KR20050046957A - Electrical therapy apparatus for performing function interlocking method using real-time feedback control loop - Google Patents

Abstract

The present invention provides a channel setting switch for generating at least one of an electrical stimulation providing unit for generating an electrical stimulation and inputting a body signal through an electrode, a response processing unit for receiving a bio signal from the electrode, an electrical stimulation providing unit, and a response processing unit. And a feedback performing unit controlling an operation of at least one of the electrical stimulation providing unit and the response processing unit by using a measurement value corresponding to at least one of the electrical stimulation unit and the biological signal of the response processing unit. The present invention relates to an electrotherapy apparatus using a function interlock method, wherein an electrotherapy device using a feedback control technique may be interlocked through a real time feedback function at the same time.

Description

Electrical therapy apparatus for performing function interlocking method using real-time feedback control loop}

The present invention relates to an electrotherapy apparatus of a function interlock method using a real-time feedback control technique, and in particular, the electrotherapy of a function interlock method using a real-time feedback control technique that allows the individual electric stimulation function, the support of the biofeedback function and each function is interlocked Relates to a device.

In general, there are surgical therapy, drug therapy, and functional therapy to treat neurological and muscle disorders of the body. Due to recent medical accidents and side effects, functional therapy is more used than surgical or drug therapy. Functional therapy is a method of alleviating or alleviating the symptoms of neurological disorders and muscle disorders by applying a pulse current or a biofeedback muscle exercise by using an electric electrode or a biofeedback method by attaching an attachment electrode or an implantable electrode to a disorder site.

1 is a configuration diagram of an electrotherapy device according to the prior art, Figure 2 is a view showing the shape of a general electrical stimulation signal.

Referring to FIG. 1, the electrotherapy apparatus according to the related art includes a body cavity insertion electrode 10, a peripheral device 20, a controller 70, a stimulus signal generator 80, and an EMG signal processor 90. The peripheral device 20 includes a display unit 25, an operation unit 30, a memory 40, a communication processor 50, and an operator terminal 60.

The electrotherapy device shown in FIG. 1 may perform an electrical stimulation function and a biofeedback function as an incontinence treatment device. However, the electrical stimulation function and the biofeedback function cannot be performed at the same time, and any one function can be selectively performed.

First, when the operator selects the electrical stimulation function using the operation unit 30, the control unit 70 transmits the electrical stimulation generation command to the stimulus signal generator 90, the stimulus signal generator 90 It is generated and input into the body through the body cavity insertion electrode (10). If necessary, the stimulus signal generator 90 may use a method of varying the pulse width in order to change the magnitude of the stimulus. Generally, the waveform of the electrical stimulation signal generated by the stimulus signal generator 90 and introduced into the body is shown in FIG. 2.

However, the conventional electrotherapy apparatus has a problem in that it cannot provide an impedance measurement function when used as an electrical stimulation function for providing electrical stimulation to the body. As a result, it is not possible to determine whether the intensity of the electrical stimulus currently applied to the body is appropriate, and there is a disadvantage in that the electrical parameter for the stimulus variable cannot be determined. In addition, since the impedance is not measured, the results before and after the treatment using the electrical stimulation are unknown. In addition, the conventional electrotherapy device has a problem that can not determine the magnitude of the current or voltage that determines the strength of the stimulation. That is, since the impedance change is not detected in real time to control the current, it causes side effects such as muscle fatigue, electric burns, and electric shocks.

In addition, the conventional electrotherapy apparatus has a problem in that it cannot provide a simulation function and an emulation function. This is because the electrotherapy device needs to suppress overcurrent in order to prevent an electric burn or an electric shock. That is, it is necessary to simulate (prediction) in advance to determine whether the degree of the electrical stimulus (that is, the current value) to be output is appropriate, and the current value that is conducted according to the impedance value after applying the stimulus current to the body It is necessary to emulate whether there is a difference from the pre-simulated current value according to the previously measured impedance value.

In addition, the conventional electrotherapy device has a problem that does not provide a rotational stimulation. That is, in the conventional electrotherapy apparatus, since the channel of the electrode (+ pole or-pole) is fixed, the impedance value is changed due to muscle fatigue or the like and does not meet the need to change the channel during treatment.

Next, when the operator selects the biofeedback function using the operation unit 30, the EMG signal processing unit 90 receives the EMG signal R-EMG from the body cavity insertion electrode 10, and encloses the received EMG signal. The detector is converted into an EMG envelope signal D-EMG and transmitted to the controller 70. The controller 70 analyzes the EMG envelope signal D-EMG and displays the analysis result data on the display unit 30. In addition, the controller 70 also displays the treatment target waveform GOAL-EMG in the memory 40 on the display unit 30.

Conventional electrotherapy devices have a problem in that they provide only a level detection function and no spectrum analysis function when used as a biofeedback function. That is, only the level was detected by the envelope detection method for the biopotential, so that only the movement of the muscle (ie, contraction or relaxation) could be visually displayed. Therefore, since it provides only the function of the exercise concept without any diagnosis function based on the spectrum analysis, proper treatment according to the patient's disability state is not possible and causes the side effect.

In addition, the conventional electrotherapy apparatus used as the biofeedback function can measure only the level in the time domain, and cannot measure the electrical parameter in the frequency domain. That is, the spectrum cannot be measured and the analysis of the various tests or the diagnosis result thereof cannot be derived, and thus, no evidence for determining the disorder of the nerve dorsal muscle (or denervation muscle) can be provided.

In addition, the conventional electrotherapy apparatus adopts a fixed gain method and a fixed low pass filtering frequency method, and thus there is a problem in that setting change (for example, gain change and channel change) during treatment is not easy. In addition, there is a problem that the discharge function of the charge accumulated through the electrode is not provided.

In addition, the conventional electrotherapy device has a problem in that the electrical stimulation function and the biofeedback function are independently performed but are not linked to each other.

Accordingly, an object of the present invention to solve the above-mentioned problems is to provide an electrotherapy apparatus of a function interlocking method using a feedback control technique in which the electrical stimulation function and the biofeedback function are simultaneously linked through a real-time feedback function.

Another object of the present invention is that the electrical stimulation function and the biofeedback function can be changed during the treatment, each function can be operated alone or in combination, and the electrical function of the function interlocking method using a feedback control technique capable of arbitrary selection of channels It is to provide a treatment device.

It is still another object of the present invention to provide a functional interlocking device using a feedback control technique, in which a diagnosis result can be compared before and after treatment.

It is still another object of the present invention to provide an electrotherapy apparatus of a function interlock method using a feedback control technique provided with an impedance measurement function and an automatic adjustment function of current for determining stimulus intensity when performing an electrical stimulation function.

Still another object of the present invention is to provide a function-based electrotherapy apparatus using a feedback control technique having a simulation and emulation function for performing an electrical stimulation function.

It is still another object of the present invention to provide an electrotherapy apparatus of a function interlock method using a feedback control technique capable of performing electromyography, automatic gain setting, and frequency setting when performing a biofeedback function.

Still another object of the present invention is to provide a functional interlocking device using a feedback control technique that can discharge charges accumulated through an electrode when performing a biofeedback function.

In order to achieve the above object, in the medical electrotherapy device which is operated by being coupled to an electrode that receives an electrical signal or inputs an electrical stimulus to a body part that is in contact with or is inserted into the body cavity of the patient, the electrical An electrical stimulation providing unit generating a stimulus and inputting the stimulus into the body through the electrode; A response processor configured to receive a bio signal from the electrode; A channel setting switch configured to connect at least one of the electrical stimulation providing unit and the response processing unit with the electrode; And a feedback performing unit controlling an operation of at least one of the electrical stimulation providing unit and the response processing unit by using a measurement value corresponding to at least one of the electrical stimulation of the electrical stimulation providing unit and the biosignal of the response processing unit. There is provided a medical electrical therapy device.

The feedback performing unit detects an electrical parameter corresponding to the electrical stimulation output from the electrical stimulation provider, and when the detected electrical parameter does not correspond to a predetermined value, a characteristic of the electrical stimulation output from the electrical stimulation provider The control signal for adjusting the signal may be transmitted to the electrical stimulation provider. If the electrical parameter is an activation amount, wherein the activation amount is a value measured as a result of being performed for inspection, diagnosis or control purpose according to a user's selection, the feedback performing unit is configured to perform the predetermined set value and the detected electrical power. A comparator for comparing the parameters; A monostable oscillator for outputting a pulse signal having a magnitude corresponding to a comparison result by the comparator; A counter for counting the pulse signal; And an activation amount calculation unit configured to calculate an activation amount using the set reference value and the counter result.

In addition, the feedback performing unit detects electrical parameters by using the biosignal of the patient input to the response processor and converts the biosignals having a predetermined size when the detected electrical parameters do not correspond to a predetermined set value. The control signal may be transmitted to the response processor. When the electrical parameters are frequency and phase, the feedback performing unit includes: a voltage controlled oscillator for generating an output oscillation frequency corresponding to an input control voltage; A programmable counter dividing the output oscillation frequency by a predetermined number; A phase comparator for generating an output voltage proportional to a phase difference with the biosignal and the voltage controlled oscillator through the programmable counter; A filter for averaging the output voltage to generate the input control voltage; A frequency meter for measuring a frequency using the output oscillation frequency; And a phase discriminator for detecting the phase of the biosignal using the input control voltage and the mapping table, wherein the mapping table is mapped with the input control voltage and the phase difference.

The feedback performing unit may predetermine a reference set value of the bio signal in the response processor, and when the measured value of the bio signal does not satisfy a predetermined set value, the feedback value of the electrical stimulation output from the electrical stimulation provider. You can adjust the size.

The feedback performer may preset an output condition of the electrical stimulation provider and set a measurement condition of the response processor to correspond to the output condition.

The electrical stimulus providing unit includes a waveform generator for generating a pulse signal corresponding to the control signal of the control unit; A characteristic combiner constituting a burst signal by combining a plurality of pulse signals generated from the waveform generator by a control signal of the controller; An output setter for adjusting the intensity of the electrical stimulus output per channel by combining a plurality of burst signals generated by the characteristic combiner; A stimulation controller for controlling the intensity of the electrical stimulation per channel by the control signal of the controller; A stimulus trigger controller to determine whether a feedback signal is received from the feedback performer; And a large signal amplifier that generates an electrical stimulus of a final stimulus intensity by multiplying the strength of the electrical stimulation per channel by a predetermined gain or a gain corresponding to the feedback signal.

The response processor may include: a differential amplifier receiving the biosignal through the electrode and the channel setting switch and detecting only a signal from which an in-phase is removed; A response trigger controller for determining whether a feedback signal or a user setting condition is input from the feedback performing unit; A filter for selectively filtering only an input signal corresponding to the feedback signal or a user setting condition; A variable amplifier for amplifying the filtered biosignal to a signal level at which visual discrimination is easy; And a signal detector that detects data corresponding to an arbitrary measurement item using the biosignal amplified by the variable amplifier.

Medical electrotherapy device according to the present invention is a memory for storing a program for performing the operation of the electrotherapy device, the data necessary for executing the program and a protocol for the diagnosis and treatment of the patient, wherein the protocol is an electrical stimulation function, A program for performing at least one of a biofeedback function and a feedback function; A display unit configured to display the measured value of the electrical stimulation and the measured value of the biological signal; And a controller configured to control operations of the electrical stimulus providing unit, the response processing unit, the channel setting switch, and the feedback performing unit using the data stored in the memory, and to control the display unit. The control unit may further include an operation unit for inputting a user's command to the control unit. Data transmission and reception between at least one of the operation unit, the memory, and the display unit and the control unit may be performed wirelessly.

The memory storage area may include a program information storage area, a first memory area group for performing an electrical stimulation function and a feedback function, and a second memory area group for performing a biofeedback function and a feedback function.

The channel setting switch may include a plurality of channels and a ground terminal, and the plurality of channels may be set to connect at least one of the electrical stimulation provider and the response processor to the electrode.

The operation unit includes first setting means for inputting information regarding a waveform of the electrical stimulation; And second setting means for setting an operation mode of the medical electrotherapy device.

According to another preferred embodiment of the present invention, a medical electrotherapy device which is operated by being coupled to an electrode that receives an electrical signal or inputs an electrical stimulus to a part of the body that is in contact with or is inserted into the body cavity of the patient An electrical stimulation providing unit for generating an electrical stimulation and inputting the electrical stimulation to the body through the electrode; A response processor configured to receive a bio signal from the electrode; A channel setting switch configured to connect at least one of the electrical stimulation providing unit and the response processing unit with the electrode; A feedback performing unit controlling the operation of at least one of the electrical stimulation providing unit and the response processing unit by using a measurement value corresponding to at least one of the electrical stimulation of the electrical stimulation providing unit and the bio-signal of the response processing unit; A memory for storing a program for performing an operation of the electrotherapy device, data for executing the program, and a protocol for diagnosis and treatment of a patient, wherein the protocol is at least one of an electrical stimulation function, a biofeedback function, and a feedback function Program for performing the functions of-; An operation unit for inputting a user command; And the electrical stimulation providing unit, the response processing unit, and the channel setting unit coupled to the electrical stimulation providing unit, the response processing unit, the feedback performing unit, the channel setting switch, the memory, and the operation unit using data stored in the memory. Medical electrotherapy device is provided, comprising a switch and a control unit for controlling the operation of the feedback performing unit.

The feedback performing unit detects an electrical parameter corresponding to the electrical stimulation output from the electrical stimulation providing unit, and the magnitude of the electrical stimulation output from the electrical stimulation providing unit when the detected electrical parameter does not correspond to a predetermined set value. An EST feedback control unit for transmitting a control signal for adjusting the control signal to the electrical stimulation providing unit; The response processor detects electrical parameters using a biosignal of a patient input to the response processor, and converts a control signal for converting a control signal into a biosignal having a predetermined size when the detected electrical parameter does not correspond to a predetermined set value. EMG feedback control unit for transmitting to; An event feedback to pre-specify the reference set value of the bio signal in the response processor and to adjust the magnitude of the electrical stimulus output from the electrical stimulus provider if the measured value of the bio signal does not satisfy a predetermined value; Control unit; And a loop feedback controller configured to preset output conditions of the electrical stimulation provider and set measurement conditions of the response processor to correspond to the output conditions.

The electrical stimulus providing unit includes a waveform generator for generating a pulse signal corresponding to the control signal of the control unit; A characteristic combiner constituting a burst signal by combining a plurality of pulse signals generated from the waveform generator by a control signal of the controller; An output setter for adjusting the intensity of the electrical stimulus output per channel by combining a plurality of burst signals generated by the characteristic combiner; A stimulation controller for controlling the intensity of the electrical stimulation per channel by the control signal of the controller; A stimulus trigger controller to determine whether a feedback signal is received from the feedback performer; And a large signal amplifier that generates an electrical stimulus of a final stimulus intensity by multiplying the strength of the electrical stimulation per channel by a predetermined gain or a gain corresponding to the feedback signal.

The response processor may include: a differential amplifier receiving the biosignal through the electrode and the channel setting switch and detecting only a signal from which an in-phase is removed; A response trigger controller for determining whether a feedback signal or a user setting condition is input from the feedback performing unit; A filter for selectively filtering only an input signal corresponding to the feedback signal or a user setting condition; A variable amplifier for amplifying the filtered biosignal to a signal level at which visual discrimination is easy; And a signal detector that detects data corresponding to an arbitrary measurement item using the biosignal amplified by the variable amplifier.

The electrode may be any one of an insertion type electrode, a skin electrode attached to a body, and a precipitation electrode.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

3 is a view showing the configuration of an electrotherapy device according to an embodiment of the present invention.

Referring to FIG. 3, the electrotherapy apparatus 310 according to the present invention may include an electrical stimulation provider 360, a channel setting switch 365, a response processor 370, a feedback performer 375, and a controller 380. Include.

The electrical stimulation providing unit 360 is a means for introducing the electrical stimulation generated by using the insertable electrode 320 which can be inserted into the vagina or anus or the epidermal electrode attached to the body. Although only the insertion type electrode is illustrated in FIG. 3, it is obvious that an epidermal electrode or a precipitation electrode may be used. Hereinafter, the case where the insertion type electrode is combined with the insertion type electrode 320 will be described. Detailed configuration and various embodiments of the electrical stimulation providing unit 360 will be described with reference to the accompanying drawings.

The channel setting switch 365 is a means for changing the setting under the control of the controller 380 so that the electrotherapy device 310 may perform an electrical stimulation function, a biofeedback function, or a feedback function. That is, the electrotherapy apparatus 310 according to the present invention may perform various functions simultaneously using the channel setting switch 365. A detailed configuration of the channel setting switch 365 and a setting for performing each function will be described in detail with reference to the accompanying drawings.

The response processor 370 receives the bio signal generated in the body through the insertion electrode 320 and the channel setting switch 365 in response to the electrical stimulation output by the electrical stimulation provider 360 (or muscle movement). Means to perform the biofeedback function. Detailed configurations and various embodiments of the response processor 370 will be described with reference to the accompanying drawings.

The feedback performing unit 375 is a means for performing individual function feedback or interlocking function feedback under the control of the control unit 380. The EST feedback processing unit 710-see FIG. 7, the EMG feedback processing unit 720-see FIG. 7, A loop feedback processor 730-FIG. 7 and an event feedback processor 740-7. Unlike the electrotherapy device 310 according to the prior art, the electrotherapy device 310 according to the present invention provides a feedback function. The individual functional feedback includes EST feedback, which is a feedback of the electrical stimulation provider 360, and EMG feedback, which is a feedback of the response processor 370. The EST feedback is performed by the EST feedback processing unit 710 to monitor the stimulus output of the electrical stimulus providing unit 360 so that a stimulus output having an appropriate signal characteristic (size) is achieved. The EMG feedback is performed by the EMG feedback processor 720, and the load characteristics (ie, the body) of the load (ie, the body) connected in series to the insertion electrode 320 using the biosignal introduced through the response processor 370. Characteristics). The interlocking function feedback can be divided into loop feedback and event feedback. The loop feedback is performed by the loop feedback processor 730 to set the electrical stimulus output condition in the electrical stimulus providing unit 360 and then measure the response of the response processor 370. The event feedback is performed by the event feedback processor 740, and the response processor 370 sets a biosignal input condition and then measures the response of the electrical stimulation provider 360. The detailed configuration of the feedback performing unit 375 will be described with reference to the accompanying drawings.

The control unit 380 uses the protocol data stored in the memory 340 (that is, a program executed for the electric stimulation function, the biofeedback function, or the interlocking feedback function) to transmit the operation command to correspond to the operation command input from the operation unit 335. The stimulus providing unit 360, the channel setting switch 365, the response processor 370, and the feedback performing unit 375 may be controlled. In addition, the display unit 330 displays detection data received from the response processor 370, the feedback performer 375, or the like.

The feedback executor 375 for interlocking the electrical stimulation provider 360 and the response processor 370 is controlled by a control signal from the controller 380, and according to the content of the control signal, the electrical stimulation provider 360 and And / or apply a control signal to the response processor 370 or transmit data collected from the electrical stimulation provider 360 or the response processor 370 to the controller 380. However, the configuration of the feedback performing unit 375 described above may be divided for convenience of description, and may be implemented as one device with the controller 380 when necessary.

The control unit 380, the electrical stimulation providing unit 360, the response processing unit 370, and the feedback performing unit 375 of the present invention are electrically insulated to reduce electrical noise and protect the patient. The insulation voltage is preferably 500 VAC or more based on the electrical stimulation providing unit 360 and the response processing unit 370, between each channel, or between electrodes. In addition, the insulation voltage with respect to the power supply terminal is 4000 VAC or more, and the insulation voltage with the ground terminal is preferably 1500 VAC or more, based on the electrotherapy apparatus 310 itself.

The electrotherapy apparatus 310 according to the present invention uses the channel setting switch 365 and the insertion electrode 320 to control the electrical stimulation (ie, current) generated by the electrical stimulation provider 360 under the control of the controller 380. Enter through the body through. In addition, the response processor 370 of the electrotherapy apparatus 310 receives the biosignal from the body through the channel setting switch 365 from the implantable electrode 320 under the control of the controller 380 and thus the biosignal itself or the biosignal. The measured electrical parameters are transferred to the controller 380. The configuration of the insertable electrode 320 connected to the electrotherapy device 310 according to the present invention inserted into the body or the epidermal electrode attached to the body surface will be described with reference to FIG. 5.

In addition, the electrotherapy device 310 according to the present invention is coupled with the display unit 330, the operation unit 335, the memory 340, and the communication processor 345, and communicates with the operator terminal 350 through the communication processor 345. Combined.

The display unit 330 may include a monitor and a printer as a means for displaying or printing various measurement data received from the electrotherapy apparatus 310. The operation unit 335 is a means for receiving a user's command and transmitting the command to the electrotherapy apparatus 310, and may include a keypad, a keyboard, a mouse, and the like. The memory 340 is a means for storing protocols, various utilities, and peripheral operation data according to diagnosis and treatment of a patient. The memory 340 may be subdivided into a program memory including data for performing the proper operation of the electrotherapy apparatus 310 and a data memory including data necessary for executing the program. Here, the memory 340 is referred to as a memory 340. Integrate and explain. The detailed configuration of the memory 340 will be described with reference to FIGS. 4A to 4L. The communication processor 345 is a means for communication with an external device. Of course, each module of the peripheral device (ie, the display unit 330, the operation unit 335, the memory 340, and the communication processor 345) may be configured independently for convenience or may be components of the electrotherapy apparatus 310. have. However, the display unit 330 may be a separate component by adding a separate wireless transceiver for noise reduction and manufacturing convenience.

Hereinafter, a method of wirelessly transmitting and receiving data between the electrotherapy apparatus 310, the peripheral apparatus, and the implantable electrode 320 will be briefly described. Of course, the communication method between the electrotherapy device 310 and the control unit 380 is also a serial (wired) communication method such as RS-232, USB, wireless communication method such as microwave (RF), infrared (IrDA), Bluetooth (Bluetooth) Naturally, the method may also be applied.

The electrotherapy device 310 according to the present invention includes an insertable electrode 320, a peripheral device (ie, a display unit 330, an operation unit 335, a memory 340, a communication processor 345, an operator terminal 350, etc.). And the like can transmit and receive the detection signal through a wireless communication method.

For example, two-way communication using a wireless transceiver included in the communication processor 345 may be applied to wireless communication between the control unit 380 and the operator terminal 350 of the electrotherapy apparatus 310. In addition, a unidirectional communication method may be used for wireless communication between the control unit 380 and the display unit 330 or the operation unit 335 of the electrotherapy apparatus 310. However, the direction of communication between the display unit 330 and the operation unit 335 will be reversed. This is because the display unit 330 performs a function of outputting data received from the control unit 380, but the operation unit 335 transmits the input command to the control unit 380. In addition, the controller 380 may perform a function corresponding to the data transmitted from the manipulation unit 335.

In addition, the wireless communication method between the electrotherapy device 310 and the implantable electrode 320 may be a unidirectional communication method similar to the communication method between the electrotherapy device 310 and the display unit 330. However, unlike the case of the display unit 330, the unidirectional wireless communication method between the electrotherapy apparatus 310 and the insertable electrode 320 does not include a receiver having an active element formed of electronic components on the insertable electrode 320. Therefore, when the electrotherapy device 310 transmits data to the implantable electrode 320, the implantable electrode 320 itself becomes an antenna to receive data. That is, the insertion type electrode 320 receives electromagnetic energy from a transmitter connected to the channel setting switch 365. This electromagnetic energy, which is applied to the present invention, is transmitted in the air as radio radiation, and the general laws of physics of wavelength, speed, and frequency apply. In this case, the insertion electrode 320 may be a precipitation electrode or a skin electrode. In the case of the precipitation electrode, the use frequency (or wavelength) can be set according to the length of the precipitation electrode or the length of the precipitation electrode can be adjusted according to the frequency. That is, if the wavelength of the medical frequency to be used and the length of the settling pole do not match according to the known laws of physics, the frequency may be added by adding a conductor (for example, a coil) of an appropriate length to the opposite side to which the settling pole is inserted. Naturally, the wavelength can be adjusted.

Electrotherapy apparatus 310 according to the present invention having a diagnosis and treatment function is a neuromuscular disorder electrotherapy device (for example, incontinence treatment device (fare plan treatment) and constipation treatment device (fecal incontinence treatment device) or electrophysiology diagnosis (test) device, etc. Can be used as

4A to 4L are diagrams showing the configuration of a memory according to an exemplary embodiment of the present invention.

The memory 340 coupled with the electrotherapy device 310 according to the present invention is a concept that collectively refers to all storage means such as RAM, ROM, hard disk (HDD), and floppy disk (FDD). It may be an internal memory of the electrotherapy device 310. The memory 340 stores data for performing the proper operation of the electrotherapy device 310, data necessary for executing any program, data detected in the course of patient treatment, and the like. The memory 340 according to the present invention stores a program that enables the independent execution of the electrical stimulation function and the biofeedback function, and the interworking of each function. Of course, programs and data for performing functions of the insertable electrode 320 and each module of the peripheral device (ie, the display unit 330, the operation unit 335, the memory 340, and the communication processor 345) may be further stored. .

When the user wants to execute a specific function of the electrotherapy device 310, the user selects a function of a desired item by using the manipulation unit 335 and the display unit 330. If any function is selected, the electrotherapy device 310 operates by calling a program corresponding to the function from the memory 340. In this case, the called program is stored in each unique area of the memory 340, and calls a unique electrical parameter stored in the memory area if necessary. Treatment, examination and diagnosis of the patient is made through the insertion electrode 320 or the epidermal electrode inserted into the body cavity of the patient and various analysis or statistical processing is made based on the data obtained through treatment, examination and diagnosis or Or by user control using a peripheral device.

The storage area of the memory 340 according to the present invention may be divided into a plurality of detailed areas. That is, the storage area of the memory 340 may include a program information storage area (first memory area), an eleventh memory area to a sixteenth memory area, a biofeedback function, and a feedback function that are called to perform an electrical stimulation function and a feedback function. The memory device may be divided into a twentieth memory area to a twenty-fourth memory area that are called to perform a function. Each storage area of memory 340 is comprised of unique electrical parameter data and each data is selectively called out as needed. Each storage area will be described in detail below.

4A illustrates a program information storage area (first memory area) of the memory 340.

Referring to FIG. 4A, a program information storage area (first memory area) is an area for storing patient information, protocols for diagnosis and treatment of each patient, data for various utilities and peripheral devices, and a system data area (D1). ), Patient data area D2, protocol data area D3, progress data area D4, session data area D5, unit data area D6, cluster data area D7, and the like. do. The hierarchical structure of the detailed areas included in D3 to D7 includes a plurality of progress data under one protocol data (that is, a program performed for electric stimulation function, biofeedback function, or interlocking feedback function). A plurality of session data is provided below the progress data, and a plurality of unit data are provided below one session data. For example, when one protocol data (ie, electrical parameter data) is selected by a user or by a specific function, sub-programs may be further linked and executed. In addition, the selected protocol is transferred to the electrical stimulation provider 360 or the response processor 370 by the controller 380 to prepare for configuring the protocol.

The system data area D1 stores data relating to various utility and peripheral device operations. The patient data area D2 stores data regarding personal information, treatment information, examination and diagnosis information, and the like. The patient data stored in the patient data area D2 is preferably databased by an RDBMS or a file structure, and includes the total number of treatments or diagnosis. The protocol data area D3 is an area for storing a plurality of programs for the entire treatment process performed during patient treatment. Each protocol data includes an identifier for discriminating whether it is an electrical stimulation function, a biofeedback function, or a feedback function according to each channel, and each function is a subordinate data consisting of a progress, a session, a unit, and a cluster structure. Has The progress data area D4 includes information on the number of treatments to be performed during the treatment period and includes a plurality of session data. The session data area D5 includes channel number information that is performed once and includes a plurality of unit data. The unit data area D6 includes data defining burst characteristics and includes a plurality of cluster data. The cluster data area D7 contains electrical parameters that define the pulse characteristics.

FIG. 4B is a diagram illustrating a stimulus mode information area (eleventh memory area) that stores program information regarding an operation mode of the electrical stimulation function so that the electrical stimulation mode of the memory 340 can be selected. When any one of the various stimulation modes shown in FIG. 4B is selected, the controller 380 transmits a stimulation mode control signal to the electrical stimulation provider 360.

Referring to FIG. 4B, the stimulation mode information area (eleventh memory area) includes a manual stimulation mode D11, an automatic stimulation mode D12, a conditional stimulation mode D13, and the like.

Passive stimulation mode (D11) is to ignore the characteristics of the body to perform the electrical stimulation in a predetermined protocol. The stimulus intensity is manually adjusted by the user. The passive stimulation mode D11 of the electrotherapy device 310 according to the present invention is for the same function as that performed in the conventional electrical stimulation device.

Automatic stimulation mode (D12) to determine the protocol by determining the characteristics of the body through the test or diagnosis, and to perform the appropriate electrical stimulation accordingly. That is, the impedance of the body is measured before the input of the electrical stimulus or measured in real time during the input of the electrical stimulus to automatically adjust the intensity of the electrical stimulus flowing into the body. Automatic stimulation mode (D12) is a unique feature of the present invention is a selection function that cannot be presented in the electrical stimulation device according to the prior art.

The conditional stimulation mode D13 allows electrical stimulation according to the needs or user's setting conditions during the execution of the manual stimulation mode D11 or the automatic stimulation mode D12. For example, the conditional stimulation mode D13 may store data for controlling the electrical stimulation function and the biofeedback function to be performed simultaneously, sequentially, or alternately.

4C is a diagram illustrating a modulation mode information area (a twelfth memory area) in which program information about a modulation mode is stored so that a modulation mode among electric stimulation functions can be selected. When any of the various modulation modes is selected, the controller 380 transmits a modulation mode control signal corresponding to the selected modulation mode to the electrical stimulation provider 360. The modulation mode information area (twelfth memory area) has a structure that can call data for setting unit pulses and bursts (pulse sets) in the time domain to implement each modulation mode.

The modulation mode information area (twelfth memory area) includes a phase modulation mode D21, a time modulation mode D22, a gradient modulation mode D23, and the like. The phase modulation mode D21 includes data for setting amplitude, pulse width, and frequency to arbitrary values so that the output phase can be varied. The time modulation mode D22 includes data for setting the burst period, the interval between bursts, and the burst chain (number) to an arbitrary value so that the output time can be varied. Gradient modulation mode (D23) is a data structure for setting the stimulus ramp-up period, stimulus sustain period (Plateau) period, ramp-down period, etc. to an arbitrary value to increase or decrease the output size Have

4D is a diagram showing a burst information area (13th memory area) that stores burst information for determining modulation characteristics for each modulation mode.

Referring to FIG. 4D, the burst information area (13th memory area) includes a burst time area D31, an inter-burst interval area D32, a burst duty area D33, a burst size area D34, and the like.

The burst time area D31 stores data for variably setting the burst time (that is, the time at which the electrical stimulus is output in the form of a pulse). The inter-burst interval area D32 stores data for variably setting the inter-burst interval (that is, the time between output bursts and bursts). The burst duty area D33 stores data that can variably set the burst duty (that is, the ratio of the time output during one period of the output burst). The burst size area D34 stores data that can variably set the burst size (that is, the amount of energy outputted).

4E is a diagram showing a pulse information area (14th memory area) for storing pulse information called to determine a characteristic of a burst among the parameters of the electrical stimulation. That is, the pulse information may be minimum basic information for performing the electrical stimulation function.

Referring to FIG. 4E, the pulse information area (14th memory area) includes a frequency area D41, a pulse width area D42, an amplitude area D43, a duty area D44, a waveform area D45, and the like. .

The frequency domain D41 stores data for allowing the frequency (i.e., the inverse of the time including the pause time in the pulse) to be arbitrarily set. The pulse width information D42 stores data that can vary the pulse width (that is, the signal waveform obtained by subtracting the rest time from one period). For example, in the case of symmetrical abnormal waves, it is calculated as twice the time of single phase waves. The amplitude area D43 stores data that can be converted into an RMS value when the amplitude (that is, the maximum value of one periodic signal representing 0 to a peak value) is expressed as a DC averaging voltage. However, if it is not a symmetrical abnormal wave, it is not symmetrical, so it is represented by a peak value to a peak value. The duty area D44 stores data varying the duty (that is, the ratio of the non-zero value in one period) according to the frequency and the pulse width. The waveform area D45 stores data for selecting signals of single phase waves, ideal waves, and polyphase waves as signal characteristics of one cycle. The electrical stimulation input to the body from the electrotherapy device 310 according to the present invention may be a combination of a fundamental wave (eg, square wave, sine wave, triangle wave) and an application wave (eg, differential wave), And sonic phase can also be combined.

4F is a diagram illustrating a channel information area (a fifteenth memory area) that stores channel information for determining channel settings and characteristics of output according to the channel.

Referring to FIG. 4F, the channel information area (15th memory area) is an area for storing program information for summing the total output energy of the electrical stimulus according to the number of channels in the case of multiple channels (two or more channels). The configuration area D51, the electrode polarity area D52, the output intensity area D53, the chain information area D54, the treatment time area D55, the location information area D56, and the like. Since the channel information area (the fifteenth memory area) is for defining characteristics relating to each electric stimulation mode in which the memory areas described above are allocated to one channel, it is necessary to define additional channel information in the case of multiple channels. to be.

The channel configuration area D51 stores data for changing the function of each channel. For example, if the channel of the electrode is composed of multiple channels and is inserted into or attached to the body and wants to change the functions of the channels (i.e. change the path of the stimulus output to another channel), physically reinsert or reattach it. Without changing the channel through the channel setting switch (365).

The electrode polarity area D52 stores data that can be selectively changed through the channel setting switch 365 without physically changing the positive and negative electrodes of each channel of the electrode.

The output intensity area D53 stores data for adjusting the intensity of the stimulus output through the electrode. That is, the output intensity represents the stimulus intensity and is defined as a burst characteristic in the time domain and ultimately is determined as the integral of the current value. The current intensity (that is, the current value converted into output per second) to determine the stimulus intensity is to be set as the output intensity, which has the effect of having a patient protection function that can limit the intensity of the stimulus.

The chain information area D54 stores data for arbitrarily setting the burst characteristics (eg, number, time) of the electrical stimulation output through the channel. The treatment time region D55 stores data that can arbitrarily vary the stimulation time output through a specific channel. The positional information area D56 stores data for setting the position of the body cavity (eg, vagina, anus) or the percutaneous area (eg, the abdomen and thigh).

FIG. 4G is a feedback information area (16th memory area) for storing feedback information for setting a biofeedback input condition to control an electrical stimulus output or vice versa for determining a condition setting or a state measurement. That is, the feedback information area (the sixteenth memory area) feeds back and measures the stimulus information output when the electrical stimulation is output through the single channel or the multichannel of the electrode, thereby measuring the load characteristics (tissue characteristics) of the body or the output stimulus information. This is to set a feedback condition for verifying abnormality. Therefore, the configuration data of the feedback information may be a biosignal detected through an electrical stimulation parameter or a biofeedback function.

The feedback information area (16th memory area) includes a loop feedback area D61, an event feedback area D62, a measurement information area D63, a condition setting information area D64, a conversion information area D65, and the like.

The loop feedback area D61 stores data for conditionally performing the biofeedback function by setting a condition such as a threshold current output from the electrical stimulation function. The event feedback area D62 stores data for conditionally performing the electrical stimulation function by setting a condition such as a threshold voltage of the biosignal input from the body in the biofeedback function. The measurement information area D63 is for measuring the impedance of the body before outputting the electrical stimulation in the electrical stimulation function so as to automatically determine the output current value. In addition, in order to measure impedance consisting of resistance and reactance, not only resistance but also frequency, inductance, and capacitance constituting reactance components are measured. The advantage is that it is possible. In addition, when the current value is manually determined, an output current or an output time of the electrical stimulation provider 360, which is set as a trigger signal based on event feedback data originally measured by the response processor 370, may be arbitrarily set.

The condition setting area D64 stores data for setting conditions (eg, threshold current) in the electrical stimulation function and conditions (eg, threshold voltage) in the biofeedback function.

The conversion information area D65 is a unit conversion, dimensional conversion and calculation (calculation) of data processed between homogeneous or heterogeneous functions of the electrotherapy device 310 as well as other heterogeneous devices (for example, magnetic electric stimulators), and the like. Stores data that can be compared with the measured data in.

4H shows a biofeedback mode information area (20th memory area) that stores program information relating to the operation mode of the biofeedback function. When the user selects a random mode, the controller 380 transmits the biofeedback mode control signal to the response processor 370.

Referring to FIG. 4H, the biofeedback mode information area (20th memory area) includes a diagnosis mode area D71, a test mode area D72, an exercise mode area D73, and the like.

The diagnostic mode area D71 stores data for measuring a spectrum of a biosignal input in the absence of electrical stimulation. The test mode area D72 stores data for measuring a spectrum of a biosignal in a state where an electrical stimulus is input. The exercise mode area D73 stores data for measuring an average value (direct current value) of the biosignal input without the electrical stimulation.

Comparing the electrotherapy device according to the prior art and the electrotherapy device 310 according to the present invention in the concept of muscle movement, the electrotherapy device according to the prior art measures only the potential difference according to the contraction, relaxation of the muscle whether the muscle movement In contrast to providing only information on, the electrotherapy device 310 according to the present invention measures the spectrum of the bio-signal according to the contraction and relaxation of the muscles, so whether the movement of the muscles, the reason for the movement, if the body tissue ( Analyze the function and condition of nerves and muscles). In addition, the electrotherapy apparatus 310 according to the present invention may increase the effect of exercise by appropriately applying electric stimulation using a feedback function when autonomic muscle movement is impossible. Therefore, the electrotherapy device 310 according to the present invention provides a method of exercise based on physiological principles rather than simple repetitive exercise of muscles, thereby providing a scientific method of exercise without side effects (aggravation) and maximizing the effect of exercise.

4I illustrates a diagnosis and exercise information area (21st memory area) that determines whether the information is generated by an external stimulus or by self-exercise as a basic unit for determining the characteristics of the biosignal. That is, the diagnosis and exercise information area (21st memory area) is an area for storing program information for measuring diagnosis results or exercise results for the nerves and muscles of the body that can be implemented by the biofeedback function. The electrical parameters stored in the diagnostic and exercise information area (21st memory area) are not the same as the electrical parameters in the electrical stimulation function, except for some features (for example, the shape of the signal is a continuous polyphase wave rather than an interrupted pulse). Is interpreted the same.

The diagnostic and exercise information region (21st memory region) includes an amplitude region D81, a frequency region D82, a phase region D83, a waveform region D84, an offset region D85, an acoustic region D86, and an energy region. (D87) and the like.

The amplitude area D81 stores data for measuring the RMS value, the maximum value, the peak value, and the RMS value of the input biological signal amplitude. For example, the biosignal may be a comparison waveform of an asymmetric polyphase wave.

The frequency domain D82 stores data for measuring the frequency of the input biosignal. Since the biosignal may be a comparison waveform of an asymmetric polyphase wave, the frequency is obtained through a peak value, zero-crossing, or fast Fourier transform (FFT), and the presence or absence of DC offset data (D85) is considered. . Therefore, the frequency domain D82 may further include data for further signal processing the measured value.

The phase area D83 stores data for measuring or calculating (calculating) phase distortion between the input signal and the output signal according to the frequency increase and decrease.

The waveform area D84 stores data for measuring one period waveform of the biosignal and comparing the waveforms measured during each period.

The offset area D85 stores data for measuring an offset (i.e., a direct current signal in an asymmetric polyphase wave comparison waveform of an alternating current signal and a direct current signal).

The sound region D86 stores data for processing sound.

The energy area D87 stores data for converting the total amount of activation using the hourly average value of the biosignal. When measuring bio signals, the body is assumed to be an energy source, and the total energy output from the body is used as a parameter for diagnosing the characteristics of nerves and muscles. Since most biological signals are composed of asymmetrical polyphase waves, the average hourly value of the input signal is the average value of the two-phase alternating signal (that is, the DC voltage), rather than the average value of one period waveform. Is detected and averaged (low pass filter concept).

Fig. 4J shows an inspection information area (22nd memory area) for inputting electrical stimulation for examination and storing inspection information for measuring the physiological phenomenon resulting therefrom. That is, the test information area (22nd memory area) stores program information for performing various tests that can be implemented as a biofeedback function in conjunction with the electrical stimulation function.

The inspection information area (22nd memory area) includes the denaturation reaction inspection area D91, the electromotive current inspection area D92, the test inspection area D93, the light-curve curve inspection area D94, the flow control ratio test area D95, Pulsation ratio test region D96, nerve excitability test region D97, nerve conduction velocity test region D98, EMG test region D99 and the like.

Reaction of degeneration (RD) region (D91) is a crackdown test for denaturation reactions (i.e., a condition in which nerves lose their electrical conductivity and fail to excite and thus contract muscles). Stimulates with a current of pulsed galvanic current and a paradic current to store current data so that the current response can be compared relatively. do. At this time, it is preferable to have a measurement means (for example, a trigger off means proportional to the minimum recognizable excitability of the tissue) for confirming the degree of excitation (response degree) of the tissue.

The Rheobase test area (D92) uses data for Rheobase, the current required for muscles to minimize contraction, to detect data of neuromuscular, denervation, and nerve dominant muscles. Save it. That is, by applying a linear current source to the excitable tissue to excite the excitable tissue, the degree of excitability of the excitable tissue and the current value of the flowing current (for example, 2 to 18 mA / 5 to 35 V in the normal case) are measured. , Denervation dorsal roots, nerve dominant muscles to determine the characteristics.

The tooth test region D93 stores data for detecting characteristics of the nerve dorsal muscle, the denervation muscle, and the nerve root muscle using the tooth tooth (Chronaxy). Chronaxy refers to the time taken to excite by stimulating twice the electromotive current under the electromotive current inspection condition. Chronaxy is a representative test for the excitability of excitatory tissues. The excitability of tissues is inversely proportional to that of excitatory tissues. Therefore, stimulating the excitable tissue using a double current value and measuring the time until the excitation occurs to determine the characteristics of the nerve domination muscles, denervation muscles, nerve dominant muscles.

The temporal curve inspection area D94 stores data for detecting the intensity of the stimulus and the magnitude of the time to confirm the degree of response according to the current intensity and the energization time (that is, the total amount is converted into energy). In electrical stimulation of excitatory tissues (eg, rhizomes and muscles), the strength of the current and the duration of energization are inversely related. The degree of reaction is determined by the strength of the current and the energization time. In this case, the two variables, strength and time, represented by graphs of X and Y coordinates are referred to as strength duration curve (SDC).

The flatstream stiffness ratio test (D95) stores data for detecting the characteristics of the galvanic tetanus ratio (GTR), which appears differently in the neuromuscular, denervation and neuromuscular muscles. The ratio of the amount of current causing contraction to the amount of current contracting is called the galvanic tetanus ratio (GTR). In general, when nerve domination is normal, stimulation with galvanic current (DC) causes immediate spasm, and stimulation with reactive (asymmetrical) current (AC) causes immediate contraction. In addition, when excitatory tissues (nerve and muscle) gradually increase the stimulus intensity (current strength), nerves have high compliance rate, but muscles have low compliance rate, resulting in different spasms and contractions. Therefore, the degree of compliance (ie, abnormalities of nerves and muscles) is determined by using the current ratio causing spasms and contractions. However, since it is not possible to use direct current (direct current) as the source of stimulation, it must be modulated to intermittent direct current and, if necessary, the use of other methods (e.g. sensitized currents) to induce stress.

The pulsation ratio test area D96 stores data for detecting characteristics of pulsation ratios that appear differently in the nerve dorsal muscles, the denervation muscles, and the nerve dorsal muscles. For example, increasing the frequency within a burst at 1 ms bursts and 100 ms bursts increases the current value. In this case, the ratio of the amount of current required to cause the same muscle contraction is called a pulse ratio.

The nerve excitability test area D97 stores data for performing a nerve excitability test for determining excitability and conductance of nerves that are different from nerve dorsal muscles, denervation muscles, and nerve dorsal muscles. First, two points (first point and second point) to be measured in the nerve path are selected to apply a stimulus having a pulse width of 100 us to the first point, and then increase the current intensity while changing the amplitude. Measure the current value from the third point until trigger off. In addition, the current value is measured in the same manner for the second point. The ratio of the current values at two points is called the neuronal excitability test.

The nerve conduction velocity test area D98 stores data for detecting characteristics of the nerve conduction velocity (NCV) that is different in the nerve dorsal muscle, the denervation muscle, and the nerve dormant muscle. Nerve conduction velocity (NCV) is the value obtained by selecting two points of the site to be measured and dividing the distance (d) between the two points of stimulation by the difference (?? t). s]. In other words, if the nerve conduction velocity is CV, CV = d / ?? t [m / s]. Nerve conduction tests stimulate peripheral nerves. Therefore, it is possible to identify diseases and injuries that are difficult to diagnose only by electromyography, for example, lesions, sites, extents, and prognosis of peripheral nerves. Of course, the motor nerve conduction velocity measurement, sensory nerve activity potential measurement, sensory nerve conduction velocity measurement can be further subdivided, and the method of calculating the nerve conduction velocity may be various. In addition, the nervous system of the body has a very complex impedance, so phase delay, such as pure inductance or capacitance, cannot be accurately detected in the time domain. Therefore, the electrotherapy device 310 according to the present invention uses energy propagation rather than signal conduction. The energy propagation method means that the electrical stimulus providing unit 360 propagates different energies (a), (b), and (c) to the response processor 370 through the electrode and the body. ) ', (b)', (c) 'Receive energy and measure the propagation time. That is, the electrical stimulation providing unit 360, the response processor 370, and the feedback performing unit 375 are used.

The EMG test area D99 stores data for measuring and analyzing an electrical signal coming from the insertion activity of the electrode and the voluntary activity after the insertion activity. The electrotherapy apparatus 310 according to the present invention may perform spectrum analysis in the frequency domain as well as signal analysis in the time domain. Electromyography (EMG) examination differs from the others described above as follows. Firstly, it does not require any external stimulus and detects electrical activity in pure nerves and muscles. Secondly, the measuring device has the capability of measuring a bio-signal composed of a frequency band of 2 to 10,000 Hz and an amplitude of 0.003 to 15.0 mV. Electrotherapy apparatus according to the present invention in order to solve the problem that the conventional EMG can not completely remove the electrical activity of the surface muscles, difficult to detect the electrical activity of the deep muscles, loss of high frequency components, etc. Reference numeral 310 enables spectrum analysis in the frequency domain.

Each trigger off means may be provided for proper performance of the various test modes described above. In order to facilitate the understanding, the configuration method of the above-described various inspection modes will be briefly described.

For example, in the case of denaturation response test, electromotive current test, dental test, lecture curve test, flat current ratio test, pulsation ratio test, and neuroexcitability test, the neuromuscular tissue assumed as a load in the electrical stimulation provider 360 ( Electrical stimulation to excitatory tissue), and measure a current or voltage input from the nerve muscle tissue to the response processor 370. In addition, when the user sets a condition for measuring at which point in time through the control unit 380 to the response processor 370 and / or the feedback performer 375, the user may return from the feedback performer 375 to the response processor 370. Measurements are made at the correct time using the trigger signal transmitted.

In addition, in the case of the nerve conduction velocity test, the electrical stimulation providing unit 360 inputs a predetermined reference signal to the body and performs a confirmation process, and then the feedback performing unit 375 that the reference signal (measured value) is applied to the body. Through the transmission to the response processor 370. The response processor 370 calculates a time difference between both signals when a biosignal matching the reference signal (measured value) received from the electrical stimulation provider 360 is received through the feedback performer 375. Of course, the biological signal detected by the response processor 370 may be transmitted to the electrical stimulation provider 360 through the feedback performer 375, and the electrical stimulation provider may calculate a time difference by comparing with a reference signal (measured value). It may be. Also, since the channel of the electrode is fixed at the time of manufacturing the electrode, the separation distance can be known, and thus the conduction speed (ie, the conduction distance / conduction time) can be easily calculated.

In addition, the EMG test may be performed by, for example, the EMG feedback processor 720. That is, when the biopotential measured by the response processor 370 is weak or does not satisfy the user setting condition, the trigger signal may be detected and fed back to the electrical stimulation provider 360 to perform electrical stimulation. This is called EMG triggered stimulation.

4K is a diagram illustrating a channel information area (a twenty-third memory area) that stores channel information when the channel information of the biofeedback function is composed of multiple channels. The configuration of the channel information area (the twenty-third memory area) is similar to that of the fifteenth memory area, but is preferably allocated separately because the data contents are different and the electrical stimulation function and the biofeedback function do not operate sequentially.

Referring to FIG. 4K, the channel information area (23rd memory area) includes the channel configuration area D101, the electrode polarity area D102, the target intensity area D103, the chain information area D104, and the pulsation time area D105. , Location information area D106, and the like.

The channel configuration area D101 stores data for changing the function of each channel. For example, if the channel of the electrode is composed of multiple channels and is inserted into or attached to the body and wants to change the functions of the channels between them (that is, change the input path of the biopotential to another channel), physically reinsert or reinsert the channel. This is to allow the channel to be arbitrarily changed through the channel setting switch 365 without being attached.

The electrode polarity area D102 stores data that can be selectively changed through the channel setting switch 365 without physically changing the positive (+) and the negative (−) of each channel of the electrode.

The target intensity area D103 stores data for changing the number of burst chains for varying the amplitude and duration of the single burst target waveform, and for varying the total momentum. The target intensity is the target waveform presented when the biofeedback function is used in the exercise mode. In order to present the target visually to the patient by varying the amplitude corresponding to the biopotential in the time domain and varying the duration to increase the total amount of exercise.

The chain information area D104 stores data for analyzing burst characteristics (for example, number and time) of bio signals input through a channel or measuring and combining all bursts.

Pulsation time region D105 stores data for measuring the amplitude and pulsation time of the burst (ie, the holding time of the individual bursts). Pulsation time is referred to as treatment time, including downtime.

The positional information area D106 stores data that can vary the application position along with the channel configuration.

4L is a feedback information area (24th memory area) that stores feedback information of a biofeedback function. The feedback information area (the twenty-fourth memory area) stores program information on whether the electrical stimulation function and the biofeedback function are individual or interlocked, and information according to each channel. The configuration of the feedback information area (24th memory area) is similar to that of the sixteenth memory area, but is preferably allocated separately because each data content is different.

The feedback information area (24th memory area) includes a loop feedback area D111, an event feedback area D112, a measurement information area D113, a condition setting information area D114, a conversion information area D115, and the like.

The loop feedback area D111 stores data for performing the biofeedback function under the set electrical stimulation condition by setting a condition such as a threshold stimulation current outputted from the electrical stimulation function to the stimulus.

In contrast to the loop feedback, the event feedback area D112 measures a biosignal input from the body in a biofeedback function, sets a condition using a threshold biovoltage, and then performs an electrical stimulation function under the set biofeedback condition. Save the data.

The measurement information area D113 is used as information for measuring the threshold voltage or current of the biosignal causing the minimum visual contraction (MVC) of excitable tissue (nerve and muscle) and feeding it back to the electrical stimulation provider 360. Or data for storing or recalling the measured value of the EST feedback information (ie, threshold voltage, current or impedance of the output stimulus signal) coupling the output of the electrical stimulus. The measurement information may be actual measured data or data calculated (calculated).

The condition setting area D114 stores data for setting conditions fed back based on the biofeedback function (eg, threshold voltage, current, frequency, etc., of a biosignal input from the body) as a trigger signal.

The transformation information area D115 may include unit conversion, dimensional transformation, and calculation (calculation) of data processed between homogeneous or heterogeneous functions of the electrotherapy device 310, as well as other heterogeneous devices (for example, a perineal pressure gauge ( It stores data that can be compared with the measured data of Perineometer, Manometer, etc.).

5A and 5B are views illustrating a configuration and a connection relationship between an electrode and a channel setting switch according to an exemplary embodiment of the present invention.

In general, an electrode is composed of a single channel or a multi-channel, and is inserted into the body cavity (ie, vagina or anus) of the body or attached to the skin to apply electrical stimulation to the body or receive a bio signal from the body. That is, the electrode may be configured in a bandage form (ie, a patch electrode) to attach to the skin, or may be configured as an insert (ie, an insertion electrode) for insertion into a body cavity (ie, vagina or anus), or may consist of a needle-like precipitation electrode. (Ie, insertion electrodes).

The electrode may be detached from or attached to the body or the electrotherapy device 310, and is configured in a disposable or recyclable form.

However, in the case of electrical stimulation, the electrode should be composed of two conductors having (+) and (-) poles per channel, and the conductors should be insulated with a non-conductor. In addition, in the case of the biofeedback, since a conductor capable of grounding is needed in addition to the (+) and (-) poles per channel, the channel is composed of a total of three conductors, and each conductor must be insulated with a non-conductor. . Therefore, both conductors or channels must be insulated, and one conductor has a structure in which an electrical stimulation function and a biofeedback function cannot be performed at the same time.

Hereinafter, referring to FIG. 5A, an electrode according to the present invention capable of simultaneously or alternately performing an electrical stimulation function and a biofeedback function (that is, an insertion electrode 320, a precipitation electrode and an epidermal electrode, hereinafter, an insertion electrode 320). ), And the configuration of the channel setting switch 365 will be described.

Referring to FIG. 5A, the insertable electrode 320 includes a positive electrode (+) and a negative electrode (−), and the channel electrode for performing the electrical stimulation function and the channel electrode for performing the biofeedback function are physically the same. It is composed. Therefore, not only the entire two-channel electrode can be used to perform the electrical stimulation function or the biofeedback function, but also each channel can independently perform the electrical stimulation function and the biofeedback function to perform the feedback function. . However, in the case of a multi-channel insertion type electrode, it is preferable to include a plurality of electrodes within a limited size and separately use them to perform various functions (that is, electrical stimulation function, biofeedback function, or feedback function). Of course, even in the case of a channel whose allocation is determined, the polarities of the electrodes forming the channel may be interchanged. For example, (a) (i.e. (+) pole) and (b) (i.e. (-) pole) assigned to the channel 1 electrode of the electrical stimulation function are respectively (a) by the channel setting switch 365. (Ie, (-) pole) and (b) (ie, (+) pole). In addition, the reference electrode (Ground) is an electrode (ie, (e) and (5)) which are physically identical in the electrical stimulation function or the biofeedback function, and is always used as the reference electrode of the input / output signal regardless of each function. This is because it is necessary for measurement or signal input in the electrical stimulation function or the biofeedback function.

5B illustrates a connection relationship of the channel setting switch 365.

As described above, the channel setting switch 365 is a means for allowing the electrotherapy device 310 to perform the electrical stimulation function, the biofeedback function or the feedback function under the control of the controller 380. The channel setting switch 365 is coupled to the insertable electrode 320, the electrical stimulation provider 360, the response processor 370, and the controller 380 as shown in FIG. 5B.

As shown in FIG. 5B, the insertion electrode 320, the electrical stimulus providing unit 360, and the response processing unit 370 are assumed to be composed of two channels, respectively. do. That is, in this case, the electrical stimulation providing unit 360 and the response processing unit 370 operate as two channels when performing the functions individually, but operate as one channel when they are performed at the same time.

First, the operation of the channel setting switch 365 when the electrotherapy device 310 according to the present invention is used only as a function of the electrical stimulation will be described.

As an input and an output for configuring two channels, the output terminals of the electrical stimulation providing unit 360 are (a), (b), (c) and (d) terminals, and the input terminal of the insertion type electrode 320 is Y1. , Y2, Y3 and Y4 terminals. If the output (a) terminal, (b) terminal and the input Y1 terminal and Y2 terminal of the electrical stimulation providing unit 360 as the terminal of the channel 1 are set, the channel setting switch 365 is the control unit 380. Channel 1 is formed by allowing them to be physically connected (switched). In addition, the channel setting switch 365 is a terminal other than the input and output terminals set to channel 1 (that is, the input of the output (c) terminal, (d) terminal and the insertion type electrode 320 of the electrical stimulation providing unit 360) Channel 2 is formed using the Y3 terminal and the Y4 terminal). That is, in forming the channel 1 and the channel 2, the output terminal of the electrical stimulation providing unit 360 and the input terminal of the insertion type electrode 320 do not overlap. The same applies to the case of using the (a) terminal, the (b) terminal and the input Y3 terminal and the Y4 terminal of the insertion type electrode 320 as the terminal of the channel 1 as the terminal.

Next, the operation of the channel setting switch 365 when the electrotherapy device 310 according to the present invention is used only as a function of the biological feedback will be described.

Even in this case, the operation of the channel setting switch 365 is similar to the case where the electrotherapy apparatus 310 according to the present invention is used only as a function of the electrical stimulation. However, only the output signal of the electrical stimulation providing unit 360 acts as an input signal of the insertable electrode 320 and the output signal of the insertable electrode 320 acts as an input signal of the response processor 370 due to signal characteristics. . That is, if the input (1) terminal, the (2) terminal and the output Y1 terminal and the Y2 terminal of the response processing unit 370 are set as the terminal of the channel 1, the channel setting switch 365 is the control unit 380. Channel 1 is formed by allowing them to be physically connected (switched). In addition, the channel setting switch 365 includes terminals other than the input and output terminals set to channel 1 (that is, the output Y3 of the response processor 370, the terminal 4, and the insertion type electrode 320; Channel 2 is formed by Y4).

Finally, the operation of the channel setting switch 365 when the electrotherapy device 310 according to the present invention performs the electrical stimulation function and the biofeedback function at the same time, that is, used as a feedback function will be described.

In this case, since the output of the electrical stimulation providing unit 360 and the input of the response processing unit 370 are required at the same time, the feedback performing unit 375 is further used, and one channel is used as the output of the electrical stimulation providing unit 360. One channel is set as the input of 370. In addition, the response processor 370 determines which output terminal of the electrical stimulus providing unit 360 is to be set by the channel setting switch 365 under the control of the control unit 380 (or the control signal via the feedback performing unit 375). You will decide which input terminal you want to set. In this case, as described above, the input and output terminals Y1, Y2, Y3, and Y4 of the insertion type electrode 320 are not simultaneously connected to the electrical stimulation provider 360 and the response processor 370. Of course, the user may arbitrarily select the input and output terminals of the electrical stimulation providing unit 360 and the response processing unit 370. For example, output terminals (a) and (b) of the electrical stimulation providing unit 360 are controlled by the control unit 380 (or a control signal received from the feedback performing unit 375). If the input terminals Y1 and Y2 are connected, the input terminals Y3 and Y4 of the insertion type electrode 320 may be connected to (1) and (2) or (3) and (4) of the response processor 370.

As described above, if the input and output terminals of the insertable electrode 320 are configured not to be used at the same time by the electrical stimulation providing unit 360 and the response processing unit 370, the channel setting switch 365 changes the channel as much as the user can. In addition, the electrode assigned to each channel can also be arbitrarily set by the user. In addition, the reference electrode (ie, ground) should always be applied to the electrical stimulation function and the biofeedback function, so that the remaining terminal is used as the ground.

As such, in the present invention, the channel setting switch 365 has a reason for performing each function because the channel change and the electrode change in the same function can increase the treatment efficiency, and perform as a heterogeneous function (that is, a feedback function). Tests and diagnostics can be made, and channel efficiency can be increased. In addition, when the electrical stimulation function and the biofeedback function are simultaneously linked using the channel setting switch 365, the user may arbitrarily assign a channel or an electrode according to each set channel. As such, if the channel setting or the electrode setting can be made arbitrarily, a feedback function capable of interlocking the electrical stimulation function and the biofeedback function can be implemented, and treatment of the disordered part of the body (or diagnosis) can be performed without changing the physical channel. In addition, the electrotherapy device 310 according to the present invention may discharge charges accumulated as free electrons or metal ions of the insertion type electrode 320 through the reference electrode (Ground) by using the channel setting switch 365. It also has the advantage of reducing the measurement error of the signal. This is because charge accumulation acts as a DC offset in a response system configuration with small-signal large-amplification characteristics, making constant gain settings impossible and leading to unreliable measurement results.

6A is a block diagram illustrating a detailed configuration and an operation process of an electrotherapy apparatus according to an exemplary embodiment of the present invention. FIG. 6B is a diagram illustrating an output waveform of an electrical stimulation provider according to the present invention.

Referring to FIG. 6A, the electrical stimulation providing unit 360 of the electrotherapy apparatus 310 according to the present invention may use pulse signals such as square waves, sinusoidal waves, and triangular waves (eg, single phase waves) by a control signal of the controller 380. Waveform generator 610 for generating an abnormal wave, polyphase wave, etc.) and a characteristic combiner for combining a pulse signal generated by the waveform generator 610 according to a control signal of the controller 380 to form one burst signal ( 615, an output setter 620 for controlling the stimulus intensity (that is, the stimulus energy) output per channel by combining the plurality of burst signals generated by the characteristic combiner 615 according to the control signal of the controller 380, and the controller. Feedback signal (for example, interrupt or stimulus output setting condition) from the stimulation controller 625 and the feedback performing unit 375 that adjusts the total stimulus intensity (ie, summing of the stimulus of each channel) according to the control signal of 380. Stimulus to determine whether) Large signal amplifier 635 and large signal amplifier which produce an electrical stimulus of final stimulus intensity by multiplying the stimulus intensity adjusted by trigger controller 630, stimulation regulator 625 with a predetermined gain or a gain corresponding to the feedback signal. And an output coupler 640 that delivers the electrical stimulus generated by 635 to the body through channel setting switch 365 and insertable electrode 320. The large signal amplifier 635 includes a transformer having a fixed gain and, for example, performs a function of stepping up to a voltage of about 100 Vp-p. The feedback performer 375 detects electrical parameters corresponding to the electrical stimulus transmitted through the output coupler 640 and applies them when performing the feedback function. The feedback function performed by the feedback performing unit 375 will be described in detail with reference to the accompanying drawings.

An output waveform of the electrical stimulation providing unit 360 input to the body through the insertable electrode 320 is illustrated in FIG. 6B. Referring to FIG. 6B, the fixed output cases 680a and 680b are cases in which the bursts of the electrical stimuli generated even after elapse of time and the pulse forms of the waveforms constituting the bursts are the same.

However, in the case of the variable output (685, 687), the shape of the burst may change over time, and the shape of the waveform constituting each burst may also vary. That is, the electrical stimulation providing unit 360 according to the present invention may be variably adjusted to generate various electrical stimuli. Electrotherapy device 310 according to the prior art was implemented in the form of only fixed output. However, as the electrotherapy device 310 according to the present invention is shown in FIG. 6B, the reason for varying the output is that the impedance of the body changes and the impedance of the body changes according to the stimulus type when the stimulus is applied to the body. Nevertheless, fixed output is the cause of side effects such as muscle fatigue.

In addition, the response processor 370 of the electrotherapy apparatus 310 according to the present invention receives a body signal of the body through the insertion electrode 320 and the channel setting switch 365 and detects only a signal from which the in-phase is removed. A filter for selectively filtering only an input signal corresponding to the feedback signal or the user setting condition, the response trigger controller 655 that determines whether the feedback signal or the user setting condition is input from the differential amplifier 650, the feedback performing unit 375, or the like. 660, a variable amplifier 665 for amplifying the biosignal from which unwanted signals are filtered and noise removed to a signal level at which visual discrimination is easy, and an input coupler for branching the amplified biosignal to the feedback performing unit 375. 670) and collects data corresponding to an arbitrary measurement item (eg, a measurement item set by the user through the operation unit 335 of the peripheral device) to the control unit 380. And a call detector 675.

Here, the filter 660 includes a low pass filter, a high pass filter, a band pass filter, a noise filter, and the like. For example, if the biological signal has a frequency bandwidth of 2 to 10,000 Hz, a low pass filter that passes frequencies below 10,000 Hz, a high pass filter that passes frequencies above 2 Hz, and only a partial frequency band within the frequency band of the bio signal. Noise filters such as a bandpass filter for detecting a signal and a notch filter for removing power supply noise such as 60 Hz (120 Hz) may be included.

In addition, the variable amplifier 665 includes a gain adjusting circuit capable of arbitrarily amplifying the input signal and includes a circuit configured to apply a gain specified by the controller 380 or to automatically maintain a constant level.

The electrical parameters measured by the signal detector 675 are current (charge), voltage, power, inductance, capacitance, impedance, etc., and the related parameters can be further measured by a combination or mutual calculation (using conventional electrical engineering formulas). have. The signal detector 675 may include an A / D converter for converting an analog signal into a digital signal, a zero potential detector, a counter for measuring a pulse input, and the like. In addition, the signal detector 675 includes, for example, a maximum value and an effective value detection circuit, a recognition circuit, a determination circuit, a differential and integral circuit, a pulse snapping circuit, a current and voltage conversion circuit, a voltage and frequency conversion circuit, a limiter, Shift circuits, linearizers and equalizers, zero potential and planarization circuits may be further included.

Hereinafter, an operation process of the electrotherapy device 310 will be briefly described with reference to FIG. 6A.

As described above, the electrical stimulation providing unit 360 is a method pre-programmed by the control of the control unit 380 according to the user's function selection and / or condition setting (for example, stimulus output conditions, biological signal input conditions) Outputs the electrical stimulation, the response processor 370 is operated in a pre-programmed manner under the control of the controller 380 to be input to the bio-signal as opposed to the electrical stimulation providing unit 360.

First, the controller 380 extracts necessary data from the memory 340 according to a user's function selection command transmitted from the manipulation unit 335, generates a program direction signal, and generates the generated program instruction signal. Transfer to the electrical stimulation providing unit 360.

The electrical stimulation providing unit 360 generates and inputs an electrical stimulation corresponding to the program instruction signal received from the control unit 380 to the body. The electrical stimulation providing unit 360 is connected to the insertion type electrode 320 through the channel setting switch 365 to form a first series electrical circuit with the body. In this process, when a trigger signal (or a stimulus adjustment control signal) is received from the feedback performing unit 375, it is additionally controlled. The feedback performing unit 375 measures the electrical stimulation output from the electrical stimulation providing unit 360 to determine whether an appropriate stimulus output is made, and transmits a trigger signal to the electrical stimulation providing unit 360 when necessary. Of course, it is natural that the stimulus measurement value signal generated by measuring the electrical stimulation output from the electrical stimulation provider 360 may be transmitted to the feedback performing unit 375.

The response processor 370 receives a biological signal from the body through the channel setting switch 365 and the insertion electrode 320 and processes the signal or inputs the signal by a management control system received from the feedback performing unit 375. The processed biosignal is reprocessed and transmitted to the controller 380. In this case, the feedback performing unit 375 may set electrical stimulus output conditions or biosignal input conditions corresponding to the measured values by measuring electrical parameters corresponding to the biosignals input to the response processor 370. Of course, electrical parameters corresponding to the biosignal may be measured by the response processor 370 and transmitted to the feedback performer 375.

The channel setting switch 365 uses a relay, a dual port multiplexer / demultiplexer, or a separate transistor so that the contact setting for performing the electrical stimulation function, the biofeedback function, and the feedback function can be performed by the control of the controller 380. (Discrete Transistor) can be configured. As described above, the channel setting switch 365 is connected to the insertable electrode 320 and the electrical stimulation providing unit 360 under the control of the controller 380, or to the insertable electrode 320 and the response processor 370. Alternatively, the insertion type electrode 320 may be connected to the electrical stimulation provider 360 and the response processor 370 for each independent channel.

The feedback performing unit 375 performs individual function feedback or interlocking function feedback under the control of the controller 380 according to the user's condition setting. Unlike the electrotherapy apparatus according to the prior art, the electrotherapy apparatus 310 according to the present invention may provide a feedback function. The feedback function performed by the feedback performer 375 will be described in detail with reference to the accompanying drawings.

7 is a diagram illustrating a connection relationship between an electrical stimulus providing unit, a response processing unit, and a feedback performing unit according to an exemplary embodiment of the present invention.

Referring to FIG. 7, the feedback performing unit 375 of the electrotherapy apparatus 310 according to the present invention includes an EST feedback processing unit 710, an EMG feedback processing unit 720, a loop feedback processing unit 730, and an event feedback processing unit 740. ). The EST feedback processing unit 710 includes an EST feedback control measuring unit 755 and a stimulus comparator 760, and the EMG feedback processing unit 720 includes an EMG feedback control measuring unit 775 and a response comparator 780.

First, the connection relationship between the electrical stimulation providing unit 360 and the EST feedback processing unit 710 will be described. The output signal (ie, the electrical stimulation signal) of the electrical stimulation provider 360 is transmitted to the channel setting switch 365 through the output coupler 640. The EST feedback processing unit 710 couples an output signal transmitted through the output coupler 640 by the control signal of the control unit 380, so that electrical parameters corresponding to the output signal (for example, current, voltage, power, Frequency, inductance, capacitance, impedance, output waveform (pulse width, period, duty, etc.) are detected, and the output signal (eg, stimulus output value) of the electrical stimulation provider 360 is detected using the detected electrical parameters. Adjust

When the user selects the EST feedback function by using the operation unit 335 of the peripheral device, the controller 380 transmits a predetermined control signal to the electrical stimulation providing unit 360 channel setting switch 365 and / or the EST feedback processing unit 710. To pass). The channel setting switch 365 allows the electrical stimulation providing unit 360 and the insertable electrode 320 to be connected by the control signal of the control unit 380. The electrical stimulation providing unit 360 generates an electrical stimulation signal and is input to the body through the insertion electrode 320. The EST feedback processor 710 may adjust the stimulus output value of the electrical stimulation provider 360 by monitoring the output signal of the electrical stimulation provider 360, and may be a load (ie, a body) connected in series with the insertion electrode 320. A test can be performed to determine the load characteristics (ie, body characteristics) of the

Referring to FIG. 7, the EST feedback processor 710 detects an electrical parameter by coupling an output signal of the electrical stimulation provider 360, and stores the detected electrical parameter in the controller 380, the stimulus comparator 760, and the loop. Compare the electrical parameters received from the EST feedback control measuring unit 755 and the EST feedback control measuring unit 765 and the electrical parameters received from the control unit 380 to the feedback processing unit 730 to generate a trigger control signal to the stimulus trigger controller 630. And a stimulus comparator 760 to deliver.

That is, the EST feedback control measuring unit 765 couples the output signal of the electrical stimulus through the output coupler 640 and then measures the electrical parameter of the output signal. Electrical parameters to be measured include current, voltage, power, frequency, inductance, capacitance, impedance, output waveforms (pulse width, period, duty), and the like. Can be calculated. The stimulus comparator 760 compares the electrical parameters measured by the EST feedback processor 710 with the electrical parameters set by the controller 380 in the same dimension (order), and uses the difference between the electrical parameters to determine the electrical stimulation agent. The trigger control unit 380 of the study 360 is controlled. Also measured by the EST feedback control measuring unit 765 of the EST feedback processing unit 710 by the user's setting using the operation unit 335 of the peripheral device or the control of the control unit 380 according to a program preset in the memory 340. The electrical parameters are transferred to the response processor 370.

In the case of the EST feedback function, the output signal is coupled and fed back, and the load characteristics (for example, the impedance of the body) of the subject to be stimulated can be known, which is useful for various test methods, and the desired stimulus output can be made according to the test result. Therefore, there is an advantage that the output control can be set automatically. These results are ultimately a safe stimulus method in terms of patient protection because they can expect effective and scientific treatment results as well as cope with medical accidents caused by overcurrent output.

Next, the connection relationship between the EMG feedback processing unit 720 and the response processing unit 370 and the configuration of the EMG feedback processing unit 720 will be described.

The EMG feedback processor 720 detects electrical parameters by coupling the biosignal input through the response processor 370 through the input coupler 670, and controls the detected electrical parameters in the controller 380 and the response comparator 780. And a response trigger controller using a difference between the electrical parameters measured by the EMG feedback control measuring unit 720 and the EMG feedback control measuring unit 720 transmitted to the event feedback processing unit 740 and the electrical parameters transmitted from the control unit 380. A response comparator 780 that controls 655.

The reason for measuring the biosignal using the EMG feedback control measurement unit 720 is a signal of electrical parameters (for example, current (charge), voltage, power, inductance, capacitance, and impedance) detected by the signal detector 675. This is because spectral measurements are necessary to analyze the characteristics. For spectrum measurement, the EMG feedback control measurement unit 720 detects the level, waveform (eg, pulse width, period, duty), activation amount detection (energy amount), frequency detection, phase detection, offset detection, and operation time detection. Perform the function. In addition, the EMG feedback control measurement unit 720 transmits the electrical parameters and the measured electrical parameters set by the user through the control unit 380 to the response comparator 780.

The biofeedback function of the electrotherapy apparatus according to the prior art uses a method of obtaining a plurality of biopotentials using a sampling technique to obtain an average (that is, detecting a muscle contraction and relaxation using a low pass filter concept of converting an analog input signal into DC). Way). This is similar to a perineal pressure gauge or strain gauge. In general, the neuromuscular disorder treatment device requires an analytical process based on a diagnosis prior to treatment, but the electrotherapy device according to the prior art has no analysis function based on a diagnosis. In the electrotherapy apparatus 310 according to the present invention, the EMG feedback control measurement unit 720 can measure spectrum, and has a wideband, high selectivity frequency and phase detection function, thereby diagnosing a disorder of the body from a biological signal. have.

EMG feedback function enables the analysis of EMG signals by coupling the input signal and feeding it back and measuring the minute electrical activity related to the structure and function of the muscle fiber membrane to the body.It occurs in peripheral nerve, nerve muscle, denervation muscle and skeletal muscle. Diagnosing lesions and determining the course and prognosis has the advantage of systematic treatment or diagnosis.

In addition, the loop feedback processor 730 receives the output of the EST feedback processor 710 to set the input (measurement) condition of the response processor 370. That is, after setting the electrical stimulation output conditions for the electrical stimulation providing unit 360, and measures the bio-signal input to the response processing unit 370. The event feedback processor 740 adjusts the stimulus output of the electrical stimulation provider 360 according to the biosignal input through the response processor 370. For example, when the EMG feedback control measuring unit 720 measures and transmits an activation amount corresponding to the biosignal, the event feedback processing unit 740 sets a target amount and periodically outputs an electrical stimulus to the body when the target amount is lower than the target amount. As a result, it is used to compare the activation amount measured again with the initial activation amount. The loop feedback processor 730 and the event feedback processor 740 will be described in detail with reference to the accompanying drawings.

8 is a diagram illustrating a method of combining an EST feedback control measurement unit and an electrical stimulation providing unit for impedance measurement according to an exemplary embodiment of the present invention.

As shown in FIG. 8, the body to which the electrical stimulation generated by the electrical stimulation providing unit 360 is applied includes the resistances R1, R2,..., Rn, and the inductance L1, L2..., Ln. , Can be modeled as capacitance components (C1, C2, ..., Cn). In this case, the EST feedback control measuring unit 765 may measure impedance by measuring a current I flowing from the electrical stimulation providing unit 360 to the body. For example, the EST feedback control measuring unit 765 may connect a resistor in series with the output coupler 640 and measure a voltage across the resistor to calculate a current. Of course, when the signal detection is not easy due to the weak signal, it is natural that an operational amplifier, a transistor, or the like having an appropriate gain can be added.

Therefore, assuming that DC power is inserted in series in the modeled body's RLC parallel circuit, and the DC power's parameter is DC = 0V, DC power has no effect on the operation of the circuit and only outputs current variables (e.g. , V1 (I1), V2 (I2), V3 (I3), ..., Vn (In)). At this time, what is important is the setting of the output signal of the electrical stimulation providing unit 360 output to the body, the configuration and the signal setting method of the electrical stimulation providing unit 360 is as described above. For example, the amplitude of the output signal can be set up to 100Vp-p and the frequency up to 50kHz. The output signal is preferably set to a symmetrical abnormal wave that does not contain a DC component. Therefore, the signal used in the impedance measurement is based on a sine wave (Bi-phasic wave) based on a sine wave that does not contain a DC component, the output current (waveform) becomes a conductance and the inverse of the current Impedance makes it easy to find the impedance. Therefore, if the inductance value is superior to the capacitance value by observing the waveform measured while sweeping the frequency of the electrical stimulation provider 360, the resonance point of the measured waveform moves to a low frequency region, and in the opposite case, the resonance point is a high frequency. Notice that we move to the area. In this case, the EMG feedback processing unit 720 adds a phase detection circuit capable of Fourier analysis, and configures the output of the electrical stimulation input unit 360 by using a method of sweeping the frequency, thereby responding to the body. We can additionally know the degree of distortion (harmonic) for. Therefore, the electrotherapy device 310 according to the present invention has a structural advantage that can analyze the noise characteristics of the measured object (body) according to the harmonic distortion (Total harmonic distortion).

In addition, the electrical stimulation providing unit 360 and the EST feedback processing unit 710 also have an advantage that the AC analysis is possible to analyze the noise characteristics of the biological signal affected by the frequency (sweep) according to the impedance component of the body. . In addition, it is possible to compare the output signal with the input signal in the time domain, so that it is possible to perform transient analysis. In the case of the transient analysis, DC analysis is performed by considering the inductance as short and the capacitance as open since the calculation of the next successive step is performed with the current calculation values for L and C as initial values. Bias point calculation). In addition, the Fourier integral, which is performed by measuring the stimulus output (i.e., current or voltage) as described above, can analyze the frequency component. It also provides an analysis function to calculate power factor. The frequency analysis function here is applied by applying the Fast Fourier Transform (FFT) function and the Fourier analysis function. FFT takes the output data output from the output of the device and calculates it with the FFT algorithm. The FFT performs the function of outputting (measuring) the frequency spectrum. The Fourier analysis uses the Fourier-integrated result with FFT result data. Because only the magnitude is provided in the FFT results, the Fourier analysis gives the magnitude, phase, and direct current. Various tests are possible by using the result of this process.

The reason why the electrotherapy device 310 according to the present invention includes the impedance measuring method is that a number of medical accidents such as electric burns and electric shocks due to inadequate side effects caused by disregarding the state of the patient and inadequate control of the output current value are caused. It is to solve. That is, in order to apply the stimulus to the body, the electrotherapy apparatus according to the prior art converts the digital waveform data generator into an analog signal by using a D / A converter when a preset digital waveform value is output, and the converted analog signal is amplified. The method applied to the body via the electrode is applied. However, this method has a problem in that it is not possible to measure the impedance value of the load (body), and it is inconvenient to manually adjust the output current value, and there is a problem that the test function cannot be performed because there is no feedback function as a simple stimulator.

However, the electrical stimulation providing unit 360 according to the present invention solves the problems of the prior art by interlocking with the feedback performing unit 375 for each use. In addition, the stimulus output characteristics set by the user through the control unit 380 can be simulated in software, and the electrical stimulation output set or preset by the user using the EST feedback control measurement unit 765 is accurately made. There is an advantage in that it can be emulated in hardware.

9 is a view showing a detailed configuration of the EST feedback control measurement unit for measuring the activation amount according to an embodiment of the present invention.

9 is an EST feedback control measuring unit 765 for measuring the amount of activation of a stimulus signal output from the electrical stimulation providing unit 360 (that is, a value measured as a result performed for inspection, diagnosis, or control according to a user's selection). The configuration of) is illustrated.

First, the integrator 910 receives a stimulus signal through an output coupler 640 of the electrical stimulus providing unit 360, converts a stimulus signal in the form of a current signal into a voltage signal, and provides it to the comparator 915. Of course, a component for converting the current signal into a DC voltage may be further included in front of the integrator 910. Also, the setting reference value of the current signal type input from the control unit 380 is converted into an analog signal through the D / A converter 920, and the setting reference value converted into the analog signal is set by the setting reference value providing unit 925. It is converted to the set reference value of the type. The setting reference value providing unit 925 transmits the setting reference value in the form of a voltage signal to the comparator 915. The comparator 915 compares the stimulus signal received from the integrator 910 with the setting reference value received from the setting reference value providing unit 925, and the comparison reference value is a setting reference value. The comparator 915 provides a comparison result to the monostable oscillator 930, and the monostable oscillator 930 outputs a pulse signal having a constant size according to the comparison result of the comparator 915. The pulse signal is input to the counter 935 at the same time as the integrator 910 is reset. The counter 935 continues counting the pulse signal of the monostable oscillator 930 and inputs the counter result (value) to the multiplier 940. The multiplier performs a multiplication using the set reference value of the voltage signal type which is converted into a digital signal by the A / D converter 945 and the counter result (value) input from the counter 935. The multiplication result of the multiplier 940 is transferred to the control unit 380, and the control unit 380 calculates the activation amount using the multiplication result value.

Although the configuration of the EST feedback control measuring unit 765 shown in FIG. 9 has been described as being limited to the electrical stimulation function for convenience of description as in the case of the impedance measurement described above, it is obvious that the same may also be applied to the biological feedback function. Therefore, duplicate description thereof will be omitted when describing the biological feedback function.

In addition, by using the configuration of the EST feedback control measurement unit 765 illustrated in FIG. 9, the controller 380 may measure an activation amount, and the measured activation amount may be converted into current, voltage, power, or energy. . Of course, the configuration of the EST feedback control measurement unit 765 for measuring the activation amount or other electrical parameters can be modified in various ways.

10 is a diagram illustrating a detailed configuration of an EMG feedback control measurement unit for frequency and phase measurement according to an exemplary embodiment of the present invention.

Referring to FIG. 10, the EMG feedback control measurement unit 720 includes a phase comparator 1010, an N setter 1015, a 1 / N programmable counter 1020, a loop filter 1025, a voltage controlled oscillator 1030, and a counter. 1035, frequency corrector 1040, A / D converter 1045, and phase discriminator 1050. The EMG feedback control measuring unit 720 according to the present invention basically includes a phase comparator 1010, a loop filter 1025, and a voltage controlled oscillator 1030 to detect the frequency and phase of the biosignal, and a programmable counter is added. Can be. In addition, a phase-locked loop (PLL) circuit may be used to implement the function.

The phase comparator 1010, also called a phase detector, is an input signal from the input coupler 670 through the loop filter 1025 and a voltage controlled oscillator through the 1 / N programmable counter 1020. Generate an average output voltage (DC) proportional to the phase difference with the voltage controlled oscillator (1030). When this output voltage is called the error voltage Vo and the conversion coefficient for converting the phase difference ?? to the voltage is the phase detection conversion gain K ??, Vo = (K ??) x (?? By detecting the DC voltage output by the relation of ??), it is possible to measure the phase difference by using a predetermined mapping table. Phase comparator 1010 is analog type (e.g. multiplier type, mixer type), digital type (e.g. Ex-OR type, RS flip-flop type), but single-chip phase frequency for easy phase and frequency detection It is preferable to use a comparator.

In the case of frequency detection, a 1 / N programmable counter 1020 may be used for configuration convenience. The 1 / N programmable counter 1020 is located between the voltage controlled oscillator 1030 and the phase comparator 1010 and is configured to facilitate digital control through the N setter 1015. In addition to the advantages of the digital control, the structure of the structure may measure the frequency in the loop when the PLL loop is locked, and may compare the value input to the controller 380 with the output value output from the controller 380 through the N setter 1015. It also has the advantage of performing the necessary operations in comparison.

Accordingly, the phase comparator 1010 receives a biosignal through the input coupler 670 and detects a phase difference by comparing a phase of the input biosignal with a feedback signal input from the 1 / N programmable counter 1020. The phase difference detected by the phase comparator 1010 is transferred to the voltage controlled oscillator 1030 through the loop filter 1025 to detect the correct phase difference.

That is, the phase comparator 1010 outputs a voltage proportional to the phase difference of the input biosignal, and the output voltage signal is averaged through the loop filter 1025 to be DC output. The DC voltage output in proportion to the phase difference is converted into an analog signal by the A / D converter 1045 and then applied to the controller 380 through the phase discriminator 1050 to which the DC voltage and the phase difference are mapped. The phase of the biosignal can be measured. On the other hand, since the output of the voltage controlled oscillator 1030 is a frequency, the frequency is measured by the counter 1035, and the frequency corrector 1040 composed of a correction table corrects the measured frequency error and then corrects it with the controller 380. Send the data. The controller 380 multiplies the frequency input through the frequency corrector 380 and the input value of the N setter 1015 that determines the output to the 1 / N programmable counter 1020, and finally measures the frequency of the biosignal.

 The voltage controlled oscillator 1030 is an oscillator whose output oscillation frequency changes in proportion to the input control voltage. Since the loop filter 1025 has a low pass filter characteristic, the high frequency component that is generated in the phase comparator 1010 and the response characteristic of the PLL are determined. As the loop filter 1025, it is preferable to use a lag-lead filter that can easily adjust the amplification degree.

If there is no input signal of the biosignal through the input coupler 670, the output voltage of the phase comparator 1010 is 0V and the circuit is in an open state. Afterwards, when an input signal is applied at some point, the frequency and phase of the input signal do not coincide with the outputs of the voltage controlled oscillator 1030 since it is not initially in sync. Therefore, the frequency matching process and the phase synchronization process through the frequency introduction process are performed. Accordingly, the circuit diagram shown in FIG. 10 is configured to measure or control this process through the controller 380. This state of synchronization is called lock-in, the range is called lock range, and the frequency range is called frequency capture range. In the present invention, since the frequency capture range is in the range of several tens of kHz (about 10 kHz), the prescaler at the front of the programmable counter may be omitted in some cases. In general, the capture range of the phase is-?? It is an integer multiple (ie ??, 2 ??, 3 ??, ...).

So far, only the biofeedback function has been described with reference to FIG. 10, but it can be applied to the electrical stimulation function in the same manner. That is, the EST feedback control measuring unit 765 may receive a signal to be measured through the output coupler 640 of the electrical stimulation providing unit 360 and measure frequency and phase using the configuration shown in FIG. 10.

The reason for measuring phase using the circuit configuration shown in FIG. 10 is to analyze the frequency characteristic and the penetration depth of energy. That is, it is because the degree of mutual interference (for example, extinction interference and increase interference) according to an arbitrary phase can be grasped and the degree of linearity or dispersion of traveling waves can be analyzed. In addition, since the phase is the difference in the advancing time of the two signals, it may be used to measure the precise time.

11 is a view showing the configuration of the EMG feedback control measurement unit for time measurement according to an embodiment of the present invention.

FIG. 11 is a diagram illustrating a configuration of the EMG feedback control measurement unit 720 for checking the response characteristic of the response processor 370 (that is, measuring the conduction velocity and the conduction time of the nerve). That is, to measure the characteristics of the body by measuring the time that the output of the electrical stimulation providing unit 360 is conducted to the response processing unit 370 through the body. This is because it is necessary to determine the conduction velocity of nerves in order to determine the lesion, site, extent and prognosis of peripheral nerves. In this case, the time measurement is performed by a biofeedback function, which is a response system, but at this time, generation of a signal to be applied to the object to be measured is required. When the signal source is for a test or diagnostic purpose, an electrical parameter is configured differently than for a therapeutic purpose. As such, when the electrical stimulation function and the biofeedback function are performed at the same time, it is natural that the electric stimulation function and the biofeedback function may be applied to the general use of the body to see the response characteristics of the body according to the stimulus in addition to the case of measuring the conduction velocity of the nerve.

If there is no external stimulus, the signal conduction time is measured for a specific time (T1 ~ T2), but if there is an external stimulus, the time can be measured using a loop feedback processing system in which the electrical stimulation function and the biofeedback function are simultaneously linked. Can be. That is, using the loop feedback processing system, the data from the electrical stimulus providing unit 360 transmits the data of the stimulus time point T1 to the control device and stores the data in the memory, and at the same time, the response time T2 is obtained using the circuit diagram of FIG. Measure and find the difference (ie, T2-T1).

Although the time measurement configuration diagram by the EMG feedback processing unit 720 illustrated in FIG. 11 illustrates only the biofeedback function for convenience, the same may be applied to the electrical stimulation function or the feedback function. Of course, even if the phase obtained by using the frequency and phase measurement method by the EMG feedback described with reference to FIG. That is because the delay of the phase can be converted into the delay (or fast) of the signal in the time domain. However, even when the phase is detected and converted into time, an inaccurate error may occur, so that a separate time measurement function may be provided as in the present invention. In the case of conduction velocity, it can be obtained from the usual relationship of conduction distance divided by measured conduction time.

Referring to FIG. 11, the EMG feedback processor 720 couples a signal under measurement through an input coupler 670 and applies it to the integrator 1110. The integral output of the integrator 1110 is input as a comparison signal of the comparator 1115. In addition, a reference signal corresponding to a reference value set by the user using the operation unit 335 of the peripheral device is input to the D / A converter 1120 by the controller 380, and the D / A converter 1120 is a reference signal. Is converted into an analog signal and input to the setting reference value providing unit 1125. The setting reference value providing unit 1125 converts the analog current output of the D / A converter 1120 into a voltage signal and inputs the converted voltage signal as a reference signal of the comparator 1115.

The comparator 1115 outputs a "1" or "0" signal according to the comparison result, and the output signal of the comparator 1115 is simultaneously applied to the monostable oscillator 1130 and the latch 1135. The monostable oscillator 1130 resets the integral output of the integrator 1110 by generating a pulse signal and transmitting the generated pulse signal to the integrator 1110 according to the comparison result of the comparator 1115. In addition, the latch 1135 inputs the same output signal to the AND gate 1140 until the inverted output signal is input from the comparator 1110. The AND gate 1140 receives a periodic clock from the clock source 1145 and applies a logic AND result to the counter 1150. The counter 1150 applies a multiplier 1155 with a count value proportional to the inversion result of the AND gate 1140 output value. The multiplier 1150 simultaneously receives the pulse width of the clock source, multiplies the unit time corresponding to the pulse width by the number of counter outputs, measures the total time, and transmits the measured value to the controller 380. Therefore, the controller 380 may measure the time that is conducted in the body tissue.

So far, the method for measuring the activation amount, frequency, phase, and conduction time has been described using the configuration of the response processor 370 and the EMG feedback processor 720. In addition, level detection, waveform detection, and offset detection are possible, but level detection and waveform detection can be easily measured using a normal A / D converter, and in the case of offset detection in which AC and DC signals are combined, a conventional shift circuit is used. Or, if the clamp circuit is used, the DC level is easily obtained, so the description thereof is omitted.

12 illustrates a system configuration for performing an event feedback function according to an exemplary embodiment of the present invention.

The system for performing the event feedback function is the insertion electrode 320, the electrical stimulation providing unit 360, the control unit 380, the channel setting switch 365, the response processing unit 370, EST feedback control measuring unit 765, EST The feedback control measuring unit 765 and the event feedback processing unit 740 are included. By coupling the biosignal input through the response processor 370, the EMG feedback control measurement unit 720 detects electrical parameters and transmits the detected electrical parameters to the controller 380. The controller 380 determines the stimulus content of the electrical stimulation provider 360 using the electrical parameters received from the EMG feedback control measurement unit 720 to be output by the electrical stimulation provider 360. At this time, the EST feedback control measuring unit 765 detects an output signal through the output coupler 640 and operates the stimulus trigger controller 630 by comparing the received signal as the event feedback information through the stimulus comparator 760. Feedback is made. That is, the event feedback processor 740 checks whether the biosignal input to the response processor 370 through the channel setting switch 365 satisfies the input condition set in the response processor 370. Thereafter, the process of adjusting the output value by controlling the electrical stimulation provider 360 according to a setting condition or a predetermined setting condition received from the controller 380 until the input condition set in the response processor 370 is satisfied (feedback) Repeat it.

As shown in FIG. 12, the event feedback processing unit 740 receives an output value corresponding to the biosignal from the EMG feedback control measuring unit 710 and sets an output condition of the electrical stimulation of the electrical stimulation provider 360. Therefore, the event feedback function is a function of setting the output condition of the electrical stimulation provider 360 according to the measurement condition of the EMG feedback control measurement unit 720 by using the event feedback processor 740, and the response condition of the response processor 370. In this case, it is used when the output of the electrical stimulation providing unit 360 is to be determined. For example, when the amount of activation of the body measured by the response processor 370 is less than or equal to a specific value, the output value of the electrical stimulation provider 360 may be increased. In this case, the event feedback processing unit 740 receives information on whether the biosignal satisfies the target activation amount from the EMG feedback control measuring unit 720, and adjusts the output value of the electrical stimulation provider 360 using the corresponding information. Determine. In addition, the event feedback processing unit 740 may further receive a control command from the control unit 380 to set the output content of the electrical stimulation providing unit 360. That is, it performs a function to change the electrical parameters (for example, current, voltage, pulse, burst, frequency, phase, etc.) to make the output. The electrical stimulation output from the electrical stimulation providing unit 360 may be measured by the EST feedback processing unit 710. In addition, the result of the EMG feedback control measuring unit 720 and the result of the EST feedback control measuring unit 765 may be input to the controller 380, and the controller 380 may check, correct, check, or analyze an error. .

In the configuration diagram shown in FIG. 12, the EST feedback processor 710 has a structure capable of quantitatively measuring the stimulus signal output from the electrical stimulus providing unit 360. Since the large signal converter 1210 and the current voltage converter 1215 of the EST feedback processing unit 710 have a preprocessor characteristic for inputting an integrator, the EST feedback processing unit 710 includes an integrator 1220, a comparator 1225, A setting reference value providing unit 1230, a monostable oscillator 1235, a counter 1240, and a multiplier 1245 are included.

In addition, the EMG feedback processor 720 may be configured similarly to the EST feedback processor 710 to enable quantitative measurement of the input signal. In the configuration diagram of FIG. 12, the EMG feedback processing unit 720 and the EST feedback processing unit 710 have a common function of quantitative measurement of signals except that the preprocessing configuration for each signal level is different because the input signal levels are different. Configured for. Therefore, in the configuration diagram of FIG. 12, the integrator 1260 of the EMG feedback processing unit 720, the setting reference value providing unit 1265, the comparator 1270, the monostable oscillator 1275, the counter 1280, and the multiplier 1285 are shown. The same function as the corresponding component of the EST feedback processing unit 710 is performed. In addition, the latch 1290 assumes a case where the user wants to set an operation of the event feedback processor 740 with a result of "1" or "0". Therefore, since the input signal type of the event feedback processor 740 may be variously changed according to the purpose of the user, the present invention is not limited to the latch 1290.

In FIG. 12, as an example, a configuration for measuring an activation amount is illustrated, but the shape and configuration of a signal to be detected vary depending on the purpose of use.

The event feedback function is to set the conditions by coupling the biofeedback signal and then to perform the electric stimulation function under the set conditions. The event feedback function can perform the treatment for muscle regeneration or nerve regeneration such as measurement of activation amount or nerve conduction velocity. There is an advantage.

13 is a diagram illustrating a system configuration for performing a loop feedback function according to an exemplary embodiment of the present invention.

The system for performing the loop feedback function includes an insert electrode 320, an electrical stimulus providing unit 360, a control unit 380, a channel setting switch 365, a response processing unit 370, an EST feedback control measuring unit 765, and an EST. A feedback control measurement unit 765 and a loop feedback processing unit 730. That is, the system for performing the loop feedback function may be configured similarly to the system for performing the event feedback function described above with reference to FIG. 12. However, the difference between the loop feedback and the event feedback is to set the output condition of the electrical stimulation provider 360 by using the measurement condition of the response processor 370 in the event feedback, whereas the electrical stimulation provider 360 in the loop feedback. The measurement condition of the response processor 370 is set using the output condition of. If the body is an ideal load, their results will be the same. However, the electrical component of the body is a very complex impedance component, which varies from patient to patient, and even in the same patient, there are differences between normal cases and disorders. Event feedback and loop feedback are special features used to identify or examine these differences. For example, in the configuration diagram showing the event feedback system and the loop feedback system, even if the event feedback processing unit 740 and the loop feedback processing unit 730 detect the activation amount under the same condition, the activation amount and the loop feedback through the event feedback function. Through the function, the activation amount is different from each other. This is a difference that occurs because the body is not an ideal load circuit (that is, the amount of current lost inside the body), which depends on the degree of damage to the neuromuscular disorder. The loop feedback function and the event feedback function can be used for various tests, diagnosis, conditional stimulus function and conditional biofeedback function of the body, thereby providing accurate diagnosis of the disease and disorders of the body and consistent treatment results based on the same. There is an advantage that can be obtained.

Referring to FIG. 13, the system for performing the loop feedback function may receive the output of the EST feedback control measurement unit 765 and set the measurement condition of the response processor 370 in the loop feedback processor 730. That is, the loop feedback function is a function of setting the measurement conditions of the response processor 370 according to the output condition of the electrical stimulation provider 360 using the loop feedback processor 730, and the threshold current output through the electrical stimulation function. By setting conditions such as (Threshold current), it is possible to conditionally perform the biofeedback function. Therefore, the loop feedback processor 730 generates a trigger signal conditionally set in the electrical stimulation provider 360, detects data regarding whether the output signal of the electrical stimulation provider 360 satisfies the set condition, and then responds to the response processor ( Condition data is applied. The electrical parameters are measured by coupling the biosignal transmitted through the response processor 370 until the set condition is satisfied.

As described above, after setting the amount of stimulation (activation amount) that is allowed by the body as an output condition of the electrical stimulation providing unit 360 using the loop feedback processing unit 730, the measurement is performed by the response processing unit 370. When the difference in response amount (activation amount) is obtained, the difference value means the amount of current lost in the body. The degree of loss in the body depends on the degree of neuromuscular disorder. Therefore, mapping the difference value with the degree of neuromuscular disorder has an advantage that it can be used as a test or diagnosis method.

As in the case of the event feedback function described above, the insertion type electrode 320 is inserted into the body (or the epidermal electrode is attached to the body), and then the EST feedback control measuring unit 765 receives the signal output from the electrical stimulation provider 360. The coupling is performed through the output coupler 640, and the electrical stimulation signal (ie, the output signal) is measured and the measured electrical parameters are transmitted to the controller 380. In addition, the EMG feedback control measurement unit 720 measures the biofeedback signal through the input coupler 670 of the response processor 370, and transmits the measured electrical parameters to the control unit 380. Therefore, the controller 380 can obtain the difference between the output signal and the input signal and can also perform various signal processing required. In this case, when the user sets a specific condition through the manipulation unit 335, the controller 380 sets a condition of the loop feedback processor 730 to correspond to the set condition.

Until the condition set by the controller 380 is satisfied, the EST feedback control measuring unit 765 measures the output signal of the electrical stimulation providing unit 360 through the output coupler 640, and measures the output signal of the electric stimulus providing unit 360. The difference from the preset program result is applied to the stimulus comparator 760 to operate the stimulus trigger controller 630 according to the result of the stimulus comparator 760. The feedback information is transferred from the EST feedback control measurement unit 765 to the response processing unit 370 through the loop feedback processing unit 730 to become an operating condition of the response processing unit 370.

In FIG. 13, a configuration diagram for measuring an activation amount is illustrated for convenience of description, but it is natural that the shape of a signal to be detected may be set differently according to a user's purpose.

The loop feedback function is to set the condition by coupling the stimulus output signal, and then perform the biofeedback function under the set condition. The loop feedback function can perform various tests or diagnosis under the nerve root or denervation muscle such as the current loss rate or the energy penetration depth of the tissue. There is an advantage.

14 is a flow chart showing the operation of the electrotherapy device according to an embodiment of the present invention.

As described above, the electrotherapy apparatus according to the prior art did not have a feedback function. Therefore, the electrical stimulation function and the biofeedback function could not be performed at the same time, and could be performed sequentially or selectively. In addition, during the electrical stimulation function and the biofeedback function, the electrotherapy device was unable to perform the measurement function, and the stimulus was outputted to one side or the signal was inputted to one side, so that the test, diagnosis or physical condition could not be determined. There was a problem.

However, the electrotherapy device according to the present invention includes a feedback function, a measurement function and the like, thereby solving the problems of the prior art.

Hereinafter, an operation process of the electrotherapy device according to the present invention will be described with reference to FIG. 14.

Referring to FIG. 14, the user determines whether EMG diagnosis is required before the patient is treated (step 1405). If the EMG diagnosis is completed or the patient is not diagnosed (no diagnosis), it is determined in step 1410 whether an electrical stimulation input is necessary. If the input of the electrical stimulation is required, a stepless stimulus variable may be set to be performed regardless of the result of EMG diagnosis (step 1415). The user determines whether to measure impedance in step 1420. If the impedance measurement is selected, the process proceeds to step 1425 and the stimulus output is set to be automatically adjusted. Otherwise, the process proceeds to step 1430 and the stimulus output is set to manual adjustment. That is, the stimulus output condition is set according to whether the impedance measurement function is selected. In operation 1435, the electrotherapy device 310 outputs the electrical stimulation corresponding to the stimulus output condition selected by the user, and inputs the electrical stimulation to the body through the electrode. In operation 1440, the user determines whether the loop feedback function needs to be performed. If the loop feedback function is required, the process proceeds to step 1445 to set a loop feedback condition. If not, continue to enter the electrical stimulation in step 1435. Of course, the user may stop the operation of the electrotherapy device 310 by stopping the input process of the electrical stimulation. The electrotherapy device 310 measures the spectrum corresponding to the biosignal in step 1450, and proceeds to step 1455 to perform the biofeedback function. That is, when the user needs to perform the biofeedback function at the same time as performing the electrical stimulation function, the user activates the loop feedback function and sets the condition, and the electrotherapy device 310 performs the biofeedback function through spectrum measurement.

In operation 1460, the electrotherapy device 310 determines whether the event feedback function is selected by the user. If selected, the process proceeds to step 1465 to select a variable for performing event feedback. That is, to adjust the intensity of the electrical stimulation based on the biological signal input from the body. Thereafter, the process proceeds to step 1420 again. However, if the event feedback function is not selected, the process proceeds to step 1470 where the user receives a selection for the purpose of using the electrotherapy device 310. Of course, all selections can be made all at once before the operation of the electrotherapy device 310 or at individual stages. For inspection purposes, proceed to step 1450 to measure the spectrum. However, for therapeutic purposes, the target waveform is selected at step 1475. That is, the user may select the biofeedback function to operate the electrotherapy device 310 to correspond to the inspection or treatment purpose. For the purpose of the test, the spectrum measurement is performed and for the therapeutic purpose, the muscle movement must be performed.

If the EMG diagnosis selection is not made as a result of the determination of step 1405, the process proceeds to step 1480 to determine whether the purpose of denervation nerve stimulation. For denervation stimulation purposes, the process proceeds to step 1485 where the denervation parameter is set by the user or the denervation variable is detected from the memory 340. The process then proceeds to step 1420.

In addition, when the determination result of step 1480 is not the purpose of denervation stimulation, the process proceeds to step 1490 to determine whether or not the purpose of nerve domination. In the case of nerve dorsal root stimulation purposes, the process proceeds to step 1495 where the nerve dorsal root variable is set by the user or the nerve dorsal root variable is detected from the memory 340. The process then proceeds to step 1420.

In addition, when the determination result of step 1490 is not the purpose of stimulating neuromuscular muscle, the process proceeds to step 1500 to determine whether the biofeedback function is selected. If the biofeedback function is selected, the process proceeds to step 1470, otherwise the process ends. Of course, the operation of the electrotherapy device 310 can be stopped at any time by the user's manipulation.

As such, the electrotherapy device 310 according to the present invention may perform the electric stimulation function (ie, step 1435) and the biofeedback function (ie, step 1455) separately, as well as the feedback function (ie, the loop feedback function). And / or as an event feedback function, the electrical stimulation function and the biofeedback function may be simultaneously performed by steps 1440 to 1445 and steps 1460 to 1465. In addition, the EST feedback function (i.e., steps 1420 to 1430) and the EMG feedback function (i.e., steps 1450 and 1470 to 1475) are the stimulus output to the body by the electrical stimulation function and the biosignal by the biofeedback function from the body. Each input provides its own and individually feedback means for measurement. As such, self feedback of the electrical stimulation function (i.e., steps 1420 to 1430) and self feedback of the biofeedback function (i.e., steps 1450 and 1470 to 1475) or mutual feedback between the electrical stimulation function and the biofeedback function (i.e., Steps 1440 to 1445 and steps 1460 to 1465 may set the output (ie, step 1465) based on the biofeedback signal input from the disorder state of the body, and vice versa. In step 1445), the EMG signal input from the body may be analyzed. In each function, this self-measurement function and feedback linkage between each function not only automatically or manually set the output condition, but also selectively perform target waveform setting or spectrum measurement according to muscle movement, so that accurate diagnosis and diagnosis can be performed. There is an advantage to systematically analyze treatment prescriptions based on the results and improved objective indicators. In addition, since the output can be measured (monitored) at all times, the effective control of excessive stimulus output is possible, so that the protection circuit function can be replaced in terms of patient protection.

Of course, as in the case of the electrical stimulation function, in the case of the biofeedback function, the feedback function can be linked in real time. For example, when the user selects the event feedback function and the condition during the biofeedback function, the electrical stimulation is performed in the opposite concept to the loop feedback, and thus the electrical stimulation function is performed simultaneously with the biofeedback function. At this time, the same conditions as the electrical stimulation conditions or any different stimulation conditions of the user may be set.

As described above, in the function interlocking type electrotherapy apparatus using the feedback control technique according to the present invention, the electrical stimulation function and the biofeedback function may be simultaneously linked through the real time feedback function.

In addition, the present invention, the electrical stimulation function and the biofeedback function can be changed during the treatment, each function can be operated alone or in combination, any channel can be selected.

In addition, the present invention may provide diagnostic results before and after treatment.

In addition, the present invention provides an impedance measurement function and an automatic adjustment function of a current for determining the stimulus intensity when performing the electrical stimulation function.

In addition, the present invention has a simulation (Emulation) function for performing the electrical stimulation function (Emulation).

In addition, the present invention enables the EMG test, automatic gain setting and frequency setting when performing the biofeedback function.

In addition, the present invention may discharge the accumulated charge through the electrode when performing the biological feedback function.

In addition, the present invention provides a means for controlling the electrical stimulation intensity through a real-time feedback function instead of a constant current source (constant voltage source) as a means to ensure safety in terms of patient protection.

Although the above has been described with reference to a preferred embodiment of the present invention, those skilled in the art to which the present invention pertains without departing from the spirit and scope of the present invention as set forth in the claims below It will be appreciated that modifications and variations can be made.

1 is a block diagram of an electrotherapy device according to the prior art.

2 is a view showing the shape of a general electrical stimulation signal.

3 is a view showing the configuration of an electrotherapy device according to an embodiment of the present invention.

4A-4L illustrate the configuration of a memory in accordance with one preferred embodiment of the present invention.

5A and 5B are views illustrating a configuration and a connection relationship between an electrode and a channel setting switch according to an exemplary embodiment of the present invention.

Figure 6a is a block diagram showing the detailed configuration and operation of the electrotherapy device according to an embodiment of the present invention.

Figure 6b illustrates the output waveform of the electrical stimulation providing unit according to the present invention.

7 is a diagram illustrating a connection relationship between an electrical stimulus providing unit, a response processing unit, and a feedback performing unit according to an exemplary embodiment of the present invention.

8 is a view showing a method of combining the EST feedback control measurement unit and the electrical stimulation providing unit for impedance measurement according to an embodiment of the present invention.

9 is a view showing a detailed configuration of the EST feedback control measurement unit for measuring the activation amount according to an embodiment of the present invention.

10 is a view showing a detailed configuration of the EMG feedback control measurement unit for frequency and phase measurement according to an embodiment of the present invention.

11 is a view showing the configuration of the EMG feedback control measurement unit for time measurement according to an embodiment of the present invention.

12 illustrates a system configuration for performing an event feedback function according to an exemplary embodiment of the present invention.

13 is a diagram illustrating a system configuration for performing a loop feedback function according to an exemplary embodiment of the present invention.

14 is a flow chart showing the operation of the electrotherapy device according to an embodiment of the present invention.

Claims (24)

In the medical electrotherapy device which operates by being coupled to an electrode that receives an electrical signal or inputs an electrical stimulus to a part of the body that is in contact with a part of the body of the patient or inserted into the body cavity, An electrical stimulation providing unit generating an electrical stimulation and inputting the electrical stimulation to the body through the electrode; A response processor configured to receive a bio signal from the electrode; A channel setting switch configured to connect at least one of the electrical stimulation providing unit and the response processing unit with the electrode; And A feedback performing unit controlling the operation of at least one of the electrical stimulation providing unit and the response processing unit by using a measurement value corresponding to at least one of the electrical stimulation of the electrical stimulation providing unit and the biosignal of the response processing unit Medical electrical treatment device comprising a. The method of claim 1, The feedback performing unit detects an electrical parameter corresponding to the electrical stimulation output from the electrical stimulation providing unit, and the magnitude of the electrical stimulation output from the electrical stimulation providing unit when the detected electrical parameter does not correspond to a predetermined set value. Transmitting a control signal to the electrical stimulus providing unit for adjusting Medical electrical treatment device characterized in that. The method of claim 2, If the electrical parameter is an activation amount, wherein the activation amount is a value measured as a result of being performed for inspection, diagnosis or control purposes according to a user selection; The feedback performing unit, A comparator for comparing the predetermined set value with the detected electrical parameter; A monostable oscillator for outputting a pulse signal having a magnitude corresponding to a comparison result by the comparator; A counter for counting the pulse signal; And Activation amount calculation unit for calculating the activation amount using the set reference value and the counter result Medical electrical treatment device comprising a. The method of claim 1, The feedback performing unit detects electrical parameters by using the biosignal input to the response processor, and converts a control signal for converting the biosignal into a biosignal having a predetermined size when the detected electrical parameter does not correspond to a predetermined set value. Passing to said response processor Medical electrical treatment device characterized in that. The method of claim 4, wherein If the electrical parameters are frequency and phase, The feedback performing unit, A voltage controlled oscillator for generating an output oscillation frequency corresponding to the input control voltage; A programmable counter dividing the output oscillation frequency by a predetermined number; A phase comparator for generating an output voltage proportional to a phase difference with the biosignal and the voltage controlled oscillator through the programmable counter; A filter for averaging the output voltage to generate the input control voltage; A frequency meter for measuring a frequency using the output oscillation frequency; And A phase discriminator for detecting a phase of the biosignal using the input control voltage and a mapping table, wherein the mapping table is mapped with an input control voltage and a phase difference Medical electrical treatment device comprising a. The method of claim 1, The feedback performing unit may pre-specify a reference set value of the bio signal in the response processor, and if the measured value of the bio signal does not satisfy a preset value, set the magnitude of the electrical stimulation output from the electrical stimulation provider. Conditioning Medical electrical treatment device characterized in that. The method of claim 1, The feedback performing unit presets an output condition of the electrical stimulus providing unit and sets a measurement condition of the response processing unit to correspond to the output condition. Medical electrical treatment device characterized in that. The method of claim 1, The electrical stimulation providing unit, A waveform generator for generating a pulse signal corresponding to the control signal of the controller; A characteristic combiner constituting a burst signal by combining a plurality of pulse signals generated by the waveform generator by a control signal of the controller; An output setter for adjusting the intensity of the electrical stimulus output per channel by combining a plurality of burst signals generated by the characteristic combiner; A stimulation controller for controlling the intensity of the electrical stimulation per channel by the control signal of the controller; A stimulus trigger controller to determine whether a feedback signal is received from the feedback performer; And A large signal amplifier that produces an electrical stimulus of final stimulus intensity by multiplying the strength of the electrical stimulation per channel by a predetermined gain or a gain corresponding to the feedback signal. Medical electrical treatment device comprising a. The method of claim 1, The response processing unit, A differential amplifier receiving the bio-signal through the electrode and the channel setting switch and detecting only a signal from which an in-phase is removed; A response trigger controller for determining whether a feedback signal or a user setting condition is input from the feedback performing unit; A filter for selectively filtering only an input signal corresponding to the feedback signal or a user setting condition; A variable amplifier for amplifying the filtered biosignal to a signal level at which visual discrimination is easy; And A signal detector for detecting data corresponding to an arbitrary measurement item using the biosignal amplified by the variable amplifier Medical electrical treatment device comprising a. The method of claim 1, A memory for storing a program for performing an operation of the electrotherapy device, data for executing the program, and a protocol for diagnosis and treatment of a patient, wherein the protocol is at least one of an electrical stimulation function, a biofeedback function, and a feedback function Program for performing the functions of-; A display unit configured to display the measured value of the electrical stimulation and the measured value of the biological signal; And A controller for controlling the operation of the electrical stimulus providing unit, the response processing unit, the channel setting switch, and the feedback performing unit using the data stored in the memory, and controlling the display unit. Medical electrical treatment device further comprises. The method of claim 10, The storage area of the memory includes a program information storage area, which is the highest concept, a first memory area group for performing an electrical stimulation function and a feedback function, and a second memory area group for performing a biofeedback function and a feedback function. Medical electrical treatment device characterized in that. The method of claim 1, The channel setting switch includes a plurality of channels and a ground terminal, wherein the plurality of channels are set such that at least one of the electrical stimulation providing unit and the response processing unit is connected to the electrode. Medical electrical treatment device characterized in that. The method of claim 1, The electrical stimulus providing unit includes a transmitter, and transmits a signal to the electrode in a wireless communication method Medical electrical treatment device characterized in that. The method of claim 1, The response processor includes a receiver and receives a signal from the electrode in a wireless communication manner Medical electrical treatment device characterized in that. The method of claim 10, An operation unit for inputting a user's command to the control unit Medical electrical treatment device further comprises. The method of claim 15, Data transmission and reception between at least one of the operation unit, the memory, and the display unit and the control unit is wireless. Medical electrical treatment device characterized in that. The method of claim 15, The operation unit First setting means for inputting information relating to a waveform of the electrical stimulation; And Second setting means for setting an operation mode of the medical electrotherapy device Medical electrical treatment device comprising a. In the medical electrotherapy device which operates by being coupled to an electrode that receives an electrical signal or inputs an electrical stimulus to a part of the body that is in contact with a part of the body of the patient or inserted into the body cavity, An electrical stimulation providing unit generating an electrical stimulation and inputting the electrical stimulation to the body through the electrode; A response processor configured to receive a bio signal from the electrode; A channel setting switch configured to connect at least one of the electrical stimulation providing unit and the response processing unit with the electrode; A feedback performing unit controlling the operation of at least one of the electrical stimulation providing unit and the response processing unit by using a measurement value corresponding to at least one of the electrical stimulation of the electrical stimulation providing unit and the bio-signal of the response processing unit; A memory for storing a program for performing an operation of the electrotherapy device, data for executing the program, and a protocol for diagnosis and treatment of a patient, wherein the protocol is at least one of an electrical stimulation function, a biofeedback function, and a feedback function Program for performing the functions of-; An operation unit for inputting a user command; And The electrical stimulation providing unit, the response processing unit, the response processing unit, the feedback performing unit, the channel setting switch, the memory, and the operation unit are coupled to the electrical stimulation providing unit, the response processing unit, and the channel setting switch using data stored in the memory. And a control unit controlling an operation of the feedback performing unit. Medical electrical treatment device comprising a. The method of claim 18, The feedback performing unit Detects an electrical parameter corresponding to the electrical stimulation output from the electrical stimulation providing unit, and adjusts the magnitude of the electrical stimulation output from the electrical stimulation providing unit when the detected electrical parameter does not correspond to a predetermined set value. An EST feedback control unit for transmitting a control signal to the electric stimulus providing unit; Detects electrical parameters by using the biosignal input to the response processor, and converts a control signal for converting the control signal into a biosignal having a predetermined size when the detected electrical parameter does not correspond to a predetermined set value to the response processor. EMG feedback control unit for transmitting; An event feedback to pre-specify the reference set value of the bio signal in the response processor and to adjust the magnitude of the electrical stimulus output from the electrical stimulus provider if the measured value of the bio signal does not satisfy a predetermined value; Control unit; And A loop feedback controller configured to preset output conditions of the electrical stimulus providing unit and set measurement conditions of the response processor to correspond to the output conditions; Medical electrical treatment device comprising a. The method of claim 18, The electrical stimulation providing unit, A waveform generator for generating a pulse signal corresponding to the control signal of the controller; A characteristic combiner constituting a burst signal by combining a plurality of pulse signals generated by the waveform generator by a control signal of the controller; An output setter for adjusting the intensity of the electrical stimulus output per channel by combining a plurality of burst signals generated by the characteristic combiner; A stimulation controller for controlling the intensity of the electrical stimulation per channel by the control signal of the controller; A stimulus trigger controller to determine whether a feedback signal is received from the feedback performer; And A large signal amplifier that produces an electrical stimulus of final stimulus intensity by multiplying the strength of the electrical stimulation per channel by a predetermined gain or a gain corresponding to the feedback signal. Medical electrical treatment device comprising a. The method of claim 18, The response processing unit, A differential amplifier receiving the bio-signal through the electrode and the channel setting switch and detecting only a signal from which an in-phase is removed; A response trigger controller for determining whether a feedback signal or a user setting condition is input from the feedback performing unit; A filter for selectively filtering only an input signal corresponding to the feedback signal or a user setting condition; A variable amplifier for amplifying the filtered biosignal to a signal level at which visual discrimination is easy; And A signal detector for detecting data corresponding to an arbitrary measurement item using the biosignal amplified by the variable amplifier Medical electrical treatment device comprising a. The method of claim 18, The electrode is an insertion type electrode inserted into the body cavity of the body Medical electrical treatment device characterized in that. The method of claim 18, The electrode is an epidermal electrode attached to the body surface of the body Medical electrical treatment device characterized in that. The method of claim 18, The electrode is a precipitation electrode that is inserted into the body Medical electrical treatment device characterized in that.