End of life indicator for robotic surgical instrument

Abstract

A surgical tool includes a drive housing, an indicator assembly disposed within the drive housing and actuatable to provide a visual indication that the surgical tool has depleted its useful life. The indicator assembly includes a drive input rotatably coupled to a bottom of the drive housing. The drive input also includes a riser and an edge, where the riser includes a channel therethrough. The indicator assembly also includes an indicator shaft extending through the channel along a longitudinal axis coaxially aligned with the drive input. The drive input is rotated to actuate the indicator assembly between an inactive state in which the indicator shaft is recessed into the drive housing and an active state in which the indicator shaft extends out of the drive housing to provide a visual indication.

Description

priority

[0001] This application claims priority and interest in U.S. Provisional Application No. 63 / 528,218, filed July 21, 2023. Background Technology

[0002] Minimally invasive surgical (MIS) instruments are generally superior to traditional open surgical devices due to reduced postoperative recovery time and minimized scarring. During MIS procedures, a variety of instruments and surgical tools can be introduced into the abdominal cavity to engage and / or manipulate tissue in various ways to achieve diagnostic or therapeutic effects. Recently, various robotic systems have been developed to assist MIS procedures by controlling such MIS instruments. Users (e.g., surgeons) can remotely operate the end effectors of the MIS instruments by grasping and manipulating one or more controllers of the robotic system in space, which are connected to tool actuators coupled to the surgical instruments. User input is processed by a computer system integrated into the robotic surgical system, and the tool actuators respond via a motion system driven by actuation cables (and more specifically, drive cables). Moving the drive cables moves the end effector joints to the desired position and configuration.

[0003] MIS instruments have a limited lifespan. For example, some MIS instruments are designed to fail after a predetermined number of uses or after a set period of time. In some cases, MIS instruments may include indicators that provide indication when the instrument's lifespan has expired. Conventional instrument indicators are mechanically powered by a tool drive within the tool actuator of the MIS instrument, which inevitably reduces the overall functionality of the MIS instrument, as such a tool drive could otherwise be used for other tool functions. Furthermore, conventional instrument indicators are not easily identifiable, so sterilization workers often fail to notice expired MIS instruments, even though they have passed their expiration date, and they are unknowingly cleaned, sterilized, stored, and subsequently sent to the operating room. Once discovered in the operating room, personnel will be required to discard the MIS instrument and obtain a replacement. This leads to patient frustration, surgical delays, and potentially additional sedation time. Therefore, providing indicators that do not utilize tool drives and are more easily identifiable can be beneficial. Attached Figure Description

[0004] The following figures are included to illustrate certain aspects of this disclosure and should not be considered as exclusive embodiments. The subject matter disclosed in this invention is capable of numerous modifications, alterations, combinations, and equivalents in form and function.

[0005] Figure 1 This is a block diagram of an example robotic surgical system that can incorporate some or all of the principles of this disclosure.

[0006] Figure 2 It is an isometric side view of an example surgical tool that can be incorporated into some or all of the principles of this disclosure.

[0007] Figure 3 It shows that Figure 2 The wrist of a surgical instrument has the potential degrees of freedom for joint movement (pivot) and translation.

[0008] Figure 4 It is based on one or more implementation schemes. Figure 2 Bottom view of the drive housing.

[0009] Figure 5A and Figure 5B It is based on one or more implementation schemes. Figure 2 Isometric view of the drive housing.

[0010] Figure 6 It is an exposed view of the interior of the drive housing according to one or more implementation schemes.

[0011] Figure 7 It is a separate view of the drive input that incorporates some or all of the principles of this disclosure.

[0012] Figure 8A It is a separate view of the indicator axis that can incorporate some or all of the principles of this disclosure.

[0013] Figure 8B It can be combined with some or all of the principles of this disclosure. Figure 8A A separate view of the indicator axis rotated 90 degrees.

[0014] Figures 9A-9C yes Figure 6 A sequential view of the indicator component from inactive to active states.

[0015] Figure 10A and Figure 10B It is a sequential cross-section of an indicator component in an inactive and active state, which can be incorporated into some or all of the principles of this disclosure.

[0016] Figure 11 It is a separate top view of the indicator axis aligned within the drive housing, which can be incorporated into some or all of the principles of this disclosure.

[0017] Figure 12 It is a cross-section of an indicator shaft that can incorporate some or all of the principles of this disclosure.

[0018] Figure 13 It is a separate view of the indicator shaft aligned within the drive housing, which can be incorporated into some or all of the principles of this disclosure. Detailed Implementation

[0019] This disclosure relates to robotic surgical systems, and more specifically to tool life indicators for surgical instruments.

[0020] The embodiments discussed herein describe a surgical tool that provides a visual indication to a user, operator, or technician when the tool's service life has been exhausted. The surgical tool may include a drive housing defining an indicator aperture, a drive input rotatably coupled to the bottom of the drive housing, and an indicator assembly disposed within the drive housing and actuable to provide a visual indication that the surgical tool has exhausted its service life. The indicator assembly may include a helical spring operatively coupled to the drive input such that rotation of the drive input correspondingly torsional of the helical spring; and an indicator shaft extending from an indicator mount along a longitudinal axis coaxially aligned with the indicator aperture. The indicator shaft can be raised or lowered via the drive input to actuate the indicator assembly between an inactive and an active state. In the inactive state, the indicator shaft is recessed into the indicator aperture; in the active state, the indicator shaft extends through the indicator aperture out of the drive housing to provide a visual indication.

[0021] Figure 1 This is a block diagram of an example robotic surgical system 100 that incorporates some or all of the principles of this disclosure. As shown, system 100 may include at least one set of user input controllers 102a and at least one control computer 104. Control computer 104 may be mechanically and / or electrically coupled to a robotic manipulator, and more specifically to one or more robotic arms 106 (alternatively referred to as “tool drivers”). In some embodiments, the robotic manipulator may be included in or otherwise mounted to an arm carriage that enables system portability. Each robotic arm 106 may include and otherwise provide a location for mounting one or more surgical instruments or tools 108 to perform various surgical tasks on patient 110. Operation of the robotic arms 106 and associated tools 108 may be guided by a clinician 112a (e.g., a surgeon) from user input controllers 102a.

[0022] In some embodiments, a second clinician 112b may operate a second set of user input controllers 102b (shown in dashed lines) to guide the operation of the robotic arm 106 and tool 108 via a control computer 104, together with the first clinician 112a. In such embodiments, for example, each clinician 112a, 112b may control a different robotic arm 106, or in some cases, full control of the robotic arm 106 may be transferred between clinicians 112a, 112b as needed. In some embodiments, additional robotic manipulators with additional robotic arms may be used on the patient 110 during surgery, and these additional robotic arms may be controlled by one or more of the user input controllers 102a, 102b.

[0023] The control computer 104 and user input controllers 102a and 102b can communicate with each other via a communication link 114, which can be any type of wired or wireless communication component configured to carry various communication signals (e.g., electrical signals, optical signals, infrared signals, etc.) according to any communication protocol. In some applications, for example, there is a tower with auxiliary equipment and a processing core designed to drive the robotic arm 106.

[0024] User input controllers 102a, 102b typically include one or more physical controllers that can be grasped by clinicians 112a, 112b and manipulated in space by surgeons while observing surgery via a stereoscopic display. The physical controllers typically include manual input devices capable of movement in multiple degrees of freedom and typically include actuable handles for actuating surgical instruments 108, such as for opening and closing opposing jaws, applying a potential (current) to electrodes, etc. Control computer 104 may also include optional feedback meters that can be viewed by clinicians 112a, 112b via a display to provide visual indications of various surgical instrument measurements, such as the magnitude of the force applied to the surgical instruments (i.e., cutting instruments or dynamic clamping members).

[0025] Figure 2 This is an isometric side view of an example surgical tool 200 that can be incorporated into some or all of the principles of this disclosure. The surgical tool 200 can be used with... Figure 1 The surgical tools 108 are the same as or similar to those used in robotic surgical systems (such as...). Figure 1 The surgical tool 200 is used in conjunction with the robotic surgical system 100. Therefore, the surgical tool 200 can be designed to be releasably coupled to a tool actuator included in the robotic surgical system 100. However, in other embodiments, aspects of the surgical tool 200 may be adapted for manual or hand-operated use without departing from the scope of this disclosure.

[0026] As shown in the figure, the surgical tool 200 includes an elongated shaft 202, an end effector 204, a wrist 206 (alternatively referred to as a "wrist joint" or "wrist joint capable of joint movement") 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 surgical tools and robotic surgical systems (e.g., Figure 1 In applications where the robotic surgical system 100 is used in conjunction with the robotic surgical system, the drive housing 208 may include a coupling feature that releasably couples the surgical tool 200 to the robotic surgical system.

[0027] The terms "proximal" and "distal" are defined herein with respect to a robotic surgical system having an interface configured to mechanically and electrically connect surgical tools 200 (e.g., housing 208) to a robotic manipulator. The term "proximal" refers to a location of an element closer to the robotic manipulator, and the term "distal" refers to a location of an element closer to the end effector 204 and therefore further away from the robotic manipulator. Alternatively, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein with respect to a user such as a surgeon or clinician. The term "proximal" refers to a location of an element closer to the user, and the term "distal" refers to a location of an element closer to the end effector 204 and therefore further away from the user. Furthermore, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used with respect to exemplary embodiments as they are shown in the figures, with upward or upper directions pointing towards the top of the corresponding figure, and downward or lower directions pointing towards the bottom of the corresponding figure.

[0028] During use of the surgical tool 200, the end effector 204 is configured to be movable (pivoted) at the wrist 206 relative to the axis 202 to position the end effector 204 at a desired orientation and location relative to the surgical site. To achieve this, the housing 208 includes various drive inputs and mechanisms (e.g., gears, actuators, etc.) designed to control the operation of various features associated with the end effector 204 (e.g., clamping, firing, cutting, rotation, articulation, etc.). In at least some applications, the axis 202 and thus the end effector 204 coupled thereto are configured to rotate about a longitudinal axis A1 of the axis 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 axis 202 about the longitudinal axis A1.

[0029] Shaft 202 is an elongated member extending distally from housing 208 and has at least one lumen extending through it along its axial length. In some embodiments, shaft 202 may be fixed to housing 208, but may alternatively be rotatably mounted to housing 208 to allow shaft 202 to rotate about longitudinal axis A1. In other embodiments, shaft 202 may be releasably coupled to housing 208, which allows a single housing 208 to be adapted to various shafts with different end actuators.

[0030] The end effector 204 can exhibit a variety of sizes, shapes, and configurations. In an illustrated embodiment, the end effector 204 includes a combined tissue gripper and vascular sealer comprising opposing first (upper) jaws 210 and second (lower) jaws 212, which are configured to move (articularly) between an open and a closed position. However, as will be understood, the opposing jaws 210, 212 may alternatively form part of other types of end effectors, such as, but not limited to, surgical scissors, applicators, needle actuators, babcock forceps including a pair of opposing gripping jaws, bipolar jaws (e.g., bipolar Maryland grippers, clamps, perforated grippers, etc.). One or both of the jaws 210, 212 may be configured to pivot to allow articulation of the end effector 204 between an open and a closed position. In other embodiments, the end effector 204 may not include opposing jaws, but may instead include other types of surgical end effectors, such as suture devices, cauterizers, suction tools, irrigation tools, etc.

[0031] Figure 3 The potential degrees of freedom of the wrist 206 to perform joint movements (pivots) and thus move the end effector 204 are shown. The wrist 206 can have any of a variety of configurations. Generally, the wrist 206 includes a joint configured to allow pivotal movement of the end effector 204 relative to axis 202. The degrees of freedom of the wrist 206 are represented by three translational variables (i.e., sway, roll, and heave) and 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 coordinate system frame. Figure 3 As shown, "swaying" refers to translational motion forward and backward, "swaying" refers to translational motion up and down, and "swaying" refers to translational motion left and right. Regarding rotational terms, "rolling" refers to tilting left and right, "swaying" refers to tilting forward and backward, and "rolling" refers to turning left and right.

[0032] Pivoting motion can include a pitching motion about a first axis (e.g., the X-axis) of the wrist 206, a yaw motion about a second axis (e.g., the Y-axis) of the wrist 206, and combinations thereof, such that the end effector 204 rotates 360° about the wrist 206. In other applications, pivoting motion may be limited to movement in a single plane, such as a pitching motion only about the first axis of the wrist 206 or a yaw motion only about the second axis of the wrist 206, such that the end effector 204 moves only in a single plane.

[0033] See you again Figure 2 The surgical tool 200 may also include multiple drive cables forming part of a cable-driven motion system (in Figure 2 (The system is shielded), and the cable-driven motion system is configured to facilitate actuation and articulation of the end effector 204 relative to the shaft 202. Moving one or more of the drive cables (performing articulation) causes the end effector 204 to move between a non-articulated position and an articulated position. The end effector 204 in... Figure 2 The image is shown in a non-jointed position, in which the longitudinal axis A2 of the end effector 204 is substantially aligned with the longitudinal axis A1 of the shaft 202, such that the end effector 204 forms a substantially zero angle with respect to the shaft 202. Due to factors such as manufacturing tolerances and the precision of the measuring devices, the end effector 204 may not form a precisely zero angle with respect to the shaft 202 in the non-jointed position, but it is still considered to be "substantially aligned" with it. In the jointed position, the longitudinal axes A1 and A2 will be offset at an angle to each other, such that the end effector 204 forms a non-zero angle with respect to the shaft 202.

[0034] In some embodiments, the surgical instrument 200 may be powered (current-powered) via a power cable 214 coupled to the housing 208. In other embodiments, the power cable 214 may be omitted, and power may be supplied to the surgical instrument 200 via an internal power source, such as one or more batteries, capacitors, or fuel cells. In such embodiments, the surgical instrument 200 may alternatively be characterized as, and in other words, referred to as, an “electrosurgery instrument” capable of supplying electrical power to the end effector 204.

[0035] Power cable 214 can position surgical instrument 200 in electrical communication with 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 surgical instrument 200 and more specifically to end effector 204. Therefore, generator 216 may include a radio frequency (RF) source, an ultrasonic source, a DC power supply, and / or any other suitable type of electrical energy source that can be activated independently or simultaneously.

[0036] In applications where the surgical tool 200 is configured for bipolar manipulation, the power cable 214 will include a power supply conductor and a return conductor. Current can be supplied from generator 216 to the active (or source) electrode located at end effector 204 via the power supply conductor, and current can flow back to generator 216 via the return conductor through the return electrode located at end effector 204. In the case of a bipolar gripper with opposing jaws, for example, the jaws serve as electrodes in which the proximal ends of the jaws are isolated from each other and the inner surfaces of the jaws (i.e., the areas where the jaws grasp tissue) apply current through the tissue in a controlled path. In applications where the surgical tool 200 is configured for unipolar manipulation, generator 216 transmits current through the power supply conductor to the active electrode located at end effector 204, and the current returns (dissipates) via a return electrode (e.g., a grounding pad) separately coupled to the patient's body.

[0037] The surgical tool 200 may also include a manual release switch 218, which can be manually actuated by a user (e.g., a surgeon) to drive the system via a control cable, thereby manually performing joint movements or manipulating the end effector 204. 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 is operable normally. However, when the release switch 218 moves to the engaged position, various internal components of the drive housing 208 move simultaneously, thereby opening the jaws 210, 212, which may prove advantageous for various reasons. In some applications, for example, the release switch 218 can move in the event of an electrical interruption that would render the surgical tool 200 inoperable. In such applications, the user would be able to manually open the jaws 210, 212, thereby releasing any grasped tissue and removing the surgical tool 200. In other applications, release switch 218 can be actuated (enabled) to open jaws 210, 212, thereby preparing surgical instrument 200 for cleaning and / or sterilization.

[0038] According to embodiments of this disclosure, the surgical tool 200 may further include a tool life end indicator component 220, which can be automatically activated (triggered) to provide a visual indication that the surgical tool 200 has reached the end of its service life and / or that its recommended service life has expired. The tool life end indicator component 220 may alternatively be referred to herein as "indicator component 220". Upon activation of the indicator component 220, the user is visually notified that the surgical tool 200 has reached the end of its service life and should not be cleaned for reuse, but rather should be discontinued (e.g., discarded).

[0039] In some examples, the surgical tool 200 may include a single tool life end indicator component 220. In other examples, the surgical tool 200 may include multiple tool life end indicator components 220, wherein the first is activated after the first use, the second after the second use, and so on; and the activation of all multiple tool life end indicator components 220 indicates that the surgical tool 200 has reached its end of life. In at least one embodiment, the tool life end indicator component 220 provides a visual indication that the surgical tool 200 has a certain amount of remaining life (or number of uses or hours of use).

[0040] Various metrics can be implemented to measure the lifespan of the surgical tool 200. For example, "lifespan" can be determined by the number of surgeries performed using the surgical tool 200 (e.g., twenty surgeries). In such embodiments, the indicator component 220 can be activated to visually notify the user once the number of uses of the surgical tool 200 reaches a predetermined threshold. Alternatively, "lifespan" can be determined by the number of hours the surgical tool 200 has been used, the number of joint movements or motions performed by the surgical tool 200, or any combination thereof. The indicator component 220 can provide a visually perceptible indication that the surgical tool 200 has exhausted its lifespan or has expired, and / or that the surgical tool 200 has a certain amount of remaining lifespan (e.g., number of uses, hours of use, etc.).

[0041] As described in more detail below, the tool life end indicator assembly 220 may include a mechanically actuated indicator button or shaft 222 that becomes visible (exposed) once the lifespan of the surgical tool 200 has been exhausted or reached. 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 visually notice the indicator shaft 222. During normal operation of the surgical tool 200, and before reaching a predetermined lifespan threshold, the indicator shaft 222 may be recessed into the drive housing 208 and, in other words, invisible. However, once it is determined that the lifespan of the surgical tool 200 has been exhausted, the indicator assembly 220 may be actuated (activated), causing the indicator shaft 222 to extend (protrude) a short distance from the drive housing 208 to provide a visual indication to the user. The indicator assembly 220 in Figure 2 As shown in the figure, the indicator axis 222 is in the active state.

[0042] Figure 4This 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 for operatively coupling the drive housing 208 to a tool driver of a robot manipulator. The tool mounting portion 402 may releasably couple the drive housing 208 to the tool driver in various ways, such as by clamping to, clipping to, or slidably engaging with the tool driver. In some embodiments, the tool mounting portion 402 may include an array of electrical connection pins that can be coupled to electrical connections on a mounting surface of the tool driver. Although the tool mounting portion 402 is described herein with respect to mechanical, electrical, and magnetic coupling elements, it should be understood that various forms of telemetry may be used, including infrared, inductive coupling, etc.

[0043] Tool mounting section 402 includes and otherwise provides an interface 404 configured to mechanically, magnetically, and / or electrically connect drive housing 208 to the tool driver. As shown, interface 404 includes and supports a plurality of drive inputs, shown as drive inputs 406a, 406b, 406c, 406d, 406e, and 406f. Each drive input 406a-406f includes a rotatable disk configured to align and engage with a corresponding actuator or "drive output" of the tool driver, such that a corresponding drive input among the rotary (actuated) drive inputs 406a-406f of a given drive output is provided. Each drive input 406a-406f may provide or define one or more surface features 408 configured to align with mating surface features disposed on a corresponding drive output. Surface features 408 may include, for example, various protrusions and / or recesses that facilitate mating engagement. In some embodiments, some or all of the drive inputs 406a-406f may include a surface feature 408 positioned closer to the axis of rotation of the associated drive input 406a-406f than other surface features 408. This can help ensure positive angular alignment of each drive input 406a-406f.

[0044] Actuation of the first drive input 406a can be configured to control the tool life end indicator assembly 220. Figure 2 The actuation of the surgical instrument 200. In some embodiments, actuating the first drive input 406a can control not only the actuation of the indicator assembly 220, as described below, but also the actuation of the surgical instrument 200. Figure 2 Another feature or operation of the actuation. However, in other embodiments, without departing from the scope of this disclosure, actuating the first drive input 406a may only control the actuation of the indicator assembly 220.

[0045] The actuation of the second drive input 406b can be configured to control the rotation of shaft 202 about its longitudinal axis A1. Shaft 202 can rotate clockwise or counterclockwise according to the rotational actuation of the second drive input 406b. In some embodiments, the actuation of the second, third, fourth, and fifth drive inputs (406b-406e) can be configured to operate the movement (axial translation) of the drive cable forming part of the cable-driven motion system, which realizes the wrist 106 ( Figure 4 Actuation and / or end effector 204 ( Figure 4 The joint movements (operations) of the tool. In some embodiments, the actuation of the sixth drive input 406f can be configured to advance and retract the drive rod, thereby correspondingly advancing or retracting the tool at the end effector 204. Each of the drive inputs 406a-406f can be actuated based on user input transmitted to the tool driver coupled to the interface 404, and the user input can be received via a computer system integrated into the robotic surgical system.

[0046] The drive housing 208 can accommodate and store surgical tools 200. Figure 2 Electronic devices that provide unique identification data. When the drive housing 208 is mounted onto the robotic surgical system 100 ( Figure 1 When operating a surgical tool 200, system 100 may be able to identify the type of tool and / or the specific tool used in a particular operation based on unique identification data. Furthermore, the electronics of the surgical tool 200 may store the lifespan of the surgical tool 200 (e.g., usage count), and the lifespan of the surgical tool 200 may be determined by logic stored on one or more components of the robotic surgical system 100. Additionally, the surgical system 100 may store information associated with a specific surgical tool 200, and then access and utilize the stored information when it recognizes that a specific surgical tool 200 is being used. For example, the robotic surgical system 100 may recognize that a surgical tool 200 has been installed in a robotic manipulator and then access its previously calculated remaining lifespan, such that the lifespan of such available tools can be updated as needed after a specific operation using the surgical tool 200.

[0047] Surgical tools 200 ( Figure 2 ) can be used with robotic surgical system 100 ( Figure 1Wireless communication. Specifically, the robotic surgical system 100 may utilize the NFC protocol to identify or authenticate the surgical tool 200 or associate the surgical tool 200 with stored data associated with it. 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) for storing and processing information and modulating and demodulating signals (i.e., radio frequency or "RF" signals) and an antenna for receiving and transmitting signals. The tag may include a battery and periodically self-activate to transmit signals, or it may include a battery but activate to transmit signals when a robotic manipulator (or other reader device) is present, or it may not include a battery and activate to transmit signals when excited by a robotic manipulator (or other reader device). The tag may be read-only, having assigned information on it, or it may be read / write, where information can be written to the tag once or multiple times. In these examples, the robotic manipulator (or reader device) sends coded radio signals to query the tag within the surgical tool 200. The tag receives coded wireless signals and responds by sending identification data and / or other information (e.g., serial number, usage count, usage time, manufacturing date, expiration date, etc.) stored in an integrated circuit to the robotic manipulator, making it analyzable by the robotic surgical system 100. Therefore, the robotic surgical system 100 is able to distinguish various surgical tools because the tag for each surgical tool will include unique identification data.

[0048] Figure 5A and Figure 5B It is an isometric view of the drive housing 208 according to one or more embodiments. Figures 5A to 5B An example actuation of the tool life end indicator assembly 220, including an indicator shaft 222, is also depicted. Figure 5A In this state, the indicator assembly 220 is in a first or "inactive" state, so the indicator axis 222 is not easily perceived. However, in Figure 5B In this state, indicator assembly 220 transitions to a second or "active" state, and indicator shaft 222 extends a short distance beyond drive housing 208 and is easily perceived by the operator. The remainder of indicator assembly 220 is housed within drive housing 208, and various embodiments of indicator assembly 220 will be discussed below.

[0049] When the indicator component 220 is in an inactive state, such as Figure 5A As shown, the indicator shaft 222 is substantially or completely housed within the drive housing 208, such that the indicator shaft 222 is mostly or completely obscured from the operator's or user's perspective. Conversely, when the indicator assembly 220 is switched to the active state, as... Figure 5BAs shown, the indicator shaft 222 moves such that the top or upper end of the indicator shaft 222 protrudes (extends) a short distance from the drive housing 208 via an indicator hole 502 defined in the drive housing 208. When the indicator shaft 222 protrudes from the drive housing 208 via the indicator hole 502, this provides the surgical tool 200 ( Figure 2 There is a definite visual indication that its service life has been exhausted, and appropriate measures should be taken.

[0050] Figure 6 yes Figure 5A and Figure 5B The diagram shows an exposed view of the indicator assembly 220. The indicator assembly 220 includes a drive input 606, a spring 610, and an indicator shaft 622, which further includes a visible upper section 624. The drive input 606 is held within a drive housing 608 and its axial movement is restricted while being allowed to rotate. The spring 610 is anchored 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 at least high enough to prevent accidental rotation and activation of the indicator assembly 220. Ideally, the torsional load provided by the spring 610 should be high enough to prevent manual actuation from handling, cleaning, packaging, or transport, and only the tool driver should be able to rotate the drive input 606 to activate the indicator assembly 220.

[0051] Figure 7 This is a separate view of the drive input 606 of the indicator assembly 220. The drive input 606 is held in the housing 608 by hooks 631a and 631b. Figure 10B As shown, hooks 631a and 631b straddle the inner surface of the housing 608 and prevent axial movement of the drive input 606 in one direction while allowing rotation. Figure 10A As can be seen, the surface 636 of the drive input 606 contacts the outer surface of the drive housing 608, preventing axial movement in the direction opposite to hooks 631a and 631b, while still allowing rotation of the drive input 606. Rotation of the drive input 606 is achieved through the engagement of the surface feature 638 with a corresponding feature on the tool driver. The surface feature 638 transmits rotation from the tool driver to the drive input 606. This rotation can be transmitted through a sterile barrier between the surface feature 638 and the corresponding feature on the tool driver. The drive input 606 also includes a central riser 620. Figure 10AAs shown, the central riser 620 may include an opening or channel 621 for receiving the indicator shaft 622. The diameter of the channel 621 may vary, as described in further detail below. The edge 626 of the riser 620 may have a helical path that begins at the vertical surface 627 and ends at the flat portion 628. The indicator shaft 622 travels along the edge 626 and is longitudinally driven along its axis by rotation of the drive input 606 about the same longitudinal axis, as described below. The length and pitch of the helical edge can be varied to adjust the timing, distance, or input required to activate the indicator assembly 220.

[0052] Figure 8A and Figure 8B An indicator shaft 622 is shown. The indicator shaft 622 has three main sections: a visible upper section, a middle actuation section, and a lower locking section. The visible upper section 624 is visible to the user in the active state or invisible to the user in the inactive state. The visible upper section 624 may include or display a color (e.g., red) that the user can easily perceive when transitioning to the active 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 (flashing) when the indicator assembly 220 transitions to the active state. The middle actuation section of the indicator shaft 622 may include a drive pin 650 that engages with an edge 626 on the drive input 606. When the drive input 606 rotates, the drive pin 650 is driven by the edge 626, causing the indicator shaft 622 to rise or fall along a helical path of the edge 626. To prevent rotation of the indicator shaft, the middle actuation section includes alignment fins. The distal fin 654 and the inner fins 652a and 652b prevent rotation of the indicator shaft 622 while allowing axial movement along the longitudinal axis. Finally, the lower locking section of the shaft 622 contains a bifurcation point 645, which generates two lower branches 641a and 641b. Although only two branches are shown, multiple branches of two or more are possible. Branches 641a and 641b have a profile symmetrical about the longitudinal axis of the indicator shaft 622. Both branches 641a and 641b have a fin-like profile that begins at the bifurcation point 645 and extends downward along the branch for approximately three-quarters of the distance. Fins 647a and 647b have a curved or inclined geometry and protrude from the longitudinal axis. The protrusions become larger with distance from the bifurcation point 645. Fins 647a and 647b terminate abruptly at termination points 643a and 643b, forming steps.

[0053] Figures 9A to 9C This illustrates the sequence in which the indicator axis 622 is driven from an inactive state to an active state by the driven input 606. (As shown...) Figure 9AAs shown in the inactive state, the indicator shaft 622 has an initial height H1 and resides within the channel 621 of the riser 620. The drive pin 650 of the indicator shaft 622 rests against the vertical surface 627 on the edge 626. Figure 9B An intermediate activation state is shown, where the indicator assembly is between an inactive state and a fully activated state. A drive input 606 is coupled to a tool driver that transmits rotational motion to the drive input via a surface feature 638. As the drive input 606 rotates, the drive pin 650 follows a helical path along edge 626 and begins to raise the indicator shaft from an initial height H1 to an intermediate height H2 above H1. Figure 9C The indicator assembly in a fully activated state is shown. The drive pin 650 has traveled across the entire spiral path of edge 626 and is now located on the flat portion 628 of edge 626, which has raised the indicator shaft 622 to a final fully activated height H3 greater than H2.

[0054] Figure 10A A cross-sectional view of the indicator assembly 222 within the drive housing 608 is shown. The drive housing 608 includes an upper housing 700 and a top cover 710. When inactive, the visible upper section 624 of the indicator shaft 622 remains within the top cover 710 and the upper housing 700 and is not visible to the user. The channel 621 on the drive input 606 has an hourglass profile with a defined neck portion 660 between a smaller diameter portion and a larger diameter portion, wherein the larger diameter portion is closer to the surface feature 638 and the tool driver. In the initial position, the neck portion 660 contacts branches 641a and 641b at fins 647a and 647b, and the termination points 643a and 643b are located within the larger diameter portion of the channel 621. When indicator assembly 222 is activated and indicator shaft begins to rise from H1 to H3, fins 647a and 647b begin to travel along neck portion 660, which compresses branches 641a and 641b toward each other. Figure 10B As can be seen, once the termination points 643a and 643b have passed through the neck portion 660 and are now located within the smaller diameter portion of the channel 621, the branches 641a and 641b are released and expand outward. At this time, the indicator shaft 622 is fully activated, and the visible upper section 624 has been exposed from the upper housing 700 and the top cover 710, and is now visible to the user. Furthermore, in the fully activated state, the indicator shaft 222 cannot move proximally back into the housing 608 because the termination points 643a and 643b are flush with the step formed by the neck portion 660 within the smaller diameter portion of the channel 621. This serves as a locking feature, preventing the indicator assembly 222 from being pushed back into the drive housing 608 without disassembling the entire drive housing 608 once deployed in the activated state.

[0055] Figure 11 This is a top view of the alignment feature that can be used to prevent the indicator shaft 622 from rotating about its longitudinal axis. When the drive input 606 rotates and the guide pin 650 begins to travel along the helical path of the edge 626, the indicator shaft 622 should be isolated and restricted from such rotation about the longitudinal axis, but still able to travel freely longitudinally. Therefore, as Figure 13 As shown, the alignment plate 720 has a through-hole coaxial with the indicator shaft 622, which allows axial movement of the indicator shaft 622 relative to the alignment plate 720. For ease of axial alignment and rotational limitation, the indicator shaft 622 may include one or more alignment fins. Figure 8A and Figure 8B As shown in Figures 654, 652a, and 652b, these mate with one or more matching recesses 754, 752a (hidden), and 752b in the alignment plate 720. When the drive input 606 actuates the indicator shaft 622, the distal fin 654 travels vertically along the longitudinal axis within the recess 754 and is restricted from rotation by the recess 754. Similarly, as Figure 12 As can be seen, the inner fin 652b moves vertically within the recess 752b, but is restricted from rotating by the groove 754. Although only the inner fin 652b is shown, the inner fin 652a (as shown) is also present. Figure 8B (As shown) It also travels within the corresponding recess 752a in the alignment plate 720. Furthermore, although only three alignment features are shown, alternative embodiments may use more or fewer than three alignment features.

[0056] Figure 13Tamper-proof features of one or more embodiments are shown. As previously described, when the indicator assembly 220 is in the inactive state, the indicator shaft 622 is recessed within the upper housing 700 and the top cover 710. However, once the indicator assembly 220 is in the active state, the visible upper section 624 of the indicator shaft 622 protrudes above the upper housing 700 and the top cover 710 and is thus exposed. Furthermore, as mentioned above, the indicator shaft 622 is restricted from rotation but is free to move vertically along its longitudinal axis. Excessive travel along the longitudinal axis in the direction protruding from the upper housing 700 and the top cover 710 could damage the indicator assembly or surgical instruments. Therefore, it is desirable to prevent the indicator shaft 622 from being excessively pulled vertically out of the upper housing 700 and the top cover 710. To prevent such excessive vertical movement, the through-hole of the alignment plate 720 has a narrowing portion 722. The inner fins 652a and 652b on the indicator shaft 622 have a diameter around the longitudinal axis that is larger than the diameter of the rest of the indicator shaft 622. As the indicator shaft 622 travels distally along the longitudinal axis, the larger diameter portion of the indicator shaft 622, including the inner fins 652a and 652b, also travels distally. At the set maximum protrusion height of the indicator shaft 622, the inner fins 652a and 652b will encounter a narrowing portion 722. Because the diameter of the indicator shaft 622 around the inner fins 652a and 652b is larger than the diameter of the narrowing portion 722, any further axial movement of the indicator shaft 622 in the distal direction is prevented.

[0057] The implementation plan disclosed in this article includes: A. A surgical instrument comprising a drive housing and an indicator assembly disposed within the drive housing and actuable to provide a visual indication that the surgical instrument has reached the end of its service life. The indicator assembly includes a drive input rotatably coupled to a bottom of the drive housing. The drive input also includes a riser and an edge, wherein the riser contains a channel therethrough. The indicator assembly further includes an indicator shaft extending through the channel along a longitudinal axis coaxially aligned with the drive input. Rotating the drive input actuates the indicator assembly between an inactive state and an active state, wherein in the inactive state the indicator shaft is recessed into the drive housing, and in the active state the indicator shaft extends out of the drive housing to provide a visual indication.

[0058] B. A method of operating a surgical tool, comprising determining that the surgical tool has reached the end of its service life. The surgical tool includes a drive housing and an indicator assembly disposed within the drive housing. The indicator assembly includes a drive input rotatably coupled to a bottom of the drive housing and an indicator shaft extending along a longitudinal axis through the drive input, and a helical spring anchored between the housing and the drive input. Rotating the drive input between an inactive state and an active state actuates the indicator assembly, in which the indicator shaft is recessed into the drive housing in the inactive state and extends out of the drive housing in the active state. The actuation of the indicator assembly utilizes the indicator shaft to provide a visual indication that the surgical tool has reached the end of its service life.

[0059] Each of Implementation Scheme A and Implementation Scheme B may have any combination of one or more of the following additional elements: Element 1: wherein the edge forms a helical path. Element 2: wherein the indicator shaft includes a guide pin that follows the helical path, such that rotation of the drive input actuates the indicator shaft along the longitudinal axis. Element 3: wherein the edge also includes a flat surface and a vertical surface on opposite sides of the helical path. Element 4: wherein the guide pin is adjacent to the vertical surface when the indicator assembly is inactive, and rests on the flat surface when the indicator assembly is active. Element 5: wherein the indicator assembly also includes a helical spring that extends about the indicator shaft and is operable to accumulate spring force as the guide pin gradually and sequentially engages the helical path. Element 6: wherein the bottom of the helical spring engages the drive input, and the top of the helical spring engages a stationary portion of the drive housing. Element 7: The indicator shaft includes a visible upper section that is concealed within the drive housing and is not visible in the inactive state, and extends beyond the drive housing and is visible in the active state. Element 8: The visible upper section is distinctly colored, with the color indicating the end-of-life state of the tool. Element 9: The visible upper section is illuminated. Element 10: The channel includes a neck portion that separates a smaller diameter portion and a larger diameter portion. Element 11: The indicator shaft includes at least two branch bodies that are accommodated within the larger diameter portion of the channel in the inactive state of the indicator assembly, and within the smaller diameter portion of the channel when the indicator assembly is active. Element 12: The branch bodies are compressed towards each other by the neck portion of the channel when transitioning from the inactive state to the active state. Element 13: Once the branches of the indicator shaft are within the smaller diameter portion of the channel, they are prevented from moving back into the larger diameter portion of the channel.

[0060] As a non-limiting example, exemplary combinations applicable to A and B include: element 1 and element 2; element 2 and element 3; element 3 and element 4; element 4 and element 5; element 5 and element 6; element 6 and element 7; element 7 and element 8; element 8 and element 9; element 10 and element 11; element 11 and element 12; element 12 and element 13; element 14 and element 15; element 15 and element 16; element 17 and element 18; element 17 and element 19; element 15 and element 19; element 19 and element 20; and element 21 and element 22.

Claims

1. A surgical instrument comprising: Drive housing; and An indicator assembly, disposed within the drive housing and actuable to provide a visual indication that the surgical tool has reached the end of its service life, the indicator assembly comprising: A drive input element, rotatably connected to the bottom of the drive housing via a riser and an edge, wherein the riser includes a channel passing through the riser; and An indicator shaft extends through the channel along a longitudinal axis coaxially aligned with the drive input. The drive input is rotated to actuate the indicator assembly between an inactive state and an active state. In the inactive state, the indicator shaft is recessed into the drive housing, and in the active state, the indicator shaft extends out of the drive housing to provide visual indication.

2. The surgical tool according to claim 1, wherein, The edges form a spiral path.

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

4. The surgical tool according to claim 2 or 3, wherein, The edge also includes a flat surface and a vertical surface on opposite sides of the spiral path.

5. The surgical tool according to claim 4, wherein, When the indicator assembly is inactive, the guide pin is adjacent to the vertical surface, and when the indicator assembly is active, the guide pin rests on the flat surface.

6. The surgical tool according to any one of claims 3 to 5, wherein, The indicator component also includes: A helical spring that extends about the indicator axis and is operable to store spring force as the guide pin progressively and sequentially engages the helical path.

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

8. The surgical instrument according to any of the preceding claims, wherein, The indicator axis includes a visible upper section that is hidden within the drive housing and is not visible in the inactive state, and extends beyond the drive housing and is visible in the active state.

9. The surgical tool according to claim 8, wherein, The visible upper section is clearly colored, with the color indicating 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 any of the preceding claims, wherein, The channel includes a neck portion that separates a smaller diameter portion from a larger diameter portion.

12. The surgical instrument according to claim 11, wherein, The indicator shaft includes at least two branch bodies, wherein the branch bodies are accommodated in the larger diameter portion of the channel in the inactive state of the indicator assembly, and are accommodated in the smaller diameter portion of the channel when the indicator assembly is active.

13. The surgical tool according to claim 12, wherein, The branch bodies are compressed toward each other by the neck portion of the channel when transitioning from the inactive state to the active state.

14. The surgical instrument according to claim 12 or 13, wherein, Once the branch body of the indicator shaft is within the smaller diameter portion of the channel, it is prevented from moving back to the larger diameter portion of the channel.

15. A method of operating a surgical instrument, comprising: The surgical tool is determined to have reached the end of its service life. The surgical tool includes a drive housing and an indicator assembly disposed within the drive housing, the indicator assembly comprising: A drive input element, rotatably coupled to the bottom of the drive housing; and An indicator shaft, extending along a longitudinal axis through the drive input; and A helical spring, which is anchored between the housing and the drive input; The drive input is rotated to actuate the indicator assembly between an inactive state and an active state, wherein in the inactive state the indicator shaft is recessed into the drive housing, and in the active state the indicator shaft extends out of the drive housing; and The indicator axis provides a visual indication that the surgical tool has reached the end of its service life.

16. The method according to claim 15, wherein, The edges form a spiral path.

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

18. The method according to claim 16 or 17, wherein, The edge also includes a flat surface and a vertical surface on opposite sides of the spiral path.

19. The method according to claim 18, wherein, When the indicator assembly is inactive, the guide pin is adjacent to the vertical surface, and when the indicator assembly is active, the guide pin rests on the flat surface.

20. The method according to any one of claims 15 to 19, wherein, The drive input is rotatably connected to the bottom of the drive housing via a riser and an edge, wherein the riser includes a channel passing through the riser; and the indicator shaft extends through the channel along a longitudinal axis coaxially aligned with the drive input, wherein the channel includes a neck portion that separates a smaller diameter portion and a larger diameter portion.

21. The method according to claim 20, wherein, The indicator shaft includes at least two branch bodies, wherein the branch bodies are accommodated in the larger diameter portion of the channel in the inactive state of the indicator assembly, and are accommodated in the smaller diameter portion of the channel when the indicator assembly is active.

22. The method according to claim 21, wherein, The branch bodies are compressed toward each other by the neck portion of the channel when transitioning from the inactive state to the active state.

23. The method according to claim 21 or 22, wherein, Once the branch body of the indicator shaft is within the smaller diameter portion of the channel, it is prevented from moving back to the larger diameter portion of the channel.

Images