Electrically driven medical instrument authentication method and device
By introducing authentication modules and encryption modules into electric drive medical devices, and using dynamic keys and RFID electronic tags for dual authentication and judgment, the problem of reuse of device accessories in the prior art is solved, ensuring the safety and formality of device accessories, and improving the hygiene and safety level of medical devices.
Patent Information
- Application Number
- CN202510201591.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-24
- Publication Date
- 2025-06-03
AI Technical Summary
The prior art cannot effectively prevent the reuse of electrically driven medical devices from different patients, cannot ensure that the device accessories are used within the safe life period, and cannot ensure that the accessory devices are safe and reliable regular products.
By introducing authentication modules and encryption modules into electric drive medical devices, dual authentication and judgment is performed using dynamic keys and RFID electronic tags to ensure that the device accessories comply with safety and formal standards before use.
It effectively eliminates the reuse of device accessories, ensures that the device accessories are used within a safe life period, and ensures that the accessory is a safe and reliable regular product, improving the hygiene and safety level of medical devices.
Smart Images
Figure CN120089323A_ABST
Abstract
Description
Technical Field
[0001] This invention patent relates to the technical field of electric drive medical device certification. Specifically, it relates to a method and device for electric drive medical device certification. Background Art
[0002] Compared with purely mechanical medical devices, electric drive medical devices reduce the labor intensity of doctors performing surgeries, which is of great significance for improving surgical efficiency and surgical outcomes, achieving smaller traumas, less tissue damage, less bleeding, greatly reducing the pain of patients, and accelerating the healing process.
[0003] However, for strict hygiene, safety, and ethical requirements, electric drive medical devices still lack higher-standard certification for use.
[0004] For example, in electric drive medical devices such as ultrasonic surgical systems and ion surgical systems, the main unit is reused, but the instrument accessories connected to the main unit, such as connecting wires, the cutting heads or electrode heads for direct surgery, are disposable.
[0005] In the prior art, it is impossible to effectively prevent the reuse of instrument accessories by different patients, ensure the use of instrument accessories within the safe service life, or ensure that the connected instrument accessories are safe, reliable, and regular products. Summary of the Invention
[0006] The purpose of the present invention is to provide a method and device for electric drive medical device certification, aiming to solve the problem in the prior art that it is impossible to effectively prevent the reuse of instrument accessories by different patients when using electric drive medical devices.
[0007] The present invention is implemented as follows. The electric drive medical device certification method includes a main unit, an active adapter, and a passive adapter. The specific certification steps are as follows: (1). The main unit includes an authentication module, and the active adapter includes an encryption module. The authentication module and the encryption module are communicatively connected. The authentication module generates a first dynamic key and sends it to the encryption module. (2). The encryption module generates a second dynamic key based on the first dynamic key and sends it to the authentication module for verification. (3). After the authentication module successfully authenticates the second dynamic key, it sends a query command to the encryption module. The encryption module transmits the product information and usage status back to the authentication module. The authentication module determines whether the product information and usage status meet the first usage condition. (4). The passive adapter includes an RFID electronic tag. The authentication module reads the product information and usage conditions of the RFID tag and determines whether they meet the second usage condition. (5) The authentication module notifies the host of the authentication and condition determination results. If all authentication and usage conditions are determined to pass, the host starts to execute the corresponding medical function. At the same time, the authentication module writes new product information and usage status to the encryption module and the RFID electronic tag respectively. If the determination fails, the host reports an error message.
[0008] Further, the encryption module is embedded inside the active adapter, and the active adapter and the passive adapter are detachably connected; the encryption module includes a storage component, and the storage component stores product information and usage status; when the active adapter and the passive adapter are assembled, the information stored in the storage component is arranged to be consistent with the passive adapter.
[0009] Further, the authentication module includes an RFID reader / writer, which is used to read the product information and usage conditions of the RFID tag, and the RFID reader / writer is used to determine whether the passive adapter meets usage condition two. When usage condition two is met, the host starts to execute the corresponding medical function and outputs an update signal to the RFID electronic tag.
[0010] Further, usage condition one is to determine whether the active adapter is within the safe service life, whether it is a safe and reliable regular product, and whether the active adapter has never been used.
[0011] Further, usage condition two is to determine whether the passive adapter has been used.
[0012] An electric drive medical device authentication device includes a host, an execution component, a connection cable, and an authentication module. The authentication module is installed on the host, and the host and the execution component are electrically connected through the connection cable; the execution component is provided with an RFID electronic tag, and the RFID electronic tag stores the product information and usage status of the execution component. The host includes an RFID reader / writer, which is used to read the information of the RFID electronic tag, and the RFID reader / writer is in signal communication with the authentication module.
[0013] Further, the execution component has an encryption module. When the host and the execution component are electrically connected, the authentication module generates a first dynamic key and sends it to the encryption module. The encryption module generates a second dynamic key according to the first dynamic key and sends it back to the authentication module for verification.
[0014] Further, the execution component has a storage component, and the storage component stores product information and usage status. The storage component is in signal communication with the encryption module.
[0015] Further, the authentication module includes an update signal. After the execution component executes the corresponding medical function, the authentication module outputs the update signal to the encryption module and the RFID electronic tag, and the encryption module and the RFID electronic tag are updated to new product information and usage status based on the update signal.
[0016] Further, the host is provided with a connection shell, and the connection cable passes through the connection shell and is electrically connected to the host; the connection shell is arranged in a rectangular shape, the connection shell has a bearing plate, the bearing plate is arranged horizontally, and the bearing plate is provided with a positioning strip, the positioning strip is arranged in a convex shape, a positioning groove is formed at the bottom of the execution component. When the positioning groove is arranged in an embedded manner with the positioning strip, the RFID electronic tag and the RFID reader are arranged corresponding to each other, and the RFID electronic tag is within the information extraction range of the RFID reader.
[0017] Compared with the prior art, for the electric drive medical device authentication method and device provided by the present invention, when the electric drive medical device is in use, the electric drive medical device is electrically connected to the host, and through the cooperation of the first dynamic key and the second dynamic key, the authentication of the electric drive medical device is realized. After the authentication is successful, the encryption module transmits back the product information and usage status of the electric drive medical device, and the authentication module makes a first judgment. Then, a second judgment is made based on the data extraction of the RFID electronic tag. Through the authentication and double judgment, the electronic locking of the electric drive medical device is realized, effectively preventing the repeated use of instrument accessories, ensuring the use of instrument accessories within the safe service life, and ensuring that the connected instrument accessories are safe, reliable and regular products, and well solving the hidden dangers in the hygiene and safety of medical devices. BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Figure 1 is a schematic flow chart of the steps of the electric drive medical device authentication method provided by the present invention; Figure 2 is a simple schematic connection diagram of the electric drive medical device authentication device provided by the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0019] In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.
[0020] The implementation of the present invention will be described in detail below with reference to specific embodiments.
[0021] In the drawings of this embodiment, the same or similar reference numerals correspond to the same or similar components; in the description of the present invention, it should be understood that if there are terms such as "upper", "lower", "left", "right", etc. indicating the orientation or positional relationship, they are based on the orientation or positional relationship shown in the drawings. This is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the terms describing the positional relationship in the drawings are only for illustrative purposes and should not be construed as a limitation of this patent. For those of ordinary skill in the art, the specific meanings of the above terms can be understood according to specific circumstances.
[0022] Referring to Figure 1 and 2 shown, it is a preferred embodiment provided by the present invention.
[0023] An electrical drive medical device authentication method, including a host 1, an active adapter, and a passive adapter. The specific authentication steps are as follows: (1). The host 1 includes an authentication module 11, and the active adapter includes an encryption module 21. The authentication module 11 and the encryption module 21 are arranged in communication connection. The authentication module 11 generates a first dynamic key and sends it to the encryption module 21; (2). The encryption module 21 generates a second dynamic key according to the first dynamic key and sends it to the authentication module 11 for verification; (3). After the authentication module 11 successfully authenticates the second dynamic key, it sends a query command to the encryption module 21. The encryption module 21 transmits the product information and usage status back to the authentication module 11, and the authentication module 11 determines whether the product information and usage status meet the usage condition 1; (4). The passive adapter includes an RFID electronic tag 22. The authentication module 11 reads the product information and usage conditions of the RFID tag and determines whether they meet the usage condition 2; (5). The authentication module 11 notifies the host 1 of the authentication and condition discrimination results. If all authentication and usage conditions are judged to pass, the host 1 starts to execute the corresponding medical function. At the same time, the authentication module 11 writes new product information and usage status to the encryption module 21 and the RFID electronic tag 22 respectively; if the discrimination fails, the host 1 reports an error message.
[0024] In the above-mentioned certification method for electric drive medical devices, when the electric drive medical device is in use, the electric drive medical device is electrically connected to the host 1. Through the cooperation of the first dynamic key and the second dynamic key, the authentication of the electric drive medical device is realized. After successful authentication, the encryption module 21 transmits back the product information and usage status of the electric drive medical device. The authentication module 11 makes a first judgment, and then, based on the data extraction of the RFID electronic tag 22, makes a second judgment. Through authentication and double judgment, the electronic locking of the electric drive medical device is realized, effectively preventing the repeated use of instrument accessories, ensuring the use of instrument accessories within the safe service life, and ensuring that the connected instrument accessories are safe, reliable and regular products, thus well solving the hidden dangers in the hygiene and safety of medical devices.
[0025] The encryption module 21 is embedded inside the active adapter to realize the placement of the encryption module 21.
[0026] The active adapter and the passive adapter are detachably connected; this facilitates the assembly and disassembly between the active adapter and the passive adapter.
[0027] The encryption module 21 includes a storage component that stores product information and usage status; in this way, after successful authentication, the storage component transmits back the stored product information and usage status to the authentication module 11 for the first judgment.
[0028] When the active adapter and the passive adapter are assembled, the information stored in the storage component is arranged in agreement with the passive adapter; that is, the information stored in the storage component is arranged in agreement with the data of the RFID electronic tag 22; this realizes the second judgment based on the data extraction of the RFID electronic tag 22.
[0029] The authentication module 11 includes an RFID reader / writer that is used to read the product information and usage conditions of the RFID tag, and the RFID reader / writer is used to judge whether the passive adapter meets the usage condition two. When it meets the usage condition two, the host 1 starts to execute the corresponding medical function, effectively preventing the repeated use of instrument accessories, ensuring the use of instrument accessories within the safe service life, and ensuring that the connected instrument accessories are safe, reliable and regular products, thus well solving the hidden dangers in the hygiene and safety of medical devices.
[0030] And an update signal is output to the RFID electronic tag 22, effectively preventing the repeated use of instrument accessories.
[0031] The usage condition one is to judge whether the active adapter is within the safe service life, whether it is a safe, reliable and regular product, and whether the active adapter has not been used.
[0032] The usage condition two is to judge whether the passive adapter has been used.
[0033] The way for the authentication module 11 to generate the first dynamic key is that when the host 1 is electrically connected to the instrument accessory, the host 1 obtains the category code of the instrument accessory. The category code is the product category of a single instrument accessory, and the first dynamic key is generated based on the category code.
[0034] The way for the authentication module 11 to generate the second dynamic key is that the encryption module 21 generates the second dynamic key according to the first dynamic key in combination with a predetermined code. The predetermined code is unique, and the predetermined code has a unique correspondence with a single instrument accessory.
[0035] The authentication module 11 prestores each second dynamic key. When the encryption module 21 generates the second dynamic key and sends it to the authentication module 11, the authentication module 11 performs authentication based on the prestored second dynamic key. If they correspond, the authentication is successful; otherwise, the discrimination fails, and the host 1 reports an error message.
[0036] When the use condition one is met and the authentication is successful, the authentication module 11 determines whether the instrument accessory is within the safe service life, determines whether the connected instrument accessory is a safe, reliable and regular product, and determines whether the active adapter has not been used.
[0037] Then, when the use condition one is met, the use condition two is judged. The authentication module 11 reads the product information and use conditions of the RFID tag, and determines whether the instrument accessory is a used instrument accessory, so as to prevent the repeated use of the instrument accessory.
[0038] The electric drive medical device authentication device includes a host 1, an execution component 2, a connection cable 3 and an authentication module 11. The authentication module 11 is installed in the host 1, and the host 1 and the execution component 2 are electrically connected through the connection cable 3; the execution component 2 is provided with an RFID electronic tag 22, and the RFID electronic tag 22 stores the product information and use status of the execution component 2. The host 1 includes an RFID reader, and the RFID reader is used to read the information of the RFID electronic tag 22. The RFID reader and the authentication module 11 are in signal communication arrangement.
[0039] For the above-mentioned electric drive medical device authentication device, during the surgical operation, the host 1 and the execution component 2 are electrically connected through the connection cable 3, and the authentication module 11 authenticates the execution component 2. After the authentication is successful, the information of the RFID electronic tag 22 is read through the RFID reader, and then the execution component 2 is discriminated. If both the authentication and the discrimination are passed, the host 1 starts the execution component 2 to perform the corresponding medical function; otherwise, the host 1 reports an error message.
[0040] The execution component 2 has an encryption module 21. When the host 1 is electrically connected to the execution component 2, the authentication module 11 generates the first dynamic key and sends it to the encryption module 21. The encryption module 21 generates the second dynamic key according to the first dynamic key and sends it back to the authentication module 11 for verification.
[0041] The execution component 2 has a storage component that stores product information and usage status, and the storage component is arranged in signal communication with the encryption module 21.
[0042] The authentication module 11 includes an update signal. After the execution component 2 executes the corresponding medical function, the authentication module 11 outputs the update signal to the encryption module 21 and the RFID electronic tag 22, and the encryption module 21 and the RFID electronic tag 22 are updated to new product information and usage status based on the update signal.
[0043] The host 1 is provided with a connection shell, and the connection cable 3 passes through the connection shell and is arranged in electrical connection with the host 1; the connection shell is arranged in a rectangular shape, the connection shell has a bearing plate, the bearing plate is arranged horizontally, and the bearing plate is provided with a positioning strip which is convexly arranged. A positioning groove is formed at the bottom of the execution component 2. When the positioning groove and the positioning strip are arranged in an embedded manner, the RFID electronic tag 22 and the RFID reader are arranged in correspondence, and the RFID electronic tag 22 is within the information extraction range of the RFID reader.
[0044] In this way, when the RFID reader reads the information of the RFID electronic tag 22, under the cooperation of the positioning groove and the positioning strip, it is convenient for the RFID reader to read the information of the RFID electronic tag 22.
[0045] Another embodiment: an electric drive medical device authentication device, including a host 1, an execution component 2, and an authentication module 11. The authentication module 11 is installed on the host 1. The host 1 has a plurality of spring pins, and each spring pin is convexly arranged. The execution component 2 has a plurality of needle slots. The host 1 and the execution component 2 are arranged in wireless communication, and each spring pin and each needle slot are arranged in one-to-one correspondence and in an embedded manner; the execution component 2 is provided with an RFID electronic tag 22, and the RFID electronic tag 22 stores the product information and usage status of the execution component 2. The host 1 includes an RFID reader for reading the information of the RFID electronic tag 22, and the RFID reader is arranged in signal communication with the authentication module 11.
[0046] For the above-mentioned electric drive medical device authentication device, during a surgical operation, the host 1 and the execution component 2 are electrically connected through the spring pins. The authentication module 11 authenticates the execution component 2. After successful authentication, the RFID reader reads the information of the RFID electronic tag 22, and then discriminates the execution component 2. If both the authentication and the discrimination are passed, the host 1 starts the execution component 2 to execute the corresponding medical function. Otherwise, the host 1 reports an error message.
[0047] The execution component 2 has an encryption module 21. When the host 1 is electrically connected to the execution component 2, the authentication module 11 generates a first dynamic key and sends it to the encryption module 21. The encryption module 21 generates a second dynamic key based on the first dynamic key and sends it back to the authentication module 11 for verification.
[0048] The execution component 2 has a storage component that stores product information and usage status. The storage component is arranged in signal communication with the encryption module 21.
[0049] The authentication module 11 includes an update signal. After the execution component 2 executes the corresponding medical function, the authentication module 11 outputs the update signal to the encryption module 21 and the RFID electronic tag 22. The encryption module 21 and the RFID electronic tag 22 are updated to new product information and usage status based on the update signal.
[0050] The electric drive medical device authentication device includes a storage rack. The storage rack is assembled with the host 1. The storage rack has an adapter block that protrudes toward the host 1 under elastic force. The adapter block is used to press the execution component 2, and the adapter is used to make the RFID electronic tag 22 of the execution component 2 within the reading range of the RFID reader.
[0051] The adapter block has an adapter surface that is recessed and arc-shaped in the direction away from the host 1, so as to cooperate with different execution components 2, facilitate the positioning of the execution component 2, and facilitate the identification and discrimination of the execution component 2.
[0052] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
Claims
1. A method for authenticating an electrically driven medical device, characterized in that: Including the host, active adapter and passive adapter, the specific authentication steps are as follows: (1) The host includes an authentication module, the active adapter includes an encryption module, the authentication module and the encryption module are arranged in a communication connection, and the authentication module generates a first dynamic key and sends it to the encryption module; (2) The encryption module generates a second dynamic key based on the first dynamic key and sends it to the authentication module for verification; (3) After the authentication module successfully authenticates the second dynamic key, it sends a query command to the encryption module, and the encryption module returns the product information and usage status to the authentication module, and the authentication module determines whether the product information and usage status meet the usage condition 1; (4) The passive adapter includes an RFID electronic tag, and the authentication module reads the product information and usage conditions of the RFID tag to determine whether the second usage condition is met; (5) The authentication module notifies the host of the authentication and condition determination results. If all authentication and usage conditions are determined to be passed, the host starts to execute the corresponding medical function. At the same time, the authentication module writes new product information and usage status to the encryption module and the RFID electronic tag respectively; if the determination fails, the host reports an error message.
2. The electric-driven medical device authentication method according to claim 1, characterized in that: The encryption module is embedded in the active adapter, and the active adapter and the passive adapter are detachably connected; the encryption module includes a storage component, and the storage component stores product information and usage status; when the active adapter and the passive adapter are assembled, the information stored in the storage component is arranged consistently with the passive adapter.
3. The electric-driven medical device authentication method according to claim 2, characterized in that: The authentication module includes an RFID reader / writer, which is used to read the product information and usage conditions of the RFID tag, and the RFID reader / writer is used to determine whether the passive adapter meets the second usage condition. When the second usage condition is met, the host starts to execute the corresponding medical function and outputs an update signal to the RFID electronic tag.
4. The electric-driven medical device authentication method according to any one of claims 1 to 3, characterized in that: The first use condition is to determine whether the active adapter is within the safe life cycle, whether it is a safe and reliable regular product, and whether the active adapter has never been used.
5. The electric-driven medical device authentication method according to claim 4, characterized in that: The second use condition is to determine whether the passive adapter has been used.
6. An electric-driven medical device authentication device, characterized in that: The system comprises a host, an execution component, a connecting cable and an authentication module, wherein the authentication module is installed in the host, and the host and the execution component are electrically connected via the connecting cable; the execution component is provided with an RFID electronic tag, and the RFID electronic tag stores the product information and usage status of the execution component; the host comprises an RFID reader / writer, and the RFID reader / writer is used to read the information of the RFID electronic tag, and the RFID reader / writer is arranged in signal communication with the authentication module.
7. The electric-driven medical device authentication device according to claim 6, characterized in that: The execution component has an encryption module. When the host is electrically connected to the execution component, the authentication module generates a first dynamic key and sends it to the encryption module. The encryption module generates a second dynamic key based on the first dynamic key and sends it back to the authentication module for verification.
8. The electric-driven medical device authentication device according to claim 7, characterized in that: The execution component has a storage component, which stores product information and usage status, and the storage component is arranged in signal communication with the encryption module.
9. The electric-driven medical device authentication device according to claim 8, characterized in that: The authentication module includes an update signal. When the execution component executes the corresponding medical function, the authentication module outputs an update signal to the encryption module and the RFID electronic tag. The encryption module and the RFID electronic tag are updated to new product information and usage status based on the update signal.
10. The electric-driven medical device authentication device according to claim 9, characterized in that: The host is provided with a connecting shell, and the connecting cable passes through the connecting shell and is electrically connected to the host; the connecting shell is arranged in a rectangular shape, and the connecting shell has a supporting plate, the supporting plate is arranged horizontally, and the supporting plate is provided with a positioning bar, the positioning bar is convexly arranged, and a positioning groove is formed at the bottom of the execution component. When the positioning groove and the positioning bar are embedded, the RFID electronic tag and the RFID reader are arranged correspondingly, and the RFID electronic tag is in the information extraction range of the RFID reader.