CN102480352B - The method for protecting of Implanted medical system and system - Google Patents
The method for protecting of Implanted medical system and system Download PDFInfo
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Abstract
本发明公开了一种植入式医疗系统的安全保障方法及系统，将植入式医疗器械的唯一识别信息和对应的病人控制器的唯一识别信息经过加密函数处理，生成的唯一密码锁写入植入式医疗器械内，对唯一密码锁进行解密处理后生成的唯一的密钥写入病人控制器内，因此能够始终保证仅具有该唯一密钥的病人控制器能够与植入式医疗器械进行通信。当病人损坏或丢失原配的病人控制器可以使用本发明的方法重新配一个新的病人控制器，即使他人拾获病人损坏或丢失原配病人控制器，由于原病人控制器内的密钥已无法与植入式医疗器械内的新密码锁相配对，因此能够防止他人误用或恶意使用其他病人控制器对植入病人的健康造成威胁。
The invention discloses a safety guarantee method and system for an implanted medical system. The unique identification information of the implanted medical device and the unique identification information of the corresponding patient controller are processed by an encryption function, and the generated unique password lock is written into the implanted medical device. In the implanted medical device, the unique key generated after decrypting the unique password lock is written into the patient controller, so it can always ensure that only the patient controller with the unique key can communicate with the implanted medical device . When the patient damages or loses the original patient controller, the method of the present invention can be used to reconfigure a new patient controller. The new combination locks within the implantable medical device are paired, thereby preventing the misuse or malicious use of other patient controls by others posing a threat to the health of the implanted patient.
Description
技术领域 technical field
本发明涉及植入式医疗系统，尤其是病人控制器与植入式医疗器械一对一安全绑定方法及植入式医疗系统。The invention relates to an implanted medical system, in particular to a one-to-one safe binding method for a patient controller and an implanted medical device and the implanted medical system.
背景技术 Background technique
植入式医疗系统通常包括植入式神经电刺激系统、植入式心脏电刺激系统(俗称心脏起搏器)、植入式药物输注系统。其中，植入式神经电刺激系统包括脑深部电刺激DBS，植入式脑皮层刺激CNS，植入式脊髓电刺激SCS，植入式骶神经电刺激SNS，植入式迷走神经电刺激VNS等。Implantable medical systems usually include implantable nerve electrical stimulation systems, implantable cardiac electrical stimulation systems (commonly known as cardiac pacemakers), and implantable drug infusion systems. Among them, implantable electrical nerve stimulation systems include deep brain electrical stimulation DBS, implantable cerebral cortex electrical stimulation CNS, implantable spinal cord electrical stimulation SCS, implantable sacral nerve electrical stimulation SNS, implantable vagus nerve electrical stimulation VNS, etc.
以植入式神经电刺激系统为例，主要包括植入体内的脉冲发生器、电极以及体外的控制装置。其中，脉冲发生器与电极相连接，从而将脉冲发生器所产生的脉冲传输到电极，脉冲发生器产生的脉冲信号由电极传输至心脏或特定神经部位进行电刺激，从而使人体机能恢复到正常运作的状态。体外控制装置包括医生程控器、病人控制器。Taking the implanted electrical nerve stimulation system as an example, it mainly includes a pulse generator implanted in the body, electrodes and external control devices. Among them, the pulse generator is connected to the electrode, so that the pulse generated by the pulse generator is transmitted to the electrode, and the pulse signal generated by the pulse generator is transmitted from the electrode to the heart or specific nerve parts for electrical stimulation, so that the human body function returns to normal state of operation. External control devices include doctor programmers and patient controllers.
其中，病人控制器是为病人配备的用来根据自己的情况控制开关或者调节体内脉冲发生器的输出参数的装置，病人通常仅能够在医生设置的调节范围内自行调节。医生程控器是医生用来根据病人情况监控调节体内脉冲发生器的输出参数的装置，通常一个医生程控器可用来控制多个脉冲发生器。病人控制器和医生程控器可通过无线通信模式、磁性线圈或其他通信方式与脉冲发生器进行通信。Among them, the patient controller is a device equipped for the patient to control the switch or adjust the output parameters of the pulse generator in the body according to his own situation. Usually, the patient can only adjust himself within the adjustment range set by the doctor. The doctor's program controller is a device used by the doctor to monitor and adjust the output parameters of the pulse generator in the body according to the patient's condition. Usually, one doctor's program controller can be used to control multiple pulse generators. The patient controller and doctor programmer can communicate with the pulse generator through wireless communication mode, magnetic coil or other communication methods.
在植入式医疗器械植入手术完成后，会给病人配备仅能与该植入式医疗器械进行通信的病人控制器，使病人回家后能够在一定范围内对植入式医疗器械的输出参数进行自主调节。该病人控制器是在出厂前就设定为与其相对应的植入式医疗器械一对一绑定，即仅有唯一的一个病人控制器能控制该植入式医疗器械，其他人利用其它公司的任何类似产品都无法对病人体内的植入式医疗器械进行控制，从而保障植入式医疗系统及病人的安全。After the implantable medical device is implanted, the patient will be equipped with a patient controller that can only communicate with the implanted medical device, so that the patient can control the output of the implanted medical device within a certain range after returning home. The parameters are adjusted independently. The patient controller is set to be one-to-one bound with its corresponding implantable medical device before leaving the factory, that is, only one patient controller can control the implantable medical device, and others use other company's Any similar products of the company cannot control the implanted medical devices in the patient's body, thereby ensuring the safety of the implanted medical system and the patient.
另外，如果病人不慎遗失或损坏该病人控制器则需要更换一个新的病人控制器，使得仅更换后的新病人控制器能够控制植入式医疗器械同时废除原病人控制器，这样即使他人拾获或修理好原病人控制器也无法再控制植入式医疗器械。因此亟需一种能够保证植入式医疗器械与病人控制器一对一安全绑定的方法及系统。In addition, if the patient accidentally loses or damages the patient controller, a new patient controller needs to be replaced, so that only the replaced new patient controller can control the implantable medical device while the original patient controller is abolished, so that even if others pick up Obtaining or repairing the original patient controller will no longer control the implantable medical device. Therefore, there is an urgent need for a method and system that can ensure one-to-one secure binding of implantable medical devices and patient controllers.
发明内容 Contents of the invention
针对现有技术中存在的不足，本发明要解决的技术问题是提供一种植入式医疗系统的安全保障方法及系统，使得始终仅有唯一一个病人控制器可以控制植入式医疗器械以保障植入式医疗系统的安全。Aiming at the deficiencies in the prior art, the technical problem to be solved by the present invention is to provide a safety guarantee method and system for an implanted medical system, so that only one patient controller can control the implanted medical device to ensure the safety of the implanted medical system. security of embedded medical systems.
根据本发明所提供的技术方案，一种病人控制器与植入式医疗器械安全绑定方法，包括以下步骤：According to the technical solution provided by the present invention, a method for safely binding a patient controller and an implantable medical device includes the following steps:
A：获取植入式医疗器械的唯一识别信息及病人控制器的唯一识别信息；A: Obtain the unique identification information of the implantable medical device and the unique identification information of the patient controller;
B：对所述植入式医疗器械的唯一识别信息及病人控制器的唯一识别信息进行加密运算处理，生成用于保护该植入式医疗器械的唯一密码锁；B: Encrypting the unique identification information of the implantable medical device and the unique identification information of the patient controller to generate a unique password lock for protecting the implantable medical device;
C：程控器对所述植入式医疗器械的唯一密码锁进行解密生成唯一密钥；C: The program controller decrypts the unique password lock of the implantable medical device to generate a unique key;
D：所述程控器将所述唯一密钥写入所述病人控制器内用于与所述植入式医疗器械进行通信。D: The programmer writes the unique key into the patient controller for communicating with the implantable medical device.
优选地，所述步骤A中获取病人控制器唯一识别信息的步骤由如下步骤构成：Preferably, the step of obtaining the unique identification information of the patient controller in the step A consists of the following steps:
A1：所述程控器与所述病人控制器建立通信并获取所述病人控制器的唯一识别信息；A1: The programmer establishes communication with the patient controller and obtains the unique identification information of the patient controller;
A2：所述程控器将该病人控制器唯一识别信息传输至植入式医疗器械；A2: The programmer transmits the unique identification information of the patient controller to the implantable medical device;
在步骤B中由所述植入式医疗器械对所述植入式医疗器械的唯一识别信息及病人控制器的唯一识别信息进行加密运算处理。In step B, the implantable medical device performs encrypted operation processing on the unique identification information of the implantable medical device and the unique identification information of the patient controller.
优选地，所述步骤A中由所述程控器与所述病人控制器建立通信获取病人控制器的唯一识别信息；所述程控器与所述植入式医疗器械建立通信获取植入式医疗器械的唯一识别信息；Preferably, in the step A, the programmer establishes communication with the patient controller to obtain the unique identification information of the patient controller; the programmer establishes communication with the implantable medical device to obtain the implantable medical device unique identification information;
在步骤B中由所述程控器对所述植入式医疗器械的唯一识别信息及病人控制器的唯一识别信息进行加密运算处理。In step B, the program controller performs encrypted operation processing on the unique identification information of the implantable medical device and the unique identification information of the patient controller.
优选地，所述植入式医疗器械唯一识别信息为植入式医疗器械的唯一序列号，所述病人控制器唯一识别信息为病人控制器的唯一序列号。Preferably, the unique identification information of the implantable medical device is the unique serial number of the implantable medical device, and the unique identification information of the patient controller is the unique serial number of the patient controller.
优选地，所述的植入式医疗器械为植入式神经刺激器、植入式心脏起搏器、植入式心律转复除颤器或者植入式药物输注器中的一种。Preferably, the implanted medical device is one of an implanted nerve stimulator, an implanted cardiac pacemaker, an implanted cardioverter-defibrillator or an implanted drug infusion set.
本发明还提供了一种病人控制器与植入式医疗器械安全绑定的植入式医疗系统，包括植入式医疗器械、可与所述植入式医疗器械通信的程控器、可与所述程控器通信的病人控制器，所述植入式医疗器械包括可对自身的唯一识别信息及病人控制器的唯一识别信息进行加密处理的加密程序控制模块、用于将加密处理后生成的唯一密码锁传输至程控器的第一通信模块，所述程控器包括用于对所述唯一加密码进行解密处理的解密程序控制模块、将解密处理后生成的唯一密钥传输至所述病人控制器的第二通信模块，所述病人控制器包括用于接收所述唯一解密密钥的第三通信模块。The present invention also provides an implantable medical system in which the patient controller is safely bound to the implantable medical device, including the implantable medical device, a programmer capable of communicating with the implantable medical device, and a programmable controller capable of communicating with the implantable medical device. The implantable medical device includes an encryption program control module that can encrypt its own unique identification information and the unique identification information of the patient controller, and is used to encrypt the unique identification information generated after encryption. The password lock is transmitted to the first communication module of the programmer, and the programmer includes a decryption program control module for decrypting the unique encryption code, and transmits the unique key generated after the decryption to the patient controller The patient controller includes a second communication module for receiving the unique decryption key.
优选地，所述第一通信模块、第二通信模块和第三通信模块均为RF无线通讯模块。Preferably, the first communication module, the second communication module and the third communication module are all RF wireless communication modules.
优选地，所述植入式医疗器械唯一识别信息为植入式医疗器械的唯一序列号，所述病人控制器唯一识别信息为病人控制器的唯一序列号。Preferably, the unique identification information of the implantable medical device is the unique serial number of the implantable medical device, and the unique identification information of the patient controller is the unique serial number of the patient controller.
优选地，所述的植入式医疗器械为植入式神经刺激器、植入式心脏起搏器、植入式心律转复除颤器或者植入式药物输注器中的一种。Preferably, the implanted medical device is one of an implanted nerve stimulator, an implanted cardiac pacemaker, an implanted cardioverter-defibrillator or an implanted drug infusion set.
本发明还提供了另一种技术方案，一种病人控制器与植入式医疗器械安全绑定的植入式医疗系统，包括植入式医疗器械、可与所述植入式医疗器械通信的程控器、可与所述程控器通信的病人控制器，其特征在于：所述程控器包括用于接收植入式医疗器械的唯一识别信息及病人控制器的唯一识别信息的第四通信模块、可对所述植入式医疗器械的唯一识别信息及病人控制器的唯一识别信息进行加密处理的加密程序控制模块、用于对所述唯一加密码进行解密处理的解密程序控制模块，所述第四通信模块将所述加密程序控制模块加密处理后生成的唯一密码锁传输至植入式医疗器械，所述第四通信模块将所述解密程序控制模块解密处理后生成的唯一密钥传输至所述病人控制器。The present invention also provides another technical solution, an implantable medical system in which the patient controller is safely bound to the implantable medical device, including the implantable medical device, a device capable of communicating with the implantable medical device A programmer, a patient controller capable of communicating with the programmer, characterized in that the programmer includes a fourth communication module for receiving the unique identification information of the implantable medical device and the unique identification information of the patient controller, An encryption program control module capable of encrypting the unique identification information of the implantable medical device and the unique identification information of the patient controller, and a decryption program control module for decrypting the unique encryption code, the first The fourth communication module transmits the unique password lock generated after encryption processing by the encryption program control module to the implantable medical device, and the fourth communication module transmits the unique key generated after decryption processing by the decryption program control module to the implanted medical device. described patient controller.
优选地，所述植入式医疗器械包括用于接收唯一密码锁的第五通信模块，所述病人控制器包括用于接收所述唯一解密密钥的第六通信模块，所述第四通信模块、第五通信模块和第六通信模块均为RF无线通讯模块。Preferably, the implantable medical device includes a fifth communication module for receiving a unique password lock, the patient controller includes a sixth communication module for receiving the unique decryption key, and the fourth communication module , the fifth communication module and the sixth communication module are all RF wireless communication modules.
优选地，所述植入式医疗器械唯一识别信息为植入式医疗器械的唯一序列号，所述病人控制器唯一识别信息为病人控制器的唯一序列号。Preferably, the unique identification information of the implantable medical device is the unique serial number of the implantable medical device, and the unique identification information of the patient controller is the unique serial number of the patient controller.
优选地，所述的植入式医疗器械为植入式神经刺激器、植入式心脏起搏器、植入式心律转复除颤器或者植入式药物输注器中的一种。Preferably, the implanted medical device is one of an implanted nerve stimulator, an implanted cardiac pacemaker, an implanted cardioverter-defibrillator or an implanted drug infusion set.
与现有技术相比本发明的优点是：由于本发明将植入式医疗器械的唯一识别信息和对应的病人控制器的唯一识别信息经过加密函数处理，生成的唯一密码锁写入植入式医疗器械内，对唯一密码锁进行解密处理后生成的唯一的密钥写入病人控制器内，因此能够始终保证仅具有该唯一密钥的病人控制器能够与植入式医疗器械进行通信。Compared with the prior art, the present invention has the following advantages: since the present invention processes the unique identification information of the implanted medical device and the corresponding patient controller through an encryption function, the generated unique password lock is written into the implanted medical device. In the medical device, the unique key generated after decrypting the unique password lock is written into the patient controller, so it can always ensure that only the patient controller with the unique key can communicate with the implanted medical device.
如果病人损坏或丢失原配的病人控制器可以使用本发明的方法重新配一个新的病人控制器，由医生或厂商使用医生程控器将新密钥写入新病人控制器内，这样，即使他人拾获病人损坏或丢失原配病人控制器，由于原病人控制器内的密钥已无法与植入式医疗器械内的新密码锁相配对，因此能够防止他人误用或恶意使用其他病人控制器对植入病人的健康造成威胁。If the patient damages or loses the original patient controller, a new patient controller can be reconfigured using the method of the present invention, and the doctor or the manufacturer uses the doctor's program controller to write the new key into the new patient controller. If the patient damages or loses the original patient controller, since the key in the original patient controller can no longer be paired with the new combination lock in the implanted medical device, it can prevent others from misusing or maliciously using other patient controllers to control the implanted device. threat to the health of patients.
附图说明 Description of drawings
附图1为本发明的模块原理图；Accompanying drawing 1 is the module schematic diagram of the present invention;
附图2为本发明的安全保密控制程序流程图(实施方式一)；Accompanying drawing 2 is the flow chart of security control program of the present invention (embodiment 1);
附图3为本发明的系统模块原理图(实施方式一)；Accompanying drawing 3 is the schematic diagram of the system module of the present invention (embodiment 1);
附图4为本发明的安全保密控制程序流程图(实施方式二)；Accompanying drawing 4 is the flow chart of security control program of the present invention (embodiment 2);
附图5为本发明的系统模块原理图(实施方式二)。Accompanying drawing 5 is the schematic diagram of the system module of the present invention (implementation mode 2).
其中：in:
1、脉冲发生器；101、加密程序控制模块；102、第一通信模块；2、电极；3、医生程控器；301、解密程序控制模块；302、第二通信模块；4、病人控制器；401、第三通信模块；1’、脉冲发生器；101’、第五通信模块；2’、电极；3’、医生程控器；301’、第四通信模块；302’、加密程序控制模块；303’、解密程序控制模块；4’、病人控制器；401’、第六通信模块。1. Pulse generator; 101. Encryption program control module; 102. First communication module; 2. Electrode; 3. Doctor program controller; 301. Decryption program control module; 302. Second communication module; 4. Patient controller; 401, the third communication module; 1', the pulse generator; 101', the fifth communication module; 2', the electrode; 3', the doctor's program controller; 301', the fourth communication module; 302', the encryption program control module; 303', decryption program control module; 4', patient controller; 401', sixth communication module.
具体实施方式Detailed ways
下面结合附图对本发明作进一步详细的说明：Below in conjunction with accompanying drawing, the present invention is described in further detail:
实施方式一：Implementation mode one:
参照图1，以植入式神经电刺激系统为例，主要包括植入体内的脉冲发生器1、电极2，以及位于体外的医生程控器3、病人控制器4。脉冲发生器1与电极2电连接，从而将脉冲发生器1所产生的脉冲传输到电极2，以对神经靶点进行电刺激，达到治疗的效果。医生程控器3和病人控制器4可调节脉冲发生器1的幅值、频率、脉宽等输出参数时，医生程控器3还具有查询病人信息等特定功能，与病人控制器4相比功能更加强大。Referring to FIG. 1 , taking an implantable electrical nerve stimulation system as an example, it mainly includes a pulse generator 1 and electrodes 2 implanted in the body, as well as a doctor program controller 3 and a patient controller 4 located outside the body. The pulse generator 1 is electrically connected to the electrode 2, so that the pulse generated by the pulse generator 1 is transmitted to the electrode 2, so as to electrically stimulate the nerve target to achieve a therapeutic effect. When the doctor programmer 3 and the patient controller 4 can adjust the output parameters such as the amplitude, frequency, and pulse width of the pulse generator 1, the doctor programmer 3 also has specific functions such as querying patient information, which is more functional than the patient controller 4. powerful.
参照图2，本发明的病人控制器与脉冲发生器安全绑定方法，包括以下步骤：Referring to Fig. 2, the safety binding method between the patient controller and the pulse generator of the present invention comprises the following steps:
A：医生程控器3与病人控制器4建立通信并获取所述病人控制器4的唯一识别信息，医生程控器3将该病人控制器4唯一识别信息传输至脉冲发生器3；A: The doctor programmer 3 establishes communication with the patient controller 4 and obtains the unique identification information of the patient controller 4, and the doctor programmer 3 transmits the unique identification information of the patient controller 4 to the pulse generator 3;
B：脉冲发生器1对自身的唯一识别信息及病人控制器4的唯一识别信息进行加密运算处理，生成用于保护该脉冲发生器的唯一密码锁；B: The pulse generator 1 performs encrypted operation processing on its own unique identification information and the unique identification information of the patient controller 4 to generate a unique combination lock for protecting the pulse generator;
C：脉冲发生器1将唯一密码锁传输至医生程控器3，医生程控器3对所述脉冲发生器1的唯一密码锁进行解密处理生成唯一密钥；C: The pulse generator 1 transmits the unique password lock to the doctor programmer 3, and the doctor programmer 3 decrypts the unique password lock of the pulse generator 1 to generate a unique key;
D：医生程控器3将所述唯一密钥写入所述病人控制器4内用于与所述脉冲发生器进行通信。D: The doctor programmer 3 writes the unique key into the patient controller 4 for communicating with the pulse generator.
本实施方式中，脉冲发生器1的唯一识别信息为脉冲发生器的唯一序列号，所述病人控制器4的唯一识别信息为病人控制器的唯一序列号。In this embodiment, the unique identification information of the pulse generator 1 is the unique serial number of the pulse generator, and the unique identification information of the patient controller 4 is the unique serial number of the patient controller.
所述的脉冲发生器1为植入式神经刺激器、植入式心脏起搏器、植入式心律转复除颤器或者植入式药物输注器中的一种。The pulse generator 1 is one of an implanted neurostimulator, an implanted cardiac pacemaker, an implanted cardioverter-defibrillator or an implanted drug infusion set.
参照图3，一种病人控制器与脉冲发生器安全绑定的植入式神经电刺激系统，包括脉冲发生器1、可与所述脉冲发生器1通信的医生程控器3、可与所述医生程控器3通信的病人控制器4。所述脉冲发生器1包括可对自身的唯一识别信息及病人控制器的唯一识别信息进行加密处理的加密程序控制模块101、用于将加密处理后生成的唯一密码锁传输至程控器的第一通信模块102。Referring to FIG. 3 , an implantable electrical nerve stimulation system in which a patient controller is safely bound to a pulse generator includes a pulse generator 1 , a doctor programmer 3 that can communicate with the pulse generator 1 , and can communicate with the pulse generator 1 . The patient controller 4 communicates with the doctor's programmer 3 . The pulse generator 1 includes an encryption program control module 101 capable of encrypting its own unique identification information and the unique identification information of the patient controller, and a first key for transmitting the unique combination lock generated after encryption to the programmer. communication module 102 .
所述医生程控器3包括用于对所述唯一加密码进行解密处理的解密程序控制模块301、将解密处理后生成的唯一密钥传输至所述病人控制器4的第二通信模块302，所述病人控制器4包括用于接收所述唯一解密密钥的第三通信模块401。The doctor programmer 3 includes a decryption program control module 301 for decrypting the unique encryption code, and a second communication module 302 that transmits the unique key generated after decryption to the patient controller 4, so that The patient controller 4 includes a third communication module 401 for receiving the unique decryption key.
所述第一通信模块102、第二通信模块302和第三通信模块401均为RF无线通讯模块。The first communication module 102, the second communication module 302 and the third communication module 401 are all RF wireless communication modules.
所述脉冲发生器1的唯一识别信息为脉冲发生器的唯一序列号，所述病人控制器4的唯一识别信息为病人控制器的唯一序列号。The unique identification information of the pulse generator 1 is the unique serial number of the pulse generator, and the unique identification information of the patient controller 4 is the unique serial number of the patient controller.
本实施方式的脉冲发生器可应用于脑深部神经刺激系统、植入式脑皮层刺激系统、植入式脊髓刺激系统、植入式骶神经刺激系统或植入式迷走神经刺激系统中。除上述植入式神经电刺激系统外，本发明还可应用于植入式心脏起搏系统、植入式心律转复除颤系统及植入式药物输注系统中。The pulse generator of this embodiment can be applied in a deep brain stimulation system, an implanted cerebral cortex stimulation system, an implanted spinal cord stimulation system, an implanted sacral nerve stimulation system or an implanted vagus nerve stimulation system. In addition to the above-mentioned implanted electrical nerve stimulation system, the present invention can also be applied to implanted cardiac pacing systems, implanted cardioverter defibrillation systems and implanted drug infusion systems.
实施方式二：Implementation mode two:
参照图4，病人控制器与脉冲发生器一对一安全绑定方法，包括以下步骤：Referring to Figure 4, the one-to-one secure binding method between the patient controller and the pulse generator includes the following steps:
A：医生程控器3与病人控制器4建立通信并获取所述病人控制器4的唯一识别信息，医生程控器3与脉冲发生器1建立通信并获取所述脉冲发生器1的唯一识别信息；A: The doctor programmer 3 establishes communication with the patient controller 4 and obtains the unique identification information of the patient controller 4, and the doctor programmer 3 establishes communication with the pulse generator 1 and obtains the unique identification information of the pulse generator 1;
B：医生程控器3对脉冲发生器1的唯一识别信息及病人控制器4的唯一识别信息进行加密运算处理，生成用于保护该脉冲发生器的唯一密码锁；B: The doctor program controller 3 encrypts the unique identification information of the pulse generator 1 and the unique identification information of the patient controller 4 to generate a unique combination lock for protecting the pulse generator;
C：医生程控器3对所述唯一密码锁进行解密处理生成唯一密钥；C: The doctor program controller 3 decrypts the unique password lock to generate a unique key;
D：医生程控器3将所述唯一密码锁写入脉冲发生器1内，将唯一密钥写入所述病人控制器4内用于与所述脉冲发生器进行通信。D: The doctor programmer 3 writes the unique password lock into the pulse generator 1 and writes the unique key into the patient controller 4 for communicating with the pulse generator.
与实施方式一不同的是，加密运算处理步骤是在医生程控器3内进行的，而实施方式一是在脉冲发生器1内进行的。通常情况下医生程控器3由于其强大的运算能力和电源不受限制的优点，加密和解密步骤都可由医生程控器3来完成。The difference from the first embodiment is that the encryption operation processing steps are carried out in the doctor's programmer 3 , while the first embodiment is carried out in the pulse generator 1 . Usually, the doctor's programmer 3 can complete the steps of encryption and decryption due to its powerful computing capability and unrestricted power supply.
一种病人控制器与脉冲发生器安全绑定的植入式神经电刺激系统，包括脉冲发生器1’、可与所述脉冲发生器1’通信的医生程控器3’、可与所述医生程控器3’通信的病人控制器4’。An implantable electrical nerve stimulation system in which a patient controller is safely bound to a pulse generator, comprising a pulse generator 1', a doctor's programmer 3' that can communicate with the pulse generator 1', and a doctor's programmable controller 3' that can communicate with the doctor The programmer 3' communicates with the patient controller 4'.
所述医生程控器3’包括用于接收脉冲发生器的唯一识别信息及病人控制器的唯一识别信息的第四通信模块301’、可对所述脉冲发生器1’的唯一识别信息及病人控制器4’的唯一识别信息进行加密处理的加密程序控制模块302’、用于对所述唯一加密码进行解密处理的解密程序控制模块303’，所述第四通信模块301’将所述加密程序控制模块302’加密处理后生成的唯一密码锁传输至脉冲发生器1’，所述第四通信模块301’将所述解密程序控制模块303’解密处理后生成的唯一密钥传输至所述病人控制器4’。The doctor programmer 3' includes a fourth communication module 301' for receiving the unique identification information of the pulse generator and the unique identification information of the patient controller, and can control the unique identification information of the pulse generator 1' and the patient controller. The encryption program control module 302' for encrypting the unique identification information of the device 4', the decryption program control module 303' for decrypting the unique encryption code, the fourth communication module 301' converts the encryption program The unique password lock generated by the control module 302' after encryption processing is transmitted to the pulse generator 1', and the fourth communication module 301' transmits the unique key generated by the decryption program control module 303' to the patient Controller 4'.
所述脉冲发生器1’包括用于接收唯一密码锁的第五通信模块101’，所述病人控制器4’包括用于接收所述唯一解密密钥的第六通信模块401’，所述第四通信模块301’、第五通信模块101’和第六通信模块401’均为RF无线通讯模块。The pulse generator 1' includes a fifth communication module 101' for receiving a unique combination lock, the patient controller 4' includes a sixth communication module 401' for receiving the unique decryption key, and the sixth The fourth communication module 301', the fifth communication module 101' and the sixth communication module 401' are all RF wireless communication modules.
本实施方式中所述脉冲发生器1’的唯一识别信息为脉冲发生器的唯一序列号，所述病人控制器4’的唯一识别信息为病人控制器的唯一序列号。In this embodiment, the unique identification information of the pulse generator 1' is the unique serial number of the pulse generator, and the unique identification information of the patient controller 4' is the unique serial number of the patient controller.
本实施方式的脉冲发生器可应用于脑深部神经刺激系统、植入式脑皮层刺激系统、植入式脊髓刺激系统、植入式骶神经刺激系统或植入式迷走神经刺激系统中。除上述植入式神经电刺激系统外，本发明还可应用于植入式心脏起搏系统、植入式心律转复除颤系统及植入式药物输注系统中。The pulse generator of this embodiment can be applied in a deep brain stimulation system, an implanted cerebral cortex stimulation system, an implanted spinal cord stimulation system, an implanted sacral nerve stimulation system or an implanted vagus nerve stimulation system. In addition to the above-mentioned implanted electrical nerve stimulation system, the present invention can also be applied to implanted cardiac pacing systems, implanted cardioverter defibrillation systems and implanted drug infusion systems.
由于本发明将植入式医疗器械的唯一识别信息和对应的病人控制器的唯一识别信息经过加密函数处理，生成的唯一密码锁写入植入式医疗器械内，对唯一密码锁进行解密处理后生成的唯一的密钥写入病人控制器内，因此能够始终保证仅具有该唯一密钥的病人控制器能够与植入式医疗器械进行通信。Since the present invention processes the unique identification information of the implantable medical device and the unique identification information of the corresponding patient controller through an encryption function, the generated unique combination lock is written into the implantable medical device, and after the unique combination lock is decrypted The generated unique key is written into the patient controller, so it can always be guaranteed that only the patient controller with the unique key can communicate with the implantable medical device.
如果病人损坏或丢失原配的病人控制器可以使用本发明的方法重新配一个新的病人控制器，由医生或厂商使用医生程控器将新密钥写入新病人控制器内，这样，即使他人拾获病人损坏或丢失原配病人控制器，由于原病人控制器内的密钥已无法与植入式医疗器械内的新密码锁相配对，因此能够防止他人误用或恶意使用其他病人控制器对植入病人的健康造成威胁。If the patient damages or loses the original patient controller, a new patient controller can be reconfigured using the method of the present invention, and the doctor or the manufacturer uses the doctor's program controller to write the new key into the new patient controller. If the patient damages or loses the original patient controller, since the key in the original patient controller can no longer be paired with the new combination lock in the implanted medical device, it can prevent others from misusing or maliciously using other patient controllers to control the implanted device. threat to the health of patients.
本发明还可有其他多种实施例，在不背离本发明精神及实质的情况下，本领域的技术人员可根据本发明作出各种相应的改变和变形，但这些相应的改变和变形都应属于本发明的权利要求保护的范围。The present invention also can have other various embodiments, without departing from the spirit and essence of the present invention, those skilled in the art can make various corresponding changes and deformations according to the present invention, but these corresponding changes and deformations should be Belong to the protection scope of the claims of the present invention.
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Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10834820B2 (en) | 2013-08-06 | 2020-11-10 | Bedrock Automation Platforms Inc. | Industrial control system cable |
| US8862802B2 (en) | 2011-12-30 | 2014-10-14 | Bedrock Automation Platforms Inc. | Switch fabric having a serial communications interface and a parallel communications interface |
| US9727511B2 (en) | 2011-12-30 | 2017-08-08 | Bedrock Automation Platforms Inc. | Input/output module with multi-channel switching capability |
| US11144630B2 (en) | 2011-12-30 | 2021-10-12 | Bedrock Automation Platforms Inc. | Image capture devices for a secure industrial control system |
| US9437967B2 (en) | 2011-12-30 | 2016-09-06 | Bedrock Automation Platforms, Inc. | Electromagnetic connector for an industrial control system |
| US8868813B2 (en) | 2011-12-30 | 2014-10-21 | Bedrock Automation Platforms Inc. | Communications control system with a serial communications interface and a parallel communications interface |
| US11967839B2 (en) | 2011-12-30 | 2024-04-23 | Analog Devices, Inc. | Electromagnetic connector for an industrial control system |
| US10834094B2 (en) | 2013-08-06 | 2020-11-10 | Bedrock Automation Platforms Inc. | Operator action authentication in an industrial control system |
| US9467297B2 (en) | 2013-08-06 | 2016-10-11 | Bedrock Automation Platforms Inc. | Industrial control system redundant communications/control modules authentication |
| US8971072B2 (en) | 2011-12-30 | 2015-03-03 | Bedrock Automation Platforms Inc. | Electromagnetic connector for an industrial control system |
| US11314854B2 (en) | 2011-12-30 | 2022-04-26 | Bedrock Automation Platforms Inc. | Image capture devices for a secure industrial control system |
| US9600434B1 (en) | 2011-12-30 | 2017-03-21 | Bedrock Automation Platforms, Inc. | Switch fabric having a serial communications interface and a parallel communications interface |
| US12061685B2 (en) | 2011-12-30 | 2024-08-13 | Analog Devices, Inc. | Image capture devices for a secure industrial control system |
| US9191203B2 (en) | 2013-08-06 | 2015-11-17 | Bedrock Automation Platforms Inc. | Secure industrial control system |
| CN103845809B (en) * | 2012-12-07 | 2016-05-11 | 苏州景昱医疗器械有限公司 | A kind of implantable medical devices and external controller wireless communications method one to one |
| CN103845806A (en) * | 2012-12-07 | 2014-06-11 | 苏州景昱医疗器械有限公司 | Safe wireless communication method of implanting-type nerve stimulation system |
| US10613567B2 (en) | 2013-08-06 | 2020-04-07 | Bedrock Automation Platforms Inc. | Secure power supply for an industrial control system |
| CN111293495B (en) | 2014-07-07 | 2022-05-24 | 基岩自动化平台公司 | Industrial control system cable |
| CN104965986B (en) * | 2015-06-25 | 2018-06-01 | 创领心律管理医疗器械（上海）有限公司 | The medical information identification card generation system and method for Implantable Medical Device |
| CN105262594B (en) * | 2015-10-10 | 2018-08-31 | 山东超越数控电子有限公司 | A kind of identity authentication method and device |
| WO2018001389A1 (en) * | 2016-06-27 | 2018-01-04 | Dongping Lin | Implantable monitor |
| CN106730332A (en) * | 2016-12-13 | 2017-05-31 | 天津高卓科技有限公司 | The method for protecting and system of the Implanted medical system based on electronic information |
| CN111375130A (en) * | 2018-12-29 | 2020-07-07 | 上海神奕医疗科技有限公司 | Method for binding patient control device and active implant device and medical control device |
| CN111346297B (en) | 2020-03-16 | 2021-03-23 | 首都医科大学宣武医院 | Multi-target point electrical stimulation circuit, electrical stimulator and signal output method thereof |
| CN116785591B (en) * | 2023-06-25 | 2024-06-25 | 北京领创医谷科技发展有限责任公司 | Method and device for initially binding energy controller and stimulator in operation and electronic equipment |
| CN116779127B (en) * | 2023-06-25 | 2024-08-09 | 北京领创医谷科技发展有限责任公司 | Investigation method for secondary applicability of stimulator and electronic equipment |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1812880A2 (en) * | 2004-09-30 | 2007-08-01 | Koninklijke Philips Electronics N.V. | System for automatic continuous and reliable patient identification for association of wireless medical devices to patients |
| US8126731B2 (en) * | 2006-10-24 | 2012-02-28 | Medapps, Inc. | Systems and methods for medical data interchange activation |
| CN101610320A (en) * | 2008-06-18 | 2009-12-23 | 中兴通讯股份有限公司 | The binding method of terminal and communication line identification and device |
| CN101441692B (en) * | 2008-11-21 | 2014-09-03 | 北京市研祥兴业国际智能科技有限公司 | Method for binding computer hardware and software |
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