CN102480352A - Safety ensuring method of implantable medical system and system thereof - Google Patents
Safety ensuring method of implantable medical system and system thereof Download PDFInfo
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- CN102480352A CN102480352A CN2010105650277A CN201010565027A CN102480352A CN 102480352 A CN102480352 A CN 102480352A CN 2010105650277 A CN2010105650277 A CN 2010105650277A CN 201010565027 A CN201010565027 A CN 201010565027A CN 102480352 A CN102480352 A CN 102480352A
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- 238000000034 method Methods 0.000 title claims abstract description 18
- 238000012545 processing Methods 0.000 claims abstract description 25
- 238000004891 communication Methods 0.000 claims description 36
- 210000005036 nerve Anatomy 0.000 claims description 16
- 230000000747 cardiac effect Effects 0.000 claims description 11
- 239000003814 drug Substances 0.000 claims description 10
- 229940079593 drug Drugs 0.000 claims description 10
- 238000001802 infusion Methods 0.000 claims description 10
- 230000036541 health Effects 0.000 abstract description 3
- 230000000638 stimulation Effects 0.000 description 14
- 239000007943 implant Substances 0.000 description 5
- 230000001537 neural effect Effects 0.000 description 4
- 210000004556 brain Anatomy 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000007383 nerve stimulation Effects 0.000 description 2
- 230000033764 rhythmic process Effects 0.000 description 2
- 230000004936 stimulating effect Effects 0.000 description 2
- 230000001515 vagal effect Effects 0.000 description 2
- 210000003169 central nervous system Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000001186 vagus nerve Anatomy 0.000 description 1
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Abstract
The invention discloses a safety ensuring method of an implantable medical system and a system thereof. The method is characterized by: carrying out encryption function processing to only identification information of an implantable medical device and the only identification information of a corresponding patient controller; writing a generated only cipher lock into the implantable medical device; writing an only secret key into the patient controller after decryption processing is performed to the only cipher lock and the only secret key is generated. Therefore, only can the patient controller possessing the only secret key be communicated with the implantable medical device. When a patient damages or losses the original patient controller, the new patient controller can be configured by using the method of the invention. Even if others get the damaged or lost original patient controller, because the secret key in the original patient controller can not match with the new cipher lock of the implantable medical device, a threat to the health of the patient, which is generated by misusing or maliciously using the patient controller of the other patient, can be prevented.
Description
Technical field
The present invention relates to the implantable medical system, especially patient's controller and implantable medical devices secure binding method and implantable medical system one to one.
Background technology
The implantable medical system generally includes implantable nerve electric stimulation, implantable cardiac electric stimulation (being commonly called as cardiac pacemaker), implanted drug infusion system.Wherein, the implantable nerve electric stimulation comprises brain deep electrostimulation DBS, and the implanted cortex stimulates CNS, implanted spinal cord stimulation trial SCS, implanted sacral nerve electrostimulation SNS, implanted vagus nerve electrostimulation VNS etc.
With the implantable nerve electric stimulation is example, mainly comprises the pulse generator, electrode and the external control device that implant.Wherein, Pulse generator is connected with electrode; Thereby the burst transmissions that pulse generator produced is arrived electrode, and the pulse signal that pulse generator produces transfers to heart by electrode or electrostimulation is carried out at specific neural position, thereby makes function of human body return to the state of normal operation.External control device comprises doctor's program controller, patient's controller.
Wherein, patient's controller is to be the device of being used for of being equipped with of patient according to the output parameter of pulse generator in own situation control switch or the control agent, and patient usually only can adjusting voluntarily in the adjustable range that the doctor is provided with.Doctor's program controller is that the doctor is used for the device according to the output parameter of pulse generator in the patient monitoring control agent, and common doctor's program controller can be used to control a plurality of pulse generators.Patient's controller and doctor's program controller can communicate through wireless communications mode, magnetic coil or other communication modes and pulse generator.
After the implantable medical devices implant surgery is accomplished, can only be equipped with patient's controller that can communicate with this implantable medical devices to patient, can be within the specific limits after patient is gone home the output parameter of implantable medical devices be carried out from main regulation.This patient's controller is before dispatching from the factory, just to be set at implantable medical devices corresponding with it to bind one to one; Promptly only there is unique patient's controller can control this implantable medical devices; Other people utilize any similar products of other company can't control the implantable medical devices in the patient body, thereby ensure implantable medical system and patient's safety.
In addition; If patient loses accidentally or damages this patient's controller then need change new patient's controller; Make new patient's controller after only changing can control implantable medical devices and abolish former patient's controller simultaneously, even other people pick up and obtain or repair former patient's controller and also can't control implantable medical devices more like this.Therefore need badly and a kind ofly can guarantee implantable medical devices and the patient's controller method and system of secure binding one to one.
Summary of the invention
To the deficiency that exists in the prior art; The technical problem that the present invention will solve provides the method for protecting and the system of a kind of implantable medical system, and making only has unique patient's controller can control implantable medical devices to ensure the safety of implantable medical system all the time.
According to technical scheme provided by the present invention, a kind of patient's controller and implantable medical devices secure binding method may further comprise the steps:
A: obtain the unique identifying information of implantable medical devices and the unique identifying information of patient's controller;
B: the unique identifying information of said implantable medical devices and the unique identifying information of patient's controller are carried out the cryptographic calculation processing, generate the unique password lock that is used to protect this implantable medical devices;
C: program controller is deciphered the unique password lock of said implantable medical devices and is generated unique key;
D: said program controller writes said unique key and is used in said patient's controller communicating with said implantable medical devices.
Preferably, the step of obtaining patient's controller unique identifying information in the said steps A is made up of following steps:
A1: said program controller is set up the unique identifying information of communicating by letter and obtaining said patient's controller with said patient's controller;
A2: said program controller transfers to implantable medical devices with this patient's controller unique identifying information;
In step B, the unique identifying information of said implantable medical devices and the unique identifying information of patient's controller are carried out the cryptographic calculation processing by said implantable medical devices.
Preferably, set up to communicate by letter with said patient's controller by said program controller in the said steps A and obtain the unique identifying information of patient's controller; Said program controller is set up to communicate by letter with said implantable medical devices and is obtained the unique identifying information of implantable medical devices;
In step B, the unique identifying information of said implantable medical devices and the unique identifying information of patient's controller are carried out the cryptographic calculation processing by said program controller.
Preferably, said implantable medical devices unique identifying information is unique sequence number of implantable medical devices, and said patient's controller unique identifying information is unique sequence number of patient's controller.
Preferably, described implantable medical devices is a kind of in embedded nerve stimulator, implantable cardiac pacemaker, implanted cardioverter-defibrillators or the implanted infusion of drug device.
The present invention also provides the implantable medical system of a kind of patient's controller and implantable medical devices secure binding; Comprise implantable medical devices, the program controller that can communicate by letter with said implantable medical devices, the patient's controller that can communicate by letter with said program controller; Said implantable medical devices comprises the encipheror control module that can carry out encryption to the unique identifying information of unique identifying information and patient's controller of self, the first communication module that is used for the unique password lock that generates after the encryption is transferred to program controller; Said program controller comprise be used for to said unique encrypted code carry out the decrypted program control module of decryption processing, with the unique key delivery that generates after the decryption processing to the second communication module of said patient's controller, said patient's controller comprises the third communication module that is used to receive said unique solution decryption key.
Preferably, said first communication module, second communication module and third communication module are the RF wireless communication module.
Preferably, said implantable medical devices unique identifying information is unique sequence number of implantable medical devices, and said patient's controller unique identifying information is unique sequence number of patient's controller.
Preferably, described implantable medical devices is a kind of in embedded nerve stimulator, implantable cardiac pacemaker, implanted cardioverter-defibrillators or the implanted infusion of drug device.
The present invention also provides another kind of technical scheme; The implantable medical system of a kind of patient's controller and implantable medical devices secure binding; Comprise implantable medical devices, the program controller that can communicate by letter with said implantable medical devices, the patient's controller that can communicate by letter with said program controller; It is characterized in that: said program controller comprise the unique identifying information of the unique identifying information that is used to receive implantable medical devices and patient's controller four-way letter module, can carry out the unique identifying information of the unique identifying information of said implantable medical devices and patient's controller encryption the encipheror control module, be used for said unique encrypted code is carried out the decrypted program control module of decryption processing; Said four-way believes that the unique password lock that generates after module is with the encryption of said encipheror control module transfers to implantable medical devices, and said four-way is believed unique key delivery to the said patient's controller that generates after module is with said decrypted program control module decryption processing.
Preferably; Said implantable medical devices comprises the five-way letter module that is used to receive the unique password lock; Said patient's controller comprises the 6th communication module that is used to receive said unique solution decryption key, and said four-way letter module, five-way letter module and the 6th communication module are the RF wireless communication module.
Preferably, said implantable medical devices unique identifying information is unique sequence number of implantable medical devices, and said patient's controller unique identifying information is unique sequence number of patient's controller.
Preferably, described implantable medical devices is a kind of in embedded nerve stimulator, implantable cardiac pacemaker, implanted cardioverter-defibrillators or the implanted infusion of drug device.
Advantage compared with prior art of the present invention is: because the present invention handles the unique identifying information of implantable medical devices and the unique identifying information of patient's controller of correspondence through encryption function; The unique password lock that generates writes in the implantable medical devices; Unique key that the unique password lock is carried out generating after the decryption processing writes in patient's controller, therefore can guarantee all the time that the patient's controller that only has this unique key can communicate with implantable medical devices.
If patient damages or patient's controller of losing the first wife can use method of the present invention to join new patient's controller again; Use doctor's program controller that new key is write in new patient's controller by doctor or manufacturer; Like this; Obtain patient's damage or lose patient's first wife controller even other people pick up; Because the key in former patient's controller can't match with the new password lock in the implantable medical devices mutually, can prevent that therefore other people from misapplying or malice uses other patient's controllers that the health of implant patient is threatened.
Description of drawings
Accompanying drawing 1 is module principle figure of the present invention;
Accompanying drawing 2 is a safe and secret control program flow chart of the present invention (execution mode one);
Accompanying drawing 4 is a safe and secret control program flow chart of the present invention (execution mode two);
Accompanying drawing 5 is system module schematic diagram of the present invention (execution mode two).
Wherein:
1, pulse generator; 101, encipheror control module; 102, first communication module; 2, electrode; 3, doctor's program controller; 301, decrypted program control module; 302, second communication module; 4, patient's controller; 401, third communication module; 1 ', pulse generator; 101 ', five-way letter module; 2 ', electrode; 3 ', doctor's program controller; 301 ', four-way letter module; 302 ', encipheror control module; 303 ', decrypted program control module; 4 ', patient's controller; The 401 ', the 6th communication module.
Embodiment
Below in conjunction with accompanying drawing the present invention is done further detailed explanation:
Execution mode one:
With reference to Fig. 1, be example with the implantable nerve electric stimulation, mainly comprise the pulse generator 1, the electrode 2 that implant, and be positioned at external doctor's program controller 3, patient's controller 4.Pulse generator 1 is electrically connected with electrode 2, thereby the burst transmissions that pulse generator 1 is produced is arrived electrode 2, so that neuronal target is carried out electrostimulation, reaches the effect of treatment.During output parameters such as the amplitude of doctor's program controller 3 and patient's controller 4 scalable pulse generators 1, frequency, pulsewidth, doctor's program controller 3 also has specific functions such as inquiry patient information, and to compare function more powerful with patient's controller 4.
With reference to Fig. 2, patient's controller of the present invention and pulse generator secure binding method may further comprise the steps:
A: doctor's program controller 3 is set up the unique identifying information of communicating by letter and obtaining said patient's controller 4 with patient's controller 4, and doctor's program controller 3 transfers to pulse generator 3 with these patient's controller 4 unique identifying informations;
B: pulse generator 1 carries out the cryptographic calculation processing to the unique identifying information of self and the unique identifying information of patient's controller 4, generates the unique password lock that is used to protect this pulse generator;
C: pulse generator 1 transfers to doctor's program controller 3 with the unique password lock, and the unique password lock of 3 pairs of said pulse generators 1 of doctor's program controller carries out decryption processing and generates unique key;
D: doctor's program controller 3 writes said unique key and is used in said patient's controller 4 communicating with said pulse generator.
In this execution mode, the unique identifying information of pulse generator 1 is unique sequence number of pulse generator, and the unique identifying information of said patient's controller 4 is unique sequence number of patient's controller.
Described pulse generator 1 is a kind of in embedded nerve stimulator, implantable cardiac pacemaker, implanted cardioverter-defibrillators or the implanted infusion of drug device.
With reference to Fig. 3, the implantable nerve electric stimulation of a kind of patient's controller and pulse generator secure binding comprises pulse generator 1, the doctor's program controller 3 that can communicate by letter with said pulse generator 1, the patient's controller 4 that can communicate by letter with said doctor's program controller 3.Said pulse generator 1 comprises the encipheror control module 101 that can carry out encryption to the unique identifying information of unique identifying information and patient's controller of self, the first communication module 102 that is used for the unique password lock that generates after the encryption is transferred to program controller.
Said doctor's program controller 3 comprise be used for to said unique encrypted code carry out the decrypted program control module 301 of decryption processing, with the unique key delivery that generates after the decryption processing to the second communication module 302 of said patient's controller 4, said patient's controller 4 comprises the third communication module 401 that is used to receive said unique solution decryption key.
Said first communication module 102, second communication module 302 and third communication module 401 are the RF wireless communication module.
The unique identifying information of said pulse generator 1 is unique sequence number of pulse generator, and the unique identifying information of said patient's controller 4 is unique sequence number of patient's controller.
The pulse generator of this execution mode can be applicable in brain deep neural stimulation system, implanted cortex stimulating system, implanted SCS system, implanted sacral nerve stimulation system or the implanted vagal stimulation system.Except that above-mentioned implantable nerve electric stimulation, the present invention also can be applicable to the implantable cardiac pacing system, the implanted rhythm of the heart changes in multiple defibrillation system and the implanted drug infusion system.
Execution mode two:
With reference to Fig. 4, patient's controller and pulse generator be the secure binding method one to one, may further comprise the steps:
A: doctor's program controller 3 is set up the unique identifying information of communicating by letter and obtaining said patient's controller 4 with patient's controller 4, and doctor's program controller 3 is set up the unique identifying information of communicating by letter and obtaining said pulse generator 1 with pulse generator 1;
B: the unique identifying information of doctor's program controller 3 paired pulses generators 1 and the unique identifying information of patient's controller 4 carry out cryptographic calculation to be handled, and generates the unique password lock that is used to protect this pulse generator;
C: 3 pairs of said unique password locks of doctor's program controller carry out decryption processing and generate unique key;
D: doctor's program controller 3 writes said unique password lock in the pulse generator 1, unique key is write be used in said patient's controller 4 communicating with said pulse generator.
Different with execution mode one is, the cryptographic calculation treatment step carries out in doctor's program controller 3, and execution mode one carries out in pulse generator 1.Generally doctor's program controller 3 is owing to its powerful operation capacity and the unrestricted advantage of power supply, and the encryption and decryption step all can be accomplished by doctor's program controller 3.
The implantable nerve electric stimulation of a kind of patient's controller and pulse generator secure binding comprises pulse generator 1 ', the doctor's program controller 3 ' that can communicate by letter with said pulse generator 1 ', the patient's controller 4 ' that can communicate by letter with said doctor's program controller 3 '.
Said doctor's program controller 3 ' comprise the unique identifying information of the unique identifying information that is used for the received pulse generator and patient's controller four-way letter module 301 ', can carry out the unique identifying information of the unique identifying information of said pulse generator 1 ' and patient's controller 4 ' encryption encipheror control module 302 ', be used for said unique encrypted code is carried out the decrypted program control module 303 ' of decryption processing; Said four-way believes that the unique password lock that generates after module 301 ' is with said encipheror control module 302 ' encryption transfers to pulse generator 1 ', and said four-way is believed unique key delivery to the said patient's controller 4 ' that generates after module 301 ' is with said decrypted program control module 303 ' decryption processing.
Said pulse generator 1 ' comprises the five-way letter module 101 ' that is used to receive the unique password lock; Said patient's controller 4 ' comprises the 6th communication module 401 ' that is used to receive said unique solution decryption key, and said four-way letter module 301 ', five-way letter module 101 ' and the 6th communication module 401 ' are the RF wireless communication module.
The unique identifying information of pulse generator 1 ' described in this execution mode is unique sequence number of pulse generator, and the unique identifying information of said patient's controller 4 ' is unique sequence number of patient's controller.
The pulse generator of this execution mode can be applicable in brain deep neural stimulation system, implanted cortex stimulating system, implanted SCS system, implanted sacral nerve stimulation system or the implanted vagal stimulation system.Except that above-mentioned implantable nerve electric stimulation, the present invention also can be applicable to the implantable cardiac pacing system, the implanted rhythm of the heart changes in multiple defibrillation system and the implanted drug infusion system.
Because the present invention handles the unique identifying information of implantable medical devices and the unique identifying information of patient's controller of correspondence through encryption function; The unique password lock that generates writes in the implantable medical devices; Unique key that the unique password lock is carried out generating after the decryption processing writes in patient's controller, therefore can guarantee all the time that the patient's controller that only has this unique key can communicate with implantable medical devices.
If patient damages or patient's controller of losing the first wife can use method of the present invention to join new patient's controller again; Use doctor's program controller that new key is write in new patient's controller by doctor or manufacturer; Like this; Obtain patient's damage or lose patient's first wife controller even other people pick up; Because the key in former patient's controller can't match with the new password lock in the implantable medical devices mutually, can prevent that therefore other people from misapplying or malice uses other patient's controllers that the health of implant patient is threatened.
The present invention also can have other various embodiments; Under the situation that does not deviate from spirit of the present invention and essence; Those skilled in the art can make various corresponding changes and distortion according to the present invention, but these corresponding changes and distortion all should belong to the scope of claim protection of the present invention.
Claims (13)
1. patient's controller and implantable medical devices secure binding method is characterized in that: may further comprise the steps:
A: obtain the unique identifying information of implantable medical devices and the unique identifying information of patient's controller;
B: the unique identifying information of said implantable medical devices and the unique identifying information of patient's controller are carried out the cryptographic calculation processing, generate the unique password lock that is used to protect this implantable medical devices;
C: program controller is deciphered the unique password lock of said implantable medical devices and is generated unique key;
D: said program controller writes said unique key and is used in said patient's controller communicating with said implantable medical devices.
2. patient's controller according to claim 1 and implantable medical devices secure binding method is characterized in that: the step of obtaining patient's controller unique identifying information in the said steps A is made up of following steps:
A1: said program controller is set up the unique identifying information of communicating by letter and obtaining said patient's controller with said patient's controller;
A2: said program controller transfers to implantable medical devices with this patient's controller unique identifying information;
In step B, the unique identifying information of said implantable medical devices and the unique identifying information of patient's controller are carried out the cryptographic calculation processing by said implantable medical devices.
3. patient's controller according to claim 1 and implantable medical devices secure binding method is characterized in that: set up to communicate by letter with said patient's controller by said program controller in the said steps A and obtain the unique identifying information of patient's controller; Said program controller is set up to communicate by letter with said implantable medical devices and is obtained the unique identifying information of implantable medical devices;
In step B, the unique identifying information of said implantable medical devices and the unique identifying information of patient's controller are carried out the cryptographic calculation processing by said program controller.
4. according to patient's controller described in claim 2 or 3 and implantable medical devices secure binding method; It is characterized in that: said implantable medical devices unique identifying information is unique sequence number of implantable medical devices, and said patient's controller unique identifying information is unique sequence number of patient's controller.
5. according to patient's controller described in claim 1 or 2 or 3 and implantable medical devices secure binding method, it is characterized in that: described implantable medical devices is a kind of in embedded nerve stimulator, implantable cardiac pacemaker, implanted cardioverter-defibrillators or the implanted infusion of drug device.
6. the implantable medical system of patient's controller and implantable medical devices secure binding; Comprise implantable medical devices, the program controller that can communicate by letter with said implantable medical devices, the patient's controller that can communicate by letter with said program controller; It is characterized in that: said implantable medical devices comprises the encipheror control module that can carry out encryption to the unique identifying information of unique identifying information and patient's controller of self, the first communication module that is used for the unique password lock that generates after the encryption is transferred to program controller; Said program controller comprise be used for to said unique encrypted code carry out the decrypted program control module of decryption processing, with the unique key delivery that generates after the decryption processing to the second communication module of said patient's controller, said patient's controller comprises the third communication module that is used to receive said unique solution decryption key.
7. implantable medical according to claim 6 system, it is characterized in that: said first communication module, second communication module and third communication module are the RF wireless communication module.
8. implantable medical according to claim 7 system, it is characterized in that: said implantable medical devices unique identifying information is unique sequence number of implantable medical devices, said patient's controller unique identifying information is unique sequence number of patient's controller.
9. according to arbitrary described implantable medical system in the claim 6 to 8, it is characterized in that: described implantable medical devices is a kind of in embedded nerve stimulator, implantable cardiac pacemaker, implanted cardioverter-defibrillators or the implanted infusion of drug device.
10. the implantable medical system of patient's controller and implantable medical devices secure binding; Comprise implantable medical devices, the program controller that can communicate by letter with said implantable medical devices, the patient's controller that can communicate by letter with said program controller; It is characterized in that: said program controller comprise the unique identifying information of the unique identifying information that is used to receive implantable medical devices and patient's controller four-way letter module, can carry out the unique identifying information of the unique identifying information of said implantable medical devices and patient's controller encryption the encipheror control module, be used for said unique encrypted code is carried out the decrypted program control module of decryption processing; Said four-way believes that the unique password lock that generates after module is with the encryption of said encipheror control module transfers to implantable medical devices, and said four-way is believed unique key delivery to the said patient's controller that generates after module is with said decrypted program control module decryption processing.
11. implantable medical according to claim 10 system; It is characterized in that: said implantable medical devices comprises the five-way letter module that is used to receive the unique password lock; Said patient's controller comprises the 6th communication module that is used to receive said unique solution decryption key, and said four-way letter module, five-way letter module and the 6th communication module are the RF wireless communication module.
12. implantable medical according to claim 11 system; It is characterized in that: said implantable medical devices unique identifying information is unique sequence number of implantable medical devices, and said patient's controller unique identifying information is unique sequence number of patient's controller.
13. according to arbitrary described implantable medical system in the claim 10 to 12, it is characterized in that: described implantable medical devices is a kind of in embedded nerve stimulator, implantable cardiac pacemaker, implanted cardioverter-defibrillators or the implanted infusion of drug device.
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| CN201010565027.7A CN102480352B (en) | 2010-11-30 | 2010-11-30 | The method for protecting of Implanted medical system and system |
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| CN201010565027.7A CN102480352B (en) | 2010-11-30 | 2010-11-30 | The method for protecting of Implanted medical system and system |
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| 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 |
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