Anvil retention and release features for a powered circular surgical stapler

By designing the anvil and suture head assembly of an electric circular surgical stapler, and combining it with an electric motor-driven staple forming and blade component cutting, the problems of incomplete tissue clamping and cutting in existing technologies have been solved, achieving a highly efficient anastomosis effect.

CN114585313BActive Publication Date: 2026-01-27CILAG GMBH INTERNATIONAL
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Patent Information

Application Number
CN202080065940.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-09-18
Filing Date
2020-09-01
Publication Date
2026-01-27
Estimated Expiration
2040-09-01

AI Technical Summary

Technical Problem

Existing circular staplers are difficult to use in surgical procedures to achieve efficient and reliable tissue clamping, cutting, and sealing, especially in end-to-end or side-to-side anastomosis, which may lead to leakage or incomplete connection.

Method used

An electrically powered circular surgical stapler comprising an anvil and a suture head assembly is designed. The anvil and suture head assembly work together via a releasable coupling to drive staple deformation in a staple forming recess using an electric motor, and combine with a blade component for cutting, providing precise tissue clamping and cutting.

Benefits of technology

It achieves efficient tissue clamping, cutting, and sealing, ensuring an unobstructed flow path at the anastomosis site, reducing the risk of leakage, and is suitable for open and endoscopic surgeries.

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Abstract

A surgical instrument includes a body assembly, a shaft assembly extending distally from the body assembly, an anvil, and a stapling head assembly. The stapling head assembly includes at least one annular array of staples, a staple driver, and a trocar. The trocar includes a shaft defining a longitudinal axis, an actuation feature coupled with a motor unit, and at least one coupling feature. The motor unit is configured to actuate the actuation feature to move the at least one coupling feature of the trocar in a transverse direction relative to the longitudinal axis of the shaft between a retracted position and a deployed position. In the retracted position, the shaft of the trocar is configured to move relative to the anvil along the longitudinal axis. In the deployed position, the shaft of the trocar is configured to move with the anvil along the longitudinal axis.
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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 of these sutures are operable to clamp a layer of tissue, cut through the clamped tissue, and drive staples through the clamped tissue to substantially seal the tissue layers together near the cut ends, thereby joining the two cut ends of an anatomical lumen. Circular sutures are constructed 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 is positioned in the first segment of the digestive tract and Figure 4 A cross-sectional side view of the suture head assembly positioned in the second segment of the digestive tract, wherein the anvil is separated from the suture head assembly;

[0014] Figure 7B It shows Figure 3 The anvil is positioned in the first segment of the digestive tract and Figure 4 A cross-sectional side view of the suture head assembly positioned 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 held 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 A perspective view of the distal end of another exemplary alternative cannula is shown;

[0019] Figure 9A It shows Figure 8 A cross-sectional side view of the distal end of the cannula, wherein the circuit of the cannula is in the open state.

[0020] Figure 9B It shows Figure 8 A cross-sectional side view of the distal end of the trocar, wherein Figure 9A The circuit is in the off state;

[0021] Figure 10 It shows Figure 1 A perspective view of the user interface features of the handle assembly of a circular stitcher;

[0022] Figure 11 A perspective view of another exemplary circular surgical suture is shown;

[0023] Figure 12 It shows Figure 11 A schematic diagram of a circular suture device, including the control system of the circular surgical suture device;

[0024] Figure 13 It shows the use of via Figure 12 Control system to control Figure 11 A schematic view of an exemplary method for using a circular stitcher;

[0025] Figure 14 A perspective view of an exemplary anvil and an exemplary suture head assembly including a cannula and a locking assembly is shown;

[0026] Figure 15 It shows Figure 14 A schematic diagram of the locking component;

[0027] Figure 16A It shows Figure 14 A cross-sectional side view of the anvil and suture head assembly cannula, wherein the anvil is positioned within a first portion of the tissue and the cannula is positioned within a second portion of the tissue spaced apart from the first portion of the tissue, such that the anvil is separated from the cannula and the locking assembly is in a locked configuration.

[0028] Figure 16B It shows Figure 14 A cross-sectional side view of the anvil and suture head assembly cannula, wherein the cannula is fully inserted into the anvil, but wherein the second part of the tissue is spaced apart from the first part of the tissue.

[0029] Figure 16C It shows Figure 14 A cross-sectional side view of the cannula of the anvil and suture head assembly;

[0030] Figure 16D It shows Figure 14 A cross-sectional side view of the anvil and suture head assembly cannula, wherein the anvil is moved proximally toward the anvil of the suture head assembly to compress the first and second portions of the tissue together into a clamping position.

[0031] Figure 16E The diagram shows the process after the suture head assembly is actuated to cut and suture the first and second portions of the tissue. Figure 14 A cross-sectional side view of the cannula of the anvil and suture head assembly;

[0032] Figure 16F It shows Figure 14 A cross-sectional side view of the cannula of the anvil and suture head assembly, wherein the cannula and anvil are advanced distally as a unit and retracted to the first tissue release position after cutting and suturing.

[0033] Figure 16G It shows Figure 14 A cross-sectional side view of the cannula of the anvil and suture head assembly, wherein the anvil is separated from the platform member at the first tissue release position;

[0034] Figure 16H It shows Figure 14 A cross-sectional side view of the cannula of the anvil and suture head assembly, wherein the cannula and anvil are advanced distally as a unit and retracted to the second tissue release position after cutting and suturing.

[0035] Figure 16I It shows Figure 14 A cross-sectional side view of the anvil and suture head assembly cannula, wherein the anvil is completely separated from the proximal retracting cannula at a third tissue release position before the first and second portions of tissue are cut and sutured, to provide emergency release of the anvil.

[0036] Figure 17A It shows Figure 16A The details include the separation of the anvil from the cannula and the locking assembly being in a locked configuration;

[0037] Figure 17B It shows Figure 16B In detail, the cannula is fully inserted into the anvil, the first retaining feature and the second retaining feature are in the retracted position, and the locking assembly is in the unlocked configuration.

[0038] Figure 17C It shows Figure 16C In the detailed section, the first retaining feature and the second retaining feature are moved to the open position using an actuator rod;

[0039] Figure 17D It shows Figure 16D In the details, the first retaining feature and the second retaining feature are in the open position, so that the cannula and the anvil retract proximally to the clamping position as a unit;

[0040] Figure 17E It shows Figure 16E The details include the suture head assembly being actuated to cut and suture the first and second parts of the tissue;

[0041] Figure 17F It shows Figure 16F In the details, the cannula is fully inserted into the anvil, the first retaining feature and the second retaining feature are in the open position, and the actuating rod is prepared to retract proximally.

[0042] Figure 17G It shows Figure 16G In detail, the cannula is fully inserted into the anvil, and the first and second retaining features are in the retracted position using an actuator rod;

[0043] Figure 17H It shows Figure 16H In the details, the cannula is fully inserted into the anvil, the first retaining feature and the second retaining feature are in the open position, and the actuating rod is prepared to retract proximally.

[0044] Figure 17I It shows Figure 16I The details include the anvil and the cannula being completely separated;

[0045] Figure 18 The operation is shown Figure 11 A schematic view of an exemplary method for using a circular stapler, the circular stapler comprising... Figure 14 The anvil and the trocar of the suture head assembly;

[0046] Figure 19A A cross-sectional side view of the cannula of another exemplary anvil and suture head assembly is shown, wherein the cannula is fully inserted into the anvil, the first and second retaining features are in the retracted position, and the locking assembly is in a position similar to Figure 16B The non-locking configuration; and

[0047] Figure 19B It shows Figure 19A A cross-sectional side view of the cannula of the anvil and suture head assembly, wherein the cannula is fully inserted into the anvil, and the first retaining feature and the second retaining feature are in the retracted position.

[0048] 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

[0049] 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.

[0050] 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.

[0051] I. Overview of Exemplary Circular Surgical Suture Instruments

[0052] 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, such as 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. As will be described in more detail below, the instrument (10) also includes a removable battery pack (120) operable to provide power to a motor (160) housed within the handle assembly (100).

[0053] 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.

[0054] 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).

[0055] A. Exemplary anvil

[0056] As in Figure 3 As best shown, the anvil (400) of this example includes a head (420) and a handle (410). The head (410) includes a proximal surface (412) defining a plurality of nail-forming recesses (414). In this example, the nail-forming recesses (414) are arranged in two concentric annular arrays. In some other forms, the nail-forming recesses (414) are arranged in three or more concentric annular arrays. The nail-forming recesses (414) are configured to deform a nail when it is driven into the nail-forming recess (414). For example, as is known in the art, each nail-forming recess (414) can deform a generally “U”-shaped nail into a “B”-shaped shape. The proximal surface (412) terminates at an inner edge (416) defining the outer boundary of an annular recess (418) surrounding the handle (420).

[0057] A handle (420) defines a hole (422) and includes a pair of pivoting latching members (430). The latching members (430) are located within the hole (422) such that a distal end (434) is positioned at a proximal end of a transverse opening (424) formed through the 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.

[0058] B. Exemplary sewn head assembly

[0059] 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 stud drive member (350) slidably housed therein. The body member (310) includes a cylindrical inner core member (312) extending distally. The body member (310) is securely attached to the outer sheath (210) of the shaft assembly (200), and thus the body member (310) and the outer sheath (210) 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 Driven Rotary InputCircular Stapler with Modular End Effector”, published March 21, 2017, the disclosure of which is incorporated herein by reference.

[0060] 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).

[0061] The nail drive member (350) is operable to be longitudinally actuated within the body member (310) in response to activation of the motor (160), as will be described in more detail below. The nail drive member (350) of this example comprises a concentric annular array of nail drivers (352) presented on both distal sides. The nail drivers (352) are arranged to correspond to the arrangement of the nail-forming recesses (414) of the anvil (400). Thus, each nail driver (352) is configured to drive a corresponding nail into a corresponding nail-forming recess (414) when the suture head assembly (300) is actuated. It should be understood that the arrangement of the nail drivers (352) and nail-forming recesses (414) shown herein can be modified in any suitable manner, provided that the nail drivers (352) and nail-forming recesses (414) are configured to align with each other to provide proper nail formation. The nail drive member (350) also defines a hole (354) configured to coaxially receive the core member (312) of the body member (310). An annular array of bolts (356) protrudes distally from a surface present around the hole (354).

[0062] A cylindrical blade member (340) is coaxially positioned within a nail drive member (350). The blade member (340) includes a sharp, rounded cutting edge (342) extending distally. The blade member (340) is sized such that it defines an outer diameter smaller than the diameter defined by the inner annular array of the nail drive member (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 drive member (350), such that the blade member (340) is securely fastened to the nail drive 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 drive member (350) will be apparent to those skilled in the art in light of the teachings herein.

[0063] 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) and stab forming recesses (414) 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 it 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.

[0064] like Figure 11 As can be seen most clearly, 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).

[0065] In some forms of the instrument (10), it may be desirable to provide an instrument (10) with certain features configured to indicate whether the anvil (400) is properly attached to the cannula (330) of the suture head assembly (300). For example, if the anvil (400) is not properly attached to the cannula (330), the operator may receive auditory and / or tactile feedback indicating incorrect attachment. Alternatively, if the anvil (400) is properly attached to the cannula (330), the operator may receive auditory, tactile, and / or visual feedback indicating correct attachment. In addition, or alternatively, the features may be configured to prevent firing of the suture head assembly (300) unless the anvil (400) is properly attached to the cannula (330). For example, firing of the suture head assembly (300) may be prevented if the anvil (400) is not properly attached to the cannula (330). If the anvil (400) is properly attached to the cannula (330), the firing head suturing head assembly (300) can be activated. Such features may include various types of visual markers, sensors, switches, etc. By way of example only, such features may include features of the type disclosed in the following patents: U.S. Patent 10,307,157, entitled “Surgical Stapler with Anvil Seating Detection”, published June 4, 2019, and U.S. Patent Publication 2017 / 0258471, entitled “Methods and Systems for Performing Circular Stapling”, published September 14, 2017, the disclosures of which are incorporated herein by reference.

[0066] C. Exemplary Axis Component

[0067] 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.

[0068] 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 be flexible 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 is 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).

[0069] 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 pin drive member (350). The proximal end of the suture head assembly driver (240) is secured to the drive bracket (250) via a pin (242). It should thus be understood that the pin drive 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 within 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 drive member (350).

[0070] D. Exemplary handle assembly and user input features

[0071] 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 first translate proximally at a relatively slow rate in response to rotation of the knob (130), and then translate proximally at a relatively fast rate.

[0072] 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.

[0073] A trigger (150) is operable to activate a motor (160), thereby actuating the suture head assembly (300). A 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) may prevent rotation 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 predefined range. Therefore, actuation of the trigger (150) is prevented by the safety trigger (140), thereby suppressing the firing of the suture head assembly (300) until the anvil position is within the predefined range.

[0074] The firing trigger (150) of this example includes an integral actuation blade (not shown) that may be similar to the blade disclosed in U.S. Patent Publication 2017 / 0258471, which is incorporated herein by reference. 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 supply power from the battery pack (120) to activate the motor (160) in response to the switching of the paddle-actuated 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 coupled to the drive bracket (250) via a gearbox coupled to the output shaft of the motor (160), a rotary cam member coupled to the output shaft of the gearbox, and a cam follower coupled to the rotary cam member, such as that disclosed in, for example, U.S. Patent Publication 2017 / 0258471, which is incorporated herein by reference.

[0075] like Figures 1 to 2As most clearly seen, 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).

[0076] E. Exemplary anastomosis surgery using a circular suture instrument

[0077] 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.

[0078] 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.

[0079] 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 central region of the handle (420) to substantially fix the position of the anvil (400) within the tubular anatomical structure (20). In some other variations, the purse-string suture (30) is tightened around the proximal end of the handle (420). In some such variations, the proximal end of the handle (420) may include a notch or other feature to securely capture the purse-string suture (30). Continuing with this example, the suture head assembly (300) is positioned within the tubular anatomical structure (40) such that the cannula (330) protrudes from the open, cut end (42) of the tubular anatomical structure (20). A purse-string suture (50) is positioned around the middle region of the axis (332) to substantially fix the position of the suture head assembly (300) within the tubular anatomical structure (40). The suture head assembly (300) is then pushed distally to ensure that the suture head assembly (300) is fully positioned at the distal end of the tubular anatomical structure (40).

[0080] 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, indicating 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).

[0081] 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 causing the blade (158) to actuate the 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 driving the distal actuation drive bracket (250), which in turn drives the distal actuation knife member (340) and nail drive 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).

[0082] 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 movement, the washer (417) is disconnected by the blade member (340). When the blade member (340) reaches the end of its distal movement, 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.

[0083] When the nail driving component (350) is from Figure 7C The position shown is to Figure 7D As the indicated position is translated distally, the nail driving member (350) drives the nail (90) through the tissue of the tubular anatomical structure (20, 40) and into the nail-forming recess (414) of the anvil (400). The nail-forming recess (414) deforms the driven nail (90) into, for example, a "B" shape or a three-dimensional shape, such that the formed nail (90) secures the ends of the tissue together, thereby connecting the tubular anatomical structure (20) and the tubular anatomical structure (40).

[0084] 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).

[0085] F. Exemplary cannula with integrated circuit

[0086] Figures 8 to 9A An exemplary cannula (450) is shown that can be readily incorporated into the instrument (10) discussed above in place of the cannula (330). The cannula (450) of this example is configured to operate substantially similarly to the cannula (330) discussed above, except for the differences discussed below. For example, the cannula (450) is operable to translate distally in response to rotation of the knob (130). As will be discussed in more detail below, the anvil (400) is configured to attach to the cannula (450) such that the translation of the cannula (450) is directly communicated with the anvil (400).

[0087] The cannula (450) includes a shaft (452) and a head (454). The head (454) includes a pointed tip (456) and an inwardly extending proximal surface (458). Thus, the shaft (452) provides a reduced outer diameter immediately adjacent to the head (454), wherein the surface (458) provides a transition between this reduced outer diameter of the shaft (452) and the outer diameter of the head (454). Although the tip (456) is pointed in this example, the tip (456) is not sharp. Therefore, the tip (456) will not easily cause tissue trauma due to accidental contact with tissue. The distal portions of the head (454) and the shaft (452) are configured for insertion into a hole (422) of an anvil (400). The proximal surface (458) and the latch shelf (436) have complementary positions and configurations such that the latch shelf (436) engages the proximal surface (458) when the handle (420) of the anvil (400) is fully seated on the cannula (450). Thus, the anvil (400) is secured to the cannula (450) by a snap-fit ​​engagement formed by the latching member (430).

[0088] The cannula (450) includes an electrical contact surface (460) disposed on a portion proximal to the head (454) surrounding an axis (452). The contact surface (460) is connected via a line (462) to a control circuit (not shown) of the instrument (10), which is configured to control the firing of the suture head assembly (300). The contact surface (460) is electrically isolated from the axis (452) of the cannula (450).

[0089] The anvil (400) in this example also includes an electrical contact surface (464) positioned within the handle (420) of the anvil (400). The contact surface (464) is electrically connected to the handle (420) of the anvil (400). The contact surfaces (460, 464), the shaft (452), the handle (420), and the wire (462) are configured to form part of a circuit that selectively initiates the firing of the suture head assembly (300). In the absence of the anvil (400) or in the presence of the anvil (400) not properly attached to the cannula (450), the circuit is in the open state, as... Figure 9A As shown, because the end (456) of the cannula (450) does not contact the contact surface (464) of the anvil (400). Since the anvil (400) is properly attached to the cannula (450), as... Figure 9B As shown, the end (456) of the cannula (450) contacts the contact surface (464) of the anvil (400), thus providing a path for electrical continuity between the shaft (452) of the cannula (450) and the contact surface (464) of the anvil (400). Furthermore, the shank (420) contacts the contact surface (460) of the cannula (450), thereby providing a path for electrical continuity between the shank (420) and the contact surface (460). Since the shank (420) is also in electrical continuity with the contact surface (464), and since the contact surface (460) is in electrical continuity with the wire (462), it should be understood that the aforementioned contact provides a path for electrical continuity between the shaft (452) of the cannula (450) and the wire (462). Figure 9B The electrical continuity of the stage shown. This closes the circuit, which enables the suture head assembly (300) to be fired. The suture head assembly (300) may not be fired before this circuit is closed. In other words, as in other examples herein, the suture head assembly (300) may not be fired until the anvil (400) is fully positioned on the cannula (450).

[0090] G. Exemplary user interface features of the handle assembly

[0091] like Figure 10Most clearly, the handle assembly (100) of the surgical suture instrument (10) also includes a user interface feature (114) configured to provide visual feedback to the operator, indicating the positioning of the anvil (400) relative to the suture head assembly (300) during surgical procedures. Thus, the operator can observe the user interface feature (114) while rotating the knob (130) to confirm that the appropriate gap distance (d) has been achieved between the anvil (400) and the suture assembly (300).

[0092] The user interface feature (114) of this example includes a graphic indicator (500) comprising fixed linear markers (502, 504, 506), a graphic representation of pins (510, 512), and a checkmark graphic (514). The user interface feature (114) also defines a window (520) through which the indicator pins (522) can be viewed. In some variations, the user interface feature (114) also includes a field (530) indicating information such as: the diameter associated with the size of the suture head assembly (300), the size of the pins in the suture head assembly (300), the size of the gap defined between the anvil (400) and the suture head assembly (300), and / or other information. By way of example only, the field (530) may indicate a suture head assembly (300) size of 23 mm, 25 mm, 29 mm, or 31 mm.

[0093] As the operator rotates the knob (130) to adjust the longitudinal position of the anvil (400) relative to the suture head assembly (300), the operator can observe the position of the indicator needle (522) through the window (520). Initially, the indicator needle (522) may be positioned at or near the distal end of the window (520). As the anvil (400) continues to move proximally, the indicator needle (522) will eventually move proximally relative to the window (520). The operator can observe the position of the indicator needle (522) relative to fixed linear markers (502, 504, 506). The distal marker (502) and the proximal marker (506) may indicate the boundary of the “green zone,” which is the acceptable range of distances between the anvil (400) and the suture head assembly (300) for successful actuation of the suture head assembly (300). Therefore, if the indicator needle (522) is located distal to the farthest mark (502), the distance between the anvil (400) and the suture head assembly (300) is too large; while if the indicator needle (522) is located proximal to the nearest mark (506), the distance between the anvil (400) and the suture head assembly (300) is too small. Mark (504) is longitudinally positioned between marks (502, 506). Graphical representation (510) indicates a relatively tall anchor (e.g., suitable for relatively thick tissue); while graphic representation (512) indicates a relatively short anchor (e.g., suitable for relatively thin tissue). Thus, graphic representations (510, 512) can, based on tissue observation or other means, facilitate the operator in determining whether and how the desired anchor height is achieved by selecting an appropriate spatial correspondence between the indicator needle (522) and the marks (502, 504, 506).

[0094] In this example, the window (520) is illuminated via a light-emitting diode (LED) (not shown), further enhancing the observation of the indicator needle (522) within the window (520). Furthermore, when the suture head assembly (300) completes the suturing and cutting cycle, the check mark pattern (514) is illuminated via another LED (not shown). Thus, the operator can further rely on the illumination of the check mark pattern (514) to confirm that the suturing and cutting cycle has been completed, thereby verifying that it is safe to advance the anvil (400) distally away from the anastomosis (70) to release tissue and then remove the instrument (10) from the patient.

[0095] The circular surgical suture instrument (10) may also be constructed and operated in accordance with at least some of the teachings in U.S. Patent Publication 2017 / 0258471, which is incorporated herein by reference.

[0096] II. An exemplary circular surgical suture instrument with independently controlled closure, suturing, and cutting.

[0097] In some cases, it may be desirable to provide a type of circular surgical suture instrument (10) that exhibits electric actuation of the anvil (400) in addition to the electric actuation of the internal firing component of the suture head assembly (300). Furthermore, it may be desirable to provide a type of instrument (10) with multiple actuators that initiate independent electric actuation of the anvil (400), the staple drive member (350), and the blade member (340), such that the resulting closure, suturing, and cutting strokes performed by such an instrument can be controlled independently of each other in response to user input.

[0098] 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.

[0099] A. Overview of circular surgical suture instruments with independently controlled actuators

[0100] Figure 11 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 hold tissue against its distally facing plateau surface (644). The suture head assembly (640) is selectively operable to eject staples distally into the held tissue and abut against the anvil (650), and to cut the held 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.

[0101] 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) adjacent to its distal end; 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 cavity (not shown) configured to releasably receive and hold a battery pack (620) similar to a battery pack (120) and operable to power a motor unit (660) housed within the housing (612) (see See [link]). Figure 12 ).

[0102] The handle assembly (610) of 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 trigger actuation of the cannula actuator (662) (see [link]). Figure 12 This achieves closure of the anvil (650) relative to the suture head assembly (640) to hold the tissue therebetween. 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 12 This allows for the suturing and cutting of the clamped tissue. (See the following text for details.) Figure 13 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 start of the cutting stroke relative to the start of the suturing stroke.

[0103] The safety member (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 directly or indirectly engage the closure trigger (624) and / or the firing trigger (626) to selectively prevent their actuation. For example, the safety member (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). Alternatively, the safety member (622) may be configured to prevent actuation of the firing trigger (626) until the anvil (650) has been positioned in a predetermined longitudinal position relative to the suture head assembly (640), which defines a specific gap distance (d) therebetween (see See... Figure 7C ).

[0104] exist Figure 12 The actuators (662, 664, 666) of the instrument (600) schematically shown are configured to operatively connect the 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 actuation of the motor unit (660) when the motor unit (660) and the cannula actuator (662) are operatively engaged, thereby actuating the anvil (650). The trocar actuator (662) may include an elongated member consisting of a trocar actuator rod (220) similar to that of the instrument (10) and a trocar actuator band assembly (230), the trocar actuator being translatably disposed within the shaft assembly (630).

[0105] The staple actuator (664) is operatively coupled to the staple drive member (not shown) of the suture head assembly (640) and the motor unit (660) independently of the cannula actuator (662). Thus, the staple actuator (664) is configured to actuate the staple drive member distally in response to activation of the motor unit (660) when the motor unit (660) is operatively engaged with the staple actuator (664), thereby actuating a staple (not shown) housed within the suture head assembly (640). The staple actuator (664) may include an elongated member similar to a suture head assembly driver (240) of the instrument (10), which is translatably disposed within the shaft assembly (630) independently of the cannula actuator (662).

[0106] A scalpel actuator (666) operatively connects the cylindrical scalpel member (not shown) of the suture head assembly (640) to the motor unit (660) independently of the cannula actuator (662) and the staple actuator (664). Thus, the scalpel actuator (666) is configured to actuate the scalpel member longitudinally 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 a 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.

[0107] 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 toward the suture head assembly (640) after partial or complete proximal retraction of the anvil (650), thereby causing the anvil (650) to extend distally away from the suture head assembly (640), for example, to release tissue trapped therein. In this type, the knob (618) may be connected to the trocar actuator (662) via a feature similar to that described above for the knob (130) of the connecting device (10) and, for example, including the threaded portion (224, 226) of the trocar actuator rod (220). However, it should be understood that in some types the knob (618) may be omitted from the device (600), so that the trocar actuator (662) is driven solely by the motor unit (660).

[0108] The device (600) may also be constructed and operated according to at least some of the following teachings: 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. Patent Publication 2018 / 0368836 for “Heights”; and / or any other patent reference identified herein, the disclosures of which are incorporated herein by reference.

[0109] B. Exemplary control system for a circular surgical suture instrument

[0110] like Figure 12As 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), these components being 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 use pulse width modulation (PWM) to control the motor unit (660) to drive the actuation of the cannula actuator (662), the staple actuator (664) and the knife actuator (666) independently for clamping, suturing and cutting tissue.

[0111] 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 all three actuators (662, 664, 666) and configured to drive all three actuators. In this embodiment, in accordance with the teachings herein and the incorporated references, the motor unit (660) may be coupled to the actuators (662, 664, 666) via one or more power transmission components (not shown), such as various suitable types of gear assemblies that will be apparent to those skilled in the art. In other embodiments, the motor unit (660) may include three motors, each dedicated to driving a corresponding actuator among the actuators (662, 664, 666). In another embodiment, the motor unit (660) may include two motors, with the assistance of a power transmission assembly, wherein the first motor is configured to drive the cannula needle actuator (662), and the second motor is configured to drive the nail actuator (664) and the knife actuator (666). It should be understood that the motor unit (660) may include various other numbers and arrangements of other types of motors.

[0112] 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 actuator (662, 664, 666) or its adjacent component. 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).

[0113] In some embodiments, the sensor (674) may be configured to detect a secure attachment of the anvil (650) to the cannula (642), as described, for example, in U.S. Patent 10,307,157, 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 of the suture head assembly (640) or the size of the staples (not shown) housed therein. In some of these embodiments, 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.

[0114] In other forms, the sensor (674) may be directly connected to the motor unit (660). For example, the sensor (674) may be in the form of a sensor assembly including 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 12Only one sensor (674) is shown in the diagram, but it should be understood that the sensor (674) may include multiple sensors, each of which is configured to monitor one or more corresponding conditions of the control module (672) with respect to the instrument (600) and to communicate with the control module. Furthermore, it should be understood that the sensor (674) may include various suitable types of sensors that will be apparent to those skilled in the art from the teachings herein and are not described further herein.

[0115] The user interface (616) is similar to the user interface (114) described above, except that the user interface (616) is also configured to receive user input and send the user input to the control module (672). In this respect, the user interface (616) may include one or more buttons, dials, other actuable elements, or display graphics that can be selected by the user to indicate certain information related to the surgical procedure to be performed or to the suture head assembly (640). By way of example only, such information may include any of the following: the desired staple 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 the tissue struck by the instrument (600); and / or the diameter of the suture head assembly (640). The control module (672) can use such information in combination with information provided by the sensor (674) to adjust the stroke and / or rate of actuation 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 the operation, as described in more detail below, for example.

[0116] C. Exemplary methods for controlling a circular surgical suture

[0117] Figure 13 It shows the use of via Figure 12 The control system (670) shown controls an exemplary method (700) of a circular surgical suture instrument (600). At step (702), for example after the instrument (600) has been removed from its packaging, the instrument (600) is powered on in response to being powered by the battery pack (620) when the battery pack (620) is fully inserted into the proximal end of the handle assembly (610). After removal from the packaging, the anvil (650) is secured to the cannula (642) and is in the fully open position, and the staple retainer (not shown) is secured to the platform surface (644).

[0118] In this example, after the instrument (600) is powered on, the control module (672) enters an anvil travel calibration mode at step (704). This mode can be entered 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 pin retainer or, alternatively, against the platform surface (644) if the pin retainer has been removed. The control module (672) can detect that the anvil (650) has reached the closed position by detecting, via the sensor (674), an increase in the current load of the motor unit (660) when the anvil (650) contacts the pin retainer or the platform surface (644). The control module (672) observes the stroke (i.e., longitudinal displacement) of the anvil (650) during the retraction process and compares it with the expected stroke of the anvil (650). Based on this comparison and any difference between the two observed stroke values, the control module (672) then performs calibration of the cannula actuator (662) to activate the actuation algorithm of the motor unit (660), thereby ensuring accurate actuation of the anvil (650) thereafter during the surgical procedure. Alternatively or additionally, the calibration of the anvil stroke may be performed by the control module (672) in real time during the surgical procedure when the anvil (650) is retracted to clamp tissue. Such calibration of the anvil stroke is described in further detail in U.S. Patent Application No. END9128USNP1, filed on the same date as this application, entitled “Method for Calibrating Movements of Actuated Members of Powered Surgical Stapler,” the disclosure of which is incorporated herein by reference. It should be understood that the stroke of one or more other actuable components of the instrument (600) can be calibrated in a similar manner before or during surgery, and the anvil closure stroke can be calibrated by the control module (672) to further calibrate the suturing and / or cutting stroke of the instrument (600).

[0119] 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 being operated on using the instrument (600). The control module (672) is configured to determine the size based on user input provided via the user interface (616) and / or, for example, information provided by the sensor (674) when the sensor (674) is configured to detect the size of the suture head assembly (640) in the manner described above.

[0120] At step (708), the control module (672) receives input from the user interface (616), such as input selected by the operator via the user interface (616), indicating the desired height of the staple to be formed in the tissue. The control module (672) equates this staple height to the corresponding gap distance (d) to be established between the anvil (650) and the platform surface (644) of the suture head assembly (640) at the closed position of the anvil (650) (see...). Figure 7C ( ), so as to achieve the selected nail height.

[0121] Although steps (704, 706, 708) are in Figure 13 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 relative to each other in various orders after the instrument (600) is powered on in step (702) and before the actuation of the nail actuator (664) described below.

[0122] 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 the suture head assembly (640) within the patient's second tubular tissue structure. The operator then attaches the anvil (650) to the cannula (642) inside the patient, for example as described above. Figures 7A to 7B As shown, at this point, the control module (672) detects that the attachment has been completed at step (710). This detection can be performed by a sensor (674), which sends a corresponding signal to the control module (672).

[0123] 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 achieving the selected pin height and corresponding gap distance (d). In some configurations, the control module (672) may be configured to trigger the retraction of the trocar (642) and anvil (650) only in response to the actuation of the closure trigger (624) that occurs after the attachment of the anvil (650) to the trocar (642) has been detected at step (710). The operator may monitor the retraction of the anvil (650) toward its closed position via visual markers and / or a graphical display of the user interface (616).

[0124] Additionally, in some configurations, the control module (672) may control the motor unit (660) to retract the anvil (650) proximally through the anvil closure 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 closure stroke, at which point the control module (672) pauses the activation of the motor unit (660) for a predetermined period of time (e.g., a few seconds). At the end of this pause, the control module (672) reactivates the motor unit (660) to continue retracting the anvil (650) through the remaining portion of the anvil closure 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, this tissue settling causes the axial extension load on the cannula (642) and the resulting current load on the motor unit (660) to decrease as the anvil (650) is advanced proximally to its fully closed position as defined by the target pin height input provided by the user in step (708).

[0125] At step (716), after the anvil closure stroke is completed, the control module (672) detects that the firing trigger (626) has been actuated by the operator. In this example, in response to the detection of this actuation, 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, thus reducing the axial load on the staple actuator (664) and the blade actuator (666) and the resulting current load on the motor unit (660) during the corresponding suture and cutting sequences. It should be understood that in some models this waiting period may be omitted.

[0126] After the waiting period indicated in step (718) is completed, the control module (672) at step (720) triggers distal actuation of the staple drive member (not shown) to begin suturing the clamped tissue. Specifically, the control module (672) activates the motor unit (660) to engage the staple actuator (664) and drives the staple actuator distally to actuate the staple drive member through the suture head assembly (640), thereby driving the staple into the tissue and abutting against the anvil (650), for example, in a manner similar to Figure 7D As shown. Upon actuation of the staple actuator (664), the control module (672) observes at step (722) another predetermined time period during which the motor unit (660) continues to drive the staple actuator (664) through the suture stroke. Simultaneously, at step (724), the control module (672) communicates with the sensor (674) to detect when the staple driving member reaches a predetermined longitudinal position within the suture head assembly (640). Such a position may correspond to the location point where various staple drivers (not shown), similar to the staple driver (352) described above, reach the platform surface (644), such that the staple is at least partially formed within the clamped tissue. This method is described in further detail in U.S. Patent Application No. END9129USNP1, filed on the same date as this application, entitled "Method for Controlling Cutting MemberActuation for Powered Surgical Stapler," the disclosure of which is incorporated herein by reference.

[0127] 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 drive member has reached a predetermined longitudinal position, the control module (672) then triggers distal actuation of the blade member (not shown) at step (726) to begin cutting tissue. Specifically, the control module (672) activates the motor unit (660) to engage the blade actuator (666) and drives the blade actuator toward the distal actuation blade member through the suture head assembly (640), thereby cutting tissue, for example, to a similar degree. Figure 7D As shown in the diagram.

[0128] As described above, the initiation of the delayed cutting stroke relative to the suture stroke, achieved by the independent actuation of the staple actuator and the blade actuator (662, 664, 666), ensures that the staple is at least partially formed within the tissue before tissue cutting begins. Advantageously, this method allows the staple to be anchored within the held tissue before cutting, thereby preventing lateral displacement of the tissue and deformation of the staple when the blade member is driven distally.

[0129] The end of the distal cutting stroke of the blade member may correspond to the location of a washer (not shown) similar to the washer (417) described above within the blade member disconnect anvil (650). Upon completion of the distal cutting stroke, 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 can be achieved by powering the motor unit (660) with a continuous, uniform range of movement, as disclosed, for example, in U.S. Patent Publication 2017 / 0258471, which is incorporated herein 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 drive the blade actuator (666) in an alternative manner to retract the blade member proximally. In any of these types, the sensor (674) may include an encoder configured to monitor the rotational output of the motor unit (660).

[0130] Simultaneously with or after the blade retraction step (728), at step (730), the control module (672) directs the motor unit (660) to drive the cannula actuator (662) distally, thereby extending the anvil (650) distally relative to the platform surface (644) of the suture head assembly (640) to a predetermined position. This distal extension allows the sutured tissue to be released between the anvil (650) and the suture head assembly (640), allowing the instrument (600) to be removed from the patient while the anvil (650) remains attached to the cannula (642).

[0131] III. Anvil Sensing and Retention

[0132] When using the instrument (10, 600), the user can perform several tasks without visualization. For example, one such task may include ensuring sufficient connection between the anvil (400, 650) and the cannula (330, 450, 642) to adequately retain the anvil (400, 650) during movement of the cannula (330, 450, 642). Another task may include opening the instrument (10) after firing without losing the trajectory of the anvil (400, 650). Yet another task may include the emergency release of the anvil (400, 650) from the cannula (330, 450, 642) in the unlikely event of a problem during use.

[0133] In some cases, continuous knowledge of the anvil's (400, 650) position may be beneficial while it is positioned within the patient. Therefore, complete release of the anvil (400, 650) from the cannula (330, 450, 642) during or even after a particular surgical procedure may be undesirable. For example, complete release of the anvil (400, 650) from the cannula (330, 450, 642) may require the user to locate the anvil (400, 650) and subsequently "retrieve" it from the patient. Retrieving the anvil (400, 650) from the patient can prolong the duration of the procedure. Furthermore, if the anvil (400, 650) is unintentionally dislodged from the cannula (330, 450, 642), this could cause errors in all data acquired by the processor during closure (e.g., for stroke / rate calibration purposes). Specifically referring to the instrument (10), it is undesirable for the latch shelf (436) of the anvil (400) to disengage from the proximal surface (338) of the cannula (330) during closure and / or firing.

[0134] Therefore, after firing, it is desirable to space the anvil (400, 650) from the platform surface (322, 644) to release tissue from the anvil (400, 650) and achieve removal of the instrument (10, 600) from the patient. In some cases, this can be performed by blindly spaced the anvil (400, 650) from the platform surface (322, 644), allowing the cannula (330, 450, 642) to extend any distance. For example, this can be performed by the user manually actuating a knob (130) located at the proximal end of the shank assembly (100). It is desirable that upon firing, the anvil (400, 650) extends a predetermined distance away from the platform surface (322, 644), providing the user with a subsequent indication that the instrument (600) is ready for removal from the patient.

[0135] A. Exemplary suture head assembly and anvil

[0136] As mentioned above (refer to the previous text) Figures 11 to 12 The instrument (600) includes a main body assembly (e.g., a handle assembly (610)), a shaft assembly (630), a suture head assembly (640), and an anvil (650). The handle assembly (610) includes a motor unit (660) for supplying power to the instrument (600). For example, as referenced above... Figures 11 to 12 The motor unit (660) may include one or more motors to power one or more actuators (e.g., actuators (662, 664, 666)). The shaft assembly (630) extends distally from the shank assembly (610).

[0137] Figures 14 to 17HAn exemplary alternative suture head assembly (800) and an exemplary alternative anvil (802) configured for use with an instrument (600) are shown. For example, the suture head assembly (800) may be used in place of the suture head assembly (640) and the anvil (802) may be used in place of the anvil (650). The suture head assembly (800) may be similar to the suture head assemblies (300, 640) unless otherwise described below. Similarly, the anvil (802) may be similar to the anvils (400, 650) unless otherwise described below. The suture head assembly (800) is positioned at the distal end of a shaft assembly (630) similar to the suture head assembly (640). The suture head assembly (800) includes at least one annular array of staples (not shown), but these staples may be similar to staples (90) formed in an annular array. The suture head assembly (800) also includes a staple driver (not shown), but this staple driver may be similar to a staple driver (352). The nail driver (352) is configured to drive at least one annular array of nails (90) against the anvil (802) to deform the nails (90).

[0138] like Figures 14 to 15 As shown, the suture head assembly (800) includes a cannula (804) and a locking assembly (806). The cannula (804) includes a shaft (808), an actuation feature (810), and at least one retaining feature (shown as a first retaining feature (812) and a second retaining feature (814)). The shaft (808) defines a longitudinal axis (LA) of the cannula (804). The shaft (808) of the cannula (804) includes a wall (816) having an inner surface (818) and an outer surface (820). The inner surface (818) of the wall (816) defines a lumen (822) of the shaft (808). The shaft (808) also includes holes (823) extending through the shaft (808) and allowing the first retaining feature (812) and the second retaining feature (814) to extend through the shaft (808) of the cannula (804). The shaft (808) also includes a pointed end (824) adjacent to the distal end (826). Similar to the pointed end (336), the pointed end (824) is not sharp and is designed to minimize the risk of tissue trauma from accidental contact with tissue. The actuation feature (810) is configured to move within the lumen (822) along the longitudinal axis (LA) to move the first retaining feature (812) and the second retaining feature (814) of the cannula (804) between a constricted position and an open position, as described below. Figures 17A to 17H A more detailed description. For example... Figure 14 As shown, the first retaining feature (812) and the second retaining feature (814) are spaced apart along the longitudinal axis (LA) of the shaft (808) of the cannula needle (804).

[0139] like Figure 14As shown, the anvil (802) includes a shaft (828) and a head (830) extending distally from the shaft (828) (see...). Figures 16A to 16I The shaft (828) includes a wall (832) having an inner surface (834) and an outer surface (836). The inner surface (834) of the wall (832) defines a lumen (838). The inner surface (818) of the wall (816) includes an outwardly tapering portion (840) adjacent to the proximal end (842) of the shaft (828) of the anvil (802). The anvil (802) may include at least one internal recess. As shown, the inner surface (834) of the anvil (802) includes a first internal recess (844) and a second internal recess (846) spaced apart from each other along a longitudinal axis (LA). Although the first internal recess (844) and the second internal recess (846) are shown, any suitable number, shape, and size of internal recesses are contemplated. For example, if the first retaining feature (812) and the second retaining feature (814) include annular rings, then the first internal recess (844) and the second internal recess (846) may be annular in shape to accommodate the annular rings. Although not shown, the first internal recess (844) and the second internal recess (846) may extend completely through the wall (832). The actuation feature (810) may be an active motor-driven actuator that is manually activated by the user or automatically activated when the anvil (802) is fully inserted into the cannula (804) of the instrument (600).

[0140] like Figure 15 As shown, the motor unit (660), as instructed by the control module (672), is configured to actuate the actuation feature (810) to move the first retaining feature (812) and the second retaining feature (814) of the cannula (804) when the locking assembly (806) is in the unlocked configuration. The actuation feature (810) is operatively coupled to the motor unit (660). The first motor is configured to power the cannula (804) to move the actuation feature (810). The second motor is configured to drive the nail actuator (664), which drives the nail driver (not shown). The actuation feature (810) provides radial displacement of the first retaining feature (812) and the second retaining feature (814) relative to corresponding first internal recesses (844) and second internal recesses (846) formed in the inner surface (834) of the shaft (828) of the anvil (802). Although in Figure 14The diagram shows a resiliently biased protrusion (848), but it is also envisioned that the first retaining feature (812) and the second retaining feature (814) may include various biasing features other than the resiliently biased protrusion (848). For example, the first retaining feature (812) and the second retaining feature (814) may include resiliently biased annular rings (e.g., a first annular ring and a second annular ring) in addition to other suitable resiliently biased protrusions.

[0141] Figures 14 to 15 An exemplary locking assembly is shown. The locking assembly (806) determines whether the anvil (802) is fully inserted into the cannula (804). Specifically, the locking assembly (806) is configured to prevent activation of the actuation feature (810) in response to incomplete engagement between the anvil (802) and the cannula (804). Conversely, the locking assembly (806) is configured to allow activation of the actuation feature (810) in response to engagement between the anvil (802) and the cannula (804), such that the first retaining feature (812) and the second retaining feature (814) are allowed to move to the open position. Figure 14 A cannula (804) including a first electrical contact (850) and an anvil (802) including a second electrical contact (852) are shown. The first electrical contact (850) and the second electrical contact (852) are configured to detect loading, engagement, and retraction of the anvil (802) relative to the shaft (808) of the cannula (804). As shown, the first electrical contact (850) is disposed on the outer surface (820) of the shaft (808) of the cannula (804), and the second electrical contact (852) is disposed on the inner surface (834) of the shaft (828) of the anvil (802). As shown, the first electrical contact (850) includes a first portion (854a) and a second portion (854b) electrically connected to a first wire (856a) and a second wire (856b), respectively. It is conceivable that the first electrical contact (850) may include more or fewer parts than the first portion (854a) and the second portion (854b). Although the locking assembly (806) is in Figures 14 to 15 The switch is shown in the middle, but it is also envisioned that the locking component (806) can be implemented using a variety of different features, including one or more sensors.

[0142] Figure 15 It shows Figure 14 A schematic diagram of a portion of the locking assembly (806) shows a first portion (854a) including an insulating portion (858). The insulating portion (858) can be coupled to the outer surface (820) of the cannula needle (804) using various methods. Figures 14 to 15As shown, an electrical signal (e.g., current) can pass through a first wire (856a) to a first electrical contact (850), then from the first electrical contact (850) to a second electrical contact (852), then from the second electrical contact (852) to a second wire (856b), and then from the second wire to the control module (672). Alternatively, reference may be made to the above. Figures 9A to 9B The diagram and description utilize a single wire, wherein the current can initially pass through the sleeve needle (804) and out through the first wire (856a).

[0143] B. Exemplary Methods

[0144] Now for reference Figures 16A to 17H An exemplary method is described for connecting an anvil (802) to a suture head assembly (800) with a cannula (804). Figure 16A and Figure 17A The anvil (802) is shown separated from the cannula (804) along the longitudinal axis (LA) before the anvil (802) is connected to the cannula (804). Figure 16A It shows Figure 14 A cross-sectional side view of the anvil (802) and the trocar (804) of the suture head assembly (800), wherein the anvil (802) is positioned within a first portion (T1) of tissue and the trocar (804) is positioned within a second portion (T2) of tissue spaced apart from the first portion (T1) along a longitudinal axis (LA). Specifically, the proximal surface (860) of the head (830) of the anvil (802) is positioned at a pre-compression distance (d). PC The cannula (804) is spaced apart from the platform surface (644). In the retracted position, the shaft (808) of the cannula (804) is configured to be movable relative to the anvil (802) along the longitudinal axis (LA) using the motor unit (660).

[0145] Figure 17A It shows Figure 16A In the details, the locking assembly (806) is in a locked configuration. Specifically, because the anvil (802) and the cannula (804) are not fully connected, the first electrical contact (850) and the second electrical contact (852) are misaligned, causing the electrical switch to be turned on. When the electrical switch is turned on, the electrical signal cannot be transmitted from the first electrical contact (850) to the second electrical contact (852). Therefore, the first retaining feature (812) and the second retaining feature (814) of the cannula (804) are prevented from engaging the anvil (802). See reference Figures 17A to 17HAs shown and described, the actuation feature (810) includes an actuation rod (862). The distal portion (864) of the actuation rod (862) includes a first narrow portion (866) and a second narrow portion (868) having a reduced cross-sectional area. The first narrow portion (866) and the second narrow portion (868) are defined by an angled surface (870). The first retaining feature (812) and the second retaining feature (814) are shown to be at least partially located within the respective first narrow portion (866) and the second narrow portion (868) in the retracted position, thereby allowing the cannula needle (804) to move relative to the anvil (802) along the longitudinal axis (LA). Thus, in the retracted position, the first retaining feature (812) is spaced apart from the first internal recess (844) and the second retaining feature (814) is spaced apart from the second internal recess (846).

[0146] Figure 16B It shows Figure 14 A cross-sectional side view of the anvil (802) and the suture head assembly (800) with the cannula (804) fully inserted into the anvil (802). For example, the cannula (804) can be advanced distally using a cannula actuator (662). Similar to... Figure 16A The second part (T2) of the tissue is spaced apart from the first part (T1) of the tissue along the longitudinal axis (LA). Specifically, the proximal surface (860) of the head (830) of the anvil (802) is at a pre-compression distance (d). PC ) is spaced apart from the platform surface (644). Figure 17B It shows Figure 16B In the detailed portion, the cannula (804) is fully inserted into the anvil (802), and the first retaining feature (812) and the second retaining feature (814) are in the retracted position. Since the anvil (802) is fully engaged with the cannula (804), the locking assembly (806) is in an unlocked configuration. Therefore, the first electrical contact (850) and the second electrical contact (852) are aligned, causing the electrical switch to be closed. When the electrical switch is closed, an electrical signal can be transmitted from the first electrical contact (850) to the second electrical contact (852). In the retracted position, the first retaining feature (812) and the second retaining feature (814) of the cannula (804) are spaced apart from the first internal recess (844) and the second internal recess (846) of the anvil (802). The first retaining feature (812) and the second retaining feature (814) are prepared to move from the contracted position to the open position in the transverse direction relative to the longitudinal axis (LA) of the shaft (808), but have not yet moved. As shown, the transverse direction is perpendicular to the longitudinal axis (LA) of the shaft (808) of the cannula (804). However, other transverse directions are also envisioned.

[0147] Figure 16C It shows Figure 14 A cross-sectional side view of the anvil (802) and the trocar (804) of the suture head assembly (800). Similar to... Figures 16A to 16B The second part (T2) of the tissue is spaced apart from the first part (T1) of the tissue along the longitudinal axis (LA). Specifically, the proximal surface (860) of the head (830) of the anvil (802) is at a pre-compression distance (d). PC ) is spaced apart from the platform surface (644). Figure 17C It shows Figure 16C In the detailed portion, the first retaining feature (812) and the second retaining feature (814) are moved to the open position using an actuator (862). The actuator (862) is driven by a motor unit (660). The motor unit (660) may be a drive actuator (862) independent of the cannula actuator (662), which uses a signal from a control module (672) to translate the cannula (804). The angled surface (870) of the distal portion (864) of the actuator (862) contacts the first retaining feature (812) and the second retaining feature (814) to push the first retaining feature (812) and the second retaining feature (814) outward into the first internal recess (844) and the second internal recess (846) of the anvil (802). In the open position, the first retaining feature (812) and the second retaining feature (814) of the cannula (804) are at least partially disposed within corresponding first internal recesses (844) and second internal recesses (846) of the anvil (802). Specifically, as shown in the figure, the first retaining feature (812) of the cannula (804) is at least partially disposed within the first internal recess (844) and the second retaining feature (814) is at least partially disposed within the second internal recess (846). In the open position, the shaft (808) of the cannula (804) is configured to move together with the shaft (828) of the anvil (802) as a unit along the longitudinal axis (LA).

[0148] Figure 16D It shows Figure 14 A cross-sectional side view of the anvil (802) and the cannula (804) of the suture head assembly (800), wherein the axis (828) of the anvil (802) is moved proximally toward the anvil (802) of the suture head assembly (800) using a cannula actuator (662) to compress the first portion (T1) and the second portion (T2) of the tissue together to a closed position. As shown, the proximal surface (860) of the head (830) of the anvil (802) is at a distance less than the pre-compression distance (d). PC Compression distance (d) C (644) are spaced apart from the platform surface. Figure 17D It shows Figure 16DIn the details, the first retaining feature (812) and the second retaining feature (814) are in the open position, so that the cannula (804) and the anvil (802) retract proximally to the closed position as a unit.

[0149] Figure 16E A suture head assembly (800) is shown, actuated to cut and suture a first portion (T1) and a second portion (T2) of tissue. A firing instrument (600) forces at least one annular array of staples (90) through the first portion (T1) and the second portion (T2) of the patient's tissue. As previously described, actuation of the firing trigger (626) is configured to activate the motor unit (660) to trigger actuation of the staple actuator (664) and the knife actuator (666) (see [link]). Figure 12 This allows for the suturing and cutting of the clamped tissue. (See the following text for details.) Figure 13 In more detail, the instrument (600) is configured to control the actuation of the nail actuator (664) and the knife actuator (666) independently in response to a single actuation of the firing trigger (626). Figure 16E This illustrates the process after the suture head assembly (800) is actuated to cut and suture the first portion (T1) and the second portion (T2) of the tissue. Figure 14 A cross-sectional side view of the anvil (802) and the trocar (804) of the suture head assembly (800). Figure 17E It shows Figure 16E The details.

[0150] Following firing, it may be desirable to move the anvil (400, 650) to a predetermined distance away from the platform surface (644). For example, it may be advantageous to open the instrument (600) to a known maximum height. Additionally, it may be desirable to actively detect and sense the anvil (400, 650) and to have means for releasing the anvil (400, 650) in an emergency and for partially releasing tissue upon completion of firing of the instrument (10, 600). Active electromechanical anvil retention and release systems may be desired that work in conjunction with the detection and sensing of the anvil (400, 650). Figure 16F , Figure 16H and Figure 16I The method may include translating the cannula (804) along its longitudinal axis (LA) between a closed position, a first tissue release position, and / or a second tissue release position as described below. For example, the method may include extending the cannula (804) to... Figure 16F The first tissue release location shown or Figure 16HThe second tissue release position is shown, while the cannula (804) remains connected to the anvil (802). This avoids the user having to retrieve the anvil (802) as previously described. In the open position, the cannula (804) and the anvil (802) can be translated together as a fixed unit along the longitudinal axis (LA) between the closed position, the first tissue release position, and the second tissue release position.

[0151] Figure 16F It shows Figure 14 A cross-sectional side view of the anvil (802) and the suture head assembly (800) cannula (804), wherein the cannula (804) and the anvil (802) are advanced distally together as a unit to a first tissue release position after the tissue has been cut and sutured. A first retaining feature (812) and a second retaining feature (814) are shown in the open position. Figure 17F It shows Figure 16F In the detailed section, the cannula (804) is fully inserted into the anvil (802), the first retaining feature (812) and the second retaining feature (814) are in the open position, and the actuating rod (862) is configured to retract proximally. As shown, the closed position and the first tissue release position are separated by a clamping distance (d). C The first distance (d) TR1 ).

[0152] Figure 16G This shows the first tissue release position after the actuating rod (862) retracts proximally. Figure 14 A cross-sectional side view of the anvil (802) and the trocar (804) of the suture head assembly (800). The motor unit (660) may be a drive actuator (862) independent of the trocar actuator (662), which uses signals from a control module (672) to translate the trocar (804). The anvil (802) is separated from the platform surface (644) at a first tissue release position, and the first retaining feature (812) and the second retaining feature (814) are in a retracted position. Specifically, after determining that the anvil (802) is fully inserted into the trocar (804), the first retaining feature (812) and the second retaining feature (814) move from the retracted position to the open position by activating the actuator (862). Figure 17G It shows Figure 16G In the detailed section, the cannula (804) is fully inserted into the anvil (802), and the first retaining feature (812) and the second retaining feature (814) are in the retracted position using the actuating rod (862). Figure 17GAs shown, the first retaining feature (812) and the second retaining feature (814) can be released from the anvil (802), thereby enabling removal. The release of the anvil (802) has a first amount and a second amount of release. The first tissue release position can be a partial opening of the anvil (8020), thereby enabling the user to remove the anvil (802) from the tissue. In the event of an unexpected problem with the instrument (600), the second tissue release position is a complete release. Partial release does not completely release the anvil (802).

[0153] Figure 16H The location of the second tissue release is shown. Figure 14 A cross-sectional side view of the anvil (802) and the cannula (804) of the suture head assembly (800). The instrument (600) can move the anvil (802) to a second tissue release position without first stopping at... Figures 16F to 16G At the first tissue release position shown. The actuation feature (810) can automatically actuate the first holding feature (812) and the second holding feature (814) to move the first holding feature (812) and the second holding feature (814) to the contracted position. At the second release position, the actuation feature (810) is configured to manually or automatically actuate the first holding feature (812) and the second holding feature (814). At the second tissue release position, the first holding feature (812) and the second holding feature (814) can be automatically actuated using the actuation feature (810), which may be motor-driven, to move the first holding feature (812) and the second holding feature (814) to the contracted position. The closed position and the second tissue release position are separated by a second distance (d). TR2 First distance (d) TR1 ) is less than the second distance (d) TR2 A ball screw actuator (not shown) is configured to rotate a predetermined number of revolutions corresponding to a desired distance to provide controlled release of the first part (T1) and the second part (T2) of the tissue.

[0154] Figure 16I It shows Figure 14 A cross-sectional side view of the anvil (802) and the trocar (804) of the suture head assembly (800). Figure 17I It shows Figure 16I In detail, the anvil (802) and the cannula (804) are completely separated. As shown in the figure, the third tissue release position is separated by a third distance (d). TR3 The third distance is greater than the first distance (d). TR1 ) and second distance (d TR2As shown in the figure, at the third tissue release position, before the first portion (T1) and the second portion (T2) of the tissue are cut and sutured, the anvil (802) is completely separated from the retracted cannula (804) proximally. In other words, this third tissue release position can be used if the user attempts to completely disengage the anvil (802) from the cannula (804) without cutting and suturing the first portion (T1) and the second portion (T2) of the tissue. This provides emergency release of the anvil (802) if needed. Although not shown, it is conceivable that the user may utilize the third tissue release position after the first portion (T1) and the second portion (T2) of the tissue have been partially cut or sutured.

[0155] The method may also include providing visual indication (e.g., graphic indicator (500)) on the instrument (600) of at least one of the following: the cannula (804) is fully extended, at least one anvil retains the feature in the open position, or the anvil (802) is spaced apart from the tissue to provide a gap for removal of the anvil (802) from the tissue after the instrument (600) is fired. (See above for reference.) Figure 10 and Figure 11 The handle assembly (610) includes a user interface (616) that includes an indicator. For example, the indicator may resemble a graphic indicator (500). The graphic indicator (500) may include, for example, fixed linear markers (502, 504, 506), a graphic representation of a pin (510, 512), and / or a checkmark graphic (514), or another suitable graphic indicator. Specifically, the indicator may be a light (e.g., an LED light) that changes state according to conditions. The graphic indicator (500) may indicate to the user when the cannula (804) is fully extended. Additionally, the graphic indicator (500) may indicate to the user when the cannula (804) is attached to the anvil (802) and when the cannula (804) is fully extended relative to the shaft assembly (630). The graphic indicator (500) may indicate to the user when the anvil (802) is attached to the fully extended cannula (804). The graphic indicator (500) can indicate to the user when the release of the anvil (802) is sufficient to remove it from the tissue after use. In addition, the graphic indicator (500) can indicate to the user when the anvil (802) is spaced apart from the tissue to remove the anvil (802) from the tissue after the firing of the nail (90).

[0156] Figure 18 The operation is shown Figure 11 A schematic view of an exemplary method (900) of an instrument (600), the instrument comprising Figure 14 The suture head assembly (800) and anvil (802). Step (902) includes connecting the cannula (804) to the anvil (802). This is in Figure 16C and Figure 17C As shown in the figure. Step (904) includes compressing the first portion (T1) and the second portion (T2) between the cannula (804) and the anvil (802) such that the proximal surface (860) of the head (830) of the anvil (802) is compressed by a distance less than the pre-compression distance (d). PC The clamping distance (d) C ) spaced apart from the platform surface (644), such as Figure 16D As shown.

[0157] Step (906) includes the firing device (600). The method also includes, after the firing of at least one pin (90) of the annulus array of the firing device (600), moving the anvil (802) of the device (600) a predetermined distance away from the platform surface (644). For example, moving the anvil (802) a predetermined distance away from the platform surface (644) may include using a ball screw (not shown) with a predetermined number of revolutions to move the anvil (802) away from the platform surface (644) a predetermined distance. Step (908) includes extending the cannula (804) to… Figure 16F The first tissue release location shown or Figure 16H The second tissue release position is shown, while the cannula (804) remains attached to the anvil (802). Step (910) involves disengaging the cannula (804) from the anvil (802) by moving the first retaining feature (812) and the second retaining feature (814) to the retracted position, as shown. Figure 17G , Figure 17H and Figure 17I As shown.

[0158] C. Exemplary alternative suture head assembly and anvil

[0159] Figures 19A to 19B A cross-sectional side view of an exemplary alternative suture head assembly (1000) and an exemplary alternative anvil (1002) is shown. The suture head assembly (1000) is similar to the one referenced above. Figures 14 to 17I The suture head assembly (800) is shown and described. Similarly, the anvil (1002) is similar to the one described above. Figures 14 to 17I Anvil (802) is shown and described. Similar to... Figure 17B of Figure 19A As shown, the cannula (1004) is fully inserted into the anvil (1002), and the first retaining feature (1012) and the second retaining feature (1014) are in the retracted position. Since the first retaining feature (1012) and the second retaining feature (1014) are in the retracted position, the locking assembly (1006) is in the unlocked configuration.

[0160] and Figure 17C and Figure 17DUnlike the actuation feature (1010), the actuation feature (1062) includes an electromechanical feature (1062) instead of an actuation rod (862). The electromechanical feature (1062) is configured to push the first retaining feature (1012) and the second retaining feature (1014) outward from the retracted position to the open position. The electromechanical feature (1062) is electrically connected to the control module (672) via a wire (1064). In the open position, the shaft (1008) of the cannula needle (1004) moves together with the anvil (1002) as a unit along the longitudinal axis (LA). Figure 19B It shows Figure 19A A cross-sectional side view of the anvil (1002) and the trocar (1004) of the suture head assembly (1000), wherein the trocar (1004) is fully inserted into the anvil (1002), and the first retaining feature (1012) and the second retaining feature (1014) are in the retracted position.

[0161] IV. Exemplary Combinations

[0162] 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.

[0163] Example 1

[0164] A surgical instrument includes: (a) a body assembly including a motor unit; (b) a shaft assembly extending distally from the body assembly; (c) an anvil; and (d) a suture head assembly positioned at a distal end of the shaft assembly, wherein the suture head assembly includes: (i) at least one annular array of staples; (ii) a staple driver configured to abut against the anvil to drive at least one annular array of staples to deform the staples; and (iii) a cannula including: (A) a shaft. The shaft defines a longitudinal axis, (B) an actuation feature connected to a motor unit, and (C) at least one connecting feature, wherein the motor unit is configured to actuate the actuation feature to move at least one connecting feature of the cannula in a retracted position and an open position in a transverse direction relative to the longitudinal axis of the shaft, wherein in the retracted position the shaft of the cannula is configured to move relative to the anvil along the longitudinal axis, and wherein in the open position the shaft of the cannula is configured to move along the longitudinal axis together with the anvil.

[0165] Example 2

[0166] According to the surgical instrument of Embodiment 1, the anvil includes at least one internal recess, wherein in the retracted position, at least one connecting feature of the cannula is spaced apart from at least one internal recess of the anvil, and wherein in the open position, at least one connecting feature of the cannula is at least partially disposed within at least one internal recess of the anvil.

[0167] Example 3

[0168] According to any one of the foregoing embodiments, the surgical instrument includes at least one connecting feature portion comprising a first connecting feature portion and a second connecting feature portion spaced apart along the longitudinal axis of the cannula, wherein the anvil includes at least a first internal recess and a second internal recess, wherein in the retracted position, the first connecting feature portion is spaced apart from the first internal recess and the second connecting feature portion is spaced apart from the second internal recess, wherein in the open position, the first connecting feature portion of the cannula is at least partially disposed within the first internal recess and the second connecting feature portion is at least partially disposed within the second internal recess.

[0169] Example 4

[0170] According to any one of the foregoing embodiments, the surgical instrument wherein the axis of the cannula includes a lumen, wherein the actuating feature is configured to move within the lumen along a longitudinal axis to move the at least one connecting feature of the cannula between a contracted position and an open position.

[0171] Example 5

[0172] The surgical instrument according to any one of the foregoing embodiments, wherein the actuation feature includes an actuation rod, wherein the distal portion of the actuation rod includes at least one narrow portion having a reduced cross-sectional area, wherein at least one connecting feature is configured to be located within at least one narrow portion in a retracted position, thereby allowing the cannula to move relative to the anvil along a longitudinal axis.

[0173] Example 6

[0174] The surgical instrument according to any one of Embodiments 1 to 4, wherein the actuation feature includes an electromechanical feature configured to push at least one connecting feature outward from a contracted position to an open position, such that the axis of the cannula is configured to move along the longitudinal axis with the anvil.

[0175] Example 7

[0176] According to any one of the foregoing embodiments, the surgical instrument includes a motor unit comprising a separate first motor and a second motor, wherein the first motor is configured to move the actuation feature and the second motor is configured to drive the nail driver.

[0177] Example 8

[0178] The surgical instrument according to any one of the foregoing embodiments further includes a locking assembly configured to prevent activation of the actuation feature in response to the anvil not being engaged with the cannula, wherein the locking assembly is configured to allow activation of the actuation feature in response to engagement of the anvil and the cannula, such that at least one engagement feature is allowed to move to an open position.

[0179] Example 9

[0180] According to the surgical instrument of embodiment 8, the locking assembly includes an electrical switch, wherein the cannula includes a first electrical contact and the anvil includes a second electrical contact, wherein when the anvil is fully connected to the cannula, the first and second electrical contacts are aligned to close the electrical switch, and when the anvil is not fully connected to the cannula, the first and second electrical contacts are misaligned to open the electrical switch.

[0181] Example 10

[0182] According to any one of the foregoing embodiments, in the open position, the cannula and anvil are configured to translate as a unit along a longitudinal axis between the closed position, the first tissue release position, and the second tissue release position, wherein the first distance between the closed position and the first tissue release position is less than the second distance between the closed position and the second tissue release position.

[0183] Example 11

[0184] According to the surgical instrument of Embodiment 10, in the first tissue release position, the actuation feature is configured to manually or automatically actuate at least one connecting feature to move at least one connecting feature to the contracted position.

[0185] Example 12

[0186] According to any one of Embodiments 10 to 11, in the surgical instrument, at the second tissue release position, the actuation feature is configured to automatically actuate at least one connecting feature to move at least one connecting feature to the contracted position.

[0187] Example 13

[0188] The surgical instrument according to any one of Embodiments 1 to 12, wherein the main body component further includes an indicator configured to indicate to the user when the cannula is fully extended.

[0189] Example 14

[0190] The surgical instrument according to any one of Embodiments 1 to 12, wherein the body assembly further includes an indicator configured to provide indication to the user when the cannula is attached to the anvil and the cannula is fully extended relative to the body assembly.

[0191] Example 15

[0192] The surgical instrument according to any one of Embodiments 1 to 12, wherein the main body component further includes an indicator configured to indicate to the user when the anvil is removed from the tissue after the firing of the nail, the anvil is spaced apart from the tissue.

[0193] Example 16

[0194] A surgical instrument includes: (a) a body assembly including a motor unit; (b) a shaft assembly extending distally from the body assembly; (c) an anvil; and (d) a suture head assembly positioned at a distal end of the shaft assembly, wherein the suture head assembly includes: (i) at least one annular array of staples; (ii) a staple driver configured to abut against the anvil to drive at least one annular array of staples to deform the staples; and (iii) a cannula including: (A) a shaft defining a longitudinal axis; (B) at least one coupling feature; and (C) an actuation feature coupled to the motor unit. The motor unit is configured to move an actuation feature to move at least one connecting feature of the cannula between a retracted position and an open position, wherein in the retracted position, the shaft of the cannula is configured to move relative to the anvil along a longitudinal axis, and wherein in the open position, the shaft of the cannula is configured to move along the longitudinal axis together with the anvil; and (iv) a locking assembly configured to prevent the motor unit from using electricity to move the actuation feature from the retracted position to the open position when the anvil and the cannula are not fully connected, wherein the locking assembly is configured to allow the motor unit to move the actuation feature from the retracted position to the open position when the anvil and the cannula are fully connected.

[0195] Example 17

[0196] According to the surgical instrument of embodiment 16, the locking assembly includes an electrical switch, wherein the electrical switch includes a first electrical contact and a second electrical contact, wherein the cannula includes the first electrical contact and the anvil includes the second electrical contact, wherein when the anvil and the cannula are fully connected, the first electrical contact and the second electrical contact are configured to be aligned such that the electrical switch is closed, wherein when the anvil and the cannula are not fully connected, the first electrical contact and the second electrical contact are configured to be misaligned such that the electrical switch is opened.

[0197] Example 18

[0198] According to the surgical instrument of embodiment 16, the first electrical contact and the second electrical contact are configured to detect the loading, connection and retraction of the anvil relative to the axis of the cannula.

[0199] Example 19

[0200] A method of operating a surgical instrument, the method comprising: (i) firing the surgical instrument to force at least one annular array of pins through a patient’s tissue; and (ii) after firing at least one annular array of pins of the surgical instrument, moving the anvil of the surgical instrument to a predetermined distance away from the anvil on a platform.

[0201] Example 20

[0202] According to the method of embodiment 19, moving the anvil to a predetermined distance away from the platform further includes moving the anvil away from the platform by a predetermined number of rotations of a ball screw.

[0203] Example 21

[0204] A method for engaging an anvil of a surgical instrument with a cannula, the method comprising: (i) using a locking assembly to prevent at least one engagement feature of the cannula from engaging the anvil when the anvil of the surgical instrument is not fully engaged with the cannula; (ii) using the locking assembly to determine that the anvil of the surgical instrument is fully inserted into the cannula; and (iii) after determining that the anvil is fully inserted into the cannula, moving the at least one engagement feature from a contracted position to an open position by activating a motor-driven actuation feature.

[0205] Example 22

[0206] The method according to embodiment 21 further includes providing visual indication on the surgical instrument of at least one of the following: the cannula is fully extended, at least one anvil is held in the open position, or the anvil is spaced apart from the tissue to provide a gap for removal of the anvil from the tissue after the surgical instrument is fired.

[0207] Example 23

[0208] According to any one of Embodiments 19 to 20, after moving the at least one anvil holding feature to the open position, the method further includes translating the cannula along the longitudinal axis of the cannula between the closed position and the tissue release position, and at the tissue release position, automatically actuating the at least one connecting feature using a control module to move the at least one connecting feature to the retracted position.

[0209] V. Miscellaneous

[0210] 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.

[0211] Furthermore, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. Patent Application No. END9128USNP1, filed on the same date as this application, entitled “Method for Calibrating Movements of Actuated Members of Powered Surgical Stapler”; U.S. Patent Application No. END9129USNP1, filed on the same date as this application, entitled “Method for Controlling Cutting Member Actuation for Powered Surgical Stapler”; and 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”. The disclosures of each of these U.S. patent applications are incorporated herein by reference.

[0212] 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.

[0213] 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.

[0214] 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.

[0215] 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.

[0216] 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. A surgical instrument, comprising: (a) A main component, the main component including a motor unit; (b) A shaft assembly extending distally from the body assembly; (c) Anvil; and (d) A suture head assembly, the suture head assembly being positioned at the distal end of the shaft assembly, wherein the suture head assembly comprises: (i) at least one ring array of nails (ii) a nail driver, said nail driver being configured to abut against the anvil and drive the nails of the at least one annular array to deform the nails, and (iii) a cannula, the cannula comprising: (A) Axis, which defines a longitudinal axis. (B) An actuation feature, which is connected to the motor unit, and (C) At least one connecting feature, wherein the motor unit is configured to actuate the actuation feature to move the at least one connecting feature of the cannula in a retracted position and an open position in a transverse direction relative to the longitudinal axis of the shaft, wherein in the retracted position, the shaft of the cannula is configured to move relative to the anvil along the longitudinal axis, wherein in the open position, the shaft of the cannula is configured to move along the longitudinal axis together with the anvil.

2. The surgical instrument according to claim 1, wherein, The anvil includes at least one internal recess, wherein in the retracted position, the at least one connecting feature of the cannula is spaced apart from the at least one internal recess of the anvil, and wherein in the open position, the at least one connecting feature of the cannula is at least partially disposed within the at least one internal recess of the anvil.

3. The surgical instrument according to claim 1, wherein, The at least one connecting feature includes a first connecting feature and a second connecting feature spaced apart along the longitudinal axis of the shaft of the cannula, wherein the anvil includes at least a first internal recess and a second internal recess, wherein in the retracted position, the first connecting feature is spaced apart from the first internal recess and the second connecting feature is spaced apart from the second internal recess, wherein in the open position, the first connecting feature of the cannula is at least partially disposed within the first internal recess and the second connecting feature is at least partially disposed within the second internal recess.

4. The surgical instrument according to claim 1, wherein, The shaft of the cannula includes a lumen, wherein the actuation feature is configured to move within the lumen along the longitudinal axis to move the at least one connecting feature of the cannula between the contracted position and the open position.

5. The surgical instrument according to claim 4, wherein, The actuation feature includes an actuation rod, wherein the distal portion of the actuation rod includes at least one narrow portion having a reduced cross-sectional area, wherein the at least one connection feature is configured to be located within the at least one narrow portion at the retracted position, thereby allowing the cannula needle to move relative to the anvil along the longitudinal axis.

6. The surgical instrument according to claim 1, wherein, The actuation feature includes an electromechanical feature configured to push the at least one connecting feature outward from the retracted position to the open position, such that the axis of the cannula is configured to move along the longitudinal axis with the anvil.

7. The surgical instrument according to claim 1, wherein, The motor unit includes a separate first motor and a second motor, wherein the first motor is configured to move the actuation feature and wherein the second motor is configured to drive the nail driver.

8. The surgical instrument of claim 1, further comprising a locking assembly configured to prevent activation of the actuation feature in response to the anvil not being engaged with the cannula, wherein the locking assembly is configured to allow activation of the actuation feature in response to engagement of the anvil with the cannula, such that the at least one engagement feature is allowed to move to the open position.

9. The surgical instrument according to claim 8, wherein, The locking assembly includes an electrical switch, wherein the cannula includes a first electrical contact and the anvil includes a second electrical contact, wherein when the anvil is fully engaged with the cannula, the first and second electrical contacts are aligned to close the electrical switch, and when the anvil is not fully engaged with the cannula, the first and second electrical contacts are misaligned to open the electrical switch.

10. The surgical instrument according to claim 1, wherein, In the open position, the cannula and the anvil are configured to translate as a unit along the longitudinal axis between the closed position, the first tissue release position, and the second tissue release position, wherein the first distance between the closed position and the first tissue release position is less than the second distance between the closed position and the second tissue release position.

11. The surgical instrument according to claim 10, wherein, At the first tissue release position, the actuation feature is configured to manually or automatically actuate the at least one connecting feature to move the at least one connecting feature to the contraction position.

12. The surgical instrument according to claim 10, wherein, At the second tissue release position, the actuation feature is configured to automatically actuate the at least one connecting feature to move the at least one connecting feature to the contraction position.

13. The surgical instrument according to claim 1, wherein, The main component also includes an indicator configured to provide guidance to the user when the cannula is fully extended.

14. The surgical instrument according to claim 1, wherein, The main body assembly also includes an indicator configured to provide indication to the user when the cannula is attached to the anvil and the cannula is fully extended relative to the main body assembly.

15. The surgical instrument according to claim 1, wherein, The main component also includes an indicator configured to provide guidance to the user when the anvil is removed from the tissue after the firing of the nail, as the anvil is spaced apart from the tissue.

16. A surgical instrument comprising: (a) A main component, the main component including a motor unit; (b) A shaft assembly extending distally from the body assembly; (c) Anvil; and (d) A suture head assembly, the suture head assembly being positioned at the distal end of the shaft assembly, wherein the suture head assembly comprises: (i) at least one ring array of nails (ii) A nail driver configured to abut against the anvil and drive the nails of the at least one annular array to deform the nails. (iii) a cannula, the cannula comprising: (A) Axis, which defines a longitudinal axis. (B) At least one connecting feature, and (C) An actuation feature, connected to the motor unit, wherein the motor unit is configured to move the actuation feature to move at least one connecting feature of the cannula between a retracted position and an open position, wherein in the retracted position, the axis of the cannula is configured to move relative to the anvil along the longitudinal axis, and wherein in the open position, the axis of the cannula is configured to move along the longitudinal axis together with the anvil; and (iv) A locking assembly configured to prevent the motor unit from using electricity to move the actuation feature from the contracted position to the open position when the anvil and the cannula are not fully engaged, wherein the locking assembly is configured to allow the motor unit to move the actuation feature from the contracted position to the open position when the anvil and the cannula are fully engaged.

17. The surgical instrument according to claim 16, wherein, The locking assembly includes an electrical switch, wherein the electrical switch includes a first electrical contact and a second electrical contact, wherein the cannula includes the first electrical contact and the anvil includes the second electrical contact, wherein when the anvil is fully engaged with the cannula, the first electrical contact and the second electrical contact are configured to align to close the electrical switch, wherein when the anvil is not fully engaged with the cannula, the first electrical contact and the second electrical contact are configured to misalign to open the electrical switch.

18. The surgical instrument according to claim 17, wherein, The first and second electrical contacts are configured to detect loading, engagement, and retraction of the anvil relative to the axis of the cannula.

Citation Information

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