End-of-life indicator for robotic surgical instruments

Abstract

The surgical tool includes a drive housing and an indicator assembly located within the drive housing and operable to provide a visual indication of when the useful life of the surgical tool has ended. The indicator assembly includes a drive input unit rotatably coupled to the bottom of the drive housing. The drive input unit further includes a riser and a rim, the riser including a passage through which it passes. The indicator assembly further includes an indicator shaft extending through the passage along a longitudinal axis coaxially aligned with the drive input unit. The drive input unit rotates to actuate the indicator assembly between a non-activated state in which the indicator shaft is recessed into the drive housing and an activated state in which the indicator shaft extends from the drive housing to provide a visual indication.

Description

Technical Field

[0001] (Priority) This application claims priority to U.S. Provisional Patent Application No. 63 / 528,218, filed on July 21, 2023.

Background Art

[0002] Minimally invasive surgical (MIS) instruments are often preferred over conventional open surgical devices because they reduce postoperative recovery time and minimize scarring. During MIS procedures, various instruments and surgical tools are introduced into the abdominal cavity to engage and / or treat tissue in numerous ways to achieve a diagnostic or therapeutic effect. To assist in MIS procedures by controlling such MIS instruments, various robotic systems have been developed in recent years. A user (e.g., a surgeon) can remotely operate the end effector of an MIS instrument by grasping and manipulating one or more controllers of a robotic system that communicates with a tool drive coupled to the surgical instrument within a space. User input is processed by a computer system incorporated within the robotic surgical system, and the tool drive responds by actuating a cable-driven motion system, more specifically by actuating drive cables. By moving the drive cables, the end effector is articulated to a desired position and configuration.

[0003] MIS instruments have a limited lifespan. For example, some MIS instruments are designed to expire after a predetermined number of uses or after a set period of time. In some cases, MIS instruments may include an indicator that provides a notification when the instrument's useful life has ended. Conventional instrument indicators are mechanically driven by one of the tool drives of the MIS instrument, but such tool drives may rather be used for other tool functions, inevitably reducing the overall functionality of the MIS instrument. Furthermore, conventional instrument indicators are not easily recognizable, and as a result, sterilization personnel often fail to notice that an MIS instrument has expired, and it is mistakenly cleaned, sterilized, and stored, and later sent to the operating room, even though it has no effective working life remaining. When discovered in the operating room, staff are required to discard the MIS instrument and obtain a replacement. This results in frustration, delays in procedures, and potentially additional sedation time for the patient. Therefore, it may be beneficial to provide an indicator that does not utilize a tool drive and is more easily recognizable. [Brief explanation of the drawing]

[0004] The following figures are included to illustrate specific aspects of this disclosure, but should not be viewed as exclusive embodiments. The disclosed subject matter is subject to considerable modification, alteration, combination, and equivalents in form and function. [Figure 1] This is a block diagram of an exemplary robotic surgical system that may incorporate some or all of the principles of this disclosure. [Figure 2] This is an isometric side view of an exemplary surgical tool that may incorporate some or all of the principles of this disclosure. [Figure 3] Figure 2 shows the potential degrees of freedom of the wrist portion of the surgical tool, which can perform joint movement (pivot) and translation. [Figure 4] This is a bottom view of the drive housing shown in Figure 2, according to one or more embodiments. [Figure 5A] This is an isometric view of the drive housing shown in Figure 2, according to one or more embodiments. [Figure 5B] This is an isometric view of the drive housing shown in Figure 2, according to one or more embodiments. [Figure 6] This is an exposed view of the interior of a drive housing according to one or more embodiments. [Figure 7] This is a diagram of a drive input section incorporating some or all of the principles of this disclosure. [Figure 8A] This is a diagram of an indicator shaft that may incorporate some or all of the principles of this disclosure. [Figure 8B] This is a separated view of the indicator shaft of Figure 8A rotated 90 degrees, which may incorporate some or all of the principles of this disclosure. [Figure 9A] Figure 6 shows a sequence of the indicator assembly from the non-activated state to the activated state. [Figure 9B] Figure 6 shows a sequence of the indicator assembly from the non-activated state to the activated state. [Figure 9C] Figure 6 shows a sequence of the indicator assembly from the non-activated state to the activated state. [Figure 10A] This is a series of cross-sectional views of an indicator assembly in a non-activated and activated state, which may incorporate some or all of the principles of this disclosure. [Figure 10B] This is a series of cross-sectional views of an indicator assembly in a non-activated and activated state, which may incorporate some or all of the principles of this disclosure. [Figure 11] This is a separate top view of an indicator shaft aligned within a drive housing that may incorporate some or all of the principles of this disclosure. [Figure 12] This is a cross-sectional view of an indicator assembly that may incorporate some or all of the principles of this disclosure. [Figure 13] This is a separate diagram of an indicator shaft aligned within a drive housing that may incorporate some or all of the principles of this disclosure. [Modes for carrying out the invention]

[0005] This disclosure relates to robotic surgical systems, and more specifically, to tool life indicators for surgical tools.

[0006] Embodiments discussed herein describe a surgical tool that provides a visual indicator to a user, operator, or technician when the useful life of the surgical tool has ended. The surgical tool may include a drive housing defining an indicator opening, a drive input rotatably coupled to the bottom of the drive housing, and an indicator assembly located within the drive housing and operable to provide a visual indication that the useful life of the surgical tool has ended. The indicator assembly may include a coil spring operablely coupled to the drive input to torque the coil spring in response to the rotation of the drive input, and an indicator shaft extending from an indicator mount along a longitudinal axis coaxially aligned with the indicator opening. The indicator shaft may be raised and lowered by the drive input to actuate the indicator assembly between a non-activated state in which the indicator shaft is recessed into the indicator opening and an activated state in which the indicator shaft extends from the drive housing through the indicator opening to provide a visual indication.

[0007] Figure 1 is a block diagram of an exemplary robotic surgical system 100 that may incorporate some or all of the principles of this disclosure. As shown, the system 100 may include at least one set of user input controllers 102a and at least one control computer 104. The control computer 104 may be mechanically and / or electrically coupled to a robotic manipulator, more specifically, one or more robotic arms 106 (alternatively referred to as “tool drives”). In some embodiments, the robotic manipulator may be contained in or otherwise mounted on an arm cart that may make the system portable. Each robotic arm 106 may include, or otherwise provide, a place to mount one or more surgical instruments or tools 108 for performing various surgical tasks on a patient 110. The operation of the robotic arms 106 and associated tools 108 may be instructed by a clinician 112a (e.g., a surgeon) from the user input controllers 102a.

[0008] In some embodiments, a second set of user input controllers 102b (shown by dashed lines) may be operated by the second clinician 112b in conjunction with the first clinician 112a to instruct the operation of the robotic arms 106 and tools 108 via the control computer 104. In such embodiments, for example, each clinician 112a,b may control a different robotic arm 106, or, as appropriate, complete control of the robotic arms 106 may be passed between clinicians 112a,b as needed. In some embodiments, an additional robotic manipulator with additional robotic arms may be used during surgery on patient 110, and these additional robotic arms may be controlled by one or more of the user input controllers 102a,b.

[0009] The control computer 104 and user input controllers 102a,b may communicate with each other according to any communication protocol via a communication link 114, which may be any type of wired or wireless telecommunications means configured to carry various communication signals (e.g., electrical, optical, infrared, etc.). In some applications, for example, there may be a tower equipped with auxiliary devices and a processing core designed to drive a robotic arm 106.

[0010] The user input controllers 102a,b generally include one or more physical controllers that clinicians 112a,b can grasp and manipulate in space while the surgeon views the procedure via a stereo display. The physical controllers generally include manual input devices that are movable in multiple degrees of freedom, and the manual input devices often include actuated handles for operating surgical tools 108 (e.g., for opening and closing opposing jaws, applying potential (current) to electrodes, etc.). To provide a visual display of various surgical instrument metrics, such as the amount of force applied to the surgical instrument (i.e., cutting instrument or dynamic clamping member), the control computer 104 may further include optional feedback meters that clinicians 112a,b can view via a display.

[0011] Figure 2 is an isometric side view of an exemplary surgical tool 200 that may incorporate some or all of the principles of this disclosure. The surgical tool 200 may be identical or similar to the surgical tool 108 in Figure 1, and therefore may be used in conjunction with a robotic surgical system, such as the robotic surgical system 100 in Figure 1. Accordingly, the surgical tool 200 may be designed to be releasably coupled to a tool drive unit included in the robotic surgical system 100. However, in other embodiments, the form of the surgical tool 200 may be adapted for use in a manual or hand-operated manner without departing from the scope of this disclosure.

[0012] As shown in the figure, the surgical tool 200 includes an elongated shaft 202, an end effector 204, a wrist portion 206 (alternatively referred to as the “wrist joint” or “articulated wrist joint”) connecting the end effector 204 to the distal end of the shaft 202, and a drive housing 208 connected to the proximal end of the shaft 202. In applications where the surgical tool is used with a robotic surgical system (e.g., the robotic surgical system 100 in Figure 1), the drive housing 208 may include a coupling mechanism that releasably connects the surgical tool 200 to the robotic surgical system.

[0013] The terms “proximal” and “distal” are defined herein in reference to a robotic surgical system having an interface configured to mechanically and electrically connect a surgical tool 200 (e.g., housing 208) to a robotic manipulator. The term “proximal” refers to the location of an element closer to the robotic manipulator, and the term “distal” refers to the location of an element closer to the end effector 204 and therefore further away from the robotic manipulator. Alternatively, in applications operated manually or by hand, the terms “proximal” and “distal” are defined herein in reference to a user, such as a surgeon or clinician. The term “proximal” refers to the location of an element closer to the user, and the term “distal” refers to the location of an element closer to the end effector 204 and therefore further away from the user. Furthermore, the use of directional terms such as up, down, upward, downward, left, and right is used in reference to illustrative embodiments as shown in the figures, where upward or upward direction is toward the top of the corresponding figure, and downward or downward direction is toward the bottom of the corresponding figure.

[0014] During use of the surgical tool 200, the end effector 204 is configured to move (pivot) relative to the shaft 202 at the wrist 206 to position the end effector 204 in a desired direction and location relative to the surgical site. To achieve this, the housing 208 includes (accommodates) various drive inputs and mechanisms (such as gears, actuators, etc.) designed to control the operation of various mechanisms associated with the end effector 204 (such as clamping, firing, cutting, rotation, articulation, etc.). In at least some embodiments, the shaft 202, and thus the end effector 204 coupled thereto, is configured to rotate about the longitudinal axis A1 of the shaft 202. In such embodiments, at least one of the drive inputs included in the housing 208 is configured to control the rotational movement of the shaft 202 about the longitudinal axis A1.

[0015] The shaft 202 is an elongated member extending distally from the housing 208 and has at least one lumen extending therethrough along its axial length. In some embodiments, the shaft 202 can be fixed to the housing 208, or alternatively, can be rotatably attached to the housing 208 to allow the shaft 202 to rotate about the longitudinal axis A1. In still other embodiments, the shaft 202 can be releasably coupled to the housing 208, thereby allowing a single housing 208 to be adaptable to various shafts having different end effectors.

[0016] The end effector 204 can assume various sizes, shapes, and configurations. In the illustrated embodiment, the end effector 204 comprises a combination of a tissue grasping instrument and a vessel sealer that includes opposing first (upper) 210 and opposing second (lower) jaws 212 configured to move (articulate) between an open position and a closed position. However, as will be appreciated later, the opposing jaws 210, 212 may alternatively form part of other types of end effectors, such as surgical scissors, clip appliers, needle holders, Babcocks including a pair of opposing grasping jaws, bipolar jaws (e.g., bipolar Maryland grasping instruments, forceps, fenestrated grasping instruments, etc.), but are not limited thereto. One or both of the jaws 210, 212 may be configured to pivot to articulate the end effector 204 between an open position and a closed position. In other embodiments, the end effector 204 may not include opposing jaws and instead may comprise other types of surgical end effectors, such as staplers, cautery devices, suction tools, irrigation tools, etc.

[0017] Figure 3 shows the potential degrees of freedom by which the wrist portion 206 can articulate (pivot) and move the end effector 204. The wrist portion 206 can have any of a variety of configurations. Generally, the wrist portion 206 comprises a joint configured to enable pivotal movement of the end effector 204 relative to the shaft 202. The degrees of freedom of the wrist portion 206 are represented by three translational variables (i.e., surge, heave, and sway), as well as three rotational variables (i.e., Euler angles or roll, pitch, and yaw). The translational and rotational variables describe the position and orientation of the end effector 204 relative to a given reference Cartesian frame. As shown in Figure 3, "surge" refers to translational movement forward and backward, "heave" refers to translational movement up and down, and "sway" refers to translational movement left and right. With respect to the rotational terms, "roll" means tilting the side, "pitch" means tilting forward and backward, and "yaw" refers to rotating left and right.

[0018] The pivot motion can include pitch motion around a first axis (e.g., the X-axis) of the wrist portion 206, yaw motion around a second axis (e.g., the Y-axis) of the wrist portion 206, and combinations thereof, enabling 360° rotational motion of the end effector 204 around the wrist portion 206. In other applications, the pivot motion can be limited to motion in a single plane, for example, only pitch motion around the first axis of the wrist portion 206, or only yaw motion around the second axis of the wrist portion 206, resulting in the end effector 204 moving only in a single plane.

[0019] Referring again to Figure 2, the surgical tool 200 may further include several drive cables (hidden in Figure 2) that form part of a cable-driven motion system configured to facilitate the operation and articulation of the end effector 204 relative to the shaft 202. By moving (actuating) one or more of the drive cables, the end effector 204 moves between an articulated position and an articulated position. In Figure 2, the end effector 204 is shown in an articulated position such that its longitudinal axis A2 is substantially aligned with the longitudinal axis A1 of the shaft 202, thereby resulting in a substantially zero angle of the end effector 204 relative to the shaft 202. Due to factors such as manufacturing tolerances and precision of the measuring device, the end effector 204 may not be at a precise zero angle relative to the shaft 202 in the articulated position, but it may still be considered "substantially aligned" with respect to the shaft 202. In the joint movement position, the longitudinal axes A1 and A2 are angularly offset from each other such that the angle of the end effector 204 with respect to the shaft 202 is not zero.

[0020] In some embodiments, the surgical tool 200 may be supplied with power (current) via a power cable 214 connected to the housing 208. In other embodiments, the power cable 214 may be omitted, and power may be supplied to the surgical tool 200 via an internal power source such as one or more batteries or fuel cells. In such embodiments, the surgical tool 200 may alternatively be characterized and referred to as an "electrosurgical instrument" capable of supplying electrical energy to the end effector 204.

[0021] The power cable 214 can allow the surgical tool 200 to communicate with the generator 216, which supplies energy such as electrical energy (e.g., radio frequency energy), ultrasonic energy, microwave energy, thermal energy, or any combination thereof, to the surgical tool 200, more specifically to the end effector 204. Thus, the generator 216 may be equipped with a radio frequency (RF) source, an ultrasonic source, a DC source, and / or any other suitable type of electrical energy source, which can be activated independently or simultaneously.

[0022] In applications where the surgical tool 200 is configured for bipolar operation, the power cable 214 includes a supply conductor and a return conductor. Current can be supplied from the generator 216 to the active (or source) electrode located at the end effector 204 via the supply conductor, and current can return to the generator 216 via the return conductor located at the end effector 204. In the case of a bipolar gripping instrument with opposing jaws, for example, the jaws are isolated from each other at their proximal ends, and the inner surfaces of the jaws (i.e., the areas of the jaws that grip tissue) function as electrodes that apply current in a controlled path through the tissue. In applications where the surgical tool 200 is configured for unipolar operation, the generator 216 transmits current via the supply conductor to the active electrode located at the end effector 204, and the current is returned (dissipated) via a return electrode (e.g., a grounding pad) separately connected to the patient's body.

[0023] The surgical tool 200 may further include a manual release switch 218, which can be manually activated by a user (e.g., a surgeon) to disable the cable-driven system, thereby allowing the end effector 204 to be manually articulated or operated. The release switch 218 is movably positioned on the drive housing 208, and the user can manually move (slide) the release switch 218 from the disengaged position to the engaged position, as shown. In the disengaged position, the surgical tool 200 can operate normally. However, when the release switch 218 is moved to the engaged position, various internal components of the drive housing 208 move simultaneously, causing the jaws 210 and 212 to open, which may prove beneficial for various reasons. In some applications, for example, the release switch 218 can be moved if an electrical failure occurs that renders the surgical tool 200 inoperable. In such applications, the user can manually open the jaws 210 and 212 to release the grasped tissue and remove the surgical tool 200. For other applications, the release switch 218 may be activated (made usable) to open the jaws 210, 212 in preparation for cleaning and / or sterilization of the surgical tool 200.

[0024] According to embodiments of the present disclosure, the surgical tool 200 may further include a tool end-of-life indicator assembly 220, which can be automatically activated (triggered) to provide a visual indication that the useful life of the surgical tool 200 has ended and / or that the recommended life of the surgical tool 200 has expired. Herein, the tool of the life indicator assembly 220 may be alternatively referred to as the “indicator assembly 220”. Upon activation of the indicator assembly 220, the user is visually notified that the useful life of the surgical tool 200 has ended and that it should not be cleaned and reused, but rather dismantled (e.g., discarded).

[0025] In some embodiments, the surgical tool 200 may include a single tool end-of-life indicator assembly 220. In other embodiments, the surgical tool 200 may include multiple tool end-of-life indicator assemblies 220, where the first tool end-of-life indicator assembly 220 is activated after a first use, the second tool end-of-life indicator assembly 220 is activated after a second use, and so on, with the activation of all multiple tool end-of-life indicator assemblies 220 indicating that the surgical tool 200 has reached the end of its lifespan. In at least one embodiment, the tool end-of-life indicator assembly 220 may provide a visual indication that a certain amount of life (or number of uses or usage time) remains in the surgical tool 200.

[0026] Various metrics can be implemented to measure the useful life of the surgical tool 200. For example, "useful life" may be determined by the number of procedures in which the surgical tool 200 was used (e.g., 20 procedures). In such an embodiment, when the number of uses of the surgical tool 200 reaches a predetermined threshold, the indicator assembly 220 may be activated to visually notify the user. Alternatively, "useful life" may be determined by the number of hours the surgical tool 200 was used, the number of joint movements or movements performed by the surgical tool 200, or any combination thereof. The indicator assembly 220 may provide a visually apparent indication that the useful life of the surgical tool 200 has run out or expired, and / or that a certain amount of life (e.g., number of uses, usage time, etc.) remains in the surgical tool 200.

[0027] As will be described in more detail below, the tool end-of-life indicator assembly 220 may include a mechanically operated indicator button or shaft 222 that becomes visible (exposed) when the useful life of the surgical tool 200 is exhausted or has reached its useful life. In one or more embodiments, as shown, the indicator assembly 220 may be located on the drive housing 208, such as on the top surface of the drive housing 208. However, the indicator assembly 220 may be located anywhere on the surgical tool 200 that allows the user to sufficiently visually notice the indicator shaft 222. The indicator shaft 222 may be recessed into the drive housing 208 during the normal operation of the surgical tool 200 and before a predetermined useful life threshold is reached, and may normally be invisible. However, when it is determined that the useful life of the surgical tool 200 has been exhausted, the indicator assembly 220 may be activated (activated), as a result the indicator shaft 222 extends (protrudes) a short distance from the drive housing 208 to provide a visual indication to the user. In Figure 2, the indicator assembly 220 is shown with the indicator shaft 222 in the activated state.

[0028] Figure 4 is a bottom view of a drive housing 208 according to one or more embodiments. As shown, the drive housing 208 may include a tool mounting portion 402 used to operably couple the drive housing 208 to the tool drive unit of a robotic manipulator. The tool mounting portion 402 may releasably couple the drive housing 208 to the tool drive unit in a variety of ways, such as clamping, clipping, or slidably fitting. In some embodiments, the tool mounting portion 402 may include an array of electrical connection pins that can be coupled to electrical connections on the mounting surface of the tool drive unit. The tool mounting portion 402 is described herein in relation to mechanical, electrical, and magnetic coupling elements, but it should be understood that a wide variety of telemetry modes, including infrared coupling, inductive coupling, and the like, may be used.

[0029] The tool mounting portion 402 is provided separately, including an interface 404 configured to mechanically, magnetically, and / or electrically couple the drive housing 208 to the tool drive unit. As shown in the figure, the interface 404 includes and supports a plurality of drive inputs, indicated as drive inputs 406a, 406b, 406c, 406d, 406e, and 406f. Each drive input 406a-f comprises a rotating disk configured to align with and couple to a corresponding actuator or "drive output" of the tool drive unit, so that the rotation (actuation) of a given drive output drives (rotates) one of the corresponding drive inputs 406a-f. Each drive input 406a-f may have or may have one or more surface features 408 configured to align with a mating surface feature provided on the corresponding drive output unit. The surface features 408 may include, for example, various protrusions and / or recesses to facilitate mating engagement. In some embodiments, some or all of the drive input sections 406a to f may include one surface feature section 408 that is positioned closer to the axis of rotation of the associated drive input section 406a to f than the other surface feature section 408. This may help ensure a positive angular alignment of each drive input section 406a to f.

[0030] The operation of the first drive input 406a may be configured to control the operation of the tool end-of-life indicator assembly 220 (Figure 2). In some embodiments, activating the first drive input 406a may control not only the operation of the indicator assembly 220, as will be described later, but also other features or operations for the surgical tool 200 (Figure 2). However, in other embodiments, activating the first drive input 406a may control the operation of the indicator assembly 220 exclusively, without departing from the scope of this disclosure.

[0031] The operation of the second drive input 406b may be configured to control the rotation of the shaft 202 around its longitudinal axis A1. The shaft 202 may rotate clockwise or counterclockwise in response to the rotational operation of the second drive input 406b. In some embodiments, the operation of the second drive input 406b, third drive input 406c, fourth drive input 406d, and fifth drive input 406e may be configured to produce motion (axial translation) of a drive cable that forms part of a cable-driven motion system, which results in the operation of the wrist portion 106 (Figure 4) and / or joint movement (action) of the end effector 204 (Figure 4). In some embodiments, the operation of the sixth drive input 406f may be configured to advance and retract the drive rod, and accordingly advance or retract the knife of the end effector 204. Each of the drive input units 406a to f may be operated based on user input communicated to a tool drive unit coupled to interface 404, and the user input may be received via a computer system incorporated into the robotic surgical system.

[0032] The drive housing 208 may house electronic equipment that stores unique identification data for a surgical tool 200 (Figure 2). When the drive housing 208 is mounted on the tool drive unit of the robotic surgical system 100 (Figure 1), the system 100 may be able to identify the type of tool used in a particular operation and / or a specific tool based on the unique identification data. In addition, the electronic equipment of the surgical tool 200 may store the useful life of the surgical tool 200 (e.g., number of uses), and the useful life of the surgical tool 200 may be determined by logic stored in one or more components of the robotic surgical system 100. Furthermore, the surgical system 100 may store information related to a particular surgical tool 200, and then access and use that stored information when it recognizes that a particular surgical tool 200 is being used. For example, the robotic surgical system 100 may recognize that a surgical tool 200 has been attached to a robotic manipulator, and then access its previously calculated remaining useful life, thereby updating the useful life of the tool as needed following a specific operation in which the surgical tool 200 is being used.

[0033] A surgical tool 200 (Figure 2) can communicate wirelessly with a robotic surgical system 100 (Figure 1). In particular, the robotic surgical system 100 can use the NFC protocol to identify or authenticate the surgical tool 200, or associate the surgical tool 200 with stored data associated with the surgical tool 200. In at least some embodiments, the surgical tool 200 includes a tag that can be read remotely and wirelessly without physical contact when excited by energy emitted from a robotic manipulator. The tag includes an integrated circuit (or chip) that stores and processes information and modulates and demodulates a signal (i.e., a radio frequency signal or "RF" signal), and an antenna that receives and transmits the signal. The tag may include a battery and be automatically activated periodically to transmit a signal, or it may include a battery and be activated to transmit a signal when a robotic manipulator (or other reading device) is present, or it may not include a battery and be activated to transmit a signal when excited by a robotic manipulator (or other reading device). The tag may be read-only, having information assigned to it, or read / write, allowing information to be written to the tag one or more times. In these embodiments, the robotic manipulator (or reading device) queries the tag in the surgical tool 200 by transmitting an encoded radio signal. The tag receives the encoded radio signal and responds by transmitting identification information and / or other information (e.g., serial number, number of uses, usage time, manufacturing date, expiration date, etc.) stored in the integrated circuit to the robotic manipulator, which can then be analyzed by the robotic surgical system 100. Thus, since each surgical tool's tag contains unique identification data, the robotic surgical system 100 may be able to distinguish between various surgical tools.

[0034] Figures 5A and 5B are isometric views of the drive housing 208 according to one or more embodiments. Figures 5A and 5B also illustrate exemplary operation of the tool end-of-life indicator assembly 220, which includes an indicator shaft 222. In Figure 5A, the indicator assembly 220 is in a first state or "non-activated" state, and therefore the indicator shaft 222 is not easily visible. However, in Figure 5B, the indicator assembly 220 has transitioned to a second state or "activated" state, and the indicator shaft 222 extends only a short distance from the drive housing 208 and is easily visible to the operator. The rest of the indicator assembly 220 is housed within the drive housing 208, and various embodiments of the indicator assembly 220 are discussed below.

[0035] As shown in Figure 5A, when the indicator assembly 220 is in a non-activated state, the indicator shaft 222 is substantially or completely receptive within the drive housing 208, thereby concealing the indicator shaft 222 almost or completely from the operator's or user's line of sight. In contrast, as shown in Figure 5B, when the indicator assembly 220 transitions to an activated state, the indicator shaft 222 moves, causing the top or upper end of the indicator shaft 222 to protrude (extend) a short distance from the drive housing 208 through an indicator opening 502 defined in the drive housing 208. When the indicator shaft 222 protrudes from the drive housing 208 through the indicator opening 502, this provides a clear visual indication that the useful life of the surgical tool 200 (Figure 2) has ended, and appropriate action should be taken.

[0036] Figure 6 is an exposed view of the indicator assembly 220 shown in Figures 5A and 5B. The indicator assembly 220 includes a drive input 606, a spring 610, and an indicator shaft 622 further including a visible upper section 624. The drive input 606 is held within a drive housing 608 and is rotatable but restricted in its axial movement. The spring 610 is fixed between the drive housing 608 and the drive input 606 to apply a torsional load to the drive input 606. The torsional load provided by the spring 610 should be large enough to prevent accidental rotation and activation of the indicator assembly 220. It is desirable that the torsional load provided by the spring 610 be large enough to prevent manual activation during handling, cleaning, packaging, or transport, and that only the tool drive can rotate the drive input 606 and thus activate the indicator assembly 220.

[0037] Figure 7 is a separate view of the drive input section 606 of the indicator assembly 220. The drive input section 606 is held within the housing 608 by hooks 631a and 631b. As shown in Figure 10B, the hooks 631a and 631b move along the inner surface of the housing 608, preventing axial movement of the drive input section 606 in one direction while allowing rotation. As shown in Figure 10A, the surface 636 of the drive input section 606 contacts the outer surface of the drive housing 608, preventing axial movement in the opposite direction to that of the hooks 631a and 631b, while still allowing rotation of the drive input section 606. Rotation of the drive input section 606 is achieved by coupling a surface feature 638 with a corresponding feature on the tool drive section. The surface feature 638 transmits rotation from the tool drive section to the drive input section 606. This rotation may be transmitted through a sterile barrier between the surface feature 638 and the corresponding feature on the tool drive section. The drive input unit 606 further includes a central riser 620. As shown in Figure 10A, the central riser 620 may include an opening or passage 621 that accommodates the indicator shaft 622. The passage 621 may have a variable diameter, as will be described in more detail below. The rim 626 of the riser 620 may have a helical path that begins at a vertical surface 627 and ends at a flat portion 628. The indicator shaft 622 moves along the rim 626, as will be described below, and is driven longitudinally along its axis by the rotation of the drive input unit 606 around the same longitudinal axis. The length and pitch of the helical rim may be modified to adjust the timing, distance, or input required to activate the indicator assembly 220.

[0038] Figures 8A and 8B show the indicator shaft 622. The indicator shaft 622 has three main parts: a visible upper section, an intermediate operating section, and a lower lockout section. The visible upper section 624 is visible to the user in the activated state and invisible to the user in the deactivated state. The visible upper section 624 may include or exhibit a color (e.g., red) that is easily visible to the user when it transitions to the activated state. Similarly, the visible upper section 624 may include a light (e.g., a light-emitting diode, or "LED") that is triggered to emit light (glow) when the indicator assembly 220 transitions to the activated state. The intermediate operating section of the indicator shaft 622 may include a drive pin 650 that mates with a rim 626 on the drive input section 606. When the drive input 606 rotates, the drive pin 650 is driven by the rim 626 to raise or lower the indicator shaft 622 along the helical path of the rim 626. The intermediate operating section includes aligned fins to prevent the indicator shaft from rotating. The distal fin 654 and intermediate fins 652a, 652b prevent rotation of the indicator shaft 622, while allowing axial movement along the longitudinal axis. Finally, the lower lockout section of the shaft 622 includes a branch point 645 that generates two lower rims 641a and 641b. Although only two rims are shown, more than two rims are possible. The rims 641a and 641b have symmetrical profiles around the longitudinal axis of the indicator shaft 622. Both rims 641a and 641b have fin-like profiles that start from the branch point 645 and extend downward to about three-quarters of the rim. Fins 647a and 647b have a curved or inclined geometric shape and protrude outward from the longitudinal axis. The protrusions become larger as they move away from the branching point 645. Fins 647a and 647b abruptly end at the terminal points 643a and 643b, forming a step.

[0039] Figures 9A to 9C illustrate a series of indicator shafts 622 driven from a non-started state to an started state by a drive input unit 606. As shown in the non-started state in Figure 9A, the indicator shaft 622 has an initial height H1 and is located inside the passage 621 of the riser 620. The drive pin 650 of the indicator shaft 622 is located on the rim 626 relative to the vertical plane 627. Figure 9B shows an intermediate started state, where the indicator assembly is between the non-started state and the fully started state. The drive input unit 606 is coupled to a tool drive unit that transmits rotational motion to the drive input unit via a surface feature 638. As the drive input unit 606 rotates, the drive pin 650 follows the helical path of the rim 626, causing the indicator shaft to begin rising from the initial height H1 to an intermediate height H2 that is higher than H1. Figure 9C shows the indicator assembly in the fully started state. The drive pin 650 travels along the entire helical path of the rim 626 and is now on the flat portion 628 of the rim 626, raising the indicator shaft 622 to the final fully activated height of H3, which is higher than H2.

[0040] Figure 10A shows a cross-sectional view of the indicator assembly 222 within the drive housing 608. The drive housing 608 includes an upper housing 700 and a top cover 710. While in a non-operating state, the visible upper section 624 of the indicator shaft 622 is held within the top cover 710 and the upper housing 700 and is not visible to the user. The passage 621 on the drive input 606 has an hourglass profile and has a neck portion 660 defined between a small diameter portion and a large diameter portion, the large diameter portion being closer to the surface feature portion 638 and the tool drive portion. In the initial position, the neck portion 660 is in contact with the rims 641a and 641b at fins 647a and 647b, and the termination points 643a and 643b are located within the large diameter portion of the passage 621. As the indicator assembly 222 is activated and the indicator shaft begins to rise from H1 to H3, the fins 647a and 647b begin to move along the neck portion 660, which compresses the rims 641a and 641b toward each other. As seen in Figure 10B, as the terminals 643a and 643b pass through the neck portion 660 and now enter the small diameter portion of the passage 621, the rims 641a and 641b are released and spread outward. At this point, the indicator shaft 622 is fully activated, and the visible upper section 624 is separated from the upper housing 700 and top cover 710 and is now visible to the user. Furthermore, in the fully activated state, the terminals 643a and 643b become flush with the step formed by the neck portion 660 within the small diameter portion of the passage 621, so the indicator shaft 222 cannot return proximal to the housing 608. This serves as a lockout feature, thereby preventing the indicator assembly 222 from proceeding to retract into the drive housing 608 without disassembling the entire drive housing 608 once deployed into the activated state.

[0041] Figure 11 is a top view of an alignment feature that may be used to prevent the indicator shaft 622 from rotating around its longitudinal axis. As the drive input 606 rotates and the guide pin 650 begins to move around the helical path of the rim 626, the indicator shaft 622 should be isolated from and have its rotation suppressed around this longitudinal axis, while still being able to move freely in the longitudinal direction. Therefore, as shown in Figure 13, the alignment plate 720 has a through hole coaxial with the indicator shaft 622, the through hole allowing axial movement of the indicator shaft 622 relative to the alignment plate 720. To facilitate axial alignment and suppress rotation, the indicator shaft 622 may include one or more alignment fins (654, ​​652a, and 652b shown in Figures 8A and 8B) which align fins engage with one or more alignment recesses 754, 752a (hidden) and 752b in the alignment plate 720. When the drive input unit 606 actsuates the indicator shaft 622, the distal fin 654 moves vertically within the recess 754 along its longitudinal axis, and its rotation is suppressed by the recess 754. Similarly, as seen in Figure 12, the intermediate fin 652b moves vertically within the recess 752b, but its rotation is suppressed by the recess 752b. Although only the intermediate fin 652b is shown, the intermediate fin 652a (shown in Figure 8B) also moves within the corresponding recess 752a of the alignment plate 720. Furthermore, although only three alignment features are shown, alternative embodiments may use more or fewer alignment features than three.

[0042] Figure 13 shows the tamper-evident features of one or more embodiments. As previously described, when the indicator assembly 220 is in a non-activated state, the indicator shaft 622 is recessed within the upper housing 700 and top cover 710. However, when the indicator assembly 220 is activated, the visible upper section 624 of the indicator shaft 622 protrudes above the upper housing 700 and top cover 710 and is therefore exposed. Also as described above, the indicator shaft 622 moves freely vertically along its longitudinal axis, although rotation is suppressed. If it moves too far along its longitudinal axis in the direction of protruding outward from the upper housing 700 and top cover 710, it may damage the indicator assembly or surgical tools. Therefore, it is desirable to prevent the indicator shaft 622 from being pulled too far vertically outward from the upper housing 700 and top cover 710. To prevent this excessive vertical movement, the through-hole of the alignment plate 720 has a constriction 722. The intermediate fins 652a and 652b on the indicator shaft 622 have a larger diameter around the longitudinal axis than the rest of the indicator shaft 622. As the indicator shaft 622 advances distally along the longitudinal axis, the larger diameter portion of the indicator shaft 622, including the intermediate fins 652a and 652b, advances accordingly. The intermediate fins 652a and 652b encounter the constriction 722 at the set maximum projection height of the indicator shaft 622. Since the diameter of the indicator shaft 622 around the intermediate fins 652a and 652b is larger than the diameter of the constriction 722, the indicator shaft 622 is prevented from any further axial movement distally.

[0043] The embodiments disclosed herein include the following:

[0044] A surgical tool comprising a drive housing and an indicator assembly located within the drive housing and operable to provide a visual indication that the useful life of the surgical tool has ended. The indicator assembly includes a drive input unit rotatably coupled to the bottom of the drive housing. The drive input unit further includes a riser and a rim, the riser including a passage through which it passes. The indicator assembly further comprises an indicator shaft extending through the passage along a longitudinal axis coaxially aligned with the drive input unit. The drive input unit rotates to actuate the indicator assembly between a non-activated state in which the indicator shaft is recessed into the drive housing and an activated state in which the indicator shaft extends from the drive housing to provide a visual indication.

[0045] B. A method for operating a surgical tool, including determining when the useful life of the surgical tool has ended. The surgical tool includes a drive housing and an indicator assembly located within the drive housing. The indicator assembly includes a drive input rotatably coupled to the bottom of the drive housing, an indicator shaft extending along its longitudinal axis through the drive input, and a coil spring fixed between the housing and the drive input. By rotating the drive input, the indicator assembly is operated between a non-activated state in which the indicator shaft is recessed into the drive housing and an activated state in which the indicator shaft extends from the drive housing to provide a visual indication. Activating the indicator assembly provides a visual indication by the indicator shaft that the useful life of the surgical tool has ended.

[0046] Each of embodiments A and B may have one or more of the following additional elements in any combination: Element 1: The rim forms a helical path. Element 2: The indicator shaft includes a guide pin that follows the helical path, so that the rotation of the drive input acts on the indicator shaft along its longitudinal axis. Element 3: The rim further includes a flat surface and a vertical surface on either side of the helical path. Element 4: The guide pin is adjacent to the vertical surface when the indicator assembly is in a non-activated state and is located on the flat surface when the indicator assembly is in an activated state. Element 5: The indicator assembly further includes a coil spring that extends around the indicator shaft and is operable to accumulate spring force as the guide pin gradually and sequentially engages with the helical path. Element 6: The bottom of the coil spring engages with the drive input, and the top of the coil spring engages with a stationary portion of the drive housing. Element 7: The indicator shaft includes a visible upper section, which is hidden and not visible within the drive housing when the indicator assembly is inactive, and extends beyond the drive housing and is visible when the indicator assembly is inactive. Element 8: The visible upper section is clearly colored, and the color represents the end-of-life state of the tool. Element 9: The visible upper section is illuminated. Element 10: The passage includes a neck portion separating a small diameter portion and a large diameter portion. Element 11: The indicator shaft includes at least two rim bodies, which are contained within the large diameter portion of the passage when the indicator assembly is inactive, and within the small diameter portion of the passage when the indicator assembly is inactive. Element 12: The rim bodies are compressed toward each other by the neck portion of the passage during the transition from the inactive state to the active state. Element 13: When the rim of the indicator shaft enters the small diameter portion of the passage, it is prevented from returning to the large diameter portion of the passage.

[0047] As a non-limiting example, exemplary combinations applicable to A and B include element 1 with element 2, element 2 with element 3, element 3 with element 4, element 4 with element 5, element 5 with element 6, element 6 with element 7, element 7 with element 8, element 8 with element 9, element 10 with element 11, element 11 with element 12, element 12 with element 13, element 14 with element 15, element 15 with element 16, element 17 with element 18, element 17 with element 19, element 15 with element 19, element 19 with element 20, and element 21 with element 22.

[0048] [Implementation Method] (1) Surgical tools, Drive housing and An indicator assembly disposed within the drive housing and operable to provide a visual indication that the useful life of the surgical tool has ended, wherein the indicator assembly is The riser and rim are rotatably coupled to the bottom of the drive housing, and the riser includes a drive input section with a passage through which it passes, The indicator assembly includes an indicator shaft extending through the passage along a longitudinal axis coaxially aligned with the drive input section, A surgical tool wherein the drive input rotates to operate the indicator assembly between a non-activated state in which the indicator shaft is recessed within the drive housing and an activated state in which the indicator shaft extends from the drive housing to provide the visual display. (2) The surgical tool according to Embodiment 1, wherein the rim forms a helical path. (3) The surgical tool according to Embodiment 2, wherein the indicator shaft includes a guide pin that follows the helical path, so that the rotation of the drive input unit causes the indicator shaft to actuate along the longitudinal axis. (4) The surgical tool according to Embodiment 2 or 3, wherein the rim further includes a flat surface and a vertical surface on both sides of the helical path. (5) The surgical tool according to Embodiment 4, wherein the guide pin is adjacent to the vertical surface when the indicator assembly is in a non-activated state and is located on the flat surface when the indicator assembly is in an activated state.

[0049] (6) The indicator assembly A surgical tool according to any one of embodiments 3 to 5, further comprising a coil spring extending around the indicator shaft and operable to accumulate spring force as the guide pin gradually and sequentially engages with the helical path. (7) The surgical tool according to embodiment 6, wherein the bottom of the coil spring engages with the drive input portion and the top of the coil spring engages with the stationary portion of the drive housing. (8) The surgical tool according to any one of embodiments 1 to 7, wherein the indicator shaft includes a visible upper section, the visible upper section being hidden and not visible within the drive housing when in a non-operating state, and extending beyond the drive housing and being visible when in an operating state. (9) The surgical tool according to Embodiment 8, wherein the visible upper section is clearly colored, and the color indicates the end-of-life state of the tool. (10) The surgical tool according to embodiment 8 or 9, wherein the visible upper section is illuminated.

[0050] (11) The surgical tool according to any one of embodiments 1 to 10, wherein the passage includes a neck portion that separates a small diameter portion and a large diameter portion. (12) The surgical tool according to Embodiment 11, wherein the indicator shaft includes at least two rim bodies, the rim bodies being included in the large-diameter portion of the passage when the indicator assembly is in a non-activated state, and included in the small-diameter portion of the passage when the indicator assembly is in an activated state. (13) The surgical tool according to embodiment 12, wherein the rim body is compressed toward each other by the neck portion of the passage while transitioning from the non-activated state to the activated state. (14) The surgical tool according to embodiment 12 or 13, wherein when the rim body of the indicator shaft enters the small-diameter portion of the passage, it is prevented from returning to the large-diameter portion of the passage. (15) A method for operating a surgical tool, Determining that the useful life of the surgical tool has ended, wherein the surgical tool includes a drive housing and an indicator assembly disposed within the drive housing, A drive input unit is rotatably coupled to the bottom of the drive housing, An indicator shaft extending along the longitudinal axis, passing through the drive input section, The system includes a coil spring fixed between the housing and the drive input section, The drive input unit is rotated, thereby causing the indicator assembly to operate between a non-started state in which the indicator shaft is recessed within the drive housing and an started state in which the indicator shaft extends from the drive housing. A method comprising providing a visual indication by the indicator shaft that the useful life of the surgical tool has ended.

[0051] (16) The method according to embodiment 15, wherein the rim forms a helical path. (17) The method according to embodiment 16, wherein the indicator shaft includes a guide pin that follows the helical path, so that the rotation of the drive input unit causes the indicator shaft to actuate along the longitudinal axis. (18) The method according to embodiment 16 or 17, wherein the rim further includes a flat surface and a vertical surface on both sides of the helical path. (19) The method according to Embodiment 18, wherein the guide pin is adjacent to the vertical surface when the indicator assembly is in a non-activated state and is located on the flat surface when the indicator assembly is in an activated state. (20) The method according to any one of embodiments 15 to 19, wherein the drive input is rotatably coupled to the bottom of the drive housing by a riser and a rim, the riser includes a passage through which it passes, the indicator shaft extends through the passage along the longitudinal axis aligned coaxially with the drive input, and the passage includes a neck portion separating a small diameter portion and a large diameter portion.

[0052] (21) The method according to Embodiment 20, wherein the indicator shaft includes at least two rim bodies, the rim bodies being included in the large-diameter portion of the passage when the indicator assembly is in a non-activated state, and included in the small-diameter portion of the passage when the indicator assembly is in an activated state. (22) The method according to embodiment 21, wherein the rim body is compressed toward each other by the neck portion of the passage while transitioning from the non-started state to the started state. (23) The method according to embodiment 21 or 22, wherein when the rim body of the indicator shaft enters the small diameter portion of the passage, it is prevented from returning to the large diameter portion of the passage.

Claims

1. It is a surgical tool, Drive housing and An indicator assembly disposed within the drive housing and operable to provide a visual indication that the useful life of the surgical tool has ended, wherein the indicator assembly is The riser and rim are rotatably coupled to the bottom of the drive housing, and the riser includes a drive input section with a passage through which it passes, The indicator assembly includes an indicator shaft extending through the passage along a longitudinal axis coaxially aligned with the drive input section, A surgical tool wherein the drive input rotates to operate the indicator assembly between a non-activated state in which the indicator shaft is recessed within the drive housing and an activated state in which the indicator shaft extends from the drive housing to provide the visual display.

2. The surgical tool according to claim 1, wherein the rim forms a spiral path.

3. The surgical tool according to claim 2, wherein the indicator shaft includes a guide pin that follows the helical path, so that the rotation of the drive input unit causes the indicator shaft to move along the longitudinal axis.

4. The surgical tool according to claim 2 or 3, wherein the rim further includes a flat surface and a vertical surface on both sides of the helical path.

5. The surgical tool according to claim 4, wherein the guide pin is adjacent to the vertical surface when the indicator assembly is in a non-activated state and is located on the flat surface when the indicator assembly is in an activated state.

6. The indicator assembly, The surgical tool according to claim 3, further comprising a coil spring extending around the indicator shaft and operable to accumulate spring force as the guide pin gradually and sequentially engages with the helical path.

7. The surgical tool according to claim 6, wherein the bottom of the coil spring engages with the drive input portion, and the top of the coil spring engages with the stationary portion of the drive housing.

8. The surgical tool according to claim 1, wherein the indicator shaft includes a visible upper section, the visible upper section being hidden and not visible within the drive housing when in a non-operating state, and extending beyond the drive housing and being visible when in an operating state.

9. The surgical tool according to claim 8, wherein the visible upper section is clearly colored, and the color indicates the end-of-life state of the tool.

10. The surgical tool according to claim 8 or 9, wherein the visible upper section is illuminated.

11. The surgical tool according to claim 1, wherein the passage includes a neck portion that separates a small diameter portion and a large diameter portion.

12. The surgical tool according to claim 11, wherein the indicator shaft includes at least two rim bodies, the rim bodies being included in the large-diameter portion of the passage when the indicator assembly is in a non-activated state, and included in the small-diameter portion of the passage when the indicator assembly is in an activated state.

13. The surgical tool according to claim 12, wherein the rim body is compressed toward each other by the neck portion of the passage while transitioning from the non-activated state to the activated state.

14. The surgical tool according to claim 12 or 13, wherein when the rim body of the indicator shaft enters the small-diameter portion of the passage, it is prevented from returning to the large-diameter portion of the passage.

15. A method for operating surgical tools, Determining that the useful life of the surgical tool has ended, wherein the surgical tool includes a drive housing and an indicator assembly disposed within the drive housing, A drive input unit is rotatably coupled to the bottom of the drive housing, An indicator shaft extending along the longitudinal axis, passing through the drive input section, The system includes a coil spring fixed between the housing and the drive input section, The drive input unit is rotated, thereby causing the indicator assembly to operate between a non-started state in which the indicator shaft is recessed within the drive housing and an started state in which the indicator shaft extends from the drive housing. A method comprising providing a visual indication by the indicator shaft that the useful life of the surgical tool has ended.

16. The method according to claim 15, wherein the rim forms a helical path.

17. The method according to claim 16, wherein the indicator shaft includes a guide pin that follows the helical path, so that the rotation of the drive input unit causes the indicator shaft to actuate along the longitudinal axis.

18. The method according to claim 16 or 17, wherein the rim further includes a flat surface and a vertical surface on both sides of the helical path.

19. The method according to claim 18, wherein the guide pin is adjacent to the vertical surface when the indicator assembly is in a non-activated state and is located on the flat surface when the indicator assembly is in an activated state.

20. The method according to claim 15, wherein the drive input is rotatably coupled to the bottom of the drive housing by a riser and a rim, the riser includes a passage through which it passes, the indicator shaft extends through the passage along the longitudinal axis aligned coaxially with the drive input, and the passage includes a neck portion separating a small diameter portion and a large diameter portion.

21. The method according to claim 20, wherein the indicator shaft includes at least two rim bodies, the rim bodies being included in the large-diameter portion of the passage when the indicator assembly is in a non-activated state, and included in the small-diameter portion of the passage when the indicator assembly is in an activated state.

22. The method according to claim 21, wherein the rim body is compressed toward each other by the neck portion of the passage while transitioning from the non-started state to the started state.

23. The method according to claim 21 or 22, wherein when the rim body of the indicator shaft enters the small-diameter portion of the passage, it is prevented from returning to the large-diameter portion of the passage.

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