CN117101002A - Double-closed-loop deep brain stimulation system and device - Google Patents
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- 230000000638 stimulation Effects 0.000 title claims abstract description 79
- 210000004556 brain Anatomy 0.000 title claims abstract description 53
- 238000001727 in vivo Methods 0.000 claims abstract description 24
- 210000004761 scalp Anatomy 0.000 claims abstract description 23
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract description 12
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- 208000004296 neuralgia Diseases 0.000 claims abstract description 7
- 208000021722 neuropathic pain Diseases 0.000 claims abstract description 7
- 238000012544 monitoring process Methods 0.000 claims description 40
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0534—Electrodes for deep brain stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
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Abstract
The scheme provides a double closed-loop deep brain stimulation system and device, relates to the technical field of implantable deep brain stimulation therapy equipment, and is used for solving the problem of secondary injury caused by induction of Ads when the implantable deep brain stimulation therapy is adopted in the prior art. The system comprises an external system and an internal system, wherein the external system acquires first control information by utilizing scalp electroencephalogram signals acquired in real time; the in-vivo system utilizes the electrophysiological signals applied to the electrode contact points in the body in real time, and adjusts the electrophysiological signals applied to the electrode contact points by combining the first control information so as to achieve the purpose of eliminating Ads, thereby forming a first closed loop; and judging whether the adjustment is effective by using electrophysiological signals generated based on the stimulation so as to achieve the aim of effectively treating diseases, thereby forming a second closed loop. The stimulation parameters of deep brain stimulation therapy for neuropathic pain are selected by an in-vitro system and an in-vivo system, and the effectiveness of treatment and the safety of patients are simultaneously considered.
Description
Technical Field
The scheme relates to the technical field of implantable deep brain stimulation therapy apparatuses, in particular to a double-closed-loop deep brain stimulation system and a device.
Background
Implantable deep brain stimulation therapy has been used clinically as an adjuvant therapy for the treatment of neuropathic pain, but deep brain stimulation is liable to induce Ads (after-disorders) during the treatment, and this evoked action potential is liable to cause secondary injury to patients, and should be avoided as much as possible during the treatment.
Therefore, in the process of treating chronic neuropathic pain by conventional deep brain stimulation, the selection of the stimulation parameters is not based on electrophysiological information such as Ads and local field potentials (Local Field Potential, LFP) of key nuclei, i.e. the safety and effectiveness of the therapy are not considered as the basis of the selection of the stimulation parameters.
Disclosure of Invention
Aiming at the defects of the prior art, the scheme provides a double closed loop deep brain stimulation system and device, which are used for solving the problem that when Ads is induced by deep brain stimulation, the Ads can be eliminated by adjusting the stimulation, and whether effective disease treatment is carried out or not is monitored.
In order to achieve the above purpose, the technical scheme of the scheme is as follows.
In a first aspect, the present disclosure provides a dual closed-loop deep brain stimulation system, the system comprising an extracorporeal system and an intracorporal system, the extracorporeal system being adapted to perform stimulation parameter adjustment in conjunction with the intracorporal system, the intracorporal system being adapted to adaptive parameter adjustment. Wherein: the external system obtains first control information by utilizing scalp electroencephalogram signals acquired in real time; the in-vivo system adjusts the electrophysiological signals applied to the electrode contact points by combining the first control information by utilizing the electrophysiological signals applied to the electrode contact points in real time so as to achieve the purpose of eliminating Ads, thereby forming a first closed loop; and judging whether the adjustment is effective by using electrophysiological signals generated based on the stimulation so as to achieve the aim of effectively treating diseases, thereby forming a second closed loop.
In one embodiment of the above technical solution, the extracorporeal system and the intracorporal system are connected by a wireless communication method, and the wireless communication method is any one of the following: bluetooth, wifi, NFC, zigbee.
In one embodiment of the foregoing technical disclosure, the in vitro system inputs the electroencephalogram signal acquired by the scalp electroencephalogram sequentially through the first signal acquisition module, the first pre-amplification and filtering module, and then inputs the electroencephalogram signal into the first control module, wherein the first control module has a trained first Ads monitoring model to calculate whether Ads (After-discharges) are generated After stimulation, and when determining that Ads are generated, the in vitro system sends first control information to the in vivo system.
In one embodiment of the above technical solution, the in-vivo system uses the second signal acquisition module to acquire the electrophysiological signal applied to the electrode contact in the in-vivo in real time, and inputs the electrophysiological signal to the second control module after passing through the second pre-amplification and filtering module; the second control module is provided with a trained second Ads monitoring model which is used for calculating whether Ads are generated or not, compares a calculation result with first control information of an in-vitro system, and adjusts stimulation according to the comparison result so as to achieve the aim of eliminating the Ads.
In one embodiment of the above technical solution, the in-vivo system uses the third signal acquisition module to acquire the electrophysiological signal generated based on the stimulus, and inputs the electrophysiological signal into the second control module through the third pre-amplification and filtering module; the second control module is provided with a trained LEP monitoring model which is used for distinguishing whether the stimulation adjustment is effective or not, and if the stimulation does not reach the effective treatment, the second control module continues to adjust the stimulation so as to achieve the aim of effectively treating the diseases.
In a second aspect, the present disclosure proposes a dual closed-loop deep brain stimulation device, by monitoring Ads generated, and based on electrophysiological information such as local field potential (Local Field Potential, LFP) of key nuclei, the dual closed-loop deep brain stimulation is implemented. The device comprises a scalp electroencephalogram electrode, a micro-power consumption electrophysiological recording controller connected with the scalp electroencephalogram electrode, an internal electrode and a double-closed-loop deep brain stimulator connected with the internal electrode;
the micro-power consumption electrophysiological recording and controller comprises a first signal acquisition module, wherein the acquired electroencephalogram signals acquired by scalp electroencephalogram are processed by a first pre-amplification and filtering module and then input into a first control module, and if Ads are judged to be generated in the first control module, the micro-power consumption electrophysiological recording and controller generates and sends first control information to the double-closed-loop deep brain stimulator;
the double-closed-loop deep brain stimulator comprises a second signal acquisition module, a second control module and a first control module, wherein the second signal acquisition module is used for acquiring deep brain stimulation signals, the deep brain stimulation signals are input into the second control module after being subjected to second pre-amplification and filtering, the second control module judges whether Ads is generated or not, the second control module compares a calculation result with the first control information, and stimulation is adjusted according to the comparison result so as to achieve the purpose of eliminating the Ads;
the double-closed-loop deep brain stimulator comprises a third signal acquisition module, a second control module and a third pre-amplification and filtering module, wherein the third signal acquisition module is used for acquiring electrophysiological signals generated by deep brain due to stimulation, the second control module is used for judging whether stimulation adjustment is effective or not, and if the stimulation does not reach effective treatment, the second control module is used for continuously adjusting the stimulation so as to achieve the aim of effectively treating diseases.
In an implementation manner of the above technical solution, the micro-power consumption electrophysiological recording and controller is connected with the dual-closed-loop deep brain stimulator through a wireless communication mode, where the wireless communication mode is any one of the following: bluetooth, wifi, NFC, zigbee.
In one embodiment of the foregoing technical solution, the first control module has a first Ads monitoring model, and the second control module has a second Ads monitoring model and an LEP monitoring model;
the first Ads monitoring model is used for judging whether Ads are generated or not according to scalp electroencephalogram signals;
the second Ads monitoring model is used for judging whether Ads are generated or not according to the deep brain electrophysiological stimulation signals;
the LEP monitoring model is used for judging whether the adjustment of the stimulation signals achieves the aim of effectively treating diseases according to the electrophysiological signals generated by stimulation in the deep brain.
In one embodiment of the foregoing solution, the first Ads monitoring model, the second Ads monitoring model, and the LEP monitoring model employ a machine learning model.
In one embodiment of the above technique, the device is used for treating neuropathic pain.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the description of the embodiments will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort to a person skilled in the art.
FIG. 1 is a schematic illustration of a dual closed loop deep brain stimulation device and its use;
FIG. 2 is a schematic diagram of an in-vivo system and an in-vitro system mechanism in one embodiment;
FIG. 3 is a schematic diagram of a dual closed loop mode in one embodiment.
Detailed Description
Aiming at the fact that Ads are easy to induce in the treatment process of the implanted deep brain stimulation therapy and secondary injury is formed on a patient, the scheme provides a double-closed-loop deep brain stimulation system for avoiding the secondary injury.
Specifically, a dual closed-loop deep brain stimulation system comprises an extracorporeal system and an intracorporal system; wherein: the external system obtains first control information by utilizing scalp electroencephalogram signals acquired in real time; the in-vivo system adjusts the electrophysiological signals applied to the electrode contact points by combining the first control information by utilizing the electrophysiological signals applied to the electrode contact points in real time so as to achieve the purpose of eliminating Ads, thereby forming a first closed loop; and judging whether the adjustment is effective by using electrophysiological signals generated based on the stimulation so as to achieve the aim of effectively treating diseases, thereby forming a second closed loop.
How the present embodiments may be carried out will now be described in detail and with reference to the drawings of embodiments thereof, it being apparent that the embodiments described are only some, but not all, of the embodiments. All other embodiments, based on the embodiments herein, which would be apparent to one of ordinary skill in the art without undue burden are within the scope of the present disclosure.
Referring to fig. 1, a dual closed-loop brain deep stimulator includes scalp electroencephalogram electrodes, a micro-power consumption electrophysiological recording and controller connected with the scalp electroencephalogram electrodes, an in-vivo electrode, and a dual closed-loop brain deep stimulator connected with the in-vivo electrode.
The scalp electroencephalogram electrode, the micropower electrophysiological record and controller connected with the scalp electroencephalogram electrode belong to an in-vitro system and are used for acquiring scalp electroencephalogram signals in real time to obtain first control information. The external system is used for patients to use in the early stage after operation in a hospital and is matched with the internal system to adjust the stimulation parameters.
An in-vivo electrode and a double closed loop brain deep stimulator connected with the in-vivo electrode belong to an in-vivo system, an electrode contact is arranged on the in-vivo electrode, and the in-vivo system is used for self-adaptive parameter adjustment after patient discharge.
The extracorporeal system and the intracorporal system can be connected in a wireless communication mode through Bluetooth, wifi, NFC, zigbee and the like.
Referring to fig. 2, the in-vitro system inputs the collected scalp electroencephalogram signals into the first control module after sequentially passing through the first signal collection module, the first pre-amplification and filtering module. The first control module is provided with a trained first Ads monitoring model, the first Ads monitoring model calculates and analyzes whether Ads (After stimulation, after the first Ads monitoring model generates the Ads, and when judging that the Ads are generated, the first control module generates first control information. The first control information is transmitted to the double-closed-loop deep brain stimulator through the first wireless communication module and the first communication antenna, wherein the first Ads monitoring model is a machine learning model suitable for scalp electroencephalogram analysis, and the first Ads monitoring model comprises but is not limited to algorithms such as a support vector machine, linear discriminant analysis and the like.
The in-vivo double-closed-loop deep brain stimulator adopts a second wireless communication module and a second communication antenna to carry out information transmission with a wireless micro-power consumption electrophysiological recording and controller, acquires electrophysiological signals at a stimulation target point through a second signal acquisition module, a second pre-amplification and filtering module and transmits the electrophysiological signals to a control module, and uses a second Ads monitoring model to monitor whether stimulated Ads are generated or not in real time, wherein the second Ads monitoring model is a machine learning model suitable for deep brain electricity Ads calculation and analysis and comprises algorithms such as a support vector machine, linear discriminant analysis and the like. And through a third signal acquisition module, a third pre-amplification and filtering module, an electrophysiological signal at a record target point is acquired and transmitted to a second control module, the effectiveness of the stimulation parameters is evaluated by using an LFP monitoring model, wherein the LFP monitoring model is a machine learning model suitable for local field potential and comprises algorithms such as a support vector machine, linear discriminant analysis and the like. The aim of treating neuropathic pain is achieved by monitoring Ads and LFP and calculating and analyzing by a machine learning model and giving the stimulus output of proper parameters to a patient.
The mode of operation of the dual closed loop system is as follows:
(1) The patient is given initial stimulation parameters in combination with the patient's image and preoperative scale assessment results. During a hospital after operation, the change of the brain electrical signal caused by the stimulation parameters is monitored in real time through scalp brain electrical electrodes and an in-vitro wireless micro-power consumption electrophysiological record and controller. The scalp electroencephalogram signal is acquired through a first signal acquisition module, a first pre-amplification and filtering module and is transmitted to a first control module, a first Ads monitoring model in the first control module performs machine learning calculation, ads are generated after stimulation is obtained through calculation, and an in-vitro wireless micro-power consumption electrophysiological record and controller sends control information to an in-vivo double-closed-loop deep brain stimulator through a first wireless communication module and a first communication antenna.
(2) The in-vivo double-closed-loop deep brain stimulator collects and transmits electrophysiological signals at a stimulation target point through a second signal collecting module, a second pre-amplifying and filtering module, after the second signals are transmitted to a control module, a second Ads monitoring model in the second control module carries out machine learning calculation, the accuracy of the calculation of the second Ads monitoring model is checked through comparison with control information transmitted by an in-vitro wireless micro-power consumption electrophysiological record and controller, and the second controller is enabled to adjust the stimulation module, so that the aim of eliminating Ads is achieved by reducing or increasing stimulation parameters.
(3) After discharge of the patient, the adjustment of the stimulation parameters is performed according to a double closed loop system in the body, as shown in fig. 3. In the first closed loop mode of Ads monitoring and eliminating, the second signal acquisition module, the second pre-amplification and filtering module are used for acquiring and transmitting local field potential at a recording target point, the LFP monitoring model is used for performing machine learning calculation to distinguish whether the stimulation parameter treatment is effective or ineffective, and if the stimulation does not reach effective treatment, the second controller is used for adjusting the output parameter of the stimulation module, and the second closed loop is formed by reducing or increasing the stimulation parameter to achieve the aim of effective treatment.
(4) Through the stimulation parameter output of the two closed loop modes, the deep brain stimulation therapy can effectively and safely treat neuropathic pain.
The terms "first," "second," "third," and the like, as used in the above description, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", or a third "may explicitly or implicitly include one or more such feature.
From the above description of embodiments, it will be apparent to those skilled in the art that the operations of determining or calculating in the system or apparatus of the present disclosure may be implemented by software plus necessary general purpose hardware, or may be implemented by special purpose hardware including an application specific integrated circuit, a special purpose CPU, a special purpose memory, a special purpose component, or the like. Generally, functions performed by computer programs can be easily implemented by corresponding hardware, and specific hardware structures for implementing the same functions can be varied, such as analog circuits, digital circuits, or dedicated circuits. However, in more cases for the present disclosure, a software program implementation is a better implementation.
Although embodiments of the present application have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the application, the scope of which is defined in the appended claims and their equivalents.
Claims (10)
1. A dual closed loop deep brain stimulation system, characterized by:
the system includes an in vitro system and an in vivo system;
the external system obtains first control information by utilizing scalp electroencephalogram signals acquired in real time;
the in-vivo system adjusts the electrophysiological signals applied to the electrode contact points by combining the electrophysiological signals applied to the electrode contact points in real time with the first control information so as to achieve the purpose of eliminating Ads (After-discharges), thereby forming a first closed loop; and judging whether the adjustment is effective by using electrophysiological signals generated based on the stimulation so as to achieve the aim of effectively treating diseases, thereby forming a second closed loop.
2. The system according to claim 1, wherein: the external system and the internal system are connected through a wireless communication mode, and the wireless communication mode is any one of the following modes: bluetooth, wifi, NFC, zigbee.
3. The system according to claim 1, wherein:
the external system inputs the electroencephalogram signals acquired by scalp electroencephalogram into the first control module after sequentially passing through the first signal acquisition module, the first pre-amplification and filtering module, a trained first Ads monitoring model is arranged in the first control module to calculate whether Ads are generated after stimulation, and when the generation of the Ads is judged, the external system sends first control information to the internal system.
4. The system according to claim 1, wherein:
the in-vivo system collects electrophysiological signals applied to the contacts of the in-vivo electrodes in real time by using a second signal collection module, and inputs the electrophysiological signals into a second control module after passing through a second pre-amplification and filtering module;
the second control module is provided with a trained second Ads monitoring model which is used for calculating whether Ads are generated or not, compares a calculation result with first control information of an in-vitro system, and adjusts stimulation according to the comparison result so as to achieve the aim of eliminating the Ads.
5. The system according to claim 4, wherein:
the in-vivo system collects electrophysiological signals generated based on stimulation by using a third signal collection module, and inputs the electrophysiological signals into a second control module through a third pre-amplification and filtering module;
the second control module is provided with a trained LEP monitoring model which is used for distinguishing whether the stimulation adjustment is effective or not, and if the stimulation does not reach the effective treatment, the second control module continues to adjust the stimulation so as to achieve the aim of effectively treating the diseases.
6. A double closed loop deep brain stimulation device, characterized in that:
the device comprises a scalp electroencephalogram electrode, a micro-power consumption electrophysiological recording controller connected with the scalp electroencephalogram electrode, an internal electrode and a double-closed-loop deep brain stimulator connected with the internal electrode;
the micro-power consumption electrophysiological recording and controller comprises a first signal acquisition module, wherein the acquired electroencephalogram signals acquired by scalp electroencephalogram are processed by a first pre-amplification and filtering module and then input into a first control module, and if Ads are judged to be generated in the first control module, the micro-power consumption electrophysiological recording and controller generates and sends first control information to the double-closed-loop deep brain stimulator;
the double-closed-loop deep brain stimulator comprises a second signal acquisition module, a second control module and a first control module, wherein the second signal acquisition module is used for acquiring deep brain stimulation signals, the deep brain stimulation signals are input into the second control module after being subjected to second pre-amplification and filtering, the second control module judges whether Ads is generated or not, the second control module compares a calculation result with the first control information, and stimulation is adjusted according to the comparison result so as to achieve the purpose of eliminating the Ads;
the double-closed-loop deep brain stimulator comprises a third signal acquisition module, a second control module and a third pre-amplification and filtering module, wherein the third signal acquisition module is used for acquiring electrophysiological signals generated by deep brain due to stimulation, the second control module is used for judging whether stimulation adjustment is effective or not, and if the stimulation does not reach effective treatment, the second control module is used for continuously adjusting the stimulation so as to achieve the aim of effectively treating diseases.
7. The device of claim 6, wherein the micro-power consumption electrophysiological recording and controller is connected to the dual closed-loop deep brain stimulator by wireless communication, wherein the wireless communication is any of the following: bluetooth, wifi, NFC, zigbee.
8. The apparatus of claim 6, wherein the first control module has a first Ads monitoring model and the second control module has a second Ads monitoring model and an LEP monitoring model;
the first Ads monitoring model is used for judging whether Ads are generated or not according to scalp electroencephalogram signals;
the second Ads monitoring model is used for judging whether Ads are generated or not according to the deep brain electrophysiological stimulation signals;
the LEP monitoring model is used for judging whether the adjustment of the stimulation signals achieves the aim of effectively treating diseases according to the electrophysiological signals generated by stimulation in the deep brain.
9. The apparatus of claim 8, wherein the first Ads monitoring model, the second Ads monitoring model, and the LEP monitoring model employ machine learning models.
10. The device of claim 8, wherein the device is used to treat neuropathic pain.
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| CN119015605A (en) * | 2024-10-28 | 2024-11-26 | 中国康复研究中心 | A brain-computer interface tibial nerve electrical stimulation closed-loop control system |
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| CN119015605A (en) * | 2024-10-28 | 2024-11-26 | 中国康复研究中心 | A brain-computer interface tibial nerve electrical stimulation closed-loop control system |
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