CN112426623A - Implanted nerve electrical stimulation asymmetric compensation system and method - Google Patents
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Abstract
The invention discloses an implantable nerve electrical stimulation asymmetric compensation system and a method, wherein a reverse coupling signal is sent to a signal transmitting module according to the output of a compensation register in the system; the asymmetry judgment circuit judges the amplified result; the compensation register and the time schedule controller control the switch controller according to the output of the asymmetry judging circuit; the switch controller controls the asymmetric compensation matrix to compensate the corresponding phase stimulation waveform of the stimulation circuit. The invention automatically detects the asymmetry of the electrical stimulation according to the circuit characteristics, judges according to the polarity and amplitude of the residual voltage, and performs corresponding current compensation in different stimulation phases, thereby improving the safety and reliability of the product, avoiding unexpected reactions and tissue injuries caused by the asymmetry of the stimulation to users, and having the advantages of low active power consumption, simplicity, practicability, easy integration and the like.
Description
Technical Field
The invention belongs to the field of implantable medical devices, and particularly relates to an implantable nerve electrical stimulation asymmetric compensation system and method.
Background
Implantable electrical nerve stimulation has been widely used in a number of medical aids, such as cochlear implants, retinal prostheses, and auditory brainstem stimulation systems. In these relatively high stimulation rate applications, the implant stimulation waveform is generally composed of three components, positive phase stimulation, stimulation interval, and negative phase stimulation. Ideally, the stimulus pulse widths of the positive and negative phase stimuli are equal, wherein to ensure that the dc charge residue is zero. Because of the alternating current stimulation signal, the current is specified to flow from the stimulation electrode to the loop electrode to be positive-phase stimulation, and the current flows from the loop electrode to the stimulation electrode to be negative-phase stimulation. The sequencing of the positive and negative stimuli can be controlled by configuration. In the practical application process, the current stimulation may be in an asymmetric state due to the fact that different phases of the current source are in different states, slight leakage occurs to the electrodes, or errors occur in the pulse width of the positive and negative phase stimulation. In order to further reduce the dc charge residue, such circuits generally use a dc blocking capacitor. However, when the stimulation rate is high enough, the dc charge residue caused by the above asymmetric electrical stimulation cannot be completely eliminated by the dc blocking capacitor, and is accumulated on the nerve tissue, causing a discharge phenomenon, damaging the nerve tissue, and bringing an unexpected response to the user. Generally, the residual direct current caused by the electrical stimulation is required to be less than 0.1 nA.
Under the condition, the implanted nerve electrical stimulation is subjected to asymmetric compensation, so that the residual direct current charge caused by asymmetric stimulation can be effectively reduced, and the use risk of a user is reduced. On the premise of easy realization and low power consumption, how to accurately detect the stimulation asymmetry and effectively compensate is a difficulty of the compensation scheme.
Disclosure of Invention
In view of the above, the present invention provides an implanted electrical stimulation asymmetric compensation system and method, which can compensate and calibrate the stimulus waveform before normal use every time, and adopts a full CMOS scheme, so that the system is simple, practical, easy to integrate, complete in full automation, free from manual intervention, obvious in compensation effect, and safe and reliable for stimulation of a user.
To achieve the above object, the present invention provides an implantable neural point stimulation asymmetry compensation system, comprising an extracorporeal device and an implant, wherein,
the extracorporeal device comprises a central processing unit, a memory and a signal transmitting module, wherein,
the central processing unit encodes information such as stimulated electrodes, amplitude, pulse width and the like, and can switch between a compensation mode and a normal stimulation mode;
the memory is connected with the central processing unit, stores stimulation information and provides the stimulation information to the central processing unit to generate a stimulation command;
the signal transmitting module is connected with the central processing unit, amplifies the coded signal sent by the central processing unit, transmits the amplified coded signal into the implant in a wireless transmitting mode, and transmits the signal sent by the implant through wireless coupling back to the central processing unit;
the implant comprises a signal receiving module, a stimulating circuit, a sampling amplifying circuit, an asymmetry judging circuit, a compensation register, a time sequence controller, a switch controller and an asymmetry compensation matrix, wherein,
the signal receiving module demodulates and decodes the signal sent by the signal transmitting module, sends a control signal to the stimulating circuit, and sends a reverse coupling signal to the signal transmitting module according to the output of the compensation register to prompt whether the compensation is finished;
the stimulation circuit is connected with the signal receiving module, and carries out alternating current stimulation on the nerve tissue according to a control signal sent by the signal receiving module, and the current value is controlled by a current source;
the sampling amplifying circuit is connected with the stimulating circuit, samples the input of the stimulating circuit after the stimulation is finished, and performs forward and reverse amplification on the sampling voltage in a retention mode;
the asymmetry judging circuit is connected with the sampling amplifying circuit, judges the forward amplified signal and the reverse amplified signal and outputs three judging results of '1', '0' and '-1';
the compensation register is connected with the asymmetry judgment circuit, when the output is not '0', the compensation register stores a data value and adds 1, when the output is '0', the compensation register stores the data value unchanged and outputs the data value to the signal receiving module to prompt that the compensation is finished;
the time schedule controller is connected with the asymmetric judgment circuit, when the input is '1', the time schedule controller outputs '1' when the stimulation is in a negative phase, the output of the rest time is '0', and when the input is '1', the time schedule controller outputs '1' when the stimulation is in a positive phase, and the output of the rest time is '0';
the switch controller is respectively connected with the compensation register, the time sequence controller and the asymmetric compensation matrix, and controls the opening and closing of the asymmetric compensation matrix switch array according to the output of the compensation register and the time sequence controller;
the asymmetric compensation matrix is connected with the stimulation circuit and consists of a plurality of current sources and switches, and the electrical stimulation is balanced and symmetric by compensating the stimulation current in the positive phase or the negative phase.
Preferably, the sampling amplifying circuit samples and retains the input signal and amplifies the retained signal.
Preferably, the asymmetry determination circuit determines the forward and reverse amplified signals, and outputs '1' when the reverse amplified output is higher than a threshold value, outputs '1' when the forward amplified output is higher than the threshold value, and outputs '0' when both outputs are smaller than the threshold value.
Preferably, the number of the current sources in the asymmetric compensation matrix is 4-16.
Based on the above purpose, the present invention further provides an implanted nerve electrical stimulation asymmetric compensation method, which adopts the implanted nerve electrical stimulation asymmetric compensation system, and comprises the following steps:
s101, after the extracorporeal device is started, the central processing unit sends a stimulation command to the implant through the signal transmitting module according to preset comfort values, threshold values and pulse widths stored in the memory;
s102, a signal receiving module in the implant controls a stimulation circuit to stimulate a corresponding electrode according to a received stimulation command;
s103, when the stimulation of the corresponding electrode is finished, the sampling amplification circuit is opened, the residual voltage is sampled and amplified, and the amplified signal is input into the asymmetry judgment circuit;
s104, comparing the signal sampled and amplified by the asymmetry judgment circuit with a threshold value, and outputting the signal as '1', '-1' or '0';
s105, when the output of the asymmetry judgment circuit is '1' or '-1', the compensation register keeps the data numerical value plus 1, and the external equipment sends the same stimulation command to the implant again;
s106, when stimulating the electrodes, the time schedule controller outputs high level at the corresponding phase, the switch controller controls the opening of the asymmetric compensation matrix according to the output of the compensation register and the time schedule controller, and after the stimulation is finished, the next step is carried out;
s107, when the output of the asymmetry judging circuit is '0', the reserved value of the compensation register is not increased, meanwhile, the signal receiving module is sent to the state information and wirelessly coupled to the signal transmitting module, the compensation is prompted to be completed, and the central processing unit enters a normal stimulation mode after receiving the state information.
Preferably, in S103, the residual voltage at two ends of the nervous tissue within 1-2 us after stimulation is sampled and amplified, and the amplification factor is 10-100 times.
Preferably, current compensation is performed at the corresponding phase according to the asymmetry judgment circuit output, and the compensation value is retained in the following normal stimulation.
The invention has the beneficial effects that: the asymmetric condition of the stimulation waveform is judged by directly measuring the voltages at the two ends of the nervous tissue, and the corresponding phase is found to be directly compensated, so that a symmetric waveform meeting the requirement is obtained, the whole scheme is safe and reliable, the integration is easy, the normal stimulation setting is not influenced, the use risk of a user is reduced, and the user is prevented from generating unexpected reaction.
Drawings
In order to make the object, technical scheme and beneficial effect of the invention more clear, the invention provides the following drawings for explanation:
fig. 1 is a specific block diagram of another specific application example of the implantable neural electrical stimulation asymmetry compensation system according to the embodiment of the present invention.
Fig. 2 is a specific circuit diagram of an implant according to an embodiment of the present invention;
FIG. 3 is a flowchart illustrating steps of an embodiment of an implanted neural electrical stimulation asymmetry compensation method according to the present invention;
fig. 4 is a stimulation waveform comparison diagram of a specific application example of the implantable neural electrical stimulation asymmetry compensation system according to the embodiment of the present invention.
Detailed Description
Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
Referring to fig. 1-2, an implantable electrical nerve stimulation asymmetry compensation system according to an embodiment of the invention is shown, comprising an extracorporeal device 10 and an implant 20, wherein,
the extracorporeal device 10 includes a central processing unit 110, a memory 120, and a signal transmission module 130, wherein,
the central processing unit 110 encodes information such as stimulated electrodes, amplitude, pulse width and the like, and can switch between a compensation mode and a normal stimulation mode;
the memory 120 is connected to the central processing unit 110, stores stimulation information of the user, and provides the information to the central processing unit 110 for generating stimulation commands;
the signal transmitting module 130 is connected to the central processing unit 110, amplifies the encoded signal sent by the central processing unit 110, transmits the amplified encoded signal to the implant 20 in a wireless transmission manner, and transmits the signal sent by the implant 20 through wireless coupling back to the central processing unit 110;
the implant 20 comprises a signal receiving module 210, a stimulation circuit 220, a sampling amplification circuit 230, an asymmetry judgment circuit 240, a compensation register 250, a timing controller 260, a switch controller 270 and an asymmetry compensation matrix 280, wherein,
the signal receiving module 210 demodulates and decodes the signal sent by the signal transmitting module 130, sends the control signal to the corresponding stimulating circuit 220, and sends a reverse coupling signal to the signal transmitting module 130 according to the output of the compensation register 250, so as to prompt whether the compensation is completed;
the stimulation circuit 220 is connected with the signal receiving module 210, and performs alternating current stimulation on the neural tissue according to a control signal sent by the signal receiving module 210, wherein the current value is controlled by a current source;
the sampling amplifying circuit 230 is connected with nodes at two ends of the neural tissue in the stimulating circuit 210, samples the input after the stimulation is finished, and performs forward and reverse amplification on the sampling voltage in a retention mode;
the asymmetry judgment circuit 240 is connected with the sampling amplification circuit 230, the output is '1' when the reverse amplification output is higher than the threshold value, the output is '1' when the forward amplification output is higher than the threshold value, and the outputs are '0' when both the outputs are smaller than the threshold value;
the compensation register 250 is connected to the asymmetry judgment circuit 240, when the output is not '0', the compensation register 250 stores the data value plus 1, and when the output is '0', the compensation register 250 stores the data value unchanged and outputs the data value to the signal receiving module 210, which prompts the completion of compensation;
the timing controller 260 is connected to the asymmetry judgment circuit 240, and when the input is '1', the timing controller 260 outputs '1' when the stimulus is a negative phase, and outputs '0' for the remaining time, and when the input is '1', the timing controller 260 outputs '1' when the stimulus is a positive phase, and outputs '0' for the remaining time;
the switch controller 270 is connected with the compensation register 250, the timing controller 260 and the asymmetric compensation matrix 280, and controls the switch array of the asymmetric compensation matrix to be opened or closed according to the output of the compensation register 250 and the timing controller 260;
the asymmetry compensation matrix 280 is connected to the stimulation circuit 220, and is composed of a plurality of small current sources and switches, and the balance and symmetry of the electrical stimulation are realized by compensating the stimulation current in the positive phase or the negative phase.
Further, the sampling amplification circuit 230 performs sampling retention on the input signal, and amplifies the retained signal.
Further, the asymmetry determination circuit 240 determines the forward and reverse amplified signals and outputs three determination results of '1', '0', and '-1'.
Furthermore, the number of the compensation current sources in the asymmetric compensation matrix is 4-16.
FIG. 2 is a schematic diagram of an implantable neural electrical stimulation asymmetric compensation system according to an embodiment of the present inventionSpecific circuit diagram of implant of body application example. The stimulation circuit 220 is composed of a current source I1DC blocking capacitor C1And four control switches S1、S2、S3、S4And (4) forming. After the stimulation is started, the signal receiving module 210 controls S2And S3Closure, S1And S4 is turned on, current flows from the return electrode to the stimulating electrode through the neural tissue to form negative phase stimulation, and then S1 and S4Closure, S2And S3And opening the circuit, and enabling current to flow into the loop electrode from the stimulation electrode through the nerve tissue to form positive-phase stimulation. After the stimulation is finished, the switches S5, S6, S9 and S11 in the sampling amplifying circuit 230 are closed, S7, S10, S12, S13 and S14 are opened, and the sampling amplifying circuit enters a sampling phase; after sampling is finished, S7, S10, S12, S13 and S14 are closed, S5, S6, S9 and S11 are opened, the sampling amplifying circuit enters an amplifying stage, and the sampled signal is amplified and output to the asymmetry judgment circuit 240. The asymmetry judgment circuit 240 is composed of two comparators a4 and a5, when the output of a4 is high, the output of a5 is low, and the asymmetry judgment circuit is equivalent to the output of '-1'; when the output of A5 is high, the output of A4 is low, and the asymmetry judgment circuit is equivalent to the output '1'; when both a4 and a5 are low, the asymmetry determination circuit is equivalent to outputting '0' at this time. When the output result of the asymmetry judgment circuit 240 is non-zero, the original stored value of the compensation register 250 is automatically added with 1; when the output result of the asymmetry judgment circuit 240 is '0', the compensation register 250 stores the value and no longer changes, and prompts the signal receiving module 210 to finish compensation. When the asymmetry determination circuit 240 outputs '1', the timing controller 260 outputs '1' when the stimulus is a negative phase, and outputs '0' for the rest of the time; when the output result of the asymmetry determination circuit 240 is '1', the timing controller 260 outputs '1' when the stimulus is a positive phase, and outputs '0' at the remaining time; when the asymmetry judgment circuit 240 outputs the result of '0', the timing controller 260 keeps the previous output result and timing unchanged. The switch controller 270 controls the switch S in the asymmetric compensation matrix 280 according to the outputs of the compensation register 250 and the timing controller 260K1～SKNOpening and closing. Compensation in asymmetric compensation matrix 280Stream source IK1～IKNCurrent source I in AND stimulation circuit 2201Parallel, open and close by switch SK1～SKNAnd (5) controlling.
Referring to fig. 3, a flowchart of the steps of an embodiment of the method of the present invention includes the following steps:
s101, after the extracorporeal device 10 is powered on, the central processing unit 110 sends a stimulation command to the implant through the signal transmitting module 130 according to the comfort value, the threshold value and the pulse width of the user stored in the memory 120;
s102, the signal receiving module 210 in the implant 20 controls the stimulation circuit 220 to stimulate the corresponding electrode according to the received stimulation command;
s103, after the stimulation of the corresponding electrode is finished, the sampling amplification circuit 230 is opened, the residual voltage at the two ends of the nervous tissue is sampled and amplified, and the amplified signal is input into the asymmetry judgment circuit 240;
s104, the asymmetry judgment circuit 240 samples the amplified signal and compares the signal with a threshold value, and outputs the signal as '1', '-1' or '0';
s105, when the asymmetry determination circuit 240 outputs '1' or '-1', the compensation register 250 holds the data value plus 1, and the extracorporeal device 10 sends the same stimulation command to the implant 20 again;
s106, when the electrodes are stimulated S102, the time sequence controller 260 outputs high level at the corresponding phase, the switch controller 270 controls the asymmetric compensation matrix 280 to be opened according to the output of the compensation register 250 and the time sequence controller 260, and after the stimulation is finished, the operation goes to S103;
s107, when the output of the asymmetry judging circuit 240 is '0', the compensation register 250 keeps the value not to be increased, and simultaneously sends the transmission status information to the signal receiving module 210 and wirelessly couples to the signal transmitting module 130 to prompt the completion of the compensation, and the central processing unit 110 enters the normal stimulation mode after receiving the status information.
And S103, sampling and amplifying residual voltages at two ends of the nervous tissue within 1-2 us after stimulation, wherein the amplification factor is 10-100 times.
According to the output of the asymmetry judging circuit 240, current compensation is performed at the corresponding phase, and the compensation value is retained in the following normal stimulation.
All the operations are automatically completed without any manual operation.
Fig. 4 is a diagram comparing stimulation waveforms of the implantable neural electrical stimulation asymmetry compensation system according to the embodiment of the present invention. Where the abscissa is time (100 microseconds/grid) and the ordinate is voltage value (500 millivolts/grid). FIG. 4(a) shows the stimulation waveforms at 2 and 3 points at two ends of the neural tissue during the first stimulation after the start-up, in which the negative phase stimulation amplitude is significantly larger than the positive phase stimulation amplitude, and the blocking capacitor C is used for blocking the DC voltage after the stimulation is finished1Under the action, a positive voltage is generated between the points 2 and 3, the threshold value of the asymmetry judgment circuit 240 is exceeded, and '1' is output, so that current compensation is carried out during positive-phase stimulation. Fig. 4(b) is a stimulation waveform at 2 and 3 points across the nerve tissue at the third stimulation, the positive phase stimulation amplitude is significantly increased, the positive voltage between 2 and 3 points after the stimulation is finished is significantly decreased, but the stimulation is still asymmetric, and the negative phase stimulation amplitude is still greater than the positive phase stimulation amplitude. Fig. 4(c) shows the stimulation waveforms at 2 and 3 points across the nerve tissue during the sixth stimulation, the positive phase stimulation amplitude continues to increase, the positive voltage between 2 and 3 points still exceeds the threshold after the stimulation is over, and the negative phase stimulation amplitude is slightly larger than the positive phase stimulation amplitude. Fig. 4(d) shows that when the ninth stimulation and the last stimulation for compensation are performed, the positive-phase stimulation amplitude continues to increase at the 2 and 3 points of the stimulation waveform at both ends of the nerve tissue, and the positive voltage between the 2 and 3 points after the stimulation is finished is smaller than the threshold value, so that the stimulation waveform is basically symmetrical.
The method and the system have the characteristics of easiness in realization, flexibility, controllability, easiness in integration and the like, the compensation is completely automatic, the safety and the reliability of products are improved, and the damage and the unexpected reaction to users are avoided.
Finally, it is noted that the above-mentioned preferred embodiments illustrate rather than limit the invention, and that, although the invention has been described in detail with reference to the above-mentioned preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the scope of the invention as defined by the appended claims.
Claims (7)
1. An implanted nerve electrical stimulation asymmetry compensation system is characterized by comprising an extracorporeal device and an implant body, wherein,
the extracorporeal device comprises a central processing unit, a memory and a signal transmitting module, wherein,
the central processing unit encodes information such as stimulated electrodes, amplitude, pulse width and the like, and can switch between a compensation mode and a normal stimulation mode;
the memory is connected with the central processing unit, stores stimulation information and provides the stimulation information to the central processing unit to generate a stimulation command;
the signal transmitting module is connected with the central processing unit, amplifies the coded signal sent by the central processing unit, transmits the amplified coded signal into the implant in a wireless transmitting mode, and transmits the signal sent by the implant through wireless coupling back to the central processing unit;
the implant comprises a signal receiving module, a stimulating circuit, a sampling amplifying circuit, an asymmetry judging circuit, a compensation register, a time sequence controller, a switch controller and an asymmetry compensation matrix, wherein,
the signal receiving module demodulates and decodes the signal sent by the signal transmitting module, sends a control signal to the stimulating circuit, and sends a reverse coupling signal to the signal transmitting module according to the output of the compensation register to prompt whether the compensation is finished;
the stimulation circuit is connected with the signal receiving module, and carries out alternating current stimulation on the nerve tissue according to a control signal sent by the signal receiving module, and the current value is controlled by a current source;
the sampling amplifying circuit is connected with the stimulating circuit, samples the input of the stimulating circuit after the stimulation is finished, and performs forward and reverse amplification on the sampling voltage in a retention mode;
the asymmetry judging circuit is connected with the sampling amplifying circuit, judges the forward amplified signal and the reverse amplified signal and outputs three judging results of '1', '0' and '-1';
the compensation register is connected with the asymmetry judgment circuit, when the output is not '0', the compensation register stores a data value and adds 1, when the output is '0', the compensation register stores the data value unchanged and outputs the data value to the signal receiving module to prompt that the compensation is finished;
the time schedule controller is connected with the asymmetric judgment circuit, when the input is '1', the time schedule controller outputs '1' when the stimulation is in a negative phase, the output of the rest time is '0', and when the input is '1', the time schedule controller outputs '1' when the stimulation is in a positive phase, and the output of the rest time is '0';
the switch controller is respectively connected with the compensation register, the time sequence controller and the asymmetric compensation matrix, and controls the opening and closing of the asymmetric compensation matrix switch array according to the output of the compensation register and the time sequence controller;
the asymmetric compensation matrix is connected with the stimulation circuit and consists of a plurality of current sources and switches, and the electrical stimulation is balanced and symmetric by compensating the stimulation current in the positive phase or the negative phase.
2. A system as claimed in claim 1, wherein the sample amplification circuit sample-retains the input signal and amplifies the retained signal.
3. The system as claimed in claim 1, wherein the asymmetry judging circuit judges the forward and reverse amplified signals, and outputs '1' when the reverse amplified output is higher than a threshold value, outputs '1' when the forward amplified output is higher than the threshold value, and outputs '0' when both outputs are smaller than the threshold value.
4. A system as claimed in claim 1, characterised in that the number of current sources in the asymmetric compensation matrix is 4 to 16.
5. An implanted nerve electrical stimulation asymmetry compensation method, characterized in that, the implanted nerve electrical stimulation asymmetry compensation system of any one of claims 1 to 4 is adopted, comprising the following steps:
s101, after the extracorporeal device is started, the central processing unit sends a stimulation command to the implant through the signal transmitting module according to preset comfort values, threshold values and pulse widths stored in the memory;
s102, a signal receiving module in the implant controls a stimulation circuit to stimulate a corresponding electrode according to a received stimulation command;
s103, when the stimulation of the corresponding electrode is finished, the sampling amplification circuit is opened, the residual voltage is sampled and amplified, and the amplified signal is input into the asymmetry judgment circuit;
s104, comparing the signal sampled and amplified by the asymmetry judgment circuit with a threshold value, and outputting the signal as '1', '-1' or '0';
s105, when the output of the asymmetry judgment circuit is '1' or '-1', the compensation register keeps the data numerical value plus 1, and the external equipment sends the same stimulation command to the implant again;
s106, when stimulating the electrodes, the time schedule controller outputs high level at the corresponding phase, the switch controller controls the opening of the asymmetric compensation matrix according to the output of the compensation register and the time schedule controller, and after the stimulation is finished, the next step is carried out;
s107, when the output of the asymmetry judging circuit is '0', the reserved value of the compensation register is not increased, meanwhile, the signal receiving module is sent to the state information and wirelessly coupled to the signal transmitting module, the compensation is prompted to be completed, and the central processing unit enters a normal stimulation mode after receiving the state information.
6. The method according to claim 5, wherein in S103, the residual voltage across the nerve tissue within 1-2 us after stimulation is sampled and amplified by a factor of 10-100.
7. The method of claim 5, wherein the current compensation is performed at the corresponding phase according to the asymmetry judgment circuit output, and the compensation value is retained in a normal stimulus thereafter.
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| US20180353760A1 (en) * | 2015-12-11 | 2018-12-13 | Sorin Crm Sas | Active electrical nerve stimulation medical device, with automatic charge compensation control |
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| CN104096313A (en) * | 2014-06-17 | 2014-10-15 | 华中科技大学 | Implantable nerve electrical stimulation device and system |
| CN204840670U (en) * | 2015-07-14 | 2015-12-09 | 深圳先进技术研究院 | Nerve stimulation ware with novel charge balance system |
| US20180353760A1 (en) * | 2015-12-11 | 2018-12-13 | Sorin Crm Sas | Active electrical nerve stimulation medical device, with automatic charge compensation control |
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Application publication date: 20210302 |