Surgical device system and method of operation thereof
The surgical device system addresses inflexibility and complex license registration by employing dual communication channels for operational data and parameter exchange, enhancing flexibility and efficiency while ensuring reliable wireless communication.
Patent Information
- Application Number
- JP2023033401
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2022-03-28
- Filing Date
- 2023-03-06
- Publication Date
- 2025-04-21
- Estimated Expiration
- 2043-03-06
AI Technical Summary
Existing surgical device systems face challenges with inflexibility and complex license registration processes, particularly due to the need for separate licenses for multiple functionalities and the cumbersome process of entering license keys through user interfaces.
The surgical device system employs a dual communication channel approach, where a first communication channel (e.g., WiFi, Bluetooth) is used for operational data exchange, and a second, independent communication channel (e.g., NFC, RFID) is used for exchanging communication channel parameters and device identification/data, thereby simplifying license registration and enhancing system flexibility.
This solution enhances the flexibility and efficiency of the surgical device system by simplifying license registration and reducing the need for complex cable wiring, while ensuring safe and reliable wireless communication of operational data.
Smart Images

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Abstract
Description
[Technical field]
[0001] The present disclosure relates to medical device systems and, more particularly, to communication between accessories or components of medical device systems. [Background technology]
[0002] Surgical methods have evolved over time. In classical surgery, separate mechanical instruments such as scalpels, forceps, and scissors have been used for various invasive and non-invasive procedures, but the mechanical functions of these instruments have been replaced or supplemented by energy functions such as monopolar or bipolar electrosurgery, ultrasound surgery, and microwave surgery. Surgical generators have been developed to supply surgical energy, usually in the form of electrical current, to each instrument.
[0003] In addition to surgical generators, additional ancillary devices have been developed to support the operation of the surgical generator and instruments, including, but not limited to, foot switches, irrigation pumps, suction pumps, coolant pumps, etc. In a typical setup, one or more surgical generators, one or more surgical instruments, and one or more auxiliary devices form a surgical system to coordinately provide surgical and auxiliary functions. In order to communicate the necessary operation data between each component of the surgical system, each component is often connected by a cable. However, such cable wiring has a major drawback in terms of operability and mobility in the operating room. To overcome such drawbacks, wireless communication is sometimes adopted.
[0004] Safe and secure wireless communication of operational data between components of a surgical device system requires the use of coded communication channels. In some surgical device systems, this is accomplished by providing auxiliary devices for use with the surgical system with a wireless communication interface, which can be connected to the surgical generator through a standard wired interface, such as a USB interface, an RS-232 interface, or a proprietary wired interface. The communication channel parameters for the wireless communication channel used by each auxiliary device are pre-programmed into the auxiliary device and the wireless communication interface. Examples of such auxiliary devices include the surgical foot switches WA91320W and WA94934W available from Olympus Europe SE & Co. KG (Germany). Summary of the Invention [Problem to be solved by the invention]
[0005] One object of the present disclosure is to provide a surgical system with improved flexibility.
[0006] Some medical devices may be configured to provide multiple functionalities, some of which may be subject to separate licenses from the medical device provider, and to enable such functionality, a user may be required to enter a license key through the user interface of the medical device.
[0007] It is a further object of the present disclosure to provide a medical device with improved license registration. [Means for solving the problem]
[0008] The present disclosure provides a surgical device system comprising at least one surgical instrument, a surgical generator for providing surgical energy to the at least one surgical instrument, and at least one auxiliary device for providing an auxiliary function to the at least one surgical generator and / or the at least one surgical instrument, wherein the surgical generator is configured to wirelessly communicate with the at least one auxiliary device, the surgical generator and the at least one auxiliary device are configured to establish a first communication channel for communicating operation data, the first communication being defined by a plurality of first communication channel parameters, and the surgical generator and the at least one auxiliary device are configured to establish a second communication channel for communicating the first communication channel parameters.
[0009] The second communication channel may be independent of the first communication channel. The communication range of the second communication channel may be less than the communication range of the first communication channel. The bandwidth of the second communication channel may be less than the bandwidth of the first communication channel. The second communication channel may be a Near Field Communication "NFC" channel. The second communication channel may be a Radio Frequency Identification "RFID" channel.
[0010] The first communication channel may be an IEEE 802.11 "WiFi" communication channel. The first communication channel may be a "Bluetooth" communication channel, where the term "Bluetooth" is meant to cover all available versions of the "Bluetooth" communication standard provided by the Bluetooth Special Interest Group. The first communication channel can be an IEEE 802.15.4 or "ZigBee" communication channel.
[0011] The at least one auxiliary device may be further configured to transmit device characteristic data and / or device identification data via the second communication channel. The at least one auxiliary device may include at least one of a foot switch, a smoke evacuation device, an irrigation pump, a suction pump, and a cooling water pump. The operational data includes at least one of an activation signal, a deactivation signal, a target flow rate, a current flow rate, a target pressure, a current pressure, a target temperature, a current temperature, a battery status, a connection quality, and a heartbeat signal.
[0012] The surgical generator may be further configured to receive, over the network connection, software update data for one or more ancillary devices, and to communicate such software update data to the one or more ancillary devices.
[0013] The present disclosure further provides a surgical device system, comprising at least one surgical instrument, a surgical generator for providing surgical energy to the at least one surgical instrument, and at least one auxiliary device for providing an auxiliary function to the at least one surgical generator and / or the at least one surgical instrument; The surgical generator is configured to communicate with at least one auxiliary device; the surgical generator and the at least one auxiliary device are configured to establish a first wired communication channel for communicating operational data; The surgical generator and the at least one auxiliary device are configured to establish a second wireless communication channel for communicating auxiliary data.
[0014] The present disclosure provides a surgical generator for a surgical device system according to the above disclosure.
[0015] The present disclosure provides an auxiliary device for a surgical device system according to the above disclosure.
[0016] The present disclosure further provides a method of operating a surgical device system, comprising: establishing a second communication channel between the surgical generator and the ancillary device; communicating the first communication channel parameters over a second communication channel; establishing a first communication channel between the surgical generator and the ancillary device using first communication channel parameters; and communicating operational data between the surgical generator and the at least one ancillary device over a first communication channel.
[0017] Methods according to the present disclosure provide that may further comprise transmitting device characteristic data and / or device identification data of the at least one supplemental device over a second communication channel.
[0018] The present disclosure further provides a method of operating a surgical device system, comprising: receiving, via a user interface, input data identifying a surgical procedure to be performed; reading from the memory a list of auxiliary devices required for the surgical procedure to be performed; establishing a second communication channel between one or more ancillary devices and the electrosurgical generator within range of the second communication channel; receiving, over a second communication channel, device identification data and / or device characteristic data from an auxiliary device within range of the second communication channel; checking (determining) whether all auxiliary devices required for the procedure to be performed have provided device identification data or device characteristic data in response to an interrogation signal; If the check is successful (positive determination), the method comprises the step of establishing one or more first communication channels between the surgical generator and the auxiliary device.
[0019] The method may further comprise the step of outputting, if the check is not satisfied (determination is negative), an error message via the user interface identifying the lack of an auxiliary device required for the procedure to be performed.
[0020] The present disclosure relates to a medical device comprising a control unit and a functional unit, the medical device being configured to provide a plurality of medical functions through the functional unit, at least one of the plurality of functions being subject to a license; The medical device further comprises a wireless communication unit configured to establish a wireless communication channel with the wireless license tag and obtain a license key for at least one feature from the wireless license tag.
[0021] The medical device may be configured to communicate medical device identification data over the wireless communication channel after establishing the wireless communication channel with the wireless license tag.
[0022] The present disclosure further provides a wireless license tag, the wireless license tag configured to establish a wireless communication channel with a medical device and communicate a license key to the medical device, the license key being stored in a memory element of the wireless license tag.
[0023] The wireless license tag is configured to store the license key in a first state and a second state, the first state representing an unused license key and the second state representing a used license key, and the wireless license tag can be configured to change the state of the stored license key from the first state to the second state after communication of the license key to the medical device.
[0024] The wireless license tag may be configured to receive medical device identification data over the wireless communication channel after establishing a wireless communication channel with the medical device, and to store the medical device identification data in a second state together with the license key. The wireless license tag may be configured to communicate the license key to the medical device when the license key is stored in the second state only if the medical device identification data received from the medical device matches the medical device identification data stored together with the license key.
[0025] Some embodiments of the present disclosure are described below in the exemplary drawings. The described embodiments are provided for better understanding and are not intended to limit the scope of the appended claims in any way. [Brief description of the drawings]
[0026] [Figure 1] FIG. 1 illustrates a surgical device system. [Diagram 2] FIG. 2 is a schematic diagram of an electrosurgical generator. [Diagram 3] FIG. 3 is a schematic diagram of an auxiliary device; [Figure 4] FIG. 4 illustrates a method of operation of the surgical device system. [Diagram 5] FIG. 5 illustrates a further method of operation of the surgical device system. [Figure 6] FIG. 6 illustrates a surgical device having a modular design. [Figure 7] FIG. 7 shows a medical device system. [Figure 8] FIG. 8 illustrates a method of operation of the medical device system. [Figure 9] FIG. 9 illustrates a further surgical device system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] 1 shows a surgical device system 1 including an electrosurgical generator 10 and an electrosurgical instrument 11. The electrosurgical instrument 11 is connected to the electrosurgical generator 10 via a cable 12 for transmitting electrosurgical treatment signals from the electrosurgical generator 10 to the electrosurgical instrument 11 and for communicating configuration and / or operational data between the electrosurgical generator 10 and the electrosurgical instrument 11. The electrosurgical instrument 11 may include activation buttons 13, 14 on a grip portion of the electrosurgical instrument 11 for operation by a practitioner holding the electrosurgical instrument 11. An activation signal from the activation buttons 13, 14 may be transmitted to the electrosurgical generator 10 via the cable 12.
[0028] The electrosurgical generator 10 may be a radio frequency generator, a microwave generator, an ultrasonic generator, or a combination thereof. The electrosurgical instrument 11 may be a cutting instrument, a sealing instrument, an ablation instrument, or a combination thereof. The surgical device system 1 further includes a wireless foot switch 15 having two pedals 16, 17. The wireless foot switch 15 may have more or less than two pedals and may have additional control elements such as toggle buttons, switches, etc.
[0029] The electrosurgical generator 10 and the wireless footswitch 15 each include a wireless communication unit 20, 21. In this embodiment, the wireless communication units 20, 21 may be configured to communicate with each other through electromagnetic signals using the IEEE 802.11 standard, commonly known as "WiFi". As such, the wireless communication units 20, 21 use a first wireless communication channel defined by a set of communication channel parameters including, but not limited to, a channel identification code, a channel authentication code, etc. Alternatively, other electromagnetic communication standards, such as "Bluetooth" or "ZigBee", may be used for the first wireless communication channel.
[0030] In this embodiment, the surgical device system further includes auxiliary devices such as an irrigation pump 25 and a suction pump 26, each connected to the surgical instrument 11 by tubing 27, 28. The irrigation pump 25 may be used to supply irrigation fluid to the surgical site via tubing 27 and the electrosurgical instrument 11. The irrigation fluid may be used to flush debris or blood from the site. The suction pump 26 may be used to evacuate fluids, such as liquids, smoke, or gases, from the surgical site via the electrosurgical instrument 11 and tubing 28.
[0031] The irrigation pump 25 and the suction pump 26 include wireless communication units 30, 31. The wireless communication units may be configured to communicate with each other and / or with one or more of the communication units 20, 21 via electromagnetic signals.
[0032] During operation of the surgical device system 1 , a user can press activation buttons 13 , 14 and / or pedals 16 , 17 of the wireless foot switch to activate different functions of the surgical device system 1 .
[0033] The first pedal 16, when depressed, can initiate transmission of a first electrosurgical treatment signal from the electrosurgical generator 10 to the electrosurgical instrument 11. The first electrosurgical signal can be a cutting signal such that the electrosurgical instrument 11 can be used to cut open a target tissue. The second pedal, when depressed, can initiate transmission of a second electrosurgical treatment signal from the electrosurgical generator 10 to the electrosurgical instrument 11. The second electrosurgical signal can be a cauterizing signal such that the electrosurgical instrument 11 can be used to cauterize bleeding, such as bleeding resulting from a previous tissue cutting operation. Depression of any one of the pedals 16, 17 of the wireless footswitch 15 is communicated to the electrosurgical generator 10 via the wireless communication units 21, 20.
[0034] A first activation button 13 on the electrosurgical instrument 11 can activate an irrigation pump 25. A practitioner can press activation button 13, for example, if blood or debris has accumulated at the surgical site, to cause a liquid, such as sterile saline, to be ejected from the electrosurgical instrument 11 to flush the blood or debris away. A second activation button 14 on the electrosurgical instrument 11 can activate a suction pump 26. A practitioner can press activation button 14, for example, if smoke, blood, or irrigation fluid needs to be evacuated from the surgical site. Activation signals from activation buttons 13,14 are transmitted via cable 12 to electrosurgical generator 10 and then via wireless communication units 20,30,31 to suction pump 25 and irrigation pump 26. The communication between the wireless communication units 20, 30, 31 may use the same communication channel as the communication between the wireless communication units 20, 21.
[0035] To effect communication between the devices of the surgical device system 1 as described above, the wireless communication units 20, 21, 30, 31 must agree on communication channel parameters. In prior art systems, this has been accomplished by providing each auxiliary device with a dedicated pair of wireless communication units, one of which is fixed to the auxiliary device and the other of which is connected to the electrosurgical generator via a standard wired interface such as a USB plug or via a proprietary wired interface. However, such designs tend to be bulky for multiple auxiliary devices.
[0036] In the system according to the present disclosure, the wireless communication units 20, 21, 30, 31 match communication channel parameters via a second wireless communication channel. The second wireless communication channel may be established between the wireless communication units 20, 21, 30, 31 using RFID or NFC technology. Thus, the wireless communication unit 20 may include an RFID interrogator, and the wireless communication units 21, 30, 31 may include an RFID transponder. The second communication channel is established by sending an interrogation signal via the RFID interrogator of the wireless communication unit 20 and receiving the interrogation signal via the RFID transponder of the wireless communication units 21, 30, 31. The interrogation signal may include communication channel parameters for the first communication channel, which may be pre-programmed into the wireless communication unit 20 and subsequently applied by the wireless communication units 21, 30, 31. Alternatively, the communication channel parameters may be negotiated between the wireless communication units 20, 21, 30, 31.
[0037] The available communication range of the second wireless communication channel using RFID or NFC technology is much shorter than the available communication range of the first communication channel. Therefore, it may be necessary to move the auxiliary devices 15, 25, 26 closer to the electrosurgical generator 10 during the setup of the surgical device system so that the second communication channel can be established. This has the technical advantage that protection measures for the second communication channel against unauthorized access via other devices may not be necessary. Such protection measures can be more easily applied in the first communication channel because the necessary parameters have been agreed (adapted) in advance by the devices participating through the second communication channel.
[0038] The second communication channel may also have a smaller communication bandwidth than the first communication channel, which is not a problem since the amount of data communicated over the second communication channel is rather small, in the range of only a few kilobytes.
[0039] After receiving the interrogation signal, the wireless communication units 21, 30, 31 may transmit a response signal to be received by the wireless communication unit 20. The response signal may include identification information and / or characteristic information from the auxiliary device 15, 25, 26.
[0040] Electrosurgical generator 10 may use the identification and / or characteristic information received from auxiliary devices 15, 25, 26 to verify that all auxiliary devices required for the intended procedure are available. Thus, a user may select a procedure from a list of available procedures via a user interface of electrosurgical generator 10. Electrosurgical generator 10 may then retrieve the list of required auxiliary devices from memory, either the internal memory of electrosurgical generator 10 or an external memory device connected to electrosurgical generator 10.
[0041] If electrosurgical generator 10 determines that all of the required auxiliary devices are available, electrosurgical generator 10 establishes a first wireless communication channel with auxiliary device 15, 25, 26 and the selected procedure is performed. If electrosurgical generator 10 discovers that one or more of the required auxiliary devices has not transmitted a response signal to the interrogation signal, a respective corresponding error message may be output through a user interface of electrosurgical generator 10.
[0042] During performance of a selected procedure, operational data is exchanged between the electrosurgical generator 10 and the ancillary devices 15, 25, 26. The operational data may include activation (start) or deactivation (stop) signals sent from the wireless footswitch 15 to the electrosurgical generator 10 or from the electrosurgical generator 10 to the aspiration pump 26 or irrigation pump 25. The operational data may further include target or current flow rates of the pumps 25, 26, target or current pressures of the pumps 25, 26, etc. In other embodiments of the surgical device system not shown in the drawings, a coolant pump may be used as an auxiliary device. In this case, the operational data may include target or current inlet and outlet temperatures of the coolant. In a further embodiment of the surgical device system not shown in the drawings, a smoke evacuation device may be used as an auxiliary device. In this case, the operational data may include target or current exhaust flow rates.
[0043] The operational data may further include battery status and / or connection quality data. The operational data may further include one or more heartbeat signals. The heartbeat signals may be used by the electrosurgical generator 10 and / or the ancillary device 15, 25, 26 to determine whether the first wireless communication channel is available. If the connection of the first wireless communication channel is lost, the electrosurgical generator 10 and / or the ancillary device 15, 25, 26 may be configured to take appropriate measures to maintain patient safety.
[0044] In a further embodiment of the surgical device system, the electrosurgical generator may be configured to receive software update data for one or more of the target auxiliary devices 15, 25, 26 via a network connection (not shown). Such software update data may be received by the electrosurgical generator 10 at any time and may be stored in the memory of the electrosurgical generator 10. After a first wireless communication channel is established between the electrosurgical generator 10 and one or more target auxiliary devices, the electrosurgical generator 10 communicates the software update data to the target auxiliary device, which can use the software update data to update its internal operating software.
[0045] The internal design of the electrosurgical generator 10 is shown in schematic form in Figure 2. The electrosurgical generator 10 has a control unit 100 for controlling the various functions of the electrosurgical generator 10. The control unit 100 may have a standard computer architecture including one or more processors and one or more memory elements. Such standard computer architectures are known to those skilled in the art and need not be described in detail here.
[0046] The electrosurgical generator 10 further comprises an electrosurgical functional unit 110. The electrosurgical functional unit may include a radio frequency generator, an ultrasonic generator, a microwave generator, or a combination thereof. The design of such electrosurgical functional units is known in the art and need not be described in detail here.
[0047] The electrosurgical generator 10 further comprises a user interface 120. The user interface 120 may include one or more displays, control buttons, keyboards, touch-sensitive displays, or combinations thereof. Through the user interface 120, the control unit may communicate operational and status information to a user and receive input from the user. Input from the user may include, but is not limited to, selection of a procedure to be performed, selection of operational parameters for the selected procedure, etc.
[0048] The electrosurgical generator further comprises a memory unit 130. The memory unit 130 may be part of the control unit 100 or may be separate therefrom. The memory unit 130 may be a static random access memory (S-RAM), a dynamic random access memory (D-RAM), a read only memory (ROM), a hard disk drive (HDD), a solid state disk (SSD), or a combination thereof. The memory unit 130 may store a list of electrosurgical procedures that can be performed by the electrosurgical generator 10. For each available procedure, the memory may store a list of ancillary devices required for the respective procedure.
[0049] The electrosurgical generator further comprises a wireless communication unit 20. The wireless communication unit 20 includes a WiFi antenna 131, an RFID interrogator 132, and associated circuitry (not shown). The control unit 100 communicates with the electrosurgical function unit 110, the user interface 120, the memory unit 10 and the wireless communication unit 20 to operate as described above.
[0050] 3 is a schematic diagram showing the internal design of the auxiliary device 200. The auxiliary device 200 may be a foot switch similar to the foot switch 15, a pump similar to the suction pump 25 or the irrigation pump 26, or other auxiliary device. The auxiliary device 200 comprises an auxiliary device control unit 210 and an auxiliary function unit 220. The auxiliary device control unit 210 may have a standard computer architecture similar to the control unit 100 of the electrosurgical generator 10. The configuration of the auxiliary function unit may vary widely depending on the type of auxiliary function to be provided by the auxiliary device 200.
[0051] Where the auxiliary device 200 is a foot switch such as foot switch 15, the auxiliary function unit 220 may comprise one or more pedals and one or more sensors for sensing whether the one or more pedals are pressed and, where appropriate, the force applied to the one or more pedals. If the auxiliary device 200 is a pump such as a suction pump 25, an irrigation pump 26, or a cooling water pump, the auxiliary function 200 may comprise a pump unit such as a peristaltic pump (tube pump), a piston pump, etc., a drive unit for driving the pump unit, and one or more sensors for sensing one or more of the pressure of the pumped medium, the flow rate of the pumped medium, and the temperature of the pumped medium.
[0052] The auxiliary device 200 further comprises a wireless communication unit 230 having a WiFi antenna 231 and an RFID transponder 232. The auxiliary control unit 210 communicates with the auxiliary function unit 220 and the wireless communication unit 230 to operate as described above.
[0053] 4 illustrates a method of operating such a surgical device system. In a first step 401, a second communication channel is established between the electrosurgical generator and one or more auxiliary devices. To establish a second communication channel, the electrosurgical generator can transmit an interrogation signal via the wireless communication unit. The interrogation signal can be an RFID interrogation signal. The interrogation signal can be received by an auxiliary device that is within communication range of the interrogation signal. After receiving the interrogation signal, the auxiliary device can transmit a response signal, which can be received by the electrosurgical generator. Through this interrogation and response, a second communication channel is established between the electrosurgical generator and one or more ancillary devices.
[0054] In a second step 402, the electrosurgical generator and the one or more ancillary devices exchange communication channel parameters for a first communication channel established between the electrosurgical generator and the one or more ancillary devices.
[0055] In some embodiments, the communication channel parameters include predetermined parameters stored in a memory of the electrosurgical generator. Such predetermined parameters may include, for example, a frequency band, such as the 2.4 GHz band, the 4.9 GHz band, etc., and a channel number, such as one of channels 1 through 14 in the 2.4 GHz band, of the WiFi connection.
[0056] In some embodiments, the communication channel parameters may include dynamic parameters that are negotiated or agreed upon between the electrosurgical generator and one or more ancillary devices. Such dynamic parameters may include encryption-related parameters, which may be determined, for example, by communicating an encryption key between the electrosurgical generator and one or more ancillary devices.
[0057] In a possible embodiment, the above-mentioned first and second steps 401, 402 may be combined into a single step. In such an embodiment, the necessary communication channel parameters may be included in the interrogation signal transmitted by the electrosurgical generator.
[0058] Along with the response signal, the one or more auxiliary devices can transmit device characteristic data and / or device identification data to the electrosurgical generator. The device characteristic data and / or device identification data of the at least one auxiliary device can be used by the electrosurgical generator to determine, in a later step, what type of operational data to communicate to the at least one auxiliary device over the first communication channel.
[0059] In a third step 403, a first communication channel is established between the electrosurgical generator and one or more auxiliary devices such that each device can transmit and receive data via its respective wireless communication unit using the communication channel parameters agreed upon in the preceding step.
[0060] In a fourth step 404, the electrosurgical generator and the one or more auxiliary units communicate operational data over the first communication channel. The operational data can include start or stop signals sent from the wireless footswitch to the electrosurgical generator or from the electrosurgical generator to the aspiration or irrigation pump. The operational data may further include a target or current flow rate of the pump, a target or current pressure of the pump, etc. The operational data may further include a target or current inlet and outlet temperature of the coolant delivered through the coolant pump.
[0061] 5 illustrates a further method of operating a surgical device system as described herein. In a first step 501, the electrosurgical generator may receive, via a user interface, input data identifying a surgical procedure to be performed. Step 501 may include retrieving a list of available procedures from a memory, which may be an internal memory of the electrosurgical generator or an external memory. The list of available procedures may then be presented to a user via the user interface. The list of available procedures may be presented in a number of ways. In one example, a plurality of virtual selection buttons are displayed on a graphic display, each virtual button assigned to one of the available operations, and a user can activate the virtual button assigned to that operation, e.g., by touching the touch display at the location where the virtual button is displayed, to select one of the operations. In a further example, the list of available procedures may be displayed as a list of text items naming and / or describing each procedure, and the user can then scroll through the list of text items using virtual or physical scroll buttons and select a procedure of interest by actuation of a virtual or physical selection button.
[0062] In a second step 502, a list of auxiliary devices necessary (required) for the selected procedure is read from a memory, which may also be an internal memory of the electrosurgical generator or an external memory. The list of required auxiliary devices may be stored in a database.
[0063] In a third step 503, the electrosurgical generator establishes a second communication channel with one or more auxiliary devices within communication range of the second communication channel. Thus, the electrosurgical generator transmits an interrogation signal to be received by all auxiliary devices within communication range of the interrogation signal. An auxiliary device receiving the interrogation signal can transmit a response signal to establish the second communication channel.
[0064] In step 504, the electrosurgical generator receives device characteristic and / or identification data from the one or more ancillary devices via a second communication channel.
[0065] In step 505, the electrosurgical generator checks whether all of the required ancillary devices are available, i.e., whether device characteristic and / or identification data has been received from all of the required ancillary devices. If all of the required ancillary devices are available, the electrosurgical generator and the one or more ancillary devices establish a first communication channel in step 506 for communicating operational data during the execution of the selected procedure. If one or more required auxiliary devices have not provided device characteristics and / or identification data through the second communication channel, the electrosurgical generator outputs an error message through the user interface in step 507. The error message may identify the type of auxiliary device that is not available. The error message may prompt the user to select any appropriate action. One available remedy is for the user to take the necessary steps in a timely manner to make available one or more missing auxiliary devices, for example by powering on an auxiliary device that was accidentally powered off, bringing an auxiliary device within range of the second communication channel that was accidentally placed out of range, etc. The user can then choose to restart the method at step 503. As a further option, the user can restart the method at step 501 and select a different procedure. As a further option, the user may choose to override (ignore) the error message and proceed to step 506.
[0066] In a modified method not shown in the drawings, the electrosurgical generator can first establish a second communication channel with all auxiliary devices within communication range of the second communication channel and receive device characteristics and / or identification data from all auxiliary devices within communication range of the second communication channel. The electrosurgical generator can then retrieve from memory a list of operations that can be performed on the set of auxiliary devices for which it has provided device characteristics and / or identification data. A list may then be presented through the user interface so that the user can select one of the available procedures to perform. When reading the list of available procedures, the electrosurgical generator may apply an inclusive strategy, where all procedures executable with the set of available auxiliary devices are included in the list, or an exclusive strategy, where only procedures that require all of the available auxiliary devices are included in the list.
[0067] In the above embodiments, it has been assumed that the electrosurgical generator functions as the master device of the surgical device system. In modified surgical device systems, another device, such as a medical device controller, may function as the master device and the electrosurgical generator may function as a further auxiliary device in the surgical device system.
[0068] In a further example shown in FIG. 6, a surgical device system can include a surgical device 600 provided in a modular design. The surgical device can include a master unit 601 and one or more slave units 602. Although four slave units 602 are shown in FIG. 6, a greater or lesser number of slave units 602 can be provided. The master unit 601 can include a master wireless communication unit 611, and each of the slave units 602 can include a slave wireless communication unit 612. The master wireless communication unit 611 can include a first master communication unit 621 and a second master communication unit 622. The slave wireless communication unit 612 can include a first slave communication unit 625 and a second slave communication unit 626.
[0069] The master unit 601 may use the second master communication portion 622 to establish a second communication channel between the master 601 unit and one or more slave units 602 through a second slave communication portion. The second master communication unit 622 may be an RFID interrogator, an NFC interrogator, etc. The second slave communication unit 626 may be an RFID transponder, an NFC transponder, etc.
[0070] To establish a second communication channel, the master unit 601 may transmit an interrogation signal via the second master communication section 622, and one or more slave units 602 may transmit a response signal via the second slave communication section 626.
[0071] After or during the establishment of the second communication channel, the master unit 601 and the one or more slave units 602 communicate, negotiate and / or agree on communication channel parameters for establishing the first communication channel using the first master communication unit 621 and the one or more first master communication units 625. The first master communication unit 621 and the first slave communication unit 625 may be a “WiFi” antenna, a “Bluetooth” antenna, etc. Thereafter, the master unit 601 and the one or more slave units 602 establish the first communication channel for communicating operational data between the master unit 601 and the one or more slave units 602.
[0072] Through the modular design, the medical device 600 can be flexibly adjusted to the specific needs of the user. For example, the medical device 600 may include a standardized rack with multiple slots, one of which may be occupied by the master unit 601 and a power supply unit (not shown). The remaining slots may be available for the slave units 602. When the slave unit 602 is inserted into the available slot, the slave unit 602 may be automatically connected to the power supply unit. The specific interface of the slave unit 602 may be located on the front of the slave unit 602, making it accessible no matter how many slave units 602 are inserted into the rack. The slave units 602 may include an electrosurgical generator unit, a microwave generator unit, an ultrasonic generator unit, an irrigation pump unit, a suction pump unit, a cooling water pump unit, etc.
[0073] 7 illustrates a medical device system 700 according to a further embodiment of the present disclosure. The medical device system 700 includes a medical device 710 and a wireless license tag 720. The medical device may be similar to the electrosurgical generator 10 shown in FIG. 2 and may include a control unit 730, a function unit 740, a user interface 750, a memory unit 760, and a wireless communication unit 770 having an RFID interrogator 771 and a WiFi antenna 772. The medical device 710 is configured to provide multiple medical functions (medical actions) through the functional unit 740. At least one of these functions is subject to a separate license from the manufacturer of the medical device 710. To enable such a function, the license must be registered in the medical device 710.
[0074] A user of a medical device 710 may purchase or otherwise obtain a wireless license tag 720 from a manufacturer of the medical device 720. The wireless license tag 720 includes a controller 780, a memory element 785, and a wireless communication unit 790, which may be an RFID transponder. The memory element 785 stores a license key.
[0075] A method 800 for registering a license with a medical device 710 is shown in FIG. In a first step 801, a wireless communication channel is established between the medical device 720 and the wireless licensed tag 720. Thus, the controller 730 activates the RFID interrogator 771 to transmit an interrogation signal that is received by the RFID transponder 790 of the wireless licensed tag. The RFID transponder 790 transmits a response signal to the RFID interrogator 771, establishing a wireless communication channel.
[0076] In a second step 802, the controller 730 activates the RFID interrogator 771 to transmit identification data identifying the medical device 710 over a wireless communication channel, which is received by the RFID transponder 790 and transmitted (forwarded) to the controller 780 of the wireless license tag.
[0077] In a third step 803 , the controller 780 of the wireless license tag 720 checks the status of the license key stored in the memory element 785 . The license key may be stored in a first state that represents an unused license key. The license key is typically stored in the first state when the wireless license tag 720 is first provided by the manufacturer of the medical device 710. The unused state of the license key indicates that the license key may be registered with any compatible medical device, such as the medical device 710.
[0078] If the license key is in the first state, then in step 804 the controller 780 of the wireless license tag 720 transmits the license key to the medical device 710 over a wireless communication channel. To prevent the license key from being used on other medical devices after its use on the medical device 710, the controller stores the license key in the memory element 785 in a second state indicating that the license key has already been used on the particular medical device in step 805. For this purpose, the license key is stored in the memory element 785 together with the identification data of the medical device 710. The license key and the identification data can be stored as separate data elements. The license key and the identification data can be combined into one data element using an encryption function.
[0079] If in step 803 the controller detects that the license key is in a second state, then in step 806 it is checked whether the identification data received in step 802 matches the identification data stored together with the license key. To this end a simple comparison or an inverse encryption function may be applied.
[0080] If the identification data matches, then in step 807 the license key is sent again to the medical device 710. If the identification data does not match, then the license key is not sent. The above method prevents multiple use of the wireless license tag 720 in different medical devices, while allowing reuse of the wireless license tag in the same medical device, which may be necessary, for example, if the license key registered to the medical device 710 is lost due to, for example, a hardware reset.
[0081] Figure 9 illustrates a surgical device system 1000 according to a further embodiment of the present disclosure. The medical device system 1000 is similar to the medical device system 1 illustrated in Figure 1, and corresponding components are indicated with reference numbers increased by 1000. In this embodiment, a foot switch device 1015 is connected to an electrosurgical generator 1010 by a cable connection 1018.
[0082] During operation of the medical device system 1000, the electrosurgical instrument 1010 and the foot switch device 1015 communicate operational data via a first wired communication channel established by cable 1018, and the electrosurgical instrument 1010 and the foot switch device 1015 further communicate auxiliary data via a second wireless communication channel established via wireless communication units 1020, 1021.
[0083] In this embodiment, the operational data may include essential operational data. The essential operational data may include operational data related to patient or procedural safety. The essential operational data may include operational data that needs to be communicated with low latency. The essential operational data may include start and / or stop signals.
[0084] The auxiliary data may include device characteristic data or device identification data for the footswitch device 1015 for use in the manner described in connection with Figure 5. The auxiliary data may include operation dates, which do not need to be communicated with low latency.
[0085] In the medical device system 1000, the number of wires in the cable 1018 can be reduced as compared to the number of wires required in a cable for a conventional auxiliary device. Alternatively, the amount of data communicated between the auxiliary device 1015 and the electrosurgical generator 1010 can be increased, such as by providing a new auxiliary device 1015 with enhanced capabilities, without the need to communicate over the existing cable 1018.
Claims
1. At least one surgical instrument (11); a surgical generator (10) for supplying surgical energy to at least one of said surgical instruments (11); at least one auxiliary device (15, 25, 26) providing auxiliary functions to at least one said surgical generator (10) and / or at least one said surgical instrument (11); the surgical generator (10) is configured for wireless communication with at least one of the auxiliary devices (15, 25, 26); the surgical generator (10) and the at least one auxiliary device (15, 25, 26) are configured to establish a first communication channel for communicating operational data; the first communication is defined by a plurality of first communication channel parameters; the surgical generator (10) and at least one of the auxiliary devices (15, 25, 26) are configured to establish a second communication channel for communicating first communication channel parameters; A surgical device system, characterized in that at least one of said auxiliary devices (15, 25, 26) is configured to transmit device characteristic data and / or device identification data via said second communication channel.
2. The surgical device system of claim 1 , wherein the communication range of the second communication channel is shorter than the communication range of the first communication channel.
3. The surgical device system of claim 1 , wherein the bandwidth of the second communication channel is lower than the bandwidth of the first communication channel.
4. The surgical device system of claim 1 , wherein the second communication channel is a Near Field Communication (NFC) channel.
5. The surgical device system of claim 1 , wherein the second communication channel is an RFID channel.
6. The surgical device system of claim 1 , wherein the first communication channel is an IEEE 802.11 (WiFi®) communication channel.
7. The surgical device system of claim 1 , wherein the first communication channel is a BLUETOOTH communication channel, an IEEE 802.15.4 communication channel, or a ZIGBEE communication channel.
8. 2. The surgical device system of claim 1, wherein the at least one auxiliary device (15, 25, 26) comprises at least one of a foot switch (15), a smoke evacuation device, an irrigation pump (25), a suction pump (26), and a cooling water pump.
9. The surgical device system of claim 1 , wherein the operational data includes at least one of a start signal, a stop signal, a target flow rate, a current flow rate, a target pressure, a current pressure, a target temperature, a current temperature, a battery status, a connection quality, and a heartbeat signal.
10. 2. The surgical device system of claim 1, wherein the surgical generator (10) is configured to receive software update data for one or more of the auxiliary devices (15, 25, 26) via a network connection and to communicate the software update data to one or more of the auxiliary devices (15, 25, 26).
11. At least one surgical instrument (1011); a surgical generator (1010) for supplying surgical energy to at least one of said surgical instruments (1011); and at least one auxiliary device (1015) providing auxiliary functions to at least one said surgical generator (1010) and / or at least one said surgical instrument (1011), the surgical generator (1010) is configured to communicate with at least one of the auxiliary devices (1015); the surgical generator (1010) and the at least one auxiliary device (1015) are configured to establish a first wired communication channel for communicating operational data; the surgical generator (1010) and the at least one auxiliary device (1015) are configured to establish a second wireless communication channel for communicating auxiliary data; A surgical device system, characterized in that at least one of the auxiliary devices (1015) is configured to transmit device characteristic data and / or device identification data via the second wireless communication channel.
12. A surgical generator (10) for supplying surgical energy to at least one surgical instrument, comprising: The surgical generator (10) comprises: at least one auxiliary device provides an auxiliary function; configured to wirelessly communicate with at least one of the auxiliary devices; configured to establish a first communication channel for communicating operational data with at least one of the auxiliary devices; the first communication is defined by a plurality of first communication channel parameters; configured to establish a second communication channel for communicating first communication channel parameters with at least one of the auxiliary devices; A surgical generator of a surgical device system configured to receive device characteristic data and / or device identification data from at least one of said auxiliary devices via said second communication channel.
13. An auxiliary device for a surgical device system according to any one of claims 1 to 11.
14. said surgical generator (10) transmitting an interrogation signal; a step of at least one of the auxiliary devices (15, 25, 26) receiving the interrogation signal transmitting a response signal; receiving the response signal by the surgical generator (10) and, through a question and response, the surgical device system establishing the second communication channel between the surgical generator (10) and at least one of the auxiliary devices (15, 25, 26); said surgical generator (10) and at least one of said auxiliary devices (15, 25, 26) communicating said first communication channel parameters over said second communication channel; establishing, by the surgical device system, the first communication channel between the surgical generator (10) and at least one of the auxiliary devices (15, 25, 26) using the first communication channel parameters; 11. A method for operating a surgical device system according to any one of claims 1 to 10, further comprising the step of communicating operational data between the surgical generator (10) and at least one of the auxiliary devices (15, 25, 26) via the first communication channel.
15. The method according to claim 14, further comprising a step of at least one of the auxiliary devices (15, 25, 26) transmitting the device characteristic data and / or the device identification data of the at least one of the auxiliary devices (15, 25, 26) via the second communication channel.
16. receiving, via a user interface (120), input data identifying a surgical procedure to be performed; Retrieving from a memory (130) a list of auxiliary devices required for the surgical procedure to be performed; establishing said second communication channel between said surgical generator (10) and one or more of said auxiliary devices (15, 25, 26) that are within communication range thereof; receiving, via the second communication channel, said device identification data and / or said device characteristic data from said auxiliary devices (15, 25, 26) within communication range of said second communication channel; determining whether all of the auxiliary devices necessary for the surgical procedure to be performed have provided the device identification data and / or the device characteristic data in response to an interrogation signal; A method for operating a surgical device system according to any one of claims 1 to 10, further comprising the step of: if the determination is successful, establishing one or more of the first communication channels between the surgical generator (10) and the auxiliary device (15, 25, 26).
17. receiving, via a user interface (120), input data identifying a surgical procedure to be performed; Retrieving from a memory (130) a list of auxiliary devices required for the surgical procedure to be performed; establishing the second wireless communication channel between the surgical generator (1010) and one or more of the auxiliary devices (1015) that are within communication range thereof; receiving, via the second wireless communication channel, the device identification data and / or the device characteristic data from the auxiliary device (1015) that is within communication range of the second wireless communication channel; determining whether all of the auxiliary devices necessary for the surgical procedure to be performed have provided the device identification data and / or the device characteristic data in response to an interrogation signal; The method of claim 11, further comprising the step of: establishing one or more of the first wired communication channels between the surgical generator (1010) and the auxiliary device (1015) if the determination is successful.
18. 17. The method of claim 16, further comprising the step of outputting, via the user interface (120), an error message identifying the lack of the auxiliary device necessary for the surgical procedure to be performed if the determination is not met.
19. 20. The method of claim 17, further comprising the step of outputting, via the user interface (120), an error message identifying the lack of the auxiliary device necessary for the surgical procedure to be performed if the determination is not met.
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