WO2005046787A1 - Electrical therapy apparatus - Google Patents

Electrical therapy apparatus Download PDF

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Publication number
WO2005046787A1
WO2005046787A1 PCT/KR2004/002951 KR2004002951W WO2005046787A1 WO 2005046787 A1 WO2005046787 A1 WO 2005046787A1 KR 2004002951 W KR2004002951 W KR 2004002951W WO 2005046787 A1 WO2005046787 A1 WO 2005046787A1
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WO
WIPO (PCT)
Prior art keywords
electrical
signal
feedback
controller
function
Prior art date
Application number
PCT/KR2004/002951
Other languages
French (fr)
Inventor
Seung-Kee Mo
Original Assignee
Seung-Kee Mo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Seung-Kee Mo filed Critical Seung-Kee Mo
Publication of WO2005046787A1 publication Critical patent/WO2005046787A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • A61N1/36034Control systems specified by the stimulation parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • A61N1/36031Control systems using physiological parameters for adjustment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36017External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin

Definitions

  • the present invention relates to an electrical treatment equipment of functional operation method using real-time feedback control techniques. More particularly, the present invention relates to the electrical treatment equipment of functional operation method using real-time feedback control techniques operational in support of individual electrical stimulation function and EMG biofeedback function, and each function related.
  • Fig. 1 is a layout of an electrical therapy equipment according to the conventional technology.
  • Fig. 2 is a diagram showing the form of general electrical stimulation signals.
  • the electrical treatment equipment of conventional technology comprises an electrode of coelomic insertion type(l ⁇ ), a peripheral equipment(20), a control part(70), a stimulation signal generator part(80), and an EMG signal processing part(90), and the peripheral equipment(20) comprises a display part(25), an control panel(30), a memory part(40), a communication processor(50), and an operator console(60).
  • the electrical treatment equipment represented in Fig. 1 is the incontinent therapy equipment, it can perform the electrical stimulation function and EMG biofeedback function. However, it can be used for any one function of the two alternatively, but not simultaneously both electrical stimulation function and EMG biofeedback function.
  • the control part(70) transmits the electrical stimulation generation command to the stimulation signal generator part(90) and the stimulation signal generator part(90) generates electrical stimulation and inputs the electrical stimulation into the body through the electrode of coelomic insertion type(l ⁇ ).
  • the stimulation signal generator(90) can make use of varying the pulse width in order to change the magnitude of stimulation.
  • the form of electrical stimulation signal which is generated by the stimulation signal generator(90), inputted into the body is represented in Fig. 2.
  • the conventional electric treatment equipment is used as electric stimulation functions to provide electric stimulations on body, there is a problem not to provide impedance measurement function.
  • the EMG signal processing part(90) receives R-EMG signals from the coelomic electrode(l ⁇ ) of insertion and the received R-EMG signals is transformed into D-EMG signals using an envelope detector, and transmitted to the control part(70).
  • the control part(70) analyzes D-EMG signals and displays the result data of analysis in the display part(30). Also, the control part(70) displays GOAL-EMG wave form of memory in the display part(30).
  • the conventional electric treatment apparatus when used as EMG biofeedback function, provides the label detection function only but can't provides spectrum analysis function.
  • the conventional electric treatment apparatus of EMG biofeedback function can measure only the label on the time domain, and can't measure the electric parameters in the frequency domain. That is, without the measurement of spectrum, we can't derive the result of diagnosis according to the analysis of various examinations and we can't get the evidence data for the judgment on dysfunction of innervation muscle(i.e., denervafion muscle).
  • the conventional electric treatment apparatus has the fixed gain method and the fixed low-pass filtering frequency method, and thereby has the problem that it is not easy to change the function during treatment(for example, gain change, channel change). Also, there is a problem that does not provide the discharge function of electricity accumulated through the electrode. Also, in the conventional electric treatment apparatus, the function of electric stimulation and the function of EMG bio feedback work independently but can't co-work. Summary of the Invention Therefore, an object of the present invention to solve the problems associated with the conventional electric treatment apparatus is to provide an electrical therapy apparatus of function cooperative method using feedback control techniques co-worked through simultaneous real-time feedback functions of electrical stimulation function and
  • Another object of the present invention is to provide an electrical therapy apparatus of function cooperative method using the feedback control method to change during the treatment both the electrical stimulation function and EMG biofeedback function, to operate stand-alone or in combination of functions, and to do the arbitrary selection of the channels.
  • a further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques in order to contrast the diagnostic result of before and after treatment.
  • a further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that enables automatic control function of electrical current for impedance measurement and determination of stimulation strength when electrical stimulation is performed on a patient.
  • a further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that has simulation and emulation functions when in treatment of electrical stimulation functions.
  • a further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that enables EMG, setting automatic gain, and setting frequency when in treatment of EMG biofeedback.
  • a further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that enables emission of electrical charges through electrodes when in execution of EMG biofeedback.
  • an electrical therapy apparatus connected to an electrode that is contacted to a patient or inserted into coelom to input an electrical stimulus on the contacted part of patent or to receive bio-signal from the contacted part of patent, comprising: an electrical stimulus generator, generating and inputting an electrical stimulus through the electrode; a response processor, receiving a bio signal inputted by the electrode; a channel setting switch, connecting at least one of the electrical stimulus generator and the response processor to the electrode; and a feedback controller, controlling at least one of the electrical stimulus generator and the response processor by use of a measured value corresponding at least one of the electrical stimulus of the electrical stimulus generator and the bio signal of the response processor.
  • the feedback controller detects an electrical parameter corresponding to the electrical stimulus of the electrical stimulus generator and sends a control signal for controlling a magnitude of the electrical stimulus to the electrical stimulus generator if the detected electrical parameter does not correspond to a predetermined setting value.
  • the feedback controller comprises: a comparator, comparing the predetermined setting value with the detected electrical parameter; a mono-stable oscillator, generating a pulse signal with a magnitude corresponding to the comparison result of the comparator; a counter, counting the pulse signal; and an activated quantity calculator, generating an activated quantity by use of the predetermined setting value and the result of the counter.
  • the feedback controller detects an electrical parameter by use of the bio signal inputted to the response processor and sends a control signal for amplifying a magnitude of the bio signal to the response processor if the detected electrical parameter does not correspond to a predetermined setting value.
  • the feedback controller comprises: a voltage controlled oscillator, generating an output oscillating frequency corresponding to an input control voltage; a programmable counter, dividing the output oscillating frequency according to a predetermined number; a phase comparator, generating an output voltage corresponding to a phase difference between the bio signal and the divided output oscillating frequency; a filter, generating the input control voltage by normalizing the output voltage; a frequency measuring device, measuring a frequency by use of the output oscillating frequency; and a phase discriminator, detecting a phase of bio signal by use of the input control voltage and a mapping table, wherein table is mapped by the inputted control voltage and phase difference.
  • the feedback controller selects a reference setting value of the bio signal of the response controller in advance and controls the magnitude of the electrical stimulus of the electrical stimulus generator if the measured value of the bio signal does not satisfy the predetermined reference setting value. Also, the feedback controller selects an output condition of the electrical stimulus generator in advance and selects a detection condition of the response processor.
  • the electrical stimulus generator comprises: a waveform generator, generating a pulse signal corresponding to a control signal of the controller; a burst generator, combining a plurality of pulse signals generated by the waveform generator to compose a burst signal; an output setter, controlling a magnitude of the electrical stimulus outputted on each channel by combining a plurality of burst signals; a stimulus adjustor, controlling a strength of the electrical stimulus on each channel according to the control signal of the controller; a stimulus trigger controller, determining whether or not a feedback signal is received from the feedback controller; and a large signal amplifier, generating the electrical stimulus with final stimulus strength by multiplying a gain predetermined to the strength of electrical stimulus on each channel or a gain corresponding to the feedback signal.
  • the response processor comprises: a differential amplifier, receiving the bio signal through the electrode and the channel setting switch and detecting a signal "that in-phase component is eliminated; a response trigger controller, determining whether or not the feedback signal from the feedback controller or a user setup condition is received; a filter, selectively filtering the input signal corresponding to the feedback signal or the user setup condition; a variable amplifier, amplifying the filtered bio signal to a signal level available for visual discrimination; and a signal detector, detecting a data corresponding to a measuring target by use of the amplified bio signal.
  • the electrical therapy apparatus further comprises: a memory, storing a program for operating the electrical therapy apparatus, a data required to operating the program, and a protocol for diagnosis and treatment, wherein the protocol is a program for at least one of electrical stimulation function, EMG biofeedback function, and feedback function; a display, displaying a measurement value of the electrical stimulation and the bio signal value; and a controller, controlling operation of the electrical stimulus generator, the response processor, the channel setting switch, and the feedback controller, and controlling the display.
  • the electrical therapy apparatus further comprises a control panel for inputting a user instruction to the controller, and at least one of the control panel, the memory, and the display communicates with the controller wirelessly.
  • the storage region of the memory comprises a program data storing region as the highest level, the first memory region group for electrical stimulus function and feedback function, and the second memory region group for EMG biofeedback function and feedback function.
  • the channel setting switch comprises a plurality of channels and a plurality of ground contacts, and the channels are connected to at least one of the electrical stimulus generator and the response processor.
  • the control panel comprises the first setup means for inputting a data relating to the waveform of the electrical stimulus, and the second setup means for setting an operation mode of the electrical therapy apparatus.
  • an electrical therapy apparatus connected to an electrode that is contacted to a patient or inserted into coelom to input an electrical stimulus on the contacted part of patent or to receive bio-signal from the contacted part of patent, comprising: an electrical stimulus generator, generating and inputting an electrical stimulus through the electrode; a response processor, receiving a bio signal inputted by the electrode; a channel setting switch, connecting at least one of the electrical stimulus generator and the response processor to the electrode; a feedback controller, controlling at least one of the electrical stimulus generator and the response processor by use of a measured value corresponding at least one of the electrical stimulus of the electrical stimulus generator and the bio signal of the response processor; a memory, storing a program for operating the electrical therapy apparatus, a data required to operating the program, and a protocol for diagnosis and treatment, wherein the protocol is a program for at least one of electrical stimulation function, EMG biofeedback function, and feedback function; a control panel for inputting a user instruction; and a controller coupled to the electrical stimulus generator
  • the feedback controller comprises: a EST feedback controller, detecting an electrical parameter corresponding to the electrical stimulus of the electrical stimulus generator and sending a control signal for controlling a magnitude of the electrical stimulus to the electrical stimulus generator if the detected electrical parameter does not correspond to a predetermined setting value; a EMG feedback controller, detecting an electrical parameter corresponding to the bio signal and sending a control signal for amplifying a magnitude of the bio signal to the response controller if the detected electrical parameter does not correspond to a predetermined setting value; an event feedback controller, selecting a reference setting value of the bio signal in advance,.
  • the electrical stimulus generator comprises: a waveform generator, generating a pulse signal corresponding to the control signal of the controller; a burst generator, combining a plurality of pulse signals generated by the waveform generator to compose a burst signal; an output setter, controlling a magnitude of the electrical stimulus outputted on each channel by combining a plurality of burst signals; a stimulus adjuster., controlling a strength of the electrical stimulus on each channel according to the control signal of the controller; a stimulus trigger controller, determining whether or not a. feedback signal is received from the feedback controller; and a large signal amplifier., generating the electrical stimulus with final stimulus strength by multiplying a gain predetermined to the strength of electrical stimulus on each channel or a gain- corresponding to the feedback signal.
  • the response processor comprises: a differential amplifier, receiving the bio signal through the electrode and the channel setting switch and detecting a signal that in-phase component is eliminated; a response trigger controller, determining whether or not the feedback signal from the feedback controller or a user setup condition is received; a filter, selectively filtering the input signal corresponding to the feedback signal or the user setup condition; a variable amplifier, amplifying the filtered bio signal to a signal level available for visual discrimination; and a signal detector, detecting a data corresponding to a measuring target by use of the amplified bio signal.
  • the electrode is one of an insertion type electrode, a surface electrode, and a needle-type electrode.
  • Fig. 1 is a layout of an electrical therapy equipment according to the conventional technology
  • Fig. 2 is a diagram showing the form of general electrical stimulation signals
  • Fig. 3 is a diagram showing the constitution of the electrical therapy apparatus according to an embodiment of the present invention
  • Figs. 4 to 15 are diagrams of the memory layout according to an embodiment of the present invention
  • Figs. 16 and 17 are diagrams of the layout and connection relationship of the electrode and channel setting switch according to an embodiment of the present invention
  • Fig. 18 is a block diagram showing the detail layout and operation process of the electrical therapy equipment according to an embodiment of the present invention
  • Fig. 1 is a layout of an electrical therapy equipment according to the conventional technology
  • Fig. 2 is a diagram showing the form of general electrical stimulation signals
  • Fig. 3 is a diagram showing the constitution of the electrical therapy apparatus according to an embodiment of the present invention
  • Figs. 4 to 15 are diagrams of the memory layout according to an embodiment of the present invention
  • Figs. 16 and 17 are diagrams of the layout and
  • FIG. 19 is a view illustrating the output wave-form of the electrical stimulus generator according to the present invention
  • Fig. 20 is a view illustrating the connection relationship between the electrical stimulus generator, response processing part, and feedback controller according to an embodiment of the present invention
  • Fig. 21 is a view illustrating a method for combining the EST feedback control & measurement part and the electrical stimulus generator to measure impedance according to an embodiment of the present invention
  • Fig. 22 is a view illustrating the detail layout of the EST feedback control & measurement part for measuring the frequency and phase according to an embodiment of the present invention
  • Fig. 23 is a view illustrating the detail configuration of the EMG feedback control & measurement part for measuring the phase and frequency according to an embodiment of the present invention
  • Fig. 24 is a view illustrating the system configuration of the EMG feedback control & measurement for measuring the time according to an embodiment of the present invention
  • Fig. 25 is a view illustrating the system configuration for the event feedback functional execution according to an embodiment of the present invention
  • Fig. 26 is a view illustrating the system configuration for the execution of loop feedback functions according to an embodiment of the present invention
  • Fig. 27 is a flow chart showing the operation process of the electrical therapy apparatus according to an embodiment of the present invention.
  • FIG. 3 is a diagram showing the constitution of the electrical therapy apparatus according to a preferred embodiment of the present invention.
  • the electrical therapy apparatus(310) is composed of an electrical stimulus generator(360), a channel setting switch(365), a response processor(370), a feedback controller(375), and a controller(380).
  • the electrical stimulus generator(360) is a means that flows the electrical stimulation into the body by employing an insertion type electrode(320) which can be inserted into the vagina or the anus or a surface electrode attached on the body.
  • an insertion type electrode is shown, but a surface electrode or needle electrode can be applied accordingly.
  • the channel setting switch(365) is a means that changes the setting by control of the controller(380) to execute the electrical treatment function, EMG biofeedback function, and feedback function. That is, the electrical therapy apparatus according to the present invention can execute the various functions using the channel setting switch(365).
  • the detail constitution and setting for execution of each function of the channel setting switch(365) referencing the related diagram will be described hereinafter.
  • the response processor(370) is a means that executes EMG biofeedback inputted by bio signals occurred from the body through the inserted type electrode and channel setting switch(365) in response to the electrical stimulation(or muscle exercise) which is outputted by the electrical stimulus generator(3 0).
  • the detail constitution and the various execution example of the response processor(370) referencing the related diagram will be described hereinafter.
  • the feedback controller(375) is a means that executes the individual function feedback or coupled function feedback according to the control of the controller(380), and comprises an EST feedback controller(710 refer to figure 20), an EMG feedback controller(720 refer to figure 20), a loop feedback controller(730 refer to figure 20), and an event feedback controller(740 refer to figure 20).
  • the electrical therapy apparatus(310) provides the feedback function different from the conventional electrical therapy apparatus(310).
  • the individual function feedback has EST feedback of the electrical stimulus generator(360), and has EMG feedback of the response processor(370).
  • EST feedback is executed by EST feedback controller(710) and EST feedback outputs stimulation as having the appropriate characteristics(magnitude) of signals supervising the stimulation output of the electrical stimulus generator(360).
  • EMG feedback is executed by EMG feedback controller(720) and EMG feedback finds out the load characteristics(i.e., body characteristics) of the load(i.e., body) connected serially to the inserted type electrode(320) using the bio signal flowed from the response processor(370). Coupled function feedback is divided into loop feedback and event feedback.
  • Loop feedback is executed by the loop feedback controller (730) and loop feedback is to measure the response of the response processor(370) after setting the electrical stimulation output condition of the electrical stimulus generator(360).
  • Event feedback is executed by the event feedback controller(740) and the event feedback is to measure the response of the electrical stimulus generator (360) after setting the bio signal input condition of the response processor(360).
  • the detail constitution of the feedback controller(375) referring to the related diagram will be described hereinafter.
  • the controller (380) executes the function of controlling the electrical stimulus generator(360), the channel setting switch(365), the response processor(370), the feedback controller(375) corresponding to the operation commands from the control panel(335) using the protocol data(i.e., the executing program for the electrical stimulation function, EMG biofeedback function or the coupled feedback function) stored in memory(340). Also the control part executes the display function on the display part(330) on the detected data received from the response processor(370), the feedback controller(375), etc. The feedback controller(375) coupled with the electrical stimulus generator (360) and the response processor(370) is controlled by the control signal from the controller(380).
  • the feedback controller(375) acknowledges the control signal to the electrical stimulus generator(360) and/or the response processor(370) according to the contents of the control signals or transmits to the controller(380) the data collected from the electrical stimulus generator(360) or the response processor(370). But the constitution of the feedback controller(375) is separated for the convenience of the explanation, when necessary, the controller(380) can include the feedback controller(375), of course.
  • the controller(380), the electrical stimulus generator(360), the response processor(370), and the feedback controller(375) of the present invention are electrically insulated to reduce the electric noise and to protect patients. 500V AC or higher of the insulation voltage is preferable on the criteria of between the electrodes, between channels, or between the electrical stimulus generator(360) and the response processor(370).
  • the electrical therapy apparatus(310) inputs into the inside of patient the electrical stimulation(i.e., the current) that is generated from the electrical stimulus generator(360) by control of the controller(380) through the channel setting switch or the inserted type electrode. Also the response processor(370) of the electrical therapy apparatus transmits to the controller(380) the bio signal itself or the electrical parameters measured from the bio signal received from the body through the channel setting switch(365) from the insertion type electrode(320) by control of the controller(380).
  • the electrical therapy apparatus(310) is connected with the display part(330), the control panel(335), the memory(340), and the communication processor(345), and through the communication processor the electrical therapy apparatus(310) is connected with the operator terminal(350).
  • the display part(330) displays various measurement data received from the electrical therapy apparatus(310) and includes a monitor and a printer as a means of printer output.
  • the control panel(335) is to receive the user's command and transmit to the electrical therapy apparatus(310) and includes a keypad, a key board, and a mouse.
  • the memory (340) is a means to store protocols of patient's diagnosis and treatment, various utility, and peripheral operation data.
  • the memory (340) can be divided to a program memory that includes data to execute the proper operation of the electrical therapy apparatus(310) and data memory that includes necessary data when the program is executing. Hereafter, it is integrated as name of memory(340).
  • the detailed constitution of memory(340) is described with referring to figure 4a or figure 41.
  • the communication processor(345) is a means to communicate to the external equipments.
  • each module of the peripheral equipments i.e., a display part(330), an control panel(335), a memory(340), and a communication processor(345)
  • the display part(330) should be composed of independent parts adding the extra transceiver for the convenience of manufacturing, of reducing the noises.
  • the method to execute data transceiving wirelessly between the electrical therapy apparatus(310), peripheral equipment and the insertion type electrode(320) is briefly described.
  • the communication method between the electrical therapy apparatus(310) and the controller(380) may be, of course, applied for the communication method between the electrical therapy apparatus(310) and the controller(380), serial(wired) communication methods such as RS-232, USB, and wireless communication methods such as microwave(RF), infrared(IrDA), or Bluetooth methods.
  • the electrical therapy apparatus(310) according to the present invention transceivers the detected signals through the wireless communication methods among the insertion type electrode(320) and peripheral equipment(i.e., the display part(330), the control panel(335), the memory(340), the communication processor(345), and the operator terminal(350), etc.)
  • the wireless communication between the control part of the electrical therapy apparatus(310) and the operator terminal can apply the bi-directional communication method using the wireless transceiver contained in the communication ⁇ rocessor(345).
  • the wireless communication between the controller(380), the display part(330) or the control panel(335) of the electrical therapy apparatus(310) can apply the uni-directional communication method.
  • the communication direction of the display part(330) and the control panel(335) is opposite since while the display part(330) displays the data received from the controller(380), the control panel(335) transmits the inputted command to the controller(380).
  • the controller(380) executes the function corresponding to the transmitted data from the control panel(335).
  • the wireless communication method between the electrical therapy apparatus(310) and the insertion type electrode can apply the uni-directional communication method as the same communication method between the electrical therapy apparatus(310) and the display part(330).
  • the insertion type electrode(320) does not have a receiver that is composed of active elements of electronic components. Accordingly, when the electrical therapy apparatus(310) transmits the data to the insertion type electrode(320), the insertion type electrode(320) itself becomes the antenna and receives the data. That is, the insertion type electrode(320) receives the electromagnetic energy from the transmitter connected with the channel setting switch(365). These electromagnetic energy applied to the present invention is transmitted as a wireless radiation in the air and is applied the physical law such as wavelength, velocity, and frequency. In this case, the insertion type electrode(320) can be either a needle electrode or a surface electrode.
  • the used frequency(or wavelength) can be set the length of the needle electrode according to the frequency can be adjusted. That is, according to the already known physical law, unless the length of medical frequency we want to use is not coincident with the length of the needle electrode, the frequency wavelength can be adjusted by adding an electric conductor of an apt length(for example, coil) in the opposite side of insertion place of the needle electrode.
  • the electrical therapy apparatus(310) that has diagnosis and treatment function according to the present invention can be used as a nerve root disorder electrical therapy apparatus(for example, incontinence treatment apparatus(Continence treatment apparatus), constipation treatment apparatus(feoal incontinence treatment apparatus) or electric physiological diagnosis(examination) apparatus.
  • Figure 4 to figure 15 are diagrams of the memory layout according to a preferred embodiment of the present invention
  • the memory(340) associated with the electrical therapy apparatus(310) is a concept of a general storage means such as RAM, ROM, HDD, FDD and this memory can be the internal memory of the electrical therapy apparatus(310).
  • this memory data for the appropriate operation of the electrical therapy apparatus(310), data necessary when arbitrary programs execute, and data detected in the process of patient treatment are stored.
  • programs are stored for independent execution of the electrical stimulation function and EMG biofeedback function, and coupled executions of each
  • the first memory region includes a system data region(Dl), a patient data region(D2), a protocol data region(D3), a progress data region(D4), a session data region(D5), a unit data region(D6), a cluster data region(D7), etc.
  • the hierarchical structure of the detail region which is included in D3-D7 can be explained as one protocol data(that is, a program that is executing for the electrical stimulation function, EMG biofeedback function or coupled feedback function) is composed of several progress data, and one progress data is composed of several session data, and one session data is composed of several unit data.
  • one protocol data is chosen by a user or by a specific function
  • the lower part of programs is linked additionally and can be executed.
  • the selected protocols are transmitted to the electrical stimulus generator (360) or the response processor(370) by the controller(380) and ready to compose another protocol .
  • system data region(Dl) data of various utility and peripheral equipment operations is stored.
  • the patient data region(D2) data of personal information, treatment information, examination and diagnosis information is stored.
  • the patient data that is stored in the patient data region(D2) has to be stored more desirably in database such as RDBMS or File structure.
  • the patient data includes the frequencies of all treatment or diagnosis.
  • the protocol data region(D3) several programs is stored for the entire treatment process performed in the patient treatment.
  • Each protocol data includes a discriminant that determines if it is the electrical stimulation function, EMG biofeedback function or feedback function according to each channel and each function is composed of progress, session, unit, cluster having the lower part(subordinate) data.
  • Progress data region(D4) contains the treatment frequency information that should execute during the treatment period and contains several session data.
  • Session data region(D5) contains the channel number information which executes once and contains several unit data.
  • Unit data region(D6) contains the data which specifies burst characteristics and contains several cluster data.
  • Cluster data region(D7) contains electrical parameters which specifies pulse characteristics.
  • Figure 5 is a diagram that shows the stimulation mode information region(number 11 memory region) which is stored the program information of the operation mode of the electrical stimulation function in order to select the electrical stimulation mode of the memory(340). As shown in figure 5, among the various stimulation modes in case that a certain stimulation mode is selected, then the controller(380) transmits the stimulation mode control signal to the electrical stimulus generator(360).
  • a stimulation mode information region(number 11 memory region) includes a manual stimulation mode(Dll), an automatic stimulation mode(D12), a condition stimulation mode(D13), etc.
  • the manual stimulation mode(Dll) executes the electrical stimulation with the pre-specified protocol regardless of the body characteristics. The user adjusts stimulation strength manually.
  • the manual stimulation mode(Dll) of the electrical therapy apparatus(310) is for the same execution as the conventional electrical stimulation apparatus.
  • the automatic stimulation mode(D12) executes an appropriate electrical stimulation after determining the protocol, finding out the body characteristics through the examination or diagnosis. That is, measuring before electrical stimulation input or real-time measuring during input of electrical stimulation the impedance of body, the strength of electrical stimulation flowed into the body can be adjusted automatically.
  • the automatic stimulation mode(D12) is a peculiar characteristic of the present invention, and an option function that the conventional electrical stimulation apparatus cannot present.
  • the condition stimulation mode(D13) is to execute the electrical stimulation according to the needs or user's setting condition during execution of manual stimulation mode(Dll) or automatic stimulation mode(D12).
  • the condition stimulation mode(D13) can store the data that controls and executes the function of the electrical stimulation and EMG biofeedback sequentially or alternately.
  • Figure 6 is a diagram that shows the modulation mode information region(number 12 memory region) which is stored the program information of the modulation mode in order to select modulation mode among the electrical stimulation functions.
  • the controller(380) transmits to the electrical stimulus generator(3 0) the modulation mode control signal corresponding to the selected modulation mode.
  • the modulation mode information region(number 12 memory region) is composed of the structure that can call the data which can set the unit pulse and burst(pulse set) in the time domain in order to implement each modulation mode.
  • the modulation mode information region(number 12 memory region) includes a phase modulation mode(D21), a time modulation mode(D22), a slope modulation mode(D23), etc.
  • the phase modulation mode(D21) includes the data that can set amplitude, pulse width, frequency to arbitrary values in order to vary output phase.
  • the time modulation mode(D22) includes the data that can set burst period, interval between burst, burst chain(number) to arbitrary values in order to vary output time.
  • the slope modulation mode(D23) has the data structure that can set ramp-up period, plateau period, ramp-down period to arbitrary values in order to increase or decrease output magnitude.
  • Figure 7 is a diagram that shows burst information region(number 13 memory region) which is stored the burst information that determines modulation characteristics of each modulation mode. Referring to figure 7, burst information region(number 13 memory region) includes a burst time region(D31), an interval region between bursts(D32), a burst duty region(D33), a burst magnitude region(D34), etc.
  • the data that can set the burst time (i.e., the time that the electrical stimulation outputs as a pulse form) can be stored variably.
  • the data that can set the interval between bursts(i.e., the time between burst to output and burst) can be stored variably.
  • the burst duty region(D33) the data that can set burst duty(i.e., ratio of hour to output during a period of burst to output) can be stored variably.
  • the burst magnitude region(D34) the data that can set burst magnitude(i.e., magnitude of energy to output) can be stored variably.
  • the pulse information region(number 14 memory region) includes a frequency region(D41), a pulse width region(D42), an amplitude region(D43), a duty region(D44), a waveform region(D45), etc.
  • the frequency region(D41) the data that can set frequency(i.e., the inverse of time including rest time from pulse) can be stored to an arbitrary value.
  • the data that can vary pulse width(i.e., the signal waveform that subtracts the rest time from a period) can be stored.
  • the data that can transform into RMS(Root Mean Square) is stored when we represent amplitude(i.e., We represent 0-peak value as maximum value of signal in a period) as the direct current averaging voltage.
  • amplitude i.e., We represent 0-peak value as maximum value of signal in a period
  • the data that can vary the duty(i.e., the ratio of not zero during a period) is stored according to frequency or pulse width.
  • the data that can select a signal of mono-phasic wave, bi-phasic wave, poly-phasic wave is stored as a signal characteristic in a period.
  • the electrical stimulation inputted into the body of the electrical therapy apparatus(310) can be in combination with the basic wave(for example, rectangular form wave, sine wave, triangular wave) and application wave(for example, differential wave) and positive wave and negative wave can be combined.
  • Figure 9 is a diagram that shows the channel information region(number 15 memory region) which is stored channel information to determine the characteristics of output according to the channel and channel setting.
  • the channel information region(number 15 memory region) in case of multi-channel(2 channels or more), is a region that is stored program information which adds the energy of all outputted electrical stimulations according to the channel numbers.
  • this region includes a channel structure region(D51), an electrode polarity(D52), an output strength region(D53), a chain information region(D54), a treatment hour region(D55), a location information region(D56), etc.
  • Afore mentioned memory regions are for defining the characteristics of each electrical stimulation mode allotted per one of channels, in case of multi-channels the channel information has to be additionally defined, so the channel information region (number 15 memory region) is necessary.
  • the channel structure region(D51) the data that can alter the function of each channel is stored. For example, in case that the electrode channel is composed of multi-channel and we want to alter the function of each channel when electrode is inserted into the body or already attached(i.e., the time when we alter the path of stimulation output to other channel), then without physical re-insertion or re-attachment the channel can be changed to another channel by the channel setting switch.
  • the data that can alter selectively through the channel setting switch(365) is stored without physical change of positive pole(+) or negative pole(-) of each channel of electrode.
  • the output strength region(D53) the data that can adjust the strength of stimulation outputted through the electrode is stored. That is, the strength of output means stimulation strength, and the integration value of the electric current can be determined when specified as burst characteristics in the time domain.
  • the current strength can be set(i.e., the conversion value of the current value to output per second) that determines stimulation strength to output strength and the above fact has the effect of patient protection function for it restricts the stimulation strength.
  • the chain information region(D54) the data that can set burst characteristics(for example, number of burst, hour) of the electric stimulation outputted from channel to arbitrary values is stored.
  • the data that can vary arbitrarily the stimulation hour through the specific channel is stored.
  • the location information region(D56) the data that can set the location of cavity region(for example, vagina, anus) or percutaneous region(for example, abdomen, thigh) is stored.
  • Figure 10 is the feedback information region(number 16 memory region) that can set the EMG biofeedback input condition in order to control the electrical stimulation output or as the inverse of the above stores feedback information to determine condition setting or condition measurement.
  • the feedback condition in order to verify abnormality of stimulation information outputted or abnormality of the load characteristics of body(tissue characteristics) is set by measuring feedback of stimulation information outputted when the electrical stimulation is outputted through mono-channel or multi-channel of electrode. Accordingly, the structured data of feedback information can be the detected bio-signal through the electrical stimulation parameters or EMG bio-feedback function.
  • Feedback information region(number 16 memory region) includes a loop feedback region(D61), an event feedback region(D62), a measurement information region(D63), a condition setting information region(D64), a transformation information region(D65), etc.
  • the data that can execute EMG biofeedback conditionally by setting threshold current condition outputted from the electrical stimulation function is stored.
  • the data that can execute the electrical stimulation function conditionally by setting threshold voltage condition of bio-signal inputted from the body of EMG biofeedback function is stored.
  • the measurement information region(D63) the current value outputted is determined automatically by measuring impedance of the body before the electrical stimulation is outputted from the electrical stimulation function. Also, in order to measure the impedance which is composed of resistance and reactance, since not only resistance but also frequency, inductance, capacitance which are composed of reactance component are measured, there are some merits that can analyze it biologically by finding out muscle fatigue of bio tissue, besides optimal current value calculation.
  • the output current or that output time of the electrical stimulus generator(360) can be set arbitrarily that are set by trigger signal of event feedback data which is measured by the response processor(370) originally.
  • the data that can set conditions of the electrical stimulation function(for example, limit current) and conditions of EMG biofeedback(for example, limit voltage) is stored.
  • the transformation region(D65) the data that can do the unit conversion, dimension transformation and arithmetic(calculation) between the homogeneous function or heterogeneous function of the electrical therapy apparatus(310), can compare each other the measurement data between the heterogeneous apparatuses(for example, magnetic electric stimulator).
  • FIG 11 shows EMG biofeedback mode information region(number 20 memory region) that is stored program information on the operation mode of EMG biofeedback function.
  • the controller(380) transmits to the response processor(370) the EMG biofeedback mode control signal.
  • EMG biofeedback mode information region(number 20 memory region) contains diagnostic mode region(D71), examination mode region(D72), exercise mode region(D73), etc.
  • diagnostic mode region(D71) the data for measuring the spectrum of bio-signal inputted is stored when there is no electrical stimulation.
  • the examination mode region the data for measuring the spectrum of bio-signal is stored when there is electrical stimulation.
  • the data for measuring the average value(the direct current value) of bio-signal is stored when there is no electrical stimulation.
  • the electrical therapy apparatus according to the conventional technology is compared to the electrical therapy apparatus according to the present invention, in contrast to providing only the information on the movement of muscle by measuring the electric potential difference according to contraction or relaxation of muscle in the side of the electrical therapy apparatus according to the conventional technology, in the other side of the electrical therapy apparatus(310) according to the present invention, we can analyze if or not the muscle moves, the reason of movement, in case that the muscle does not move, the function and state of body tissue(nerve and muscle) by measuring the spectrum of bio-signal according to contraction or relaxation of muscle.
  • the electrical therapy apparatus(310) enhances the effect of exercise by admitting the electrical stimulation aptly using the feedback function in case that autonomous muscle exercise is impossible. Therefore, the electrical therapy apparatus(310) provides scientific exercise methods that have no side effect( worsening) and maximize the effect of exercises by supplying not simple repetitive exercise of muscle, but exercise methods based on the
  • Figure 12 shows the diagnosis and exercise information region(number 21 region) that determines if this information is based on external stimulation or exercise itself as the basic unit of deciding the characteristic of bio-signals. That is, the diagnosis and exercise information region(number 21 region) is a region that is stored program information which measures diagnosis result or exercise result of nerve and muscle of the body to implement EMG biofeedback function. In the diagnosis and exercise information region(number 21 memory), electrical parameters are stored that are almost the same with electrical parameters of the electrical stimulation function except a few characteristic (for example, the form of signal is not an intermittent pulse, but the continuous poly-phasic wave.
  • the diagnosis and exercise information region(number 21 memory region) includes an amplitude region(D81), a frequency region(D82), a phase region(D83), a waveform region(D84), an offset region(D85), a sound region(D86), an energy region(D87), etc.
  • the amplitude region(D81) the data that can measure RMS of bio-signal amplitude, maximum, minimum, RMS inputted is stored.
  • bio-signal can be non-altemate wave of asymmetric poly-phasic wave.
  • the frequency region(D82) the data that can measure the frequency of bio-signal inputted is stored.
  • the frequency can be evaluated by peak value, zero-crossing, or FFT because bio-signal is non-alternate waveform of asymmetric poly-phasic wave.
  • the frequency region(D82) includes the data additionally for signal processing the measured value.
  • the data is stored for measuring or calculating(arithmetic) phase distortion between input signal and output signal according to the increase or decrease of frequency.
  • the waveform region(D84) the data that can compare each other waveforms measured during each period is stored after measuring a period waveform of bio-signal.
  • the data for measuring offset is stored (i.e., direct current signal component of asymmetric poly-phasic wave non-alternate waveform of shape that adds alternate current signal to direct current signal)
  • the data for processing the sound is stored.
  • the energy region(D87) the data is stored for converting all activating quantity using the average value per hour of bio-signal. It is supposed that the body is the source of energy when measuring bio-signal and all energy outputted from the body is used as the parameter diagnosing the characteristic of nerve and muscle.
  • an average hourly value of input signal is not the average value of waveform per period, which is average value(i.e., DC voltage) of bi-phase alternating signal, but the average value(low-pass filter concept) of randomly detected input values for certain hours.
  • Figure 13 shows the inspection information region(number 22 memory region) that is stored inspection information in order to measure the physiological phenomenon as a result of inputting the electrical stimulation for inspection. That is, in the inspection information region(number 22 memory region), the program information is stored for carrying out each inspection to implement EMG bio-feedback function coupled with the electrical stimulation function.
  • Inspection information region(number 22 memory region) includes a reaction of degeneration region(D91), a Rheobase inspection region(D92), a Chronaxy inspection region(D93), a Strength duration curve inspection region(D94), a Galvanic tetanus ratio Inspection region(D95), a Pulse ratio Inspection region(D96), a Nerve excitability test inspection region(D97), a Nerve conduction velocity inspection region(D98), an Electromyography inspection region(D99), etc.
  • the data is stored that can compare relatively the degree or state of the current response to confirm the current response after stimulating with Faradic current(asymmetric bi-phasic alternating current) or pulsed Galvanic current(pulsed mono-phasic wave Galvanic current) in order to inspect the reaction of degeneration(i.e., because electric conduction ability of the nerve is lost, thereby, there is no excitation, and stimulating with pulsed Galvanic current or faradic current in order to contract the muscle). It is desirable to prepare the measurement means(for example, trigger off means proportional to excitability of tissue recognized minimally) to confirm excited degree(response degree) of tissue at this time.
  • the data is stored for detecting the characteristic of innervation muscle, denervation muscle and reinnervation muscle using Rheobase value in order to contract the muscle minimally. That is, in order to find out characteristics of innervation muscle, denervation muscle and renervation muscle by measuring flowing Rheobase value(for example, in the normal case 2-18mA/5-35V) at this time and excited degree of exciter tissue admitting linear current source to exciter tissue in order to excite the exciter tissue.
  • the data is stored for detecting characteristic of innervation muscle, denervation muscle and reinnervation muscle using Chronaxy.
  • Chronaxy means the hour that is taken to arouse excitation stimulating 2 times of Rheobase with the condition of Rheobase inspection. Chronaxy, as the representative inspection that indicates excitability of stimulating tissue, is inversely proportional to excitability of tissue. Therefore, the hour is measured from stimulating excitability tissue to occurring excitability using 2 times value of Rheobase, thereby the characteristic of innervation muscle, denervation muscle and reinnervation muscle can be determined.
  • the strength duration curve inspection region(D94) the data that can detect the strength of stimulation and magnitude of duration to confirm the response degree according to the cunent duration and conducting timeri.e., total is converted to energy is stored.
  • Galvanic tetanus ratio inspection region(D95) the data is stored for detecting the characteristic of Galvanic tetanus ratio differently represented in innervation muscle, denervation muscle and reinnervation muscle.
  • Galvanic rigidity ratio is the ratio of current capacity for rigidity to current capacity for spasm(.
  • the data is stored for detecting characteristic of pulse ratio which is appeared differently in innervation muscle, denervation muscle and renervation muscle. For example, if the frequency of the burst between 1 ms burst and 100 ms burst is increased, current value is increased. At this time, ratio of current that is needed to incur the identical muscle contraction is called pulse ratio.
  • the nerve excitability test region(D97) the data is stored for finding out excitability and transferability that appeared differently in innervation muscle, denervation muscle and rennervation muscle.
  • stimulus having 100 micro second pulse width is assigned as the number 1 point and current strength increases with varying amplitude.
  • the current value is measured until triggered off.
  • the current value is measured by applying the same method.
  • the ratio of 2 points' current values is called nerve excitability test.
  • the nerve conduction velocity inspection region(D98) the data is stored for detecting characteristic of nerve conduction velocity that appeared differently in innervation muscle, denervation muscle and renervation muscle.
  • conduction velocity(CV) value is calculated by dividing distance(d) of 2 locations giving stimulus by the
  • NCV inspection stimulates peripheral nerve. Therefore, with only EMG inspection, it is difficult to diagnose diseases and injuries such as potential diseases, region, and degree, prognosis. But with NCV it is possible to find out the above details. Of course, NCV can be divided even more into exercise NCV measurement, sensory nerve activity electric potential measurement, and sensory nerve conduction velocity measurement. Methods for calculating NCV can be various. Also, because our body's nerve structure has very complex impedance, phase delay can't be detected in the time domain accurately while pure inductance or capacitance can.
  • the electrical therapy apparatus employs energy propagation method not signal conduction method.
  • the energy propagation method is a method that if the mutually different (a), (b), (c) energies in the electrical stimulus generator(360) are propagated to the response processor(370) by way of electrode or body, the response processor(3 0) receiving (a)', (b)', (c)' energies measure the propagation time. That is, the electrical stimulus generator(360), response processor(370), and feedback controller(375) are employed.
  • EMG inspection region(D99) the data that can analyze and measure the electric signal coming from the electrode insertion and activity after insertion is stored.
  • the electrical therapy apparatus(310) can analyze the signal analysis in the time domain as well as the spectrum analysis in the frequency domain.
  • Electromyography(EMG) inspection has difference from the above inspection methods. First, it is an inspection that detects electrical activity which is occurred purely in nerve and muscle while not necessary for external stimulus source. Secondly, the measurement equipment has performance to measure bio-signal which is composed of 2-10,000Hz frequency band and 0.003-15.0mV amplitude.
  • the electrical therapy apparatus(310) according to the present invention can do spectrum analysis in order to solve the problem that can't completely eliminate electrical activity of superficial remained in the conventional EMG inspection, and the problem that can't detect selectively the electrical activity of deep, and the problem that losts the high frequency component.
  • the electrical therapy apparatus(310) of the present invention can further comprise each trigger off means in order to execute appropriately the above various inspection modes.
  • each trigger off means for the convenience of understanding, the composition method of the above various inspection modes is briefly described. For example, in case of reaction of degeneration, Rheobase inspection,
  • the electrical stimulus generator(360) admits the electrical stimulus to nerve muscle tissue(excitability tissue) which is supposed load, the method is peformed to measure current or voltage inputted from nerve muscle tissue to the response processor(370). Also, if the user sets the condition of measuring time to the response processor(370) and/or feedback controller through the controller(380), the measurement can be done at accurate time using trigger signal transmitted from the feedback controller(375) to the response processor(370).
  • the admission into the body of criteria signal(measurement value) is transmitted to the response processor(370) through the feedback controller(375).
  • the response processor(370) calculates the time difference of the above 2 signals.
  • time difference comparing the bio-signal with the criteria signal(measurement value) in the electrical stimulus generator(360) is calculated.
  • EMG inspection can be performed, for example, by the EMG feedback controller(720). That is, in case that bio-potential is weak measured through the response processor(370) or in case that user setting condition is not satisfied, the electrical stimulation can be performed by detecting trigger signal and employing feedback to the electrical stimulus generator(360). This is called EMG triggered stimulation.
  • Figure 14 is a diagram that shows channel information region(number 23 memory region) which is stored channel information in case that channel information of EMG bio-feedback function is composed of multi-channel.
  • the channel information region(number 23 memory region) includes a channel structure region(DlOl), an electrode polarity region(D102), a goal strength region(D103), a chain information region(D104), a pulse time region(D105), a location information region(D106), etc.
  • the channel structure region(DlOl) the data that can change function of each channel is stored.
  • the channel can be arbitrarily changed through channel setting switch without re-insertion or re-attachment.
  • the electrode polarity region(D102) we store the data that can change selectively through channel setting switch without change of pole(+) and pole(-) of each channel of electrode.
  • the goal strength region(D103) the data that can change the chain number of burst to vary amplitude and duration of goal waveform of mono-burst and to vary all momentums is stored.
  • Goal strength is a goal waveform presented when EMG biofeedback is used as exercise mode.
  • the chain information region(Dl 04) the data that can be in combination with all by measuring each burst or analyzing characteristic( for example, number or hour ) of burst of bio-signal through channel is stored.
  • the pulse hour region(D105) the data is stored for measuring amplitude of burst and pulse hour(i.e., duration time of each burst). Burst hour is the treatment hour including rest hour.
  • the location information region(D106) the data varying the applied location together with channel structure is stored.
  • Figure 15 is feedback information region(number 24 memory region) that is stored feedback information of the EMG bio-feedback function.
  • the data is stored for program information if the electrical stimulation function and EMG bio-feedback function is individual or coupled and for information according to each channel.
  • the composition of feedback information region(number 24 memory region) is similar to that of number 16 memory region, but the contents of data are different, so it is desirable to allocate each separately.
  • Feedback information region(number 24 memory region) includes a loop feedback region(Dlll), an event feedback region(D112), a measurement information region(Dl 14), a transformation region(Dl 15), etc.
  • the data is stored for carrying out the EMG bio-feedback function with the electrical stimulation set with the condition including threshold current outputted from the stimulation of the electrical stimulation function.
  • the data is stored for carrying out the electrical stimulation function with the EMG bio-feedback condition set after setting threshold voltage condition measuring bio-signal inputted from the body of EMG bio-feedback function.
  • the data is stored for storing or calling the measurement value of the EST feedback information coupled with the output of the electrical stimulation or measuring the critical voltage or current of bio-signal and feedback the information to the electrical stimulus generator(360) which is occurred from the minimal visual contraction of exciter tissue(nerve and muscle).
  • the measurement data can be really measured data or calculated(arithmetic) data.
  • the condition setting region(D114) the data that can set the trigger signal to the conditions which is feedbacked on the criteria of EMG bio-feedback is stored.
  • FIG. 16 or figure 17 are diagrams that shows the composition and connections of electrode and channel setting switch according to the preferred embodiment of the present invention.
  • electrode is composed of mono-channel or multi-channel, and the electrical stimulation is admitted into the body once inserted into the cavity of the body(i.e., vagina or anus) or attached on the skin or bio-signal is inputted from the body.
  • the electrode is composed of the adhesive form(i.e., patch electrode) in order to be attached on the skin or composed of the insertion type (i.e., insertion electrode) in order to be inserted into the cavity(i.e., vagina or anus) or composed of needle electrode of needle form(i.e., pierce electrode)
  • Electrode is attached or detached on the body or the electrical therapy apparatus, and is composed of the form of one time or reuse.
  • electrode is made of 2 electric conductors having (+) and (-) poles per channel, and non-conductor should insulate between conductors. And in case of the EMG bio-feedback, one more conductor is needed to ground in addition to (+) and (-) poles, totaling 3 electric conductors.
  • the composition of electrode(i.e., insertion type electrode(320), needle electrode and surface electrode hereafter, we call insertion type electrode in united way) and channel setting switch according to the present invention that can execute simultaneously or alternately the electrical stimulation function and EMG biofeedback function is described.
  • the insertion type electrode is composed of a channel of
  • a channel electrode for execution of electrical stimulation function and channel electrode for execution of EMG biofeedback function is composed physically identical one. Therefore, in order to use two channel electrodes not only for conducting the electrical stimulation function or EMG biofeedback function but also for conducting the feedback function execution, each channel can be executed independently for the electrical stimulation function and EMG biofeedback function. However, in case of multi-channel insertion type electrode, it is desirable to include several electrodes within limited size and to separately allocate in order to execute various functions(i.e., electrical stimulation function, EMG biofeedback function, or feedback function). Of course, in case of the channel allocated already, each polarity of electrode shaping channel can be exchanged each other.
  • channel 1 electrode of electrical stimulation function is allocated (a)(i.e., (+) pole) and (b)(i.e., (-) pole) that can be changed to (a)(i.e., (-) pole and (b) (i.e., (+) pole) by each channel setting switch(365).
  • ground is the same electrode physically (i.e., (e) and (5)) in the electrical stimulation function and EMG biofeedback function, and regardless of each function, ground is used as the criteria of input/output signal always. And this fact is due to that has to be the measurement or signal input in the electrical stimulation function or EMG biofeedback function.
  • Figure 17 shows the connection relationship of the channel setting switch(365).
  • the channel setting switch(365) is a means that can carry out the electrical stimulation function, EMG biofeedback function and feedback function through the control of the controller(380) by the electrical stimulation apparatus(310).
  • the channel setting switch(365) is associated with the insertion type electrode(320), the electrical stimulus generator(360), the response processor(370) and the controller(380).
  • the insertion type electrode(320), the electrical stimulus generator(360) and the response processor(370) are composed of 2 channels, respectively, the function of channel setting switch(365) is briefly described. That is, in this case, 2 channels are operated when the electrical stimulus generator(3 0) and the response processor(370) execute the functions individually, but when simultaneous execution, 1 channel of each is operated.
  • the operation of the channel setting switch(365) is described in case that the electrical stimulation apparatus(310) is used as the function of the electrical stimulation only.
  • outputs of the electrical stimulus generator(360) are (a), (b), (c) and (d)
  • inputs of the insertion type electrodes(320) are Yl, Y2, Y3 and Y4. If as ports of channel 1, outputs (a), (b) of the electrical stimulus generator(360) and inputs Yl, Y2 of the insertion type electrode are set, the channel setting switch(365) creates channel 1 by interfacing( switch on) those ports by the control of the controller(380).
  • the channel setting switch(365) creates channel 2 with the ports(i.e., outputs of (c) and (d) of the electrical stimulus generator(365) and inputs Y3, Y4 of insertion type electrode(320)) except input/output ports set by the channel 1. That is, in case that creates channel 1 and channel2, output of the electrical stimulus generator(360) and inputs of insertion type electrode do not have duplication. In the same way, as ports of channel 1 , (a), (b) outputs of the electrical stimulus generator(360), Y3,Y4 inputs of the insertion type electrode are also used.
  • the operation of the channel setting switch(365) in case that the electrical therapy apparatus(310) is used as EMG biofeedback function only according to the present invention is described hereinafter.
  • the operation of the channel setting switch(365) is similar to the case that the electrical therapy apparatus according to the above present invention is used only as the function of the electrical stimulation.
  • output signal of the electrical stimulus generator(360) has to be input signal of the insertion type electrode(320) and the output signal of the insertion type electrode(320) has to be input signal of the response processor(370) and this fact is different from the case of the feedback function.
  • the channel setting switch(365) creates channel 1 by interfacmg(switching) physically through the control of the controller(380). Also, the channel setting switch(365) creates channel 2 in combination with ports(i.e., (3), (4) outputs of the response processor(370), Y3, Y4 outputs of the insertion type electrode) except input/output ports set by channel 1.
  • the electrical therapy ap ⁇ aratus(310) carries out the electrical stimulation function and EMG biofeedback function simultaneously, that is, the operation of the channel setting switch(365) in case that feedback function is used will be described hereinafter.
  • the feedback controller(375) because output of the electrical stimulus generator (360) and input of the response processor(370) are necessary, it is required to use the feedback controller(375) once more, thereby, output of the electrical stimulus generator(360) is set as 1 channel and input of the response processor(370) is set as 1 channel.
  • the channel setting switch(365) determines what output port of the electrical stimulus generator (360) should be set and what input port of the response processor(370) should be set by the control of the controller(380) (or the feedback controiler(375)).
  • the controller(380) or the feedback controiler(375)
  • Yl, Y2, Y3, and Y4 I/O of the insertion type electrode are not connected to the electrical stimulus generator(360) and the response processor(370) simultaneously.
  • user can select arbitrarily input/output of the electrical stimulus generator(360) and the response processor(370).
  • outputs of the electrical stimulus generator(360) have to be connected to Yl and Y2
  • inputs of the insertion type electrode(320) have to be connected to (1) and (2), or (3) and (4), of the response processor(370).
  • the channel setting switch(365) enables the user to vary the channel arbitrarily and also to vary and set the electrode allocated to each channel.
  • the criteria electrode(i.e., ground) should be applied to the electrical stimulation function and EMG biofeedback always, the remaining port has to be used as ground.
  • the reason to carry out each function with the channel setting switch(365) is to enhance treatment efficiency by ability to vary channel and electrode at the same function and is to enable user to inspect or diagnose to carry out the heterogeneous function(i.e., feedback function) and also to enhance the channel efficiency.
  • the channel setting switch(365) is to be coupled with the electrical stimulation function and EMG biofeedback function simultaneously, user has the merit of arbitrary channel allocation or of electrode allocation according to each channel which is set.
  • the feedback function which is coupled with the electrical stimulation function and EMG biofeedback function, can be implemented and also, without physical channel change (or diagnose) the disorder region of body can be treated.
  • the electrical therapy apparatus(310) has the merit of reducing the measurement error of input signal, discharging through ground the electric potential accumulated free electronics or metal ion of the insertion type electrode(320) by using the channel setting switch(365). Because the electric potential accumulation operates as DC offset in the response system of the characteristic of small signal large amplification, it is impossible to set the constant gain, thereby introducing unreliable measurement results.
  • the electrical stimulus generator(360) of the electrical therapy apparatus(310) according to the present invention includes a waveform generator(610) that generates pulse signal(for example, mono-phasic wave, bi-phasic wave, poly-phasic wave, etc) such as rectangular shaped wave, a sin wave, a triangular wave by control signal of the controller(380), a burst generator with pulse combinational 5) that composes one burst signal in combination with pulse signal generated by the waveform generator(610) according to control signal of the controller(380), an output setter(620) that adjusts stimulation strength(i.e., stimulation energy) outputted per channel in combination with several burst signals generated by the burst generator with pulse combination according to control signal of the controUer(380), a stimulation adjuster(625)
  • pulse signal for example, mono-phasic wave, bi-phasic wave, poly-phasic wave, etc
  • pulse signal for example, mono-phasic wave, bi-phasic wave, poly-phasic wave, etc
  • the large signal arnplifier(635) includes a transformer that has the fixed gain, and for example, executes the function that increases voltage such as about lOOVp-p.
  • the feedback controller(375) detects the electrical parameters corresponding to the electrical stimulation transmitted through the output coupler(640) and applied when the feedback function executes.
  • Figure 19 shows the output waveform of the electrical stimulus generator(360) inputted into the body through the insertion type electrode(320).
  • case of fixed output(680a, 680b) is the same as the burst of the electrical stimulation and pulse form of waveform that composes the burst generated after the duration of time.
  • variable output (685, 687)
  • the form of burst is changed after the duration of time
  • the shape of pulse form that composes each burst can be changed. That is, the electrical stimulus generator(360) according to the present invention can be adjusted variably in order to generate various electrical stimulations.
  • the electrical therapy apparatus(310) according to the conventional technology was implemented to generate the fixed output. But, as shown figure 19, when stimulation is admitted into the body, the impedance of the body varies according to stimulation shapes and in spite of changes of impedance of the body, if fixed output occurs, the side-effect such as muscle fatigue occurs is the reason that the electrical therapy apparatus(310) according to the present invention outputs variably.
  • the response processor(370) of the electrical therapy apparatus(310) includes an differential amplifier(650) that detects only the signal that in-phase deleted and inputted the bio-signal of the body through the insertion type electrode(320) and the channel setting switch(365), a response trigger controller(655) that judges if feedback signal from the feedback controller(375) or user setting condition is inputted, a filter(660) that filters selectively only the input signal corresponding to feedback signal or user setting condition, a variable amplif ⁇ er(665) that amplifies the bio-signal that is unwanted signal-filtered and noise-removed as visually easy signal label, an input coupler(670) that branches the amplified bio-signal to the feedback controller ⁇ 75) and a signal detector(380) that transmits to the controller(380) data that is gathered corresponding to any measurement items(for example, measurement items set by the user through the control part(335) of the peripherals), etc.
  • an differential amplifier(650) that detects only the signal that in-phase deleted and inputted the bio-
  • example of the filter(660) includes low pass filter, high pass filter, band pass filter, noise filter, etc.
  • frequency bandwidth of bio-signal is 2-10,000Hz
  • the low pass filter passes frequency less than or equal to 10,000Hz
  • the high pass filter passes greater than or equal to 2 Hz
  • the band pass filter passes partial frequency bandwidth within the frequency band of bio-signal
  • the noise filter such as notch filter deletes power supply noise of 60 Hz(120Hz).
  • the variable amplifier(665) includes gain adjustment circuit that amplifies input signal arbitrarily and also includes circuit that applies the specified gain by the controller(380) or sets to maintain the constant label automatically.
  • the electrical parameters detected by the signal detector(675) are current(potential), voltage, power, inductance, capacitance, impedance, etc, and even further related parameters can be measured through combination or mutual arithmetic(using ordinary electronics engineering calculation).
  • the signal detector(675) includes A/D converter that transforms analog into digital, zero potential detector, and counter that measures pulse input. Also, the signal detector, for example, includes maximum value and root mean square value(RMS value) detect circuit, recognition) circuit, decision circuit, differentiation and integration circuit, pulse snapping circuit, current and voltage transformation circuit, voltage and frequency transformation circuit, remitter and shift circuit, linearizer and equalizer, zero potential and planarization circuit, etc.
  • RMS value root mean square value
  • the electrical stimulus generator(360) outputs electrical stimulation in the pre-programmed way by control of the controUer(380) according to user's function options and/or condition setting(for example, stimulation output condition, bio-signal input condition) and the response processor(370), in the opposite way of the electrical stimulus generator(360), operates in the pre-programmed way, by control of the controller(380) in order to be inputted the bio-signal.
  • the controller(380) after extracting the necessary data from the memory(340) corresponding to user's function selection order transmitted from the control panel(335), generates program direction signal and transmits the program direction signal to the electrical stimulus generator(360).
  • the electrical stimulus generator(360) generates electrical stimulation corresponding to the program direction signal received from the control part and inputs it to the body.
  • the electrical stimulus generator(360) composes number 1 direct circuit with the body connecting the insertion type electrode(320) through channel setting switch(365).
  • the trigger signal is received from the feedback controller(375)
  • the feedback controller(375) measures electrical stimulation outputted from the electrical stimulus generator(360), judging that the appropriate stimulation output is generated and if necessary, the feedback controller(375) transmits trigger signal to the electrical stimulus generator(360).
  • stimulus measurement value signal that first measures electrical stimulation outputted from the electrical stimulus generator(360) and generated can be transmitted to the feedback controller(375).
  • the response processor(370) is inputted from the body the bio-signal through channel setting switch(365) and the insertion type electrode and does signal processing.
  • the response processor(370) transmits to the controller(380) the re-processed bio-signal that is inputted by management control system which is received from the feedback controller(375).
  • the feedback controller(375) can set the stimulation output condition or the bio-signal input condition corcesponding to the measured value after measuring electrical parameters corresponding to the bio-signal inputted to the response processor(370).
  • the response processor(370) measures electrical parameters corresponding to the bio-signal and transmits to the feedback controller(375).
  • the channel setting switch(365) is composed of a relay or dual port multiplexer/demultiplexer or discrete transistor that enables junction point setting for execution of electrical stimulation function, EMG bio-feedback function and feedback function according to user's selection by control of the controller(380). As explained earlier, the channel setting switch(365) connects the insertion type electrode(320) and the electrical stimulation supply(360), the insertion type electrode(320) and the response processor(370) or connects the insertion type electrode(320) as an independent channel to the electrical stimulus generator (360) and the response processor(370) by control of the controller ⁇ 80).
  • the feedback controIler(375) executes individual function feedback or coupled function feedback according to user's condition setting by control of the controller(380).
  • the electrical therapy apparatus can provide the feedback function.
  • the feedback function execution of the feedback controller ⁇ 75) will be described.
  • Figure 20 is a diagram that shows the connection relationship between the electrical stimulus generator, the response processor and the feedback controller according to the prefened embodiment of the present invention.
  • the feedback controller(375) of the electrical therapy apparatus(310) according to the present invention includes an EST feedback controller(710), an EMG feedback controller(720), a loop feedback controller(730) and an event feedback controller(740).
  • the EST feedback controller(710) includes an EST feedback control measurement part(755) and stimulation comparator(760), and the EMG feedback controller(720) includes an EMG feedback control measurement part(775) and a response comparator(780).
  • Output signal(i.e., electrical stimulation signal) of the electrical stimulus generator (360) is transmitted through the output coupler(640) to the channel setting switch(365).
  • EST feedback controller(710) detects electrical parameters(for example, current, voltage, power, frequency, inductance, capacitance, impedance, output waveform(pulse width, period, duty), etc) conesponding to output signal coupling output signal transmitted through the output coupler by control of the controller(380) and adjusts the output signal(for example, stimulation output value) of the electrical stimulus generator(360) using detected electrical parameters. If user selects EST feedback function using the control panel(335) of peripherals, then the controller(380) transmits the pre-specified control signal to the electrical stimulus generator(360), the channel setting switch(365), and/or EST feedback controller(710).
  • electrical parameters for example, current, voltage, power, frequency, inductance, capacitance, impedance, output waveform(pulse width, period, duty), etc
  • the channel setting switch(365) connects the electrical stimulus generator(360) and the insertion type electrode(320) by control of the controller(380).
  • the electrical stimulus generator(360) generates the electrical stimulation signal and through the insertion type electrode inputs the signal into the body.
  • EST feedback controller(710) supervises the output signal of the electrical stimulus generator(360) and adjusts stimulus output value of the electrical stimulus generator(360), and executes inspection to find out load characteristics(i.e., body characteristics) of serially connected load(i.e., body).
  • load characteristics i.e., body characteristics of serially connected load(i.e., body.
  • EST feedback controller(710) detects electrical parameter coupling output signal of the electrical stimulus generator(360) and the EST feedback control measurement part(755) transmits the detected electrical parameters to the control part, stimulation comparator(760), and loop feedback controller(730).
  • the stimulation comparator compares electrical parameters received from EST feedback control measurement part(765) and electrical parameters received from the controller(380) and transmits trigger control signal to stimulus trigger controller.
  • EST feedback controller(710) contains EST feedback control measurement part(755) and stimulation comparator. That is, EST feedback control measurement part(765) measures the electrical parameters of output signal after coupling output signal of electrical stimulation through output coupler(640). Measured electrical parameters includes current, voltage, power, frequency, inductance, capacitance, impedance, output waveform(pulse width, period, duty) etc. it is possible to calculate electric potential, energy from the above electrical parameters by the known electric engineering formula.
  • the stimulus comparator(760) compares in the same dimension(degree) electrical parameters measured from EST feedback controller(710) and electrical parameters set by the controller(380)and using the difference of each electrical parameter controls trigger controller(380)of the electrical stimulus generator(360). According to user setting using the control panel of peripherals or the already specified program in memory(340), by control of the controller(380) the electrical parameters measured by EST feedback control measurement part(765) of EST feedback controller(710) are transmitted to the response processor(370).
  • EST feedback function coupling and feedbacking the output signal, we come to know load characteristic of object stimulated, so various inspection methods are useful. And, because according to the result of inspection, stimulus output to be achievable, there is the merit of setting output control automatically.
  • EMG feedback controller(720) detects electrical parameters coupling through the input coupler(670) the bio-signal inputted from the response processor(370), and the EMG feedback control measurement part(720) transmits detected electrical parameters to the controller(380), the response comparator(780) and event feedback controller(720). And, the response comparator controls response trigger controller(655) using the difference between electrical parameters measured by the EMG feedback control measurement part(720) and electrical parameters transmitted from the controller ⁇ 80).
  • the reason to measure the bio-signal using the EMG feedback control measurement part(720) is that spectrum measurement is required in order to analyze signal characteristics of electrical parameters(for example, current(potential), voltage, power, inductance, capacitance, impedance) detected by signal detector(675).
  • the EMG feedback control measurement part(720) executes function of label detection, waveform detection, activated quantity detection(energy), frequency detection, phase detection, offset detection, operation hour detection. Also, the EMG feedback control measurement part(720) transmits to the response comparator(780) electrical parameters set by user through the controller(380) and electrical parameters measured.
  • the EMG bio-feedback function of the electrical therapy apparatus according to the conventional technology is the averaging(using the low pass filter concept converting analog input signal into DC, thereby, method to detect contraction and relaxation of muscle) method obtaining multi bio-electric potentials with the sampling techniques.
  • the above is similar to perineometer or strain gauge, etc.
  • the electrical therapy apparatus according to the conventional technology has not analysis function based on diagnosis.
  • EMG feedback control measurement part(720) of the electrical therapy apparatus according to the present invention can diagnose the bio-signal if there is physical disorder of the body because EMG feedback control measurement part(720) enables spectrum measurement, is broad band, has frequency of high options and function of phase detection.
  • EMG signal analysis is possible by coupling and feedbacking input signal, and then measuring microscopic electric activity of related structure and function of sarcolemma in the body, and by diagnosing pathology which is occurred in peripheral nerve, nerve root, denervation, skeletal muscle, and judging the progress and prognosis, we have the merit to enable systematic treatment and diagnosis.
  • the loop feedback controller(730) which is inputted the output of the EST feedback controller(710) executes function of setting the input(measurement) conditions of the response processor(370). That is, after setting the electrical stimulation output condition, it is for measuring the bio-signal inputted to the response processor(370).
  • the event feedback controller(740) executes the function that adjusts the stimulation output of the electrical stimulus generator(360) according to the bio-signal inputted from the response processor(370). For example, if the EMG feedback control measurement part(720) measures activated quantity conesponding to the bio-signal and transmits to the event feedback controller(740), the event feedback controller(740) is used to compare the initial activated quantity and the measured activated quantity that is the result, after setting goal quantity, in case of less than or equal to goal quantity, periodically outputting electrical stimulation into the body, as the result we use to compare remeasured activated quantity with initial activated quantity.
  • the loop feedback controller(730) and event feedback controller(740) will be explained in detail refening to the related diagram, hereafter,.
  • Figure 21 is a diagram that shows the association of EST feedback control measurement part and the electrical stimulus generator in order to measure impedance.
  • EST feedback control measurement part(765) can measure impedance by measuring cunent(I) flowing into the body from the electrical stimulus generator(360).
  • EST feedback control measurement part(765) can calculate current by measuring voltage of end points of resistance, and connecting resistance serially in the output coupler(640).
  • amplitude of output signal can be set to maximum 100 Vp-p frequency can be set to maximum 50kHz. It is desirable that output signal is to be set symmetric bi-phasic wave not including DC component. Accordingly, signal used in the impedance measurement has to be bi-phasic wave based on sin wave not including DC component, and in case of using bi-phasic wave, we can solve easily impedance because output cunent(waveform) is just conductance, the inverse of current is impedance. Therefore, by observing the waveform measured, sweeping the frequency of the electrical stimulus generator(360) if inductance value is advantageous over capacitance value, resonance point of waveform measured is moving to lower frequency region, conversely, resonance point is moving to higher frequency region, we know.
  • the EMG feedback controller(720) adds phase detect circuit to enable Fourier analysis if composes output of the electrical stimulation input part(360) by using the method of sweeping frequency, we can know the degree of distortion(harmonic) on the response signal of the body additionally. Therefore, the electrical therapy apparatus according to the present invention, has the structural merit to analyze the noise characteristics of measured object(body) due to total harmonic distortion. Also, the electrical stimulus generator(360) and EST feedback controller(710) have the merit to enable alternating current analysis and to enable analysis of noise characteristics of the bio-signal affecting the frequency(sweep) due to impedance component of the body. Also, there is the merit to enable transient analysis because it compares input signal and output signal in the time domain basically.
  • analysis function provides that calculates average value, basic wave, RMS value, inverse ratio by the ordinary calculation formula, after measuring magnitude, phase, direct current component.
  • FFT Fast Fourier Transform
  • FFT is to calculate output data outputted from output port of equipment with FFT algorithm, and, function outputting(measuring) f equency spectrum is excuted
  • Fourier analysis uses fhe theory that obtains result by Fourier integrating FFT result data. Because we obtain only magnitude in FFT result, but when we execute Fourier analysis, we can obtain magnitude, phase, cunent component. Using these result of process, it is possible to do various inspections.
  • the reason that the electrical therapy apparatus(310) according to the present invention prepares method of impedance measuring is to solve various problems of medical accidents such as electric fire injury, electric impulse by side-effects occuned unaware of patient state and incautious of adjusting output cunent value.
  • the electrical stimulus generator(360) solves problems of the conventional technology by coupling feedback controller(375) according to each use. Also, we can simulate with software characteristics of stimulation output set by user through controller(380).
  • FIG 22 is a diagram that shows the detail composition of EST feedback control measurement part to measure activated quantity according to the preferred embodiment of the present invention.
  • Figure 22 illustrates the composition of EST feedback control measurement part(765) to measure activated quantity (i.e., the measured value as the result of execution with goal of inspection, diagnosis and control according to the user option) of stimulation signal outputted from the electrical stimulus generator(360).
  • an integrator(910) provides to comparator(915) the voltage signal transformed from stimulation signal of cunent signal form, receiving stimulation signal through output coupler(640) of the electrical stimulus generator(360).
  • the composite element to transform cunent signal to direct cunent voltage.
  • the setting criteria value of cunent signal form inputted from the controller(380) is transformed to the setting criteria value of voltage signal form by the setting criteria supply part(925).
  • the setting criteria supply part(925) transmits to comparator(915) the setting criteria value of voltage signal form.
  • Comparator(915) compares stimulation signal received from integrator(910) with the setting criteria value received from the setting criteria supply part(925), and, comparison criteria value is the setting criteria value.
  • Comparator(915) provides comparison result to mono-stable oscillator(930) which outputs pulse signal of certain magnitude according to comparison result of comparator(915).
  • composition of EST feedback control measurement part(765) is shown in figure 9 and as the same case of impedance measurement explained earlier is , we restricted the category of the electrical stimulation function for convenience of explanation, the above explanation is applied to EMG biofeedback function in the same way. Accordingly, the duplicated explanation is omitted when the EMG biofeedback function is described.
  • the controller(380) can measure activated quantity and the measured activated quantity can be converted to cunent, voltage, power, or energy.
  • the composition of EST feedback control measurement part(765) can be modified or changed in the various ways.
  • FIG 23 is a diagram that shows the detail composition of EMG feedback control measurement part for measuring frequency and phase according to the prefened embodiment of the present invention.
  • the EMG feedback control measurement part(720) includes a phase comparator(l ⁇ l ⁇ ), a setter(1015), 1/N programmable counter(1020), a loop filter(1025), a voltage control oscillator(1030), counter(1035), a frequency compensation 1040), A/D converter(1045), and a phase discriminatory 050).
  • the EMG feedback control measurement part(720) inlcudes basically the phase comparator(l l ⁇ ), fhe loop filter(1025),the voltage control oscillator(1030) in order to detect frequency and phase of bio-signal, a programmable counter can be additionally included. And for the purpose of the above function implementation, PLL(phase-locked loop) can be necessary.
  • Phase comparator(1010 also called phase detector, generates average output voltage(DC) which is proportional to phase difference between input signal from input coupler(670) through loop filter(1025) and voltage controlled oscillator(1030) through 1/N programmable counter.
  • digital type for example, Ex-OR type, R-S flip-flop type
  • 1/N programmable counter can be used for convenience of composition. 1/N programmable counter(1020) sits between voltage controlled oscillator(1030) and phase comparator, easy digital control is composed through the N setter.
  • composition has besides merit of digital control also, has merit of carrying out needed calculation to compare mutually value that inputted into controller(380) measuring frequency ⁇ thin loop when PLL loop is locked, and output value that outputted through the N setter(1015) from the controller ⁇ 80). Therefore, the phase comparator(l ⁇ l ⁇ ) compares bio-signal inputted from input coupler and phase of feedback signal inputted from the 1/N programmable counter(1020), and detects phase difference. Phase difference detected by the phase comparator ⁇ 010) is transmitted to the voltage controlled oscillator(1030) through the loop filter(1025) and thereby accurate phase difference is detected.
  • phase comparator(l ⁇ l ⁇ ) outputs voltage proportional to phase difference of bio-signal inputted and outputted voltage signal is averaged by fhe loop filter(1025) and is outputted DC.
  • Dc voltage that is outputted proportional to phase difference is converted analog signal by the A/D converter, we can measure the phase of bio-signal by admission to controller(380) through phase discriminatory 050) which is mapped DC voltage and phase difference.
  • frequency for output of voltage controlled oscillator is frequency, this frequency is measured by counter(1035), and the measured frequency enor is calibrated by frequency compensation unit(1040) that has calibration table, and the calibrated data is transmitted to controller(380).
  • the controller(380) multiplies frequency inputted from frequency compensation unit(380) by inputted value of N setter(1015) that determines output of 1/N programmable counter(1020) finally getting frequency of bio-signal.
  • Voltage controlled oscillator(1030) is an oscillator that output oscillation frequency is changed in proportion to input controlled voltage.
  • Loop filter(1025) has low pass filter characteristic, so loop filter determines elimination of high frequency component and PLL response characteristic which are occurred in the phase comparator(l ⁇ l ⁇ ). It is desirable that the loop filter(1025) uses lag-lead filter of which amplitude adjusting is easy.
  • phase comparator(l ⁇ l ⁇ ) OV and circuit is in an open state.
  • frequency and phase of input signal is not identical to output of a voltage controlled oscillator. Accordingly.
  • circuit diagram shown in figure 10 is composed to measure and control these process through the controller(380).
  • the state that becomes in a synchronous state is called lock-in, and the range is called lock-range and frequency range is called frequency capture range.
  • frequency capture range is within about 10 kHz, so pre-scaler can be omitted at the front of programmable output oscillating frequency counter.
  • phase capture range is within - ⁇ + And has the value of multiples of integer(i.e., ,2,3,—)-
  • the EMG biofeedback is only explained, but the electrical stimulation function can be applied, too, in the same way. That is, the EST feedback control measurement part(765) is inputted the signal to measure through the output coupler(640) of the electrical stimulus generator(360), and the EST feedback control measurement part(765) can measure frequency and phase using the composition shown in figure 23.
  • phase is the difference of proceeding hour of two signals, it can be used to measure the precise hour.
  • Figure 24 is a diagram that shows the composition of the EMG feedback control measurement part for time measurement according to the prefened embodiment of the present invention.
  • Figure 24 is a diagram that illustrates the composition of the EMG feedback control measurement part(720) for confirmation of response characteristics of response processor(370). That is, to measure the time that output of the electrical stimulus generator(360) is transmitted, by way of the body, to the response processor(370) is to find out the characteristic of the body.
  • the signal transmission time can be measured during specific hour(Tl-T2), but in case that there is an external stimulation ⁇ using loop feedback processing system coupled simultaneously with the electrical stimulation function and EMG bio-feedback function, thereby the time can be measured. That is, we transmit to the control equipment and store in the memory, the data of stimulus time(Tl) from the electrical stimulus generator(360) using loop feedback processing system and at the same time, using the circuit schematics of figure 24. measuring fhe response time(T2) we get the difference( i.e., T2-T1 ).
  • time measurement function can be replaced for the obtained phase. That is, because phase delay can be converted to signal delay(or earliness) in the time domain.
  • conversion of detection of phase to time can produce inconect enor, like the present invention, extra time measurement function is prepared. In order to get transmission speed, transmission distance is divided by transmission time from the ordinary formula.
  • the integration output of the integrator is inputted as the comparison signal of the comparator(1115).
  • the criteria signal conesponding to the setting criteria value is inputted to D/A converter(l 120) by the controUer(380).
  • D/A converter(l 120) converts criteria signal to analog signal which is inputted to the setting criteria supply part(1125).
  • the setting the criteria supply part(1125) converts analog cunent output of D/A converter to voltage signal and the converted voltage signal is inputted to comparator(l 115) as the criteria signal.
  • Com ⁇ arator(1115) outputs 1 or 0 as the comparison result, and output signal of comparator(1115) is acknowledged to mono-stable oscillator(1130) and latch(1 135) simultaneously.
  • Mono-stable oscillator(1130) generates pulse signal as the comparison result of comparator ⁇ 115) and transmits to integrator(l l l ⁇ ) and resets integration output of integrator(lll ⁇ ).
  • latch(1135) inputs to AND gate(1140) the identical output signal until reversed output signal from comparator(l l l ⁇ ) is inputted.
  • AND gate(1140) that is inputted the periodical clock from clock source(1145) acknowledges the logic AND result value to counter(1150).
  • Counter(l 150) acknowledges to multiplier the count value that is proportional to the reversed result of AND gate (1140) output value.
  • Multiplier(l 150) receives pulse width of clock source as input and multiplies unit time of pulse width by the number of counter outputs, thereby obtaining total hour, and transmitting to the controller(380) the measurement value. Therefore, the controller(380) can measure the transmitted hour in the body system.
  • label detection, waveform detection, offset detection is possible, but, in case of label detection, and waveform detection, we can measure them easily using usual A/D converter and in case of offset detection, that combines alternating cunent signal and direct cunent signal, we can obtain DC label easily shift circuit or clamp circuit. We omit the explanation about them.
  • Fig. 25 is a view illustrating the system configuration for the event feedback functional execution according to an embodiment of the present invention.
  • a system to execute the event feedback function comprises an insertion type electrode(320), an electrical stimulus generator(360), a controller(380), a channel setting switch(365), a response processor(370), an EST feedback control measurement part(765), and event feedback controller(740).
  • the EMG feedback control measurement part(720) detects electrical parameters by coupling the bio signal inputted from the response processor(370) and transmits detected electrical parameters to the control part(380).
  • the control of the control part(380) measures stimulation of the electrical stimulus generator(360) employing the electrical parameters received from the EMG- feedback control measurement part(720) outputs the result.
  • the EST feedback control measurement part(765) detects output signal through the output coupler(640) and compares with data received as event feedback data by the stimulation comparator(760) to perform feedback operating the stimulation trigger controller(630). That is, the event feedback controller(740) determines if the bio signal inputted from the response ⁇ rocessor(370) through the channel setting switch(365) satisfies input conditions set in the response processor(370).
  • the feedback process to control an input value is repeatedly performed by controlling the electrical stimulus generator(360) according to the set condition received from the controller(380) or predetermined set condition until the input condition set in the response processor(370). The goal degree of activation and determines output value of the electrical stimulus generator(360) by employing the received information.
  • the event feedback controller(740) additionally receives control demand from the controller(380) and may set output of the electrical stimulus generator(360). That is, it performs function to output by changing electrical parameters(e.g. harmony cunent(potential), voltage, pulse, burst, frequency, phase etc,).
  • the electrical stimulation outputted from the electrical stimulus generator(360) can be measured by the EST feedback controller(710).
  • the result both from the EST feedback controller(710) and the EST feedback control measurement part(765) is input to the controller (380) which identifies, amends, checks, or analyses enors.
  • the EST feedback controller(710) has the configuration which allows to determine quantities of stimulation signal output from the electrical stimulus generator(360).
  • the EST feedback controller(710) comprises integrator(1220), comparator(1225), setting criteria supply part(1230), mono-stable oscillator(1235), counter(1240), and multiplied 1245).
  • the EMG feedback controller(720) can have similar configuration to the EST feedback contr ⁇ ller(710) to determine quantities of stimulation signal. In the configuration of figure 25, the EMG feedback controller(720) and the EST feedback controller(710) have different level of signals each other and thus both are constituted for common function of quantity determination except for the pre-treatment configuration.
  • each integrator(1260), setting criteria supply part(1265), comparator ⁇ 270), mono-stable oscillator(1275), counter(1280), and multiplier(1285) of the EMG feedback controller(720) performs the same function as the corcesponding parts of the EST feedback controller( 10).
  • the latch(1290) is to assume a case that a user sets operation of the event feedback controller(740) with result of "1" or "0". Thus, since according to the user's purpose can input signal of the event feedback controller(740) be variously changed, it is not limited to the latch(1290).
  • FIG 25 it illustrates the system configuration to measure degree of activation as an embodiment but types and configurations of signals to detect are varied with the purpose.
  • Fig. 26 is a view illustrating the system configuration for the execution of loop feedback functions according to an embodiment of the present invention.
  • a system to execute the loop feedback function comprises an insertion type electrode(320), an electrical stimulus generator(360), a controller(380) , a channel setting switch(365), a response processor(370), an EST feedback control measurement part(765), and a loop feedback controller(730). That is, the system to execute the loop feedback function may have similar configuration to that to the event feedback function described accompanying with figure 25.
  • the event feedback controller(740) and the loop feedback controller(730) detect degree of activation under the same condition, the degree of activation detected from each is different from each other since the body is not ideal circuit. The difference is due to different amount of lost cunent inside the body and different degree of damaged nerve muscle. Accordingly, use of the event feedback function and loop feedback function provides accurate diagnosis and consistent results based on the detected diagnosis since they can be used for various examinations, diagnoses, conditional stimulation functions, and conditional EMG biofeedback functions.
  • the system to execute the loop feedback function receives the output of the EST feedback control measurement ⁇ art(765) and sets as the set condition of the response processor(370) at the loop feedback controller(730). That is, the loop feedback function is function to set the set condition of the response processor(370) according to the output condition of the electrical stimulus generator(360) and can execute EMG biofeedback conditionally by setting threshold cunent condition outputted from the electrical stimulation function. Therefore, the loop feedback controller(730) generates the trigger signal set conditionally in the electrical stimulus generator(360), detects data according to whether the output signal of the electrical stimulus generator(360) satisfies fhe set condition, and authorizes the data to the response processor(370).
  • the value difference means amount of lost cunent inside the body.
  • the degree of lost cunent varies with severity of the nerve muscle disorder. Therefore, when the value difference is mapped with the severity of the nerve muscle disorder, it can be applicable for use in the diagnosis or treatment of patient.
  • EST feedback control measurement part(765) After inserting the insertion-type electrode(230) into the body (or attaching on the skin) likely to the event feedback function as described above, EST feedback control measurement part(765) performs coupling through the coupler(640), measures the electrical stimulation signal(i.e., output signal), and sends the measured electrical parameters to the controller(380). Also, EMG feedback controller(720) measures the EMG feedback signal through the input coupler(670) of the response processor(370), and sends the measured electrical parameters to the controller(380). Thus, the controller(380) can calculate the difference between the output signal and the input signal, and performs various signal processing.
  • the controller(38O) sets up the condition of the loop feedback controller(730) conesponding to the user's condition.
  • EST feedback control measurement part(765) measures fhe output signal of the electrical stimulus generator (360) through the output coupler(640), and user setting value or result of program stored in the memory is provided to the stimulation comparator(760) to operate the stimulation trigger controller(630) according to the comparison result of the stimulation comparator(760).
  • This feedback data is sent from the EST feedback control measurement part(765) to the response processor(370) through the loop feedback controller(730) and is used as the operation condition of the response processor(370).
  • Fig. 27 is a flow chart showing the operation process of the electrical therapy apparatus according to an embodiment of the present invention. As described above, the conventional electrical therapy apparatus does not have a feedback function. Thus, the electrical stimulation function and EMG feedback function can not be executed simultaneously, but only successively or selectively.
  • the electrical therapy apparatus cannot perform the measurement function during the execution of the electrical stimulation function and EMG feedback function, and examination, diagnosis, or a body condition cannot be checked because of its unidirectional structure, namely, outputting stimulus or receiving signal in one way.
  • the electrical therapy apparatus of the present invention comprises the feedback function, measurement function, etc., the problems of the prior art can be solved.
  • the operation of the electrical therapy apparatus will be described with Fig. 27. Referring to Fig. 27, at step 1405, the user determines whether or not EMG is needed before treating the patient. If EMG is finished or is not needed, at step 1410, the user determines whether or not the electrical stimulation is needed.
  • a stimulation variable can be determined for preforming the electrical stimulation regardless of the result of EMG.
  • the user determines whether or not measure the impedance. If the impedance measurement is selected, at step 1425, the stimulation output is set to be automatically controlled; otherwise, at step 1430, the stimulation output is set to be manually controlled. That is, the stimulation output condition is set according to the selection of impedance measurement function.
  • the electrical therapy apparatus (310) outputs the electrical stimulation conesponding to the stimulation output condition, and inputs it to the body.
  • the user determines whether or not the loop feedback function is needed. If needed, at step 1445, fhe user sets up the loop feedback condition.
  • the input of electrical stimulation is continued.
  • the user can stop the operation of the electrical therapy apparatus(310) by stopping the input of electrical stimulation.
  • the electrical therapy apparatus(310) measures fhe spectrum conesponding to the bio signal, and at step 1455 performs the EMG bio feedback function. That is, if the operation of EMG bio feedback function is needed together with the operation of electrical stimulation function, the user activates the loop feedback function and selects the condition, then the electrical therapy apparatus(310) performs the EMG bio feedback function through the spectrum measurement.
  • the electrical therapy apparatus(310) determines whether or not the user selects the event feedback function. If selected, at step 1465, a variable for event feedback is set up.
  • the variable is for controlling the strength of electrical stimulation based on the bio signal from the body. Then, the operation process returns to step 1420. But, if not selected, at step 1470, the user inputs the purpose of using the electrical therapy apparatus(310). Of course, whole selection steps can be performed before the operation of electrical therapy apparatus(310) or can be performed individually.
  • examination purpose at step 1450, the spectrum is measured.
  • the treatment purpose at step 1475, the target waveform is selected. That is, the user can operate the electrical therapy apparatus(310) conesponding to the examination purpose or treatment purpose by selecting the EMG bio feedback function. Since the spectrum has to be measured in the examination purpose and muscle movement has to be performed, then the target waveform will be set up.
  • EMG is not selected at step 1405, at step 1480, it is determined whether or not the denervation muscl stimulation purpose.
  • a denervation muscle variable is set up by the user or extracted from the memory(340). Then the operation process returns to step 1420.
  • the result of determination at step 1480 is not the denervation muscle stimulation purpose, at step 1490, it is determined whether or not the innervation muscle stimulation purpose.
  • a innervation muscle variable is set up by the user or exracted from the memory(340).
  • step 1490 it is determined whether or not the EMG bio feedback function selection.
  • the operation process returns to step 1470;otherwise, the operation process terminates.
  • the operation of electrical therapy apparatus(310) can be terminated at any time by the control of user.
  • the electrical therapy apparatus(310) can performs not only the electrical stimulation function(i.e., step 1435) and the EMG bio feedback function(i.e., step 1455) simultaneously but also the electrical stimulation function and EMG bio feedback function simultaneously by the feedback function(i.e., loop feedback function and/or event feedback function at step 1440 to 1445, 1460 to 1465).
  • EST feedback function(i.e., step 1420 to 1430) and EMG feedback function(i.e, step 1450, 1470 to 1475) provide a means for measuring by individual feedbacks of the stimulation output to the body and the bio signal input from the body.
  • the self feedbacks of the electrical stimulation function(i.e., step 1420 to 1430) and EMG bio feedback(i.e., step 1450, 1470 to 1475), or the mutual feedbacks of the electrical stimulation function and EMG bio feedback(i.e., step 1440 to 1445, 1460 to 1465) can set up the output based on the EMG bio feedback signal inputted from the troubles of body(i.e., step 1465), and also can analyze EMG signal inputted from the body under the contrary condition(i.e., step 1445).
  • the self measurement in each function and feedback interlocking between each function make it possible not only to set up the output condition as automatic or manual but also to selectively perform the target waveform according to the muscle movement or spectrum measurement, the conect diagnosis of troubles, the treatment prescription based on the diagnosis result, the objective index improved by treatment, etc., can be analyzed systematically. Also, since effective control of excessive stimulation output is possible because fhe constant detection(monitoring) is available, the present invention can replace the protection circuit in the view of patient protection. Of course, likely the electrical stimulation function, the feedback function can be interlocked in realtime in case of EMG bio feedback function.
  • the electrical therapy apparatus of function cooperative method using feedback control techniques co-works through simultaneous real-time feedback functions of electrical stimulation function and EMG bio feedback function.
  • the present invention can change during the treatment both the electrical stimulation function and EMG bio feedback function, to operate stand-alone or in combination of functions, and do the arbitrary selection of the channels.
  • the present invention can provide diagnosis result before and after the treatment.
  • the present invention provides the impedance measurement function and automatic control function of cunent for determining the strength of stimulation when electrical stimulation is performed on a patient.
  • the present invention provides the simulation and emulation functions for performing the electrical stimulation function.
  • the present invention can perform EMG, automatic gain control, and frequency setting during the operation of EMG bio feedback function.
  • the present invention can discharge accumulated during the operation of EMG bio feedback function.
  • the present invention provides a means for controlling the strength of electrical stimulation by realtime feedback function not a stationary cunent source(voltage source) in the view of patient protection.

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Abstract

The electrical stimulus generator that generates electric stimulus and inputs to the body through the electrode, the response processor that is inputted bio-signal from the electrode, the channel setting switch that connects the electrode with at least one of the electrical stimulus generator, or the response processor, and using the measured value corresponding to at least one of electrical stimulus of the electrical stimulus generator, or bio-signal of the response processor, the present invention is about the electrical therapy apparatus of function coupling method, using real-time feedback control techniques including the feedback controller that controls at least one of operation among the electrical stimulus supply part or the response processor. The electrical therapy apparatus of function coupling method using feedback control techniques is coupled through real-time feedback function simultaneously with the electrical stimulus function and EMG bio-feedback function.

Description

Title of the invention ELECTRICAL THERAPY APPARATUS
Technical Field of the Invention The present invention relates to an electrical treatment equipment of functional operation method using real-time feedback control techniques. More particularly, the present invention relates to the electrical treatment equipment of functional operation method using real-time feedback control techniques operational in support of individual electrical stimulation function and EMG biofeedback function, and each function related.
Background of the Invention Generally, as the methods to treat the neuro dysfunctions and the muscle dysfunctions of the body, there are surgery, pharmacotherapy and functional therapy. Recently, due to the medical accidents and side-effects functional therapy has been used more than surgery and pharmacotherapy. The functional therapy is the method to relax or reduce the neuro dysfunction and muscle dysfunction through pulse current or EMG biofeedback muscle exercise using electrical stimulation or EMG biofeedback, placing electrode of attached type or electrode of inserted type on the dysfunction region. Fig. 1 is a layout of an electrical therapy equipment according to the conventional technology. Fig. 2 is a diagram showing the form of general electrical stimulation signals. When Fig. 1 is referred to, the electrical treatment equipment of conventional technology comprises an electrode of coelomic insertion type(lθ), a peripheral equipment(20), a control part(70), a stimulation signal generator part(80), and an EMG signal processing part(90), and the peripheral equipment(20) comprises a display part(25), an control panel(30), a memory part(40), a communication processor(50), and an operator console(60). As the electrical treatment equipment represented in Fig. 1 is the incontinent therapy equipment, it can perform the electrical stimulation function and EMG biofeedback function. However, it can be used for any one function of the two alternatively, but not simultaneously both electrical stimulation function and EMG biofeedback function. First of all, in case that an operator chooses the electrical stimulation function using the control panel(30), the control part(70) transmits the electrical stimulation generation command to the stimulation signal generator part(90) and the stimulation signal generator part(90) generates electrical stimulation and inputs the electrical stimulation into the body through the electrode of coelomic insertion type(lθ). When necessary, the stimulation signal generator(90) can make use of varying the pulse width in order to change the magnitude of stimulation. Generally, the form of electrical stimulation signal which is generated by the stimulation signal generator(90), inputted into the body, is represented in Fig. 2. However, when the conventional electric treatment equipment is used as electric stimulation functions to provide electric stimulations on body, there is a problem not to provide impedance measurement function. Therefore, it is a defect that we can't determine whether the strength of electrical stimulation which currently penetrates the body is appropriate or not and also, we can't decide electrical parameter of stimulation variable. Also, because the impedance can't be measured, we can' know the result of before and after treatment using the electrical stimulation. And there is another problem not to determine the magnitude of current or voltage which equals the strength of stimulation in the conventional electrical treatment equipment. That is, because the impedance real-time can't be detected, and the current can't be controlled, it causes muscle fatigue, electrical burn, and electrical impact. Also, the conventional electric treatment apparatus had a problem that can't provide simulation function and emulation function. The electric treatment apparatus needs to restrict over-current in order that electric burns and electric impact do not occur. That is, it requires to simulate(predicf) beforehand whether the strength of electrical stimulation(i.e, the value of current) of output is appropriate, and it also requires to do emulate(verification) whether there is the difference between the simulated current value according to the impedance value measured before and the current value flowed according to the impedance value after the stimulation current to the body is permitted. There is a further problem with the conventional electric treatment apparatus that can't provide the revolving stimulations. That is, because the conventional electric treatment apparatus has the fixed channel(positive pole and negative pole) of electrode, it cannot satisfy the necessary of changing the channel due to muscle fatigues or during the treatment, the channel cannot be changed. Next, in case that an operator chooses EMG biofeedback function using the control panel(30), the EMG signal processing part(90) receives R-EMG signals from the coelomic electrode(lθ) of insertion and the received R-EMG signals is transformed into D-EMG signals using an envelope detector, and transmitted to the control part(70). The control part(70) analyzes D-EMG signals and displays the result data of analysis in the display part(30). Also, the control part(70) displays GOAL-EMG wave form of memory in the display part(30). The conventional electric treatment apparatus, when used as EMG biofeedback function, provides the label detection function only but can't provides spectrum analysis function. That is, it can only display the exercise of muscle(i.e., contraction or relaxation) with only the label according to time by detecting with envelope detector for the bio region,. Therefore, because the functions of exercise concept is only provided without the diagnosis function which is based on the spectrum analysis, it can't provide the appropriate treatment according to patients' dysfunction and can be further cause of side-effects. And, the conventional electric treatment apparatus of EMG biofeedback function can measure only the label on the time domain, and can't measure the electric parameters in the frequency domain. That is, without the measurement of spectrum, we can't derive the result of diagnosis according to the analysis of various examinations and we can't get the evidence data for the judgment on dysfunction of innervation muscle(i.e., denervafion muscle). Also, the conventional electric treatment apparatus has the fixed gain method and the fixed low-pass filtering frequency method, and thereby has the problem that it is not easy to change the function during treatment(for example, gain change, channel change). Also, there is a problem that does not provide the discharge function of electricity accumulated through the electrode. Also, in the conventional electric treatment apparatus, the function of electric stimulation and the function of EMG bio feedback work independently but can't co-work. Summary of the Invention Therefore, an object of the present invention to solve the problems associated with the conventional electric treatment apparatus is to provide an electrical therapy apparatus of function cooperative method using feedback control techniques co-worked through simultaneous real-time feedback functions of electrical stimulation function and
EMG bio feedback function. Another object of the present invention is to provide an electrical therapy apparatus of function cooperative method using the feedback control method to change during the treatment both the electrical stimulation function and EMG biofeedback function, to operate stand-alone or in combination of functions, and to do the arbitrary selection of the channels. A further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques in order to contrast the diagnostic result of before and after treatment. A further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that enables automatic control function of electrical current for impedance measurement and determination of stimulation strength when electrical stimulation is performed on a patient. A further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that has simulation and emulation functions when in treatment of electrical stimulation functions. A further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that enables EMG, setting automatic gain, and setting frequency when in treatment of EMG biofeedback. A further object of the present invention is to provide an electrical therapy apparatus of the function cooperative method using the feedback control techniques that enables emission of electrical charges through electrodes when in execution of EMG biofeedback.
Technical Solution To achieve aforementioned objects, according to one aspect of the present invention, there is provided an electrical therapy apparatus connected to an electrode that is contacted to a patient or inserted into coelom to input an electrical stimulus on the contacted part of patent or to receive bio-signal from the contacted part of patent, comprising: an electrical stimulus generator, generating and inputting an electrical stimulus through the electrode; a response processor, receiving a bio signal inputted by the electrode; a channel setting switch, connecting at least one of the electrical stimulus generator and the response processor to the electrode; and a feedback controller, controlling at least one of the electrical stimulus generator and the response processor by use of a measured value corresponding at least one of the electrical stimulus of the electrical stimulus generator and the bio signal of the response processor. The feedback controller detects an electrical parameter corresponding to the electrical stimulus of the electrical stimulus generator and sends a control signal for controlling a magnitude of the electrical stimulus to the electrical stimulus generator if the detected electrical parameter does not correspond to a predetermined setting value. If the electrical parameter is an activated quantity that is measured value as the result of execution with goal of inspection, diagnosis and control according to the user option, the feedback controller comprises: a comparator, comparing the predetermined setting value with the detected electrical parameter; a mono-stable oscillator, generating a pulse signal with a magnitude corresponding to the comparison result of the comparator; a counter, counting the pulse signal; and an activated quantity calculator, generating an activated quantity by use of the predetermined setting value and the result of the counter. Also, The feedback controller detects an electrical parameter by use of the bio signal inputted to the response processor and sends a control signal for amplifying a magnitude of the bio signal to the response processor if the detected electrical parameter does not correspond to a predetermined setting value. If the electrical parameter is a frequency and a phase, the feedback controller comprises: a voltage controlled oscillator, generating an output oscillating frequency corresponding to an input control voltage; a programmable counter, dividing the output oscillating frequency according to a predetermined number; a phase comparator, generating an output voltage corresponding to a phase difference between the bio signal and the divided output oscillating frequency; a filter, generating the input control voltage by normalizing the output voltage; a frequency measuring device, measuring a frequency by use of the output oscillating frequency; and a phase discriminator, detecting a phase of bio signal by use of the input control voltage and a mapping table, wherein table is mapped by the inputted control voltage and phase difference. Also, the feedback controller selects a reference setting value of the bio signal of the response controller in advance and controls the magnitude of the electrical stimulus of the electrical stimulus generator if the measured value of the bio signal does not satisfy the predetermined reference setting value. Also, the feedback controller selects an output condition of the electrical stimulus generator in advance and selects a detection condition of the response processor. The electrical stimulus generator comprises: a waveform generator, generating a pulse signal corresponding to a control signal of the controller; a burst generator, combining a plurality of pulse signals generated by the waveform generator to compose a burst signal; an output setter, controlling a magnitude of the electrical stimulus outputted on each channel by combining a plurality of burst signals; a stimulus adjustor, controlling a strength of the electrical stimulus on each channel according to the control signal of the controller; a stimulus trigger controller, determining whether or not a feedback signal is received from the feedback controller; and a large signal amplifier, generating the electrical stimulus with final stimulus strength by multiplying a gain predetermined to the strength of electrical stimulus on each channel or a gain corresponding to the feedback signal. The response processor comprises: a differential amplifier, receiving the bio signal through the electrode and the channel setting switch and detecting a signal "that in-phase component is eliminated; a response trigger controller, determining whether or not the feedback signal from the feedback controller or a user setup condition is received; a filter, selectively filtering the input signal corresponding to the feedback signal or the user setup condition; a variable amplifier, amplifying the filtered bio signal to a signal level available for visual discrimination; and a signal detector, detecting a data corresponding to a measuring target by use of the amplified bio signal. The electrical therapy apparatus according to the present invention further comprises: a memory, storing a program for operating the electrical therapy apparatus, a data required to operating the program, and a protocol for diagnosis and treatment, wherein the protocol is a program for at least one of electrical stimulation function, EMG biofeedback function, and feedback function; a display, displaying a measurement value of the electrical stimulation and the bio signal value; and a controller, controlling operation of the electrical stimulus generator, the response processor, the channel setting switch, and the feedback controller, and controlling the display. The electrical therapy apparatus further comprises a control panel for inputting a user instruction to the controller, and at least one of the control panel, the memory, and the display communicates with the controller wirelessly. The storage region of the memory comprises a program data storing region as the highest level, the first memory region group for electrical stimulus function and feedback function, and the second memory region group for EMG biofeedback function and feedback function. The channel setting switch comprises a plurality of channels and a plurality of ground contacts, and the channels are connected to at least one of the electrical stimulus generator and the response processor. The control panel comprises the first setup means for inputting a data relating to the waveform of the electrical stimulus, and the second setup means for setting an operation mode of the electrical therapy apparatus. According to another aspect of the present invention, there is provided an electrical therapy apparatus connected to an electrode that is contacted to a patient or inserted into coelom to input an electrical stimulus on the contacted part of patent or to receive bio-signal from the contacted part of patent, comprising: an electrical stimulus generator, generating and inputting an electrical stimulus through the electrode; a response processor, receiving a bio signal inputted by the electrode; a channel setting switch, connecting at least one of the electrical stimulus generator and the response processor to the electrode; a feedback controller, controlling at least one of the electrical stimulus generator and the response processor by use of a measured value corresponding at least one of the electrical stimulus of the electrical stimulus generator and the bio signal of the response processor; a memory, storing a program for operating the electrical therapy apparatus, a data required to operating the program, and a protocol for diagnosis and treatment, wherein the protocol is a program for at least one of electrical stimulation function, EMG biofeedback function, and feedback function; a control panel for inputting a user instruction; and a controller coupled to the electrical stimulus generator, the response processor, the feedback controller, the channel setting switch, the memory, and the control panel, controlling an operation of at least one of the electrical stimulus generator, the response processor, the feedback controller, and the channel setting switch by use of the data stored in the memory. The feedback controller comprises: a EST feedback controller, detecting an electrical parameter corresponding to the electrical stimulus of the electrical stimulus generator and sending a control signal for controlling a magnitude of the electrical stimulus to the electrical stimulus generator if the detected electrical parameter does not correspond to a predetermined setting value; a EMG feedback controller, detecting an electrical parameter corresponding to the bio signal and sending a control signal for amplifying a magnitude of the bio signal to the response controller if the detected electrical parameter does not correspond to a predetermined setting value; an event feedback controller, selecting a reference setting value of the bio signal in advance,. controlling the magnitude of the electrical stimulus of the electrical stimulus generator if the measured value of the bio signal does not satisfy the reference setting value; and a loop feedback controller, selecting an output condition of the electrical stimulus generator in advance and selecting a measurement condition of the response processor corresponding to the output condition. The electrical stimulus generator comprises: a waveform generator, generating a pulse signal corresponding to the control signal of the controller; a burst generator, combining a plurality of pulse signals generated by the waveform generator to compose a burst signal; an output setter, controlling a magnitude of the electrical stimulus outputted on each channel by combining a plurality of burst signals; a stimulus adjuster., controlling a strength of the electrical stimulus on each channel according to the control signal of the controller; a stimulus trigger controller, determining whether or not a. feedback signal is received from the feedback controller; and a large signal amplifier., generating the electrical stimulus with final stimulus strength by multiplying a gain predetermined to the strength of electrical stimulus on each channel or a gain- corresponding to the feedback signal. The response processor comprises: a differential amplifier, receiving the bio signal through the electrode and the channel setting switch and detecting a signal that in-phase component is eliminated; a response trigger controller, determining whether or not the feedback signal from the feedback controller or a user setup condition is received; a filter, selectively filtering the input signal corresponding to the feedback signal or the user setup condition; a variable amplifier, amplifying the filtered bio signal to a signal level available for visual discrimination; and a signal detector, detecting a data corresponding to a measuring target by use of the amplified bio signal. The electrode is one of an insertion type electrode, a surface electrode, and a needle-type electrode.
Brief Description of the Drawings The aforementioned aspect and other features of the present invention will be explained in the following detailed description, taken in conjunction with the accompanying drawings, wherein: Fig. 1 is a layout of an electrical therapy equipment according to the conventional technology; Fig. 2 is a diagram showing the form of general electrical stimulation signals; Fig. 3 is a diagram showing the constitution of the electrical therapy apparatus according to an embodiment of the present invention; Figs. 4 to 15 are diagrams of the memory layout according to an embodiment of the present invention; Figs. 16 and 17 are diagrams of the layout and connection relationship of the electrode and channel setting switch according to an embodiment of the present invention; Fig. 18 is a block diagram showing the detail layout and operation process of the electrical therapy equipment according to an embodiment of the present invention; Fig. 19 is a view illustrating the output wave-form of the electrical stimulus generator according to the present invention; Fig. 20 is a view illustrating the connection relationship between the electrical stimulus generator, response processing part, and feedback controller according to an embodiment of the present invention; Fig. 21 is a view illustrating a method for combining the EST feedback control & measurement part and the electrical stimulus generator to measure impedance according to an embodiment of the present invention; Fig. 22 is a view illustrating the detail layout of the EST feedback control & measurement part for measuring the frequency and phase according to an embodiment of the present invention; Fig. 23 is a view illustrating the detail configuration of the EMG feedback control & measurement part for measuring the phase and frequency according to an embodiment of the present invention; Fig. 24 is a view illustrating the system configuration of the EMG feedback control & measurement for measuring the time according to an embodiment of the present invention; Fig. 25 is a view illustrating the system configuration for the event feedback functional execution according to an embodiment of the present invention; Fig. 26 is a view illustrating the system configuration for the execution of loop feedback functions according to an embodiment of the present invention; and Fig. 27 is a flow chart showing the operation process of the electrical therapy apparatus according to an embodiment of the present invention.
Detailed Description of the Invention Hereinafter, the preferred embodiments of the present invention will be described with accompanying drawings. Figure 3 is a diagram showing the constitution of the electrical therapy apparatus according to a preferred embodiment of the present invention. As shown in Figure 3, the electrical therapy apparatus(310) according to the present invention is composed of an electrical stimulus generator(360), a channel setting switch(365), a response processor(370), a feedback controller(375), and a controller(380). The electrical stimulus generator(360) is a means that flows the electrical stimulation into the body by employing an insertion type electrode(320) which can be inserted into the vagina or the anus or a surface electrode attached on the body. In Figure 3, only the insertion type electrode is shown, but a surface electrode or needle electrode can be applied accordingly. In the followings, the case in association with an insertion type electrode(320) is mainly described. And the detail constitution and various application examples of the electrical stimulus generator(360) referencing the related diagram will be described hereinafter. The channel setting switch(365) is a means that changes the setting by control of the controller(380) to execute the electrical treatment function, EMG biofeedback function, and feedback function. That is, the electrical therapy apparatus according to the present invention can execute the various functions using the channel setting switch(365). In the followings, the detail constitution and setting for execution of each function of the channel setting switch(365) referencing the related diagram will be described hereinafter. The response processor(370) is a means that executes EMG biofeedback inputted by bio signals occurred from the body through the inserted type electrode and channel setting switch(365) in response to the electrical stimulation(or muscle exercise) which is outputted by the electrical stimulus generator(3 0). The detail constitution and the various execution example of the response processor(370) referencing the related diagram will be described hereinafter. The feedback controller(375) is a means that executes the individual function feedback or coupled function feedback according to the control of the controller(380), and comprises an EST feedback controller(710 refer to figure 20), an EMG feedback controller(720 refer to figure 20), a loop feedback controller(730 refer to figure 20), and an event feedback controller(740 refer to figure 20). The electrical therapy apparatus(310) according to the present invention provides the feedback function different from the conventional electrical therapy apparatus(310). The individual function feedback has EST feedback of the electrical stimulus generator(360), and has EMG feedback of the response processor(370). EST feedback is executed by EST feedback controller(710) and EST feedback outputs stimulation as having the appropriate characteristics(magnitude) of signals supervising the stimulation output of the electrical stimulus generator(360). EMG feedback is executed by EMG feedback controller(720) and EMG feedback finds out the load characteristics(i.e., body characteristics) of the load(i.e., body) connected serially to the inserted type electrode(320) using the bio signal flowed from the response processor(370). Coupled function feedback is divided into loop feedback and event feedback. Loop feedback is executed by the loop feedback controller (730) and loop feedback is to measure the response of the response processor(370) after setting the electrical stimulation output condition of the electrical stimulus generator(360). Event feedback is executed by the event feedback controller(740) and the event feedback is to measure the response of the electrical stimulus generator (360) after setting the bio signal input condition of the response processor(360). The detail constitution of the feedback controller(375) referring to the related diagram will be described hereinafter. The controller (380) executes the function of controlling the electrical stimulus generator(360), the channel setting switch(365), the response processor(370), the feedback controller(375) corresponding to the operation commands from the control panel(335) using the protocol data(i.e., the executing program for the electrical stimulation function, EMG biofeedback function or the coupled feedback function) stored in memory(340). Also the control part executes the display function on the display part(330) on the detected data received from the response processor(370), the feedback controller(375), etc. The feedback controller(375) coupled with the electrical stimulus generator (360) and the response processor(370) is controlled by the control signal from the controller(380). The feedback controller(375) acknowledges the control signal to the electrical stimulus generator(360) and/or the response processor(370) according to the contents of the control signals or transmits to the controller(380) the data collected from the electrical stimulus generator(360) or the response processor(370). But the constitution of the feedback controller(375) is separated for the convenience of the explanation, when necessary, the controller(380) can include the feedback controller(375), of course. The controller(380), the electrical stimulus generator(360), the response processor(370), and the feedback controller(375) of the present invention are electrically insulated to reduce the electric noise and to protect patients. 500V AC or higher of the insulation voltage is preferable on the criteria of between the electrodes, between channels, or between the electrical stimulus generator(360) and the response processor(370). Also 4000V AC or higher of the insulation voltage of power supply part and 1500 VAC or higher of the insulation voltage of ground part are preferable on the criteria of the electrical therapy aρparatus(310) itself. The electrical therapy apparatus(310) according to the present invention inputs into the inside of patient the electrical stimulation(i.e., the current) that is generated from the electrical stimulus generator(360) by control of the controller(380) through the channel setting switch or the inserted type electrode. Also the response processor(370) of the electrical therapy apparatus transmits to the controller(380) the bio signal itself or the electrical parameters measured from the bio signal received from the body through the channel setting switch(365) from the insertion type electrode(320) by control of the controller(380). We will explain referring to figure 5 the constitution of the insertion type electrode inserted into the inside of body and the surface electrode attached on the body surface in connection with the electrical therapy apρaratus(310) according to the present invention. Also, the electrical therapy apparatus(310) according to the present invention is connected with the display part(330), the control panel(335), the memory(340), and the communication processor(345), and through the communication processor the electrical therapy apparatus(310) is connected with the operator terminal(350). The display part(330) displays various measurement data received from the electrical therapy apparatus(310) and includes a monitor and a printer as a means of printer output. The control panel(335) is to receive the user's command and transmit to the electrical therapy apparatus(310) and includes a keypad, a key board, and a mouse. The memory (340) is a means to store protocols of patient's diagnosis and treatment, various utility, and peripheral operation data. The memory (340) can be divided to a program memory that includes data to execute the proper operation of the electrical therapy apparatus(310) and data memory that includes necessary data when the program is executing. Hereafter, it is integrated as name of memory(340). The detailed constitution of memory(340) is described with referring to figure 4a or figure 41. The communication processor(345) is a means to communicate to the external equipments. Of course, each module of the peripheral equipments(i.e., a display part(330), an control panel(335), a memory(340), and a communication processor(345)) is composed independently for the convenience or the constitution parts of the electrical therapy apparatus(310). But, it is desirable that the display part(330) should be composed of independent parts adding the extra transceiver for the convenience of manufacturing, of reducing the noises. Hereafter, the method to execute data transceiving wirelessly between the electrical therapy apparatus(310), peripheral equipment and the insertion type electrode(320) is briefly described. It may be, of course, applied for the communication method between the electrical therapy apparatus(310) and the controller(380), serial(wired) communication methods such as RS-232, USB, and wireless communication methods such as microwave(RF), infrared(IrDA), or Bluetooth methods. The electrical therapy apparatus(310) according to the present invention transceivers the detected signals through the wireless communication methods among the insertion type electrode(320) and peripheral equipment(i.e., the display part(330), the control panel(335), the memory(340), the communication processor(345), and the operator terminal(350), etc.) For example, the wireless communication between the control part of the electrical therapy apparatus(310) and the operator terminal can apply the bi-directional communication method using the wireless transceiver contained in the communication ρrocessor(345). Also, the wireless communication between the controller(380), the display part(330) or the control panel(335) of the electrical therapy apparatus(310) can apply the uni-directional communication method. However, the communication direction of the display part(330) and the control panel(335) is opposite since while the display part(330) displays the data received from the controller(380), the control panel(335) transmits the inputted command to the controller(380). And, the controller(380) executes the function corresponding to the transmitted data from the control panel(335). Also, the wireless communication method between the electrical therapy apparatus(310) and the insertion type electrode can apply the uni-directional communication method as the same communication method between the electrical therapy apparatus(310) and the display part(330). However, in the uni-directional wireless communication method between the electrical therapy apparatus(310) and the insertion type electrode(320), different from the case of the display part(330), the insertion type electrode(320) does not have a receiver that is composed of active elements of electronic components. Accordingly, when the electrical therapy apparatus(310) transmits the data to the insertion type electrode(320), the insertion type electrode(320) itself becomes the antenna and receives the data. That is, the insertion type electrode(320) receives the electromagnetic energy from the transmitter connected with the channel setting switch(365). These electromagnetic energy applied to the present invention is transmitted as a wireless radiation in the air and is applied the physical law such as wavelength, velocity, and frequency. In this case, the insertion type electrode(320) can be either a needle electrode or a surface electrode. In the case of the needle electrode, usually, according to the length of a needle electrode the used frequency(or wavelength) can be set the length of the needle electrode according to the frequency can be adjusted. That is, according to the already known physical law, unless the length of medical frequency we want to use is not coincident with the length of the needle electrode, the frequency wavelength can be adjusted by adding an electric conductor of an apt length(for example, coil) in the opposite side of insertion place of the needle electrode. The electrical therapy apparatus(310)that has diagnosis and treatment function according to the present invention can be used as a nerve root disorder electrical therapy apparatus(for example, incontinence treatment apparatus(Continence treatment apparatus), constipation treatment apparatus(feoal incontinence treatment apparatus) or electric physiological diagnosis(examination) apparatus.
Figure 4 to figure 15 are diagrams of the memory layout according to a preferred embodiment of the present invention According to the present invention, the memory(340) associated with the electrical therapy apparatus(310) is a concept of a general storage means such as RAM, ROM, HDD, FDD and this memory can be the internal memory of the electrical therapy apparatus(310). In this memory, data for the appropriate operation of the electrical therapy apparatus(310), data necessary when arbitrary programs execute, and data detected in the process of patient treatment are stored. In memory(340) according to the present invention, programs are stored for independent execution of the electrical stimulation function and EMG biofeedback function, and coupled executions of each
function. Referring to figure 4, in the program information storage region(the first memory region) data of the patient information, the protocol according to the diagnosis and treatment of each patient, various utility data and peripheral equipment operation data is stored in this region. The first memory region includes a system data region(Dl), a patient data region(D2), a protocol data region(D3), a progress data region(D4), a session data region(D5), a unit data region(D6), a cluster data region(D7), etc. The hierarchical structure of the detail region which is included in D3-D7 can be explained as one protocol data(that is, a program that is executing for the electrical stimulation function, EMG biofeedback function or coupled feedback function) is composed of several progress data, and one progress data is composed of several session data, and one session data is composed of several unit data. For example, in the case that one protocol data is chosen by a user or by a specific function, the lower part of programs is linked additionally and can be executed. And the selected protocols are transmitted to the electrical stimulus generator (360) or the response processor(370) by the controller(380) and ready to compose another protocol . In the system data region(Dl), data of various utility and peripheral equipment operations is stored. In the patient data region(D2), data of personal information, treatment information, examination and diagnosis information is stored. The patient data that is stored in the patient data region(D2) has to be stored more desirably in database such as RDBMS or File structure. And the patient data includes the frequencies of all treatment or diagnosis. In the protocol data region(D3), several programs is stored for the entire treatment process performed in the patient treatment. Each protocol data includes a discriminant that determines if it is the electrical stimulation function, EMG biofeedback function or feedback function according to each channel and each function is composed of progress, session, unit, cluster having the lower part(subordinate) data. Progress data region(D4) contains the treatment frequency information that should execute during the treatment period and contains several session data. Session data region(D5) contains the channel number information which executes once and contains several unit data. Unit data region(D6) contains the data which specifies burst characteristics and contains several cluster data. Cluster data region(D7) contains electrical parameters which specifies pulse characteristics. Figure 5 is a diagram that shows the stimulation mode information region(number 11 memory region) which is stored the program information of the operation mode of the electrical stimulation function in order to select the electrical stimulation mode of the memory(340). As shown in figure 5, among the various stimulation modes in case that a certain stimulation mode is selected, then the controller(380) transmits the stimulation mode control signal to the electrical stimulus generator(360). Referring to figure 5, a stimulation mode information region(number 11 memory region) includes a manual stimulation mode(Dll), an automatic stimulation mode(D12), a condition stimulation mode(D13), etc. The manual stimulation mode(Dll) executes the electrical stimulation with the pre-specified protocol regardless of the body characteristics. The user adjusts stimulation strength manually. According to the present invention, the manual stimulation mode(Dll) of the electrical therapy apparatus(310) is for the same execution as the conventional electrical stimulation apparatus. The automatic stimulation mode(D12) executes an appropriate electrical stimulation after determining the protocol, finding out the body characteristics through the examination or diagnosis. That is, measuring before electrical stimulation input or real-time measuring during input of electrical stimulation the impedance of body, the strength of electrical stimulation flowed into the body can be adjusted automatically. The automatic stimulation mode(D12) is a peculiar characteristic of the present invention, and an option function that the conventional electrical stimulation apparatus cannot present. The condition stimulation mode(D13) is to execute the electrical stimulation according to the needs or user's setting condition during execution of manual stimulation mode(Dll) or automatic stimulation mode(D12). For example, the condition stimulation mode(D13) can store the data that controls and executes the function of the electrical stimulation and EMG biofeedback sequentially or alternately. Figure 6 is a diagram that shows the modulation mode information region(number 12 memory region) which is stored the program information of the modulation mode in order to select modulation mode among the electrical stimulation functions. In case that an arbitrary modulation mode is selected among various modulation modes, the controller(380) transmits to the electrical stimulus generator(3 0) the modulation mode control signal corresponding to the selected modulation mode. The modulation mode information region(number 12 memory region) is composed of the structure that can call the data which can set the unit pulse and burst(pulse set) in the time domain in order to implement each modulation mode. The modulation mode information region(number 12 memory region) includes a phase modulation mode(D21), a time modulation mode(D22), a slope modulation mode(D23), etc. the phase modulation mode(D21) includes the data that can set amplitude, pulse width, frequency to arbitrary values in order to vary output phase. The time modulation mode(D22) includes the data that can set burst period, interval between burst, burst chain(number) to arbitrary values in order to vary output time. The slope modulation mode(D23) has the data structure that can set ramp-up period, plateau period, ramp-down period to arbitrary values in order to increase or decrease output magnitude. Figure 7 is a diagram that shows burst information region(number 13 memory region) which is stored the burst information that determines modulation characteristics of each modulation mode. Referring to figure 7, burst information region(number 13 memory region) includes a burst time region(D31), an interval region between bursts(D32), a burst duty region(D33), a burst magnitude region(D34), etc. In the burst time region(D31), the data that can set the burst time(i.e., the time that the electrical stimulation outputs as a pulse form) can be stored variably. In the interval region between bursts(D32), the data that can set the interval between bursts(i.e., the time between burst to output and burst) can be stored variably. In the burst duty region(D33), the data that can set burst duty(i.e., ratio of hour to output during a period of burst to output) can be stored variably. In the burst magnitude region(D34), the data that can set burst magnitude(i.e., magnitude of energy to output) can be stored variably. As shown in figure 8, in the pulse information region(number 14 memory region), the pulse information that is called to determine the characteristics of burst among the electrical stimulation parameters can be stored. That is, the pulse information is the minimum basic information for execution of the electrical stimulation function. Referring to 8, the pulse information region(number 14 memory region) includes a frequency region(D41), a pulse width region(D42), an amplitude region(D43), a duty region(D44), a waveform region(D45), etc. In the frequency region(D41), the data that can set frequency(i.e., the inverse of time including rest time from pulse) can be stored to an arbitrary value. In the pulse width information(D42), the data that can vary pulse width(i.e., the signal waveform that subtracts the rest time from a period) can be stored. For example, in case of symmetric bi-phasic wave, it is computed as the twice time of mono-phasic wave. In the amplitude region(D43), the data that can transform into RMS(Root Mean Square) is stored when we represent amplitude(i.e., We represent 0-peak value as maximum value of signal in a period) as the direct current averaging voltage. However, in case of not a symmetric bi-phasic wave, it is not symmetric so it is represented as a peak value - a peak value. In the duty region(D44), the data that can vary the duty(i.e., the ratio of not zero during a period) is stored according to frequency or pulse width. In the waveform region(D45), the data that can select a signal of mono-phasic wave, bi-phasic wave, poly-phasic wave is stored as a signal characteristic in a period. According to the present invention, the electrical stimulation inputted into the body of the electrical therapy apparatus(310) can be in combination with the basic wave(for example, rectangular form wave, sine wave, triangular wave) and application wave(for example, differential wave) and positive wave and negative wave can be combined. Figure 9 is a diagram that shows the channel information region(number 15 memory region) which is stored channel information to determine the characteristics of output according to the channel and channel setting. Referring to figure 9, the channel information region(number 15 memory region), in case of multi-channel(2 channels or more), is a region that is stored program information which adds the energy of all outputted electrical stimulations according to the channel numbers. And this region includes a channel structure region(D51), an electrode polarity(D52), an output strength region(D53), a chain information region(D54), a treatment hour region(D55), a location information region(D56), etc. Afore mentioned memory regions are for defining the characteristics of each electrical stimulation mode allotted per one of channels, in case of multi-channels the channel information has to be additionally defined, so the channel information region (number 15 memory region) is necessary. In the channel structure region(D51), the data that can alter the function of each channel is stored. For example, in case that the electrode channel is composed of multi-channel and we want to alter the function of each channel when electrode is inserted into the body or already attached(i.e., the time when we alter the path of stimulation output to other channel), then without physical re-insertion or re-attachment the channel can be changed to another channel by the channel setting switch. In the channel polarity region(D52), the data that can alter selectively through the channel setting switch(365) is stored without physical change of positive pole(+) or negative pole(-) of each channel of electrode. In the output strength region(D53), the data that can adjust the strength of stimulation outputted through the electrode is stored. That is, the strength of output means stimulation strength, and the integration value of the electric current can be determined when specified as burst characteristics in the time domain. The current strength can be set(i.e., the conversion value of the current value to output per second) that determines stimulation strength to output strength and the above fact has the effect of patient protection function for it restricts the stimulation strength. In the chain information region(D54), the data that can set burst characteristics(for example, number of burst, hour) of the electric stimulation outputted from channel to arbitrary values is stored. In the treatment hour region the data that can vary arbitrarily the stimulation hour through the specific channel is stored. In the location information region(D56), the data that can set the location of cavity region(for example, vagina, anus) or percutaneous region(for example, abdomen, thigh) is stored. Figure 10 is the feedback information region(number 16 memory region) that can set the EMG biofeedback input condition in order to control the electrical stimulation output or as the inverse of the above stores feedback information to determine condition setting or condition measurement. That is, in the feedback information region(number 16 memory region), the feedback condition in order to verify abnormality of stimulation information outputted or abnormality of the load characteristics of body(tissue characteristics) is set by measuring feedback of stimulation information outputted when the electrical stimulation is outputted through mono-channel or multi-channel of electrode. Accordingly, the structured data of feedback information can be the detected bio-signal through the electrical stimulation parameters or EMG bio-feedback function. Feedback information region(number 16 memory region) includes a loop feedback region(D61), an event feedback region(D62), a measurement information region(D63), a condition setting information region(D64), a transformation information region(D65), etc. In the loop feedback region(D61), the data that can execute EMG biofeedback conditionally by setting threshold current condition outputted from the electrical stimulation function is stored. In the event feedback region(D62), the data that can execute the electrical stimulation function conditionally by setting threshold voltage condition of bio-signal inputted from the body of EMG biofeedback function is stored. In the measurement information region(D63), the current value outputted is determined automatically by measuring impedance of the body before the electrical stimulation is outputted from the electrical stimulation function. Also, in order to measure the impedance which is composed of resistance and reactance, since not only resistance but also frequency, inductance, capacitance which are composed of reactance component are measured, there are some merits that can analyze it biologically by finding out muscle fatigue of bio tissue, besides optimal current value calculation. Also, in case that determines the current value manually, the output current or that output time of the electrical stimulus generator(360) can be set arbitrarily that are set by trigger signal of event feedback data which is measured by the response processor(370) originally. In the condition setting region(D64), the data that can set conditions of the electrical stimulation function(for example, limit current) and conditions of EMG biofeedback(for example, limit voltage) is stored. In the transformation region(D65), the data that can do the unit conversion, dimension transformation and arithmetic(calculation) between the homogeneous function or heterogeneous function of the electrical therapy apparatus(310), can compare each other the measurement data between the heterogeneous apparatuses(for example, magnetic electric stimulator). Figure 11 shows EMG biofeedback mode information region(number 20 memory region) that is stored program information on the operation mode of EMG biofeedback function. In case that a user select an arbitrary mode, the controller(380) transmits to the response processor(370) the EMG biofeedback mode control signal. Referring to the figure 11, EMG biofeedback mode information region(number 20 memory region) contains diagnostic mode region(D71), examination mode region(D72), exercise mode region(D73), etc. In the diagnostic mode region(D71), the data for measuring the spectrum of bio-signal inputted is stored when there is no electrical stimulation. In the examination mode region, the data for measuring the spectrum of bio-signal is stored when there is electrical stimulation. In the exercise mode region(D73), the data for measuring the average value(the direct current value) of bio-signal is stored when there is no electrical stimulation. With regard to the concept of muscle exercise, if the electrical therapy apparatus according to the conventional technology is compared to the electrical therapy apparatus according to the present invention, in contrast to providing only the information on the movement of muscle by measuring the electric potential difference according to contraction or relaxation of muscle in the side of the electrical therapy apparatus according to the conventional technology, in the other side of the electrical therapy apparatus(310) according to the present invention, we can analyze if or not the muscle moves, the reason of movement, in case that the muscle does not move, the function and state of body tissue(nerve and muscle) by measuring the spectrum of bio-signal according to contraction or relaxation of muscle. And also, the electrical therapy apparatus(310) enhances the effect of exercise by admitting the electrical stimulation aptly using the feedback function in case that autonomous muscle exercise is impossible. Therefore, the electrical therapy apparatus(310) provides scientific exercise methods that have no side effect( worsening) and maximize the effect of exercises by supplying not simple repetitive exercise of muscle, but exercise methods based on the
principle of physiology. Figure 12 shows the diagnosis and exercise information region(number 21 region) that determines if this information is based on external stimulation or exercise itself as the basic unit of deciding the characteristic of bio-signals. That is, the diagnosis and exercise information region(number 21 region) is a region that is stored program information which measures diagnosis result or exercise result of nerve and muscle of the body to implement EMG biofeedback function. In the diagnosis and exercise information region(number 21 memory), electrical parameters are stored that are almost the same with electrical parameters of the electrical stimulation function except a few characteristic (for example, the form of signal is not an intermittent pulse, but the continuous poly-phasic wave. The diagnosis and exercise information region(number 21 memory region) includes an amplitude region(D81), a frequency region(D82), a phase region(D83), a waveform region(D84), an offset region(D85), a sound region(D86), an energy region(D87), etc. In the amplitude region(D81), the data that can measure RMS of bio-signal amplitude, maximum, minimum, RMS inputted is stored. For example, bio-signal can be non-altemate wave of asymmetric poly-phasic wave. In the frequency region(D82), the data that can measure the frequency of bio-signal inputted is stored. The frequency can be evaluated by peak value, zero-crossing, or FFT because bio-signal is non-alternate waveform of asymmetric poly-phasic wave. In the above case, we consider if there is DC offset data(D85) or not. Therefore, the frequency region(D82) includes the data additionally for signal processing the measured value. In the phase region(D83), the data is stored for measuring or calculating(arithmetic) phase distortion between input signal and output signal according to the increase or decrease of frequency. In the waveform region(D84), the data that can compare each other waveforms measured during each period is stored after measuring a period waveform of bio-signal. In the offset region(D85), the data for measuring offset is stored (i.e., direct current signal component of asymmetric poly-phasic wave non-alternate waveform of shape that adds alternate current signal to direct current signal) In the sound region(D86), the data for processing the sound is stored. In the energy region(D87), the data is stored for converting all activating quantity using the average value per hour of bio-signal. It is supposed that the body is the source of energy when measuring bio-signal and all energy outputted from the body is used as the parameter diagnosing the characteristic of nerve and muscle. Because bio-signal is composed of asymmetric poly-phasic wave, an average hourly value of input signal is not the average value of waveform per period, which is average value(i.e., DC voltage) of bi-phase alternating signal, but the average value(low-pass filter concept) of randomly detected input values for certain hours. Figure 13 shows the inspection information region(number 22 memory region) that is stored inspection information in order to measure the physiological phenomenon as a result of inputting the electrical stimulation for inspection. That is, in the inspection information region(number 22 memory region), the program information is stored for carrying out each inspection to implement EMG bio-feedback function coupled with the electrical stimulation function. Inspection information region(number 22 memory region) includes a reaction of degeneration region(D91), a Rheobase inspection region(D92), a Chronaxy inspection region(D93), a Strength duration curve inspection region(D94), a Galvanic tetanus ratio Inspection region(D95), a Pulse ratio Inspection region(D96), a Nerve excitability test inspection region(D97), a Nerve conduction velocity inspection region(D98), an Electromyography inspection region(D99), etc. In the reaction of degeneration region(D91), the data is stored that can compare relatively the degree or state of the current response to confirm the current response after stimulating with Faradic current(asymmetric bi-phasic alternating current) or pulsed Galvanic current(pulsed mono-phasic wave Galvanic current) in order to inspect the reaction of degeneration(i.e., because electric conduction ability of the nerve is lost, thereby, there is no excitation, and stimulating with pulsed Galvanic current or faradic current in order to contract the muscle). It is desirable to prepare the measurement means(for example, trigger off means proportional to excitability of tissue recognized minimally) to confirm excited degree(response degree) of tissue at this time. In the Rheobase inspection region(D92), the data is stored for detecting the characteristic of innervation muscle, denervation muscle and reinnervation muscle using Rheobase value in order to contract the muscle minimally. That is, in order to find out characteristics of innervation muscle, denervation muscle and renervation muscle by measuring flowing Rheobase value(for example, in the normal case 2-18mA/5-35V) at this time and excited degree of exciter tissue admitting linear current source to exciter tissue in order to excite the exciter tissue. In the Chronaxy inspection region(D93), the data is stored for detecting characteristic of innervation muscle, denervation muscle and reinnervation muscle using Chronaxy. Chronaxy means the hour that is taken to arouse excitation stimulating 2 times of Rheobase with the condition of Rheobase inspection. Chronaxy, as the representative inspection that indicates excitability of stimulating tissue, is inversely proportional to excitability of tissue. Therefore, the hour is measured from stimulating excitability tissue to occurring excitability using 2 times value of Rheobase, thereby the characteristic of innervation muscle, denervation muscle and reinnervation muscle can be determined. In the strength duration curve inspection region(D94), the data that can detect the strength of stimulation and magnitude of duration to confirm the response degree according to the cunent duration and conducting timeri.e., total is converted to energy) is stored. When excitable tissue(for example, myoscope and muscle) is stimulated, the current strength is inversely proportional to conducting time. The degree of response is determined by the current strength and conducting time, and at this time, variables of strength and time that are represented as the graph of X, Y coordinates are called as strength duration curve(SDC). In the Galvanic tetanus ratio inspection region(D95), the data is stored for detecting the characteristic of Galvanic tetanus ratio differently represented in innervation muscle, denervation muscle and reinnervation muscle. Galvanic rigidity ratio is the ratio of current capacity for rigidity to current capacity for spasm(. in case of the normal innervation generally, if stimulated with Galvanic current, DC, then spasm immediately occurs, if stimulated with Faradic current, AC, then rigidity immediately occurs. Also, if excitable tissue(nerve and muscle) increases excitation strength(current strength), nerve has high accommodation rate but, muscle has low accommodation rate, so twitch and rigidity appear differently. Accordingly, using the current ratio that incurs twitch and rigidity, the degree of accommodation rate(i.e., nerve and muscle abnormality) may be determined. However, because Galvanic current(DC) cannot be used, it is necessary to modulate DC to interrupted galvanic current, when necessary, it is considered to use of other mefhods(for example, Faradic current, AC) that incur rigidity. In the pulse ratio inspection ratio(D96), the data is stored for detecting characteristic of pulse ratio which is appeared differently in innervation muscle, denervation muscle and renervation muscle. For example, if the frequency of the burst between 1 ms burst and 100 ms burst is increased, current value is increased. At this time, ratio of current that is needed to incur the identical muscle contraction is called pulse ratio. In the nerve excitability test region(D97), the data is stored for finding out excitability and transferability that appeared differently in innervation muscle, denervation muscle and rennervation muscle. First of all, after selecting 2 points(number 1 point and number 2 point) in order to measure among nerve paths, stimulus having 100 micro second pulse width is assigned as the number 1 point and current strength increases with varying amplitude. At the number 3 point, the current value is measured until triggered off. Also, on the number 2 point, the current value is measured by applying the same method. The ratio of 2 points' current values is called nerve excitability test. In the nerve conduction velocity inspection region(D98), the data is stored for detecting characteristic of nerve conduction velocity that appeared differently in innervation muscle, denervation muscle and renervation muscle. After selecting 2 points' of the region to measure the nerve conduction velocity, conduction velocity(CV) value is calculated by dividing distance(d) of 2 locations giving stimulus by the
difference of latency (Δ t) and the unit is [m/s]. That is, if nerve conduction velocity is represented as CV, then CV=d/t [m/s] holds. NCV inspection stimulates peripheral nerve. Therefore, with only EMG inspection, it is difficult to diagnose diseases and injuries such as potential diseases, region, and degree, prognosis. But with NCV it is possible to find out the above details. Of course, NCV can be divided even more into exercise NCV measurement, sensory nerve activity electric potential measurement, and sensory nerve conduction velocity measurement. Methods for calculating NCV can be various. Also, because our body's nerve structure has very complex impedance, phase delay can't be detected in the time domain accurately while pure inductance or capacitance can. Therefore, the electrical therapy apparatus according to the present invention employs energy propagation method not signal conduction method. The energy propagation method is a method that if the mutually different (a), (b), (c) energies in the electrical stimulus generator(360) are propagated to the response processor(370) by way of electrode or body, the response processor(3 0) receiving (a)', (b)', (c)' energies measure the propagation time. That is, the electrical stimulus generator(360), response processor(370), and feedback controller(375) are employed. In EMG inspection region(D99), the data that can analyze and measure the electric signal coming from the electrode insertion and activity after insertion is stored. According to the present invention the electrical therapy apparatus(310) can analyze the signal analysis in the time domain as well as the spectrum analysis in the frequency domain. Electromyography(EMG) inspection has difference from the above inspection methods. First, it is an inspection that detects electrical activity which is occurred purely in nerve and muscle while not necessary for external stimulus source. Secondly, the measurement equipment has performance to measure bio-signal which is composed of 2-10,000Hz frequency band and 0.003-15.0mV amplitude. The electrical therapy apparatus(310) according to the present invention can do spectrum analysis in order to solve the problem that can't completely eliminate electrical activity of superficial remained in the conventional EMG inspection, and the problem that can't detect selectively the electrical activity of deep, and the problem that losts the high frequency component. The electrical therapy apparatus(310) of the present invention can further comprise each trigger off means in order to execute appropriately the above various inspection modes. For the convenience of understanding, the composition method of the above various inspection modes is briefly described. For example, in case of reaction of degeneration, Rheobase inspection,
Chronaxy, strength duration curve, Galvanic rigidity ratio, pulse ratio, and nerve excitability test, the electrical stimulus generator(360) admits the electrical stimulus to nerve muscle tissue(excitability tissue) which is supposed load, the method is peformed to measure current or voltage inputted from nerve muscle tissue to the response processor(370). Also, if the user sets the condition of measuring time to the response processor(370) and/or feedback controller through the controller(380), the measurement can be done at accurate time using trigger signal transmitted from the feedback controller(375) to the response processor(370). Also, in case of nerve conduction velocity inspection, after confirmation that inputting to the body the pre-specified criteria signal from the electrical stimulus generator, the admission into the body of criteria signal(measurement value) is transmitted to the response processor(370) through the feedback controller(375). When the criteria signal(measurement value) received from the electrical stimulus generator(360) through the feedback controller(375) is the same as bio-signal received, the response processor(370) calculates the time difference of the above 2 signals. Of course, after the bio-signal detected from the response processor(370) is transmitted to the electrical stimulus generator(360) through the feedback controller(375), time difference comparing the bio-signal with the criteria signal(measurement value) in the electrical stimulus generator(360) is calculated. Also, because channel of electrode is fixed when manufacturing electrode, distance therebetween can be obtained, thereby conduction velocity( i.e., conduction distance/ conduction time ) can be easily calculated. Also, EMG inspection can be performed, for example, by the EMG feedback controller(720). That is, in case that bio-potential is weak measured through the response processor(370) or in case that user setting condition is not satisfied, the electrical stimulation can be performed by detecting trigger signal and employing feedback to the electrical stimulus generator(360). This is called EMG triggered stimulation. Figure 14 is a diagram that shows channel information region(number 23 memory region) which is stored channel information in case that channel information of EMG bio-feedback function is composed of multi-channel. The composition of the channel information region(number 23 memory region) is similar to that of the number 15 memory region, but the contents of each data is different, and the electrical stimulation function and EMG biofeedback do not operate sequentially, therefore the above have to be allocated separately. Referring to figure 14, the channel information region(number 23 memory) includes a channel structure region(DlOl), an electrode polarity region(D102), a goal strength region(D103), a chain information region(D104), a pulse time region(D105), a location information region(D106), etc. In the channel structure region(DlOl), the data that can change function of each channel is stored. For example, in case that the electrode channel is composed of multi-channels and it is required to change the function of each channel when electrode is inserted into the body or attached on the region of body(i.e., input path of bio-electric potential has to be changed to another channel), the channel can be arbitrarily changed through channel setting switch without re-insertion or re-attachment. In the electrode polarity region(D102), we store the data that can change selectively through channel setting switch without change of pole(+) and pole(-) of each channel of electrode. In the goal strength region(D103), the data that can change the chain number of burst to vary amplitude and duration of goal waveform of mono-burst and to vary all momentums is stored. Goal strength is a goal waveform presented when EMG biofeedback is used as exercise mode. We set the amplitude variably corresponding to bio-electric potential in the time domain and vary the duration hour, thereby make more momentum and present to the patient the goal visually. In the chain information region(Dl 04), the data that can be in combination with all by measuring each burst or analyzing characteristic( for example, number or hour ) of burst of bio-signal through channel is stored. In the pulse hour region(D105), the data is stored for measuring amplitude of burst and pulse hour(i.e., duration time of each burst). Burst hour is the treatment hour including rest hour. In the location information region(D106), the data varying the applied location together with channel structure is stored. Figure 15 is feedback information region(number 24 memory region) that is stored feedback information of the EMG bio-feedback function. In the feedback information region(number 24 memory region), the data is stored for program information if the electrical stimulation function and EMG bio-feedback function is individual or coupled and for information according to each channel. The composition of feedback information region(number 24 memory region) is similar to that of number 16 memory region, but the contents of data are different, so it is desirable to allocate each separately. Feedback information region(number 24 memory region) includes a loop feedback region(Dlll), an event feedback region(D112), a measurement information region(Dl 14), a transformation region(Dl 15), etc. In the loop feedback region(Dl 11), the data is stored for carrying out the EMG bio-feedback function with the electrical stimulation set with the condition including threshold current outputted from the stimulation of the electrical stimulation function. In the event feedback region(Dl 12), opposite from the loop feedback, the data is stored for carrying out the electrical stimulation function with the EMG bio-feedback condition set after setting threshold voltage condition measuring bio-signal inputted from the body of EMG bio-feedback function. In the measurement information region(D113), the data is stored for storing or calling the measurement value of the EST feedback information coupled with the output of the electrical stimulation or measuring the critical voltage or current of bio-signal and feedback the information to the electrical stimulus generator(360) which is occurred from the minimal visual contraction of exciter tissue(nerve and muscle).The measurement data can be really measured data or calculated(arithmetic) data. In the condition setting region(D114), the data that can set the trigger signal to the conditions which is feedbacked on the criteria of EMG bio-feedback is stored. In the transformation information region(Dl 15), the data that can compare each measurement data of heterogeneous equipments(for example, perineometer, manometer) as well as unit conversion, dimension conversion, and calculation(arithmetic) of homogeneous function or heterogeneous function of the electrical therapy apparatus(310) is stored. Figure 16 or figure 17 are diagrams that shows the composition and connections of electrode and channel setting switch according to the preferred embodiment of the present invention. In general, electrode is composed of mono-channel or multi-channel, and the electrical stimulation is admitted into the body once inserted into the cavity of the body(i.e., vagina or anus) or attached on the skin or bio-signal is inputted from the body. That is, the electrode is composed of the adhesive form(i.e., patch electrode) in order to be attached on the skin or composed of the insertion type (i.e., insertion electrode) in order to be inserted into the cavity(i.e., vagina or anus) or composed of needle electrode of needle form(i.e., pierce electrode) Electrode is attached or detached on the body or the electrical therapy apparatus, and is composed of the form of one time or reuse. However, electrode is made of 2 electric conductors having (+) and (-) poles per channel, and non-conductor should insulate between conductors. And in case of the EMG bio-feedback, one more conductor is needed to ground in addition to (+) and (-) poles, totaling 3 electric conductors. Between conductors, non-conductor is needed to insulate. Accordingly, all conductors and channels have to be insulated, one conductor has basically the structure that cannot carry out the electrical stimulation function and EMG biofeedback function simultaneously. Hereafter, referring to figure 16, the composition of electrode(i.e., insertion type electrode(320), needle electrode and surface electrode hereafter, we call insertion type electrode in united way) and channel setting switch according to the present invention that can execute simultaneously or alternately the electrical stimulation function and EMG biofeedback function is described. Referring to figure 16, the insertion type electrode is composed of a channel of
(+) pole and (-) pole, and a channel electrode for execution of electrical stimulation function and channel electrode for execution of EMG biofeedback function is composed physically identical one. Therefore, in order to use two channel electrodes not only for conducting the electrical stimulation function or EMG biofeedback function but also for conducting the feedback function execution, each channel can be executed independently for the electrical stimulation function and EMG biofeedback function. However, in case of multi-channel insertion type electrode, it is desirable to include several electrodes within limited size and to separately allocate in order to execute various functions(i.e., electrical stimulation function, EMG biofeedback function, or feedback function). Of course, in case of the channel allocated already, each polarity of electrode shaping channel can be exchanged each other. For example, if channel 1 electrode of electrical stimulation function is allocated (a)(i.e., (+) pole) and (b)(i.e., (-) pole) that can be changed to (a)(i.e., (-) pole and (b) (i.e., (+) pole) by each channel setting switch(365). And, ground is the same electrode physically (i.e., (e) and (5)) in the electrical stimulation function and EMG biofeedback function, and regardless of each function, ground is used as the criteria of input/output signal always. And this fact is due to that has to be the measurement or signal input in the electrical stimulation function or EMG biofeedback function. Figure 17 shows the connection relationship of the channel setting switch(365). As explained earlier, the channel setting switch(365) is a means that can carry out the electrical stimulation function, EMG biofeedback function and feedback function through the control of the controller(380) by the electrical stimulation apparatus(310). As shown in figure 17, the channel setting switch(365) is associated with the insertion type electrode(320), the electrical stimulus generator(360), the response processor(370) and the controller(380). As shown figure 17, it is supposed that the insertion type electrode(320), the electrical stimulus generator(360) and the response processor(370) are composed of 2 channels, respectively, the function of channel setting switch(365) is briefly described. That is, in this case, 2 channels are operated when the electrical stimulus generator(3 0) and the response processor(370) execute the functions individually, but when simultaneous execution, 1 channel of each is operated. First of all, the operation of the channel setting switch(365) is described in case that the electrical stimulation apparatus(310) is used as the function of the electrical stimulation only. As the input and output that are composed of 2 channels, outputs of the electrical stimulus generator(360) are (a), (b), (c) and (d), inputs of the insertion type electrodes(320) are Yl, Y2, Y3 and Y4. If as ports of channel 1, outputs (a), (b) of the electrical stimulus generator(360) and inputs Yl, Y2 of the insertion type electrode are set, the channel setting switch(365) creates channel 1 by interfacing( switch on) those ports by the control of the controller(380). Also, the channel setting switch(365) creates channel 2 with the ports(i.e., outputs of (c) and (d) of the electrical stimulus generator(365) and inputs Y3, Y4 of insertion type electrode(320)) except input/output ports set by the channel 1. That is, in case that creates channel 1 and channel2, output of the electrical stimulus generator(360) and inputs of insertion type electrode do not have duplication. In the same way, as ports of channel 1 , (a), (b) outputs of the electrical stimulus generator(360), Y3,Y4 inputs of the insertion type electrode are also used. Next, the operation of the channel setting switch(365) in case that the electrical therapy apparatus(310) is used as EMG biofeedback function only according to the present invention is described hereinafter. In this case also, the operation of the channel setting switch(365) is similar to the case that the electrical therapy apparatus according to the above present invention is used only as the function of the electrical stimulation. However, as the characteristic of signal, output signal of the electrical stimulus generator(360) has to be input signal of the insertion type electrode(320) and the output signal of the insertion type electrode(320) has to be input signal of the response processor(370) and this fact is different from the case of the feedback function. That is, if as a channel 1 port, (1), (2) inputs of the response processor(370) and Yl, Y2 outputs of the insertion type electrode(320) are set, the channel setting switch(365) creates channel 1 by interfacmg(switching) physically through the control of the controller(380). Also, the channel setting switch(365) creates channel 2 in combination with ports(i.e., (3), (4) outputs of the response processor(370), Y3, Y4 outputs of the insertion type electrode) except input/output ports set by channel 1. And finally in case that the electrical therapy apρaratus(310) according to the present invention carries out the electrical stimulation function and EMG biofeedback function simultaneously, that is, the operation of the channel setting switch(365) in case that feedback function is used will be described hereinafter. In this case, because output of the electrical stimulus generator (360) and input of the response processor(370) are necessary, it is required to use the feedback controller(375) once more, thereby, output of the electrical stimulus generator(360) is set as 1 channel and input of the response processor(370) is set as 1 channel. And, the channel setting switch(365) determines what output port of the electrical stimulus generator (360) should be set and what input port of the response processor(370) should be set by the control of the controller(380) (or the feedback controiler(375)). As explained previously, this case too, Yl, Y2, Y3, and Y4 I/O of the insertion type electrode are not connected to the electrical stimulus generator(360) and the response processor(370) simultaneously. Of course, user can select arbitrarily input/output of the electrical stimulus generator(360) and the response processor(370). For example, if (a) and (b), outputs of the electrical stimulus generator(360) have to be connected to Yl and Y2, inputs of the insertion type electrode(320) by control (or, control signal received from the feedback controlIer(375)) of the control part(360), Y3 and Y4, inputs of the insertion type electrode(320) have to be connected to (1) and (2), or (3) and (4), of the response processor(370). As explained in detail earlier, if I/O of the insertion type electrode are composed not to be used in the electrical stimulus generator(360) and the response processor(3 0), the channel setting switch(365) enables the user to vary the channel arbitrarily and also to vary and set the electrode allocated to each channel. And, the criteria electrode(i.e., ground) should be applied to the electrical stimulation function and EMG biofeedback always, the remaining port has to be used as ground. Like this way, the reason to carry out each function with the channel setting switch(365) is to enhance treatment efficiency by ability to vary channel and electrode at the same function and is to enable user to inspect or diagnose to carry out the heterogeneous function(i.e., feedback function) and also to enhance the channel efficiency. Also, if the channel setting switch(365) is to be coupled with the electrical stimulation function and EMG biofeedback function simultaneously, user has the merit of arbitrary channel allocation or of electrode allocation according to each channel which is set. Like this way, if channel or electrode can be set arbitrarily, then the feedback function, which is coupled with the electrical stimulation function and EMG biofeedback function, can be implemented and also, without physical channel change (or diagnose) the disorder region of body can be treated. The electrical therapy apparatus(310) has the merit of reducing the measurement error of input signal, discharging through ground the electric potential accumulated free electronics or metal ion of the insertion type electrode(320) by using the channel setting switch(365). Because the electric potential accumulation operates as DC offset in the response system of the characteristic of small signal large amplification, it is impossible to set the constant gain, thereby introducing unreliable measurement results.
Figure 18 is a block diagram that shows the detail constitution and operation process of the electrical therapy apparatus according to the preferred embodiment of the present invention, and figure 19 is a diagram that illustrates output waveform of the electrical stimulus generator according to the present invention. Referring to figure 18, the electrical stimulus generator(360) of the electrical therapy apparatus(310) according to the present invention includes a waveform generator(610) that generates pulse signal(for example, mono-phasic wave, bi-phasic wave, poly-phasic wave, etc) such as rectangular shaped wave, a sin wave, a triangular wave by control signal of the controller(380), a burst generator with pulse combinational 5) that composes one burst signal in combination with pulse signal generated by the waveform generator(610) according to control signal of the controller(380), an output setter(620) that adjusts stimulation strength(i.e., stimulation energy) outputted per channel in combination with several burst signals generated by the burst generator with pulse combination according to control signal of the controUer(380), a stimulation adjuster(625) that adjusts total stimulation strength(i.e., sum of stimulation of each channel) according to control signal of the controller(380), a stimulation trigger controller(630) that judges if feedback signal(i.e., for example, interrupt or stimulation output setting condition) from the feedback controller(375) is received, a large signal amplifϊer(635) that generates the electrical stimulation of the final stimulation strength that multiplies stimulation strength adjusted by the stimulation adjuster(625) by the pre-specified gain or gain corresponding to the above feedback signal and output coupler(640) that transmits to the body the electrical stimulation generated by the large signal amplifier(635) through channel setting switch(365) and insertion type electrode(320), etc. the large signal arnplifier(635) includes a transformer that has the fixed gain, and for example, executes the function that increases voltage such as about lOOVp-p. The feedback controller(375) detects the electrical parameters corresponding to the electrical stimulation transmitted through the output coupler(640) and applied when the feedback function executes. Hereafter, referring to the related diagram the feedback function that is executed by the feedback controller(375) will be described. Figure 19 shows the output waveform of the electrical stimulus generator(360) inputted into the body through the insertion type electrode(320). Referring to figure 19, case of fixed output(680a, 680b) is the same as the burst of the electrical stimulation and pulse form of waveform that composes the burst generated after the duration of time. However, in case of variable output(685, 687), the form of burst is changed after the duration of time, the shape of pulse form that composes each burst can be changed. That is, the electrical stimulus generator(360) according to the present invention can be adjusted variably in order to generate various electrical stimulations. The electrical therapy apparatus(310) according to the conventional technology was implemented to generate the fixed output. But, as shown figure 19, when stimulation is admitted into the body, the impedance of the body varies according to stimulation shapes and in spite of changes of impedance of the body, if fixed output occurs, the side-effect such as muscle fatigue occurs is the reason that the electrical therapy apparatus(310) according to the present invention outputs variably. Also, the response processor(370) of the electrical therapy apparatus(310) according to the present invention includes an differential amplifier(650) that detects only the signal that in-phase deleted and inputted the bio-signal of the body through the insertion type electrode(320) and the channel setting switch(365), a response trigger controller(655) that judges if feedback signal from the feedback controller(375) or user setting condition is inputted, a filter(660) that filters selectively only the input signal corresponding to feedback signal or user setting condition, a variable amplifϊer(665) that amplifies the bio-signal that is unwanted signal-filtered and noise-removed as visually easy signal label, an input coupler(670) that branches the amplified bio-signal to the feedback controller^ 75) and a signal detector(380) that transmits to the controller(380) data that is gathered corresponding to any measurement items(for example, measurement items set by the user through the control part(335) of the peripherals), etc. Here, example of the filter(660) includes low pass filter, high pass filter, band pass filter, noise filter, etc. For example, if frequency bandwidth of bio-signal is 2-10,000Hz, then the low pass filter passes frequency less than or equal to 10,000Hz, the high pass filter passes greater than or equal to 2 Hz, the band pass filter passes partial frequency bandwidth within the frequency band of bio-signal, and the noise filter such as notch filter deletes power supply noise of 60 Hz(120Hz). And, the variable amplifier(665) includes gain adjustment circuit that amplifies input signal arbitrarily and also includes circuit that applies the specified gain by the controller(380) or sets to maintain the constant label automatically. The electrical parameters detected by the signal detector(675) are current(potential), voltage, power, inductance, capacitance, impedance, etc, and even further related parameters can be measured through combination or mutual arithmetic(using ordinary electronics engineering calculation). The signal detector(675) includes A/D converter that transforms analog into digital, zero potential detector, and counter that measures pulse input. Also, the signal detector, for example, includes maximum value and root mean square value(RMS value) detect circuit, recognition) circuit, decision circuit, differentiation and integration circuit, pulse snapping circuit, current and voltage transformation circuit, voltage and frequency transformation circuit, remitter and shift circuit, linearizer and equalizer, zero potential and planarization circuit, etc. Hereafter, referring to figure 18, the operation process of the electrical therapy apparatus(310) will be briefly described. As explained earlier, the electrical stimulus generator(360) outputs electrical stimulation in the pre-programmed way by control of the controUer(380) according to user's function options and/or condition setting(for example, stimulation output condition, bio-signal input condition) and the response processor(370), in the opposite way of the electrical stimulus generator(360), operates in the pre-programmed way, by control of the controller(380) in order to be inputted the bio-signal. First of all, the controller(380), after extracting the necessary data from the memory(340) corresponding to user's function selection order transmitted from the control panel(335), generates program direction signal and transmits the program direction signal to the electrical stimulus generator(360). The electrical stimulus generator(360) generates electrical stimulation corresponding to the program direction signal received from the control part and inputs it to the body. The electrical stimulus generator(360) composes number 1 direct circuit with the body connecting the insertion type electrode(320) through channel setting switch(365). In the above process, in case that the trigger signal is received from the feedback controller(375), it is controlled by this trigger signal additionally. The feedback controller(375) measures electrical stimulation outputted from the electrical stimulus generator(360), judging that the appropriate stimulation output is generated and if necessary, the feedback controller(375) transmits trigger signal to the electrical stimulus generator(360). Of course, stimulus measurement value signal that first measures electrical stimulation outputted from the electrical stimulus generator(360) and generated can be transmitted to the feedback controller(375). The response processor(370) is inputted from the body the bio-signal through channel setting switch(365) and the insertion type electrode and does signal processing. The response processor(370) transmits to the controller(380) the re-processed bio-signal that is inputted by management control system which is received from the feedback controller(375). At this time, the feedback controller(375) can set the stimulation output condition or the bio-signal input condition corcesponding to the measured value after measuring electrical parameters corresponding to the bio-signal inputted to the response processor(370). Of course, the response processor(370) measures electrical parameters corresponding to the bio-signal and transmits to the feedback controller(375). The channel setting switch(365) is composed of a relay or dual port multiplexer/demultiplexer or discrete transistor that enables junction point setting for execution of electrical stimulation function, EMG bio-feedback function and feedback function according to user's selection by control of the controller(380). As explained earlier, the channel setting switch(365) connects the insertion type electrode(320) and the electrical stimulation supply(360), the insertion type electrode(320) and the response processor(370) or connects the insertion type electrode(320) as an independent channel to the electrical stimulus generator (360) and the response processor(370) by control of the controller^ 80). The feedback controIler(375) executes individual function feedback or coupled function feedback according to user's condition setting by control of the controller(380). Different from the electrical therapy apparatus of the conventional technology, the electrical therapy apparatus according to the present invention can provide the feedback function. Referring to the related diagram, the feedback function execution of the feedback controller^ 75) will be described. Figure 20 is a diagram that shows the connection relationship between the electrical stimulus generator, the response processor and the feedback controller according to the prefened embodiment of the present invention. Referring to figure 20, the feedback controller(375) of the electrical therapy apparatus(310) according to the present invention includes an EST feedback controller(710), an EMG feedback controller(720), a loop feedback controller(730) and an event feedback controller(740). The EST feedback controller(710) includes an EST feedback control measurement part(755) and stimulation comparator(760), and the EMG feedback controller(720) includes an EMG feedback control measurement part(775) and a response comparator(780). First of all, the connection relationship between the electrical stimulus generator(360) and EST feedback controller(710) will be described. Output signal(i.e., electrical stimulation signal) of the electrical stimulus generator (360) is transmitted through the output coupler(640) to the channel setting switch(365). EST feedback controller(710) detects electrical parameters(for example, current, voltage, power, frequency, inductance, capacitance, impedance, output waveform(pulse width, period, duty), etc) conesponding to output signal coupling output signal transmitted through the output coupler by control of the controller(380) and adjusts the output signal(for example, stimulation output value) of the electrical stimulus generator(360) using detected electrical parameters. If user selects EST feedback function using the control panel(335) of peripherals, then the controller(380) transmits the pre-specified control signal to the electrical stimulus generator(360), the channel setting switch(365), and/or EST feedback controller(710). The channel setting switch(365) connects the electrical stimulus generator(360) and the insertion type electrode(320) by control of the controller(380). The electrical stimulus generator(360) generates the electrical stimulation signal and through the insertion type electrode inputs the signal into the body. EST feedback controller(710) supervises the output signal of the electrical stimulus generator(360) and adjusts stimulus output value of the electrical stimulus generator(360), and executes inspection to find out load characteristics(i.e., body characteristics) of serially connected load(i.e., body). Referring figure 20, EST feedback controller(710) detects electrical parameter coupling output signal of the electrical stimulus generator(360) and the EST feedback control measurement part(755) transmits the detected electrical parameters to the control part, stimulation comparator(760), and loop feedback controller(730). The stimulation comparator compares electrical parameters received from EST feedback control measurement part(765) and electrical parameters received from the controller(380) and transmits trigger control signal to stimulus trigger controller. And, EST feedback controller(710) contains EST feedback control measurement part(755) and stimulation comparator. That is, EST feedback control measurement part(765) measures the electrical parameters of output signal after coupling output signal of electrical stimulation through output coupler(640). Measured electrical parameters includes current, voltage, power, frequency, inductance, capacitance, impedance, output waveform(pulse width, period, duty) etc. it is possible to calculate electric potential, energy from the above electrical parameters by the known electric engineering formula. The stimulus comparator(760) compares in the same dimension(degree) electrical parameters measured from EST feedback controller(710) and electrical parameters set by the controller(380)and using the difference of each electrical parameter controls trigger controller(380)of the electrical stimulus generator(360). According to user setting using the control panel of peripherals or the already specified program in memory(340), by control of the controller(380) the electrical parameters measured by EST feedback control measurement part(765) of EST feedback controller(710) are transmitted to the response processor(370). In case of EST feedback function, coupling and feedbacking the output signal, we come to know load characteristic of object stimulated, so various inspection methods are useful. And, because according to the result of inspection, stimulus output to be achievable, there is the merit of setting output control automatically. The above result leads us to expect not only ultimately effective and scientific treatment result but also it is secure stimulus method for the protection of patient for we prevent medical accidents following over current output. Next, the connection relationship between EMG feedback controller(720) and the response processor(370), and the composition of EMG feedback controller(720) will be described. The EMG feedback controller(720) detects electrical parameters coupling through the input coupler(670) the bio-signal inputted from the response processor(370), and the EMG feedback control measurement part(720) transmits detected electrical parameters to the controller(380), the response comparator(780) and event feedback controller(720). And, the response comparator controls response trigger controller(655) using the difference between electrical parameters measured by the EMG feedback control measurement part(720) and electrical parameters transmitted from the controller^ 80). The reason to measure the bio-signal using the EMG feedback control measurement part(720) is that spectrum measurement is required in order to analyze signal characteristics of electrical parameters(for example, current(potential), voltage, power, inductance, capacitance, impedance) detected by signal detector(675). In order to measure the spectrum, the EMG feedback control measurement part(720) executes function of label detection, waveform detection, activated quantity detection(energy), frequency detection, phase detection, offset detection, operation hour detection. Also, the EMG feedback control measurement part(720) transmits to the response comparator(780) electrical parameters set by user through the controller(380) and electrical parameters measured. The EMG bio-feedback function of the electrical therapy apparatus according to the conventional technology is the averaging(using the low pass filter concept converting analog input signal into DC, thereby, method to detect contraction and relaxation of muscle) method obtaining multi bio-electric potentials with the sampling techniques. The above is similar to perineometer or strain gauge, etc. Generally, in spite that neuromuscular treatment device needs analysis process based on diagnosis before treatment, the electrical therapy apparatus according to the conventional technology has not analysis function based on diagnosis. EMG feedback control measurement part(720) of the electrical therapy apparatus according to the present invention can diagnose the bio-signal if there is physical disorder of the body because EMG feedback control measurement part(720) enables spectrum measurement, is broad band, has frequency of high options and function of phase detection. In case of EMG feedback function, EMG signal analysis is possible by coupling and feedbacking input signal, and then measuring microscopic electric activity of related structure and function of sarcolemma in the body, and by diagnosing pathology which is occurred in peripheral nerve, nerve root, denervation, skeletal muscle, and judging the progress and prognosis, we have the merit to enable systematic treatment and diagnosis. And, the loop feedback controller(730) which is inputted the output of the EST feedback controller(710) executes function of setting the input(measurement) conditions of the response processor(370). That is, after setting the electrical stimulation output condition, it is for measuring the bio-signal inputted to the response processor(370). The event feedback controller(740) executes the function that adjusts the stimulation output of the electrical stimulus generator(360) according to the bio-signal inputted from the response processor(370). For example, if the EMG feedback control measurement part(720) measures activated quantity conesponding to the bio-signal and transmits to the event feedback controller(740), the event feedback controller(740) is used to compare the initial activated quantity and the measured activated quantity that is the result, after setting goal quantity, in case of less than or equal to goal quantity, periodically outputting electrical stimulation into the body, as the result we use to compare remeasured activated quantity with initial activated quantity. The loop feedback controller(730) and event feedback controller(740) will be explained in detail refening to the related diagram, hereafter,.
Figure 21, according to the preferced embodiment of the present invention, is a diagram that shows the association of EST feedback control measurement part and the electrical stimulus generator in order to measure impedance. As shown in figure 21, we can model with variables such as resistance(Rl, R2, ,Rn), inductance(Ll,L2, ,Ln) and capacitance component(Cl, C2, , Cn) on the body inputted the electrical stimulation generated from the electrical stimulus generator(360). At this time, EST feedback control measurement part(765) can measure impedance by measuring cunent(I) flowing into the body from the electrical stimulus generator(360). For example, EST feedback control measurement part(765) can calculate current by measuring voltage of end points of resistance, and connecting resistance serially in the output coupler(640). Of course, in case that it is not easy to detect signal due to low power signal, we can add arithmetic amplifier that has proper gain, transister, etc. Accordingly, suppose direct current is inserted serially to modeled RLC parallel circuit of the body and parameter of direct current power DC=0V, direct current power executes the role of only outputted cunent variable(for example, VI (II, V2(I2), V3(I3)„Vn(In)) not influencing the operation of circuit. At this time, it is important to set the output signal of the electrical stimulus generator(3 0) outputted to the body. And, the composition of the electrical stimulus generator(360) or signal setting is the same as we explained earlier. For example, amplitude of output signal can be set to maximum 100 Vp-p frequency can be set to maximum 50kHz. It is desirable that output signal is to be set symmetric bi-phasic wave not including DC component. Accordingly, signal used in the impedance measurement has to be bi-phasic wave based on sin wave not including DC component, and in case of using bi-phasic wave, we can solve easily impedance because output cunent(waveform) is just conductance, the inverse of current is impedance. Therefore, by observing the waveform measured, sweeping the frequency of the electrical stimulus generator(360) if inductance value is advantageous over capacitance value, resonance point of waveform measured is moving to lower frequency region, conversely, resonance point is moving to higher frequency region, we know. At this time, the EMG feedback controller(720) adds phase detect circuit to enable Fourier analysis if composes output of the electrical stimulation input part(360) by using the method of sweeping frequency, we can know the degree of distortion(harmonic) on the response signal of the body additionally. Therefore, the electrical therapy apparatus according to the present invention, has the structural merit to analyze the noise characteristics of measured object(body) due to total harmonic distortion. Also, the electrical stimulus generator(360) and EST feedback controller(710) have the merit to enable alternating current analysis and to enable analysis of noise characteristics of the bio-signal affecting the frequency(sweep) due to impedance component of the body. Also, there is the merit to enable transient analysis because it compares input signal and output signal in the time domain basically. In case of transient analysis, because we execute calculation of the next step which is continuous from the current step considering always the current calculation value of L and C as the initial value, it is different from DC analysis that analyze and consider inductance as short, capacitance as open. Also, as explained earlier, because it enables to analyze frequency component with Fourier integration that measures and executes stimulation output(i.e., current or voltage), analysis function provides that calculates average value, basic wave, RMS value, inverse ratio by the ordinary calculation formula, after measuring magnitude, phase, direct current component. Here, as we apply FFT(Fast Fourier Transform) function and Fourier analysis function, frequency analysis function is applied. FFT is to calculate output data outputted from output port of equipment with FFT algorithm, and, function outputting(measuring) f equency spectrum is excuted, Fourier analysis uses fhe theory that obtains result by Fourier integrating FFT result data. Because we obtain only magnitude in FFT result, but when we execute Fourier analysis, we can obtain magnitude, phase, cunent component. Using these result of process, it is possible to do various inspections. The reason that the electrical therapy apparatus(310) according to the present invention prepares method of impedance measuring is to solve various problems of medical accidents such as electric fire injury, electric impulse by side-effects occuned ignorant of patient state and incautious of adjusting output cunent value. That is, in the electrical therapy apparatus according to the conventional technology, for the admission of stimulation into the body, if digital waveform data generator outputs pre-specified digital waveform value, then digital waveform is transformed into analog signal by D/A converter, the transformed analog signal is amplified and through electrode method of admission into the body is applied. But, because this method cannot measure impedance value of the body, there have been problems that inconvenience of adjusting output cunent value manually and inability to carry out inspection function because of no feedback function as a simple stimulator. However, the electrical stimulus generator(360) according to the present invention solves problems of the conventional technology by coupling feedback controller(375) according to each use. Also, we can simulate with software characteristics of stimulation output set by user through controller(380). And, we have the merit to emulate with hardware if electrical stimulation output that user set or pre-specified is conect using EST feedback control measurement part(765). Figure 22 is a diagram that shows the detail composition of EST feedback control measurement part to measure activated quantity according to the preferred embodiment of the present invention. Figure 22 illustrates the composition of EST feedback control measurement part(765) to measure activated quantity (i.e., the measured value as the result of execution with goal of inspection, diagnosis and control according to the user option) of stimulation signal outputted from the electrical stimulus generator(360). First of all, an integrator(910) provides to comparator(915) the voltage signal transformed from stimulation signal of cunent signal form, receiving stimulation signal through output coupler(640) of the electrical stimulus generator(360). Of course, there has to be included additionally at the front of integrator(910) the composite element to transform cunent signal to direct cunent voltage. The setting criteria value of cunent signal form inputted from the controller(380) is transformed to the setting criteria value of voltage signal form by the setting criteria supply part(925). The setting criteria supply part(925) transmits to comparator(915) the setting criteria value of voltage signal form. Comparator(915) compares stimulation signal received from integrator(910) with the setting criteria value received from the setting criteria supply part(925), and, comparison criteria value is the setting criteria value. Comparator(915) provides comparison result to mono-stable oscillator(930) which outputs pulse signal of certain magnitude according to comparison result of comparator(915). When integrator(910) is reset, this pulse signal, simultaneously is inputted to the counter(935). The counter(935) counts pulse signal of mono-stable oscillator and inputs the counter result(number) to multiplier(940). Multiplier(940) executes multiplication using the setting criteria value of voltage signal form which is inputted the digital signal transformed by A/D converter(945) and counter result(numerical value) inputted from counter(935). Multiplication result value of the multiplier(940) is transfened to the controller(380) and the controller(380) calculates activated quantity using multiplication result values. As the composition of EST feedback control measurement part(765) is shown in figure 9 and as the same case of impedance measurement explained earlier is , we restricted the category of the electrical stimulation function for convenience of explanation, the above explanation is applied to EMG biofeedback function in the same way. Accordingly, the duplicated explanation is omitted when the EMG biofeedback function is described. Also, using the composition of EST feedback control measurement part(765) shown in figure 9, the controller(380) can measure activated quantity and the measured activated quantity can be converted to cunent, voltage, power, or energy. Of course, in order to measure activated quantity or other electrical parameters, the composition of EST feedback control measurement part(765) can be modified or changed in the various ways.
Figure 23 is a diagram that shows the detail composition of EMG feedback control measurement part for measuring frequency and phase according to the prefened embodiment of the present invention. Referring to figure 23, the EMG feedback control measurement part(720) includes a phase comparator(lθlθ), a setter(1015), 1/N programmable counter(1020), a loop filter(1025), a voltage control oscillator(1030), counter(1035), a frequency compensation 1040), A/D converter(1045), and a phase discriminatory 050). The EMG feedback control measurement part(720) inlcudes basically the phase comparator(l lθ), fhe loop filter(1025),the voltage control oscillator(1030) in order to detect frequency and phase of bio-signal, a programmable counter can be additionally included. And for the purpose of the above function implementation, PLL(phase-locked loop) can be necessary. Phase comparator(1010, also called phase detector, generates average output voltage(DC) which is proportional to phase difference between input signal from input coupler(670) through loop filter(1025) and voltage controlled oscillator(1030) through 1/N programmable counter. If this output voltage is enor voltage(Vo) and transformed coefficient that phase difference(Pd) is converted to voltage is phase detection transformed gain(K), by Vo=(K)*(Pd) formula we can detect outputted direct cunent voltage, and measure the phase difference using pre-specified mapping table. Although digital type( for example, Ex-OR type, R-S flip-flop type ) is available, it is desirable to use single chip phase frequency comparator for easy detection of phase and frequency. And, in case of frequency detection, 1/N programmable counter can be used for convenience of composition. 1/N programmable counter(1020) sits between voltage controlled oscillator(1030) and phase comparator, easy digital control is composed through the N setter. This characteristics of composition has besides merit of digital control also, has merit of carrying out needed calculation to compare mutually value that inputted into controller(380) measuring frequency ΛΛάthin loop when PLL loop is locked, and output value that outputted through the N setter(1015) from the controller^ 80). Therefore, the phase comparator(lθlθ) compares bio-signal inputted from input coupler and phase of feedback signal inputted from the 1/N programmable counter(1020), and detects phase difference. Phase difference detected by the phase comparator^ 010) is transmitted to the voltage controlled oscillator(1030) through the loop filter(1025) and thereby accurate phase difference is detected. That is, the phase comparator(lθlθ) outputs voltage proportional to phase difference of bio-signal inputted and outputted voltage signal is averaged by fhe loop filter(1025) and is outputted DC. And, after Dc voltage that is outputted proportional to phase difference is converted analog signal by the A/D converter, we can measure the phase of bio-signal by admission to controller(380) through phase discriminatory 050) which is mapped DC voltage and phase difference. In the other hand, for output of voltage controlled oscillator is frequency, this frequency is measured by counter(1035), and the measured frequency enor is calibrated by frequency compensation unit(1040) that has calibration table, and the calibrated data is transmitted to controller(380). The controller(380) multiplies frequency inputted from frequency compensation unit(380) by inputted value of N setter(1015) that determines output of 1/N programmable counter(1020) finally getting frequency of bio-signal. Voltage controlled oscillator(1030) is an oscillator that output oscillation frequency is changed in proportion to input controlled voltage. Loop filter(1025) has low pass filter characteristic, so loop filter determines elimination of high frequency component and PLL response characteristic which are occurred in the phase comparator(lθlθ). It is desirable that the loop filter(1025) uses lag-lead filter of which amplitude adjusting is easy. And, if there is not an input signal of bio-signal through input coupler, then output voltage of phase comparator(lθlθ) is OV and circuit is in an open state. Hereinafter, at some time, if there is additional input signal, for in the beginning it is not in a synchronous state, frequency and phase of input signal is not identical to output of a voltage controlled oscillator. Accordingly. Frequency identical process and phase synchronous process through frequency introducing process are executed. Therefore, circuit diagram shown in figure 10 is composed to measure and control these process through the controller(380). Like this, the state that becomes in a synchronous state is called lock-in, and the range is called lock-range and frequency range is called frequency capture range. In case of the present invention, frequency capture range is within about 10 kHz, so pre-scaler can be omitted at the front of programmable output oscillating frequency counter. Generally, phase capture range is within -~ + And has the value of multiples of integer(i.e., ,2,3,—)- Until now, referring to figure 23, the EMG biofeedback is only explained, but the electrical stimulation function can be applied, too, in the same way. That is, the EST feedback control measurement part(765) is inputted the signal to measure through the output coupler(640) of the electrical stimulus generator(360), and the EST feedback control measurement part(765) can measure frequency and phase using the composition shown in figure 23. The reason to measure phase using the circuit composition shown in figure 23, Is for the goal to analyze frequency characteristic and for the analysis of penetration depth of energy. That is, according to arbitrary phase the degree of mutual interference(for example, extinction interference, increased interference) can be identified, therefore, the degree of linear characteristic and dispersion of proceeding wave can be analyzed. Also, because phase is the difference of proceeding hour of two signals, it can be used to measure the precise hour.
Figure 24 is a diagram that shows the composition of the EMG feedback control measurement part for time measurement according to the prefened embodiment of the present invention. Figure 24 is a diagram that illustrates the composition of the EMG feedback control measurement part(720) for confirmation of response characteristics of response processor(370). That is, to measure the time that output of the electrical stimulus generator(360) is transmitted, by way of the body, to the response processor(370) is to find out the characteristic of the body. In order to find out pathology, region, degree, prognosis of peripheral nerve, it is required to know the transmission speed of the nerve- In this case, time measurement can be done EMG biofeedback function as the response system and at this time, occunence of admitted signal must need on the body, and in case of diagnosis or inspection, the electrical parameters are composed differently from the case of the treatment of patient. Likewise, in case that the electrical stimulation function and EMG biofeedback function are executed simultaneously besides the case of measuring the transmission speed of nerve the general usage can be applied in order to see the response characteristics of the body according to stimulation. In case that there is no external stimulation, the signal transmission time can be measured during specific hour(Tl-T2), but in case that there is an external stimulation^ using loop feedback processing system coupled simultaneously with the electrical stimulation function and EMG bio-feedback function, thereby the time can be measured. That is, we transmit to the control equipment and store in the memory, the data of stimulus time(Tl) from the electrical stimulus generator(360) using loop feedback processing system and at the same time, using the circuit schematics of figure 24. measuring fhe response time(T2) we get the difference( i.e., T2-T1 ). In he time measurement diagram by EMG feedback controller(720) shown in figure 24 EMG bio-feedback for convenience of explanation is only explained, but the electrical stimulation function or feedback function too, can be applied in the same way. Of course, refening to figure 24, using frequency and phase measurement method by EMG feedback as already explained, time measurement function can be replaced for the obtained phase. That is, because phase delay can be converted to signal delay(or earliness) in the time domain. However, conversion of detection of phase to time can produce inconect enor, like the present invention, extra time measurement function is prepared. In order to get transmission speed, transmission distance is divided by transmission time from the ordinary formula. Referring to figure 24, the EMG feedback controtler(720), coupling the signal by input coupler(670), admits to the integrator(l l lθ). The integration output of the integrator is inputted as the comparison signal of the comparator(1115). And, user, using the control panel(335) of the peripheral equipment, the criteria signal conesponding to the setting criteria value is inputted to D/A converter(l 120) by the controUer(380). D/A converter(l 120) converts criteria signal to analog signal which is inputted to the setting criteria supply part(1125). The setting the criteria supply part(1125) converts analog cunent output of D/A converter to voltage signal and the converted voltage signal is inputted to comparator(l 115) as the criteria signal. Comρarator(1115) outputs 1 or 0 as the comparison result, and output signal of comparator(1115) is acknowledged to mono-stable oscillator(1130) and latch(1 135) simultaneously. Mono-stable oscillator(1130) generates pulse signal as the comparison result of comparator^ 115) and transmits to integrator(l l lθ) and resets integration output of integrator(lllθ). Also, latch(1135) inputs to AND gate(1140) the identical output signal until reversed output signal from comparator(l l lθ) is inputted. AND gate(1140) that is inputted the periodical clock from clock source(1145) acknowledges the logic AND result value to counter(1150). Counter(l 150) acknowledges to multiplier the count value that is proportional to the reversed result of AND gate (1140) output value. Multiplier(l 150) receives pulse width of clock source as input and multiplies unit time of pulse width by the number of counter outputs, thereby obtaining total hour, and transmitting to the controller(380) the measurement value. Therefore, the controller(380) can measure the transmitted hour in the body system. Up to now, it is described for the measurement method of activated quantity, frequency, phase, transmission hour using the composition of the response processor(370) and EMG feedback controller(720). Besides the above, label detection, waveform detection, offset detection is possible, but, in case of label detection, and waveform detection, we can measure them easily using usual A/D converter and in case of offset detection, that combines alternating cunent signal and direct cunent signal, we can obtain DC label easily shift circuit or clamp circuit. We omit the explanation about them.
Fig. 25 is a view illustrating the system configuration for the event feedback functional execution according to an embodiment of the present invention. A system to execute the event feedback function comprises an insertion type electrode(320), an electrical stimulus generator(360), a controller(380), a channel setting switch(365), a response processor(370), an EST feedback control measurement part(765), and event feedback controller(740). The EMG feedback control measurement part(720) detects electrical parameters by coupling the bio signal inputted from the response processor(370) and transmits detected electrical parameters to the control part(380). The control of the control part(380) measures stimulation of the electrical stimulus generator(360) employing the electrical parameters received from the EMG- feedback control measurement part(720) outputs the result. At this time, the EST feedback control measurement part(765) detects output signal through the output coupler(640) and compares with data received as event feedback data by the stimulation comparator(760) to perform feedback operating the stimulation trigger controller(630). That is, the event feedback controller(740) determines if the bio signal inputted from the response ρrocessor(370) through the channel setting switch(365) satisfies input conditions set in the response processor(370). The feedback process to control an input value is repeatedly performed by controlling the electrical stimulus generator(360) according to the set condition received from the controller(380) or predetermined set condition until the input condition set in the response processor(370). The goal degree of activation and determines output value of the electrical stimulus generator(360) by employing the received information. Further, the event feedback controller(740) additionally receives control demand from the controller(380) and may set output of the electrical stimulus generator(360). That is, it performs function to output by changing electrical parameters(e.g.„ cunent(potential), voltage, pulse, burst, frequency, phase etc,). The electrical stimulation outputted from the electrical stimulus generator(360) can be measured by the EST feedback controller(710). The result both from the EST feedback controller(710) and the EST feedback control measurement part(765) is input to the controller (380) which identifies, amends, checks, or analyses enors. In fhe configuration of figure 25, the EST feedback controller(710) has the configuration which allows to determine quantities of stimulation signal output from the electrical stimulus generator(360). Since the large signal converter(1210) of the EST feedback controller(710) and the cunent- voltage converter(1215) has pre-treatment function for input of integrator, the EST feedback controller(710) comprises integrator(1220), comparator(1225), setting criteria supply part(1230), mono-stable oscillator(1235), counter(1240), and multiplied 1245). Further, the EMG feedback controller(720) can have similar configuration to the EST feedback contrøller(710) to determine quantities of stimulation signal. In the configuration of figure 25, the EMG feedback controller(720) and the EST feedback controller(710) have different level of signals each other and thus both are constituted for common function of quantity determination except for the pre-treatment configuration. Therefore, each integrator(1260), setting criteria supply part(1265), comparator^ 270), mono-stable oscillator(1275), counter(1280), and multiplier(1285) of the EMG feedback controller(720) performs the same function as the corcesponding parts of the EST feedback controller( 10). The latch(1290) is to assume a case that a user sets operation of the event feedback controller(740) with result of "1" or "0". Thus, since according to the user's purpose can input signal of the event feedback controller(740) be variously changed, it is not limited to the latch(1290). In figure 25, it illustrates the system configuration to measure degree of activation as an embodiment but types and configurations of signals to detect are varied with the purpose. The event feedback function has an advantage in performing for the excise of muscles and regeneration of nerves including determination of the degree of activation and nerve conduction velocity since it performs electric stimulation function under the setting condition which is set by coupling with the EMG biofeedback signal. Fig. 26 is a view illustrating the system configuration for the execution of loop feedback functions according to an embodiment of the present invention. A system to execute the loop feedback function comprises an insertion type electrode(320), an electrical stimulus generator(360), a controller(380) , a channel setting switch(365), a response processor(370), an EST feedback control measurement part(765), and a loop feedback controller(730). That is, the system to execute the loop feedback function may have similar configuration to that to the event feedback function described accompanying with figure 25. The only difference between is that while the output condition of the electrical stimulus generator(360) is set by employing set condition of the response processor(370) in the event feedback, that of the response processor(370) is set by employing set condition of the electrical stimulus generator(360). If the body is ideal load, the result of both feedback will be identical. However, the result can be different since the electrical component of the body is complicate impedance component, it varies with people, or even if it is the same patient, it is different when one is normal and abnormal. The event feedback and loop feedback provide special function to examine and detect such difference. For example, in the configuration of the event feedback and loop feedback, even if the event feedback controller(740) and the loop feedback controller(730) detect degree of activation under the same condition, the degree of activation detected from each is different from each other since the body is not ideal circuit. The difference is due to different amount of lost cunent inside the body and different degree of damaged nerve muscle. Accordingly, use of the event feedback function and loop feedback function provides accurate diagnosis and consistent results based on the detected diagnosis since they can be used for various examinations, diagnoses, conditional stimulation functions, and conditional EMG biofeedback functions. Referring to figure 26, the system to execute the loop feedback function receives the output of the EST feedback control measurement ρart(765) and sets as the set condition of the response processor(370) at the loop feedback controller(730). That is, the loop feedback function is function to set the set condition of the response processor(370) according to the output condition of the electrical stimulus generator(360) and can execute EMG biofeedback conditionally by setting threshold cunent condition outputted from the electrical stimulation function. Therefore, the loop feedback controller(730) generates the trigger signal set conditionally in the electrical stimulus generator(360), detects data according to whether the output signal of the electrical stimulus generator(360) satisfies fhe set condition, and authorizes the data to the response processor(370). Electrical parameters are measured by coupling bio signals transmitted through the response processor(370) until they satisfy the set condition. As described above, when the difference in the degree of response measured by the response processor (370) after the degree of stimulation(degree of activation) available in the body is set as the output condition of the electrical stimulus generator(360) by employing the loop feedback controller(730), the value difference means amount of lost cunent inside the body. The degree of lost cunent varies with severity of the nerve muscle disorder. Therefore, when the value difference is mapped with the severity of the nerve muscle disorder, it can be applicable for use in the diagnosis or treatment of patient. After inserting the insertion-type electrode(230) into the body (or attaching on the skin) likely to the event feedback function as described above, EST feedback control measurement part(765) performs coupling through the coupler(640), measures the electrical stimulation signal(i.e., output signal), and sends the measured electrical parameters to the controller(380). Also, EMG feedback controller(720) measures the EMG feedback signal through the input coupler(670) of the response processor(370), and sends the measured electrical parameters to the controller(380). Thus, the controller(380) can calculate the difference between the output signal and the input signal, and performs various signal processing. At this time, if the user sets up a certain condition through the control panel(335), the controller(38O) sets up the condition of the loop feedback controller(730) conesponding to the user's condition. Until the condition set up by the controller(380) is satisfied, EST feedback control measurement part(765) measures fhe output signal of the electrical stimulus generator (360) through the output coupler(640), and user setting value or result of program stored in the memory is provided to the stimulation comparator(760) to operate the stimulation trigger controller(630) according to the comparison result of the stimulation comparator(760). This feedback data is sent from the EST feedback control measurement part(765) to the response processor(370) through the loop feedback controller(730) and is used as the operation condition of the response processor(370). Although the configuration for measuring the activated quantity is described in Fig. 26 for the convenience of description, it is apparent that the form of signal to be detected will be changed accroding to the purpose of the user. Since the loop feedback function is for performing the EMG bio feedback under the condition that is set up after coupling fhe stimulation signal, various examination or diagnosis in the nerve root or denervation such as the loss rate of cunent or energy permeation depth can be performed. Fig. 27 is a flow chart showing the operation process of the electrical therapy apparatus according to an embodiment of the present invention. As described above, the conventional electrical therapy apparatus does not have a feedback function. Thus, the electrical stimulation function and EMG feedback function can not be executed simultaneously, but only successively or selectively. Also, there are some problems that the electrical therapy apparatus cannot perform the measurement function during the execution of the electrical stimulation function and EMG feedback function, and examination, diagnosis, or a body condition cannot be checked because of its unidirectional structure, namely, outputting stimulus or receiving signal in one way. But, since the electrical therapy apparatus of the present invention comprises the feedback function, measurement function, etc., the problems of the prior art can be solved. Hereinafter, the operation of the electrical therapy apparatus will be described with Fig. 27. Referring to Fig. 27, at step 1405, the user determines whether or not EMG is needed before treating the patient. If EMG is finished or is not needed, at step 1410, the user determines whether or not the electrical stimulation is needed. If the electrical stimulation is needed, at step 1415, a stimulation variable can be determined for preforming the electrical stimulation regardless of the result of EMG. At step 1420, the user determines whether or not measure the impedance. If the impedance measurement is selected, at step 1425, the stimulation output is set to be automatically controlled; otherwise, at step 1430, the stimulation output is set to be manually controlled. That is, the stimulation output condition is set according to the selection of impedance measurement function. At step 1435, the electrical therapy apparatus (310) outputs the electrical stimulation conesponding to the stimulation output condition, and inputs it to the body. At step 1440, the user determines whether or not the loop feedback function is needed. If needed, at step 1445, fhe user sets up the loop feedback condition. If not, at step 1435, the input of electrical stimulation is continued. Of course, the user can stop the operation of the electrical therapy apparatus(310) by stopping the input of electrical stimulation. At step 1450, the electrical therapy apparatus(310) measures fhe spectrum conesponding to the bio signal, and at step 1455 performs the EMG bio feedback function. That is, if the operation of EMG bio feedback function is needed together with the operation of electrical stimulation function, the user activates the loop feedback function and selects the condition, then the electrical therapy apparatus(310) performs the EMG bio feedback function through the spectrum measurement. At step 1460, the electrical therapy apparatus(310) determines whether or not the user selects the event feedback function. If selected, at step 1465, a variable for event feedback is set up. Namely, the variable is for controlling the strength of electrical stimulation based on the bio signal from the body. Then, the operation process returns to step 1420. But, if not selected, at step 1470, the user inputs the purpose of using the electrical therapy apparatus(310). Of course, whole selection steps can be performed before the operation of electrical therapy apparatus(310) or can be performed individually. In case of examination purpose, at step 1450, the spectrum is measured. But, in the treatment purpose, at step 1475, the target waveform is selected. That is, the user can operate the electrical therapy apparatus(310) conesponding to the examination purpose or treatment purpose by selecting the EMG bio feedback function. Since the spectrum has to be measured in the examination purpose and muscle movement has to be performed, then the target waveform will be set up. If EMG is not selected at step 1405, at step 1480, it is determined whether or not the denervation muscl stimulation purpose. In case of the denervation muscle stimulation purpose, at step 1485, a denervation muscle variable is set up by the user or extracted from the memory(340). Then the operation process returns to step 1420. Also, if the result of determination at step 1480 is not the denervation muscle stimulation purpose, at step 1490, it is determined whether or not the innervation muscle stimulation purpose. In case of the innervation muscle stimulation purpose, at step 1495, a innervation muscle variable is set up by the user or exracted from the memory(340).
Then fhe operation process returns to step 1420. Also, if the result of determination at step 1490 is not the innervation muscle stimulation purpose, at step 1490, it is determined whether or not the EMG bio feedback function selection. In case of the EMG bio feedback function selection, at step 1500, the operation process returns to step 1470;otherwise, the operation process terminates. Of course, the operation of electrical therapy apparatus(310) can be terminated at any time by the control of user. As described above, the electrical therapy apparatus(310) according to the present invention can performs not only the electrical stimulation function(i.e., step 1435) and the EMG bio feedback function(i.e., step 1455) simultaneously but also the electrical stimulation function and EMG bio feedback function simultaneously by the feedback function(i.e., loop feedback function and/or event feedback function at step 1440 to 1445, 1460 to 1465). Also, EST feedback function(i.e., step 1420 to 1430) and EMG feedback function(i.e, step 1450, 1470 to 1475) provide a means for measuring by individual feedbacks of the stimulation output to the body and the bio signal input from the body. As described above, the self feedbacks of the electrical stimulation function(i.e., step 1420 to 1430) and EMG bio feedback(i.e., step 1450, 1470 to 1475), or the mutual feedbacks of the electrical stimulation function and EMG bio feedback(i.e., step 1440 to 1445, 1460 to 1465) can set up the output based on the EMG bio feedback signal inputted from the troubles of body(i.e., step 1465), and also can analyze EMG signal inputted from the body under the contrary condition(i.e., step 1445). Since the self measurement in each function and feedback interlocking between each function make it possible not only to set up the output condition as automatic or manual but also to selectively perform the target waveform according to the muscle movement or spectrum measurement, the conect diagnosis of troubles, the treatment prescription based on the diagnosis result, the objective index improved by treatment, etc., can be analyzed systematically. Also, since effective control of excessive stimulation output is possible because fhe constant detection(monitoring) is available, the present invention can replace the protection circuit in the view of patient protection. Of course, likely the electrical stimulation function, the feedback function can be interlocked in realtime in case of EMG bio feedback function. For example, by selecting the event feedback function and condition during the operation of EMG bio feedback, the electrical stimulation is performed as a contrary concept of loop feedback, so finally the EMG bio feedback and the electrical stimulation are performed simultaneously. At this time, same condition as the electrical stimulation condition or different conditon can be set up. The accompanying drawings and the detailed description are only exemplary for describing the present invention, not for limiting the spirits or scope of the present invention. Therefore, those skilled in the art easily understand that various changes and equivalent embodiments can be made. Thus, the true scope of the present invention must be determined by accompanying claims.
Industrial applicability As described above, the electrical therapy apparatus of function cooperative method using feedback control techniques co-works through simultaneous real-time feedback functions of electrical stimulation function and EMG bio feedback function. And the present invention can change during the treatment both the electrical stimulation function and EMG bio feedback function, to operate stand-alone or in combination of functions, and do the arbitrary selection of the channels. Also, the present invention can provide diagnosis result before and after the treatment. Also, the present invention provides the impedance measurement function and automatic control function of cunent for determining the strength of stimulation when electrical stimulation is performed on a patient. Also, the present invention provides the simulation and emulation functions for performing the electrical stimulation function. Also, the present invention can perform EMG, automatic gain control, and frequency setting during the operation of EMG bio feedback function. Also, the present invention can discharge accumulated during the operation of EMG bio feedback function. Also, the present invention provides a means for controlling the strength of electrical stimulation by realtime feedback function not a stationary cunent source(voltage source) in the view of patient protection.

Claims

Claims 1. An electrical therapy apparatus connected to an electrode that is contacted to a patient or inserted into coelom to input an elecfrical stimulus on the contacted part of patent or to receive bio-signal from the contacted part of patent, comprising: an electrical stimulus generator, generating and inputting an electrical stimulus through the electrode; a response processor, receiving a bio signal inputted by the electrode; a channel setting switch, connecting at least one of said electrical stimulus generator and said response processor to the electrode; and a feedback controller, controlling at least one of said electrical stimulus generator and said response processor by use of a measured value conesponding at least one of the electrical stimulus of said electrical stimulus generator and the bio signal of said response processor.
2. The electrical therapy apparatus in claim 1, wherein said feedback controller detects an electrical parameter conesponding to the electrical stimulus of said electrical stimulus generator and sends a confrol signal for controlling a magnitude of the electrical stimulus to said electrical stimulus generator if the detected electrical parameter does not conespond to a predetermined setting value.
3. The electrical therapy apparatus in claim 2, wherein if the electrical parameter is an activated quantity that is measured value as the result of execution with goal of inspection, diagnosis and control according to the user option, said feedback controller comprises: a comparator, comparing fhe predetermined setting value with the detected electrical parameter; a mono-stable oscillator, generating a pulse signal with a magnitude conesponding to the comparison result of said comparator; a counter, counting the pulse signal; and an activated quantity calculator, generating an activated quantity by use of the predetermined setting value and the result of said counter.
4. The electrical therapy apparatus in claim 1, wherein said feedback controller detects an electrical parameter by use of the bio signal inputted to said response processor and sends a control signal for amplifying a magmtude of the bio signal to said response processor if the detected electrical parameter does not conespond to a predetermined setting value.
5. The electrical therapy apparatus in claim 4, wherein if the electrical parameter is a frequency and a phase, said feedback controller comprises: a voltage controlled oscillator, generating an output oscillating frequency conesponding to an input control voltage; a programmable counter, dividing the output oscillating frequency according to a predetermined number; a phase comparator, generating an output voltage conesponding to a phase difference between the bio signal and the divided output oscillating frequency; a filter, generating the input confrol voltage by normalizing the output voltage; a frequency measuring device, measuring a frequency by use of the output oscillating frequency; and a phase discriminator, detecting a phase of bio signal by use of the input control voltage and a mapping table, wherein table is mapped by the inputted control voltage and phase difference.
6. The electrical therapy apparatus in claim 1, wherein said feedback controller selects a reference setting value of the bio signal of said response controller in advance and controls the magnitude of the electrical stimulus of said electrical stimulus generator if the measured value of the bio signal does not satisfy the predetermined reference setting value.
7. The electrical therapy apparatus in claim 1, wherein said feedback controller selects an output condition of said electrical stimulus generator in advance and selects a detection condition of said response processor.
8. The electrical therapy apparatus in claim 1, wherein said electrical stimulus generator comprises: a waveform generator, generating a pulse signal conesponding to a control signal of said controller; a burst generator, combining a plurality of pulse signals generated by said waveform generator to compose a burst signal; an output setter, controlling a magmtude of the electrical stimulus outputted on each channel by combining a plurality of burst signals; a stimulus adjustor, controlling a sfrength of the electrical stimulus on each channel according to the control signal of said controller; a stimulus trigger controller, determining whether or not a feedback signal is received from said feedback controller; and a large signal amplifier, generating the electrical stimulus with final stimulus strength by multiplying a gain predetermined to the sfrength of electrical stimulus on each channel or a gain conesponding to the feedback signal.
9. The electrical therapy apparatus in claim 1, wherein said response processor comprises: a differential amplifier, receiving the bio signal through the electrode and said channel setting switch and detecting a signal that in-phase component is eliminated; a response trigger controller, determining whether or not the feedback signal from said feedback controller or a user setup condition is received; a filter, selectively filtering the input signal conesponding to the feedback signal or the user setup condition; a variable amplifier, amplifying the filtered bio signal to a signal level available for visual discrimination; and a signal detector, detecting a data conesponding to a measurement target by use of the amplified bio signal.
10. The electrical therapy apparatus in claim 1 further comprising: a memory, storing a program for operating the electrical therapy apparatus, a data required to operating the program, and a protocol for diagnosis and treatment, wherein the protocol is a program for at least one of electrical stimulation function, EMG biofeedback function, and feedback function; a display, displaying a measurement value of the electrical stimulation and the bio signal value; and a controller, controlling operation of said electrical stimulus generator, said response processor, said channel setting switch, and said feedback controller, and controlling said display.
11. The electrical therapy apparatus in claim 10, wherein storage region of said memory comprises a program data storing region as the highest level, a first memory region group for electrical stimulus function and feedback function, and a second memory region group for EMG biofeedback function and feedback function.
12. The electrical therapy apparatus in claim 1, wherein said channel setting switch comprises a plurality of channels and a plurality of grounds contacts, and said channels are connected to at least one of said electrical stimulus generator and said response processor.
13. The electrical therapy apparatus in claim 1, wherein said elecfrical stimulus generator comprises a transmitter for wireless communication.
14. The electrical therapy apparatus in claim 1, wherein said response processor comprises a receiver for wireless communication.
15. The electrical therapy apparatus in claim 10 further comprising a control panel for inputting a user instruction to said controller.
16. The electrical therapy apparatus in claim 15, wherein at least one of said confrol panel, said memory, and said display communicates with said controller wirelessly.
17. The electrical therapy apparatus in claim 15, wherein said control panel comprises: a first setup means for inputting a data relating to the waveform of the electrical stimulus; and a second setup means for setting an operation mode of the electrical therapy apparatus.
18. An electrical therapy apparatus connected to an electrode that is contacted to a patient or inserted into coelom to input an electrical stimulus on the contacted part of patent or to receive bio-signal from the contacted part of patent, comprising: an electrical stimulus generator, generating and inputting an electrical stimulus through the electrode; a response processor, receiving a bio signal inputted by the electrode; a channel setting switch, connecting at least one of said electrical stimulus generator and said response processor to the electrode; and a feedback controller, controlling at least one of said electrical stimulus generator and said response processor by use of a measured value conesponding at least one of the electrical stimulus of said electrical stimulus generator and the bio signal of the response processor; a memory, storing a program for operating the electrical therapy apparatus, a data required to operating the program, and a protocol for diagnosis and treatment, wherein the protocol is a program for at least one of electrical stimulation function, EMG biofeedback function, and feedback function; a confrol panel for inputting a user instruction; and a controller coupled to said electrical stimulus generator, said response processor, said feedback controller, said channel setting switch, said memory, and said confrol panel, controlling an operation of at least one of said electrical stimulus generator, said response processor, said feedback controller, and said channel setting switch by use of the data stored in said memory.
19. The electrical therapy apparatus in claim 18, wherein said feedback controller comprises: a EST feedback controller, detecting an electrical parameter conesponding to the electrical stimulus of said electrical stimulus generator and sending a control signal for controlling a magnitude of the electrical stimulus to said electrical stimulus generator if the detected electrical parameter does not conespond to a predetermined setting value; a EMG feedback controller, detecting an electrical parameter conesponding to the bio signal and sending a control signal for amplifying a magnitude of the bio signal to said response controller if the detected electrical parameter does not conespond to a predetermined setting value; an event feedback controller, selecting a reference setting value of the bio signal in advance, controlling the magnitude of the elecfrical stimulus of said electrical stimulus generator if the measured value of the bio signal does not satisfy the reference setting value; and a loop feedback controller, selecting an output condition of said electrical stimulus generator in advance and selecting a measurement condition of said response processor conesponding to the output condition.
20. The electrical therapy apparatus in claim 18, wherein electrical stimulus generator comprises: a waveform generator, generating a pulse signal corresponding to the control signal of said confroller; a burst generator, combining a plurality of pulse signals generated by said waveform generator to compose a burst signal; an output setter, controlling a magnitude of the electrical stimulus outputted on each channel by combining a plurality of burst signals; a stimulus adjustor, controlling a strength of the electrical stimulus on each channel according to the control signal of said controller; a stimulus trigger controller, determining whether or not a feedback signal is received from said feedback controller; and a large signal amplifier, generating the electrical stimulus with final stimulus strength by multiplying a gain predetermined to the strength of electrical stimulus on each channel or a gain conesponding to the feedback signal.
21. The electrical therapy apparatus in claim 18, wherein said response processor comprises: a differential amplifier, receiving the bio signal through the electrode and said channel setting switch and detecting a signal that in-phase component is eliminated; a response trigger controller, determining whether or not the feedback signal from said feedback controller or a user setup condition is received; a filter, selectively filtering the input signal conesponding to the feedback signal or the user setup condition; a variable amplifier, amplifying the filtered bio signal to a signal level available for visual discrimination; and a signal detector, detecting a data conesponding to a measuring target by use of the amplified bio signal.
22. The electrical therapy apparatus in claim 18, wherein the electrode is an insertion type electrode being inserted into the coelom.
23. The electrical therapy apparatus in claim 18, wherein the electrode is a surface electrode being attached on the skin.
24. The electrical therapy apparatus in claim 18, wherein the electrode is a needle-type electrode being pierced into the body.
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