Method and device for selecting peripheral muscle movement-based stimulation intensity

Abstract

The present invention relates to a method for selecting a peripheral muscle movement-based stimulation intensity, which is applied to an electrical stimulator having an electrode array, the method comprising the steps of: measuring impedance values between each electrode and the skin, and using the impedance values so as to inspect whether the electrical stimulator is properly worn; applying electrical stimulation while narrowing an electrode range, and calculating a change in a signal acquired from an acceleration sensor and an electromyogram sensor according to the applied electrical stimulation, so as to select an electrode pair to which therapeutic electrical stimulation is to be applied; and applying, with therapeutic stimulation intensity, electrical stimulation of the highest stimulation intensity at which muscle movement does not occur to the electrode pair selected in the step of selecting the electrode pair.

Description

Method and device for selecting stimulation intensity based on peripheral muscle movement

[0001] The present invention was made under the support of the Ministry of Science and ICT under the project identification number 1711196093 and project number 00220534. The research management specialized organization of the project is the National Research Foundation of Korea, the research project name is "Development of Electronic Drug Technology", the research project title is "Development of a Fully Implantable, Organ-Integrated Electronic Drug Platform for Long-Term Management and Fundamental Treatment of Urinary Diseases", the lead organization is Korea University, and the research period is from April 1, 2023 to December 31, 2025.

[0002] The present invention was made with the support of the Ministry of Science and ICT under the grant number 1711189022 and grant number 2021R1F1A1063173. The research management organization of the above-mentioned project is the National Research Foundation of Korea, the research project name is "Basic Research", the research project title is "Development of noninvasive sacral nerve stimulation technology based on superimposition of multi-channel electrical stimulation for the treatment of overactive bladder", the main organization is Samsung Seoul Hospital, and the research period is from March 1, 2021 to February 29, 2024.

[0003] The present invention was made under the support of the Ministry of Health and Welfare under the project identification number 1465039253 and project number HR21C0885030023. The research management specialized organization of the project is the Korea Health Industry Development Institute, the research project name is "Research-oriented Hospital Promotion", the research project name is "Development of personalized intelligent electronic medicine to overcome intractable diseases", the main organization is Samsung Seoul Hospital, and the research period is from July 1, 2021 to December 31, 2029.

[0004] This invention was made with the support of the Ministry of Science and ICT under the grant number 1711160399 and grant number 2021M3A9G1015618. The research management organization of the said project is the National Research Foundation of Korea, the research project name is "Market-linked Future Biotechnology Development", the research project name is "Bio Research Data Verification Support Project", the main organization is the Korea Institute for Science and Technology Promotion, and the research period is from January 1, 2021 to December 31, 2025.

[0005] The present invention was made with the support of the Ministry of Science and ICT under the project identification number 1711190260 and project number 2022M3C1A3081294. The research management specialized organization of the project is the National Research Foundation of Korea, the research project name is "STEAM Research", the research project title is "Development of a fully autonomous neural reset system to overcome intractable chronic diseases due to neural homeostasis imbalance", the main organization is Pohang University of Science and Technology, and the research period is from 2022.06.01. to 2026.12.31.

[0006] The present invention was made under the support of the Ministry of Science and ICT under the project identification number 00398460, project number RS-2024-00398460, and the research management specialized institution of the project is the National Research Foundation of Korea, the research project name is "Development of Leading Convergence Technology in Brain Science", the research project title is "Development of minimally invasive on-chip closed-loop distributed deep brain stimulation technology capable of extracranial long-term seizure EEG measurement and multi-point simultaneous interference stimulation and verification of epilepsy treatment effect", the main institution is Korea University, and the research period is from 2024.04.01. to 2028.12.31.

[0007] The present invention relates to a method and device for selecting stimulation intensity based on peripheral muscle movement, and more particularly, to a method and device for selecting stimulation intensity based on peripheral muscle movement, which allows the device to apply stimulation that can have the highest stimulation transmission efficiency at the attachment site when using a disease treatment device through noninvasive peripheral nerve stimulation.

[0008] Electronic drugs, which are currently being developed to replace chemical drugs, aim to treat diseases by regulating neural circuits in the body through stimulation of specific peripheral nerves.

[0009] In order to accurately stimulate peripheral nerves, the nerves must be stimulated accurately through an implantable stimulator. However, because surgery or a procedure is required, accessibility is low from the patient's perspective. In addition, there are many things to consider from the perspective of individualizing the device. Therefore, devices based on non-invasive nerve stimulation technology are being released, even though the stimulation is delivered inaccurately.

[0010] In the case of these non-invasive stimulators, patients often do not have any physiological background knowledge when wearing and using them, making it difficult to determine the intensity to appropriately stimulate the target nerves, which inevitably reduces the therapeutic effect.

[0011] Meanwhile, for a stimulus signal to be effective, it must induce firing in the target nerves, which requires a certain level of stimulation intensity. Generally, stronger stimulation intensity leads to activation of a wider range of nerves, resulting in greater therapeutic effects. However, higher intensities can also cause movement due to muscle contraction, and even stronger stimulation can cause pain.

[0012] Therefore, there is a need for a method and device for selecting stimulation intensity based on peripheral muscle movement that can enable patients to wear the device in an appropriate location so that the device can always achieve a consistent therapeutic effect, and that can produce an optimal therapeutic effect without causing discomfort to the patient.

[0013] The present invention aims to provide a method and device for selecting stimulation intensity based on peripheral muscle movement that can cause an optimal therapeutic effect without causing discomfort to the patient and that can enable a patient to wear the device in a suitable position so that the device can always achieve a constant therapeutic effect.

[0014] In order to achieve the above object, the present invention is characterized by a method for selecting a stimulation intensity based on peripheral muscle movement applied to an electrical stimulator having an electrode array, the method comprising: a step of measuring an impedance value between each electrode and the skin and using the impedance value to check whether the electrical stimulator is properly worn; a step of applying an electrical stimulus while narrowing down the electrode range, calculating a change in a signal obtained from an acceleration sensor and an electromyography sensor according to the applied electrical stimulus, and selecting an electrode pair to which a therapeutic electrical stimulus is to be applied; and a step of applying an electrical stimulus with the highest stimulation intensity at which no muscle movement occurs as the therapeutic stimulation intensity to the electrode pair selected in the step of selecting the electrode pair.

[0015] Preferably, the checking step can generate a guide to wear the electrical stimulator again if the ratio of electrodes having the impedance value greater than or equal to a preset value is greater than or equal to a certain ratio.

[0016] Preferably, the step of selecting the electrode pair may include a first step of dividing the electrode array into one or more zones having a size of M*N, applying an electrical stimulus to each of the divided one or more zones, and then selecting the top two zones with high responsiveness; a second step of dividing the two zones selected in the first step into one or more zones having a size of m*n, applying an electrical stimulus to each of the divided one or more zones, and then selecting the top ten zones with high responsiveness; and a third step of dividing all possible electrode pairs in the zones within ten selected in the second step, applying an electrical stimulus to all divided electrode pairs, and then selecting the electrode pair with the highest responsiveness.

[0017] Preferably, the step of applying the electrical stimulation may select the highest stimulation intensity among the stimulation intensities that only cause sensory nerves to fire without causing motor nerves to fire as the highest stimulation intensity.

[0018] Preferably, the intensity of the stimulus that fires only the sensory nerve without firing the motor nerve may be an intensity of the electrical stimulus generated with a voltage that is lower than the threshold voltage of the motor nerve and higher than the threshold voltage of the sensory nerve.

[0019] Preferably, the step of applying the electrical stimulation may include an initial stimulation application step of averaging the highest stimulation intensities obtained from a plurality of people to generate a highest stimulation intensity average value, and applying the electrical stimulation using the highest stimulation intensity average value as a therapeutic stimulation intensity.

[0020] Preferably, the step of applying the electrical stimulation may include a step of applying the electrical stimulation by reducing the stimulation intensity by half when movement occurs in the peripheral muscles with the electrical stimulation applied in the initial stimulation applying step, and applying the electrical stimulation by increasing the stimulation intensity by half of the current intensity when movement does not occur in the peripheral muscles with the electrical stimulation applied in the initial stimulation applying step.

[0021] Preferably, the step of applying the electrical stimulation may be repeated twice or more until there is no movement of the peripheral muscles or the minimum voltage control limit of the stimulator is reached.

[0022] In addition, the present invention is characterized in that it includes a peripheral muscle movement-based stimulation intensity selection device applied to an electrical stimulator having an electrode array, the device including: a wearing inspection unit that measures an impedance value between each electrode and the skin and inspects whether the electrical stimulator is properly worn using the impedance value; an electrode pair selection unit that applies electrical stimulation by narrowing down the electrode range and calculates changes in signals obtained from an acceleration sensor and an electromyography sensor according to the applied electrical stimulation, thereby selecting an electrode pair to which a therapeutic electrical stimulation is to be applied; and an electrical stimulation application unit that applies electrical stimulation to the electrode pair selected by the electrode pair selection unit, using the highest stimulation intensity at which no muscle movement occurs as the therapeutic stimulation intensity.

[0023] The present invention has the advantage of maximizing the therapeutic effect through electrical stimulation by providing a device that can select and personalize the exact stimulation intensity.

[0024] In addition, the present invention has the advantage that even patients without specialized knowledge can find the exact stimulation location.

[0025] Figure 1 shows a flowchart of a peripheral muscle movement-based stimulation intensity selection method according to an embodiment of the present invention.

[0026] Figure 2 shows a detailed configuration of a peripheral muscle movement-based stimulation intensity selection device according to an embodiment of the present invention.

[0027] Figure 3 shows a flowchart of a step of selecting an electrode pair according to an embodiment of the present invention.

[0028] FIG. 4 is a diagram illustrating a step of selecting an electrode pair according to an embodiment of the present invention.

[0029] Figure 5 shows a graph for explaining the third step according to an embodiment of the present invention.

[0030] Figure 6 shows a transmission path of a nerve stimulation signal and a transmission path of a movement signal generated by stimulation according to an embodiment of the present invention.

[0031] Figure 7 shows the relationship between stimulation time and threshold voltage in sensory nerves and motor nerves according to an embodiment of the present invention.

[0032] Figure 8 shows a graph comparing the number of searches according to the individual neural threshold voltage search method according to an embodiment of the present invention.

[0033] Figure 9 shows a configuration diagram of a peripheral muscle movement-based stimulation intensity selection device according to an embodiment of the present invention.

[0034] In a method for selecting stimulation intensity based on peripheral muscle movement applied to an electrical stimulator having an electrode array,

[0035] A step of measuring the impedance value between each electrode and the skin and checking the state of wearing an electrical stimulator using the impedance value;

[0036] A step of applying electrical stimulation by narrowing down the electrode range, calculating changes in signals acquired from an acceleration sensor and an electromyography sensor according to the applied electrical stimulation, and selecting an electrode pair to which to apply therapeutic electrical stimulation; and

[0037] A step of applying electrical stimulation at the highest stimulation intensity that does not cause muscle movement to the electrode pair selected in the step of selecting the electrode pair as the therapeutic stimulation intensity;

[0038] A method comprising:

[0039] Hereinafter, the present invention will be described in detail with reference to the contents described in the attached drawings. However, the present invention is not limited or restricted by the exemplary embodiments. The same reference numerals presented in each drawing indicate components that perform substantially the same functions.

[0040] The purpose and effects of the present invention can be naturally understood or made clearer by the following description, and the purpose and effects of the present invention are not limited solely by the following description. Furthermore, in describing the present invention, if a detailed description of known technologies related to the present invention is deemed to unnecessarily obscure the gist of the present invention, such detailed description will be omitted.

[0041] The terminology used herein is merely used to describe specific embodiments and is not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this application, it should be understood that the terms "comprise" or "have" indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the description of the invention, but do not preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0042] While terms like "first" and "second" may be used to describe various components, these components should not be limited by these terms. These terms are used solely to distinguish one component from another. For example, without departing from the scope of the present invention, a first component could be referred to as a "second component," and similarly, a second component could also be referred to as a "first component."

[0043] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and shall not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0044] When interpreting components, even if there is no explicit description, it is interpreted as including the margin of error. When describing temporal relationships, for example, when temporal continuity is described with phrases such as "after," "following," "next to," or "before," this also includes cases where the relationship is not continuous, unless "immediately" or "directly" is used.

[0045] Hereinafter, the technical configuration of the present invention will be described in detail with reference to the attached drawings.

[0046] Fig. 1 illustrates a flowchart of a peripheral muscle movement-based stimulation intensity selection method according to an embodiment of the present invention. Referring to Fig. 1, the peripheral muscle movement-based stimulation intensity selection method may include a step of checking the state of wearing an electrical stimulator (S100), a step of selecting an electrode pair (S300), and a step of applying electrical stimulation (S500).

[0047] This method of selecting stimulation intensity based on peripheral muscle movement allows patients to wear the device in the appropriate location, ensuring consistent therapeutic effects. This method also allows for optimal therapeutic effects without causing discomfort. This method allows patients to select the combination of electrodes and intensity that maximizes stimulation delivery efficiency at the attachment site, maximizing therapeutic effects by delivering consistent stimulation regardless of who uses the device.

[0048] Fig. 2 illustrates a detailed configuration of a peripheral muscle movement-based stimulation intensity selection device (10) according to an embodiment of the present invention. Referring to Fig. 2, the peripheral muscle movement-based stimulation intensity selection device (10) may be composed of a stimulator and a cuff.

[0049] The cuff can be worn by wrapping it around a body part of a patient, and the inner surface of the cuff can be equipped with an array of electrodes. The outer surface of the cuff can be equipped with one or more magnets that can securely attach the cuff to a stimulator, and a connector that can electrically connect to the stimulator and transmit an electrical signal. The cuff can be worn on the patient's foot or arm, and can be secured using a Velcro. While the present invention exemplifies a cuff as an example, the invention is not limited thereto and can take any possible form, such as an attachable type. Furthermore, the Velcro can be any detachable means, such as a snap button.

[0050] The stimulator may include one or more processors, memories, and storage devices that perform a method for selecting stimulation intensity based on peripheral muscle movement. The stimulator may have a touchscreen on the front, and the patient may control the stimulation intensity, stimulation location, etc. by manipulating the touchscreen. The stimulator may have one or more magnets on the back that can secure the stimulator and the cuff together, and a connector that is electrically connected to the stimulator and can transmit electrical signals.

[0051] The stimulator can perform two main functions: first, it can automatically search for a stimulation location, and second, it can perform treatment by determining the stimulation intensity based on peripheral muscle movement.

[0052] The step (S100) of checking the state of wearing an electric stimulator can measure the impedance value between each electrode and the skin and check the state of wearing an electric stimulator using the impedance value.

[0053] Step (S100) of checking the state of wearing the electric stimulator Step (S100) of checking the state of wearing the electric stimulator can generate guidance to wear the electric stimulator again if the ratio of electrodes whose impedance value is higher than a preset value is higher than a certain ratio.

[0054] Step (S100) of checking the wearing status of the electrical stimulator is to measure the impedance between the electrodes and the skin by applying a microcurrent to each electrode when the patient first puts on the cuff. If the proportion of electrodes with an impedance value exceeding a certain standard (e.g., 10 kΩ) is above a certain level (e.g., 20%), the cuff may be requested to be re-wound. The impedance value and the proportion of electrodes may be set differently depending on the treatment area or treatment method, and the patient or medical staff may change the settings via the touchscreen.

[0055] The step of selecting an electrode pair (S300) can select an electrode pair to which a therapeutic electrical stimulus will be applied by narrowing down the electrode range and applying an electrical stimulus, and calculating changes in signals acquired from an acceleration sensor and an electromyography sensor according to the applied electrical stimulus.

[0056] Depending on the position of the electrode pairs used to apply therapeutic electrical stimulation, the amount of current actually delivered to the nerves varies, resulting in variations in stimulation efficiency and, consequently, differences in muscle movement. Quantitative analysis of differences in muscle movement can be achieved by measuring electromyography (EMG), a biosignal, or by measuring the physical quantities of actual movement. The present invention utilizes EMG and acceleration, one of the physical quantities of actual movement.

[0057] Fig. 3 illustrates a flowchart of a step (S300) of selecting an electrode pair according to an embodiment of the present invention. Referring to Fig. 3, the step (S300) of selecting an electrode pair may include a first step (S310), a second step (S330), and a third step (S350).

[0058] Fig. 4 is a diagram illustrating a step (S300) of selecting an electrode pair according to an embodiment of the present invention. Referring to Fig. 4, the first step (S310) divides the electrode array into one or more zones having a size of M*N, applies an electrical stimulus to each of the divided one or more zones, and then selects the top two zones with high responsiveness.

[0059] Step 1 (S310) can be used to determine the approximate location before finely selecting the electrode pair to apply therapeutic electrical stimulation.

[0060] Step 1 (S310) can divide the entire active array of A*B into all possible areas of size (A-2)*(B-2) to apply electrical stimulation, and select one or more areas that show the greatest response among them. In one embodiment, Step 1 (S310) can divide the entire 5*5 electrode array into six areas of size 3*3 to apply electrical stimulation, and select two areas that show the greatest response among them.

[0061] The second step (S330) divides the two areas selected in the first step (S310) into one or more areas having a size of m*n, applies an electrical stimulus to each of the divided one or more areas, and then selects the top ten areas with the highest responsiveness.

[0062] The second step (S330) can divide one or more areas (M*N) selected in the first step (S330) into one or more areas having a size of (M-1)*(N-1), and after applying an electrical stimulus to each of the divided one or more areas, one or more areas with high responsiveness can be selected.

[0063] In one embodiment, the second step (S330) can divide the two areas selected in the first step (S330) into all possible areas with a size of 2*2, and after applying an electrical stimulus to each of the possible areas, select up to 10 areas with high responsiveness.

[0064] Here, responsiveness can mean the magnitude of acceleration, which is one of the physical quantities of electromyography and actual movement, and M > m and N > n.

[0065] FIG. 5 is a graph illustrating a third step according to an embodiment of the present invention. Referring to FIG. 5, the third step (S350) may identify all possible electrode pairs in the 10 or fewer areas selected in the second step, apply electrical stimulation to all identified electrode pairs, and then select the electrode pair with the greatest responsiveness. The third step (S350) may apply electrical stimulation to all possible electrode pair combinations in one or more areas with high responsiveness selected in the second step (S330), and select the electrode pair with the greatest responsiveness. The electrode pair with the greatest responsiveness may be understood as the location of electrical stimulation that can exhibit the greatest therapeutic effect.

[0066] Referring to Figure 5, when an electrode array is positioned along the nerve path and current is generated in different combinations of electrode pairs, different movements of the toes can occur depending on the degree of nerve stimulation. If the stimulation is performed at the correct location, large movements (measured by an accelerometer) and EMG signals can be observed, as shown in the figure on the left. However, if the stimulation location is significantly off the nerve, almost no movement and EMG signals can be observed, as shown in the figure on the right.

[0067] Figure 6 illustrates the transmission path of a nerve stimulation signal and the transmission path of a movement signal generated by the stimulation according to an embodiment of the present invention. Referring to Figure 6, the transmission path of the nerve stimulation signal and the transmission path of the movement signal generated by the stimulation can be confirmed. When the nerve is stimulated at the ankle with a sufficient current strength, a movement occurs in which the big toe is lifted upward, and the movement generates an acceleration signal and an electromyography signal, so that the change in movement can be measured through a stimulator located at the ankle.

[0068] The step of applying electrical stimulation (S500) may apply electrical stimulation to the electrode pair selected in the step of selecting the electrode pair, with the highest stimulation intensity that does not cause muscle movement as the therapeutic stimulation intensity. The step of applying electrical stimulation (S500) may perform only a minimal search in selecting an intensity that can produce the optimal stimulation effect.

[0069] The step of applying electrical stimulation (S500) can select the highest stimulation intensity as the highest stimulation intensity among the stimulation intensities that only cause sensory nerves to fire without causing motor nerves to fire.

[0070] The stimulus intensity that fires only sensory nerves without firing motor nerves can be an electrical stimulus intensity generated with a voltage that is lower than the threshold voltage of the motor nerves and higher than the threshold voltage of the sensory nerves.

[0071] For a stimulus signal to be effective, it must induce firing of the target nerve, which requires a certain level of stimulation intensity. Generally, a stronger stimulus intensity can activate a wider range of nerves, resulting in greater therapeutic effects. However, as the intensity increases, muscle contraction can induce movement. Since even stronger stimuli can cause pain, the step of applying the electrical stimulation (S500) can be considered an appropriate stimulus for increased usability, with the highest intensity that does not induce movement being determined as the most appropriate.

[0072] Figure 7 illustrates the relationship between stimulation time and threshold voltage in sensory and motor nerves according to an embodiment of the present invention. Referring to Figure 7, a single nerve bundle typically contains both efferent motor nerves and afferent sensory nerves, and the stimulus intensity required for each nerve to fire may differ.

[0073] The step of applying electrical stimulation (S500) can define the threshold voltage (V1) that fires the sensory nerve using the following mathematical formula 1. Here, d represents the stimulation time.

[0074] [Mathematical Formula 1]

[0075]

[0076] The step of applying electrical stimulation (S500) can define the threshold voltage (V2) that fires the motor nerves using the following mathematical formula 2.

[0077] [Equation 2]

[0078]

[0079] Therefore, the step of applying electrical stimulation (S500) can derive the threshold voltage relationship between the motor nerve and the sensory nerve for signals having the same stimulation time as in the following mathematical expression 3.

[0080] [Equation 3]

[0081]

[0082] The step of applying electrical stimulation (S500) can select a stimulation intensity that independently fires only sensory nerves without firing motor nerves regardless of the stimulation length through the above mathematical expression 3, thereby achieving a therapeutic effect without discomfort such as movement and pain due to muscle contraction.

[0083] The step of applying electrical stimulation (S500) may include an initial stimulation application step (S510) and a stimulation intensity adjustment step (S530).

[0084] In order to find the appropriate intensity for stimulation, a method of checking muscle movement using methods such as electromyography or acceleration measurement is used while performing the stimulation. However, there is a problem that the longer it takes to find the appropriate stimulus in the stimulation intensity search process, the more discomfort the patient experiences, which may reduce usability and decrease the effectiveness of the treatment. The step of applying electrical stimulation (S500) can solve this problem through the initial stimulation application step (S510) and the stimulation intensity adjustment step (S530).

[0085] The initial stimulation application step (S510) can generate a maximum stimulation intensity average value by averaging the maximum stimulation intensities obtained from multiple people, and apply electrical stimulation using the maximum stimulation intensity average value as the therapeutic stimulation intensity.

[0086] While the threshold voltage range for triggering a nerve typically varies from person to person, statistically, it is known to follow a normal distribution. Therefore, the initial stimulation application step (S510) can apply a search technique that utilizes prior information about the normal distribution probability to determine the stimulus intensity.

[0087] In the stimulation intensity control step (S530), if movement occurs in the peripheral muscles due to the electrical stimulation applied in the initial stimulation application step (S510), the stimulation intensity may be reduced by half to apply the electrical stimulation, and if movement does not occur in the peripheral muscles due to the electrical stimulation applied in the initial stimulation application step, the stimulation intensity may be increased by half of the current intensity to apply the electrical stimulation.

[0088] The step of applying electrical stimulation (S500) may further include a repetition step (S550) of repeating the stimulation intensity adjustment step twice or more until there is no movement of the peripheral muscles or the minimum voltage adjustment limit of the stimulator is reached.

[0089] Specifically, the step of applying electrical stimulation (S500) can start the stimulation with the average value A0 (e.g., 2 mA) that can statistically fire the nerves of the largest number of people. If there is movement after the stimulation, the stimulation intensity is reduced by half and the stimulation is performed again. If there is no movement, the stimulation intensity is increased by half of the current intensity and the stimulation is performed to check whether there is muscle movement. If there is muscle movement, the stimulation intensity is reduced by half of the previous change (A n+1 =A n -|A n -A n-1 | / 2), if there is no muscle movement, the stimulus intensity can be increased by half of the previous change (A n+1 =A n +|A n -A n-1 | / 2). The highest intensity that does not cause movement can be selected as the therapeutic stimulation intensity by repeating the procedure until no movement occurs twice or until the minimum voltage control limit of the stimulator is reached.

[0090] Assuming that the threshold voltage for neural firing is normally distributed in the range of 1 to 3 mV and that the minimum voltage adjustment limit of the stimulator is 0.01 mV, when using the sequential increase / decrease method, which is the simplest stimulus search method, a maximum of 100 stimulations and an average of about 20 stimulations are required, and the error that occurs at this time is 0.0025 mV on average. If the voltage adjustment range that can be searched at one time is increased to reduce the number of searches, if the change is 0.05 mV, the voltage can be selected with a maximum of 20 stimulations and an average of 4.1 stimulations, but the error range of the final value increases to 0.0125 mV.

[0091] Figure 8 is a graph comparing the number of searches according to the individual neural threshold voltage search method according to an embodiment of the present invention. Referring to Figure 8, when using the step of applying electrical stimulation (S500) of the present invention, a maximum of 8 stimulations are required, an average of approximately 5.7 stimulations are required, and the average error is 0.0025 mV, allowing for very accurate and fast voltage selection.

[0092] Specifically, Figure 8 is a graph comparing the methods for randomly selecting a virtual stimulation target value (the maximum intensity without movement that would trigger stimulation when wearing an actual device) and finding the target value using a conventional sequential increase / decrease method and the proposed method. In all graphs, the horizontal axis represents a randomly generated target value.

[0093] In the graphs of the upper and middle parts of Fig. 8, the vertical axis represents the number of stimuli required to reach the target value from the stimulation start intensity of 2 mV. Referring to the upper graph of Fig. 8, the upper graph of Fig. 8 shows the number of stimuli when the minimum voltage adjustment unit of the stimulator is 0.01 mV and 0.05 mV in a general increase / decrease method. For example, when finding the closest value to the target value of 2.456 mV, 42 stimuli are required with an adjustment unit of 0.01 mV, which may result in an error of 0.005 mV. When the adjustment unit is 0.05 mV, 7 stimuli are required, which may result in an error of 0.015 mV.

[0094] Referring to the interrupt graph of Fig. 9, the interrupt graph of Fig. 8 represents the number of stimulations when using the present invention. For example, when finding the closest value to the target value of 2.456 mV, 5 stimulations are required at 0.01 mV, which may result in an error of 0.005 mV.

[0095] Referring to the lower graph of Fig. 8, the lower graph of Fig. 8 shows that the vertical axis represents the frequency of appearance of a total of 10,000 target values ​​randomly generated to draw the upper and middle graphs, and that it has a normal distribution between 1 and 3 mV.

[0096] Fig. 9 illustrates a configuration diagram of a peripheral muscle movement-based stimulation intensity selection device (10) according to an embodiment of the present invention. Referring to Fig. 9, the peripheral muscle movement-based stimulation intensity selection device (10) may include a wear inspection unit (100), an electrode pair selection unit (300), and an electrical stimulation application unit (500).

[0097] The peripheral muscle movement-based stimulation intensity selection device (10) may be a device (10) that performs the peripheral muscle movement-based stimulation intensity selection method described above, and may perform all of the peripheral muscle movement-based stimulation intensity selection methods described above.

[0098] The wear inspection unit (100) can measure the impedance value between each electrode and the skin and use the impedance value to check whether the electric stimulator is worn properly. The wear inspection unit (100) can perform the step (S100) of checking the wearing state of the electric stimulator described above.

[0099] The electrode pair selection unit (300) can apply electrical stimulation by narrowing the electrode range, and select an electrode pair to which therapeutic electrical stimulation will be applied by calculating changes in signals acquired from the acceleration sensor and the electromyography sensor according to the applied electrical stimulation. The electrode pair selection unit (300) can perform the step (S300) of selecting the aforementioned electrode pair.

[0100] The electrical stimulation application unit (500) can apply electrical stimulation to the electrode pair selected by the electrode pair selection unit at the highest stimulation intensity that does not cause muscle movement as the therapeutic stimulation intensity. The electrical stimulation application unit (500) can perform the step of applying electrical stimulation (S500).

[0101] While the present invention has been described in detail through representative examples above, those skilled in the art will understand that various modifications to the above-described embodiments are possible without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the described embodiments, but should be defined not only by the claims described below but also by all changes or modifications derived from the claims and equivalent concepts.

[0102] The present invention aims to provide a method and device for selecting stimulation intensity based on peripheral muscle movement that can cause an optimal therapeutic effect without causing discomfort to the patient and that can enable a patient to wear the device in a suitable position so that the device can always achieve a constant therapeutic effect.

Claims

1. A method for selecting stimulation intensity based on peripheral muscle movement applied to an electrical stimulator having an electrode array, A step of measuring the impedance value between each electrode and the skin and checking the state of wearing an electrical stimulator using the impedance value; A step of applying electrical stimulation by narrowing down the electrode range, calculating changes in signals acquired from an acceleration sensor and an electromyography sensor according to the applied electrical stimulation, and selecting an electrode pair to which to apply therapeutic electrical stimulation; and A step of applying electrical stimulation at the highest stimulation intensity that does not cause muscle movement to the electrode pair selected in the step of selecting the electrode pair as the therapeutic stimulation intensity; A method comprising:

2. In paragraph 1, The above inspection steps are: A method for generating guidance to re-wear the electrical stimulator when the ratio of electrodes having the above impedance value greater than or equal to a preset value is greater than or equal to a certain ratio.

3. In paragraph 1, The step of selecting the above electrode pair is: A first step of dividing the above electrode array into one or more zones having a size of M*N, applying an electrical stimulus to each of the divided one or more zones, and then selecting the top two zones with high responsiveness; A second step of dividing the two areas selected in the first step into one or more areas having a size of m*n, applying electrical stimulation to each of the divided one or more areas, and then selecting the top 10 areas with the highest responsiveness; and A method comprising a third step of distinguishing all possible electrode pairs in the 10 or fewer areas advertised in the second step, applying electrical stimulation to all distinguished electrode pairs, and then selecting the electrode pair with the greatest responsiveness. (Here, M > m and N > n) 4. In paragraph 1, The step of applying the above electrical stimulation is: A method of selecting the highest stimulus intensity among the stimulus intensities that fire only sensory nerves without firing motor nerves as the maximum stimulus intensity.

5. In paragraph 4, The intensity of the stimulus that fires only the sensory nerves without firing the above motor nerves is A method in which the intensity of an electrical stimulus is generated with a voltage lower than the threshold voltage of a motor nerve and higher than the threshold voltage of a sensory nerve.

6. In paragraph 4, The step of applying the above electrical stimulation is: A method comprising: an initial stimulation application step of averaging the highest stimulation intensities obtained from multiple people to generate a highest stimulation intensity average value, and applying electrical stimulation using the highest stimulation intensity average value as a therapeutic stimulation intensity.

7. In paragraph 6, The step of applying the above electrical stimulation is: A method comprising a stimulation intensity control step of applying electrical stimulation by reducing the stimulation intensity by half when movement occurs in peripheral muscles due to the electrical stimulation applied in the initial stimulation application step, and applying electrical stimulation by increasing the stimulation intensity by half of the current intensity when movement does not occur in peripheral muscles due to the electrical stimulation applied in the initial stimulation application step.

8. In paragraph 7, The step of applying the above electrical stimulation is: A method of repeating the above stimulation intensity adjustment step until there is no movement of the peripheral muscles more than twice or until the minimum voltage adjustment limit of the stimulator is reached.

9. In a peripheral muscle movement-based stimulation intensity selection device applied to an electrical stimulator having an electrode array, A wear test unit that measures the impedance value between each electrode and the skin and uses the impedance value to test the wearing status of the electrical stimulator; An electrode pair selection unit that applies electrical stimulation by narrowing down the electrode range, calculates changes in signals acquired from the acceleration sensor and electromyography sensor according to the applied electrical stimulation, and selects an electrode pair to which to apply therapeutic electrical stimulation; and An electrical stimulation application unit that applies electrical stimulation to the electrode pair selected from the electrode pair selection unit at the highest stimulation intensity that does not cause muscle movement as the therapeutic stimulation intensity; A device comprising:

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