Devices for instrument use logging, devices for logging instrument reprocessing events, and related systems and methods

Abstract

An instrument can include a shaft having a proximal portion and a distal portion, an end effector at the distal portion of the shaft, and a transmission mechanism at the proximal portion of the shaft. The transmission mechanism can include a driven input device that is engageable with an external drive mechanism. The instrument can include an indicator that is operably coupled to the driven input device and is movable through each of a plurality of successive positions, each of the plurality of successive positions being associated with a unique indicia of a non-zero number of uses remaining for the instrument. In response to the driven input device being driven, the indicator moves from a current position of the plurality of positions to a subsequent position of the plurality of positions. Devices, systems, and methods relate to instrument use recording and record reprocessing cycles.

Description

TECHNICAL FIELD

[0001] This application claims priority to U.S. Provisional Application No. 63 / 003,986, filed April 2, 2020; U.S. Provisional Application No. 63 / 003,987, filed April 2, 2020; and U.S. Provisional Application No. 63 / 025,563, filed May 15, 2020, each of which is incorporated herein by reference in its entirety.

[0002] Aspects of the present disclosure relate to devices, systems, and methods for recording the number of times an instrument is used and communicating such usage information to an individual and / or a control system that controls use of the instrument. Other aspects of the present disclosure relate to recording occurrences of a medical instrument being subjected to one or more environmental conditions associated with a reprocessing process or other event for which it is desirable to record. Related devices, systems, and methods are also disclosed. BACKGROUND

[0003] Various instruments can be used to perform a procedure, such as a surgical procedure, other medical procedure, or non-medical procedure. For example, a medical instrument can be used with a manipulator of a teleoperated computer-assisted surgical system. Other surgical instruments can include handheld, manually operated instruments. Industrial instruments likewise can include instruments used with a computer-assisted system or a manually operated system. In many cases, such instruments have a predetermined lifespan such that once the predetermined lifespan is reached, use of the instrument can be prohibited or not recommended, regardless of whether the instrument is still operable. Such predetermined lifespan can be indicated by various factors, such as the susceptibility of components of the instrument to wear or other degradation, design limitations related to fatigue life, the ability of the instrument to withstand repeated cleaning and / or sterilization processes, or other factors including regulatory requirements.

[0004] Use of such instruments can be tracked manually, such as by keeping manual records based on instrument identification numbers. Further, for instruments that are electronically coupled with a system, such as a teleoperated computer-assisted manipulator system, such use can be tracked electronically, for example, relying on instrument identification data stored on the instrument, and the number of uses can be communicated through an electronic display associated with the manipulator system. However, the latter type of approach does not communicate usage information when the instrument is disconnected from the manipulator system, and the former type of approach is prone to error and can also pose challenges to accessing manually saved records.

[0005] Further, in many cases, it is desirable to subject the used instrument to one or more types of cleaning processes (e.g., washing and / or sterilization) to ensure that the instrument has sufficient cleanliness and / or sterility prior to another use of the instrument. As used herein, the term "reprocessing" is meant to encompass any process or combination thereof used to prepare the instrument for subsequent use. Reprocessing can include, but is not limited to, any one or more of washing, heat sterilization, ultrasonic cleaning, autoclaving, and disinfecting.

[0006] Due to various factors, it can be desirable and in certain cases required by regulation to limit the number of times an instrument can be reprocessed and subsequently used. Accordingly, there is a need to track the number of times an instrument has been reprocessed. Because there are challenges in manually tracking such information, and because such manual tracking can be time intensive, it is desirable to automate such tracking of reprocessed instruments.

[0007] There is a need to track the number of times an instrument has been used in a manner that does not require additional effort by the user or support staff and that provides usage information accessible from the instrument, regardless of whether the instrument is connected to a manipulator system (or other powered system). Further, there is a need for reliable and robust devices, systems, and methods that accurately record reprocessing to which an instrument is subjected. Further, there is a need for devices, systems, and methods that store and communicate information to individuals and / or control systems regarding the number of times an instrument has experienced reprocessing. Further, there is a need to record, store, and / or communicate information regarding changes in environmental conditions to which an instrument is subjected, which can include any one or more of temperature excursions, pressure excursions, and various forms of energy to which the instrument is subjected, such as ultrasonic waves. SUMMARY

[0008] Exemplary embodiments of the present disclosure can address one or more of the issues set forth above and / or can exhibit one or more of the desirable features set forth above. Other features and / or benefits can become apparent from the following description.

[0009] According to at least one embodiment of the present disclosure, an instrument includes a shaft having a proximal portion and a distal portion, an end effector at the distal portion of the shaft, and a transmission mechanism at the proximal portion of the shaft. The transmission mechanism includes a driven input device that is engageable with an external drive mechanism. The instrument includes an indicator that is operably coupled to the driven input device and is movable through each of a plurality of consecutive positions, each of the plurality of consecutive positions being associated with a unique indicia of a non-zero number of available uses remaining for the instrument. In response to the driven input device being driven, the indicator moves from a current position of the plurality of positions to a subsequent position of the plurality of positions.

[0010] According to at least another embodiment of the present disclosure, a method of indicating a number of available uses of an instrument includes coupling the instrument with a manipulator system, operating a driven input device of the instrument by actuating a drive mechanism of the manipulator, and moving an indicator of the instrument from a current position of a plurality of positions to a subsequent position of the plurality of positions. The subsequent position of the indicator is associated with a marker that indicates a non-zero number of available uses that is less than a marker associated with the current position.

[0011] According to at least another embodiment of the present disclosure, a medical device includes a first indicator movable through a first plurality of positions and a second indicator movable through a second plurality of positions. Each position of the first plurality of positions is associated with a unique marker of a number of available uses remaining on the instrument. Each position of the second plurality of positions is associated with an occurrence of a change in an environmental condition experienced by the instrument.

[0012] According to at least another embodiment of the present disclosure, a device for recording changes in environmental conditions experienced by a medical instrument can include a state change element transitionable between a first state and a second state in response to a change in an environmental condition, the amount of the change can be predetermined. The device can include a counter mechanism operably coupled to the state change element. The counter mechanism can incrementally move in response to a transition of the state change element from the first state to the second state. A user-accessible storage device can be operably coupled to the counter mechanism, and the user-accessible storage device can be configured to store and provide information representative of a number of transitions of the state change element.

[0013] According to at least another embodiment of the present disclosure, a device for recording changes in environmental conditions experienced by a medical instrument includes an electronic non-volatile memory and a voltage source in a circuit with the memory. The memory is operably coupled to the voltage source such that, under conditions in which the device is exposed to a change in an environmental condition, the voltage source applies a voltage to the memory.

[0014] According to at least another embodiment of the present disclosure, a device for recording changes in environmental conditions experienced by a medical instrument includes a state change element transitionable between a first state and a second state in response to a predetermined change in an environmental condition. A counter mechanism is operably coupled to the state change element, and the counter mechanism is incrementally movable in response to a transition of the state change element from the first state to the second state. A visual indicator is operably coupled to the counter mechanism, and the visual indicator is configured to display information representative of a number of transitions of the state change element. An indicator flag is configured to occlude a field of view of the visual indicator in the event that the visual indicator reaches a predetermined value of the information representative of the number of transitions of the state change element.

[0015] Additional objects, features and / or benefits will be apparent in view of the following description and appended claims, and will be learned through practice of the disclosure and / or claims. At least some of these objects and benefits will be realized by means imparted hereunder in the particular embodiments, and will be learned through practice of the disclosure and / or claims.

[0016] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure, as claimed; the disclosure being entitled to broad scope, equivalents, and full scope of the claims. BRIEF DESCRIPTION OF DRAWINGS

[0017] The present disclosure can be understood, by itself, and in conjunction with the accompanying drawings. The drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate one or more embodiments of the present teachings and, together with the description, explain certain principles and operations. In the drawings,

[0018] Figure 1 is a schematic side view of an instrument including a device for recording instrument use according to an exemplary embodiment of the present disclosure.

[0019] Figure 2 is a side perspective view of a portion of an instrument including a device for recording instrument use according to another exemplary embodiment of the present disclosure.

[0020] Figure 3 is a bottom perspective view of the portion of the instrument of Figure 2 .

[0021] Figure 4 is a perspective view of a rotatable disc of a device for recording instrument use according to an embodiment of the present disclosure. Figure 2

[0022] Figure 5 is a perspective view of a drive mechanism for coupling to an instrument according to an exemplary embodiment of the present disclosure.

[0023] Figure 6 is an exploded view of an instrument base, a rotatable disc of a device for recording instrument use, and a drive mechanism according to an embodiment of the present disclosure.

[0024] Figures 7A-7D shows a bottom view of the device of Figure 3 at different positions of the rotatable disc of the device for recording instrument use.

[0025] Figure 8 is a partial perspective view of an instrument and a portion of a device for recording instrument use according to another exemplary embodiment of the present disclosure, with a housing portion removed to reveal features of the device for recording instrument use.​

[0026] Figure 9 yes Figure 8 Detailed view of part 9-9 of the device shown.

[0027] Figure 10 This is a perspective view of a portion of an apparatus and a device for recording the use of the apparatus according to another exemplary embodiment of this disclosure.

[0028] Figure 11 yes Figure 10 A perspective view of a portion of the apparatus, with the outer casing removed to reveal the features of this disclosure.

[0029] Figure 12 This is a flowchart illustrating a workflow for operating a device for recording instrument use, according to exemplary embodiments of the present disclosure.

[0030] Figure 13 This is a perspective view of a manipulator system with an instrument installed according to an embodiment of the present disclosure.

[0031] Figure 14 This is a schematic diagram of an embodiment of a manipulator system with two instruments in the mounting position, according to another embodiment of the present disclosure.

[0032] Figure 15 This is a schematic side view of an apparatus including a device for recording the use of the apparatus, according to another exemplary embodiment of this disclosure.

[0033] Figure 16 This is a schematic side view of an apparatus equipped with a device for recording the reprocessing process undergone by the apparatus, according to an exemplary embodiment of the present disclosure.

[0034] Figure 17 This is a perspective view of an apparatus for recording a reprocessing process according to another embodiment of the present disclosure.

[0035] Figure 18A yes Figure 17 A plan view of the device, showing the device in a first state according to an embodiment of the present disclosure.

[0036] Figure 18B An embodiment according to this disclosure is shown. Figure 18A The device is in the second state.

[0037] Figure 19 This is a schematic diagram of an apparatus for recording a reprocessing process according to another exemplary embodiment of the present disclosure.

[0038] Figure 20Ais a perspective view of a device for recording reprocessing procedures according to an example embodiment of the present disclosure, with the housing omitted to show internal components.

[0039] Figure 20B is Figure 20A a perspective view of the device with the housing portion in place.

[0040] Figure 21 is a plan view of a housing of an instrument with visual indicia according to another example embodiment of the present disclosure.

[0041] Figure 22 is a schematic side view of a device for recording reprocessing procedures according to another example embodiment of the present disclosure.

[0042] Figure 23A is a perspective view of a device for storing and providing information about reprocessing procedures undergone by an instrument according to an example embodiment of the present disclosure.

[0043] Figure 23B is Figure 23A another perspective view of the device shown.

[0044] Figure 24 is a schematic circuit diagram of a device for storing and providing information about reprocessing procedures of an instrument according to another example embodiment of the present disclosure.

[0045] Figure 25 is a block diagram of a device for storing and providing information about reprocessing procedures undergone by an instrument according to yet another example embodiment of the present disclosure.

[0046] Figure 26A is a schematic plan view of a locking device according to an example embodiment of the present disclosure.

[0047] Figure 26B is Figure 26A a schematic side view of the locking device.

[0048] Figures 27A-27E is a detailed perspective view of a device for storing and providing information about reprocessing procedures undergone by an instrument according to yet another example embodiment of the present disclosure.

[0049] Figure 28 is a schematic side view of another device for storing and providing information about reprocessing procedures undergone by an instrument according to yet another example embodiment of the present disclosure.

[0050] Figure 29 is a perspective view of a device for recording reprocessing procedures undergone by an instrument according to another example embodiment of the present disclosure.

[0051] Figure 30 is another perspective view of the device of Figure 29

[0052] Figure 31 is yet another perspective view of the device of Figure 29

[0053] Figure 32 is a partial side view of the device of Figure 29

[0054] Figure 33 is a schematic side view of a portion of an instrument including a device for recording use of the instrument and a device for recording reprocessing of the instrument according to an example embodiment of the present disclosure.

[0055] Figure 34 is a side view of a portion of an instrument including a device for recording use of the instrument and a device for recording reprocessing of the instrument according to an example embodiment of the present disclosure.

[0056] Figure 35 is a side view of a portion of an instrument of Figure 34 wherein the housing is omitted.

[0057] Figure 36 is an enlarged side view of a device for recording reprocessing of an instrument of Figure 34

[0058] Figure 37 is a schematic side view of a portion of an instrument including a device for recording use of the instrument and a device for recording reprocessing of the instrument according to another example embodiment of the present disclosure. DETAILED DESCRIPTION

[0059] The present disclosure provides various devices for recording use of an instrument and for communicating such use information, as well as related systems and methods. Such recording devices can be included in or integrated with tools such as surgical or industrial instruments. Recording devices according to the present disclosure can operate based on mechanical inputs to the recording device that occur when the instrument is coupled with a manipulator system, such as a manipulator system operated at least partially under computer assistance or a manually operated manipulator system.

[0060] ​​​​The recording device of various exemplary embodiments can include various components configured to be operably coupled with a drive mechanism of a manipulator system. The drive mechanism can be configured to drive a component with a specified input based on, for example, an initial connection with the manipulator system, use of an instrument with the manipulator system for a specified period of time, use of the instrument for a specified series of motions or a specified number of motions, or selection of other particular criteria indicative of use of the tool. Examples of various criteria that can be used to determine when use should be recorded are provided in U.S. Patent No. 7,835,823 (filed November 6, 2006) and U.S. Patent Application Publication No. US 2016 / 0361048 Al (filed March 17, 2015), the entireties of each of which are incorporated herein by reference.

[0061] The recording device can be configured to communicate information, such as by exhibiting a marker of the number of remaining uses of a plurality (i.e., nonzero) of the remaining available uses of the instrument. Additionally or alternatively, the marker can exhibit the number of uses of the instrument that have been used. Other recording devices according to the present disclosure can be configured to display the remaining available portion or the used portion of the total life of the instrument. Such devices can be implemented in a gauge-type approach, such as similar to a vehicle fuel gauge, or other types of analog and / or digital indicators. The marker can include, but is not limited to, a visual marker, a tactile marker, an audible marker, or any marker that provides a form of feedback to a user.

[0062] The marker can be provided on an indicator of the instrument that is accessible whether or not the instrument is connected to any manipulator system or other powered system to which the instrument is coupled when in use. In this way, the marker can represent a mechanical form of “non-volatile” storage. The marker can be positioned and designed to be easily recognized and understood by a user of the instrument or by personnel responsible for transporting, storing, tracking, or otherwise handling the instrument. For example, the marker can be a visual marker configured to be visible through an aperture (which can be covered or uncovered) in the housing of the instrument.

[0063] The marker can be in the form of an integer number of remaining uses, an integer number of uses that the instrument has experienced, a fractional indication of remaining or used life of the instrument, or other types of indicators. Other types of indicators can include gauge-type indicators, color-coded indicators, or other indication schemes, such as using tactile, audible, or other feedback. Further, the indicator associated with the marker can include a feature that maintains the marker in a given configuration upon removal of the instrument from the manipulator, and such a feature can maintain the indicator in a given configuration until a subsequent use of the instrument causes the recording device to advance the indicator to another configuration in response to use of the instrument.

[0064] Regardless of the specific form of the indicia, embodiments of the present disclosure can provide information as to how much of the total number of uses of the instrument that are intended for the instrument remain. Such information can be used to provide additional information about the remaining life of the instrument to help plan a procedure in which the instrument is to be used, which in some cases can require multiple uses of the instrument. Thus, knowing whether the instrument has enough uses left can be helpful to the staff when selecting an instrument for a particular procedure.

[0065] In addition to information about the number of uses to which the instrument has been subjected, it can also be desirable to provide information about the number of reprocessing procedures to which the instrument has been subjected. Thus, in addition to a recording device that records the number of uses of the instrument, the present disclosure provides a device for recording one or more events to which the instrument has been subjected, such as changes in environmental conditions that occur during a reprocessing procedure. Such reprocessing procedures can involve the application of heat and resulting temperature excursions, the application of ultrasonic or other mechanical energy, exposure to pressure cycling or other conditions. In various embodiments, such a reprocessing recording device can operate based on exposure to temperature changes, exposure to pressure changes, and / or the application of various forms of energy to which the instrument can be subjected (e.g., ultrasonic energy) so as to be able to record the number of instances to which the instrument has been so subjected.

[0066] Such a reprocessing recording device can be a mechanical device made of relatively few moving parts. Moreover, in some embodiments, the reprocessing recording device does not require a constant power source to operate. Moreover, the reprocessing recording device according to various exemplary embodiments can reliably and independently operate in relatively extreme environments, such as one or more of a humid or steam environment, an environment with chemicals, an environment with relatively high or relatively low temperatures, including cleaning, disinfecting, and / or autoclave temperatures, such as an environment with high humidity levels, an environment at relatively high or low pressures, and an environment subjected to various energy modalities, such as in an ultrasonic washer environment, fluid flushing, and / or mechanical agitation.

[0067] Providing an instrument according to the present disclosure that includes both a use recording device and a reprocessing recording device can ensure that the instrument is able to reliably provide useful information to a user about how many uses and reprocessing events the instrument has experienced, and thus provide a final suitability of the instrument.

[0068] Instrument use recording device, system, and method

[0069] Reference is now made to Figure 1FIG. 1 shows a schematic side view of an instrument 100 according to example embodiments of the present disclosure. The instrument 100 includes a distal end portion 102, which can include an end effector 104, which can include, without limitation, a surgical tool such as scissors, forceps, a needle, an electrosurgical tool, an imaging or other sensing device, a suturing device, or any other medical or non-medical implement. A shaft 106 extends from the distal end portion 102 of the instrument 100 to a proximal end portion 108. The proximal end portion 108 can be or include a transmission mechanism 110 configured to be operably coupled with a surgical manipulator system, for example, a teleoperated surgical system operating at least in part under computer assistance, such as the da Vinci® Surgical System commercialized by Intuitive Surgical, Inc. of Sunnyvale, California, or it can be manually controlled through manually operated (e.g., handheld) actuators (not shown). Optionally, the instrument 100 can include a wrist 105 coupling the end effector 104 to a distal end portion of the shaft 106 to provide one or more degrees of freedom of motion of the end effector 104 relative to the shaft 106. The surgical system, or it can be manually controlled through manually operated (e.g., handheld) actuators (not shown). Optionally, the instrument 100 can include a wrist 105 coupling the end effector 104 to a distal end portion of the shaft 106 to provide one or more degrees of freedom of motion of the end effector 104 relative to the shaft 106.

[0070] The instrument 100 includes a device for recording instrument usage, which can include an indicator 112 including indicia reflecting information about a number of times of instrument usage that has occurred during a predetermined lifetime, as will be described in greater detail below, a general subject matter tag such as Figure 1 is shown to represent the indicia that can be displayed. The usage recording device can be integrated into a housing of the instrument 100, as in the example embodiments of Figure 1 . The usage recording device can record and communicate information about a number of times of instrument usage (e.g., one or both of a number of times of usage out of a predetermined number of times of usage or a remaining number of available times of usage) of a predetermined lifetime of the instrument 100, such as via visual indicia. Such recording can be based on actuation of an input device of the instrument by a driving device, for example, a driving device of a manipulator to which the instrument and thus the input device are operably coupled. The input device of the instrument actuated by the driving device can be referred to herein as a driven input device.

[0071] Reference is now made to Figure 2 , which shows a transmission mechanism portion of an instrument including a usage recording device according to example embodiments of the present disclosure (the shaft and distal end portion are not shown for simplicity in Figure 2 . Figure 2A perspective view is shown, primarily showing the side of the transmission mechanism 210 of the device 200, with the indicator 212 visible from the side of the device 200. The shaft 206 of the device 200 typically extends from a collar 211 at the bottom of the transmission mechanism 210. The indicator 212 is configured to be visible from the outside of the device 200. For example, the housing portion of the transmission mechanism 210 may include holes, transparent windows, or other features that reveal the indicator, making it visible from the outside of the device 200. As described above, the indicator may include one or more of integer, fractional, meter-type, color-coded indicator schemes, or other indicators. Furthermore, non-visual types of indicators are contemplated, such as tactile indicators (e.g., Braille integers in addition to or replacing visual integers, or other tactile indicators), auditory indicators, or indicators utilizing other types of feedback.

[0072] exist Figure 2 In the device shown, the housing portion 214 of the transmission mechanism 210 (in) Figure 2 The base of the device (in the center) includes a hole 215 through which a visual mark 216 is shown. The mark 216, visible through the hole 215, is an integer representing the remaining (non-zero) number of uses available for the device 200. (Except for or instead of) Figure 2 The markings shown may expose other types of markings, such as color-coded indicators, gauge indicators such as tapered bar graphics, tactile indicators, etc., as discussed herein. As used herein, "markings" refers to one or more markings that individually or collectively indicate or convey information.

[0073] As described above, the indicator can be operatively coupled to an external drive mechanism, such as the drive mechanism of the manipulator to which device 200 is attached. The manipulator may include, for example, a manipulator system (such as the following combination) Figure 13 and Figure 14 The manipulator systems discussed herein are manual operating instruments or other manipulator systems. The indicator may have multiple unique positions, each representing the remaining number of uses of the instrument. Changing the position of the indicator results in different markings being exposed through aperture 215. This change of position can be accomplished by actuating the drive mechanism of the manipulator system coupled to the instrument, such as a manual manipulator system or a remote manipulator system that is at least partially operated with computer assistance.

[0074] Figure 3 Shown in perspective Figure 2The transmission mechanism 210 of the instrument 200 is shown primarily on the drive interface side of the instrument 200. The drive interface includes multiple input discs configured to be coupled to drive output members (e.g., in the case of a remote computer-assisted surgical system, a manipulator system). The multiple input discs include a rotatable disc 218 for an indicator. The rotatable disc 218 can engage with the drive mechanism of the manipulator system, as will be discussed in more detail below. The rotatable disc 218 is located within a cavity 219 of the housing portion 214, and its outer sidewall 220 is visible through a hole 215. Figure 4 Part of ).

[0075] Now for reference Figure 4 The exploded view shows the housing portion 214 of the device 200. Figure 3 ) cavity 219 ( Figure 3 Remove the rotatable disk 218 from the ( ). For example... Figure 4 As shown, the rotatable disk 218 includes visual markings displayed in integer form around the outer sidewall 220 of the rotatable disk 218. The integers may be printed, molded, embossed, or otherwise provided on the outer sidewall 220 of the rotatable disk 218. As mentioned above, other types of markings may be provided in place of or alongside the integers, such as tapered bar graphic indicators or other types of fractional indicators showing a proportion of the tool's remaining lifespan. Those skilled in the art will understand that various other markings (such as the alternatives discussed above) may be used to convey the remaining or approximate remaining lifespan of the instrument. The rotatable disk 218 may have multiple consecutive positions, each corresponding to a different marking visible from the outside of the instrument, representing a non-zero number of remaining usable uses of the instrument.

[0076] The recording device may include various features configured to prevent unintentional movement of its mechanical components when the transmission mechanism 210 of the instrument 200 is not coupled to the operating system (e.g., during storage, transport, or other handling of the instrument 200). Such features may include a locking mechanism that prevents unintentional backward or forward driving of the recording device, which could lead to unintentional and incorrect alteration of the information transmitted by the indicator.

[0077] For example, in Figures 2-4 In the illustrated device, both the rotatable disk 218 and the housing portion 214 may include features configured to prevent unintentional rotation of the rotatable disk 218 when the instrument 200 is not coupled to the operating system. (See again) Figure 3, the cavity 219 of the housing portion 214 includes a plurality of grooves 222 formed on the inner side wall of the cavity 219, generally so as to surround the rotatable disc 218. The rotatable disc 218 includes features configured to engage the plurality of grooves 222 of the cavity 219. As best seen in Figure 4 , the rotatable disc 218 includes a first flexible member 224 and a second flexible member 226, each having a radially extending portion 228 extending therefrom and configured to engage the housing portion 214 within the grooves 222 in the cavity 219 to prevent rotation of the rotatable disc 218, as discussed further below. The grooves 222 and the radially extending portions 228 can be arranged such that each position of the radially extending portion 228 within a pair of grooves 222 is associated with a different indicium (e.g., different integer, different bar graph height, etc.) being displayed by the aperture. Figure 3

[0078] With continued reference to Figure 4 , the first and second flexible members 224, 226 each include a cam surface 225, 227 that is oblique with respect to the radial. The cam surfaces 225, 227 are located at respective free ends of the flexible members 224, 226. The rotatable disc 218 further includes release portions 229, 231 adjacent to the cam surfaces 225, 227 and extending circumferentially around a portion of the rotatable disc 218. In the device disclosed in conjunction with Figures 2-4 , the release portions 229, 231 are offset with respect to the rotational axis A D of the rotatable disc 218.

[0079] In the illustrated embodiment, the two flexible members 224, 226 are disposed diametrically opposite one another on the rotatable disc 218. Those of ordinary skill in the art will appreciate that one or more flexible members can be used without departing from the scope of the present disclosure.

[0080] As noted above, components of the use logging device of the present disclosure, such as the rotatable disc 218, can be configured to operably engage an external drive mechanism, for example an output drive mechanism associated with a manipulator system used in conjunction with the instrument of the present disclosure. For example, the use logging device of the present disclosure can be configured to engage a rotatable output drive mechanism of a manipulator system. Referring now to Figure 5 , an output drive mechanism 530 of a manipulator system (e.g., the manipulator system shown in Figure 13 and Figure 14 ) is shown separately. The drive mechanism 530 includes features configured to interact with mechanical components of the use logging device. While the drive mechanism 530 of Figure 5 is a drive disc, those of ordinary skill in the art will appreciate that other configurations of drive mechanisms can also be within the scope of the present disclosure. ​

[0081] The drive mechanism 530 includes one or more protrusions, such as two protrusions 532 and 534. The two protrusions are located at different circumferential and radial positions on the drive mechanism 530. For example, in Figure 5 In the embodiment, the protrusions 532 and 534 are relative to the rotation axis A of the drive mechanism 530 R They are positioned diametrically opposite each other, and protrusions 532 and 534 are also radially offset from each other. That is, each protrusion 532 and 534 is located at a distance from the rotation axis A of the drive mechanism 530. R The radial distances are different.

[0082] Figure 6 The device 200 is shown. Figure 2 The base of the outer casing 214, the rotatable disk 218 ( Figure 4 ) and drive mechanism 530 ( Figure 5 An exploded view of the device 200. When the device 200 is coupled to a manipulator (e.g., the drive interface of the transmission mechanism 210 is coupled to the manipulator, as shown below). Figure 13 and Figure 14 (As discussed), the rotation axis A of the output drive mechanism 530 R The axis of rotation A of the rotatable disk 218 D Alignment, as shown by the dashed connecting lines. When the instrument 200 is coupled to the manipulator, in the release portions 229, 231 of the rotatable disk 218 ( Figure 4 The contents include protrusions 532 and 534 of the drive mechanism 530. Once the instrument and manipulator are coupled and ready for use, or when use of the instrument and manipulator begins, they are operably coupled to the control system of the manipulator (e.g., with...). Figure 13 The system 1300 shown or Figure 14 The control system 1462 shown, associated with the control system 1362, can evaluate whether use should be reduced from the use recording device based on any of the criteria described above. As used in the discussion below, "reduced" lifespan from the use recording device may include any and all of the displayed integers being reduced to indicate less remaining use, any and all of the displayed integers being increased to indicate more uses the device has undergone, increasing or decreasing the fraction type display, or any other change in visual or other markings displayed at the indicator of the use recording device that can provide an indication of the remaining number of uses of the device.

[0083] Combination Figures 7A-7D The operation of the recording device when coupled with a manipulator was discussed. Now refer to... Figure 7A The illustration shows Figure 3FIG. 6 is a bottom view of the device of FIG. 5, the projections 532 and 534 of the drive mechanism 530 are shown as being received within the release portions 229, 231 at an initial position that represents the relationship of the drive mechanism 530 ( Figure 6 ) and the rotatable disk 218 when the instrument 200 is initially coupled with the manipulator system. As is familiar to those of ordinary skill in the art, the manipulator system can include a self-indexing capability to place the drive mechanism 530 in the initial position relative to the rotatable disk 218, as shown in Figure 7A , for example. The drive mechanism 530 can be spring-loaded, for example, such that the drive mechanism 530 can be placed in contact with the rotatable disk 218 regardless of the relative rotational orientation of the components. In other words, the drive mechanism 530 and / or the projections 532, 534 can be biased in the direction of the rotational axis A R such that the projections 532, 534 do not have to be aligned with the release portions 229, 231 for the drive mechanism 530 to be coupled to the rotatable disk 218. In such an example embodiment, upon coupling, the manipulator can drive the drive mechanism 530 in a counterclockwise direction (relative to the view of Figure 7A ) until the biased projections reach and enter the release portions 229, 231. The drive mechanism 530 is further driven counterclockwise until the projections 532, 534 abut the ends of the release portions 229, 231 opposite the rotational direction of the cam surfaces 225, 227 and the associated flexible members 224, 226 due to the engagement of the radially extending portions 228 in the grooves 222. In this configuration, the drive mechanism 530 (except for the projections 532, 534, which are not shown) is indexed at the initial position shown in Figure 7A , and information regarding this initial position can be stored by, for example, an electronic controller of the manipulator system.

[0084] In the state shown in Figure 7A , at least a portion of the rotatable disk 218 can be seen through the aperture 215 Figure 2 to show the desired indicia of remaining predetermined life. In one non-limiting embodiment, for example, the indicia is one of a plurality of integers provided on the rotatable disk 218 that represents a unique indication of a particular number of uses available shown through the aperture 215.

[0085] Referring to Figure 7B , once the control system (such as the control system 1362 associated with the system 1300 shown in Figure 13 or the control system 1462 shown in Figure 14 ) determines that usage should be reduced from the usage recording device, the control system causes the drive mechanism 530 Figure 6 to be actuated, for example, as shown in Figure 7BThe indicator is rotated clockwise to advance its use via the rotation of the rotatable disk 218. As the drive mechanism 530 rotates, protrusion 532 contacts cam surface 225 and protrusion 534 contacts cam surface 227. The contact between protrusions 532 and 534 and cam surfaces 225 and 227, as well as the continuous torque applied by the drive mechanism 530, causes flexible members 224 and 226 to deflect radially inward, thereby pulling radial extension 228 radially inward and out of groove 222 of cavity 219, thus disengaging flexible members 224 and 226 from groove 222 and enabling the rotatable disk 218 to rotate.

[0086] refer to Figure 7C With the drive mechanism 530 ( Figure 6 Continuing to rotate clockwise, the rotatable disk 218 rotates together with the drive mechanism 530 until the radial extension 228 and a set of grooves 223 adjacent to the groove 222 in which the radial extension 228 was previously positioned are aligned. The drive mechanism 530 stops rotating clockwise and briefly rotates counterclockwise, causing the protrusions 532 and 534 to disengage from the cam surfaces 225 and 227, thereby allowing the flexible members 224 and 226 to return to their undeflected state and the radial extension 228 to re-enter the groove 223, as... Figure 7D As shown.

[0087] Once the flexible members 224 and 226 enter an adjacent set of grooves 223, another integer among the plurality of integers passes through the hole 215 ( Figure 2 (See). For example, according to an exemplary embodiment, if the number 5 is... Figure 7A The position of the rotatable disk 218 shown is visible through hole 215, therefore... Figure 7B and Figure 7C After the decreasing process, the number 4 will be located in Figure 7D The hole 215 in the position is visible, indicating that it shows a larger... Figure 7A The position of the rotatable disk 218 is one of the few indicators of the number of uses available.

[0088] The manipulator can be controlled via a control system (e.g., with...) Figure 13 The system 1300 shown or Figure 14The control system 1362 associated with the control system 1462 shown in FIG. 6 is controlled to rotate the drive mechanism 530 only the distance necessary to move the rotatable disc 218 from one set of grooves 222 to an adjacent set of grooves 223, such movement representing a decrement in the single number of uses available. Additionally or alternatively, the manipulator can be programmed to reduce the number of uses by driving the rotatable disc 218 through multiple sets of adjacent grooves 222 based on the length of use, type of use, or other factors. The number of grooves 222 can equal the number of uses / reductions or can differ from the number of uses / reductions depending on various factors such as the total number of uses expected, the diameter of the rotatable disc 218, and other considerations.

[0089] Once the drive mechanism 530 has reduced the use recording device 213, the drive mechanism 530 can remain stationary until the instrument 200 is decoupled from the manipulator. The rotatable disc is held in place by the radial extension 228 within the groove 222, thereby reliably displaying the appropriate number or fraction or other desired indicia to provide information on the number of uses remaining of the predetermined life of the instrument 200 even while the instrument 200 is stored, transported, and otherwise handled until the next use.

[0090] Referring now to Figure 8 , another embodiment of a use recording device for an instrument according to the present disclosure is shown. In Figure 8 , a portion of a transmission mechanism 810 of an instrument is shown, with the housing omitted to show the internal components. In Figure 8 , the transmission mechanism 810 includes a use recording device that includes a worm drive 836 directly connected to an input shaft 838. The input shaft 838 in turn can be coupled to an external output drive mechanism, such as the drive mechanism 530 described above in connection with Figure 5 . Unlike the embodiment of Figures 2-7D , the input shaft 838 includes a recess (not shown) in which the protrusions 532 and 534 can be accommodated, and can or can not include flexible members similar to those discussed above in connection with the use recording device 213. In the embodiment of Figure 8 , other components (e.g., the detent 848 and the pawl 846 discussed here) serve as a locking mechanism to prevent inadvertent movement of the recording device (e.g., unwanted back driving or forward driving). The input shaft 838 can alternatively include any interface capable of transmitting torque between the input shaft 838 and an external output drive mechanism (e.g., a manual drive mechanism or from a remote computer-aided manipulator system).

[0091] The worm drive 836 is operably engaged with a rotatable disc 818 that includes indicia (e.g. Figure 8(the integers shown), or any other type of marker discussed above. The omitted housing portion of the device 800 may include holes (such as hole 215). Figure 2 The hole displays a single integer number from the rotatable disk 818. Figure 8 In one embodiment, the rotatable disk 818 is operatively engaged with a worm gear drive 836 via a rotatable sub-shaft 840 carried by a bracket 842. The sub-shaft 840 carries pinions 844, one of which engages the worm gear drive 836, and the other of which engages the rotatable disk 818.

[0092] The use of recording device 814 includes features that prevent the rotary disk 818 from being reverse-driven and ensure that the rotary disk 818 remains in the same indicated position when the instrument is disconnected from (e.g., from an external drive mechanism, or otherwise) and stored, transported, or otherwise disposed of. For example, now referring to Figure 9 , showed Figure 8 Part 9-9 is an enlarged detailed perspective view. The input shaft 838 includes one or more pawls 846 positioned to contact one or more stops 848 on the housing 815 of the device 800. The pawl 846 has a ramped leading edge 850 and a flat trailing edge 852. When the input shaft 838 moves along... Figure 9 When rotated clockwise, it is driven by a mechanism (e.g., Figure 5 The torque applied by the drive mechanism 530 is sufficient to drive the ramp leading edge 850 past the stop 848, but interference between the flat trailing edge 852 and the stop 848 prevents the input shaft 838 from... Figure 9 Reverse drive in the counterclockwise direction. Other configurations of components preventing reverse drive of recording devices are within the scope of this disclosure, such as, but not limited to, those similar to... Figures 2-4 The flexible components 224, 226 of the equipment, the system, ratchet mechanism or other arrangement.

[0093] Now for reference Figure 10 The illustration shows a perspective view of another embodiment of a transmission mechanism portion of an instrument using a recording device. The transmission mechanism 1010 includes a visual display 1012 showing markings visible through a hole 1015 in the housing 1017 of the transmission mechanism 1010. Figure 10 (The number 3 in the example is merely an example).

[0094] Figure 11 It shows Figure 10drive mechanism 1010, with the housing 1017 removed to reveal components of the use recording device. The use recording device includes a spool 1054, which includes, for example, a polymeric film, a fibrous sheet, or other flexible substrate. The spool 1054 includes visual indicia such as integers, tapered graphical indicators, or other visual indicia as described above. The spool 1054 extends around a feed pulley 1056, passes over an idler pulley 1058, and is wrapped around a take-up pulley 1060. The take-up pulley 1060 is operably coupled to an input device 1038 Figure 10 ), which can be engaged with an external output drive mechanism of a manipulator system (such as the manipulator systems discussed below in connection with Figure 13 and Figure 14 ). Such engagement can include any of the arrangements described above, or other engagement arrangements apparent to those of ordinary skill in the art. When the instrument 1000 is engaged with a manipulator system, the manipulator system can actuate the output drive mechanism (such as the output drive mechanism 530 in Figure 5 ) to rotate the input device 1038, as discussed above with reference to Figure 10 . Rotation of the input device 1038 causes the take-up pulley 1060 to rotate and causes the spool 1054 to wrap around the take-up pulley 1060 and unspool from the feed pulley 1056, thereby advancing the portion of the spool 1054 shown through the aperture 1015.

[0095] As the spool 1054 is wrapped around the take-up pulley 1060, the effective diameter of the take-up pulley 1060 increases due to the thickness of the material of the spool 1054 wrapped around it. Thus, for a given amount of rotation of the take-up pulley 1060, a larger additional portion of the spool 1054 will be wrapped around the take-up pulley 1060 depending on how much of the spool 1054 is already present on the take-up pulley 1060. To accommodate this, the markings on the spool 1054 can be provided at successively larger intervals, such that as larger amounts of the spool 1054 are wrapped around the take-up pulley 1060, each marking still appears in the aperture 1015. Alternatively, the manipulator system can be programmed to advance a smaller rotational amount for each rotation of the take-up pulley, thereby allowing equidistant markings on the spool 1054 to each properly appear in the aperture 1015.

[0096] While the embodiments shown and described above in connection with Figures 2-11 include markings featuring integers, other configurations of markings are within the scope of the present disclosure, as described above. For example, Figure 15 shows an instrument 1500 having a use recording device, in Figure 15A visual display 1512 of the instrument 1500 including a cone-shaped graphic 1564 is shown in FIG. 15. The visual display 1512 includes a pointer 1566 coupled to a usage recording device, which can be or include the usage recording devices described above in connection with Figures 2-11 the discussion of the usage recording device components, or other systems. As the instrument 1500 is used, the pointer 1566 on the incremental movable component (e.g., the rotatable dial 218 Figure 2 ), the rotatable dial 828 Figure 8 ), or the spool 1054 Figure 10 ) moves along the cone-shaped graphic 1564 and the position of the pointer relative to the cone-shaped graphic indicates a fraction of the remaining life of the instrument 1500. Alternatively, the cone-shaped graphic can be in the form of a bar graph, a progressively increasing dot, a progressively changing color segment (e.g., green, yellow, orange, red), or have other configurations. Further, rather than having the pointer move in response to usage, the cone-shaped graphic can be optionally placed on a moving component of the usage recording device, such as on the rotatable dial 218 Figure 2 ), 828 Figure 8 ), or the spool 1054 Figure 10 ) or other component, and a fixed pointer or other indicator can be provided on, for example, the housing of the instrument 1500. Similar to the embodiment of the pointer moving, the relative position of the cone-shaped graphic and the pointer indicates a fraction of the remaining life of the instrument. Further, in addition to providing the pointer, a portion of the cone-shaped graphic can be exposed (e.g., through a hole in the housing), and the portion of the cone-shaped graphic exposed indicates a fraction of the remaining life of the instrument.

[0097] Figure 12 is a flowchart showing a workflow 1200 for recording and indicating the remaining available uses of an instrument. At 1202, the method includes coupling the instrument with a manipulator system, such as a teleoperational system working in part with a computer-assisted or manual manipulator system. For example, the instrument 100, 200, 800 can be coupled with a manipulator system such as the manipulator systems described below in connection with Figure 13 and Figure 14The method includes, at 1204, operating a driven input device of the instrument by actuating an external drive mechanism, such as an output drive mechanism of a manipulator system. For example, the rotatable dial 218, input shaft 838, or input shaft 1038 is rotated by an external output drive mechanism. At 1206, the method includes moving an indicator on the instrument from a current position of a plurality of positions to a subsequent position of the plurality of positions having indicia indicating fewer non-zero available uses than the current position of the indicator. For example, the rotatable dial 218, 818, or spool 1054 can be moved to display a different indicia representing a particular number of remaining available uses, which number decreases from an initial number or non-numeric indicia according to examples discussed herein.

[0098] While the various indicators disclosed herein show a series of consecutive integers reflecting one use per position, other configurations are contemplated, including a series of non-consecutive integers. For example, based on the configuration and programming of the manipulator system, uses can be counted down in multiples. For example, a rotatable dial or other indicator can have consecutive positions counted down in 2s, 3s, 5s, 10s, etc., and the manipulator can be programmed accordingly to decrement one position per 2, 3, 5, 10, etc. uses. Further, the indicators disclosed herein can be used to indicate only a portion of a series of uses that the instrument can undergo. For example, the indicator can be used to indicate only the last 10, 5, or other number of uses of a larger total number of available uses. In such embodiments, the manipulator system can be programmed to only begin decrementing the indicator device after the initial number of uses is completed. For example, for an instrument having, for example, a total of 30 available uses, the manipulator can be programmed to allow 20 uses, and then begin decrementing a 10-use counter for the last 10 uses of the instrument. Other arrangements are also contemplated in the present disclosure, such as an irregular count on the indicator, for example, showing an irregular series of 20, 10, 9, 8, 7, etc. down to 0 available uses.

[0099] Embodiments of the present disclosure provide reliable and robust devices that record and display one or both of a number of times an instrument has been used or a number of available remaining uses of the instrument. Such devices can be easily viewed by personnel when the devices are not connected to a manipulator system, for example, during storage or during shipping.

[0100] Instrument reprocessing record devices, systems, and methods

[0101] Further embodiments of the present disclosure include various devices and related systems and methods for recording one or more events experienced by an instrument, such as a medical instrument, such as changes in environmental conditions that occur during a reprocessing procedure. Such reprocessing procedures can involve the application of heat and resulting temperature excursions, the application of ultrasound or other mechanical energy, exposure to pressure cycling or other conditions. In various embodiments, recording devices according to the present disclosure can operate based on exposure to temperature changes, exposure to pressure changes, and / or the application of various forms of energy that the instrument can be subjected to, such as ultrasound energy, for example during a reprocessing procedure, in order to be able to record a number of instances that the instrument has been so subjected. These reprocessing recording devices can be mechanical devices made from relatively few moving parts. Further, in some embodiments, the recording devices do not require a constant power source to operate. Further, recording devices according to various exemplary embodiments can operate reliably and independently within relatively extreme environments, such as one or more of a humid or steam environment, an environment with chemicals, an environment with relatively high or relatively low temperatures, including cleaning, disinfecting, and / or autoclave temperatures, such as an environment with high humidity levels, an environment at relatively high or low pressures, and an environment subjected to various energy modalities, such as in an ultrasonic washer environment, fluid flushing, and / or mechanical agitation.

[0102] Reprocessing recording devices according to various embodiments can optionally include devices such as electronic devices and / or analog devices for storing and allowing readout of information regarding the number of occurrences of recorded events that the instrument has been subjected to, such as during a reprocessing procedure. In various embodiments, such storing and indicating devices can also not require any external power source. Further, reprocessing recording devices according to various embodiments incorporate features that mitigate damage to electronics and other components that might otherwise occur due to the environments that the instrument can be subjected to, such as during use or during reprocessing.

[0103] Reprocessing recording devices according to various embodiments of the present disclosure can include one or more state-changing elements, such as but not limited to temperature-responsive elements, pressure-responsive elements, or vibration-responsive elements, that undergo a state change in response to a change in environmental conditions. Such changes in conditions can include one or more of a change in temperature, a change in pressure, a change in humidity, a change in mechanical agitation, and other changes in environmental conditions that the elements can be subjected to and designed to respond to through a state change. In non-limiting embodiments, the amount of change that results in a state-changing element changing state can be predetermined and / or can be associated with a reprocessing procedure that the instrument is subjected to.

[0104] For example, one or more temperature-responsive elements can be configured to transition from a first state to a second state when a temperature transitions from a first temperature to at least a second temperature. In example embodiments, the first temperature can be below a predetermined threshold temperature and the second temperature can be at or above the predetermined threshold temperature. Such temperature-responsive elements can include various components, such as shape memory components, wax motors, bimetallic components, temperature-sensitive electronic switches, capsules or other containers containing a substance that undergoes a state and / or volume change in response to a temperature change, or other components. These components are designed to undergo a state change, such as a change in physical dimensions, shape, position, and / or phase, in order to exert a force or other action as a result of reaching a predetermined temperature threshold, in example embodiments, the state change can be associated with reprocessing.

[0105] Other state-changing elements can include pressure-responsive elements (such as, but not limited to, pressure-responsive actuators) that generate movement based on the application of pressure (such as atmospheric pressure) that deviates from a set pressure, energy-harvesting devices that generate an electrical current based on the application of mechanical energy (such as ultrasonic vibrations), or other devices that exhibit a state change based on a change in conditions to which the element is exposed.

[0106] The state-changing element can be operably coupled with a counter mechanism that records the occurrence of an event associated with a change in an environmental condition in response to which the state-changing element changes state. As a non-limiting example, the event can be an event associated with a reprocessing procedure. The counter mechanism and the state-changing element can be operably coupled such that the counter mechanism is incremented to reflect the occurrence of the instrument undergoing such a reprocessing procedure when the instrument comprising the reprocessing recording device undergoes a reprocessing procedure. For example, the counter mechanism can incrementally move in response to each state change of the state-changing element from a first state to a second state. That is, the counter mechanism can record the number of transitions of the state-changing element from a first state to a second state.

[0107] In various example embodiments, the counter mechanism can include or be operably coupled with a storage device that stores and / or provides information indicative of the number of occurrences of one or more exposure to changes in environmental conditions, such as temperature, pressure, or energy excursions (e.g., at least to a predetermined threshold), etc., that can be associated with reprocessing procedures experienced by the instrument. In some cases, this information can be, for example, the number of reprocessing procedures that the instrument can experience. For example, the storage device can be a visual indicator (such as an incremental counter) that displays one or both of the number of reprocessing procedures that the instrument has experienced and the number of reprocessing procedures that the instrument can experience. In other embodiments, the storage device can include a gauge-type indicator that shows the proportion of reprocessing procedures used or remaining in the total amount of acceptable reprocessing procedures, such as similar to a vehicle fuel gauge. Additionally or alternatively, the counter mechanism can include or be operably coupled to an electronic non-volatile memory of the storage device that can be subsequently electrically read out, such as when coupled to a surgical system. Storage devices including indicators and electronic non-volatile memories according to the present disclosure can be referred to herein as "user-accessible storage devices."

[0108] In some aspects of the present disclosure, the recording device can be configured to disable operation of the instrument after the counter mechanism has counted a specified number of predetermined levels of temperature, pressure, energy, or other environmental exposure conditions (e.g., conditions associated with reprocessing procedures) that the instrument has experienced. For example, in one embodiment, a lockout of the instrument (making the instrument unusable) can occur in addition to or instead of providing information about the number of reprocessing procedures that the instrument has experienced or the number of such remaining acceptable procedures. For example, such a lockout can be used to signify an instrument that is intended to be a single-use device and not designed to be reprocessed for subsequent use.

[0109] Reference is now made to Figure 16This illustration shows a schematic diagram of an instrument 1600 according to exemplary embodiments of the present disclosure. Instrument 1600 includes a shaft 1606 extending from a distal portion 1602 where an end effector 1604 is located to a proximal portion 1608 where a drive mechanism 1610 is located (1610 shows the housing of the drive mechanism). The end effector 1604 may include, but is not limited to, surgical instruments such as scissors, forceps, electrosurgical instruments, imaging devices or other sensors, suture tools, or any other medical or non-medical instruments. The drive mechanism 1610 may include various drive mechanisms (e.g., gears, winches, linkages, input discs, etc.) connected to various cables and rods to control the movement and operation of the shaft and the end effector, as is known to those skilled in the art. The drive mechanism 1610 may optionally be configured to be operatively coupled to a computer-controlled (e.g., remotely controlled) surgical manipulator system, such as, as a non-limiting example, any manipulator system that is at least partially part of a remotely controlled surgical system and is operated with computer assistance, such as the daemon commercialized by Intuitive Surgical Manipulation Inc. of Sunnyvale, California. Surgical systems. However, those skilled in the art will understand that the instruments, devices, and techniques discussed herein can be implemented using other types of remotely operated computer-aided surgical platforms. In yet another embodiment, the drive mechanism 1610 may include actuators (not shown) for manually controlling various functions / movements of the instrument 1600, and the instrument 1600 may be a manually operated instrument.

[0110] The device 1600 also includes a recording device 1614 for recording one or more changes in environmental conditions experienced by the device. The recording device 1614 may be mounted to or otherwise integrated into the housing of the drive mechanism 1610 or into another part of the device 1600. The recording device 1614 may record and optionally store and provide information indicating the occurrence of temperature, pressure, and / or applied energy shifts, for example, this information may be correlated with the number of reprocessing procedures to which the device 1600 has been exposed. For example, such recording may be based on state changes of state-changing elements operatively coupled to the recording device.

[0111] Now for reference Figure 17 , Figure 18A and Figure 18B This illustrates a reprocessing recording apparatus according to an exemplary embodiment of the present disclosure. For ease of illustration, in... Figure 17 The text shows the relationship with... Figure 16The recording device 1214 can be a separate instrument 1600 isolated environment exposure recording device 1214, but as noted above, the recording device 1214 can also be integrated as part of a component of the instrument 1600, such as a backend drive mechanism, as will be appreciated by those of ordinary skill in the art. The recording device 1214 includes a temperature-responsive, state-changing element that is configured to undergo a state change based on exposure to a temperature change, such as a temperature increase associated with a reprocessing event (e.g., cleaning with or without ultrasonic energy, and / or high-pressure sterilization, drying, etc.). Further, those of ordinary skill in the art will appreciate that a temperature change, such as a shift to a lower temperature, can be recorded instead of, or in addition to, a temperature increase.

[0112] The temperature-responsive element can be or include a material that changes a physical configuration, such as one or more of a physical dimension (e.g., length, width, height, shape, and / or volume, etc.) or another state change (e.g., position, stiffness, charge, color, and / or phase), in response to exposure to a temperature above (or below) a specified threshold temperature. The threshold temperature can be defined by the conditions of a reprocessing procedure that the instrument is to undergo. For example, the threshold temperature can be selected to be greater than a temperature that the instrument is to undergo during normal use and lower than a maximum temperature that the instrument is to undergo during reprocessing. For example, a high-pressure sterilization procedure can involve a temperature at or above 120°C for a particular period of time, while a cleaning (e.g., ultrasonic cleaning) process can include a temperature increase above a normal ambient (e.g., room temperature) temperature but below a high-pressure sterilization temperature, even below 100°C. The threshold temperature of the temperature-responsive element can be selected so that the recording device records only high-pressure sterilization procedures, such as by selecting a threshold temperature above, for example, 100°C, 120°C, or another threshold temperature, or records both cleaning and high-pressure sterilization at elevated temperatures, such as by selecting a threshold temperature above a temperature for cleaning (e.g., a temperature in a range of, for example, 70°C to 90°C, depending on the temperature used in the cleaning process). Those of ordinary skill in the art will appreciate how to design and configure a device according to the present disclosure to respond to more than one type of temperature shift, such as using different temperature-responsive, state-changing elements to record different types of reprocessing procedures with different temperature characteristics, if desired.

[0113] In the exemplary device of Figure 17 , Figure 18A and Figure 18B The temperature-responsive element is a wire, cable, or other similar member made of a shape-memory metal such as nickel-titanium alloy (e.g., nitinol) in the exemplary device. Other embodiments can include other temperature-responsive elements, including but not limited to a wax motor, a bimetallic component, a temperature-sensitive electronic switch, or other components. These temperature-responsive elements can be configured to undergo a state change upon a temperature change, such as heating to at least a threshold temperature.

[0114] The shape memory wire 1216 is operably coupled with the counter mechanism 1213 such that the counter mechanism 1213 records a state change of the shape memory wire 1216 due to exposure to a temperature elevated above a specified threshold temperature. One end of the shape memory wire 1216 is routed around a pulley 1217, and an opposite end of the shape memory wire 1216 is fixed to a base 1215 of the reprocessing logging device 1214 (not shown in Figure 17 ; shown as 1216A in Figure 23A and Figure 23B , described further below).

[0115] In the devices of Figure 17 , Figure 18A and Figure 18B , the counter mechanism 1213 is configured to incrementally move based on the state change of the shape memory wire 1216. For example, in the embodiments of Figure 17 , Figure 18A and Figure 18B , the counter mechanism 1213 includes a ratchet mechanism 1220. The ratchet mechanism 1220 includes a ratchet 1221 having ratchet teeth 1222 that engage with one or more drive pawls 1226 mounted to a drive pawl carrier 1224. The ratchet 1221 is incrementally moved for each temperature excursion above the specified threshold temperature by engagement with the drive pawls 1226 and operation of the drive pawl carrier 1224, described further below. As discussed in greater detail below, the ratchet mechanism 1220 can include or be operably coupled with a user-accessible storage mechanism, such as the example visual indicator 1418( Figure 19 ), 2018( Figure 20A and Figure 20B ), 2118( Figure 21 ), 2218( Figure 22 ), an electronic storage device (such as the example electronic logging device described below in connection with Figure 23A and Figure 23B ), or other devices.

[0116] Referring to Figure 18A and Figure 18B , the pawl carrier 1224 is rotatable about an axis A. The drive pawl carrier 1224 carries at least one drive pawl 1226. In Figure 17 , Figure 18A and Figure 18BIn some embodiments, the drive pawl carrier 1224 includes two drive pawls 1226 positioned opposite each other on the pawl carrier 1224; however, this configuration is not limiting, and other numbers and arrangements of drive pawls 1226 will be apparent to those skilled in the art. The ends of the shape memory wires 1216 opposite to the ends wound around the pulley 1217 are secured to the drive pawl carrier 1224 in any suitable manner. For example, in Figure 17 , Figure 18A and Figure 18B In one embodiment, the end of the shape memory wire 1216 is coiled to form a loop, and the loop is secured around a tension tab 1225 extending from one side of the drive pawl carrier 1224. Furthermore, one or more hard stops 1230 are positioned to provide interference with the rotation of the drive pawl carrier 1224, thereby limiting the range of rotation of the pawl carrier 1224, so that the ratchet 1221 can rotate with each incremental advance.

[0117] The ratchet mechanism 1220 may include features configured to prevent reverse drive of the ratchet mechanism 1220. For example, the ratchet mechanism may include a locking pawl 1228 configured to engage with anti-reverse ratchet teeth (not shown). The locking pawl 1228 allows the ratchet 1221 to move in the drive direction, but prevents the ratchet 1221 from rotating in the opposite direction to the drive direction after advance (e.g., the locking pawl 1228 allows the ratchet to...). Figure 18A and Figure 18B The ratchet moves counterclockwise as shown, preventing ratchet 1221 from rotating clockwise. Although in Figure 17 , Figure 18A and Figure 18B In one embodiment, the locking pawl 1228 engages with a separate anti-reverse ratchet tooth; in other exemplary embodiments, the locking pawl 1228 may be configured to engage with ratchet teeth 1222. That is, in some designs, both the drive pawl 1226 and the locking pawl 1228 may engage with the same set of ratchet teeth, as will be apparent to those skilled in the art.

[0118] The locking pawl 1228 can be coupled to (e.g., integrated into) the flexible arm 1229. Figure 17 , Figure 18A and Figure 18BIn the device, the flexible arm 1229 is molded as part of the base 1215, and the elastic deformation of the flexible arm 1229 allows the ratchet 1221 to rotate in the drive direction because the anti-reverse ratchet tooth 1223 deflects the locking pawl 1228 away from the ratchet 1221. As will be readily understood, the flexible arm 1229 may alternatively be hinged to the base 1215 and provided with one or more biasing members (e.g., springs) to ensure that the locking pawl 1228 returns to the undeflected position engaged with the anti-reverse ratchet to prevent the ratchet 1221 from being driven in the opposite direction.

[0119] The reprocessing recording device 1214 can also be configured to bias the pawl carrier 1224 in an initial position (e.g., Figure 18A (The location shown). Figure 18A In the device, a biasing element in the form of a tension spring 1232 is coupled to a pawl carrier 1224 to bias the pawl carrier 1224 to a biased position. The tension spring 1232 is fixed at one end to the base 1215 of the recording device 1214 and at a location near the shape memory wire 1216 that is fixed to the drive pawl carrier 1224, for example in… Figure 17 , Figure 18A and Figure 18B In this embodiment, it is fixed to the tension tab 1225. The tension spring 1232 typically extends and retracts along the direction of extension and contraction of the shape memory wire 1216. Although the tension spring 1232, the rigid stop 1230, and the locking pawl 1228 are in Figure 17 , Figure 18A and Figure 18B The device is shown as being integrated with or coupled to base 1215, but those skilled in the art will understand that base 1215 may be device 1600. Figure 16 Individual components, or may be integrated with the housing or main rack of the instrument 1600, such as the rear drive mechanism 1610. Figure 16 Integrate them together.

[0120] The operation of the counter mechanism 1213 is actuated by the temperature shift of the shape memory wire 1216. For example, due to the transformation of the nitinol material from a martensitic to an austenitic state, the length of the shape memory wire 1216 decreases when heated to or above a specified threshold temperature. As the shape memory wire 1216 shortens, the tension generated in the shape memory wire 1216 resists the biasing force of the tension spring 1232, causing the spring 1232 to extend and resulting in the rotation of the drive pawl carrier 1224, for example... Figure 18A and Figure 18B The direction of rotation is shown as counterclockwise. The drive pawl 1226 engages the ratchet tooth 1222 of the visual indicator 1218 and rotates the ratchet 1221 counterclockwise. Although the drive pawl 1226... Figure 18A and Figure 18BThe ratchet 1221 is rotated counterclockwise, but other possible arrangements are also within the scope of this disclosure, including rotation of the ratchet 1221 clockwise.

[0121] like Figure 18B As shown, the drive pawl carrier 1224 rotates counterclockwise to a predetermined limit until it engages with the hard stop 1230 that prevents further rotation of the pawl carrier 1224. When the ratchet 1221 rotates with the pawl carrier 1224 due to the engagement of the drive pawl 1226 with the ratchet teeth 1222, the locking pawl 1228 passes over one or more anti-reverse ratchet teeth 1223 because the ratchet 1221 presents a new rotational position in which the locking pawl 1228 prevents reverse rotation (e.g., in the clockwise position as described above). As will be apparent to those skilled in the art, the described ratchet tooth functions of the drive pawl 1226 and locking pawl 1228, along with the ratchet teeth 1222 and anti-reverse ratchet teeth 1223, can be obtained through the profile of the respective teeth, the orientation and shape of the drive pawl, and other factors readily understood by those skilled in the art.

[0122] When cooled from the elevated temperature to restore its martensitic state, the shape memory wire 1216 elongates, eliminating the force exerted against the bias force of the tension spring 1232, and allowing the tension spring 1232 to retract and return the drive pawl carrier 1224 to its original position. Figure 18A The initial position is shown. Due to the engagement of the locking pawl 1228 with the ratchet tooth 1222, the ratchet 1221 remains in the new rotational position.

[0123] The length of the shape memory wire 1216 can be selected such that the total length of the shape memory wire changes sufficiently to move the drive pawl carrier 1224 by the amount required to bring the ratchet 1221 to a new position. Figure 17 , Figure 18A and Figure 18B In one embodiment, winding the shape memory wire 1216 around the pulley 1217 provides additional length within the small footprint of the recording device 1214 to accommodate larger changes in total length when needed. Other configurations of the shape memory element (including the use of more than one pulley and orientation changes, zigzag patterns, or any configuration where the shape memory element provides sufficient length) are within the scope of this disclosure. Additionally, although Figure 17 , Figure 18A and Figure 18B The embodiments include pulley 1217 to reduce friction on the shape memory wire 1216, but arrangements with or without pulleys are possible. Depending on the available space in the device and the changes in the total length required by the design of the ratchet mechanism, the wire arrangement can also extend generally straight without changing the length.

[0124] Rotation of the ratchet 1221 can correspond to a change in the number of indicated reprocessing cycles that can be used for an instrument to undergo (or the number of indicated reprocessing cycles that an instrument has already undergone), as discussed below in connection with Figures 19-22

[0125] In Figure 17 Figure 18A and Figure 18B Embodiments of the temperature-responsive element are electrical wires 1216 made of a shape memory metal such as nickel-titanium alloy (e.g., nitinol). Other embodiments can include other temperature-responsive elements, including but not limited to a wax motor, a bimetallic component, a temperature-sensitive electronic switch, or a bladder or other container containing a substance that undergoes a phase change, a change in size, a change in position, a change in volume, or other change in response to a change in temperature, or other component. These temperature-responsive elements can be configured to undergo a state change when heated to a specified threshold temperature. Additionally, while embodiments of the Figure 17 Figure 18A and Figure 18B Embodiments of the temperature-responsive element are electrical wires 1216 made of a shape memory metal such as nickel-titanium alloy (e.g., nitinol). Other embodiments can include other temperature-responsive elements, including but not limited to a wax motor, a bimetallic component, a temperature-sensitive electronic switch, or a bladder or other container containing a substance that undergoes a phase change, a change in size, a change in position, a change in volume, or other change in response to a change in temperature, or other component. These temperature-responsive elements can be configured to undergo a state change when heated to a specified threshold temperature. Additionally, while embodiments of the

[0126] In some cases, a high-pressure sterilization process can include several temperature and / or pressure cycles during a single process. For example, a high-pressure sterilization can be configured to repeatedly cycle the pressure in a high-pressure sterilization environment from a high-pressure environment to a low (e.g., at or near a vacuum) pressure environment back to a high pressure to ensure that steam is driven into crevices and other relatively hard-to-reach areas of an instrument. The temperature of the high-pressure sterilization environment likewise cycles according to pressure changes based on the physical relationship between pressure and temperature in an enclosed system, as will be clear to one of ordinary skill in the art. To avoid the temperature-responsive element undergoing a state change in each individual pressure cycle in the high-pressure sterilization environment, the temperature-responsive element can be tailored to provide a response time long enough that the state change does not repeatedly occur for each pressure cycle. Alternatively, a pressure-responsive state change element (e.g., an element discussed in connection with Figure 28

[0127] A temperature-responsive element with a desired response time can be configured using various methods. One method can include configuring the thermal mass of the temperature-responsive element such that the temperature-responsive element provides a desired response time. For example, a temperature-responsive element with a relatively large thermal mass will generally exhibit a relatively long response time. Another method for adjusting the response time of a temperature-responsive element can include providing insulation material around the temperature-responsive element to slow the flow of heat into and out of the temperature-responsive element. For example, in Figure 17 ,​​​​Figure 18A and Figure 18B In the device of

[0128] Referring now to Figure 19 , an exemplary embodiment of a reprocessing record device 1414 is shown that uses a wax motor 1416 as a temperature-responsive state-changing element. The wax motor 1416 includes a volume of wax enclosed within a reservoir 1442. The reservoir 1442 is in communication with a piston 1444 in a bore 1446. The counter mechanism includes a ratchet 1421 positioned proximate the wax motor 1416, which includes ratchet teeth 1422. Similar to the embodiments of Figure 17 , Figure 18A and Figure 18B , a locking pawl 1428 is engaged with the ratchet teeth 1422 to allow rotation of the ratchet 1421 in one direction while preventing rotation in the opposite direction. The ratchet 1421 can be operably coupled to or include a user-accessible storage device, such as a visual indicator 1418, which functions similarly to, for example, but not limited to, any and all of the various storage devices described herein.

[0129] Upon exposure to at least a specified threshold temperature, the wax in the reservoir 1442 expands and forces the piston 1444 through the bore 1446. The piston 1444 can be configured to interact with the counter mechanism and / or storage device, similarly as discussed elsewhere herein. For example, the piston 1444 can include a drive pawl 1445 that engages with the ratchet teeth 1422 on the ratchet 1421, thereby rotating the ratchet 1421 to a new rotational position. Upon cooling, the piston 1444 retracts, while the locking pawl 1428 holds the ratchet 1421 in the new rotational position. Those of ordinary skill in the art will appreciate that the wax motor 1416 can be replaced by a similar device that uses a substance other than wax that has temperature-dependent properties, such as other substances that undergo changes in phase, viscosity, volume, or other changes upon exposure to a temperature excursion. For example, in some embodiments, water can be used as the temperature-activated substance. Because water undergoes a significant volume change at 100°C, and a typical autoclave process exposes the instrument to a temperature excursion above 100°C, a water-containing reservoir can be configured to operate similarly to the wax motor 1416 discussed in connection with Figure 19 above. Further, the threshold temperature can be specified, for example, but not limited to, as described above in connection with the embodiments of Figure 17 , Figure 18A and Figure 18BAs discussed in the associated exemplary embodiments.

[0130] exist Figure 19 In the illustrated device, ratchet 1421 includes an indicator 1418. The indicator 1418 can be combined with other markings on device 1414 to store and / or provide information about the number of reprocessing cycles that device 1414 has undergone.

[0131] For example, as described above, the recording device according to an exemplary embodiment of this disclosure can be operatively coupled to a storage device to store tracking information about a counter mechanism and to provide information about the counter mechanism to a user. Such a user-accessible storage mechanism may include, but is not limited to, a machine vision indicator, such as those shown in Figure 20- Figure 22 The machine vision indicators and / or electronic devices shown and discussed include, for example, electronic memory recording devices as shown and discussed in conjunction with Figure 23.

[0132] For example, as mentioned above, visual indicators can be combined with Figure 17 , Figure 18A and Figure 18B A portion or combination of ratchet 1221 discussed in detail Figure 19 The ratchet 1421 is discussed. Therefore, temperature-responsive elements, such as shape memory wire 1216 ( Figure 17 , Figure 18A and Figure 18B ) or wax motor 1416 ( Figure 19 ) and visual indicators (e.g., indicator 1418) Figure 19 )), 2018 ( Figure 20A and Figure 20B ) or 2118 ( Figure 21 The visual indicator is coupled so that it moves incrementally for each temperature offset above a specified threshold temperature.

[0133] Figure 20A and Figure 20B Examples of machine vision indicators according to exemplary embodiments of the present disclosure are provided, which can be used in conjunction with an instrument when the counter mechanism of the recording device is contained within a housing or as another internal component of the instrument. Reference is now made to... Figure 20A It shows something similar to Figure 17 , Figure 18A and Figure 18B The recording device 1214 includes a reprocessing recording device 2014. The reprocessing recording device 2014 includes an indicator 2018 coupled to a ratchet mechanism 2020, which functions similarly to a coupling... Figure 17 , Figure 18A and Figure 18BThe ratchet mechanism 1220 is discussed. In this particular embodiment, the indicator 2018 includes a pointer 2019 that is arranged to rotate with the ratchet mechanism 2020 when the ratchet mechanism 2020 responds to temperature excursions in the manner discussed in connection with Figure 17 、 Figure 18A and Figure 18B .

[0134] The indicator 2018 can be used in conjunction with additional indicators or other indicia of the instrument to provide information about the number of times the instrument has been subjected to temperature excursions, such as temperature excursions associated with reprocessing procedures. For example, referring now to Figure 20B , the instrument housing 2034 includes an aperture 2036 through which the visual indicator 2018 is visible. The visual indicator 2018 can be coupled to or part of a component of the recording device, such as the reprocessing recording device 1214 Figure 17 、 Figure 18A and Figure 18B or 1414 Figure 19 .

[0135] The instrument housing 2034 can be provided with additional visual indicia that, when viewed in conjunction with the visual indicator 2018, reflect information about the number of temperature excursions to which the instrument has been exposed. For example, the information can represent the number of reprocessing procedures to which the instrument can be subjected, the number of reprocessing procedures to which the instrument has been exposed, or other information. In the device of Figure 20B , the visual indicia includes a generally circular band 2038 that decreases in thickness (tapers) as it extends around the aperture 2036. The pointer 2019 or other indicia on the visual indicator 2018 points to a portion of the circular band 2038 at which the thickness of the circular band 2038 corresponds to the number of remaining reprocessing procedures to which the instrument can be subjected. In operation, as the instrument undergoes subsequent reprocessing procedures, the rotating visual indicator 2018 points to successively narrower portions of the circular band 2038 to indicate the number of reprocessing procedures that can be used. It is also contemplated that instead of a tapered band 2038, a series of dots of varying size can be used as the visual indicia on the housing.

[0136] As an alternative to the graphical score-type indicator discussed above, some devices in accordance with the present disclosure can include an indicator that includes an integer that represents the number of possible reprocessing procedures to which the instrument can be subjected. For example, as shown in Figure 21 , when the instrument is exposed to a temperature excursion (such as a temperature excursion associated with reprocessing), the rotating visual indicator 2118 can be provided with a line 2119 or other indicia that points to successively higher or lower integers provided on the housing 2134, and the actuation of the temperature-responsive state-changing element and counter mechanism described above occurs.

[0137] As discussed above, the number of times an instrument can be subjected to a reprocessing procedure can depend on a number of factors, including regulatory requirements. The various reprocessing record devices and indicators discussed herein can be configured to provide an indication of the number of times an instrument has been reprocessed. The total number of reprocessing procedures an instrument can be subjected to can range, for example, from a single reprocessing procedure to tens, hundreds, thousands, or more reprocessing procedures, and the various indicators described herein can be configured to indicate these quantities accordingly. As one non-limiting example range, depending on various factors, an instrument can be subjected to a number of reprocessing procedures ranging from about 15 procedures to about 40 procedures, and the associated indicators can be configured accordingly.

[0138] Further, rather than including visual indicia on the housing and markings on the indicator, visual indicia can be provided on the indicator and markings can be provided on the housing, or only the portion of the indicator having visual indicia can be made visible through the aperture. For example, a series of integers can be provided on the indicator, and the aperture can be sized such that only one number is visible, the visible number indicating the number of reprocessing cycles remaining available. It will be apparent to those of ordinary skill in the art that other indicator configurations are possible, such as color-based indicator schemes (e.g., moving through green, yellow, orange, red in sequence as reprocessing procedures occur) or other indicator schemes.

[0139] While Figures 19-21 Embodiments of the reprocessing record device 2214 include various rotary visual indicators 1418, 2018, 2118, but different configurations of ratchet mechanisms and visual indicators are within the scope of the present disclosure. For example, it will be apparent to those of ordinary skill in the art that linear ratchet mechanisms and linear indicators can be contemplated to operate in similar ratcheting action. Such linear ratchet mechanisms and linear indicators can be implemented with any of the temperature-responsive elements discussed herein, such as the shape memory alloy wire 1216, the wax motor 1416, or other temperature-responsive elements.

[0140] Referring now to Figure 22 FIG. 22 shows a schematic view of one embodiment of a reprocessing record device 2214 having a linear ratchet mechanism 2220 and an associated indicator 2218. Figure 22 Embodiments of the reprocessing record device 2214 show implementation with a wax motor 2216 temperature-responsive state-changing element, but as discussed above, any other temperature-responsive state-changing element can be used. The wax motor 2216 includes a drive pawl 2245 engaged with a rack 2270, which includes ratchet teeth 2222. A lock pawl 2228 is biased into engagement with the ratchet teeth 2222 by any of the configurations discussed elsewhere herein. The rack 2270 includes an indicator 2218, which in this embodiment is a series of integers, in this case the number 1. Figure 22In the device of FIG. 22, the indicator 2218 can be a line or other pointer indicator. However, any other configuration of indicia disclosed elsewhere herein can be used with the device of FIG. 22. Figure 22

[0141] Based on a temperature excursion associated with, for example, exposure to a reprocessing process, the wax motor 2216 extends the drive pawl 2245 to advance the rack 2270 in the direction D. Upon return to the initial temperature condition, for example, at the end of a reprocessing cycle, the wax motor 2216 retracts the drive pawl 2245. As the drive pawl 2245 retracts, the lock pawl 2228 maintains the rack 2270 in the position advanced to by the drive pawl 2245. The rack 2270 and associated indicator 2218 are thereby advanced based on the occurrence of a temperature excursion substantially as discussed above in connection with the recording devices 2214 and 2214.

[0142] In some embodiments, the user-accessible storage device can be or include electronic circuitry that provides an electronic indication of the number of reprocessing cycles that the instrument has undergone or can undergo. The use of electronic and electrical sensors on the instrument to detect temperature cycles or otherwise identify cleaning or sterilization cycles involves certain challenges that example embodiments of the present disclosure seek to address. For example, if the instrument is configured for use with a computer-assisted surgical system, the instrument is typically disconnected from the system and power supply prior to reprocessing, and no power supply is available to operate the electronics. Likewise, if the instrument is manually operated, the instrument can have no power supply to operate the electronics during reprocessing. Moreover, some electrical componentry can be particularly susceptible to exposure to high temperatures, chemicals, humidity, or other conditions of the reprocessing process. For example, batteries can be sensitive to elevated or reduced temperatures, and extreme temperatures can negatively impact battery life in terms of power and mechanical integrity.

[0143] The present disclosure contemplates electronic recording devices that include passive devices that are only powered when connected to an external power source or active circuitry that includes an integrated power supply. Passive devices can include electronic user-accessible storage devices that can be operably coupled to mechanical recording devices according to the present disclosure, such as reprocessing recording devices 1214 Figure 17 , Figure 18A and Figure 18B ), 1914 Figure 19 ), and 2214 Figure 22 ). Moreover, such devices can be used on instruments that do not limit to any use recording devices, reprocessing recording devices, and instruments that include both use recording devices, such as the recording devices disclosed in connection with Figures 1-15 and reprocessing recording devices disclosed herein.

[0144] ​One example of a passive electronic user-accessible storage device is a device in which movable electrical contacts are coupled to make contact between a plurality of unique patterns of conductive traces when the electrical contacts are moved. A passive integrated circuit can be operably coupled with the contacts and can be configured to assign a particular address, number, or other unique identifier to each of a plurality of unique combinations of conductive traces contacted by the electrical contacts. In this way, the movable electrical contacts act as a counter mechanism by virtue of their electrical connection with various combinations of conductive traces, while the integrated circuit provides an indication of the number of reprocessing procedures that the instrument has undergone or can undergo. This electronic arrangement can be used in addition to, or instead of, a visual indicator.

[0145] For example, referring now to FIGS. 1-3, various perspective views of a recording device 1214 of Figure 23A and Figure 23B are shown. Figure 17 , Figure 18A and Figure 18B . Figure 23A and Figure 23B show a side of the recording device 1214 opposite the plan views of Figure 18A and Figure 18B . While the recording device 1214 discussed in connection with Figure 17 , Figure 18A and Figure 18B shows a passive electronic recording device, such electronic recording devices can be used in conjunction with any other mechanical recording device embodiments disclosed herein.

[0146] Passive electronic recording devices according to the present disclosure can include electrical components coupled with mechanical components of a mechanical recording device, similar to those discussed above in connection with Figure 17 , Figure 18A and Figure 18B . In embodiments of Figure 23A and Figure 23B , a ratchet 1221( Figure 2 ) is coupled with a shaft 1858 extending through a printed circuit board (PCB) 1860. The PCB 1860 includes a plurality of conductive traces 1859 that are circumferentially inscribed as arc segments around the shaft 1858. The conductive traces 1859 are conductively coupled with respective pins 1863 of an integrated circuit (IC) 1861, for example, through conductive paths (not shown) of the PCB between the PCB pins 1863 and the conductive traces 1859. Contact arms 1862 are coupled to and extend radially outward from the shaft 1858. Rotation of the shaft 1858 (e.g., due to a temperature- biased ratchet mechanism 1220( Figure 17 , Figure 18A and Figure 18BThe operation of the device causes the contact arm 1862 to move, creating conductive paths between various conductive traces 1859 as the contact arm 1862 sweeps around the PCB. Therefore, the contact arm 1862 rotates around the PCB due to temperature shifts in the recording device 1214, such as temperature increases or decreases associated with reprocessing processes like cleaning (e.g., ultrasonic cleaning) or autoclaving cycles.

[0147] IC 1861 can assign a unique identifier, such as an integer, to the position of the movable contact arm 1862 based on a specific combination of conductive traces 1859 that make conductive contact with the movable contact arm 1862. When connecting an instrument to electroelectronic equipment (such as an electrical interface or other interface at the robotic arm of a remotely operated computer-assisted surgical system), the unique identifier assigned by IC 1861 can be read and displayed on a display that may be associated with the surgical system, and / or entered into a database (or other processor / controller) for tracking instrument reprocessing and other uses.

[0148] As a combination Figure 23A and Figure 23B Alternatives to the discussed conductive trace 1859 and movable contact arm 1862, other embodiments of the passive electronic recording device may include analog configurations. For example, the passive electronic recording device may be or include a potentiometer-like device having resistive pads on PCB 1860 and a movable contact arm with a sweep frequency generator in contact with the resistive pads. The resistance between the sweep frequency generator and the conductive pads changes depending on the rotational position of the sweep frequency generator. In such an embodiment, IC 1861 may exhibit the ability to convert the resistance detected between the conductive pads and the sweep frequency generator into discrete values ​​associated with multiple exposures to reprocessing processes. As described above, when operatively connected to a surgical system, the IC may, for example, provide information about the number of reprocessing processes the device has undergone through the surgical system's user interface. Other alternative components and configurations of the passive electronic recording device may include, for example, position-sensitive magnetic or inductive coupling, optical encoders, or other devices.

[0149] Although combined Figure 23A and Figure 23B The passive electronic recording device under discussion is shown with Figure 17 , Figure 18A and Figure 18B It is used in conjunction with visual recording devices, but this will be easily understood by those skilled in the art. Figure 23A and Figure 23B The passive electronic recording device can be used as a standalone device or in combination with other recording devices described herein, such as in combination with Figure 19 The publicly disclosed recording devices 1414 and 2214 Figure 22), or other devices such as, but not limited to, those described in connection with Figures 1-15 The disclosed use logging device.

[0150] As noted above, exposure to extreme temperatures can have a negative impact on the life of a battery. In particular, when a battery is required to operate for long periods of time under extreme temperature conditions, the life of the battery and the mechanical integrity of the battery package can be potentially compromised. Accordingly, a device in accordance with the present disclosure can include a voltage source, such as a battery, an energy harvesting device, or other voltage source in a configuration that mitigates degradation of the voltage source.

[0151] Reference is now made to Figure 24 , which shows a circuit diagram of an active electronic reprocessing logging device 2414. The active electronic reprocessing logging device 2414 is configured to enable the use of a battery in an instrument by limiting the amount of time the battery is required to operate during a reprocessing cycle and by operating the battery only within a temperature range in which the performance of the battery is not severely compromised.

[0152] The reprocessing logging device 2414 includes a voltage source, which includes a battery 2464 having a positive terminal 2466 and a negative terminal 2468 that form a circuit 2470. Two temperature operated switches, a first switch 2472 and a second switch 2474, are positioned in the circuit 2470. The first switch 2472 is a normally open switch that is closed at a first temperature. The second switch 2474 is a normally closed switch that is opened at a second temperature that is higher than the first temperature.

[0153] Between the first switch 2472 and the second switch 2474 is a memory device 2476, which can be in the form of an integrated circuit that records (e.g., on non-volatile memory) electronic data indicative of the number of times a voltage is applied to the memory device 2476.

[0154] The first switch 2472 remains open and the second switch 2474 remains closed under operating conditions such as those experienced by the instrument during use. The circuit 2470 is in an open state, and the battery 2464 does not generate current. The first switch 2472 can be configured to close at a specified first elevated temperature that is lower than the highest temperature associated with the reprocessing cycle (e.g., 80°C). When the temperature reaches the first elevated temperature, the first switch 2472 closes, completing the circuit 2470. The voltage potential across the positive terminal 2466 and the negative terminal 2468 of the battery is thereby applied to the memory device 2476. The memory device 2476 records the instance of the applied voltage, for example, by incrementing a record saved on non-volatile memory. The second switch 2474 can be configured to open at a specified second elevated temperature that is higher than the first elevated temperature but lower than the temperature at which the recording device 2414 is to be saved for a significant period of time. For example, if the first switch 2472 is configured to close at 80°C, the second switch 2474 can be configured to open at 90°C. Once the temperature reaches the specified second elevated temperature, the second switch 2474 opens, thereby opening the circuit 2470 for the duration of the reprocessing cycle, which can be performed at a temperature higher than the specified second temperature (e.g., 121°C).

[0155] Because the circuit 2470 is only closed and the battery 2464 is operable for a relatively short period of time, for example, during the temperature transition from the instrument's use to the elevated temperature associated with the reprocessing cycle, the battery 2464 need only operate at the predetermined (e.g., elevated) temperature for a short time. The battery life is therefore increased as compared to a battery that is required to operate throughout the reprocessing process. That is, the configuration of the circuit 2470 reduces (e.g., minimizes) the time required for the battery to operate at the elevated (or reduced) temperature condition. While the circuit 2470 is shown as an arrangement for recording the reprocessing process, the first temperature operating switch and the second temperature operating switch can be used in a similar manner to extend the battery life in any instrument or device that is exposed to high temperatures. Further, while the first switch 2472 and the second switch 2474 are shown as being located on either side of the memory device 2476, any other arrangement of the first switch 2472 and the second switch 2474 is within the scope of the present disclosure. For example, the first switch 2472 and the second switch 2474 can both be located on the same leg of the circuit, i.e., both switches are in series between the positive or negative terminal of the battery 2464 and the memory device 2476, or can be rearranged in any order that closes the first switch 2472 to close the circuit 2470 and opens the second switch 2474 to open the circuit.

[0156] When the instrument is in use or otherwise coupled to a powered surgical system (e.g., a teleoperated computer-assisted surgical system or other interface), information stored in the non-volatile memory of the memory device 2476 can be retrieved from the memory device. Alternatively or additionally, the instrument can include an LCD, e-ink screen, or other electronic display that will show the number of reprocessing procedures that the instrument has undergone and / or the number of reprocessing procedures that the instrument can undergo. To maintain the preservation of battery life provided by the arrangement of circuitry 2470, the display can be operably coupled to the battery by, for example, a user-actuated button such that the display only operates when the button is pressed. Additionally or alternatively, a temperature-operated switch similar to the switches 2472 and 2474 discussed above can be configured to remove power from the display when a certain elevated temperature is reached.

[0157] Some embodiments of the active electronic recording device can include a voltage source that operates based on conditions that occur during a reprocessing procedure, such as the application of heat and associated elevated temperatures, mechanical energy such as ultrasonic vibrations, the application of pressure, or other conditions. For example, the active electronic recording device can include a voltage source that can be or include an energy harvesting device that converts thermal energy, pressure, and / or mechanical energy into an electrical current.

[0158] Referring now to Figure 25 , a block diagram of an embodiment of an environmental exposure recording device 2514 that includes an energy harvesting device 2578 is shown. The energy harvesting device 2578 can be or include, for example, a piezoelectric element that generates an electrical current based on mechanical vibrations, or a thermocouple or multiple thermocouple (e.g., thermopile) device that generates an electrical current in response to exposure to a temperature differential or other type of energy harvesting device. The energy harvesting device 2578 can be operably coupled to a memory device 2576 (similar to the memory device 1976 discussed in connection with Figure 24 .

[0159] In the exemplary embodiment of Figure 25 , the energy harvesting device 2578 is a piezoelectric type energy harvesting device. Upon exposure to vibrations such as ultrasonic vibrations, the energy harvesting device 2578 generates an electrical current that is applied to the memory device 2576, causing the memory device 2576 to increase the recording of events on the non-volatile memory substantially as discussed in connection with Figure 24 .

[0160] Other embodiments can include an energy harvesting device 2578 that operates based on exposure to a temperature gradient. For example, the energy harvesting device can be or include a thermocouple or thermopile, or another temperature-actuated device. Upon exposure to elevated temperature conditions associated with a reprocessing procedure, the energy harvesting device 2578 generates an electrical current that causes the memory device 2576 to increase the recording of events on the non-volatile memory.

[0161] Temperature-responsive state-changing elements, such as those discussed above, can additionally be operably coupled with a component configured to disable an instrument that is not designed to withstand conditions associated with an autoclaving procedure. For example, referring now to Figure 26A , the wax motor 2616 is coupled with a locking device 2648. The locking device 2648 includes a gear tooth 2650 that is configured to engage with a gear 2649 of a rotary instrument input, such as an input disc 2651 of an instrument configured for use with a computer-assisted, teleoperated surgical system. Figure 26B A side view of the system of Figure 26A is shown. The locking device 2648 includes a locking pawl 2654 that can engage with a complementary pawl 2656 on a housing or other fixed portion of the instrument.

[0162] Upon exposure to elevated temperature conditions, such as during a cleaning process, an autoclave cycle, or other reprocessing procedure, the wax motor 2616 pushes the locking device 2648 into contact with the gear 2649 of the input disc 2651, and the locking pawl 2654 engages the complementary pawl 2656, thereby preventing use of the instrument. While the wax motor is shown in Figure 26A and Figure 26B devices, a nitinol wire, bimetallic component, or other temperature-responsive device can also be used in a similar manner to immobilize and render an instrument unusable.

[0163] Further, Figure 26A and Figure 26B the locking device 2648 of the device of Figure 26A and Figure 26B embodiments discussed above. Alternatively, a system similar to that described in connection with Figure 26A and Figure 26B can be used for a disposable instrument that is not designed to withstand autoclaving, such that the instrument is immediately disabled upon first exposure to autoclave conditions or any specified temperature threshold.

[0164] Referring now to Figures 27A-27E , another exemplary embodiment of a recording device 2714 is shown that includes a counter mechanism 2713. The recording device 2714 includes a visual indicator 2718 that includes visual indicia in the form of integers to be exposed through an aperture of the instrument housing, such as Figures 27A-27E illustrated, or any other type or configuration of indicia as discussed elsewhere herein. The visual indicator 2718 is operably coupled with a gear 2780. In the device illustrated, the visual indicator 2718 is coaxial with the gear 2780, but in alternative configurations, the gear 2780 can be coupled to the visual indicator 2718 by drive components such as gears, belts and pulleys, or other mechanisms. Figures 27A-27E

[0165] The gear 2780 includes a first set of teeth 2782 on a first surface 2783 of the gear 2780 and a second set of teeth 2784 on a second surface 2785 of the gear 2780. The first teeth 2782 are each characterized by a radially outward sloped surface 2786, and the second teeth 2784 are each characterized by a radially inward sloped surface 2787. The plunger 2788 includes a first arm 2789 positioned adjacent the first teeth 2782 and a second arm 2790 positioned adjacent the second teeth 2784.

[0166] The plunger 2788 is operably coupled to a temperature-responsive state-changing element (not shown in the view of Figures 27A-27E ), which imparts a reciprocating linear motion to the plunger 2788, such as a wax motor similar to that discussed in connection with Figure 19 . However, the temperature-responsive element can be or include any of the state-changing components and devices discussed elsewhere herein, such as but not limited to a shape memory alloy component, a wax motor or other bladder or reservoir-type device, a bimetallic element, a pressure-responsive actuator, or any other device that can be configured to provide a reciprocating linear motion.

[0167] Referring now to Figure 27A , the reprocessing recording device 2714 is shown in an initial position, with the plunger 2788 retracted from the gear 2780. Upon exposure of the device to elevated temperature conditions sufficient to actuate the temperature-responsive element (e.g., in association with a reprocessing procedure), the temperature-responsive element advances the plunger 2788 toward the gear 2780. As the plunger 2788 advances toward the gear 2780, the first arm 2789 contacts the radially outward sloped surface 2786 of one of the first set of teeth 2782, as illustrated in Figure 27B , causing the gear to rotate in direction R to the state illustrated in Figure 27C .

[0168] ​Upon stopping the elevated temperature condition, the temperature-responsive element causes the plunger 2788 to begin retracting from the gear 2780 (i.e., the plunger 2788 begins to return to Figure 27A the position shown), as Figure 27D indicated. As the plunger 2788 retracts, the second arm 2790 contacts a radially inward facing ramp surface 2787 of one of the teeth in the first set of teeth 2782, causing the gear 2780 to further rotate in the direction R. The plunger 2788 fully retracts to Figure 27E the position shown, and the logging device 2714 has completed logging of the temperature shift to the elevated temperature.

[0169] The total angular rotation of the gear 2780 is the same as the angular separation of the indicia of the visual indicator 2718 through the sequence shown in Figures 27A-27E , such that after the sequence shown in Figures 27A-27E , the indicia are visible to decrement (or increment, depending on the arrangement) by a single integer. As discussed elsewhere herein, various other configurations of indicia are within the scope of the present disclosure, such as graphical type indicators, color-based indicators, non-sequential integer sequences, and other arrangements.

[0170] While Figures 27A-27E embodiments are described as having temperature-responsive state-changing elements, any of the state-changing elements discussed above can be used without departing from the scope of the present disclosure, such as but not limited to pressure-responsive elements, vibration-responsive elements, or other state-changing elements that experience a change in physical dimension, position, phase, or other characteristic under a change in environmental condition.

[0171] Figure 28 A schematic diagram showing another embodiment of a reprocessing logging device including a pressure-responsive state-changing element instead of a temperature-responsive state-changing element is shown. The reprocessing logging device 2814 includes a pressure-responsive state-changing element 2816, which can be or include, for example, a pressure-responsive actuator including a diaphragm, a piston-cylinder device, or other type of pressure-responsive element. The pressure-responsive state-changing element 2816 can be operably coupled with a plunger 2886, which is coupled to a drive pawl 2845. The drive pawl 2845 is positioned proximate to the ratchet 2821 such that extending the plunger 2886 in response to actuation of the pressure-responsive element 2816 (e.g., due to a pressure condition above or below atmospheric pressure) causes the ratchet 2821 to rotate in the direction R. When the plunger 2886 and the drive pawl 2845 retract upon returning to atmospheric pressure, the locking pawl 2828 holds the ratchet 2821 in the new rotational orientation. The ratchet 2821 can include or be coupled to a visual indicator 2818 of any form and configuration discussed herein.

[0172] As noted above, some high-level disinfection and other reprocessing processes involve rapid cycling of pressure and / or temperature. Accordingly, the recording device 2814 can be configured such that the response time of the pressure-responsive element 2816 is such that it actuates once throughout the high-level disinfection or other reprocessing process. For example, the recording device 2814 can include a damper 2892 configured to mechanically slow the response of the pressure-responsive element 2816 to a desired degree. Other methods of specifically setting the response time of the pressure-responsive element 2816 can include thermally insulating the pressure-responsive element, measuring the flow rate of the ambient fluid (air, steam, etc.) to the pressure-responsive element, or other methods apparent to those skilled in the art.

[0173] In certain instances, it can be desirable to clearly indicate to a user that the instrument has undergone the maximum allowed number of reprocessing cycles via the use counting device or the reprocessing recording device. In some devices herein, such as the use recording device and the reprocessing recording device, once the maximum allowed number of uses and / or reprocessing cycles has been met, these devices can be configured to provide an indication that is different in quality from the counting indication. For example, the use recording device or the reprocessing recording device, or both, can optionally include a component such as an indicator flag that appears when the maximum allowed number of uses or reprocessing cycles is met. In devices where the recording device indicates the number of uses or reprocessing cycles via a visual indicia, the indicator flag can optionally be configured to cover the visual indicia and clearly indicate to the user that the allowed number of uses or reprocessing cycles has been met, and that the instrument cannot acceptably undergo any further uses or reprocessing cycles. The indicator flag can be configured with a warning message such as text or indicia indicating that the instrument cannot acceptably undergo further uses or reprocessing cycles, a general warning indicia such as red, or other features.

[0174] Once the maximum allowed number of uses or reprocessing cycles has been met, certain instruments or systems can not be configured to actively prevent continued use of the instrument. Accordingly, a warning that the maximum allowed number of uses or reprocessing cycles has been met can go unnoticed and the instrument can be continued to be used and / or subjected to reprocessing cycles, contrary to applicable recommendations and / or regulations. In certain instances, it can be desirable to track uses or reprocessing cycles that occur after the maximum allowed number, even in instruments that include an indicator flag that obscures the visual indicia.

[0175] Referring now to Figures 29-32 , another embodiment of a reprocessing recording device 2914 is shown. While the devices of Figures 29-32 are reprocessing recording devices, various features, components, and arrangements of the reprocessing recording device 2914 are also applicable to use recording devices disclosed herein. The reprocessing recording device 2914 includes a housing 2912, a pressure-responsive element 2916, and a recording device 2918. The recording device 2918 can be configured to record the number of reprocessing cycles to which the instrument has been subjected. The recording device 2918 can be configured to provide an indication of the number of reprocessing cycles to which the instrument has been subjected. The recording device 2918 can be configured to provide an indication of the number of reprocessing cycles to which the instrument has been subjected that is different in quality from the indication of the number of reprocessing cycles to which the instrument has been subjected. The recording device 2918 can be configured to provide an indication of the number of reprocessing cycles to which the instrument has been subjected that is different in quality from the indication of the number of reprocessing cycles to which the instrument has been subjected, and the instrument cannot acceptably undergo any further reprocessing cycles. The recording device 2918 can be configured to provide an indication of the number of reprocessing cycles to which the instrument has been subjected that is different in quality from the indication of the number of reprocessing cycles to which the instrument has been subjected, and the instrument cannot acceptably undergo any further reprocessing cycles, and the recording device 2918 can be configured to provide a warning message such as text or indicia indicating that the instrument cannot acceptably undergo further reprocessing cycles, a general warning indicia such as red, or other features. Figures 16-28The disclosed recording devices disclose various features similar to those of the disclosed devices, such as the state-changing element 2916 and the counter mechanism with visual indicator 2918. In Figure 29 In the devices of the '712, the state-changing element 2916 includes a wax motor. However, other state-changing elements, such as but not limited to other temperature and / or pressure responsive elements as discussed herein, can optionally be used in conjunction with the device 2914.

[0176] In the devices of the '715, Figures 1-28 In various devices of the embodiments of the '715, the visual indicator includes a single component that includes visual indicia to indicate to a user the number of remaining reprocessing cycles that the instrument can be exposed to, or the number of cycles that the instrument has been exposed to. In some devices, the visual indicia can include multiple components to indicate different numerical position values. In other words, two or more counter mechanisms can be used with different numbers of environmental exposures or triggers to move to the next visual indicator. For example, the recording devices of the present disclosure can optionally include separate components with separate indicia for counting single uses, tens of reprocessing cycles, hundreds of reprocessing cycles, etc. In the devices of the '715, Figure 29 and Figure 30 The recording device 2914 shown in the '717 includes a visual indicator 2918 that includes a ones place counter wheel 2918A and a tens place counter wheel 2918B. The ones place counter wheel 2918A can be provided with indicia indicating individual reprocessing cycles, and the tens place counter wheel 2918B can be provided with indicia indicating tens of reprocessing cycles. For example, the ones place counter wheel 2918A can display cycles 0-9, while the tens place counter wheel 2918B can display cycles 0-2, 0-3, 0-4, up to 0-9, etc., depending on the total number of cycles allowed for exposure of the instrument. As with other embodiments disclosed herein, the indicia of the ones place counter wheel 2918A and the tens place counter wheel 2918B can be configured to be exposed through an aperture (not shown) in the housing of the instrument. While Figure 29 and Figure 30 While the devices of the '718 and the '719 include a ones place counter and a tens place counter, other embodiments can include additional counters, such as a hundreds place, a thousands place, etc., depending on the total number of uses and / or reprocessing cycles allowed. Furthermore, the counters need not use a base-ten numbering, but counters employing other bases, hexadecimal numbering, or other numbering systems are within the scope of the present disclosure. Using separate counters to represent different positional numbering locations can facilitate an overall smaller device for a given total number of uses or reprocessing cycles, and / or can facilitate recording a greater number of uses or reprocessing cycles.

[0177] In one embodiment, the units counter wheel 2918A and the tens counter wheel 2918B are mechanically coupled in a manner similar to a mechanical odometer, a totalizer counter, or other similar mechanism. That is, the rotation of the units counter wheel 2918A and the tens counter wheel 2918B are coupled such that for a full rotation of the units counter wheel 2918A, the tens counter wheel 2918B is incremented once (i.e., showing a larger or smaller indicia depending on whether the counter is counting up to a maximum value or down to zero). For example, the units counter wheel 2918A and the tens counter wheel 2918B are engaged with first and second impellers 2925A and 2925B rotatably held by a layshaft 2919. The first and second impellers 2925A and 2925B are rotatable independently of one another. For example, both the first and second impellers 2925A and 2925B can be free to rotate on the layshaft 2919. The first and second impellers 2925A and 2925B are provided with engagement vanes configured to engage various features of the units counter wheel 2918A and the tens counter wheel 2918B, as will be discussed further with respect to the operation of the recording device 2914.

[0178] As noted above, some embodiments using a recording device and / or reprocessing a recording device can include an indicator flag that indicates that the maximum number of allowed uses or reprocessing cycles has been met. Referring now to Figure 31 , a perspective view of the recording device 2914 shows a side of the recording device 2914 opposite to that primarily shown in the views of Figure 29 and Figure 30 In the view of Figure 31 , the indicator flag 3021 is shown in a deployed position, i.e., it covers the position of the user’s view of the units counter wheel 2918A and the tens counter wheel 2918B. The indicator flag 3021 can be configured to reliably remain in the deployed position such that the indicator flag 3021 does not inadvertently shift from the deployed position during processing. For example, in the device 2914, the indicator flag 3021 includes a resilient retention member 3023 that engages a detent 3025 to hold the indicator flag 3021 in the deployed position.

[0179] In use, exposure to an elevated temperature (e.g., a temperature associated with a reprocessing cycle or a portion thereof) actuates the state change element 2916. In the device 2914, the state change element 2916 is a wax motor having a reservoir of material that expands upon exposure to an elevated temperature. Referring again to Figure 29 and Figure 30The units counter wheel 2918A includes a ratchet 2921 that interfaces with a drive pawl 2922 and an anti-reverse pawl 2923. The state change element 2916 includes a movable portion 2917 that is mechanically coupled to the drive pawl 2922 that interfaces with the ratchet 2921. Actuation of the state change element 2916 causes the movable portion 2917 of the state change element to translate in direction D, causing the drive pawl 2922 to rotate the units counter wheel 2918A in direction R, advancing the units counter wheel 2918A (e.g., 1 / 10th of a rotation) to reflect a single additional reprocessing cycle. Upon cessation of the elevated temperature condition, the movable portion 2917 retracts, and the anti-reverse pawl 2923 prevents the units counter wheel 2918A from rotating in reverse as the movable portion 2917 retracts. The state change element 2916 and the units counter wheel 2918A can be configured such that exposure to a single reprocessing cycle causes the units counter to increase by one, reflecting that more than one reprocessing cycle has been performed on the instrument or that one less reprocessing cycle remains that the instrument can be exposed to.

[0180] The interaction between the units counter wheel 2918A, the tens counter wheel 2918B, and the first impeller 2925A and the second impeller 2925B held by the secondary shaft 2912 is arranged to advance the tens counter wheel 2918B to display an additional ten reprocessing cycles for each full rotation of the units counter wheel 2918A. As shown, the first impeller 2925A includes alternating long impellers 2927A and short impellers 2927B on a first side of the first impeller 2925A. Referring now to Figure 29 Figure 31 The units counter wheel 2918A includes a groove 2928 that is configured to accommodate a long blade 2927A. Two protrusions 2929 on either side of the groove 2928 are arranged to interface with a short blade 2927B. The groove 2928 is positioned such that when the units counter wheel 2918A rotates around a full rotation in response to actuating the state change element 2916, one short blade 2927B contacts one of the two protrusions 2929, causing the first impeller 2925A to rotate opposite the rotation of the units counter wheel 2918A when one long blade 2927A enters the groove 2928. Continued rotation of the units counter wheel 2918A causes the first impeller 2925A to rotate until the long impeller 2927A exits the groove 2928.

[0181] The first impeller 2925A includes a second short impeller 2927C that is always meshed with a corresponding impeller 2931 on the tens counter wheel 2918B. Thus, as the first impeller 2925A rotates in response to the groove 2928 of the units counter wheel that interfaces with the first impeller 2925A, the tens counter wheel 2918B also rotates. In Figures 29-31 ​For each complete rotation of the units counter wheel 2918A, the tens counter wheel 2918B is incremented once in the device 2914.

[0182] The indicator flag 3021 can be actuated in response to movement of the tens counter wheel 2918B using an arrangement similar to the arrangement operably coupling the tens counter wheel 2918B and the units counter wheel 2918A. Referring to Figure 30 , the tens counter wheel 2918B includes a recess 2932 and two protrusions 2934. The second impeller 2925B is engaged with the tens counter wheel 2918B. As the tens counter wheel 2918B rotates in response to rotation of the first impeller 2925A, the long impeller 2927D and the short impeller 2927E of the second impeller 2925B engage the recess 2932 and the protrusions 2934 of the tens counter wheel 2918B. With the recess 2932 and the protrusions 2934 of the tens counter wheel engaged with the long impeller 2927D and the short impeller 2927E of the second impeller 2925B, rotation of the tens counter wheel 2918B drives rotation of the second impeller 2925B.

[0183] Referring to Figure 32 , which shows a side cross-sectional view of the recording device 2914, the second impeller 2925B includes a sector gear 2933 that intermeshes with teeth 2935 on the indicator flag 3021. Rotation of the second impeller 2925B in the direction R2, e.g., in response to rotation of the tens counter wheel 2918B as described above, rotates the indicator flag 3021 in the direction R3 from a retracted position (indicated by the dashed line 3021A in Figure 32 ) to a deployed position, as shown in Figure 32 .

[0184] After the indicator flag 3021 reaches the deployed position, the units counter wheel 2918A and the tens counter wheel 2918B can continue to rotate and increment in the manner described above in response to the instrument being exposed to reprocessing cycles. The sector gear 2933 of the second impeller 2925B disengages from the teeth 2935 of the indicator flag 3021, and the indicator flag 3021 remains in the deployed position shown in the figures regardless of further movement of the units counter wheel 2918A or the tens counter wheel 2918B. Thus, the device 2914 continues to mechanically record the number of reprocessing cycles to which it can be exposed while providing the user with a clear indication that the number of times allowed for the reprocessing cycle has been satisfied.

[0185] Embodiments of the present disclosure provide a reliable and robust device that records the number of times an instrument is subjected to a reprocessing cycle and is easily viewable by a user of the instrument and / or readable by a system to which the instrument can be connected.

[0186] In some embodiments, instruments according to the present disclosure can include a variety of recording and indicating devices, such as the environmental exposure recording and use recording devices disclosed in connection with the embodiments of Figures 16-32 Accordingly, in accordance with various embodiments disclosed herein, some instruments according to the present disclosure can include both a use recording device (such as any of the various embodiments of use counters disclosed herein) and a reprocessing recording device for recording changes in environmental conditions (such as conditions associated with a reprocessing procedure) experienced by the instrument. As discussed herein, such devices can include one or more state-changing elements, such as, but not limited to, temperature-responsive elements, pressure-responsive elements, or vibration-responsive elements, that undergo a state change in response to a change in environmental conditions.

[0187] The state-changing element(s) can be operably coupled with a counter mechanism that records the occurrence of an event associated with a predetermined change in the condition that causes the state-changing element to change states. As a non-limiting example, the event can be an event associated with a reprocessing procedure. The counter mechanism and the state-changing element can be operably coupled such that when the instrument including the recording device undergoes a reprocessing procedure, the counter mechanism is incremented to reflect the occurrence of such a reprocessing procedure by the instrument. For example, the counter mechanism can be incrementally moved in response to each state change of the state-changing element from a first state to a second state. That is, the counter mechanism can record the number of transitions of the state-changing element from a first state to a second state. The counter mechanism is a form of user-accessible storage device that records and provides information to a user regarding the number of changes in environmental conditions (such as conditions associated with a reprocessing procedure).

[0188] Figure 33 A schematic view of an instrument 3300 according to the present disclosure is shown, including a use recording device 3314 and a device 3315 for recording a reprocessing procedure (or other change in environmental conditions). As shown, Figure 33 The instrument 3300 includes the use recording device 3314 and the reprocessing recording device 3315 adjacent to one another on the outside of the housing 3301 of the instrument 3300. Alternatively, in other embodiments, the use recording device 3314 and the reprocessing recording device 3315 can be located on the same side of the instrument or at different locations on different sides of the housing 3301 of the instrument 3300. The reprocessing recording device 3315 includes a state-changing element 3316 operably coupled to a counter mechanism 3313 that includes indicia that displays information related to the number of times the instrument has undergone a reprocessing procedure or other change in environmental conditions.

[0189] Reference is now made to Figure 34, another example embodiment of an instrument 3400 including both a use recording device 3414 and a reprocessing recording device 3415 is shown. In Figure 34 , only the respective indicator portions of the use recording device 3414 and the reprocessing recording device 3415 are shown, with other components of the devices obscured by the housing of the instrument 3400. As discussed above in connection with various embodiments of use recording devices disclosed herein, the use recording device 3414 includes indicia that indicate to a user the remaining number of uses available for the instrument. The reprocessing recording device 3415 includes indicia that indicate to a user the remaining number of reprocessing procedures that the instrument 3400 can be exposed to. While both the use recording device 3414 and the reprocessing recording device 3415 include indicia comprising consecutive numerical indicators that count down from the maximum number of uses or reprocessing procedures, respectively, that the instrument 3400 can be subjected to, other indicia and indicator schemes are possible, as discussed in detail above. For example, indicator schemes comprising pyramidal graphics, bar graphics, color-based indicators, textual indicators, or any other type of indicator are within the scope of the present disclosure. Further, the indicia for the use recording device and the reprocessing recording device can be similar, as in the instrument 3400, or can be dissimilar. That is, the features of one of the use recording device 3414 and the reprocessing recording device 3415 can be set to one indicator scheme, such as the consecutive numbering scheme shown in Figure 34 , while the features of the other of the use recording device 3414 and the reprocessing recording device 3415 can be set to another indicator scheme, such as a graphical indicator, a color indicator, etc., as described above. Alternatively, both the use recording device 3414 and the reprocessing recording device 3415 can use non-numerical indicators, such as graphical indicators, color-based indicators, or other indicator schemes as discussed herein, in any desired combination as disclosed herein.

[0190] The reprocessing recording device 3415 can include, but is not limited to, a state-changing element including a temperature-responsive element, a pressure-responsive element, or a vibration-responsive element that is operable to change state in response to reaching a temperature threshold. These state changes can then be used to translate the motion or actuation of other elements in order to provide a counter mechanism that advances when the instrument is subjected to a predefined temperature threshold, triggering a reprocessing or other “use” of the instrument associated with a pre-set environmental condition or set condition that the instrument is subjected to. Such state-changing elements can be or include shape-memory alloy components, material reservoirs such as wax motors, pressure-sensitive diaphragms, or other components. The use recording device 3414 can be or include a rotatable dial 218, as discussed herein in connection with Figures 2-4The use recording device under discussion can be relatively easily combined packaged with various reprocessing recording devices disclosed herein due to the potential small overall size and low part count of the use recording device employing the rotatable disk 218. However, any of the various embodiments of the use recording device disclosed herein can be used in combination with any of the reprocessing recording devices disclosed herein.

[0191] Referring now to Figure 35 , an internal view of the instrument 3400 is shown with the outer housing 3401( Figure 34 ) omitted to reveal the internal components of the instrument 3400. In the embodiment shown, the reprocessing recording device 3415 includes a state changing element 3416 that includes a shape memory alloy wire that is operably coupled to an indicator wheel 3470 that has visual indicia 3471 in the form of consecutive numbers that are individually displayed through an aperture 3472( Figure 34 ) in the outer housing 3401( Figure 34 ) of the instrument 3400. The state changing element 3416 can be operably coupled to the indicator wheel 3470 through mechanical components discussed herein, such as a ratchet system that advances the indicator wheel a specified amount when the instrument is exposed to a reprocessing process (e.g., advancing the indicator wheel 3470 to subsequently display a fewer number of reprocessing cycles that the instrument can be exposed to).

[0192] Temperature-responsive elements may be or include one or more of the following: a material that responds to a change in physical configuration, such as physical dimensions (e.g., length, width, height, shape, and / or volume) or another change in state (e.g., position, stiffness, charge, color, and / or phase), in response to exposure to temperatures above (or below) a specified threshold temperature. The threshold temperature may be defined by the conditions of the reprocessing procedure the device is to undergo. For example, the threshold temperature may be selected to be greater than the temperature the device is to be subjected to during normal use and lower than the highest temperature the device is to be subjected to during reprocessing. For example, an autoclaving process may involve temperatures at or above 120°C for a specified period of time, while a cleaning process (e.g., ultrasonic cleaning) may involve temperatures rising above normal ambient (e.g., room temperature) but below the autoclaving temperature, or even below 100°C. The threshold temperature of the temperature response element can be selected such that the recording device (e.g., by selecting a threshold temperature higher than, for example, 100°C) records only the autoclaving process, or (e.g., by selecting a threshold temperature higher than the temperature used for cleaning (e.g., a temperature in the range of, for example, 70°C to 90°C, depending on the temperature used during the cleaning process)) records cleaning and autoclaving at elevated temperatures. Those skilled in the art will understand how to design and configure the device according to this disclosure to respond to more than one type of temperature shift when needed, for example, by using different temperature responses, state-changing elements to record different types of reprocessing processes with different temperature characteristics.

[0193] Figure 36 yes Figure 35 An enlarged view of the reprocessing recording device 3415 shown. Figure 35 and Figure 36 In the exemplary device, the state-changing element 3416 is a wire, cable, or other similar component made of a shape memory metal such as a nickel-titanium alloy (e.g., nitinol). The state-changing element 3416 is routed by a series of pulleys 3417. Other embodiments may include other temperature-responsive elements, including (but not limited to) wax motors, bimetallic components, temperature-sensitive electronic switches, or other components. These temperature-responsive elements may be configured to undergo a state change upon temperature change (e.g., heating to at least a threshold temperature). The state-changing element 3416 is operatively coupled to a counter mechanism such that the counter mechanism records the state change of the shape memory wire state-changing element 3416 due to exposure to temperatures rising above a specified threshold temperature.

[0194] The counter mechanism is configured to move incrementally based on a state change of the state-changing element 3416. For example, in Figure 35 and Figure 36In one embodiment, the counter mechanism includes a ratchet mechanism 3420. The ratchet mechanism 3420 includes an indicator wheel 3470 with ratchet teeth 3422 that engage with one or more drive pawls 3426 mounted to a drive pawl carrier 3424. Through the engagement of the ratchet teeth 3422 with the drive pawls 3426 and the operation of the drive pawl carrier 3424, the indicator wheel 3470 moves incrementally for each temperature offset above a specified threshold temperature. As discussed in more detail below, the ratchet mechanism 3420 may include or be operatively coupled to a user-accessible storage mechanism, such as the exemplary indicator wheel 3470, or other user-accessible storage mechanisms discussed herein.

[0195] Drive pawl carrier 3424 can follow Figure 36 The direction P is indicated by translational movement. The drive pawl carrier 3424 carries at least one drive pawl 3426, but this configuration is not limiting, and other numbers and arrangements of drive pawls will be apparent to those skilled in the art. The end of the state-changing element 3416 is secured to the drive pawl carrier 3424 in any suitable manner. For example, in… Figure 36 In one embodiment, the end of the state-changing element 3416 is curled to form a loop and the loop is secured to the drive pawl carrier 3424.

[0196] The ratchet mechanism 3420 may include features configured to prevent reverse drive of the ratchet mechanism 3420. For example, the ratchet mechanism 3420 may include a locking pawl 3428 configured to engage with an anti-reverse ratchet tooth 3423. The locking pawl 3428 allows the indicator wheel 3470 to move in the drive direction, but prevents the indicator wheel 3470 from rotating in the opposite direction to the drive direction after being pushed forward (e.g., as shown in the image). Figure 35 and Figure 36 As shown, the locking pawl 3428 allows the ratchet to move counterclockwise and prevents the indicator wheel 3470 from rotating clockwise. Although in Figure 35 and Figure 36 In one embodiment, the locking pawl 3428 engages with the anti-reverse ratchet tooth 3423, but in other exemplary embodiments, the locking pawl 3428 may be configured to engage with the ratchet tooth 3422. That is, in some designs, it will be apparent to those skilled in the art that both the drive pawl 3426 and the locking pawl 3428 may engage with the same set of ratchet teeth.

[0197] The locking pawl 3428 can be coupled to (e.g., integrated into) the flexible arm 3429. Figure 36In the middle, the flexible arm 3429 is shown in dashed line. The elastic deformation of the flexible arm 3429 allows the indicator wheel 3470 to rotate in the drive direction as the anti-reverse ratchet teeth 3423 deflect the locking pawl 3428 away from the indicator wheel 3470. As will be readily appreciated, the flexible arm 3429 can instead be hinged and one or more biasing members, such as springs, can be provided to ensure that the locking pawl 3428 returns to the undeflected position in engagement with the anti-reverse ratchet teeth 3423 to prevent reverse drive of the indicator wheel 3470.

[0198] The drive pawl carrier 3424 is biased to an initial position (e.g., the position shown in the middle). A biasing element in the form of a tension spring 3432 is coupled to the drive pawl carrier 3424 to bias the drive pawl carrier 3424 in the position shown in the middle. Figure 36 Figure 36 One end of the tension spring 3432 is fixed to the base 3403 of the reprocessing record device 3415 and the opposite end is fixed to the drive pawl carrier 3424. The tension spring 3432 extends and retracts generally in the direction in which the state change element 3416 extends and contracts.

[0199] The operation of the counter mechanism 3413 is affected by the exposure of the state change element 3416 to a temperature excursion. For example, the state change element 3416 decreases in length upon heating to or above a specified threshold temperature due to the transition of the nitinol material from the martensitic state to the austenitic state. As the state change element 3416 shortens, the tension generated in the state change element 3416 acts against the biasing force of the tension spring 3432, extending the tension spring 3432 and causing the drive pawl carrier 3424 to translate in the direction P. The drive pawl 3426 engages the ratchet teeth 3422 of the indicator wheel 3470 and rotates the indicator wheel 3470 in the counterclockwise direction, as shown in the middle. Figure 36

[0200] As the indicator wheel 3470 rotates counterclockwise due to the engagement of the drive pawl 3426 with the ratchet teeth 3422, the locking pawl 3428 clears one or more of the anti-reverse ratchet teeth 3423 as the indicator wheel 3470 assumes a new position of the plurality of unique positions. Each position is provided with indicia associated with a change in environmental conditions, such as indicia associated with a reprocessing cycle. Once the indicator wheel 3470 is in the new position, the locking pawl 3428 prevents the indicator wheel 3470 from rotating in the reverse direction (e.g., in the clockwise position as described above). As will be readily apparent to one of ordinary skill in the art, the described ratchet tooth functionality of the drive pawl 3426 and the locking pawl 3428, along with the ratchet teeth 3422 and the anti-reverse ratchet teeth 3423, can be obtained through the profile of the respective teeth, the orientation and shape of the pawls, and other factors readily understood by one of ordinary skill in the art.

[0201] ​​Upon cooling from the elevated temperature to recover its martensitic state, the state change element 3416 elongates, removing the force exerted against the biasing force of the tension spring 3432, and allowing the tension spring 3432 to retract and cause the drive pawl carrier 3424 to return in a direction opposite direction P. Due to the engagement of the locking pawl 3428 with the ratchet teeth 3422, the indicator wheel 3470 remains in the new rotational position.

[0202] The rotation advancement of the indicator wheel 3470 can correspond to a change in the number of reprocessing cycles that can be used for an indication that the instrument has undergone (or the number of reprocessing cycles that the instrument has experienced) because the advancement of the indicator wheel 3470 results in a different indicia being shown through the aperture 3472 Figure 34 ) as shown.

[0203] In embodiments of Figure 35 and Figure 36 , the state change element 3416 is a wire made of a shape memory metal such as nickel titanium alloy (e.g., nitinol). Other embodiments can include other temperature responsive elements including, but not limited to, a wax motor, a bimetallic element, a temperature sensitive electronic switch, a bladder or other container containing a substance that undergoes a phase change, a size change, a position change, a volume change, or other change in response to a temperature change, or other component. These temperature responsive elements can be configured to undergo a state change upon heating to a specified threshold temperature.

[0204] For example, referring now to Figure 37 , there is shown an external schematic view of another instrument 3700 according to yet another example embodiment of the present disclosure, with components of the instrument schematically represented by dashed lines. The instrument 3700 includes a reprocessing record device 3715 that includes a reservoir 3774 containing a state change material (e.g., a wax motor) that is operably coupled to a user-accessible storage device, such as an indicator wheel (not shown), which can generally be similar to the indicator wheel 3470 discussed in connection with Figure 35 and Figure 36 . The reservoir 3474 can be a wax motor or other reservoir that actuates movement of the indicator wheel upon exposure of the instrument 3700 to a predetermined temperature threshold (e.g., associated with a reprocessing process), as discussed herein.

[0205] The embodiments described herein can be used, for example, with teleoperated computer-assisted systems such as teleoperated surgical systems, such as those described in U.S. Patent No. 9,358,074 to Schena et al. (filed May 31, 2013) entitled “Multi-Port Surgical Robotic System Architecture,” U.S. Patent No. 9,295,524 to Schena et al. (filed May 31, 2013) entitled “Redundant Axis and Degree of Freedom for Hardware-Constrained Remote Center Robotic Manipulator,” and U.S. Patent No. 8,852,208 to Gomez et al. (filed August 12, 2010) entitled “Surgical System Instrument Mounting,” each of which is incorporated herein by reference in its entirety. In addition, the embodiments described herein can be used with teleoperated computer-assisted surgical systems such as the da Vinci® Surgical System, da Vinci® Xi® Surgical System, da Vinci® Surgical System, da Vinci® Surgical System, da Vinci® Surgical System, da Vinci® Surgical System, da Vinci® Surgical System, da Vinci® Surgical System.

[0206] The embodiments described herein are not limited to the above-mentioned surgical systems, and various other teleoperated, computer-assisted surgical system configurations can be used with the embodiments described herein. In addition, although various embodiments described herein are discussed in connection with manipulator systems for teleoperated surgical systems, the present disclosure is not limited to use with teleoperated surgical systems. The various embodiments described herein can optionally be used in connection with handheld manual instruments.

[0207] As noted above, in accordance with various embodiments, the surgical instruments of the present disclosure are configured for use with teleoperated, computer-assisted surgical systems that employ robotics (sometimes referred to as robotic surgical systems). Reference is now made to Figure 13, an embodiment of a manipulator system 1300 of a computer-assisted surgical system is shown, to which surgical instruments are configured to be mounted for use. Such a surgical system can also include a user control system, such as a surgeon's console (not shown) for receiving input from a user to control an instrument coupled to the manipulator system 1300, and an auxiliary system, such as the da Vinci® Surgical System mentioned above, associated with the system.

[0208] As shown in an embodiment of Figure 13 , the manipulator system 1300 includes a base 1320, a main column 1340, and a main boom 1360 connected to the main column 1340. The manipulator system 1300 also includes a plurality of manipulator arms 1310, 1311, 1312, 1313, each connected to the main boom 1360. The manipulator arms 1310, 1311, 1312, 1313 each include an instrument mounting portion 1322 to which an instrument 1330 can be mounted, which is illustrated as being attached to the manipulator arm 1310.

[0209] According to one embodiment, the instrument mounting portion 1322 includes a drive assembly 1323 to which a transmission mechanism 1334 of the instrument 1330, which can generally correspond to the transmission mechanism 110 discussed in connection with Figure 1 , is connected. The drive assembly 1323 contains a variety of drive and other mechanisms that are controlled to respond to input commands at a surgeon's console and to transmit forces to the transmission mechanism 1334 to actuate the instrument 1330. For ease of viewing, while Figure 13 embodiments show the instrument 1330 attached to only the manipulator arm 1310, an instrument can be attached to any and each of the manipulator arms 1310, 1311, 1312, 1313.

[0210] Other configurations of surgical systems are also contemplated, such as surgical systems configured for single port surgery. For example, referring now to Figure 14 , a portion of an embodiment of a manipulator arm 2140 of a manipulator system is shown having two surgical instruments 2300, 2310 in mounted positions. The surgical instruments 2300, 2310 can generally correspond to the instruments discussed above, such as the instrument 100 disclosed in connection with Figure 1 . For example, embodiments described herein can be used with the da Vinci® Surgical System commercialized by Intuitive Surgical, Inc. of Sunnyvale, California. For simplicity, Figure 14 ​The schematic diagram depicts only two surgical instruments, but as those skilled in the art will recognize, more than two surgical instruments may be mounted at the manipulator system. Each surgical instrument 2300, 2310 includes shafts 2320, 2330 that have a movable end effector or endoscope, camera or other sensing device at its distal end, and may include or exclude a wrist mechanism (not shown) for controlling distal movement.

[0211] Transmission mechanisms 2385 and 2390 (which can usually correspond to the coupling) Figure 1 The disclosed transmission mechanism 110 is disposed at the proximal end of each shaft 2320, 2330 and connected to the drive components 2420, 2430 via sterile adapters 2400, 2410. The drive components 2420, 2430 include various internal mechanisms (not shown) controlled by a controller (e.g., at the control trolley of the surgical system) to transmit force to the transmission mechanism 2385, 2390 in response to input commands at the surgeon's side console of the surgical system to actuate the surgical instruments 2300, 2310.

[0212] The embodiments described herein are not limited to Figure 13 and Figure 14 The embodiments described herein, as well as various other remote-controlled, computer-aided surgical system configurations, can be used in conjunction with the embodiments described herein.

[0213] The accompanying drawings, which describe and illustrate various embodiments, should not be considered limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the scope of this specification and the claimed invention (including equivalents). In some cases, well-known structures and techniques are not shown or described in detail to avoid obscuring this disclosure. Identical numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated features described in detail with reference to one embodiment may be included in other embodiments where they are not specifically shown or described, provided it is practiceable. For example, if an element is described in detail with reference to one embodiment but not with reference to a second embodiment, that element may still be claimed to be included in the second embodiment.

[0214] For purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities, percentages or ratios, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term "about," unless and except when the context clearly indicates otherwise. Accordingly, unless indicated otherwise, the numerical parameters are approximations and may vary depending upon the desired properties sought to be obtained by the applications. At the very least, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0215] Note that as used herein in the specification and in the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used herein, the term "includes" and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not a disclaimer of additional or

[0216] In addition, the terminology of this specification is not intended to be limiting. For example, spatially relative terms (e.g., "under," "below," "lower," "above," "upper," "proximal," "distal," and the like) can be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., locations) and orientations (i.e., rotational placements) of the devices in use or operation in addition to the positions and orientations shown in the figures. For example, if a device in the figures is turned over, elements described as "below" or "under" other elements or features would then be "above" or "over" other elements or features. Thus, the exemplary term "below" can encompass both positions and orientations of above and below. Devices can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0217] Further modifications and alternative embodiments will be apparent to those of ordinary skill in the art in view of the foregoing description. For example, while the devices and methods are described with respect to particular implementations, the devices and methods can include additional components or steps omitted from the figures and descriptions for the sake of clarity. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching the general manner of carrying out the present teachings to others skilled in the art. It is to be understood that the various embodiments shown and described herein are to be interpreted merely as illustrative. Elements and materials are to be understood as being throughout in alternative combinations in addition to those explicitly set forth herein. Parts and processes can be reversed and certain features can be utilized independently, all as would be understood by one of ordinary skill in the art after perusing this description. Changes can be made to the elements described herein without departing from the spirit and scope of the present teachings and the following claims.

[0218] It is to be understood that the particular example and embodiments set forth herein are non-limiting and that modifications can be made to the structures, sizes, materials, and methods without departing from the scope of the present teachings.

[0219] Other embodiments in accordance with the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the application disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope of the application being indicated by the following claims, which are to be construed in accordance with the applicable law.

Claims

1. An instrument comprising: a shaft comprising a proximal portion and a distal portion; an end effector at the distal portion of the shaft; a device configured to record changes in environmental conditions experienced by the instrument; and a transmission mechanism at the proximal portion of the shaft, the transmission mechanism comprising: a driven input device engageable with an external drive mechanism, and an indicator operably coupled to the driven input device and movable through each of a plurality of successive positions, wherein each of the plurality of successive positions is associated with a unique indicia of remaining non-zero available uses of the instrument, and wherein in response to the driven input device being driven by the external drive mechanism, the indicator moves from a current position of the plurality of positions to a subsequent position of the plurality of positions.

2. The instrument of claim 1, wherein the subsequent position is associated with an indicia indicating fewer available uses than the indicia associated with the current position.

3. The instrument of claim 2, wherein the subsequent position indicates one fewer available use than the current position.

4. The instrument of claim 1, wherein the driven input device comprises a rotatable disk.

5. The instrument of claim 4, wherein the indicator comprises a visual indicia on the rotatable disk.

6. The instrument of claim 5, wherein the visual indicia comprises a series of integers.

7. The instrument of claim 6, wherein the series comprises a series of consecutive integers.

8. The instrument of claim 6, wherein the series comprises a series of non-consecutive integers.

9. The instrument of claim 5, wherein the visual indicia comprises a graphical indicator.

10. The instrument of claim 5, wherein: the instrument comprises a housing in which the transmission mechanism is located; the housing comprises an aperture; and the visual indicia is visible through the aperture.

11. The instrument of claim 5, wherein the visual indicia is located on a lateral sidewall of the rotatable disk.

12. The instrument of claim 5, wherein the visual indicia is located on a plane of the rotatable disk.

13. The instrument of claim 1, wherein the driven input device comprises a locking mechanism configured to maintain the indicator in a given position of the plurality of successive positions in the absence of the driven input device being driven by the external drive mechanism.

14. The instrument of claim 13, wherein: the instrument comprises a housing in which the transmission mechanism is located, the housing comprising a plurality of grooves, and the locking mechanism comprises a plurality of flexible members engageable with the grooves.

15. The instrument of claim 14, wherein the flexible members further comprise cam surfaces engageable with the external drive mechanism to deflect the plurality of flexible members out of engagement with the grooves in the housing.

16. The apparatus of claim 1, further comprising a state change element that is transitionable between a first state and a second state in response to a predetermined change in the environmental condition.

17. The apparatus of claim 16, further comprising a counter mechanism operably coupled to the state change element, the counter mechanism incrementally moving in response to a transition of the state change element from the first state to the second state.

18. The apparatus of claim 1, wherein the device further comprises a user-accessible storage device configured to store and provide information regarding a number of changes in the environmental condition that the apparatus has been subjected to.

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