System and method for measuring electrode impedance and method of assessing electrode health

By transmitting a specific frequency current between multiple electrodes and calculating the impedance spectrum, the problem of inconsistent electrode impedance measurements is solved, enabling accurate assessment of electrode health and validity of results, while adapting to individual patient differences.

CN120037578BActive Publication Date: 2025-11-11BEIJING LEADING INNOVATION MEDICAL VALLEY CO LTD
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Patent Information

Application Number
CN202510195107.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-02-21
Publication Date
2025-11-11
Estimated Expiration
2045-02-21

AI Technical Summary

Technical Problem

In the existing technology, the electrode impedance measurement methods in implantable neurostimulation systems cannot be uniformly processed, resulting in inaccurate assessment of electrode health, especially since the impedance data of edge electrodes cannot be uniformly compared with other electrodes.

Method used

A specific frequency current is transmitted between multiple electrodes. The impedance of each electrode at different frequencies is calculated by the controller. The current transmission between electrodes eliminates manufacturing inconsistencies. The electrode health is evaluated by impedance spectrum and standard deviation and average value methods.

Benefits of technology

It enables standardized processing and accurate assessment of electrode impedance, improves the effectiveness and accuracy of electrode health assessment, adapts to individual patient differences, and reduces the need for trials.

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Abstract

This invention relates to a system and method for measuring electrode impedance and a method for assessing electrode health. The system includes multiple electrodes, a current generator, and a controller. Multiple electrodes are implanted into the human body for electrical stimulation. The current generator is electrically connected to each electrode, generating a current of a specific frequency that is transmitted between the multiple electrodes. The controller is electrically connected to the current generator, causing the current of the specific frequency generated by the current generator to be transmitted between a target electrode and all other electrodes besides the target electrode, which is any one of the multiple electrodes; the voltage at the target electrode caused by the current of the specific frequency is measured; the impedance of the target electrode at the specific frequency is calculated based on the measured voltage at the target electrode; and the impedance of each electrode at the specific frequency is calculated individually, treating each electrode as a target electrode. The measured electrode impedances can then be processed uniformly for assessing electrode health.
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Description

Technical Field

[0001] This invention relates to the field of implantable neurostimulation technology, and more particularly to systems and methods for measuring electrode impedance and methods for assessing electrode health. Background Technology

[0002] Implantable neurostimulation is a method that uses electrical pulses to stimulate target nerves to adjust or restore the function of the brain, nerves, or muscles, thereby alleviating symptoms. Currently, implantable neurostimulation systems mainly consist of a stimulator implanted in the body and a controller implanted externally. The stimulator and controller can communicate via radio frequency and transmit energy. The controller provides radio frequency electrical energy to the stimulator, which then provides real-time stimulation pulse commands to drive the electrodes of the stimulator, thereby applying a stimulating current to the patient's treatment site. However, electrodes can undergo electrolytic reactions under the influence of current and tissue fluid, or in tissues containing tissue fluid and ions, galvanic cell reactions may occur in addition to electrolysis. Due to the long-term effects of the internal environment and electrochemical reactions (primarily electrolysis), the conductivity of the electrodes can change, and the electrodes may corrode. For electrodes, conductivity is the most important indicator of their health. Electrode impedance is typically used to characterize conductivity and assess electrode health.

[0003] Figure 1 This is a paired measurement method for electrode impedance based on existing technology. For example... Figure 1 As shown, two adjacent electrodes (e.g., electrodes E1 and E2) form a pair, and the current generated by the current generator can be transmitted between these two electrodes. Specifically, the current can be alternating current. The current generator applies current to one electrode in this pair (e.g., electrode E1), with the current output from electrode E1 (a "+" sign indicating current output) and input to the other electrode (i.e., electrode E2) (a "-" sign indicating current input). When the current direction changes, the current outputs from electrode E2 and inputs to electrode E1. Thus, the impedance of electrode E1 can be determined by measuring the voltage at electrode E1, and the impedance of electrode E2 can be determined by measuring the voltage at electrode E2. Similarly, by forming multiple pairs of electrodes, such as E2 and E3, E3 and E4, E5 and E6, E6 and E7, and E7 and E8, the impedance of each electrode in each pair can be measured.

[0004] However, the drawback of the paired measurement method is that the electrodes at the edge (i.e., electrodes E1 and E8) can only measure the impedance once, while the electrodes at the non-edge (i.e., electrodes E2 to E7) can measure the impedance twice, which makes it impossible to process the impedance data uniformly in the future.

[0005] The above description of the background technology is only for the purpose of facilitating a deeper understanding of the technical solution of the present invention (the technical means used, the technical problems solved, and the technical effects produced, etc.), and should not be regarded as an admission or in any form an implication that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide a system and method for measuring electrode impedance and a method for assessing electrode health, wherein the measured electrode impedance can be uniformly processed for assessing electrode health.

[0007] According to one embodiment of the present invention, a system for measuring electrode impedance is provided, the system comprising: a plurality of electrodes configured to be implanted in a human body for electrical stimulation; a current generator electrically connected to each of the plurality of electrodes and configured to: generate a current of a specific frequency for transmission between the plurality of electrodes; a controller electrically connected to the current generator and configured to: transmit the current of the specific frequency generated by the current generator between a target electrode and all other electrodes except the target electrode, wherein the target electrode is any one of the plurality of electrodes; measure the voltage at the target electrode caused by the current of the specific frequency; calculate the impedance of the target electrode at the specific frequency based on the measured voltage at the target electrode; and calculate the impedance of each of the plurality of electrodes at the specific frequency by treating each of the plurality of electrodes individually as the target electrode.

[0008] The controller is further configured to change the frequency of the current generated by the current generator to calculate the impedance of each of the multiple electrodes at different frequencies.

[0009] The controller is configured to make the frequency of the current generated by the current generator conform to:

[0010] f = {0, f1, f2, ..., f} n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n ,f 2n+1 ,…f m}

[0011] Where f is the frequency of the current generated by the current generator, f n It is a pre-set frequency for electrical stimulation;

[0012] f 2n =2f n ;

[0013] 0,f1,f2,…,f n-1 ,f n ,fn+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the relationship: δ1 < δ2.

[0014] According to another embodiment of the present invention, a method for measuring electrode impedance is provided, wherein the electrodes are configured as a plurality of electrodes implanted in the human body for electrical stimulation, the method comprising: transmitting a current of a specific frequency between a target electrode and all other electrodes other than the target electrode, wherein the target electrode is any one of the plurality of electrodes; measuring the voltage at the target electrode caused by the current of the specific frequency; calculating the impedance of the target electrode at the specific frequency based on the measured voltage at the target electrode; and calculating the impedance of each of the plurality of electrodes at the specific frequency, treating each of the plurality of electrodes individually as the target electrode.

[0015] The method for measuring electrode impedance further includes: changing the frequency of the current to calculate the impedance of each of the plurality of electrodes at different frequencies.

[0016] The steps to change the frequency of an electric current include making the frequency of the current match:

[0017] f = {0, f1, f2, ..., f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n ,f 2n+1 ,…f m}

[0018] Where f is the frequency of the current, f n It is a pre-set frequency for electrical stimulation;

[0019] f 2n =2f n ;

[0020] 0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the relationship: δ1 < δ2.

[0021] According to another embodiment of the present invention, a method for assessing the health of electrodes is provided, wherein the electrodes are configured as a plurality of electrodes implanted in the human body for electrical stimulation, the method comprising the steps of: obtaining the impedance of each of the plurality of electrodes at different frequencies; calculating the variance of the impedance of the plurality of electrodes at each frequency based on the obtained impedance of each of the plurality of electrodes at different frequencies; comparing the calculated variances and determining the frequency corresponding to the smallest variance as a reference frequency; calculating the standard deviation and average value of the impedance of the plurality of electrodes at the reference frequency; determining the difference between the average and the standard deviation, the sum of the average and the standard deviation, twice the difference between the average and the standard deviation, and twice the sum of the average and the standard deviation based on the calculated standard deviation and the average value; comparing the impedance of each of the plurality of electrodes at the reference frequency with the difference between the average and the standard deviation, the sum of the average and the standard deviation, twice the difference between the average and the standard deviation, and twice the sum of the average and the standard deviation; and assessing the health of each of the plurality of electrodes based on the comparison results.

[0022] The steps for assessing the health of each of the multiple electrodes based on the comparison results include: assessing the electrode's health as poor when the electrode's impedance at the reference frequency is less than twice the difference between the mean and the standard deviation, or greater than the sum of twice the mean and the standard deviation; assessing the electrode's health as fair when the electrode's impedance at the reference frequency is greater than or equal to twice the difference between the mean and the standard deviation and less than the difference between the mean and the standard deviation, or when the electrode's impedance at the reference frequency is greater than the sum of the mean and the standard deviation and less than or equal to twice the sum of the mean and the standard deviation; and assessing the electrode's health as good when the electrode's impedance at the reference frequency is greater than or equal to the difference between the mean and the standard deviation and less than or equal to the sum of the mean and the standard deviation.

[0023] The steps of obtaining the impedance of each of a plurality of electrodes at different frequencies include: transmitting a current of a specific frequency between a target electrode and all other electrodes except the target electrode, wherein the target electrode is any one of the plurality of electrodes; measuring the voltage at the target electrode caused by the current of the specific frequency; calculating the impedance of the target electrode at the specific frequency based on the measured voltage at the target electrode; calculating the impedance of each of the plurality of electrodes at the specific frequency by treating each of the plurality of electrodes individually as the target electrode; and calculating the impedance of each of the plurality of electrodes at different frequencies by changing the frequency of the current.

[0024] The steps to change the frequency of an electric current include making the frequency of the current match:

[0025] f = {0, f1, f2, ..., f} n-1 ,f n ,f n+1 ,…,f 2n-1 ,f2n ,f 2n+1 ,…f m}

[0026] Where f is the frequency of the current, f n It is a pre-set frequency for electrical stimulation;

[0027] f 2n =2f n ;

[0028] 0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the relationship: δ1 < δ2.

[0029] The present invention, employing the above technical solution, has the following beneficial effects: the electrode impedance measured using the present invention can be uniformly processed for assessing electrode health. Furthermore, by inducing current transmission between the electrode and all other electrodes besides itself, in stimulators including multiple electrodes, the inconsistencies in the electrodes themselves caused by the manufacturing process, as in existing pairwise measurement methods, can be eliminated, further improving the validity and accuracy of the results. Moreover, the value compared to the electrode impedance is a value calculated using the electrode impedance, rather than a value determined through extensive testing. Different measured electrode impedances result in different values ​​for comparison, accommodating individual patient differences. Attached Figure Description

[0030] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. For clarity, the same components in different drawings are shown with the same reference numerals. It should be noted that the drawings are for illustrative purposes only and are not necessarily drawn to scale. In these drawings:

[0031] Figure 1 It is a paired measurement method of electrode impedance based on existing technology.

[0032] Figure 2 This is a schematic diagram of a system for measuring electrode impedance according to an embodiment of the present invention.

[0033] Figure 3 An example of the impedance spectrum of an electrode is shown.

[0034] Figure 4 This is a flowchart of a method for measuring electrode impedance according to an embodiment of the present invention.

[0035] Figure 5 This is a flowchart of a method for assessing electrode health according to an embodiment of the present invention.

[0036] Figure 6 A schematic diagram illustrating the evaluation of electrode health according to an exemplary embodiment of the present invention is shown. Detailed Implementation

[0037] The following provides a detailed description of the embodiments of the present invention. These embodiments are implemented based on the technical solution of the present invention, and provide detailed implementation methods and specific operation processes. However, the scope of protection of the present invention is not limited to the following embodiments.

[0038] Figure 2 This is a schematic diagram of a system for measuring electrode impedance according to an embodiment of the present invention. Figure 2 As shown, a system for measuring electrode impedance according to an embodiment of the present invention includes multiple electrodes (e.g., electrode E1, electrode E2, ..., electrode E8), a current generator 10, and a controller 20.

[0039] Multiple electrodes are positioned for implantation into the human body to provide electrical stimulation. Figure 2 In the specific implementation shown, multiple electrodes E1, E2, ..., E8 can be placed at multiple points on the nerve 30 to be stimulated. Each of the multiple electrodes has impedance.

[0040] The current generator 10 is electrically connected to each of the plurality of electrodes and configured to generate a current of a specific frequency for transmission between the plurality of electrodes. In this context, a current of a specific frequency refers to alternating current whose magnitude and direction change periodically with time, and the frequency of the current refers to the number of times the current completes its periodic changes within one second. For example, the current could be an alternating current that varies sinusoidally with time.

[0041] The controller 20 is electrically connected to the current generator 10 and is configured to transmit a current of a specific frequency generated by the current generator 10 between the target electrode and all other electrodes except the target electrode. The target electrode is any one of a plurality of electrodes.

[0042] like Figure 2As shown, when electrode E1 is the target electrode, controller 20 applies a current of a specific frequency generated by current generator 10 to electrode E1. Current is output from electrode E1; a "+" sign indicates current output. This current output from electrode E1 is input to all other electrodes besides E1, i.e., current is input to each of electrodes E2, E3, E4, E5, E6, E7, and E8; a "-" sign indicates current input. When the current direction changes, current is output from each of electrodes E2, E3, E4, E5, E6, E7, and E8, and input to electrode E1, which is the target electrode. The same logic applies when other electrodes are used as target electrodes.

[0043] The controller 20 is configured to measure the voltage at the target electrode caused by a current at a specific frequency, and to calculate the impedance of the target electrode at the specific frequency based on the measured voltage at the target electrode.

[0044] Specifically, controller 20 uses known digital signal processing methods to extract the voltage at the target electrode caused by a current of a specific frequency. In some examples of the invention, controller 20 can process the measured voltage using techniques including, but not limited to, digital filtering, discrete Fourier transform, fast Fourier transform, and / or a combination of Gosser algorithms. Once the voltage at the target electrode is obtained, the impedance of the target electrode can be derived from the voltage at the target electrode, for example, by using known gain / offset calibration coefficients for calculating impedance.

[0045] Therefore, the controller 20 can use each of the multiple electrodes as a target electrode to calculate the impedance of each of the multiple electrodes at a specific frequency.

[0046] According to an exemplary embodiment of the present invention, the controller 20 can change the frequency of the current generated by the current generator 10. Similar to the operation of the controller 20 described above, the controller 20 uses each of the plurality of electrodes as a target electrode, transmits the frequency-changed current between the target electrode and all other electrodes, and can then calculate the impedance of each of the plurality of electrodes at different frequencies.

[0047] Unlike the paired measurement methods according to the prior art, the electrode impedance measured using the embodiments of the present invention can be processed uniformly thereafter. Furthermore, by inducing current transfer between the electrode and all other electrodes besides itself, in stimulators including multiple electrodes, the inconsistencies in the electrodes themselves caused by the manufacturing process in the paired measurement methods according to the prior art can be eliminated, further improving the validity and accuracy of the results.

[0048] For each electrode, the relationship between impedance and frequency can be represented by an impedance spectrum. Figure 3An example of the impedance spectrum of the electrode is shown. Figure 3 As shown, the vertical axis of the impedance spectrum represents impedance, and the horizontal axis represents the frequency of the current generated by the current generator 10 under the control of the controller 20.

[0049] In an exemplary embodiment of the present invention, the controller 20 is configured to cause the frequency of the current generated by the current generator 10 to conform to:

[0050] f = {0, f1, f2, ..., f} n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n ,f 2n+1 ,…f m}

[0051] Where f is the frequency of the current generated by the current generator 10, f n It is a pre-set frequency used for electrical stimulation. Figure 2 In the specific implementation shown, by placing multiple electrodes E1, E2, ..., E8 at multiple points on the nerve 30 to be stimulated, electrical stimulation using these electrodes can help relieve pain for the patient. For example, medical personnel may suggest setting the frequency for electrical stimulation to 100Hz to achieve a good pain-relieving effect. That is, f n =100Hz.

[0052] In addition, f 2n =2f n And 0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the relationship: δ1 < δ2.

[0053] In other words, smaller measurement steps are applied within ±100% of the recommended frequency of 100 Hz for electrical stimulation (i.e., 0 to 200 Hz), while larger measurement steps are applied outside the 0 to 200 Hz range.

[0054] Since the frequency f of the current generated by the current generator 10 can be reflected on the horizontal axis of the impedance spectrum, therefore, as Figure 3 As shown in the impedance spectrum, the frequency f of the current generated by the current generator 10 conforms to:

[0055] f={0,10,20,…,90,100,110,…,190,200,300,…2000}

[0056] Therefore, f n =f 10 =100Hz, f 2n =f 20 =200Hz, f m =f 38 =2000Hz.

[0057] The difference between any two adjacent values ​​in the range 0, 10, 20, ..., 90, 100, 110, ..., 190, 200 is δ1 = 10 Hz. That is, within the range of 0 to 200 Hz, the measurement step value is 10 Hz. The difference between any two adjacent values ​​in the range 200, 300, ..., 2000 is δ2 = 100 Hz, therefore δ1 < δ2. That is, within the range of 200 Hz to 2000 Hz, the measurement step value is 100 Hz, which is greater than 10 Hz.

[0058] However, the present invention is not limited thereto. Depending on the treatment site and function of the electrode implantation, medical personnel may recommend different frequencies f for electrical stimulation. n They may differ; furthermore, preferably, a larger frequency range can be used, for example, f m It can reach 20kHz.

[0059] Figure 4 This is a flowchart of a method for measuring electrode impedance according to an embodiment of the present invention. Figure 4 As shown, the method for measuring electrode impedance according to an embodiment of the present invention includes: transmitting a current of a specific frequency between a target electrode and all other electrodes other than the target electrode (S11), wherein the target electrode is any one of a plurality of electrodes.

[0060] Next, the voltage at the target electrode caused by a current at a specific frequency is measured (S12), and the impedance of the target electrode at the specific frequency is calculated based on the measured voltage at the target electrode (S13).

[0061] The impedance of each of the multiple electrodes at a specific frequency is calculated by treating each of the multiple electrodes as a target electrode (S14).

[0062] Next, the frequency of the current is changed to calculate the impedance of each of the multiple electrodes at different frequencies (S15).

[0063] Specifically, the step of changing the frequency of the current may include making the frequency of the current conform to:

[0064] f = {0, f1, f2, ..., fn-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n ,f 2n+1 ,…f m}

[0065] Where f is the frequency of the current, f n It is a pre-set frequency for electrical stimulation.

[0066] f 2n =2f n And 0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the relationship: δ1 < δ2.

[0067] After obtaining the impedance of each of the multiple electrodes at different frequencies, the health of each of the multiple electrodes can be evaluated using the obtained impedance of each of the multiple electrodes at different frequencies.

[0068] In existing technologies, electrode impedance is often calibrated through experiments. Specifically, when assessing health, the electrode impedance is compared to a fixed nominal value. However, individual variability leads to differences in electrode impedance, making it difficult to accommodate individual patient variations. In such cases, extensive clinical testing by medical personnel is necessary to assess electrode health.

[0069] Figure 5 This is a flowchart of a method for assessing electrode health according to an embodiment of the present invention.

[0070] Obtain the impedance of each of the multiple electrodes at different frequencies (S21). Specifically, step S21 may include steps S11 to S15 of the method for measuring electrode impedance described above.

[0071] Taking four electrodes E1, E2, E3, E4 and three current frequencies f1, f2, f3 as examples, Table 1 shows the impedance corresponding to the electrodes and frequencies.

[0072] Table 1

[0073] impedance <![CDATA[frequency f1]]> <![CDATA[Frequency f2]]> <![CDATA[Frequency f3]]> Electrode E1 a1 b1 c1 Electrode E2 a2 b2 c2 Electrode E3 a3 b3 c3 Electrode E4 a4 b4 c4

[0074] Based on the impedance of each of the multiple electrodes at different frequencies, calculate the variance of the impedance of the multiple electrodes at each frequency (S22).

[0075] Taking Table 1 as an example, at frequency f1, the variance of the impedance from electrode E1 to electrode E4 refers to the variance σ of a1, a2, a3, and a4. 2 a At frequency f2, the variance of the impedance from electrode E1 to electrode E4 refers to the variance σ of b1, b2, b3, and b4. 2 b At frequency f3, the variance of the impedance from electrode E1 to electrode E4 refers to the variance σ of c1, c2, c3, and c4. 2 c .

[0076] The calculated variances are compared, and the frequency corresponding to the smallest variance is determined as the reference frequency (S23).

[0077] The variance σ of a1, a2, a3, and a4 2 a The variance σ of b1, b2, b3, and b4 2 b The variance σ of c1, c2, c3, and c4 2 c Compare the sizes of the values ​​of b1, b2, b3, and b4. For example, if the comparison result is the variance σ of b1, b2, b3, and b4... 2 b If the minimum value is found, then the reference frequency is f2.

[0078] Calculate the standard deviation and average value of the impedance of multiple electrodes at the reference frequency (S24).

[0079] Given a reference frequency of f2, calculate the standard deviation σ of b1, b2, b3, and b4. z and average value μ z .

[0080] Based on the calculated standard deviation and mean, determine the difference between the mean and the standard deviation, the sum of the mean and the standard deviation, the difference of twice the mean and the standard deviation, and the sum of twice the mean and the standard deviation (S25).

[0081] In other words, based on the standard deviation σ z and average value μ z To determine the difference μ between the mean and the standard deviation. z -σ z The sum of the mean and standard deviation, μ z +σ z The difference μ between the mean and twice the standard deviation z -2σz The sum of the mean and twice the standard deviation, μ. z +2σ z .

[0082] The impedance of each of the multiple electrodes at the reference frequency is compared with the difference between the mean and the standard deviation, the sum of the mean and the standard deviation, the difference between twice the mean and the standard deviation, and the sum of twice the mean and the standard deviation (S26). Finally, the health of each of the multiple electrodes is evaluated based on the comparison results (S27).

[0083] Connect each of b1, b2, b3, and b4 with μ z -σ z μ z +σ z μ z -2σ z μ z +2σ z By comparison, determine each of b1, b2, b3, and b4 in terms of μ. z -σ z μ z +σ z μ z -2σ z μ z +2σ z The position within the defined interval is used to assess the health of the electrode.

[0084] Therefore, unlike existing technologies that compare electrode impedance to a fixed nominal value, according to embodiments of the present invention, the value compared to the electrode impedance is a value calculated using the electrode impedance, rather than a value determined through extensive testing. Furthermore, different measured electrode impedances result in different values ​​for comparison, thus accommodating individual patient variability.

[0085] Figure 6 A schematic diagram illustrating the evaluation of electrode health according to an exemplary embodiment of the present invention is shown.

[0086] The health of an electrode is assessed as poor when the impedance at the reference frequency is less than twice the difference between the average and the standard deviation, or greater than twice the sum of the average and the standard deviation.

[0087] like Figure 6 As shown, for example, when b1 < μ z -2σ z Or b1 > μ z +2σ z When this happens, the health of electrode E1 (which corresponds to impedance b1) can be assessed as poor.

[0088] The health of an electrode is assessed as average when the impedance at the reference frequency is greater than or equal to the difference between the average and the standard deviation but less than the difference between the average and the standard deviation, or when the impedance at the reference frequency is greater than the sum of the average and the standard deviation but less than or equal to the sum of the average and the standard deviation.

[0089] For example, when μ z -2σ z ≤b2<μ z -σ z or μ z +σ z <b2≤μ z +2σ z At that time, the health of electrode E2 (which corresponds to impedance b2) can be assessed as average.

[0090] The health of an electrode is assessed as good when the impedance at the reference frequency is greater than or equal to the difference between the average and the standard deviation and less than or equal to the sum of the average and the standard deviation.

[0091] For example, when μ z -σ z ≤b3≤μ z +σ z At this time, the health of electrode E3 (which corresponds to impedance b3) can be assessed as good.

[0092] The system and method for measuring electrode impedance and the method for assessing electrode health according to embodiments of the present invention allow for the subsequent unified processing of electrode impedance data measured using the present invention for assessing electrode health.

[0093] Furthermore, the system and method for measuring electrode impedance according to embodiments of the present invention, by generating current transmission between the electrode and all other electrodes besides itself, can eliminate the inconsistencies of the electrodes themselves caused by the manufacturing process in the pairwise measurement methods according to the prior art in stimulators including multiple electrodes, thereby further improving the validity and accuracy of the results.

[0094] Furthermore, in the method for assessing electrode health according to embodiments of the present invention, the value compared with electrode impedance is a value calculated using electrode impedance, rather than a value determined through extensive testing. Different measured electrode impedances result in different values ​​used for comparison, thus accommodating individual patient variability.

[0095] The various embodiments of the present invention are not an exhaustive list of all possible combinations, but are intended to describe representative aspects of the invention, and the contents described in the various embodiments can be applied independently or in two or more combinations.

[0096] The description of the exemplary embodiments presented above is merely illustrative of the technical solutions of the present invention and is not intended to be exhaustive, nor is it intended to limit the invention to the precise forms described. Obviously, those skilled in the art can make many changes and variations based on the above teachings. The exemplary embodiments were chosen and described to explain the specific principles of the invention and its practical applications, thereby enabling others skilled in the art to understand, implement, and utilize the various exemplary embodiments of the invention and their various alternatives and modifications. The scope of protection of the present invention is intended to be defined by the appended claims and their equivalents.

Claims

1. A system for measuring electrode impedance, the system comprising: Multiple electrodes configured to be implanted into the human body for electrical stimulation; A current generator, which is electrically connected to each of a plurality of electrodes, and is configured to generate a current of a specific frequency for transmission between the plurality of electrodes; The controller, which is electrically connected to the current generator, is configured as follows: The current generated by the current generator at a specific frequency is transmitted between the target electrode and all other electrodes except the target electrode, wherein the target electrode is any one of a plurality of electrodes; Measure the voltage at the target electrode caused by a current of a specific frequency; The impedance of the target electrode at a specific frequency is calculated based on the measured voltage at the target electrode. The impedance of each of the multiple electrodes at a specific frequency is calculated by treating each of the multiple electrodes as a target electrode. The impedance of each of the multiple electrodes at different frequencies is calculated by changing the frequency of the current generated by the current generator.

2. The system for measuring electrode impedance according to claim 1, wherein, The controller is configured to make the frequency of the current generated by the current generator conform to: f={0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n ,f 2n+1 ,…f m } Where f is the frequency of the current generated by the current generator, f n It is a pre-set frequency for electrical stimulation; in 2n =2f n ; 0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between any two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the following relationship: δ1<δ2.

3. A method for measuring electrode impedance, wherein the electrodes are configured as a plurality of electrodes implanted in the human body for electrical stimulation, the method comprising: A current of a specific frequency is transmitted between a target electrode and all other electrodes except the target electrode, wherein the target electrode is any one of a plurality of electrodes; Measure the voltage at the target electrode caused by a current of a specific frequency; The impedance of the target electrode at a specific frequency is calculated based on the measured voltage at the target electrode. The impedance of each of the multiple electrodes at a specific frequency is calculated by treating each of the multiple electrodes as a target electrode. The impedance of each of the multiple electrodes at different frequencies is calculated by changing the frequency of the current.

4. The method for measuring electrode impedance according to claim 3, wherein, The steps to change the frequency of an electric current include making the frequency of the current match: f={0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n ,f 2n+1 ,…f m } Where f is the frequency of the current, f n It is a pre-set frequency for electrical stimulation; in 2n =2f n ; 0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between any two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the following relationship: δ1<δ2.

5. A method for assessing the health of electrodes, said electrodes being configured as a plurality of electrodes implanted in the human body for electrical stimulation, the method comprising the steps of: Obtain the impedance of each of the multiple electrodes at different frequencies; Based on the impedance of each of the multiple electrodes at different frequencies, calculate the variance of the impedance of the multiple electrodes at each frequency. The calculated variances are compared, and the frequency corresponding to the smallest variance is determined as the reference frequency. Calculate the standard deviation and average value of the impedance of multiple electrodes at the reference frequency; Based on the calculated standard deviation and mean, determine the difference between the mean and the standard deviation, the sum of the mean and the standard deviation, the difference between twice the mean and the standard deviation, and the sum of twice the mean and the standard deviation; The impedance of each of the multiple electrodes at the reference frequency is compared with the difference between the average and the standard deviation, the sum of the average and the standard deviation, the difference of twice the average and the standard deviation, and the sum of twice the average and the standard deviation. The health of each of the multiple electrodes is assessed based on the comparison results; The step of obtaining the impedance of each of the multiple electrodes at different frequencies includes: A current of a specific frequency is transmitted between a target electrode and all other electrodes except the target electrode, wherein the target electrode is any one of a plurality of electrodes; Measure the voltage at the target electrode caused by a current of a specific frequency; The impedance of the target electrode at a specific frequency is calculated based on the measured voltage at the target electrode. The impedance of each of the multiple electrodes at a specific frequency is calculated by treating each of the multiple electrodes as a target electrode. The impedance of each of the multiple electrodes at different frequencies is calculated by changing the frequency of the current.

6. The method for assessing electrode health according to claim 5, wherein, The steps for assessing the health of each of the multiple electrodes based on the comparison results include: When the impedance of an electrode at a reference frequency is less than twice the difference between the average value and the standard deviation, or greater than twice the sum of the average value and the standard deviation, the health of the electrode is assessed as poor. When the impedance of the electrode at the reference frequency is greater than or equal to the difference between the average and the standard deviation and less than the difference between the average and the standard deviation, or when the impedance of the electrode at the reference frequency is greater than the sum of the average and the standard deviation and less than or equal to the sum of the average and the standard deviation, the health of the electrode is assessed as average. The health of an electrode is assessed as good when the impedance at the reference frequency is greater than or equal to the difference between the average and the standard deviation and less than or equal to the sum of the average and the standard deviation.

7. The method for assessing electrode health according to claim 5, wherein, The steps to change the frequency of an electric current include making the frequency of the current match: f={0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n ,f 2n+1 ,…f m } Where f is the frequency of the current, f n It is a pre-set frequency for electrical stimulation; in 2n =2f n ; 0,f1,f2,…,f n-1 ,f n ,f n+1 ,…,f 2n-1 ,f 2n The difference between any two adjacent values ​​is the difference δ1, f 2n+1 ,…f m The difference between any two adjacent values ​​is δ2, and the difference δ1 and the difference δ2 satisfy the following relationship: δ1<δ2.

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