Method for calibrating motion of an actuation member of an electric surgical stapler

Abstract

A method is provided for operating a powered surgical stapler having a motor unit, a controller, and a stapling assembly having a plurality of movable members that are longitudinally actuatable by the motor unit to clamp, staple, and cut tissue. The controller determines that the movable members of the stapling assembly are at a first predetermined position and then executes an actuation algorithm to activate the motor unit to cause the movable members to be longitudinally actuated from the first predetermined position toward a second predetermined position. The controller observes an actual longitudinal displacement of the movable members between the first predetermined position and the second predetermined position. The controller compares the actual longitudinal displacement to an expected longitudinal displacement and determines that the actual longitudinal displacement differs from the expected longitudinal displacement by a difference value. The controller then adjusts the actuation algorithm based on the difference value.

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”, published September 27, 1994; U.S. Patent 5,350,104 entitled “Surgical Anastomosis Stapling Instrument”, published July 9, 1996; and U.S. Patent 8,910,847 entitled “Low Cost Anvil Assembly for a Circular Stapler”, published 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 No. 2015 / 0083772, entitled “Surgical Stapler with Rotary Cam Drive and Return,” published March 26, 2015; U.S. Patent No. 2015 / 0083773, entitled “Surgical Stapler with Drive Assembly Having Toggle Features,” published March 26, 2015; U.S. Patent No. 2015 / 0083774, entitled “Control Features for Motorized Surgical Stapling Instrument,” published March 26, 2015; and U.S. Patent No. 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 prior to 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] Figure 1 A perspective view of an exemplary circular surgical suture is shown;

[0008] Figure 2 It shows Figure 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] Figure 3 Show Figure 1 A perspective view of the anvil of a circular sewing machine;

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

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

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

[0013] Figure 7A It shows Figure 3 The anvil located in the first segment of the digestive tract and Figure 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] Figure 7B It shows Figure 3 The anvil located in the first segment of the digestive tract and Figure 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] Figure 7C It shows Figure 3 The anvil located in the first segment of the digestive tract and Figure 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] Figure 7D It shows Figure 3 The anvil located in the first segment of the digestive tract and Figure 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] Figure 7E It shows Figure 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] Figure 8 It shows Figure 1 A perspective view of the user interface features of the handle assembly of a circular stitcher;

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

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

[0021] Figure 11 It shows the use of via Figure 10Control system to control Figure 9 A schematic view of an exemplary method using a circular surgical suture device;

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

[0023] Figure 13A It shows Figure 9 A schematic side cross-sectional view of the suture head assembly and anvil of a circular surgical stapler, showing the anvil in the fully open position relative to the suture head assembly;

[0024] Figure 13B It shows Figure 9 A schematic side cross-sectional view of the suture head assembly and anvil of a circular surgical stapler, showing the anvil in a partially closed position relative to the suture head assembly;

[0025] Figure 13C It shows Figure 9 A schematic side cross-sectional view of the suture head assembly and anvil of a circular surgical stapler, showing the anvil abutting the suture head assembly in the fully closed position;

[0026] Figure 14 It shows Figure 9 A schematic side cross-sectional view of the staple assembly and anvil of a circular surgical stapler, showing the anvil in the fully closed position with the staple retainer abutting against the staple head assembly;

[0027] Figure 15 A line graph is shown, which illustrates... Figure 9 The longitudinal displacement of the anvil of a circular surgical stapler from the fully open position to the fully closed position and back to the fully open position shows the calibration of the anvil travel after closing and before reopening;

[0028] Figure 16 It shows Figure 9 A schematic diagram of the graphical indicator of the user interface features of a circular surgical suture device, showing an exemplary first tissue gap setting and a second tissue gap setting for the anvil;

[0029] Figure 17A It shows Figure 9 A schematic side view of the suture head assembly and anvil of a circular surgical suture device, showing its positioning to define... Figure 16 The first tissue gap is set with an anvil corresponding to the first larger tissue gap;

[0030] Figure 17B It shows Figure 9 A schematic side view of the suture head assembly and anvil of a circular surgical suture device, showing its positioning to define... Figure 16 The second tissue gap is provided with an anvil corresponding to the second smaller tissue gap;

[0031] Figure 18 It shows Figure 9 A schematic side front view of the suture head assembly and anvil of a circular surgical stapler, showing the side portion, which is cut open to expose the staple driver and the corresponding staples housed in the respective staple openings of the suture head assembly, showing the staple driver and staples in the fully recessed position.

[0032] Figure 19A It shows Figure 18 A side front view of the nail driver and nail, showing the nail driver and nail in a fully recessed proximal position;

[0033] Figure 19B It shows Figure 18 A side front view of the nail driver and the nail, showing the nail driver and the nail in a partially extended middle position, wherein the upper end of the nail driver and the crown of the nail are positioned on the platform surface of the suture head assembly and the nail.

[0034] Figure 19C It shows Figure 18 A side front view of the nail driver and the nail, showing the nail driver and the nail in a fully extended distal position, wherein the nail leg is entirely formed by the anvil.

[0035] Figure 20 A line graph is shown, illustrating the passage of time. Figure 9 Exemplary relationships between the operating elements of a circular surgical suture device, including anvil displacement, blade displacement, and firing load on the motor unit; and

[0036] Figure 21 A line graph is shown, illustrating the progression over time based on two different firing algorithms. Figure 9 The firing load of a circular surgical suture device.

[0037] 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

[0038] 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.

[0039] 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.

[0040] I. Overview of Exemplary Circular Surgical Suture Instruments

[0041] Figures 1 to 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.

[0042] 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.

[0043] The suture head assembly (300) is located at the distal end of the shaft assembly (200). For example... Figures 1 to 2 As 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).

[0044] A. Exemplary anvil

[0045] As in Figure 3 As most clearly seen, the anvil (400) of this example includes a head (420) and a shank (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 shank (420).

[0046] A handle (420) defines a hole (422) and includes a pair of pivoting latching members (430). The latching members (430) are positioned 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.

[0047] B. Exemplary sewn head assembly

[0048] like Figure 4 and Figure 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.

[0049] 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).

[0050] 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).

[0051] 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) appearing on its distal side. 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 in light of the teachings herein.

[0052] 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.

[0053] like Figure 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).

[0054] In some forms of the device (10), it may be desirable to provide a device (10) having 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.

[0055] C. Exemplary Axis Component

[0056] Figure 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.

[0057] 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).

[0058] 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).

[0059] D. Exemplary handle assembly and user input features

[0060] like Figure 1As shown, the handle assembly (100) includes a housing (110) and receives a battery pack (120), the housing having a lower portion defining a pistol-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).

[0061] 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. Figure 7C As shown.

[0062] 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).

[0063] 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. Figure 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.

[0064] like Figures 1 to 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).

[0065] E. Exemplary anastomosis surgery using a circular suture instrument

[0066] Figures 7A to 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... Figures 7A to 7E The tubular anatomical structures (20, 40) represent the remaining cut portions of the colon.

[0067] like Figure 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... Figures 7A to 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.

[0068] like Figure 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 middle 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).

[0069] Next, the anvil (400) is secured to the cannula (330) by inserting the cannula (330) into the hole (422), as follows: Figure 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. Figure 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).

[0070] 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... Figure 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).

[0071] like Figure 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... Figure 7C The position shown is to Figure 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.

[0072] When the nail driver component (350) is from Figure 7C The position shown is to Figure 7D As the indicated position is translated distally, the staple driver component (350) drives the staple (90) through the tissue of the tubular anatomical structure (20, 40) and into the staple forming recess (414) of the anvil (400). The staple forming recess (414) deforms the driven staple (90) into, for example, a "B" shape or a three-dimensional shape, such that the formed staple (90) secures the ends of the tissue together, thereby connecting the tubular anatomical structure (20) with the tubular anatomical structure (40).

[0073] The operator has already Figure 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 attached to the cannula (330). Referring again to the example of the tubular anatomy (20, 40) including a segment of the patient's colon, the instrument (10) can be removed via the patient's rectum. With the instrument (10) removed, the tubular anatomy (20, 40) is secured together at the anastomosis (70) by two annular arrays of staples (90), as shown. Figure 7E As shown. The inner diameter of the anastomosis portion (70) is defined by the cut edge (60) left by the blade member (340).

[0074] F. Exemplary user interface features of the handle assembly

[0075] like Figure 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).

[0076] The user interface feature (114) of this example includes a graphic indicator (500) comprising fixed linear markers (502, 504, 506), a graphic representation of the 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.

[0077] 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) can 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) indicate the boundaries 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. Marks (504) are longitudinally positioned between marks (502, 506). Graphical representation (510) indicates relatively high spiking heads (e.g., suitable for relatively thick tissue); while graphic representation (512) indicates relatively short spiking heads (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 spiking head height is achieved by selecting the appropriate spatial correspondence between the indicator needle (522) and the marks (502, 504, 506).

[0078] In this example, the window (520) is illuminated via a light-emitting diode (LED) (not shown), further facilitating the viewing of the indicator needle (522) in 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.

[0079] 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.

[0080] II. An exemplary circular surgical suture instrument with independently controlled closure, suturing, and cutting.

[0081] 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.

[0082] 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.

[0083] A. Overview of circular surgical suture instruments with independently controlled actuators

[0084] Figure 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) of the suture head assembly (640). 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.

[0085] 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...). Figure 10 )powered by.

[0086] 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]). Figure 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]). Figure 10 The actuation of the suture mechanism allows for the suturing and cutting of the clamped tissue. (See the following text for details.) Figure 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.

[0087] 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 Figure 7C The predetermined longitudinal position of ).

[0088] exist Figure 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, the cannula actuator (662) operatively connects the cannula (642) of the suture head assembly (640) 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 trocar actuator (662) may include an elongated member similar to the trocar actuator rod (220) combined with the trocar actuator band assembly (230) of the instrument (10), which is translatably disposed within the shaft assembly (630).

[0089] 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).

[0090] 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.

[0091] 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 towards 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).

[0092] 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.

[0093] B. Exemplary control system for a circular surgical suture instrument

[0094] like Figure 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.

[0095] 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.

[0096] 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).

[0097] 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.

[0098] 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 Figure 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.

[0099] 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.

[0100] C. Exemplary methods for controlling a circular surgical suture

[0101] Figure 11 It shows the use of via Figure 10 An exemplary method (700) for controlling a circular surgical suture instrument (600) using a control system (670) is shown. At step (702), the instrument (600) is energized in response to power from a 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 (646) (see...) Figure 14 ) is fixed to the platform surface (644).

[0102] After the instrument (600) in this example is powered on, the control module (672) enters an 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, thereby closing the anvil (650) against the staple retainer (646), or alternatively against the platform surface (644) if the staple retainer (646) has been removed. The control module (672) can detect that the anvil (650) has reached the closed position by detecting an increase in the current load of the motor unit (660) via the sensor (674) after the anvil (650) contacts the staple retainer (646) 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).

[0103] 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.

[0104] 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...). Figure 7C ), so as to achieve the selected nail height.

[0105] Although steps (704, 706, 708) are in Figure 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.

[0106] 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) within the patient, for example as described above. Figures 7A to 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).

[0107] 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).

[0108] 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).

[0109] 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 load 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.

[0110] 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 Figure 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.

[0111] 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 component through the suture head assembly (640) and thereby cutting tissue, for example, similar to Figure 7D As shown in the diagram.

[0112] As described above, delaying the initiation of the cutting stroke relative to the initiation of the suturing stroke, as achieved by 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 component is driven distally.

[0113] 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).

[0114] 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).

[0115] III. Exemplary method for calibrating the actuation stroke of a circular surgical suture

[0116] As described above, it may be desirable to calibrate the longitudinal actuation (or “stroke”) of the cannula actuator (662), staple actuator (664), and knife actuator (666) before or during surgical procedures. This is based on a given rotational output of the motor unit (660) to ensure that the actual longitudinal displacement of the anvil (650), staple driver assembly (not shown), and knife assembly (not shown) matches the corresponding expected longitudinal displacement predicted by the control module (672). As described below, proper calibration of these strokes enables the circular stapler (600) to provide precise clamping, suturing, and cutting of patient tissue.

[0117] The control module (672) of this example is configured to store and execute: a closure member actuation algorithm to longitudinally actuate the cannula actuator (662) (and thus actuate the cannula (642) and the anvil (650)) to clamp tissue; a staple driver member actuation algorithm to longitudinally actuate the staple actuator (664) (and thus actuate the staple driver member) to suture tissue; and a blade member actuation algorithm to longitudinally actuate the blade actuator (666) (and thus actuate the blade member) to cut tissue. Each of these actuation algorithms stored by 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 actuating member of the suturer (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 stroke of the actuators (662, 664, 666) can be calibrated by adjusting the corresponding actuation algorithm stored in the control module (672).

[0118] A. Exemplary Actuation Stroke Calibration Method

[0119] Figure 12 An exemplary method is shown for calibrating the stroke of at least the trocar actuator (662) (and the connected trocar (642) and anvil (650)) by adjusting the correlation between the rotational output of the motor unit (660) and the longitudinal displacement of the trocar actuator (662) by adjusting the closure member actuation algorithm. Figure 11 As described in step (704) of the operating method (700), this calibration process can be performed after the initial unpacking of the circular suture device (600) before surgery. Alternatively, this calibration process can be performed in real-time during surgery, as described in more detail below. Furthermore, as described below, the adjustment of the closure member actuation algorithm can also be performed by the control module (672) to adjust the nail driver member actuation algorithm and the blade member actuation algorithm, thereby calibrating the nail driver member stroke and the blade member stroke. However, in some types, similar to... Figure 12 The steps shown can be performed by the control module (672) to adjust the nail driver component actuation algorithm and the knife component actuation algorithm independently of the closing component actuation algorithm.

[0120] like Figure 12As shown, the calibration method (800) begins with a start event in step (802), which can be: the initial engagement of the battery pack (620) and the handle assembly (610) after opening the device packaging; or alternatively, the actuation of the trigger (624) after attaching the anvil (650) to the cannula (642) during surgery. In response to the start event (802), the control module (672) executes a stored closure member actuation algorithm in step (804) to activate the motor unit (660) to actuate the cannula actuator (662) proximally, thereby changing the anvil (650) to the closed state. Before or during the execution of the closing member actuation algorithm, the control module (672) in step (806) determines that one of the monitored trocar actuator (662), trocar (642), or anvil (650) (each referred to herein as a "closing member") is in a first predetermined position, for example, by detection by a sensor (674) in the form of a position sensor. By way of example only, the first predetermined position may correspond to, for example, Figure 13A The image shows the fully open state (X). O The anvil (650) is positioned at its furthest point relative to the platform surface (644). In other examples, the first predetermined position may correspond to the anvil (650) in a partially closed state. While the control module (672) observes the actual longitudinal displacement of one of the monitored closing members (642, 650, 662) at step (808), the motor unit (660) continues to retract the needle actuator (662) proximally, for example via a sensor (674), which is in the form of a sensor. It should be understood that in this example, the needle actuator (662), the needle (642), and the anvil (650) translate together such that their longitudinal displacement is the same for a given output of the motor unit (660).

[0121] In step (810), the control module (672) determines that the monitored closing members (642, 650, 662) have reached a second predetermined position near the first predetermined position. By way of example only, the second predetermined position may correspond to the anvil (650) in its initial closed state, where the anvil (650) faces the platform surface (644) rather than being pulled against it, for example as... Figure 13B Position in (X) C As shown in the diagram. In other types, the second predetermined position may correspond to the anvil (650) in a fully closed and overloaded state, wherein the anvil (650) presses against the platform surface (644) or another structure. For example, Figure 13C The example shows both fully off and overloaded states (X). OL The anvil (650) is pulled against the platform surface (644). Figure 14 Another exemplary fully closed and overloaded states (X) of the anvil (650) are shown. OL In this manner, the anvil (650) is pulled against the staple retainer (646) before the retainer (646) is removed from the staple head assembly (640) after the circular stapler (600) package is opened. In this respect, it should be understood that... Figures 13A to 14 An exemplary position of the anvil (650) is shown in the absence of tissue (e.g., before surgery is performed on a patient). However, as described above, the calibration method (800) can also be performed in real time during surgery while the anvil (650) on the patient's tissue is closed.

[0122] In any of this type, the second predetermined position of the monitored closure components (642, 650, 662) corresponds to the state in which the anvil (650) is pulled against another structure (e.g., platform surface (644), staple retainer (646), or patient tissue), and can be identified by the control module (672) based on the observed increase in load on the closure system components. This load can be detected in the form of a longitudinal force applied to the cannula actuator (662) (and thus to the anvil (650) and the cannula (642)), or the current consumed by the motor unit (660) while actuating the cannula actuator (662). In this regard, it should be understood that the anvil (650) abutting against a certain structural closure induces a longitudinal extending force in the anvil (650), the cannula (642), and the cannula actuator (662), making it more difficult for the motor unit (660) to further retract these closed components towards the proximal end, thus increasing the current load on the motor unit (660). This increase in closure load can be detected by one or more sensors, which are in the form of current sensors or force sensors connected to the control module (672).

[0123] After confirming that the monitored closed members (642, 650, 662) have reached the second predetermined position, the control module (672) proceeds to step (812) and compares the actual longitudinal displacement of the monitored closed members (642, 650, 662) with the expected longitudinal displacement stored by the control module (672) via one or more sensors (674). In step (814), the control module (672) evaluates whether there is a difference between the observed actual longitudinal displacement and the stored expected longitudinal displacement. If the two longitudinal displacement values ​​are equal or within a predetermined acceptable range, such that there is no significant difference, the control module (672) proceeds to step (816) to execute the original actual storage algorithm in response to the user actuating the closing trigger (624) and the firing trigger (626), for example, as outlined above in the steps of method (700).

[0124] Alternatively, if the control module (672) determines that there is a significant difference between the actual longitudinal displacement and the expected longitudinal displacement, the control module (672) proceeds to step (818) to adjust at least the closing member actuation algorithm based on the determined difference. More specifically, in this example, the control module (672) redefines the stored correlation between a given rotational output of the motor unit (660) and the corresponding expected longitudinal displacement of the monitored closing member (642, 650, 662). During the observation of longitudinal displacement of the closing member (642, 650, 662), the newly defined correlation associates the observed actual longitudinal displacement of the closing member (642, 650, 662) with the rotational output of the motor unit (660). This rotational output of the new correlation may be the same as or different from the rotational output of the original correlation.

[0125] In some models, the nail member actuation algorithm and the blade member actuation algorithm can be adjusted in a similar manner based on the same difference determined by the control module (672) in conjunction with the actuation of the monitored closure members (642, 650, 662). It should be understood that the calibration of all three actuation algorithms ensures accurate longitudinal actuation of the anvil (650), nail driver member, and blade member of the stitcher (600). After adjusting the closure member actuation algorithm, and optionally also the nail driver member actuation algorithm and the blade member actuation algorithm, the control module (672) proceeds to step (820) to execute the adjusted actual algorithm in response to the user actuating the closure trigger (624) and the firing trigger (626), for example, as outlined above in the steps of method (700).

[0126] As mentioned above, it should be understood that Figure 12The closure component calibration process (800) can be performed prior to surgery to ensure that the longitudinal travel of the cannula actuator (662) (as well as the cannula (642) and anvil (650)) is correctly calibrated before gripping the tissue. Alternatively, during surgery, one or more calibration processes (800) can be performed on the tissue to ensure that the longitudinal travel of the cannula actuator (662), as well as the optional pin actuator (664) and knife actuator (666), remains correctly calibrated throughout use.

[0127] Figure 15 A line graph (830) is shown illustrating an exemplary calibration of the trocar actuator (662) (and thus the trocar (642) and anvil (650)) according to the method (800) described above. The X-axis of Figure (830) represents time, and the Y-axis of Figure (830) represents the distal displacement (δ) of the trocar actuator (662) relative to the nearest position (i.e., the distal displacement of the anvil (650) relative to the platform surface (644), as explained by the control module (672). The first horizontal portion (834) of the curve (832) shown indicates that the trocar actuator (662) is in the fully extended position at displacement (δ1) before the longitudinal travel is calibrated. In this example, the cannula actuator (662) remains in the fully extended position throughout the initial event, including: removing the suture (600) from the package, as shown by the vertical dashed line (836); attaching the battery pack (620) to the shank assembly (610), as shown by the vertical dashed line (838); and attaching the anvil (650) to the cannula (642), as shown by the vertical dashed line (840).

[0128] The first descending portion (842) of curve (832) represents the initial proximal retraction of the cannula actuator (662) to change the anvil (650) from a fully open position to a partially closed position at a first rapid actuation rate. The second descending portion (844) of curve (832) represents the final proximal retraction of the cannula actuator (662) to change the anvil (650) from a partially closed state to a fully closed state at a second slower actuation rate. When the anvil (650) reaches a fully closed and overloaded state (X... OL Following this, the motor unit (660) experiences a sudden increase in current load, as indicated by the vertical line (846). The control module (672) detects this increase in current load via the sensor (674) and thereby determines that the anvil (650) has reached the fully closed state. The control module (672) then compares the actual observed longitudinal displacement of the cannula actuator (662) observed during proximal retraction with the expected longitudinal displacement, and the control module (672) determines the difference between the two values.

[0129] In this example, based on the determined difference, the control module (672) adjusts the closure member actuation algorithm to, for example, re-zero the proximal end of the longitudinal travel of the trocar actuator (662) via the steps described above in conjunction with method (800). Subsequently, the control module (672) executes the adjusted closure member actuation algorithm to extend the trocar actuator (662) distally to a fully extended state, thereby returning the anvil (650) to a fully open state (X). O As shown in the rising curve portion (848). Because the longitudinal travel is now calibrated with the appropriate "zero" point, the fully extended state of the cannula actuator (662) and the corresponding fully open state of the anvil (650) are as follows (X). O The new, larger displacement (δ2) is registered based on the displacement ratio applied by the control module (672). As shown in Figure (830), the difference between the original displacement value (δ1) and the adjusted displacement value (δ2) is equal to the amount of displacement by which the control module (672) adjusts the "zero" point of the cannula actuator (662). The control module (672) compares this difference with the fully extended state of the cannula actuator (662) (i.e., the fully open state of the anvil (650)). O Related to ))

[0130] The adjusted closure member actuation algorithm is executed for subsequent actuation of the cannula actuator (662), which ensures accurate positioning of the anvil (650) relative to the platform surface (644), and thus ensures precise tissue clamping for each user input. As mentioned above, the control module (672) can also apply this calibration of the closure member actuation algorithm to calibrate the staple member actuation algorithm and the blade member actuation algorithm, thereby providing equally accurate tissue suturing and cutting.

[0131] B. Exemplary actuation of the suture head assembly based on a user-specified tissue gap.

[0132] As described above, the user interface (616) of the circular surgical suture device (600) is configured to receive and transmit user input to the control module (672). Figure 16 As shown, the visual display (680) of the user interface (616) (which may be in the form of a window similar to a window (520) in other types) includes a distal linear marker (682) and a proximal linear marker (684). The linear markers (682, 684) define the boundaries of an acceptable range of tissue gaps (referred to as “green zones”) longitudinally defined between the anvil (650) and the platform surface (644) of the suture head assembly (640) to allow properly shaped staples to be fired into the tissue. The distal linear marker (682) indicates a large tissue gap setting, which provides a distal “high” closed position (A TThe anvil (650) defines a large tissue gap (δ) between the anvil (650) and the platform surface (644). AT ),like Figure 17A As shown. The proximal linear marker (684) indicates a small tissue gap setting, which provides a proximal "low" closure position (A). L The anvil (650) defines a small tissue gap (δ) between the anvil (650) and the platform surface (644). AT ),like Figure 17B As shown in the symbols (686, 688) of the user interface (616), a large tissue gap setting results in the formed staple (692) having a higher forming height (e.g., for thicker tissue), and a small tissue gap setting results in the formed staple (692) having a shorter forming height (e.g., for thinner tissue).

[0133] The user interface (616) includes one or more selectable input features that allow the user to specify a desired tissue gap setting for the anvil (650) in the closed position, which is then transmitted by the user interface (616) to the control module (672). As described in step (714) of the method (700) above, the control module (672) is configured to: control the motor unit (660) to retract the cannula actuator (662) proximally until the anvil (650) achieves the target tissue gap setting specified by the user input. This can be confirmed by the control module (672) via communication with a sensor (674), which is in the form of a position sensor, for example, which may be located in the suture head assembly. As described in the method (700) above... Figures 12 to 15 The longitudinal travel of the cannula actuator (662) can be calibrated before and / or during the closure of the anvil (650) on the patient tissue, such that the actual tissue gap (δ) defined between the anvil (650) and the platform surface (644) is equal to the target tissue gap (δ) specified by the user via the user interface (616).

[0134] The target tissue gap (δ) input via the user interface (616) can be referenced by the control module (672) to simultaneously control other operational aspects of the suturer (600). For example, in addition to controlling the longitudinal displacement of the cannula actuator (662) during the anvil closure stroke, the control module (672) can also 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 the tissue gap user input. Specifically, the control module (672) can customize the longitudinal displacement of each actuator (662, 664, 666) to ensure that the actuators (662, 664, 666) are longitudinally actuated by an appropriate amount, thereby providing a complete suturing stroke and a complete cutting stroke, rather than under-actuated or over-actuated relative to the target tissue gap. 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. As described above, the corresponding nail member actuation algorithm and knife member actuation algorithm can be appropriately adjusted based on the adjustments made to the closure member actuation algorithm via the calibration method (800). Alternatively, the nail member actuation algorithm and knife member actuation algorithm can be adjusted independently of the closure member actuation algorithm, for example via steps similar to those in method (800).

[0135] The target tissue gap can also be referenced by the control module (672) to control the actuation rate of one or more actuators (662, 664, 666). For example, 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. In this regard, it should be understood that larger tissue gaps are often chosen to accommodate thicker tissues, which can result in a higher current load on the motor unit (660) during suturing and cutting. The thicker the tissue, the lower the actuation rate of the staple actuator (664) and the scalpel actuator (666), which can therefore help maintain the current load on the motor unit (660) below the desired threshold.

[0136] IV. An exemplary method for controlling the actuation of a blade component relative to the actuation of a nail driver component.

[0137] As described above in steps (720-726) of the combined method (700), the control module (672) is configured to: control the motor unit (660) to independently actuate the staple actuator (664) and the blade actuator (666), such that the blade actuator is actuated distally only once the staple (692) driven by the staple driver member is at least partially formed within the tissue by the anvil (650). More specifically, the control module (672) communicates with the sensor (674) to detect the staple actuator (664), the staple driver member (not shown), or each staple driver (690) of the staple driver member (see See... Figure 18 When the predetermined longitudinal position is reached, the upper end of the nail driver (690) and the crown (694) of the nail (692) are positioned on the platform surface (644), such that the nail leg (696) is partially deformed by the anvil (650), for example, as described below. Figure 19B As shown and described.

[0138] Figure 18 and Figure 19A An exemplary staple driver (690) of a staple driver assembly of a circular stapler (600) in a fully recessed position (D0) is shown, the fully recessed position being within a corresponding staple opening (699) of the staple head assembly (640). Although not shown, it should be understood that the staple driver assembly (not shown) of the staple head assembly (640) includes a plurality of staple drivers (690) arranged in a ring similar to the staple drivers (352) of the aforementioned staple driver assembly (350). Each staple driver (690) is slidably arranged within a corresponding staple opening (699) of the platform assembly (698) and has an upper end of a crown (694) supporting the corresponding staple (692). As the staple actuator (664) is driven distally by the motor unit (660) in response to activation of the control module (672), the staple driver (690) drives the corresponding staple (692) distally from the staple opening (699), as... Figure 19B and Figure 19C As shown. Figure 19B A nail driver (690) in a partially extended position (D1) is shown, wherein the upper end of the nail driver (690) and the nail crown (694) are positioned at the upper end of the nail opening (699), aligned with the platform surface (644). In this position, the nail leg (696) has been received by the nail forming recess (652) of the anvil (650), causing the nail leg (696) to partially deform within tissue (not shown) held between the anvil (650) and the platform surface (644). Figure 19C A staple driver (690) in its fully extended position (D2) is shown, wherein the staple leg (696) of the staple (692) is fully abutted against the anvil (650) within the clamped tissue. Figure 19B and Figure 19CAs shown, the free end of the nail leg (696) bends toward the nail crown (694) in the formed state.

[0139] The control module (672) of this type is configured to: upon determining that the nail driver (690) has arrived Figure 19B After the partial extension position (D2) shown, the distal actuation of the actuating blade actuator (666) (and thus the distal actuation of the blade member) is initiated. This determines that the pin driver (690) has reached... Figure 19B The partial extension position (D2) shown can be made by the control module (672) via communication with one or more sensors configured to monitor the longitudinal position of one or more of the staple actuator (664), staple driver member, or staple driver (690). Additionally, as described above, the longitudinal travel of the cannula actuator (662) is calibrated before actuating the staple actuator (664), ensuring that the anvil (650) in the closed position defines an appropriate tissue gap (δ) relative to the platform surface (644), which corresponds to the target tissue gap specified via the user interface (616). This, in turn, ensures that distal actuation of the blade actuator (666) does not initiate until the staple leg (696) has indeed deformed at least partially by the expected amount based on the user-specified target tissue gap. This method ensures that the clamped tissue is not damaged by engagement via the blade member during the initial stage of staple formation. Advantageously, this allows the nail (692) to be properly shaped within the clamped tissue, thereby maximizing hemostasis along the shaped nail line.

[0140] Figure 20 A line graph (900) is shown, illustrating exemplary curves representing the actuation of the cannula actuator (662), staple actuator (664), and scalpel actuator (666) by the motor unit (660) over time during exemplary surgical procedures on thin, medium-thickness, and thick tissues. The anvil displacement curve (902) represents the longitudinal displacement of the cannula actuator (662), and consequently the longitudinal displacement of the cannula (642) and anvil (650), over time. The lower dashed portion (904) of the anvil displacement curve (902) represents the original expected closure stroke of the anvil (650) before the closure member actuation algorithm was calibrated in the manner described above.

[0141] The first motor load curve (910) represents the current load of the motor unit (660) while the actuating pin actuator (664) and therefore the actuating pin driver component and its pin driver (690) drive the pin (692) distally through thin tissue against the anvil (650). The second motor load curve (912) represents the current load of the motor unit (660) while the actuating pin actuator (664) and therefore the actuating pin driver component and its pin driver (690) drive the pin (692) distally through medium-thickness tissue against the anvil (650). The third motor load curve (914) represents the current load of the motor unit (660) while the actuating pin actuator (664) and therefore the actuating pin driver component and its pin driver (690) drive the pin (692) distally through thick tissue against the anvil (650). The first cutter displacement curve (920) represents the longitudinal displacement of the cutter actuator (666) over time, and thus the longitudinal displacement of the cutter member through thin tissue. The second cutter displacement curve (922) represents the longitudinal displacement of the cutter actuator (666) over time, and thus the longitudinal displacement of the cutter member through medium-thickness tissue. The third cutter displacement curve (924) represents the longitudinal displacement of the cutter actuator (666) over time, and thus the longitudinal displacement of the cutter member through thick tissue.

[0142] As shown in the motor load curves (910, 912, 914) and blade displacement curves (920, 922, 924), the control module (672) in this example is configured to control the motor unit (660) to actuate the staple actuator (664) and blade actuator (666) more slowly distally as tissue thickness increases. This is evident in Figure (900) due to the horizontally elongated configuration of the medium tissue thickness curves (912, 922) and the thick tissue curves (914, 924) relative to the thin tissue curves (910, 920). This method ensures that the current load of the motor unit (660) does not exceed a predetermined threshold during the suturing and cutting strokes. In this respect, as mentioned above, the distal actuation of the staple (692) and the blade member passing through increasingly thick tissue causes the motor unit (660) to consume a higher current load.

[0143] Each motor load curve (910, 912, 914) includes a first rise (A) that reflects the first portion of the stitching stroke through which the distal actuated nail actuator (664) passes, actuating the nail driver (690) from a fully recessed position (D0) to a new position (D1), as... Figures 18 to 19BAs shown, the pin (692) is driven against the anvil (650) throughout the initial forming stage. Each motor load curve (910, 912, 914) also includes a second rise (B) that reflects the distal actuated pin actuator (664) passing through the second part of the stitching stroke, which actuates the pin driver (690) from the new position (D1) to the fully extended position (D2), as... Figures 19B to 19C As shown, the staple (692) is driven distally against the anvil (650) throughout the final shaping stage. As shown in Figure (900) for each of the three tissue thickness scenarios, the control module (672) initiates distal actuation of the blade actuator (666) to perform the cutting stroke when the staple driver (690) has reached its new position (D1), which is represented by the transition between the first and second curve portions (A, B) in the motor load curve. As described above... Figures 18 to 19C The method of staggering the initiation of suture and cutting strokes is used to mitigate the risk of staple deformation, thereby ensuring proper staple placement within the patient's tissue. In this example, Figure (900) illustrates an exemplary time difference (Δt) between initiating the scalpel actuator (666) in thin tissue surgery and initiating the scalpel actuator (666) in thick tissue surgery.

[0144] In the circular stitcher (600) type, where the sensor (674) includes a current sensor operatively coupled to the motor unit (660) in the manner described above, the control module (672) can control the actuation rate (or "speed") of one or more actuators (662, 664, 666) and their respective components based on the current detected by the current sensor and consumed by the motor unit (660). For example, in response to a detected increase in current load exceeding a predetermined threshold, the control module (672) can reduce the actuation rate of the actuator (662, 664, 666) being actuated. Similarly, in the form of a suture device (600), where the sensor (674) includes a force sensor operatively coupled to one or more of the cannula actuator (662), nail actuator (664), knife actuator (666), or their associated components (e.g., cannula (642)), the control module (672) may be configured to reduce the actuation rate of a particular actuator (662, 664, 666) during its actuation in response to detecting an increase in the longitudinal force applied to that actuator (662, 664, 666).

[0145] 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, in the presence of a relatively large diameter suture head assembly (640), the control module (672) can decrease the actuation rate of one or more actuators (662, 664, 666); and in the presence of a relatively small diameter suture head assembly (640), increase the actuation rate of one or more actuators (662, 664, 666). Additionally, 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.

[0146] V. Exemplary identification of a sutured head assembly via radio frequency identification

[0147] As described above, in some cases, it may be desirable to detect certain characteristics (e.g., diameter) of the suture head assembly (640) via a sensor (674) and transmit such information to the control module (672), particularly where various types of suture head assemblies (640) are interchangeable with the shaft assembly (630). Figure 9 As shown, the end effector (640, 650) of the surgical instrument (600) may include a radio frequency identification (RFID) tag (1000) configured to store information relating to selected characteristics of the end effector (640, 650). Additionally, one of the shaft assembly (630) or the shank assembly (610) may include a sensor (674), in the form of an RFID scanner, configured to read the information stored by the RFID tag (1000) and transmit such information to the control module (672). Based on this information, the control module (672) may appropriately adjust one or more actuation algorithms of the actuators (662, 664, 666) to ensure appropriate longitudinal displacement, actuation rate, and / or time pauses between strokes of the actuators (662, 664, 666), for example, as described in more detail below and in U.S. Provisional Patent Application No. 62 / 868,457, which are incorporated herein by reference.

[0148] like Figure 21 As shown in Figure (2260), the relationship between firing load (pounds) on the Y-axis and firing time (seconds) on the X-axis is illustrated. Figure 21The unadjusted default firing algorithm (2263) and the adjusted firing algorithm (2263) are shown. Figure (2260) also shows a default maximum firing load threshold (2261) (e.g., 400 lbs) and a final maximum firing load threshold (2262) (e.g., 485 lbs) for the firing load applied to the suture head assembly (640) by the motor unit (660) via the nail actuator (664) and the knife actuator (666). The default maximum firing load threshold (2261) is adjusted to the final maximum firing load threshold (2262) based on end effector information of the end effectors (640, 650) stored in the RFID tag (1000) of the suture head assembly (640) and read by the RFID scanner (674). Figure 21 In the example, the end effector information indicates that the suture head assembly (640) (or “embedding cartridge”) has a larger size (e.g., 31 mm) than the default cartridge (e.g., 25 mm). The default cartridge size (e.g., 25 mm) is associated with the default firing algorithm (2263) and the default maximum firing load threshold (2261). Meanwhile, the larger cartridge size (e.g., 31 mm) is associated with the final firing algorithm (2264) and the final maximum firing load threshold (2262).

[0149] The end effector information stored in the RFID tag (1000) may include the cartridge size and / or a firing load adjustment value based on the cartridge size (e.g., 85 psi). In the case of cartridge size, the control module (672) may use a database or lookup table of cartridge size and corresponding firing load adjustment values ​​to find a suitable firing load adjustment value.

[0150] Furthermore, input from the RFID scanner (674) indicating end effector information causes the control module (672) to adjust the default maximum firing load threshold (2261) (e.g., 400) to the final maximum firing load threshold (2262) (e.g., 485 lbs), and keeps the firing algorithm (2264) below the final maximum firing load threshold (2262), such as Figure 21 As shown.

[0151] exist Figure 21In the example, before the motor unit (660) applies the firing algorithm (2263) to the end effectors (640, 650), the control module (672) adjusts or introduces a minimum waiting time “t”. In various cases, the minimum waiting time “t” is the time interval between the completion of the closure sequence of the end effector of the surgical instrument (600) (where tissue is grasped by the end effector (640, 650) in a closed configuration) and the start of the firing sequence of the end effector (640, 650) (where the grasped tissue is sutured and cut). The minimum waiting time “t” allows tissue creep, whereby the grasped tissue adapts to a lower average pressure, thereby reducing the maximum firing load necessary to complete the firing sequence of the end effector (640, 650) to a value at or below the final maximum firing load threshold (2262). In the default firing algorithm (2263), since there is no minimum waiting time "t", the firing algorithm (2263) must be interrupted (2267) from the time period t3 to t4 to prevent the firing load from exceeding the final maximum firing load threshold (2262). In contrast, the firing algorithm (2264) continues throughout the entire time period between t3 and t4, as... Figure 21 As shown.

[0152] Still referencing Figure 21 Another factor that can affect the minimum waiting time “t” is the user-selected shaping height of the staple (692) deployed from the suture head assembly (640), which, as described above, is directly proportional to the tissue gap distance defined by the anvil (650) in the closed position. Also as described above, the control module (672) can be configured to prompt the user to select the desired staple shaping height (i.e., tissue gap) via the user interface (616). In at least one example, the control module (672) can present the user with a number of staple shaping heights to choose from. In addition or alternatively, the control module (672) can recommend an optimal shaping height based on the tissue being processed by the surgical instrument (600). In any case, the user-selected shaping height can cause the control module (672) to further adjust the minimum waiting time “t”. In at least one example, the control module (672) stores the shaping height and the corresponding waiting time adjustment value in a database or lookup table. The control module (672) can adjust the minimum waiting time “t” by identifying a waiting time adjustment value associated with the forming height selected by the user, and then adjusting the minimum waiting time “t” according to the identified waiting time adjustment value.

[0153] Generally speaking, a more shaped pin is associated with a larger firing load and requires a longer minimum waiting time "t" than a less shaped pin. Figure 21In the example, the user-selected forming height (2265) is associated with the firing load "F2" and is greater than the minimum forming height (2266) associated with the minimum firing load "F1". The minimum firing loads "F1" and "F2" represent the firing loads at which the bolt legs begin to buckle. Therefore, in Figure 21 In the example shown, the selected waiting time “t” is the result of the selected larger size pin cartridge and the selected forming height (2265).

[0154] VI. Exemplary Combinations

[0155] 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.

[0156] Example 1

[0157] A method of operating an electric surgical suture device, the electric surgical suture device having a motor unit, a controller in communication with the motor unit, and a suture assembly operatively coupled to the motor unit and having a plurality of movable members, wherein the movable members are longitudinally actuated by the motor unit to clamp, suture, and cut tissue, the method comprising: (a) determining, using the controller, that the movable members of the suture assembly are in a first predetermined position; (b) executing an actuation algorithm using the controller to activate the motor unit, thereby longitudinally actuating the movable members from the first predetermined position toward a second predetermined position; (c) determining, using the controller, that the movable members have reached the second predetermined position; (d) observing, using the controller, the actual longitudinal displacement of the movable members between the first predetermined position and the second predetermined position; (e) comparing, using the controller, the actual longitudinal displacement with a expected longitudinal displacement stored by the controller, and determining that the actual longitudinal displacement differs from the expected longitudinal displacement by a difference value; and (f) adjusting the actuation algorithm using the controller based on the difference value.

[0158] Example 2

[0159] The method according to Embodiment 1 further includes: executing an adjusted actuation algorithm with the controller to activate the motor unit, thereby further longitudinally actuating the movable member.

[0160] Example 3

[0161] According to any one of the foregoing embodiments, the method further includes an encoder operatively coupled to the motor unit and the controller, wherein the encoder is operable to transmit a rotational output of the motor unit to the controller during actuation of the movable member, wherein the actuation algorithm includes a first correlation between the expected longitudinal displacement and a first rotational amount of the motor unit, wherein adjusting the actuation algorithm based on the difference includes defining a second correlation between the actual longitudinal displacement and a second rotational amount of the motor unit.

[0162] Example 4

[0163] According to any one of the foregoing embodiments, the method wherein the electric surgical suture device further includes a sensor communicating with the controller.

[0164] Example 5

[0165] According to the method of embodiment 4, wherein the sensor includes a position sensor operatively coupled to the movable member, and wherein the method further includes: determining the actual longitudinal displacement using the controller based on a signal provided by the position sensor.

[0166] Example 6

[0167] According to any one of embodiments 4 to 5, the sensor includes a current sensor operatively connected to the motor unit, wherein the method further includes: determining, based on a signal provided by the current sensor, that the movable member has reached the second predetermined position using the controller, the signal indicating an increase in current consumed by the motor unit.

[0168] Example 7

[0169] According to any one of the preceding embodiments 4 to 6, the sensor includes a force sensor operatively coupled to the movable member, wherein the method further includes: determining, based on a signal provided by the force sensor, that the movable member has reached the second predetermined position using the controller, the signal indicating an increase in the longitudinal force applied to the movable member.

[0170] Example 8

[0171] According to any one of Embodiments 4 to 7, the sensor includes at least one of a current sensor or a force sensor, and the method further includes: adjusting the actuation rate of the movable member with the controller based on a signal provided by the sensor, wherein the signal indicates at least one of a current consumed by the motor unit or a longitudinal force applied to the movable member.

[0172] Example 9

[0173] According to any one of the foregoing embodiments, the suture assembly is actuable between an open state for receiving tissue and a closed state for clamping the tissue, wherein in the closed state the suture assembly defines a gap in which the tissue is positioned, wherein the method further comprises: (a) receiving user input corresponding to a target size of the gap using the controller; and (b) controlling the actuation rate of the movable member using the controller based on the user input.

[0174] Example 10

[0175] According to any one of the foregoing embodiments, the suture assembly includes: (a) a closing member actuated to clamp tissue with the suture assembly; (b) a staple driver member actuated to drive staples into the clamped tissue; and (c) a blade member actuated to cut the clamped tissue, wherein the closing member, the staple driver member, and the blade member are operatively coupled to the motor unit and actuated independently of each other by the motor unit, and wherein the movable member includes at least one of the closing member, the staple driver member, or the blade member.

[0176] Example 11

[0177] According to the method of embodiment 10, the movable member includes the closing member, wherein the first predetermined position of the closing member corresponds to the open state of the suture assembly, and wherein the second predetermined position of the closing member corresponds to the at least partially closed state of the suture assembly.

[0178] Example 12

[0179] According to the method of embodiment 11, the closing member includes a cannula needle configured to be releasably coupled to an anvil, wherein the knife member includes a cylindrical knife.

[0180] Example 13

[0181] The method according to any one of Embodiments 11 to 12 further includes: (a) in response to a first user input, executing the adjusted actuation algorithm with the controller to actuate the closure member, thereby changing the suture assembly to a closed state for clamping tissue; and (b) in response to a second user input following the first user input: (i) actuating the staple driver member with the motor unit to drive a staple into the clamped tissue, and (ii) actuating the blade member with the motor unit to cut the clamped tissue.

[0182] Example 14

[0183] According to the method of embodiment 13, (a) after actuating the staple driver component, it is determined that the staple driver component has reached a predetermined longitudinal position; and (b) in response to determining that the staple driver component has reached the predetermined longitudinal position, the actuation of the blade component is initiated by the motor unit to cut the clamped tissue.

[0184] Example 15

[0185] According to any one of Embodiments 13 to 14, the method wherein the controller is configured to store and execute a tool member actuation algorithm to activate the motor unit, thereby actuating the tool member, wherein the method further comprises: (a) adjusting the tool member actuation algorithm with the controller based on the difference before actuating the tool member; and (b) executing the adjusted tool member actuation algorithm with the controller to actuate the tool member with the motor unit.

[0186] Example 16

[0187] A method of operating an electric surgical suture device, the electric surgical suture device having a motor unit, a controller in communication with the motor unit, and a suture assembly operatively coupled to the motor unit and operable to clamp, suture, and cut tissue, wherein the suture assembly includes a closure member actuable to transition the suture assembly between an open state and a closed state for clamping tissue, the method comprising: (a) determining, using the controller, that the closure member is in a first predetermined position; (b) executing, using the controller, a closure member actuation algorithm to activate the motor unit, thereby longitudinally actuating the closure member from the first predetermined position toward a second predetermined position; (c) determining, using the controller, that the closure member has reached the second predetermined position; (d) observing, using the controller, the actual longitudinal displacement of the closure member between the first predetermined position and the second predetermined position; (e) comparing, using the controller, the actual longitudinal displacement with a expected longitudinal displacement stored by the controller, and determining that the actual longitudinal displacement differs from the expected longitudinal displacement by a difference value; and (f) adjusting the closure member actuation algorithm using the controller based on the difference value.

[0188] Example 17

[0189] According to the method of embodiment 16, the closing member includes a cannula needle configured to be releasably connected to an anvil.

[0190] Example 18

[0191] The method according to any one of Embodiments 16 to 17 further includes a current sensor operatively coupled to the motor unit and the controller, wherein the current sensor is configured to transmit a signal to the controller indicating the current consumed by the motor unit, and wherein the method further includes at least one of: (a) determining, based on the signal provided by the current sensor, that the closing member has reached the second predetermined position; or (b) adjusting the actuation rate of the closing member based on the signal provided by the current sensor.

[0192] Example 19

[0193] A method of operating an electric surgical suture device, the electric surgical suture device having a motor unit, a controller in communication with the motor unit, and a suture assembly operatively coupled to the motor unit and having a first movable member and a second movable member, wherein the controller is configured to store and execute a first actuation algorithm to activate the motor unit, thereby actuating the first movable member to clamp or suture at least one of tissue, wherein the controller is further configured to store and execute a second actuation algorithm to activate the motor unit, thereby actuating the second movable member to cut the tissue, the method comprising: (a) determining, using the controller, that the first movable member is in a first predetermined position; (b) performing the first actuation algorithm with the controller. (c) Using the controller, the first movable member is actuated from the first predetermined position toward the second predetermined position; (d) Using the controller, the first movable member is determined to have reached the second predetermined position; (e) Using the controller, the actual displacement of the first movable member between the first predetermined position and the second predetermined position is observed; (f) Using the controller, the actual displacement is compared with a expected displacement stored by the controller, and a difference is determined between the actual displacement and the expected displacement; (g) Based on the difference, the second actuation algorithm is adjusted using the controller; and (h) Using the controller, the adjusted second actuation algorithm is executed to activate the motor unit, thereby actuating the second movable member to cut tissue.

[0194] Example 20

[0195] According to the method of embodiment 19, wherein the first movable member includes a closing member, wherein actuating the first movable member from the first predetermined position to the second predetermined position includes: actuating the closing member to change the suture assembly toward a closed state.

[0196] VII. Miscellaneous

[0197] 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.

[0198] 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. END9129USNP1, filed on the same date as this application, entitled “Method for Controlling Cutting Member Actuation for Powered Surgical Stapler”; U.S. Patent Application No. END9130USNP1, filed on the same date as this application, entitled “Method for Controlling End Effector Closure 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.

[0199] 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.

[0200] 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.

[0201] 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.

[0202] 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.

[0203] 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 electric surgical suture device, the electric surgical suture device having a motor unit, a controller in communication with the motor unit, and a suture assembly operatively coupled to the motor unit and having a first movable member and a second movable member, wherein the controller is configured to store and execute a first actuation algorithm to activate the motor unit, thereby actuating the first movable member to clamp or suture at least one of tissue, wherein the controller is further configured to store and execute a second actuation algorithm to activate the motor unit, thereby actuating the second movable member to cut the tissue, the electric surgical suture device further including a sensor in communication with the controller, wherein the controller is further configured to: (a) Determine that the first movable member is in a first predetermined position; (b) Execute the first actuation algorithm to activate the motor unit, thereby actuating the first movable member longitudinally from the first predetermined position toward the second predetermined position; (c) Determine that the first movable member has reached the second predetermined position; (d) Observe the actual displacement of the first movable component between the first predetermined position and the second predetermined position; (e) Compare the actual displacement with the expected displacement stored by the controller, and determine that the actual displacement differs from the expected displacement by a difference value; (f) Adjusting the second actuation algorithm based on the difference; and (g) Execute the modified second actuation algorithm to activate the motor unit, thereby actuating the second movable member to cut the tissue.

2. The electric surgical suture device according to claim 1, wherein, The controller is further configured to adjust the first actuation algorithm based on the difference.

3. The electric surgical suture device according to claim 2, wherein, The controller is configured to execute a modified first actuation algorithm to activate the motor unit, thereby further actuating the first movable member longitudinally.

4. The electric surgical suture device according to any one of the preceding claims, further comprising an encoder operatively coupled to the motor unit and the controller, wherein the encoder is operable to transmit a rotational output of the motor unit to the controller during actuation of the first movable member, wherein the actuation algorithm includes a first correlation between the expected displacement and a first amount of rotation of the motor unit, wherein adjusting the first actuation algorithm or the second actuation algorithm based on the difference includes: A second correlation is defined between the actual displacement and the second rotation amount of the motor unit.

5. The electric surgical suture device according to claim 1 or 2, wherein, The sensor includes a position sensor operatively coupled to the first movable member, wherein the controller is configured to determine the actual displacement based on a signal provided by the position sensor.

6. The electric surgical suture device according to claim 1 or 2, wherein, The sensor includes a current sensor operatively coupled to the motor unit, wherein the controller is configured to determine, based on a signal provided by the current sensor, that the first movable member has reached the second predetermined position, the signal indicating an increase in the current consumed by the motor unit.

7. The electric surgical suture device according to claim 1 or 2, wherein, The sensor includes a force sensor operatively coupled to the movable member, wherein the controller is configured to determine, based on a signal provided by the force sensor, that the first movable member has reached the second predetermined position, the signal indicating an increase in the longitudinal force applied to the first movable member.

8. The electric surgical suture device according to claim 1 or 2, wherein, The sensor includes at least one of a current sensor or a force sensor, wherein the controller is configured to adjust the actuation rate of the first movable member based on a signal provided by the sensor, wherein the signal indicates at least one of a current consumed by the motor unit or a longitudinal force applied to the first movable member.

9. The electric surgical suture device according to claim 1 or 2, wherein, The suture assembly is actuable between an open state for receiving tissue and a closed state for clamping the tissue, wherein in the closed state the suture assembly defines a gap in which the tissue is positioned, wherein the controller is configured to: (a) Receive user input corresponding to the target size of the gap; as well as (b) Controlling the actuation rate of the first movable member based on the user input.

10. The electric surgical suture device according to claim 1 or 2, wherein, The suture assembly includes: (a) A closure member, said closure member being actuable to clamp tissue with said suture assembly, (b) A staple driver component, said staple driver component being actuable to drive a staple into the clamped tissue, and (c) A blade member, actuable to cut the clamped tissue. The closing member, the nail driver member, and the blade member are operatively coupled to the motor unit and can be actuated independently of each other by the motor unit. The first movable member includes at least one of the closing member, the nail driver member, or the knife member.

11. The electric surgical suture device according to claim 10, wherein, The first movable member includes the closing member, wherein the first predetermined position of the closing member corresponds to the open state of the suture assembly, and wherein the second predetermined position of the closing member corresponds to the at least partially closed state of the suture assembly.

12. The electric surgical suture device according to claim 11, wherein, The closing member includes a cannula needle configured to be releasably coupled to an anvil, wherein the knife member includes a cylindrical knife.

13. The electric surgical suture device of claim 11, wherein the controller is further configured to: (a) In response to a first user input, the adjusted actuation algorithm is executed to actuate the closure member, thereby changing the suture assembly to a closed state for holding tissue; and (b) A second user input following the first user input: (i) Actuating the pin driver member with the motor unit to drive the pin into the clamped tissue, and (ii) Actuate the blade member with the motor unit to cut the clamped tissue.

14. The electric surgical suture device of claim 13, wherein the controller is configured to: (a) After actuating the nail driver component, determine that the nail driver component has reached a predetermined longitudinal position; and (b) In response to determining that the nail driver member has reached a predetermined longitudinal position, the motor unit actuates the blade member to cut the clamped tissue.

15. The electric surgical suture device according to claim 13, wherein, The controller is configured to store and execute a cutting tool actuation algorithm to activate the motor unit, thereby actuating the cutting tool, wherein the controller is further configured to: (a) Adjusting the actuation algorithm of the tool member based on the difference before actuating the tool member; and (b) Execute the adjusted tool component actuation algorithm to actuate the tool component with the motor unit.

16. The electric surgical suture device according to claim 15, wherein, The first movable member includes the closing member, wherein actuating the closing member causes the suture assembly to move toward a closed state.

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