Monitoring the use of reusable surgical devices

Abstract

Certain aspects of this disclosure provide a system and method for monitoring the use of reusable surgical devices in a surgical setting. In certain embodiments, the method may be performed by a surgical console. The method includes receiving an indicator of intent to use a reusable surgical device in a surgical procedure. The method also includes, in response to the received indicator, receiving a usage value from memory associated with the reusable surgical device, associated with the previous usage of the reusable surgical device. The method also includes evaluating the acceptability of the reusable surgical device for use in a surgical procedure based on a comparison of the usage value with a usage threshold associated with the usage limit of the reusable surgical device. The method also includes permitting or denying the use of the reusable surgical device in a surgical procedure based on the evaluated acceptability.

Description

Background Art

[0001] Many surgical devices can be safely reused in multiple surgical procedures. However, the ability to reuse surgical devices is usually limited. Since surgical devices often move between different surgical environments and systems, it can be difficult to track their usage.

Summary of the Invention

Means for Solving the Problems

[0002] This disclosure relates to surgical systems and methods, and more particularly, to systems and methods for monitoring the use of reusable surgical devices.

[0003] In certain embodiments, a general aspect includes a method for monitoring the use of a reusable surgical device in a surgical environment. The method can be executed by a surgical console. The method includes receiving an indicator of an intention to use a reusable surgical device in a surgical procedure. The method also includes receiving, in response to the received indicator, a usage value associated with a previous usage amount of the reusable surgical device from a memory associated with the reusable surgical device. The method also includes evaluating the acceptability of the reusable surgical device for use in the surgical procedure based on a comparison of the usage value and a usage threshold associated with a usage limit of the reusable surgical device. The method also includes permitting or denying the use of the reusable surgical device in the surgical procedure based on the evaluated acceptability of the reusable surgical device.

[0004] In certain embodiments, another general aspect includes a system for monitoring the use of reusable surgical devices in a surgical setting. The system includes a reader and a surgical console communicatively coupled to the reader. The surgical console is operable to receive an indicator of intent to use a reusable surgical device in a surgical procedure. The surgical console is also operable to receive, via the reader, a usage value associated with the previous use of the reusable surgical device from a memory associated with the reusable surgical device in response to the received indicator. The surgical console is further operable to evaluate the acceptability of the reusable surgical device for use in a surgical procedure based on a comparison of the usage value with a usage threshold associated with the usage limit of the reusable surgical device. In addition, the surgical console is operable to permit or deny the use of the reusable surgical device in a surgical procedure based on the evaluated acceptability of the reusable surgical device.

[0005] To allow for a more detailed understanding of the features of this disclosure described above, a more specific description of this disclosure, which has been briefly summarized above, can be obtained by referring to embodiments, some of which are shown in the accompanying drawings. However, it should be noted that the accompanying drawings are merely illustrative embodiments and should not be considered limiting in scope, as other similarly effective embodiments may be recognized. [Brief explanation of the drawing]

[0006] [Figure 1] Figure 1 shows a surgical environment with various surgical devices and systems according to a specific embodiment of this disclosure. [Figure 2] Figure 2 shows a specific aspect of the surgical environment of Figure 1 according to a particular embodiment of the present disclosure. [Figure 3] Figure 3 illustrates how various components of the surgical environment shown in Figures 1-2 communicate and work together in a particular embodiment of this disclosure. [Figure 4]Figure 4 shows an example of a process for monitoring the use of a surgical device according to a specific embodiment of the present disclosure. [Figure 5] Figure 5 shows an example of a process for monitoring the use of a surgical device via usage values, according to a specific embodiment of this disclosure. [Modes for carrying out the invention]

[0007] To facilitate understanding, identical elements common to the drawings are designated using the same reference numerals where possible. It is assumed that elements and features of one embodiment may be usefully incorporated into other embodiments without further explanation.

[0008] In the following description, details are given as examples to facilitate understanding of the subject matter disclosed. However, it should be apparent to those skilled in the art that the disclosed implementations are examples and do not encompass all possible implementations. Therefore, please understand that references to the examples described are not intended to limit the scope of this disclosure. Any modifications and further alterations to the devices, apparatus, and methods described, as well as any further applications of the principles of this disclosure, are readily conceivable to those skilled in the art in which this disclosure relates. In particular, features, components, and / or steps described in relation to one implementation may be readily conceived in combination with features, components, and / or steps described in relation to other implementations of this disclosure.

[0009] The number and complexity of surgical procedures, including ophthalmic procedures such as retinal and vitreous surgery, are increasing daily. Various surgical devices, including surgical tools such as ophthalmic handpieces and their components, can be used to perform these procedures. While some surgical devices can be sterilized and safely reused, even reusable devices eventually reach a point where they are no longer suitable for surgical use and should be discarded and / or replaced. Therefore, in certain embodiments, it would be advantageous to monitor parameters related to device utilization, such as shelf life and usage. However, the problem is that surgical devices often move between different surgical environments and systems, thus making tracking difficult. This problem is further complicated by the fact that surgical devices are used in sterile environments. Consequently, contact-based tracking methods are generally unsuitable due to the risk of contamination.

[0010] One approach to the above problem might be to use packaging labels or marks, such as barcodes or quick-response (QR) codes, to provide specific device information for tracking purposes. However, since packaging labels and marks are generally not updatable, such methods would be limited to providing static information such as identifiers. Such tracking or monitoring systems rely on device-specific data being stored and updated elsewhere in relation to the provided identifiers, which presents challenges as devices move between the environment and the system.

[0011] This disclosure describes an example of monitoring the use of a reusable surgical device by, for example, maintaining device-specific profile data in memory embedded in, coupled to, or otherwise inherently associated with the device. The memory may reside, for example, in a radio frequency identification (RFID) or near-field communication (NFC) tag to enable contactless access. In various embodiments, a computer associated with a surgical environment, such as a surgical console or its components, may evaluate the acceptability of a given surgical device at or near the time of a surgical procedure based, for example, device-specific profile data obtained from memory associated with the device. In various embodiments, the computer may refuse to use the device in a surgical procedure if it determines that the device is unacceptable due to, for example, a decrease in safety or practicality. In various embodiments, the computer may update the device-specific data to include new information, such as data reflecting the usage of the device in the surgical procedure in question. Thus, the surgical use of the device can be tracked, and the device can be discarded and / or replaced when it reaches its usage limit.

[0012] Advantageously, in certain embodiments, the systems described herein can monitor the use of reusable surgical devices without any external storage of device-specific profile data in a network, system, or cloud storage location. In certain embodiments, the device-specific profile data is stored and maintained in memory inherently associated with the device, so that such data moves with the device when it moves between different environments and systems. Furthermore, in embodiments where RFID, NFC, or similar protocols are used for data transfer, device-specific data can be retrieved and updated without posing a risk of contamination to the device, thus making it suitable for sterile environments, such as those involving sterile surgical ophthalmic devices.

[0013] As used herein, the term “surgical system” may refer to any surgical system, console, or device for performing surgical procedures. For example, the term “surgical system” may refer to a surgical console such as an phacoemulsification console, a vitrectomy console, a laser system, or any other console, system, or device used in an ophthalmic operating room, as is known to those skilled in the art. While specific embodiments described herein are described in relation to ophthalmic systems, devices, and environments, it should be noted that the embodiments described herein are equally applicable to other types of medical or surgical systems, devices, and environments.

[0014] As used herein, the term “sensor” may refer to any type of device that detects or measures, records, indicates, or otherwise responds to a physical input. For example, the term “sensor” may refer to a device configured to detect or measure the position, location, proximity (e.g., relative to the surgical console), tilt, height, velocity (e.g., accelerometer), temperature, etc., of a surgical device, system, or user. In certain embodiments, the term “sensor” may refer to a device configured to detect a touch, i.e., contact by a user with a surgical device or system, such as a capacitive or resistive touch sensor. In certain embodiments, the term “sensor” may refer to an imaging device configured to detect and relay image-based information, such as an active pixel sensor (APS), such as a charge-coupled device (CCD) or complementary metal-oxide-semiconductor (CMOS) sensor.

[0015] While ophthalmic surgical devices and systems will be described in general with reference, the devices and systems described herein may be implemented by other devices and systems, such as devices and systems for other surgeries, without departing from the scope of application of this application.

[0016] Figure 1 shows an embodiment of a surgical environment 100, such as an ophthalmic surgical environment, in which a surgical console 120 may be used for performing surgical procedures, according to embodiments of the present disclosure. As shown, the surgical environment 100 further includes a surgeon 110, a patient 112, and several surgical systems and devices such as a surgical console 120 having a display device 122, a microscope system 124, surgical tools 126, and a surgical tray 128. Generally, suitable surgical systems that may be included in the surgical environment 100 include surgical devices and consoles for performing retinal and vitreous procedures, cataract surgery, corneal transplantation, glaucoma surgery, LASIK (Laser-Assisted Incision Knee Surgery), refractive lens replacement, trabeculectomy, corneal incision procedures, and corneal transplantation, or other devices and consoles identifiable to those skilled in the art. Consoles capable of performing two or more of these procedures are also within the scope of the present disclosure. An example of a console configured for performing retinal and vitreous procedures is the Constellation® system, available from Alcon Laboratories, Inc., Fort Worth, Texas. An example of a console configured for cataract surgery is the Centurion® system, available from Alcon Laboratories, Inc., Fort Worth, Texas.

[0017] Furthermore, the surgical console 120 includes a controller 104. The controller 104 is configured to cause the surgical console 120 to perform one or more tasks for driving surgical tools, for example, surgical tool 126. In the embodiment shown in Figure 1, the controller 104 is integrated within the surgical console 120, and the controller 104 includes or refers to one or more processors and / or memory integrated within the surgical console 120. In certain other embodiments, the controller 104 is, for example, a standalone device or module that communicates wirelessly or wired with the surgical console 120 and other devices in the surgical environment 100. In certain embodiments, the controller 104 refers to a set of software instructions configured to be executed by a processor associated with the surgical console 120. In certain embodiments, the operation of the controller 104 may be performed in part by the controller 104 and / or a processor associated with the surgical console 120, and in part in a public or private cloud.

[0018] Figure 2 shows a specific embodiment of the surgical environment 100 in more detail. In the example in Figure 2, the surgical tool 126 is an ophthalmic handpiece having a reusable surgical device 232 as an attachment. In a typical embodiment, the reusable surgical device 232 is shown to be a removable component of the surgical tool 126 that can be reused in multiple surgical procedures according to medical standards or practices.

[0019] The surgical tray 128 is shown to have a surgical pad 230 located near (e.g., on) the surgical tray 128 so that surgical tools 126 can be placed on the surgical pad 230 in preparation for a surgical procedure. It should be understood that the surgical pad 230 can be any appropriate size, shape, or layout relative to the surgical tray 128. In some embodiments, the surgical pad 230 is omitted, and its components may be implemented directly within other equipment, such as within the surgical tray 128. In certain embodiments, the surgical pad 230, surgical tray 128, and / or surgical console 120 may include a use sensor configured to detect the placement of surgical tools 126 on the surgical pad 230. For example, the use sensor may be a laser sensor, a weight sensor, or other type of similar device that is positioned and configured to detect the placement of surgical tools 126 on the surgical pad 230, thereby indicating to the controller 104 the intention to use the surgical tools 126, including a reusable surgical device 232 connected thereto.

[0020] While the surgical pad 230 includes or is associated with a reader 206 that communicates with the controller 104, the reusable surgical device 232 includes or is associated with a transponder 240. The reader 206 may include any suitable interface for contactless, wireless communication (e.g., one-way or two-way signaling) between the controller 104 and, for example, the transponder 240. For example, the reader 206 may be or include an RFID reader, an NFC reader, or another similar wireless type reader or receiver. Similarly, the transponder 240 may be or include a passive or active RFID or NFC transponder, sometimes called a tag, or another similar device for transmitting (i.e., communicating) device-specific profile data to the reader 206. In some cases, the reader 206 and transponder 240 may be configured for ultra-high frequency (UHF) RFID communication. For illustrative purposes, examples of the reader 206 and transponder 240 configured for RFID communication may be described periodically herein.

[0021] More specifically, the transponder 240 can store profile data relating to the reusable surgical device 232 in its memory. The profile data may include various device-specific parameters, such as a device identifier, a usage value indicating the amount of use of the reusable surgical device 232, a manufacturing date, a manufacturing lot identifier, a manufacturing power output, and / or other information. In various embodiments, the profile data stored by the transponder 240 may be updated by the controller 104 via the reader 206. Those skilled in the art will understand that the transponder 240 can be associated with the reusable surgical device 232 in any suitable manner, including being embedded, positioned, and / or mounted in any suitable location for the reusable surgical device 232. In the illustrated embodiment, the transponder 240 is shown embedded within the reusable surgical device 232.

[0022] Referring together to Figures 1 and 2, during the performance of an ophthalmic surgical procedure on patient 112, surgeon 110 may utilize one or more surgical devices, including surgical tools 126, which include the reusable surgical device 232 as described above. In certain embodiments, the controller 104 can be operated to monitor not only the use of the reusable surgical device 232 but also the use of other similarly configured surgical devices, using profile data stored in the transponder 240. For example, in certain embodiments, before performing an ophthalmic procedure, the controller 104 can automatically determine the acceptability (e.g., safety and / or usefulness) of the reusable surgical device 232 for the ophthalmic procedure and refuse to use the reusable surgical device 232 if it is deemed unacceptable. Furthermore, in various embodiments, the controller 104 can be operated to update the profile data stored in the transponder 240 to reflect additional use of the reusable surgical device 232. Examples of monitoring the use of surgical devices are described in relatively detail with reference to Figures 3 to 5.

[0023] FIG. 3 shows an exemplary diagram illustrating how the various components of the surgical environment 100 shown in FIGS. 1-2 communicate and operate together. As shown, a transponder 240 associated with the reusable surgical device 232 includes profile data 334 in its memory. The profile data 334 can include any parameter or combination of parameters that describe the reusable surgical device 232, such as, for example, usage values indicating previous usage of the reusable surgical device 232, manufacturing date, manufacturing lot identifier, manufacturing power output, and the like.

[0024] In various embodiments, at least a portion of the profile data 334 is updatable. For example, the usage value described above can be adjusted or updated in response to further use of the reusable surgical device 232. For example, if the usage value reflects the number of uses, the usage value can be an integer that starts at zero and increases with each additional surgical use of the reusable surgical device 232. Alternatively, if the usage value reflects the number of uses, the usage value can be an integer that starts at a predetermined upper bound (e.g., 10) and decreases with each additional surgical use of the reusable surgical device 232. In other examples, the usage value can be made to increase or decrease as needed in proportion to the amount of time per additional surgical use, reflecting other usage indicators such as usage time.

[0025] As shown, the surgical console 120 includes, without limitation, a controller 104 and a reader 206, which enable the connection of the controller 104 to the transponder 240 of the reusable surgical device 232. The controller 104 includes an interconnect 310 and a network interface 312 for connection to the data communication network 350. The controller 104 further includes a central processing unit (CPU) 316, a memory 318, and a storage 320.

[0026] The CPU 316 can not only retrieve and store application data in the memory 318, but also retrieve and execute instructions stored in the memory 318. The interconnect 310 transmits programming instructions and application data between the CPU 316, the network interface 312, the memory 318, the storage 320, and the reusable surgical device 232. The CPU 316 may represent a single CPU, multiple CPUs, a single CPU with multiple processing cores, etc. The memory 318 represents random access memory. The storage 320 may be a disk drive. Although shown as a single unit, the storage 320 may be a combination of fixed or removable storage devices such as a fixed disk drive, removable memory card or optical storage, network-attached storage (NAS), or storage area network (SAN).

[0027] The storage 320 may include a acceptability configuration 338 that can be used to determine the acceptability of a surgical device, such as a reusable surgical device 232, for a surgical procedure. In various embodiments, the acceptability configuration 338 may include one or more sets of criteria for determining safety, effectiveness, practicality, etc., based on device-specific profile data, such as profile data 334 of the reusable surgical device 232. In various embodiments, the acceptability configuration 338 may include different configurations for different types of surgical devices, different models of surgical devices, different surgical procedures, etc.

[0028] For example, with respect to a reusable surgical device 232, the acceptability configuration 338 may include usage criteria such as a usage threshold associated with the usage limits of the reusable surgical device 232. The usage threshold may conform to the format or type of usage value in the profile data 334. In one example, if the usage value increases with each use, the usage threshold may correspond to an upper limit defined as necessary, such as the number of uses or total usage time. In another example, if the usage value decreases with each use, the usage threshold may correspond to a predetermined lower limit, such as zero. In some cases, the acceptability configuration 338 may include different threshold combinations for various different usage values ​​that may be provided in the profile data 334.

[0029] As a further example, with respect to a reusable surgical device 232, the acceptability configuration 338 may include a shelf life criterion, such as a shelf life threshold associated with the shelf life limit of the reusable surgical device 232. Generally, the shelf life threshold can be used in combination with at least some of the profile data 334, such as the manufacturing date, to assess the shelf life. The shelf life threshold can be specified in any suitable way. For example, the shelf life threshold could be a time quantity, and as a result, devices manufactured before that time quantity should not be used (e.g., before 90 days ago). In another example, the shelf life threshold could be a specified date, and as a result, devices manufactured before the specified date should not be used (e.g., before January 1, 2023).

[0030] In some cases, a specific acceptability configuration 338 may be specified with respect to parameters of profile data 334, and such a configuration takes into account the availability of real-time data through other processes of the surgical console 120. For example, the acceptability configuration 338 may include a power criterion such as a target power output, which is a criterion from, for example, profile data 334 to the manufactured power output. The evaluation of the target power output may depend, for example, on the measured power output supplied by a calibration process performed before or in parallel with the acceptability evaluation. In various cases, the target power output may correspond to the manufactured power output or may be a range defined relative to the manufactured power output. The target power output may also be defined in another appropriate way.

[0031] In certain embodiments, storage 320 may include exception data 340 that functions as a device blacklist. For example, exception data 340 can identify surgical devices that should be automatically considered unacceptable for use in all surgical procedures or certain types of surgical procedures. Such surgical devices may be identified, for example, by manufacturer, manufacturing date, manufacturing lot identifier, etc. Examples of exception data 340 include product recalls, safety warnings, guidelines, etc.

[0032] The memory 318 may contain an operating system and / or one or more applications that, when executed by the CPU 316, power the surgical console 120. As shown in the figure, the memory 318 includes a device evaluation module 336. In various embodiments, the device evaluation module 336, when executed by the CPU 316, monitors the use of the surgical device.

[0033] More specifically, in certain embodiments, the device evaluation module 336 monitors the surgical environment 100 for indications of intent to use a surgical device, such as the reusable surgical device 232, in a surgical procedure. For example, when such an indication is received as a result of the reusable surgical device 232 being placed on the surgical pad 230, the device evaluation module 336 reads profile data 334 via the reader 206 and evaluates the acceptability of the reusable surgical device 232 according to the acceptability configuration 338 and / or exception data 340. In general, the device evaluation module 336 can establish that the reusable surgical device 232 is acceptable for use in a surgical procedure if there are no grounds to consider the reusable surgical device 232 unacceptable.

[0034] In various embodiments, the device evaluation module 336 can determine, based on the acceptability configuration 338, that the reusable surgical device 232 is unacceptable for use in surgical procedures. For example, the device evaluation module 336 can compare a usage value from profile data 334 with a usage threshold from the acceptability configuration 338 and determine that the usage threshold has been reached. In another example, the device evaluation module 336 can compare manufacturing information from profile data 334, such as the manufacturing date, with a storage life threshold from the acceptability configuration 338 and determine that the storage life threshold has been reached. In yet another example, the device evaluation module 336 can compare the measured power output of the reusable surgical device 232 with a target power output defined by the acceptability configuration 338 and determine, for example, that the target power output is not met due to a discrepancy between the manufactured power output and the measured power output. In various embodiments, any of the above determinations may establish that the reusable surgical device 232 is unacceptable for use in surgical procedures.

[0035] In addition, or alternatively, the device evaluation module 336 may establish, based on exception data 340, that the reusable surgical device 232 is unacceptable for use in a surgical procedure. As previously stated, the exception data 340 may include, for example, recall data accessible to the device evaluation module 336. For example, the device evaluation module 336 may compare manufacturing information from profile data 334, such as a manufacturing lot identifier, with the exception data 340 and determine that at least some of the exception data 340 are met. For example, it may be determined that the manufacturing lot identifier matches the identifier of a recalled manufacturing lot. In various embodiments, a determination that the reusable surgical device satisfies or matches any of the exception data 340 may result in the establishment that the reusable surgical device 232 is unacceptable for use in a surgical procedure.

[0036] In certain embodiments, the device evaluation module 336 permits the use of the reusable surgical device 232 in a surgical procedure in response to a determination that the reusable surgical device 232 is acceptable. Conversely, in typical embodiments, the device evaluation module 336 denies the use of the reusable surgical device 232 in a surgical procedure in response to a determination that the reusable surgical device 232 is unacceptable. In certain embodiments, the device evaluation module 336 can update the profile data 334 in conjunction with permitting or denying the use of the reusable surgical device 232. Illustrative operation of the device evaluation module 336 permitting or denying the use of the reusable surgical device 232 and updating the profile data 334 will be described in more detail with reference to Figures 4 and 5.

[0037] Figure 4 shows an example of a process 400 for monitoring the use of a surgical device. In a particular embodiment, process 400 can be performed by any system capable of processing data. For the sake of simplicity, any number of systems can perform process 400, either entirely or partially, but process 400 is described in relation to exemplary components of the surgical environment 100, which are described in relation to Figures 1-3.

[0038] In block 402, the device evaluation module 336 receives an indicator of intent to use the reusable surgical device 232 in a surgical procedure. The indicator may be any suitable trigger, such as the detection of the placement of the surgical tool 126 on the surgical pad 230. In some cases, the indicator may be supplied by the user in connection with the user placing the surgical tool 126 on the surgical pad 230. Furthermore, in some embodiments, the indicator may be received from another process in the surgical console 120, such as a calibration process performed in parallel with process 400.

[0039] In block 404, in response to the received indicator, the device evaluation module 336 receives profile data 334 from the memory associated with the reusable surgical device 232. Block 404 may include, for example, causing the reader 206 to read the profile data 334 from the transponder 240 by querying the transponder 240. As previously stated, the profile data 334 may include, for example, a device identifier, a usage value indicating the amount of use of the reusable surgical device 232, a manufacturing date, a manufacturing lot identifier, a manufacturing power output, and / or other information.

[0040] In block 406, the device evaluation module 336 evaluates the acceptability of a reusable surgical device 232 for use in a surgical procedure. The evaluation may be based on a comparison of profile data 334 with acceptability configuration 338 and / or exception data 340. In general, block 406 may include the device evaluation module 336 establishing whether the reusable surgical device is acceptable or unacceptable in any of the methods described with respect to Figure 3.

[0041] In determination block 408, the device evaluation module 336 determines whether the reusable surgical device 232 has been established as acceptable for use in a surgical procedure. If the reusable surgical device 232 has been established as acceptable, process 400 proceeds to block 410. In block 410, the device evaluation module 336 authorizes the use of the reusable surgical device 232 in a surgical procedure. Authorization may include, for example, notifying or informing the user of the surgical console 120 in any appropriate way (e.g., via the display device 122), recording the authorization, or authorizing the next step in the workflow. In embodiments in which the user is notified or informed of the authorization, the notification may further include any information received or generated during process 400. After block 410, process 400 proceeds to block 414.

[0042] If, in determination block 408, it is determined that the reusable surgical device 232 has been established as unacceptable for use in a surgical procedure, process 400 proceeds to block 412. In block 412, the device evaluation module 336 rejects the use of the reusable surgical device 232 in a surgical procedure. Rejection may include taking one or more actions to prevent the use of the reusable surgical device 232. For example, rejection may include notifying or informing the user of the surgical console 120, interrupting other processes of the surgical console 120 (e.g., the calibration process for the reusable surgical device 232), notifying one or more designated users inside or outside the surgical environment, stopping the current workflow, or starting a different exceptional workflow. From block 412, process 400 proceeds to block 414.

[0043] In block 414, the device evaluation module 336 optionally updates the profile data 334 in the transponder 240 based on the operation of process 400. Generally, block 414 may include the device evaluation module 336 causing the reader 206 to write the update to the transponder 240. In certain embodiments, block 414 may be omitted if there are no updates to perform. In various cases, the device evaluation module 336 may update the profile data 334 in response to the acceptability and / or unacceptability of the reusable surgical device 232.

[0044] For example, if the use of a reusable surgical device 232 in a surgical procedure is permitted, the usage value may be updated as described in more detail with reference to Figure 5. In another example, if the use of the reusable surgical device 232 is denied for a specific safety-related reason, such as due to exceptional data 340 or a mismatch between the manufactured power output and the target power output, block 414 may include updating at least one value in the profile data 334 to reflect that safety-related reason. In one example, the usage value may be set to a usage threshold so that further use is not permitted. In another example, the usage value may be set to a negative number to indicate a general safety issue. In yet another example, the usage value may be set to a specific negative number to indicate a specific safety-related reason. Other examples will become apparent to those skilled in the art after a detailed examination of this disclosure. After block 414, process 400 ends.

[0045] Figure 5 shows an example of a process 500 for monitoring the use of a surgical device via usage values. In a particular embodiment, process 500 can be carried out by any system capable of processing data. For the sake of simplicity, any number of systems can carry out process 400, either entirely or partially, but process 500 is described in relation to exemplary components of the surgical environment 100, which are described in relation to Figures 1-3.

[0046] In block 502, the device evaluation module 336 receives an indicator of intent to use the reusable surgical device 232 in a surgical procedure. The indicator may be any suitable trigger, such as the detection of the placement of the surgical tool 126 on the surgical pad 230. In some cases, the indicator may be supplied by the user in connection with the user placing the surgical tool 126 on the surgical pad 230. Furthermore, in some embodiments, the indicator may be received from another process in the surgical console 120, such as a calibration process performed in parallel with process 400.

[0047] In block 504, in response to the received indicator, the device evaluation module 336 receives a usage value from the memory associated with the reusable surgical device 232, which is associated with the previous usage of the reusable surgical device 232. Block 404 may include causing the reader 206 to read the usage value from the profile data 334 on the transponder 240, for example by querying the transponder 240. The usage value may be identified in any form as described in relation to Figure 3.

[0048] In block 506, the device evaluation module 336 evaluates the acceptability of the reusable surgical device 232 for use in surgical procedures. The evaluation may be based on a comparison of the use value with the use criteria specified in the acceptability configuration 338. The use criteria may be or include use thresholds associated with the limit of use of the reusable surgical device 232. In general, block 506 may include the device evaluation module 336 establishing, based on the use thresholds, whether the reusable surgical device is acceptable or unacceptable, for example, in one of the methods described with respect to Figure 3.

[0049] In determination block 508, the device evaluation module 336 determines whether the usage threshold has been reached. If the usage threshold has been reached and it is established that the reusable surgical device 232 is unacceptable for use, process 500 proceeds to block 512. In block 512, the device evaluation module 336 rejects the use of the reusable surgical device 232 in the surgical procedure. The rejection may include taking one or more actions to prevent the use of the reusable surgical device 232. For example, the rejection may include notifying or informing the user of the surgical console 120 that the usage threshold has been reached, halting other processes in the surgical console 120 (e.g., calibration processes related to the reusable surgical device 232), notifying one or more designated users inside or outside the surgical environment, stopping the current workflow, or starting a different exceptional workflow. From block 512, process 500 terminates.

[0050] If, in determination block 508, it is determined that the usage threshold has not been reached, so that the reusable surgical device 232 is established as acceptable for use, process 500 proceeds to block 510. In block 510, the device evaluation module 336 authorizes the use of the reusable surgical device 232 in a surgical procedure. Authorization may include, for example, notifying or informing the user of the surgical console 120 in any appropriate way (e.g., via the display device 122), recording the authorization, or authorizing the next step in the workflow. In embodiments in which the user is notified or informed of the authorization, the notification may further include any information received or generated during process 400. Additionally or alternatively, the notification may include, for example, indicating the remaining number of uses of the reusable surgical device 232, or whether the authorized use will be the final use because the usage threshold has now been reached.

[0051] In block 514, the device evaluation module 336 updates the usage value in memory associated with the reusable surgical device 232 to reflect additional authorized usage. Generally, block 414 may include the device evaluation module 336 causing the reader 206 to write the update to the profile data 334 on the transponder 240. For example, to reflect authorized usage, the device evaluation module 336 may increase or decrease the usage value in any of the ways described in relation to Figure 3. After block 514, process 500 terminates.

[0052] As used herein, the phrase “at least one of” a list of items refers to any combination of these items, including a single member. For example, “at least one of a, b or c” includes a, b, c, ab, ac, bc and abc, as well as any combination of multiple identical elements (e.g., aa, aaa, aab, aac, abb, acc, bb, bbb, bbc, cc and ccc, or any other order of a, b and c).

[0053] The above description is provided so that those skilled in the art may carry out the various embodiments described herein. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments. Accordingly, the claims are not intended to be limited to the embodiments shown herein, but rather the entire scope consistent with the language of the claims should be recognized.

[0054] Even when an element is referred to in the singular in a claim, unless otherwise specified, it is intended to mean "one or more" and not "only one." Unless specifically specified otherwise, the term "several" refers to one or more. All structural and functional equivalents to the various embodiments of the elements described throughout this disclosure, which are known to or will be known to those skilled in the art, are expressly incorporated by reference herein and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, whether such disclosure is expressly enumerated in the claims or not. No element of a claim shall be construed under Section 112(f) of the U.S. Patent Act unless the element is expressly described using the phrase "means for" or, in the case of a method claim, using the term "step for." In this specification, the term "exemplary" is used to mean "serving as an example, illustration, or diagram." Any embodiment described as "exemplary" herein should not necessarily be construed as being preferable or advantageous to other embodiments.

Claims

1. A method for monitoring the use of reusable surgical devices in a surgical setting, wherein the surgical console is used to monitor the use of reusable surgical devices. Receiving an indicator of the intention to use reusable surgical devices in surgical procedures, In response to the received indicator, the system retrieves a usage value from the memory associated with the reusable surgical device that is associated with the previous usage of the reusable surgical device, The acceptability of the reusable surgical device for use in the surgical procedure is evaluated based on a comparison of the usage value with the usage threshold associated with the usage limit of the reusable surgical device, A method comprising permitting or denying the use of the reusable surgical device in the surgical procedure based on the evaluated acceptability of the reusable surgical device.

2. The evaluation includes establishing that the reusable surgical device is unacceptable for use in the surgical procedure, based on the determination that the usage value has reached the usage threshold. The method according to claim 1, wherein the permission or denial includes refusing to use the reusable surgical device in the surgical procedure in response to a determination that the reusable surgical device is unacceptable.

3. The evaluation includes establishing that the reusable surgical device is acceptable for use in the surgical procedure, based on the determination that the usage value has not reached the usage threshold associated with the usage limit of the reusable surgical device. The method according to claim 1, wherein the permission or denial includes permitting the use of the reusable surgical device in the surgical procedure in response to the establishment that the reusable surgical device is acceptable.

4. The method according to claim 3, further comprising updating the usage value in the memory associated with the reusable surgical device using the surgical console to reflect the permitted usage.

5. The method according to claim 4, wherein the updating includes reducing the usage value.

6. The method according to claim 1, wherein the granting or denial of the use includes notifying the user of the granted or denied use.

7. The method according to claim 1, wherein the reusable surgical device is an attachment to a surgical tool.

8. The method according to claim 1, wherein receiving the indicator includes detecting the placement of the reusable surgical device in the vicinity of the surgical tray of the surgical console.

9. In response to the received indicator, the surgical console further includes receiving manufacturing information of the reusable surgical device from the memory associated with the reusable surgical device, The evaluation of the acceptability of the reusable surgical device is further based on a comparison of the manufacturing information with a shelf life threshold associated with the shelf life of the reusable surgical device. The evaluation includes establishing that the reusable surgical device is unacceptable for use in the surgical procedure based on the determination that it has reached the storage life threshold. The method according to claim 1, wherein the permission or denial includes refusing to use the reusable surgical device in the surgical procedure in response to the determination that the reusable surgical device is unacceptable.

10. In response to the received indicator, the surgical console further includes receiving manufacturing information of the reusable surgical device from the memory associated with the reusable surgical device, The evaluation of the acceptability of the reusable surgical device is further based on a comparison of the manufacturing information with recall data accessible from the surgical console. The evaluation includes establishing that the reusable surgical device is unacceptable for use in the surgical procedure, based on the determination that the manufacturing information matches at least a portion of the recall data. The method according to claim 1, wherein the permission or denial includes refusing to use the reusable surgical device in the surgical procedure in response to a determination that the reusable surgical device is unacceptable.

11. In response to the received indicator, the surgical console further includes receiving a manufacturing power output for the reusable surgical device from the memory associated with the reusable surgical device, The evaluation of the acceptability of the reusable surgical device is based on a comparison of the measured power output of the reusable surgical device with the manufactured power output. The evaluation includes determining, based on the discrepancy between the manufactured power output and the measured power output, that the reusable surgical device is unacceptable for use in the surgical procedure. The method according to claim 1, wherein the permission or denial includes refusing to use the reusable surgical device in the surgical procedure in response to the determination that the reusable surgical device is unacceptable.

12. The method according to claim 11, further comprising updating at least one value in the memory associated with the reusable surgical device using the surgical console to reflect the discrepancy.

13. A system for monitoring the use of reusable surgical devices in a surgical setting, wherein the system is The leader, A surgical console is communicatively coupled to the aforementioned reader, The surgical console includes, Upon receiving an indicator of intent to use reusable surgical devices in surgical procedures, In response to the received indicator, the reader receives a usage value associated with the previous usage of the reusable surgical device from the memory associated with the reusable surgical device. Based on a comparison between the usage value and the usage threshold associated with the usage limit of the reusable surgical device, the acceptability of the reusable surgical device for use in the surgical procedure is evaluated. Based on the evaluated acceptability of the reusable surgical device, the use of the reusable surgical device in the surgical procedure may be permitted or denied. A system capable of operating in this manner.

14. The system according to claim 13, further comprising a surgical tray, wherein the reader is a radio frequency identification (RFID) reader and is positioned near the surgical tray.

15. The system according to claim 14, further comprising a surgical pad adjacent to the surgical tray, wherein the reader is embedded in the surgical pad.

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