Extending the usable life of instruments in remote surgery systems
Patent Information
- Application Number
- JP2024098480
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2017-08-10
- Filing Date
- 2024-06-19
- Publication Date
- 2026-10-01
- Estimated Expiration
- 2038-07-27
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Abstract
Description
[[Technical Field]]
[0001] Cross-Reference to Related Applications This application is a non-provisional application claiming the benefit of U.S. Provisional Patent Application No. 62 / 543,726, filed on August 10, 2017, claims priority to that application, and the entire content of that application is incorporated herein by reference.
[0002] Technical Field Aspects of the present invention relate to operating modes of telesurgery systems and instruments. [[Background Art]]
[0003] Minimally invasive surgical techniques reduce the amount of tissue damage during diagnostic or surgical procedures, thereby reducing a patient's recovery time, discomfort, and adverse side effects. A common form of minimally invasive surgery is endoscopy, and a common form of endoscopy is laparoscopy, which is minimally invasive examination and surgery within the abdominal cavity. In standard laparoscopic surgery, the patient's abdomen is insufflated with gas, and cannula sleeves are passed through small (about 0.5 inch or less) incisions to provide entry ports for surgical instruments. Other forms of minimally invasive surgery include thoracoscopy, arthroscopy, and similar "keyhole" surgeries used to perform surgical procedures in the abdomen, chest, throat, rectum, joints and other regions.
[0004] Computer-assisted remotely operated surgical systems are known. These surgical systems are used in both minimally invasive surgery and "open" surgery, where a sufficiently large incision is made to allow the surgeon access to the surgical site. Examples of minimally invasive open surgery include not only the surgeries mentioned above, but also neurosurgery, joint replacement surgery, vascular surgery, and other surgeries using remotely operated surgical instruments with both rigid and flexible shafts. An example of a remotely operated surgical system is the da Vinci Xi® surgical system (model IS4000), commercialized by Intuitive Surgical, Inc. of Sunnyvale, California. Other examples include the Sensei® and Magellan® systems commercialized by Hansen Medical (Auris Surgical Robotics Inc.), the RIO® system commercialized by Mako Surgical (Stryker Corporation), and the Flex® system commercialized by Medrobotics Corporation.
[0005] Remotely operated surgical systems may utilize interchangeable surgical instruments driven by robotic manipulator technology. Some of these instruments are intended for single use only, or for use during a single surgical procedure only. Because they are not reused, they are treated as disposable. Some of these disposable instruments are expensive, resulting in increased surgical costs. Other types of instruments are designed for multiple uses, and these multi-use instruments are typically cleaned and sterilized between surgical procedures. The advantage of multi-use instruments is a reduced instrument cost per surgical procedure. However, mechanical limitations, such as cable wear, limit the number of times these multi-use instruments can be used. Thus, increasing the number of times multi-use instruments can be used further reduces the instrument cost per surgical procedure. [Overview of the project]
[0006] In one embodiment, the surgical system includes a remotely operated manipulator and a control system. An instrument is coupled to the manipulator, and the instrument includes mechanically movable parts. The control system operates the surgical system in a first operating mode, in which the control system drives the mechanically movable parts within a first range of operating parameters, such as the full range of motion of the mechanical parts. The control system also operates the surgical system in a second operating mode, in which the control system drives the mechanically movable parts within a second range of operating parameters that is more limited than the first range, such as less than the full range of motion of the mechanical parts. Other operating parameters include speed, acceleration, and mechanical load. Additional operating modes and parameter ranges are also optionally available.
[0007] The surgeon can select one or more operating modes depending on clinical needs.
[0008] The usable life of an instrument decreases based on its operating range in the first and second operating modes. Alternatively, the usable life of an instrument decreases based on its operating range in the first and second operating parameter ranges. Operating within a more restricted second parameter range results in relatively less mechanical wear of the components. The remaining usable life of the instrument decreases by an amount corresponding to operation in the first operating mode or first parameter range, and by a second amount less than the first amount corresponding to operation in the first operating mode or first parameter range. As a result, the usable life of the instrument is extended, and the overall cost per surgical procedure is reduced.
[0009] Additional embodiments are presented for limiting the operation of mechanical components to correspondingly extend the service life of the device. [Brief explanation of the drawing]
[0010] [Figure 1] This is a schematic diagram of a remote surgery system. [Figure 2]This is a schematic diagram of the instruments and exemplary operating parameter ranges for a remote surgery system. [Figure 3A] This is a schematic diagram of the equipment components and the associated operating parameter ranges. [Figure 3B] This is a schematic diagram of the equipment components and the associated operating parameter ranges. [Figure 3C] This is a schematic diagram of the equipment components and the associated operating parameter ranges. [Modes for carrying out the invention]
[0011] This description and accompanying drawings illustrating aspects, embodiments, embodiments, or uses of the present invention should not be construed as limiting, but rather define the invention protected by the claims. Various mechanical, compositional, structural, electrical, and operational modifications can be made without departing from the spirit and scope of this description and the claims. In some cases, well-known circuits, structures, or techniques are not illustrated or described in detail so as not to obscure the invention. The same number in two or more figures represents the same or similar element.
[0012] Furthermore, any specific words chosen to describe one or more embodiments and optional elements or features are not intended to limit the invention. The singular forms “a, an” and “the” are also intended to include the plural forms unless otherwise indicated in the context. In addition, terms such as “comprises,” “includes,” and “has” specify the presence of the described function, step, operation, element, and / or component, but do not exclude the presence or addition of one or more other similar, analogous, or different functions, steps, operations, elements, components, and / or groups.
[0013] While this explanation is intended to be sufficiently clear, concise, and accurate, please understand that meticulous and comprehensive linguistic precision is not always possible or desirable. For example, considering video signals, readers skilled in the art will understand that an oscilloscope described as displaying a signal does not display the signal itself, but rather its representation, and a video monitor described as displaying a signal does not display the signal itself, but rather the video information that the signal conveys.
[0014] Elements described in detail with reference to one embodiment, embodiment, or use may optionally be included in other embodiments, embodiments, or uses in which they are not specifically shown or described, if it is practical. For example, if an element is described in detail with reference to one embodiment but not with reference to a second embodiment, it may nevertheless be argued that the element is included in the second embodiment. Thus, to avoid unnecessary repetition in the following description, one or more elements shown and described in reference to one embodiment, embodiment, or use may be incorporated into other embodiments, embodiments, or forms, unless otherwise specified, provided that one or more elements do not render the embodiment or embodiment non-functional and that two or more elements do not conflict with each other.
[0015] The elements described as being connected may be directly connected electrically or mechanically, or they may be connected indirectly through one or more intermediate components.
[0016] Aspects of the present invention will primarily be described in relation to embodiments using the da Vinci® surgical system, commercialized by Intuitive Surgical, Inc. of Sunnyvale, California. Examples of such surgical systems include the da Vinci Xi® surgical system (Model IS4000) and the da Vinci Si® surgical system (Model IS3000). However, those familiar with the subject will understand that aspects of the present invention disclosed herein can be embodied and implemented in a variety of ways, including manual and computer-assisted embodiments and computer-assisted and hybrid combinations of embodiments. Embodiments in the da Vinci® surgical system (e.g., Model IS4200, Model IS4000, Model IS3000, Model IS2000, Model IS1200) are merely illustrative and should not be considered to limit the scope of aspects of the present invention disclosed herein. Where applicable, aspects of the present invention can be embodied and implemented in both relatively small, handheld manual devices and relatively large systems with additional mechanical support.
[0017] Remotely operated surgical systems (remote surgical systems) that operate at least partially with computer assistance include both mechanically grounded and handheld devices. Such remote surgical systems typically include one or more surgical instruments for treatment, diagnosis, or image processing. In handheld remote surgical systems, such as surgical staplers or bone tools, the instrument and the handheld part are typically combined. In mechanically grounded systems, the instrument is typically mechanically supported with respect to mechanical grounding.
[0018] This description focuses on mechanically grounded remote surgical systems, but can be applied to handheld remote surgical systems as needed. An example of a mechanically grounded remote surgical system is the da Vinci® surgical system. Those skilled in the art will be familiar with various remote surgical system architectures, including those described in U.S. Patent No. 6,246,200 (filed August 3, 1999), U.S. Patent No. 6,331,181 (filed October 15, 1999), and U.S. Patent No. 6,788,018 (filed December 20, 2001).
[0019] Figure 1 is a schematic diagram of a remote surgery system 100 and surgical instruments 102 associated with this remote surgery system. System 100 and instruments 102 are examples of various remote surgery system configurations. As shown, the main components of the remote surgery system include a remotely operated manipulator 104, a base unit 106, and a computer control system 108. These main components and their associated functions may be configured as a single unit or distributed among two or more separate interconnected units. For example, the da Vinci Xi® surgical system includes a remotely operated manipulator system (patient-side unit) located next to the patient, a surgeon control unit located away from the patient-side unit, and an auxiliary equipment unit.
[0020] The manipulator 104 includes a series of links interconnected by joints and extends from the base unit 106 to the end-side instrument drive interface 110, to which the instrument 102 is attached. As shown, the manipulator 104 is an example of various remotely operated manipulator configurations, which may move the instrument 102 as a whole, move one or more individual components of the instrument 102 while keeping the main part of the instrument 102 stationary, or both. The manipulator 104 operates under the control of a surgeon, who inputs motor control and instrument function operation commands to the control system 108, which then commands the manipulator 104 to perform the corresponding movement or function. However, in an optional embodiment, the control system 108 may autonomously command specific movements of the manipulator 104 or functions of the instrument 102 related to the performance of a medical procedure.
[0021] As shown in the illustration, the base unit 106 is mechanically grounded, but in handheld embodiments, for example, it may optionally not be grounded. The base unit 106 represents various separate or combined configurations consisting of one or more patient-side units (e.g., a single unit with two or more manipulators, two or more units, each with a single manipulator, etc.), a surgeon control unit, and one or more auxiliary equipment units.
[0022] The computer control system 108 may be centralized or distributed within a telesurgery system. And, as described below, aspects of the instrument data related to the computer control system 108 and the computer control system 108 may be remote from the telesurgery system, for example at a location within a network to which the telesurgery system is coupled. Computer control systems are known and generally comprise a logic unit and a memory system, wherein the memory system stores instructions executed by the logic unit and data determined by the logic unit. U.S. Patent No. 6,424,885, filed August 13, 1999, is an example of a computer control system for a telesurgery system, which document is incorporated herein by reference.
[0023] The computer control system 108 receives a user's surgical instrument movement command via a master input 112, and controls the manipulator 104 such that the movement of the instrument 102 follows the movement of the master input 112 in response thereto. The master input 112 may optionally have one or more additional control inputs that control functions of the instrument 102, such as application of electrosurgical energy, application of surgical staples, and the like, via the control system 108. As illustrated, the computer control unit 108 receives a user's instrument operation command via an operation mode input 114. Aspects of these operation modes will be described in detail. The operation mode input 114 may be combined with the master input 112, or may be disposed separately. For example, the operation mode input 114 may be a switch on the master input, or on a touchpad of a surgeon control unit, or on a similar input device.
[0024] Referring to FIG. 2, the main components of the instrument 102 include a proximal end mechanism 116, a hollow instrument shaft 118 having one end coupled to the proximal end mechanism 116, a movable surgical end effector 120 coupled to the distal end of the instrument shaft 118, and an optional movable wrist mechanism 122 coupled between the distal end of the shaft 118 and the end effector 120. The proximal direction (located away from the patient) and the distal direction (located toward the patient) are shown in the drawings for clarity. The instrument shaft 118 may be straight, curved or articulated, and the shaft may be rigid or flexible. The end effector 120 performs a surgical function of treatment, diagnosis, or imaging, or any combination of these functions. Various instrument wrist mechanism configurations are known. See, for example, U.S. Patent No. 6,394,998, filed September 17, 1999; U.S. Patent No. 6,817,974, filed June 28, 2002; U.S. Patent No. 9,060,678, filed June 13, 2007; and U.S. Patent No. 9,259,275, filed November 12, 2010. The disclosures of these documents are incorporated herein by reference.
[0025] As illustrated, the proximal end mechanism 116 includes two exemplary rotary cable drive capstans 124a, 124b surrounded by a housing 126. A first pair of cables 128a, 128b is wound around the capstan 124a, such that when the capstan 124a rotates, one cable is paid out and the other cable is retracted, and vice versa. Similarly, a second pair of cables 130a, 130b is wound around the capstan 124b, such that when the capstan 124b rotates, one cable is paid out and the other cable is retracted, and vice versa. The capstans 124a, 124b receive drive inputs from the instrument drive interface 110 under the control of the control system 108, as described above.
[0026] Cables 128a and 128b extend through the instrument shaft 118 and are connected to a movable end effector component 132, such as a movable jaw, scissor blade, electrocautery hook, or blade. Thus, the end effector component 132 moves in accordance with the rotation of the capstan 124a. Similarly, cables 130a and 130b extend through the instrument shaft 118 and are connected to the wrist 122 such that the wrist 132 moves in accordance with the rotation of the capstan 124b. The wrist 122 is an example of a mechanical wrist configuration with various joints, such as the nested clevis and continuous link (snake) configuration of the Endowrist (registered trademark) surgical instrument commercialized by Intuitive Surgical.
[0027] The capstans 124a, 124b and their associated drive inputs, cable routing guides or pulleys, bearings, etc., are examples of various mechanisms (transmission mechanisms) that receive force or torque drive inputs and transmit the received drive inputs to corresponding movements used to control end-side instrument components such as the wrist 122 or end-effector component 132. Such transmission mechanisms include rotating disks and various other axial rotation inputs; rotation, rack, or worm gear inputs; lever or gimbal inputs; slide tabs and other lateral translation inputs; pins and other axial translation inputs; fluid pressure inputs; etc. Furthermore, the capstans 124a, 124b are examples of instrument configurations in which one or more motors are mounted within or coupled to the housing 126 and receive motor control inputs from the control system 108 via the housing 126. One or more motors drive the corresponding transmission mechanisms. Thus, instrument components can be moved externally (e.g., to the manipulator to which the instrument is mounted, or to the instrument itself) or internally by the motors.
[0028] Cable pairs 128a, 128b and 130a, 130b are examples of various components (actuating parts) that are optionally used to transmit force or torque from the transmission mechanism to the end components of the instrument. Such acting parts include tensioning parts (cables, cable-hypotubing combinations, pull rods, etc.), compression parts (push rods, Bowdin cables, etc.), rotating parts (shafts, gear trains, etc.), and parts that combine these properties (push / pull rods, rotating and translating spline shafts, etc.).
[0029] Additional transmission and operating components include rotating shafts, gears, hinges, pivot points, rolling surfaces, rotating or sliding parts, cam surfaces and cam pins, lead screws, universal joints or constant velocity joints, load-bearing bearings, surfaces, or points.
[0030] Operating mode In aspects of the present invention, parameters affecting the lifespan of an instrument are divided into two or more ranges. One range has a relatively small impact on the instrument's lifespan, while the other range has a relatively large impact. While parameter ranges that have a relatively large impact on the instrument's lifespan are available as needed, the instrument's lifespan is extended by operating the instrument within the parameter ranges that have a relatively small impact on its lifespan. An example of a parameter is the range of motion (ROM) of a mechanical component. Aspects of the present invention are generally illustrated by remote surgical system components that make two ROMs available for user selection, and it should be understood that aspects include systems having three or more ROMs available for user selection. In addition, while aspects of the present invention are illustrated by mechanical ROMs, those skilled in the art will understand that other instrument or remote surgical system parameter ranges can be defined and selected, as described below. Thus, two, three, or more parameter ranges can be selected.
[0031] Figure 2 shows that each of the movable endpiece components of the device 102 has a ROM. Furthermore, according to embodiments of the present invention, the ROM of one or more endpiece components can be selectively changed. The limited ROM within the maximum ROM of a component can be defined to be selected by operation in the corresponding operating mode. As shown, for example, the end effector component 132 rotates around axis 134 within a first selected ROM 134a (e.g., ±30°) or a second selected ROM 134b (e.g., ±60°) that is greater than the first selected ROM. Similarly, the wrist 122 rotates around axis 136 within a first selected ROM 136a (e.g., ±30°) or a second selected ROM 136b (e.g., ±60°) that is greater than the first selected ROM. The various selected ROMs are optionally symmetrical or asymmetrical (e.g., ±30°, +0° to -45°, +45° to -15°, +30° to +60°, etc.). The first and second ROMs either completely overlap (for example, the first ROM is ±60° from the reference angle and the second ROM is ±30°) or partially overlap (for example, the first ROM is +15° to -45° from the reference angle and the second ROM is 0° to -60°). The selected ROM corresponds to the type of joint (for example, rotational ROM is selected for a rotational joint, and translational ROM is selected for a prismatic joint, etc.).
[0032] The illustrated wrist 122 and end effector component 132 are shown to have a single mechanical degree of freedom (DOF). However, when a single joint or joint assembly corresponds to two or more DOFs, each with its associated ROM, the DOFs and the ROMs associated with the DOFs can be selectively limited in various ways. For example, one ROM selected with respect to such a joint or joint assembly may limit the ROM of a first DOF but not a second DOF, while a second ROM selected with respect to such a joint or joint assembly may limit both the first and second DOF ROMs. As another example, the wrist mechanism of an apparatus may include two or more mechanical joints with single DOFs, but controlled as a single joint with multiple DOFs, allowing for a very large number of selectable ROMs for the wrist mechanism (e.g., pitch ±45° and yaw ±45°; pitch ±60° and yaw ±60°; pitch +15° to -45° and yaw ±45°, etc.). In some embodiments, the selected ROM corresponds to the full mechanical ROM of a single mechanical joint (i.e., from one mechanical stop to the next).
[0033] Furthermore, in a remote surgery system with two or more instruments, the selected ROM can be applied to a single instrument or a group of two or more instruments. For example, in the first operating mode of the remote surgery system, the first selected ROM corresponds to two or more instruments operating with full mechanical ROM, and the second selected ROM corresponds to two or more instruments operating within a limited ROM. Alternatively, the selectable ROM can be used independently for two or more individual instruments.
[0034] In another embodiment, the two or more selectable ROMs depend on the specific instrument type attached to the manipulator. For example, a first instrument type (e.g., a gripper) may have two selectable operating modes: a first mode in which the full pitch and yaw ROM of the first instrument wrist is available, and a second mode in which the pitch and yaw ROM of the first instrument wrist is limited (e.g., ±45°). A second instrument type (e.g., unipolar cauterizing shears) may have two different selectable operating modes: a first mode in which the full pitch and yaw ROM of the second instrument wrist is available, and a second mode in which the pitch and yaw ROM of the second instrument wrist is limited (e.g., ±30°). Similarly, a first instrument type may have a certain amount (e.g., two) of selectable ROMs available, and a second instrument type may have a different amount (e.g., three) of selectable ROMs available. Furthermore, in some embodiments, one particular instrument type may not have selectable ROMs available (i.e., the full ROM of the instrument is always available), while another particular instrument type may have two or more selectable ROMs available.
[0035] According to aspects of the present invention, these operating modes are used to extend the lifespan of instruments in a remote surgical system, as described below.
[0036] Range of operating parameters Various operating parameters can be used to describe the environment in which the control system 108 commands the motion of the apparatus and its components. As discussed above, one parameter is the position or orientation within the operating range. Other parameters include the velocity, acceleration, static force or torque application and load of the component, and dynamic force or torque application and load. Thus, various ranges within these parameters can be defined and selected as described above.
[0037] For example, Figures 3A and 3C show the operating parameters of the device. Figure 3A is a schematic diagram of a device 151 having a serpentine tip (e.g., catheter, guide tube, etc.). The bidirectional arrow 150 represents the total parameter range related to the motion of flexible device components, such as mechanical ROM, lateral force, tip velocity, tip acceleration, and tensile force on the operating cable, constrained by the physical limitations of the device and associated operating components. The bidirectional arrow 152 represents a limited parameter range, such as that constrained by the control system.
[0038] Figure 3B is a schematic diagram of a device component 155 that translates at a linear joint (e.g., a push rod, knife blade, stapler sled, etc.). The bidirectional arrows 154 represent the total parameter ranges related to linear or curved translation, such as mechanical ROM, axial push or pull force, component velocity, and component acceleration, constrained by the physical limitations of the joint, component, and associated actuators. The bidirectional arrows 156 represent limited parameter ranges, such as those constrained by the control system.
[0039] Figure 3C is a schematic cross-sectional view of a device component 159 (e.g., a rotary drive shaft, disk, gear, hinge pin, etc.). The bidirectional arrows 158 represent the total range of rotation-related parameters such as mechanical ROM, torque, angular velocity, and angular acceleration, which are constrained by the physical limitations of the component and associated operating parts. The bidirectional arrows 160 represent the limited parameter range, which are constrained by the control system.
[0040] During the operation of the remote surgery system, the values of each of these parameters can be determined within a certain range, allowing the control system to record the amount of time the component spent within a predetermined parameter range. Similarly, the control system can record the number of events related to the parameter range or value.
[0041] For example, a control system can record the time a movable component operates within a parameter range, such as the time it spends moving within a ROM at a range of 60 to 90 degrees. Alternatively, it can record events such as the number of times a component moves within a ROM at a range of 60 to 90 degrees, or the number of times a component exceeds 60 degrees.
[0042] According to aspects of the present invention, information regarding these parameter ranges or events is used to extend the lifespan of instruments in a remote surgical system, as described below. This information can be combined with information regarding the operating range of selected parameters, or it can be used independently of the selected operating parameter range.
[0043] Lifespan of the device As with all mechanisms, movable instrument components can deteriorate with use. Therefore, for safety reasons, remote surgical systems typically limit the time an instrument can be used. For example, the instrument design is tested to determine the expected average maximum lifespan, and then a large safety margin is introduced to specify a maximum usable lifespan that is shorter than the expected average maximum lifespan.
[0044] The maximum usable life can be defined in various ways, such as by specifying the maximum permissible individual use (life) of the instrument, or by specifying the maximum permissible usage time of the instrument. For example, each new instrument is assigned 10 permissible individual uses (discrete lives), and the number of remaining permissible individual uses is stored in the instrument's or the remote surgery system's memory, or in a network location, so that the control system 108 can access the stored information. Similarly, each new instrument is assigned a permissible usage time, and the remaining permissible usage time is stored in the instrument's or the remote surgery system's memory, or in a network location, so that the control system 108 can access the stored information. Once the maximum permissible individual use or the permissible maximum usage time of the instrument is assigned, the number of remaining individual uses or the remaining usage time decreases as the instrument is used during treatment.
[0045] In one variation, one usable individual lifespan is reduced for each surgical procedure (one patient - from start to finish), and during the surgical procedure, the instrument is used until the remaining usable individual lifespan is zero, at which point the surgical system prevents further use of the individual instrument.
[0046] In another modification, each time an individual instrument is attached to the manipulator and initialized, one available individual lifespan is deducted until the available individual lifespan becomes zero.
[0047] In another exemplary variant, once an instrument is used, the surgical system reduces the remaining usable time until it reaches zero. When the remaining usable time reaches zero, the surgical system optionally (a) prevents further use of the instrument and notifies that instrument replacement is necessary; (b) allows continued use of the instrument until it is removed from the manipulator and prevents further use of the instrument after it has been removed from the manipulator; or (c) allows continued use of the instrument throughout the entire surgical procedure, including one or more removals from the manipulator and one or more subsequent attachments, and prevents further use of the instrument after the surgical procedure.
[0048] Thus, the usable life of an instrument begins with a specified initial maximum usable life and decreases as the instrument is used until its remaining usable life reaches zero. In this explanation, the usable life of an instrument is expressed in terms of remaining individual life or remaining usage time, but other measures of usable life of the instrument's performance (such as the perceived actual part position relative to the commanded part position, perceived electrosurgical energy, perceived torque for surgical stapling, etc.) can also be applied as dynamic indicators of the remaining usable life.
[0049] The usable lifespan of individual instruments, such as their permissible individual lifespan or remaining usage time, can optionally be stored in the instrument itself, the remote surgery system, or on the network with which the remote surgery system communicates. Furthermore, updates to the usable lifespan can optionally occur at various times. For example, the remaining time can be continuously updated during instrument use, or the control system can record the total usage time of the instrument and update the remaining usable time when the instrument is withdrawn from the patient. Similarly, the remaining usable individual lifespan can be reduced during instrument use, or the control system can determine the used individual lifespan and update the remaining individual lifespan when the instrument is withdrawn. Another example is that while an instrument is attached to a manipulator, the time used or individual lifespan is recorded for the instrument, and then the remaining time or lifespan is updated when the instrument is reattached to the manipulator.
[0050] Referring again to Figure 2, in one embodiment, the surgical instrument 102 includes a memory 138, which in some embodiments contains stored information such as the instrument type, the instrument's unique serial number, and the remaining usable life (e.g., the number of allowed individual lives or the remaining time). This information stored in the memory 138 is communicated to the control system 108 via the drive interface 110 (140). Optionally, updated information such as the allowed individual lives or remaining time is communicated from the control system 108 to the memory 138 via the drive interface 110 (140) so that this information can then be accessed when using the instrument in the remotely operated surgical system. An example of instrument memory and communication via the drive interface can be found in U.S. Patent No. 6,331,181 (filed October 15, 1999), which is incorporated herein by reference. Similarly, individual life or time information of an instrument can be stored in a network location accessed by the control system 108 of the remote surgical system.
[0051] The degree of degradation in the performance of an instrument in many situations varies depending on the range of operating parameters over which the instrument is used. For example, when an instrument component moves within the relevant DOF ROM, more mechanical degradation may be expected at the edges of the ROM than near the center of the ROM. More specifically, the cable used to move the jaws of an end effector may experience relatively little degradation over time because it is routed around one or more pulleys or guide surfaces and moves the jaws ±30° from a defined center position (e.g., the longitudinal axis of the instrument between the proximal and distal ends). The cable may experience relatively more degradation over time because it is routed around one or more pulleys or guide surfaces and moves the jaws ±60° from a defined center position. The cable may experience even more degradation over time because it is routed around one or more pulleys or guide surfaces and moves the jaws ±90° from a defined center position.
[0052] Furthermore, the amount of degradation may not be a linear function of the parameter values within a given range. For example, the degradation of transmission mechanism components or operating components may not be a linear function of the ROM position of the relevant end-effector components. As a more specific example, the degradation of components related to the movement of the end-effector jaw near the maximum ROM of the jaw (e.g., close to 90°) is significantly higher (e.g., more than 3 times) than the jaw movement near a specified center position or within a limited ROM (e.g., ±30°), where 90 is 3 times 30.
[0053] Furthermore, moving parts may degrade relatively more rapidly as their speed or acceleration increases. For example, if the speed of a part is limited only by its maximum possible operating speed, the degradation of the part over time may be relatively high, while if the speed is limited to a value less than its maximum possible operating speed, the degradation of the part over time may be relatively low. Similarly, if the acceleration of a part is limited only by its maximum possible operating acceleration, the degradation of the part over time may be relatively high, while if the acceleration is limited to a value less than its maximum possible acceleration, the degradation of the part over time may be relatively low.
[0054] Furthermore, movable transmission mechanism components or actuarial components may degrade relatively more rapidly as the static force or torque load, dynamic mechanical actuarial force or torque load, or combination of static and dynamic actuarial loads on the component increases. For example, if the allowable maximum actuarial load of a component is the maximum possible actuarial load (e.g., generating maximum gripping force, maximum bending force, or maximum torque on the component; operating near or within the elastic range of the component), the degradation of the component over time may be relatively high, while if the allowable maximum actuarial load of a component is less than the maximum possible actuarial load, the degradation of the component over time may be relatively low. The load may be measured directly (e.g., using a force or torque sensor coupled to the component) or indirectly (e.g., by detecting the motor current of a motor used to move the component or hold it in place under load and inferring the load from the motor current used).
[0055] Similarly, in devices where a preload force or torque is always present on a component (such as a cable), if the preload force or torque is at a first value, the application of the acting force or torque may result in relatively greater degradation of the component over time. Conversely, if the preload force or torque is at a second value, less than the first value, the application of the acting force or torque may result in relatively less degradation of the component over time. An example of such a preload force is a constant preload tension on the operating cable of a device to prevent the cable from sagging or deviating from its designated path. Another example of preload force is the force experienced by a transmission mechanism or actuarial component used to eliminate lost motion caused by a gap (backlash) in an antagonistic control pair, where one component moves the component in one direction (e.g., pitch / winding up, yaw / leftward swing, clockwise rotation, or proximal swing), and the other drive train of the pair moves the component in the opposite direction (e.g., pitch / downward swing, yaw / rightward swing, counterclockwise rotation, or proximal swing). Thus, the component may experience relatively high degradation over time with a combination of relatively high preload force and actuarial force, and relatively low degradation over time with a combination of relatively low preload force and the same actuarial force. Furthermore, even prolonged static load alone can cause mechanical degradation, such as cable stretching under high preload tension for months. The amount of time from when the device is constructed (e.g., when static preload is first applied) until the device is used may be related to the device's performance.
[0056] Determining the lifespan of an appliance In one embodiment, the control system records the amount of time spent in each of two or more operating modes, which are restricted in such a way that the parameters differ, and then uses these times to determine the remaining usable life of the appliance. For example, the control system records the amount of time spent in a first selection mode in which the ROM is restricted and the amount of time spent in a second selection mode in which the ROM is not restricted.
[0057] In another embodiment, the control system records the amount of time spent in two or more parameter ranges and then uses these times to determine the remaining usable life of the instrument. For example, the control system records the time spent in a first predetermined mechanical ROM (e.g., 0 to 30°) and the time spent beyond the first predetermined mechanical ROM in a second predetermined mechanical ROM (e.g., 30 to 60°).
[0058] In another embodiment, the remaining usable time of the appliance is determined by combining the time spent in each of two or more operating modes and the time spent in one or more parameter ranges. For example, the control system records the time spent in a first selection mode (0-45°) where the ROM is limited and the time spent in a second selection mode (0-90°) where the ROM is not limited. The control system also records the amount of time spent in a predetermined ROM (e.g., 70-90°). The control system then uses this combined information to determine the remaining usable life of the appliance.
[0059] Again, while mechanical ROM is used as an example of a parameter, these ROMs represent parameters that influence mechanical degradation over time, can be monitored or changed from one value to another, or from one range of values to another, and accordingly, whose mechanical degradation changes over time. Furthermore, while the above examples are individual parameters such as ROM, speed, acceleration, actuation force or torque, preload force or torque, limiting two or more of these parameters can further reduce the deterioration of equipment components over time. Thus, the term "selected parameter range" includes both the range of a single parameter and the range of two or more parameters.
[0060] As mentioned above, in some cases, the degradation of individual components depends on two or more parameter values. For example, when the bending angle of a Carden joint is zero, the degradation of the Carden joint over time may be primarily caused by the maximum permissible velocity or working load. However, when the bending angle of the Carden joint is high (e.g., 60°), the bending angle can become the primary parameter for the degradation of the joint over time, either in combination with the maximum permissible angular velocity or working load, or in combination with both the maximum permissible angular velocity and working load. Thus, the parameters related to the degradation of instrument components over time may have a single dimension, or they may have two, three, or more dimensions. Furthermore, one parameter value or one-dimensional parameter can determine the influence of a second parameter or second dimension on the degradation of a component over time.
[0061] In many cases, one or more fixture components degrade faster over time than others, and these one or more components determine the expected average maximum lifespan of the fixture type, and consequently, the specified maximum usable lifespan of the fixture type. Limiting the degradation of these one or more components over time increases both the expected average maximum lifespan of the fixture type and the correspondingly specified maximum usable lifespan of the fixture type.
[0062] Accordingly, in one embodiment, the maximum usable life of an instrument is extended in a mode in which the range of one or more instrument operating parameters (such as range of motion) of one or more movable instrument components is restricted, compared to the maximum usable life of an instrument in a mode in which the range of the instrument's operating parameters is not restricted. The computer control unit of the remote surgery system determines the extended allowable individual life or time as a function of the restricted operating parameters (e.g., time spent in restricted parameter operating mode), adjusts the remaining allowable life or time of the instrument, and saves the adjusted allowable remaining individual life or time for access in one or more subsequent surgical procedures.
[0063] Since the remaining permissible individual life can optionally be reduced by a fraction of the individual life, operation in a mode that limits the instrument operating parameters for two or more procedures is necessary to extend the permissible individual life of the instrument by the full individual life.
[0064] For example, as a result of a first surgical procedure in which a limited parameter range is selected, the remaining permissible individual lifespan of the instrument is reduced by half. Then, as a result of a second surgical procedure in which a limited parameter range is selected, the remaining permissible individual lifespan of the instrument is reduced by another half. Thus, after the first and second surgical procedures, the permissible individual lifespan of the instrument is extended by the instrument's total individual lifespan, because only one individual lifespan is reduced after the two procedures, instead of two individual lifespans (one for each procedure). The remote surgery system determines the number of remaining total individual lifespans of the instrument, so that the instrument's additional total individual lifespan can be used for subsequent surgical procedures.
[0065] The time spent in an operating mode can optionally be correlated with the remaining allowable individual lifespan of the instrument or an extension of its time. For example, during the first surgical procedure, a limited operating parameter range is selected for half (1 / 2) of the instrument's usage time, thus reducing the remaining allowable individual lifespan of the instrument by 3 / 4. Then, during the second surgical procedure, the limited operating parameter range is selected for the entire procedure, thus reducing the remaining allowable individual lifespan of the instrument by half (1 / 2). And during the third surgical procedure, the limited operating parameter range is selected for 3 / 4 of the procedure, thus reducing the remaining allowable individual lifespan of the instrument by 5 / 8. Thus, after these three procedures, the total individual lifespan is reduced by less than 2, and additional individual lifespan of the instrument becomes available. As another example, during the first surgical procedure, the limited operating parameter range is selected for half (1 / 2) of the instrument's usage time, so the remaining usable time is reduced by 3 / 4 of the total time the instrument is used. The correlations in these examples are arbitrarily selected as examples. In practice, correlations are elucidated based on actual lifecycle testing of the equipment, which may vary depending on the type of equipment and the range of parameters selected.
[0066] In another embodiment, the maximum usable life of the instrument is extended by a control system that senses and records the time spent or generated when one or more movable instrument components operate with one or more operating parameters (such as operating range), adjusts the instrument's allowable remaining individual life or time, and stores the adjusted remaining life or time for access in one or more subsequent surgical procedures. The adjustment can be performed in a manner similar to the adjustment method used when an operating mode is individually selected.
[0067] In another embodiment, the parameter range can be associated with the remaining usable life of the instrument. The instrument may optionally default to the full parameter range during the initial part of its remaining life, then default to a limited parameter range during the latter part of its remaining life, with the full or increased parameter range available as needed. For example, in the case of an instrument with a mechanical DOF of ±90° ROM, ±60° ROM can be used as the default when the instrument is first used, and the surgeon can select the full ±90° ROM as needed. However, once the instrument's usable life has been consumed beyond a certain value, the default ROM is changed to ±45° ROM, and the surgeon can select the full ±90° ROM as needed. As a further example, once the instrument's usable life has been consumed beyond a certain value, the default ROM is changed to ±45° ROM, and ±60° and ±90° ROM become available as needed. As yet another example, once the instrument's usable life has been consumed beyond a certain value, the default ROM is changed to ±45° ROM, and the surgeon can select the less restricted ±60° ROM as needed, but not the full ±90° ROM. In this situation, if the full parameter range is required, an instrument with an unrestricted full parameter range must be used.
[0068] In variations of this embodiment, the parameter range is associated with the remaining usable life of an appliance that does not have more than two selectable parameter ranges. As the appliance's usable life is consumed, the parameter range is restricted accordingly. For example, the full parameter range is available during the initial part of the appliance's usable life, and only the restricted parameter range is available during the latter part of the appliance's usable life. Again, if the full parameter range is required, an appliance with an unrestricted full parameter range must be used.
[0069] Selecting an operating mode Referring again to Figure 1, in one embodiment, the surgeon selects one of two or more instrument operating parameter limitations by inputting a selection via the operating mode input 114 of the surgical control unit as described above. Generally, in one operating mode, the surgeon has access to the full parameter range when clinically required. In a second operating mode, the parameter range is limited. The remote surgery system may optionally operate in various other operating modes (3, 4, 5, etc.) that further limit the range of one parameter, limit one or more additional parameter ranges, or both.
[0070] In one embodiment, a remotely operated surgical system is initially set to a first operating mode in which the range of the instrument's operating parameters is limited to a first range, and the surgeon can select a second operating mode in which the range of the instrument's operating parameters is limited to a second range greater than the first range or unlimited. For example, a remotely operated surgical system may be initialized in a first operating mode in which the instrument's wrist pitch and yaw ROM are limited to ±45°, and the surgeon can then select a second operating mode in which the instrument's pitch and yaw ROM are unlimited or limited to or near the full physical ROM. Default settings of limited ranges may occur during system startup, instrument placement, re-establishment of the master / slave relationship after interruption, detection of operation within a limited range for a predetermined period of time, or other relevant system events.
[0071] In one embodiment, a remotely operated surgical system is defaulted to a first operating mode in which the range of instrument operating parameters is unrestricted or restricted to near the full range of parameters, and the surgeon can select a second operating mode in which the range of instrument operating parameters is restricted. For example, a remotely operated surgical system is initialized with the instrument's wrist pitch and yaw ROM unrestricted or restricted to or near the full physical ROM, and then the surgeon can select a second operating mode in which the instrument's pitch and yaw ROM are restricted to ±45°. The default setting to an unrestricted range may occur when the system is started up, when an instrument is set up, when a master / slave relationship is established after an interruption, when a predetermined number of times the tactile limit on the master's parameters is reached within a predetermined period, or in the event of other relevant system events.
[0072] In one embodiment, when a remote surgery system is operating in a mode in which instrument operating parameters are restricted, the computer control system of the remote surgery system restricts the corresponding master input parameters so that the surgeon can understand that the parameters are restricted. For example, in an operating mode of the remote surgery system in which the ROM of a movable instrument component is restricted, the ROM of the corresponding master is restricted. If the ROM of the instrument component is restricted to ±45° in the first operating mode, the control system sets a tactile restriction on the master that restricts the corresponding master DOF to ±45°. This allows the surgeon to sense the restricted ROM and, if additional ROM of the instrument component is desired, to select a second operating mode in which the ROM is not restricted. As described above, the surgeon may select the second operating mode in various ways, such as by individual selection on the master or surgical control unit, by moving through tactile sensory cues (e.g., tactile "walls"), or by other appropriate control inputs (e.g., foot pedals, voice, eye-tracking menu selection, etc.).
[0073] In one embodiment, the control system automatically selects an operating mode associated with a limited parameter range after a mechanically movable part has operated within that limited parameter range for a predetermined amount of time. For example, the control system initially selects an operating mode of a first limited parameter range (e.g., ±60° ROM) when the instrument is first installed. The surgeon then selects and uses an operating mode of a second unlimited parameter range (e.g., ±90° ROM) for clinical requirements. If the surgeon continues to work for a specified time, the control system determines that the surgeon can no longer use the unlimited parameter range, and therefore selects the first limited parameter range again to prevent the surgeon from inadvertently operating within the second parameter range, which would increase the mechanical degradation of the part. The surgeon may select the second operating mode again if necessary.
[0074] The following is an example of the claims as originally filed. [Example 1] A remote surgery system, said remote surgery system, Remote-controlled manipulator and It includes a control system, The control system operates the remote surgery system in a first operating mode, and in the first operating mode, the control system drives the mechanical components of the surgical instrument coupled to the manipulator within a first operating parameter range. The control system operates the remote surgery system in a second operating mode, and in the second operating mode, the control system drives the mechanical components of the surgical instrument coupled to the manipulator within a second operating parameter range smaller than the first operating parameter range. Remote surgery system. [Example 2] The first operating parameter range includes the mechanical degrees of freedom of the first range of motion, The remote surgery system according to Embodiment 1, wherein the second operating parameter range includes the mechanical degrees of freedom of the second range of motion. [Example 3] The first operating parameter range includes a first mechanical degree of freedom of the first range of motion and a second mechanical degree of freedom of the first range of motion. The remote surgery system according to Embodiment 1, wherein the second operating parameter range includes the first mechanical degree of freedom of the second range of motion and the second mechanical degree of freedom of the second range of motion. [Example 4] The first operating parameter range includes a first speed range for the components of the surgical instrument. The remote surgery system according to Embodiment 1, wherein the second operating parameter range includes a second speed range for the components of the surgical instrument. [Example 5] The first operating parameter range includes the first acceleration range of the component of the surgical instrument, The remote surgery system according to Embodiment 1, wherein the second operating parameter range includes a second acceleration range of the component of the surgical instrument. [Example 6] The first operating parameter range includes a first mechanical load range on the components of the surgical instrument, The remote surgery system according to Embodiment 1, wherein the second operating parameter range includes a second mechanical load range on the components of the surgical instrument. [Example 7] Under the condition that the control system operates the remote surgical system only in the first operating mode during a surgical procedure, the control system reduces the remaining usable life of the surgical instrument by a first amount. The remote surgery system according to Embodiment 1, provided that the control system operates the remote surgery system in the second operating mode during the surgical procedure, the control system reduces the remaining usable life of the surgical instrument by a second amount less than the first amount. [Example 8] The control system reduces the remaining usable time of the surgical instrument by a first amount as a result of the remote surgery system operating in the first operating mode. The remote surgery system according to Embodiment 1, wherein the control system reduces the remaining usable time of the surgical instrument by a second amount less than the first amount as a result of the remote surgery system operating in the second operating mode. [Example 9] The control system reduces the number of individual lifespans remaining in the surgical instruments by a first amount as a result of the remote surgery system operating in the first operating mode. The remote surgery system according to Embodiment 1, wherein the control system reduces the number of individual lifespans remaining in the surgical instruments by a second amount less than the first amount, as a result of the remote surgery system operating in the second operating mode. [Example 10] The control system reduces the number of individual lifespans remaining in the surgical instrument by one individual lifespan as a result of the remote surgery system operating in the first operating mode throughout the entire surgical procedure. The remote surgery system according to Embodiment 1, wherein the control system reduces the number of individual lifespans remaining in the surgical instrument by less than one individual lifespan as a result of the remote surgery system operating in the second operating mode throughout the entire surgical procedure. [Example 11] The control system reduces the number of individual lifespans remaining in the surgical instrument by one individual lifespan as a result of the remote surgery system operating in the first operating mode for a predetermined amount of time. The remote surgery system according to Embodiment 1, wherein the control system reduces the number of permissible individual lifespans remaining in the surgical instrument by less than one individual lifespan as a result of the remote surgery system operating in the second operating mode for a predetermined amount of time. [Example 12] It further includes an operating mode input, The remote surgery system according to Embodiment 1, wherein the control system changes from operating the remote surgery system in the second operating mode to operating the remote surgery system in the first operating mode in response to a user input received via the operating mode input. [Example 13] The remote surgery system according to Embodiment 12, wherein, after the control system changes from operating the remote surgery system in the second operating mode to operating the remote surgery system in the first operating mode in response to the user input, the control system changes from operating the remote surgery system in the first operating mode to operating the remote surgery system in the second operating mode in response to the control system's determination that it has driven the mechanical component of the surgical instrument within the second operating parameter range for a predetermined amount of time. [Example 14] A remote surgery system, said remote surgery system, Surgical instruments including movable parts, It includes a control system, The control system operates the components of the surgical instrument within a first range of operating parameters over a first time period. The control system operates the component of the surgical instrument within a second operating parameter range smaller than the first operating parameter range for a second period of time. The control system reduces the remaining usable time of the surgical instrument by a first amount based on the first amount of time. The control system reduces the usable time remaining in the surgical instrument by a second amount less than the first amount, based on the first amount of time. Remote surgery system. [Example 15] A remote surgery system, said remote surgery system, Surgical instruments including movable parts, It includes a control system, The control system operates the components of the surgical instrument within a first range of operating parameters over a first time period. The control system operates the component of the surgical instrument within a second operating parameter range smaller than the first operating parameter range for a second period of time. The control system reduces the number of individual lifespans remaining in the surgical instrument by a first amount based on the first amount of time. The control system reduces the number of individual lifespans remaining in the surgical instrument by a second amount less than the first amount, based on the second amount of time. Remote surgery system. [Example 16] The remote surgery system according to Example 15, wherein the first amount of the number of individual lifespans remaining in the surgical instrument is less than the total individual lifespan. [Example 17] The remote surgery system according to Example 15, wherein the second amount of the number of individual lifespans remaining in the surgical instrument is less than the total individual lifespan. [Example 18] The first operating parameter range includes a first speed range for the component, The remote surgery system according to Embodiment 14 or 15, wherein the second operating parameter range includes a second speed range for the component. [Example 19] The first operating parameter range includes the first acceleration range of the component, The remote surgery system according to Embodiment 14 or 15, wherein the second operating parameter range includes a second acceleration range of the component. [Example 20] The first operating parameter range includes a first mechanical load range for the component, The remote surgery system according to Example 14 or 15, wherein the second operating parameter range includes a second mechanical load range for the component.
Claims
1. Surgical instruments, said surgical instruments are, Operating parts and A movable part connected to the operating part, Includes memory, The memory is, To store the remaining usable lifespan of the surgical instrument in question. The recipient receives an updated remaining usable life value for the surgical instrument, the updated remaining usable life value is determined by reducing the remaining usable life value by a first amount and a second amount different from the first amount, the first amount increasing as the degree of movement of the movable part within a first operating parameter range increases, the second amount increasing as the degree of movement of the movable part within a second operating parameter range different from the first operating parameter range increases, the degree of movement corresponding to (i) the frequency and / or duration of movement of the movable part within or beyond the first operating parameter range and / or (ii) the location and / or intensity of movement of the movable part within the first operating parameter range and / or the second operating parameter range, and the first amount and the second amount are different because the first operating parameter range and the second operating parameter range have different reductions with respect to the remaining usable life of the surgical instrument, and It is configured to store the updated remaining usable life value. Surgical instruments.
2. The surgical instrument according to claim 1, wherein the updated remaining usable lifespan value is an individual number representing the remaining lifespan of the surgical instrument.
3. The surgical instrument according to claim 1, wherein the updated remaining usable lifespan value is an indicator of the remaining usage time of the surgical instrument.
4. The surgical instrument according to claim 1, wherein the memory is further configured to store a unique identification number of the surgical instrument.
5. The surgical instrument according to claim 1, wherein the first operating parameter range includes a first range of motion of the mechanical degrees of freedom, and the second operating parameter range includes a second range of motion of the mechanical degrees of freedom.
6. A medical device, said medical device, Surgical instruments including memory, A control system configured to execute commands and perform actions, The aforementioned operation includes, To receive the remaining usable lifespan value of the surgical instrument from the memory, Monitoring the amount of use of the surgical instrument, wherein the amount of use includes a first amount that increases as the degree of operation of the surgical instrument within a first operating parameter range increases, and a second amount that increases as the degree of operation of the surgical instrument within a second operating parameter range different from the first operating parameter range increases, wherein the first amount is different from the second amount, and the degree of operation corresponds to (i) the frequency and / or duration of operation of the surgical instrument within or beyond the first operating parameter range, and / or (ii) the location and / or intensity of operation of the surgical instrument within the first operating parameter range or the second operating parameter range, and the first amount and the second amount are different because the first operating parameter range and the second operating parameter range have different rates of decrease with respect to the remaining usable life of the surgical instrument. Determining the updated remaining usable lifespan of the surgical instrument based on the amount of use of the surgical instrument, wherein determining the updated remaining usable lifespan includes reducing the remaining usable lifespan by the first and second amounts, and This includes saving the updated remaining usable lifespan value to the memory of the surgical instrument. Medical device.
7. The medical device according to claim 6, wherein the memory is configured to store the updated remaining usable life value at least until the future use of the surgical instrument.
8. The medical device according to claim 7, wherein the memory is configured to transmit to the control system the updated remaining usable life value stored in the memory before the future use of the surgical instrument.
9. The medical device according to claim 8, wherein the control system is configured to prevent the future use of the surgical instrument if the updated remaining usable lifespan falls below a predetermined value.
10. The medical device according to claim 6, wherein the remaining usable lifespan value is the remaining number of permissible individual lives or the remaining amount of permissible time, and the updated remaining usable lifespan value is the updated remaining number of permissible individual lives or the updated amount of permissible time.
11. A method, and said method is The steps include receiving the remaining usable life value of the surgical instrument from the memory of the surgical instrument via the control system, A step of monitoring the amount of use of the surgical instrument, wherein the amount of use includes a first amount that increases as the degree of operation of the surgical instrument within a first operating parameter range increases, and a second amount that increases as the degree of operation of the surgical instrument within a second operating parameter range different from the first operating parameter range increases, wherein the first amount is different from the second amount, and the degree of operation corresponds to (i) the frequency and / or duration of operation of the surgical instrument within or beyond the first operating parameter range, and / or (ii) the location and / or intensity of operation of the surgical instrument within the first operating parameter range or the second operating parameter range, and the first amount and the second amount are different because the first operating parameter range and the second operating parameter range have different depreciation rates with respect to the remaining usable life of the surgical instrument, A step of determining the updated remaining usable lifespan of a surgical instrument based on the amount of use of the surgical instrument, wherein determining the updated remaining usable lifespan includes reducing the remaining usable lifespan by the first and second amounts, The step includes storing the updated remaining usable lifespan value in the memory of the surgical instrument, method.
12. The method according to claim 11, wherein the step of storing the updated remaining usable lifespan value in the memory includes storing the updated remaining usable lifespan value in the memory for at least until the future use of the surgical instrument.
13. The method according to claim 12, further comprising the step of transmitting the updated remaining usable life value stored in the memory to the control system before the future use of the surgical instrument.
14. The method according to claim 13, further comprising the step of preventing the future use of the surgical instrument if the updated remaining usable lifespan falls below a predetermined value.
15. The method according to claim 11, wherein the remaining usable life value is the remaining number of allowed individual lives or the remaining amount of allowed time, and the updated remaining usable life value is the updated remaining number of allowed individual lives or the updated amount of allowed remaining time.
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