example... FIGS. 1-2As shown and as will be described in more detail below, the anvil (400) is configured to be removably coupled adjacent to the suture head assembly (300) and the shaft assembly (200). Furthermore, as will be described in more detail below, the anvil (400) and the suture head assembly (300) are configured to cooperate in manipulating tissue in three ways, including clamping, cutting, and suturing. A knob (130) at the proximal end of the handle assembly (100) is rotatable relative to the housing (110) to provide precise clamping of tissue between the anvil (400) and the suture head assembly (300). The firing trigger (150) can be actuated to provide cutting and suturing of tissue when the safety trigger (140) of the handle assembly (100) pivots away from the firing trigger (150) of the handle assembly (100).

[0034] A. Example Anvil

[0035] As in FIG. 3 As best shown, the anvil (400) of this example includes a head (420) and a handle (410). The head (410) includes a proximal surface (412) defining a plurality of nail-forming recesses (414). In this example, the nail-forming recesses (414) are arranged in two concentric annular arrays. In some other forms, the nail-forming recesses (414) are arranged in three or more concentric annular arrays. The nail-forming recesses (414) are configured to deform a nail when it is driven into the nail-forming recess (414). For example, as is known in the art, each nail-forming recess (414) can deform a generally “U”-shaped nail into a “B”-shaped shape. The proximal surface (412) terminates at an inner edge (416) defining the outer boundary of an annular recess (418) surrounding the handle (420).

[0036] A handle (420) defines a hole (422) and includes a pair of pivoting latching members (430). The latching members (430) are located within the hole (422) such that a distal end (434) is positioned at a proximal end of a transverse opening (424) formed through a sidewall of the handle (420). Thus, the transverse opening (424) provides a clearance for the distal end (434) and the latching shelf (436) to deflect radially outward from the longitudinal axis defined by the handle (420). However, the latching members (430) are configured to resiliently bias the distal end (434) and the latching shelf (436) to pivot radially inward toward the longitudinal axis defined by the handle (420). The latching members (430) thus function as a retaining clamp. This allows the anvil (400) to be removably secured to an actuable closure member in the form of a cannula (330) of the suture head assembly (300), as will be described in more detail below. However, it should be understood that the latching member (436) is merely optional. The anvil (400) can be removably secured to the cannula (330) using any other suitable component, feature, or technique.

[0037] B. Example Stapling Head Assembly

[0038] like FIG. 4 and FIG. 5 As most clearly seen, the stitch head assembly (300) of this example is coupled to the distal end of the shaft assembly (200) and includes a body member (310) and a staple driver member (350) slidably housed therein. The body member (310) includes a cylindrical inner core member (312) extending distally. The body member (310) is fixedly attached to the outer sheath (210) of the shaft assembly (200), and the body member (310) and the outer sheath (210) thus together serve as mechanical grounding for the stitch head assembly (300). In some embodiments, the stitch head assembly (300) may be configured to be releasably coupled to the distal end of the shaft assembly (200), for example as disclosed in U.S. Patent 9,597,081 entitled “Motor DrivenRotary Input Circular Stapler with Modular End Effector”, published March 21, 2017, the disclosure of which is incorporated herein by reference.

[0039] The cannula (330) is coaxially positioned within the inner core member (312) of the body member (310). As will be described in more detail below, the cannula (330) is operable to translate distally and proximally relative to the body member (310) in response to rotation of the knob (130) relative to the housing (110) of the shank assembly (100). The cannula (330) includes a shaft (332) and a head (334). The head (334) includes a pointed end (336) and an inwardly extending proximal surface (338). Thus, the shaft (332) provides a reduced outer diameter immediately adjacent to the head (334), wherein the surface (338) provides a transition between this 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. Therefore, the tip (336) will not easily cause tissue trauma due to accidental contact with the tissue. The distal portions of the head (334) and shaft (332) are configured for insertion into the hole (422) of the anvil (400). The proximal surface (338) and 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 cannula (330). Thus, the anvil (400) is secured to the cannula (330) by a snap-fit ​​engagement provided by the latch member (430).

[0040] The staple driver assembly (350) is operable to be longitudinally actuated within the body assembly (310) in response to the actuation of the motor (160), as will be described in more detail below. The staple driver assembly (350) of this example comprises a concentric annular array of staple drivers (352) presented on both distal sides. The staple drivers (352) are arranged to correspond to the arrangement of staple forming recesses (414) of the anvil (400). Thus, each staple driver (352) is configured to drive a corresponding staple into a 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 staple forming recesses (414) shown herein can be modified in any suitable manner, provided that the staple drivers (352) and staple forming recesses (414) are configured to align with each other to provide proper staple formation. The nail driver component (350) also defines a hole (354) configured to coaxially receive the core component (312) of the body component (310). An annular array of bolts (356) protrudes distally from a surface present around the hole (354).

[0041] A cylindrical blade member (340) is coaxially positioned within a nail actuator member (350). The blade member (340) includes a sharp, rounded cutting edge (342) extending distally. The blade member (340) is sized such that it defines an outer diameter smaller than the diameter defined by the inner annular array of the nail actuator (352). The blade member (340) also defines an opening configured to coaxially receive a core member (312) of the body member (310). The openings (346) of the annular array formed in the blade member (340) are configured to complement the bolts (356) of the annular array of the nail actuator member (350), such that the blade member (340) is securely fastened to the nail actuator member (350) via the bolts (356) and the openings (346). By way of example only, the studs (356) may be thermally riveted to the blade member (340) using techniques known in the art. Other suitable structural relationships between the knife member (340) and the nail driver member (350) will be apparent to those skilled in the art, taking into account the teachings herein.

[0042] The platform member (320) is securely fixed to the distal end of the main member (310). The platform member (320) includes a platform surface (322) distally presenting two concentric annular arrays of stab openings (324). The stab openings (324) are arranged to correspond to the arrangement of the stab actuators (352) and stab forming recesses (414) described above. Thus, each stab opening (324) is configured to provide a path for the corresponding stab actuator (352) to drive the corresponding stab through the platform member (320) and into the corresponding stab forming recess (414) when the suture head assembly (300) is actuated. It should be understood that the arrangement of the stab openings (324) can be modified to correspond to the arrangement of the actuators (352) of the stab forming recesses (414) as described above. It should also be understood that various structures and techniques can be used to accommodate the stab within the suture head assembly (300) before the suture head assembly (300) is actuated. Such a structure and technique for housing the staple within the suture head assembly (300) prevents the staple from inadvertently falling out through the staple opening (324) before the suture head assembly (300) is actuated. Various suitable forms of such a structure and technique will be apparent to those skilled in the art in light of the teachings herein.

[0043] like FIG. 9 As is most clearly seen, the platform member (320) defines an inner diameter that is only slightly larger than the outer diameter defined by the blade member (340). Therefore, the platform member (320) is configured to allow the blade member (340) to translate distally to a point where the cutting edge (342) is away from the platform surface (322).

[0044] In some forms of the instrument (10), it may be desirable to provide an instrument (10) with certain features configured to indicate whether the anvil (400) is properly attached to the cannula (330) of the suture head assembly (300). For example, if the anvil (400) is not properly attached to the cannula (330), the operator may receive auditory and / or tactile feedback indicating incorrect attachment. Alternatively, if the anvil (400) is properly attached to the cannula (330), the operator may receive auditory, tactile, and / or visual feedback indicating correct attachment. In addition, or alternatively, the features may be configured to prevent firing of the suture head assembly (300) unless the anvil (400) is properly attached to the cannula (330). For example, firing of the suture head assembly (300) may be prevented if the anvil (400) is not properly attached to the cannula (330). If the anvil (400) is properly attached to the cannula (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 those of the types disclosed in U.S. Patent 10,307,157, entitled “Surgical Stapler with Anvil Seating Detection,” published June 4, 2019, and U.S. Publication 2017 / 0258471, entitled “Methods and Systems for Performing Circular Stapling,” published September 14, 2017, the disclosures of which are incorporated herein by reference.

[0045] C. Example Shaft Assembly

[0046] FIG. 6 Various components of a shaft assembly (200) are shown, which connect the components of the head assembly (300) to the 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 pre-formed curved section as described above.

[0047] The shaft assembly (200) also includes a needle actuator rod (220) and a needle actuator band assembly (230). The distal end of the needle actuator band assembly (230) is securely attached to the proximal end of the needle shaft (332). The proximal end of the needle actuator band assembly (230) is securely attached to the distal end of the needle actuator rod (220). Therefore, it should be understood that the needle (330) translates longitudinally relative to the outer sheath (210) in response to translation of the needle actuator band assembly (230) and the needle actuator rod (220) relative to the outer sheath (210). The needle actuator band assembly (230) is configured to bend such that when the needle actuator band assembly (230) translates longitudinally relative to the outer sheath (210), the needle actuator band assembly (230) can advance along a pre-formed curve in the shaft assembly (200). However, the needle actuation band assembly (230) has sufficient column strength and tensile strength to transmit distal and proximal forces from the needle actuation rod (220) to the needle shaft (332). The needle actuation rod (220) is rigid. A clamp (222) is securely attached to the needle actuation rod (220) and configured to cooperate with complementary features within the shank assembly (100) to prevent rotation of the needle actuation rod (220) within the shank assembly (100) while still allowing longitudinal translation of the needle actuation rod (220) within the shank assembly (100). The needle actuation rod (220) also includes coarse helical threads (224) and fine helical threads (226).

[0048] The shaft assembly (200) also includes a suture head assembly driver (240) slidably received within an outer sheath (210). The distal end of the suture head assembly driver (240) is secured to the proximal end of the staple driver member (350). The proximal end of the suture head assembly driver (240) is secured to the drive bracket (250) via a pin (242). Therefore, it should be understood that the staple driver member (350) will translate longitudinally relative to the outer sheath (210) in response to translation of the suture head assembly driver (240) and the drive bracket (250) relative to the outer sheath (210). The suture head assembly driver (240) is configured to bend such that when the suture head assembly driver (240) translates longitudinally relative to the outer sheath (210), the suture head assembly driver (240) can advance along a preformed curve in the shaft assembly (200). However, the suture head assembly driver (240) has sufficient column strength to transfer distal forces from the drive bracket (250) to the nail driver component (350).

[0049] D. Example Handle Assembly and User Input Features

[0050] like FIG. 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-style grip (112) with a defined tilt 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 the anvil (400) and the stitching 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 connected to a cannula needle actuation rod (220) via a nut (not shown), such that a coarse helical thread (224) selectively engages a threaded engagement feature inside the nut; and a fine helical thread (226) selectively engages a threaded engagement feature inside the knob (130). These complementary structures are configured such that the cannula actuator (220) will translate proximally first at a relatively slow rate and then at a relatively fast rate in response to rotation of the knob (130).

[0051] It should be understood that when the anvil (400) is engaged with the cannula (330), rotation of the knob (130) will provide a corresponding translation of the anvil (400) relative to the suture head assembly (300). It should also be understood that the knob (130) can be rotated in a first angular direction (e.g., clockwise) to retract the anvil (400) toward the suture head assembly (300); and can be rotated in a second angular direction (e.g., counterclockwise) to advance the anvil (400) away from the suture head assembly (300). Therefore, the knob (130) can be used to adjust the gap distance (d) between the opposing surfaces (412, 322) of the anvil (400) and the suture head assembly (300) until a suitable gap distance (d) is achieved, for example, as described below. FIG. 7C As shown.

[0052] The trigger (150) is operable to activate the motor (160), thereby actuating the suture head assembly (300). The safety trigger (140) is operable to selectively prevent actuation of the trigger (150) based on the longitudinal position of the anvil (400) relative to the suture head assembly (300). The shank assembly (100) also includes components 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) can be prevented from rotating from the engaged position to the disengaged position until the position of the anvil (400) relative to the suture head assembly (300) is within a predetermined range. Therefore, until the anvil position is within the predetermined range, actuation of the trigger (150) is prevented by the safety trigger (140), thereby suppressing the firing of the suture head assembly (300).

[0053] The firing trigger (150) of this example includes an integral actuation blade (not shown), which may be similar to the blade disclosed in U.S. Publication 2017 / 0258471, which is incorporated herein by reference above. The blade is configured to actuate the switch of the motor activation module (180) when the firing trigger (150) is pivoted to the firing position. FIG. 1 The motor activation module (180) is connected to 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) to activate the motor (160) in response to the switching of the propeller actuation motor activation module (180). Thus, the motor (160) will be activated when the trigger (150) pivots. This activation of the motor (160) will actuate the stitch head assembly (300) via the drive bracket (250), as described in more detail below. Although not shown, but by way of example only, the motor (160) may be operatively connected to the drive bracket (250) via a gearbox connected to the output shaft of the motor (160), a rotary cam member connected to the output shaft of the gearbox, and a cam follower connected to the rotary cam member, as disclosed, for example, in U.S. Publication 2017 / 0258471, which is incorporated above by reference.

[0054] like FIGS. 1-2As most clearly shown, the handle assembly (100) is also configured to releasably receive a battery pack (120) operable to supply power to the motor (160), as described above. It should be understood that the battery pack (120) and the handle assembly (100) may have complementary electrical contacts, pins and sockets, and / or other features providing a path for electrical communication from the battery pack (120) to the electric components in the handle assembly (100) when the battery pack (120) is engaged with the handle assembly (100). It should also be understood that in some configurations, the battery pack (120) may be integrally integrated within the handle assembly (100) such that the battery pack (120) cannot be removed from the handle assembly (100).

[0055] E. Example Stapling Procedures Utilizing a Circular Stapling Instrument

[0056] FIGS. 7A-7E An instrument (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 segments of the patient's esophagus, segments of the patient's colon, other segments of the patient's digestive tract, or any other tubular anatomical structure. In some configurations, one or more diseased portions of the patient's colon are removed, wherein... FIGS. 7A-7E The tubular anatomical structures (20, 40) represent the remaining cut portions of the colon.

[0057] like FIG. 7A As shown, the anvil (400) is positioned within a tubular anatomical structure (20), and the suture head assembly (300) is positioned within another tubular anatomical structure (40). In the form where the tubular anatomical structures (20, 40) include segments of the patient's colon, the suture head assembly (300) can be inserted via the patient's rectum. It should also be understood that... FIGS. 7A-7E The procedure shown is an open surgical procedure, although it can be performed laparoscopically as an alternative. Based on the teachings herein, the various suitable ways in which the instrument (10) can be used to form an anastomosis (70) in laparoscopic surgery will be apparent to those skilled in the art.

[0058] like FIG. 7AAs shown, the anvil (400) is positioned within the tubular anatomical structure (20) such that the handle (420) protrudes from the open, cut end (22) of the tubular anatomical structure (20). In this example, a purse-string suture (30) is positioned around the central region of the handle (420) to substantially fix the position of the anvil (400) within 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 within the tubular anatomical structure (40) such that the cannula (330) protrudes from the open, cut end (42) of the tubular anatomical structure (20). A purse-string suture (50) is positioned around the middle region of the axis (332) to substantially fix the position of the suture head assembly (300) within the tubular anatomical structure (40). The suture head assembly (300) is then pushed distally to ensure that the suture head assembly (300) is fully positioned at the distal end of the tubular anatomical structure (40).

[0059] Next, the anvil (400) is secured to the cannula (330) by inserting the cannula (330) into the hole (422), as follows: FIG. 7B As shown. The latching member (430) engages the head (334) of the cannula (330), thereby providing a secure fit between the anvil (400) and the cannula (330). The operator then rotates the knob (130) while keeping the housing (110) stationary via the pistol grip (112). This rotation of the knob (130) causes the cannula (330) and the anvil (400) to retract proximally. FIG. 7C As shown, this proximal retraction of the cannula (330) and anvil (400) compresses the tissue of the tubular anatomical structure (20, 40) between the surfaces (412, 322) of the anvil (400) and the suture head assembly (300). When this occurs, the operator can observe tactile resistance or feedback via the knob (130) as the knob (130) is turned, where 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 shank assembly (100) to determine whether the gap distance (d) between the opposing surfaces (412, 322) of the anvil (400) and the suture head assembly (300) is appropriate; and make any necessary adjustments via the knob (130).

[0060] Once the operator has properly set the clearance distance (d) via the knob (130), the operator pivots the safety trigger (140) toward the pistol grip (112) to actuate the firing trigger (150). The operator then pivots the firing trigger (150) toward the pistol grip (112), thereby actuating the switch of the paddle (158) actuating motor activation module (180) and thus activating the rotation of the motor (160). This rotation of the motor (160) actuates (or “fires”) the suture head assembly (300) by actuating the distal actuating drive bracket (250), thereby driving the distal actuating knife member (340) and nail driver member (350), as... FIG. 7D As shown, when the blade member (340) is translated distally, the cutting edge (342) of the blade member (340) cuts the excess tissue located in the annular recess (418) of the anvil (400) and inside the blade member (340).

[0061] like FIG. 3 As shown, the anvil (400) of this example includes a detachable washer (417) positioned within an annular recess (418). When the knife member (340) is removed from... FIG. 7C The position shown is to FIG. 7D When the indicated position completes its full distal range of motion, the washer (417) is disconnected by the blade member (340). When the blade member (340) reaches the end of its distal range of motion, the features of the stapler (10) can be configured to provide an increased mechanical advantage, thereby providing greater force to disconnect the washer (417). Of course, in some configurations, the disconnectable washer (417) can be omitted entirely. In configurations that include the washer (417), it should be understood that the washer (417) can also act as a cutting plate for the blade member (340) to cut the tissue.

[0062] When the nail driver component (350) is from FIG. 7C The position shown is to FIG. 7D As the indicated position is translated distally, the nail driver component (350) drives the nail (90) through the tissue of the tubular anatomical structure (20, 40) and into the nail-forming recess (414) of the anvil (400). The nail-forming recess (414) deforms the driven nail (90) into, for example, a "B" shape or a three-dimensional shape, such that the formed nail (90) secures the ends of the tissue together, thereby connecting the tubular anatomical structure (20) with the tubular anatomical structure (40).

[0063] The operator has already FIG. 7DAfter actuating the suture head assembly (300), the operator rotates the knob (130) to drive the anvil (400) distally away from the suture 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, with the anvil (400) still fixed to the cannula (330). Referring again to the example of tubular anatomy structures (20, 40) including segments of the patient's colon, the instrument (10) can be removed via the patient's rectum. With the instrument (10) removed, the tubular anatomy structures (20, 40) are secured together at the anastomosis (70) by two annular arrays of staples (90), as shown. FIG. 7E As shown. The inner diameter of the anastomosis portion (70) is defined by the cut edge (60) left by the blade member (340).

[0064] F. Example User Interface Features of Handle Assembly

[0065] like FIG. 8 As most clearly seen, the handle assembly (100) of the surgical suture instrument (10) also includes a user interface feature (114) configured to provide the operator with visual feedback during surgery indicating the positioning of the anvil (400) relative to the suture head assembly (300). Thus, the operator can observe the user interface feature (114) while rotating the knob (130) to confirm that the appropriate clearance distance has been achieved between the anvil (400) and the suture assembly (300).

[0066] The user interface feature (114) of this example includes a graphic indicator (500) comprising fixed linear markers (502, 504, 506), a graphic representation of pins (510, 512), and a checkmark graphic (514). The user interface feature (114) also defines a window (520) through which the indicator pins (522) can be viewed. In some variations, the user interface feature (114) also includes a field (530) indicating information such as: the diameter associated with the size of the suture head assembly (300), the size of the pins in the suture head assembly (300), the size of the gap defined between the anvil (400) and the suture head assembly (300), and / or other information. By way of example only, the field (530) may indicate a suture head assembly (300) size of 23 mm, 25 mm, 29 mm, or 31 mm.

[0067] As the operator rotates the knob (130) to adjust the longitudinal position of the anvil (400) relative to the suture head assembly (300), the operator can observe the position of the indicator needle (522) through the window (520). Initially, the indicator needle (522) may be positioned at or near the distal end of the window (520). As the anvil (400) continues to move proximally, the indicator needle (522) will eventually move proximally relative to the window (520). The operator can observe the position of the indicator needle (522) relative to fixed linear markers (502, 504, 506). The distal marker (502) and the proximal marker (506) may indicate the boundary of the “green zone,” which is the acceptable range of distances between the anvil (400) and the suture head assembly (300) for successful actuation of the suture head assembly (300). Therefore, if the indicator needle (522) is located distal to the farthest mark (502), the distance between the anvil (400) and the suture head assembly (300) is too large; while if the indicator needle (522) is located proximal to the nearest mark (506), the distance between the anvil (400) and the suture head assembly (300) is too small. Mark (504) is longitudinally positioned between marks (502, 506). Graphical representation (510) indicates a relatively high anchor (e.g., suitable for relatively thick tissue); while graphic representation (512) indicates a relatively short anchor (e.g., suitable for relatively thin tissue). Thus, graphic representations (510, 512) can, based on tissue observation or other means, facilitate the operator in determining whether and how the desired anchor height is achieved by selecting an appropriate spatial correspondence between the indicator needle (522) and the marks (502, 504, 506).

[0068] In this example, the window (520) is illuminated via a light-emitting diode (LED) (not shown), further enhancing the observation of the indicator needle (522) within the window (520). Furthermore, when the suture head assembly (300) completes the suturing and cutting cycle, the check mark pattern (514) is illuminated via another LED (not shown). Thus, the operator can further rely on the illumination of the check mark pattern (514) to confirm that the suturing and cutting cycle has been completed, thereby verifying that it is safe to advance the anvil (400) distally away from the anastomosis (70) to release tissue and subsequently remove the instrument (10) from the patient.

[0069] The circular surgical suture instrument (10) may be further configured and operated in accordance with at least some of the teachings in U.S. Publication 2017 / 0258471, which is incorporated above by reference.

[0070] II. Example Circular Surgical Stapling Instrument with Independent Control of Closure, Stapling, and Cutting

[0071] In some cases, it may be desirable to provide a type of circular surgical suturing instrument (10) that, in addition to the electric actuation of the internal firing mechanism of the suture head assembly (300), also exhibits electric actuation of the anvil (400). Furthermore, it may be desirable to provide an instrument (10) of such a type having multiple actuators that enable independent electric actuation of the anvil (400), the staple driver assembly (350), and the blade assembly (340), so that the resulting closure, suturing, and cutting strokes performed by such an instrument can be independently controlled in response to user input.

[0072] While the teachings below are disclosed in the context of circular surgical staplers, it should be understood that such teachings may also be applied to other types of surgical staplers. By way of example only, such other staplers may include right-angled surgical staplers of the type disclosed in U.S. Patent 10,045,780, entitled “Method of Applying Staples in Lower Anterior Bowel Resection,” published August 14, 2018, the disclosure of which is incorporated herein by reference.

[0073] A. Overview of Circular Surgical Stapling Instrument with Independently Controlled Actuators

[0074] FIG. 9 An exemplary circular surgical suturing instrument (600) exhibiting the configuration and function described above is shown. It should be understood that, unless otherwise stated below, the instrument (600) is similar to the instrument (10) described above. Similar to the instrument (10), the instrument (600) generally includes a body assembly in the form of a handle assembly (610), a shaft assembly (630) extending distally from the handle assembly (610), a suture head assembly (640) disposed at the distal end of the shaft assembly (630), and an anvil (650) configured to be releasably coupled to an actuable closure member in the form of a cannula (642). The anvil (650) can be selectively retracted and extended relative to the suture head assembly (640) by the cannula (642) to clamp tissue on its distally facing platform surface (644). The suture head assembly (640) is selectively operable to eject staples distally into the clamped tissue and abut against the anvil (650), and to cut the clamped tissue with a cylindrical blade member (not shown) similar to the blade member (340) described above. Thus, the suture head assembly (640) and the anvil (650) cooperate to define an end-actuator suture assembly operable to clamp, suture, and cut tissue in response to user input.

[0075] The handle assembly (610) includes a housing (612) defining a pistol grip (614), a user interface (616) disposed on the upper side of the housing (612) and adjacent to the distal end of the housing (612), and a knob (618) rotatably disposed at the proximal end of the housing (612). Unless otherwise described below, the user interface (616) and knob (618) are similar to the user interface (114) and knob (130) described above. The housing (612) of this example includes an open proximal chamber (not shown) configured to releasably receive and hold a battery pack (620), which is similar to a battery pack (120) and operable as a motor unit (660) housed within the housing (612) (see See FIG. 10 )powered by.

[0076] The handle assembly (610) in this example also includes a safety member (622), a closing trigger (624), and a firing trigger (626), each of which is independently movable relative to the pistol grip (614). Actuation of the closing trigger (624) is configured to activate the motor unit (660) to actuate the cannula actuator (662) (see [link]). FIG. 10 The actuation of the anvil (650) and thereby achieves closure of the anvil (650) relative to the suture head assembly (640) to hold the tissue therein. The actuation of the firing trigger (626) is configured to activate the motor unit (660) to actuate the staple actuator (664) and the scalpel actuator (666) (see [link to relevant documentation]). FIG. 10 The actuation of the suture mechanism allows for the suturing and cutting of the clamped tissue. (See the following text for details.) FIG. 11 In more detail, the instrument (600) is configured to independently control the actuation of the staple actuator (664) and the knife actuator (666) in response to a single actuation of the firing trigger (626). This allows for precise timing of the cutting stroke initiation relative to the suturing stroke initiation.

[0077] The safety element (622) in this example is in the form of a protrusion, such as a pivotable trigger similar to the safety trigger (140), and is configured to engage the closure trigger (624) and / or the firing trigger (626) directly or indirectly to selectively prevent their actuation. For example, the safety element (622) may be configured to prevent actuation of the closure trigger (624) until the instrument (600) detects that the anvil (650) has been fully attached to the cannula (642). In addition or alternatively, the safety element (622) may be configured to prevent actuation of the firing trigger (626) until the anvil (650) has taken a specific gap distance (d) relative to and defining therebetween the suture head assembly (640) (see See FIG. 7C The predetermined longitudinal position of ).

[0078] existFIG. 10 The actuators (662, 664, 666) of the instrument (600) schematically shown are configured to operatively connect corresponding actuable parts of the instrument (600) to the motor unit (660). Specifically, a cannula actuator (662) operatively connects a cannula (642) to the motor unit (660). Thus, the cannula actuator (662) is configured to actuate the cannula (642) proximally and distally in response to activation of the motor unit (660) when the motor unit (660) is operatively engaged with the cannula actuator (662), thereby actuating the anvil (650). The cannula actuator (662) may include an elongated member similar to a cannula actuator rod (220) combined with the cannula actuator band assembly (230) of the instrument (10), which is translatably disposed within the shaft assembly (630).

[0079] The staple actuator (664) independently of the cannula actuator (662) operatively connects the staple driver member (not shown) of the suture head assembly (640) to the motor unit (660). Thus, the staple actuator (664) is configured to distally actuate the staple driver member in response to activation of the motor unit (660) when the motor unit (660) is operatively engaged with the staple actuator (664), thereby actuating the staple (not shown) housed within the suture head assembly (640). The staple actuator (664) may include an elongated member similar to the suture head assembly driver (240) of the instrument (10), which is translatably disposed within the shaft assembly (630) independently of the cannula actuator (662).

[0080] A scalpel actuator (666) independently of the cannula actuator (662) and the staple actuator (664) operatively connects the cylindrical scalpel member (not shown) of the suture head assembly (640) to the motor unit (660). Thus, the scalpel actuator (666) is configured to longitudinally actuate the scalpel member in response to activation of the motor unit (660) when the motor unit (660) is operatively engaged with the scalpel actuator (666). The scalpel actuator (666) may include an elongated member similar to the suture head assembly driver (240) of the instrument (10), which is translatably disposed within the shaft assembly (630) independently of the cannula actuator (662) and the staple actuator (664). In this way, the actuators (662, 664, 666) are configured to cooperate with the motor unit (660) to provide independently actuated tissue clamping, tissue suturing, and tissue cutting.

[0081] In this example, the knob (618) of the handle assembly (610) is operatively coupled to the cannula actuator (662), such that the knob (618) can be operated as an anvil closure emergency feature. In this respect, the cannula actuator (662) is primarily driven by the motor unit (660) but can also be longitudinally translated in response to rotation of the knob (618), for example, when the motor unit (660) is deactivated or otherwise disengaged from the cannula actuator (662). Thus, the knob (618) can be rotated after the anvil (650) has partially or completely retracted proximally toward the suture head assembly (640), thereby extending the anvil (650) distally away from the suture head assembly (640), for example, to release tissue trapped therein. In this type, the knob (618) can be connected to the trocar actuator (662) via a feature similar to that described above for the knob (130) of the connecting device (10), including, for example, the threaded portion (224, 226) of the trocar actuator rod (220). However, it should be understood that in some types, the knob (618) can be omitted from the device (600), so that the trocar actuator (662) is driven solely by the motor unit (660).

[0082] The device (600) may be further configured and operated according to at least some of the teachings of the following U.S. patents: U.S. Patent 9,445,816, entitled “Circular Stapler with Selectable Motorized and Manual Control”, published September 20, 2016; U.S. Patent 9,532,783, entitled “Circular Stapler with Select Motorized and Manual Control, Including a Control Ring”, published January 3, 2017; U.S. Patent 9,597,081, entitled “Motor Driven Rotary Input Circular Stapler with Modular End Effector”, published March 21, 2017; U.S. Patent 9,463,022, entitled “Motor Driven Rotary Input Circular Stapler with Lockable Flexible Shaft”, published October 11, 2016; and U.S. Patent 9,463,022, entitled “Surgical Stapler with Independently Actuated Drivers to Provide Varying Staple”, published December 27, 2018. U.S. Publication 2018 / 0368836 for “Heights”; and / or any other patent references identified herein, the disclosures of which are incorporated herein by reference.

[0083] B. Example Control System for a Circular Surgical Stapling Instrument

[0084] like FIG. 10As schematically shown, the instrument (600) also includes a control system (670) operable to control the actuation of the cannula actuator (662), nail actuator (664), and knife actuator (666) of the instrument (600). The control system (670) includes a control module (672), a motor unit (660), a user interface (616), and sensors (674), suitably arranged such that the control module (672) communicates with each of the motor unit (660), the user interface (616), and the sensors (674). The control module (672) includes a processor and is operable to store pre-programmed instrument control algorithms and receive input from the user interface (616) and the sensors (674). Based on these stored control algorithms and received inputs, the control module (672) is configured to control the motor unit (660) with pulse width modulation (PWM) to drive the cannula actuator (662), the staple actuator (664) and the knife actuator (666) to actuate independently of each other to clamp, suture and cut tissue.

[0085] The motor unit (660) includes one or more motors and is operatively coupled to the cannula needle actuator (662), the nail actuator (664), and the knife actuator (666). In some embodiments, the motor unit (660) may include a single motor operatively coupled to and configured to drive all three actuators (662, 664, 666). In this embodiment, the motor unit (660) may be coupled to the actuators (662, 664, 666) via one or more power transmission components (not shown), such as gear assemblies, various suitable types of which will be apparent to those skilled in the art from the teachings herein and the incorporated references. In other embodiments, the motor unit (660) may include three motors, each dedicated to driving a corresponding one of the actuators (662, 664, 666). In another embodiment, the motor unit (660) may include two motors, the first motor being configured to drive the cannula actuator (662), and the second motor being configured to drive the nail actuator (664) and the knife actuator (666) with the assistance of a power transmission assembly. It should be understood that the motor unit (660) may include various other numbers and arrangements of motors in other embodiments.

[0086] A sensor (674) is disposed within or otherwise coupled to a suture head assembly (640), shaft assembly (630), or shank assembly (610) and is operable to monitor one or more conditions of the instrument (600) during use. For example, the sensor (674) may be configured to monitor translation of any one or more actuators (662, 664, 666) and / or adjacent components such as a cannula (642). In some of this type, the sensor (674) may be directly mounted to any of the actuators (662, 664, 666) or an adjacent component thereof. In other of this type, the sensor (674) may be fixedly mounted within the suture head assembly (640), shaft assembly (630), or shank assembly (610) such that the actuators (662, 664, 666) and their adjacent components move relative to the sensor (674).

[0087] In some embodiments, the sensor (674) may be configured to detect a secure attachment between the anvil (650) and the cannula (642), as disclosed, for example, in: U.S. Patent 10,307,157, which is incorporated herein by reference above; or U.S. Patent Application No. END9142USNP1, filed on the same date as this application, entitled “Anvil Retention and Release Features for Powered Circular Surgical Stapler,” the disclosure of which is incorporated herein by reference. In other embodiments, the sensor (674) may be configured to detect certain characteristics of a particular suture head assembly (640) coupled to the shaft assembly (630), such as the diameter (640) of the suture head assembly or the size of the staple (not shown) housed therein. In some of this type, the sensor (674) may be configured to detect such characteristics of the suture head assembly (640) via radio frequency identification (RFID) of electronic information stored in a tag element disposed on or within the suture head assembly (640), for example as disclosed in U.S. Provisional Patent Application 62 / 868,457, filed June 28, 2019, entitled “Surgical Systems with Multiple RFID Tags,” the disclosure of which is incorporated herein by reference.

[0088] In other forms, the sensor (674) may communicate directly with the motor unit (660). For example, the sensor (674) may include a current sensor or an encoder, the current sensor being operable to monitor the current consumed by the motor unit (660), and the encoder being operable to monitor the rotational output of the motor unit (660). Furthermore, although in FIG. 10The diagram shows only one sensor (674), but it should be understood that the sensor (674) may include multiple sensors, each individual sensor (674) being configured to monitor the control module (672) and communicate with the control module regarding one or more corresponding conditions of the device (600). Furthermore, it should be understood that, with reference to the teachings herein, the sensor (674) may be in the form of a sensor assembly comprising various suitable types of sensors that will be apparent to those skilled in the art and are not described further herein.

[0089] The user interface (616) is similar to the user interface (114) described above, except that the user interface (616) is further configured to receive user input and transmit the user input to the control module (672). In this regard, the user interface (616) may include one or more buttons, dials, other actuable elements, or display graphics selectable by the user to indicate certain information relating to the surgical procedure to be performed or the suture head assembly (640). By way of example only, such information may include any of the following: the required pin formation height; the corresponding gap between the anvil (650) and the suture head assembly (640), to which the anvil (650) should be actuated during closure; the type or nominal thickness of tissue struck by the instrument (600); and / or the diameter of the suture head assembly (640). Such information, combined with information provided by the sensor (674), can be used by the control module (672) to adjust the stroke and / or actuation rate of the actuators (662, 664, 666), and / or to adjust the timing pauses between the electric actuations of the actuators (662, 664, 666) to ensure optimal tissue clamping, suturing, and cutting during surgery, as described in more detail below, for example.

[0090] C. Example Method for Controlling a Circular Surgical Stapler

[0091] FIG. 11 It shows the use of via FIG. 10 An exemplary method (700) for controlling a circular surgical suture instrument (600) using the control system (670) shown. At step (702), the instrument (600) is energized in response to power from the battery pack (620), for example, when the battery pack (620) is fully inserted into the proximal end of the handle assembly (610) after the instrument (600) has been removed from its packaging. Upon removal from the packaging, the anvil (650) is secured to the cannula (642) and is in a fully open position, and the staple retainer (not shown) is secured to the platform surface (644).

[0092] After the instrument (600) in this example is powered on, the control module (672) enters anvil travel calibration mode at step (704), which may occur automatically or in response to user input, for example, provided via a user interface (616). In this calibration mode, the control module (672) activates the motor unit (660) to drive the cannula actuator (662) to retract the cannula (642) proximally and thereby close the anvil (650) against the pin retainer, or alternatively against the platform surface (644) if the pin retainer has been removed. The control module (672) can detect that the anvil (650) has reached the closed position by detecting, via the sensor (674), an increase in the current load of the motor unit (660) after the anvil (650) contacts the pin retainer or the platform surface (644). The control module (672) observes the stroke (i.e., longitudinal displacement) of the anvil (650) during this retraction process and compares it with the expected stroke of the anvil (650). Based on this comparison and any differences observed between the two stroke values, the control module (672) then calibrates the actuation algorithm, which is executed to activate the motor unit (660), thereby actuating the cannula actuator (662), and thus ensuring accurate actuation of the anvil (650) thereafter during surgery. In addition or alternatively, the calibration of the anvil stroke may be performed by the control module (672) in real time during surgery as the anvil (650) retracts to clamp tissue. Such calibration of the anvil stroke is described in further detail below. It should be understood that the stroke of one or more other actuable components of the instrument (600) may be calibrated in a similar manner before or during surgery, and the calibration of the anvil closure stroke may also be applied by the control module (672) to also calibrate the suture stroke and / or cutting stroke of the instrument (600).

[0093] At step (706), the control module (672) determines the diameter of the suture head assembly (640). As described above, the suture head assembly (640) can be releasably attached to the shaft assembly (630), allowing suture head assemblies (640) of various diameters to be interchangeably coupled to the distal end of the shaft assembly (630), depending on the lumen size of the tissue structure on which the instrument (600) is operated. The control module (672) is configured to perform this size determination based on user input provided via a user interface (616) and / or information provided by a sensor (674), for example, when the sensor (674) is configured to detect the size of the suture head assembly (640) in the manner described above.

[0094] At step (708), the control module (672) receives input from the user interface (616) indicating the desired height of the staple to be formed in the tissue, as selected by the operator via the user interface (616). The control module (672) sets the staple height to be equal to the corresponding gap distance (d) established between the anvil (650) and the platform surface (644) of the suture head assembly (640) in the closed position of the anvil (650) (see...). FIG. 7C ), so as to achieve the selected nail height.

[0095] Although steps (704, 706, 708) are in FIG. 11 The steps (704, 706, 708) are shown to be performed in a specific order, but it should be understood that these steps (704, 706, 708) may be performed in various orders relative to each other after the instrument (600) is energized in step (702) and before the actuation of the nail actuator (664) described below.

[0096] After completing steps (704, 706, 708), the operator removes the anvil (650) from the cannula (642) and continues to position the anvil (650) within the patient's first tubular tissue structure and separately positions the suture head assembly (640) within the patient's second tubular tissue structure. The operator then attaches the anvil (650) to the cannula (642) inside the patient, for example as described above. FIGS. 7A-7B As shown, at this point, the control module (672) detects that attachment has been performed at step (710). This detection can be performed by a sensor (674), which transmits a corresponding signal to the control module (672).

[0097] At step (712), the control module (672) detects that the closure trigger (624) has been actuated by the operator. The control module (672) then proceeds to step (714) and directs the motor unit (660) to drive the trocar actuator (662) to actuate the trocar (642) proximally, thereby causing the anvil (650) to retract to a closed position that achieves the selected pin height and corresponding gap distance (d). In some configurations, the control module (672) may be configured to initiate the retraction of the trocar (642) and anvil (650) only in response to the actuation of the closure trigger (624) that has occurred after the anvil (650) has been attached to the trocar (642) at step (710). The operator can monitor the retraction of the anvil (650) to its closed position via visual markers and / or a display graphic of the user interface (616).

[0098] Additionally, in some configurations, the control module (672) may control the motor unit (660) to retract the anvil (650) proximally through the anvil's closing stroke in two consecutive phases. For example, the control module (672) may guide the motor unit (660) to retract the anvil (650) through the first portion of the anvil's closing stroke, at which point the control module (672) pauses the activation (660) of the motor unit for a predetermined period of time (e.g., a few seconds). At the end of this waiting period, the control module (672) reactivates the motor unit (660) to continue retracting the anvil (650) through the remaining portion of the anvil's closing stroke to its closed position. Including this pause during the retraction of the anvil (650) allows tissue compressed between the anvil (650) and the platform surface (644) to at least partially settle (or "creep"). Advantageously, as the anvil (650) is advanced proximally to its fully closed position (defined in step (708) by the target pin height input provided by the user), this settlement of the tissue results in a reduction of the axial extension load on the cannula (642) and the resulting current load on the motor unit (660).

[0099] At step (716), the control module (672) detects that the firing trigger (626) has been actuated by the operator after the anvil closure stroke has been completed. In this example, in response to this actuation detection, the control module (672) observes the completion of a predetermined time period measured from the completion of the anvil closure stroke, during which the staple actuator (664) and the blade actuator (666) remain stationary. This waiting period after anvil closure allows the clamped tissue to settle (or “creep”) to its fully compressed state before the suture head assembly (640) is fired, thereby reducing the axial force on the staple actuator (664) and the blade actuator (666) and reducing the resulting current load on the motor unit (660) during the corresponding suture and cutting sequences. It should be understood that this waiting period may be omitted in some models.

[0100] After the waiting period indicated in step (718) is completed, the control module (672) initiates distal actuation of the staple driver component (not shown) at step (720) to begin suturing the clamped tissue. Specifically, the control module (672) activates the motor unit (660) to engage and drive the staple actuator (664), thereby distally actuating the staple driver component to pass it through the suture head assembly (640), and thereby driving the staple into the tissue and abutting against the anvil (650), for example, similar to FIG. 7DAs shown. After actuation of the staple actuator (664), the control module (672) at step (722) observes that the motor unit (660) continues to drive the staple actuator (664) through another predetermined time period during the suturing stroke. Simultaneously, at step (724), the control module (672) communicates with the sensor (674) to detect when the staple driver member reaches a predetermined longitudinal position within the suturing head assembly (640). This position may correspond to the point where the individual staple drivers (not shown) reach the platform surface (644) similar to the point described above, such that the staple is at least partially formed within the clamped tissue. This process is described in further detail below with reference to Figures 17 through 19 and is also described in the following patent application: U.S. Patent Application No. END9129USNP1, filed on the same date as this application, entitled “Method for Controlling Cutting Member Actuation for Powered SurgicalStapler,” the disclosure of which is incorporated herein by reference.

[0101] In response to the detection of completion of a predetermined time period in step (722) and / or the detection at step (724) that the staple driver component has reached a predetermined longitudinal position, the control module (672) then initiates distal actuation of the blade component (not shown) at step (726) to begin cutting tissue. Specifically, the control module (672) activates the motor unit (660) to engage and drive the blade actuator (666), thereby distally actuating the blade driver component through the suture head assembly (640) and thereby cutting tissue, for example, similar to FIG. 7D As shown in the diagram.

[0102] As described above, delaying the initiation of the cutting stroke relative to the initiation of the suturing stroke, such as through independent actuation of the staple and blade actuators (662, 664, 666), ensures that at least a portion of the staples are formed within the tissue before tissue cutting begins. Advantageously, this method allows the staples to be anchored within the clamped tissue before cutting, thereby preventing lateral displacement of the tissue and deformation of the resulting staples when the blade member is driven distally.

[0103] The end of the distal cutting stroke of the blade member may correspond to the point where the blade member breaks off the washer (not shown) within the anvil (650), similar to the washer (417) described above. After the distal cutting stroke is completed, the control module (672) at step (728) directs the motor unit (660) to retract the blade member proximally into the suture head assembly (640). In some embodiments, the distal extension and subsequent proximal retraction of the blade member through a continuous, uniform range of motion can be achieved by powering the motor unit (660), for example as disclosed in U.S. Publication 2017 / 0258471, which is incorporated above by reference. In other embodiments, the control module (672) may be programmed to communicate with a sensor (674) to detect the completion of the distal cutting stroke and subsequently specifically direct the motor unit (660) to alternatively drive the blade actuator (666) to retract the blade member proximally. In any of this type, the sensor (674) may include an encoder configured to monitor the rotational output of the motor unit (660).

[0104] Simultaneously or subsequently with the knife retraction step (728), the control module (672) at step (730) directs the motor unit (660) to drive the cannula actuator (662) distally, thereby extending the anvil (650) distally to a predetermined position relative to the platform surface (644) of the suture head assembly (640). This distal extension allows the sutured tissue to be released between the anvil (650) and the suture head assembly (640), enabling the instrument (600) to be withdrawn from the patient while the anvil (650) remains attached to the cannula (642).

[0105] III. Example Methods for Calibrating Closure Rate and / or Closure Stroke

[0106] As described above, it may be desirable to refine the longitudinal actuation (“closure stroke”) and / or actuation rate (“closure rate”) of the movable component to improve clamping. Proper calibration of this closure stroke and / or closure rate allows the circular stapler (600) to clamp patient tissue more precisely. Tissue compression can be improved by monitoring initial tissue contact, gap, and / or force to control the closure rate and / or closure stroke, as will be described in more detail below.

[0107] The control module (672) of this example is configured to store and execute movable component actuation algorithms (e.g., including closure stroke and closure rate) to longitudinally actuate the cannula actuator (662) (and thus the cannula (642) and anvil (650)) to clamp tissue. It may be desirable to calibrate the cannula actuator (662), staple actuator (664), and knife actuator (666) before or during surgery. The control module (672) of this example is configured to store and execute staple actuator member actuation algorithms to longitudinally actuate the staple actuator (664) (and thus the staple actuator member) to suture tissue. The control module (672) of this example is configured to store and execute knife actuator member actuation algorithms to longitudinally actuate the knife actuator (666) (and thus the knife member) to cut tissue. Each of these actuation algorithms stored in the control module (672) includes a correlation between a given rotational output of the motor unit (660) and the expected longitudinal displacement of the corresponding actuated member of the instrument (600) achieved by that particular rotational output. As described above, the rotational output of the motor unit (660) can be monitored by an encoder operatively coupled to the motor unit (660) and communicating with the control module (672). As described below, the longitudinal travel of the actuators (662, 664, 666) can be calibrated by adjusting the corresponding actuation algorithm stored in the control module (672).

[0108] A. First Example Method for Adjusting Closure Rate and / or Closure Stroke

[0109] An exemplary method (800) for operating an electric surgical suture device such as a circular surgical suture instrument (600) is referenced. FIG. 12 Shown and described. Specifically, FIG. 12 A schematic view of method (800) is shown, for adjusting by FIG. 10 The control system (670) executes an actuation algorithm to calibrate FIG. 9 The closing rate and / or closing stroke of the movable components of the instrument (600) (e.g., cannula (642), anvil (650), or cannula actuator (662)). (See previous references) FIG. 9 The described instrument (600) includes a motor unit (660), a shaft assembly (630) operatively coupled to the motor unit (660), a controller (e.g., a control module (672)) communicating with the motor unit (660), and a sensor assembly (674) communicating with the control module (672), an anvil (650), and a platform surface (644) opposite the anvil (650). Movable components (e.g., FIG. 13 The cannula (642) and anvil (650) or cannula actuator (662) shown are actuated between an open position and a closed position. In the open position (similar to...) FIG. 7CThe reference instrument (10) and the cannula (642) are configured to receive at least a first tissue layer and a second tissue layer (T1, T2) between the platform surface (644) and the anvil (650). In the closed position (similar to...) FIG. 7D The reference device (10), the anvil (650) and the platform surface (644) compress the first tissue layer and the second tissue layer (T1, T2) together at least.

[0110] like FIG. 12 As shown, the method (800) begins at step (802) with a start event, which may be the actuation of a closure trigger (624) after the anvil (650) is attached to the cannula (650) during surgery. In response to the start event, the control module (672) at step (804) executes a stored movable component actuation algorithm to activate the motor unit (660) to actuate the cannula actuator (662) proximally, thereby transitioning the anvil (650) from an open position to a closed position. Before or during the execution of the movable component actuation algorithm, the control module (672) determines that one of the monitored cannula (642), anvil (650), or cannula actuator (662) is in a predetermined position, for example, detected by a position sensor (680) via the sensor assembly (674). By way of example only, the predetermined position may correspond to the anvil (650) being in the fully open position.

[0111] At step (806), the method (800) includes first using the sensor assembly (674) to sense closure data as the movable member (cannula (642), anvil (650), or cannula actuator (662)) moves from the open position to the closed position. The closure data may include the initial tissue contact location (see [link to documentation]). FIG. 13 ), and the gap (δ) between the anvil (650) and the opposite platform surface (644) QC δ FC δ AT ), or the axial force (F) on the anvil (650). A One or more of the following. For example... FIG. 13 As shown, the initial tissue contact position is defined as the location where the first and second tissue layers (T1, T2) are completely close but not yet compressed together. At the initial tissue contact position, the initial tissue contact gap (δ) FC It is confined between the platform surface (644) or the anvil (650). Further reference. FIG. 13 and FIG. 14 gap (δ) QC δ FC δ ATThe retraction occurs as the movable member moves from the open position to the closed position. Similar to step (806) above, the method (800) also includes step (808) after the first time, when the movable member moves from the open position to the closed position, a second time using the sensor assembly (674) to sense closure data.

[0112] FIG. 13 It shows the relationship with FIG. 10 The control system (670) is operatively connected to FIG. 9 A schematic side cross-sectional view of the cannula (642) and anvil (650) of a circular surgical suture instrument (600), wherein a first tissue layer and a second tissue layer (T1, T2) are disposed between the cannula (642) and the platform surface (644). FIG. 13 As shown, the sensor assembly (674) may include one or more of a current sensor (676), a force sensor (678), or a position sensor (680), which may be operatively coupled to the motor unit (660). The sensor assembly (674) communicates with a control module (672), which communicates with the motor unit (660) to influence the cannula actuator (662). The control module (672) may determine the current longitudinal displacement of the anvil (650) relative to the platform surface (644) based on the signal provided by the position sensor (680). FIG. 13 As shown, the position sensor (680) may include a first sensor portion and a second sensor portion (682, 684), wherein the first sensor portion (682) is disposed on the proximal surface (686) of the anvil (650), and the second sensor portion (684) is disposed on the platform surface (644). As shown, the proximal surface (686) is configured to face the platform surface (644) and pass through a gap (δ). QC δ FC δ AT Separate

[0113] Axial force (F) A This increase can be detected by one or more sensors of the sensor assembly (674), which are in the form of a current sensor (676) or a force sensor (678) and communicate with the control module (672), such as FIG. 13 As shown. For example, the control module (672) can determine the axial force (F) on the anvil (650) based on the closure data provided by the force sensor (678). A The closure data has been changed, indicating the axial force (F) applied to the trocar actuator (662) (and consequently the anvil (650) and the trocar (642)). A The increase of ) . Similarly, the axial force (F AThe current can be applied to the needle actuator (662) (and consequently the anvil (650) and the needle (642)), or it can be the current consumed by the motor unit (660) when the needle actuator (662) is actuated. The axial force (F) on the anvil (650) during movement from the open position to the closed position... A The force is proportional to the current consumed by the motor unit (660). It should be understood that the closure of the anvil (650) abutment structure induces a longitudinal extending force in the anvil (650), cannula (642), and cannula actuator (662), making it more difficult for these closing components to retract further proximal to the end via the motor unit (660), thus increasing the current force on the motor unit (660). Therefore, the control module (672) can determine the axial force (F) on the anvil (650) based on the closure data provided by the current sensor (676). A The current has increased, and this closed data indicates an increase in the current consumed by the motor unit (660).

[0114] FIG. 14 A line graph (900) of an exemplary closure of the trocar actuator (662) (and thus the trocar (642) and anvil (650)) according to the method (800) described above is shown. For the closure displacement curve (DC), the X-axis of the figure (900) represents time, and the Y-axis of the figure (900) represents the anvil closure gap (δ), as explained by the control module (672). For the displacement curve (DC), the predetermined gap can be the rapid closing gap (δ). QC ), which has a greater density than the first tissue closure gap (δ FC The higher first closing velocity (CV1) is shown below the second closing velocity (CV2). Closing velocities (CV1, CV2, CV3, CV4) are measured as changes in the displacement curve (DC) (i.e., the slope). FIG. 14 As shown, the gap (δ) formed between the anvil (650) and the opposite platform surface (644) QC δ FC δ AT As the movable components (cannula (642), anvil (650), cannula actuator (662)) move from the open position to the closed position (by the gap (δ) AT1 (This is shown) and decreases.

[0115] For the closed force curve (FC), the X-axis of Figure (900) represents time, and the Y-axis of Figure (900) represents the anvil force (F). A As interpreted by the control module (672). The closed displacement curve (DC) and the closed force curve (FC) are superimposed to show the correlation at different times, such as at the initial time (t0) and the rapid closing time (t... QCAt point ), partial shutdown time (t) AT ) and complete shutdown time (t) AT1 At the location shown in the figure, once in contact with the tissue, the axial force (F) on the anvil (650) is... A The force increases. Since the first and second tissue layers (T1, T2) are not actively compressed together, no significant force (F) is applied to the anvil (650) in the rapid closing region. A Fast shutdown time (t) QC ) and initial tissue contact time (t FC The increase in the closed force curve (FC) between the two tissue layers (T1, T2) is caused by the complete proximity of the first and second tissue layers. The axial force (F) on the anvil (650) A ) at near complete shutdown time (t AT1 It reaches its peak at () and then decreases thereafter.

[0116] At step (810), method (800) also includes transmitting the closure data of sensor assembly (674) to control module (672). At step (812), control module (672) compares the current longitudinal displacement of the monitored movable member observed by control module (672) via sensor assembly (674) with the closure rate and closure stroke stored by control module (672). Control module (672) at step (812) determines whether there is a difference between the current closure rate and closure stroke and the closure rate and closure stroke obtained using the closure data. If the values ​​are equal or within a predetermined acceptable range for each other, such that there is no significant difference, control module (672) proceeds to step (814) to continue executing the current algorithm in response to user actuation of closure trigger (624) and firing trigger (626), for example as outlined above in the steps of method (700).

[0117] Alternatively, if the control module (672) determines that there is a significant difference between the values, the control module (672) proceeds to step (816) to adjust the closing rate to an adjusted closing rate and the closing stroke to an adjusted closing stroke based on the determined difference. The adjusted closing rate is the speed at which the gap between the anvil (650) and the relative platform surface (644) contracts toward the closed position. The adjusted closing stroke is the longitudinal distance between the anvil (650) and the relative platform surface (644) between the open and closed positions. Adjusting the closing rate and / or closing stroke can improve the compression of the first and second tissue layers (T1, T2) relative to the user-selected nail size.

[0118] At step (818), the method (800) also includes controlling the motor unit (660) by performing at least one of an adjusted closing rate or an adjusted closing stroke, based on the determination of the control module (672). Alternatively, the control unit (672) may control the motor unit (660) using each of an adjusted closing rate and an adjusted closing stroke, based on the determination of the control module (672). At step (820), the method (800) includes determining with the control module (672) whether the movable member has reached the closed position. If yes, the method (800) may proceed to step (822), whereby the algorithm may terminate once the closed position is reached using the adjusted closing rate and / or the adjusted closing stroke. If no, the method (800) may loop back to sense the closing data an additional time as discussed above with reference to steps (806, 808), allowing the method (800) to continue.

[0119] The gap and axial force (F) at the first contact position of the tissue and the position of the anvil. A The combined sensing of the instrument (600) improves the closure rate and / or closure stroke to reduce collateral damage and improve compression relative to the user's staple size selection, thereby improving anastomosis. Furthermore, as a means of adjusting the closure rate and / or closure stroke, the first tissue contact position, the anvil position tissue gap, and the axial force (F) are sensed. A It can increase reliability, minimize collateral damage and improve hemostasis.

[0120] B. Adjusting Stapling and / or Knife Algorithms Based on Closure Rate and / or Closure Stroke

[0121] In addition to controlling the longitudinal displacement of the cannula actuator (662) during the anvil closure stroke, the control module (672) can control the longitudinal displacement of the staple actuator (664) during the suturing stroke and the longitudinal displacement of the blade actuator (666) during the cutting stroke based on user input of the tissue gap. Specifically, the control module (672) can customize the longitudinal displacement of each actuator (662, 664, 666) to ensure that the actuators (662, 664, 666) actuate longitudinally by an appropriate amount, thereby providing the full suturing component actuation stroke and the full blade component actuation stroke, rather than under-actuating or over-actuating relative to the target tissue gap.

[0122] In this regard, it should be understood that calibration of the longitudinal stroke of the nail actuator (664) and the knife actuator (666) may be necessary to ensure that the nail actuator (664) and the knife actuator (666) actuate by an appropriate amount during surgical procedures. Furthermore, it may be advantageous to use closure data obtained during the movable component actuation algorithm to influence the nail component actuation algorithm and the knife component actuation algorithm. Therefore, the corresponding nail component actuation algorithm and knife component actuation algorithm can be appropriately adjusted based on the adjustments made to the movable component actuation algorithm via method (800). Alternatively, the nail component actuation algorithm and the knife component actuation algorithm can be adjusted independently of the movable component actuation algorithm.

[0123] With the cannula (642) in the closed position, the control unit (672) can control the motor unit (660) to initiate adjusted actuation of the staple driver component, thereby driving the staple into the clamped tissue. In some models, the staple component actuation algorithm and the blade component actuation algorithm can be adjusted in a similar manner based on the same difference determined by the control module (672) in conjunction with the monitored actuation of the movable components. It should be understood that calibration of all three actuation algorithms ensures accurate longitudinal actuation of the anvil (650), staple driver component, and blade component of the instrument (600). The movable components (e.g., the cannula (642), anvil (650), or cannula actuator (662)), staple driver component, and blade component are operatively coupled to the motor unit (660) and can be actuated independently of each other by the motor unit (660).

[0124] After performing the adjusted closing rate and / or closing stroke, the method (800) may include actuating a staple driver component (not shown but similar to staple driver component (350)) using the adjusted closing rate and / or closing stroke to drive a staple into the clamped first and second tissue layers (T1, T2). For example, a staple actuator (664) may be used to actuate the staple driver component according to the staple closing stroke, the staple closing rate, and a staple pause sequence combining the adjusted closing stroke and the initial tissue contact position as described above.

[0125] Similarly, the method (800) may also include an actuating blade member (not shown but similar to blade member (340)) to cut the clamped tissue using an adjusted closing rate and / or closing stroke. For example, the control module (672) may respond to the initial tissue contact position (δ FC The motor unit (660) is controlled to initiate the adjusted actuation of the blade component to cut the clamped tissue, based on both the gap formed between the anvil (650) and the opposing platform surface (644). More specifically, the blade closing stroke, blade closing rate, and the adjusted closing stroke combined with the initial tissue contact position (δ) are used to cut the clamped tissue. FCThe tool component is actuated by a tool pause sequence. Alternatively, the actuation can be based on the tool closing stroke, tool closing rate, and combined with the adjusted closing stroke and initial tissue contact position (δ). FC The actuation algorithm uses the tool pause sequence, along with the aforementioned pin closing stroke, pin closing rate, and pin pause sequence, to actuate the tool component. Therefore, the tool component actuation algorithm considers both the movable component actuation algorithm and the pin component actuation algorithm.

[0126] Step (816) may include: the control module (672) controlling the motor unit (660) to adjust each of the adjusted closing rate, adjusted closing stroke, and closing pause based on closing data from the sensor assembly (674) communicating with the control module (672), wherein the closing pause is the period of time during which the anvil (650) and the relative platform surface (644) do not move toward the closed position. In other words, the closing stroke, closing rate, and closing pause may be incorporated into the actuation algorithm of the blade and nail components based on the closing stroke and the first contact tissue position.

[0127] It should be understood that the actuation rate of one or more actuators (662, 664, 666) can also be controlled based on other factors, such as the size of the suture head assembly (640) or the target tissue gap specified by the user via the user interface (616). By way of example only, the control module (672) can decrease the actuation rate of one or more actuators (662, 664, 666) in the presence of a relatively large diameter suture head assembly (640), and increase the actuation rate of one or more actuators (662, 664, 666) in the presence of a relatively small diameter suture head assembly (640). In addition, the control module (672) can decrease the actuation rate of one or more actuators (662, 664, 666) for larger tissue gaps, and increase the actuation rate of one or more actuators (662, 664, 666) for smaller tissue gaps, as described in more detail above.

[0128] C. Second Example Method for Adjusting Closure Rate

[0129] A second exemplary method (1000) for operating an electric surgical suture device such as a circular surgical suture instrument (600) is referenced. FIGS. 15A-15B Shown and described. Specifically, FIGS. 15A-15B A schematic view of method (1000) is shown, for adjusting by FIG. 10 The control system (670) executes an actuation algorithm to calibrate FIG. 9 The closing rate of the movable components of the circular suture. FIG. 15A The first part of method (1000) is shown, and FIG. 15BThe second part of method (1000) is shown. According to method (1000), the anvil closure rate varies based on the gap remaining when sensing the initial tissue contact position, and also varies based on the rate of increase in current sensed by the motor unit (660) using the cannula actuator (662) to close the anvil (650). The cannula (642) is actuable between an open position, a partially closed position, and a closed position, the open position for receiving at least a first tissue layer and a second tissue layer (T1, T2), and the closed position, in which at least the first tissue layer and the second tissue layer (T1, T2) are compressed together.

[0130] like FIG. 15A As shown, the method (1000) begins at step (1002) with a start event, which may be the actuation of a closure trigger (624) after the anvil (650) is attached to the cannula (642) during surgical procedures. In response to the start event, the control module (672) executes a stored movable member actuation algorithm at step (1004) to activate the motor unit (660) to actuate the cannula actuator (662) proximally, thereby transitioning the anvil (650) to a closed state. At step (1004), the method (1000) includes: the control module (672) controlling the motor unit (660) to actuate the cannula (642), thereby moving the anvil (650) from an open position to a partially closed position. Before or during the execution of the movable component actuation algorithm, the control module (672) determines that the monitored movable component (one of the cannula actuator (662), cannula (642), or anvil (650)) is in a predetermined position, for example, by means of a sensor assembly (674) using a position sensor (680). By way of example only, the predetermined position may correspond to the anvil (650) being in the fully open state.

[0131] At step (1006), the method (1000) includes: first using a position sensor (680) of the sensor assembly (674) to sense a gap formed between the anvil (650) and the opposing platform surface (644) as the cannula (642) moves from an open position toward a partially closed position. The partially closed position may be a predetermined position (e.g., a quick-closing gap (δ)). QC ))or FIG. 13 The initial tissue contact position is shown in the figure. As illustrated, the initial tissue contact position is defined as the position where the first and second tissue layers (T1, T2) are completely close but not yet compressed together. At the initial tissue contact position, the initial tissue contact gap (δ) is... FC It is confined between the platform surface (644) or the anvil (650). Further reference. FIG. 13 and FIG. 14 gap (δ) QC δFC As the movable member moves from the open position toward the partially closed position, it retracts. Similar to step (1006), the method (1000) also includes step (1008): after the first use of the sensor assembly (674), a second use of the position sensor (680) of the sensor assembly (674) to sense the gap formed between the anvil (650) and the relative platform surface (644) when the movable member moves from the open position toward the closed position.

[0132] The position sensor (680) of the sensor assembly (674) communicates with the control module (672), which in turn communicates with the motor unit (660) to influence the cannula actuator (662). The control module (672) can determine the current longitudinal displacement of the anvil (650) relative to the platform surface (644) based on the signal provided by the position sensor (680). FIG. 13 As shown, the position sensor (680) includes a first sensor portion and a second sensor portion (682, 684), wherein the first sensor portion (682) is disposed on the anvil (650), and the second sensor portion (684) is disposed on the platform surface (644). At step (1010), the method (1000) also includes transmitting the gap data obtained from the position sensor (680) of the sensor assembly (674) to the control module (672).

[0133] At step (1012), the control module (672) compares the current closing rate of the monitored movable member, observed by the control module (672) via the position sensor (680), with the closing rate stored by the control module (672). The control module (672) determines at step (1012) whether there is a difference between the current closing rate and the closing rate obtained using the gap data. If the values ​​are equal or within a predetermined acceptable range, such that there is no significant difference, the control module (672) proceeds to step (1014) to continue executing the current algorithm in response to user actuation of the closing trigger (624) and the firing trigger (626). The method (800) may loop back to the corresponding sensing gap data as discussed above with reference to steps (1006, 1008), causing the method (1000) to continue.

[0134] Alternatively, if the control module (672) determines that there is a significant difference between the values, the control module (672) proceeds to step (1016) to adjust the closing rate to a first adjusted closing rate based on the determined difference. The first adjusted closing rate is the gap (δ) formed between the anvil (650) and the opposing platform surface (644). QC δ FCThe speed of the retraction movement toward the partially closed position. In other words, at step (1016), method (1000) also includes: controlling the motor unit (660) to adjust the closing rate as the cannula (642) moves from the open position toward the partially closed position based on gap data from the sensor assembly (674) communicating with the control module (672). Adjusting the closing rate can improve the compression of the first and second tissue layers (T1, T2) relative to the user-selected pin size. It is also envisioned that the closing stroke could be adjusted using gap data in a manner similar to adjusting the closing rate to the first adjusted closing rate.

[0135] At step (1020), the method (800) includes using the control module (672) to determine whether the movable member has reached a partially closed position. The partially closed position may be a predetermined position (e.g., a quick-closing gap (δ)). QC ))or FIG. 13 The initial tissue contact position is shown. If so, once the partially closed position is reached using the adjusted closing rate, the method (800) can move to... FIG. 15B Step (1022). This determination can be based on gap data obtained from the position sensor (680).

[0136] At step (1024), the method (1000) includes: a control module (672) controlling a motor unit (660) to actuate the cannula (642), thereby moving the anvil (650) from a partially closed position to a closed position. At step (1026), the method (1000) also includes a third use of the sensor assembly (674) to sense current data, wherein the current data includes the current as the cannula (642) moves from the partially closed position to the closed position (δ). AT1 The current consumed by the motor unit (660) when the cannula needle (642) moves from the partially closed position to the closed position (δ). Similarly, at step (1028), the method (1000) also includes a fourth use of the sensor assembly (674) to sense current data, wherein the current data includes the current consumed by the motor unit (660) when the cannula needle (642) moves from the partially closed position to the closed position (δ). AT1 The current consumed by the motor unit (660) during the closing of the anvil (650) abutment structure induces a longitudinal extending force in the anvil (650), cannula (642), and cannula actuator (662), making it more difficult for these closing components to retract further proximal to the end via the motor unit (660), thus increasing the current force on the motor unit (660). Therefore, the first adjusted closing rate can be increased or decreased in response to the current sensor (676) detecting an increase in the current consumed by the motor unit (660).

[0137] Axial force (F) AThis increase can be detected by one or more sensors of the sensor assembly (674), which are in the form of a current sensor (676) or a force sensor (678) and communicate with the control module (672), such as FIG. 13 As shown. Axial force (F) A The current can be applied to the needle actuator (662) (and consequently the anvil (650) and the needle (642)), or it can be the current consumed by the motor unit (660) when the needle actuator (662) is actuated. The control module (672) can determine the axial force (F) on the anvil (650) based on the current data provided by the force sensor (678). A The closure data has been changed, indicating the axial force (F) applied to the trocar actuator (662) (and consequently the anvil (650) and the trocar (642)). A The axial force (F) on the anvil (650) increases as it moves from the open position to the closed position. A The current is proportional to the current consumed by the motor unit (660). Therefore, the force sensor (678) can also generate current data. At step (1030), the method (1000) also includes transmitting the current data obtained from the sensor assembly (674) (e.g., the current sensor (676) or the force sensor (678)) to the control module (672).

[0138] At step (1032), the control module (672) compares the closing rate observed by the control module (672) using a current sensor (676) or a force sensor (678) with a first adjusted closing rate stored by the control module (672). The control module (672) determines at step (1032) whether there is a difference between the closing rate obtained using the current data and the current closing rate (e.g., the first adjusted closing rate). If the values ​​are equal or within a predetermined acceptable range, such that there is no significant difference, the control module (672) proceeds to step (1034) to continue executing the first adjusted closing rate.

[0139] Alternatively, if the control module (672) determines that there is a significant difference between the values, the control module (672) proceeds to step (1036) to adjust the first adjusted closing rate to a second adjusted closing rate based on the determined difference. The second adjusted closing rate is the closing rate formed between the anvil (650) and the opposing platform surface (644) toward the closed position (by the closing gap (δ)). AT1 (This shows) the speed of the contraction motion. Adjusting the first adjusted closure rate to the second adjusted closure rate can improve the compression of the first and second tissue layers (T1, T2) relative to the user-selected nail size.

[0140] At step (1038), method (1000) also includes controlling motor unit (660) using a second adjusted closing rate based on the determination of control module (672). At step (1040), method (1000) includes using control module (672) to determine whether a movable member (e.g., cannula (642), anvil (650), or cannula actuator (662)) has reached the closed position. If yes, method (1000) may proceed to step (1042), whereby the algorithm may terminate once the closed position is reached using the adjusted closing rate. If no, method (1000) may loop back to the corresponding sensed current data as discussed above with reference to steps (1026, 1028), allowing method (1000) to continue.

[0141] As previously discussed, it may be advantageous to use one or more of a first adjusted closing rate and a second adjusted closing rate obtained during the movable component actuation algorithm to influence the nail component actuation algorithm and the knife component actuation algorithm. Therefore, the corresponding nail component actuation algorithm and knife component actuation algorithm can be appropriately adjusted based on the adjustments made to the movable component actuation algorithm via method (1000). Alternatively, the nail component actuation algorithm and knife component actuation algorithm can be adjusted independently of the movable component actuation algorithm.

[0142] IV. Example Combinations

[0143] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. The following examples are not intended to limit the scope of any claim that may be filed at any time in this patent application or any subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim set forth in this patent application or any subsequent filing relating to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0144] EMBODIMENT 1

[0145] A method of operating an electric surgical suture device, the electric surgical suture device including a motor unit, at least one movable member operatively coupled to the motor unit, a controller communicating with the motor unit, a sensor assembly communicating with the controller, an anvil, and a opposing platform surface, wherein the movable member is actuable between an open position and a closed position, the open position for receiving at least a first and a second layer of tissue, and the closed position in which at least a first and a second layer of tissue are compressed together, the method comprising: (a) controlling the motor unit to actuate the movable member from the open position toward the closed position; and (b) using the sensor assembly to sense closure data, wherein the closure data... The data includes each of the following: (i) the initial tissue contact position; (ii) the gap formed between the anvil and the opposing platform surface when the movable member moves from the open position to the closed position; and (iii) the axial force on the anvil when the movable member moves from the open position to the closed position; (c) transmitting the closure data of the sensor assembly to the controller; (d) using the controller to determine at least one of an adjusted closure rate or an adjusted closure stroke; and (e) controlling the motor unit using at least one of the adjusted closure rate or the adjusted closure stroke based on the determination by the controller.

[0146] EMBODIMENT 2

[0147] According to the method of Embodiment 1, the adjusted closing rate is the speed at which the gap between the anvil and the opposite platform surface contracts toward the closed position, and the adjusted closing stroke is the longitudinal distance between the anvil and the opposite platform surface between the open position and the closed position.

[0148] EMBODIMENT 3

[0149] According to any one of the foregoing embodiments, the initial tissue contact position is the position when at least the first and second layers of the tissue are fully close but not yet compressed together.

[0150] EMBODIMENT 4

[0151] According to any one of the foregoing embodiments, the at least one movable member includes a cannula actuator, a cannula, or the anvil.

[0152] EMBODIMENT 5

[0153] According to any one of the foregoing embodiments, the method further includes a pin driver component, wherein the at least one movable member further includes a blade component, and wherein the method further includes: (a) with the movable member in the closed position, controlling the motor unit to initiate an adjusted actuation of the pin driver component to drive a pin into the clamped tissue in response to both the initial tissue contact position and the gap formed between the anvil and the opposing platform surface; and (b) controlling the motor unit to initiate an adjusted actuation of the blade component to cut the clamped tissue in response to both the initial tissue contact position and the gap formed between the anvil and the opposing platform surface.

[0154] EMBODIMENT 6

[0155] According to any one of the foregoing embodiments, the method of using the controller to determine at least one of the adjusted closing rate or the adjusted closing stroke further includes using the controller to determine the adjusted closing rate and the adjusted closing stroke, wherein controlling the motor unit based on the controller's determination of at least one of the adjusted closing rate or the adjusted closing stroke further includes using the controller to determine the adjusted closing rate and the adjusted closing stroke.

[0156] EMBODIMENT 7

[0157] According to the method of embodiment 6, controlling the motor unit to adjust each of the closing rate and the closing stroke further includes controlling the motor unit to adjust each of the adjusted closing rate, the adjusted closing stroke, and the closing pause based on the closing data transmitted to the sensor assembly of the controller, wherein the closing pause is the period of time during which the anvil and the relative platform surface do not move toward the closed position.

[0158] EMBODIMENT 8

[0159] The method according to any one of Examples 1 to 4 and Examples 6 to 7 further includes: (a) actuating the movable member to clamp tissue using at least one of the adjusted closing rate or the adjusted closing stroke; (b) actuating the pin driver member to drive pins into the clamped tissue; and (c) actuating the blade member to cut the clamped tissue.

[0160] EMBODIMENT 9

[0161] According to the method of embodiment 8, the closing member, the nail driver member and the knife member are operatively connected to the motor unit and can be actuated independently of each other by the motor unit.

[0162] EMBODIMENT 10

[0163] According to any one of Embodiments 8 to 9, actuating the staple driver component further includes actuating the staple driver component according to the staple closing stroke, the staple closing rate, and the staple pause sequence combining the adjusted closing stroke and the initial tissue contact position, wherein actuating the blade component further includes actuating the blade component according to the blade closing stroke, the blade closing rate, and the blade pause sequence combining the adjusted closing stroke and the initial tissue contact position.

[0164] EMBODIMENT 11

[0165] According to the method of embodiment 10, actuating the blade component further includes actuating the blade component according to the blade closing stroke, the blade closing rate, and the blade pausing sequence in combination with the adjusted closing stroke, the initial tissue contact position, the pin closing stroke, the pin closing rate, and the pin pausing sequence.

[0166] EMBODIMENT 12

[0167] According to any one of the foregoing embodiments, the sensor assembly includes a force sensor operatively coupled to one of the anvil or the cannula, wherein the method further includes using the controller to determine that the axial force on the anvil has changed based on closure data provided by the force sensor, the closure data indicating an increase in the longitudinal force applied to the movable member.

[0168] EMBODIMENT 13

[0169] According to any one of the foregoing embodiments, the method wherein the sensor assembly includes a current sensor operatively coupled to the motor unit, wherein the method further includes using the controller to determine that the axial force on the anvil has increased based on the closure data provided by the current sensor, the closure data indicating an increase in the current consumed by the motor unit.

[0170] EMBODIMENT 14

[0171] According to any one of the foregoing embodiments, the method of controlling the motor unit using at least one of the adjusted closing rate or the adjusted closing stroke further includes reducing the adjusted closing rate or the adjusted closing stroke in response to the current sensor detecting an increase in the current consumed by the motor unit.

[0172] EMBODIMENT 15

[0173] According to any one of the foregoing embodiments, the method includes a position sensor operatively coupled to at least one of the anvil or the cannula, wherein the method further includes using the controller to determine the actual longitudinal displacement of the anvil relative to the platform surface based on the closure data provided by the position sensor.

[0174] EMBODIMENT 16

[0175] A method of operating an electric surgical suture device, the electric surgical suture device including a motor unit, at least one movable member operatively coupled to the motor unit, a controller communicating with the motor unit and a sensor assembly communicating with the controller, an anvil and a opposing platform surface, wherein the movable member is actuable between an open position and a closed position, the open position for receiving at least a first and a second layer of tissue, and the closed position in which at least a first and a second layer of tissue are compressed together, the method comprising: (a) controlling the motor unit to actuate the movable member from the open position toward the closed position; (b) using the sensor assembly to sense closure data, wherein the closure data includes at least one of: (i) an initial tissue contact position defined when at least a first and a second layer of tissue are close but not yet compressed together, (ii) (iii) the gap formed between the anvil and the opposing platform surface when the movable member moves from the open position to the closed position; (c) the axial force on the anvil when the movable member moves from the open position to the closed position; (d) the closure data of the sensor assembly being transmitted to the controller; (e) the controller using the closure data to determine an adjusted closure rate and an adjusted closure stroke; and (f) the motor unit being controlled based on the controller's determination using the adjusted closure rate and the adjusted closure stroke, wherein the adjusted closure rate is the speed at which the gap formed between the anvil and the opposing platform surface moves toward the closed position, and wherein the adjusted closure stroke is the longitudinal distance between the anvil and the opposing platform surface between the open position and the closed position.

[0176] EMBODIMENT 17

[0177] According to the method of Embodiment 16, the closure data includes each of the following: the initial tissue contact position, the position of the anvil relative to the opposing platform surface, and the axial force on the anvil.

[0178] EMBODIMENT 18

[0179] The method according to any one of Embodiments 16 to 17 further comprises: (a) actuating the movable member to clamp tissue using at least one of the adjusted closing rate or the adjusted closing stroke; (b) actuating the pin driver member to drive a pin into the clamped tissue; and (c) actuating the blade member to cut the clamped tissue, wherein actuating the pin driver member further comprises actuating the pin driver member according to the pin closing stroke, the pin closing rate, and a pin pause sequence combining the adjusted closing stroke and the initial tissue contact position, wherein actuating the blade member further comprises actuating the blade member according to the blade closing stroke, the blade closing rate, and a blade pause sequence combining the adjusted closing stroke and the initial tissue contact position.

[0180] EMBODIMENT 19

[0181] A method of operating an electric surgical suture device, the electric surgical suture device including a motor unit, at least one movable member operatively coupled to the motor unit, a controller communicating with the motor unit, a sensor assembly communicating with the controller, an anvil operatively coupled to the movable member, and an opposing platform surface, wherein the movable member is actuable between an open position, a partially closed position, and a closed position, the open position for receiving at least a first and second layer of tissue, and the closed position in which at least a first and second layer of tissue are compressed together, the method comprising: (a) controlling the motor unit to actuate the movable member from the open position toward the partially closed position; (b) sensing gap data using the sensor assembly, wherein the gap data includes a gap formed between the anvil and the opposing platform surface when the movable member moves from the open position toward the partially closed position; (c) transmitting the gap data from the sensor assembly to the controller; and (d) using the gap data for... The controller determines a first closing rate; (e) controls the motor unit to adjust the first closing rate based on gap data transmitted to the sensor assembly of the controller as the movable member moves from the open position to the partially closed position, wherein the first closing rate is the speed at which the gap formed between the anvil and the opposing platform surface contracts toward the partially closed position; (f) uses the sensor assembly to sense current data, wherein the current data includes the current consumed by the motor unit as the movable member moves from the partially closed position to the closed position; (g) transmits the current data of the sensor assembly to the controller; (h) uses the current data to determine a second closing rate with the controller; and (i) controls the motor unit to adjust the second closing rate based on the current data transmitted to the sensor assembly of the controller, wherein the second closing rate is the speed at which the gap formed between the anvil and the opposing platform surface contracts toward the closed position.

[0182] EMBODIMENT 20

[0183] According to the method of Embodiment 19, the partial closure position is a predetermined position or initial tissue contact position based on the position of the anvil relative to the opposing platform surface, wherein the gap data further includes the initial tissue contact position defined when the at least first and second layers of tissue are close but not yet compressed together.

[0184] EMBODIMENT 21

[0185] An electric surgical suture device includes: (a) a motor unit; (b) at least one movable member operatively coupled to the motor unit, wherein the movable member is configured to be actuated at least between an open position and a closed position, the open position for receiving at least a first and a second layer of tissue, and the closed position in which the at least a first and a second layer of tissue are compressed together; (c) a sensor assembly configured to sense: (i) an initial tissue contact position, and (iii) an axial force as the movable member moves from the open position toward the closed position; and (d) a controller communicating with the motor unit and the sensor assembly, wherein the controller is configured to: (i) operate a control program, and (ii) switch to an adaptive control program when the controller determines, using data of an increase in the axial force from the sensor assembly, that the initial tissue contact position has been reached.

[0186] EMBODIMENT 22

[0187] The electric surgical suture device according to Embodiment 21 further includes an anvil and a relative platform surface, wherein the sensor assembly is configured to sense a gap formed between the anvil and the relative platform surface as the movable member moves from the open position to the closed position, and wherein the controller is configured to switch to the adaptive control program when the controller uses data on the increase in axial force from the sensor assembly and determines that the initial tissue contact position has been reached by using the travel position of the gap formed between the anvil and the relative platform surface.

[0188] EMBODIMENT 23

[0189] According to one or more of Embodiments 21 to 22, the electric surgical suture device, wherein the control program includes a closure rate and a closure stroke, wherein the adaptive closure program includes at least one of an adjusted closure rate different from the closure rate or an adjusted closure stroke different from the closure stroke, wherein the controller is configured to determine at least one of the adjusted closure rate or the adjusted closure stroke using the initial tissue contact position and the axial force acquired by the sensor assembly.

[0190] EMBODIMENT 24

[0191] According to the electric surgical suture device of embodiment 23, the controller is configured to determine each of the adjusted closure rate or the adjusted closure stroke using the initial tissue contact position and the axial force acquired by the sensor assembly.

[0192] EMBODIMENT 25

[0193] The electric surgical suture device according to any one of Embodiments 23 to 24 further includes an anvil and a relative platform surface, wherein the adjusted closure rate is the speed at which the gap between the anvil and the relative platform surface contracts toward the closed position, and wherein the adjusted closure stroke is the longitudinal distance between the anvil and the relative platform surface between the open position and the closed position.

[0194] EMBODIMENT 26

[0195] According to any one of Embodiments 21 to 25, the electric surgical suture device wherein the initial tissue contact position is the position when at least the first and second layers of the tissue are fully close but not yet compressed together.

[0196] EMBODIMENT 27

[0197] According to any one of Embodiments 21 to 26, the electric surgical suture device, wherein the at least one movable member includes a cannula actuator, a cannula, or the anvil.

[0198] EMBODIMENT 28

[0199] The electric surgical suture device according to any one of embodiments 21 to 27 further includes a staple driver member configured to drive staples into the clamped tissue, and a blade member configured to cut the clamped tissue.

[0200] EMBODIMENT 29

[0201] According to any one of Embodiments 21 to 28, the electric surgical suture device wherein the movable member, the staple driver member, and the blade member are operatively coupled to the motor unit and configured to be actuated independently of each other by the motor unit.

[0202] EMBODIMENT 30

[0203] The electric surgical suture device according to any one of embodiments 21 to 29 further includes an anvil, wherein the sensor assembly includes a force sensor operatively coupled to one of the anvil or the cannula, wherein the controller is configured to determine that the axial force on the anvil has changed based on data provided by the force sensor, the data indicating an increase in the longitudinal force applied to the movable member.

[0204] EMBODIMENT 31

[0205] According to any one of embodiments 21 to 30, the electric surgical suture device further includes an anvil, wherein the sensor assembly includes a current sensor operatively coupled to the motor unit, wherein the controller is configured to determine that the axial force on the anvil has increased based on data provided by the current sensor, the data indicating an increase in the current consumed by the motor unit.

[0206] EMBODIMENT 32

[0207] According to any one of Embodiments 21 to 31, the electric surgical suture device further includes an anvil, a cannula, and a platform surface, wherein the sensor assembly includes a position sensor operatively coupled to at least one of the anvil or the cannula, and wherein the controller is configured to determine the actual longitudinal displacement of the anvil relative to the platform surface based on closure data provided by the position sensor.

[0208] V. Miscellaneous

[0209] It should also be understood that any one or more of the teachings, expressions, embodiments, examples, etc., described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the aforementioned teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0210] Furthermore, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. Patent Application No. END9128USNP1, filed on the same date as this application, entitled “Method for Calibrating Movements of Actuated Members of Powered Surgical Stapler”; U.S. Patent Application No. END9129USNP1, filed on the same date as this application in 2018, entitled “Method for Controlling Cutting Member Actuation for Powered Surgical Stapler”; and U.S. Patent Application No. END9142USNP1, filed on the same date as this application, entitled “Anvil Retention and Release Features for Powered Circular Surgical Stapler”. The disclosures of each of these U.S. patent applications are incorporated herein by reference.

[0211] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other public material set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with any existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that the incorporated material does not conflict with any existing public material.

[0212] The aforementioned devices can be applied to both traditional medical treatments and surgeries performed by medical professionals and robot-assisted medical treatments and surgeries. By way of example only, the various teachings herein can be readily incorporated into robotic surgical systems, such as the DAVINCI system from Intuitive Surgical, Inc. (Sunnyvale, California). TM system.

[0213] The types described above may be designed to be discarded after a single use, or they may be designed to be used multiple times. In either or both cases, these types may be repaired for reuse after at least one use. Repair may include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts, and subsequently reassembling. Specifically, some types of devices may be disassembled, and any combination may be used to selectively replace or remove any number of specific parts or portions of the device. While cleaning and / or replacing specific components, some types of devices may be reassembled at a repair facility or by the user prior to surgery for subsequent use. Those skilled in the art will appreciate that device repair can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired devices are within the scope of this application.

[0214] By way of example only, the types described herein can be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

[0215] Various embodiments of the invention have been shown and described, and further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An electrically powered surgical suture device, the electrically powered surgical suture device comprising a motor unit, at least one movable member operatively coupled to the motor unit, a controller in communication with the motor unit, a sensor assembly in communication with the controller, an anvil, and a opposing platform surface, wherein the movable member is actuable between an open position and a closed position, the open position for receiving at least a first and a second layer of tissue, and in the closed position, at least a first and a second layer of tissue being compressed together, wherein the sensor assembly is configured to: Sensing closure data, wherein the closure data includes each of the following: (i) Initial tissue contact location (ii) the gap formed between the anvil and the opposing platform surface when the movable member moves from the open position to the closed position, and (iii) The axial force on the anvil when the movable member moves from the open position toward the closed position; in, The controller is configured to: (a) Controlling the motor unit to actuate the movable member from the open position toward the closed position; (b) Receive the closure data from the sensor assembly; (c) Use the closure data to determine at least one of the adjusted closure rate or the adjusted closure stroke; as well as (d) The motor unit is controlled using at least one of the adjusted closing rate or the adjusted closing stroke; The controller is configured to use the closure data to determine the adjusted closure rate and the adjusted closure stroke, and to use the adjusted closure rate and the adjusted closure stroke to control the motor unit. The controller is further configured to control the motor unit to: (e) Actuate the movable member to clamp the tissue using at least one of the adjusted closing rate or the adjusted closing stroke; (f) After actuating the movable member to clamp the tissue, actuating the pin driver member to drive the pin into the clamped tissue; and (g) After actuating the pin driver member to drive the pin into the clamped tissue, actuating the blade member to cut the clamped tissue; The movable member, the nail driver member, and the knife member are operatively connected to the motor unit and can be actuated independently of each other by the motor unit. The pin driver component is actuated according to the pin closing stroke, the pin closing rate, and a pin pause sequence combining the adjusted closing stroke and the initial tissue contact position. The blade component is actuated according to the blade closing stroke, the blade closing rate, and a blade pause sequence combining the adjusted closing stroke, the initial tissue contact position, the pin closing stroke, the pin closing rate, and the pin pause sequence.

2. The electric surgical suture device according to claim 1, wherein, The adjusted closing rate is the speed at which the gap between the anvil and the opposing platform surface contracts toward the closed position, wherein the adjusted closing stroke is the longitudinal distance between the anvil and the opposing platform surface between the open position and the closed position.

3. The electric surgical suture device according to claim 1, wherein, The initial tissue contact position is the position where at least the first and second layers of the tissue are fully close but not yet compressed together.

4. The electric surgical suture device according to claim 1, wherein, The at least one movable component includes a cannula actuator, a cannula, or the anvil.

5. The electric surgical suture device of claim 1, wherein the controller is further configured to: (a) With the movable member in the closed position, in response to both the initial tissue contact position and the gap formed between the anvil and the opposing platform surface, the motor unit is controlled to initiate adjusted actuation of the staple driver member to drive the staple into the clamped tissue; and (b) In response to both the initial tissue contact position and the gap formed between the anvil and the opposing platform surface, the motor unit is controlled to initiate an adjusted actuation of the blade member to cut the clamped tissue.

6. The electric surgical suture device according to claim 1, wherein, The controller is also configured to control the motor unit based on the closure data from the sensor assembly to adjust each of the adjusted closure rate, the adjusted closure stroke, and the closure pause, wherein the closure pause is the period of time during which the anvil and the relative platform surface do not move toward the closed position.

7. The electric surgical suture device according to claim 1, wherein, The sensor assembly includes a force sensor operatively coupled to one of the anvil or cannula, wherein the controller is configured to determine that the axial force on the anvil has changed based on closure data provided by the force sensor, the closure data indicating an increase in the longitudinal force applied to the movable member.

8. The electric surgical suture device according to claim 1, wherein, The sensor assembly includes a current sensor operatively coupled to the motor unit, wherein the controller is further configured to determine that the axial force on the anvil has increased based on closure data provided by the current sensor, the closure data indicating an increase in the current consumed by the motor unit.

9. The electric surgical suture device according to claim 8, wherein, The controller is configured to control the motor unit by reducing the adjusted closing rate or the adjusted closing stroke in response to an increase in the current consumed by the motor unit detected by the current sensor.

10. The electric surgical suture device according to claim 1, wherein, The sensor assembly includes a position sensor operatively coupled to at least one of the anvil or cannula, wherein the controller is configured to determine the actual longitudinal displacement of the anvil relative to the platform surface based on the closure data provided by the position sensor.

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