Shaft deflection detection system for surgical instrument

Abstract

A surgical instrument includes a shaft deflection detection system that includes one or more sensors positioned at a first mechanical junction between a shaft and an actuator coupled to the shaft and / or at a second mechanical junction between the shaft and an end effector coupled to the shaft. The shaft is movable relative to the actuator at a first mechanical joint and / or relative to the end effector at a second mechanical joint. The one or more sensors are configured to generate a signal indicative of movement of the shaft relative to the actuator and / or the end effector. Movement of the shaft is caused by an external force experienced by the shaft when the shaft of the surgical instrument is manipulated within the body of the patient.

Description

Background Art

[0001] Surgical instruments (such as surgical staplers) can be used for various manual and / or robotic surgical procedures. For example, circular surgical staplers can be used to provide end-to-end, side-to-side or end-to-side anastomosis between two segments of an anatomical cavity (such as a portion of a patient's digestive tract). In some settings, laparoscopic or endoscopic surgical instruments may be preferred relative to traditional open surgical instruments to minimize the size of the surgical incision and postoperative recovery time and complications. Endoscopic surgical instruments can be adapted to place the end effector at the desired surgical site by cannulation of a trocar. For various surgical instruments, distal end effectors (e.g., endoscopic cutters, graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy delivery devices, and energy delivery devices using ultrasound, RF, lasers, etc.) can engage tissue in a variety of ways to achieve a diagnostic or therapeutic effect. Some such surgical instruments can operate to clamp tissue layers, cut through the clamped tissue layers, and drive staples through the tissue layers to substantially seal the cut tissue layers together near the cut ends of the tissue layers. Such endoscopic surgical staplers can also be used for laparotomy and / or other non-endoscopic surgeries. By way of example only, in thoracic surgery, a surgical stapler can be inserted through a thoracotomy and thus positioned between the patient's ribs to reach one or more organs, without using a trocar as a conduit for the stapler. Such surgery may include using a stapler to cut off and close blood vessels leading to organs such as the lungs. For example, before an organ is removed from the chest cavity, a stapler can be used to cut off and close blood vessels leading to the organ. Of course, the surgical stapler can be used in various other situations and operations.

[0002] Surgical instruments suitable for use in open or endoscopic procedures may include a shaft extending proximally from an end effector to an actuator, such as a manually operated handle portion manipulated by a clinician or a robotic arm operated by a robot. Such a shaft may facilitate insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby facilitating positioning of the end effector within the patient's body. Positioning of the end effector may be further facilitated by including one or more articulation joints or features that enable the end effector to be selectively articulated or otherwise deflected relative to the longitudinal axis of the shaft.

[0003] During such open or endoscopic surgical procedures, it is important to ensure that the shaft of the surgical instrument is not manipulated too forcefully within the patient's body during the procedure (e.g., during insertion of the surgical instrument into the patient's body and / or removal of the surgical instrument from the patient's body) in order to ensure that surrounding anatomical structures (e.g., lumens, veins, arteries, nerves, etc.) are not injured during the surgical procedure. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0005] Figure 1 depicts a perspective view of an example surgical instrument in the form of a circular surgical stapler including a handle assembly, a shaft assembly, and an end effector having a stapling head and an anvil;

[0006] Figure 2 Depicts Figure 1 a perspective view of the surgical instrument with the battery pack partially removed from the handle and the anvil separated from the stapling head assembly;

[0007] Figure 3 Depicts Figure 1 A perspective view of an anvil of a surgical instrument;

[0008] Figure 4 Depicts Figure 1 A perspective view of a suturing head of a surgical instrument;

[0009] Figure 5 Depicts Figure 4 An exploded perspective view of the suture head;

[0010] Figure 6 Depicts Figure 1 an exploded perspective view of a surgical instrument of FIG, wherein portions of the shaft are shown separated from one another;

[0011] Figure 7A Depicts location within the first segment of the digestive tract Figure 3 The anvil is positioned within the isolated second segment of the digestive tract. Figure 4 a cross-sectional side view of a stapling head with the anvil separated from the stapling head assembly;

[0012] Figure 7B Depicts location within the first segment of the digestive tract Figure 3 The anvil is positioned within the isolated second segment of the digestive tract. Figure 4 a cross-sectional side view of a stapling head assembly with an anvil secured to the stapling head assembly;

[0013] Figure 7C Depicts location within the first segment of the digestive tract Figure 3 The anvil is positioned within the isolated second segment of the digestive tract. Figure 4 a cross-sectional side view of a stapling head with the anvil retracted toward the stapling head, thereby clamping tissue between the anvil and the stapling head assembly;

[0014] Figure 7D Depicts location within the first segment of the digestive tract Figure 3 The anvil and the second segment of the digestive tract Figure 4 a cross-sectional side view of a suturing head of FIG. 1 , wherein the suturing head is actuated to sever and sew the clamped tissue, thereby joining the first and second segments of the digestive tract;

[0015] Figure 7E Depicts Figure 7A The first and second segments of the digestive tract are used Figure 1 A cross-sectional side view of an end-to-end anastomosis formed by a circular stapler;

[0016] Figure 8 Another example of a surgical instrument configured as a surgical stapler is depicted;

[0017] Figure 9 Depicts Figure 8 an end effector of a surgical instrument that has been actuated through tissue via a single firing stroke;

[0018] Figure 10 An example of a surgical instrument configured to enable attachment of the surgical instrument to a robotic device, such as a robotic arm, is depicted;

[0019] Figure 11 depicts an example surgical instrument equipped with a shaft deflection detection system;

[0020] Figure 12 Depicts Figure 11 A cross-sectional view of a shaft deflection detection system for a surgical instrument in a neutral or static state;

[0021] Figure 13 Depicts Figure 11 A cross-sectional view of a shaft deflection detection system of a surgical instrument in a state where the shaft of the surgical instrument is subjected to an external force;

[0022] FIG. 14A to FIG. 14B depicts an example diagram that can be used to illustrate corrective actions to guide a user of a surgical instrument in mitigating forces experienced by a shaft of the surgical instrument; and

[0023] Figure 15 is a flow chart of an example method for monitoring forces experienced by a shaft of a surgical instrument as the shaft is manipulated within a patient's body.

[0024] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; it should be understood, however, that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0025] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is provided by way of example, which is one of the best modes contemplated for implementing the present technology. As will be appreciated, the technology described herein is capable of other different and obvious aspects, all of which do not depart from the present technology. Accordingly, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0026] For clarity of the disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic operator of a surgical instrument. The term "proximal" refers to a position of an element that is closer to a human or robotic operator of a surgical instrument and further away from a surgical end effector of the surgical instrument. The term "distal" refers to a position of an element that is closer to a surgical end effector of a surgical instrument and further away from a human or robotic operator of the surgical instrument. In addition, the terms "upper," "lower," "lateral," "transverse," "bottom," and "top" are relative terms to provide additional clarity to the description of the figures provided below. Therefore, the terms "upper," "lower," "lateral," "transverse," "bottom," and "top" are not intended to unnecessarily limit the invention described herein.

[0027] Furthermore, the terms "about," "approximately," "substantially," and the like, as used herein in connection with any numerical value, numerical range, and / or geometric / positional quantification, are intended to encompass the exact value or quantification recited, as well as a suitable tolerance such that the recited feature or combination of features can be used for the intended purpose described herein. For example, "substantially parallel" encompasses nominally parallel structures.

[0028] As used herein in conjunction with the various examples of end effector jaw tips, a tip described as "angled," "curved," or "bent" encompasses tip configurations in which the longitudinal path (e.g., linear or arcuate) along which the tip extends is non-coaxial and non-parallel to the longitudinal axis of the jaw body; in particular, configurations in which the longitudinal tip path extends distally toward the opposing jaws. Conversely, a tip described as "straight" encompasses tip configurations in which the longitudinal axis of the tip is substantially parallel or coaxial with the longitudinal axis of the jaw body.

[0029] I. Exemplary Surgical Instruments

[0030] Figures 1 to 2 An example surgical instrument 10 is depicted that can be used to provide an end-to-end, side-to-side, or end-to-side anastomosis between two segments of an anatomical cavity, such as a portion of a patient's digestive tract. The surgical instrument 10 of this example is a circular surgical stapler and includes: a body assembly in the form of an actuator, such as a manually operated handle portion 100; a shaft 200 extending distally from the handle portion 100; an end effector in the form of a suturing head 300 located at the distal end of the shaft 200; and an anvil 400 configured to be releasably coupled and cooperating with the suturing head 300 to clamp, suturing, and cutting tissue. The instrument 10 also includes a removable battery pack 120 operable to provide power to a motor 160 housed in the handle 100, as described in more detail below.

[0031] like Figures 1 to 2 As shown in FIG, and as described in more detail below, anvil 400 is configured to be removably coupled to shaft 200 adjacent to stapling head 300. As also described in more detail below, anvil 400 and stapling head 300 are configured to cooperate to manipulate tissue in three ways, including clamping tissue, cutting tissue, and suturing tissue. The rotatable knob 130 at the proximal end of handle 100 is rotatable to provide precise clamping of tissue between anvil 400 and stapling head 300. When the safety trigger 140 of handle 100 is pivoted away from the firing trigger 150 of handle 100, firing trigger 150 can be actuated to provide cutting and suturing of the clamped tissue.

[0032] As in Figure 3 As best seen in the anvil 400 of this example, the anvil 400 includes a head 420 and a handle 410. The head 410 includes a proximal suturing surface 412 defining a plurality of staple forming pockets 414. In this example, the staple forming pockets 414 are arranged in two concentric annular arrays. The staple forming pockets 414 are configured to deform the staples as they are driven into the staple forming pockets 414. The proximal suturing surface 412 terminates at an inner edge 416 that defines the outer boundary of an annular recess 418 surrounding the handle 420. A frangible washer 417 is positioned within the annular recess 418 and is configured to provide a tactile and audible indication to the operator that the distal firing stroke has been completed, in addition to serving as a cutting plate, as described in more detail below.

[0033] The handle 420 defines an aperture 422 and includes a pair of pivoting latch members 430. The latch members 430 are positioned within the aperture 422 so that the distal ends 434 are positioned at the proximal ends of the transverse opening 424 formed through the sidewall of the handle 420. The latch members 430 thus act as a retaining fixture. This allows the anvil 400 to be removably secured to an actuable closure member in the form of a trocar 330 of the stapling head 300, as will be described in greater detail below. The handle 420 of the anvil 400 and the trocar 330 of the stapling head 300 thus cooperate with each other to act as a coupling member.

[0034] As in Figure 4 and Figure 5 As best seen in FIG, the stapling head 300 of the present example is coupled to the distal end of the shaft 200 and includes a tubular body member 310 and a staple drive member 350 slidably received therein. The body member 310 includes a cylindrical inner core member 312 coaxially positioned therein and extending distally. The body member 310 is securely fixed to the outer sheath 210 of the shaft 200, and thus the body member 310 and the outer sheath 210 together serve as a mechanical ground for the stapling head 300.

[0035] Trocar 330 is coaxially positioned within inner core member 312 of body member 310. As described in greater detail below, trocar 330 is operable to translate distally and proximally relative to body member 310 in response to rotation of knob 130 relative to housing 110 of handle portion 100. Trocar 330 includes a shaft 332 and a head 334. Head 334 includes a pointed tip 336 and a radially inwardly extending proximal surface 338. Head 334 and a distal portion of shaft 332 are configured for insertion into aperture 422 of anvil 400. Proximal surface 338 and latch shelf 436 have complementary positions and configurations such that latch shelf 436 engages proximal surface 338 when shaft 420 of anvil 400 is fully seated on trocar 330. Thus, anvil 400 is secured to trocar 330 via the snap fit provided by latch member 430.

[0036] Staple drive member 350 is operable to be actuated longitudinally within body member 310 in response to activation of motor 160, as described in greater detail below. Figure 5As best shown in the figure, the staple drive member 350 of this example includes two concentric annular arrays of distally presented staple drivers 352. The staple drivers 352 are arranged to correspond to the arrangement of the staple forming pockets 414 of the anvil 400. Thus, each staple driver 352 is configured to drive a corresponding staple distally into a corresponding staple forming pocket 414 when the stapling head 300 is actuated (or "fired"). The staple drive member 350 further defines a hole 354 that is configured to coaxially and slidably receive the core member 312 of the body member 310. An annular array of bolts 356 protrudes distally from a surface that is distally presented around the hole 354.

[0037] A cylindrical knife member 340 is coaxially positioned within a distally open central recess of the staple drive member 350 that communicates with the aperture 354. The knife member 340 includes a distally presented sharp, circular cutting edge 342. The knife member 340 is sized such that the outer diameter defined by the knife member 340 is just smaller than the diameter defined by the radially innermost surface of the inner annular array of staple drivers 352. The knife member 340 also defines a central opening configured to coaxially receive the core member 312 of the body member 310. An annular array of openings 346 formed in the knife member 340 is configured to mate with an annular array of bolts 356 of the staple drive member 350, such that the knife member 340 is securely secured to the staple drive member 350 via the bolts 356 and the openings 346.

[0038] The annular platform member 320 is securely secured to the distal end of the body member 310. The platform member 320 includes a distally presented suturing surface in the form of a platform surface 322 having two concentric annular arrays of staple openings 324. The staple openings 324 are arranged to align with the arrangement of the staple drivers 352 of the staple drive member 350 and the staple forming recesses 414 of the anvil 400 described above. Each staple opening 324 is configured to slidably receive and provide a path for a corresponding staple driver 352 when the suturing head 300 is actuated to drive the corresponding staple distally through the platform member 320 and into the corresponding staple forming recess 414. As shown in Figure 5 As best seen in the figures, the central opening of the platform member 320 defines an inner diameter that is only slightly larger than the outer diameter defined by the knife member 340. The platform member 320 is therefore configured to permit longitudinal translation of the knife member 340 through the central opening, concurrent with longitudinal translation of the staple driving member 350. Specifically, the knife member 340 is configured to be actuated relative to the platform member 340 between a proximally retracted position and a distally extended position, wherein the cutting edge 342 is located proximally of the platform surface 322 in the proximally retracted position and distally of the platform surface 322 in the distally extended position.

[0039] Figure 6Various components of shaft 200 are shown that operably couple components of stapling head 300 with components of handle 100. Specifically, and as described above, shaft 200 includes an outer sheath 210 that extends between handle 100 and body member 310 and includes a mid-portion that extends along a tortuous path.

[0040] Shaft 200 also includes a trocar actuation rod 220 having a proximal end operably coupled to rotatable knob 130 and a distal end coupled to a flexible trocar actuation band assembly 230, the assembly of which is slidably received within outer sheath 210. The distal end of trocar actuation band assembly 230 is securely secured to the proximal end of trocar shaft 332 such that trocar 330 will longitudinally translate relative to outer sheath 210 in response to translation of trocar actuation band assembly 230 and trocar actuation rod 220 relative to outer sheath 210, wherein translation of the trocar actuation band assembly and trocar actuation rod relative to outer sheath occurs in response to rotation of rotatable knob 130. Clamp 222 is securely secured to trocar actuation rod 220 and is configured to cooperate with complementary features within handle portion 100 to prevent rotation of trocar actuation rod 220 within handle portion 100 while still permitting longitudinal translation of trocar actuation rod 220 within handle portion 100. Trocar actuation rod 220 also includes a coarse helical thread section 224 and a fine helical thread section 226 located proximal to coarse helical thread section 224 that are configured to control the rate of longitudinal advancement of trocar actuation rod 220, as described in greater detail below.

[0041] The shaft 200 also includes a stapling head driver 240 that is slidably housed within the outer sheath 210 and around the combination of the trocar actuation rod 220 and the trocar actuation band assembly 230. The stapling head driver 240 includes a distal end securely secured to the proximal end of the staple drive member 350, a proximal end secured to the drive carriage 250 via a pin 242, and a flexible section disposed therebetween. It will be appreciated that the staple drive member 350 will translate longitudinally relative to the outer sheath 210 in response to translation of the stapling head driver 240 and the drive carriage 250 relative to the outer sheath 210.

[0042] like Figure 1As shown, the handle portion 100 includes a housing 110 and releasably receives a battery pack 120, the housing having a lower portion defining a pistol grip 112 with an angled orientation and an upper portion supporting a user interface feature 114, as described in more detail below. The handle portion 100 also includes several features operable to actuate the anvil 400 and the stapling head 300. Specifically, the handle portion 100 includes a rotatable knob 130, a safety trigger 140, a firing trigger 150, a motor 160, and a motor activation module 180. The knob 130 is coupled to the trocar actuation rod 220 via a nut (not shown) such that the coarse helical thread 224 will selectively engage the threaded engagement feature of the interior of the nut; and such that the fine helical thread 226 will selectively engage the threaded engagement feature within the interior of the knob 130. These complementary structures are configured such that trocar actuation rod (220) will translate proximally initially at a relatively slow rate and then at a relatively faster rate in response to rotation of knob (130).

[0043] It should be understood that when the anvil 400 is coupled to the trocar 330, rotation of the knob 130 will provide a corresponding translation of the anvil 400 relative to the stapling head 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 proximally toward the stapling head 300; and rotated in a second angular direction (e.g., counterclockwise) to extend the anvil 400 distally away from the stapling head 300. Thus, the knob 130 can be used to adjust the gap distance (d) between the opposing stapling surfaces 412, 322 of the anvil 400 and the stapling head 300 until a suitable gap distance is achieved, for example, as described below. Figure 7C shown.

[0044] The firing trigger 150 is operable to activate the motor 160, thereby actuating the stapling head 300 to staple and cut tissue clamped between the anvil 400 and the stapling head 300. The safety trigger 140 is operable to selectively block actuation of the firing trigger 150 based on the longitudinal position of the anvil 400 relative to the stapling head 300. The handle portion 100 also includes a component operable to selectively lock both triggers 140, 150 based on the position of the anvil 400 relative to the stapling head 300. For example, the safety trigger 140 can be blocked from rotating from the engaged position to the disengaged position until the position of the anvil 400 relative to the stapling head 300 is within a predetermined range. Thus, actuation of the firing trigger 150 is blocked by the safety trigger 140, thereby preventing the stapling head 300 from firing until the anvil position is within the predetermined range.

[0045] When the firing trigger 150 is pivoted proximally to the firing position, the firing trigger 150 is operable to actuate a switch ( Figure 1). Motor activation module 180 is in communication with battery pack 120 and motor 160 such that motor activation module 180 is configured to provide power from battery pack 120 for activation of motor 160 in response to firing trigger 150 actuating a switch of motor activation module 180. Thus, motor 160 will be activated when firing trigger 150 is pivoted. Such activation of motor 160 will actuate stapling head 300 via drive bracket 250, as described in greater detail below.

[0046] 7A to 7E An apparatus 10 is shown for forming an anastomosis 70 between two tubular anatomical structures 20, 40. By way of example only, the tubular anatomical structures 20, 40 may include a segment of a patient's esophagus, a colon or other portion of a patient's digestive tract, or any other tubular anatomical structure.

[0047] like Figure 7A As shown, the anvil 400 is positioned in one tubular anatomical structure 20, and the stapling head 300 is positioned in another tubular anatomical structure 40. Figure 7A As shown, the anvil 400 is positioned in the tubular anatomical structure 20 such that the shaft 420 protrudes from the open, severed end 22 of the tubular anatomical structure 20. In this example, the purse-string suture 30 is disposed around the middle region of the shaft 420 to generally secure the position of the anvil 400 in the tubular anatomical structure 20. The suturing head 300 is positioned in the tubular anatomical structure 40 such that the trocar 330 protrudes from the open, severed end 42 of the tubular anatomical structure 20. The purse-string suture 50 is disposed around the middle region of the trocar shaft 332 to generally secure the position of the suturing head 300 in the tubular anatomical structure 40. The suturing head 300 is then pushed distally to ensure that the suturing head 300 is fully seated at the distal end of the tubular anatomical structure 40.

[0048] Next, the anvil 400 is secured to the trocar 330 by inserting the trocar 330 into the hole 422, as shown. Figure 7B As shown. The latch member 430 of the anvil 400 engages the head 334 of the trocar 330, thereby providing a secure fit between the anvil 400 and the trocar 330. The operator then rotates the knob 130 while holding the housing 110 stationary via the pistol grip 112. This rotation of the knob 130 causes the trocar 330 and the anvil 400 to retract proximally. Figure 7CAs shown, this proximal retraction of the trocar 330 and the anvil 400 compresses the tissue of the tubular anatomical structure 20, 40 between the surfaces 412, 322 of the anvil 400 and the stapling head 300. When this occurs, the operator can feel tactile resistance or feedback via the knob 130 when turning the knob 130, wherein such tactile resistance or feedback indicates that the tissue is being compressed. As the tissue is compressed, the operator can visually observe the position of the indicator pointer (not shown) within the user interface feature 114 of the handle portion 100 to determine whether the gap distance (d) between the opposing surfaces 412, 322 of the anvil 400 and the stapling head 300 is appropriate; and make any necessary adjustments via the knob 130.

[0049] Once the operator has appropriately set the gap distance (d) via knob 130, the operator pivots safety trigger 140 toward pistol grip 112 to initiate actuation of firing trigger 150. The operator then pivots firing trigger 150 toward pistol grip 112, causing firing trigger 150 to actuate a switch of motor activation module 180 and thereby activate rotation of motor 160. This rotation of motor 160 causes actuation (or "firing") of stapling head 300 by distally actuating drive carriage 250, thereby driving knife member 340 and staple drive member 350 together distally, as shown. Figure 7D shown.

[0050] As the knife member 340 translates distally, the cutting edge 342 of the knife member 340 cuts excess tissue positioned within the annular recess 418 of the anvil 400 and the interior of the knife member 340. Figure 7C The location shown to Figure 7D Throughout the distal range of motion to the position shown, a washer 417 positioned within annular recess 418 of anvil 400 is severed by knife member 340. It should be understood that washer 417 can also act as a cutting plate for knife member 340 to assist in cutting tissue.

[0051] When the nail driving member 350 is Figure 7C The location shown to Figure 7D When translated distally from the illustrated position, the staple driving member 350 drives the staples 90 through the tissue of the tubular anatomical structures 20, 40 and into the staple forming pockets 414 of the anvil 400. The staple forming pockets 414 deform the driven staples 90 into, for example, a "B" shape or a three-dimensional shape, such that the formed staples 90 secure the ends of the tissue together, thereby coupling the tubular anatomical structures 20 and 40.

[0052] The operator has Figure 7DAfter actuating (or "firing") the stapling head 300 as shown, the operator rotates the knob 130 to drive the anvil 400 distally away from the stapling head 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 secured to the trocar.

[0053] With the instrument 10 removed, the tubular anatomical structures 20, 40 are secured together at the anastomosis 70 by two annular arrays of staples 90, as shown. Figure 7E The inner diameter of the stapling portion 70 is defined by the severed edge 60 left by the knife member 340 .

[0054] The apparatus 10 may also be constructed and operated in accordance with any of the teachings of the following references, the disclosures of which are incorporated herein by reference: U.S. Patent No. 5,292,053, entitled “Surgical Anastomosis Stapling Instrument,” issued on March 8, 1994; U.S. Patent No. 5,333,773, entitled “Surgical Anastomosis Stapling Instrument,” issued on August 2, 1994; U.S. Patent No. 5,350,104, entitled “Surgical Anastomosis Stapling Instrument,” issued on September 27, 1994; and U.S. Patent No. 5,533,661, entitled “Surgical Anastomosis Stapling Instrument,” issued on July 9, 1996; and U.S. Patent No. 5,533,661, entitled “Low Cost Anvil Assembly for a Surgical Anastomosis Stapling Instrument,” issued on December 16, 2014. No. 8,910,847, entitled “Surgical Stapler with Rotary Cam Drive and Return,” published on March 26, 2015, now abandoned; U.S. Patent No. 9,936,949, entitled “Surgical Stapler Instrument with Drive Assembly Having Toggle Features,” published on April 10, 2018; U.S. Patent No. 9,907,552, entitled “Control Features for Motorized Surgical Stapling Instrument,” published on March 6, 2018; U.S. Patent No. 9,713,469, entitled “Surgical Stapler with Rotary Cam Drive,” published on July 25, 2017; and U.S. Patent No. 9,713,469, entitled “Staple Forming Pocket Configurations for Circular Surgical Stapler,” published on May 17, 2018. and / or U.S. Patent No. 10,709,452, entitled “Methods and Systems for Performing Circular Stapling,” issued on July 14, 2020.

[0055] Figure 8 An example of a surgical stapling and severing instrument 800 is depicted, which is sized to be inserted through a trocar cannula or incision (e.g., a thoracotomy, etc.) into a surgical site of a patient to perform a surgical procedure. The instrument 810 of this example includes an actuator in the form of a manually operated handle portion 820 connected to a shaft 822. The shaft 822 terminates distally in an articulation joint 811, which is further coupled to an end effector 812. Once the articulation joint 811 and the end effector 812 are inserted through the cannula channel of the trocar, the articulation joint 811 can be remotely articulated via an articulation control 813, such that the end effector 812 can be deflected at a desired angle (α) from the longitudinal axis (LA) of the shaft 822. The end effector 812 of this example includes a lower jaw 816 (also referred to herein as a cartridge jaw) and an upper jaw 818 in the form of a pivotable anvil jaw, the lower jaw including a staple cartridge 837.

[0056] Unless otherwise described, the term "pivot" (and variations thereof) as used herein encompasses, but is not necessarily limited to, pivotal motion about a fixed axis. For example, in some versions, upper jaw 818 can pivot about an axis defined by a pin (or similar feature) that slidably translates along an elongated slot or channel as upper jaw 818 moves toward lower jaw 816. Such translation can occur before, during, or after the pivotal motion. It should therefore be understood that such combinations of pivotal and translational motions are encompassed by the term "pivot" and variations thereof as used herein.

[0057] The handle portion 820 includes a pistol grip 824 and a closure trigger 826. The closure trigger 826 is pivotable toward the pistol grip 824 to cause the upper jaw 818 to clamp or close toward the lower jaw 816 of the end effector 812. Such closure of the upper jaw 818 is provided by a closure tube 832 and a closure ring 833, both of which translate longitudinally relative to the handle portion 820 in response to pivoting of the closure trigger 826 relative to the pistol grip 824. The closure tube 832 extends along the length of the shaft 822; and the closure ring 833 is positioned distal to the articulation joint 811. The articulation joint 811 is operable to transfer / transmit longitudinal motion from the closure tube 832 to the closure ring 833.

[0058] The handle portion 820 also includes a firing trigger (at Figure 8822 and transmits a longitudinal firing motion from the handle portion 820 to the firing beam in response to actuation of the firing trigger. This distal translation of the firing beam causes the tissue clamped in the end effector 812 to be stapled and severed. The end effector 812 includes a cutting edge for cutting through tissue and a staple cartridge that is removably insertable into a channel of the end effector 812 containing staples and staple drivers for driving the staples into the tissue.

[0059] According to various embodiments, a more detailed description of the operation of an instrument, such as surgical instrument 800, may be found in the following references, the disclosures of which are incorporated herein by reference: U.S. Patent No. 8,210,411, entitled “Motor-Driven Surgical Instrument,” issued on July 3, 2012; U.S. Patent No. 9,186,142, entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks,” issued on November 17, 2015; U.S. Patent No. 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” issued on December 13, 2016; U.S. Patent No. 9,622,746, entitled “Distal Tip Features for End Effector of Surgical Instrument,” issued on April 18, 2017; and U.S. Patent No. 9,622,746, entitled “Lockout Feature for Movable Cutting Member of Surgical Instrument,” issued on August 1, 2017. No. 9,717,497, entitled “Surgical Instrument”; No. 9,795,379, entitled “Surgical Instrument with Multi-Diameter Shaft”, issued on October 24, 2017; No. 9,808,248, entitled “Installation Features for Surgical Instrument End Effector Cartridge”, issued on November 7, 2017; No. 9,839,421, entitled “Jaw Closure Feature for End Effector of Surgical Instrument”, issued on December 12, 2017; and / or No. 10,092,292, entitled “Staple Forming Features for Surgical Stapling Instrument”, issued on October 9, 2018.

[0060] Figure 9The end effector 812 is shown having been actuated through tissue 990 by a single firing stroke. The cutting edge of the end effector 812 has cut through the tissue 990, and the staple driver has driven three alternating rows of staples 847 through the tissue 990 on each side of the cut line created by the cutting edge of the end effector 812. After the first firing stroke is completed, the end effector 812 can be withdrawn from the patient, the empty staple cartridge 837 can be replaced with a new staple cartridge 837, and then the end effector 812 can be reinserted into the patient to reach the suturing site for further cutting and stapling. This process can be repeated until the desired number and pattern of firing strokes across the tissue 990 have been completed.

[0061] Figure 10 An example of a surgical instrument 1010 is shown that is configured so that it can be attached to a robotic system, such as a robotic arm. The instrument 1010 includes an actuator, such as a manually operated handle portion 1020, and a shaft 1022. The instrument 1010 has a modular configuration such that the shaft 1022 can be selectively removed from and attached to the handle portion 1020.

[0062] Instrument 1010 is constructed similarly to instrument 10 or instrument 810, such that the operability and use of instrument 1010 are the same as those described above for instrument 10 or instrument 810, with an additional feature of instrument 1010 being a modular configuration. Through its modular configuration, instrument 1010 provides a method for replacing an end effector. This change in the end effector can be made to replace an otherwise worn end effector, or to provide different end effector configurations based on surgical procedures or user preferences. In addition to or in lieu of the foregoing, features operable to provide the modular configuration of instrument 1010 can be constructed in accordance with at least some of the teachings of U.S. Patent No. 10,182,813, issued on January 22, 2019, entitled “Surgical Stapling Instrument with Shaft Release, Powered Firing, and Powered Articulation,” the disclosure of which is incorporated herein by reference. Other suitable components, features, and configurations for providing instrument 1010 with a modular configuration will be apparent to those of ordinary skill in the art in view of the teachings herein. Furthermore, those of ordinary skill in the art will appreciate that instrument 10, 810 may be modified to include a modular configuration, as shown and described with respect to instrument 1010 or other instruments incorporated herein by reference, in view of the teachings herein.

[0063] exist Figure 10In the example shown, the instrument 1010 includes a linear end effector 1012 having an upper jaw 1018 with an angled distal tip 1019. It should be understood that the end effector 1012 may be used in place of a linear end effector having an upper jaw 1018 with an angled distal tip 1019. Figure 1 The end effector of the suturing head 300 is shown Figure 8 The end effector 812 shown, or having Figure 1 The end effector of the suturing head 300 is shown Figure 8 The illustrated end effector 812 can be used in place of end effector 1012. In some versions, end effector 1012 can be integrally formed with shaft 1022, or alternatively can be formed separately and then combined. In some versions, end effector 1012 can be provided for use in a robotic system. In such a robotic system, a modular shaft 1022 having end effector 1012 can be attached to an actuator rather than a manually operated handle portion. For example, a modular shaft 1022 having end effector 1012 can be attached to a portion of a robotic system (such as a robotic arm) for use, such that handle portion 1020 is replaced by a component of the robotic system. However, in other examples, end effector 1012 can be adapted for use with a robotic system in a manner in which end effector 1012 is connected to the robotic system without having to connect the entire modular shaft 1022. Other ways of incorporating an end effector having an angled, elastically deformable anvil tip into a user-operated or robotically operated instrument will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0064] II. Shaft Displacement Detection in Surgical Instruments

[0065] Enhanced sensing, feedback, and connectivity are desirable for both robotic and handheld instruments used in laparoscopic and open surgery. The surgical suturing features of the present disclosure attempt to enhance preoperative planning, surgical performance, therapeutic support, and training to improve patient outcomes and reduce injuries. Specifically, the surgical suturing features of the present disclosure help inform intraoperative decisions based on data sensed and obtained by the shaft deflection detection system by providing feedback, thereby enhancing and increasing a user's (e.g., surgeon or robotic system) perception of external forces applied to various parts of the surgical instrument.

[0066] In some cases, when manipulating a surgical instrument in a patient's body, such as during insertion of the surgical instrument into the patient's body or removal of the surgical instrument from the patient's body, the components of the surgical instrument (e.g., shaft, end effector, etc.) may push against tissue or other surrounding anatomical structures in the patient's body with sufficient force, thereby potentially causing damage to the patient. For example, in an anastomotic procedure in which a circular stapler is inserted into a tubular structure (such as an intestine) in the patient's body or removed from the tubular structure, if the components of the circular stapler forcefully push against one side of the tubular structure, the circular stapler may scratch or puncture the tubular structure. As another example, in a thoracic surgery in which an endoscopic stapler is inserted to reach a remote surgical site in the patient's body, the endoscopic stapler may push against ribs or other anatomical structures (e.g., veins, arteries, nerves, etc. between the ribs) with sufficient force, and the surgical instrument needs to be manipulated around to reach the remote surgical site, thereby damaging the ribs or other anatomical structures in the patient's body.

[0067] In some cases, the user operating the surgical instrument may be able to avoid causing damage to the patient by ensuring that the surgical instrument is properly handled within the patient's body. For example, an experienced surgeon may feel the resistance generated by the forceful contact of the surgical instrument with the tissue or other anatomical structure within the patient's body and may ease the push on the surgical instrument and / or reposition the surgical instrument to avoid causing damage to the patient. However, in other cases, the user may not feel or notice the resistance (or may not understand the consequences of such resistance) and may therefore continue to apply excessive force to the tissue or other anatomical structure within the patient's body, thereby potentially causing damage to the patient. For example, this may occur when the user is not an experienced surgeon, but rather an assistant or medical student working with the surgeon. Moreover, when performing robotic surgery, the surgeon's surgical understanding of tissue, force, and trajectory (such as tactile feedback or sensation) that he or she may have when performing the surgery manually may be lost, and if the robotic system is not prevented from applying excessive force to the tissue or other anatomical structure within the patient's body, the patient may be harmed.

[0068] In the embodiments described below, a surgical instrument is equipped with a shaft deflection detection system that can detect movement or displacement of a shaft relative to another component that can be coupled to the shaft of the surgical instrument. The other component may include, for example, an actuator coupled to the shaft of the surgical instrument (e.g., a handle portion coupled to the shaft of the surgical instrument or a robotic arm attached to the shaft of the surgical instrument). Additionally or alternatively, the other component may include an end effector coupled to the shaft of the surgical instrument. Thus, the shaft deflection detection system can detect shaft displacement caused by external forces experienced by the shaft when the shaft is manipulated within the body of a patient. Such external forces may be due to, for example, the end effector coupled to the shaft of the surgical instrument encountering resistance from surrounding tissue or other anatomical structures when the shaft is manipulated within the body of a patient.

[0069] The shaft deflection detection system may include one or more springs (e.g., linear or nonlinear coil springs) that couple the shaft to the other component at a mechanical joint between the shaft and the other component. The one or more springs may allow controlled movement or deflection of the shaft relative to the other component, the controlled movement or deflection being proportional to the external force to which the shaft is subjected when the surgical instrument is manipulated within the patient's body. The shaft deflection detection system may also include one or more sensors positioned at the mechanical joint between the shaft and the other component. For example, the one or more sensors may include a plurality of sensors distributed among a plurality of points around the circumference of the shaft, located at the mechanical joint. The one or more sensors may be configured to sense movement of the shaft and to generate a signal indicative of displacement of the shaft when the shaft is manipulated within the patient's body.

[0070] The signals generated by the one or more sensors may be provided to a controller that may be communicatively coupled to the shaft deflection detection system. The controller may be configured to determine, based on the signals generated by the one or more sensors, the magnitude and direction of the external force experienced by the shaft when the shaft is manipulated within the patient's body. For example, the controller may convert the displacement of the shaft into a force based on a spring force function of one or more springs coupling the shaft to another component. In an embodiment where the one or more sensors include a plurality of sensors distributed among a plurality of points around the circumference of the shaft, the controller may determine a vector comprising the magnitude and direction of the external force experienced by the shaft at the plurality of points around the circumference of the shaft.

[0071] The controller can detect when an axis is subjected to excessive force based on signals received from one or more sensors. For example, if the external force experienced by the axis exceeds a predetermined threshold, the controller can determine that the axis is subjected to excessive force. When excessive force is detected, the controller can generate an alarm and cause the alarm to be provided to a user (e.g., a clinician or a robot) operating or otherwise using the surgical instrument. The alarm can include, for example, a tactile feedback signal provided via the handle portion of the surgical instrument. Additionally or alternatively, a visual and / or audible alarm can be provided. The alarm can remind the user that the user should apply less force to the surgical instrument and / or reposition the surgical instrument to reduce the force and avoid harming the patient. In some embodiments, additional information about the force can be provided to the user. For example, the controller can determine the magnitude and / or direction of the force experienced by the axis and provide the user with a display of the magnitude and / or direction of the force. Such a display of the magnitude and / or direction of the force can be provided, for example, on a screen located in the operating room where the surgical instrument is used. In embodiments, the display of the magnitude and / or direction of the force can be superimposed with a visual representation of the axis being manipulated within the anatomical structure of the patient's body. Such additional information may inform the user how gently the user should relax and / or in which direction the user should move the surgical instrument to alleviate excessive forces experienced by the shaft.

[0072] In some embodiments, the controller may also be configured to determine corrective actions that can be performed by the user in order to reduce excessive force and avoid obstructions or obstacles during insertion and / or removal. In such embodiments, an indication of the corrective action may be provided to the user, for example, via a screen or other display located on the handle of the surgical instrument or in the operating room where the surgical instrument is used. The indication may inform the user of a recommendation to move or rotate the surgical instrument in a certain direction to reduce the force. The indication may also inform the user of the recommended degree of movement for reducing the force. These and other technologies described herein can reduce the possibility of harming the patient when the surgical instrument is manipulated within the patient's body (such as during the insertion of the surgical instrument into the patient's body or the removal of the surgical instrument from the patient's body). For example, sensing and communicating the force experienced by the shaft can alert the user to excessive force and help navigate "hang-ups" during insertion and removal. Displaying or otherwise communicating this information to the user helps to keep the user informed during surgery so that the user can ensure that the surgical instrument is manipulated correctly and appropriately to avoid harming the patient during surgery.

[0073] Figure 11An exemplary surgical instrument 1100 equipped with a shaft deflection detection system 1102 is depicted in accordance with an embodiment. In an embodiment, surgical instrument 1100 corresponds to surgical instrument 10. Although shaft deflection detection system 1102 is generally described below with reference to surgical instrument 1100 and surgical instrument 10, in some embodiments, shaft deflection detection system 1102 can be used with surgical instruments other than surgical instrument 1100 or surgical instrument 10. For example, in an embodiment, Figure 8 The surgical instrument 810 may be equipped with a shaft deflection detection system that is the same as or similar to the shaft deflection detection system 1102. As another example, in an embodiment, Figure 10 The surgical instrument 1010 may be equipped with a shaft deflection detection system that is the same as or similar to the shaft deflection detection system 1102 .

[0074] The surgical instrument 1100 includes a shaft 1108 (e.g., corresponding to Figure 1 The shaft 200 of the instrument 10 is connected to a manually operable handle portion 1110 (e.g., corresponding to Figure 1 The shaft 1108 may also be coupled to an actuator in the form of a handle portion 100 of the instrument 10. The shaft 1108 may also be coupled to an end effector 1109 (e.g., corresponding to a distal end of the shaft 1108). Figure 1 The shaft deflection detection system 1102 includes one or more sensors 1104 positioned at a mechanical interface 1106 between a shaft 1108 and a handle portion 1110 of the surgical instrument 1100. In another example, the shaft 1108 may be coupled to an actuator other than the handle portion 1110 at the mechanical interface 1106. For example, the shaft 1108 may be attached to a component of a robotic system (e.g., the end of a robotic arm) at the mechanical interface 1106.

[0075] For example, the one or more sensors 1104 may include a plurality of sensors (e.g., a sensor array) distributed among a plurality of points around the circumference of the shaft 1108, located at the mechanical joint 1106. The shaft deflection detection system 1102 may further include one or more springs 1114 that couple the shaft 1108 to the handle portion 1110 at the mechanical joint 1106. When no load or force is applied to the shaft 1108, the one or more springs 1114 can be used to bias the shaft 1108 to a nominally centered or neutral position. For example, the one or more springs 1114 can include a linear coil spring. The mechanical joint 1106 can be designed so that the shaft 1108 has a certain degree of flexibility or compliance, thereby allowing the shaft 1108 to move relative to the handle portion 1110. For example, the mechanical joint 1106 can be made of a suitable material that has sufficient flexibility or compliance to allow the shaft 1108 to move relative to the handle portion 1110. Thus, as the shaft 1108 is subjected to external forces as the shaft or another component (e.g., end effector 1109) pushes against tissue or other anatomical structures within the patient's body, the shaft 1108 can move relative to the handle portion 1110. The one or more sensors 1104 are configured to measure the movement of the shaft 1108 relative to the handle portion 1110 and generate a signal indicative of the forces experienced by the shaft 1108 as the shaft 1108 is manipulated within the patient's body.

[0076] In an example, the sensors 1104 may include four sensors 1104 distributed at 90-degree angles relative to one another around the circumference of the axis 1108. In this example, the sensors 1104 may be configured to measure movement of the axis 1108 in, for example, north, south, east, and west directions. In another example, the sensors 1104 may include a suitable number of sensors other than four. For example, the sensors 1104 may include a greater number of sensors to provide greater granularity in force direction measurement. By way of example only, the sensors 1104 may include eight sensors 1104 distributed at 45-degree angles relative to one another around the circumference of the axis 1108. In another example, the sensors 1104 may include fewer than four sensors, for example to reduce the complexity and cost of the surgical instrument 1100 while still providing useful shaft deflection measurements. By way of example only, the sensors 1104 may include two sensors 1104 distributed at 180-degree angles relative to one another around the circumference of the axis 1108. In this example, each of the two sensors 1104 can be configured to sense movement of the axis 1108 in two directions. For example, the first sensor 1104 can be configured to sense movement of the axis 1108 in the north and south directions, and the second sensor 1104 can be configured to sense movement of the axis 1108 in the east and west directions. In other examples, the axis deflection detection system 1102 can include other suitable numbers and / or other suitable configurations of sensors 1104.

[0077] For example, the sensor 1104 may include a Hall effect sensor or other magnetic sensor positioned on the inner surface of the handle portion 1110 at the mechanical interface 1106. The shaft deflection detection system 1102 may further include one or more magnets 1112 positioned on the outer surface of the shaft 1108 at the mechanical interface 1106, at least substantially directly opposite the sensor 1104. In another example, the one or more sensors 1104 may be positioned on the outer surface of the shaft 1108 at the mechanical interface 1106, and the one or more magnets 1112 may be positioned on the inner surface of the handle portion 1110 at the mechanical interface 1106, at least substantially directly opposite the sensor 1104. One or more springs 1114 may be positioned between the shaft 1108 and the handle portion 1110 at the mechanical interface 1106, such that movement of the shaft 1108 relative to the handle portion 1110 compresses or decompresses the springs 1114. For example, springs 1114 can be positioned around the circumference of shaft 1108 in the space between sensors 1104. One or more springs 1114 can include linear coil springs characterized by a predetermined spring force function (e.g., spring constant). In other examples, springs other than linear coil springs and / or nonlinear springs can be used. For example, a nonlinear spring can be characterized by a known spring function.

[0078] In an embodiment, the Hall effect sensor 1104 may include a plurality of sensors (e.g., a sensor array) distributed among a plurality of points around the circumference of the handle portion 1110, located at the mechanical interface 1106. The magnet 1112 may similarly include a plurality of magnets (e.g., a magnet array) distributed among a plurality of points around the circumference of the shaft 1108, located at the mechanical interface 1106. In another example, the magnet 1112 may include a single magnet that covers the circumference of the shaft 1108 at the mechanical interface 1106. The Hall effect sensor 1104 may sense the magnetic field generated by the magnet 1112 and generate a signal proportional to the magnetic field sensed by the sensor 1104. When the shaft 1108 deflects relative to the handle 1110 at the mechanical interface 1106 due to external forces experienced along the shaft 1108, the magnetic field sensed by the Hall effect sensor 1104 changes due to the change in the distance between the Hall effect sensor 1104 and the magnet 1112. Thus, the sensed magnetic field changes may indicate the magnitude of external forces experienced by the shaft 1108 at various points around the circumference of the shaft 1108 as the shaft 1108 is manipulated within the patient's body.

[0079] The shaft deflection detection system 1102 may include or be communicatively coupled to a controller 1130. The controller 1130 may be located in the handle portion 1110 of the surgical instrument 1100. In another example, the controller 1130 may be implemented at least partially external to the surgical instrument 1100. For example, the controller 1130 may be implemented at least partially on a processor of a computer, which may be located in an operating room in which the surgical instrument 1100 can be used. The controller 1130 may be configured to receive a signal generated by the sensor 1104 and detect an external force experienced by the shaft 1108 based on the signal received from the sensor 1104. For example, the controller 1130 may be configured to convert a detected deflection of the shaft 1108 into a magnitude of the force experienced by the shaft 1108 based on a predetermined spring force function (e.g., a spring constant) of the spring 1114. In embodiments where the sensor 1104 includes a plurality of sensors (e.g., a sensor array) distributed among a plurality of points about the circumference of the axis 1108, the controller 1130 can be configured to determine a vector of the force experienced along the axis 1108 at the plurality of points about the circumference of the axis 1108. The vector can indicate the direction and magnitude of the force experienced along the axis 1108. As such, the vector can indicate the motion of the axis 1108.

[0080] The controller 1130 can detect when the external force experienced by the shaft 1108 is excessive based on the determined forces experienced by the shaft 1108 at one or more points around the circumference of the shaft 1108. For example, the controller 1130 can determine that the shaft 1108 is experiencing excessive force when the magnitude of one or more determined forces exceeds a predetermined threshold. In some embodiments, a plurality of predetermined thresholds can be provided. For example, different thresholds can be defined for different types of tissue and / or other anatomical structures within the patient's body. The plurality of thresholds can be stored in a memory contained in or coupled to the controller 1130. The controller 1130 can then select an appropriate threshold based on the type of tissue or other anatomical structure, for example, according to settings provided by a user according to a surgical procedure.

[0081] When excessive force is detected, the controller 1130 can generate an alarm and can cause the alarm to be provided to the user. The alarm can alert the user that the user should ease the push on the surgical instrument 1100 and / or should reposition the surgical instrument 1100 to reduce the external force. The alarm can include, for example, a tactile feedback signal that can be provided via the handle portion 1110. Additionally or alternatively, the controller 1130 can be configured to generate and provide visual and / or audible alarms to the user.

[0082] In some embodiments, additional information about the external force experienced by shaft 1108 can be provided to the user. For example, controller 1130 can determine the magnitude and / or direction of the external force experienced by shaft 1108. The magnitude and / or direction of the force can be displayed to the user. For example, controller 1130 can cause such a display to be provided to the user via a screen located on handle portion 1110 of surgical instrument 1100 or via a screen or display in the operating room where surgical instrument 1100 is used. In an embodiment, the display of the magnitude and / or direction of the external force can be superimposed with a visual representation of shaft 1108 being manipulated within the anatomical structure within the patient's body. Such additional information (such as a vector display) can inform the user of the degree to which the user should ease up and / or the direction in which the user should move surgical instrument 1100 to reduce excessive force on tissue or other anatomical structures (e.g., bone, etc.). In some embodiments, controller 1130 can also be configured to determine corrective actions that can be performed by the user to reduce excessive force. The controller 1130 may cause instructions for corrective actions to be provided to the user, for example, via a screen or other display located on the handle portion 1110 of the surgical instrument 1100 or in the operating room where the surgical instrument 1100 is used.

[0083] Controller 1130 may include any suitable analog and / or digital circuitry configured to detect the external forces experienced by shaft 1108 and provide an indication to the user of surgical instrument 1100 when it is determined that shaft 1108 is experiencing excessive force. For example, controller 1130 may be a fully analog controller that may include analog circuitry, such as one or more comparators, that compares the amplitude of a signal received from sensor 1104 to a threshold value and generates an indication of excessive force when the amplitude of the signal exceeds the threshold value. Controller 1130 may also include an analog indicator that provides an indication of shaft force and / or provides an excessive force alert to the user. In an example, controller 1130 may include or be coupled to one or more light-emitting devices, such as light-emitting diodes (LEDs), that may visually indicate the point at which shaft 1108 is experiencing excessive force. In an embodiment, corresponding LEDs may be disposed on an outer surface of handle portion 1110, for example, around the circumference of handle portion 1110, to correspond to corresponding sensors in sensors 1104. The controller 1130 can be configured to cause the corresponding LED to illuminate (e.g., green or red) to indicate whether normal force or excessive force is detected based on the signal received from the corresponding sensor 1104. In another example, a single light emitting device can be provided, and the controller 1130 can be configured to cause the single light emitting device to illuminate (e.g., red) in response to excessive force being detected at any point around the circumference of the axis 1108. In another embodiment, one or more audio indications can be provided to the user in addition to or in lieu of one or more visual indications.

[0084] In some implementations, the controller 1130 can be at least partially digital. In some examples, the controller 1130 can be implemented using dedicated hardware, such as one or more of discrete components, integrated circuits, application specific integrated circuits (ASICs), programmable logic devices (PLDs), processors that execute firmware instructions, processors that execute software instructions, or any combination thereof. When implemented using a processor that executes software or firmware instructions, the software or firmware instructions can be stored in any suitable computer-readable memory, such as on a magnetic disk, optical disk, or other storage medium. The software or firmware instructions may include machine-readable instructions that, when executed by one or more processors, cause the one or more processors to perform various actions related to: determining the force experienced by the shaft 1108; determining whether the force or strain is excessive at one or more points around the circumference of the shaft 1108; determining that corrective action can be taken to alleviate the excessive force; providing instructions to a user of the surgical instrument 1100, and the like. In some embodiments, the controller 1130 may include one or more digital-to-analog converters (DACs) and one or more analog-to-digital converters (ADCs), wherein the one or more analog-to-digital converters are configured to convert signals between analog signals received from the sensor 1104 into digital signals suitable for processing by the digital circuits of the controller 1130.

[0085] In various examples, an alarm and / or corrective action indication can be provided to the user via one or more of: i) a visual indicator, such as an LED, which can be provided, for example, on the handle portion 1110 of the surgical instrument 1110, ii) an audio indicator, and / or iii) a digital screen or other display, which can be integrated with or communicatively coupled to the surgical instrument 1100. For example, a transmitter can be coupled to the controller 1130 to wirelessly transmit a force signal generated based on a signal received from the sensor 1104 to a processor of a computer, which can be located, for example, in an operating room in which the surgical instrument 1100 is used. The processor of the computer can be configured to further process the force signal, for example, to identify one or more points around the circumference of the shaft 1108 at which the shaft 1108 is subjected to excessive force, determine a corrective action that can be performed to alleviate the excessive force experienced by the shaft 1108, cause the alarm and / or corrective action indication to be displayed on a display coupled to the computer, and the like.

[0086] It should be noted that while the shaft deflection detection system 1102 is generally described herein as including a Hall effect sensor 1104 configured to measure movement of the shaft 1108 and generate a signal indicative of the force experienced by the shaft 1108, the shaft deflection detection system 1102 may include sensors other than Hall effect sensors and / or may be configured to measure an amount of shaft movement other than movement due to an external force experienced by the shaft 1108. For example, the shaft deflection detection system 1102 may be configured to measure strain, pressure, etc. experienced by the shaft 1108 in addition to or in lieu of measuring the force experienced by the shaft. In some examples, the one or more sensors 1104 may include: i) one or more encoding strips (e.g., magnetic scales) positioned or distributed around the circumference of the shaft 1108 or handle portion 1110 and configured to move with movement of the shaft 1108 relative to the handle portion 1110; and ii) one or more electromagnetic encoders or readheads configured to read the movement of the encoders or readheads and provide a signal indicative of deflection of the shaft 1108 relative to the handle portion 1110 based on detecting the position of the one or more magnetic scales positioned around the circumference of the shaft 1108 or handle portion 1110. As another example, the one or more sensors 1104 may include a strain gauge sensor configured to measure strain on the shaft 1108. As yet another example, the one or more sensors 1104 may include a piezoelectric (e.g., piezoelectric) sensor configured to measure pressure experienced by the shaft 1108. In other examples, other suitable sensors (e.g., resistive sensors, capacitive sensors, etc.) may be used. In some examples, the sensor 1104 and the corresponding spring 1114 can be combined into a single sensor element in the shaft deflection detection system 1102. For example, the deflection of the spring can change a measurable electrical characteristic or other measurable characteristic indicative of the movement of the shaft 1108, and such characteristic can be measured by the sensor element to generate a signal indicative of the movement of the shaft 1108.

[0087] In some examples, the shaft deflection detection system 1102 may omit one or more magnets 1112 and / or one or more springs 1114. For example, when no load or force is applied to the shaft 1108, a mechanism other than the one or more springs 1114 may be used to bias the shaft 1108 to a nominally centered or neutral position. In some embodiments, for example, a rubber or polymer material may be used in place of the one or more springs 1114. In an example, a rubber or polymer gasket may be placed around the shaft 1108 at the mechanical interface 1106 between the shaft 1108 and the handle portion 1110. The rubber or polymer gasket may act as a seal between the shaft 1108 and the handle portion 1110 and may also stretch in any direction when the shaft 1108 is subjected to a load or force. In other embodiments, other suitable biasing materials and / or mechanisms may be used to bias the shaft 1108 to a nominally centered or neutral position while having the ability to stretch (e.g., compress or decompress) when the shaft 1108 is subjected to a load or force.

[0088] It should also be noted that while the deflection detection system 1102 is generally described herein as being positioned at the mechanical joint 1106 between the shaft 1108 and the handle portion 1110 (sometimes referred to herein as the "first mechanical joint"), in some embodiments, the deflection detection system 1102 may additionally or alternatively include the sensor 1104 (and, if desired, other corresponding components, such as the magnet 1112 and spring 1114 described herein) located at a mechanical joint other than the mechanical joint 1106 between the shaft 1108 and the handle portion 1110. For example, in some embodiments, the shaft deflection detection system 1102 may additionally or alternatively include the sensor 1104 (and, if desired, other corresponding components, such as the magnet 1112 and spring 1114 described herein) located at the mechanical joint 1107 between the shaft 1108 and the end effector 1109 (sometimes referred to herein as the "second mechanical joint"). The sensor 1104 positioned at the mechanical joint 1107 can detect the movement of the shaft 1108 relative to the end effector 1109.

[0089] Figure 12 A cross-sectional view of a shaft deflection detection system 1102 is depicted according to an embodiment in which a Hall effect sensor is used. Figure 12 100 is shown in a neutral or static state. This neutral or static state corresponds to a state in which the shaft 1108 of the surgical instrument 1100 is not subjected to external forces or is subjected to very small external forces. Figure 12As shown, in a neutral or static state, the distances between the Hall effect sensors 1104 and the corresponding magnets 1112 of the shaft deflection detection system 1102 can be at least approximately equal. Consequently, the amplitudes of the signals generated by different Hall effect sensors in the Hall effect sensors 1104 can be approximately equal to one another. In some embodiments, the controller 1130 can be calibrated to the neutral state of the shaft deflection detection system 1102. For example, the controller 1130 can be configured to measure the magnitude of the signal received from the sensor 1104 when the shaft deflection detection system 1102 is in the neutral state and store it in memory.

[0090] Figure 13 A cross-sectional view of a shaft deflection detection system 1102 is depicted in accordance with an embodiment in a state where a shaft 1108 of a surgical instrument 1100 is subjected to an external force 1302. The external force 1302 may be due to, for example, the shaft 1108 pushing against tissue or other material (e.g., bone, ribs, etc.) within the patient's body, such as during insertion of the surgical instrument 1100 into or removal from the patient's body (e.g., insertion into or removal from a tubular structure (such as the intestine) within the patient's body). The force 1302 causes the shaft 1108 to deflect relative to the handle portion 1110 of the surgical instrument 1100. As a result, the distance between the Hall effect sensor 1104 and the corresponding magnet 1112 changes with the movement of the shaft 1108. For example, as Figure 13 1304 in FIG, 1305 , when a magnet 1112 positioned on the shaft 11108 is pushed toward a corresponding sensor 1104 positioned on the handle portion 1110, the distance between the Hall effect sensor 1104 and the corresponding magnet 1112 at or near the point about the circumference of the shaft 1108 at which the external force 1302 is applied along the shaft 1108 decreases. Additionally, when the magnet 1112 positioned on the shaft 11108 is pushed farther away from the corresponding sensor 1104 positioned on the handle portion 1110, the distance between one or more sensors 1104 farther away from (e.g., opposite) the point about the circumference of the shaft 1108 at which the external force 1302 is applied along the shaft 1108 increases. This change in the distance between the sensor 1104 and the magnet 1112 results in a corresponding change in the magnetic field sensed by the sensor 1104, thereby changing the amplitude of the signal generated by the sensor 1104.

[0091] Controller 1130 can thus detect a change in the distance between Hall effect sensor 1104 and the corresponding magnet 1112, for example, by comparing the distance to a corresponding distance measured in the neutral state of shaft deflection detection system 1102. In an example, controller 1130 can convert the deflection distance indicated by the signal received from sensor 1104 into a corresponding force based on a predetermined spring force function (e.g., a spring constant) of spring 1114. For example, the force experienced at a particular point on the circumference of shaft 1108 can be determined by dividing the change in distance between sensor 1104 located at or closest to that particular point on the circumference of handle portion 1110 and the corresponding sensor 1104 on shaft 1108. Controller 1130 can also be configured to determine whether the force experienced by shaft 1108 is excessive. For example, controller 1130 can be configured to determine whether the force is excessive based on a comparison of the determined force to a predetermined threshold.

[0092] In an embodiment, if the controller 1130 determines that the force at one or more points around the circumference of the axis 1108 exceeds a predetermined threshold, the controller 1130 may generate an alarm and / or determine a corrective action, and may provide the alarm and / or the determined corrective action to the user of the surgical instrument 1100. Thus, the user may soften the thrust of the surgical instrument 1100 to avoid causing injury to the patient. The user may also perform corrective actions, for example, by shifting the surgical instrument 1100 in a direction determined by the controller 1130, rotating the instrument 1100 as determined by the controller 1130, and so forth. Thus, the user may ensure safe handling of the surgical instrument 1100 during a surgical procedure, such as during insertion of the instrument 1100 into or removal of a tubular structure within a patient's body (e.g., the intestine). Thus, the user may ensure that components of the surgical instrument 1100 will not, for example, rupture a tubular structure within the patient's body during a surgical procedure.

[0093] FIG. 14A to FIG. 14B Depicted are examples of graphics 1400, 1450 that may be displayed to a user to inform the user of corrective actions that may be performed to reduce excessive forces experienced by the shaft of a surgical instrument (e.g., surgical instrument 1100). For example, the graphics 1400, 1450 may be displayed on a display (e.g., a screen) of the handle portion 1110 of the surgical instrument 1100, or on a computer that may be located in the room where the surgical instrument 1100 is used. The graphics 1400, 1450 may provide a visual illustration of the handle portion 1110 and instructions on how to manipulate (e.g., rotate or otherwise move) the handle portion 1110 in order to reduce excessive forces experienced by the shaft 1108 of the surgical instrument 1100. Reference Figure 14A, graphic 1400 includes an illustration of a user's hand 1402 gripping handle portion 1110 with arrow 1404 pointing in a clockwise direction. Thus, the user may be directed to rotate handle portion 1110 in the direction indicated by the clockwise direction of arrow 1404 in order to relieve the forces experienced by shaft 1108. In this case, the user would be directed to tilt the distal end of handle portion 1110 downward and / or tilt the proximal end of handle portion 1110 upward. Now referring to Figure 14B , graphic 1450 includes an illustration 1452 in which a user's hand holds handle portion 1110 in a current position and arrow 1454 directs the user to illustration 1456, which shows handle portion 1110 tilted downward relative to the current position. Thus, in this case, the user can be directed to tilt handle portion 1110 downward to reduce the force experienced by shaft 1108.

[0094] In some examples, various graphics may be provided that continuously display the determined forces experienced by shaft 1108. For example, a display of the determined forces experienced by shaft 1108 may be provided as an overlay of the forces on a graphical representation of handle portion 1110 and / or shaft 1108 to illustrate that the forces are relieved as the user moves (e.g., rotates, tilts, etc.) handle portion 1110. In other examples, other suitable graphics may be generated and displayed to alert the user to excessive forces experienced by shaft 1108, guide the user to relieve the forces, provide a real-time display of the forces as the user moves handle portion 1110, etc. Such graphics may help the user avoid "hanging up" or causing any damage to the patient while manipulating components of surgical instrument 1100 within the patient's body.

[0095] Figure 15 is a flow chart of an example method 1500 for monitoring the forces experienced by a shaft of a surgical instrument as it is manipulated within a patient's body, according to an embodiment. In an embodiment, the method 1500 is implemented by the controller 1130 to monitor Figure 11 The force experienced by the shaft 1108 of the surgical instrument 1100. However, it should be noted that in other embodiments, the method 1500 can be performed by a controller other than the controller 1130 and / or using a controller other than the controller 1130. Figure 11 The surgical instrument 1100 is implemented by the surgical instrument.

[0096] At block 1502, the controller 1130 may receive a plurality of signals from a plurality of sensors positioned at one or both of: i) a first mechanical interface between a shaft and an actuator coupled to the shaft, or ii) a second mechanical interface between the shaft and an end effector coupled to the shaft. For example, the actuator may comprise a handle portion of a surgical instrument. In another example, the actuator may comprise a robotic arm attached to the shaft of the surgical instrument. The plurality of sensors may be configured to sense movement of the shaft relative to the actuator and / or the end effector while the shaft is being manipulated within the patient's body. Thus, the signals generated by the sensors may indicate forces experienced by the shaft while being manipulated within the patient's body. In an example, the plurality of sensors may comprise sensors distributed among a plurality of points around the circumference of the shaft, located at the first mechanical interface and / or the second mechanical interface. Thus, the signals generated by the sensors may indicate forces experienced along the shaft at the plurality of points around the circumference of the shaft while being manipulated within the patient's body.

[0097] At block 1504, the controller 1130 may detect when the force experienced by the shaft when the shaft is manipulated within the patient's body meets a predetermined excessive force standard based on a plurality of signals. For example, the controller 1130 may determine the corresponding forces experienced by the shaft at a plurality of points around the circumference of the shaft based on corresponding signals received from corresponding sensors of a plurality of sensors. The controller 1130 may compare the corresponding forces experienced by the shaft at a plurality of points around the circumference of the shaft with predetermined thresholds and may determine that the force experienced by the shaft meets the predetermined excessive force standard in response to determining that one or more of the corresponding forces exceeds the predetermined threshold. In an embodiment, the controller 1130 may also be configured to further process the signals received from the plurality of sensors, for example to determine the magnitude and / or direction of the force experienced by the shaft.

[0098] At block 1506, controller 1130 may generate an alarm and provide the alarm to the user to inform the user that the shaft is experiencing excessive force. Controller 1130 may generate the alarm at block 1506 in response to detecting at block 1504 that the force experienced by the shaft meets predetermined excessive force criteria. The alarm may include, for example, a tactile feedback signal provided via the handle portion of the surgical instrument. Additionally or alternatively, a visual and / or audible alarm may be provided. The alarm may remind the user that the user should apply less force on the surgical instrument and / or reposition the surgical instrument to reduce the force and avoid injury to the patient. In some embodiments, additional information regarding the force may be provided to the user. For example, the magnitude and / or direction of the force may be displayed to the user on a screen located on the handle portion of the surgical instrument or in the operating room where the surgical instrument is used. Such additional information may inform the user of the degree to which the user should apply less force and / or the direction in which the user should move the surgical instrument to reduce the force.

[0099] In some embodiments, the controller may also be configured to determine corrective actions that may be performed by the user to alleviate the excessive force. In such embodiments, an indication of the corrective action may be provided to the user, for example, via a screen or other display located on the handle portion of the surgical instrument or in the operating room where the surgical instrument is used.

[0100] Embodiments disclosed herein provide an axis detection system that is configured to detect movement of a shaft of a surgical instrument relative to another component of the surgical instrument. The movement of the shaft can indicate forces, pressures, strains, etc. experienced by the shaft while the surgical instrument is being manipulated within the body of a patient. Thus, the axis detection system can provide an indication of when the shaft is subjected to excessive forces and / or provide an indication of corrective actions that can be taken to mitigate the forces when the shaft is being manipulated within the body of a patient. These and other techniques described herein can reduce the likelihood of injury to a patient due to, for example, components of a surgical instrument forcefully pushing against anatomical structures within the patient's body during insertion of the surgical instrument into or removal of the surgical instrument from the patient's body.

[0101] III. Examples of Combinations

[0102] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided for illustrative purposes only. It is envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise expressly indicated as such by the inventor or a successor with an interest in the inventor at a later date. If any claim set forth in this patent application or subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.

[0103] 1. A surgical instrument, comprising:

[0104] a shaft configured to be coupled to the actuator at a first mechanical interface between the shaft and the actuator;

[0105] an end effector coupled to the shaft at a second mechanical interface between the shaft and the end effector, wherein i) the end effector is configured to clamp, staple, and cut tissue, and ii) the actuator is configured to operate the end effector via the shaft, and wherein the shaft is one or both of: i) movable relative to the actuator at the first mechanical interface between the shaft and the actuator, or ii) movable relative to the end effector at the second mechanical interface between the shaft and the end effector; and

[0106] A shaft deflection detection system comprising one or more sensors positioned at one or both of the first mechanical joint or the second mechanical joint, wherein the one or more sensors are configured to generate a signal indicative of movement of the shaft relative to one or both of the actuator or the end effector, wherein the movement of the shaft is caused by an external force experienced by the shaft of the surgical instrument when it is manipulated within the patient's body.

[0107] 2. The surgical instrument of claim 1 , wherein:

[0108] The end effector comprises a circular stapler; and

[0109] The one or more sensors are configured to detect movement of the shaft of the surgical instrument relative to one or both of the actuator or the end effector as the shaft is manipulated within an anatomical lumen within the body of the patient.

[0110] 3. The surgical instrument of claim 1 , wherein the one or more sensors comprise a plurality of sensors distributed among a plurality of points around the circumference of the shaft, located at one or both of: i) the first mechanical joint between the shaft and the actuator, or ii) the second mechanical joint between the shaft and the end effector.

[0111] 4. The surgical instrument of claim 3, further comprising a controller communicatively coupled to the shaft deflection detection system, the controller being configured to:

[0112] receiving a respective signal generated by a respective sensor of the plurality of sensors;

[0113] determining, based on the respective signals generated by respective sensors of the plurality of sensors, respective forces experienced by the shaft at respective ones of the plurality of points about the circumference of the shaft;

[0114] comparing the respective forces experienced by the shaft at the respective points to a predetermined threshold; and

[0115] Responsive to determining that one or more of the respective forces exceeds the predetermined threshold, it is determined that excessive force is experienced at one or more points about the circumference of the shaft.

[0116] 5. A surgical instrument according to claim 4, wherein the controller is further configured to generate an alarm in response to determining that the shaft is subjected to excessive force at one or more points around the circumference of the shaft and provide the alarm to a user of the surgical instrument to inform the user that the shaft is subjected to excessive force.

[0117] 6. The surgical instrument of claim 5, wherein the alarm is a tactile buzzer provided to the user via a handle portion of the surgical instrument.

[0118] 7. The surgical instrument of claim 5, wherein the controller is further configured to determine the magnitude and direction of the external force experienced by the shaft based on the respective signals generated by respective sensors of the plurality of sensors.

[0119] 8. The surgical instrument of claim 7, wherein the controller is further configured to:

[0120] determining a corrective action to mitigate the excessive force experienced by the shaft based on one or both of the magnitude or the direction of the external force; and

[0121] An indication of the corrective action is provided to the user to enable the user to alleviate the excessive force experienced by the shaft.

[0122] 9. The surgical instrument of claim 7, wherein the controller is further configured to:

[0123] generating a real-time graphic illustrating one or both of the direction or the magnitude of the external force experienced by the shaft of the surgical instrument as the user manipulates the shaft within the body of the patient; and

[0124] The real-time graphics are caused to be displayed to the user.

[0125] 10. The surgical instrument of claim 4, wherein:

[0126] the plurality of sensors comprising a plurality of Hall effect sensors positioned at the first mechanical joint on the outer surface of the shaft at the plurality of points around the circumference of the shaft; and

[0127] The shaft deflection detection system further includes

[0128] a plurality of magnets positioned at the first mechanical interface at a plurality of points on an inner surface of the actuator coupled to the shaft such that corresponding ones of the plurality of magnets are positioned opposite corresponding ones of the plurality of Hall effect sensors, and

[0129] a plurality of springs positioned in spaces between corresponding ones of the plurality of Hall effect sensors, the springs coupled between the outer surface of the shaft and the inner surface of the actuator coupled to the shaft such that the springs compress or decompress with movement of the shaft relative to the actuator coupled to the shaft, wherein the springs are characterized by a predetermined spring force function.

[0130] 11. The surgical instrument of claim 10 , wherein the controller is configured to determine the respective forces experienced along the shaft at the plurality of points about the circumference of the shaft based on: i) the signals indicative of the motion of the shaft received from respective ones of the plurality of Hall effect sensors, and ii)

[0131] The predetermined spring force function.

[0132] 12. The surgical instrument of claim 1, wherein the actuator comprises a manually operable handle portion coupled to the shaft.

[0133] 13. The surgical instrument of claim 1, wherein the actuator comprises a robotic arm attached to the shaft.

[0134] 14. A surgical instrument, comprising:

[0135] axis;

[0136] a handle portion coupled to the shaft, wherein the shaft is movable relative to the handle portion at a mechanical interface between the handle portion and the shaft; and

[0137] a shaft deflection detection system comprising a plurality of sensors positioned at the mechanical interface between the handle portion and the shaft,

[0138] wherein the sensors of the plurality of sensors are distributed at a plurality of points around the circumference of the axis, and wherein the sensors of the plurality of sensors are configured to generate signals indicative of external forces experienced along the axis at the plurality of points around the circumference of the axis when the axis of the surgical instrument is manipulated within the body of a patient.

[0139] 15. The surgical instrument of claim 14, wherein:

[0140] The surgical instrument further includes a circular stapler end effector coupled to the shaft; and

[0141] The plurality of sensors are configured to detect movement of the shaft of the surgical instrument relative to the handle portion as the shaft is manipulated within an anatomical lumen within the body of the patient.

[0142] 16. The surgical instrument of claim 14, further comprising a controller communicatively coupled to the shaft deflection detection system, the controller being configured to:

[0143] receiving the signal generated by the sensor of the plurality of sensors;

[0144] detecting, based on the signals generated by the sensors of the plurality of sensors, when the shaft is subjected to excessive force at one or more of the plurality of points about the circumference of the shaft; and

[0145] An alarm is generated in response to detecting that the shaft is experiencing excessive force at one or more points around the circumference of the shaft and provided to a user of the surgical instrument to inform the user that the shaft is experiencing excessive force.

[0146] 17. The surgical instrument of claim 16, wherein the controller is further configured to:

[0147] determining a magnitude and direction of the excessive force experienced by the shaft based on the signal generated by the sensor of the plurality of sensors;

[0148] determining a corrective action to mitigate the excessive force experienced by the shaft based on one or both of the magnitude and the direction of the external force; and

[0149] An indication of the corrective action is provided to the user to enable the user to alleviate the excessive force experienced by the shaft.

[0150] 18. The surgical instrument of claim 16, wherein:

[0151] the plurality of sensors comprising a plurality of Hall effect sensors positioned at the mechanical interface on an outer surface of the shaft at a plurality of points around the circumference of the shaft;

[0152] The shaft deflection detection system further includes

[0153] a plurality of magnets positioned at the mechanical interface at a plurality of points on an inner surface of the handle portion coupled to the shaft such that corresponding ones of the plurality of magnets are positioned opposite corresponding ones of the plurality of Hall effect sensors, and

[0154] a plurality of springs positioned in spaces between corresponding ones of the plurality of Hall effect sensors, the springs coupled between the outer surface of the shaft and the inner surface of the handle portion coupled to the shaft such that the springs compress or decompress with movement of the shaft relative to the handle portion coupled to the shaft, wherein the springs are characterized by a predetermined spring force function; and

[0155] The controller is configured to be capable of determining respective forces experienced along the shaft at the plurality of points about the circumference of the shaft based on: i) the signals received from respective ones of the plurality of Hall effect sensors indicative of the movement of the shaft, and ii) the predetermined spring force function.

[0156] 19. A method for monitoring forces experienced by a shaft of a surgical instrument as the shaft is manipulated within a patient's body, the method comprising:

[0157] receiving, at a controller of the surgical instrument, a plurality of signals from a plurality of sensors positioned at one or both of: i) a first mechanical interface between the shaft and an actuator coupled to the shaft, or ii) a second mechanical interface between the shaft and an end effector coupled to the shaft, the plurality of sensors being distributed among a plurality of points around a circumference of the shaft at one or both of the first and second mechanical interfaces;

[0158] detecting, by the controller based on the plurality of signals, that a force experienced by the shaft when the shaft is manipulated within the body of the patient satisfies a predetermined excessive force criterion; and

[0159] In response to detecting that the force experienced by the shaft meets the predetermined excessive-force criterion, an alarm is generated by the controller and provided to a user to inform the user that the shaft is experiencing excessive force.

[0160] 20. The method of claim 19, wherein detecting when the force experienced by the shaft meets the predetermined excessive force criteria comprises:

[0161] determining respective forces experienced by the shaft at a plurality of points about the circumference of the shaft based on respective signals generated by respective sensors of the plurality of sensors;

[0162] comparing the respective forces experienced by the shaft at the plurality of points about the circumference of the shaft to predetermined thresholds; and

[0163] In response to determining that one or more of the respective forces exceeds the predetermined threshold, detecting that the force experienced by the shaft meets the predetermined excessive-force criterion.

[0164] IV. Miscellaneous

[0165] It should 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 above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Based on the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0166] In addition, 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. 63 / 467,622, filed on May 19, 2023, entitled “Surgical Stapler Cartridge Having Intermediate Raised Tissue Engagement Protrusions”; U.S. Patent Application No. 63 / 467,623, filed on May 19, 2023, entitled “Surgical Stapler CartridgeHaving Tissue Engagement Protrusions with Enlarged Engagement Surface”; U.S. Patent Application No. 63 / 467,648, filed on May 19, 2023, entitled “Surgical Stapler CartridgeHaving Raised Surface to Promote Buttress Adhesion”; U.S. Patent Application No. 63 / 467,650, filed on May 19, 2023, entitled “Surgical Stapler CartridgeHaving CartridgeRetention U.S. patent application No. 63 / 467,469, filed on May 19, 2023, entitled “Surgical Stapler Anvil Having Staple Forming Pockets with Laterally Varying Orientations”; U.S. patent application No. 63 / 459,739, filed on May 19, 2023, entitled “Surgical Stapler With Discretely Positionable Distal Tip”; and / or U.S. patent application No. 63 / 467,656, filed on May 19, 2023, entitled “Surgical Stapler With Discretely Positionable Distal Tip”; and / or U.S. patent application No. 63 / 467,615, filed on May 19, 2023, entitled “Incompatible Staple Cartridge Use Prevention Features for Surgical Stapler.”

[0167] In addition, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent application: U.S. Patent Application No. 63 / 459,739, entitled “Surgical Stapler Anvil Having Staple Forming Pockets with Laterally Varying Orientations,” filed on April 17, 2023. The disclosures of each of these U.S. patent applications are incorporated herein by reference in their entirety.

[0168] In addition, 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 No. 11,304,697, entitled “Surgical Stapler with Deflectable Distal Tip,” published on April 19, 2022, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 11,317,912, entitled “Surgical Stapler with Rotatable Distal Tip,” published on May 3, 2022, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 11,439,391, entitled “Surgical Stapler with Toggling Distal Tip,” published on September 13, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0169] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, allegedly incorporated herein that conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.

[0170] The versions of the devices described above may be applied to traditional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into robotic surgical systems, such as those offered by Auris Health, Inc. (Redwood City, CA) or by Intuitive Surgical, Inc. (Sunnyvale, California).

[0171] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both cases, these types can be repaired for reuse after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can utilize a variety of techniques to disassemble, clean / replace, and reassemble. The use of such technology and the resulting repair device are all within the scope of this application.

[0172] By way of example only, the devices 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 field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. The device can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0173] Various embodiments of the present invention have been shown and described, and further improvements to the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should be understood not to be limited to the details of construction and operation shown and described in the specification and drawings.

Claims

1. A surgical instrument, comprising: a shaft configured to be coupled to the actuator at a first mechanical interface between the shaft and the actuator; an end effector coupled to the shaft at a second mechanical interface between the shaft and the end effector, wherein i) the end effector is configured to clamp, staple, and cut tissue, and ii) the actuator is configured to operate the end effector via the shaft, and wherein the shaft is one or both of: i) movable relative to the actuator at the first mechanical interface between the shaft and the actuator, or ii) movable relative to the end effector at the second mechanical interface between the shaft and the end effector; and A shaft deflection detection system comprising one or more sensors positioned at one or both of the first mechanical joint or the second mechanical joint, wherein the one or more sensors are configured to generate a signal indicative of movement of the shaft relative to one or both of the actuator or the end effector, wherein the movement of the shaft is caused by an external force experienced by the shaft of the surgical instrument when it is manipulated within the patient's body.

2. The surgical instrument of claim 1 , wherein: The end effector comprises a circular stapler; and The one or more sensors are configured to detect movement of the shaft of the surgical instrument relative to one or both of the actuator or the end effector as the shaft is manipulated within an anatomical lumen within the body of the patient.

3. The surgical instrument according to claim 1, wherein: The one or more sensors include a plurality of sensors distributed among a plurality of points around the circumference of the shaft, located at one or both of: i) the first mechanical joint between the shaft and the actuator, or ii) the second mechanical joint between the shaft and the end effector.

4. The surgical instrument of claim 3, further comprising a controller communicatively coupled to the shaft deflection detection system, the controller being configured to: receiving a respective signal generated by a respective sensor of the plurality of sensors; determining, based on the respective signals generated by respective sensors of the plurality of sensors, respective forces experienced by the shaft at respective ones of the plurality of points about the circumference of the shaft; comparing the respective forces experienced by the shaft at the respective points to a predetermined threshold; as well as Responsive to determining that one or more of the respective forces exceeds the predetermined threshold, it is determined that excessive force is experienced at one or more points about the circumference of the shaft.

5. The surgical instrument according to claim 4, wherein: The controller is further configured to generate an alarm in response to determining that the shaft is experiencing excessive force at one or more points around the circumference of the shaft and provide the alarm to a user of the surgical instrument to inform the user that the shaft is experiencing excessive force.

6. The surgical instrument according to claim 5, wherein: The alarm is a tactile buzzer provided to the user via the handle portion of the surgical instrument.

7. The surgical instrument according to claim 5, wherein: The controller is further configured to be capable of determining a magnitude and direction of the external force experienced by the shaft based on the respective signals generated by respective sensors of the plurality of sensors.

8. The surgical instrument according to claim 7, wherein: The controller is further configured to: determining a corrective action to mitigate the excessive force experienced by the shaft based on one or both of the magnitude or the direction of the external force; and An indication of the corrective action is provided to the user to enable the user to alleviate the excessive force experienced by the shaft.

9. The surgical instrument according to claim 7, wherein: The controller is further configured to: generating a real-time graphic illustrating one or both of the direction or the magnitude of the external force experienced by the shaft of the surgical instrument as the user manipulates the shaft within the body of the patient; and The real-time graphics are caused to be displayed to the user.

10. The surgical instrument of claim 4, wherein: the plurality of sensors comprising a plurality of Hall effect sensors positioned at the first mechanical joint on the outer surface of the shaft at the plurality of points around the circumference of the shaft; and The shaft deflection detection system further includes a plurality of magnets positioned at the first mechanical interface at a plurality of points on an inner surface of the actuator coupled to the shaft such that corresponding ones of the plurality of magnets are positioned opposite corresponding ones of the plurality of Hall effect sensors, and a plurality of springs positioned in spaces between corresponding ones of the plurality of Hall effect sensors, the springs coupled between the outer surface of the shaft and the inner surface of the actuator coupled to the shaft such that the springs compress or decompress with movement of the shaft relative to the actuator coupled to the shaft, wherein the springs are characterized by a predetermined spring force function.

11. The surgical instrument according to claim 10, wherein: The controller is configured to be capable of determining respective forces experienced along the shaft at the plurality of points about the circumference of the shaft based on: i) the signals received from respective ones of the plurality of Hall effect sensors indicative of the movement of the shaft, and ii) the predetermined spring force function.

12. The surgical instrument according to claim 1, wherein The actuator includes a manually operable handle portion coupled to the shaft.

13. The surgical instrument according to claim 1, wherein The actuator includes a robotic arm attached to the shaft.

14. A surgical instrument, comprising: axis; a handle portion coupled to the shaft, wherein the shaft is movable relative to the handle portion at a mechanical interface between the handle portion and the shaft; and a shaft deflection detection system comprising a plurality of sensors positioned at the mechanical interface between the handle portion and the shaft, wherein the sensors of the plurality of sensors are distributed at a plurality of points around the circumference of the axis, and wherein the sensors of the plurality of sensors are configured to generate signals indicative of external forces experienced along the axis at the plurality of points around the circumference of the axis when the axis of the surgical instrument is manipulated within the body of a patient.

15. The surgical instrument of claim 14, wherein: The surgical instrument further includes a circular stapler end effector coupled to the shaft; and The plurality of sensors are configured to detect movement of the shaft of the surgical instrument relative to the handle portion as the shaft is manipulated within an anatomical lumen within the body of the patient.

16. The surgical instrument of claim 14, further comprising a controller communicatively coupled to the shaft deflection detection system, the controller being configured to: receiving the signal generated by the sensor of the plurality of sensors; detecting, based on the signals generated by the sensors of the plurality of sensors, when the shaft is subjected to excessive force at one or more of the plurality of points about the circumference of the shaft; as well as An alarm is generated in response to detecting that the shaft is experiencing excessive force at one or more points around the circumference of the shaft and provided to a user of the surgical instrument to inform the user that the shaft is experiencing excessive force.

17. The surgical instrument according to claim 16, wherein: The controller is further configured to: determining a magnitude and direction of the excessive force experienced by the shaft based on the signal generated by the sensor of the plurality of sensors; determining a corrective action to mitigate the excessive force experienced by the shaft based on one or both of the magnitude and the direction of the external force; as well as An indication of the corrective action is provided to the user to enable the user to alleviate the excessive force experienced by the shaft.

18. The surgical instrument of claim 16, wherein: the plurality of sensors comprising a plurality of Hall effect sensors positioned at the mechanical interface on an outer surface of the shaft at a plurality of points around the circumference of the shaft; The shaft deflection detection system further includes a plurality of magnets positioned at the mechanical interface at a plurality of points on an inner surface of the handle portion coupled to the shaft such that corresponding ones of the plurality of magnets are positioned opposite corresponding ones of the plurality of Hall effect sensors, and a plurality of springs positioned in spaces between corresponding ones of the plurality of Hall effect sensors, the springs coupled between the outer surface of the shaft and the inner surface of the handle portion coupled to the shaft such that the springs compress or decompress with movement of the shaft relative to the handle portion coupled to the shaft, wherein the springs are characterized by a predetermined spring force function; and The controller is configured to be capable of determining respective forces experienced along the shaft at the plurality of points about the circumference of the shaft based on: i) the signals received from respective ones of the plurality of Hall effect sensors indicative of the movement of the shaft, and ii) the predetermined spring force function.

19. A method for monitoring forces experienced by a shaft of a surgical instrument as the shaft is manipulated within a patient's body, the method comprising: receiving, at a controller of the surgical instrument, a plurality of signals from a plurality of sensors positioned at one or both of: i) a first mechanical interface between the shaft and an actuator coupled to the shaft, or ii) a second mechanical interface between the shaft and an end effector coupled to the shaft, the plurality of sensors being distributed among a plurality of points around a circumference of the shaft at one or both of the first and second mechanical interfaces; detecting, by the controller based on the plurality of signals, that a force experienced by the shaft when the shaft is manipulated within the body of the patient satisfies a predetermined excessive force criterion; as well as In response to detecting that the force experienced by the shaft meets the predetermined excessive-force criterion, an alarm is generated by the controller and provided to a user to inform the user that the shaft is experiencing excessive force.

20. The method according to claim 19, wherein Detecting when the force experienced by the shaft meets the predetermined excessive force criterion includes: determining respective forces experienced by the shaft at a plurality of points about the circumference of the shaft based on respective signals generated by respective sensors of the plurality of sensors; comparing the respective forces experienced by the shaft at the plurality of points about the circumference of the shaft to predetermined thresholds; and In response to determining that one or more of the respective forces exceeds the predetermined threshold, detecting that the force experienced by the shaft meets the predetermined excessive-force criterion.

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